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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22JUL2025 has been entered.
Status of Claims
The amendments and remarks filed on 22JUL2025 have been entered and considered.
Claims 1-2, 4-7, 10, 13, 17, 31-32, 39, 44, 46-48, & 68-71 are currently pending.
Claims 1-2, 4-7, 13, 17, 31-32, 39 have been amended.
No claims are withdrawn.
No new matter has been added. Support for a first set of data can be found on Page 10 of the Specification. Support for data indicative of a distance traveled can be found on Page 5 of the Specification.
Claims 3, 8-9, 11-12, 14-16, 18-30, 33-38, 40-43, 45, & 49-67 have been canceled.
Claims 70-71 have been added.
Claims 1-2, 4-7, 10, 13, 17, 31-32, 39, 44, 46-48, & 68-71 are under examination.
Response to Arguments
Applicant's amendments filed 22JUL2025 regarding the rejections under 35 U.S.C 102(a)(1) & 103 have been fully considered and are found to obviate the rejections. A new ground for rejection can be found below in regards to references Mishra Villarreal, and Yoo.
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 1-2, 4-7, 10, 13, 17, 31-32, 39, 44, 46-48, & 68-71 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.
Regarding Claim 1:
The limitation “receiving the first set of data from the one or more sensors both: prior to a first treatment of the subject by stimulating the tibial nerve using the implant, and subsequently to the first treatment of the subject by stimulating the tibial nerve using the implant” in Lines 8-13 is unclear how a single data set is received more than one time such as prior and subsequently to stimulation. For the purposes of examination, the examiner is interpreting this as being initial data sets for each instance of measurement during the first stimulation protocol.
Claims 2, 4-7, 10, 13, 17, 31-32, 39, 44, 46-48, & 68-71 are rejected for depending upon the rejected claim 1.
Regarding Claim 32:
The claim recites limitation “a positive result of the stimulation based at least in part on a post-treatment-initiation distance traveled by the subject” in Lines 3-4. It is unclear if this positive result represents a percent increase in distance to show a positive result, or a longer distance traveled, or something else. For the purpose of examination, the examiner is interpreting this as a longer distance traveled. Clarification is required.
The term “positive” in claim 32 is a relative term which renders the claim indefinite. The term “positive” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The limitation “result of the stimulation based at least in part on a post-treatment-initiation distance traveled by the subject” in the claim has been rendered indefinite by the use of the term “positive”.
Regarding Claim 70:
The claim recites limitation “data indicative of a post-treatment-initiation distance traveled by the subject” in Lines 2-3. It is unclear what the data indicative of a post-treatment-initiation distance traveled by the subject should be. For the purpose of examination, the examiner is interpreting this as a distance traveled. Clarification is required.
Claim Rejections - 35 USC § 102
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 1-2, 10, 13, 17, 31, 39, 44, 46-48, & 68-69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mishra et al. (US Publication No. 20190374776).
Regarding claim 1, Mishra discloses a method for assessing treatment of a subject who has overactive bladder (OAB) (Mishra ¶0106 “ The first implantable device can be used in a trialing procedure in which the stimulation apparatus is assessed for acceptable use (e.g. by the patient and/or clinician) and/or one or more stimulation settings are optimized or otherwise determined.”; ¶0121 “In some embodiments, apparatus 10 is configured to treat a patient disease or disorder selected from the group consisting of: chronic pain; acute pain; migraine; cluster headaches; urge incontinence; pelvic dysfunction such as overactive bladder; “ ), the method comprising: using an implant, stimulating a tibial nerve of the subject according to a first stimulation protocol (Mishra ¶0106 “ The first implantable device can be used in a trialing procedure in which the stimulation apparatus is assessed for acceptable use (e.g. by the patient and/or clinician) and/or one or more stimulation settings are optimized or otherwise determined.”; ¶0231 “apparatus 10 is configured to treat pelvic, bladder and/or bowel disorders, such as by stimulating sacral, pudendal and/or tibial nerves.”; ¶0245 “ Implantable device 200/800 can deliver stimulation energy to the stimulation elements 260”; ¶0244; ¶0255) extending over at least one week, (Mishra ¶0046 “the trial period comprises a duration of at least 1 week”); a electronic processor (Mishra ¶0149 “the programmer 550 uses information recorded by one or more implantable devices 200, implantable device 800, apparatus 10 information, and/or information from external devices 500 to adapt configuration parameters of one or more components of apparatus 10.”); receiving a first set of data from one or more sensors (Mishra ¶0156 “a sensor configured to record data related to a patient parameter (e.g. a patient physiologic