DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Preliminary Amendment
This Office Action is in response to the preliminary amendment filed on 08/12/2024. Claim 1 is as originally presented. Claims 2-25 are as currently amended. As such, claims 1-25 are pending in the instant application.
The amendment to the specification (filed 08/12/2024) has been considered and has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the difference in material composition comprising a preceding section and an interceding section each formed of a difference material composition to the other (claim 3), a repeated sequence of the preceding section and the interceding section to form a plurality of interceding sections (claim 4), a count of the plurality of interceding section of the one or more first model specific acoustical features being different from a count of a plurality of interceding section of the different patient interface models that have respectively different one or more model specific acoustical features (claim 5), one or more first model specific acoustical features comprising a difference in material thickness of at least a portion of a wall section of the flow path (claim 18), the difference in material thickness comprising a preceding section and an interceding section where each are formed of a different material thickness to the other (claim 19), a repeated sequence of a preceding section with a first material thickness and an interceding section with a second material thickness to form a plurality of interceding sections (claim 20), and a count of the plurality of interceding sections with a second material thickness that is different from a count of a plurality of interceding sections with a given material thickness of the different patient interface models (claim 21) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 12-16, 23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fox et al. (US 20230191063 A1; hereinafter “Fox”).
Regarding claim 1, Fox discloses a patient interface model (user interface 124; Fig. 2) for delivering a respiratory therapy to a patient via an air circuit (conduit 126; Fig. 2) from a respiratory therapy device (respiratory therapy device 122; Fig. 2; “The user interface 124 engages a portion of the user's face and delivers pressurized air from the respiratory therapy device 122”, [0051]), the patient interface model comprising:
an inlet (inlet of connector 127; Fig 1) that is connectable with the air circuit (“connector 127 is configured to connect and fluidly couple the user interface 124 to the conduit 126”, [0052]);
a plenum chamber (chamber formed between face mask and user’s face, see [0184]) integrated with the inlet and in fluid communication with the inlet, wherein the inlet and plenum chamber form a flow path for the respiratory therapy, wherein the plenum chamber is configured for coupling with a respiratory system of the patient for delivery of the respiratory therapy to the patient (“at least one feature of the user interface can be, for example, the expansion from the connection of the conduit to the chamber formed by the cushion of a full face mask against a user's face”, [0184]); and
a positioning and stabilising structure configured to engage the plenum chamber with the patient (headgear associated with user interface 124, see Fig. 2, see last sentence of [0076]),
wherein the patient interface (124) is adapted with one or more first model specific acoustical features (“the user interface 124 can include one or more additional features that change the acoustic impedance of the acoustic signal 502, which further generates the acoustic reflection 510”, [0126]) in the flow path (for example, see feature 504 in Fig. 5) that are configured to produce an acoustic response to sound in the flow path that distinguishes the model of the patient interface from different patient interface models that have respectively different one or more model specific acoustical features (“Acoustic data associated with the respiratory therapy system is received. The received flow data and the received acoustic data are analyzed. Based at least in part on the analysis, a mask type for the user interface is determined”, [0006]; [0016]; [0125]-[0127]).
Regarding claim 2, Fox discloses the invention as set forth in claim 1, wherein the one or more first model specific acoustical features (one or more features that change the acoustic impedance of acoustic signal 502, see claim 1 above) comprises a difference in material composition of at least a portion of a wall section of the flow path (“For each change in the path (e.g., a cavity, a junction, a change in shape), a reflection at that point based on speed of sound is seen. The different types and distances of reflection(s) can be used to define a type and/or a model of user interface 124”, [0128]; “…the analyzed acoustic data can be used to identify the conduit based on the same methods disclosed for identifying the user interface. For example, different conduits (e.g., different diameters, lengths, materials, etc.) can be used within the respiratory therapy system … the conduit can be identified along with identifying the user interface…”, [0202]-[0203]; Examiner’s Note: Interpreting “material composition … of the flow path” as – physical characteristics of the flow path – such as the length, diameter, shape, spacing, etc., based on the recitation of “additional variations in the configuration of such material composition difference section(s), such as length of the section, spacing between sections, and/or number of interceding sections, may be applied to different models to provide detectable model specific acoustic responses” in paragraph [0074] of Applicant’s specification).
