DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on March 3, 2026 were received and fully considered. Claims 1, 3, 5-7, 10, 11, 13, 15, and 17-19 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 December 2025 and 11 March 2026 have been considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Little et al. (US PG Pub. No. 2013/0313130 A1) (hereinafter “Little”) in view of Rogers et al. (US PG Pub. No. 2014/0305900 A1) (hereinafter “Rogers”).
Little was applied in the previous office action.
With respect to claim 1, Little teaches an analyte sensor apparatus (abstract; par.0002), comprising: a working electrode (WE1 in Fig. 13D); a counter electrode (CE in Fig. 13D); a metal layer (par.0062, 0075); the working electrode comprises a metal having an electroactive surface (par.0028 “metallization layer pattern to form desired electronic elements”, which would include the working electrode), and the working electrode and the counter electrode are non-interdigitated (Fig. 13D shows WE and CE are spaced apart, i.e. non-interdigitated); and an analyte sensing layer on the working electrode (par.0041 “an analyte sensing layer disposed over the working electrode”), wherein the analyte sensing layer detectably alters electrical current at the working electrode in a presence of an analyte (par.0041 “analyte sensing layer…includes one or more agents that detectably alter the electrical current at the working electrode in the presence of an analyte (e.g. glucose oxidase)”).
Although Little does not explicitly teach an insulation layer between the working electrode and the counter electrode, the insulation layer having a first side and a backside opposite the first side; and a metal layer on the backside, wherein: the working electrode is spatially separated from the counter electrode by a distance of at least 1 micrometer, further modification to incorporate these features would have been obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Little expressly teaches an insulation layer covering the electrical portions of the analyte sensor in several other embodiments (see par.0028, 0056, 0060, 0087, 0090). Therefore, PHOSITA would have had predictable success when the invention was filed modifying Little’s embodiment, as depicted in Fig. 13D, to incorporate an insulation layer in order to protect the electrical components of the analyte sensor, as suggested by Little (par.0090). Moreover, it would have been prima facie obvious to PHOSITA when the invention was filed to arrange the insulation layer between Little’s working electrode and counter electrode since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Lastly, PHOSITA would have had predictable success modifying Little when the invention was filed such that the working electrode is spatially separated from the counter electrode by a distance of at least 1 micrometer since it has been held that where the general conditions1 of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
However, Little does not teach the metal layer on the backside has an adhesion that allows peeling of the metal layer from a direct contact with a substrate so as to remove the analyte sensor apparatus from the substrate on which the analyte sensor apparatus was fabricated.
Rogers teaches metal layer on the backside has an adhesion that allows peeling of the metal layer from a direct contact with a substrate so as to remove the analyte sensor apparatus from the substrate on which the analyte sensor apparatus was fabricated (par.0055 “Lamination of metal foil on a carrier substrate… peeling off the device from the carrier substrate”; see also par.0155).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Little to provide a backside metal layer having an adhesion selected to permit peeling from a substrate in order to enable transfer or removal of fabricated sensor devices, as evidence by Rogers (par.0055, 0155).
With respect to claim 2, Little teaches wherein the working electrode and the counter electrode are on a same side of the analyte sensor apparatus comprising a glucose sensor (Fig. 13D shows WE1 and CE on the same side of the glucose sensor; see also par.0002).
With respect to claim 3, Little does not explicitly teach the counter electrode is on a second side of the insulation layer opposite the first side. However, PHOSITA would have had predictable success when the invention was filed further modifying Little in the manner recited since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
With respect to claim 4, Little teaches a sensing portion and a connection portion, the connection portion including at least one of a first contact pad or a second contact pad; the sensing portion including the working electrode and the counter electrode; and the sensing portion being flexible so as to allow formation of a fold between the sensing portion and the connection portion (abstract “foldable substrates”; par.0012, 0041; Fig. 13D).
With respect to claim 5, Little teaches the metal layer comprises the counter electrode on the second side comprising the backside (par.0062, 0075, 0097).
With respect to claim 6, Little suggests further comprising: the metal layer comprising a surface exposed after being peeled from the substrate; a reference electrode on the first side of the insulation layer; insulation between the reference electrode and the working electrode; first contact metal electrically contacting the working electrode, the first contact metal comprising a first contact pad; second contact metal electrically contacting the counter electrode, the second contact metal comprising a second contact pad; and wherein: the insulation layer and the insulation comprise polyimide, and the working electrode, the counter electrode, the insulation layer, the insulation, and the analyte sensing layer are flexible (par.0007, 0012, 0039, 0047, 0062, 0075, 0097).
With respect to claim 7, Little teaches wherein the metal layer comprises at least one structured layer selected from a patterned layer, a roughened layer, a non- uniform layer, a layer including voids, and a layer comprising pillars, the at least one structured layer controlling the adhesion to the substrate (par.0004, 0009, 0028, 0062).
With respect to claim 8, Little teaches wherein the analyte sensor apparatus comprises a glucose sensor (abstract).
With respect to claim 9, Little teaches wherein the counter electrode comprises physical vapor deposited (PVD) metal (par.0061).
With respect to claim 10, Little teaches wherein the metal layer comprises gold (par.0062).
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,583,213. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art rejection section above for more detail, updated citations (new Rogers reference), and updated obviousness rationale.
Examiner acknowledges applicant holding the current double patenting rejections in abeyance until other issues are resolved. Therefore, these rejections are maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 Little discloses the general conditions, i.e. working electrode (WE1) is spatially separated from the counter electrode (CE) by a small gap/distance, as depicted in Fig. 13D.
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