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 10/21/25 and 05/16/24 have been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Invention I (Claims 1-9) in the reply filed on 02/02/26 is acknowledged. The traversal is on the ground(s) that Applicant notes the subject matter of each of the claim Groups is linked by a common inventive concept, and there is no serious burden on the Examiner to examine the different claim Groups. This is not found persuasive because the apparatus can be used to practice another and materially different process that does not comprise implanting the sensor within a mammal. The sensor may be used as an ex vivo sensor instead. Invention II (Claims 10-15) has been withdrawn
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112B
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.
Claim 7 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.
The term “about 50%-80% crosslinking agent and about 20%-50% polymerizable monomer” in claim 7 is a relative term which renders the claim indefinite. The term “about 50%-80% crosslinking agent and about 20%-50% polymerizable monomer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear just how close to the claimed percentages the crosslinking agent and monomer must be to meet the limitation.
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 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (US 2017/0315077 A1) and in further view of Heller (US 2009/0308743 A1) and Li (US 2019/0357827 A1).
Rao was applied in Applicant’s IDS filed on 05/16/24
Regarding claim 1, Rao teaches an amperometric analyte sensor [fig. 5A, element 100; par. 6 and 25] comprising: a first base layer [fig. 5A, element 102A; par. 46]; a conductive layer [fig. 5A, element 104] disposed on the first base layer [par. 46], wherein the conductive layer includes a first working electrode [par. 46 “An operating sensor 100 typically includes a plurality of electrodes such as a working electrode”]; an analyte sensing layer [fig. 5A, element 110], comprising an enzyme selected to generate a detectable electrical signal upon exposure to glucose disposed on the working electrode [par. 38, 39, 48 “Typically, the analyte sensing layer 110 is an enzyme layer”]; and a layer is formed by a reaction mixture comprising a photoinitiator agent [par. 28, 34]; and the interference rejection layer is formed when the reaction mixture is polymerized by exposure to light [par. 28, 34]
A second embodiment of Rao teaches 10an interference rejection layer [fig. 5B, element 120; par. 41] and analyte sensing layer [fig. 5B, element par. 41 and 48], wherein: the interference rejection layer is formed by a reaction mixture comprising a polymerizable monomer and a crosslinking agent [par. 60]; and 15an analyte modulating layer disposed on the interference rejection layer [par. 28, 68-70, and 112];
Additionally, Examiner notes that Rao teaches an embodiment that includes all components of the first and second embodiments that is not represented in the figures [par. 78, i.e., a base layer, conductive layer, analyte sensing layer, interference rejection layer, and analyte modulating layer]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by the first embodiment of Rao, to incorporate an interference rejection layer and analyte sensing layer, wherein: the interference rejection layer is formed by a reaction mixture comprising a polymerizable monomer and a crosslinking agent; and 15an analyte modulating layer disposed on the interference rejection layer, for preventing a spurious signal that can confound measurements of the signal generated by the analyte to be measured, as evidence by the second embodiment of Rao [par. 41].
However, Rao does not teach the interference rejection layer is disposed on the analyte sensing layer
Heller teaches the interference rejection layer is disposed on the analyte sensing layer [par. 6 “a sensor that includes a sensing layer disposed on a substrate and a multilayer flux-limiting membrane disposed over the sensing layer”, par. 21 “The purpose of the membrane is to reduce analyte-flux or reduce or prevent interferent flux to the electrode”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Rao, to incorporate the interference rejection layer is disposed on the analyte sensing layer, for reducing or eliminating the flux of interferents to the conductive material of the electrode, as evidence by Heller [par. 37].
However, Rao does not teach the interference rejection layer is formed by a reaction mixture comprising a photoinitiator agent; and the interference rejection layer is formed when the reaction mixture is polymerized by exposure to light
Li teaches the interference rejection layer is formed by a reaction mixture comprising a photoinitiator agent [547, 548]; and the interference rejection layer is formed when the reaction mixture is polymerized by exposure to light [par. 547]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Rao, to incorporate the interference rejection layer is formed by a reaction mixture comprising a photoinitiator agent; and the interference rejection layer is formed when the reaction mixture is polymerized by exposure to light, as it is believed that visible light exposure is preferable to ionizing radiation, which crosslinks the interference domain and thereby creates a tighter, less permeable network than an interference domain that has not been exposed to ionizing radiation, as evidence by Li [par. 547].
Regarding claim 2, Rao further teaches wherein: the reaction mixture forms a polyvinyl alcohol polymer or a poly(2-hydroxyethyl methacrylate) polymer; the polymerizable monomer comprises a hydroxyethylmethacrylate monomer, a methyl methacrylate monomer and/or a hydroxybutyl methacrylate monomer; and/or the crosslinking agent comprises an ethylene glycol and/or a silane [par. 60].
