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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 7/30/26, amended claim(s) 1, 4, 6, 10, 26, 28, 30, 33, and 36, and canceled claim(s) 2, 32, and 34-35 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
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, 6, 10, 13-26, 30, 33, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2009/0294307 to Liu et al. (hereinafter “Liu”) in view of U.S. Patent Application Publication No. 2020/0319134 to Xu et al. (hereinafter “Xu”) and U.S. Patent Application Publication No. 2022/0202326 to LaTour et al. (hereinafter “LaTour”).
For claim 1, Liu discloses a creatinine sensor (Abstract) (para [0054]) comprising:
a first portion (see portion where reference numeral “500” is pointing in Fig. 5B) configured to (Examiner’s Note: functional language/intended use, i.e., capable of) be positioned above a user's skin (as can be seen in Fig. 5B) and a second portion (530) (Fig. 5B) configured to (Examiner’s Note: functional language/intended use, i.e., capable of) be positioned below the user's skin and in contact with the user's biological fluid to monitor the level of creatinine in vivo (as can be seen in Fig. 5B), the second portion comprising:
a first working electrode (501) (Fig. 5B) (para [0073]),
a creatinine sensing layer disposed on at least a portion of the first working electrode (para [0081]), the creatinine sensing layer comprising a redox mediator (para [0084]-[0086]);
a second working electrode (“more than one working electrode,” para [0083]),
a background sensing layer disposed on at least a portion of the second working electrode (one or more of the working electrodes … may have a sensing layer,” para [0083]), wherein the background sensing layer comprises the redox mediator (para [0083]), and wherein the background sensing layer does not comprise creatinine amidohydrolase and does not detect creatinine (see full document of Liu, which does not disclose creatinine amidohydrolase and does not detect creatinine) (also see para [0083], which teaches “a sensing layer which does not contain one or more components (e.g., an electron transfer agent and/or catalyst) needed to electrolyze the analyte”),
an Ag/AgCl reference electrode (“Ag/AgCl reference electrode” (para [0134]-[0135]),
wherein the first working electrode is configured to generate a first signal (“analyte signal,” para [0083]) at a potential of -5 mV to -100 mV relative to the Ag/AgCl reference electrode, the first signal being indicative of creatinine concentration and background interference (“analyte signal,” para [0083]) (also see para [0050] and [0054]),
wherein the second working electrode is configured to generate a second signal (“background signal,” para [0083]) at the potential, the second signal indicative of background interference (“background signal,” para [0083]),
wherein a difference obtained by subtracting the second signal from the first signal is indicative of the creatinine concentration (para [0083]).
Liu does not expressly disclose that the creatinine sensing layer comprises creatinine amidohydrolase, creatine amidinohydrolase, and sarcosine oxidase, the background sensing layer comprises creatine amidinohydrolase, and sarcosine oxidase; and a first mass transport limiting membrane permeable to creatinine, the membrane disposed over the creatinine sensing layer and the background sensing layer.
However, Xu teaches that creatine sensors made of platinum electrodes may include creatinine amidohydrolase (“creatininase,” para [0042]), creatine amidinohydrolase (“creatinase,” para [0042]), and sarcosine oxidase (“sarcosine oxidase,” para [0042]), and a first mass transport limiting membrane permeable to creatinine (Examiner’s Note: para [0142] of Applicant’s specification as originally filed identifying this membrane as a “first hydrophilic polyurethane membrane”) (para [0042]), the membrane disposed over the entire creatine sensor electrode (para [0042]).
It would have been obvious to a skilled artisan to modify Liu such that the creatinine sensing layer comprises creatinine amidohydrolase, creatine amidinohydrolase, and sarcosine oxidase, the background sensing layer comprises creatine amidinohydrolase, and sarcosine oxidase; and a first mass transport limiting membrane permeable to creatinine, the membrane disposed over the creatinine sensing layer and the background sensing layer, in view of the teachings of Xu, because such a composition is a suitable composition to detect creatinine, while also providing a protective outer layer for the sensor while the sensor is sensing underneath the skin. In making this modification, it is noted that Xu teaches the entire sensor comprises creatine amidinohydrolase and sarcosine oxidase. Therefore, it would logically flow that Liu’s entire sensor, which would include both the creatinine sensing layer and the background sensing layer, comprises creatine amidinohydrolase and sarcosine oxidase. However, a skilled artisan, reading Liu and Xu in their entirety, would not carry the creatinine amidohydrolase from Xu over to Liu because that would contradict the explicit teaching in Liu of “a sensing layer which does not contain one or more components (e.g., an electron transfer agent and/or catalyst) needed to electrolyze the analyte.” The creatinine amidohydrolase would be the electron transfer agent and/or catalyst to electrolyze the analyte being analyzed in Liu. This is consistent with court precedence that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference (i.e., not bodily incorporating everything from Xu because Liu expressly teaches not including the electron transfer agent and/or catalyst). Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reference would have suggested leaving the creatinine amidohydrolase out of the background sensing layer in Liu so that the second working electrode in Liu may perform its intended function of generating a background signal (see para [0083] of Liu).
