Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to the election and claims filed 10/16/25. Claims 1-52 are pending with claims 12-19 and 38-45 withdrawn as being directed towards non-elected subject matter. Claims 1-11, 20-37, and 46-52 are examined below.
Election/Restrictions
Claims 12-19 and 38-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/16/25.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 202 and 413. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 403. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 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 1-11, 20-21, 26-37, 46-47, and 52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., law of nature, natural phenomenon, or an abstract idea) without significantly more.
Each of claims 1-11, 20-21, 26-37, 46-47, and 52 have been analyzed to determine whether it is directed to any judicial exceptions
Step 2A, Prong 1
The claims recite at least one step or instruction for receiving a signal from a sensor, calculating a measure indicative of arousal based thereon, and indicating an occurrence of arousal event, which is grouped as a mental process and/or mathematical concept under the 2019 PEG. Accordingly, each of the claims recites an abstract idea.
Specifically, claims 1 and 27 recites receiving a signal (observation, which is a mental process under the 2019 PEG); calculating a measure indicative of arousal (judgement or evaluation, which is a mental process and/or mathematical concept under the 2019 PEG); and indicating an occurrence of an arousal event based thereon (judgement or evaluation, which is a mental process under the 2019 PEG).
Accordingly, as indicated above, the above identified claim recites an abstract idea.
Further, dependent claims 2-11, 20-21, 26, 28-37, 46-47, and 52 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 (claim 20 and 46 for example) because they’re merely incidental or token additions to the claims that do not alter or affect how the mental process/mathematical concept steps are performed (claim 21 and 47 for example which set forth well-known and conventional element of a flow generator, claims 1 and 27 which set forth a sensor and a controller).
Step 2A, Prong 2
The above-identified abstract idea in each independent claims 1 and 27 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG because they do not include any additional elements or steps which, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. In light of the disclosure it is understood that a controller is performing the steps of receiving a signal from a sensor, calculating and indicating arousal event and such a controller is a generic computer element which do not improve the functioning of a computer, or any other technology or technical field. Nor would the controller 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 controller and sensor do not add a meaningful limitations to the abstract idea because it amounts to simply implementing the abstract idea on a computer system. 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.
For at least these reasons, the abstract idea identified above in independent claims 1 and 27 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Step 2B
None of claims 1-11, 20-21, 26-37, 46-47, and 52 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims do not appear to include additional elements that amount to significantly more than the judicial exception. As discussed above, independent claims 1 and 27 include a sensor and a controller and dependent claims 21 and 47 include elements such as a flow generator, but these are well-known and conventional elements in the art and do not amount to significantly more than the abstract idea. However, such a controller is reasonably construed as a generic computer 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 controller. 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).
A recitation of a controller 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 obtain, manipulate or display 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 claims 1-11, 20-21, 26-37, 46-47, and 52 are directed to applying an abstract idea (e.g., mental process and/or mathematical concept) 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 the claims 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 and 27 (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 1-11, 20-21, 26-37, 46-47, and 52 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 amounts to significantly more than the abstract idea itself. Accordingly, claims 1-11, 20-21, 26-37, 46-47, and 52 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.
Note: claims 22, 47, and their dependents are not rejected under 35 USC 101 because the claim specifies that the controller adjusts respiratory therapy based on the indication of occurrence of arousal event.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-2, 20-23, 27-28, and 46-49 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport et al. (2006/0009708) in view of Yagi (4,798,538).
