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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to an analyte sensor, classified in A61B 5/14865.
II. Claim 20, drawn to a method for forming a membrane layer, classified in A61K 9/7007.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the process as claimed can be practiced by another and materially different apparatus such as where the EVA copolymer has a melt flow index up to 500 grams.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Bethany J. Whelan on 12/9/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 1 objected to because of the following informalities: The phrase “in accordance with ASTM D1238-20” is unnecessary in view of the recited test temperature and load and tends to import extraneous material into the claim. Applicant may wish to amend the claim to recite simply “a melt flow index of from about 1 to about 400 grams per 10 minutes, measured at a temperature of 190°C and a load of 2.16 kilograms” without reference to the external standard. Appropriate correction (or acknowledgment) is required.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0003] reads “more comfortable” and should read “more comfortably”
Paragraph [0018] reads “references characters” and should read “reference characters”.
Paragraph [0026] reads “ATEVAR” and should read “ATEVA®”
Paragraph [0037] reads “no or more”
Paragraph [0048] reads “an analytes” and should read “an analyte”.
Paragraph [0050] reads “over at the entire” and should read “over the entire”.
Paragraph [0057] reads “operable coupled” and should read “operably coupled”.
Paragraph [0060] reads “subcutaneously” and should read “subcutaneously”
The element labeled 130 is referred to by two different names “sensor control unit” and “sensor assembly”
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20210076993 A1 to Somasuntharam et al. (hereinafter, Somasuntharam) in view of US 20190358167 A1 to Schneider et al. (hereinafter, Schneider).
Regarding Claim 1, Somasuntharam discloses an analyte sensor (Abstract “…the device is a glucose sensor comprising a polymeric composition that includes amounts of one or more immunosuppressant agents...”) comprising inter alia:
an implantable sensor configured to measure a signal indicative of an analyte concentration in a user (Somasuntharam discloses an “amperometric analyte sensor” with a working electrode, analyte sensing layer, and analyte modulating layer that is implanted and sense analyte levels in vivo, paragraph [0006]); and
at least one membrane layer disposed on at least a portion of the implantable sensor, (Somasuntharam discloses a analyte modulating layer disposed on the analyte sensing layer, paragraph [0006]), wherein the membrane layer comprises a membrane polymer matrix and one or more therapeutic agents dispersed within the membrane polymer matrix (Somasuntharam discloses the sensor includes a material that released a immunosuppressant agent, paragraphs [0006] and [0008],discloses where the analyte modulating layer comprises the immunosuppressant agent (e.g., dexamethasone) selected to inhibit an immune response to the implanted sensor, paragraph [0006], and discloses forming the analyte modulating layer on the analyte sensing layer, which includes disposing a polymeric material on the sensor that comprises the immunosuppressant agent, paragraphs [0005]-[0007]), wherein the at least one membrane layer is permeable to an analyte (Somasuntharam discloses specific analyte modulating layer permeabilities in paragraph [0009]).
Somasuntharam discloses the claimed invention as set forth and cited above except for expressly disclosing, wherein membrane polymer matrix is a ethylene vinyl acetate copolymer having a melt flow index of from about 1 to about 400 grams per 10 minutes as determined in accordance with ASTM D1238-20 at a temperature of 190°C and a load of 2.16 kilograms.
However, Schnieder an implantable analyte sensor that includes a membrane layer that comprises a membrane polymer matrix (Schneider teaches a core polymer matrix that includes a hydrophobic polymer, paragraph [0029]) that includes an ethylene vinyl acetate (EVA) copolymer (“ethylene vinyl acetate”, paragraph [0034]) with one or more therapeutic agents dispersed within the membrane polymer matrix (“…the membrane layer generally contains the drug compound…” paragraph [0047] and copolymer matrix has a drug compound dispersed within, paragraph [0029]), and further teaches that EVA has a melt flow index of from about 1 to about 400 grams per 10 minutes as determined in accordance with ASTM D1238-20 at a temperature of 190°C and a load of 2.16 kilograms (paragraphs [0033] and [0046]).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the membrane polymer matrix of Somasuntharam with the EVA and associated properties of Schnieder, as Schnieder teaches this would have helped control the release of the drug compound from the device (paragraphs [0034]). Regarding Claim 2, Somasuntharam in view of Schnieder teach analyte sensor of claim 1, wherein the ethylene vinyl acetate copolymer has a melting temperature of from about 40°C to about 120°C as determined in accordance with ASTM D3418-15 (Schnieder paragraph [0034] “…melting temperature of such an olefin copolymer may, for instance, range from about 40° C. to about 140° C…”).