Regarding claim 3, Fox discloses the invention as set forth in claim 2, wherein the difference in material composition comprises a preceding section and an interceding section, each formed of a different material composition to the other (“The acoustic signal 502 travels down the length L of the conduit 126 until the acoustic signal 502 contacts a feature 504 of the user interface 124 at or near a connection 506 of the user interface 124 with the conduit 126. The feature 504 can include a widening (or a narrowing) of the pathway 508 formed through the conduit 126 and the user interface 124. The widening at the feature 504 causes a change in the acoustic impedance of the acoustic signal 502 and an acoustic reflection 510.”, [0125], hence a preceding section of the flow path and an interceding section of the flow path may have different physical characteristics, such as two different diameters).
Regarding claim 4, Fox discloses the invention as set forth in claim 4, wherein a repeated sequence of the preceding section and the interceding section form a plurality of interceding sections (“the user interface 124 can include one or more additional features that change the acoustic impedance of the acoustic signal 502, which further generates the acoustic reflection 510. Thus, although only the feature 504 is illustrated and described as causing the acoustic reflection 510, there can be multiple features of the user interface 124 that can all contribute to the acoustic reflection 510”, [0126], hence a preceding section of the flow path and an interceding section of the flow path may have different physical attributes, as explained in claim 3 above, where it would be well-understood by one of ordinary skill in the art that the one or more additional features could be the repeated sequence of a preceding section followed by an interceding section where each has a different physical characteristic, such as a repeated sequence of a section of the flow path having a first diameter followed by a section of the flow path with a widened diameter, see claim 3 above).
Regarding claim 5, Fox discloses the invention as set forth in claim 4, wherein the one or more first model specific acoustical features (one or more features that change the acoustic impedance of acoustic signal 502, see claim 1 above) comprises a count of the plurality of interceding sections (“the user interface 124 can include one or more additional features that change the acoustic impedance of the acoustic signal 502, which further generates the acoustic reflection 510. Thus, although only the feature 504 is illustrated and described as causing the acoustic reflection 510, there can be multiple features of the user interface 124 that can all contribute to the acoustic reflection 510”, [0126], hence there can be plurality of interceding sections) that is different from a count of a plurality of interceding sections of the different patient interface models that have respectively different one or more model specific acoustical features ([0125], wherein the number of interceding section is different between the different patient interface models such that the acoustic reflections between the different patient interface models are different, allowing the different patient interface models to be identified and categorized accordingly; [0206]).
Regarding claim 6, Fox discloses the invention as set forth in claim 2, wherein the difference in material composition comprises a first material composition that is different from a second material composition of the different patient interface models that have respectively different one or more model specific acoustical features ([0125], where the detected acoustic reflection is different between different patient interface models such that the acoustic data generated in response to the acoustic reflection allows for the analysis and characterization of the patient interface model; [0206]).
Regarding claim 7, Fox discloses the invention as set forth in claim 1, wherein the one or more first model specific acoustical features (one or more features that change the acoustic impedance of acoustic signal 502, see claim 1 above) comprises a length of a portion of the flow path that is different from lengths of the portion of the flow path of the different patient interface models that have respectively different one or more model specific acoustical features ([0184], lines 1-17; [0202]-[0204]).
Regarding claim 8, Fox discloses the invention as set forth in claim 7, wherein the portion of the flow path comprises a sounding chamber (portion of flow path between microphone 140 and feature of user interface that creates an acoustic reflection representative of the patient interface model, see Fig. 5, see [0125]).
Regarding claim 9, Fox discloses the invention as set forth in claim 8, wherein the sounding chamber comprises an expansion of the flow path (see feature 504 in Fig. 5).