Regarding claim 1, Rapoport discloses an apparatus for detection of arousal from sleep (see Fig. 1 showing a positive airway pressure system/apparatus, abstract and para. 0023-0026, and 0030 disclosing ability to detect sleep state including awake/arousal from sleep), the apparatus including at least one sensor and a controller (see Fig. 1, sensor 23 para. 0020, controller 24 or 24 and 25, para. 0020) the controller configured to receive a signal from the sensor to generate a measure of respiratory flow (see para. 0020 and 0023-0024 for example, controller receives signal from sensor corresponding to airflow such as breath pattern); calculate a measure indicative of arousal based on the measure of respiratory flow wherein the calculated measure indicative of arousal is a ventilation/breathing pattern (see para. 0023-0026 and 0030, the patients breathing pattern is monitored and their sleep status is calculated including arousal/awake state); and indicating an occurrence of an arousal event based on the calculated measure (see para. 0023-0026 and 0030-0034, adjusting/controlling pressure based on arousal/awake state is an indication of an occurrence of an arousal event). Rapoport discloses determining measure indicative of arousal based on ventilation/breathing pattern (para. 0023-0025), but is silent as to using a ventilation ratio representing an increase in ventilation; however, changes in breathing pattern would include either an increase or decrease of a breathing pattern parameter and Yagi discloses ventilation ratio being a well-known parameter for determining ideal breathing pattern (see Yagi abstract, col. 2 ln. 42-62 and col. 3 ln. 55-65 for example). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Rapoport device to utilize ventilation ratio as its breathing pattern parameter, as taught by Yagi, as this is a well-known parameter indicative of ideal breathing pattern (Yagi abstract, col. 2 ln. 42-62 and col. 3 ln. 55-65) and it would have been obvious to try/choose an increase to this parameter from finite number of possibilities.
Regarding claim 2, the modified Rapoport device’s calculated measure includes ventilation change following an indication of flow limitation in a measure of flow limitation (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation).
Regarding claim 20, the modified Rapoport device’s controller is configured to determine a count of arousal incidents with the indication of the arousal event for evaluation of a respiratory therapy (see Rapoport para. 0023-0026 and 0030-0034, adjusting/controlling pressure based on arousal/awake state is an indication of an occurrence of an arousal event and as such each change would represent a count thereof).
Regarding claim 21, the modified Rapoport device includes a flow generator and the controller being configured to control the flow generator to provide a respiratory therapy (see Rapoport Fig. 1 and para. 0020, flow generator 22; see also para. 0023-0026 and 0030-0034).
Regarding claim 22, the modified Rapoport device’s controller is configured to adjust the respiratory therapy based on the indication of the occurrence of the arousal event (see Rapoport para. 0023-0026 and 0030-0034).
Regarding claim 23, the modified Rapoport device is such that an index representing the indication of arousal event is input to a therapy algorithm (see Rapoport para. 0023-0026 and 0030-0034 which discloses therapy algorithm performed by controller/system, para. 0025 disclosing indices, it being obvious to apply indices of arousal/awaken state).
Regarding claim 27, the use of the Rapoport system includes a method in a controller of an apparatus for detection of arousal from sleep (see Fig. 1 showing a positive airway pressure system/apparatus, controller 24 or 24 and 25, para. 0020, abstract and para. 0023-0026, and 0030 disclosing ability to detect sleep state including awake/arousal from sleep) including the steps of receiving a signal from a sensor (see Fig. 1, sensor 23 para. 0020) configured to generate a measure of respiratory flow (see para. 0020 and 0023-0024 for example, controller receives signal from sensor corresponding to airflow such as breath pattern); calculating a measure indicative of arousal based on the measure of respiratory flow wherein the calculated measure indicative of arousal is a ventilation/breathing pattern (see para. 0023-0026 and 0030, the patients breathing pattern is monitored and their sleep status is calculated including arousal/awake state); and indicating an occurrence of an arousal event based on the calculated measure (see para. 0023-0026 and 0030-0034, adjusting/controlling pressure based on arousal/awake state is an indication of an occurrence of an arousal event). Rapoport discloses determining measure indicative of arousal based on ventilation/breathing pattern (para. 0023-0025), but is silent as to using a ventilation ratio representing an increase in ventilation; however, changes in breathing pattern would include either an increase or decrease of a breathing pattern parameter and Yagi discloses ventilation ratio being a well-known parameter for determining ideal breathing pattern (see Yagi abstract, col. 2 ln. 42-62 and col. 3 ln. 55-65 for example). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Rapoport method to utilize ventilation ratio as its breathing pattern parameter, as taught by Yagi, as this is a well-known parameter indicative of ideal breathing pattern (Yagi abstract, col. 2 ln. 42-62 and col. 3 ln. 55-65) and it would have been obvious to try/choose an increase to this parameter from finite number of possibilities.
