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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 21-32, in the reply filed on January 05, 2026 is acknowledged. Group II, claims 33-40, is withdrawn.
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.
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Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,355 B2 in view of Gregg et al.
US 5320725 A (hereafter “Gregg”). Although the claims at issue are not identical, they are not patentably distinct from each other because Zeikus meets all of the limitations of claim 1 of the instant application except for the limitation “. . . ., wherein one or more of the ketoreductase, the diaphorase, and the oxidized nicotinamide adenine dinucleotide (NAD+) or oxidized nicotinamide adenine dinucleotide phosphate (NAD(P)+) is covalently bonded to the polymer. [italicizing by the Examiner]” It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have one or more of the ketoreductase, the diaphorase, and the oxidized nicotinamide adenine dinucleotide (NAD+) or oxidized nicotinamide adenine dinucleotide phosphate (NAD(P)+) be covalently bonded to the polymer because (1) claim 1 of U.S. Patent No. 11,918,355 B2 does require “. . . ., wherein the at least one alcohol-responsive active area comprises a polymer, and wherein the (i) ketoreductase and (ii) diaphorase are chemically bound to the polymer…”, and (2) Gregg, which is about an enzyme modified sensor electrode, discloses, “The term "immobilized" is meant to describe a peroxidase enzyme or a peroxidase-like molecule which is retained within the redox polymer network and does not freely diffuse away. The peroxidase may be entrapped, but is preferably chemically bound, and more preferably covalently bonded to the redox polymer. [italicizing by the Examiner]” See the Gregg title, Abstract, and col. 4:51-56. Put another way, it is prima facie obvious to have one or more of the ketoreductase, the diaphorase, and the oxidized nicotinamide adenine dinucleotide (NAD+) or oxidized nicotinamide adenine dinucleotide phosphate (NAD(P)+) be covalently bonded to the polymer because, in light of Gregg, this is just use of a known technique to improve a similar device in the same way, which is consistent with the “chemically bound” limitation of claim 1 of U.S. Patent No. 11,918,355 B2. See MPEP 2143(I)(C).
4. Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 22 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of U.S. Patent No. 11,918,355 B2 meets the additional limitation of claim 22 of the instant application.
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 23 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of U.S. Patent No. 11,918,355 B2 meets the additional limitation of claim 23 of the instant application.
5. Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 24 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,918,355 B2 as modified by Gregg already meets the additional limitation of claim 24 of the instant application. See again the rejection of underlying claim 21, particularly in regard to how Gregg is applied.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 25 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,918,355 B2 as modified by Gregg already meets the additional limitation of claim 25 of the instant application. See again the rejection of underlying claim 21, particularly in regard to how Gregg is applied.
5. Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 26 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of U.S. Patent No. 11,918,355 B2 meets the additional limitation of claim 26 of the instant application.
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 27 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because (1) claim 6 of U.S. Patent No. 11,918,355 B2 requires “. . . ., wherein the at least one alcohol-responsive active area comprises an electron transfer agent…”, and (2) Gregg discloses
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Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 27, from which claim 28 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because Gregg discloses
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Put another way, to have the transition metal complex be an osmium-containing complex is, in light of Gregg, prima facie obvious as simple substitution of one known element (electron transfer agent) for another to obtain predictable results. See MPEP 2143(I)(B).
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 21 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because (1) claim 6 of U.S. Patent No. 11,918,355 B2 requires “. . . ., wherein the at least one alcohol-responsive active area comprises an electron transfer agent…”, and (2) Gregg discloses
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Put another way, to have the electron transfer agent comprise an osmium complex bonded to a poly(vinylpyridine)-based polymer, in light of Gregg, prima facie obvious as simple substitution of one known element (electron transfer agent) for another to obtain predictable results. See MPEP 2143(I)(B).
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 30 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of U.S. Patent No. 11,918,355 B2 meets the additional limitation of claim 30 of the instant application.
10. Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 21, from which claim 31 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,918,355 B2 meets the additional limitation of claim 31 of the instant application. See that claim 1 preamble.
Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,918,355 B2 in view of Gregg.
Claim 31, from which claim 32 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,918,355 B2 meets the additional intended use limitation of claim 32 of the instant application.
Other Relevant Prior Art
Bendinskas et al., “Enzymatic Detection of Gamma-Hydroxybutyrate Using Aldo-keto Reductase 7A2, . J Forensic Sci, May 2011, Vol. 56, No. 3 (hereafter “Bendinskas”) discloses a sensing composition comprising: a ketoreductase; diaphorase; oxidized nicotinamide adenine dinucleotide (NAD+) or oxidized nicotinamide adenine dinucleotide phosphate (NAD(P)+) as a co-factor, and an electron transfer agent (2,6-dichlorophenolindophenol). See the title, Abstract, and Figure 2. Note that although 2,6-dichlorophenolindophenol is used in Bendinskas as an optical detection agent, it is known to be used in the sensor art as an electron transfer agent for an enzyme-based sensor, that is, it has the inherent property of being able to be an electron transfer agent. See, for example, Findley et al. US 4,713,327 the title and col. 6:25-39, especially line 33-34.
However, in contrast to the sensing composition of Applicant’s claim 1, the sensing composition of Bendinskas does not comprise “a polymer, wherein one or more of the ketoreductase, the diaphorase, and the oxidized nicotinamide adenine dinucleotide (NAD+) or oxidized nicotinamide adenine dinucleotide phosphate (NAD(P)+) is covalently bonded to the polymer.” Moreover, and perhaps more importantly, the sensing composition of Bendinskas is not an alcohol sensing composition, but a Gamma-hydroxybutyrate sensing composition. See the title and Abstract. In fact, Bendinskas states, “We used AKR7A2, which is also called succinic semialdehyde reductase (27,28), to develop an assay that can detect GHB in various beverages without having ethanol produce false positives. [underlining by the Examiner]” See the first full sentence in the left column on page 784. Also, “We have developed an assay that uses aldo-keto reductase 7A2 (AKR7A2) for the specific determination of GHB in various drinks.” See the Abstract.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795