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 .
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29, line 3, “the identification information” should read “the device identification information”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites the limitation "the sensor data" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the sensor data is referring to the acoustic data, the image data, the movement data, or a different set of data entirely. For purposes of examination, calibrating the sensor data is being interpreted as performing a calibration based on the device identification information.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 37-41, and 43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 37-41, and 43 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 37-41, and 43 recites at least one step or instruction for receiving data such as acoustic data, image data to determine an air leak and provide an indicator to indicate the location of the air leak which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 37-41, and 43 recites an abstract idea.
Specifically, Claim 1 recites
A method for detecting air leaks of a user interface worn by a user (additional element), comprising:
receiving, at a computing device (additional element), a command to begin air leak detection of the user interface being worn by the user; (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG)
receiving, from one or more sensors (additional element), acoustic data; (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG)
identifying a location of an air leak using the received acoustic data; (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG)
and presenting an indicator (additional element) that is indicative of the location of the identified air leak. (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG)
Specifically, Claim 41 recites
A system comprising: a control system including one or more processors (additional element); and
a memory (additional element) having stored thereon machine readable instructions (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
wherein the control system is coupled to the memory (additional element), and the method of claim 1 is implemented when the machine executable instructions in the memory (additional element) are executed by at least one of the one or more processors of the control system (additional element) (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG)
Specifically, Claim 43 recites
A computer program product (additional element) embodied on a non-transitory computer readable medium (additional element),
the computer-program product comprising instructions which, when executed by a computer (additional element), cause the computer to carry out the method of claim 1. (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1, 41, and 43 (and their respective dependent Claims , 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 41, and 43), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of:
a user-interface, a computing device, one or more sensors, and in indicator, as recited in independent Claim 1 and its dependent claims;
a control system, one or more processors, and a memory as recited in independent Claim 41 and its dependent claims; and
a computer program product, non-transitory computer readable medium, and computer as recited in independent Claim 43 and its dependent claims
are generically recited structural/computer elements in independent Claims 1, 41 and 43 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 41, and 43 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (a computing device, control system including one or more processors, and a computer claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 41, and 43 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 41, and 43 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of:
a user-interface, a computing device, one or more sensors, and in indicator, as recited in independent Claim 1 and its dependent claims;
a control system, one or more processors, and a memory as recited in independent Claim 41 and its dependent claims; and
a computer program product, non-transitory computer readable medium, and computer as recited in independent Claim 43 and its dependent claims
The above-identified additional elements are generically claimed structural/computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the computing device is a smartphone or table computer [0013], the control system includes one or more processors where the processor can be a general or special purpose processor or microprocessor, and the control system can include any suitable number of processors (e.g., one processor, two processors, five processors, ten processors, etc.), [0064]. Additionally, the memory device can be any suitable computer readable storage device or media, such as, for example, a random or serial access memory device, a hard drive, a solid state drive, a flash memory device, etc., [0065]
Accordingly, in light of Applicant’s specification, the claimed a computing device, control system including one or more processors, and memory are reasonably construed as a generic computing device is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computing device, control system including one or more processors, and memory are reasonably construed as a generic computing device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the methods, system, and product of Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 41, and 43 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1, 2, 6-7, 9-11, 17-22, 24-25, 27, 29, 33, 35, 38, 41, and 43 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
To overcome the 101 rejection, it is necessary to integrate the abstract idea into practice. An example of this would be “the ventilator configured to operate based on the acoustic data and an indication of the identified air leak”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 9, 17-19, 21, 22, 24, 25, 33, 38, 41, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lawrenson (US 20170203071).
Regarding claim 1, Lawrenson discloses
a method for detecting air leaks of a user interface worn by a user (“detect a leak between the patient interface and the patient's head that might occur due to a misalignment of the patient interface”; [0064]), comprising:
receiving, at a computing device, a command to begin air leak detection of the user interface being worn by the user (fig. 1; apparatus 10 such as a mobile device which has an input unit 62 including buttons or fields for activation and microphone 44 for recording sound during usage of patient interface/pressure support system; [0035], [0061], and [0105]);
receiving, from one or more sensors, acoustic data (figs. 2-3; apparatus 10 comprises microphone 44 is to detect noise/sound; [0061]-[0066] and [0102]);
identifying a location of an air leak using the received acoustic data (figs. 1-3; “The microphone 44 may e.g. include a beam-formed microphone array that is configured to detect a location of such a leak”; [0102]); and
presenting an indicator that is indicative of the location of the identified air leak (see fig. 1; “the advice unit is configured to generate the personalized advice (indicator) based on the virtual model, the technical data and the usage data, wherein the usage data include the determined characteristic and/or location of said sound”; [0063] and [0102]).
