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 .
Priority
This application is a continuation of US Application no. 17/404,542, now US Patent no. 12,005,258, filed 17 August 2021, which is a division of US Application no. 16/394,942, filed 25 April 2019, now abandoned, which claims the benefit of domestic priority from US Provisional Application no. 62/663,055 filed 26 April 2018.
Information Disclosure Statement
The information disclosure statements filed 2 June 2025 and 9 August 2024 have been considered.
Claim Rejections - 35 USC § 102
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 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(s) 21-23, 28, and 30 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by An et al. (US Publication no. 2013/0116578 – disclosed by Applicant).
In regard to claim 21, An et al. is directed to system that manages patient therapy and includes a risk analysis technique to detect heart failure risk and possible worsening heart failure conditions. The following is disclosed:
an implantable medical device comprising one or more electrodes configured to be implanted within a patient's body, to acquire first signals sensed from within the patient's body, and to generate first data transmissions in response to the acquired first signals (para 4, 37-39, IMD 102) ;
a non-implantable device comprising one or more electrodes configured to be positioned in contact with an external surface of the patient's body, to acquire second signals sensed from the external surface of the patient's body, and to generate second data transmissions in response to the acquired second signals (para 4, 37, 41, and 42; one or more external sensors 107 may be used to measure physiological data, e.g., blood pressure measured from a sphygmomanometer worn on a some portion of the subject); and
one or more processors configured to: (para 177, e.g., microprocessor, ASIC, etc) (see para 170-203 discussing the algorithms for determining the heart failure status of the patient outlined in the steps below):
receive the first data transmissions and the second data transmissions (para 188, 190, 192, and 200; one or more physiological signals are obtained), calculate a heart failure risk score based on the received first data transmissions and the received second data transmissions (para 190 and 200; a risk analysis module 3005 determines a heart failure risk score by comparing the first physiological parameter to a pre-specified threshold; the heart failure risk score is calculated for more than one physiological parameters), wherein the first data transmissions are weighted differently than the second data transmissions (para 200; individual risk scores may be calculated for a plurality of individual physiological measurements, wherein the individual risk scores may be combined using a weighted function; para 54, weightings used on the weighted function may be assigned based on certain factors such as reliability of the type of sensor used), and determine a heart failure worsening episode based on the heart failure risk score (para 191-193, the heart failure risk score is used by the WHF detection module 3010 to indicate a worsening heart failure risk; para 204 the heart failure risk score is used to indicate susceptibility of the subject to experiencing worsening heart failure).
In regard to claim 22, An et al. teach that the one or more processors are associated with the implantable medical device, the non-implantable medical device, or both (para 177).
In regard to claim 23, An et al. teach that the one or more processors is further configured to display, on a graphical user interface, one of an indication of the heart failure worsening episode or the heart failure risk score in response to determination of the heart failure worsening episode (para 176, the indication of predicted worsening heart failure as determined by the heart failure risk score is communicated to a device for display).
In regard to claim 28, An et al. is directed to system that manages patient therapy and includes a risk analysis technique to detect heart failure risk and possible worsening heart failure conditions. The following is disclosed:
method for managing patient therapy, the method comprising:
acquiring, from one or more electrodes associated with an implantable medical device disposed within a patient's body, first signals sensed from within the patient's body and generating first data transmissions in response to the acquired first signals (para 4, 37-39, IMD 102);
acquiring, from electrodes capable of being positioned over an external surface of the patient's body, second signals from the external surface of the patient's body and generating second data transmissions in response to the acquired second signals (para 4, 37, 41, and 42; one or more external sensors 107 may be used to measure physiological data, e.g., blood pressure measured from a sphygmomanometer worn on a some portion of the subject);
receiving, via one or more processors, the first data transmissions and the second data transmissions (para 177, e.g., microprocessor, ASIC, etc) (see para 170-203 discussing the algorithms for determining the heart failure status of the patient outlined in the steps below; para 188, 190, 192, and 200; one or more physiological signals are obtained);
calculating, via the one or more processors, a heart failure risk score based on the received first data transmissions and the received second data transmissions (para 190 and 200; a risk analysis module 3005 determines a heart failure risk score by comparing the first physiological parameter to a pre-specified threshold; the heart failure risk score is calculated for more than one physiological parameters), wherein the first data transmissions are weighted differently than the second data transmissions (para 200; individual risk scores may be calculated for a plurality of individual physiological measurements, wherein the individual risk scores may be combined using a weighted function; para 54, weightings used on the weighted function may be assigned based on certain factors such as reliability of the type of sensor used);
determining, via the one or more processors, whether data of the received first data transmissions and the received second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score (para 191-193, the heart failure risk score is used by the WHF detection module 3010 to indicate a worsening heart failure risk; para 204 the heart failure risk score is used to indicate susceptibility of the subject to experiencing worsening heart failure).
