DETAILED ACTION
Claims 1-30, 33-66 are presented for examination. Claims 1-4, 29-30, 42, 51-63 are amended. This office action is response to the submission on 12/24/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/23/2025 and 1/28/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
In light of the amendments to the specification filed on 12/24/2025, the objection to the specification is withdrawn.
Response to Arguments
With respect to Specification Objections:
Applicant’s arguments, see pages 18 of applicant response filed 12/24/2025, are persuasive in light of the amended specification submitted 12/24/2025. The objection is withdrawn.
With respect to 35 U.S.C. §112 (b) Rejections:
Applicant’s arguments, see page 18 of applicant response filed 12/24/2025, are persuasive in light of the amended claims submitted 12/24/2025. The 35 U.S.C. §112 (b) Rejections are withdrawn.
With respect to 35 U.S.C. §102/103 Rejections:
Applicant’s arguments, see page 18 of applicant response filed 12/24/2025, with respect to the rejection(s) of claim 1 under 35 U.S.C. §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yu et al. (JP2017523827A), in view of Dunn et al. (US20140209098A1).
Applicant argues that Yu does not disclose determining a knitting structure specification based on landmark feature locations and data representative of one or more functional requirements. Examiner agrees that Yu does not teach the newly added claim limitation, however Yu in view of Dunn does teach this claim limitation.
Applicant argues that the secondary references do not provide the missing teachings because there is no teaching of determining manufacturing specifications based on landmark feature locations and data representative of one or more functional requirements. Examiner disagrees. Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine (See Dunn [0178]), and that the knit of the strap may be adjusted in order to adjust the shape or stretch of fabric (see Dunn [0125-0126]).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 62 recites the following limitations that invoke 112(f):
“means for obtaining information representative of one or more landmark feature locations for a human's head and one or more functional requirements associated with the human;” This limitation is interpreted to be a smartphone, tablet, computer, server, and their equivalents as described in specification [0395] “In examples, local processing facilities at the point of capturing the image data (e.g. the smart phone 130A, tablet 130B, or computer 130C) may be used to identify the landmark features (including generation of the three-dimensional model in examples). In alternative examples, the image data may be communicated to remote processing facilities (e.g. customisation server 102) for further processing.”
“means for determining a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the one or more functional requirements” This limitation is interpreted to be a system including a processor and memory and their equivalents as described in specification [0376] “FIG. 18 shows a schematic view of an exemplary system 100 that may be used to perform various aspects of the present technology as described herein. It will be appreciated that system 100 may receive data from, and send data to, external systems, and may control the operation of components outside of the system 100. The system 100 may generally include a customisation server 102 that manages the collection and processing of data relating to the design and production of a customised component for a patient interface 3000. The customisation server 102 has processing facilities represented by one or more processors 104, memory 106, and other components typically present in such computing devices. It should be appreciated that the server 102, processors 104, and memory 106 may take any suitable form known in the art, for example a “cloud-based” distributed server architecture or a dedicated server architecture.”
“means for producing the patient respiratory interface component based on the set of manufacturing specifications.” This limitation is interpreted to be manufacturing machines 142 and their equivalents as described in [0462] “In some examples, producing the customised component at 7300 comprises additive manufacturing (for example, 3D printing) of the customised component. The manufacturing machines 142 may comprise a 3D printer to print the customised component, for example one or more of a frame 3500, plenum chamber 3200 or seal-forming structure 3100. The manufacturing machines 142 may comprise a laser cutter to cut-out and/or modify a customised component, for example one or more of a frame 3500, plenum chamber 3200 or seal-forming structure 3100.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-24, 28-30, 33-40, 43-44, 49-64 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (JP2017523827A), in view of Dunn et al. (US20140209098A1).
Claim 1:
Yu teaches “A processor-implemented method for producing a customised patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the method comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B teach a respiratory interface comprising a headgear strap
PNG
media_image1.png
366
318
media_image1.png
Greyscale
PNG
media_image2.png
437
473
media_image2.png
Greyscale
),
“receiving, using communication circuitry, data representative of one or more landmark features of a head of a human and data representative of one or more functional requirements associated with the human;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry
PNG
media_image3.png
874
634
media_image3.png
Greyscale
),
“identifying, using at least one processor, one or more landmark feature locations of the landmark features based on the data representative of one or more landmark features” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."),
“determining, using the at least one processor, a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the data representative of the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions;” (Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“and causing one or more manufacturing machines to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.
PNG
media_image4.png
894
534
media_image4.png
Greyscale
).
Yu does not appear to explicitly teach “determining, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 2:
Yu in view of Dunn teaches “The method of claim 1, wherein the data representative of one or more landmark features comprises two-dimensional image data.” (Yu teaches the patient taking multiple photos or videos of their head and face in Yu [0317] "FIG. 6 is an illustration of another method of data collection involving passive stereo photogrammetry. In this method, multi-linked cameras 6001, 6002 capture multiple still images of an object 6050 and estimate the three-dimensional coordinates of points on the object. The estimated coordinates can be determined by measurements made in two or more images taken from different positions from the cameras 6001, 6002. Common points are then identified on each image and a line of sight (or ray) is formed from the camera position to a point on the subject. The intersection of these rays (triangulation) helps determine the three-dimensional position of the point. In this way, important features on the image are determined and a three-dimensional point cloud is generated on the display 6003. In use, the patient 6050 can take multiple photos or videos of their head and face (nose, cheeks, eyes, teeth, ears, etc.) from different angles. These images are then processed to generate a three-dimensional model of the patient's head and face.").
Claim 3:
Yu in view of Dunn teaches “The method of claim 1, wherein the data representative of one or more landmark features comprises two-dimensional image data.” (Yu teaches the patient taking multiple photos of their head and face i.e. two-dimensional image data that is then processed in Yu [0317] "FIG. 6 is an illustration of another method of data collection involving passive stereo photogrammetry. In this method, multi-linked cameras 6001, 6002 capture multiple still images of an object 6050 and estimate the three-dimensional coordinates of points on the object. The estimated coordinates can be determined by measurements made in two or more images taken from different positions from the cameras 6001, 6002. Common points are then identified on each image and a line of sight (or ray) is formed from the camera position to a point on the subject. The intersection of these rays (triangulation) helps determine the three-dimensional position of the point. In this way, important features on the image are determined and a three-dimensional point cloud is generated on the display 6003. In use, the patient 6050 can take multiple photos or videos of their head and face (nose, cheeks, eyes, teeth, ears, etc.) from different angles. These images are then processed to generate a three-dimensional model of the patient's head and face.").
Claim 4:
Yu in view of Dunn teaches “The method of claim 1, wherein the data representative of one or more landmark features comprises three-dimensional image data.” (Yu teaches using incoming 3D geometric surface data to calculate the custom component in Yu [0371] "5.11.5 Patient Interface Design 4500 The patient interface design 4500 includes a system of algorithms that process the data packages 4451, 4452. The patient interface design 4500 acts as a smart system that responds to inputs that are data packages and calculates outputs as a custom interface designed from that particular data package. Thus, the patient interface design 4500 takes the incoming data package and uses the data (3D geometric surfaces and/or 2D pressure maps) along with the patient's preference input to calculate at least one custom component.").