Regarding claim 2, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 1,
wherein the identified air leak is an unintentional air leak (“ detect a leak between the patient interface and the patient's head that might occur due to a misalignment of the patient interface”, [0064]; a leak occurring due to misalignment is unintentional).
Regarding claim 9, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 1, further comprising
receiving movement data associated with movement of the computing device relative the user interface (figs. 1-3; “The system may in this case also comprise an inertial/position that is configured to track the position and/or orientation of the apparatus/system relative to the patient's head/interface”; [0065] and [0102]),
wherein identifying the location of the air leak uses the acoustic data and the movement data (figs. 1-3; “The signals of the microphone and the signals of the inertial sensor may thus be used to determine the position and magnitude of the leak”; [0065] and [0102]).
Regarding claim 17, Lawrenson further discloses
the method (Lawrenson: detecting leaks of patient interface) of claim 1, further comprising
presenting an instruction display (see fig. 1; “The output unit 50 preferably includes a display 52 with which the apparatus 10 is equipped.”; [0098]),
wherein the instruction display is indicative of a movement path for moving the computing device relative to the user interface (figs. 1-3; the system/apparatus 10 (mobile device) may comprise an inertial/position sensor and distance sensor that is configured to track the position and/or orientation of the apparatus/system 10 relative to the patient's head/interface” at each point of a route while the apparatus 10 moves along the prescribed route around the patient’s head; [0065] and [0102]).
Regarding claim 18, Lawrenson further discloses
the method (Lawrenson: detecting leaks of patient interface) of claim 17,
wherein presenting the instruction display comprises presenting feedback associated with the accuracy of the computing device's movement along the movement path (fig. 1; “The advice unit 36 may be configured to generate an advice to the patient 12 how he/she has to hold and/or move the apparatus 10” when using inertial/position sensor and distance sensor to track position relative to the patient interface when moving along the prescribed route; [0102]).
Regarding claim 19, Lawrenson further discloses
the method of claim 1 (Lawrenson: detecting leaks of patient interface), further comprising
receiving depth data associated with a distance between the computing device and the user interface (figs. 1-3; camera 42 and distance sensor 46 to detect a distance between microphone and known part of the patient’s head/interface; [0097] and [0101]-[0102]),
wherein identifying a location of the air leak further comprises (see claim 1 above, detect a location of such a leak”; [0102]):
generating a three-dimensional mapping of the user interface relative to the computing device (fig. 1; system/apparatus 10 comprises a 3D scanner/camara to create a 3D model of the patient’s head (patient is wearing the user interface, see fig. 1) during a live session; [0095]); and
identifying the location of the air leak using the three-dimensional mapping of the user interface (see fig. 1, provides advice to remove leak from advice unit using virtual 3D model and usage date (data from distance sensor 46, microphone 44, and camera 42), [0065], [0097]-[0098], and [0101]-[0102]).
Regarding claim 21, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 1, further comprising
receiving image data associated with the user interface (figs. 1-3; take one or more images of him-/herself after he/she has worn the patient interface 18, the images are received by the receiving unit 32 of mobile device 10; [0103]),
wherein presenting the indicator comprises presenting a visual indicator superimposed on the image data associated with the user interface (see fig. 1; “exemplary advice may include an image displayed on the display 52, wherein the image shows the patient wearing the patient interface 18 including a written advice 56 which is virtually overlaid on said image”; [0098]-[0099]).
Regarding claim 22, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 21,
wherein receiving the image data associated with the user interface (see figs. 1-3; “one or more images are received by the receiving unit 32” of mobile device 10; [0101]) comprises capturing the image data using a camera of the computing device (“use the camera 42 of the system 10 (mobile device 10) to image him-/herself wearing the patient interface 18; [0101]) and displaying the image data on a display of the computing device (see fig. 1; an image displayed on the display 52, wherein the image shows the patient wearing the patient interface 18; [0099]).