In regard to claim 30, An et al. teach that the one or more processors is further configured to display, on a graphical user interface, one of an indication of the heart failure worsening episode or the heart failure risk score in response to determination of the heart failure worsening episode (para 176, the indication of predicted worsening heart failure as determined by the heart failure risk score is communicated to a device for display).
In regard to claim 35, An et al. is directed to system that manages patient therapy and includes a risk analysis technique to detect heart failure risk and possible worsening heart failure conditions. The following is disclosed:
an implantable device comprising one or more electrodes, the implantable device configured to acquire first signals sensed from within a patient's body, and to generate first data transmissions in response to the acquired first signals (para 4, 37-39, IMD 102);
a non-implantable device comprising one or more electrodes, the non-implantable device configured to acquire second signals sensed from an external surface of the patient's body, and to generate second data transmissions in response to the acquired second signals (para 4, 37, 41, and 42; one or more external sensors 107 may be used to measure physiological data, e.g., blood pressure measured from a sphygmomanometer worn on a some portion of the subject); and
one or more processors configured to (para 177, e.g., microprocessor, ASIC, etc) (see para 170-203 discussing the algorithms for determining the heart failure status of the patient outlined in the steps below):
receive the first data transmissions and the second data transmissions (para 188, 190, 192, and 200; one or more physiological signals are obtained),
adjust the received second data transmissions based on a correction factor determined based on comparison of the received first data transmissions and the received second data transmissions (para 200; individual risk scores may be calculated for a plurality of individual physiological measurements, wherein the individual risk scores may be combined using a weighted function; para 54, weightings used on the weighted function may be assigned based on certain factors such as reliability of the type of sensor used, in this manner, the weighting applied by An et al. is considered to comprise the adjustment recited here. The reasoning for this is found in the present specification at paragraph 92 which teaches that the correction factor is the weighting factor assigned to the type of sensor),
calculate a heart failure risk score based on the adjusted second data transmissions, determine whether data of the adjusted second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score (para 190 and 200; a risk analysis module 3005 determines a heart failure risk score by comparing the first physiological parameter to a pre-specified threshold; the heart failure risk score is calculated for more than one physiological parameters).
In regard to claim 36, An et al. teach that the one or more processors is further configured to display, on a graphical user interface, one of an indication of the heart failure worsening episode or the heart failure risk score in response to determination of the heart failure worsening episode (para 176, the indication of predicted worsening heart failure as determined by the heart failure risk score is communicated to a device for display).
In regard to claims 37-39, An et al. teach that the score is calculated in real-time, periodically, recurrently, etc (para 54, 112).
In regard to claim 40, An et al. teach that the heart failure risk score is calculated based on the adjusted second data transmissions and the first data transmissions (para 191-193, the heart failure risk score is used by the WHF detection module 3010 to indicate a worsening heart failure risk; para 204 the heart failure risk score is used to indicate susceptibility of the subject to experiencing worsening heart failure).
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 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.
Claim(s) 24-27 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over An et al. (US Publication no. 2013/0116578 – disclosed by Applicant).
In regard to claims 24-27 and 31-34, An et al. does not provide teaching for the particular weightings afforded to the first and second data transmissions. An et al. teaches that signal from different sensors may be weighted differently (para 200). Additionally, An et al. teach that the weighting afforded to the signal may be based on the types or number of sensors used (para 53). Specifics with regard to the actual weightings are absent. However, the particular weightings recited are considered to comprise result effective variables for providing optimized estimations. It has been held by the reviewing courts that discovering an optimum value of a result effective variable only involves routine skill in the art. In re Boesch, 617 F.2d 272,205, USPQ 215 (CCPA 198C). Therefore the weightings are considered obvious.
Further in regard to claims 27 and 34, An et al. suggests that due to reliability of certain types of sensors, more reliable sensors may be assigned a higher rating than that of sensors considered to be less reliable (para 54), which is considered suggestive of the claimed limitations.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over An et al. (US Publication no. 2013/0116578 – disclosed by Applicant) in view of Libbus et al. (US Publication no. 2007/0260285 – disclosed by Applicant).
In regard to claim 29, An et al. is directed to system that manages patient therapy and includes a risk analysis technique to detect heart failure risk and possible worsening heart failure conditions. An et al. is considered to substantially describe the invention as claimed however does not teach the step of adjusting, via the one or more processors, a patient’s therapy in response to the heart failure worsening episode being determined. Libbus et al. is directed to a heart failure management system. Libbus et al. teach a closed loop stimulation therapy system for heart failure therapy that modulates the therapy based on heart failure status (para 27). In this manner, appropriate device therapy is triggered to effectively treat a patient’s heart failure. As An et al. is directed to determining a patient’s heart failure status, particularly as patient’s worsening heart failure, the modification of An et al. for adjusting, via the one or more processors, a patient’s therapy in response to the heart failure worsening episode being determined is considered to have been obvious to one of ordinary skill in the art at the time of the invention since Libbus et al. demonstrates that closed loop control for modulation of therapy is effective for accurately treating a patient’s heart failure.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,005,258. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘258 recites limitations that anticipate each and every limitation of the present invention. The conflict between the claims is exhibited below.
