Prosecution Insights
Last updated: October 04, 2026
Application No. 18/225,129

SYSTEM AND METHOD FOR NERVE STIMULATION

Non-Final OA §102§103§112
Filed
Jul 22, 2023
Priority
Jul 22, 2022 — provisional 63/391,574 +1 more
Examiner
WEBSTER, KARMEL JOHANNA
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Regenerative Bioelectronics Inc.
OA Round
2 (Non-Final)
68%
Grant Probability
Favorable
2-3
OA Rounds
3m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allowance Rate
17 granted / 25 resolved
-2.0% vs TC avg
Strong +29% interview lift
Without
With
+28.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
31 currently pending
Career history
59
Total Applications
across all art units

Statute-Specific Performance

§101
5.0%
-35.0% vs TC avg
§103
68.5%
+28.5% vs TC avg
§102
15.6%
-24.4% vs TC avg
§112
8.8%
-31.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 25 resolved cases

Office Action

§102 §103 §112
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 filed on June 10, 2026 have been fully considered but they are not fully persuasive. In regard to applicant’s response regarding the claim objections, the claim objections have been withdrawn. In regard to Applicant’s response to the 112(b) amendments, the 112(b) rejections will not be withdrawn due to claim 9 still reciting “a nerve” instead of “the nerve” and due to claim 12 still reciting “the effect of the symptom signal” instead of “an effect of a symptom signal.” Secondly, in regard to applicant’s first argument regarding the 35 U.S.C. 102 rejections, applicant argues that Carmena does not disclose an open channel whose size and shape are adjustable by movement of the arm in response to contact with the nerve. The examiner respectfully disagrees. In addition to previously cited paragraphs [0093]-[0094], para [0091] of Carmena states the following: “ the curved members may be flexible, which allows for deformation of the curved members during implantation of the device. For example, the cured members may be flexed outwardly while the device is being positioned on the nerve.” Furthermore, para [0097] states the following: “The size, shape, and spacing of the one or more curved members on the device can depend on the type and size of tissue that device engages…… The inner surface of the curved members form a cylindrical space through which the nerve and/or filamentous tissue passes. The diameter of the cylindrical space formed by the curved members depends on the target nerve and/or filamentous tissue that the implantable device will engage. ” As previously stated, because the curved member(s) deform (allowing for nerve to travel through the channel as shown in fig. 2A-2B, 208 & 222, and the size and shape of the open channel to be adjustable by movement of the arm in response to contact of the nerve), Carmena does disclose and identify a nerve contact responsive channel adjustment while also teaching a channel through which the nerve travels as stated and shown in fig. 2A-2B and as explained in the previous paragraphs. Furthermore, in regards to Applicant’s second argument, applicant states that Carmena does not identify contact with the nerve as the cause of that flexing, and does not disclose the claimed channel which the nerve travels. The examiner respectfully disagrees with this statement. As explicitly shown in figs. 2A-3A and explained in para [0039], para [0094], and specifically described in para [0097] stated above, Carmena does identify contact with the nerve as the cause of that flexing, and does disclose the claimed channel which the nerve travels as shown and described in the reference. In regard to Applicant’s arguments for claims 2-6 and 9, Applicant first presents the argument for claim 4 stating that Carmena does not teach nerve relief spaces defined by the moveable arm. The examiner agrees with this statement. However, in regard to Applicant’s arguments regarding the distal end of the electrode being embedded within the moveable arm, this argument has been found to be unpersuasive. In regard to Applicant’s arguments regarding the 35 U.S.C. 103 rejection of claim 11, this arguments against Carmena have been found to be unpersuasive for the reasons previously set forth above, which will be further explained in the rejection below. Moreover, in view of the persuasive arguments regarding the claim 4 rejection and the claim amendments, the following rejection will be addressed in a second-action non-final as shown below. 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 9 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 9, the claim recites, “a nerve” in line 3. It is unclear whether or not this limitation refers to the “nerve” disclosed in claims 1 and ll. For examination purposes, this limitation has been interpreted as “the nerve”. Regarding claim 12, the claim recites “the effect of the symptom signal” in lines 3-4 This limitation lacks insufficient antecedent basis. For examination purposes, this limitation has been interpreted as “an effect of a symptom signal.” 