Regarding claim 24, Lawrenson further discloses
the method (detecting leaks of patient interface ) of claim 22,
wherein the image data is live image data (see fig. 1, “data may include one or more images or a video of the patient wearing the patient interface. Hence, such images or videos show how the patient is using the patient interface”, [0035]; additionally, a mobile device such as a mobile phone is capable of taking a live photo and video).
Regarding claim 25, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 21, further comprising:
identifying guidance for reducing the air leak based on the location of the air leak (fig. 1; “the advice unit 32 is configured to generate the personalized advice based on the virtual model, the technical data and the usage data, wherein the usage data include the determined characteristic and/or location of said sound”; [0063] and [0102]);
generating a guidance image based on the guidance for reducing the air leak (see fig. 1; “generates personalized advice 56 to help patient 12 remove the detected leak”; [0063]-[0066] and [0102]); and
presenting the guidance by superimposing the guidance image on the image data associated with the user interface (see fig. 1; “exemplary advice may include an image displayed on the display 52, wherein the image shows the patient wearing the patient interface 18 including a written advice 56 which is virtually overlaid on said image”; [0098]-[0099]).
Regarding claim 33, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 1, further comprising:
presenting an instruction to adjust the user interface, wherein adjustment of the user interface induces, increases, or reduces the air leak (see fig. 1; “generates personalized advice 56 to help patient 12 remove the detected leak”; [0063]-[0066] and [0102]);
determining guidance to improve fit of the user interface based on identifying the location of the air leak; and presenting the determined guidance (see fig. 1; advice unit 36 provides advice 56 (such as tightening/pulling the strap) to remove a leak based on virtual 3D model received, magnitude/position of leak, and technical data (such as type of patient interface); [0072]-[0073], [0094], and [0098]-[0102]).
Regarding claim 38, Lawrenson further discloses
the method (detecting leaks of patient interface) of claim 1, further comprising:
receiving image data associated with the user interface over a duration of time (see fig. 1; the system may use augmented reality to display personalized advice on the display in text form or graphical form overlaid on the image or video that the patient takes from him-/herself wearing the patient interface during a live session; [0082] and [0095]); and
determining relative positions of a microphone with respect to the user interface during the duration of time using the image data (figs. 1-3; “the distance sensor 46 may be used to determine the distance between the microphone 44 and the patient's head/interface”; [0065] and [0102]),
wherein the microphone is moved with respect to the user interface during the duration of time (figs. 1-3; “patient 12 may hold the apparatus 10 including the microphone 44 at a prescribed position relative to his/her head. Alternatively, the patient 12 may move the apparatus 10 along a prescribed route around his/her head, e.g. moving the apparatus in a loop fully circumnavigating the head of the patient 12 and/or the patient interface 18”; [0065] and [0102]);
wherein receiving the acoustic data includes receiving the acoustic data from the microphone during the duration of time (figs. 1-3; sounds recorded by the microphone 44 are transferred to sound analysis unit 60; [0065] and [0102]), and
wherein identifying the location of the air leak using the received acoustic data further includes using the determined relative positions of the microphone with respect to the user interface (figs. 1-3; “The sound analysis unit 60 may be configured to determine a characteristic and/or location of said sounds as well as signals received from the distance sensor 46 and/or the inertial/position sensor (not shown). Based on these information the sound analysis unit 60 may e.g. determine a magnitude and a location of a leak occurring at the interface between the patient interface 18 and the head of the patient 12.”; [0102]).
Regarding claim 41, Lawrenson further discloses
a system (system including mobile device 10; [0094])comprising:
a control system including one or more processors (figs. 1-3; advice unit 36 may be realized as software/hardware and may include a processor with program modules configured to carry out an advice adapting algorithm; [0099]); and
a memory having stored thereon machine readable instructions (computer-readable storage medium contains instructions for execution by the processor; [0026]);
wherein the control system is coupled to the memory (the system comprises a processor and computer-readable storage medium; [0026]), and the method of claim 1 (see citations of claim 1 above) is implemented when the machine executable instructions in the memory are executed by at least one of the one or more processors of the control system (“the computer readable storage medium contains instructions for execution by the processor, wherein the instructions cause the processor to perform the steps of receiving a virtual model, technical data, usage data, and generate personalized advice for detecting and removing leaks (see claim 1); [0026]-[0032]) .
