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 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 1-20 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.
In regards to claim 1, “the damaged tissue” lacks antecedent basis.
In regards to claim 10, “the nerves and muscles” lacks antecedent basis.
The remaining claims are rejected by virtue of their dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In regards to claim 1, the limitation “conductive hydrogel (100) injected into the damaged tissue” inferentially includes “the damaged tissue” in the apparatus claim, which part of a human organism and is ineligible subject matter. It is respectfully suggested to recite a hydrogel “configured to be injected” (or the like) into the damaged tissue, and such language would obviate this rejection.
The remaining claims are rejected by virtue of their dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 9-11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Franke et al. (US 2020/0188660, hereinafter “Franke”).
In regards to claim 1, Franke discloses a wireless electrical stimulation device comprising:
(a) conductive hydrogel injected into the damaged tissue of a subject (par. 0913 describing injecting, par. 0187 describing the conductive hydrogel, par. 0612);
(b) an induction coil that induces current in the conductive hydrogel (Figs. 102-105B, element 86, par. 0618, “coil 86”); and
(c) a high-frequency induction coil controller electrically connected to the induction coil and controlling the magnitude and direction of the current flowing through the induction coil (par. 0200, “kilohertz frequency”, pars. 0582, 0615, transferring energy from a signal generator),
wherein the conductive hydrogel and induction coil are arranged in spaced apart (par. 0582, “just beneath the surface of the skin to a location several millimeters or even several centimeters deep inside the body away from the skin”) and an alternating current is passed through the induction coil by the high-frequency induction coil controller, whereby current is induced within the conductive hydrogel by the electromagnetic waves generated therefrom (pars. 0583, 0601, 0616, “electrically induced currents”).
In regards to claim 4, the current flowing through the induction coil has a frequency ranging from 1 Hz to 1,000 kHz (pars. 0554, 0689, 0815, 0906).
In regards to claim 9, Franke discloses a nerve regeneration promotion device comprising the wireless electrical stimulation device of claim 1 (par. 0236 “regenerative growth substrate for repairing damaged neurons/axons”).
In regards to claim 10, Franke discloses a method for promoting the regeneration of damaged tissue (par. 0236 “regenerative growth substrate for repairing damaged neurons/axons”), comprising the following steps:
(a) injecting a conductive hydrogel into the damaged tissue of a subject (par. 0913 describing injecting, par. 0187 describing the conductive hydrogel, par. 0612);
(b) positioning a wireless electrical stimulation device, comprising an induction coil, adjacent to the tissue region into which the conductive hydrogel has been injected (Figs. 102-105B, element 86, par. 0618, “coil 86”); and
(c) applying an alternating current to the induction coil to induce current within the injected conductive hydrogel, thereby stimulating the nerves and muscles (pars. 0583, 0601, 0616, “electrically induced currents”; par. 0236 “regenerative growth substrate for repairing damaged neurons/axons”; par. 0178, targets include nerve and muscle).
In regards to claim 11, the wireless electrical stimulation device comprises an induction coil and a high-frequency induction coil controller (Figs. 102-105B, element 86, par. 0618, “coil 86”; par. 0200, “kilohertz frequency”, pars. 0582, 0615, transferring energy from a signal generator), and the applied power operates the high-frequency induction coil controller to cause alternating current to flow through the induction coil (pars. 0583, 0601, 0616, “electrically induced currents”).
In regards to claim 13, the induction coil of the wireless electrical stimulation device can be positioned on the surface of the skin over the damaged tissue (par. 0582, “just beneath the surface of the skin to a location several millimeters or even several centimeters deep inside the body away from the skin”; Figs. 102-105B).
In regards to claim 14, the device further includes at least one connector designed to connect with an external device (Fig. 102, elements 88 and 10).
In regards to claim 15, the connector is connected to an external power source (par. 0200, “kilohertz frequency”, pars. 0582, 0615, transferring energy from a signal generator) and includes a wire for transmitting current from the external power source to the induction coil (Fig. 102, elements 10).
In regards to claim 16, the wireless electrical stimulation device is introduced into clothing and integrated with conductive fabric, in a wearable form (par. 0649, head band or arm band with conductive coils).
