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 .
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 12 - 25 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.
In regard to claims 12 - 19, claims 12 - 19 are directed towards a method, but only claim limitations directed towards the makeup of the sensor and not further method steps making the metes and bounds of the claim unclear. While claim 10 includes the limitation “”exposing the analyte sensor of claim 1 to interstitial fluid,” the actual structure of the “sensor of claim 1” is not clearly included in such a way that incorporates the limitations of claims 12 - 19, which include structural details of the analyte sensor, into the method. Examiner suggests amending line 3, claim 10, from which claims 12 - 19 depends, from “exposing the analyte sensor of claim 1 to interstitial fluid” to --providing and exposing the analyte sensor of claim 1 to interstitial fluid-- in order to establish the structure of the analyte sensor within the method claim.
In regard to claim 20, step b) recites “communicating… signals… to a processor” and steps c) and d) recite, “correlating the… signals to corresponding first and second lactate concentrations” and “determining hybrid variance between the first and second lactate concentrations”. However, it is unclear if the processor is performing the “correlating” and “determining” steps in addition to receiving the first and second signals in step b). Further details are required to define the metes and bounds of the claim. Claims 21 - 25 are rejected by virtue of dependence on claim 20.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 - 10 & 12 - 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US 20210219885 A1).
In regard to claim 1, Wang discloses an electrochemical analyte sensor (FIG. 1, component 100) for detecting lactate (paragraph [0045]) in vivo where the sensor comprises a proximal portion configured to be positioned above a user’s skin and a distal portion configured to be transcutaneously positioned through a user’s skin (paragraph [0052], sensor (FIG. 1, component 104) is adapted to be partially inserted into a tissue of interest) such that it is in contact with a user’s interstitial fluid to detect lactate (paragraph [0121]). The distal portion further comprises a substrate (FIG. 5C, component 212) with a first and second working electrode (FIG. 5C, component 214a & 214b) located on the substrate where each working electrode includes a lactate-responsive sensing area disposed on the surface of the working electrodes (FIG. 5C, 218a & 218b). Examiner notes that Wang specifies that the analyte sensors include multiple active areas that detect analytes of the same type upon two or more working electrodes (paragraph [0073]) and that the analyte-specific responsive active areas are lactate-responsive (paragraph [0062]). Wang further discloses that the distal portion of the sensor includes a membrane (FIG. 5C, component 220) that covers both the first and second lactate-responsive sensing areas (FIG. 5C, 218a & 218b), where the membrane comprises a polymeric material with permeability for the analyte being measured, such as lactate (paragraph [0069]). Wang discloses that the first and second lactate-responsive sensing areas are configured to independently produce a first and second signal indicative of an analyte concentration measured at the first and second working electrodes (paragraph [0107]).
In regard to claims 2 - 7, Wang discloses the invention of claim 1. Wang further discloses that the first and second lactate-responsive sensing areas comprise lactate oxidase (paragraph [0119]). The first and second lactate-responsive sensing areas comprise a polymer, such as polyvinylpyridine, and an electron-transfer agent that is covalently bonded to the polymer in the lactate-responsive sensing areas (paragraphs [0106] - [0107]).
In regard to claim 8, Wang discloses the invention of claim 1. Wang further discloses that the distal portion includes a reference electrode (FIG. 5C, component 216) and a counter electrode (FIG. 5C, component 217).
In regard to claim 9, Wang discloses the invention of claim 1. Wang further discloses that the membrane (FIG. 5C, component 220) comprises polyvinylpyridine (paragraph [0077]).
In regard to claim 10, Wang discloses the invention of claim 1. Wang further discloses a method for monitoring lactate levels in vivo in an individual comprising exposing the analyte sensor of claim 1 to interstitial fluid (paragraphs [0121] and [0135]), applying a potential to the first and second working electrode and obtaining a first and second signal at or above an oxidation-reduction potential of the first and second lactate-responsive sensing areas where the first and second signals are proportional to the concentration of an analyte, in this case lactate, in the interstitial fluid (paragraph [0135]), and further correlating the first and second signals to first and second lactate concentrations in the interstitial fluid (paragraph [0146]).
In regard to claims 12 - 17, Wang discloses the invention of claim 10. Wang further discloses that the first and second lactate-responsive sensing areas comprise lactate oxidase (paragraph [0119]). The first and second lactate-responsive sensing areas comprise a polymer, such as polyvinylpyridine, and an electron-transfer agent that is covalently bonded to the polymer in the lactate-responsive sensing areas (paragraphs [0106] - [0107]).
