DETAILED ACTION
Terminal Disclaimer
The terminal disclaimer filed on 12/8/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USP #11,478,174 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US 2007/0027385) in view of Knopefmacher et al. (US 2017/0342459).
As to claim 1, Brister teaches a wire-based ([0269]) three-pole electrochemical sensor ([0272]) for subcutaneous insertion ([0392]) comprising: a working electrode comprising a first split wire (Fig. 7M – E1) having a first flat surface along a length of the first split wire (Fig. 7M), the first flat surface created from a first full wire having a circular cross-section with a portion removed ([0345]); a reference electrode comprising a second split wire having a second flat surface along a length of the second split wire (Fig. 7M – R1), the second flat surface created from a full wire defined by a chord across a circular cross-section of the split wire (Fig. 7M), and a counter electrode ([0345] – at least one of the working electrodes is a counter electrode, E2) comprising a third split wire having a third flat surface along a length of the third split wire, the third flat surface created from a wire defined by a third chord across a circular cross-section of the split wire (Fig. 7M); wherein the second and third flat surface face toward one another (Fig. 7M – right side of R1 and left side of E2); wherein a cross-sectional diameter of the first split wire, the second split wire, and the third split wire coupled together is less than an inner diameter of an insertion needle ([0310] – inherent as the needle is able to insert the sensor and subsequently slide back over the sensor and release the sensor from the needle, something that can only be achieved if the electrodes, coupled together, is smaller than the diameter of the insertion needle).
Brister does not necessarily teach that the three electrodes are all created from their own “full wires” or a support sheet on the first flat surface. However, it would have been obvious, if not necessarily inherent, to create individual electrodes from their own wire for various reasons including ease of manufacture. Knopfmacher teaches an electrode in which a conductor layer is laid on the substrate, said conductor layer comprising combinations of carbon nanotude, graphene, and polyaniline ([0068]). As such, it would have been obvious to modify Brister further with Knopfmacher to utilize materials that is known to serve well as materials for an electrochemical sensor.
As to claims 2, 3, and 12, Knopfmacher teaches the support sheet comprises carbon, graphene, or polyaniline ([0068]).
As to claims 4 and 13, Knopfmacher teaches the support sheet is electrically conductive (210) and coupled to a flat surface of a substrate (Fig. 2B – 212), which in combination with Brister, would result in being electrically coupled to the first surface of the first split wire.
As to claims 5 and 11, Brister teaches a sensing chemistry deposited on the electrode (electrode domain 24) on the electroactive surface, which in combination with Knopfmacher would result in its deposition on the support sheet ([0278]).
As to claims 6 and 14, Brister teaches a polymer layer over the support sheet (Fig. 2A – any of 24, 26, 28, and 30) which in combination with Knopfmacher would result in its deposition on the support sheet ([0278-0310]).
As to claims 7-8 and 15-16, Brister does not explicitly teach the specific cross-section shapes recited for the various electrodes in the above embodiment. However, Brister teaches numerous configurations of electrodes, including those that have a semicircular cross-section (Fig. 7F) as well as those with a rectangular cross-section (Fig. 7G). It would have been obvious for one of ordinary skill in the art to mix and match the various shapes as they are all taught and such a modification would be obvious to try.
As to claims 9-10 and 17-18, Brister does not explicitly teach the specific percentage and range of percentages recited for the surface area and the cross-section area. However, Brister teaches an electrode structure in which various electrodes are shaped in such a way relative to a wire electrode that the split wires can have the percentages recited (Fig. 7M). It would be a mere matter of routine optimization to derive at the specific numbers being recited, as there is no disclosed criticality to the recited numbers.
Response to Arguments
Applicant's arguments filed 12/8/25 have been fully considered but they are not persuasive.
Applicant has argued that neither reference individually teaches “a support sheet on the first flat surface”. In particular, applicant has argued that Knopfmacher teaches a conductor layer on a nonconductive substrate to render the substrate conductive for planar sensor operation, not to interface with a wire electrode. In contrast, applicant argues that the support sheet of the present claims is electrically coupled to the wire and conducts signals from the sensing chemistry into the wire, forming part of the electrochemical circuit for in vivo monitoring. However, examiner notes that the claim 1 merely recites “a support sheet on the first flat surface”, and does not recite any of the functionality that the applicant asserts.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant has also argued that Knopfmacher is non-analogous art, as it is primarily directed to planar, in vitro electrochemical sensing. However, the only aspect of Knopfmacher that is being incorporated is its teaching of a “support sheet on a flat surface”, and one of ordinary skill in the art would be readily capable of applying its teachings to an in vivo implantable device. Moreover, while applicant repeatedly emphasizes that Knopfmacher’s teaching is “optimized for planar surfaces” and that it does not “contemplate adapting carbon-based sheets to curved wire surfaces for subcutaneous insertion”, the examiner notes that the support sheet, as recited, is applied to a “flat surface” (i.e. planar) and not directly to any “curved wire surfaces”.
Finally, the applicant argues that the recited invention delivers results that could not have been predicted by the teachings of Brister and Knopfmacher as it enables a three-pole sensor that fits within the space traditionally occupied by two wires. The examiner again notes that such a feature is not recited in the claims. Moreover, the primary embodiment applied in the rejection, as taught by Brister (Fig. 7M), actually allows for 5 separate electrodes within the space that would otherwise be occupied by a single wire, making this argument similarly unpersuasive.
Lastly, the examiner notes that even if the claim recited a support “sheet” on a curved wire surface, such a feature would not be considered novel or non-obvious. Feldman et al. (US 2014/0171771) teaches an implantable dermal glucose sensor (Abstract, [0049], [0067]) in which a working electrode is formed by first coating a conductive layer such as silver on a non-planar substrate, and additional “support layers” such as a carbon layer can be disposed on top of this first conductive layer, and then be further covered with a membrane including sensing chemistry ([0055]). It teaches that this additional layer serves as a support layer in enhancing electrode conductivity and/or adhesion of any additional layers, such as the sensing chemistry layer ([0053]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Feldman et al. (US 2014/0171771). See above for details.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 12/17/25
Prosecution Insights