DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-14 in the reply filed on June 12, 2026 is acknowledged. Currently claims 1-20 are pending in this application, with claims 15-20 withdrawn from consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 requires “including a first electrode is configured to be coupled…” in lines 2-3. This is grammatically confusing. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-14 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.
The specification, as originally filed, does not disclose the limitation “indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template by a first specificized percentage.” The specification does not disclose measuring a difference between a heart beat complex and a reference heart beat complex template by a certain percentage. The specification only provides comparisons between heart rates by a specific percentage (e.g. as disclosed in paragraph 211 of the instant application) but does not disclose measuring a percentage difference between a heart beat complex and a reference heart beat complex template by a certain percentage.
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 1-14 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 1 recites the limitation “indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template by a first specificized percentage.” It is unclear how the matching of the heart beat complex and the reference heart beat complex template are compared by a specificized percentage, as it is unclear what portions of the complex are compared and how a percentage is calculated.
Claim 2 is 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 2 recites the limitation "the seizure" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications as follow fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Applications number 17/831,753; 16,77,7930, 15/246,313, 14/583,099, 13/899,267, 12/886,419.
None of the above applications disclose “indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template by a first specificized percentage.” Therefore, claims 1-14 are not entitled to the benefit of the prior applications.
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,082,939. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are simply narrower than the claims of the ‘939 patent. The only difference, as shown below, is the addition of the limitation “by a first specificized percentage,” which simply narrows the claimed invention.
Instant Application (18/827,249)
USPN 12,082,939
1. A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including a first electrode is (Claim objection) configured to be coupled to a first cranial nerve structure and a second electrode configured to be coupled to a second cranial nerve structure, the method comprising:
1. A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including a first electrode configured to be coupled to a first cranial nerve structure and a second electrode configured to be coupled to a second cranial nerve structure, the method comprising:
obtaining data relating to at least a portion of a heart beat complex from a patient;
obtaining data relating to at least a portion of a heart beat complex from a patient;
comparing the at least the portion of the heart beat complex with a corresponding portion of a first reference heart beat complex template of the patient;
comparing the at least the portion of the heart beat complex with a corresponding portion of a first reference heart beat complex template of the patient;
indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template by a first specificized percentage; (Simply narrower limitation)
indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template;
providing a first electrical signal to the first cranial nerve structure of the patient, the first electrical signal is configured to induce action potentials in the first cranial nerve structure and a charge accumulates based on the first electrical signal; and
providing a first electrical signal to the first cranial nerve structure of the patient, the first electrical signal is configured to induce action potentials in the first cranial nerve structure and a charge accumulates based on the first electrical signal; and
providing a second electrical signal to the second cranial nerve structure, the second electrical signal is configured to induce action potentials in the second cranial nerve structure where at least a portion of the second electrical signal comprises the accumulated charge from the first electrical signal.
providing a second electrical signal to the second cranial nerve structure, the second electrical signal is configured to induce action potentials in the second cranial nerve structure where at least a portion of the second electrical signal comprises the accumulated charge from the first electrical signal.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,350,871. Although the claims at issue are not identical, they are not patentably distinct from each other except for an anode and a cathode. It would have been obvious to one of ordinary skill in the art at the time of the invention to treat a medical condition, especially an undisclosed medical condition such as in the claims, using a biphasic current, since biphasic stimulation reduces charge buildup on patient tissue for greater patient safety and comfort.
Instant Application (18/827,249)
USPN 11,350,871
1. A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including a first electrode is (Claim objection) configured to be coupled to a first cranial nerve structure and a second electrode configured to be coupled to a second cranial nerve structure,
1. A method of treating a medical condition in a patient using an implantable medical device, the implantable medical device including a first electrode configured to be coupled to a first cranial nerve structure and a second electrode configured to be coupled to a second cranial nerve structure,
the method comprising:
where the first cranial nerve structure is a left portion of a cranial nerve and the second cranial nerve structure is a right portion of the cranial nerve (narrower limitation), the method comprising:
obtaining data relating to at least a portion of a heart beat complex from a patient;
obtaining data relating to at least a portion of a heart beat complex from a patient;
comparing the at least the portion of the heart beat complex with a corresponding portion of a first reference heart beat complex template of the patient;
comparing the at least the portion of the heart beat complex with a corresponding portion of a first reference heart beat complex template of the patient;
indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template by a first specificized percentage; (narrower unclear limitation)
indicating an occurrence of a state change based upon a determination that the heart beat complex fails to match the first reference heart beat complex template;
providing a first electrical signal to the first cranial nerve structure of the patient, the first electrical signal is configured to induce action potentials in the first cranial nerve structure
providing a first electrical signal to the first cranial nerve structure of the patient using a first polarity configuration in which the first electrode functions as a cathode and the second electrode functions as an anode (narrower limitation), the first electrical signal is configured to induce action potentials in the first cranial nerve structure
and a charge accumulates based on the first electrical signal; and
wherein a charge accumulates at the anode and the cathode as a result of the first electrical signal; switching from the first polarity configuration to a second polarity configuration upon termination of the first electrical signal where the first electrode functions as the anode and the second electrode functions as the cathode in the second polarity configuration (narrower limitation); and
providing a second electrical signal to the second cranial nerve structure, the second electrical signal is configured to induce action potentials in the second cranial nerve structure where at least a portion of the second electrical signal comprises the accumulated charge from the first electrical signal.
providing a second electrical signal to the second cranial nerve structure in the second polarity configuration (narrower limitation), the second electrical signal is configured to induce action potentials in the second cranial nerve structure where at least a portion of the second electrical signal comprises the accumulated charge from the first electrical signal.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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