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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/30/24 and 03//04/24 have been considered by the examiner.
Election/Restriction
Applicant’s election with traverse of Invention I (Claims 1-9) in the reply filed on 12/29/25 is acknowledged. Invention II (Claims 10-19) and Invention III (Claim 20) have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites:
“the diffusion” in line 7. This term was not mentioned previously.
Claim 6 recites:
“the environment” in line 4. This term was not mentioned previously
“the sensor” in line 4. Does this refer to “the amperometric analyte sensor” mentioned previously in claim 1?
Appropriate correction is required.
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 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 1-6, 8, and 9 are rejected under 35 U.S.C. 103 as being obvious under Somasuntharam (U.S. Patent Application Publication 2021/0076993 A1) in view of Vaddiraju (U.S. Patent Application Publication 2018/0328877 A1)
Somasuntharam was applied in Applicant’s IDS filed on 03/04/24
Regarding claim 1, Somasuntharam teaches an amperometric analyte sensor [par. 5] comprising: a working electrode comprising: a base layer [fig. 2A, element 102; par. 68]; a conductive layer [fig. 2A, element 104] disposed over the base layer [par. 68]; an analyte sensing layer [fig. 2A, element 110] disposed over the conductive layer [par. 70]; and an analyte modulating layer [fig. 2A, element 112] disposed over the analyte sensing layer [par. 6, 72], wherein: the analyte modulating layer permselectively modulates the diffusion of glucose and oxygen therethrough such that the diffusion of glucose is limited relative to oxygen [par. 52 “an analyte modulating layer that functions to both release an immunosuppressant agent as well as in analyte diffusion control (e.g. to modulate the amounts of glucose and oxygen exposed to the analyte sensing layer)”, par. 53 “the analyte modulating layer is formed to exhibit a first permeability to glucose and a second permeability to O.sub.2, and the permeability to O.sub.2 is greater than the permeability to glucose”]; and the analyte modulating layer comprises a hydrogel [par. 72 “glucose limiting membranes can be made from a wide variety of materials known to be suitable for such purposes, e.g. … hydrogels”] having a polymer reversibly coupled to a bioactive agent such that the bioactive agent is uncoupled from the polymer in response to a stimuli [par. 8, 30, 37 “the polymeric material used to make the analyte modulating layer and/or sublayers, the amount of and/or thickness of the sublayers, and the concentration of the immunosuppressant agent in the sublayers is precisely controlled so to create one or more specific release profiles for the immunosuppressant agent”, 52].
However, Somasuntharam does not teach a layer comprising an acrylate hydrogel
Vaddiraju teaches a layer comprising an acrylate hydrogel [par. 56]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam to incorporate a layer comprising an acrylate hydrogel, to improve adhesion, as evidence by Vaddiraju [par. 56]
Regarding claim 2, Somasuntharam further teaches the bioactive agent is at least one of: an antibacterial agent, an anti-inflammatory agent and an anticoagulant agent; and/or the analyte modulating layer exhibits a permeability to glucose and oxygen that is altered by less than 10% following release of the bioactive agent from the analyte modulating layer [par. 43]
Regarding claim 3, Somasuntharam further teaches the bioactive agent comprises at least one of a dexamethasone, a heparin or a fluoroquinolone [par. 43]
Regarding claim 4, Somasuntharam further teaches the bioactive agent is noncovalently entrapped within the polymer; and/or the bioactive agent is covalently coupled to the polymer; and/or the bioactive agent is coupled to the polymer by an acrylate moiety disposed on the bioactive agent [par. 55, 97 “the various layers (e.g. the analyte sensing layer) of the sensors can have one or more bioactive and/or inert materials incorporated therein. The term “incorporated” as used herein is meant to describe any state or condition by which the material incorporated is held on the outer surface of or within a solid phase or supporting matrix of the layer. Thus, the material “incorporated” may, for example, be immobilized, physically entrapped, attached covalently to functional groups of the matrix layer(s)”]
Regarding claim 5, Somasuntharam further teaches the analyte modulating layer comprises at least one of: a Poly(2-hydroxyethyl methacrylate), a polyurethane and a chain extender [par. 55, 63]
Regarding claim 6, Somasuntharam further teaches the bioactive agent is uncoupled from the polymer in response to: exposure to aqueous media;exposure to endogenous stimuli present in the environment in which the sensor is disclosed; an alteration in the pH of the environment in which the amperometric analyte sensor is disposed; an alteration in the temperature of the environment in which the amperometric analyte sensor is disposed; and/or an electrochemical stimuli selected from: a voltage applied to the amperometric analyte sensor; and/or a current within the amperometric analyte sensor [Examiner notes the agent is released after implantation]
Regarding claim 8, Somasuntharam further teaches the amperometric analyte sensor consists of a single sensor flex assembly comprising a flexible planar element having a longitudinal member comprising a first side and a second side [fig. 7A; par. 31]
Regarding claim 9, Somasuntharam further teaches the bioactive agent is coupled to an external surface of the analyte modulating layer [par. 31 “the immunosuppressant agent is coupled to or disposed within a primary analyte sensing component that functions in analyte sensing, for example the analyte modulating layer… the shaded regions on the longitudinal arm of the sensor flex assembly shown in these figures indicate different illustrative regions and ways in which a composition comprising an immunosuppressant agent can be disposed in an analyte sensor (e.g. in dots on top of an analyte modulating layer”]
Claim 7 is rejected under 35 U.S.C. 103 as being obvious under Somasuntharam in view of Vaddiraju and in further view of Garcia (U.S. Patent Application Publication 2022/0313124 A1)
Regarding claim 7, Somasuntharam and Vaddiraju teach an amperometric analyte sensor, as disclosed in claim 1.
However, Somasuntharam and Vaddiraju do not teach the bioactive agent is uncoupled from the polymer in response to: active oxygen species including hydrogen peroxide.
Garcia teaches the bioactive agent is uncoupled from the polymer in response to: active oxygen species including hydrogen peroxide [par. 253]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam and Vaddiraju, to incorporate uncoupling the bioactive agent from the polymer in response to: active oxygen species including hydrogen peroxide, to bind-up or substantially inactivate interferants, as evidence by Garcia [par. 253]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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GRACE L ROZANSKI/
Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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