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 .
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on July 9, 2026. Claims 1-25 are pending in the application and are being examined herein.
Examiner notes that claim 11 has the status identifier “(Currently Amended)” but will be treated at “(Previously Presented)” since there are no amendments to that claim.
Status of Objections and Rejections
The objection to claim 10 is withdrawn in view of Applicant’s amendment.
New objections to the claims are necessitated by the amendments.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection under nonstatutory double patenting are necessitated by the amendments.
New grounds of rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, and 35 U.S.C. 103 are necessitated by the new claims.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 15, “the transfer of water” should read “transfer of water”.
In line 16, “the transfer of silver cations” should read “transfer of silver cations”.
Appropriate correction is required.
Claim 22 is objected to because of the following informalities: in line 2, “the sensor” should read the analyte sensor”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New matter is shown in bold. Claim 23 recites the limitation “wherein the protective layer is substantially impenetrable to water” in lines 1-2 of the claim. The specification does not contain support for the protective layer being substantially impenetrable to water. Instead, the specification discloses that the protective layer is a membrane that allows transfer of water through the membrane (see para. [0089] of the instant US PGPub). The specification also discloses that the protective layer comprises a hydrophobic polymer material that has a water uptake of less than 2% by weight (see para. [0090], [0100]-[0101] of the instant US PGPub). This means that the hydrophobic polymer material itself has a water uptake of less than 2% by weight, while the protective layer still allows transfer of water through the membrane. Therefore, the protective layer is not substantially impenetrable to water. Applicant is required to cancel the new matter in reply to this Office 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, 18-20, and 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18/587,177 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant application claims 1 and 18 are anticipated by copending application claim 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 18/587,177 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant application claim 9 is obvious over copending application claim 8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of copending Application No. 18/587,177 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant application claim 10 is anticipated by copending application claim 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss et al. (US 2010/0230285 A1).
Regarding claim 18, Hoss teaches an analyte sensor for determining an analyte (an implantable analyte sensor 900, Figs. 9A-9C, para. [0106]), comprising:
a substrate comprising a first conductive material and a second conductive material (a substrate 902 having a top conductive layer 904a and a bottom conductive layer 904b, Figs. 9A-9C, para. [0107]);
a first electrode located on the first conductive material (a sensing component 906 disposed over the top conductive layer 904a to form an active area of a working electrode, Figs. 9A & 9C, para. [0109]);
a second electrode located on the second conductive material, the second electrode comprising a silver comprising layer having a width and a length and edges that define the periphery of the silver comprising layer (a secondary conductive Ag/AgCl layer 910 disposed over the bottom conductive layer 904b to collectively form a reference electrode, Figs. 9B-9C, para. [0112]; the secondary conductive Ag/AgCl layer 910 has a width and a length and edges that define the periphery of the secondary conductive Ag/AgCl layer 910); and
a protective layer covering the silver comprising layer (an insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910, Figs. 9B-9C, para. [0113]).
Hoss teaches that the insulation/dielectric layer 908b has a length greater than the length of the secondary conductive Ag/AgCl layer 910 in the left-right direction of Figs. 9B-9C (para. [0112]-[0113]), so the insulation/dielectric layer 908b covers those two edges of the secondary conductive Ag/AgCl layer 910. Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). See MPEP § 2125(I). Hoss teaches that the secondary conductive Ag/AgCl layer 910 is provided in a continuous stripe/band between and substantially orthogonal to the substrate's side edges 914a, 914b (Fig. 9B, para. [0112]), and the secondary conductive Ag/AgCl layer 910 appears to have the same width as the insulation/dielectric layer 908b in the up-down direction of Fig. 9B, so this embodiment of Hoss fails to teach wherein the protective layer covers all the edges of the silver comprising layer.
However, Hoss teaches another embodiment where the working electrode 804/806 (Figs. 8A-8B) is smaller in width than the insulation/dielectric layer 808 (para. [0102]). This embodiment of Hoss teaches that the sensing material 806 is also smaller than the conductive layer 804 in width (Figs. 8A-8B, para. [0102]-[0104]). Hoss also teaches that the same materials and methods may be used to fabricate the top (working) and bottom (reference) electrodes (para. [0110]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width of the secondary conductive Ag/AgCl layer 910 to be less than the widths of the insulation/dielectric layer 908b and the bottom conductive layer 904b as taught by another embodiment of Hoss in order to yield the predictable result of forming the reference electrode of the sensor. Furthermore, the Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). MPEP § 2144.04(IV)(A). Therefore, Modified Hoss teaches wherein the insulation/dielectric layer 908b covers all the edges of the secondary conductive Ag/AgCl layer 910.