Claim 21 of the present invention:
A system for managing patient therapy, the system comprising:
an implantable medical device comprising one or more electrodes configured to be implanted within a patient's body, to acquire first signals sensed from within the patient's body, and to generate first data transmissions in response to the acquired first signals;
a non-implantable device comprising one or more electrodes configured to be positioned in contact with an external surface of the patient's body, to acquire second signals sensed from the external surface of the patient's body, and to generate second data transmissions in response to the acquired second signals; and
one or more processors configured to: receive the first data transmissions and the second data transmissions,
calculate a heart failure risk score based on the received first data transmissions and the received second data transmissions, wherein the first data transmissions are weighted differently than the second data transmissions, and determine a heart failure worsening episode based on the heart failure risk score.
Claim 1 of the ‘258 patent:
A system for managing patient therapy, the system comprising:
(a) an implantable medical device comprising one or more electrodes configured to be implanted within a patient's body, to acquire first signals corresponding to one or more physiological signals sensed from within the patient's body, and to generate first data transmissions in response to the acquired first signals;
(b) a wearable device comprising one or more electrodes configured to be positioned in contact with an external surface of the patient's body, to acquire second signals corresponding to at least one of the one or more physiological signals sensed from the external surface of the patient's body, and to generate second data transmissions in response to the acquired second signals;
(c) an input/output device to receive the first data transmissions and the second data transmissions; and
(d) one or more processors configured to: (i) receive the first data transmissions and the second data transmissions,
(ii) calculate a heart failure risk score based on comparing the received first data transmissions and the received second data transmissions to one or more thresholds, and weighting the first data transmissions differently than the second data transmissions,
(iii) determine whether data of the received first data transmissions and the received second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score, and
(iv) displaying display one of an indication of the heart failure worsening episode or the heart failure risk score on a graphical user interface of a computing device in response to the heart failure worsening episode being detected.
Claim 1 of the ‘258 sets forth each and every feature of present claim 21. The additionally recited limitation for displaying reads on present claim 23. Additionally, the wearable device recited in claim 1 of the ‘258 patent anticipates the “non-implantable” device of present claim 1 since a wearable device is non-implantable. Additionally, similar conflict exists between present claims 23-27 over claims 3-6 of the ‘258 patent.
Claim 28 of the present invention:
A method for managing patient therapy, the method comprising:
acquiring, from one or more electrodes associated with an implantable medical device disposed within a patient's body, first signals sensed from within the patient's body and generating first data transmissions in response to the acquired first signals;
acquiring, from electrodes capable of being positioned over an external surface of the patient's body, second signals from the external surface of the patient's body and generating second data transmissions in response to the acquired second signals;
receiving, via one or more processors, the first data transmissions and the second data transmissions;
calculating, via the one or more processors, a heart failure risk score based on the received first data transmissions and the received second data transmissions, wherein the first data transmissions are weighted differently than the second data transmissions;
determining, via the one or more processors, whether data of the received first data transmissions and the received second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score.
Claim 8 of the ‘258 patent:
A method for managing patient therapy, the method comprising:
a. sensing one or more physiological signals from one or more electrodes associated with an implantable medical device disposed within a patient's body;
b. acquiring first signals corresponding to the one or more physiological signals sensed from within the patient's body and generating first data transmissions in response to the acquired first signals;
C. sensing at least one of the one or more physiological signals from electrodes capable of being positioned over an external surface of the patient's body, acquiring second signals from the external surface of the patient's body and generating second data transmissions in response to the acquired second signals;
d. receiving the first data transmissions and the second data transmissions by an input/output device;
e. receiving the first data transmissions and the second data transmissions via one or more processors,
f. calculating a heart failure risk score based on comparing, via the one or more processors, the received first data transmissions and the received second data transmissions to one or more thresholds and weighting the first data transmissions differently than the second data transmissions,
g. determining, via the one or more processors, whether data of the received first data transmissions and the received second data transmissions is indicative of a heart failure worsening episode based on the heart failure risk score, and
h. adjusting, via the one or more processors, a patient's therapy in response to the heart failure worsening episode being determined.
Claim 8 of the ‘258 sets forth each and every feature of present claim 28. The additionally recited limitation for adjsuting reads on present claim 29. Additionally, similar conflict exists between present claims 31-33 over claims 9-11 of the ‘258 patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 3 June 2026
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