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 .
Claim Objections
Claim 1 is objected to because of the following informalities: typo. Claim 1 recites, “the device the movable arm” in the 3rd to last line and should be amended to remove “the device”. Appropriate correction is required.
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 3, 9, and 11-20 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 3, the claim recites, “a nerve” in ll. 2. It is unclear whether or not this limitation refers to the “nerve” disclosed in claim 1, ll. 9. For examination purposes, this limitation has been interpreted as “the nerve”.
Regarding claim 9, the claim recites, “a nerve” in ll. 2. It is unclear whether or not this limitation refers to the “nerve” disclosed in claim 1, ll. 9. For examination purposes, this limitation has been interpreted as “the nerve”.
Regarding claim 11, the claim recites “a nerve” in ll. 10 & 17. It is unclear whether or not this limitation refers to the “nerve” disclosed in the preamble. For examination purposes, this limitation has been interpreted as “the nerve”.
Also regarding claim 11, the claim recites “the central axis” in ll. 19. This limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “the longitudinal axis”.
As a result of dependence on claim 11, subsequent dependent claims 12-20 are also rejected as indefinite.
Regarding claim 12, the claim recites “the prescribed nerve” in ll. 2. It is unclear whether or not this limitation refers to the nerve of claim 11, and this limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “the nerve”.
Also regarding claim 12, the claim recites “the effect of the symptom signal” in ll. 4. This limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “an effect of a symptom signal”.
Regarding claim 13, the claim recites “the prescribed nerve” in ll. 1-2. It is unclear whether or not this limitation refers to the nerve of claim 11, and this limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “the nerve”.
Regarding claim 14, the claim recites “the prescribed somatic nerve” in ll. 2. It is unclear whether or not this limitation refers to the nerve of claim 11, and this limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “the nerve”.
Regarding claim 19, the claim recites “the prescribed somatic motor nerve” in ll. 1. It is unclear whether or not this limitation refers to the nerve of claim 11, and this limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “the nerve”.
Also regarding claim 19, the claim recites “the perineal nerve” and “the perineal or pelvic floor nerve”. These limitations lack antecedent basis. For examination purposes, these limitations have been interpreted as “a perineal nerve” and “the perineal nerve” respectively.
Regarding claim 20, the claim recites “the symptom control signal” in ll. 2. This limitation lacks antecedent basis. For examination purposes, this limitation has been interpreted as “a symptom control 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) 1-6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carmena et al. (US 2021/0308462) (hereinafter Carmena).
Regarding claim 1, Carmena discloses a neuromodulation device (Abstract; Fig. 2A, device 200) comprising: a main body comprising a hermetically sealed housing containing electronics therein (Fig. 2A, body 202; para. 83: “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 (para. 100 discloses the housing may be coated with an elastomeric or non-elastomeric coating); a movable arm coupled with the main body (Fig. 2A, curved members 204, 206), the movable arm configured to transition between an open configuration and a closed configuration, the movable arm being biased towards the closed configuration (para. 93-94: “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”); 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, 206 and electrodes 212, with nerve 208 resting therein), the size and shape of the chamber being adjustable by the movement of the arm in response to contact with the nerve (para. 93-94 as set forth above); 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, 206 through which nerve 208 travels), the size and shape of the channel being adjustable by the movement of the arm in response to contact with the nerve (para. 93-94), wherein the channel is continuously axial along a longitudinal axis of the channel when the movable arm is in the closed configuration (Fig. 2A, channel appears continuously axial along longitudinal axis in closed configuration); and an electrode within the chamber (Fig. 2A, electrodes 212).
Regarding claim 2, Carmena discloses a second movable arm (Fig. 2A, curved member 206), the second movable arm configured to transition between an open configuration and a closed configuration, the 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 (para. 93-94).
Regarding claim 3, Carmena discloses the movable arm is configured to atraumatically retain the nerve (para. 101: “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”) 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 (para. 97: “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”).
Regarding claim 4, Carmena discloses the chamber includes one or more relief spaces defined by the movable arm (Fig. 2A, gap 214; para. 94: “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”).
Regarding claim 5, Carmena discloses the moveable arm includes one or more bending points (para. 91: “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”, necessarily requiring one or more bending points in the curved member to allow for deformation of the curved members as disclosed).
Regarding claim 6, Carmena discloses a distal end of the electrode is embedded within the moveable arm (Fig. 2A, electrodes 212 are embedded within curved members 204, 206).
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 (para. 98: “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”).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of Maharbiz et al. (WO 2021/077022) (hereinafter Maharbiz).
Regarding claim 7, Carmena does not disclose a continuous feedthrough electric conductor wire extending through the hermetically sealed housing forms the electrode.
Maharbiz, however, teaches a nerve cuff (Abstract) comprising a continuous feedthrough electric conductor wire (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; para. 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Carmena such that a continuous feedthrough electric conductor wire extending through the hermetically sealed housing forms the electrode. Making this modification would be useful for allowing electrical connection between the body and electrode, as taught by Maharbiz (para. 106).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of Maharbiz, further in view of Romero-Ortega et al. (US 2019/0290902) (hereinafter Romero-Ortega).
Regarding claim 8, modified Carmena does not teach the channel is non-linear.
Romero-Ortega, however, teaches a neuromodulation device (Abstract) wherein the channel is non-linear (Fig. 1B depicts L-shaped channel; para. 10: “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”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Carmena such that the channel is non-linear. Making this modification would be useful for facilitating facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation to prevent nerve damage during implantation, as taught by Romero-Ortega.
Claims 10-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carmena in view of Romero-Ortega.
Regarding claim 10, Carmena discloses the channel is continuously axial (Fig. 2A, channel appears continuously axial along longitudinal axis).