Claim 5:
Yu in view of Dunn teaches “The method of claim 1, further comprising the step of identifying, using the at least one processor, at least one relationship between two or more of the landmark feature locations, wherein determining the set of manufacturing specifications is based at least in part on the at least one relationship between the two or more of the landmark feature locations.” (Yu teaches identifying characteristics of the patient's face and applying appropriate characteristics to the patient interface in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches that special considerations are required for prominent nose bridges i.e. the features taken into consideration may be the distance between the pronasale and the sellion in Yu [0359] "In addition to the pressure sensitivity, pressure compliance, shear sensitivity and shear compliance indicators mentioned above, special considerations are required for facial hair, hairstyles and prominent nose bridges, sunken cheeks, etc.").
Claim 6:
Yu in view of Dunn teaches “The method of claim 5, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining distance between two or more of: a subnasale, a sellion, a tragion, a posterior-most point of the head, a superior-most point of the head, a lateral-most point of the orbital margin, an inferior-most point of the orbital margin, the Frankfort horizontal plane, and a coronal plane aligned with the tragion.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 7:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a distance in the sagittal plane between the subnasale and the tragion.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the subnasale and the tragion in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 8:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a vertical distance in the sagittal plane between the subnasale and the sellion.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the subnasale and the sellion in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 9:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a distance between the subnasale and the coronal plane aligned with the tragion, the distance being normal to said coronal plane.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the subnasale and the coronal plane aligned with the tragion in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 10:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a distance between the lateral-most point of the orbital margin and the coronal plane aligned with the tragion, the distance being normal to said coronal plane.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the lateral-most point of the orbital margin and the coronal plane aligned with the tragion in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 11:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a vertical distance between the subnasale and the superior-most point of the head.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the subnasale and the superior-most point of the head in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 12:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a vertical distance between the superior-most point of the head and the Frankfort horizontal plane.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the superior-most point of the head and the Frankfort horizontal plane in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 13:
Yu in view of Dunn teaches “The method of claim 6, wherein identifying the at least one relationship between the two or more of the landmark feature locations comprises determining a distance between a rearmost point of the head and a coronal plane aligned with the tragion, the distance being normal to said coronal plane.” (Yu teaches a laser scanning system that acquires the 3D surface of the face i.e. the point cloud of the subject's face will define the distance between the features on the face, including the distance between the rearmost point of the head and a coronal plane aligned with the tragion in Yu [0316] "FIG. 5 illustrates one method of data collection involving laser scanning. Generally, this method uses time-of-flight and triangulation techniques to scan the 3D surface of an object. As shown, the laser scanning system 5000 may include a laser 5001 that directs a laser or light wave at an object 5050 (e.g., a patient's head). The reflected light then passes through lens 5002 and is collected by sensor 5003. The sensor may include a position sensitive sensor or a charge coupled device. As shown in FIG. 5, the distance da corresponds to the distance db. Once properly calibrated in this manner, the laser scanning system 5000 can be used to acquire the 3D surface of the face (nose, cheeks, mouth, eyes, teeth, ears, etc.) as well as the 3D surface of the general shape of the head. A point cloud of surface samples from the subject's face and head can then be created, and the point cloud can be reconstructed to recreate the relevant 3D surface (e.g., a surface representing the patient's forehead).").
Claim 14:
Yu in view of Dunn teaches “The method of claim 1, comprising the step of determining, using the at least one processor, at least one performance requirement for the patient respiratory interface component based on the one or more landmark feature locations.” (Yu teaches that the length and/or stiffness i.e. performance requirement of the elastic material i.e. strap can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data.").
Claim 15:
Yu in view of Dunn teaches “The method of claim 14, wherein the at least one performance requirement comprises one or more of: (Yu teaches that the length and/or stiffness i.e. performance requirement of the elastic material i.e. strap can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data.").
Claim 16:
Yu in view of Dunn teaches “The method of claim 14, wherein the patient respiratory interface component comprises a plurality of regions, and at least one performance requirement is determined for each region.” (Yu teaches selecting materials, which would affect elasticity, feel, breathability, and heat dissipation for different parts of the structure i.e. regions in Yu [0382] "The customized intermediate structure 13010 provides optimal sealing around the patient interface, increasing patient comfort and evenly distributing contact pressure. Furthermore, materials may be selected as desired for different parts of the intermediate structure. For example, the nose bridge area may comprise a softer grade of silicone, foam or thermoplastic elastomer than other areas which may comprise a single grade of silicone or other harder material. Material selection also depends on patient preference. Thus, materials are selected to relieve pressure points, provide a good seal and increase comfort and/or stability.").
Claim 17:
Yu in view of Dunn teaches “The method of claim 14, wherein the at least one performance requirement is determined based at least in part on properties of another component of the patient interface intended for use with the customised patient respiratory interface component.” (Yu teaches an anchoring point of the mask, its location being determined based on collected data, its location affecting the straps in Yu [0427] "Additionally, anchoring points can be selected based on collected data to improve stability when the patient interface is worn by the patient. If the anchoring point is the bridge of the nose, as with eyeglasses, then the bridge of the nose, mouth, eyes, ears and teeth serve as anchoring points for the respiratory patient interface. Thus, knowing the location of these features allows the patient interface to be designed to provide sufficient stability. FIG. 16A is an illustration of an anchoring point associated with a patient interface. An algorithm can be used to analyze the collected data to determine the optimal location of the anchoring point. Some possible anchor points are identified in FIG. 16A and include a nose bridge anchor point 16002, mouth anchor points 16004, 16006 and an ear anchor point 16008. Data is collected and the location of anchor points is analyzed from the collected data to create a patient interface and headgear with optimal performance and stability."
PNG
media_image5.png
309
308
media_image5.png
Greyscale
).
Claim 18:
Yu in view of Dunn teaches “The method of claim 14, wherein determining the set of manufacturing specifications is based at least in part on the at least one performance requirement.” (Yu teaches selecting materials in order to affect feel of the device, which would determine manufacturing specifications in Yu [0382] "The customized intermediate structure 13010 provides optimal sealing around the patient interface, increasing patient comfort and evenly distributing contact pressure. Furthermore, materials may be selected as desired for different parts of the intermediate structure. For example, the nose bridge area may comprise a softer grade of silicone, foam or thermoplastic elastomer than other areas which may comprise a single grade of silicone or other harder material. Material selection also depends on patient preference. Thus, materials are selected to relieve pressure points, provide a good seal and increase comfort and/or stability.").
Claim 19:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprise at least one material specification.” (Yu teaches selecting materials in Yu [0382] "The customized intermediate structure 13010 provides optimal sealing around the patient interface, increasing patient comfort and evenly distributing contact pressure. Furthermore, materials may be selected as desired for different parts of the intermediate structure. For example, the nose bridge area may comprise a softer grade of silicone, foam or thermoplastic elastomer than other areas which may comprise a single grade of silicone or other harder material. Material selection also depends on patient preference. Thus, materials are selected to relieve pressure points, provide a good seal and increase comfort and/or stability.").
Claim 20:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprise at least one construction technique specification.” (Yu [0461] "Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments.").
Claim 21:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprise at least one dimension specification.” (Yu teaches that the length i.e. dimension specification of the elastic material i.e. strap can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data.").
Claim 22:
Yu in view of Dunn teaches “The method of claim 1, wherein determining the set of manufacturing specifications comprises selecting the set of manufacturing specifications from a plurality of pre-existing sets of manufacturing specifications.” (Yu teaches selecting an elbow for the frame from an existing array of elbows in Yu [0378] "In a third embodiment (FIG. 12C), the patient's face 12050 is scanned and an algorithm copies and offsets the relevant surfaces to create a customized frame assembly 12030 with a shape that blends these surfaces into standardized tube/elbow attachment points in the coronal plane. This technique distributes contact pressure evenly, increasing stability, reducing headgear tension and allowing for standardization similar to frame 12020. In this way, the frame 12030 provides a lock/key interface with a variety of elbows/short tubes or uses an existing arrangement of elbows (e.g., select one of three or more elbows).").
