DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
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been timely paid, the finality of the previous Office action (mailed 17 December 2025, "1st Final Rejection") has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 February 2026 has been entered.
Status of Claims
Claim(s) 137 and 158 is/are currently amended. Claim(s) 1-136 has/have been canceled. New claim(s) 161 has/have been added. Claim(s) 137-161 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) presented in the 1st Final Rejection, but not reproduced below, has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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 pre-AIA 35 U.S.C. 112, first paragraph:
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(s) 137-161 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 137 and claims dependent thereon, Applicant discloses determining a current estimated oxygen desaturation signal based on sensed physiologic information including rotational chest wall motion, a breath-to-breath timing, and/or a respiratory motion amplitude (Fig. 20; ¶ [00258]). Applicant further discloses, "It will be understood that these inputs are mere examples, and that the known inputs (from the implanted accelerometer signal) may comprise any sensed physiologic information (including respiratory information) pertinent to determining an estimated blood oxygen desaturation" (¶ [00258]). Applicant neither appears to expressly identify any other physiologic information that is "pertinent to determining an estimated blood oxygen desaturation," nor discloses any criteria/characteristics of sufficiently "pertinent" physiological information by which one of ordinary skill in the art could ascertain what physiological information is encompassed by the above-noted disclosure. Accordingly, the only physiologic information Applicant sufficiently discloses as being useable to determine a current estimated oxygen desaturation signal are the respiratory motion parameters of rotational chest wall motion, a breath-to-breath timing, and/or a respiratory motion amplitude. Applicant discloses respiratory motion may be sensed/measured with an accelerometer implanted in a "respiratory body portion," such as the chest or abdomen (¶ [00166]). However, claim 137 recites sensing any physiological information via an accelerometer implanted in any location or portion of a body of a user, and determining a current estimated oxygen desaturation signal based on said physiological information. The scope of claim 137 encompasses, as one example, sensing physiological information from an accelerometer implanted in a peripheral region of the body (Fig. 2C, 285) and determining a current estimated oxygen desaturation signal based only on said physiological information. Applicant fails to sufficiently disclose physiological information that may be sensed from a peripheral region that is "pertinent to determining an estimated blood oxygen desaturation," or disclose any algorithm using such information for determining a current estimated oxygen desaturation signal. Accordingly, the scope of claim 137 is broader than the subject matter sufficiently disclosed and therefore is directed to and/or encompasses new matter.
Regarding claim 138 and claims dependent thereon, claim 137 requires treating OSA in response to an amplitude of the current estimated oxygen desaturation signal meeting a predetermined criteria, thereby indicating/implying "an amplitude of the current estimated oxygen desaturation signal meeting a predetermined criteria" is indicative of OSA, or an OSA event. Accordingly, the relationship between applying stimulation therapy to an upper airway patency-related nerve to treat OSA in response to an amplitude of the current estimated oxygen desaturation signal meeting a predetermined criteria as required by claim 137, and implementing the determination of the SDB measurement as an OSA measurement as required by claim 138 is unclear. Specifically, it is unclear if "implementing the determination of the sleep disordered breathing measurement as an obstructive sleep apnea (OSA) event measurement" encompasses determining if an amplitude of the current estimated oxygen desaturation signal meets the predetermined criteria, which must logically occur before stimulation therapy is applied, or if claim 138 requires a further "implementation" of the sleep disordered breathing measurement and/or current estimated oxygen desaturation signal. If the latter, it is further unclear what step(s) "implementation" requires.
Regarding claim 141 and claims dependent thereon, Applicant discloses sensing respiratory rate and/or tidal volume (e.g., ¶¶ [00568]-[00569]) via an implanted accelerometer, and further discloses respiratory rate and/or tidal volume may be used to identify a recovery period(s) (e.g., ¶¶ [00273]-[00273]). However, Applicant fails to disclose determining a current estimated oxygen desaturation signal based on respiratory rate and/or tidal volume, and/or fails to provide any indication respiratory rate and/or tidal volume are pertinent to determining an estimated blood oxygen desaturation. Accordingly, claim 141 is directed to and/or encompasses new matter.
Regarding claims 142-144 and claims dependent thereon, Applicant discloses sensing other non-respiratory gross body movement (body position), with or without posture information (e.g., ¶ [00315]) via an implanted accelerometer (e.g., ¶ [00324]). Applicant fails to disclose either sensing periodic limb movement via an implanted accelerometer, or sensing snoring via an implanted accelerometer. Rather, Applicant discloses limb movement may be sensed via EMG measurements and/or computer vision (¶ [00232]), and snoring may be sensed via an external microphone (¶ [00332]). Applicant further fails to disclose determining a current estimated oxygen desaturation signal based on any of periodic limb movement, other non-respiratory gross body movement, and/or snoring, and/or fails to provide any indication periodic limb movement, other non-respiratory gross body movement, and/or snoring are pertinent to determining an estimated blood oxygen desaturation. Accordingly, claims 142-144 are directed to and/or encompass new matter.
