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
Claims 1-16 are objected to because of the following informalities: claims 1 and 8 are written as independent claims and should clearly set forth the transitional phrase for the body of the claim with a colon and the following limitations on separate lines. Examiner suggests amending the claim 1 to state “a microneedle, comprising:” and claim 8 to state “A neural interface system, comprising:”. Appropriate correction is required.
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 8-16 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). Claim 8 discloses “the attachment unit is attached to a posterior wall of an eyeball”. This limitation is written to require the posterior wall of the eyeball as part of the claimed invention.
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 4, 7, 13 and 16 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.
Claims 4 and 13 state “each provided thereon” and “the lining plate is provided thereon”. It is unclear as to what structure is considered “thereon”.
Claims 7 and 16 state “the microelectrode is provided thereon”. It is unclear as to what structure is considered “thereon”.
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) 1-3, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toth et al (2019/0274746).
Regarding claim 1, Toth et al disclose a microneedle (microneedle – [0361];[0364]), comprising at least one microprobe (probe 1700 – fig.17A), wherein the at least one microprobe each comprising a lining plate of an arc-shaped structure (the interconnect for the microelectrode, the interconnect may be plated with an interfacing material – [0304];[0308]) and at least one microelectrode (a microneedle electrode – [0364]).
Regarding claim 2, Toth et al disclose wherein the microneedle comprises at least one integrated circuit chip, and the at least one microprobe and the at least one integrated circuit chip are in a one-to-one correspondence (the sheath introducer may include an embedded circuit and/or connector for interfacing with one or more of the electrodes – [0295]).
Regarding claim 3, Toth et al disclose wherein when the microprobe is in number of at least two, the at least one integrated circuit chip is located between two adjacent microprobes (an embedded circuit and/or connector for interfacing with one or more electrodes, probes, etc. – [0295]. Examiner notes a second microprobe is considered optional and is not positively recited).
Regarding claim 6, Toth et al disclose wherein the microelectrode is located at an inner side of the lining plate (the tines may be deployed from within a jacket – [0311]; sheath introducer may include an embedded circuit – [0295];[0314).
Regarding claim 7, Toth et al disclose wherein the microelectrode is provided thereon with at least one microelectrode point (microelectrodes mounted – [0166]).
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(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al (2019/0274746) in view of Evans et al (2020/0360690).
Regarding claim 4, Toth et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the at least one integrated circuit chip is each provided thereon with at least one welding spot, the lining plate is provided with at least one welding spot, and the at least one integrated circuit chip and the corresponding lining plate are bonded through the at least one welding spot.
However, Evans et al teach in the same medical field of endeavor, wherein at least one integrated circuit chip is each provided thereon with at least one welding spot, a lining plate is provided with at least one welding spot, and the at least one integrated circuit chip and the corresponding lining plate are bonded through the at least one welding spot (integrated circuits may be attached to the substrate, for example by soldering, to provide localized smart circuitry – [0174]. Examiner notes the claims disclose “welding spots” and “bonding”, but do not disclose how the bonding is performed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one integrated circuit chip embedded in a lining plate of Toth et al with a welding spot of Evans et al as it would provide localized smart circuitry.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al (2019/0274746) in view of Sabes et al (2020/0129766).
Regarding claim 5, Toth et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the microelectrode is a Utah electrode, a Michigan electrode or an optogenetic electrode.
However, Sabes et al teach in the same medical field of endeavor, wherein a microelectrode is a Utah electrode or a Michigan electrode (exemplary electrode arrays include Utah arrays and Michigan arrays – [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the microelectrode of Toth et al with a Utah electrode or Michigan electrode as it would provide a well-known and conventional type of electrode for stimulation.
Claim(s) 8-12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al (2019/0274746) in view of Jung et al (2020/0061357).