Claim 23:
Yu in view of Dunn teaches “The method of claim 22, wherein selecting the set of pre-existing manufacturing specifications is based on a comparison between the one or more landmark feature locations determined for the human, and one or more landmark feature locations associated with the set of pre-existing manufacturing specifications.” (Yu teaches selecting a standardized frame based on the collected data i.e. the landmark features in Yu [0380] "In Figures 12D-F, three standardized frames 12040, 12041, 12042 were provided to the user. Based on the data collection 4300, an algorithm can determine which of the standardized frames 12040, 12041, 12042 is best suited for the patient. Customized intermediate structures and/or sealing elements 11003 are then independently formed and configured to interlock with the standardized frame. An appropriate frame is selected based on face size and may include a keyed interlock system 12060 for mating with other customized components 12070 of the patient interface.").
Claim 24:
Yu in view of Dunn teaches “The method of claim 1, wherein determining the set of manufacturing specifications comprises selecting a plurality of manufacturing specifications to form the set of manufacturing specifications from a plurality of pre-existing manufacturing specifications.” (Yu teaches that the intermediate structure 11002 can be standardized like the frames in Yu [0380-0381] "In Figures 12D-F, three standardized frames 12040, 12041, 12042 were provided to the user. Based on the data collection 4300, an algorithm can determine which of the standardized frames 12040, 12041, 12042 is best suited for the patient. Customized intermediate structures and/or sealing elements 11003 are then independently formed and configured to interlock with the standardized frame. An appropriate frame is selected based on face size and may include a keyed interlock system 12060 for mating with other customized components 12070 of the patient interface. 5.11.5.2 Customizing the Intermediate Structure Like the frame, the intermediate structure 11002 can also be standardized or customized.").
Claim 28:
Yu in view of Dunn teaches “The method of claim 1, wherein producing the patient respiratory interface component comprises mechanical manipulation of yarn to produce the component.” (Yu teaches that knitted fabric may be used to create the customized headgear in Yu [0472] "Customized woven/knitted/molded fabrics are also used. The technique is similar to the 3D printing process, except it uses thread i.e. yarn instead of plastic. The structure of the textile components can be knitted into any three-dimensional shape, which is ideal for assembling customized headgear.").
Claim 29:
Yu in view of Dunn teaches “The method of claim 1, wherein the at least one knitting structure specification to be used is determined based on a length and/or a direction of the at least one portion of the one-piece headgear strap.” (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data may be used to determine strap length in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the angular orientation of the top strap may be altered, which may be accomplished by adjusting the direction of the knit e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Claim 30:
Yu in view of Dunn teaches “The method of claim 29, wherein causing one or more manufacturing machines to produce the patient respiratory interface component based on the set of manufacturing specifications further comprises at least one of flat knitting and circular knitting.” (Dunn teaches flat knitting and circular knitting to form headgear in Dunn [0116] "In accordance with an example of the disclosed technology, headgear may be formed by interlooping such as knitting (e.g., threading yarn or thread to form a knitted fabric). The headgear may be formed by flat knitting or circular knitting, however other forms of knitting may also be possible." And in Dunn [0130] "Preferably, the headgear is formed by flat knitting or circular knitting, wherein the headgear has selvedges. That is, the headgear may be formed to have a finished configuration such that the ends of the yarns used to construct the headgear are substantially absent from the edges of the headgear components. An advantage of fashioning the headgear components to the finished shape is that the yarns are not being cut, and are thus less likely to unravel and may require fewer finishing steps.").
Claim 33:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises at least one dimension of a posterior strap portion for the headgear strap, the posterior strap portion configured to lie against at least posterior surfaces of the head in use.” (Yu teaches customization of at least one interface component including stabilizing structure 3300 in Yu [0310] "5.11 Customization of Patient Interfaces 5.11.1 Customization Overview Customized patient interfaces can be manufactured using rapid prototyping techniques (e.g., 3D printing). In the following embodiments, customization may be directed to the entire patient interface or at least to components of the patient interface (eg, self-forming structure 3100, frame 11001, positioning and stabilizing structure 3300, etc.)."; Yu Fig. 3A teaches a stabilising structure 3300 which would be positioned on the posterior of the head.
PNG
media_image6.png
444
443
media_image6.png
Greyscale
).
Claim 34:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises a length of each one of a pair of upper strap portions for the headgear strap, each upper strap portion being configured to lie on a respective side of the head in use.” (Yu teaches adjusting length of strings 15012 which as seen in Yu Fig. 15B [As shown above in claim 1] are upper strap portions that lie on a side of a head in Yu [0310] "Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."
Claim 35:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises an upper strap location on a posterior strap portion for the headgear strap from which each one of a pair of upper strap portions for the headgear strap extends.” (Yu teaches adjusting crown attachment 15042 which as seen in Yu Fig. 15B [As shown above in claim 1] is where the upper strap connects to the posterior strap in Yu [0426] "Finally, the neck attachment 15040 and crown attachment 15042 are adjusted taking into account the collected data on head and/or neck shape and size. In this example, the geometry of the head and neck shape can determine the position (longitude) of the neck attachment 15040 and the crown attachment 15042. The length of the third strap 15014 can also be adjusted based on the neck attachment 15040 and the crown attachment 15042.").
Claim 36:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises an upper strap direction in which one of a pair of upper strap portions for the headgear strap extends from a posterior strap portion for the headgear strap.” (Yu teaches adjusting crown attachment 15042, which as seen in Yu Fig. 15B [As shown above in claim 1] is where the upper strap connects to the posterior strap, which would adjust the direction of strap 15012 in Yu [0426] "Finally, the neck attachment 15040 and crown attachment 15042 are adjusted taking into account the collected data on head and/or neck shape and size. In this example, the geometry of the head and neck shape can determine the position (longitude) of the neck attachment 15040 and the crown attachment 15042. The length of the third strap 15014 can also be adjusted based on the neck attachment 15040 and the crown attachment 15042.").
Claim 37:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises a length of each one of a pair of lower strap portions for the headgear strap, each lower strap portion being configured to lie on a respective side of the head in use.” (Yu teaches adjusting strings 15010 which as seen in Yu Fig. 15B [As shown above in claim 1] are lower strap portions that lie on the side of a head in Yu [0425] "Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data.").
Claim 38:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises a lower strap location on a posterior strap portion for the headgear strap from which each one of a pair of lower strap portions extends.” (Yu teaches adjusting neck attachment 15040 which as seen in Yu Fig. 15B [As shown above in claim 1] is where the lower straps connect to the posterior strap in Yu [0426] "Finally, the neck attachment 15040 and crown attachment 15042 are adjusted taking into account the collected data on head and/or neck shape and size. In this example, the geometry of the head and neck shape can determine the position (longitude) of the neck attachment 15040 and the crown attachment 15042. The length of the third strap 15014 can also be adjusted based on the neck attachment 15040 and the crown attachment 15042.").