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. Claim(s) 1-2, 5-6, 11, 13-15, 17-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0308462 A1 to Carmena et al. (hereinafter “Carmena”). Regarding claims 1 and 11, Carmena teaches a neuromodulation device and method (See abstract and Fig. 2A, device 200) comprising: a main body comprising a hermetically sealed housing containing electronics therein (Fig. 2A – 202 and para [0083] - “The housing can enclose the one or more ultrasonic transducers and the integrated circuit (which includes the computational circuit, the non-transitory memory, the battery, the modulation circuit, a detection circuit, and/or a stimulation circuit (which can include a stimulating capacitor)). The hosing may be sealed closed (for example by soldering or laser welding) to prevent interstitial fluid from coming in contact with the ultrasonic transducer(s) and/or the integrated circuit.” and a buffer layer at least partially encapsulating the hermetically sealed housing (See para [0100] - discloses the housing may be coated with an elastomeric or non-elastomeric coating); a movable arm coupled with the main body/housing (See Fig. 2A – 202 & 204, para [0039], and para [0094]), the movable arm configured to transition between an open configuration and a closed configuration, the movable arm being biased towards the closed configuration (See para. [0093]-[0094] - “The curved members can be flexible, which allows for deformation of the curved members during implantation of the device. The cured members can be flexed outwardly while the device is being positioned on the nerve. Release of the curved members allows the curved members to wrap around the nerve or filamentous tissue containing the nerve….. the first curved member 204 and the second curved member 206 arc flexible members that are separated by a gap (i.e., a separation) 214. In this configuration, the first curved member 204 and the second curved member 206 can be flexed outwardly (thereby widening the gap 214) to allow the nerve 208 to be positioned within the space between the curved members, and the curved members can be released so that the curved members wrap around the nerve” – the curved member 204 is the moveable arm in this claim). Due to the moveable arm opening/widening the gap (causing deformation in the outward configuration) and then wrapping around the curve, the moveable arm is biased towards the closed configuration. Furthermore, Carmena teaches a nerve stimulation chamber defined at least in part by the movable arm, the nerve stimulation chamber configured to retain a nerve therein (See Fig. 2A, nerve stimulation chamber defined by curved members 204 and electrodes 212, with nerve 208 resting therein, and para [0096]), the size and shape of the chamber being adjustable by the movement of the arm in response to contact with the nerve (See para [0093]-[0094] and para [0097]); an open channel through which the nerve travels, the channel defined at least in part by the movable arm (Fig. 2A, channel is defined by curved members 204 through which nerve 208 travels and para [0097] as set forth above), the size and shape of the channel being adjustable by the movement of the arm in response to contact with the nerve (para. [0093]-[0094] and para [0097]), wherein the channel is continuously axial along a longitudinal axis of the channel when the movable arm is in the closed configuration (Figs. 2A-3B, channel appears continuously axial along longitudinal axis in closed configuration, and para [0039]-[0041]), and an electrode within the chamber (Fig. 2A, electrodes 212), and, in regard to claim 11, Carmena teaches moving the nerve through the channel, wherein contact between the nerve and the moveable arm moves the moveable arm from the closed configuration towards the open configuration to enlarge the channel (see para [0091] – “The curved members may be flexible, which allows for deformation of the curved members during implantation of the device. For example, the cured members may be flexed outwardly while the device is being positioned on the nerve. Release of the curved members allows the curved members to wrap around the nerve or filamentous tissue containing the nerve”, para [0093]- [0094], and para [0097]- first sentence: “The size, shape, and spacing of the one or more curved members on the device can depend on the type and size of tissue that device engages.”), and positioning the nerve within the chamber/channel (see annotated fig. 2A below, para [0093]-[0094], and para [0097] – [0098]). PNG media_image1.png 340 904 media_image1.png Greyscale Regarding claim 2, Carmena teaches the device of claim 1, wherein a second movable arm (See Fig. 2A, curved member 206), the second movable arm configured to transition between an open configuration and a closed configuration, the second movable arm being biased towards the closed configuration, wherein movement of the second movable arm adjusts a size of the chamber and/ or a size of the channel (see fig. 2A- 204 and 206, para. [0093]-[0094] and para [0097]). Regarding claim 5, Carmena discloses the device of claim 1, wherein the moveable arm includes one or more bending points (See para [0091] - “The curved members may be flexible, which allows for deformation of the curved members during implantation of the device. For example, the cured members may be flexed outwardly while the device is being positioned on the nerve.” The curved member(s)/arm require one or more bending points to allow for deformation of the curved member(s)). Regarding claim 6, Carmena discloses the device of claim 1, wherein a distal end of the electrode is embedded within the moveable arm (See fig. 2A, electrodes 212 are embedded within curved member 204). Regarding claim 13, Carmena teaches the method of claim 11, wherein positioning the nerve within the chamber contacts the nerve with the electrode (See fig. 2A, nerve 208 contacts electrodes 212). Regarding claim 14, Carmena teaches the method of claim 11, wherein positioning the movable arm in the closed position compresses the nerve in the chamber, such that the cross-sectional shape of the