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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 13, 2026 has been entered.
Response to Arguments
Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. 112(b), Applicant has argued that claims 1 and 4-8 are not indefinite. Specifically, Applicant has argued that the phrase “for a human control group without ADHD” provides a baseline reference for determining whether the measured lipid concentrations are increased or decreased. The Examiner maintains that it is unclear how the claim compares lipids from a patient sample to a control group as the claim does not require measuring lipids from a control group. In an effort to advance prosecution, the Examiner suggest Applicant amend the claims to recite concentrations measured in a human control group, to provide clarity with respect to the control group lipid concentrations. With respect to claim 6, the Examiner notes that the amendments to the claim have overcome the rejection under 35 U.S.C. 112(b), thus the rejection of claim 6 has been removed.
With respect to the rejection under 35 U.S.C. 101, Applicant has argued that the claims are not directed to a judicial exception without significantly more, but instead recite a specific laboratory method for detecting lipids in a blood sample and classifying the sample based on the lipid concentrations. The Examiner does not find these arguments to be persuasive, and contends that the claims are directed to a law of nature and an abstract idea without significantly more. First, the Examiner notes that the claims are directed to a law of nature in that the concentration of lipids in a peripheral blood sample are utilized to determine whether a patient has ADHD. The concentration of lipids results from the patients disease state, thus the lipid concentrations compared to a control group is nothing more than a law of nature. The Examiner also notes that independent claims 1 and 8 do not recite any specific laboratory techniques as “obtaining” a blood sample, and “measuring” lipids in the blood sample do not recite any specific techniques. As such, the Examiner contends that the claims are directed to a law of nature. Second, the Examiner notes that the claims are also directed to an abstract idea in that the steps of determining a variation in concentration compared to a control group, and classifying a sample as positive for ADHD are mental steps that only require analyzing the measured concentration data. For example, determining a variation in lipid concentrations compared to a control group only require reviewing the concentration data generated from the measuring step, and forming a conclusion in ones mine as to whether the measured concentration is different from the control group. The determining steps can be performed solely in one’s mind as the claims do not recite any specific steps or techniques that are utilized to determine a difference in the measured concentration compared to the control group. Similarly, the step of classifying a sample as positive for ADHD is a mental step that only requires analyzing the concentration data and making a determination as to whether the sample is positive for ADHD. Again, the claims do not recite any specific steps or techniques that are utilized to classify the sample; thus, the Examiner contends that the classifying step can be performed in a person’s mind. As such, the Examiner maintains that the determining and classifying steps are abstract ideas.
The Examiner also contends that the claims are not directed to a practical application as nothing occurs after the determining and classifying steps. Applicant has argued that the determining and classifying steps themselves are practical application; however, as detailed above, the Examiner deems those steps to be abstract ideas. The Examiner notes that abstract ideas cannot be practical applications, thus the Examiner maintains that the claims are not directed to a practical application.
Finally, the Examiner contends that the claims do not recite any additional elements that amount to sufficiently more as the step of measuring the claimed lipids are known in the art. Applicant has argued that the step of measuring lipids in a blood sample cannot be performed mentally as the measurement requires specific techniques such as extraction, chromatography and mass spectrometry. The Examiner has cited references to Schaffer et al., and Jackowski et al., both of which teach measuring lipids utilizing techniques like extraction, chromatography, and mass spectrometry. As such, the Examiner notes that references to Schaffer et al., and Jackowski et al., show that various laboratory techniques including extraction, chromatography, and mass spectrometry are utilized for measuring lipids in a sample. Therefore, based on the limitations of the instant claims, and the arguments provided here, the Examiner contends that the limitations of the instant claims are directed to a law of nature, and an abstract idea without significantly more, and therefore are directed to ineligible subject matter under 35 U.S.C. 101.
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 1 and 4-8 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.
For claims 1 and 4-8, the claims do not recite a step of measuring lipids for a human control group, thus it is unclear how the claim compares lipids from a patient sample to a control group to classify or diagnose ADHD as the claim does not require measuring lipids from a control group. Claims 4-7 depend directly, or indirectly from claim 1 and are also indefinite.
For claim 1, the variations of the lipids exhibiting an increase or decrease (lines 28, 30, 32, and 34) is unclear as the claim does not recite a baseline concentration measurement by which one can determine an increase or decrease in lipid concentration in the peripheral blood sample.
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 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) a law of nature and 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. The amount of lipids in a blood sample results from the disease state of the subject, thus the levels of lipids in the blood sample are nothing more than a law of nature. The step of determining whether there is a variation in the concentration of Deoxy dihydro-ceramide C24:1 and Sphinganin 1-phosphatein the peripheral blood sample with corresponding concentrations of a population or control group without ADHD is an abstract idea as 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. Similarly, 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. As such, claim 1 recites both a law of nature and an abstract idea. 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, claim 8 also recites a law of nature and 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 (MPEP 2106.04(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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797