In regards to claim 17, the induced current generated in the conductive hydrogel has an intensity of 50 pA to 10 mA (par. 0390, “1 mA”).
In regards to claim 18, the frequency of the induced current generated in the conductive hydrogel is 1 Hz to 1,000 KHz (pars. 0554, 0689, 0815, 0906).
In regards to claim 19, the stimulation of the nerves and muscles provides at least one of:
i) functional recovery of the damaged nerve (par. 0236, “for repairing damaged neurons/axons”),
ii) increased weight of the damaged muscle,
iii) increased muscle action potential of the damaged muscle, and
iv) increased sensory responsiveness of the damaged area.
In regards to claim 20, the stimulation of the nerves and muscles is performed for about 15 minutes to about 2 hours per day, about 1 to 3 times per day, about 1 to 7 times per week, or for a period of about 1 week to about 52 weeks or longer (par. 0394, provided for a month until follow-up and then verifying and adjusting settings; par. 0472, weeks to months).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Franke in view of Frangineas, Jr. et al. (US 2022/0152379, hereinafter “Frangineas”). Franke discloses the essential features of the claimed invention, but is silent as to the value of the current flowing through the induction coil. However, Frangineas in the same field of endeavor of transcutaneous field transfer teaches providing an induction coil with a current of 2000 amps (claim 11) to provide the predictable results of optimizing the amount of stimulation in nerve fibers and neuromuscular tissue of a patient (par. 0040). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Franke by providing current flowing through the induction coil at a magnitude ranging from 1 to 3,500 A to provide the predictable results of optimizing the amount of stimulation in nerve fibers and neuromuscular tissue of a patient.
Claim 5 is rejected under 35 U.S.C. 102(a)(1) and (2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Franke. Franke discloses the essential features of the claimed invention, including what appears to be a distance between the induction coil and the conductive hydrogel ranging from 1 to 100 mm (par. 0582, “a location several millimeters or even several centimeters deep inside the body away from the skin”). The examiner is considering “several millimeters” to fall within the range of 1 to 100 mm.
Alternatively and additionally, Franke recognizes at paragraph 0582 that the distance between the coil and hydrogel is a results-effective variable and it has been held that “"where 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Franke by providing a distance between 1 and 100 mm to yield no more than predictable results.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Franke in view of Bright et al. (US 2022/0409902, hereinafter “Bright”).
Franke discloses the essential features of the claimed invention, including wherein the conductive hydrogel is a biocompatible natural polymer containing noble metal nanoparticles (pars. 0235, 0989; par. 0389, “platinum elements on a nano-scale level”),
wherein the natural polymer is selected from the group consisting of cellulose, collagen, chitin, chitosan, keratin, silk, elastin, hyaluronic acid, and combinations thereof (par. 0235, “collagen”; par. 0784);
wherein the noble metal nanoparticles are selected from the group consisting of silver (Ag), gold (Au), platinum (Pt), palladium (Pd), iridium (Ir), osmium (Os), and combinations thereof (par. 0389, “platinum elements on a nano-scale level”; par. 0989); and
the noble metal nanoparticles are dispersed on the network (pars. 0235, 0989).
Franke does not disclose that the biocompatible natural polymer is connected by biphenyl to form a network. However, Bright in the same field of endeavor of gels to interface with nerves teaches providing a substrate wherein a biocompatible hydrogel is connected by biphenyl to form a network (par. 0284, “biphenyl”) to provide the predictable results of optimizing the hydrolysis rate of the implanted hydrogel (pars. 0283-0284). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Franke by providing a substrate wherein a biocompatible hydrogel is connected by biphenyl to form a network to provide the predictable results of optimizing the hydrolysis rate of the implanted hydrogel.
Allowable Subject Matter
Claims 2 and 12 are 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: although the sensing of current is generally known in the art, the prior art does not disclose or fairly render unpatentable the combination of elements, including a current resistance electronic meter for receiving current signals from the conductive hydrogel. For instance, Franke utilizes an injected hydrogel, but does not describe receiving current signals from the conductive hydrogel, let alone using a current resistance electronic meter for receiving current signals. The remaining prior art does not remedy this deficiency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Yoo et al. (US 2016/0263376) is another example of an electrical nerve regeneration device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, 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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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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