Claim 39:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications comprises a length of a ring strap portion for the headgear strap,” (Yu teaches that the length of the string 15014, which as seen in Yu Fig. 15B [As shown above in claim 1] is part of a ring portion of the headgear strap can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“the ring strap portion having a superior portion configured to overlay the parietal bones of the head in use and having an inferior portion configured to overlay or lie inferior to the occipital bone of the head in use.” (Yu teaches that the string 15014 overlays the parietal bones and occipital bone while in use as seen in Yu Fig. 15B [As shown above in claim 1]).
Claim 40:
Yu in view of Dunn teaches “The method of any one of claim 1, wherein the set of manufacturing specifications is determined such that when the patient interface is donned by the human in use, the headgear strap applies a predetermined force to a seal-forming structure of the patient interface.” (Yu teaches that when a force of 1 to 10 Newtons is applied in the direction T1, the seal formed by the device is not disrupted i.e. the headgear exerts a predetermined force on the patient in Yu [0434] "FIG. 16G is a plan view illustrating the effect of applying a force to the headgear 16352, also referred to herein as the positioning and stabilizing structure, worn by the patient 16350. As shown, a first oblique force T1 is applied to the headgear at location 16A near the patient's ears. Force 1 becomes a second force T2 at location 16B at the junction between headgear 16352 and frame 16354, and a third force T3 at location 16C. In some configurations, the patient interface is configured to ripple outward at location 16C to isolate frame movement, separating the nostril frame from movement due to tube drag and maintaining a seal. In at least some embodiments, the header 16352 is configured to compensate for a force of about 1 Newton to about 10 Newtons without reducing the seal contact which can result in red marks on the patient's face, disrupting the seal with the patient, or causing discomfort to the patient.").
Claim 43:
Yu in view of Dunn teaches “The method of claim 1, wherein the patient respiratory interface component comprises a frame of the patient interface.” (Yu [0373] "The frame 11001 is generally considered to be the component that provides an offset distance from the patient's face and associated functional dead space. This is also the component where the pneumatic connection from the flow source is likely to be made. The intermediate structure 11002 has several functions. First, the intermediate structure 11002 serves to offset the frame 11001 from the face. The frame 11001 and sealing element 11003 are also provided with attachment means. It provides a geometric transition between the standardized frame and the custom sealing element 11003.").
Claim 44:
Yu in view of Dunn teaches “The method of claim 43, wherein the set of manufacturing specifications comprises frame dimensions.” (Yu teaches using the scanned face to determine the shape of the frame in Yu [0375] "In the first example (FIG. 12A), the patient's face 12050 is scanned using any of the techniques discussed in data collection 4300. The algorithm then offsets and trims surfaces such as non-sealing surfaces of the patient's face 12050 to create a patient interface frame 12010 that is a transformed copy of the patient's face. The offset is a predetermined offset value of 01. In some embodiments, the offset value O1 is between about 0 and 20.0 mm. In at least some other embodiments, the offset value O1 is between about 5.0 and 10.0 mm. The offset value 01 may be variable or constant around the face.").
Claim 49:
Yu in view of Dunn teaches “The method of claim 1, wherein the patient respiratory interface component comprises a plenum chamber of the patient interface.” (Yu [0099] "5.3.2 Plenum Chamber 3200 Preferably, the plenum chamber 3200 has a periphery that is shaped to complement the contours of the average human facial surface in the area where a seal is formed during use. In use, the peripheral edge of the plenum chamber 3200 is positioned adjacent to the adjacent surface of the face. The actual contact with the face is made by seal-forming structure 3100. Preferably, the seal-forming structure 3100 can extend around the entire periphery of the plenum chamber 3200 when in use."; See Yu Fig. 3A [As shown above in claim 33]).
Claim 50:
Yu in view of Dunn teaches “The method of claim 1, wherein the patient respiratory interface component comprises a seal-forming structure of the patient interface.” (Yu [0092-0094] "A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional features: a self-forming structure 3100 (also referred to as a sealing element), a plenum chamber 3200, a positioning and stabilizing structure 3300, and a form of connection port 3600 for connection to an air circuit 1600. In some embodiments, the functional features may be provided by one or more physical components. In some embodiments, one physical component can provide one or more functional features. In use, the seal-forming structure 3100 is placed around the entrance to the patient's airways and positive air pressure is supplied to the airways. 5.3.1 Seal-forming structure 3100 In one form of the present technology, the seal-forming structure 3100 provides a sealing surface and may also provide cushioning functionality. A seal-forming structure 3100 according to the present technology can be constructed from a soft, flexible, and resilient material such as silicone."; See Yu Fig. 3A [As shown above in claim 33]).
Claim 51:
Yu in view of Dunn teaches “The method of claim 1, wherein the set of manufacturing specifications identify specifications for a headgear strap of a positioning and stabilising structure for a patient interface” (Yu teaches that the length and/or stiffness of the elastic material i.e. strap can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."),
“and include at least one of (Yu teaches that the stiffness of the elastic material i.e. material composition can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“wherein the one or more of manufacturing specifications define a stretch characteristic of the positioning and stabilising structure.” (Yu teaches that the stiffness of the elastic material i.e. stretch characteristic can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data.").
Claim 52:
Yu in view of Dunn teaches “The method of claim 1, wherein the determined at least one knitting structure specification is further based the headgear strap dimensions.” (Yu teaches customizing the length of the strings 15010, 15012, 15014 i.e. headgear straps based on the collected data i.e. adjusting the length of the strap would require adjusting the knitting structure specification if the strap is knitted in Yu [0425] "Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data.").