parameter),”), based on the first set of data, performing a first assessment of a characteristic of a response of the subject to the stimulation over the first time period; responsively to the first assessment, determining a second stimulation protocol (Mishra ¶0149 “the programmer 550 uses information recorded by one or more implantable devices 200, implantable device 800, apparatus 10 information, and/or information from external devices 500 to adapt configuration parameters of one or more components of apparatus 10.” ) and stimulating the tibial nerve according to a second stimulation protocol (Mishra ¶0156 “ In some embodiments, operation of one or more implantable devices 200/800 (e.g. stimulation energy delivered by one or more implantable devices 200/800) is configured to be delivered based on the data recorded by one or more sensor-based functional elements 299/599/899, such as in a closed-loop energy delivery mode.” Showing there would be iterative updates to operation protocols based on the recorded data.) over a second time period extending over at least one week (Mishra ¶0050 “the therapy period comprises a duration of at least 3 months”) using the electronic processor, receiving a second set of data from the one or more sensors, the data being indicative of activity of the subject over the second time period; and based on the second set of data, performing a second assessment of the characteristic of the response of the subject to the stimulation over the second time period (Mishra ¶0156 “ In some embodiments, operation of one or more implantable devices 200/800 (e.g. stimulation energy delivered by one or more implantable devices 200/800) is configured to be delivered based on the data recorded by one or more sensor-based functional elements 299/599/899, such as in a closed-loop energy delivery mode.” Showing there would be iterative updates to operation protocols based on the recorded data.), receiving data that is indicative of a distance traveled prior to a first treatment of the subject by stimulating the tibial nerve using the implant and subsequently to the first treatment of the subject by stimulating the tibial nerve using the implant (Mishra ¶0156 “ In some embodiments, operation of one or more implantable devices 200/800 (e.g. stimulation energy delivered by one or more implantable devices 200/800) is configured to be delivered based on the data recorded by one or more sensor-based functional elements 299/599/899, such as in a closed-loop energy delivery mode.” Showing there would be iterative updates to operation protocols based on the recorded data.; ¶0157 “Functional element 299/599/899 can comprise one or more sensors configured to record data regarding a patient parameter selected from the group consisting of: blood glucose; blood pressure; EKG; heart rate; cardiac output; oxygen level;……….; physical activity level; “).
Regarding claim 2, Claim 1 is anticipated by Mishra. Mishra further discloses receiving the first set of data not indicative of a frequency of specific voiding episodes of the subject. (Mishra ¶0206 “comprises one or more sensors configured to record data representing a physiologic parameter of the patient. Stimulation element 260 can comprise one or more sensors selected from the group consisting of: electrode; sensor configured to record electrical activity of tissue; blood glucose sensor; gas sensor; blood gas sensor;…..; and combinations of one or more of these.”).
Regarding claim 10, Claim 1 is anticipated by Mishra. Mishra further discloses outputting to the subject an indication of the first assessment.(Mishra ¶0219 “Diagnostic assembly 91 could provide a user interface (e.g. a speaker, a text screen and/or a video display) that provides quality or other information (go/no go information, digital or other discrete level information, and/or analog information). Diagnostic assembly 91 could be further configured to provide information confirming detection of one or more implantable devices 200/800, status of one or more implantable devices 200/800 (e.g. parameter level and/or fault detection status),”).
Regarding claim 13, Claim 1 is anticipated by Mishra. Mishra further discloses wherein receiving the first set of data comprises receiving the first set of data indicative of a level of physical activity of the subject. (Mishra ¶0157 “Functional element 299/599/899 can comprise one or more sensors configured to record data regarding a patient parameter selected from the group consisting of: blood glucose; blood pressure; EKG; heart rate; cardiac output; oxygen level;……….; physical activity level; “).
Regarding claim 17, Claims 1 & 13 are anticipated by Mishra. Mishra further discloses wherein receiving the data comprises receiving smartphone-derived data. (Mishra ¶0146 “a second transmitter of transmitter 553/530 can be configured to transmit data to tool 60 or another device such as: external device 500 (e.g. when the transmission emanates from transmitter 553 of programmer 550); programmer 550 (e.g. when the transmission emanates from transmitter 530 of external device 500); a cell phone; a computer; a tablet; a computer network such as the internet or a LAN; and combinations of one or more of these.”).
