DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/28/2026 has been entered.
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3, 6, 22-23, 30, 44-45, 75-78, 82-83, 90-93, 105, 107, 119-120, 154, 155 are pending, claims 75-78, 82-83, 90 are withdrawn.
This action is Non-Final.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 22, the limitations “wherein the determined one or more features include an amplitude of flow rate signal, wherein the control system is further configured to compare the amplitude of the flow rate signal in a range of fundamental frequency of human respiration with the amplitude of the flow rate signal at frequency ranges higher than the fundamental frequency of human respiration” lacks adequate written description for the scope being claimed. As further addressed below, the first aspect of the claim is clear in that the feature is an amplitude of a flow rate signal, which is a time domain signal. However, the requirements of the control system are not clear in what is being required as in view of the disclosure, it is not an amplitude of the time domain signal which is being evaluated, but an amplitude of a frequency domain signal of the flow rate signal. Thus such scope as set forth is not supported and not clear in meaning. The closest passage in the disclosure appears to be “For example, a relative reduction in frequency content of the signal at or around the fundamental frequency of the human respiratory rate (e.g. 6 to 30 breaths per minute, or potentially higher frequencies for children), and/or an increase in frequency content or signal amplitude and/or impulsiveness at higher frequencies may be indicative features of user movement. Analysis of the flow rate signal may include spectral analysis, such as by taking the Fourier Transform of the signal and comparing the amplitude of the signal at different frequency ranges. For example, comparing the amplitude of the signal in the range of the fundamental frequency of human respiration, with the amplitude at frequency ranges higher than the fundamental frequencies of respiration. In some implementations, the analysis can include an estimate of the amplitude modulation of the higher frequency components of the signal in the range of the fundamental frequencies of respiration. In this way, it is possible to distinguish between signal noise due to patient movement from signal noise associated with respiration, such as snoring.” As is clearly illustrated by these passages, the description does not first use a time signal for these comparisons, but uses frequency domain signals.
As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed.
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.
Claims 1, 3, 6, 22-23, 30, 44-45, 91-93, 105, 107, 119-120, 154-155 are 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.
Regarding claims 1 and 91, the limitations “A system for identifying a body position of a user of a respiratory therapy system, the system comprising:…a respiratory therapy device configured to generate pressurized air and deliver the pressurized air to the user…adjust a therapeutic pressure delivered to the user by the respiratory therapy system” and “A method for identifying a body position of a user of a respiratory therapy system during a sleep session…generating, via a respiratory therapy device, pressurized air to be delivered to the user…adjusting a therapeutic pressure delivered to the user by the respiratory therapy system” renders the claims indefinite. It is unclear whether the respiratory therapy system is the same as the therapy device as set forth in the claims. As set forth, the therapy device generates air to be delivered, but then the claims reference pressure delivered by the therapy system, which is not actually part of the claimed system of claim 1. Thus it is unclear if such a step is being completed by the positively recited components of claim 1 or components outside the system. Similarly, it is not clear what aspect is adjusting therapeutic pressure as the method states such is from the respiratory system and not the respiratory device, such that it is unclear if any adjustment therapy is actively being performed as the claims refer to such as “delivered” but the claims do not recite such function from the same structures and the metes and bounds of the claims unclear. To clarify, for the system, it is not clear whether this component is intended to be a key part of the system for implementing the therapy/adjusted therapy, or is merely an intended use of the results of the claimed system. For the method, it is not clear if any therapy is actually being actively provided to allow for any active adjusting steps to be made. For these reasons the metes and bounds of the claim are unclear which renders the claims indefinite. Perhaps the adjusting should be provided by the therapy device? For examination purposes including art and 101, the last instance of therapy system is interpreted to be therapy device.
The dependent claims are rejected for depending on a rejected claim.