nerve changes without damaging the nerve (See para [0101] – “The one or more curved members grip the nerve and/or filamentous tissue by exerting an inward pressure on the nerve and/or filamentous tissue. The amount of inward pressure exerted by the one or more curved members can be determined based on the size and curvature of the curved members, as well as by the spring constant of the curved members. The inward pressure should be sufficient to hold the implantable device in place while the tissue heals after insertion, but not so high that the epineurium or vascular walls that contact the curved members are damaged”). Regarding claim 15 , Carmena teaches the method of claim 11, wherein the housing includes a projection (second curved member – see fig. 2A - 206) configured to press against the movable arm in the closed configuration (see fig. 2A – 204 & 206), the projection configured to limit the amount of compression on the nerve from the movable arm (See para [0090]-[0091], para [0093]-[0094], and para [0101] – “In some embodiments, the one or more curved members grip the nerve and/or filamentous tissue by exerting an inward pressure on the nerve and/or filamentous tissue. The amount of inward pressure exerted by the one or more curved members can be determined based on the size and curvature of the curved members, as well as by the spring constant of the curved members. The inward pressure should be sufficient to hold the implantable device in place while the tissue heals after insertion, but not so high that the epineurium or vascular walls that contact the curved members are damaged.”). The second curved member/protrusion (See fig. 2A- 206) from the housing/body (fig. 2A -202) is configured to press against the moveable arm to keep the nerve in place, while also limiting the amount of compression exerted on the nerve. Regarding claim 17, Carmena teaches the method of claim 11, wherein the electrode contacts more than 50 percent of a perimeter of the nerve (See para [0098] - “Similarly, the one or more curved electrode pads, may circumscribe… at least 50%, at least 66%, at least 75%, at least 90%, or at least 100% of the nerve). Regarding claim 18, Carmena teaches the method of claim 11, wherein the movable arm is biased towards the closed position (See para [0094] - “In this configuration, the first curved member 204 and the second curved member 206 can be flexed outwardly (thereby widening the gap 214)…..the curved members can be released so that the curved members wrap around the nerve”). Regarding claim 20, Carmena as modified teaches the method of claim 12, wherein transmitting comprises using a signal generator (See Carmena, fig. 1 - stimulation circuit) configured to produce and transmit a control signal with the electrode (See abstract of Carmena - “The body includes an ultrasonic transducer configured to receive ultrasonic waves and convert energy from the ultrasonic waves into an electrical energy; and a computational circuit configured to receive a detection signal based on a detected electrophysiological signal, generate a stimulation signal based on the detection signal, and operate the electrode pads of to emit an electrical pulse to the nerve based on the stimulation signal”), the control signal being transmitted using one or more of wired or wireless communication media (See para [0125]-[0127] of Carmena – First two sentences are from para [0125], followed by the first sentence of para [0127]: “Although the implantable device can emit an electrical pulse in response to a detected electrophysiological signal through a closed-loop, on-board computational circuit, in some embodiments there is a system that includes a closed-loop implantable device described herein and an interrogator configured to emit ultrasonic waves that power the device. …..If implanted, the interrogator can wirelessly communicate with an external device, for example using ultrasonic communication or radiofrequency (RF)…... Information encoded in the ultrasonic waves emitted by the interrogator and received by the closed-loop implantable device can include, for example, instructions for starting or stopping closed-loop neuromodulation, one or more calibration instructions, one or more updates to the operation software, and/or or one or more templates (such as template electrophysiological signals, one or more template electrophysiological signals, and/or one or more template stimulation signals)”). 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 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Carmena. Regarding claim 3, Carmena discloses the device of claim 1, wherein the movable arm is configured to atraumatically retain the nerve (See para. [0101] - “The inward pressure should be sufficient to hold the implantable device in place while the tissue heals after insertion, but not so high that the epineurium or vascular walls that contact the curved members are damaged”), and having a resting maximum cross-sectional dimension of between 0.5 mm and 4 mm in the chamber when the movable arm is biased towards the closed configuration (See para. [0097] - “The size, shape, and spacing of the one or more curved members on the device can depend on the type and size of tissue that device engages… .The inner surface of the curved members form a cylindrical space through which the nerve and/or filamentous tissue passes. The diameter of the cylindrical space formed by the curved members depends on the target nerve and/or filamentous tissue that the implantable device will engage. In some embodiments, the one or more curved members of the device form a cylindrical space with a diameter of about 50 μm to about 15 mm”). Therefore, 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 cross-section dimension range of 0.5mm to 4mm in order to safely and properly retain and accommodate the target nerve. 