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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a nanogenerator unit” in claims 1 and 6-9. For examination purposes, “a nanogenerator unit” will be interpreted as a piezoelectric nanogenerator, a triboelectric nanogenerator, or a pyroelectric nanogenerator as supported by page 3, lines 26-28.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 recites, “The sensory restoration device according to claim 1, comprising…”. Examiner suggests amending the claim to recite “The sensory restoration device according to claim 1, further comprising…”. 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 11, 14, 16, and 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 11 recites the limitation "the group" in line 2. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies. For examination purposes, Examiner will be interpreting “the group” as “a group”.
Claim 30 recites the limitation "the sensitivity" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner will be interpreting “the sensitivity” as “a sensitivity”.
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, 11, 20, 22, 26, and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webster et al (US 2019/0009083) hereinafter Webster.
Regarding claim 1, Webster discloses an implantable device for at least partially restoring tactile sensation to a subject in need thereof (Fig. 1), the device comprising:
at least one nanogenerator unit (implanted nanogenerator device 20) configured to be positioned subcutaneously and to produce an electric signal upon exertion of an external stimulus [0022]; and
at least one electrode (implanted electrodes 40) configured to be connected to at least one functional sensory nerve of the subject [0021];
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 ([0021] implanted nanogenerator device 20, which is connected via implanted electrical leads 45 to implanted electrodes 40; [0029] increasing nerve regeneration),
wherein said nanogenerator is further coated with a heat sensitive material ([0022] top layer includes or consists of a conductive metal such as gold, silver, copper, aluminum, or chromium), thereby at least partially restoring the tactile sensation to the subject ([0029] increasing nerve regeneration).
Regarding claim 2, Webster discloses wherein the electric signal is proportional to the magnitude of the external stimulus ([0022] collect electrical charges separated in the piezoelectric material by applied mechanical stress and conduct a direct current to one of the electrodes).
Regarding claim 3, Webster discloses wherein the external stimulus comprises: pressure, friction, traction, shear force and/or temperature change ([0021] External signal generator 30 is worn at the waist on belt 35, and overlays the implanted nanogenerator, to which it imparts mechanical force).
Regarding claim 6, Webster discloses wherein said nanogenerator unit is adapted to be connected to a single nerve ([0022] configuration, position, and surface area of the electrodes as well as the shape, size, and configuration of the nanogenerator housing will determine the distribution of the generated electric field and current flow, and can be freely selected according to the needs of the application; [0029] increasing nerve regeneration).
Regarding claim 11, Webster discloses wherein the nanogenerator unit is selected from the group consisting of a piezoelectric nanogenerator, a triboelectric nanogenerator, and a pyroelectric nanogenerator ([0020] an implanted piezoelectric nanogenerator). Examiner notes the current claim language requires only one of a piezoelectric nanogenerator, a triboelectric nanogenerator, and a pyroelectric nanogenerator. As discussed above, Webster discloses a piezoelectric nanogenerator and satisfies the claim language as currently written since the triboelectric nanogenerator and pyroelectric nanogenerator are claimed in the alternative.
Regarding claim 20, Webster discloses wherein said nanogenerator is self-powered ([0004] The internal part of the system includes a self-powered nanogenerator device).
Regarding claim 22, Webster discloses a method for at least partially restoring tactile sensation to a subject in need thereof, comprising the steps of: providing the sensory restoration device of claim 1 to said subject ([0020] the use of an implanted piezoelectric nanogenerator to provide the DC signal, which stimulates healing of a tissue), thereby at least partially restoring tactile sensation to a subject in need thereof ([0029] increasing nerve regeneration).
Regarding claim 26, Webster discloses wherein the electrical signal is proportional to the magnitude of the external stimulus ([0022] collect electrical charges separated in the piezoelectric material by applied mechanical stress and conduct a direct current to one of the electrodes).
Regarding claim 28, Webster discloses a system (Fig. 1: system 10) comprising the device of claim 1 and an external controller (external signal generator 30) configured to control one or more operating parameters of the device ([0021] imparts mechanical force according to a program or user settings).
Regarding claim 29, Webster discloses wherein the controller is wirelessly associated with the device ([0021] External signal generator 30 is worn at the waist on belt 35, and overlays the implanted nanogenerator; Fig. 1).
Regarding claim 30, Webster discloses wherein the controller is configured to control the sensitivity of the sensory restoration device ([0021] External signal generator 30 is worn at the waist on belt 35, and overlays the implanted nanogenerator, to which it imparts mechanical force according to a program or user settings; Examiner notes if the belt is too loose, too tight, or off center with the nanogenerator, it would affect the device’s sensitivity to the imparted force).
