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 .
Status of Application, Amendments and Claims
Applicant's submission filed on 09 July 2026 has been entered. Claims 1-2 and 5-21 are pending in the application; claims 1, 9, 12-13 and 18-20 are amended; and claim 21 is newly added.
Response to Arguments
Applicant's arguments filed 09 July 2026 with respect to the rejections claims 1-2 and 5-21 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. The applicant argues on pages 10-11 of the remarks that the cancellation of claims 3-4 and the amendments to the remaining claims have obviated the rejections. The examiner respectfully disagrees. An updated rejection to address the amended limitation is presented below. The applicant has not specifically pointed out how the amendments to claims overcome the written description issues. The examiner maintains that the disclosure of “categorical risk values” does not sufficiently describe the invention to those of ordinary skill in the art. The applicant’s disclosure does not identify the categories and risk values that are used to practice the invention but rather merely indicates that categories and risk values may be identified as high risk or low risk. Applicant points to paragraphs [0052] and [0053] which provides examples that may be used to define high or low risk. Some examples relate to quartiles, means or medians. However, the applicant’s disclosure does not identify any particular categories or risk values and there corresponding definitions. Similarly, the applicant argues the “weighted combination of physiological information” using weighting coefficients a, b, c, d, and e is adequately described because generic “statistical analysis” and “machine learning techniques” are mentioned in the disclosure. Specifically, applicant argues paragraphs [0057] and [0058] provide and equation and list known statistical analysis techniques that would inform one of ordinary skill in the art. The examiner respectfully disagrees because the disclosure does not demonstrate a particular analysis or learning technique to determine the coefficients of the equation for any type of data. The example equation is providing examples of what data could potentially be used but does not specifically disclose equations for the physiological measures presented din the claims.
Applicant's arguments filed 09 July 2026 with respect to the rejections claims 1-2 and 5-21 under 35 U.S.C. 101 have been fully considered and are persuasive. The amendments incorporate the patent eligible limitations from claims 9, 12 and 20.
Applicant’s arguments with respect to claims 1-20 under 35 U.S.C. 102/103 have been considered but are persuasive. The prior art does not suggest weighted combination of S3, S1 and at least one of respiratory rate information, impedance information or activity information.
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.
Claims 1-2 and 5-21 are 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 claims 1-2 and 21, the limitation “risk values satisfying a pre-determined condition” in claims 1 and 21, and “wherein the predetermined condition comprises determined categorical risk values indicating the high risk” in claim 2 lack sufficient written description. The original disclosure does not define the “pre-determined condition” beyond the limitation in claim 2 presented above and paragraph [0020] of the specification, which also states “wherein the predetermined condition comprises determined categorical risk values indicating the high risk.” There is no definition of a “condition … indicating the high risk.” Thus, the disclosure does not provide sufficient disclosure of the pre-determined condition. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
Regarding claims 13-14, the limitation “risk values satisfying a condition” in claim 13 and “wherein the condition comprises determined categorical risk values indicating the high risk” in claim 14 lack sufficient written description. The original disclosure does not define the “condition” beyond the limitation in claim 2 presented above and paragraph [0020] of the specification, which states “wherein the predetermined condition comprises determined categorical risk values indicating the high risk.” There is no definition of a “condition … indicating the high risk.” Thus, the disclosure does not provide sufficient disclosure of the pre-determined condition. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
Regarding claim 18, the limitation “determine a mortality risk metric using a weighted combination of physiological information” lacks sufficient written description. The original disclosure does not explain how to determine the weighting of the physiological information. The only disclosure of determining weights is found in paragraph [0057] of the specification, which states: “For example, the function can be illustrated as: M = (a*HL-+- b*RR + c*S3/SJ)/(d*TI-+- e*Activity), where M is the mortality risk metric, HL is the HeartLogic™ index (described above), RR is respiratory rate information (e.g., daily median respiratory rate), S3/SJ is the S3 normalized by changes in S1, TI is thoracic impedance, Activity is commensurate with time active by the patient, and a, b, c, d, and e are coefficients representing weights for respective measures.” While this disclosure provides an equation, the disclosure does not describe how the weight coefficients a, b, c, d, and e are determined. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
All remaining claims are rejected based on their dependency on a claim lacking sufficient written description.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 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, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 31 July 2026
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