Regarding claim 12, Fox discloses the invention as set forth in claim 1, wherein the one or more first model specific acoustical features comprises a first deviation or gradient in a portion of the flow path (see feature 504 in Fig. 5).
Regarding claim 13, Fox discloses the invention as set forth in claim 12, wherein the first deviation or gradient comprises a change in diameter in the portion of the flow path (see Fig. 5, where feature 504 has a greater diameter compared to conduit 126 and user interface 124).
Regarding claim 14, Fox discloses the invention as set forth in claim 12, wherein the one or more first model specific acoustical features comprises a second deviation or gradient in the portion of the flow path ([0126]).
Regarding claim 15, Fox discloses the invention as set forth in claim 14, wherein the first deviation or gradient (feature 504, see Fig. 5) and the second deviation or gradient (a second widening or narrowing of the flow path, see [0126]) form a sounding chamber having a first length (portion of flow path between microphone 140 and second widening or narrowing feature of the flow path forms a sounding chamber having a first length, see Fig. 5, see [0125]-[0126] and [0128]) that is different from lengths of sounding chambers in flow paths of the different patient interface models that have respectively different one or more model specific acoustical features ([0128], where the different types and distances of acoustic reflections created by the first and second deviation or gradient are specific to a type or model of user interface 124).
Regarding claim 16, Fox discloses the invention as set forth in claim 15, wherein additional deviations or gradients (additional widening or narrowing of the flow path, see [0126]) form a further sounding chamber having a second length that is different from lengths of further sounding chambers in flow paths ([0125]-[0126] and [0128], where it would be well-understood by one of ordinary skill in the art that the additional widened and/or narrowed sections of the flow path, and the length between the microphone 140 and the widened/narrowed section of the flow path spaced furthest from the microphone 140 form further sounding chambers of different lengths) of the different patient interface models that have respectively different one or more model specific acoustical features ([0128], where the different types and distances of acoustic reflections created by the first and second deviation or gradient are specific to a type or model of user interface 124).
Regarding claim 23, Fox discloses the invention as set forth in claim 1, wherein the one or more first model specific acoustical features in the flow path are formed in the inlet (“The acoustic signal 502 travels down the length L of the conduit 126 until the acoustic signal 502 contacts a feature 504 of the user interface 124 at or near a connection 506 of the user interface 124 with the conduit 126”, [0125]).
Regarding claim 25, Fox discloses the invention as set forth in claim 1, wherein an inner surface of the air circuit from the respiratory therapy device is substantially smooth (see inner surface of 126 in Fig. 5; Examiner’s Note: Interpretation of “substantially smooth” based on [0076] of Applicant’s specification, see US PGPub 2024/0390631 A1).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Fox (US 20230191063 A1).
With regard to claim 10, while Fox discloses a length of a portion of the flow path is different between the different patient interface models (see claim 7 above), Fox does not explicitly disclose the length of the portion of the flow path that is different from lengths of the portion of the flow path of the different patient interface models is different by at least five millimeters.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the length of the portion of the flow path between the different patient interface models taught by Fox because Applicant has not disclosed that the length of the portion of the flow path that is different from the lengths of the portion of the flow path of the different patient interface models being at least five millimeters provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant’s specification states “In some instances, the length H may be differed by at least 5 mm between different models to produce a unique acoustic signature. In some instances, the length H may be differed between different models so that each differs by 5 mm from a first model (e.g., 5 mm difference for a second model, an additional 5 mm (i.e., 2 times 5 mm) for a third model, and another 5 mm (i.e., 3 times 5 mm) for a fourth model etc. In some instances the length H may be differed by at least a length difference in a range of between 5 mm and 10 mm, or more e.g., for different models to produce a unique acoustic signature” ([0071] of US PGPub 2024/0390631 A1) and “For example, in some implementations, an integrated inlet tube and/or connection port to the mask plenum chamber that is present on many masks could be lengthened or shortened slightly so as to provide different lengths for different models. Such a difference in length may be, for example, greater than five-millimetres” ([0067] of US PGPub 2024/0390631 A1). One of ordinary skill in the art, furthermore, would have expected Fox’s different lengths of the portion of the flow path between the different patient interface models, and Applicant’s difference in length of at least five millimeters of the portion of the flow path between the different patient interface models, to perform equally well because both mechanisms perform the same function of altering the acoustic impedance between the different patient interface models due to the difference in the length of the portion of the flow paths of the different patient interface models. Therefore, it would have been prima facie obvious to modify Fox to obtain the invention as specified in claim 10 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired five millimeter difference in length of the portion of the flow path between the different patient interface models and thus fails to patentably distinguish over the prior art of Fox. Furthermore, the functionality of the portion of the flow path, or the flow path as a whole, would not be modified.