Regarding claim 22, the limitations “wherein the determined one or more features include an amplitude of flow rate signal, wherein the control system is further configured to compare the amplitude of the flow rate signal in a range of fundamental frequency of human respiration with the amplitude of the flow rate signal at frequency ranges higher than the fundamental frequency of human respiration.” renders the claim indefinite. The first aspect of the claim is clear in that the feature is an amplitude of a flow rate signal, which is a time domain signal. However, the requirements of the control system are not clear in what is being required as in view of the disclosure, it is not an amplitude of the time domain signal which is being evaluated, but an amplitude of a frequency domain signal. Thus it is not clear what is meant for the claimed scope as it appears a frequency domain amplitude signal is what is evaluated for a particular range compared to the amplitude of a different range. The closest passage in the disclosure appears to be “For example, a relative reduction in frequency content of the signal at or around the fundamental frequency of the human respiratory rate (e.g. 6 to 30 breaths per minute, or potentially higher frequencies for children), and/or an increase in frequency content or signal amplitude and/or impulsiveness at higher frequencies may be indicative features of user movement. Analysis of the flow rate signal may include spectral analysis, such as by taking the Fourier Transform of the signal and comparing the amplitude of the signal at different frequency ranges. For example, comparing the amplitude of the signal in the range of the fundamental frequency of human respiration, with the amplitude at frequency ranges higher than the fundamental frequencies of respiration. In some implementations, the analysis can include an estimate of the amplitude modulation of the higher frequency components of the signal in the range of the fundamental frequencies of respiration. In this way, it is possible to distinguish between signal noise due to patient movement from signal noise associated with respiration, such as snoring.”. As the claimed features and not clear and appear to be inconsistent with the disclosure as filed, the metes and bounds of the claim are unclear which renders the claim indefinite. Due to such uncertainties and considerable speculation which must be made to the proper interpretation, it would be improper to speculatively reject the claimed features in view of prior art. MPEP 2173.06 “Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
Regarding claims 154-155, the limitations “the therapeutic pressure provided by the respiratory therapy system” lacks proper antecedent basis and the same issues of the independent claims as discussed prior. This makes the metes and bounds of the claims unclear which renders the claim indefinite. It appears that the amendments to the independent claims should be carried into these claims as well to overcome the rejections.
The dependent claims are rejected for depending on a rejected claim.
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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6, 30, 44-45, 91-93, 105, 107, 119-120, 154-155 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Goff et al. (Goff, US 2015/0367092).
Regarding claim 1, Goff teaches a system for identifying a body position of a user of a respiratory therapy system (see at least Fig. 1), the system comprising:
a respiratory therapy device configured to generate pressurized air and deliver the pressurized air to the user (see at least Figure 1, [0017]-[0019]);
a sensor configured to generate airflow data associated with the user (see at least [0017] sensors);
a memory storing machine-readable instructions (see at least Figure 1, [0019]-[0021], [0037], [0041], [0044], [0091] programmed algorithms/stored data, library inherent, or in the alternative obvious that the controller has memory with readable instructions); and
a control system including one or more processors configured to execute the machine-readable instructions (see at least Figure 1, [0041]) to:
receive the airflow data associated with the user during a sleep session (see at least [0075], [0081], [0083]);
determine one or more features derived from the airflow data associated with the user, wherein the one or more features are indicative of a respiratory pattern of the user (see at least [0017]-[0018], [0075], [0081], [0083]);
based at least in part on the determined one or more features, identify the body position of the user during a first portion of the sleep session (see at least [0017], [0075], [0081], [0083]); and
based at least in part on the identified body position of the user adjust a therapeutic pressure delivered to the user by the respiratory therapy system/device (see at least [0017]-[0019], [0081], [0083]).
Regarding claim 3, Goff teaches wherein the airflow data includes flow rate data, pressure data, or both (see at least [0019]).