Regarding claim 8, Toth et al disclose a neural interface system, comprising the microneedle according to claim 1 (see claim 1 above) and an attachment unit (attachment of components – [0310]), but fail to explicitly disclose wherein the microneedle is configured for stimulating an optic nerve and/or collecting an optic nerve signal; and the attachment unit is attached to a posterior wall of an eyeball.
However, Jung et al teach in the same medical field of endeavor, wherein a microneedle is configured for stimulating an optic nerve and/or collecting an optic nerve signal (the other electrode was attached to the end of the optic nerve to facilitate electrical connectivity – [0135]); and an attachment unit is attached to a posterior wall of an eyeball (the target tissue of the eye is the posterior pole or posterior segment of the eye – [0013]; the electrode can be placed around the microneedle so that the electrode can attach on the eye tissues – [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the neural interface system of Toth et al with stimulating or collecting an optic never signal and attachment to a posterior wall of an eyeball of Jung et al as it would provide optic applications treatment of the eye.
Regarding claim 9, Toth et al disclose wherein the microneedle and the attachment unit are connected by a connecting line (the traces, the lead wire interconnects – [0310]).
Regarding claim 10, Toth et al disclose wherein the attachment unit is made from a biocompatible material (the composition may be biostable or bioerodable, biocompatible with minimal toxicity to surrounding tissues – [0187]).
Regarding claim 11, Toth et al disclose wherein the microneedle comprises at least one integrated circuit chip, and the at least one microprobe and the at least one integrated circuit chip are in a one-to-one correspondence (the sheath introducer may include an embedded circuit and/or connector for interfacing with one or more of the electrodes – [0295]).
Regarding claim 12, Toth et al disclose wherein when the microprobe is in number of at least two, the at least one integrated circuit chip is located between two adjacent microprobes (an embedded circuit and/or connector for interfacing with one or more electrodes, probes, etc. – [0295]. Examiner notes a second microprobe is considered optional and is not positively recited).
Regarding claim 15, Toth et al disclose wherein the microelectrode is located at an inner side of the lining plate (the tines may be deployed from within a jacket – [0311]; sheath introducer may include an embedded circuit – [0295];[0314).
Regarding claim 16, Toth et al disclose wherein the microelectrode is provided thereon with at least one microelectrode point (microelectrodes mounted – [0166]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al (2019/0274746) in view of Jung et al (2020/0061357) as applied to claim 11 above, and further in view of Evans et al (2020/0360690).
Regarding claim 13, Toth et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the at least one integrated circuit chip is each provided thereon with at least one welding spot, the lining plate is provided with at least one welding spot, and the at least one integrated circuit chip and the corresponding lining plate are bonded through the at least one welding spot.
However, Evans et al teach in the same medical field of endeavor, wherein at least one integrated circuit chip is each provided thereon with at least one welding spot, a lining plate is provided with at least one welding spot, and the at least one integrated circuit chip and the corresponding lining plate are bonded through the at least one welding spot (integrated circuits may be attached to the substrate, for example by soldering, to provide localized smart circuitry – [0174]. Examiner notes the claims disclose “welding spots” and “bonding”, but do not disclose how the bonding is performed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the at least one integrated circuit chip embedded in a lining plate of Toth et al with a welding spot of Evans et al as it would provide localized smart circuitry.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al (2019/0274746) in view of Jung et al (2020/0061357) as applied to claim 8 above, and further in view of Sabes et al (2020/0129766).
Regarding claim 14, Toth et al disclose the invention substantially as claimed, but fail to explicitly disclose wherein the microelectrode is a Utah electrode, a Michigan electrode or an optogenetic electrode.
However, Sabes et al teach in the same medical field of endeavor, wherein a microelectrode is a Utah electrode or a Michigan electrode (exemplary electrode arrays include Utah arrays and Michigan arrays – [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the microelectrode of Toth et al with a Utah electrode or Michigan electrode as it would provide a well-known and conventional type of electrode for stimulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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, Christopher Koharski can be reached at (571)272-7230. 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.
/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797