Modified Hoss teaches the insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910 (Figs. 9B-9C, para. [0113]). Modified Hoss fails to teach wherein the protective layer comprises at least one opening configured to provide access to the second electrode for the analyte.
However, Hoss teaches that the secondary conductive Ag/AgCl layer has a portion that is not covered by the insulation/dielectric layer and is exposed to the in vivo environment when in operative use (para. [0114]). Hoss teaches another embodiment wherein an insulating coverlay material 118 covers the electrodes 121a, 121b, 121c which includes the Ag/AgCl reference electrode 121c (Figs. 3A-3B, para. [0076]-[0077]). Hoss teaches that openings 120 may be created in the insulating coverlay material 118 to expose one or more of the electrodes 121a, 121b, 121c (Figs. 3A-3B, para. [0078]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the insulation/dielectric layer 908b of Modified Hoss to include an opening as taught by another embodiment of Hoss in order to yield the predictable result of exposing the secondary conductive Ag/AgCl layer 910 to the in vivo environment when in operative use. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Regarding claim 19, Modified Hoss teaches wherein the protective layer has a width greater than the width of the silver comprising layer (the insulation/dielectric layer 908b covers all the edges of the secondary conductive Ag/AgCl layer 910 and thus has a width greater than the width of the secondary conductive Ag/AgCl layer 910, see modification supra).
Regarding claim 20, Modified Hoss teaches wherein the protective layer has a length greater than the length of the silver comprising layer (the insulation/dielectric layer 908b has a length greater than the length of the secondary conductive Ag/AgCl layer 910 in the left-right direction of Figs. 9B-9C, para. [0112]-[0113]).
Regarding claim 21, Modified Hoss teaches wherein the second conductive layer has a width greater than the width of the silver comprising layer (the bottom conductive layer 904bb has a width greater than the width of the secondary conductive Ag/AgCl layer 910, see modification supra).
Regarding claim 22, Modified Hoss teaches wherein the second conductive layer comprises a cut edge terminating at a corresponding edge of the sensor (the bottom conductive layer 904b comprises a cut edge terminating at a corresponding edge of the implantable analyte sensor 900, Figs. 9B-9C, para. [0107], [0112]).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The instant invention of claim 1 is drawn to an analyte sensor for determining at least one analyte. The analyte sensor comprises a substrate comprising at least one first conductive material and at least one second conductive material, at least one first electrode which is located on the at least one first conductive material, at least one second electrode which is located on the at least one second conductive material, the at least one second electrode comprising a silver comprising layer having a width and a length, at least one protective layer covering the silver comprising layer, the at least one protective layer having a width greater than the width of the silver comprising layer and a length greater than the length of the silver comprising layer. The at least one protective layer comprises at least one opening, wherein the at least one opening is designed to provide access to the at least one second electrode for the at least one analyte. The at least one protective layer allows the transfer of water and chloride anions through the at least one protective layer but restricts the transfer of silver cations and silver chloride through the at least one protective layer.
The prior art does not disclose nor render obvious all of the cumulative limitations of the analyte sensor of independent claim 1, with particular attention to the limitations: “the at least one protective layer allows the transfer of water and chloride anions through the at least one protective layer but restricts the transfer of silver cations and silver chloride through the at least one protective layer” in combination with the other limitations of independent claim 1.
The closest prior art of record is considered to be Hoss et al. (US 2010/0230285 A1).
Hoss teaches an insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910 (Figs. 9B-9C, para. [0113]). Hoss fails to teach wherein “the at least one protective layer allows the transfer of water and chloride anions through the at least one protective layer but restricts the transfer of silver cations and silver chloride through the at least one protective layer” in combination with the other limitations of independent claim 1.
Examiner further notes that claim 1 is still provisionally rejected on the ground of nonstatutory double patenting.
Claims 2-17 are objected to as being dependent upon rejected base claim 1.
Claims 24-25 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. Examiner further notes that claims 24-25 are still provisionally rejected on the ground of nonstatutory double patenting.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Arguments
Applicant's arguments filed July 9, 2026 have been fully considered but they are not persuasive.
In the arguments presented on page 10 of the amendment, Applicant argues Hoss teaches that the edges of the silver comprising layer are cut by singulation and exposed, and Hoss thus does not teach the features of independent claim 18.
Examiner respectfully disagrees. As discussed in the rejection supra, Hoss is modified in view of an alternative embodiment to teach the features of independent claim 18.
Conclusion
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 VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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