DETAILED CORRESPONDENCE
Summary
This is the initial Office Action on the merits based on the Ouyang, et al. application filed with the Office on 25 January 2024.
Claims 23, 24, 27, 28, 30-32, 36, 39, 40, 46, and 75-83 are currently pending and have been fully considered.
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 II, claims 23, 24, 27, 28, 30-32, 36, 39, 40, 46, and 75-83, in the reply filed on 13 January 2026, is acknowledged.
Priority
The instant application claims priority to a US Provisional Patent Application, 63/481,498, filed on 25 January 2023. Thus, an effective filing date of 25 January 2026, is afforded to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 1 October 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
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 40 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 40 is drawn dependent from claim 39 and recites the limitations: wherein the ratio of m and n is from about 1:1 to about 1:100, from about 1:1 to about 100:1, from about 4:1 to about 1:4 or from about 1:1 to about 1:4 and/or wherein m ranges from about 1 to about 90 and n ranges from about 1 to about 90. However, the m and n are not positively recited limitations in claim 39. They are recited in the alternative (“… and/or wherein the copolymer has the structure of Formula I … wherein m and n are each a positive integer”), and the limitations of claim 40 do not address the possibility that the cited limitation of claim 39 is not the chosen alternative embodiment. Therefore, claim 40 is indefinite for failing to particularly point out and distinctly claim the subject matter.
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.
Claims 23, 24, 27, 28, 31, 32, 46, 75-79 and 82 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a US Patent Application Publication to Oja, et al. (US 2020/0237276 A1; hereinafter, “Oja”).
Regarding claim 23, Oja discloses an analyte sensor (Title) comprising:
(i) an in vivo portion ([0088]: “In some or other more specific embodiments, the fluid is a biological fluid and the analyte sensor is exposed to the biological fluid in vivo within an individual.”) comprising at least a first working electrode;
(ii) a first active area disposed upon a surface of the first working electrode ([0053]: “The sensor tail may comprise at least one working electrode and one or more active areas (sensing regions/spots or sensing layers) located upon the at least one working electrode and that are active for sensing one or more analytes of interest.”);
(iii) a first membrane permeable to a first analyte that overcoats at least the first active area, ([0048]: “Some sensor configurations may have an active area overcoated with a multi-component membrane containing two or more different membrane polymers.”, Abstract; “Membranes configured to provide tailored permeability for multiple analytes are also described herein …”)
wherein the first membrane comprises a copolymer of at least a first monomer comprising an acrylamide and a second monomer comprising a heterocycle-containing component ([0069]: “According to various embodiments of the present disclosure, a polymer may be present in each active area of any of the analyte sensors or analyte sensor configurations disclosed herein. Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )), polyvinylimidazoles ( e.g., poly(1-vinylimidazole )), or any copolymer thereof. Illustrative copolymers that may be suitable for inclusion in the active areas include those containing monomer units such as … acrylamide, methacrylamide …”, wherein 4-vinylpyridine & 1-vinylimidazole are heterocycle-containing components).
Regarding claim 24, Oja teaches the analyte sensor of claim 23, wherein the (i) first active area comprises one or more enzymes responsive to the first analyte ([0007]: “In vivo analyte sensors typically are configured to analyze for a single analyte in order to provide specific analyses, often employing an enzyme to provide the analytical specificity.”),
(ii) the first active area comprises an electron transfer agent ([0067]: “According to various embodiments of the present disclosure, an electron transfer agent may be present in one or more of the active areas of any of the analyte sensors or analyte sensor configurations disclosed herein.”) and/or
(iii) the first analyte is selected from the group consisting of glucose, glutamate, ketones, lactate, creatine, creatinine, potassium, sarcosine and ascorbate ([0048]: “In some sensor configurations of the present disclosure, the multiple enzymes may facilitate independent detection of multiple analytes, such as glucose and lactate.”).
Regarding claims 27 and 28, Oja teaches the analyte sensor of claim 23, wherein the acrylamide is an N-alkyl acrylamide & the analyte sensor of claim 27, wherein the alkyl of the N-alkyl acrylamide is a C1-C6 straight or branched alkyl group or a C3-C6 cycloalkyl group ([0069]: “Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )), polyvinylimidazoles ( e.g., poly(1-vinylimidazole )), or any copolymer thereof. Illustrative copolymers that may be suitable for inclusion in the active areas include those containing monomer units such as … acrylamide, methacrylamide …”, wherein methacrylamide is a N-alkyl acrylamide).