Liu and Xu do not expressly disclose that the first signal is at a potential of -5 mV to -100 mV relative to the Ag/AgCl reference electrode and the second signal is at the potential.
However, LaTour teaches an analyte sensor that is responsive to an analyte “below about” -80 mv relative to an Ag/AgCl reference (para [0018] and [0023]).
Therefore, it would have been obvious to a skilled artisan to modify Liu that the first signal is at a potential of -5 mV to -100 mV relative to the Ag/AgCl reference electrode and the second signal is at the potential, in view of the teachings of LaTour, because such a modification is the simple substitution of one mv value for another mv value that would lead to the predictable result of being able to measure changes in analyte concentration, which is what Liu wants to do.
For claim 6, Liu, as modified, further discloses wherein the first hydrophilic polyurethane is capable of absorbing 5% to 25% by weight water (para [0043] and/or [0044] of Xu).
For claim 10, Liu further discloses wherein the sensor further comprises a counter electrode (503).
For claim 13, Liu further discloses wherein the redox mediator is to an electrode (para [0081] and [0084]-[0086]).
Xu teaches wherein the creatinine amidohydrolase, creatine amidinohydrolase, and sarcosine oxidase, or any combination thereof is attached to an electrode (para [0042]).
It would have been obvious to a skilled artisan to modify Liu wherein the creatinine amidohydrolase, creatine amidinohydrolase, sarcosine oxidase, or any combination thereof is attached to the redox mediator, in view of the teachings of Xu, since they are both attached to the electrode and therefore attaching them to each other would also attach them to the electrode.
For claim 14, Liu further discloses wherein the redox mediator comprises a polymer and an electron transfer agent (para [0084]-[0086]).
For claim 15, Liu further discloses wherein the polymer comprises a backbone comprising poly(4-vinylpyridine), poly(1-vinylimidazole), poly(styrene), poly(thiophene), poly(aniline), poly(pyrrole), poly(acetylene), or any combination thereof (para [0086]).
For claim 16, Liu further discloses wherein the polymer comprises a polymer or copolymer repeat unit comprising at least one pendant pyridinyl group, at least one pendant imidazolyl group, or both at least one pendant pyridinyl and at least one pendant imidazolyl group (para [0029]-[0032]).
For claim 17, Liu further discloses wherein the electron transfer agent comprises a transition metal complex (para [0087]).
For claim 18, Liu further discloses wherein the transition metal complex comprises osmium, ruthenium, iron, cobalt, or any combination thereof (para [0087]).
For claim 19, Liu further discloses wherein the transition metal complex is an osmium transition metal complex comprising one or more ligands (para [0087]), wherein at least one ligand comprises a nitrogen-containing heterocycle (para [0087]).
For claim 20, Liu further discloses wherein the redox mediator comprises an osmium complex bonded to a poly(vinylpyridine)-based polymer (para [0029]-[0032] and [0087]).
For claim 21, Liu further discloses wherein the polymer is crosslinked with a crosslinking agent (para [0041]-[0042]).
For claim 22, Liu further wherein the crosslinking agent is a polyepoxide, cyanuric chloride, N-hydroxysuccinimide, an imidoester, epichlorohydrin, or any combination thereof (para [0041]-[0042]).
For claim 23, Liu further discloses wherein the crosslinking agent is a polyethylene glycol diglycidylether (PEGDGE) (para [0132]).
For claim 24, Liu further discloses wherein the creatinine sensing layer is continuously disposed on the first working electrode (para [0047]).
For claim 25, Liu further discloses wherein the creatinine sensing layer is discontinuously disposed on the first working electrode (para [0047]).
For claim 26, Liu does not expressly disclose a second hydrophilic polyurethane membrane overcoating at least the background sensing layer.
However, Xu teaches a hydrophilic polyurethane membrane overcoating at least a sensing layer (para [0042]).
It would have been obvious to a skilled artisan to modify Liu to include a second hydrophilic polyurethane membrane overcoating at least the background sensing layer, in view of the teachings of Xu, for the obvious advantage of providing a protective outer layer for the sensor while the sensor is sensing underneath the skin.
For claim 30, Liu, as modified, further discloses wherein the second hydrophilic polyurethane is capable of absorbing 5% to 25% by weight water (para [0043] and/or [0044] of Xu).
