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 .
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on June 9, 2026. Claims 1-2 and 5-6 are pending in the application and are being examined herein.
Status of Objections and Rejections
The rejections of claims 29-31 are obviated by Applicant’s cancellation.
All other rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New objections to the claims are necessitated by the amendments.
New grounds of rejection under 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 Objections
Claim 1 is objected to because of the following informalities:
In line 5, “counter electrode” should read “the counter electrode”.
In line 6, “is configured” should read “being configured”.
In line 6, “is sized” should read “and sized”.
In line 15, “creatinine” should read “the creatinine”.
In line 16, “sarcosine dehydrogenase” should read “the sarcosine dehydrogenase”.
In line 23, “creatinine” should read “the creatinine”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 2 and 5-6 are 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 2 recites the limitation “the reagent coating includes a surfactant, a binder, stabilizers, and a buffer” in lines 1-2 of the claim. Claim 2 depends from claim 1 which requires “the reagent coating comprising a surfactant, a binder, a stabilizer, a buffer” in lines 9-10 of claim 1. It is unclear whether “a surfactant, a binder, stabilizers, and a buffer” in claim 2 is the same as or different from the previously recited “a surfactant, a binder, a stabilizer, a buffer” of claim 1. For the purpose of examination, Examiner interprets them to be the same.
Claim 5 recites the limitation “the reagent coating includes a surfactant and a buffer” in lines 1-2 of the claim. Claim 5 depends from claim 1 which requires “the reagent coating comprising a surfactant, a binder, a stabilizer, a buffer” in lines 9-10 of claim 1. It is unclear whether “a surfactant and a buffer” in claim 5 is the same as or different from the previously recited “a surfactant” and “a buffer” of claim 1. For the purpose of examination, Examiner interprets them to be the same. Claim 6 is rejected as dependent thereon.
Claim 6 recites the limitation “the buffer includes a binder and a stabilizer” in lines 1-2 of the claim. Claim 6 ultimately depends from claim 1 which requires “the reagent coating comprising a surfactant, a binder, a stabilizer, a buffer” in lines 9-10 of claim 1. It is unclear whether “the buffer includes a binder and a stabilizer” in claim 6 is the same as or different from the previously recited “a binder, a stabilizer, a buffer” of claim 1. For the purpose of examination, Examiner interprets them to be the same.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-2 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Siedel et al. (US 4,816,393 A) in view of Cai et al. (US 2004/0217019 A1) in view of Monbouquette et al. (US 6,241,863 B1), as evidenced by Monbouquette with respect to claim 1.
Regarding claim 1, Siedel teaches a system for the electrochemical detection of creatinine levels in blood (test strips for the quantitative or qualitative determination of creatinine, Siedel, col. 8, lns. 10-14), the system comprising:
a test strip (the test strips have thereon a porous carrier material impregnated with a reagent for the determination of creatinine, the reagent containing creatinine deiminase, 1-methylhydantoinase, N-carbamoylsarcosine amidohydrolase, sarcosine dehydrogenase, and a buffer substance, Siedel, col. 7, lns. 48-55, col. 8, lns. 10-14).
Seidel fails to teach that the test strip comprises a sample receiving port defining a sample reception area, a working electrode, and a counter electrode, the working electrode and counter electrode located proximate to the sample reception area, the sample reception area is configured to wick blood into the test strip and is sized to receive approximately 1.2 microliters of blood.
Cai teaches a creatinine electrochemical sensor that requires less sample volume for measuring (Cai, para. [0020]). Cai teaches a sensor strip 10 comprising a fluid sampling end 110 including a sampling end aperture 114, a sample fluid channel 112, working electrodes W1/W2, and reference electrode R positioned proximate to the sample fluid channel 112 (Cai, Figs. 1-2, para. [0068], [0071], [0080], [0082], [0107]). Cai teaches that the blood sample fluid fills the sample fluid channel 112 by capillary action (Cai, Figs. 1-2, para. [0046], [0070], [0081], [0114], [0127]). Cai teaches that the volume of the fluid sample channel 112 is calculated to be 1.54 microliters (Cai, Figs. 1-2, para. [0107]). Cai teaches that the working electrodes W1/W2 and reference electrode R hold chemical reagents for measuring creatinine (Cai, Figs. 1-2, para. [0071], [0079], [0101]). With respect to the reference electrode being a counter electrode, the term “counter” does not further define the actual structure of the electrode. Moreover, one of ordinary skill in the art would be well aware that in a two-electrode electrochemical sensor (like each working electrode and reference electrode pair of Cai), the second electrode of that two-electrode electrochemical sensor can be referred to as either a counter or reference electrode because it is providing both functions for the two-electrode sensor.