Regarding claim 31, Claim 1 is anticipated by Mishra. Mishra further discloses wherein receiving the first set of data comprises receiving GPS-derived data (Mishra ¶0096).
Regarding claim 39, Claim 1 is anticipated by Mishra. Mishra further discloses based on the first set of data, calculating a quality-of-life score indicative of a level of recovery of the subject from OAB. (Mishra ¶0246 “In some embodiments, apparatus 10 is configured to provide temporary stimulation therapy of tissue to treat overactive bladder, such as by using one or more external devices 500, such as to provide power and/or data to one or more implantable devices 200/800 to confirm acceptable improvement of the patient's overactive bladder (e.g. successful stimulation of one or more sacral nerves, tibial nerves or other tissue), before closing an incision or otherwise fully implanting one or more implantable devices 200/800.”).
Regarding claim 44, Claim 1 is anticipated by Mishra. Mishra further discloses wherein: stimulating the tibial nerve according to the first stimulation protocol comprises stimulating the tibial nerve during a first number of daily stimulation sessions, and the step of stimulating the tibial nerve according to the second stimulation protocol comprises stimulating the tibial nerve during a second number of daily stimulation sessions. (Mishra ¶0245 “ implantable system 20 is configured to provide daily or hourly sessions that deliver stimulation for between 10 minutes and 60 minutes. In some embodiments, apparatus 10 is configured to achieve an approximate 50% reduction in urinary urge incontinence and/or urinary urgency/frequency episodes.” Where previously it has been stated to be an iterative process therefore requiring a a number of daily sessions related to each new program.).
Regarding claim 46, Claim 1 is anticipated by Mishra. Mishra further discloses wherein determining the second stimulation protocol comprises determining a change in a parameter of internal operation of the implant. (Mishra ¶0119 “implantable system 20 can be configured to rectify the power signal, and produce a stimulation waveform with entirely different characteristics (e.g. amplitude, frequency, and/or duty cycle) from the rectified power signal. “).
Regarding claim 47, Claims 1 & 46 are anticipated by Mishra. Mishra further discloses wherein: stimulating the tibial nerve according to the first stimulation protocol comprises stimulating the tibial nerve at a first amplitude of individual current pulses (Mishra ¶0104 “The term “train envelope” where used herein can refer to a curve outlining the amplitude extremes of a series of pulses in a train. The term “burst envelope” where used herein can refer to a curve outlining the amplitude extremes of a series of pulses in a burst. “) determining the change in the parameter comprises determining a change in the amplitude of individual current pulses, and the step of stimulating the tibial nerve according to the second stimulation protocol comprises stimulating the tibial nerve at a second amplitude of, individual current pulses. (Mishra ¶0119 “implantable system 20 can be configured to rectify the power signal, and produce a stimulation waveform with entirely different characteristics (e.g. amplitude, frequency, and/or duty cycle) from the rectified power signal. “).
Regarding claim 48, Claims 1 & 46-47 are anticipated by Mishra. Mishra further discloses wherein: stimulating the tibial nerve according to the first stimulation protocol comprises stimulating the tibial nerve at a first pulse frequency of applied current, determining the change in the parameter comprises determining a change in the pulse frequency of applied current, and the step of stimulating the tibial nerve according to the second stimulation protocol comprises stimulating the tibial nerve at a second pulse frequency of applied current. (Mishra ¶0119 “implantable system 20 can be configured to rectify the power signal, and produce a stimulation waveform with entirely different characteristics (e.g. amplitude, frequency, and/or duty cycle) from the rectified power signal. “).
Regarding claim 68, Claim 1 is anticipated by Mishra. Mishra further discloses implanting the implant adjacent to the tibial nerve (Mishra ¶0241 “The tibial nerve can also be accessed approximately half way up the lower leg adjacent to the tibia. One or more leads 265 can be inserted percutaneously in this location.”), wherein receiving the data comprises receiving the data from the one or more sensors both: prior to implanting the implant (Mishra ¶0220 “Diagnostic assembly 91 can be configured to perform numerous performance tests (e.g. of one or more implantable devices 200/800 or implantation locations for one or more implantable devices 200/800), prior to completion of the implantation procedure (e.g. prior to closing one or more incisions”)., and subsequently to implanting the implant (Mishra ¶0043 “implanting a first implantable lead and the first implantable device in the patient, and connecting the first implantable lead to the first implantable device; (c)delivering stimulation energy to patient tissue via the first implantable device for a trial period”).
