DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1 - 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 10,220,211, and claims 1 – 20 of U.S. Patent No. 11,103,707, and claims 1 – 20 of U.S. Patent No. 12,144,992. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application, the ‘211 patent, the ‘707 patent, and the ‘992 patent all claim a system and method which calculates/determines first and second depression detection values; applies weights to the values, determines a depression state, and initiates neurostimulation therapy based on the determined depression state. The claims of the ‘211, ‘707, and ‘992 patents contain further limitations. Therefore, the present application is more broad than the listed patents and the claims of the listed patents anticipate the claims of the present application.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 – 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reeve (US PGPUB 2007/0173901 – in IDS) in view of Osorio et al. (US PGPUB 2005/0197590 – in IDS).
Regarding claims 1, 2, 8, 9, and 20, Reeve discloses a system and method comprising: one or more memory devices having instructions stored thereon that, when executed by one or more processors, cause the one or more processors to perform operations comprising: calculating a depression detection value based on a weighting applied to a depression-indicative value associated with a body parameter (e.g. ¶ 22); comparing the depression detection value to a first threshold to detect an onset of a depression episode (e.g. ¶ 22); and initiating neurostimulation therapy by one or more electrodes responsive to detecting the onset of the depression episode (e.g. ABSTRACT), but fails to teach using two thresholds wherein the first threshold is associated with the onset of the depression episode and the second threshold is associated with an offset of the depression episode.
Osorio discloses a detection system and method that uses different thresholds that represent onsets and offsets of medical episodes (e.g. ¶ 26).
It would have been obvious to one having ordinary skill in the art to modify the weighted depression thresholds as taught by Reeve, with the multiple thresholds representing onsets and offsets as taught by Osorio, since such a modification would provide the predictable results of giving more information to the closed loop system to adjust therapy once the episode is completed.
Regarding claim 3, Reeve discloses receiving, from at least one sensor, sensor data corresponding to a first body parameter value and a second body parameter value for a patient (e.g. ¶ 18).
Regarding claims 4, 5, 12, 13, and 15 – 19, neither Reeve nor Osorio disclose adjusting the weighting applied to the depression values. However, dynamic weighting is well known on the art. It would have been obvious to one having ordinary skill in the art to adjust the weighting as taught by Reeve in view of Osorio in order to have more accurate thresholds in real time based on patient activity.
Regarding claims 6 and 10, Reeve discloses the neurostimulation therapy initiated in response to determining that the depression episode indicates depression onset is a closed-loop therapy (e.g. ABSTRACT).
Regarding claims 7 and 14, Reeve discloses the body parameter is at least one of skin temperature, skin conductance, heart rate, change in heart rate, blood oxygen saturation, acceleration, respiration rate, or a value determined as a combination thereof (e.g. ¶ 10).
Regarding claim 11, Reeve discloses cranial nerve stimulation (CNS), and wherein the CNS comprises external trigeminal nerve stimulation (TNS), vagus nerve stimulation (VNS), or a combination thereof (e.g. ¶ 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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, Jennifer McDonald can be reached on 571-270-3061. 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.
/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3792
Prosecution Insights