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 the invention of group I, claims 1-3, 5-7. 9-10, 12, 14, 18, 21, 23-24 in the reply filed on 03/30/2026 is acknowledged.
Claims 26, 28, 30-31, 33, 35, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
Status of Claims
Claims 1-3, 5-7. 9-10, 12, 14, 18, 21, 23-24, 26, 28, 30-31, 33, 35, and 39 are pending.
Claims 26, 28, 30-31, 33, 35, and 39 are withdrawn. Claims 1-3, 5-7. 9-10, 12, 14, 18, 21, 23-24 have been treated on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites the limitation "the electrode". There is insufficient antecedent basis for this limitation in the claim. The independent claim has referred to multiple electrodes, it is therefore unclear which electrode is being referred to. Amendment to make clear which one, or if all electrodes are being referred to would provide clarity.
The courts have indicated that before claimed subject matter can properly be compared to the prior art, it is essential to know what the claims do in fact cover. See, e.g., the following decisions: In re Steele, 305 F 2d. 859, 134 USPQ 292 (CCPA 1962); In re Moore 439 F 2d. 1232, 169 USPQ 236 (CCPA 1969); In re Merat, 519 F 2d. 1390, 186 USPQ 471 (CCPA 1975).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-7. 9-10, 12, 14, 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sobe (USPGPub 20190360018/IDS submitted).
Regarding claim 1 and the limitation “A method of measuring a target substance concentration in a sample comprising: contacting the sample comprising the target substance with a biosensor which comprises an enzyme electrode comprising an oxidoreductase immobilized on the electrode, and a reference electrode;.” Sode teaches a method of measuring the concentration of a target substance in a sample by contacting the sample with a biosensor comprising an immobilized oxidoreductatse on an electrode, a counter electrode and a reference electrode (Abstract, [0012]-[0025]).
Regarding claims 1 and 24 and the limitations “measuring a time-dependent change of an open circuit potential between the enzyme electrode and the reference electrode; and calculating the concentration of the target substance based on the time-dependent change of the open circuit potential”, and “wherein the time-dependent change is dOCP/dt or dOCP/-dt.” Sobe teaches measuring a change in the OCP between the enzyme and reference and using this to calculate the concentration, Sobe teaches that this measurement has to be taken over time to get an accurate reading ([0012], [0075]-[0082]). As such the measurement and concentration determination from the change in OCP is dependent on time and thus falls within the broadest reasonable interpretation of a time dependent change.
Regarding claim 2 and the limitation “wherein the biosensor further comprises a counter electrode”, Sobe discloses embodiments with a counter electrode and reference electrode ([0012]-[0022]).
Regarding claim 3 and the limitation “wherein the target substance is selected from the group consisting of D-serine, lactate, glucose, glycated proteins, glycated amino acid, hydrogen peroxide, cholesterol, glycerol, glycerol-3-phosphate, fructose, urate, ethanol, galactose, 1,5- anhydro-D-glucitol, NAD(P)H, dopamine, 3-hydroxybutyrate, Levodopa (L-DOPA), L-glutamate, L-glutamine, sarcosine, creatine, and creatinine.” Sobe teaches the device for measureting target substances such as lactates, glucose, glycerol, ethanol fructose among other compounds ([0049]) .
Regarding claim 5 and the limitation “wherein the measuring is continuous”, Sode teaches that the measurement may be continuous ([0098], [0133]-[0137]).
Regarding claim 6 and the limitation “wherein no potential is applied before measuring the time-dependent change of the open circuit potential”, Sode teaches that the potential is applied prior to measurement, as it is applied it was not applied prior to this and thus it can be considered that no potential was applied before beginning measurement ([0016]-[0017], [0075]-[0083])
Regarding claim 7 and the limitation “wherein the time for an initial measurement is less than 60 seconds”, Sode teaches that the upper time is not bounded but teaches an embodiment of measurements not lasting not more than 20 seconds ([0078]-[0080]).
