DETAILED CORRESPONDENCE
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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 7/2/26 is acknowledged. Claims 11-16, 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/27/23 and 6/5/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-16, 19-21 are pending with claims 1-10 being examined and claims 11-16, 19-21 deemed withdrawn.
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 3, 6-9 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 pre-AIA the applicant regards as the invention.
Regarding claim 3, it is unclear how the base can be formed of glass microfibers. The claims are directed to a paper-based sensor. If the base is defined by glass microfibers, then it is unclear how the sensor is paper-based, and it is also unclear how the glass microfibers would be configured in relation to any paper.
As to claims 6-9, it is unclear what “the biomarker” is referring to because the claims recite “the biomarker” where a singular specific biomarker has not been previously recited. Claim 1 recites a plurality of biomarkers; however, no singular biomarker is recited. Therefore, there is insufficient antecedent basis. Perhaps applicants intend to refer to at least one of the plurality of biomarkers.
Appropriate correction and/or clarification is required.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Suresh et al (WO2019045647; hereinafter “Suresh”; already of record).
As to claim 1, Suresh teaches a paper-based sensor for simultaneously determining a plurality of biomarkers present in a biological sample, said paper-based sensor comprising: a) a sample zone for receiving said biological sample containing said plurality of biomarkers; and b) a plurality of detection zones in fluid communication with said sample zone, each of said plurality of detection zones comprising sensing material specific to each of said plurality of biomarkers, wherein said plurality of biomarkers are selected from the group consisting of temperature, trimethylamine (TMA), pH, moisture, and uric acid (Suresh teaches a paper based sensor with a sample zone connected to a plurality of detection zones that are surrounded by hydrophobic wax, where the sensor can detect a plurality of analyte biomarkers including uric acid and pH; Figs. 1, 6, 8, p. 2 line 25-30, p. 4 line 10-16, p. 6 line 25-30, p. 8 line 14-p. 9 line 10, p. 13 line 20-p. 14 line 5, p. 14 line 26-p. 15 line 4, p. 18 line 10-13, p. 20 line 25-p. 21 line 30, p. 22 lines 10-14, p. 24 line 8-20, p. 25 lines 6-26. The examiner notes that the biomarkers a function of what is detected in the detection zones, and that the biomarkers are not positively recited and therefore what the biomarkers are defined by is a matter of intended use/function).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Suresh teaches the paper-based sensor of claim 1 (see above), wherein each of said detection zones is connected to said sample zone via respective channels (Suresh; Figs. 1, 6, 8, claim 12).
As to claim 3, Suresh teaches the paper-based sensor of claim 1 (see above), further comprising a base selected from a cellulose base, nitrocellulose base, and glass microfibers (Suresh; p. 8 lines 14-24, Figs. 6, 8).
As to claim 4, Suresh teaches the paper-based-sensor of claim 1 (see above), wherein each of said detection zones extends radially outwards from said sample zone (Suresh; Figs. 6, 8).
As to claim 5, Suresh teaches the paper-based sensor of claim 1 (see above), further comprising a hydrophobic region surrounding said sample zone and said detection zones, wherein said hydrophobic region comprises wax (Suresh; p. 8 line 26-p 9 line 10, Figs. 6, 8).
As to claim 6, Suresh teaches the paper-based sensor of claim 1 (see above), wherein when the biomarker is temperature, the sensing material for said temperature biomarker comprises a mixture of cholesteric liquid crystals (CLCs) (“When” the biomarker is temperature does not necessarily have to occur since it is a conditional statement, thereby being functional and not further defining the apparatus structure beyond that of a capability (MPEP 2114 and 2111.04). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Thus, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. (See § MPEP 2111.04). The PTAB has determined that analysis of the claimed method as a whole requires giving the claim its broadest reasonable interpretation, where “if the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed”. Therefore, evidence of the obviousness of all contingent method steps is not required to be performed under a broadest reasonable interpretation of the claim; however, in the case of system claims, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations to render the claimed system obvious. See Ex parte Schulhauser, PTAB Appeal No. 2013-007847 (April 28, 2016) (precedential) for an analysis of contingent claim limitations in the context of both method claims and system claims. In this case, Suresh teaches the biomarkers of pH and uric acid and temperature is not required by the claims).
As to claim 7, Suresh teaches the paper-based sensor of claim 1 (see above), wherein when the biomarker is trimethylamine, and the sensing material for said trimethylamine biomarker comprises a solvatochromic dye dissolved in alcoholic solvent (“When” the biomarker is trimethylamine does not necessarily have to occur since it is a conditional statement, thereby being functional and not further defining the apparatus structure beyond that of a capability (MPEP 2114 and 2111.04). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Thus, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. (See § MPEP 2111.04). The PTAB has determined that analysis of the claimed method as a whole requires giving the claim its broadest reasonable interpretation, where “if the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed”. Therefore, evidence of the obviousness of all contingent method steps is not required to be performed under a broadest reasonable interpretation of the claim; however, in the case of system claims, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations to render the claimed system obvious. See Ex parte Schulhauser, PTAB Appeal No. 2013-007847 (April 28, 2016) (precedential) for an analysis of contingent claim limitations in the context of both method claims and system claims. In this case, Suresh teaches the biomarkers of pH and uric acid and trimethylamine is not required by the claims).