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 test strip of Siedel to comprise a fluid sampling end including a sampling end aperture, a sample fluid channel, working electrodes, and reference/counter electrode positioned proximate to the sample fluid channel which has a volume of 1.54 microliters and is filled with the blood sample by capillary action as taught by Cai in order to yield the predictable result of measuring creatinine using the test strip comprising the working electrode coated with the reagent. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A). It has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP § 2144.05(I). In the instant case, the sample fluid channel disclosed by Modified Siedel serves the purpose of filling and holding the sample fluid for measuring. Thus, it is obvious to have a sample fluid channel that has a volume of approximately 1.2 microliters because such volume, although not explicitly disclosed by Modified Siedel, would serve the same purpose and provide the same properties as the volume of 1.54 microliters that is disclosed by Modified Siedel.
Modified Siedel teaches reagent coating disposed on the working electrode (the reagent for the determination of creatinine is disposed on the working electrode of the test strip, Siedel, col. 7, lns. 48-55, col. 8, lns. 10-14, Cai, Figs. 1-2, para. [0071], [0079], [0101], see modification supra), the reagent coating comprising a buffer, creatinine deiminase, 1-methylhydantoinase (NMHase) enzyme, N-carbamoylsarcosine amidohydrolase (CSHase) enzyme, sarcosine dehydrogenase (the reagent containing creatinine deiminase, 1-methylhydantoinase, N-carbamoylsarcosine amidohydrolase, sarcosine dehydrogenase, and a buffer substance, Siedel, col. 7, lns. 48-55, col. 8, lns. 10-14), wherein the reagent coating is configured to convert creatinine in the blood to sarcosine and to generate an electrochemical response using sarcosine dehydrogenase without requiring oxygen (the reagent converts the creatinine into sarcosine, which is detected with sarcosine dehydrogenase, Siedel, col. 6, lns. 5-17). As evidenced by Monbouquette, the utilization of sarcosine dehydrogenase eliminates the requirement for oxygen (Monbouquette, col. 12, lns. 10-12)
Modified Siedel is silent with respect to a surfactant, a binder, a stabilizer, and potassium ferricyanide in the reagent coating. However, Siedel teaches that the detection of sarcosine with sarcosine dehydrogenase is known and the conditions known to the expert for this purpose can be used according to the present invention (Siedel, col. 7, lns. 6-9).
Monbouquette teaches an amperometric biosensor for the quantification of biological substrates such as creatinine and sarcosine using sarcosine dehydrogenase (Monbouquette, abstract). Monbouquette teaches that the sarcosine dehydrogenase is deposited on an electrode as the sensing enzyme, and a mediator such as potassium ferricyanate is also utilized with the enzyme (Monbouquette, col. 4, lns. 13-31, Examiner interprets potassium ferricyanate to be potassium ferricyanide). Monbouquette teaches that the utilization of sarcosine dehydrogenase eliminates the requirement for oxygen because this enzyme can be reoxidized by the potassium ferricyanate mediator to amperometrically detect sarcosine and creatinine (Monbouquette, col. 12, lns. 10-20). Monbouquette teaches that the biosensor electrode is further modified with a surfactant, a binder to facilitate electrostatic binding of the enzymes, and a stabilizer to stabilize the enzyme (Monbouquette, col. 3, lns. 58-63, col. 4, lns. 36-38, col. 9, lns. 42-44, claim 3).
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 reagent coating of Modified Siedel to further include a surfactant, a binder, a stabilizer, and potassium ferricyanide as taught by Monbouquette in order to yield the predictable result of a reagent coating on the working electrode that detects sarcosine and creatinine using sarcosine dehydrogenase and the known conditions (surfactant, a binder, a stabilizer, and potassium ferricyanide) for the reaction. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Modified Siedel teaches the test strip for the determination of creatinine using the reagent coating which converts the creatinine into sarcosine, which is detected with sarcosine dehydrogenase (Siedel, col. 6, lns. 5-17, col. 8, lns. 10-14). Modified Siedel fails to teach an analyzer configured to receive the test strip and determine an amount of creatinine based on the electrochemical response.
