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
Newly submitted claims 9 and 10 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the liquid chromatography-tandem mass spectrometry and gas chromatography platforms can be utilized to measure analytes that are not the lipids recited in claim 1. As such, the system of claims 9 and 10 can be utilized in a materially different process.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 9 and 10 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed September 24, 2026 have been fully considered but they are not persuasive. With respect to the rejections under 35 U.S.C. 112(b), the Examiner notes that the amendments to the instant claims have overcome the rejections, thus the rejections under 35 U.S.C. 112(b) have been removed. With respect to the rejection under 35 U.S.C. 101, the Examiner has not found Applicant’s arguments to be persuasive, thus the rejection under 35 U.S.C. 101 is maintained.
Applicant has amended independent claims 1 and 8 to recite centrifuging a peripheral blood sample, extracting serum lipids from the blood sample, and performing liquid chromatography-tandem mass spectrometry and gas chromatography-mass spectrometry to quantify lipids in the sample, and argued that the amended limitations overcome the rejection under 35 U.S.C. 101. The Examiner respectfully disagrees.
With respect to liquid chromatography-tandem mass spectrometry and gas chromatography-mass spectrometry, the Examiner notes that the MPEP explicitly states that determining the level of a biomarker in blood by any means is considered well-understood, routine, and conventional activity, thus Applicant’s arguments regarding LC-MS/MS and GC-MS are not persuasive. Given that determining a biomarker in blood by any means is considered as well-understood, routine, and conventional, the Examiner contends that Applicant’s arguments regarding LC-MS/MS and GC-MS are not sufficient to overcome the rejection under 35 U.S.C. 101. Similarly, the Examiner notes that centrifuging a sample and extracting analytes from the centrifuged sample are well known and widely used in the art. As such, the means by which the analytes are extracted and determined in the claims do not render the claims patent eligible.
Applicant has also argued that the claims are not directed to mere data gathering, and therefore overcomes the rejection. Here, the Examine points to MPEP 2106.05(g) which states that performing clinical tests to obtain information, and determining a level of a biomarker in blood is considered as mere data gathering (MPEP 2106.05(g). As such, the Examiner contends that the step of classifying a peripheral blood sample as being positive for ADHD is an abstract idea in that it only requires analyzing data generated from clinical tests, and making a mental determination on ADHD based on the collected data. The processes by which the data is collected is considered to be well-understood, routine, and conventional activity, or mere data gathering, thus the additional limitations of the claims do not overcome the rejection under 35 U.S.C 101. In light of these views, the Examiner contends that the limitations of the instant claims are recite an abstract idea without significantly more, and are directed to ineligible subject matter under 35 U.S.C. 101.
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 and 4-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea. Independent claim 1 recites an in vitro detection method of lipids in a patient comprising detecting Ceramide C16:0, Ceramide C24:0, Deoxy dihydro-ceramide C24:1, Sphinganin 1-phosphate, docosahexaenoic acid, and eicosapentaenoic acid in a peripheral blood sample, determining whether there is a variation in concentration for Deoxy dihydro ceramide C24:1 and Sphinganin 1-phosphate of the peripheral blood sample when compared to a population or control group without ADHD, and determining whether there is a variation in a ratio of Ceramide C16:0 to Ceramide C24:0and a ratio of DHA to EPA when comparing the ratios of the concentration of the peripheral blood sample to a population or a control group without ADHD. Classifying the peripheral blood sample as positive for ADHA based on increases and/or decreases in the concentrations only requires the mental step of analyzing the concentration data, and making a determination of positive for ADHD. Similarly, claim 8 is directed to a method of diagnosing a human patient with ADHD comprising measuring various lipids in a peripheral blood sample, determining a variation in a ratio of the concentration of the lipids compared to a control group, and diagnosing a patient with ADHD based on the variation of the lipid concentrations. The steps of determining variations of a ratio of lipid concentrations is an abstract idea in that it only requires the mental analysis of data pertaining to the amount of lipids in the peripheral blood sample and the population or control group. Diagnosing the patient with ADHD is also an abstract idea in that it only requires the mental step of analyzing the concentration data, and making a determination of positive or negative for ADHD. As such, the claims recite an abstract idea. This judicial exception is not integrated into a practical application because no action is taken after classifying a sample as positive for ADHD, or after diagnosing the patient with ADHD. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of the claims are directed to routine and conventional data gathering steps. As set forth in the MPEP, determining a level of a biomarker in blood by any means has been recognized as routine and conventional activity, or as insignificant extra solution activity (MPEP 2106.05(d)), (MPEP 2106.05(g)). Additionally, the MPEP states that collecting information, analyzing the information, and displaying results is an abstract idea when the analysis steps are recited at a high level of generality such that they could be performed in the human mind (MPEP2106.04(a)(2) III A). Here, the Examiner points to references to Schaffer et al., (US 2019/0101550, 2018/0306797) and Jackowski et al., (US 2013/0040913) who teach measuring Ceramides, DHA, and EPA in blood samples respectively. Given the teachings of these references, the Examiner contends that measuring Ceramides, DHA, and EPA, are well understood, routine, and conventional activity. Therefore, based on the limitations of the instant claims, the Examiner contends that the claims are directed to ineligible subject matter without significantly more, thus the rejection under 35 U.S.C. 101 is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