As to claim 9, Suresh teaches the paper-based sensor of claim 1 (see above), wherein when the biomarker is moisture, and the sensing material for said moisture biomarker comprises a transition metal salt dissolved in a mixture of polyhydroxyethylmethacrylate/alcoholic solution (“When” the biomarker is moisture does not necessarily have to occur since it is a conditional statement, thereby being functional and not further defining the apparatus structure beyond that of a capability (MPEP 2114 and 2111.04). Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Thus, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. (See § MPEP 2111.04). The PTAB has determined that analysis of the claimed method as a whole requires giving the claim its broadest reasonable interpretation, where “if the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed”. Therefore, evidence of the obviousness of all contingent method steps is not required to be performed under a broadest reasonable interpretation of the claim; however, in the case of system claims, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations to render the claimed system obvious. See Ex parte Schulhauser, PTAB Appeal No. 2013-007847 (April 28, 2016) (precedential) for an analysis of contingent claim limitations in the context of both method claims and system claims. In this case, Suresh teaches the biomarkers of pH and uric acid and moisture is not required by the claims).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Suresh et al (WO2019045647; hereinafter “Suresh”; already of record) in view of Rogers, J (US 20170224257; hereinafter “Rogers”).
As to claim 6, Suresh teaches the paper-based sensor of claim 1 (see above), wherein various biomarker analytes are detected (Suresh; p. 4 line 10-16, p. 14 line 12-25, p. 24 line 2-p. 25 line 25, Fig. 1, 6, 8).
Suresh does not specifically teach wherein when the biomarker is temperature, the sensing material for said temperature biomarker comprises a mixture of cholesteric liquid crystals (CLCs). However, Rogers teaches the analogous of a sensor for biomarkers wherein when the biomarker is temperature, the sensing material for said temperature biomarker comprises a mixture of cholesteric liquid crystals (CLCs) (Rogers teaches a biomarker sensor with colorimetric indicators that include a chiral nematic liquid crystal/cholesteric liquid crystal for detecting temperature change amongst a variety of markers; [11, 17, 101, 109, 151, 345]). It would have been obvious to one of ordinary skill in the art to have modified the sensor for detecting biomarker analytes of Suresh to have also detected temperature as in Rogers because Rogers teaches that sensing temperature is important for various health screening and assessments (Rogers; [108, 118, 119]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Suresh et al (WO2019045647; hereinafter “Suresh”; already of record) in view of Suslick et al (US 20170336379; hereinafter “Suslick”) in view of Steven J (US 20190049473; hereinafter “Steven”).
As to claim 7, Suresh teaches the paper-based sensor of claim 1 (see above), wherein various biomarker analytes are detected (Suresh; p. 4 line 10-16, p. 14 line 12-25, p. 24 line 2-p. 25 line 25, Fig. 1, 6, 8).
Suresh does not specifically teach wherein when the biomarker is trimethylamine, and the sensing material for said trimethylamine biomarker comprises a solvatochromic dye dissolved in alcoholic solvent. However, Suslick teaches the analogous of a sensor wherein when the marker is trimethylamine, and the sensing material for said trimethylamine marker comprises a solvatochromic dye (Suslick teaches a sensor with solvatochromic dyes that are useful in detection and/or quantification of trimethylamine; [8-11, 57, 58, 69, 71, 72, 74]). It would have been obvious to one of ordinary skill in the art to have modified the sensor for detecting biomarker analytes of Suresh to have also detected trimethylamine as in Suslick because Suslick teaches that trimethylamine detection via solvatochromic dyes are commonly used and known (Suslick; [8-11, 57, 58, 69, 71, 72, 74]) and because Suslick teaches that detecting trimethylamine via solvatochromic dyes is a simple, portable, inexpensive and sensitive detection method (Suslick; [57, 58]) and is also useful for the diagnosis and monitoring of trimethylamine levels for patients with trimethylaminuria (Suslick; [58]).
Modified Suresh does not specifically teach the solvatochromic dye dissolved in alcoholic solvent. However, Steven teaches the analogous of solvatochromic dye for detection where the solvatochromic dye is dissolved in alcoholic solvent (Steven teaches solvatochromic dyes for detection where the solvatochromic dyes are dissolved in alcohol; [12, 93, 110], Tables 1, 2). It would have been obvious to one of ordinary skill in the art to have modified the solvatochromic dye of modified Suresh to have been dissolved in an alcoholic solvent as in Steven because Steven teaches that alcohol solvents are one of the known solvents used to dissolve solvatochromic dyes, and also that selecting the appropriate solvent such as alcohol does not require undue experimentation (Steven; [12, 93, 110], Tables 1, 2).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Suresh et al (WO2019045647; hereinafter “Suresh”; already of record) in view of Yang et al (US 20160109435; hereinafter “Yang”).