Regarding claim 43, Lawrenson further discloses
a computer program product embodied on a non-transitory computer readable medium (a computer program may be stored/distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, [0026] and [0109]; optical storage and solid-state mediums are considered non-transitory computer readable mediums), the computer-program product comprising
instructions which, when executed by a computer, cause the computer to carry out the method of claim 1 (“computer program comprising program code means for causing a computer to carry out the steps of the method as claimed (receiving a virtual model, technical data, usage data, and generate personalized advice for detecting and removing leaks) in claim 14; when said computer program is carried out on a computer, see claim 15 of prior art; see rejection of claim 1 above).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Kwok (US 20100180895).
Regarding claim 6, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 1,
wherein the user interface is coupled to a respiratory therapy device via a conduit (“the patient interface 18 may be connected to a hose or conduit 26 via which the personalized flow of breathable gas is transferred from the pressure generator 16 to the patient interface 18”; [0091]), the method further comprising
wherein receiving the acoustic data occurs while the respiratory therapy device is operating (“The sounds recorded by the microphone 44 during the usage of the pressure support system 14”; [0102]).
Lawrenson is silent as to the method further comprising presenting an instruction to set the respiratory therapy device to a preset flow rate, and the respiratory therapy device operating at the preset flow rate.
Kwok discloses a respiratory system that can detect/calculate leak in the mask where the method comprises
presenting an instruction to set the respiratory therapy device to a preset flow rate,
and the respiratory therapy device is operating at the preset flow rate (method for assessing fir of patient interface where glow generator generates a treatment pressure and limits gas flow applied to the patient at a predetermined flow rate; [0037]-[0042], and claim 60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure support system of Lawrenson with the method of limiting gas flow to a predetermined flow as taught in Kwok in order to make a determination that the seal of the patient interface to the patient is inadequate (Kwok: [0037]-[0042], and claim 60).
Regarding claim 7, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 1,
wherein the user interface is coupled to a respiratory therapy device via a conduit (“the patient interface 18 may be connected to a hose or conduit 26 via which the personalized flow of breathable gas is transferred from the pressure generator 16 to the patient interface 18”; [0091]), the method further comprising
wherein receiving the acoustic data occurs while the respiratory therapy device is operating (The sounds recorded by the microphone 44 during the usage of the pressure support system 14”; [0102]).
Lawrenson is silent as to the method further comprising the method further comprising transmitting a flow rate command in response to receiving the command to begin air leak detection, wherein the flow rate command, when received by the respiratory therapy device, sets the respiratory therapy device to a preset flow rate, and the respiratory therapy device is operating at the preset flow rate.
Kwok discloses a respiratory system that can detect/calculate leak in the mask where the method comprises
transmitting a flow rate command in response to receiving the command to begin air leak detection (“the device is switched to a "mask fitting" (leak) operational mode and flow generator is controlled to apply a normal range treatment pressure, and set a predetermined flow rate ; [0037]-[0042], [0087] and claim 60),
wherein the flow rate command, when received by the respiratory therapy device, sets the respiratory therapy device to a preset flow rate, and the respiratory therapy device is operating at the preset flow rate (flow rate limited to a flow approximately equal to or slightly above the vent flow rate for the mask (predetermined flow rate); [0037]-[0042], [0087] and claim 60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure support system of Lawrenson with the method of limiting gas flow to a predetermined flow as taught in Kwok in order to make a determination that the seal of the patient interface to the patient is inadequate (Kwok: [0037]-[0042], and claim 60).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Farbarik (US 20080078248).
Regarding claim 10, Lawrenson discloses
the method (Lawrenson: detecting leaks of patient interface) of claim 1,
Lawrenson does not disclose wherein identifying the location of the air leak comprises: accessing baseline acoustic data associated with intentional venting of the user interface; and filtering the baseline acoustic data to the acoustic data to identify the air leak.
