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 amendment filed 1/16/2026 has overcome all of the 35 USC 112b rejections other than the rejection of Claim 32. The 35 USC 112b rejection of claims 1, 2, 4, 6, 7, 10-12, 17, 19, 23, 28, 29 and 45 have been withdrawn. Only the rejection of Claim 32 is maintained.
Applicant's arguments filed 1/16/2026 regarding the 35 USC 102 rejection of the claims with respect to Levine have been fully considered but they are not persuasive. Applicant argues on p. 8 under the Remarks, “Furthermore, Applicant respectfully asserts that Levine is completely silent as to treating a hypermotility disorder through application of "at least one temporal pattern of electrical stimulation [that] is applied prior to a refractory period in the subject's colon to suppress colonic contractions and motility, thereby treating the hypermotility disorder," as recited in the currently pending claims. That is, Levine fails to disclose or characterize any temporal pattern of electrical stimulation with respect to a hypermotility disorder, let alone electrical stimulation tied to a refractory period in a subject's colon.” The Examiner respectfully disagrees. Levin discloses in par. [0009], “ In some embodiments, the patient may be monitored to determine a type of motility the patient has, to determine whether to apply a synchronous electrical modulation if hypomotility is detected or to apply a inhibitory electrical modulation if uncoordinated hypermotility is detected.” Levine further discloses in par. [0061], with respect to the hypermotility embodiment, “In some embodiments, IEM may reduce the tone and tension of the small bowel to allow nutrients to pass through the small intestine with reduced resistance. This may be accomplished by stimulating the bowel out of phase with natural myoelectrical activity by stimulating at over 12 ppm (in the duodenum) at between about 15 ppm and about 30 ppm, in some embodiments, between about 18 ppm and 22 ppm, with parameters similar to those described above.” Thes pulses to inhibit nerve conduction would not occur during a refractory period as that period is defined by the inability of the nerve to generate an action potential. There is nothing to inhibit. An inhibitory pulse effectively forces the nerve into a refractory period and thus would clearly be understood to be applied before a refractory period of the nerve. Nerve action potentials are generated before a refractory period (the refractory period occurs after action potentials are generated )and to inhibit those action potentials as taught by Levine, the signal would have to be delivered during the period before the refractory period in which action potentials are generated. The end result is disrupting activity that leads to hypermotility, which is the same result claimed by Applicant. Therefore, the rejection is maintained.
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.
Claim 32 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 32 states “the at least one temporal pattern…is delivered to a single subject at one or more timepoints”. The use of “a subject” implies a subject different than the subject of Claim 28. The Examiner suggests amending the claim to read “the subject” to overcome the current rejection.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, 7, 10-12, 22, 23, 28, 29 and 32 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Levine et al. (2016/0121111).
Regarding Claims 1, 2, 7, 10, 22, 28 and 32, Levine discloses applying a temporal pattern of electrical stimulation that targets the enteric nerves of the duodenum of a human (par. [0036, 0087]) in order to treat one of hypermotility (par. [0009]). Levine discloses treating hypermotility by applying inhibitory electrical modulation (IEM) stimulation, which would inherently occur before the refractory period in order to prevent further contraction (out of phase with natural myoelectric activity, see par. [0061]). Stimulation applied during a refractory period would have no effect given that the nerve is refractory (not susceptible to stimulation and unable to produce action potentials).
Regarding Claims 4 and 29, Levine discloses that the stimulation is applied to a human wherein the typical refractory period for the nerves of colonic motor complex in humans is between as large as 10-50 seconds and as narrow as 10-20 seconds (see par. [0004, 0063]) of Applicant’s specification. Levine discloses the off-time of the pulses (which defines the interval between bursts) is 1.5 seconds (par. [0077]), which is less than the refractory period as required by the claim.
With regard to Claims 6 and 11, Applicant is providing a well-known understanding of a refractory period, which is a period between contractions in which a nerve is refractory. That is the period of time in which the refractory period naturally occurs.
In regard to Claim 12, Applicant indicates this time range is the inherent range of the refractory period of the nerves of colonic motor complex in humans is between as large as 10-50 seconds and as narrow as 10-20 seconds (see par. [0004, 0063]). This is an inherent feature of the nerves targeted by both Applicant and Levine.
In regards to Claim 23, Levine discloses stimulation can be applied to patients exhibiting symptoms such as diarrhea or constipation (par. [0028]).
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 (i.e., changing from AIA to pre-AIA ) 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 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (2016/0121111).
In regard to Claims 17 and 19, Levine discloses applying a pulse train wherein the frequency is between 0.05 Hz and 200 Hz; pulse width of 10 microseconds to 66 milliseconds and can be applied for a time range of 0-10 min (par. [0077]). There are combinations of parameters within these ranges that result in pulse bursts of 50 to 150 pulses. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to limit the number of pulses per burst to 50 to 150 pulses and to limit each phase of pulses within the burst to 50-1000 microseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Levine discloses applying similar stimulation pulses to the same claimed areas to treat the same conditions. Identifying the optimal stimulation parameters is a routine optimization problem.
Claims 45 is rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (2016/0121111) in view of DiLorenzo (2019/0329042).
Regarding Claim 45, Levine discloses targeting the enteric nerves but fails to disclose targeting other nerves. However, in the same field of endeavor of treating hypermotility and other gastrointestinal disorders, DiLorenzo discloses targeting nerves such as the splanchnic nerves in addition to the enteric nerves (par. [0447, 0450, 0483, 0484, 0495]) for the purpose of decreasing gastrointestinal symptoms such as motility (Claim 41). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Levine reference to include targeting the splanchnic nerve, as taught and suggested by DiLorenzo, for the purpose of decreasing gastrointestinal symptoms such as motility.
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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