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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 27, 2026 has been entered.
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on February 27, 2026. Claims 1, 9-11, 13, and 21-24 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objection to the claims is withdrawn in view of Applicant’s amendment.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9-11, 13, and 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. New matter is shown in bold.
Claim 1 recites the limitation “a separation chemistry being applied as a layer that encapsulates the first reactive chemistry, the second reactive chemistry and the electrode reactive surface” in lines 18-20 of the claim. The specification does not contain support for the separation chemistry 112 encapsulating all three of the first reactive chemistry 110, the second reactive chemistry 302, and the electrode reactive surface 116. The instant specification discloses one embodiment wherein the separation chemistry 112 encapsulates the first reactive chemistry 110 but not the electrode reactive surface 116 (Fig. 1C, para. [0029] of the instant US PGPub), and is silent with respect to a second reactive chemistry. The instant specification discloses an alternative embodiment wherein the first reactive chemistry 110 encapsulates the second reactive chemistry 302 (Figs. 3B-5 & 5, para. [0039], [0046] of the instant US PGPub), but is silent with respect to a separation chemistry. There is no description or support for how the separation chemistry 112 of Fig. 1C can be incorporated into the alternative embodiment of Fig. 3B-5 or where it would be positioned with respect to each of the first reactive chemistry 110, the second reactive chemistry 302, and the electrode reactive surface 116. The specification is silent with respect to an embodiment wherein the separation chemistry encapsulates all three of the first reactive chemistry 110, the second reactive chemistry 302, and the electrode reactive surface 116. Applicant is required to cancel the new matter in reply to this Office Action. Claims 9-11, 13, and 21-24 are rejected as dependent thereon.
Claim 13 recites the limitation “the interference reduction material is selected based on ability to reduce another analyte generated by a reaction between an endogenous analyte and the first reactive chemistry or the second reactive chemistry” in lines 2-4 of the claim. The specification does not contain support for the interference reduction material being selected based on ability to reduce another analyte generated by a reaction between an endogenous analyte and the first reactive chemistry. The instant specification discloses that the interference reduction material 304 is able to catalyze interfering compounds generated via reaction between endogenous analytes and the second reactive chemistry 302 (para. [0035]-[0036], [0039] of the instant US PGPub), but is silent with respect to catalyzing compounds generated via reaction between endogenous analytes and the first reactive chemistry 110. Applicant is required to cancel the new matter in reply to this Office Action.
Claim 24 recites the limitation “wherein the separation chemistry extends to the first and second lateral edges” in lines 1-2 of the claim. The specification does not contain support for the separation chemistry extending to the first and second lateral edges. The instant disclosure only shows embodiments where the separation chemistry 112 does not extend to the first and second lateral edges 14a, 14b (Figs. 1B-1C). The instant specification is silent with respect to the separation chemistry extending to the first and second lateral edges. Applicant is required to cancel the new matter in reply to this Office Action.
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 9 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 9 recites the limitation "the first transport material" in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1, 9-11, 13, 21-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Petisce et al. (US 2009/0143658 A1) in view of Zhang et al. (US 2010/0331728 A1).
Regarding claim 1, Petisce teaches an in-vivo sensor assembly measuring a presence of an analyte (a sensor assembly 11 configured for intravenous insertion for measuring an analyte, Petisce, Figs. 1-3, para. [0087], [0097]), comprising:
a working conductor having an electrode reactive surface, the working conductor being located between a first lateral edge and a second lateral edge of the in-vivo sensor assembly (a working electrode 19 having an electroactive surface and located between a first lateral edge and a second lateral edge of the sensor assembly 11, Petisce, Figs. 1-3, para. [0088], [0097], [0099]);
a first reactive chemistry being responsive to a first analyte, the first reactive chemistry being applied as a layer overlapping the electrode reactive surface but not extending to the first and second lateral edges (an enzyme layer 23 that chemically reacts with the analyte and overlaps the electroactive surface of the working electrode 19 but does not extend to the first and second lateral edges of the sensor assembly 11, Petisce, Figs. 2-3, para. [0089], [0098]-[0099]).
Petisce teaches that the enzyme layer 23 includes glucose oxidase which catalyzes an electrochemical reaction with glucose (Petisce, Figs. 2-3, para. [0050], [0098]). Petisce is silent with respect to a cofactor, and therefore fails to teach wherein the first reactive chemistry includes a cofactor.
Zhang teaches electrode structures having one or more conductive materials configured for use as analyte sensors for in vivo uses (Zhang, abstract, para. [0095]). Zhang teaches that the working electrode includes a conductive material and a sensing layer disposed thereon (Zhang, para. [0099]). Zhang teaches that the sensing layer includes an analyte responsive enzyme which is capable of catalyzing a reaction of the analyte (Zhang, para. [0100]). Zhang teaches that glucose oxidase or nicotinamide adenine dinucleotide (NAD) dependent glucose dehydrogenase may be used when the analyte of interest is glucose (Zhang, para. [0100]). Zhang also teaches that nicotinamide adenine dinucleotide (NAD) dependent hydroxybutyrate dehydrogenase (HBDH) may be used where the analyte of interest is a ketone body (Zhang, para. [0100]). Zhang teaches that in order to facilitate the electrochemical reaction of the analyte sensor, the sensing layer also includes an enzyme cofactor such as nicotinamide adenine dinucleotide (NAD+) (Zhang, para. [0104]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the glucose oxidase in the enzyme layer 23 of Petisce with NAD-dependent hydroxybutyrate dehydrogenase and a NAD+ cofactor as taught by Zhang in order to yield the predictable result of catalyzing a reaction of an analyte of interest in vivo such as a ketone body.