Farbarik discloses a breathing assistance system with a noise control system
wherein identifying the location of the air leak (monitoring system 35 is used to analyze sounds to detect gas leakage at one more locations of the system) comprises:
accessing baseline acoustic data associated with intentional venting of the user interface (leakage sound data 300B may be pre-recorded (e.g., from testing and recording sounds of leaks at one or more locations of system 10 or a similar system and loaded into monitoring system; [0103]); and
filtering the baseline acoustic data to the acoustic data to identify the air leak (use leakage data 300b stored in monitoring system 35 and detect/record sounds near a potential leak area to compare over time and determine changes in the sounds that may indicate a leak; [0103] and [0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sound analysis unit and processor of Lawrenson with the method of using pre-recorded/tested sounds of leaks and comparing to raw data over time as taught in Farbarik to better detect and monitor the presence/magnitude of gas leaks through determining/comparing changes in the sounds that may indicate a leak (Farbarik: [0103] and [0105]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Chamtie (WO 2019006496).
Regarding claim 11, Lawrenson discloses
the method (Lawrenson: detecting leaks of patient interface) of claim 1,
Lawrenson is silent as to wherein identifying the location of the air leak comprises:
analyzing the acoustic data to identify a spectral frequency characteristic associated with the air leak; and determining a relative strength of the air leak based on the spectral frequency characteristic.
Chamtie discloses an acoustic measurement system and method for a respiration system
wherein identifying the location of the air leak (correlating the frequency spectral components to characteristic pneumatic noise signals generated by either the pressure generator, the air conduit or the patient interface; [0057]) comprises:
analyzing the acoustic data to identify a spectral frequency characteristic associated with the air leak (analyzing long-term changes in spectral frequency characteristics (analyzing data correlating to pneumatic noise signals) to detect an increase of air flow leakage attributable to sealing properties of the patient interface; [0057] and [0065]); and
determining a relative strength of the air leak based on the spectral frequency characteristic (analyzing long-term changes in baseline spectral frequency characteristics to detect an increase of air flow leakage, [0065]; in other words, detecting the changes of magnitude in the spectral frequency characteristic/air leak).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and sound analysis unit of Lawrenson with the method of analyzing and evaluating long-term changes in the spectral frequency characteristics of the acoustic signal as taught in Chamtie in order to detect an increase of air flow leakage in the patient interface over a duration of time (Chamtie: [0056]-[0060], [0065], [0285], and [0299]).
Claims 20 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of McMahon (WO 2018050913).
Regarding claim 20, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 1,
wherein the acoustic data is associated with acoustic signals between 20 Hz and 20 kHz.
Lawrenson is silent to the acoustic data being associated with acoustic signals between 20 Hz and 20 kHz.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microphone to detect audio within the range of 20Hz to 20kHz and that the sounds of the detected leak of Lawrenson would be in the range between 20Hz and 20kHz as “the typical “audio frequency” standard range (for hearing) is around 20 Hz to 20,000 Hz (20kHz), see [67] of McMahon.
Regarding claim 29, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 1, further comprising:
Lawrenson does not disclose determining device identification information associated with the computing device, wherein the identification information is usable to identify a manufacturer of the computing device, a model of the computing device, or an identification of one or more sensors of the computing device, or any combination thereof, and calibrating the sensor data based on the device identification information.
McMahon discloses sound/movement detection for a respiratory breathing system which uses a mobile device ([5]-[6])
determining device identification information associated with the computing device (system learns device (smartphone, tablet, laptop [219]) and model specific characteristics, [221]; additionally, it would have been readily understood by one in the art that specific model information such as manufacturer, serial number, model number, etc. can be found in the phone/device user settings),
wherein the identification information is usable to identify a manufacturer of the computing device, a model of the computing device, or an identification of one or more sensors of the computing device, or any combination thereof (device (phone) or model specific characteristics such as different operating systems, baseline noise characteristics of microphones, [221]-[222] number of microphones (mics) [224], presence of manufacturer or third party phone covers [231], and placement/orientation of microphone [78]), and
calibrating the sensor data based on the device identification information (system auto-calibrates to the specific device (phone) or model characteristics such as different operating systems, baseline noise characteristics of microphones, [221]-[222] number of microphones (mics) [224], presence of manufacturer or third party phone covers [231], and placement/orientation of microphone [78]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/apparatus of Lawrenson with the method of determining and calibrating the sensor data based on the specific device or model characteristic as taught in McMahon to be able to support a wide range and varieties of smart devices such as the large and disparate ecosystem of Android phones (McMahon: [221]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Paul (US 20150133809).
