DETAILED ACTION
This Office Action is in response to the communication dated 11 February 2026 concerning Application No. 18/550,361 filed on 13 September 2023.
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 .
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 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.
Status of Claims
Claims 1-14 are pending and currently under consideration for patentability; claims 1, 5-7, and 9-13 have been amended.
Response to Arguments
Applicant’s arguments dated 11 February 2026 have been fully considered, but they are not persuasive or 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.
Applicant has amended the independent claims to further limit the medical device to using a blood pressure signal. Applicant argues that the Addison reference “is specifically designed to receive a plethysmograph signal” (Arguments, p. 10). The Examiner has addressed the amended limitations in the updated text of the rejection below. Specifically regarding the Addison reference, although the Examiner agrees that Addison’s description is focused on the plethysmograph signal, the Examiner respectfully submits that Addison also accounts for measuring and using subject’s blood pressure ([0074]).
Applicant argues that “Applicant’s claims require the absolute maximums/minimums of an interval to be averaged to obtain an average maximum/average minimum, whereas Addison determines the base value of an interval as the average of the maximum and minimum of the interval” (Arguments, p. 10). The Examiner respectfully submits that Addison’s description of averaging the maximum and minimum values requires that the absolute maximum and minimum values are obtained first, in order to be averaged. Therefore, the Examiner respectfully maintains that there is no substantial difference between Addison’s averaging step and that recited by Applicant’s claims.
Applicant argues that “the calculation according to Addison is based on the filtered data, whereas Applicant’s calculation is not” (Arguments, p. 11). the Examiner respectfully maintains that Addison describes that certain steps may be omitted, therefore suggesting the use of raw or unfiltered data.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (US 2014/0323824 A1).
Regarding claim 1, Addison describes a medical device for determining an extremum of a periodic signal ([0105]), comprising a computing unit 100, a memory unit 174, and a detecting unit 102 configured to detect a periodic signal of a human or animal ([0080]), the memory unit comprises a non-transitory computer-readable program ([0067]) that causes the computing unit to perform the following steps when executed on the computing unit
detecting a periodic signal with the detecting unit ([0115])
dividing the periodic signal into a plurality of equally long intervals each interval having an interval length, wherein the interval length is chosen such that it is longer than an expected maximum periodic time of the periodic signal ([0118]: “the value indicative of fluid responsiveness may be determined repeatedly over a time period corresponding to a breathing period of the subject…DPOP may be determined repeatedly every 5 seconds, every 10 seconds, or at any other suitable interval”)
determining at least one of an absolute maximum and an absolute minimum of the periodic signal within each interval ([0118])
calculating at least one of an average value of the determined absolute maxima and an average value of the determined absolute minima ([0118])
storing ([0067]) or outputting the calculated average value of the determined absolute maxima and/or the calculated average value of the determined absolute minima as extremum of the periodic signal ([0119])
Regarding claim 1, although Addison focuses on using a plethysmograph signal, Addison also describes monitoring, measuring, and performing analysis on a periodic blood pressure signal ([0037] [0074]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to determine the extrema of periodic blood pressure signal obtained by Addison, as doing so advantageously allows the resulting system to fully evaluate the subject’s blood pressure in order to monitor for potential clinical conditions.
Regarding claim 5, Addison describes wherein the detecting unit is also configured to detect a periodic physiologic signal in the form of a photoplethysmography signal ([0115]).
Regarding claim 6, Addison describes wherein the program causes the computing unit to perform the steps of detecting the periodic signal, dividing the periodic signal into a plurality of equally long intervals, determining at least one of an absolute maximum and an absolute minimum, calculating at least one average value, and storing or outputting the calculated average value without filtering a raw signal of the detected periodic signal ([0114], steps may be omitted).
Regarding claim 7, Addison describes wherein the program causes the computing unit to perform the steps of detecting the periodic signal, dividing the periodic signal into a plurality of equally long intervals, determining at least one of an absolute maximum and an absolute minimum, calculating at least one average value, and storing or outputting the calculated average value without smoothing the detected periodic signal ([0114]).
Regarding claim 8, Addison describes wherein the computing unit is a microprocessor ([0067]).
Regarding claim 9, Addison describes a non-transitory computer program product comprising computer-readable code that causes a computing unit to perform the following steps when executed on the computing unit ([0067])
detecting a periodic signal with a detecting unit of a medical device for determining an extremum of a periodic signal ([0115])
dividing the periodic signal into a plurality of equally long intervals each interval having an interval length, wherein the interval length is chosen such that it is longer than an expected maximum periodic time of the periodic signal ([0118])
determining at least one of an absolute maximum and an absolute minimum of the periodic signal within each interval calculating at least one of an average value of the determined absolute maxima and an average value of the determined absolute minima ([0118])
storing ([0067]) or outputting the calculated average value of the determined absolute maxima and/or the calculated average value of the determined absolute minima as extremum of the periodic signal ([0119])
Regarding claim 9, although Addison focuses on using a plethysmograph signal, Addison also describes monitoring, measuring, and performing analysis on a periodic blood pressure signal ([0037] [0074]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to determine the extrema of periodic blood pressure signal obtained by Addison, as doing so advantageously allows the resulting system to fully evaluate the subject’s blood pressure in order to monitor for potential clinical conditions.
