DETAILED ACTION
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7, 8, 11-13, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,478,174. Although the claims at issue are not identical, they are not patentably distinct from each other because they are largely broader recitations of the above claims.
Claims 6, 9-10, 14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,478,174 and Brister (US 2007/0027385).
As to claims 6 and 14, the ‘174 patent does not recite a polymer layer over the support sheet. Brister teaches an electrode configuration in which the electrodes have an enzyme layer applied to the electroactive surfaces ([0345]), said enzyme layer comprising polymers ([0297]). Accordingly, it would have been obvious to modify the above patent with Brister to allow for an enzyme polymer applied to the electrode to target specific analytes.
As to claims 9-10 and 17-18, the specific percentage and range of percentages recited for the surface area and the cross-section area are not recited by the ’174 patent. However, Brister (US 2007/0027385) 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.
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.
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 on 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 3/28/25