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 .
Response to Arguments
Applicant's arguments filed 6/10/26 have been fully considered but they are not persuasive.
Note that the statutory double patenting rejection has not been addressed. If it is persuasively argued that a statutory double patenting rejection is not correct, the non-statutory double patenting rejection will need to be addressed.
The arguments regarding the 112a rejection, and similarly the priority requirement, are not persuasive. The argument that the disclosure provides numerous places that discuss the claimed limitations of increasing the therapy, and detecting HRV changes to set the therapy parameter threshold to treat anxiety is not persuasive.
Anxiety is only mentioned twice in the original disclosure. Once in paragraph 6, providing background of previous used stimulation devices for treating diseases such as sleep, mood, and anxiety disorders. The disclosure does not state that these previously diseases/disorders are being treated with the further described “present invention” and stimulation system newly set forth in the disclosure. Therefore paragraph 6 cannot be stated as a teaching of the presently claimed invention as set forth in the claims, such as claim 1.
The second occurrence of the term anxiety is in paragraph 151. Paragraph 151 states “[I]n another example, the controller can be configured to determine feedback using user input commands and cause the signal generator to generate the therapy signals in accordance with the feedback. Thus, the user could indicate via an input whether they are perceiving any improvement, such as a reduction in anxiety or stress, with this input being used to adjust the applied therapy signals”.
This paragraph states it is “in another example” of how to determine feedback to generate therapy signals. The paragraph does not contain all of the currently claimed limitations of monitoring HRV, and using the HRV to set a therapy signal parameter “threshold”, or relate this “another example” to those claimed limitations. Finally, the paragraph does not state the therapy signal is to treat the subject for anxiety, but only that the patient may perceive an improvement such as a reduction in anxiety. Anxiety is a symptom of many diseases, such as cardiovascular diseases/arrhythmias, PTSD, depression, endocrine disorders, etc., and while the anxiety may be reduced/improved, this does not mean the therapy signal is meant to treat anxiety, but used to treat one of the many other diseases that have a symptom of anxiety.
Election/Restriction
During a telephone conversation with Timothy Worrall on 2/12/26 a provisional election was made without traverse to prosecute the invention of species 1, claims 1-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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. 19(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) 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 application, Application No. 17/634954 fails 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.
The prior filed application fails to provide adequate support or enablement for the vagus nerve stimulation system delivering therapy to treat anxiety where the stimulation is progressively changed, HRV is measured during the change, and a therapy signal parameter threshold is based on the changes in heart rate, in combination with the other elements/functions in the claim(s).
The original disclosure only discussed anxiety in 2 places--paragraph 6 when discussing previous used VNS systems and those systems being approved for anxiety, and in paragraph 151. In paragraph 151, the disclosure states that the anxiety therapy parameters are controlled by user input information when they perceive improvement, and not during a progressive change of stimulation and the use of HRV to indicate the threshold therapy parameter.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application:
The prior filed application fails to provide adequate support for the vagus nerve stimulation system delivering therapy to treat anxiety where the stimulation is progressively changed, HRV is measured during the change, and a therapy signal parameter threshold is based on the changes in heart rate, in combination with the other elements/functions in the claim(s).
The original disclosure only discussed anxiety in 2 places--paragraph 6 when discussing previous used VNS systems and those systems being approved for anxiety, and in paragraph 151. In paragraph 151, the disclosure states that the anxiety therapy parameters are controlled by user input information when they perceive improvement, and not during a progressive change of stimulation and the use of HRV to indicate the threshold therapy parameter.
This application repeats a substantial portion of prior Application No. 17/634954 filed 2/11/22, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
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 1-18 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 subject matter which was not described in the specification is the vagus nerve stimulation system delivering therapy to treat “anxiety” where the stimulation is progressively changed, HRV is measured during the change, and a therapy signal parameter threshold is based on the changes in heart rate, in combination with the other elements/functions in the claim(s).
While the applicant had the general idea of performing this action for treating anxiety (as set forth only in the original claims of 11/26/25), they did not possess the specific details of how this specific action is carried out when they filed the application. The disclosure does not discuss while treating anxiety, that the system/method uses a controller to control the progressive stimulation, measures HRV, and sets the therapy based on the progressive stimulation and measured HRV. No amount of guidance is provided as to what specifically is done with the measured HRV and how to set the threshold according to the measured HRV.
The original disclosure only discussed anxiety in 2 places--paragraph 6 when discussing previous used VNS systems and those systems being approved for anxiety, and in paragraph 151. In paragraph 151, the disclosure states that the anxiety therapy parameters are controlled by user input information when they perceive improvement, and not during a progressive change of stimulation and the use of HRV to indicate the threshold therapy parameter. Paragraph 151 relates to how the person controls the setting of anxiety therapy parameters and not to the controller using progressive stimulation and HRV measurements to indicate threshold therapy parameters.
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 1-18 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.
In claim 1, line 3, “a securing member…” is vague and makes the claim incomplete for omitting structural cooperative relationship between elements. The securing member is not connected to any other element in the claim and the claim is just a listing of part. It is suggested to use “via the securing member attached to the electrodes” in line 6. In line 12, “heart rate variability” is vague as that term is also used in line 11 and it is unclear if they are the same element. It is suggested to use “the heart rate variability” is line 12.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-18 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-23 of prior U.S. Patent No. 12465272. This is a statutory double patenting rejection.
Claims 1-18 contain the exact same structural limitations as in claims 1-23 of the patent, except the current application’s claims state that the therapy is for treating anxiety versus treating atrial fibrillation in the patent.
In the situation where the therapy or stimulation parameters that treat anxiety are the same that are used to treat atrial fibrillation, then the two structures are exactly the same and deliver the same therapy and are not patentably distinct.
IN THE ALTERNATIVE, if it is convincingly argued that the anxiety therapy is different than the atrial fibrillation therapy, a non-statutory double patenting rejection is given below.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12465272. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims contain the same structural limitations as the currently pending claims. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by the patent claims, with its use on another disease or condition, such as anxiety, as is well known and common knowledge in the art, since it would provide the predictable results of using the same vagus nerve stimulator to treat multiple different diseases, such as anxiety, so that multiple different devices are not needed in the patient or by the providing hospital, and since it is known that VNS systems can be used to treat atrial fibrillation, anxiety, and multiple other diseases.
Conclusion
THIS ACTION IS MADE FINAL. 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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 6/30/26
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