As to claim 8, Suresh teaches the paper-based sensor of claim 1 (see above), wherein when the biomarker is pH, and there is a sensing material for said pH biomarker (Suresh; p. 10 line 20-30, p. 13 line 29-p. 14 line 5, p. 24 line 7-p. 25 line 20, Figs. 1, 6, 8).
Suresh does not specifically teach the sensing material for said pH biomarker comprises aqueous phenol red, neutral blue, or bromothymol blue. However, Yang teaches the analogous of detecting pH wherein the sensing material for said pH biomarker comprises aqueous phenol red, neutral blue, or bromothymol blue (Yang teaches bromothymol blue for detecting pH; [25, 26]). It would have been obvious to one of ordinary skill in the art to have modified the reagent for detecting pH of Suresh to have been the bromothymol blue as in Yang because Yang teaches that bromothymol blue is commonly used and known to detect pH (Yang; [26]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Suresh et al (WO2019045647; hereinafter “Suresh”; already of record) in view of Tsigara et al (Tsigara et al. Hybrid polymer/cobalt chloride humidity sensors based on optical diffraction. Sensors and Actuators B; 120; published 2007; pages 481-486; hereinafter “Tsigara”).
As to claim 9, Suresh teaches the paper-based sensor of claim 1 (see above), wherein various biomarker analytes are detected (Suresh; p. 4 line 10-16, p. 14 line 12-25, p. 24 line 2-p. 25 line 25, Fig. 1, 6, 8).
Suresh does not specifically teach wherein when the biomarker is moisture, and the sensing material for said moisture biomarker comprises a transition metal salt dissolved in a mixture of polyhydroxyethylmethacrylate/alcoholic solution. However, Tsigara teaches the analogous of a sensor wherein when the biomarker is moisture, and the sensing material for said moisture biomarker comprises a transition metal salt dissolved in a mixture of polyhydroxyethylmethacrylate/alcoholic solution (Tsigara teaches a sensor for moisture/humidity, where cobalt chloride is dissolved with a methacrylate and methanol; abstract, p. 481-482, abstract, sections 1, 2.1). It would have been obvious to one of ordinary skill in the art to have modified the sensor for detecting biomarker analytes of Suresh to have also detected moisture as in Tsigara because Tsigara teaches that sensing humidity is important in medical fields since it affects the end product quality, functionality and quality control, and because this provides a rapid and sensitive detection method (Tsigara; p. 481-482, abstract, sections 1, 2.1).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Suresh et al (WO2019045647; hereinafter “Suresh”; already of record) in view of Cliniqa (Uric Acid Reagent, Raichem, Cliniqa product brochure; retrieved via the wayback machine at https://web.archive.org/web/20170910120251/https:/www.cliniqa.com/Portals/0/documents/Public/Inserts/Insert-PNR80040,PNR80041.pdf; hereinafter “Cliniqa”; published 9/10/17, screenshot and actual brochure included as separate NPL) in view of Fang et al (Translation of CN108663355; hereinafter “Fang”).
As to claim 10, Suresh teaches the paper-based sensor of claim 1 (see above), wherein when the biomarker is uric acid, then the sensing material for said uric acid biomarker comprises an enzyme (Suresh; p. 10).
Suresh does not specifically teach the sensing material for said uric acid biomarker comprises uricase enzyme in a stabilizer solution in an enzymatic substrate in sodium 3,5-dichloro-2-hydroxybenzenesulfonate (DHBS) with horseradish peroxidase (HRP) in stabilizer solution on a biopolymer matrix. However, Cliniqa teaches the analogous art of a uric acid reagent that includes uricase enzyme in a stabilizer solution in an enzymatic substrate in sodium 3,5-dichloro-2-hydroxybenzenesulfonate (DHBS) with horseradish peroxidase (HRP) in stabilizer solution (Cliniqa; page 1). It would have been obvious to one of ordinary skill in the art to have modified the enzyme reagent for detecting uric acid of Suresh to have been the uricase enzyme in DHBSA and HRP as in Cliniqa because Cliniqa teaches that these components are commonly used and known to detect uric acid (Cliniqa; page 1).
Modified Suresh does not specifically teach that the reagents include a biopolymer matrix. However, Fang teaches the analogous art of a paper sensor to detect uric acid (Fang; [2, 65]) with a biopolymer matrix (Fang teaches where chitosan is included to increase the stability; [34, 64]). It would have been obvious to one of ordinary skill in the art to have modified the enzyme reagent for detecting uric acid of Suresh to have included a biopolymer matrix as in Fang because Fang teaches that chitosan as a biopolymer is included to increase the stability of reagents (Fang; [34]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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