Regarding claim 3, Rao further teaches the analyte sensing layer is formed by a reaction mixture comprising a polymerizable monomer, a crosslinking agent and a photoinitiator agent and the 30analyte sensing layer is formed when the reaction mixture is polymerized by exposure to light [par. 28 and 34].
Regarding claim 5, Rao further teaches the conductive layer includes a second working electrode comprising the analyte sensing layer and the analyte modulating layer and does not include the interference rejection layer [par. 82]; and glucose is sensed by comparing an electrical signal at the first working electrode in the presence of glucose with an electrical signal at the second working electrode in the presence of glucose [par. 82, 83].
Regarding claim 6, Rao further teaches the conductive layer includes a background electrode that does not comprise an analyte sensing layer, an analyte modulating layer; or an interference rejection layer [par. 83 “one working electrode is coated with an analyte sensing layer comprising glucose oxidase (and optionally two are coated with GOx) and at least one working electrode is not coated with an analyte sensing layer comprising glucose oxidase”]; and glucose is sensed by comparing an electrical signal at the first working electrode in the presence of glucose with an electrical signal at the background electrode in the presence of glucose [par. 82, 83]
Regarding claim 7, Rao further teaches the crosslinking agent comprises an ethylene glycol diacrylate [par. 8, 36]; and the relative amounts of crosslinking agent and polymerizable monomer disposed within the reaction mixture is selected such that the reaction mixture comprises about 50%-80% crosslinking agent and about 20%-50% polymerizable monomer.
Although Rao does not explicitly teach the relative amounts of crosslinking agent and polymerizable monomer disposed within 25the reaction mixture is selected such that the reaction mixture comprises about 50%-80% crosslinking agent and about 20%-50% polymerizable monomer, this would be obvious to a person having ordinary skill in the art when the invention was filed since Rao also suggests the amount of crosslinker reagent and monomers are selected and mixed in a specific ratio control analyte specific permeability in the membrane [see par. 29-30]. Examiner also notes that the ratio is sensor specific and depends on the level of permeability intended. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to Rao, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, Rao further teaches contact pads and/or conductor traces disposed on the base do not comprise an interference rejection layer [par. 47; Examiner notes the contact pads or conductive paths may be covered with an insulating cover or exposed].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rao, Heller and Li in further view of Shull (US 2006/228767 A1).
Shull was applied in Applicant’s IDS filed on 05/16/24
Regarding claim 4, Rao, Heller and Li teach an amperometric analyte sensor, as disclosed above, and the layer comprising an enzyme comprises glucose oxidase or comprises an analyte modulating layer; or the layer comprising an enzyme does not comprise glucose oxidase or does not comprise an analyte modulating layer [par. 20 and 33].
However, Rao, Heller and Li do not teach a layer comprising an ascorbic acid oxidase enzyme.
Shull teaches a layer comprising an ascorbic acid oxidase enzyme [par. 40].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Rao, Heller and Li, to incorporate a layer comprising an ascorbic acid oxidase enzyme, for removing the interferent ascorbic acid, as evidence by Shull [par. 40].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rao, Heller and Li in further view of Wang (US 2018/0325436 A1).
Regarding claim 9, Rao, Heller and Li teach an amperometric analyte sensor, as disclosed above
However, Rao, Heller and Li do not teach the analyte sensing layer, the interference rejection layer or the analyte modulating layer comprises: a diisocyanate; a hydrophilic polymer comprising a hydrophilic diol or hydrophilic diamine; a siloxane having an amino, hydroxyl or carboxylic acid functional group at a terminus; or a polycarbonate diol
Wang teaches the analyte sensing layer, the interference rejection layer or the analyte modulating layer comprises: a diisocyanate; a hydrophilic polymer comprising a hydrophilic diol or hydrophilic diamine; a siloxane having an amino, hydroxyl or carboxylic acid functional group at a terminus; or a polycarbonate diol [par. 45 “the analyte modulating layer comprises a polyurethane/polyurea polymer formed from a mixture comprising: a diisocyanate; a hydrophilic polymer comprising a hydrophilic diol or hydrophilic diamine; and a siloxane having an amino, hydroxyl or carboxylic acid functional group at a terminus”].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Rao, Heller and Li, to incorporate the analyte sensing layer, the interference rejection layer or the analyte modulating layer comprises: a diisocyanate; a hydrophilic polymer comprising a hydrophilic diol or hydrophilic diamine; a siloxane having an amino, hydroxyl or carboxylic acid functional group at a terminus; or a polycarbonate diol, as the quantity of diisocyanate employed in the preparation of the polyurethane/polyurea polymer will be sufficient to provide at least about 100% of the —NCO groups necessary to react with the hydroxyl or amino groups of the remaining reactants, as evidence by Wang [par. 49].
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