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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/20/26 has been entered.
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 based on at least one component of the first threshold for claim 17, or the second threshold being calculated based on at least one component of the first threshold for claim 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 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 17-24 and 26-30 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 17, the last line, “the second threshold based on at least one component of the first threshold” is vague, in the passive voice, and unclear if a positive method step is being recited/claimed. To positively recite/claim a method step, it is suggested to use active voice, such as “basing the second threshold on at least one component of the first threshold”. As the claim now stands, the thresholds are relative, undefined, and arbitrary and do not actually require the method to determine a second threshold using the first threshold. The claim only sets forth that the stimulation must be adjusted between two numbers (i.e. the claimed thresholds) to meet the functional/intended use recitation of “the second threshold based on at least one component of the first threshold” since the claim contains no step to actually calculating/determining the second threshold based on the first threshold. Note that claim 28 is the first positive recitation of actually determining the first and second thresholds.
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, 26-33, 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 based on at least one component of the first threshold for claim 17, or the second threshold being calculated based on at least one component of the first threshold for claim 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 § 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 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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-19, 24, and 26-28 are rejected under 35 U.S.C. 102a1 as being anticipated by Jaax (2014/0277282). Jaax discloses the following claimed features:
--a method (e.g. figures 5, 6, etc.) and system carrying out the method
--having a plurality of terminals connected to electrodes (e.g. figures 1 and 2, element 12, para. 44, etc.) connected to stimulation circuitry (e.g. element 50, figure 4, paras. 53-54, etc.) and control circuitry (e.g. figure 4, all elements at 14 except for modulation output circuitry 50, paras. 55-58, etc.)
--that measures neural response, such as a magnitude of ECAPS or an average of the magnitudes of the ECAPS (e.g. paras. 10, 14, 44, 64, etc.; which is a size/shape of ECAP for claims 18, 19, and 24)
-- contains a first lower threshold that represents a pre-defined neural response such as a lower level of neural response (e.g. paras. 41, 45, etc.) and a second upper threshold corresponding to a stimulation evoking a sensation in the patient, such as a discomfort/painful overstimulation associated with paresthesia (e.g. paras. 41, 45, for claims 26 and 27--paresthesia above comfortable paresthesia which is painful, etc.) that compares the magnitude feature of the ECAPS to the thresholds to adjust the neural stimulation to be between the thresholds (e.g. figure 5, steps 106-114, paras. 11, 66, etc.).
For claim 28, note that since the thresholds have values based on the stimulation being painful, comfortable, or efficient, that the thresholds have been determined (e.g. paras. 41, 45, etc.).
For the new limitation of claim 17 of “the second threshold being based on at least one component of the first threshold” and the stimulation being between the first and second thresholds, note that this is not a positive method step recitation of performing this function, and is only an intended/functional use recitation, that to be met, the prior art only has to be capable of performing this intended use. The first and second thresholds in claim 17 have not been set forth as being calculated or determined, and neither has the claim set forth calculating the second threshold based on the first threshold. Therefore, since Jaxx as described above does adjust the stimulation between a lower/first and upper/second threshold, where the claimed thresholds are arbitrary/relative, Jaxx is capable of meeting the intended/functional use of adjusting the stimulation to a second threshold that has been based on one component of the first threshold since the thresholds are relative/arbitrary and/or since any first threshold may be used in Jaax and any second threshold can be used in Jaxx that is based on at least one component of the first threshold.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20-23 and 29-30 are rejected under 35 U.S.C. 103 as obvious over Jaax in view of Baynham et al (2015/0032181). Jaax discloses the claimed invention except for the different ways to determine the features of the ECAPs used for analyzing the ECAP signal, such as the width/length, amplitude, peak, delay and/or morphology (claims 20-23), and adjusting the stimulation based on when the patient is awake or unconscious (claims 29-30). Baynham discloses the claimed invention and adjusting the stimulation based on features of the ECAPS such as the width/length, amplitude, peak, delay and/or morphology (e.g. paras. 17, 25, 57, 60, 61, 82, etc.) to provide different ways to measure the ECAPs to determine if the stimulation is effective, and measures physical activity or time of day to determine when to start the adjusting of stimulation (e.g. para. 52, etc.) and therefore provides for occurrences when the patient is awake/moving or may be sleeping/unconscious. 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 (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Jaax, with the different ways to determine the features of the ECAPs used for analyzing the ECAP signal, such as the width/length, amplitude, peak, delay and/or morphology, and adjusting the stimulation based on when the patient is awake or unconscious, as taught by Baynham, since it would provide the predictable results of providing different ways to measure the patient’s ECAPS to determine if the stimulation is effective, and allowing different stimulations to be tested and used when the patient is active/awake to meet the patient’s needs during different physical activities, or when the patient is sleeping/unconscious to allow for testing when no other external stimuli or noise is present or when the patient is sleeping. In the alternative for claims 29-30, 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 (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by Jaax, or Jaax in view of Baynham, with adjusting the stimulation when the patient is awake or unconscious, as is well known and common knowledge in the art (mpep 2144I, 2144.03) since it would provide the predictable results of allowing different stimulations to be tested and used when the patient is active/awake to meet the patient’s needs during different physical activities, or when the patient is sleeping/unconscious to allow for testing when no other external stimuli or noise is present or when the patient is sleeping.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Conclusion
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.
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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 2/3/26