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 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18, line 1 should be amended to recite, “further comprising a circuitry”.
Appropriate correction is respectfully requested.
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 1-3, 6-7, 9, 13-14, 16, 18, 20, 22-24, and 26-30 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.
Claim 1 recites the limitation "the group" in line 3. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies.
Claim 9 recites the limitation "the plurality of nanogenerator units" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the sensory restoration device" in line 3. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies.
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.
Claim(s) 1-3, 6, 16, 18, 20, 22-23, and 26-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Towe et al (US 2014/0316499) hereinafter Towe as evidenced by Cantin et al (US 2006/0129210) hereinafter Cantin.
Regarding claim 1, Towe discloses an implantable device for at least partially restoring tactile sensation to a subject in need thereof, the device comprising:
at least one nanogenerator unit (piezoelectric element) selected from the group consisting of a piezoelectric nanogenerator, a triboelectric nanogenerator, and a pyroelectric nanogenerator, configured to be positioned subcutaneously and to produce an electric signal upon exertion of an external stimulus [0056]; and
at least one electrode configured to be connected to at least one functional sensory nerve of the subject ([0052] piezoelectric chip is located proximate a nerve fiber 216; [0056] piezoelectric chip 220 includes a thin piezoelectric element 222 to which a diode 224 is attached);
such that the electric signal produced by the at least one nanogenerator unit in response to the external stimulus is conveyed to the at least one functional sensory nerve of the subject, via the at least one electrode, thereby at least partially restoring the tactile sensation to the subject [0053],
wherein said at least one nanogenerator unit is coated with a heat sensitive material comprising a pyroelectric material (piezoelectric element may be constructed from PVDF) configured to generate an electric signal in response to temperature changes [0057].
Examiner notes that polyvinylidene fluoride (PVDF) is also a pyroelectric material [0074] as evidenced by Cantin.
Regarding claim 2, Towe discloses wherein the electric signal is proportional to the magnitude of the external stimulus ([0053] The ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip. The excitation of the piezoelectric materials in the piezoelectric chip generates an electric current).
Regarding claim 3, Towe discloses wherein the external stimulus comprises: pressure, friction, traction, shear force and/or temperature change ([0053] ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip).
Regarding claim 6, Towe discloses wherein said nanogenerator unit selected from the group consisting of a piezoelectric nanogenerator, a triboelectric nanogenerator, and a pyroelectric nanogenerator is adapted to be connected to a single nerve ([0052] The piezoelectric chip is located proximate a nerve fiber 216).
Regarding claim 16, Towe discloses wherein the triboelectric nanogenerator (TENG) is configured to convert pressure, friction and/or traction force applied to said TENG into an electric signal that is supplied to said at least one sensory nerve ([0053] The ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip. The excitation of the piezoelectric materials in the piezoelectric chip generates an electric current that can then be used to stimulate an action potential or inhibit the creation of an action potential in a nerve fiber).
Regarding claim 18, Towe discloses a circuitry (drive circuitry 2020) which is configured to change the electrical features of an electric pulse generated by the TENG ([0053] drive circuitry 202 generates a drive signal that is provided to the ultrasound transducer which creates a pressure wave that is incident on the piezoelectric chip).
Regarding claim 20, Towe discloses wherein said nanogenerator is self-powered ([0053] The excitation of the piezoelectric materials in the piezoelectric chip generates an electric current).
Regarding claim 22, Towe discloses method for at least partially restoring tactile sensation to a subject in need thereof, comprising the step of:
providing the sensory restoration device of claim 1 to said subject, thereby at least partially restoring tactile sensation to a subject in need thereof ([0053] The excitation of the piezoelectric materials in the piezoelectric chip generates an electric current that can then be used to stimulate an action potential or inhibit the creation of an action potential in a nerve fiber).
Examiner notes that the limitation “thereby at least partially restoring tactile sensation to a subject in need thereof’ is merely an intended result of a positively recited method/process step. Since Towe discloses delivering an electrical signal produced by the at least one nanogenerator in response to the external stimulus as required by claim 1, Towe would also necessarily at least partially restore tactile sensation to a subject in need thereof.
Regarding claim 23, Towe discloses wherein the sensory restoration device is subcutaneously implanted and electrically connected to a functional nerve of the subject via the electrode ([0056] piezoelectric chip 220 includes a thin piezoelectric element 222 to which a diode 224 is attached; [0070] implanting a piezoelectric chip proximate the nerve fiber, generating a pressure wave incident on the piezoelectric chip 244 and using an electric current generated by the piezoelectric chip to stimulate the nerve fiber 246).
Regarding claim 26, Towe discloses wherein the electrical signal is proportional to the magnitude of the external stimulus ([0053] The ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip. The excitation of the piezoelectric materials in the piezoelectric chip generates an electric current).
