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 .
Election/Restrictions
Applicant’s election without traverse of claims 53-64 in the reply filed on 7/18/2025 is acknowledged.
Claims 65-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/18/2025.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 53-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant has not pointed out where the new (or amended) claim 53 is supported, nor does there appear to be a written description of the claim limitation “correlating a quantity of the fatty acid metabolite present in the fluid sample to a quantity of the fatty acid in the fluid sample” in the application as filed.
Claim Rejections - 35 USC § 112(b)
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.
Claim 58 is 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 58 recites the limitation "hydrolyzing agent" in line 1. There is insufficient antecedent basis for this limitation in the claim. For prosecution, the claim will be considered dependent on claim 56 that has antecedent basis for “hydrolyzing agent”.
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 53-64 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility - Step 1:
Claims 53-64 are directed to a method of quantifying a fatty acid present in a fluid sample on a microfluidic device. Accordingly, claims 53-64 are separately directed to statutory subject matter under Step 1.
Subject Matter Eligibility - Step 2A, Prong 1:
Claim 53 each recite the following limitation that, under their broadest reasonable interpretation, are directed to an abstract idea: The recited step of “correlating a quantity of the fatty acid metabolite present in the fluid sample to a quantity of the fatty acid in the fluid sample” of claim 53 are considered a type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo). Additionally, the correlation step could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams)Regarding claims 54-64, are directed at modifying the device or the process, and do not modify the abstract idea.
Subject Matter Eligibility - Step 2A, Prong 2:
The judicial exception is not integrated into a practical application for claim 53-64.
Claim 53 recites the quantity of fatty acid metabolite inputs are performed by quantifying a fatty acid metabolite present in the fluid sample by performing a bioassay on the microfluidic device. These are considered merely indicating a field of use or technological environment in which to apply the judicial exception (see MPEP 2106.05(h): example vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). The bioassay on the microfluidic device are merely generating the analysis results to analyze in the abstract idea. These are considered data gathering and analyzing steps that are insignificant extra-solution activity in the field of sensing. Thus these elements are used to gather data that is then used in the abstract idea which does not integrate (MPEP 2106.05(g)). The step of quantifying therefore represents data gathering for input to perform the recited judicial exception as a mathematical calculation.
Subject Matter Eligibility - Step 2B:
The claim 53 recites the microfluidic device to perform the abstract idea on the data gathering steps. The microfluidic device is considered to be routine and conventional. As discussed below, Watkins et al (US 20100233724) teach microfluidics to quantify fatty acid metabolites (Para. 0098) and are therefore well-understood, routine, and conventional.
Dependent claims 54-64 do not recite the abstract idea, but recite details of the fatty acid (claims 54, 57, and 64) and fluids (claims 60) and reagents (claims 55-56, 58-59) and the bioassay (claims 61-63).
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) 53-55, 60-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watkins et al (US 20100233724).
Regarding claim 53, Watkins teach a method of quantifying a fatty acid present in a fluid sample on a microfluidic device (Para. 0098: microfluidics are well known methods to isolate and/or quantifying lipid metabolites), the method comprising: quantifying a fatty acid metabolite present in the fluid sample by performing a bioassay; and correlating a quantity of the fatty acid metabolite present in the fluid sample to a quantity of the fatty acid in the fluid sample (Para. 0008-0009: determining amounts of lipid metabolites including fatty acids and eicosanoids). Watkins is silent to the lipid metabolite of fatty acids embodiment specifically quantified by the microfluidic embodiment. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the microfluidic detector method in Para. 0098 to detect the fatty acid metabolite in Para. 0008-0009 to provide the above advantage of quantifying lipid metabolites using well known device to isolate and quantify lipid metabolites.
Regarding claim 54, Watkins teach the fatty acid is a precursor of the fatty acid metabolite (Para. 0008-0009: eicosanoids have fatty acid as precursor)
Regarding claim 55, Watkins teach combining the fluid sample with an extraction agent on the microfluidic device to separate the fatty acid metabolite from a carrier protein (Para. 0102: extraction); detecting the fatty acid metabolite by performing the bioassay (Para. 0102: fatty acid quantification); and quantifying the fatty acid metabolite in the fluid sample. (Para. 0102: fatty acid quantification)
Regarding claim 60, Watkins teach the fluid sample is blood, filtering the fluid sample into red blood cells and plasma prior to or after normalizing a volume of the fluid sample. (Para. 0009: blood, plasma, serum)
Regarding claim 61, Watkins teach performing the bioassay generates a colorimetric response to quantify the fatty acid metabolite. (Para. 0098: colorimetric)
Regarding claim 62, Watkins teach performing the bioassay generates an electrochemical, a fluorescence or a chemiluminescence response to quantify the fatty acid metabolite. (Para. 0099: chemiluminescence)
Regarding claim 63, Watkins teach the bioassay generates a response detectable by a cellular phone spectrophotometer (Para. 0098: colorimetric is capable of being detected by cellular phone spectrophotometer).
Claim(s) 56-59, 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watkins et al (US 20100233724) in view of Shinohara et al, "Functional metabolomics reveals novel active products in the DHA metabolome" Front Immunol. 2012 Apr 17; 3:81; pp. 1-9.
Regarding claim 56-59, 64, Watkins teach combining the fluid sample with an extraction agent on the microfluidic device to separate the fatty acid metabolite from a carrier protein (Para. 0102: extraction); detecting the fatty acid metabolite and the additional fatty acid metabolite by performing the bioassay; and quantifying the fatty acid metabolite in the fluid sample (Para. 0008-0009: determining amounts of lipid metabolites including fatty acids and eicosanoids)
Watkins teach omega 3 fatty acids such as DHA changes provide biomarkers for diseases such as NASH, a fatty inflammation of the liver (Para. 0002, 0134) is silent to combining the fluid sample with a hydrolyzing agent on the microfluidic device to cleave additional fatty acid metabolite from fatty acid esters present in the fluid sample; wherein the fatty acid is docosahexaenoic acid (DHA); wherein the hydrolyzing agent is an enzyme; wherein the enzyme is selected from a group consisting of: 5-lipoxgenase (5-LOX), soybean lipoxgenase, 12-lipoxgenase (12-LOX), 15-lipoxgenase (15-LOX), human ALOX15-2, cyclooxygenase-1 (COX-1), cyclooxygenase-2 (COX-2), cytochromes P450 (CYP450), a combination of 15-LOX and 5-LOX, a combination of 12-LOX and 15-LOX, a combination of cyclooxygenase-2 (COX-2) and acetylsalicylic acid (ASA), and soluble epoxide hydrolase (sEH).
Shinohara et al teach DHA metabolism related to anti-inflammatory and organ-protective properties. The metabolism of DHA metabolizes into specialized pro-resolving mediators such as dihydroxy-docosahexaenoic acid or PD1 using 15-LOX (Table 1, Fig. 5; p.3 col. 2 para. 1) are desirable potent anti-inflammatory actions (p. 6 col. 2 para. 4). It is desirable to provide detection of the quantity of novel bioactive products known to reduce inflammation to follow if there is low levels that can lead to inflammation. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the DHA with 15-LOX to detect the PD1 to provide the above advantage of detecting potent anti-inflammatory metabolites to follow if there is low levels that can lead to inflammation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758