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, 23-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Webster (US 2019/0009083) in view of Karr et al (US 10,369,362) hereinafter Karr.
Regarding claim 7, Webster discloses the device of claim 1 as discussed above, but fails to disclose a plurality of nanogenerator units 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 Webster 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 Webster 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 Webster 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 23, Webster discloses wherein the sensory restoration device is subcutaneously implanted ([0021] implanted nanogenerator 20), and discloses using the device for nerve regeneration [0029], but fails to explicitly disclose wherein the sensory restoration device is electrically connected to the functional nerve of the subject via the electrode. However, Karr discloses wherein the sensory restoration device is electrically connected to the functional nerve of the subject via the electrode (Col. 4, ln 54-57: In this example, communication circuit 122 corresponds to a signal conditioner that is configured to couple electrical signals (e.g., via one or more electrodes) to the nerve).
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 Webster with wherein the sensory restoration device is electrically connected to the functional nerve of the subject via the electrode as taught by Karr. Such a modification would provide the predictable results of allowing the brain to receive sensory information and interpret it as touch or feel (Karr, Col. 4, ln 28-34).
Regarding claim 24, Webster 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 Webster 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).
Regarding claim 27, Webster discloses a step of implanting the device such that the nanogenerator is placed subcutaneously ([0021] implanted nanogenerator device 20 which is connected via implanted electrical leads 45 to implanted electrodes 40), but fails to explicitly disclose the electrode is in physical contact with a corresponding functional nerve. However, Karr discloses the electrode is in physical contact with a corresponding functional nerve (Col. 4, ln 54-57: In this example, communication circuit 122 corresponds to a signal conditioner that is configured to couple electrical signals (e.g., via one or more electrodes) to the nerve). 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 Webster with the electrode is in physical contact with a corresponding functional nerve 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) 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Webster (US 2019/0009083) in view of Cantin et al (US 2006/0129210) hereinafter Cantin.
Regarding claim 11, Webster discloses wherein the nanogenerator unit is a piezoelectric nanogenerator [0020], but fails to disclose wherein the nanogenerator is a pyroelectric nanogenerator. However, Cantin discloses wherein the nanogenerator is a pyroelectric nanogenerator ([0074] 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 Webster with wherein the nanogenerator is a pyroelectric nanogenerator 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]).
Regarding claim 13, Webster discloses the device of claim 11 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 Webster 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 Webster (US 2019/0009083) in view of DiUbaldi et al (US 2010/0249677) hereinafter DiUbaldi.
Regarding claim 14, Webster discloses wherein the piezoelectric is a pressure sensor ([0022] collect electrical charges separated in the piezoelectric material by applied mechanical stress and conduct a direct current to one of the electrodes), 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 Webster 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]).
Claim(s) 11, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Webster (US 2019/0009083) in view of Wang et al (US 2019/0381324) hereinafter Wang.
Regarding claim 11, Webster discloses wherein the nanogenerator unit is a piezoelectric nanogenerator [0020], but fails to disclose wherein the nanogenerator is a triboelectric nanogenerator. However, Wang discloses wherein the nanogenerator is a triboelectric nanogenerator ([0042] generator 24 may be a triboelectric generator). 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 Webster with a triboelectric nanogenerator as taught by Wang. Such a modification would provide the predictable results of sending signals to the user’s brain using nerve stimulation (Wang, Abstract).
Regarding claim 16, Webster discloses the system of claim 11 as discussed above, but fails to disclose 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. However, Wang 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 ([0042] generator 24 may be any type of power generator that uses the movements of the stomach 16 during peristalsis to convert the mechanical or kinetic energy into electrical energy delivered to the vagus nerves 12 as an electrical charge).
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 Webster with 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 as taught by Wang. Such a modification would provide the predictable results of sending signals to the user’s brain using nerve stimulation (Wang, Abstract).
Regarding claim 18, the modified Wang discloses the system of claim 16 as discussed above, but fails to disclose a circuitry which is configured to change the electrical features of an electric pulse generated by the TENG. However, Wang discloses a circuitry which is configured to change the electrical features of an electric pulse generated by the TENG ([0077] on-off circuitry may be incorporated to disable and/or enable the flow of current through the electrode wires). 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 Webster with a circuitry which is configured to change the electrical features of an electric pulse generated by the TENG as taught by Wang. Such a modification would provide the predictable results of controlling when to send signals to the user’s brain using nerve stimulation (Wang, Abstract).
Conclusion
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