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)). Regarding claim 9, Carmena discloses the chamber is configured so that the electrode is curved and sized to contact at least 20% of the perimeter of the nerve having a maximum cross-sectional dimension of between 0.5 mm and 4 mm (See para [0097]- “The size, shape, and spacing of the one or more curved members on the device can depend on the type and size of tissue that device engages… ….. The diameter of the cylindrical space formed by the curved members depends on the target nerve and/or filamentous tissue that the implantable device will engage. In some embodiments, the one or more curved members of the device form a cylindrical space with a diameter of about 50 μm to about 15 mm”, and Para [0098] - “the one or more curved electrode pads, may circumscribe at least 25%, at least 33%, at least 50%, at least 66%, at least 75%, at least 90%, or at least 100% of the nerve”). Therefore, 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 contact size of at least 20% and cross-section dimension range of 0.5mm to 4mm in order to safely and properly accommodating the target nerve while providing the necessary therapeutic stimulation. 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)). Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of US 2014/0046407 A1 to Ben-Ezra et al. (hereinafter “Ben-E”). Regarding claim 4, Carmena discloses the chamber (see figs. 2A-3A – location where the nerve 208, 222, and 314 is located), but does not disclose wherein the chamber includes one or more relief spaces defined by the movable arm. However, Ben-E teaches an electrode device configured provide stimulation to the parasympathetic site of a patient (see abstract, para [0249], para [0504], and para [0529]), the device (figs. 1A-1B) teaches wherein the chamber includes one or more relief spaces defined by the movable arm (See annotated figs. 1A-1B and 4B below, para [1270]- “For applications in which cuff 24 is applied to a nerve, recesses 70 may serve to prevent damage to the nerve by allowing the nerve to swell in at least one radial direction into at least one of the recesses, along entire length L.sub.C of the cuff”, para [1271], para [0308], and para [0310]). PNG media_image2.png 677 1049 media_image2.png Greyscale PNG media_image3.png 213 550 media_image3.png Greyscale 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 teachings of Carmena with the recesses disclosed by Ben-E to arrive at the claimed invention. Such modification would improve the system by preventing trauma to the target nerve as previously disclosed by the reference. Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of WO 2021/077022 A1 to Maharbiz et al. (hereinafter “Maharbiz”). Regarding claim 7, Carmena teaches the device of claim 1, but does not disclose a continuous feedthrough electric conductor wire extending through the hermetically sealed housing forms the electrode. However, Maharbiz teaches a nerve cuff comprising a continuous feedthrough electric conductor wire (See abstract, Fig. 19A, extending portion 1910 of electrode 1908) extending through the hermetically sealed housing forms the electrode (See Fig. 19A - portion 1910 extends from the body 1904 and forms electrode 1908, and para [0106]). 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 of Carmena with the teachings of Maharbiz to arrive at the claimed invention. Such modification would improve the system by allowing for more seamless communication and stimulation between the body and electrode. Regarding claim 16, Carmena teaches the method of claim 11, but does not disclose a continuous feedthrough conductor extending through the hermetically sealed housing forms the electrode. However, Maharbiz teaches a nerve cuff (See abstract) comprising a continuous feedthrough electric conductor wire (See fig. 19A, extending portion 1910 of electrode 1908) extending through the hermetically sealed housing forms the electrode (Fig. 19A, portion 1910 extends from the body 1904 and forms electrode 1908, and para [0106]). 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 of Carmena with the teachings of Maharbiz to arrive at the claimed invention. Such modification would improve the system by allowing for more seamless communication and stimulation between the body and electrode. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of Maharbiz, and further in view of US 2019/0290902 A1 to Romero-Ortega et al. (hereinafter “Romero”). Regarding claim 8, Carmena as modified teaches the device of claim 7, but does not disclose wherein the channel is non-linear. However, Romero teaches a neuromodulation device (See abstract), wherein the channel is non-linear (See Fig. 1B depicts L-shaped channel and para [0010] - “….a device described herein, in some cases, can comprise a unique L-shaped longitudinal channel that allows access to the recording/stimulating chamber. This design offers a slide-in-lock mechanism using a slit opening calculated to be 5-50% of the nerve diameter, through which a nerve can be inserted via a soft and brief stretching of the nerve tissue, and then released or relaxed or “unstretched” inside an electrode chamber. The design facilitates facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation to prevent nerve damage during implantation”). 