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 with respect to the claims have been considered but are not persuasive.
Th arguments that the claimed “the second threshold being calculated based on at least one component of the first threshold” has support in the disclosure, such as from figures 4A and B, and paragraphs 62-64 and 68-69, and since after determining the first threshold, the system/method then increases the stimulation intensity that was used to find the first threshold to determine the second threshold (e.g. para. 64) are not persuasive for several reasons.
First, the applicant is mixing in the claims different embodiments of determining the thresholds--i.e. the embodiment of figures 4A and 4B, with the different embodiment of figure 7--that have not been disclosed as being used collectively, with different steps from one embodiment intermingled with different steps of the other.
The present claims deal with using a sensed neural response/ECAP for determining the thresholds. This embodiment was introduced in figure 7 (page 29 and on), and done by delivering different stimulation waveforms to then determine the distribution of sensed responses/ECAPs to compare to profiles to get both the first and second thresholds. This embodiment does not contain the claimed “the second threshold being calculated based on at least one component of the first threshold”. This embodiment has not been stated as being intermingled with the different embodiment of figures 4A and B of determining the thresholds by a different process.
Note that paragraph 86 states that figure 7 can be used in place of, or in parallel, with the operations of figures 4A/B, but not that different steps from one embodiment can be used with different steps of another embodiment. In addition, no guidance of how this intermingling is to be performed is given in the original disclosure.
Second, the claims use the terminology of a calculation—a mathematical equation or process—to determine the second threshold from a component of the first threshold. However, the increase of the delivery of the stimulation is not a mathematical equation or process. More importantly, the increase in stimulation intensity (e.g. pulse width, frequency, and/or amplitude) is not a component of the first threshold. The increased stimulation is part of the delivery of stimulation, but is not a component of the first threshold (the first threshold being just a number where the ECAP/neural response/sensation occurs). In addition, the claim says “based on at least one component”, meaning 1 or more components. The stimulation intensity only represents one/a component and not more.
If the applicant wishes to further define in the claims that the second threshold is determined using part of the process when determining the first threshold, the examiner will consider this new limitation if presented. It is noted that this new limitation may not have support with the rest of the combination of elements/steps in the claims of sensing the ECAP.
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 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior applications (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent applications 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, Application Nos. 17/008715, 15/937427, 14/978664, 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.
The prior filed applications fail to provide adequate support or enablement for the second threshold being calculated based on at least one component of the first threshold for claims 17 and 31, in combination with the other steps or elements set forth in the claim(s).
The disclosure does not disclose determining/calculating the second threshold based on or using at least one component of the first threshold, or more than one component of the first threshold. This claimed limitation was added after filing on 6/21/23 in claims 25 and 35.
The disclosure calculates each threshold, such as THpf and THu, separately and without using one component (or more than one component) of the other. This can be seen in paragraphs 62 and 68, paragraphs 73 and 76, and using specific profiles to determine the THpf and THu thresholds in paragraphs 98 and 99, where stored templates/profiles establish the thresholds, and sensed frequency components are compared to the profiles to set the thresholds.
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 17-24, 26-27, 29-33, and 35-36 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 original disclosure is the second threshold being calculated based on at least one component of the first threshold for claims 17 and 31, in combination with the other steps or elements set forth in the claim(s).
The disclosure does not disclose determining/calculating the second threshold based on or using at least one component of the first threshold, or more than one component of the first threshold. This claimed limitation was added after filing on 6/21/23 in claims 25 and 35.
The disclosure calculates each threshold, such as THpf and THu, separately and without using one component (or more than one component) of the other. This can be seen in paragraphs 62 and 68, paragraphs 73 and 76, and using specific profiles to determine the THpf and THu thresholds in paragraphs 98 and 99, where stored templates/profiles establish the thresholds, and sensed frequency components are compared to the profiles to set the thresholds.
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 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 on 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 7/29/26
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