Regarding claim 28, the modified Rapoport method’s calculated measure includes ventilation change following an indication of flow limitation in a measure of flow limitation (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation).
Regarding claim 46, the modified Rapoport method’s controller is configured to determine a count of arousal incidents with the indication of the arousal event for evaluation of a respiratory therapy (see Rapoport para. 0023-0026 and 0030-0034, adjusting/controlling pressure based on arousal/awake state is an indication of an occurrence of an arousal event and as such each change would represent a count thereof).
Regarding claim 47, the modified Rapoport method includes a flow generator and the controller being configured to control the flow generator to provide a respiratory therapy (see Rapoport Fig. 1 and para. 0020, flow generator 22; see also para. 0023-0026 and 0030-0034).
Regarding claim 48, the modified Rapoport method’s controller is configured to adjust the respiratory therapy based on the indication of the occurrence of the arousal event (see Rapoport para. 0023-0026 and 0030-0034).
Regarding claim 49, the modified Rapoport method is such that an index representing the indication of arousal event is input to a therapy algorithm (see Rapoport para. 0023-0026 and 0030-0034 which discloses therapy algorithm performed by controller/system, para. 0025 disclosing indices, it being obvious to apply indices of arousal/awaken state).
Claims 3-4 and 29-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport and Yagi as applied to claims 2, 1, 28, and 27 above, and further in view of Stahmann et al. (2005/0115561).
Regarding claim 3, the modified Rapoport device is silent as to the controller determining a measure of flow limitation and to buffer the values (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation); however, Stahmann discloses a similar device which includes buffering gathered parameter values (see Stahmann para. 0799, 0806, and 0807). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to buffer parameter values, as taught by Stahmann, in order to provide temporary storage of data values.
Regarding claim 4, the modified Rapoport device is silent as to the controller configured to buffer values of the ventilation ratio; however, Stahmann discloses a similar device which includes buffering gathered parameter values (see Stahmann para. 0799, 0806, and 0807). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to buffer parameter values, as taught by Stahmann, in order to provide temporary storage of data values.
Regarding claim 29, the modified Rapoport method is silent as to the controller determining a measure of flow limitation and to buffer the values (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation); however, Stahmann discloses a similar device which includes buffering gathered parameter values (see Stahmann para. 0799, 0806, and 0807). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport method to buffer parameter values, as taught by Stahmann, in order to provide temporary storage of data values.
Regarding claim 30, the modified Rapoport method is silent as to the controller configured to buffer values of the ventilation ratio; however, Stahmann discloses a similar device which includes buffering gathered parameter values (see Stahmann para. 0799, 0806, and 0807). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport method to buffer parameter values, as taught by Stahmann, in order to provide temporary storage of data values.
Claims 7 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport, Yagi, and Stahmann as applied to claims 3 and 29 above, and further in view of Rapoport et al. (5,490,502) (hereinafter Rapoport ‘502.
Regarding claim 7, the modified Rapoport device is silent as to summing flow limitation values and to limit the sum to a range; however, Rapoport ‘502 teaches a similar device which teaches this summation feature (see Rapoport ‘502 col. 7 ln. 55 through col. 8 ln. 3). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to sum values, as taught by Rapoport ‘502, as this is a well-known data processing technique and would have been obvious to try to provide improved data processing.
Regarding claim 33, the modified Rapoport method is silent as to summing flow limitation values and to limit the sum to a range; however, Rapoport ‘502 teaches a similar device which teaches this summation feature (see Rapoport ‘502 col. 7 ln. 55 through col. 8 ln. 3). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport method to sum values, as taught by Rapoport ‘502, as this is a well-known data processing technique and would have been obvious to try to provide improved data processing.