Regarding claim 27, Towe discloses a step of implanting the device such that the nanogenerator is placed subcutaneously ([0070] implanting a piezoelectric chip proximate the nerve fiber) and the electrode is in physical contact with a corresponding functional nerve ([0056] piezoelectric chip 220 includes a thin piezoelectric element 222 to which a diode 224 is attached).
Regarding claim 28, Towe discloses a system comprising the device of claim 1 (as discussed above) and an external controller configured to control one or more operating parameters of the device ([0053] The drive circuitry 202 generates a drive signal that is provided to the ultrasound transducer. The drive signal enables the ultrasound transducer to generate a desired pressure wave; Fig. 7).
Regarding claim 29, Towe discloses wherein the controller is wirelessly associated with the device (Fig. 7 shows driving circuitry 202 being wireless to piezoelectric chip 206; [0053] The ultrasound transducer (connected to driving circuitry 202) is positioned to create a pressure wave that is incident on the piezoelectric chip).
Regarding claim 30, Towe discloses wherein the controller is configured to control a sensitivity of the sensory restoration device ([0053] ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip; Examiner notes that the placement of the transducer relative to the piezoelectric chip would affect the device’s sensitivity to the imparted pressure waves).
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.
Claim(s) 7, 9, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Towe (US 2014/0316499) in view of Karr et al (US 10,369,362) hereinafter Karr as evidenced by Cantin (US 2006/0129210).
Regarding claim 7, Towe discloses the device of claim 1 as discussed above, but fails to disclose wherein said nanogenerator units are adapted to be connected to a single nerve. However, Karr discloses a plurality of nanogenerator units adapted to be connected to a single nerve (Col. 4, ln 26-28: One or more bionic implants 120 are placed in locations where sensor information is desirable). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Towe with a plurality of nanogenerator units adapted to be connected to a single nerve as taught by Karr. Such a modification would provide the predictable results of allowing the brain to receive sensory information from more than one location and interpret it as touch or feel (Karr, Col. 4, ln 28-34).
Regarding claim 9, the modified Towe discloses the device of claim 7 as discussed above, but fails to disclose wherein the plurality of nanogenerator units are connected in an array. However, Karr discloses wherein the plurality of nanogenerator units are connected in an array (Col. 4, ln 26-28: One or more bionic implants 120 are placed in locations where sensor information is desirable; Fig. 1). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the device as taught by Towe with the plurality of nanogenerator units are connected in an array as taught by Karr. Such a modification would provide the predictable results of allowing the brain to receive sensory information from more than one location and interpret it as touch or feel (Karr, Col. 4, ln 28-34).
Regarding claim 24, Towe discloses the method of claim 22 as discussed above, but fails to disclose wherein the subject has an impaired tactile sensation caused by nerve damage. However, Karr discloses wherein the subject has an impaired tactile sensation caused by nerve damage (Col. 4, ln 51-54: the patient has damaged a nerve ending in a finger such that touch sensitivity is impaired). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Towe with the subject having an impaired tactile sensation caused by nerve damage as taught by Karr. Such a modification would provide the predictable results of allowing the brain to receive sensory information from the damaged nerve and interpret it as touch or feel (Karr, Col. 4, ln 28-34).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Towe (US 2014/0316499) in view of Cantin (US 2006/0129210).
Regarding claim 13, Towe discloses the device of claim 1 as discussed above, but fails to disclose wherein a response time and reset time of the pyroelectric nanogenerator is more than 0.001s. However, Cantin discloses wherein a response time and reset time of the pyroelectric nanogenerator is more than 0.001s ([0074] If signal response times of over a few milliseconds are required, a pyroelectric material, such as polyvinylidene fluoride (PVDF), may be preferable). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Towe with a response time and reset time of the pyroelectric nanogenerator is more than 0.001s as taught by Cantin. Such a modification would provide the predictable results of easy deposition using wet coating techniques and a thickness of a few tens of micrometers (Cantin, [0074]).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Towe (US 2014/0316499) in view of DiUbaldi et al (US 2010/0249677) hereinafter DiUbaldi as evidenced by Cantin (US 2006/0129210).
Regarding claim 14, Towe discloses wherein the piezoelectric nanogenerator is a pressure sensor ([0053] ultrasound transducer is positioned to create a pressure wave that is incident on the piezoelectric chip. The excitation of the piezoelectric materials in the piezoelectric chip generates an electric current that), but fails to disclose said nanogenerator has a wurtzite structure or a perovskite structure. However, DiUbaldi discloses a nanogenerator having a wurtzite structure ([0024] piezoelectric materials include ceramics with perovskite or tungsten-bronze structures). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the device as taught by Towe with a nanogenerator having a wurtzite structure as taught by DiUbaldi. Such a modification would provide the predictable results of piezoelectric stimulation of a nerve (DiUbaldi, [0003]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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