Regarding claim 27, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 25, further comprising
user interface identification information is usable to identify a type of the user interface (technical data (such as geometry, size, and type of patient interface); [0072]-[0073], [0094], and [0098]-[0102])
wherein identifying guidance for reducing the air leak is based on the user interface identification information (see fig. 1; advice unit 36 provides advice 56 to remove a leak based on virtual 3D model received, magnitude/position of leak, and technical data (such as type of patient interface); [0072]-[0073], [0094], and [0098]-[0102]).
Lawrenson is silent as to determining user interface identification information based on the received image data, wherein the user interface identification information is usable to identify a manufacturer of the user interface, a type of the user interface, or a model of the user interface, or any combination thereof.
Paul discloses a respiratory system with a mask guide section
determining user interface identification information based on the received image data (figs. 1-4 and 9; reading a bar code on mask/patient interface 20 or by capturing a digital image of the mask or patient interface 20 using portable electronic device 8 and using recognition software on portable electronic device 8; [0047])
wherein the user interface identification information is usable to identify a manufacturer of the user interface, a type of the user interface, or a model of the user interface, or any combination thereof (“using recognition software provided on portable electronic device 8 to identify the mask type and model from the captured image”; [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and display of apparatus (mobile device) of Lawrenson with the recognition software of Paul to determine the type and model of the patient interface in order to provide information to the user regarding the particular interface such as text, photos, drawing, instruction, or videos of the set mask model and use thereof (Paul: [0046] and [0047]).
Claims 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Vlutters (US 20160092645) and further in view of Paul (US 20150133809).
Regarding claim 35, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 1, further comprising:
receiving image data associated with the user interface (see fig. 1; take one or more images of him-/herself after he/she has worn the patient interface 18, the images are received by the receiving unit 32 of mobile device 10; [0103]); and
identifying a region of interest using the received image data (see fig. 1; advice 56 identifies area of interest that needs altering in order to remove leak; [0099]-[0102]),
wherein identifying the location of the air leak using the received acoustic data further includes using the identified region of interest (see fig. 1; advice unit 36 provides advice 56 (points to area that needs altering such as tightening/pulling the strap) to remove a leak based on virtual 3D model received, magnitude/position of leak, and technical data (such as type of patient interface); [0072]-[0073], [0094], and [0098]-[0102]), and
Lawrenson does not disclose wherein identifying the region of interest using the received image data includes: applying the image data to a comparison database to identify a matching user interface, the comparison database including a collection of geometric models of a range of user interfaces; and determining the region of interest using the matching user interface.
Vlutters discloses a method to select a patient interface based on 3d modelling by
identifying a region of interest using the received image data (see figs. 11-13; determines contour of the patient’s face and highlights areas of high interaction levels; [0076]-[0080]), wherein identifying the region of interest using the received image data (see figs. 11-13; areas of high interaction levels and low interaction levels; [0076]-[0080]) includes:
the comparison database including a collection of geometric models of a range of user interfaces (patient interface device information database 20 and geometric fit score database 360 is configured to store plurality of 3-D models of patient interface devices along with additional information associated with the patient interface devices; [0035]-[0038] and [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and display of apparatus 10 of Lawrenson with the database including 3d models/information of the patient interfaces, processor, and interaction map display of Vlutters to determine areas of high and low interaction levels that can be used to perform a visual inspection of how well the respective patient interface device fits the patient’s face such as if areas need to be adjusted for comfort or if there are areas for leaks (Vlutters: [0013]-[0016] and [0076]-[0082]).
The modified device of Lawrenson does not explicitly disclose applying the image data to a comparison database to identify a matching user interface, determining the region of interest using the matching user interface.
Paul discloses a respiratory system with a mask guide section
applying the image data to a comparison database to identify a matching user interface (figs. 1-4 and 9; identify the mask type and model from the captured image by reading a bar code on mask/patient interface 20 or by capturing a digital image of the mask or patient interface 20 using portable electronic device 8 and using recognition software on portable electronic device 8, [0047]; includes mask listing (database) of different masks, [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and display of apparatus (mobile device) of Lawrenson with the recognition software of Paul to determine the type and model of the patient interface in order to provide information to the user regarding the particular interface such as text, photos, drawing, instruction, or videos of the set mask model and use thereof (Paul: [0046] and [0047]).