Regarding claim 11, Fox as modified teaches the invention as set forth in claim 10, wherein each length of the lengths of the portion of the flow path of the different patient interface models are different from each other by at least five millimeters (see claim 10 above).
With regard to claim 17, while Fox discloses a sounding chamber having a first length between the first deviation or gradient (feature 504, Fig. 5) and the second deviation or gradient (a second widening or narrowing of the flow path, see [0126]; see claim 15 above) and a further sounding chamber having a second length (see claim 16 above), Fox does not explicitly disclose the first length is different from the second length by at least five millimeters.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the length of the first length and the second length in the Fox device because Applicant has not disclosed that a difference of five millimeters in length between the first length and the second length provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant’s specification states “FIG. 5 illustrates a cross-section view 508a of an example integrated part 508, which may serve as an example sounding chamber … [where] the length H may be differed between different models so that each differs by 5 mm from a first model (e.g., 5 mm difference for a second model, an additional 5 mm (i.e., 2 times 5 mm) for a third model, and another 5 mm (i.e., 3 times 5 mm) for a fourth model etc. In some instances the length H may be differed by at least a length difference in a range of between 5 mm and 10 mm, or more e.g., for different models to produce a unique acoustic signature” (see [0071] of US PGPub 2024/0390631 A1). One of ordinary skill in the art, furthermore, would have expected the difference in length between the first length and the second length of Fox’s sounding chambers, and the five millimeter difference in length between the first length and the second length of Applicant’s sounding chambers, to perform equally well because both mechanisms perform the same function of altering the acoustic impedance between the different patient interface models due to the difference in the length of the portion of the flow paths of the different patient interface models, such that the type and/or model of patient interface may be identified. Therefore, it would have been prima facie obvious to modify Fox to obtain the invention as specified in claim 17 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired five millimeter difference in length between the first length of the sounding chamber and the second length of the further sounding chamber and thus fails to patentably distinguish over the prior art of Fox. Furthermore, the function of the first length of the sounding chamber and the second length of the further sounding chamber would not be modified.
Claims 18-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Fox (US 20230191063 A1) in view of Dantanarayana et al. (WO 2021207796 A1; hereinafter “Dantanarayana”).
Regarding claim 18, Fox discloses the one or more first model specific acoustical features are one or more features that change the acoustic impedance of an acoustic signal (see claim 1 above), but fails to explicitly disclose a feature that is a difference in material thickness of at least a portion of a wall section of the flow path.
However, Dantanarayana teaches an analogous device for detecting and identifying a patient interface model using acoustic detection and analysis ([0449]), where determining the type of patient interface includes identifying difference in a mask’s acoustic reflections compared to different patient interfaces, where the mask’s acoustic reflections are determined by at least one of mask shapes, mask configurations, mask materials, conduit materials, and/or conduit dimensions including, but not limited to, the thickness and/or length of the tubing ([0519]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the one or more first model specific acoustical features of Fox to include the thickness of at least a portion of the wall of the flow path, as taught by Dantanarayana above, to improve the analysis of various acoustic properties of a patient interface model based on reflected frequencies and/or timing of the reflected signals (last sentence of Dantanarayana [0519]).