For claim 33, Liu, as modified, further discloses a method for sensing creatinine (para [0054]) comprising: exposing the creatinine sensor of claim 1 (see rejection of claim 1) to a fluid comprising creatinine (para [0051] and [0053]); applying the potential to the first working electrode and second working electrode (para [0091]) (also see para [0026] and [0136]) (moreover, see para [0083]);obtaining the first signal from the first working electrode (para [0050]) (also see para [0054]); first signal obtaining the second signal from the second working electrode (para [0083]); and determining the concentration of creatinine in the fluid by subtracting the second signal from the first signal (para [0083]).
For claim 36, Liu does not expressly disclose wherein the potential applied is -80 mV relative to the Ag/AgCl reference electrode.
However, LaTour teaches an analyte sensor that is responsive to an analyte “below about” -80 mv relative to an Ag/AgCl reference (para [0018] and [0023]).
Therefore, it would have been obvious to a skilled artisan to modify Liu wherein the potential applied is -80 mV relative to the Ag/AgCl reference electrode, in view of the teachings of LaTour, because such a modification is the simple substitution of one mv value for another mv value that would lead to the predictable result of being able to measure changes in analyte concentration, which is what Liu wants to do.
Claim(s) 3 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Xu and LaTour, and further in view of U.S. Patent Application Publication No. 2023/0277101 to Sliozberg et al. (hereinafter “Sliozberg”).
For claim 3, Liu, Xu, and LaTour do not expressly disclose wherein the first hydrophilic polyurethane membrane is a thermoplastic polyurethane elastomer.
However, Sliozberg teaches wherein a hydrophilic polyurethane membrane is a thermoplastic polyurethane elastomer (para [0161] and [0164]).
It would have been obvious to a skilled artisan to modify Liu wherein the first hydrophilic polyurethane membrane is a thermoplastic polyurethane elastomer, in view of the teachings of Sliozberg, because a thermoplastic polyurethane elastomer is a suitable type of polyurethane that would lead to the predictable result of being a coating.
For claim 27, Liu, Xu, and LaTour do not expressly disclose wherein the second hydrophilic polyurethane membrane is a thermoplastic polyurethane elastomer.
However, Sliozberg teaches wherein a hydrophilic polyurethane membrane is a thermoplastic polyurethane elastomer (para [0161] and [0164]).
It would have been obvious to a skilled artisan to modify Liu wherein the second hydrophilic polyurethane membrane is a thermoplastic polyurethane elastomer, in view of the teachings of Sliozberg, because a thermoplastic polyurethane elastomer is a suitable type of polyurethane that would lead to the predictable result of being a coating.
Claim(s) 4 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Xu and LaTour, and further in view of U.S. Patent Application Publication No. 2013/0245412 to Rong et al. (hereinafter “Rong”).
For claim 4, Liu, Xu, and LaTour do not expressly disclose wherein the first hydrophilic polyurethane has a Shore A hardness of 60A to 93A.
However, Rong teaches wherein the polyurethane has a Shore A hardness of 60A to 93A (para [0279]).
It would have been obvious to a skilled artisan to modify Liu wherein the first hydrophilic polyurethane has a Shore A hardness of 60A to 93A, in view of the teachings of Ring, because such a shore hardness is a suitable property for the hydrophilic polyurethane to be able to perform the predictable result of being a coating.
For claim 28, Liu, Xu, and LaTour do not expressly disclose wherein the second hydrophilic polyurethane has a Shore A hardness of 60A to 93A.
However, Rong teaches wherein the polyurethane has a Shore A hardness of 60A to 93A (para [0279]).
It would have been obvious to a skilled artisan to modify Liu wherein the second hydrophilic polyurethane has a Shore A hardness of 60A to 93A, in view of the teachings of Ring, because such a shore hardness is a suitable property for the hydrophilic polyurethane to be able to perform the predictable result of being a coating.
Claim(s) 7 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Xu and LaTour, and further in view of U.S. Patent Application Publication No. 2014/0275896 to Hughes et al. (hereinafter “Hughes”).
For claim 7, Liu, Xu, and LaTour do not expressly disclose wherein the first hydrophilic polyurethane membrane is not crosslinked.
However, Hughes teaches wherein the polyurethane membrane is not crosslinked (para [0140]).
It would have been obvious to a skilled artisan to modify Liu wherein the first hydrophilic polyurethane membrane is not crosslinked, in view of the teachings of Hughes, for the obvious advantage of maintaining the flexibility or flow of the polyurethane.
For claim 31, Liu, Xu, and LaTour do not expressly disclose wherein the second hydrophilic polyurethane membrane is not crosslinked.
However, Hughes teaches wherein the polyurethane membrane is not crosslinked (para [0140]).
It would have been obvious to a skilled artisan to modify Liu wherein the second hydrophilic polyurethane membrane is not crosslinked, in view of the teachings of Hughes, for the obvious advantage of maintaining the flexibility or flow of the polyurethane.
Response to Arguments
Applicant’s arguments filed 7/30/26 have been fully considered.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 103 rejections, Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 7/30/26.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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