It directly follows that the modified method of Lawrenson would meet the claimed structural limitations since:
The modified device of Lawrenson combined discloses
determining the region of interest (Lawrenson: see fig. 1; advice 56 identifies area of interest that needs altering in order to remove leak; [0099]-[0102]; Vlutters: see figs. 11-13; determines contour of the patient’s face and highlights areas of high interaction levels; [0076]-[0080]) using the matching user interface (Paul : recognition software to determine mask type and model; [0046] and [0047]).
Regarding claim 37, the modified method of Lawrenson further discloses
the method (Lawrenson: detecting leaks of patient interface; Vlutters: identifying region of interest using comparison of databases; Paul: recognition software for types of masks) of claim 35,
wherein identifying the location of the air leak using the received acoustic data (Lawrenson: figs. 1-3; sound analysis unit 60 may e.g. determine a magnitude and a location of a leak; [0102]) and the identified region of interest (Vlutters: see figs. 11-13; interaction map 160 determines contour of the patient’s face and highlights areas of high interaction levels that correlate to contact pressure of the patient interface to the user’s face; [0013]-[0016] and [0076]-[0082]) includes identifying a portion of the received acoustic data associated with the region of interest and analyzing the portion of the received acoustic data to identify the air leak (Lawrenson: figs. 1-3; “the sound analysis unit 60 may be configured to determine a characteristic and/or location of said sounds as well as signals received from the distance sensor 46 and/or the inertial/position sensor (not shown). Based on these information the sound analysis unit 60 may e.g. determine a magnitude and a location of a leak”; [0102]; Vlutters: see figs. 11-13; interaction map 160 determines contour of the patient’s face and highlights areas of high interaction levels; [0013]-[0016] and [0076]-[0082]; processor of modified device/method is able to determine acoustic data of leak as well as areas of interests/contact pressure based on the interaction map).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Chamtie (WO 2019006496) and further in view of Eckert (Article: Location of Leaks in Pressurized Petroleum Pipelines By Means of Passive-Acoustic Sensing Methods).
Regarding claim 39, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 38,
wherein identifying the location of the air leak using the received acoustic data and the determined relative positions of the microphone with respect to the user interface (figs. 1-3; “The sound analysis unit 60 may be configured to determine a characteristic and/or location of said sounds as well as signals received from the distance sensor 46 and/or the inertial/position sensor (not shown). Based on these information the sound analysis unit 60 may e.g. determine a magnitude and a location of a leak occurring at the interface between the patient interface 18 and the head of the patient 12.”; [0102]) includes:
determining the location of the air leak with respect to the user interface using the determined distances between the microphone and the acoustic source and the relative positions of the microphone with respect to the user interface (figs. 1-3; sound analysis unit determines a magnitude and a location of a leak occurring at the interface between the patient interface 18 and the head of the patient 12 using microphone 44 to detect sounds and distance/inertia sensor to detect position of the microphone in relation to the patient interface/head; [0102]).
Lawrenson is silent as to identifying the location of the leak including identifying one or more dominant spectral components of an acoustic source from the acoustic data; calculating an unwrapped phase of the one or more dominant spectral components over time; determining distances between the microphone and the acoustic source using the unwrapped phase; and determining the location of the air leak with respect to the user interface using the determined distances between the microphone and the acoustic source and the relative positions of the microphone with respect to the user interface.
Chamtie discloses an acoustic measurement system and method for a respiration system
identifying the location of the leak (correlating the frequency spectral components to characteristic pneumatic noise signals generated by either the pressure generator, the air conduit or the patient interface; [0057]) including
identifying one or more dominant spectral components of an acoustic source from the acoustic data (analyzing long-term changes in spectral frequency characteristics (such as dominant acoustic components and frequencies) to detect an increase of air flow leakage attributable to sealing properties of the patient interface; [0057], [0065], and [0154]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sound analysis unit and processor of Lawrenson with the acoustic detection system of Chamtie in order to creating a frequency spectrum representative of the acoustic signal and analyze the changes of spectral frequencies to detect an increase of air flow leakage (Chamtie: [0057], [0065], and [0154]).