Regarding claim 31 and 32, Oja teaches the analyte sensor of claim 23, wherein the heterocycle of the heterocycle-containing component is selected from the group consisting of furan, thiophene, pyrrole, pyridine, pyrimidine, imidazole, oxadiazole, isoxazole, oxazole, pyrazole, isothiazole, thiazole, pyrazine, isoquinoline, quinoline, benzofuran, and benzimidazole & The analyte sensor of claim 31, wherein the heterocycle is a pyridine (([0069]: “Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )) …”).
Regarding claim 46, Oja teaches the analyte sensor of claim 23, wherein the analyte sensor further comprises:
(iv) a second working electrode; and
(v) a second active area disposed upon a surface of the second working electrode and responsive to a second analyte differing from the first analyte or for detecting a background signal,
wherein a second portion of the first membrane overcoats the second active area or a second separate membrane overcoats the second active area ([0137]: “… a sensor tail comprising at least a first working electrode and a second working electrode, a first active area located upon a surface of the first working electrode, a second active area located upon a surface of the second working electrode, a multi-component membrane overcoating the first active area, and a homogenous membrane overcoating the second active area. The first active area comprises a first polymer and a first analyte responsive enzyme that is reactive with a first analyte, and the second active area comprises a second polymer and a second analyte-responsive enzyme that is reactive with a second analyte. The first analyte-responsive enzyme and the second analyte-responsive enzyme are different and are reactive with different analytes.”).
Regarding claim 75, Oja teaches The analyte sensor of claim 23, wherein the first active area comprises an electron transfer agent ([0067]: “According to various embodiments of the present disclosure, an electron transfer agent may be present in one or more of the active areas of any of the analyte sensors or analyte sensor configurations disclosed herein.”)
Regarding claim 76, Oja teaches the analyte sensor of claim 23, wherein the first analyte is selected from the group consisting of glucose, glutamate, ketones, lactate, creatine, creatinine, potassium, sarcosine and ascorbate ([0048]: “In some sensor configurations of the present disclosure, the multiple enzymes may facilitate independent detection of multiple analytes, such as glucose and lactate.”).
Regarding claims 78 and 79, Oja teaches the analyte sensor of claim 23, wherein the heterocycle of the heterocycle-containing component is a vinylpyridine & the analyte sensor of claim 78, wherein the vinylpyridine is selected from the group consisting of 2-vinylpyridine, 4-vinylpyridine and a combination thereof ([0069]: “According to various embodiments of the present disclosure, a polymer may be present in each active area of any of the analyte sensors or analyte sensor configurations disclosed herein. Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )) …).
Regarding claim 82, Oja teaches the analyte sensor of claim 23, wherein the heterocycle of the heterocycle-containing component is a polyvinylimidazole ([0069]: “According to various embodiments of the present disclosure, a polymer may be present in each active area of any of the analyte sensors or analyte sensor configurations disclosed herein. Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )), polyvinylimidazoles ( e.g., poly(1-vinylimidazole )), or any copolymer thereof.”)
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.
Claims 30, 36, 39, 77, 80, 81, and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Oja in view of a US Patent Application Publication to Hoss, et al. (US 2015/0313520 A1; hereinafter, “Hoss”).
Regarding claim 30, Oja teaches the limitations of claim 23, as outlined above.
Oja does not teach wherein the N-alkyl acrylamide is N-isopropylacrylamide.
However, Hoss discloses analyte sensors which include membrane structures (Abstract), wherein the membranes may include a negative temperature coefficient polymer, such as poly(n-isopropyl acrylamide) ([0036]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the Hoss taught poly(n-isopropyl acrylamide) in placed of the acrylamide or methacrylamide disclosed by Oja as it would allow structuring a membrane that is substantially temperature independent (Hoss, [0035]).
Regarding claim Oja teaches the limitations of claim 23, as outlined above.