Carmena does not disclose the channel is non-linear.
Romero-Ortega, however, teaches a neuromodulation device (Abstract) wherein the channel is non-linear (Fig. 1B depicts L-shaped channel; para. 10: “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”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Carmena such that the channel is non-linear. Making this modification would be useful for facilitating facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation to prevent nerve damage during implantation, as taught by Romero-Ortega.
Regarding claim 11, Carmena discloses a method of stimulating a nerve comprising: providing a neuromodulation device having: a main body comprising a hermetically sealed housing containing electronics therein, and a buffer layer at least partially encapsulating the hermetically sealed housing, a movable arm coupled with the main body, the movable arm configured to transition between an open configuration and a closed configuration, the movable arm being biased towards the closed configuration, a nerve stimulation chamber defined at least in part by the movable arm, the nerve stimulation chamber configured to retain the nerve therein, the size and shape of the chamber being adjustable by the movement of the arm, a channel through which the nerve travels, the channel defined at least in part by the movable arm, the size and shape of the channel being adjustable by the movement of the arm, wherein the channel is continuously axial along a longitudinal axis of the channel and an electrode within the chamber (see rejection of claim 1 above).
Carmena does not disclose reducing a maximum cross-sectional dimension of the nerve to define a stretched nerve having a reduced cross-sectional dimension; moving the stretched nerve through the channel along the longitudinal axis; positioning the nerve in the chamber and increasing the cross-sectional dimension of the stretched nerve.
Romero-Ortega, however, teaches a neuromodulation device (Abstract) and reducing a maximum cross-sectional dimension of a nerve to define a stretched nerve having a reduced cross-sectional dimension; moving the stretched nerve through the channel along the longitudinal axis (para. 14: “engaging the nerve within the neuromodulation device may include briefly stretching at least a portion of the nerve so as to reduce the average diameter of the stretched portion of the nerve, and sliding the stretched portion of the nerve through the channel into the chamber where it is relaxed”); the nerve 200 is being moved through channel 102, Fig. 2); positioning the nerve in the chamber and increasing the cross-sectional dimension of the stretched nerve (Fig. 2, when nerve 200 is within chamber 101; para. 10: “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”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Carmena to include reducing a maximum cross-sectional dimension of the nerve to define a stretched nerve having a reduced cross-sectional dimension; moving the stretched nerve through the channel along the longitudinal axis; positioning the nerve in the chamber and increasing the cross-sectional dimension of the stretched nerve. Making this modification would be useful for facilitating facile and rapid implantation of the neuromodulation device while minimizing nerve manipulation to prevent nerve damage during implantation, as taught by Romero-Ortega (para. 10).
Regarding claim 12, modified Carmena does not 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.
Romero-Ortega, however, teaches a neuromodulation device (Abstract) and transmitting, via the electrode, a control signal to the nerve (para. 13: “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 (para. 132: “the activation of motor axons in pelvic and perineal nerves due to stimulation by the neruomodulation device may activate, recruit, and/or repair damaged axons, reform neuromuscular connections”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modifed Carmena to include 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. Making this modification would be useful for activating, recruiting, and/or repairing damaged axons and reforming neuromuscular connections, as taught by Romero-Ortega.
Regarding claim 13, Carmena discloses positioning the nerve within the chamber contacts the nerve with the electrode (Fig. 2A, nerve 208 contacts electrodes 212).
Regarding claim 14, Carmena discloses 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 (para. 101: “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 17, Carmena discloses the electrode contacts more than 50 percent of a perimeter of the nerve (para. 98: “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 discloses the movable arm is biased towards the closed position (para. 94: “the curved members can be released so that the curved members wrap around the nerve”).
Regarding claim 19, modified Carmena does not teach the nerve comprises a perineal nerve, further wherein the perineal nerve is part of the coccygeal and/or perineal plexus.
Romero-Ortega, however, teaches a neuromodulation device (Abstract) and the nerve comprises a perineal nerve further wherein the perineal nerve is part of the coccygeal and/or perineal plexus (para. 129: “Nerves innervating the pelvic floor muscles include… perineal nerve or branches of the pudendal nerve...its branches forming the iliococcygeal, pubococcygeal, puborectal, and coccygeal nerves”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Carmena such that the nerve comprises a perineal nerve, further wherein the perineal nerve is part of the coccygeal and/or perineal plexus. Making this modification would be useful for stimulating a nerve so as to cause observable muscle contraction which may be used to treat, mitigate, reverse, or repair pelvic disorders and their related biological systems (para. 129).
Regarding claim 20, Carmena discloses transmitting comprises using a signal generator (Fig. 1, stimulation circuit) to produce and transmit a symptom control signal with the electrode (Abstract: “generate a stimulation signal… and operate the electrode pads of to emit an electrical pulse to the nerve based on the stimulation signal”), the symptom control signal being transmitted using one or more of wired or wireless communication media (signal must be transmitted wirelessly or wired inherently; Fig. 1 appears to depict wireless and/or wired connection between electrode pads and stimulation circuit).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over modified Carmena in view of Maharbiz.
Regarding claim 16, modified Carmena does not teach a continuous feedthrough conductor extending through the hermetically sealed housing forms the electrode.
Maharbiz, however, teaches a nerve cuff (Abstract) comprising a continuous feedthrough electric conductor wire (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; para. 106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Carmena such that a continuous feedthrough electric conductor wire extending through the hermetically sealed housing forms the electrode. Making this modification would be useful for allowing electrical connection between the body and electrode, as taught by Maharbiz (para. 106).
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: The cited prior art does not teach or suggest the housing includes a projection configured to press against the movable arm in the closed position, the projection configured to limit the amount of compression on the nerve from the movable arm, in combination with other limitations.
Conclusion
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792