The modified device of Lawrenson does not disclose calculating an unwrapped phase of the one or more dominant spectral components over time; determining distances between the microphone and the acoustic source using the unwrapped phase
Eckert discloses a method for determining the location of leaks using acoustic sensing methods where multiple acoustic sensors are used to measure acoustic signals (see page 4) and location algorithm is used by
calculating an unwrapped phase of the one or more dominant spectral components over time (leak location is estimated based on location algorithm which uses a coherence function analysis, measuring phase shift to estimate propagation speed of acoustic wave, estimate time delay (pages 3-4 and 9-11), and applying a phase unwrapping algorithm to measure dφ/df over a wide range of frequencies, page 14);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sound analysis unit, microphone, and spectral frequencies of the modified method of Lawrenson with the method of using multiple acoustic sensors, a location algorithm, and a phase unwrapping algorithm of Eckert provide a non-destructive method of leak location that is accurate and relatively simple to perform (Eckert: page 2).
It directly follows that the resultant sound analysis unit of modified Lawrenson combined with the unwrapping of Eckert would meet the claimed structural limitations since:
determining distances between the microphone and the acoustic source using the unwrapped phase (Lawrenson: figs. 1-3; sound analysis unit 60 which includes microphone 44; [0102]; Eckert: multiple acoustic sensors and estimating leak location using location and phase unwrapping algorithm; pages 9-14).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Lawrenson (US 20170203071) in view of Eckert (Article: Location of Leaks in Pressurized Petroleum Pipelines By Means of Passive-Acoustic Sensing Methods).
Regarding claim 40, Lawrenson discloses
the method (detecting leaks of patient interface) of claim 38,
wherein identifying the location of the air leak using the received acoustic data and the determined relative positions of the microphone with respect to the user (figs. 1-3; “The sound analysis unit 60 may be configured to determine a characteristic and/or location of said sounds as well as signals received from the distance sensor 46 and/or the inertial/position sensor (not shown). Based on these information the sound analysis unit 60 may e.g. determine a magnitude and a location of a leak occurring at the interface between the patient interface 18 and the head of the patient 12.”; [0102]) interface includes:
identifying a change in distance between the microphone and the user interface using the relative positions of the microphone with respect to the user interface over the duration of time (figs. 1-3; camera 42 and distance sensor 46 to detect a distance between microphone and known part of the patient’s head/interface; [0097] and [0101]-[0102]);
determining a change in distance between the microphone and an acoustic source over the duration of time using the identified change in distance between the microphone and the user interface (figs. 1-3; sound analysis unit determines a magnitude and a location of a leak occurring at the interface between the patient interface 18 and the head of the patient 12 using microphone 44 to detect sounds and distance/inertia sensor to detect position of the microphone in relation to the patient interface/head; [0102]).
Lawrenson does not disclose determining a phase shift of an acoustic source during the duration of time using the received acoustic data; and determining the location of the air leak using the determined phase shift, the determined change in distance between the microphone and the acoustic source over time, and a speed of sound.
Eckert discloses a method for determining the location of leaks using acoustic sensing methods where multiple acoustic sensors are used to measure acoustic signals (see page 4) and location algorithm is used by
determining a phase shift of an acoustic source during the duration of time using the received acoustic data (uses a coherence function analysis to isolate the acoustic spectrum, and measures phase shift within the frequency bands to estimate propagation speed or differential sensor separation; page 4); and
determining the location of the air leak using the determined phase shift, the determined change in distance between the microphone and the acoustic source over time, and a speed of sound (leak location is estimated based on location algorithm which uses a coherence function analysis, measuring phase shift to estimate propagation speed of acoustic wave, estimate time delay (pages 3-4 and 9-11), and applying a phase unwrapping algorithm to measure dφ/df over a wide range of frequencies, page 14), .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sound analysis unit, microphone, and spectral frequencies of the modified method of Lawrenson with the method of using multiple acoustic sensors, a location algorithm, and a phase unwrapping algorithm of Eckert provide a non-destructive method of leak location that is accurate and relatively simple to perform (Eckert: page 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Richard (US 20150306330) – A mask selection tool that has a comparison database and guidelines on how to move the camera
Lashinsky (20200384229) – A patient therapy mask selection tool that provides directions/instructions on camera setup for taking image
Sadnoori (20210038117) – a mask selection tool using a captured 3d image of the patient’s face
Selvarajan (20080060652) – A mask fitting system and method using a patient scan, questionnaire, and database to determine the best mask fit
Wickham (WO 02053217) – A mask system which determines leak using a deliberate air leak to be compared with an unintentional leak
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785