Regarding claims 145-147 and claims dependent thereon, Applicant sufficiently discloses sensing first physiological information including rotational chest wall motion, a breath-to-breath timing, and/or a respiratory motion amplitude, using said first physiological information along with an externally measurable oxygenation desaturation measurement to construct a data model relating the first physiological information and a current estimated oxygen desaturation signal (Fig. 20) and implementing a determination of a subsequent current estimated oxygen desaturation signal using second, later measurements of the above-noted physiological information and the constructed data model (Fig. 21).
Applicant further discloses at least one externally measurable input including respiration information may be used a known input in constructing the above-noted data model (e.g., Fig. 22), and broadly discloses, "It will be understood that additional and/or other externally measured inputs 1720 may be used which are pertinent to respiration, oxygen desaturation, and/or related parameters" (¶ [00263]). Applicant neither appears to expressly identify any other physiologic information or externally-measurement input that is "pertinent to respiration, oxygen desaturation, and/or related parameters," nor discloses any criteria/characteristics of sufficiently "pertinent" physiological information by which one of ordinary skill in the art could ascertain what physiological information is encompassed by the above-noted disclosure. Accordingly, the only externally measurable input Applicant sufficiently discloses as being useable to construct the data model is respiration information, including inspiratory effort, breath-to-breath timing, and/or respiratory airflow (e.g. amplitude) (Fig. 22; ¶ [00263]). In view of the above, Applicant fails to disclose determining a current estimated oxygen desaturation signal based on externally measurable cardiac information, including heart rate, heart rate variability, and/or frequency content of heart rate variability, or on externally measurable non-respiratory body movement information, or constructing the data model based on said cardiac information.
Lastly, Applicant fails to disclose constructing a data model for determining a current estimated oxygen desaturation signal using a measurable output comprising an externally measurable OSA event measurement. For at least the reasons noted above, claims 145-147 are directed to and/or encompass new matter.
Regarding claims 148, 150-153 and claims dependent thereon, similar to claims 144-147 discussed above, Applicant sufficiently discloses sensing first physiological information including rotational chest wall motion, a breath-to-breath timing, and/or a respiratory motion amplitude, using said first physiological information along with an externally measurable oxygenation desaturation measurement to construct a data model relating the first physiological information and a current estimated oxygen desaturation signal (Fig. 20) and implementing a determination of a subsequent current estimated oxygen desaturation signal using second, later measurements of the above-noted physiological information and the constructed data model (Fig. 21). However, Applicant fails to disclose other physiological information that may be sensed via the implanted accelerometer may be useable in constructing said data model and/or useable with the constructed data model. Specifically, Applicant fails to sufficiently disclose what, if any, other physiological information sensed via the implanted accelerometer falls within the scope of being "pertinent to determining an estimated blood oxygen desaturation." More particularly, Applicant fails to disclose determining a current estimated oxygen desaturation signal based on cardiac information, including heart rate, heart rate variability, and/or frequency content of heart rate variability, sensed via the implanted accelerometer, or constructing a data model for such a determination using said cardiac information as an input.
Applicant does disclose at least one externally measurable input including respiration information may be used a known input in constructing the above-noted data model (e.g., Fig. 22). Applicant further broadly discloses, "It will be understood that additional and/or other externally measured inputs 1720 may be used which are pertinent to respiration, oxygen desaturation, and/or related parameters" (¶ [00263]). Applicant neither appears to expressly identify any other externally-measurable input that is "pertinent to respiration, oxygen desaturation, and/or related parameters," nor discloses any criteria/characteristics of sufficiently "pertinent" externally-measurable inputs by which one of ordinary skill in the art could ascertain what physiological information is encompassed by the above-noted disclosure. Accordingly, the only externally measurable input Applicant sufficiently discloses as being useable to construct the data model is respiration information, including inspiratory effort, breath-to-breath timing, and/or respiratory airflow (e.g. amplitude) (Fig. 22; ¶ [00263]). In view of the above, Applicant fails to disclose determining a current estimated oxygen desaturation signal based on externally measurable cardiac information, including heart rate, heart rate variability, and/or frequency content of heart rate variability, or externally measurable non-respiratory body movement information, or constructing the data model based on said cardiac and/or non-respiratory body movement information.
Lastly, Applicant fails to disclose constructing a data model for determining a current estimated oxygen desaturation signal using a measurable output comprising an externally measurable obstructive sleep apnea (OSA) event measurement. For at least the reasons noted above, claims 148-153 are directed to and/or encompass new matter.
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 pre-AIA 35 U.S.C. 112, 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(s) 137-161 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 137 and claims dependent thereon, the limitation "in response to an amplitude of the current estimated oxygen desaturation signal meeting a predetermined criteria" is indefinite, particularly the use of "a […] criteria." It is unclear if "criteria," a plural noun, is being used as a singular noun (e.g., comparable to the manner in which "data" is sometimes used as a singular, despite "datum" being the proper singular form), and the amplitude of the current estimated oxygen desaturation signal is only required to meet a single condition, or if "meeting […] criteria" requires the amplitude of the current estimated oxygen desaturation signal to satisfy multiple conditions before stimulation therapy is applied.
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791