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 teachings of Carmena with the non-linear channel of Romero to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the non-linear channel would facilitate facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation and nerve damage during implantation, as taught by Romero. Claims 10, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of Romero-Ortega. Regarding claim 10, Carmena as modified teaches the device of claim 1, wherein the channel is continuously axial (See fig. 2A – the channel appears continuously axial along longitudinal axis), but does not explicitly disclose wherein the channel is non-linear. However, Romero teaches a neuromodulation device (See abstract), wherein the channel is non-linear (See Fig. 1B depicts L-shaped channel and para [0010] - “….a device described herein, in some cases, can comprise a unique L-shaped longitudinal channel that allows access to the recording/stimulating chamber. This design offers a slide-in-lock mechanism using a slit opening calculated to be 5-50% of the nerve diameter, through which a nerve can be inserted via a soft and brief stretching of the nerve tissue, and then released or relaxed or “unstretched” inside an electrode chamber. The design facilitates facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation to prevent nerve damage during implantation”). 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 teachings of Carmena with the non-linear channel of Romero to arrive at the claimed invention. Such modification would have led to a reasonable expectation for success, since the non-linear channel would facilitate facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation and nerve damage during implantation, as taught by Romero. Regarding claim 12, Carmena teaches the method of claim 11, but does not explicitly disclose transmitting, via the electrode, a control signal to the nerve, the control signal configured to activate the pelvic floor in a prescribed manner to mitigate an effect of a symptom signal on the spinal cord. However, Romero teaches a neuromodulation device (See abstract) and transmitting, via the electrode, a control signal to the nerve (See para [0013] - “stimulating at least a portion of the engaged nerve by sending electrical signals from the at least one electrode”), the control signal configured to activate the pelvic floor in a prescribed manner to mitigate an effect of a symptom signal on the spinal cord (See para [0132] - “In some embodiments, the activation of motor axons in pelvic and perineal nerves due to stimulation by the ne[u]romodulation device may activate, recruit, and/or repair damaged axons, reform neuromuscular connections, and/or repair and strengthen the pelvic muscles innervated by the pelvic and perineal nerves.”). 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 of Carmena to include the system of Romero to arrive at the claimed invention. Such modification would improve the system allowing for efficient activating and recruiting of damaged axons while reforming neuromuscular connections, as taught by Romero. Regarding claim 19, Carmena teaches the method of claim 11, wherein the stimulated nerve includes the pudendal nerve (see para [0113]), but does not explicitly disclose wherein the nerve comprises a perineal nerve. However, Romero teaches a neuromodulation device (See abstract) wherein stimulation of the nerve comprises a perineal nerve (See para [0129] - “Pelvic disorders may be the result of abnormal relaxation or contraction of the pelvic floor muscles, which in turn may be due to partial damage by trauma or age. Nerves innervating the pelvic floor muscles include (but are not limited to) the following: perineal nerve or branches of the pudendal nerve innervating the scrotum or labia majora skin…… One or more of the nerves innervating the pelvic or perineal muscles may form a sling around the urogenital hiatus and rectum thereby forming a sphincter. Accordingly, activation of the pelvic or perineal muscles may promote their closure”). 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/method of Carmena with the teachings of Romero to arrive at the claimed invention, since such modification would improve the current system by providing useful stimulation to the perineal nerve in order to treat and/or mitigate pelvic disorders and their related biological systems. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fang et al. (US 10,758,723 B2) teaches a nerve cuff electrode for stimulating and improving bladder function (see abstract and col. 2, lines 39-49). Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARMEL J WEBSTER whose telephone number is (703)756-5960. The examiner can normally be reached Monday-Friday 7:30am-5:00pm. 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, NIKETA PATEL can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /K.J.W./Examiner, Art Unit 3792 /NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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Prosecution Timeline

Jul 22, 2023
Application Filed
Nov 03, 2025
Non-Final Rejection (signed) — §102, §103, §112
Dec 10, 2025
Non-Final Rejection mailed — §102, §103, §112
Jun 10, 2026
Response Filed
Sep 17, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

2-3
Expected OA Rounds
68%
Grant Probability
97%
With Interview (+28.7%)
3y 5m (~3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 25 resolved cases by this examiner. Grant probability derived from career allowance rate.

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