Oja does not explicitly teach wherein the copolymer comprises (i) from about 20 mer% to about 70 mer% of the first monomer or from about 40 mer% to about 60 mer% of the first monomer and/or (ii) from about 30 mer% to about 80 mer% of the second monomer or from about 30 mer% to about 60 mer% of the second monomer.
However, it would be obvious to one of ordinary skill in the art to have tried various percentages of copolymers, including those within the currently claimed ranges, as an routine experimentation to determine the optimal composition of the membrane.
Regarding claim 39, Oja teaches the limitations of claim 23, as outlined above.
Oja further teaches the heterocycle is 4-vinylpyridine ([0069]: “According to various embodiments of the present disclosure, a polymer may be present in each active area of any of the analyte sensors or analyte sensor configurations disclosed herein. Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )) …).
Oja does not teach the acrylamide is N-isopropylacrylamide.
However, Hoss discloses analyte sensors which include membrane structures (Abstract), wherein the membranes may include a negative temperature coefficient polymer, such as poly(n-isopropyl acrylamide) ([0036]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the Hoss taught poly(n-isopropyl acrylamide) in placed of the acrylamide or methacrylamide disclosed by Oja as it would allow structuring a membrane that is substantially temperature independent (Hoss, [0035]).
Regarding claim 77, Oja teaches the limitations of claim 23, as outlined above.
Oja does not teach wherein the alkyl of the N-alkyl acrylamide is a branched alkyl group.
However, Hoss discloses analyte sensors which include membrane structures (Abstract), wherein the membranes may include a negative temperature coefficient polymer, such as poly(n-isopropyl acrylamide) ([0036]), a branched alkyl group.
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the Hoss taught poly(n-isopropyl acrylamide) in placed of the acrylamide or methacrylamide disclosed by Oja as it would allow structuring a membrane that is substantially temperature independent (Hoss, [0035]).
Regarding claim Oja teaches the limitations of claim 80, as outlined above.
Oja does not explicitly teach wherein the copolymer comprises (i) from about 40 mer% to about 60 mer% of the first monomer and/or (ii) from about 30 mer% to about 60 mer% of the second monomer.
However, it would be obvious to one of ordinary skill in the art to have tried various percentages of copolymers, including those within the currently claimed ranges, as an routine experimentation to determine the optimal composition of the membrane.
Regarding claim 80, Oja teaches the limitations of claim 23, as outlined above.
Oja further teaches the heterocycle is 4-vinylpyridine ([0069]: “According to various embodiments of the present disclosure, a polymer may be present in each active area of any of the analyte sensors or analyte sensor configurations disclosed herein. Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )) …).
Oja does not teach the acrylamide is N-isopropylacrylamide.
However, Hoss discloses analyte sensors which include membrane structures (Abstract), wherein the membranes may include a negative temperature coefficient polymer, such as poly(n-isopropyl acrylamide) ([0036]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the Hoss taught poly(n-isopropyl acrylamide) in placed of the acrylamide or methacrylamide disclosed by Oja as it would allow structuring a membrane that is substantially temperature independent (Hoss, [0035]).
Regarding claim 83, Oja teaches the limitations of claim 23, as outlined above.
Oja further teaches the heterocycle is polyvinylimidazole ([0069]: “According to various embodiments of the present disclosure, a polymer may be present in each active area of any of the analyte sensors or analyte sensor configurations disclosed herein. Suitable polymers for inclusion in the active areas may include, but are not limited to, polyvinylpyridines ( e.g., poly( 4-vinylpyridine )), polyvinylimidazoles ( e.g., poly(1-vinylimidazole )), or any copolymer thereof.”)
Oja does not teach the acrylamide is N-isopropylacrylamide.
However, Hoss discloses analyte sensors which include membrane structures (Abstract), wherein the membranes may include a negative temperature coefficient polymer, such as poly(n-isopropyl acrylamide) ([0036]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the Hoss taught poly(n-isopropyl acrylamide) in placed of the acrylamide or methacrylamide disclosed by Oja as it would allow structuring a membrane that is substantially temperature independent (Hoss, [0035]).
Interview with the Examiner
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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
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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 JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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 Van can be reached at (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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/J. Christopher Ball/ Primary Examiner, Art Unit 1795