Regarding claims 9 and 10 and 12 and the limitations “wherein the oxidoreductase is selected from the group consisting of oxidases, dehydrogenases, monooxigenases, and dioxygenases.” And “wherein the oxidoreductase is selected from the group consisting of glucose dehydrogenase, glucose oxidase, lactate oxidase, lactate dehydrogenase, D-amino acid oxidase, fructosyl amino acid/peptide oxidases, peroxidase, cholesterol oxidase, glycerol-3-phosphate oxidase, cellobiose dehydrogenase, and fructose dehydrogenase, uricase, alcohol oxidase, alcohol dehydrogenase, galactose oxidase, galactose dehydrogenase, pyranose oxidase, pyranose dehydrogenase, glucose-3-dehydrogenase, diaphorase, thyrosinase, 3-hydroxybutyrate dehydrogenase, amine oxidase, monoamine oxidase, polyamine oxidase, dopamine 4,5-DOPA dioxygenase extradiol, glutamate oxidase, and sarcosine oxidase.”, and “wherein the oxidoreductase is an engineered oxidoreductase or a fusion enzyme. “
Regarding claim 14 and the limitation “wherein i) the target substance is glucose and the oxidoreductase is glucose dehydrogenase; ii) the target substance is glucose and the oxidoreductase is glucose oxidase; iii) the target substance is lactate and the oxidoreductase is lactate oxidase; or Page 4 iv) the target substance is D-serine and the oxidoreductase is D-amino acid oxidase”, Sode teaches the use of lactate, glucose and D amino acid oxidase ([0049]).
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.
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.
Claim(s) 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sobe as applied to claims 1-3, 5-7. 9-10, 12, 14, and 24 above.
Regarding claim 18 and the limitation “wherein the enzyme electrode, counter electrode, or reference electrode is less than about 100 µm in diameter” Sobe exemplifies the device and method as using electrodes having a surface area of 7 mm2, And thus teaches devices in small scale. One of oridanry skill in the are would thus have found it obvious that small diameter electrodes could be used and would have a reasonable expectation of success in doing so as Sobe demonstrates the use of small electrodes.
Regarding claim 21 and the limitation “wherein the reference electrode is a leakless reference electrode.“ Sobe teaches the use of calomel electrodes ([0045]), as calomel electrodes contain mercury, one of ordinary skill would find it obvious that they be leakless.
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 1-3, 5-7. 9-10, 12, 14, 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of U.S. Patent No.11608515. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘515 claims a method of measuring a target compound with a biosensor using enzyme immobilized electrode as well as counter and reference electrodes to then use the open circuit potential to calculate the concentration. The use of this method effectively as noted in the specification requires an amount of time to pass prior to taking measurement, Sobe teaches measuring a change in the OCP between the enzyme and reference and using this to calculate the concentration, Sobe teaches that this measurement has to be taken over time to get an accurate reading ([0012], [0075]-[0082]). Thus the claimed method used effectively results in measurement and concentration determination from the change in OCP is dependent on time and thus falls within the broadest reasonable interpretation of a time dependent change (claim 1 and instant claims 1 and 24).
Instant
‘515
Claim 2
Claims a counter electrode (claim 1)
Claims 3, 9, 10, 14,
Claims Glucose and glucose dehydrogenase as oxido reductast (claim 8)
Claim 12
As ‘515 describes the enzyme may be a fusion this falls within the scope of claim 8.
Claim 5
As ‘515 describes the method may be continuous this falls within the scope of claim 1
Claim 6
As potential is applied for a time it was not applied previously (Claim 3)
Claim 7
‘515 claims pontential being applied for at least 0.1 second which includes within its scope less than 60 second (Claim 3)
The instant claims are thus rendered obvious by the claims of ‘515 and the claims of ‘515 render obvious the instant claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/ Examiner, Art Unit 1657
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