Regarding claim 6, Goff teaches wherein the determined one or more features include one or more of a respiratory rate, an amplitude of flow rate signal, a change in amplitude of flow rate signal a number of apnea, a number of hypopnea events, a duration of an apnea event, a duration of a hypopnea event, a respiration rate, a change in respiration rate, an amplitude of flow rate signal, a change in amplitude of flow rate signal, a change in impulsiveness of flow rate signal, a spectral content of the flow rate signal, a randomness of the flow rate signal, a frequency content of flow rate signal a kurtosis flow rate signal, a spectral entropy of the flow rate signal, a variance of the flow rate signal, a variance of envelope of the flow rate signal, a root mean square of the flow rate signal, a median respiratory rate for the first portion of the sleep session, a standard deviation in respiratory rate for the first portion of the sleep session, a median amplitude of flow rate signal for the first portion of the sleep session, and a standard deviation in amplitude of the flow rate signal for the first portion of the sleep session (see at least [0018]-[0019], [0075], [0077], [0081] reasonably reads on the signature or lack of signature in sensor data recognized by the system for position determination).
Regarding claim 30, Goff teaches wherein the received airflow data is processed for the first portion of the sleep session to determine the one or more features associated with the user of the respiratory therapy system for the first portion of the sleep session (see at least [0051]).
Regarding claim 44, Goff teaches wherein the identifying the body position of the user of the respiratory therapy system includes comparing the determined one or more features to a plurality of historical features associated with a plurality of corresponding historical body positions (see at least [0018]-[0020], [0041], [0075], [0077], [0081] comparing data to identify signatures for head position).
Regarding claim 45, Goff teaches wherein the plurality of historical features and the plurality of corresponding historical body positions are obtained from stored data associated with (i) the user of the respiratory therapy system, (ii) one or more other users of one or more other respiratory therapy systems, or (iii) both (i) and (ii) (see at least [0018]-[0020], [0041], [0075], [0077], [0081] comparing data to identify signatures for head position by programing or preprogramming).
Regarding claim 91, Goff teaches a method for identifying a body position of a user of a respiratory therapy system during a sleep session (see at least Fig. 1), the method comprising:
generating, via a respiratory therapy device, pressurized air to be delivered to the user (see at least Figure 1, [0017]-[0019]);
receiving airflow data associated with the user of the respiratory therapy system during the sleep session (see at least [0075], [0081], [0083]);
determining one or more features derived from the airflow data associated with the user, wherein the one or more features are indicative of a respiratory pattern of the user (see at least [0017]-[0018], [0075], [0081], [0083]);
based at least in part on the determined one or more features, identifying the body position of the user during a first portion of the sleep session (see at least [0017], [0075], [0081], [0083]); and
based at least in part on the identified body position of the user, adjusting a therapeutic pressure delivered to the user by the respiration therapy system (see at least [0017]-[0019], [0081], [0083]).
Regarding claim 92, Goff teaches wherein the airflow data includes flow rate data, pressure data, or both (see at least [0019]).
Regarding claim 93, Goff teaches wherein the determined one or more features include a respiratory rate, a change in respiratory rate, an amplitude of flow rate signal, a change in amplitude of the flow rate signal, a number of apnea events, a number of hypopnea events, a duration of apnea events, a duration of hypopnea events, or any combination thereof (see at least [0018]-[0019], [0075], [0077], [0081] reasonably reads on the signature or lack of signature in sensor data recognized by the system for position determination).
Regarding claim 105, Goff teaches wherein the received airflow data is processed for the first portion of the sleep session to determine the one or more features associated with the user of the respiratory therapy system for the first portion of the sleep session (see at least [0051]).
Regarding claim 107, Goff teaches wherein the first portion of the sleep session corresponds to a number of breaths, and wherein the number of breaths is one breath, two breaths, three breaths, four breaths, or five breaths (interpretation as during of detecting to include any one of these breaths, appears to be case in [0048] indicates instantaneous detected for inhalation and expiration which would include detection for 1 breath at the least for designation of a first portion).
Regarding claim 119, Goff teaches wherein the identifying the body position of the user of the respiratory therapy system includes comparing the determined one or more features to a plurality of historical features associated with a plurality of corresponding historical body positions (see at least [0018]-[0020], [0041], [0075], [0077], [0081] comparing data to identify signatures for head position).
