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
1. Claims 1, 5, 7-9 and 11-13 have been amended, claims 2-4, 6 and 10 canceled and claim 13 added as requested in the amendment filed on August 28, 2025. Following the amendment, claims 1, 5, 7-9 and 11-13 are pending in the instant application.
2. Claim 12 stands withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 April 09, 2025.
3. Newly submitted claim 13 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claim belongs to Group II, reagent kit, currently not elected.
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 Accordingly, claim 13 is withdrawn from consideration as being directed to a non-elected invention.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.
4. Claims 1, 5, 7-9 and 11 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on August 28, 2025 have been fully considered but found to be not persuasive for reasons set forth below.
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.
7. Claims 1, 5, 7-9 and 11 stand rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more for reasons of record in Paper mailed on May 28, 2025. Method claim(s) 1, 5, 7-9 and 11, directed to a method for assisting the diagnosis of Parkinson’s disease, set forth laws of nature by reciting relationship between changes in the levels of naturally occurring factors, phosphatidylserine and tetraspanin, and the pathology itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
Applicant traverses the rejection at pp. 14-15 of the Response. Specifically, Applicant argues that, “the claims are not drawn to measuring exosomes in general. Rather, they recite a specific diagnostic methodology requiring measurement of exosomes carrying both phosphatidylserine and CD9, CD63, or CD81, and comparing the amount, or the ratio to total
tetraspanin-positive exosomes, against a reference value derived from healthy patients. Such
specificity was neither known nor suggested in the art at the time of filing. No prior art teaches or suggests that the defined subsets of exosomes are biomarkers for Parkinson's disease, let alone that their ratio to total tetraspanin-positive exosomes would serve as a diagnostic indicator.” Applicant further submits that, “[T]he claims are expressly directed to a method of
assisting in the diagnosis of Parkinson's disease-a concrete, practical application with clinical
utility. Measuring specific molecular features of exosomes using defined affinity reagents, and
calculating ratios thereof, integrates the natural correlation into a diagnostic tool that improves the field of Parkinson's disease diagnostics. This is not a claim that monopolizes a natural law itself, but rather a claim to a specific and practical application of that law.” Applicant also explains, “claim 1 and its dependent claims recite the step of calculating the ratio of the amount of exosomes having phosphatidylserine and tetraspanin to the amount of exosomes having tetraspanin. This calculation constitutes a significant additional element, as it requires more than detection-it requires quantitative analysis of specific defined subsets of exosomes. Such a ratio- based approach is not a mental process nor a routine assay step, but rather a novel and inventive diagnostic tool that transforms raw biological data into a clinically meaningful diagnostic indicator.” Applicant’s arguments have been fully considered bit found to be not persuasive for reasons that follow.
As explained earlier, based upon an analysis with respect to the claim as a whole, claims 1, 5, 7-9 and 11 are determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1, 5, 7-9 and 11 are directed to a process. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims 1, 5, 7-9 and 11 encompass changes in the amounts of exosomes having phosphatidylserine and exosomes having tetraspanin during pathology of Parkinson’s disease, the process that is governed by a law of nature, and thus is a judicial exception. The phosphatidylserine and tetraspanin are all naturally occurring factors that are expressed differently during pathology of PD apart from any human action. The relation between the levels of expression of the phosphatidylserine and tetraspanin and pathology of PD exists in principle and is a consequence of the ways these factors are metabolized by the body, entirely natural process, a natural phenomenon, and thus a judicial exception (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure naturally occurring factors during a naturally occurring pathology. (Step 2A/2: No).
Finally, claims 1, 5, 7-9 and 11 do not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claims—measuring the amount of phosphatidylserine and tetraspanin by antibody binding—represent routine steps that are recited at a high level of generality and encompass well-understood and purely conventional routine techniques in the art. (Step 2B: No).
Thus, for reasons fully explained earlier and reasons above, claims 1, 5, 7-9 and 11 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Conclusion
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
June 17, 2026
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