Claims 8 and 34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport and Yagi as applied to claims 1 and 27 above, and further in view of Rapoport ‘502.
Regarding claim 8, the modified Rapoport device is silent as to the controller indicating arousal based on a limited sum of flow limitation values and maximum ventilation ratio (it being obvious to choose max values of the ratio signaling greater change in breathing pattern); however, Rapoport ‘502 teaches a similar device which teaches this summation feature (see Rapoport ‘502 col. 7 ln. 55 through col. 8 ln. 3). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to sum values, as taught by Rapoport ‘502, as this is a well-known data processing technique and would have been obvious to try to provide improved data processing.
Regarding claim 34, the modified Rapoport method is silent as to the controller indicating arousal based on a limited sum of flow limitation values and maximum ventilation ratio (it being obvious to choose max values of the ratio signaling greater change in breathing pattern); however, Rapoport ‘502 teaches a similar device which teaches this summation feature (see Rapoport ‘502 col. 7 ln. 55 through col. 8 ln. 3). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to sum values, as taught by Rapoport ‘502, as this is a well-known data processing technique and would have been obvious to try to provide improved data processing.
Claims 24 and 50 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport and Yagi as applied to claims 23 and 49 above, and further in view of Berthon-Jones (5,704,345).
Regarding claim 24, the modified Rapoport device is silent as to explicitly setting a threshold for evaluation of a flow limitation index for raising pressure (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation, para. 0025 disclosing indices); however, Berthon-Jones teaches a similar device which includes setting threshold values for evaluation (see Berthon-Jones col. 2 ln. 47-61 and col. 3 ln. 4-21). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to set thresholds for evaluation, as taught by Berthon-Jones, as this is a well-known technique for data processing and prevent false positives to raise pressure when not needed.
Regarding claim 50, the modified Rapoport method is silent as to explicitly setting a threshold for evaluation of a flow limitation index for raising pressure (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation, para. 0025 disclosing indices); however, Berthon-Jones teaches a similar device which includes setting threshold values for evaluation (see Berthon-Jones col. 2 ln. 47-61 and col. 3 ln. 4-21). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport method to set thresholds for evaluation, as taught by Berthon-Jones, as this is a well-known technique for data processing and prevent false positives to raise pressure when not needed.
Claims 25 and 51 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rapoport and Yagi as applied to claims 23 and 49 above, and further in view of Estes (5,794,615).
Regarding claim 25, the modified Rapoport device is silent as to the index of indication of arousal event being applied to set a gain for raising pressure in response to flow limitation index (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation, para. 0025 disclosing indices); however, Estes teaches a similar respiratory therapy device which includes controlling pressure/flow of respiratory therapy device by setting a gain (see Estes Fig. 4, abstract, col. 13 ln. 11-23 for example). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport device to set a gain for raising pressure, as taught by Estes, as this is a well-known method of controlling pressure adjustment in a respiratory therapy device and would be obvious substitution/obvious to try.
Regarding claim 51, the modified Rapoport method is silent as to the index of indication of arousal event being applied to set a gain for raising pressure in response to flow limitation index (Rapoport para. 0020, 0023-0025, detection of apnea, i.e. flow limitation, para. 0025 disclosing indices); however, Estes teaches a similar respiratory therapy device which includes controlling pressure/flow of respiratory therapy device by setting a gain (see Estes Fig. 4, abstract, col. 13 ln. 11-23 for example). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the modified Rapoport method to set a gain for raising pressure, as taught by Estes, as this is a well-known method of controlling pressure adjustment in a respiratory therapy device and would be obvious substitution/obvious to try.
Allowable Subject Matter
Claims 5-6, 9-11, 26, 31-32, 35-37, and 52 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
Prosecution Insights