DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 9, 2026 has been entered. Currently claims 1-10, 12-13, and 15-17 are pending in this application, with claims 1-9 withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10, 12-13, and 15-17 have been considered but not persuasive inasmuch as they apply to the amendments to the claims.
Examiner notes that the amendments to the claims have changed the scope of the claims and required new rejections under 35 U.S.C. 112, some of which have been previously presented in Office actions.
As previously discussed, Examiner notes that, as best can be determined, stimulation of vagus nerve, part of the parasympathetic system, is only capable of adjusting parasympathetic tone. The specification, furthermore, does not disclose adjusting sympathetic tone via an electrode and programmable electrical stimulator generator connected to a sympathetic nerve of the patient as described in the claims. The specification only discloses that “. . . 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.” (Paragraph 177). It does not include any other information as to how the stimulation is applied.
Claim Rejections - 35 USC § 112 – New Matter
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 10, 12-13 and 15-17 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.
Claim 10, lines 12-14 recite the limitation “the one or more processors are configured to via the at least one electrode increase a sympathetic tone or to decrease a sympathetic tone to increase the heart rate of the patient based on the first triggering event via the programmable electrical signal generator.” The specification as originally filed does not disclose increasing or decreasing a sympathetic tone using the electrode system as taught in Figures 1-3 and disclosed in claim 10.
The specification only discloses that “. . . 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.” (Paragraphs 177 & 178). It does not include any other information as to how this stimulation to affect sympathetic tone is applied. The specification does not disclose that stimulation to affect sympathetic tone is performed by the electrode and electrical stimulation generator described in the specification, and thus the specification as originally filed does not show that the applicant had possession of the claimed invention at the time of filing.
Similar issues exist in dependent claim 13.
Claim Rejections - 35 USC § 112 - Enablement
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 10, 12-13, and 15-17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 10, lines 12-14 recite the limitation “the one or more processors are configured to via the at least one electrode increase a sympathetic tone or to decrease a sympathetic tone to increase the heart rate of the patient based on the first triggering event via the programmable electrical signal generator.” The specification as originally filed does not disclose increasing or decreasing a sympathetic tone using the electrode system as taught in Figures 1-3 and disclosed in claim 10.
The specification only discloses that “. . . 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.” (Paragraphs 177 & 178). It does not include any other information as to how this stimulation is applied, and thus it is not clear how one of ordinary skill in the art would be able to make/use the invention.
Similar issues exist is dependent claim 13.
Claim Rejections - 35 USC § 112 – Second Paragraph
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 10, 12-13, and 15-17 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 10, lines 7-9 recite the limitation “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”. It is unclear how the how the “one or more data points relating to the heart rate” are determined, as they are neither collected via the sensor nor determined via the heart rate unit. It is unclear if the “one more data points relating to heart rate” are actually heart rate data or other data.
Claim 10, lines 10-11 recites the limitation,
“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,”
while lines 12-14 recite the limitation,
“the one or more processors are configured to via the at least one electrode increase a sympathetic tone or to decrease a sympathetic tone to increase the heart rate of the patient based on the first triggering event via the programmable electrical signal generator.”
It is unclear whether the limitation that the one or more processors are “configured to initiate one or more actions to change the heart rate of the patient” is a separate from the limitation that the one or more processors are configured to . . . to increase the heart rate of the patient based on the first triggering event via the programmable electrical signal generator” or if the second limitation is simply further limiting the first limitation.
For the purposes of examination these are taken to be two different limitations, but further clarification is required.
Conclusion
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.
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, Unsu Jung can be reached on 571-272-8506. 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.
/Amanda K Hulbert/ Primary Examiner, Art Unit 3792