Regarding claim 10, Addison describes a method for determining an extremum of a periodic signal ([0105]) with a non-implanted medical device positioned on or near an outside of a body of a human or an animal ([0029]), the medical device comprising a computing unit 100, a memory unit 174, and a detecting unit 102 configured to detect a periodic physiologic signal of the human or animal, the method comprising the following steps
detecting a periodic signal with the detecting unit ([0115])
dividing the periodic signal into a plurality of equally long intervals, each interval having an interval length, wherein the interval length is chosen such that it is longer than an expected maximum periodic time of the periodic signal ([0118])
determining at least one of an absolute maximum and an absolute minimum of the periodic signal within each interval, calculating at least one of an average value of the determined absolute maxima and an average value of the determined absolute minima ([0118])
storing ([0067]) or outputting the calculated average value of the determined absolute maxima and/or the calculated average value of the determined absolute minima as extremum of the periodic signal ([0119])
Regarding claim 10, although Addison focuses on using a plethysmograph signal, Addison also describes monitoring, measuring, and performing analysis on a periodic blood pressure signal ([0037] [0074]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to determine the extrema of periodic blood pressure signal obtained by Addison, as doing so advantageously allows the resulting system to fully evaluate the subject’s blood pressure in order to monitor for potential clinical conditions.
Regarding claim 12, Addison describes a diagnostic method for making a diagnosis of a human or animal in need thereof ([0119]), the method comprising the following steps
providing an average value of absolute maxima and/or an average value of absolute minima of a periodic signal by carrying out a method according to claim 10 ([0018])
determining a deviation of the average value of absolute maxima and/or the average value of absolute minima of the periodic signal from a given standard value ([0054])
making a diagnosis and/or a therapeutic decision with respect to a parameter or a status of health of the human or animal based on the determined deviation ([0119], [0125])
Regarding claim 13, Addison describes a diagnostic method for making a diagnosis of a human or animal in need thereof ([0119]), the method comprising the following steps
providing an average value of absolute maxima and/or an average value of absolute minima of a periodic signal by carrying out a method according to claim 10 ([0118])
determining a trend of the average value of absolute maxima and/or the average value of absolute minima of the periodic signal ([0083], [0108])
making a diagnosis and/or a therapeutic decision with respect to a parameter or a status of health of the human or animal based on the determined trend ([0119], [0125])
Regarding claim 14, Addison describes a diagnostic method according to claim 12 ([0119]).
Claims 2-4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Addison in view of Iyer et al. (US 2020/0001094 A1).
Regarding claim 2, Addison describes the medical device according to claim 1 but does not explicitly disclose wherein the medical device is a miniaturized medical device having a battery with a battery capacity of less than 150 mAh, in particular of less than 100 mAh, in particular of less than 15 mAh, in particular of less than 10 mAh. However, Iyer also describes a medical device for evaluating a periodic signal ([0005]), including wherein the medical device is a miniaturized medical device having a battery with a battery capacity of less than 150 mAh, in particular of less than 100 mAh ([0097]). As Iyer is also directed towards medical devices and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a miniaturized medical device with the battery ratings described by Iyer when using the computing steps described by Addison, as doing so advantageously allows the resulting device to have a smaller form factor and thereby be more easily implanted in a larger amount of locations. Specifically regarding the battery capacity being “less than 15 mAh, in particular of less than 10 mAh,” although neither Addison nor Iyer explicitly disclose such capacities, Iyer does state that the “examples of batteries that may be charged using the multi-axis antenna described in this paragraph are not limited to these mAh or voltage ratings, and for example may include batteries having larger or smaller mAh ratings…” ([0097], emphasis added). Therefore, as Iyer suggests that batteries with smaller battery capacities may be used, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use batteries with smaller mAh ratings, such as less than 10 mAh, as doing so would be a matter of optimizing the result-effective variable of battery capacity through routine experimentation (please see MPEP 2144.05).
Regarding claim 3, Iyer describes wherein the medical device is a miniaturized medical device consisting of implantable sensors or implantable therapeutic devices ([0004]).
Regarding claim 4, Iyer describes wherein the medical device is an active implant ([0004]).
Regarding claim 11, Addison describes a method for determining an extremum of a periodic signal ([0105]) with a medical device, the medical device comprising a computing unit 100, a memory unit 174, and a detecting unit 102 configured to detect a periodic signal of the human or animal ([0115]), the method comprising the following steps
detecting a periodic signal with the detecting unit ([0115])
dividing the periodic signal into a plurality of equally long intervals each interval, having an interval length, wherein the interval length is chosen such that it is longer than an expected maximum periodic time of the periodic signal ([0118])
determining at least one of an absolute maximum and an absolute minimum of the periodic signal within each interval, calculating at least one of an average value of the determined absolute maxima and an average value of the determined absolute minima ([0118])
storing ([0067]) or outputting the calculated average value of the determined absolute maxima and/or the calculated average value of the determined absolute minima as extremum of the periodic signal ([0119])
Regarding claim 11, although Addison focuses on using a plethysmograph signal, Addison also describes monitoring, measuring, and performing analysis on a periodic blood pressure signal ([0037] [0074]). Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to determine the extrema of periodic blood pressure signal obtained by Addison, as doing so advantageously allows the resulting system to fully evaluate the subject’s blood pressure in order to monitor for potential clinical conditions.
Regarding claim 11, Addison does not explicitly disclose using an implanted medical device implanted into a body of a human or an animal. However, Iyer also describes a medical device for evaluating a periodic signal, including wherein the medical device is an implanted medical device implanted into a body of a human or an animal ([0005]). As Iyer is also directed towards medical devices and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use an implanted medical device similar to that described by Iyer when using the steps described by Addison, as doing so advantageously allows for a larger number of devices to be used and more varieties of data to be analyzed.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792