Claim 53:
Yu teaches “A system for producing a customised patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the system comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“one or more processors for receiving data representative of one or more landmark features of a head of a human and data representative of one or more functional requirements associated with the human;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry),
“the one or more processors further configured to identify one or more landmark feature locations of the landmark features based on the data representative of one or more landmark features;” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."),
“the one or more processors further configured to determine a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the data representative of the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions;” (Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“and at least one manufacturing machine configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “the one or more processors further configured to determine, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 54:
Yu teaches “A processor-implemented method performed by a processing system including at least one processor and communication circuitry for production of a patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the method comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“receiving, using the communication circuitry, data representative of one or more landmark features of a head of a human and data representative of one or more functional requirements associated with the human;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry),
“identifying, using the processing system, one or more landmark feature locations of the landmark features based on the data representative of one or more landmark features;” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."), and
“determining, using the processing system, a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the data representative of the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions;” (Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“and communicating, using the communication circuitry, the set of manufacturing specifications to a manufacturing system comprising at least one manufacturing machine configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “determining, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 55:
Yu teaches “A system for producing a customised patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the system comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“one or more processors for receiving data representative of one or more landmark features of a head of a human and data representative of one or more functional requirements associated with the human;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry),
“the one or more processors further configured to identify one or more landmark feature locations of the landmark features based on the data representative of one or more landmark features;” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."),
“the one or more processors further configured to determine a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the data representative of the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions;” (Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“and the one or more processors further configured to communicate the set of manufacturing specifications to a manufacturing system comprising at least one manufacturing machine configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “the one or more processors further configured to determine, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 56:
Yu teaches “A processor-implemented method performed by a processing system including at least one processor and communication circuitry for production of a patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the method comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“receiving, using the communication circuitry, one or more landmark feature locations of landmark features of a head of a human and data representative of one or more functional requirements associated with the human, the one or more landmark feature locations identified from data representative of the one or more landmark features of the head;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry),
“determining, using the processing system, a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the data representative of the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions;” (Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“and communicating, using the communication circuitry, the set of manufacturing specifications to a manufacturing system comprising at least one manufacturing machine configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “determining, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 57:
Yu teaches “A system for producing a customised patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the system comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“one or more processors for receiving one or more landmark feature locations of landmark features of a head of a human and data representative of one or more functional requirements associated with the human, the one or more landmark feature locations identified from data representative of the one or more landmark features of the head;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry),
“the one or more processors further configured to determine a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the data representative of the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions;” (Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“and the one or more processors further configured to communicate the set of manufacturing specifications to a manufacturing system comprising at least one manufacturing machine configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “the one or more processors further configured to determine, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 58:
Yu teaches “A processor-implemented method for production of a patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the method comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“receiving, using communication circuitry, a set of manufacturing specifications for production of the patient respiratory interface component, wherein the set of manufacturing specifications are determined based on one or more landmark feature locations identified from data representative of one or more landmark features of a head of a human and based on data representative of one or more functional requirements associated with the human, wherein the set of manufacturing specifications comprises headgear strap dimensions; and” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry; Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“causing one or more manufacturing machines to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “receiving, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 59:
Yu teaches “A system for producing a customised patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the system comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“one or more processors for receiving a set of manufacturing specifications for production of the patient respiratory interface component, wherein the set of manufacturing specifications are determined based on one or more landmark feature locations identified from data representative of one or more landmark features of a head of a human and based on data representative of one or more functional requirements associated with the human, wherein the set of manufacturing specifications comprises headgear strap dimensions; and” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry; Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."),
“at least one manufacturing machine configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “one or more processors for receiving, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 60:
Yu teaches “A processor-implemented method for production of a patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the method comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“obtaining, based on data received from a device using communication circuitry, information representative of one or more landmark feature locations for a human's head;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry;),
“determining, using at least one processor, a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on data representative of one or more functional requirements associated with the human, wherein the set of manufacturing specifications comprises headgear strap dimensions; and” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."; Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“causing one or more manufacturing machines to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “determining, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 61:
Yu teaches “A system for producing a patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the system comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“one or more processors for obtaining information representative of one or more landmark feature locations for a human head and one or more functional requirements associated with the human;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry;),
“the one or more processors further configured to determine a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based the one or more functional requirements associated with the human, wherein the set of manufacturing specifications comprises headgear strap dimensions; and” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."; Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“the one or more processors further configured to produce the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “the one or more processors further configured to determine, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 62:
Yu teaches “Apparatus for producing a patient respiratory interface component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the apparatus comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“means for obtaining information representative of one or more landmark feature locations for a human's head and one or more functional requirements associated with the human;” (Yu teaches collecting relaxed state data 4301 i.e. information representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry;),
“means for determining a set of manufacturing specifications for production of the patient respiratory interface component based on the one or more landmark feature locations and based on the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions; and” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."; Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“means for producing the patient respiratory interface component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “means for determining, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 63:
Yu teaches “A processor-implemented method for producing a customised component of an apparatus or device for treatment of a respiratory disorder, the customised component comprising a headgear strap of a positioning and stabilising structure for a patient interface, the method comprising:” (Yu [0422] "15A-B show an example of headgear associated with a patient interface. The patient 15050 is wearing a patient interface 15002 secured by headgear 15004 . In this example, the headgear 15004 includes a first strap 15010 and a second strap 15012 attached to a first end of the patient interface 15002. The second string 15012 includes a residizer that can form a predetermined shape. The first string 15010 and the second string 15012 extend toward the back of the patient's head (see FIG. 15B) and are attached at the neck attachment 15040 to the third string 1514 and the crown attachment 15042, respectively. As best shown in Figure 15B, the vectors formed by the first string 15010 and the second string 15012 are labeled V15010 and V15012, respectively."; Yu Figs. 15A and 15B [As shown above in claim 1] teach a respiratory interface comprising a headgear strap),
“receiving, using communication circuitry, data representative of one or more landmark features of a head of a human and data representative of one or more functional requirements which are not derived from the landmark feature locations;” (Yu teaches collecting relaxed state data 4301 i.e. data representative of one or more landmark features of a head of a human and user input 4304 which may be a user preference for comfort or functionality i.e. data representative of one or more functional requirements associated with the human in Yu [0314] "5.11.2 Data Collection 4300 The customized patient interface is visually optimized according to the patient's preferences and/or geometrically optimized to fit the patient's unique facial configuration. To create a customized patient interface for each unique patient, a collection of data is assembled as shown in FIG. Relaxed state data collection 4301 refers to data such as three-dimensional data of a patient's face acquired in a relaxed, undeformed state. Deformed data collection 4302 refers to data collected from the patient's face showing areas that have been deformed due to loading from the patient interface or different patient sleep positions (e.g., supine, side, front, etc.). In addition to geometry related patient data, the mapping technique 4303 also collects pressure data to ensure proper sealing of the patient interface during use. User input 4304, such as varying user preferences for aesthetics, comfort or functionality, is also collected."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry;),
“determining, using at least one processor, a set of manufacturing specifications for production of the component based on the landmark features and the one or more functional requirements, wherein the set of manufacturing specifications comprises headgear strap dimensions; and” (Yu teaches identifying characteristics of the patient's face in Yu [0357] "5.11.3.3 Specific Feature Processing 4403 Areas or features on the patient's face require special consideration. Identifying and adjusting these characteristics can improve the overall comfort of the patient interface. From the data collection and estimation techniques described above, appropriate characteristics can be applied to a customized patient interface."; Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."; Yu teaches that the length of the elastic material i.e. headgear strap dimensions can be adjusted based on the collected data in Yu [0424-0425] "Second, the register of the second string 15012 can also be modified. In some embodiments, once the eye position and cheek contours are known, the string 15012 can be shaped to follow the contours of the patient's face, clearing the patient's eyes to reduce irritation and reducing obstruction to the view from the patient interface. Third, modify the length of any strings 15010, 15012, 15014 to take into account the shape and/or size of the collected head and/or neck. For example, if the head circumference (eg, C1) at different latitudes is known, string lengths can be predicted and recommended to the patient. In some embodiments, the strings 15010, 15012, 15014 can be elastic. In such cases, the length and/or stiffness of the elastic material can be adjusted based on the collected data."), and
“causing one or more manufacturing apparatuses to produce the component based on the set of manufacturing specifications.” (Yu [0461-0462] "5.11.8 Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing. The completed patient interface design package 4550 includes data or information relating to any of the following: a list of components in the patient interface system (e.g., frame, intermediate structures, sealing elements, headgear and/or elbows, tubing, headgear clips and), CAD or other data files for each component, manufacturing techniques for each component, material(s) required for each component, and designer and/or user comments. The patient's CAD file and/or photograph (if available) is stored to assist in the selection of visually aesthetic features and to stylize the patient interface according to the patient's preferences and tastes. 5.11.9 Manufacturing 4600 The completed patient interface design package 4550 is sent to Manufacturing 4600. There are many different manufacturing techniques available for assembling any of the components described above."; Yu Fig. 4 teaches receiving the collected data 4301-4304, processing the data 4400 to create a design 4500, and manufacturing the design 4600 to create a final product 4700.; Yu teaches a CNC machine i.e. machine to form components of the patient interface in Yu [0463] “The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014 . Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface. In some cases, materials such as silicone or thermoplastic elastomers are frozen into a rigid structure prior to machining.”).