Modified Petisce teaches a second reactive chemistry being responsive to a product of the first reactive chemistry and the first analyte, the second reactive chemistry being applied as a layer that is located between the first reactive chemistry and the electrode reactive surface, the second reactive chemistry being encapsulated by the first reactive chemistry and further being in direct contact with the electrode reactive surface (an interference layer 50 is located between the enzyme layer 23 and the electroactive surface of the working electrode 19 such that the interference layer 50 is encapsulated by the enzyme layer 23 and in direct contact with the electroactive surface of the working electrode 19, Petisce, Figs. 2-3, para. [0054], [0071], [0098]; the interference layer 50 allows diffusion of the product from the reaction between the enzyme layer 23 and the analyte of interest, Figs. 2-3, para. [0058], [0072]); and
a separation chemistry being applied as a layer that encapsulates the first reactive chemistry, the second reactive chemistry and the electrode reactive surface, the separation chemistry entrapping the cofactor of the first reactive chemistry (a flux limiting membrane 25 encapsulates the enzyme layer 23, the interference layer 50, and the electroactive surface of the working electrode 19, thereby sealing the enzyme layer 23, Petisce, Fig. 3, para. [0099]).
The limitations “in vivo,” “measuring a presence of an analyte,” “responsive to a first analyte,” and “responsive to a product of the first reactive chemistry and the first analyte” are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The sensor assembly disclosed by Modified Petisce teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as mapped in the rejection supra.
Regarding claim 9, Modified Petisce teaches wherein the separation chemistry further enables selective transport of the analyte between the first reactive chemistry and the first transport material (the flux limiting membrane 25 selectively allows diffusion of the analyte between the enzyme layer 23 and an additional biocompatible layer on the flux limiting membrane 25, Petisce, Fig. 3, para. [0099]).
The limitation “enables selective transport of the analyte” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The flux limiting membrane 25 of the sensor assembly disclosed by Modified Petisce teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as mapped in the rejection supra.
Regarding claim 10, Modified Petisce teaches an interference reduction material (an additional interference layer may be formed to block an interferent, Petisce, para. [0068]-[0070]).
Regarding claim 11, Modified Petisce teaches wherein the interference reduction material is selected based on an ability to reduce an endogenous analyte (the additional interference layer restricts or eliminates the passage therethrough of one or more interfering species to prevent or reduce the equivalent analyte signal of the interferent, Petisce, para. [0064], [0070]).
The limitation “selected based on an ability to reduce an endogenous analyte” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The additional interference layer of the sensor assembly disclosed by Modified Petisce teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as mapped in the rejection supra.
Regarding claim 13, Modified Petisce teaches wherein the interference reduction material is selected based on ability to reduce another analyte generated by a reaction between an endogenous analyte and the first reactive chemistry or the second reactive chemistry (the additional interference layer restricts or eliminates the passage therethrough of one or more interfering species to prevent or reduce the equivalent analyte signal of the interferent, Petisce, para. [0064], [0070]).
The limitation “selected based on ability to reduce another analyte generated by a reaction between an endogenous analyte and the first reactive chemistry or the second reactive chemistry” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The additional interference layer of the sensor assembly disclosed by Modified Petisce teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as mapped in the rejection supra.
Regarding claim 21, Modified Petisce teaches wherein the first reactive chemistry includes 3-hydroxybutyrate dehydrogenase (the enzyme layer 23 includes NAD-dependent hydroxybutyrate dehydrogenase and a NAD+ cofactor, Petisce, Figs. 2-3, para. [0098], Zhang, para. [0100], [0104], see modification supra).
Regarding claim 22, Modified Petisce teaches wherein the working conductor is substantially centered between the first and second lateral edges (the working electrode 19 is substantially centered between the first and second lateral edges, Petisce, Figs. 2-3).
Regarding claim 24, Modified Petisce teaches the separation chemistry (the flux limiting membrane 25, Petisce, Fig. 3, para. [0099]), but fails to teach wherein the separation chemistry extends to the first and second lateral edges.
However, the Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Furthermore, generally, differences in shape will not support the patentability of subject matter encompassed by the prior art absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(IV)(B).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size and shape of the flux limiting membrane of Modified Petisce to extend to the first and second lateral edges in order to yield the predictable result of selectively allowing diffusion from blood to the components of the sensing assembly (Petisce, para. [0099]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Petisce in view of Zhang as applied to claim 21 above, and further in view of Cozzette et al. (US 2002/0090738 A1).
Regarding claim 23, Modified Petisce teaches the second reactive chemistry (the interference layer 50, Petisce, Figs. 2-3, para. [0098]) and the first reactive chemistry (the enzyme layer 23 includes NAD-dependent hydroxybutyrate dehydrogenase and a NAD+ cofactor, Petisce, Figs. 2-3, para. [0098], Zhang, para. [0100], [0104], see modification supra). Modified Petisce fails to teach wherein the second reactive chemistry includes NADH oxidase.
Cozzette teaches an electronic device for the analyses of biologically significant analyte species (Cozzette, abstract). Cozzette teaches a biosensor comprising a biolayer 7 including enzymes such as NADH oxidase with an organic cofactor in order to detect the analyte (Cozzette, Fig. 8A, para. [0072], [0145], [0150]-[0151], [0171], claim 35).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the interference layer 50 of Modified Petisce to further include NADH oxidase in order to yield the predictable result of reacting with the NADH produced by the reaction catalyzed by the NAD-dependent hydroxybutyrate dehydrogenase and a NAD+ cofactor in the enzyme layer 23.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794