DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant’s amendment dated December 13, 2025 is acknowledged. Currently claims 1-20 are pending in this application with claims 1-11 are withdrawn from consideration.
Response to Arguments
Applicant's arguments filed December 13, 2025 have been fully considered but they are not persuasive inasmuch as they apply to the amended rejections required by the amendments to the claims.
Double Patenting Rejection
As Applicant has not directly addressed the double patenting rejections, they have been included again in this action.
35 U.S.C. 112 rejection of claim 12 - “autonomic body signals”
Again, Applicant's arguments regarding the rejections under 35 U.S.C. 112 regarding the rejection of the phrase "autonomic body signals” in claim 12 under 35 U.S.C. 112(b) are not considered persuasive. As stated previously, it is unclear what is included in " autonomic body signals" and one of ordinary skill in the art would not understand the limitations of the term. While Applicant has broadly stated that “a person of ordinary skill in the art would understand the phrase autonomic body signals,” Applicant has not provided any persuasive facts or arguments that a person of ordinary skill in the art would understand what signals are and are not included in the term.
Applicant has added that “[i]n one example, autonomic body signals are involuntary physiological responses (e.g., heart rate, breathing, digestion) regulated by the autonomic nervous system.” This sentence finds no support in the specification and it is not clear that this specific definition of autonomic body signals is known to one having ordinary skill in the art. A patent search for the term only provides the Applicant’s own applications. Examiner concludes that since the term is not defined in the specification, one of ordinary skill would not understand the limitations of the term.
35 U.S.C. 112 rejection of claim 13 – “sympathetic tone”
Applicant arguments with respect to the rejection claim 13 under 35 U.S.C. 112, second paragraph are not persuasive. As stated in the previous rejections, the rejection is included because the specification does not disclose does not disclose adjusting sympathetic tone via a vagus nerve stimulator, but rather “... the method may comprise reducing the patient's sympathetic tone, such as by applying high-frequency stimulation to a sympathetic nerve trunk or ganglion or administering an anti-cholinergic drug.”
Despite Applicant’s assertion that claim 13 recites that “the processor via the at least one electrode coupled to the vagus nerve” performs this adjustment of sympathetic tone, the specification does not disclose this action. Nearly the entirety of the specification is directed towards adjusting parasympathetic tone.
The specification only discloses adjusting sympathetic tone “such as by applying high-frequency stimulation to a sympathetic nerve trunk or ganglion or administering an anti-cholinergic drug.” The claim as currently filed does not include a stimulator attached to a sympathetic nerve trunk or ganglion, therefore it is unclear how the processor performs this limitation.
Applicant cites paragraph 2 of the specification that cites the sentence from the specification stating “This disclosure relates generally to medical devices, and, more particularly, to methods, apparatus, and systems for performing vagus nerve stimulation (VNS) for treating epileptic seizures characterized by cardiac changes, including ictal tachycardia. (emphasis added by Applicant).” While the specification does disclose performing vagus nerve stimulation, it does not disclose “adjusting the patient's sympathetic tone via a vagus nerve stimulator,” but rather only “discloses adjusting the patient’s sympathetic tone via a high-frequency stimulation to a sympathetic nerve trunk” as previously discussed.
35 U.S.C. 102 rejection of claims 12 and 15-16 under Ben David
Applicant’s arguments regarding the rejection under 35 U.S.C. 102 have been considered and are not persuasive. Applicant argues that Ben-David does not disclose comparing both a heart rate and an autonomic signal to threshold values to determine a triggering event. Examiner disagrees.
As described in the 112 rejection, the term "autonomic body signals" is not defined by the specification nor is it a term of art that one of ordinary skill in the art would readily understand what "body signals" were included in the term.
Since the term is unclear, for the purposes of Examination, using the broadest reasonable interpretation of the term, Examiner has taken ECG data (other than heart rate) to be autonomic signals, including R-wave data.
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 12-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10-17 of copending Application No. 18/141427 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are simply broader than the claims of the copending application. In addition it appears dependent claim 13 is not patentable distinct from claim 10 of the ‘427 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the phrase “a unit capable of determining a heart rate and autonomic body signals” in lines 6-7. The phrase “autonomic body signals” is unclear, as the term is not defined in the specification, nor is it term of art that is readily known.
The term “autonomic” is only mentioned in the specification four times, and the none of those mentions define the term “autonomic body signals.” Paragraph [0009] recites the phrase “Many patients with intractable, refractory seizures experience changes in heart rate and/or other autonomic body signals near the clinical onset of seizures,” indicating that heart rate is considered an autonomic body signal, but no other examples are given in the specification as currently filed. Thus, it is unclear if the heart rate is the autonomic body signal, or if an additional body signal determination is required. It is also unclear if “determining autonomic body signals” requires determining a signal autonomic body signal or multiple body signals or how the how the unit is capable of determining a heart rate and autonomic body signals.
Claim 12 recites the limitation “a first triggering event,” in line 13. It is now unclear if “a triggering event” of claim 12, lines 10-11 is the same or different than “a first triggering event” of claim 12, lines 13.
Claim 13 recites the limitation to decrease or increase the sympathetic tone to increase or decrease the heart rate of the patient. It is unclear how a processor can increase or decrease a sympathetic tone to increase the heart rate of the patient, because the claim does not describe what actions the processor is directing or taking to perform these steps. It is unclear how a processor can increase or decrease a sympathetic tone without requiring any sort of action.
Furthermore, the specification does not disclose adjusting sympathetic tone via a vagus nerve stimulator, but rather “. . . the method may comprise reducing the patient's sympathetic tone, such as by applying high-frequency stimulation to a sympathetic nerve trunk or ganglion or administering an anti-cholinergic drug.” The claim as currently filed does not include a stimulator attached to a sympathetic nerve trunk or ganglion, therefore it is unclear how the processor performs this limitation.
Similar issues exist in claims 17 and 20.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 12 and 15-16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ben David (US 2008/0091240).
Regarding claim 12, as best the claim can be understood, Ben-David discloses the claimed system for treating a medical condition in a patient, comprising (e.g. Figures 1 and 7):
a sensor for sensing at least one body data stream (e.g. ECG monitor 24 that monitors sensed parameters including R-waves; Paragraph 812);
at least one electrode coupled to a vagus nerve of the patient (e.g. multipolar electrode device 26; Paragraph 651);
a programmable electrical signal generator (e.g. vagal nerve stimulation system 18 that applies signal to induce the propagation of efferent nerve impulses towards the heart; Paragraph 651).
a unit capable of determining a heart rate and autonomic body signals of the patient based on the at least one body data stream (e.g. ECG monitor 24 that both monitors heart rate and sends ECGs (which include “autonomic body signals” to the control system wherein the ECG is monitored to determine if an LTA event is occurring); and
a logic unit configured via one or more processors to compare a monitored value which is determined based on one or more data points relating to the heart rate to one or more threshold values (e.g. the determination at 102 that a life threatening arrythmia is occurring can be a ventricular tachycardia, which occurs when a heart rate is greater than a threshold value; Paragraph 531),
the logic unit further configured to determine a first triggering event based on the comparison (e.g. the determination of an LTA event at 102);
wherein the one or more processors are configured to initiate one or more actions to change the heart rate of the patient based on the determination of the first triggering event (e.g. the application of parasympathetic stimulation at 104 is an attempt to change the heart rate of the patient to a slower, more desirable level).
Regarding claims 15-16, as best the claim can be understood, Ben-David additionally discloses adjusting the parasympathetic stimulation based upon a triggering event (e.g. steps 124 and 126 of Figure 8).
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 Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792