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 .
Election/Restrictions
Applicant’s election of Group I and species restriction of the S3 root or segment, intensity of about 6V and/or 6mA, and stimulation being applied intermittently (claims 1, 2, 7, 8, and 12-14) in the reply filed on July 27, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 3-4 read “wherein the electrical pulses are delivered at a frequency of from about 3 Hz to about 10Hz” but should read “wherein the electrical pulses are delivered at a frequency of from about 3 Hz to about 10Hz” (i.e. without the “of”).
Appropriate correction is required.
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.
Claims 1-2, 7-8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0252285 A1 to Toong et al. (hereinafter “Toong”) in view of US 2019/0060647 A1 to Su et al. (hereinafter “Su”).
Regarding claim 1, Toong teaches:
A method of inducing colon contractions and/or defecation in a patient (see abstract and para [0002], para [0020], and para [0089]-[0090]), comprising:
stimulating one or more sacral roots of the patient's spinal cord and/or one or more sacral segments of the patient's spinal cord with a plurality of electrical pulses (see para [0100]-[0103]),
wherein the electrical pulses can be delivered at varying frequency of from about 3 Hz to about 10 Hz (see fig. 7 and para [0060]), but does not disclose wherein the electrical pulses can be delivered at varying frequency of from about 3 Hz to about 10 Hz.
However, Su teaches a method for delivering electrical stimulation therapy to the sacral nerve of the patient to treat urinary and/or fecal incontinence (see abstract and para [0005]). The system (fig. 1) teaches wherein the electrical pulses can be delivered at varying frequency of about 10 Hz, and wherein the stimulation (see para [0025]-[0028]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to modify the system of Toong with the teachings of Su to arrive at the claimed invention. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to discover the optimal frequency range of 3 Hz to about 10 Hz to arrive at the claimed invention. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Doing so would improve the system by ensuring the stimulation frequency is at an appropriate range that would provide optimal therapeutic benefit to the patient.
Regarding claim 2, Toong as modified teaches:
The method of claim 1, wherein the one or more sacral roots or sacral cord segments are one or more of the patient's S1, S2, S3, S4, and/or S5 sacral roots or sacral cord segments (see para [0103] - [0104]).
Regarding claim 7, Toong as modified teaches:
The method of claim 1, wherein the stimulation is applied to the patient's S2 and/or S3 ventral/anterior root (para [0109]-[0112]).
Regarding claim 8, Toong as modified teaches:
The method of claim 1, wherein the stimulation is applied at a frequency ranging from 1Hz to 150Hz (see fig. 7 and para [0060]), but does not explicitly teach wherein the stimulation is applied at a frequency of about 7 Hz.
However, Su teaches wherein the stimulation applied can be at a frequency ranging from 1Hz to 20 Hz (see para [0025]-[0028] and para [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to modify the system of Toong with the teachings of Su to arrive at the claimed invention. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to discover the optimal frequency of 7 Hz to arrive at the claimed invention. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Doing so would improve the system by ensuring the stimulation frequency is at an appropriate level that would provide optimal therapeutic benefit to the patient.
Regarding claim 12, Toong as modified teaches:
The method of claim 8, but does not disclose wherein the stimulation is applied at an intensity of about 6 V and/or 6 mA.
However, Sue teaches wherein the stimulation is applied at an intensity ranging from 0.1 Volts to 50 Volts, or 0.1 mA to 50 mA (see abstract and para [0070]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to modify the system of Toong with the teachings of Su to arrive at the claimed invention. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to discover the optimal intensity of 6 Volts and/or 6 mA to arrive at the claimed invention. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Doing so would improve the system by ensuring the intensity is at an appropriate level that would provide optimal therapeutic benefit to the patient.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Toong in view Su, and further in view of US 2014/0249595 A1 to Chancellor et al. (hereinafter “Chancellor”).
Regarding claim 13, Toong as modified teaches:
The method of claim 1, but does not explicitly disclose wherein the stimulation is applied continuously or intermittently.
However, Chancellor teaches a method and apparatus for controlling defecation (see abstract). The system (fig. 1), teaches wherein the stimulation is applied continuously or intermittently (see para [0021]).
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 modified system of Toong with the teachings of Chancellor to arrive at the claimed invention, since such modification would improve the system by providing adjustable stimulation for each patient, ultimately providing optimal therapeutic benefit for each user.
Regarding claim 14, Toong as modified teaches:
The method of claim 13, but does not explicitly disclose wherein the intermittent stimulation is applied for about 1 minute followed by about 1 minute where no stimulation is applied.
However, Chancellor teaches wherein the intermittent stimulation is applied for about 0.5 seconds to 60 second of stimulation, followed by 0.5 seconds to 5 minutes of no stimulation (see para [0005] – first sentence and para [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to modify the system of Toong with the teachings of Chancellor to arrive at the claimed invention. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to discover the intermittent stimulation of 1 minute on and 1 minute off to arrive at the claimed invention. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Such modification would improve the system by providing adjustable stimulation for each patient, ultimately providing optimal therapeutic benefit for each user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 7,054,689 B1 to Whitehurst et al. teaches an implantable stimulator used to treat urinary and/or bowel dysfunction (see abstract, col. 3, lines 56-67, and col. 4, lines 1-3).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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