Cai teaches a creatinine electrochemical sensor that requires less sample volume for measuring (Cai, para. [0020]). Cai teaches a sensor strip 10 comprising working electrodes W1/W2 and reference electrode R positioned proximate to the sample fluid channel 112 (Cai, Figs. 1-2, para. [0068], [0071], [0080], [0082], [0107]). Cai teaches that the working electrodes W1/W2 and reference electrode R hold chemical reagents for measuring creatinine (Cai, Figs. 1-2, para. [0071], [0079], [0101]). Cai teaches that an end of the sensor strip 10 makes an electrical connection to a reading device such as an electrochemical analyzer for measurement of the current response of the sensor strip 10 to determine the concentration of creatinine (Cai, Figs. 1-2, para. [0021], [0079], [0087], [0110]-[0111], [0114], claim 1).
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 test strip of Modified Siedel to be received by an electrochemical analyzer as taught by Cai in order to yield the predictable result of measuring the current response of the electrodes having the reagent coating on the test strip and determining the concentration of creatinine. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
The limitations “for the electrochemical detection of creatinine levels in blood,” “wick blood into the test strip,” “receive approximately 1.2 microliters of blood,” “to convert creatinine in the blood to sarcosine and to generate an electrochemical response using sarcosine dehydrogenase and potassium ferricyanide without requiring oxygen,” and “determine an amount of creatinine based on the electrochemical response” 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 test strip and electrochemical analyzer disclosed by Modified Siedel teach all of the structural limitations of the claim and thus are configured for and capable of the intended use and/or functional language as recited in the rejection supra.
Furthermore, the limitations "blood" and "creatinine in the blood" are with respect to an article worked upon (blood and creatinine) and not a positively recited element of the system. Inclusion of the material or article worked upon (blood and creatinine) by a structure (the system) being claimed does not impart patentability to the claims. The claims are directed to an apparatus (the system) which works upon an article or material (blood and creatinine) in its intended use. MPEP § 2115.
Regarding claims 2 and 5-6, Modified Siedel teaches wherein the reagent coating includes a surfactant, a binder, stabilizers, and a buffer, of instant claim 2, wherein the reagent coating includes a surfactant and a buffer, of instant claim 5, and wherein the buffer includes a binder and a stabilizer, of instant claim 6 (the reagent includes a surfactant, a binder to facilitate electrostatic binding of the enzymes, a stabilizer to stabilize the enzyme, and a buffer substance, Siedel, col. 7, lns. 48-55, Monbouquette, col. 3, lns. 58-63, col. 4, lns. 36-38, col. 9, lns. 42-44, claim 3, see modification supra).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot in light of new grounds of rejection. Prior art Siedel modified in view of Cai and Monbouquette are now relied on for the features of claim 1 as recited supra.
Applicant's arguments filed June 9, 2026 have been fully considered but they are not persuasive.
In the arguments presented on page 5 of the amendment, Applicant argues that Siedel's multi-component reaction system would not operate as the claimed dried reagent coating in a small-volume blood-wicking test strip using potassium ferricyanide to generate the electrochemical response.
Examiner respectfully disagrees. Siedel teaches that the test strip has thereon a porous carrier material impregnated with a reagent for the determination of creatinine, the reagent containing creatinine deiminase, 1-methylhydantoinase, N-carbamoylsarcosine amidohydrolase, sarcosine dehydrogenase, and a buffer substance (Siedel, col. 7, lns. 48-55, col. 8, lns. 10-14). Thus, the reagent of Siedel is capable of being coated on a test strip, and as modified in view of Cai and Monbouquette as recited supra, the test strip is a small-volume blood-wicking test strip using potassium ferricyanide to generate the electrochemical response.
In the arguments presented on page 5 of the amendment, Applicant argues that Monbouquette also does not provide a reasonable expectation of success for potassium ferricyanide in the modified creatinine system. Applicant asserts that although Monbouquette broadly lists potassium ferricyanate among potential synthetic mediators for sarcosine dehydrogenase, Monbouquette later reports that only phenazine methosulfate and 2,6- dichlorophenol indophenol served as effective mediators for the creatine and creatinine systems.
Examiner respectfully disagrees. Monbouquette explicitly teaches that potassium ferricyanate (potassium ferricyanide) can be used as a mediator for a three-enzyme system including sarcosine dehydrogenase for detection of sarcosine, creatine, and/or creatinine (Monbouquette, Fig. 7, col. 4, lns. 13-31, col. 11, lns. 55-67, col. 12, lns. 1-21), and that sarcosine dehydrogenase can be reoxidized by potassium ferricyanate thus eliminating the requirement for oxygen (col. 12, lns. 10-15). Therefore, Monbouquette does not teach away from using potassium ferricyanide as a mediator in a creatinine assay.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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