In regard to claim 18, Wang discloses the invention of claim 10. Wang further discloses that the distal portion includes a reference electrode (FIG. 5C, component 216) and a counter electrode (FIG. 5C, component 217).
In regard to claim 19, Wang discloses the invention of claim 10. Wang further discloses that the membrane (FIG. 5C, component 220) comprises polyvinylpyridine (paragraph [0077]).
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.
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 11 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20210219885 A1) as applied to claims 1 & 10 above, and further in view of Ou (US 20220008017 A1).
In regard to claim 11, Wang discloses the invention of claim 10. While Wang discusses the use of multiple working electrodes for detecting analytes of the same type (paragraph [0073]) and determining a concentration of an analyte by correlating the first and second signals measured by a first and second working electrode (FIG. 5C, 218a & 218b) to first and second analyte concentrations in the interstitial fluid (paragraph [0146]) where the results of the sensed analyte information can be displayed to a user in a variety of forms (paragraph [0082]), they do not discuss comparing the two measurement results prior to displaying the results to a user or determining a variance between the first and second lactate concentrations.
However, Ou teaches an analyte device that includes multiple working electrodes for detecting an analyte that includes comparing two calculated quantities representing the analyte value or concentrations based on the determined variance of the values to determine which result is more reliable and should be presented (paragraph [0215] - [0216]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Wang with the teaching of Ou that includes comparing two analyte concentrations by determining the variance between the two values because Wang discusses determining a concentration of an analyte by correlating the first and second signals measured by a first and second working electrode such that modifying Wang with the teaching of Ou that includes determining which sensor result is more reliable and should be presented would be considered combining prior art elements according to known methods to yield the predictable result of determining a concentration of an analyte and displaying the result to a user.
In regard to claim 20, Wang discloses a method comprising continuously measuring signals (paragraph [0048]) indicative of lactate concentrations in a biological fluid (paragraphs [0121] and [0135]) with a sensing system (FIG. 1, component 100) comprising the sensor of claim 1 (FIG. 5C), communicating first and second signals indicative of a lactate concentrations measured at the first and second working electrodes to a processor that is communicatively coupled to the sensor (FIG. 1, component 104; paragraph [0051]) and correlating the first and second signals to first and second lactate concentrations in the interstitial fluid (paragraph [0146]). While Wang discusses the use of multiple working electrodes for detecting analytes of the same type (paragraph [0073]) and determining a concentration of an analyte by correlating the first and second signals measured by a first and second working electrode (FIG. 5C, 218a & 218b) to first and second analyte concentrations in the interstitial fluid (paragraph [0146]) where the results of the sensed analyte information can be displayed to a user in a variety of forms (paragraph [0082]), they do not discuss comparing the two measurement results prior to displaying the results to a user or determining hybrid variance between the first and second lactate concentrations.
However, Ou teaches an analyte device that includes multiple working electrodes for detecting an analyte that includes comparing two calculated quantities representing the analyte value or concentrations based on statistical properties of each measurement channel or electrode, including the determined variance and standard deviation of the values to determine which result is more reliable and should be presented (paragraph [0215] - [0216]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Wang with the teaching of Ou that includes comparing two analyte concentrations by determining the variance between the two values because Wang discusses determining a concentration of an analyte by correlating the first and second signals measured by a first and second working electrode such that modifying Wang with the teaching of Ou that includes determining which sensor result is more reliable and should be presented would be considered combining prior art elements according to known methods to yield the predictable result of determining a concentration of an analyte and displaying the result to a user.
Allowable Subject Matter
The following is an examiner’s statement of reasons for the indication of allowable subject matter.
In regard to claims 21 - 25, while Wang discloses a method for continuously sensing lactate concentrations in a biological fluid using multiple working electrodes as discussed above and Ou further teaches that measurements can be assessed based on statistical parameters including variance and standard deviation, neither Wang nor Ou disclose or suggest the method steps of calculating the standard deviation of the first and second lactate concentrations and multiplying the standard deviation by 40 to obtain hybrid variance or calculating covariance of the first and second lactate concentrations and multiplying covariance by 100 to obtain hybrid variance. Additionally, neither Wang nor Ou discuss using the mean concentration value of 2.5 mM lactate to determine how hybrid variance should be calculated. The method steps of claim 21 are additionally not disclosed or suggested by the art on record cited in the Applicant’s IDS.
Claims 21 - 25 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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