Yu does not appear to explicitly teach “determining, as part of the set of manufacturing specifications for production of the patient respiratory interface component, at least one knitting structure specification to be used for at least one portion of a one-piece headgear strap;” However, Dunn does teach this claim limitation (Dunn teaches that custom headgear may be manufactured based on a 3D scan and that the custom model may be sent to a knitting machine i.e. the scanned data/landmark features are used in determining how to knit the mask's straps in Dunn [0178] "Custom headgear may be manufactured for an individual patient in accordance with an example of the disclosed technology. Data regarding the shape and size of the patient's head is acquired (e.g., via photo, 3D scan). Measurements that may be used to manufacture a custom headgear may include the circumference of the patient's crown, length from the occiput to the crown, and the position of the patient's ears, eyes and nose. Visual modeling software (e.g., CADCAM) operating on a computer may create a custom headgear model according to the patient's measurements and needs. This model may then be sent to a machine (e.g, a knitting machine or 3D printer) for creation of the headgear."; Dunn teaches that the direction of the knit may be altered in order to adjust the shape or stretch of fabric e.g. based on the 3D scan in Dunn [0125-0126] "The headgear 630 includes crown straps 632, 634, top strap 640, and lower headgear straps 650. The knit may be pulled tight or formed loosely to adjust the fit and enhance comfort in certain areas. For example, the illustrated crown straps 632, 634 have a looser knit which enhances breathability in the area near the top of the patient's head. In contrast, the lower headgear straps 650 have a tight knit which creates a more rigid strap for stabilizing the mask. The top strap 640 includes a thinned region 642 designed to avoid obstruction of the patient's vision. Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a top portion 1102, a rear portion 1104, and a lower portion 1106. The lower portion 1106 may bifurcate or branch out at a junction to form the top portion 1102 and the rear portion 1104. The angular orientation of the top portion 1102 may be different compared to the rear portion 1104 e.g. the top portion 1102 may extend at about 30-110 degrees, or about 90 degrees or perpendicular to the rear portion 1104. The direction of the knit, or the grain or course 1150 of the knit, may be altered to adjust the shape or stretch of the fabric in certain areas. For example, the grain or course 1150 may be configured to curve the strap at a cheek region to avoid obstructing the patient's eyes. Further, as shown in FIG. 11A, the grain or course 1150 may curve, as shown by the arrows B, to a split thereby forming the top portion 1102 and the rear portion 1101. Such configurations of the top portion 1102 and the rear portion 1101 may stabilize the straps in position on the patient's head and thus better enable the strap 1100 to hold a mask assembly on a patient's face in a manner that enhances the seal with the patient's face.").
Yu and Dunn are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu and Dunn before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu to include the custom specifications of a mask including knitting specifications of Dunn because adding the Manufactured to shape headgear and masks of Dunn would reduce material waste and be more comfortable as described in Dunn [0107] “Knitting various headgear sections in a continuous manner may be advantageous as there are no or very few additional manufacturing steps that would be required to sew, fuse, adhere or otherwise attach adjoining sections. As a result, the manufacturing process may have reduced steps, the amount of material waste is reduced, there would be virtually no seams in the headgear between the adjoining sections, and the headgear made of a fabric without distinctive joins or seams may be more comfortable for patients.”
Claim 64:
Yu in view of Dunn teaches “The processor-implemented method of claim 63, wherein the producing the patient respiratory interface component comprises (and/or (Yu teaches that knitted fabric may be used to create the customized headgear in Yu [0472] "Customized woven/knitted/molded fabrics are also used. The technique is similar to the 3D printing process, except it uses thread i.e. yarn instead of plastic. The structure of the textile components can be knitted into any three-dimensional shape, which is ideal for assembling customized headgear.").
Claim 66:
Yu in view of Dunn teaches “The processor-implemented method of claim 63, wherein the method is performed by a manufacturing system including the at least one processor and the communication circuitry.” (Yu teaches a processor generating diagrams from pressure values i.e. identifying facial features in Yu [0340] "To ensure a proper seal around the periphery of the patient interface, a pressure value within a predetermined range is targeted. The data acquired in this process includes the known geometry of the dummy patient interface 8020 along with a grid of pressure measurements on the patient contact surface. Such data can be sent to a computer having a processor 8022 and used to generate a chart, table, or diagram such as a pressure map 8030 from the pressure values obtained by this technique."; Yu Fig. 9A [As shown above in claim 1] teaches the collected data 4301-4304 being transferred e.g. by communication circuitry to the data processing section then outputting the data packages e.g. by communication circuitry).
Claims 25-27 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (JP2017523827A), in view of Dunn et al. (US20140209098A1), further in view of Kimmel et al. (US20190160247A1).
Claim 25:
Yu in view of Dunn teaches “The method of claim 1, further comprising producing, using the at least one processor, manufacturing machine programming instructions for production of the patient interface or component thereof based on the set of manufacturing specifications,” (Yu teaches using the data collected from skin and complete design package to use a CNC machine i.e. provide programming instructions for production of the component in Yu [0463] "The first group of techniques is called subjective techniques. In the subjective technique, data is collected from the patient's skin 18050, analyzed, and a completed patient interface design package is sent to manufacturing (FIG. 18A). A large blank component 18010 is modified to remove excess material 18012 so that remaining portion 18014 forms the desired custom component. In some embodiments, large blank component 18010 is large enough to encompass most possible variations for custom component 18014. Some methods under the subtractive technique involve machining using CNC machines to form components from large blocks or materials in the shape of the patient interface.”; Yu teaches that the design package is customized i.e. based on the set of manufacturing specifications in Yu [0461] “Complete Patient Interface Design Package 4550 Once the patient interface and/or headgear have been customized, the completed patient interface design package 4550 is a group of files containing the files for the individually designed patient interface components ready for manufacturing.").
Yu and Dunn do not appear to explicitly teach “wherein producing the patient respiratory interface component comprises programming the at least one manufacturing machine with the manufacturing machine programming instructions, and operating the at least one manufacturing machine according to the manufacturing machine programming instructions.” However, Kimmel does teach this claim limitation (Kimmel teaches modifying the design model as a set of manufacturing instructions in Kimmel [0051] "The digital design model so modified may then be exported in a step 214 of FIG. 2 as a set of manufacturing instructions, e.g., for (i) producing a mold of the contacting interface into which is then injected a suitable material for producing the final product, or (ii) printing directly a contacting interface using an additive printing process.").
Yu, Dunn, and Kimmel are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu, Dunn, and Kimmel before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu modified to include the custom specifications of a mask including knitting specifications of Dunn to include the programming of a machine and operating it of Kimmel because adding the Process and system for generating personalized facial masks of Kimmel would provide uniformly distributed pressure as described in Kimmel [0031] “It was found that the present process offered improvements over currently available designs. Specifically, it was found that the present process provided for uniformly distributed pressure along the contact area between the mask interface and the face.”