Regarding claim 19, Fox as modified teaches the invention as set forth in claim 18, wherein the difference in material thickness comprises a preceding section and an interceding section, each formed of a different material thickness to the other (Dantanarayana [0519]; Fox [0125], where a preceding section of the flow path and an interceding section of the flow path may have different physical characteristics, such as different material thicknesses to one another, as taught by Dantanarayana in claim 18 above).
Regarding claim 20, Fox as modified teaches the invention as set forth in claim 19, wherein a repeated sequence of the preceding section and the interceding section form a plurality of interceding sections ([0126], where a preceding section of the flow path and an interceding section of the flow path may have different physical attributes, as explained in claims 18-19 above, hence it would be well-understood by one of ordinary skill in the art that the one or more additional features could be the repeated sequence of a preceding section followed by an interceding section where each has a different physical characteristic, such as a repeated sequence of a section of the flow path having a first material thickness followed by a section of the flow path having a second material thickness).
Regarding claim 21, Fox as modified teaches the invention as set forth in claim 20, wherein the one or more first model specific acoustical features (one or more features that change the acoustic impedance of acoustic signal 502, see claim 1 above) comprises a count of the plurality of interceding sections ([0126], where there can be plurality of interceding sections) that is different from a count of a plurality of interceding sections of the different patient interface models that have respectively different one or more model specific acoustical features ([0125], wherein the number of interceding section is different between the different patient interface models such that the acoustic reflections between the different patient interface models are different, allowing the different patient interface models to be identified and categorized accordingly; [0206]).
Regarding claim 24, Fox discloses the invention as set forth in claim 23, but fails to explicitly disclose the inlet comprises a swivel.
However, Dantanarayana teaches an analogous patient interface model (Figs. 1A-1C), where an inlet to the patient interface model includes a swivel connection (see Figs. 1A-1C; “In certain forms an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees”, [0588]; “the swivel may be constructed to rotate through an angle of at least 360 degrees”, [0597]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the connector (127) of Fox to be a swivel connector, as taught by Dantanarayana above, to improve patient comfort while using the device and to avoid tension or pulling on the conduit and/or patient interface when the patient moves while using the device.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fox (US 20230191063 A1) as applied to claim 17 above, and further in view of Dantanarayana (WO 2021207796 A1).
Regarding claim 22, Fox as modified teaches the invention as set forth in claim 17, and further teaches the one or more first model specific acoustical features are one or more features that change the acoustic impedance of an acoustic signal (see claim 1 above), but fails to explicitly teach the difference in material composition comprises a first material thickness that is different from a second material thickness of the different patient interface models that have respectively different one or more model specific acoustical features.
However, Dantanarayana teaches an analogous device for detecting and identifying a patient interface model using acoustic detection and analysis ([0449]), where determining the type of patient interface includes identifying difference in a mask’s acoustic reflections compared to different patient interfaces, where the mask’s acoustic reflections are determined by at least one of mask shapes, mask configurations, mask materials, conduit materials, and/or conduit dimensions including, but not limited to, the thickness and/or length of the tubing ([0519]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the one or more first model specific acoustical features of Fox to include the thickness of at least a portion of the wall of the flow path, as taught by Dantanarayana above, such that a first material thickness that is different from a second material thickness of the different patient interface models (Dantanarayana [0519]; Fox [0125], where the detected acoustic reflection is different between different patient interface models such that the acoustic data generated in response to the acoustic reflection allows for the analysis and characterization of the patient interface model; [0206]) to improve the analysis of various acoustic properties of a patient interface model based on reflected frequencies and/or timing of the reflected signals (last sentence of Dantanarayana [0519]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Holyoake et al. (US 20180085544 A1): Regarding a user interface system including a patient interface with an inlet having a substantially smooth interior surface, and a flow path through a conduit and the patient interface have sections of varying material thickness.
Shouldice et al. (US 20230377738 A1): Regarding a system to automatically identify a user interface type and/or model based on resonant frequencies and/or acoustic impedances of the user interface and/or conduit, where the style of the user interface and/or conduit is defined by various parameters including length, diameter, and material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 9:00 AM to 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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