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
The Amendment filed on 9/30/2025 has been entered. Claims 1, 2, 4, 5 and 7-19 remain pending in the application.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 9/30/2025 is acknowledged. The traversal is on the ground(s) that the step of “assessing an aggravation risk of COVID-19 based on a result of the quantification of the liver-type fatty acid binding protein” constitutes a special technical feature. This is not found persuasive because as shown below the references still teach these limitations. Additionally, the applicant argues that one of ordinary skill in the art would not have had a reasonable expectation of success in the step above is not found persuasive. Based upon the reference of Wang, one of ordinary skill in the art would have recognized that Chronic Liver Disease is a comorbidity of COVID-19 and based upon that, one of ordinary skill in the art would have looked to method to determine if someone has Chronic Liver Disease to determine if they have the comorbidity. One would have therefore looked to Kamijo which teaches looking at the liver-type fatty acid binding protein to determine if one has chronic liver disease and based upon this determine the person has a comorbidity of COVID-19 and therefore determine they have an aggravation risk.
The applicant additionally argues unexpected results and points to paragraph [0049] of the specification is merely an argument unaccompanied by evidentiary support, and, thus, is insufficient to rebut Examiner's finding of obviousness. Arguments of counsel cannot take the place of evidence in the record (MPEP §§ 2145, 2129, 2144.03, 716.01(c)). Evidence must be provided which provides a comparison between the prior art and the claimed subject matter which provides proof of the proposed unexpected results. Additionally, the unexpected results the applicant is trying to show is not commensurate in scope with the claimed invention as the paragraph is discussing a specific value in the urine which is being measured and this value is not claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5 and 7-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 4 and 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) quantifying a liver-type fatty acid binding protein and then assessing an aggravation risk of SARS-CoV-2 based on the quantification. This judicial exception is not integrated into a practical application because the metho only determines the aggravation risk of SARS-CoV-2 and then nothing happens and therefore there is no application into a particular practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only other step is the quantifying step which is considered a data gathering step and is therefore an insignificant extra solution activity which would not be considered beyond what is well understood routine and conventional.
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.
Claim(s) 1, 4, 16, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang, Chang-Zheng et al., “Early risk factors of the exacerbation of coronavirus disease 2019 pneumonia”, Journal of Medical Virology, 2020, Vol. 159, No. 104946, 7 pages, hereinafter Wang in view of Kamijo, Atsuko et al., “Urinary liver-type fatty acid binding protein as a useful biomarker in chronic kidney disease”, Molecular and Cellular Biochemistry, 2006, Vol. 284, pages 175-182, hereinafter Kamijo.
Regarding claim 1, Wang teaches a method of assessing an aggravation risk of SARS-CoV-2 infectious disease (COVID-19) (abstract), the method comprising: assessing an aggravation risk of SARS-CoV-2 infectious disease (COVID-19) based on a result of the quantification (abstract and Table 1, specifically Chronic kidney disease being a comorbidity of COVID-19).
Wang fails to teach quantifying a liver-type fatty acid binding protein in urine collected from a subject.
Kamijo teaches that urinary excreation of liver-type fatty acid binding protein increases with deterioration of renal functions and liver-type fatty acid binding protein is therefore a useful clinical biomarker for monitoring chronic kidney disease (Kamijo, page 181, column 2, paragraph 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have quantified a liver-type fatty acid binding protein in urine collected from a subject because it is a useful clinical biomarker for monitoring chronic kidney disease (Kamijo, page 181, column 2, paragraph 3) and therefore would indicate if the subject has one of the comorbidities of COVID-19 and therefore have a higher aggravation risk of COVID-19.
Regarding claim 4, modified Wang teaches wherein the quantification is performed by a material for quantifying a liver-type fatty acid binding protein, and the material for quantifying a liver-type fatty acid binding protein is an anti-L-FABP antibody (Kamijo, page 176, column 1, paragraph 5, ELISA utilizes the antibody-antigen interaction and therefore would use an anti-L-FABP antibody).
Regarding claim 16, modified Wang teaches wherein the quantification is performed using an anti-L-FABP antibody, based on the binding of the anti-L-FABP antibody to the liver-type fatty acid binding protein in the urine sample (Kamijo, page 176, column 1, paragraph 5 ELISA utilizes the antibody-antigen interaction and therefore would use an anti-L-FABP antibody).
Regarding claim 18, modified Wang teaches further comprising: determining whether a concentration of the quantified liver-type fatty acid binding protein is higher than or equal to a specific cutoff value having an aggravation risk (Kamijo, figure 1 and page 178, columns 1-2, paragraphs 5-3), and/or whether a concentration of the quantified liver-type fatty acid binding protein is lower than or equal to a specific cutoff value having no potential aggravation risk (Kamijo, figure 1 and page 178, columns 1-2, paragraphs 5-3).
Regarding claim 19, modified Wang teaches further comprising: diagnosing a concentration of the quantified liver-type fatty acid binding protein is higher than or equal to a specific cutoff value as having an aggravation risk (Kamijo, figure 1 and page 178, columns 1-2, paragraphs 5-3), and/or diagnosing a concentration of the quantified liver-type fatty acid binding protein is lower than or equal to a specific cutoff value as having no potential aggravation risk (Kamijo, figure 1 and page 178, columns 1-2, paragraphs 5-3).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Kamijo as applied to claim 1 above, and further in view of United States Application Publication No. 2012/0282595, hereinafter Cheng.
Regarding claim 2, Wang and Kamijo teach all limitations of claim 1; however, they fail to teach the quantification is performed at least 2 times at specific intervals of days.
Cheng teaches an ELISA system in which ELISA assays are repeated on different days to determine assay reproducibility and reliability (Cheng, paragraph [0132]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have performed the quantification at least 2 times at specific intervals of days because it would allow for the determination of assay reproducibility and reliability (Cheng, paragraph [0132]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Kamijo as applied to claim 1 above, and further in view of United States Application Publication No. 2013/0029363, hereinafter Ebinuma.
Regarding claim 15, Wang and Kamijo teach all limitations of claim 1; however, they fail to teach the quantification is performed after the urine sample is subjected to denaturation with a surfactant.
Ebinuma teaches a method in which a surfactant is utilized for the pretreatment of the sample before an ELISA method is utilized because it attains a high precision through a very simple procedure (Ebinuma, paragraph [0042]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have subjected the sample to a surfactant before the quantification because it would allow for a high precision measurement through a very simple procedure (Ebinuma, paragraph [0042]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Kamijo as applied to claim 1 above, and further in view of United States Application Publication No. 2007/0218519, hereinafter Urdea.
Regarding claim 17, Wang and Kamijo teach all limitations of claim 1; however, Wang and Kamijo only teach using and ELISA kit, but no details regarding the kit.
Urdea teaches an ELISA kit in which the area under the curve as a result of the receiver operating characteristics analysis has a high degree of diagnostic accuracy which the AUC is at least 70% (Urdea, paragraph [0145]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the AUC 70% or more because it would provide a high degree of diagnostic accuracy (Urdea, paragraph [0145]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796