Claim 26:
Yu in view of Dunn, further in view of Kimmel teaches “The method of claim 25, wherein producing the manufacturing machine programming instructions comprises generating a map representing the set of manufacturing specifications,” (Kimmel teaches providing a 3D model of a human face in Kimmel [0034] "In a next step 208 of FIG. 2, a 3D scan of the face of a subject is received (or is actively performed as part of the method, using a suitable 3D scanner or 3D imaging apparatus) and designated as the “target model” within the process 200. The target model may be generated using any commercially available 3D imaging technique, and may be provided in various configurations and formats, including as a polygon mesh, a depth map, a parameterized polynomial, or a subspace representation."; Kimmel teaches modifying a model i.e. map to conform to the patient in Kimmel [0035] "In a next step 210 of FIG. 2, there is performed an image transformation process which conforms the reference model to the target model. More specifically, an automatic deformation technique is used to align the features of the reference model with the corresponding features of target model. The deformation procedure of step 210 results in a modified reference model, which faithfully reflects the geometric features of the specific subject. An example of such modified reference model is provided in a reference model 600 of FIG. 6. It will be appreciated that, in the course of this process, the pre-determined “generic” contact area 302 of FIG. 3 is transformed into a “personalized” contact area 602 of FIG. 6, which now conforms precisely to the contours of the respective area of the face of the subject."), and
“and generating the manufacturing machine programming instructions based on the map.” (Kimmel teaches modifying the design model as a set of manufacturing instructions in Kimmel [0051] "The digital design model so modified may then be exported in a step 214 of FIG. 2 as a set of manufacturing instructions, e.g., for (i) producing a mold of the contacting interface into which is then injected a suitable material for producing the final product, or (ii) printing directly a contacting interface using an additive printing process.").
Claim 27:
Yu in view of Dunn, further in view of Kimmel teaches “The method of claim 26, wherein producing the manufacturing machine programming instructions comprises generating a model of the patient respiratory interface component based on the set of manufacturing specifications,” (Yu teaches generating a 3D model of a sealing element for a particular patient i.e. based on the manufacturing specifications in Yu [0452] "During fabrication, a three-dimensional model 17310 of the sealing element 17300 can be computer generated for a particular patient and converted into a two-dimensional flat profile 17300 (FIG. 17L)."), and
“and generating the manufacturing machine programming instructions based on the model.” (Kimmel teaches providing a 3D model of a human face in Kimmel [0034] "In a next step 208 of FIG. 2, a 3D scan of the face of a subject is received (or is actively performed as part of the method, using a suitable 3D scanner or 3D imaging apparatus) and designated as the “target model” within the process 200. The target model may be generated using any commercially available 3D imaging technique, and may be provided in various configurations and formats, including as a polygon mesh, a depth map, a parameterized polynomial, or a subspace representation."; Kimmel teaches modifying a model i.e. map to conform to the patient in Kimmel [0035] "In a next step 210 of FIG. 2, there is performed an image transformation process which conforms the reference model to the target model. More specifically, an automatic deformation technique is used to align the features of the reference model with the corresponding features of target model. The deformation procedure of step 210 results in a modified reference model, which faithfully reflects the geometric features of the specific subject. An example of such modified reference model is provided in a reference model 600 of FIG. 6. It will be appreciated that, in the course of this process, the pre-determined “generic” contact area 302 of FIG. 3 is transformed into a “personalized” contact area 602 of FIG. 6, which now conforms precisely to the contours of the respective area of the face of the subject."; Kimmel teaches modifying the design model as a set of manufacturing instructions in Kimmel [0051] "The digital design model so modified may then be exported in a step 214 of FIG. 2 as a set of manufacturing instructions, e.g., for (i) producing a mold of the contacting interface into which is then injected a suitable material for producing the final product, or (ii) printing directly a contacting interface using an additive printing process.").
Claim 65:
Yu in view of Dunn, further in view of Kimmel teaches “The processor-implemented method of claim 63, wherein producing the component based on the set of manufacturing specifications comprises generating instructions for the one or more manufacturing apparatuses configured to produce the component and controlling the one or more manufacturing apparatuses to produce the component based on the generated instructions.” (Kimmel teaches providing a 3D model of a human face in Kimmel [0034] "In a next step 208 of FIG. 2, a 3D scan of the face of a subject is received (or is actively performed as part of the method, using a suitable 3D scanner or 3D imaging apparatus) and designated as the “target model” within the process 200. The target model may be generated using any commercially available 3D imaging technique, and may be provided in various configurations and formats, including as a polygon mesh, a depth map, a parameterized polynomial, or a subspace representation."; Kimmel teaches modifying a model i.e. map to conform to the patient in Kimmel [0035] "In a next step 210 of FIG. 2, there is performed an image transformation process which conforms the reference model to the target model. More specifically, an automatic deformation technique is used to align the features of the reference model with the corresponding features of target model. The deformation procedure of step 210 results in a modified reference model, which faithfully reflects the geometric features of the specific subject. An example of such modified reference model is provided in a reference model 600 of FIG. 6. It will be appreciated that, in the course of this process, the pre-determined “generic” contact area 302 of FIG. 3 is transformed into a “personalized” contact area 602 of FIG. 6, which now conforms precisely to the contours of the respective area of the face of the subject."; Kimmel teaches modifying the design model as a set of manufacturing instructions and printing the model directly i.e. controlling a manufacturing apparatus to produce the component in Kimmel [0051] "The digital design model so modified may then be exported in a step 214 of FIG. 2 as a set of manufacturing instructions, e.g., for (i) producing a mold of the contacting interface into which is then injected a suitable material for producing the final product, or (ii) printing directly a contacting interface using an additive printing process.").
Claims 41-42 and 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (JP2017523827A), in view of Dunn et al. (US20140209098A1), further in view of Formica et al. (US20110197341A1).
Claim 41:
Yu in view of Dunn teaches “The method of claim 40,” as described above. Yu and Dunn do not appear to explicitly teach “wherein the predetermined force is between 3N and 5N.” However, Formica does teach this claim limitation (Formica teaches that an elastic top strap may require no more than 4N of force to stretch the elastic 100mm i.e. depending on the patient's head shape, the top strap may be stretched to apply a force of 4N in Formica [0151] "Elastic provided to a top strap of a headgear (for example, top strap 3012 in FIG. 20) may be 250-450 mm in length. Preferably, elastic top strap may be about 320-400 mm. Preferably, elastic top strap may require no more than 10N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 6N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 4N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 3N of force to stretch the elastic 100 mm from its original length. This may ensure the headgear is comfortable for a range of patient's head sizes.").
Yu, Dunn, and Formica are analogous art because they are from the same field of endeavor of creating custom respiratory masks. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having teachings of Yu, Dunn, and Formica before him/her, to modify the teachings of a custom patient interface and methods of making the same of Yu modified to include the custom specifications of a mask including knitting specifications of Dunn to include the predetermined force of the top strap being no more than 4N of Formica because adding the headgear for masks of Formica would ensure the headgear is comfortable for a range of patient head sizes as described in Formica [0151] "Elastic provided to a top strap of a headgear (for example, top strap 3012 in FIG. 20) may be 250-450 mm in length. Preferably, elastic top strap may be about 320-400 mm. Preferably, elastic top strap may require no more than 10N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 6N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 4N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 3N of force to stretch the elastic 100 mm from its original length. This may ensure the headgear is comfortable for a range of patient's head sizes.").
Claim 42:
Yu in view of Dunn, further in view of Formica teaches “The method of claim 41, wherein the predetermined force is about 4N.” (Formica teaches that an elastic top strap may require no more than 4N of force to stretch the elastic 100mm i.e. depending on the patient's head shape, the top strap may be stretched to apply a force of 4N in Formica [0151] "Elastic provided to a top strap of a headgear (for example, top strap 3012 in FIG. 20) may be 250-450 mm in length. Preferably, elastic top strap may be about 320-400 mm. Preferably, elastic top strap may require no more than 10N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 6N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 4N of force to stretch the elastic 100 mm from its original length. Preferably, elastic top strap may require no more than 3N of force to stretch the elastic 100 mm from its original length. This may ensure the headgear is comfortable for a range of patient's head sizes.").