Regarding Claim 3, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the ethylene vinyl acetate copolymer has a vinyl acetate content of from about 10 wt.% to about 60 wt.% (Schnieder paragraph [0034] “… the polar monomeric content of the copolymer may be selectively controlled to be within a range of from about 10 wt. % to about 60 wt. %...” ).
Regarding Claim 4, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the ethylene vinyl acetate copolymer in the membrane polymer matrix is from about 20 wt.% to about 99 wt.% (Schnieder paragraph [0034] “… in some embodiments about 20 wt. % to about 55 wt. %...”).
Regarding Claim 5, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the membrane polymer matrix includes a first ethylene vinyl acetate copolymer and a second ethylene vinyl acetate copolymer (a wide variety of first ethylene vinyl acetate copolymers are taught in paragraph [0035] of Schnieder, including ATEVA and EVTANE and also teaches that there may be first and second polymers that may be the same or different, paragraph [0046]).
Regarding Claim 6, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the one or more therapeutic agents includes a steroidal agent, an anti-inflammatory agent, an anti-coagulation agent, or combinations thereof (Somasuntharam, “dexamethasone”, paragraph [0006]).
Regarding Claim 7, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the sensor has a generally circular cross-sectional shape (Somasuntharam discloses a generally circular cross-section in an implanted rod type fashion in Fig. 1).
Regarding Claim 8, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein one or more additional membrane layers are disposed between the at least one membrane layer and the sensor (Somasuntharam discloses a stack of sensor base/electrodes, sensing layer, modulating/drug layer, paragraph [0006]).
Regarding Claim 9, Somasuntharam in view of Schnieder teach the analyte sensor of claim 8, wherein the one or more additional membrane layers comprise a polymer matrix composition that is different from the membrane polymer matrix (Somasuntharam discloses an analyte sensing layer that includes oxidoreductase enzymes and crosslinked hydrophilic polymers (e.g., PHEMA), while the analyte modulating layer is polyurethane-based coating, paragraph [0009]).
Regarding Claim 10, Somasuntharam in view of Schnieder teach the analyte sensor of claim 8, wherein the one or more additional membrane layers comprise a sensing layer comprising an analyte-responsive enzyme. (Somasuntharam paragraph [0009] “… wherein the analyte sensing layer includes an oxidoreductase…”).
Regarding Claim 11, Somasuntharam in view of Schnieder teach the analyte sensor of claim 8, wherein one or more additional membrane layers are disposed on an outer surface of the membrane layer (Somasuntharam paragraphs [0010], [0030], [0033] “sublayers”).
Regarding Claim 12, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the amount of therapeutic agent in the membrane polymer matrix is from about 5 wt.% to about 75 wt.% (Schnieder paragraph [0029] “… macromolecular drug compounds will constitute from about 5 wt. % to about 60 wt. %...”).
Regarding Claim 13, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the membrane layer is loaded with about 10 mg to about 100 mg of the one or more therapeutic agents (Schnieder paragraph [0031] “… an effective amount will typically range from about 5 pg to about 200 mg, in some embodiments from about 5 pg to about 100 mg per day, and in some embodiments, from about 10 pg to about 1 mg of the macromolecular drug compound delivered per day…”).
Regarding Claim 14, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the membrane layer is capable of releasing the therapeutic agent for a time period of about 1 day to about 21 days or more (Schnieder paragraph [0030] “…5 days … 10 days … 20 days …”).
Regarding Claim 15, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the membrane polymer matrix comprises one or more hydrophilic compounds (Schnieder paragraph [0029] “…hydrophobic polymer … 50 wt.% …”).
Regarding Claim 16, Somasuntharam in view of Schnieder teach the analyte sensor of claim 15, Somasuntharam in view of Schnieder teach wherein the one or more hydrophilic compounds are present in an amount of from about 1 wt.% to about 60 wt.% (Schnieder paragraph [0029] “…hydrophobic polymer … 50 wt.% …”).
Regarding Claim 17, Somasuntharam in view of Schnieder teach the analyte sensor of claim 15, wherein the one or more hydrophilic compounds comprises polyethylene glycol (PEG) (Schnieder paragraph [0061] “…membrane layer … PEG…”).
Regarding Claim 18, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the analyte is glucose (Somasuntharam, see Abstract).
Regarding Claim 19, Somasuntharam in view of Schnieder teach the analyte sensor of claim 1, wherein the analyte sensor is a transcutaneous analyte sensor (Somasuntharam, see Abstract).
Conclusion
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791