Regarding claim 69, Claim 1 is anticipated by Mishra. Mishra further discloses determining a parameter representing a difference between: the characteristic of the response of the subject to the stimulation over the first time period, and the characteristic of the response of the subject to the stimulation over the second time period (Mishra ¶0246 “ In some embodiments, apparatus 10 is configured to provide temporary stimulation therapy of tissue to treat overactive bladder, such as by using one or more external devices 500, such as to provide power and/or data to one or more implantable devices 200/800 to confirm acceptable improvement of the patient's overactive bladder (e.g. successful stimulation of one or more sacral nerves, tibial nerves or other tissue), before closing an incision or otherwise fully implanting one or more implantable devices 200/800. “).
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 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (US Publication No. 20190374776) in view of Yoo et al. (US Publication No. 20250281742).
Regarding claims 4-7, Claim 1 is anticipated by Mishra. Mishra does not disclose receiving the first set of data comprises receiving the first set of data indicative of a cumulative duration of time during which the subject is not at home; a cumulative duration of time during which the subject is not in a workplace of the subject; a cumulative duration of time during which the subject is not indoors; and a cumulative duration of a plurality of periods of motion of the subject. Yoo in the similar field of activity tracking for medical monitoring to treat ailments teaches receiving data indicative of a cumulative duration of time during which the subject is not at home; a cumulative duration of time during which the subject is not in a workplace of the subject; a cumulative duration of time during which the subject is not indoors; and a cumulative duration of a plurality of periods of motion of the subject. (Yoo ¶0157 “Further, the second processor is configured to access information values stored in memory 60 such as in at least one table that can be related to treatment of a patient such as: parameter values for a stimulation program, treatment credits, activation interval during which the device 51a is permitted to operate, values related to a status or limitations of a prescription of a patient, compliance data and/or criteria of a patient,….., and/or geographic location information related to a neurostimulator if the neurostimulator (or other system component) has GPS or uses other geo-location technology.”, where the compliance data and geographic locations are accounted for in assessments. This will tell the locations traveled as well as time spent in an area or activity).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Mishra by integrating the methods for categorizing data, the data being a cumulative representation of a plurality of patient activities over a period of time, as taught by Yoo, into the stimulation device of Mishra for the purposes of providing indications of symptom relief (Mishra ¶0246).
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (US Publication No. 20190374776) in view of Villarreal (US Publication No. 20210393953).
Regarding claim 71, Claim 1 is anticipated by Mishra. Mishra does not disclose wherein the data indicative of the distance traveled by the subject is indicative of the distance traveled by the subject by vehicular transport. Villarreal in a similar field of endeavor of tibial nerve stimulation further teaches wherein the data indicative of the distance traveled by the subject is indicative of the distance traveled by the subject by vehicular transport. (Villarreal System 100 as seen in Figure 1 showing a motorized wheelchair device. This may be considered a vehicle since the support system is motorized and mobile).
Before the effective filing date of the claimed invention, it would have been obvious to a person of skill in the art to modify system of Mishra by integrating the methods wherein the data indicative of the distance traveled by the subject is indicative of the distance traveled by the subject by vehicular transport, as taught by Villarreal, into the stimulation device of Mishra for the purpose of providing indications of symptom relief (Mishra ¶0246).
Allowable Subject Matter
Claims 32 & 70 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 32 recites “performing the first assessment of the characteristic of the response of the subject to the stimulation based at least in part on a post-treatment-initiation distance traveled by the subject subsequently to the first time that the tibial nerve is stimulated using the implant being greater than a predetermined threshold distance during a given time period.”. Claim 70 recites “performing the first assessment of the characteristic of the response of the subject comprises comparing data indicative of a post- treatment-initiation distance traveled by the subject subsequently to the first treatment of the subject by stimulating the tibial nerve using the implant to data indicative of a baseline distance traveled by the subject prior to the first treatment of the subject by stimulating the tibial nerve using the implant”
The closest relevant art does not disclose tracking the progress of therapy by comparing a distance traveled by the patient to a threshold or baseline distance traveled by the patient to determine changes.
Therefore, claims 32 & 70 contain allowable subject matter once the 112(b) rejections have been overcome. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796