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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 11, 2026 has been entered.
Response to Arguments
Applicant's arguments filed September 11, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to recite a flow rate of 1 ml/min to 2 ml/min and cardiomyocytes circulating in a whole blood sample. Applicant has argued that the claims are not directed to a judicial exception without significantly more. The Examiner respectfully disagrees.
Regarding the rejection under 35 U.S.C. 101, Applicant has argued that the claims are not directed to an abstract idea without significantly more, and provides a practical application of determining cardiovascular disease in a subject. The Examiner contends that the claims recite an abstract idea in that the step of determining whether a subject has a cardiovascular disease is a mental process that only requires analyzing the expression if cardiovascular disease associated biomarkers, and making a determination of the subject’s health status based on the expressed biomarkers. As such, the Examiner maintains that the claims are directed to an abstract idea. The Examiner notes that nothing occurs after the determination is made, thus the claim does not recite a practical application of the judicial exception. Applicant has argued that the claimed apparatus, its operation parameters, the biological target, and the clinical outcome all contribute to integrating the claims into a practical application. The Examiner disagrees, and notes that the apparatus, its operating parameters, the biological target and the clinical outcome are all well-known in the art, and therefore represents well understood, routine, and conventional activity. Specifically, the Examiner points to reference to Bhagat et al., (US 2016/0303565) who teach a microfluidic device for cell sorting wherein the device comprises an inlet, a plurality of outlets, a curvilinear fluid passageway, and a widened channel portion for separation cells into different outlets wherein the flow rate ranges from 2.5 ml/min to 5 µl/min. Additionally, as set forth in the MPEP, determining a level of a biomarker in blood by any means is recognized as well-understood, routine, and conventional activity, thus Applicant’s arguments regarding a whole blood sample are not persuasive. As such, the separating and collecting steps are known in the art, and do not provide significantly more than the judicial exception. As such, the Examiner contends that the additional limitations recited in the claims are well-understood, routine, and conventional activity, and maintains that the claims recite to an abstract idea without significantly more, thus the claims 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 therefore, subject to the conditions and requirements of this title.
Claims 1-3, 5, 6, 8-10, and 12-15 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. Claim 1 is directed to a method of diagnosing a cardiovascular disease comprising obtaining a sample fluid from a subject, separating components of the sample fluid into a plurality of fluid fractions using a microfluidic device comprising a curvilinear fluid passageway having at least one inlet, a plurality of outlets and a widened channel portion connecting the inlet with the plurality of outlets, collecting one or more fluid fractions at a flow rate of 1 ml/min to 2 ml/min, detecting one or more cardiovascular disease associated biomarkers, and determining one or more cardiovascular diseases in the subject. Determining one or more cardiovascular diseases based on the presence or amount of cardiovascular disease biomarkers is an abstract idea in that it only requires the mental step of analyzing the biomarker data, and making a determination of whether a subject has a cardiovascular disease or not. This judicial exception is not integrated into a practical application because nothing occurs after determining the presence of a cardiovascular disease. No practical steps to treat, or attenuate the cardiovascular disease are recited in the claim, thus no practical application of the abstract idea is recited by the claim. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are directed to well-understood, routine, and conventional activity. The Examiner notes that determining the level of a biomarker in blood by any means is well-understood, routine, and convention activity (MPEP 2106.05(d) II), thus the step of detecting one or more cardiovascular disease-associated biomarkers does amount to significantly more. Additionally, utilizing a microfluidic device comprising a curvilinear fluid passageway having a widened channel portion connecting the inlet with the plurality of outlets is known in the art as evidenced by reference to Bhagat et al., (US 2016/0303565) (paragraph 0021, figure 1a, b) who teach sorting cells by size with a spiral microfluidic channel having a widened channel portion that connects the inlet with a plurality of outlets (paragraph 0021, figure 1a, b). Bhagat et al., teach a flow rate ranging from 2.5 ml/min to 5 µl/min which encompasses the claimed 1 ml/min to 2 ml/min. Because these elements are known within the prior art, the Examiner contends that the obtaining, separating, collecting, and detecting steps are conventional and well known in the art.
Therefore, when considered as a whole, the Examiner contends that the limitations of claim 1 are directed to ineligible subject matter without significantly more, and therefore do not comply with 35 U.S.C. 101. For the sake of brevity, the Examiner has limited the discussion to claim 1, but notes that the rationale holds for claims 2, 3, 5, 6, 8-15, and 17.
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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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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