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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 23, 2025 has been entered.
Status of Objections and Rejections
The rejection from the previous office action are withdrawn in view of Applicant’s amendments.
New grounds of rejection are necessitated by the amendments.
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(s) 7, 13-15, and 21 is/are 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 pre-AIA the applicant regards as the invention.
Claim 7 recites the limitation “wherein the compound is neither N-methyl-N-phenyl-1,4-phenylenediamine nor N-methyl-N-(3-methoxyphenyl)-1,4-phenylenediamine, and wherein the compound is neither
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,” which is definite because it was an attempt to claim the invention by excluding what the inventors did not invent rather than distinctly and particularly pointing out what they did invent. In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953).
Subsequent dependent claims 13-15 and 21 are rejected due to their dependencies on rejected base claim 7.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites the compound having a structure of formula I which includes the excluded compounds in claim 7. Claim 14 recites the compound having a structure of formula Ia which also includes the excluded compounds in claim 7. They do not further limit claim 7 because they fail to include all the limitations of claim 7 upon which they depend.
Subsequent dependent claims 14-15 are rejected due to their dependencies on rejected base claim 13.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Examiner suggests to put the generic formula into the independent claims before excluding specific compounds.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 7 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Umegae (U.S. Patent Pub. 2010/0062469).
Regarding claim 7, Umegae teaches a composition ([0012]: a method for electrochemically measuring 1,5-anhydroglucitol in blood; [0013]: (1) an enzyme for measuring 1,5-anhydroglucitol; (5) 1,5-anhydroglucitol is electrochemically measured in the presence of a redox mediator) comprising:
an enzyme ([0013]: (1) an enzyme); and
an electrode modifying agent or an electron transfer promoting agent ([0013]: (5) a redox mediator) comprising a compound,
wherein the compound is neither N-methyl-N-phenyl-1,4-phenylenediamine nor N-methyl-N-(3-methoxyphenyl)-1,4-phenylenediamine ([0039]: examples of the redox mediator include diphenyl amine compounds such as 4,4’-Bis(dimethylamino)diphenylamine).
As evidenced by PubChem, 4,4-Bis(dimethylamino)diphenylamine has a structure as disclosed in the specification, Formula 1,
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wherein R1 is -NR7R8, R7 is hydrogen, R8 is hydrogen, R2 is -NR10R11, R10 is hydrogen, R11 is phenyl substituted with X, where X is amino, and R3, R4, R5, and R6 are each independently hydrogen.
The limitation “having a property of being adsorbed, without being bound to a polymer or without being polymerized, onto and electrode untreated with an acid” is deemed to be inherent to the claimed compound because the material is the same in the prior art and the specification. Umegae teaches a p-phenylenediamine compound, e.g., 4,4’-Bis(dimethylamino)diphenylamine, used as a redox mediator for electrochemical measurement ([0013], [0039]), which is the same material as disclosed in the instant specification (PGpub [0027] Formula 1). Thus, this p-phenylenediamine compound must have the same property, i.e., being adsorbed, without being bound to a polymer or without being polymerized, onto an electrode untreated with an acid.
Umegae fails to teach wherein the compound is neither
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(claim 7) or wherein the compound is selected from the group consist of [Formula 9]
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(claim 15).
However, Umegae teaches a p-phenylenediamine compound ([0039]: examples of the redox mediator include diphenylamine compounds, such as N-methyl-N-phenyl-1,4-phenylenediamine), evidenced by Molbase as the following structure:
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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Umegae by substituting N-methyl-N-phenyl-1,4-phenylenediamine with the compound of Formula 9 because p-phenylenediamine compound is a suitable redox mediator for electrochemical measurement ([0012]-[0013], [0039]). The claimed p-phenylenediamine compound has a very close structural similarity to N-methyl-N-phenyl-1,4-phenylenediamine, making a prima facie case of obviousness for chemical compounds having very close structural similarities and similar utilities. MPEP 2144.09(I).
Regarding claim 13, Umegae teaches the compound having a structure of formula I:
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wherein R1 is -NR7R8, R7 is hydrogen, R8 is hydrogen, R2 is -NR10R11, R10 is hydrogen, R11 is phenyl substituted with X, where X is amino, and R3, R4, R5, and R6 are each independently hydrogen ([0039]: examples of the redox mediator include diphenyl amine compounds such as 4,4’-Bis(dimethylamino)diphenylamine). As described in claim 7, it is obvious to one of ordinary skill in the art to use the similar compounds (as shown as Formula 9).
Regarding claim 14, Umegae teaches the compound having a structure of formula Ia:
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wherein R1a is -NR7aR8a, R7a is hydrogen, R8a is hydrogen, R2a is -NR10aR11a, R10a is hydrogen, R11a is phenyl substituted with X, where X is amino, and R3a, R4a, R5a, and R6a are each independently hydrogen ([0039]: examples of the redox mediator include diphenyl amine compounds such as 4,4’-Bis(dimethylamino)diphenylamine). As described in claim 7, it is obvious to one of ordinary skill in the art to use the similar compounds (as shown as Formula 9).
Regarding claim 21, Umegae teaches wherein the enzyme is an oxidoreductase ([0013] (2) wherein the enzyme is an oxidoreductase).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive in light of new grounds for rejection.
Applicant argues claim 15 is not obvious over the teachings of Umegae (pp. 14-16). Applicant argues there is nothing significant with N-methyl-N-phenyl-1,4,phenylenediamine or 4,4’-Bis(dimethylamino)diphenylamine (p. 15, para. 1). This argument is unpersuasive. First, if Azure I is better than both N-methyl-N-phenyl-1,4,phenylenediamine and 4,4’-Bis(dimethylamino)diphenylamine, Applicant may claim Azure I if intended. However, Applicant tries to claim a compound having a generic formula that includes both N-methyl-N-phenyl-1,4,phenylenediamine or 4,4’-Bis(dimethylamino)diphenylamine. Since Applicant elected the species IPPD and 6PPD, with formula
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, Applicant is required to provide support and evidence that they are better than the disclosed compound of Umegae, e.g., N-methyl-N-phenyl-1,4-phenylenediamine) having a formula of
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or the additional functional groups (e.g., the dimethyl groups in IPPD) generates surprising or unpredictable results for rebuttal of the prima facie case of obviousness. Otherwise, it is obvious to one of ordinary skill in the art to use these compounds with similar structure and thus inherently having similar functions and properties.
Interview with the Examiner
If at any point during the prosecution it is believe an interview with the Examiner would further the prosecution of an application, please consider this option.
The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
The AIR form can be filled out online, and is automatically forwarded to the Examiner, who will call to confirm a requested time and date, or set up a mutually convenient time for the interview. The form can be found at:
https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3. Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C. SUN/Primary Examiner, Art Unit 1795