DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 04/04/2025. Claims 1-19 are pending and examined below.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 12588844 B2 in view of further rationale.
Regarding claim 1, US 12588844 B2 teaches all the limitations of the Instant Application except “wherein a distance between the ketones-responsive active area and the glucose-responsive active area is 0.4 mm to 1.1 mm”. However, it would have been obvious to one having ordinary skill in the art at the time the invention effectively filed to wherein a distance between the ketones-responsive active area and the glucose-responsive active area is 0.4 mm to 1.1 mm, since it has been held that where the general conditions 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.
Conclusion
Claim 1 is rejected under a Double Patenting Rejection, but provides subject matter not found in the prior art search.
Regarding claim 1, Feldman (cited in IDS US 20090294306 A1) teaches an analyte sensor for detecting glucose and ketones in vivo (Paragraph 0047-0051, 0069, 0071—methods and devices for detecting at least one analyte…in vivo monitoring of the level of one or more analytes; Paragraph 0051-0052: “Analytes that may be monitored include … glucose …ketone bodies”, ”a sensor may include more than one working electrode”; Fig. 5A, sensor 500), the sensor comprising: a first working electrode and a second working electrode (Paragraph 0071: insertion tip 530 comprises a working electrode 501, reference electrode 502, and a counter electrode 503…”a sensor may include more than one working electrode”; paragraph 0064, 0071-- Fewer or greater electrodes may be employed. For example, the counter and reference electrode functions may be served by a single counter/reference electrode, there may be more than one working electrode and/or reference electrode and/or counter electrode, etc.; Fig. 5A, working electrode 501), a counter electrode (Paragraph 0071: insertion tip 530 comprises a working electrode 501, reference electrode 502, and a counter electrode 503; Fig. 5A, counter electrode 503), and a reference electrode (Paragraph 0071: insertion tip 530 comprises a working electrode 501, reference electrode 502, and a counter electrode 503; Fig. 5A, reference electrode 502); a ketones-responsive active area disposed upon a surface of the first working electrode (Paragraph 0052: “Analytes that may be monitored include …ketone bodies”), the ketones-responsive active area comprising a first polymer (Paragraph 0083-0085: electron transfer agents may include a redox species covalently bound in a polymeric composition…one or more ligands covalently bound in a polymer…; Paragraph 0089, 0095-0096—in some embodiments, the sensing element is a redox active component that includes…a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are crosslinked together; paragraph 0090-0093—a mass-transport limiting membrane may be included in the sensor…may include polymers and may be bio-compatible; paragraph 0096-0098—a sensing layer may contain a redox polymer…substrate may be formed using polymeric materials…), and an enzyme system (Paragraph 0001-0002—biosensors, such as glucose biosensors utilize a reaction of an analyte with an enzyme, such as glucose with glucose oxidase; Paragraph 0042—enzymes present in the sensing layer; paragraph 0076, 0079, 0086-0087—analyte sensors may include an analyte-responsive enzyme to provide a sensing component or a sensing layer; paragraph 0086-0087—may utilize enzymes such as nicotinamide adenine dinucleotide (NAD) or flavine adenine dinucleotide (FAD)); a glucose-responsive active area disposed upon a surface of the second working electrode (Paragraph 0001-0002, 0051-0052: “Analytes that may be monitored include … glucose”), the glucose-responsive active area comprising a second polymer (Paragraph 0083-0085: electron transfer agents may include a redox species covalently bound in a polymeric composition…one or more ligands covalently bound in a polymer…; Paragraph 0089, 0095-0096—in some embodiments, the sensing element is a redox active component that includes…a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are crosslinked together; paragraph 0090-0093—a mass-transport limiting membrane may be included in the sensor…may include polymers and may be bio-compatible; paragraph 0096-0098—a sensing layer may contain a redox polymer…substrate may be formed using polymeric materials…)) and a glucose-responsive enzyme (Paragraph 0001-0002—biosensors, such as glucose biosensors utilize a reaction of an analyte with an enzyme, such as glucose with glucose oxidase; Paragraph 0042—enzymes present in the sensing layer; paragraph 0076, 0079, 0086-0087—analyte sensors may include an analyte-responsive enzyme to provide a sensing component or a sensing layer); wherein the sensor is configured to be partially inserted into a user’s skin such that a distal portion of the sensor is in contact with an interstitial fluid to detect glucose and ketones in vivo (paragraph 0049--The sensor may be, for example, subcutaneously positionable in a patient for the continuous or periodic monitoring of a level of an analyte in a patient's interstitial fluid…; Paragraph 0071--insertion tip 530 positionable below the skin, e.g. penetrating through the skin and into, e.g., the subcutaneous space; Fig. 5A, insertion tip 530).
However, the prior art fails to teach of suggest “a ketones-responsive active area disposed upon a surface of the first working electrode, the ketones-responsive active area comprising an enzyme system comprising nicotinamide adenine dinucleotide (NAD) and at least two enzymes that facilitate detection of ketones” in combination with the other limitatations of the claim.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791
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