Regarding claim 120, Goff teaches wherein the plurality of historical features and the plurality of corresponding historical body positions are obtained from stored data associated with (i) the user of the respiratory therapy system, (ii) one or more other users of one or more other respiratory therapy systems, or (iii) both (i) and (ii) (see at least [0018]-[0020], [0041], [0075], [0077], [0081] comparing data to identify signatures for head position by programing or preprogramming).
Regarding claim 154, Goff teaches further comprising: prior to adjusting the therapeutic pressure provided by the respiratory therapy system, verify, for a predetermined period of time based on the airflow data with the user, the body position of the user during the first portion of the sleep session (claimed as intended use and not further limiting the claimed system positively recited elements, see at least [0032] time required by computer to process and implement changes).
Regarding claim 155, Goff teaches further comprising: prior to adjusting the therapeutic pressure provided by the respiratory therapy system, verifying, for a predetermined period of time based on the airflow data with the user, the body position of the user during the first portion of the sleep session (see at least [0032] time required by computer to process and implement changes).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Goff et al. (Goff, US 2015/0367092) as applied to claim 1 above, and further in view of Sullivan et al. (Sullivan, US 2017/0035303).
Regarding claim 23, the limitations are met Goff, but the limitations of wherein the determined one or more features include a kurtosis of flow rate signal, a spectral entropy of the flow rate signal, a variance of the flow rate signal, a variance of envelope of the flow rate signal, a root mean square of the flow rate signal, a variance of the root mean square of the flow rate signal, or any combination thereof are not directly taught.
Sullivan teaches a related system that uses known signal analysis techniques to evaluate body positions, which reasonably teaches the features wherein the determined one or more features include a kurtosis of flow rate signal, a spectral entropy of the flow rate signal, a variance of the flow rate signal, a variance of envelope of the flow rate signal, a root mean square of the flow rate signal, a variance of the root mean square of the flow rate signal, or any combination thereof (see [0120] “Signal analysis carried out in accordance with the present disclosure, e,g., to identify portions or features of signals corresponding to changes in body position breathing-related events, heartbeats or otherwise, may employ a variety of different signal processing techniques. Amplitude analysis, time domain analysis and/or frequency domain analysis may be carried out, utilising RMS values, variance, probability density, time history, impulse response, correlation, covariance, filters and/or Fourier transforms, for example.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predicable results of using known signal analysis techniques known for identifying body positions in order to aid in determining accurate body positions of individuals from sensed data.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 5/28/2026.
Applicant’s comments regarding the claim objections and renumbering of claims are acknowledged.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112 have been fully considered and are partially persuasive due to the amendments to the claims and arguments with support and explanation. However, the issues related to the independent claims and claim 22 are maintained as the amendments do not remedy the issues raised, or necessitate updated grounds of rejections.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered and are persuasive due to the amendments to the claims and with the interpretation as explained in the 112b rejections that the last instance of therapy system is interpreted to be therapy device. The rejections are withdrawn.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive as the amended scope is still taught by the disclosure of Goff. Applicant argues that the amended features are not taught because the reference uses gravity to determine position. This is not found persuasive because the gravitational movement causes signature changes in the airflow signals captured, which are indicative of respiration (i.e. including oscillations [0018] occur due to respiration flow and are indicative of such respiration flow pattern occurring), which is used to identify the position, thus, the scope of the features claimed are indeed taught ([0017] “In some embodiments, the gravity-driven physical sensing systems employ an element which, when actuated by gravity, modifies the airflow through the device, creating an airflow signature. This airflow signature is recognized by the air pressure and/or airflow sensors in the system (e.g., which may be integrated into a PAP system console), and used to determine the position of the device user.”). The rejections are respectfully maintained as presented above to account for the amendments to the claims.
Conclusion
No prior art rejection has been applied to claim 22 as explained above, See MPEP 2173.06 In re Steele, but the claim is not allowable due to the rejections under 35 U.S.C. 101/112.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2005/0107722, US 2015/0313535 teach related features of position detection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
Prosecution Insights