Claim 45:
Yu in view of Dunn, further in view of Formica teaches “The method of claim 43, wherein the set of manufacturing specifications comprises a length of each one of a pair of (Yu teaches a rigidizer arm that is connected to an arm strap in Yu [0449] "The frame 17000 in FIG. 17J illustrates the connection of the discharge conduit 17005 to the opening 17230 and to the slot 17135 via the rigidizer arm 17250 of the headgear 17010. In one embodiment, the rigidizer arm 17250 is substantially L-shaped and includes a first end 17252 extending generally in the coronal plane for insertion into and connection to the slot 17135, and a second end 17254 extending in the sagittal plane for connection to the headgear 17010 (e.g., connection to any of the strings described above). The rigidizer arm 17250 is substantially rigid and hard and is made of metal or a hard polymer such as polypropylene, Hytrel, or the like. Additionally, the L-shape of the rigidizer arm 17250 provides stable fixation and a stable seal against the patient's face, absorbing headgear forces, e.g., force F1, and creating force F2 on the frame 17000 to push the frame 17000 toward the patient's nostrils."; Yu teaches that the arc length of the rigidizer arm 17250 may be selected specific for a patient in Yu [0455] "The contour, shape, arc length and flexibility of the registerizer arm 17250 can be selected to suit the patient. For example, a patient's face may be wide or narrow, and the Regisizer Arm 17250 can be customized to apply minimal clamping pressure to the patient's face, closely follow the contours of the patient's face, and optimally route the headgear straps between the patient's eyes and ears."
PNG
media_image7.png
598
612
media_image7.png
Greyscale
), and
“a pair of upper arms of the frame, each upper arm being configured to connect with a respective upper strap portion of a positioning and stabilising structure in use.” (Formica Fig. 8 teaches an upper strap 620 connected to an upper arm of the frame
PNG
media_image8.png
493
396
media_image8.png
Greyscale
).
Claim 46:
Yu in view of Dunn, further in view of Formica teaches “The method of claim 43, wherein the set of manufacturing specifications comprises a direction at which each one of a pair of (Yu teaches a rigidizer arm that is connected to an arm strap in Yu [0449] "The frame 17000 in FIG. 17J illustrates the connection of the discharge conduit 17005 to the opening 17230 and to the slot 17135 via the rigidizer arm 17250 of the headgear 17010. In one embodiment, the rigidizer arm 17250 is substantially L-shaped and includes a first end 17252 extending generally in the coronal plane for insertion into and connection to the slot 17135, and a second end 17254 extending in the sagittal plane for connection to the headgear 17010 (e.g., connection to any of the strings described above). The rigidizer arm 17250 is substantially rigid and hard and is made of metal or a hard polymer such as polypropylene, Hytrel, or the like. Additionally, the L-shape of the rigidizer arm 17250 provides stable fixation and a stable seal against the patient's face, absorbing headgear forces, e.g., force F1, and creating force F2 on the frame 17000 to push the frame 17000 toward the patient's nostrils."; Yu teaches that the shape, which would affect the direction of the arms of the rigidizer arm 17250 may be selected specific for a patient in Yu [0455] "The contour, shape, arc length and flexibility of the registerizer arm 17250 can be selected to suit the patient. For example, a patient's face may be wide or narrow, and the Regisizer Arm 17250 can be customized to apply minimal clamping pressure to the patient's face, closely follow the contours of the patient's face, and optimally route the headgear straps between the patient's eyes and ears."), and
“a pair of upper arms of the frame extends from a central portion of the frame.” (Formica Fig. 8 [As shown above in claim 45] teaches an upper strap 620 connected to arms extending from the frame.).
Claim 47:
Yu in view of Dunn, further in view of Formica teaches “The method of claim 43, wherein the set of manufacturing specifications comprises a length of each one of a pair of (Yu teaches a rigidizer arm that is connected to an arm strap in Yu [0449] "The frame 17000 in FIG. 17J illustrates the connection of the discharge conduit 17005 to the opening 17230 and to the slot 17135 via the rigidizer arm 17250 of the headgear 17010. In one embodiment, the rigidizer arm 17250 is substantially L-shaped and includes a first end 17252 extending generally in the coronal plane for insertion into and connection to the slot 17135, and a second end 17254 extending in the sagittal plane for connection to the headgear 17010 (e.g., connection to any of the strings described above). The rigidizer arm 17250 is substantially rigid and hard and is made of metal or a hard polymer such as polypropylene, Hytrel, or the like. Additionally, the L-shape of the rigidizer arm 17250 provides stable fixation and a stable seal against the patient's face, absorbing headgear forces, e.g., force F1, and creating force F2 on the frame 17000 to push the frame 17000 toward the patient's nostrils."; Yu teaches that arc length of the rigidizer arm 17250 may be selected specific for a patient in Yu [0455] "The contour, shape, arc length and flexibility of the registerizer arm 17250 can be selected to suit the patient. For example, a patient's face may be wide or narrow, and the Regisizer Arm 17250 can be customized to apply minimal clamping pressure to the patient's face, closely follow the contours of the patient's face, and optimally route the headgear straps between the patient's eyes and ears."), and
“a pair of lower arms of the frame, each lower arm being configured to connect with a respective lower strap portion of a positioning and stabilising structure in use.” (Formica Fig. 8 [As shown above in claim 45] teaches a lower strap 630 connected to a lower arm of the frame).
Claim 48:
Yu in view of Dunn, further in view of Formica teaches “The method of claim 43, wherein the set of manufacturing specifications comprises a direction at which each one of a pair of (Yu teaches a rigidizer arm that is connected to an arm strap in Yu [0449] "The frame 17000 in FIG. 17J illustrates the connection of the discharge conduit 17005 to the opening 17230 and to the slot 17135 via the rigidizer arm 17250 of the headgear 17010. In one embodiment, the rigidizer arm 17250 is substantially L-shaped and includes a first end 17252 extending generally in the coronal plane for insertion into and connection to the slot 17135, and a second end 17254 extending in the sagittal plane for connection to the headgear 17010 (e.g., connection to any of the strings described above). The rigidizer arm 17250 is substantially rigid and hard and is made of metal or a hard polymer such as polypropylene, Hytrel, or the like. Additionally, the L-shape of the rigidizer arm 17250 provides stable fixation and a stable seal against the patient's face, absorbing headgear forces, e.g., force F1, and creating force F2 on the frame 17000 to push the frame 17000 toward the patient's nostrils."; Yu teaches that the shape, which would affect the direction of the arms of the rigidizer arm 17250 may be selected specific for a patient in Yu [0455] "The contour, shape, arc length and flexibility of the registerizer arm 17250 can be selected to suit the patient. For example, a patient's face may be wide or narrow, and the Regisizer Arm 17250 can be customized to apply minimal clamping pressure to the patient's face, closely follow the contours of the patient's face, and optimally route the headgear straps between the patient's eyes and ears."), and
“a pair of lower arms of the frame extends from a central portion of the frame.” (Formica Fig. 8 [As shown above in claim 45] teaches a lower strap 630 connected to a lower arm of the frame).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zachary A Cain whose telephone number is (571)272-4503. The examiner can normally be reached Mon-Fri 7:00-3:30 CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kenneth M Lo can be reached at (571) 272-9774. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Z.A.C./ Examiner, Art Unit 2116