DETAILED ACTION
1. This action is written in response to applicant’s correspondence filed 3/9/2026. Applicant has amended claims 20, 27-29, 32 and 38-39, canceled claim 46, and added new claim 47. Claims 20-45 and 47 are currently pending for examination. All the amendments and arguments have been thoroughly reviewed but are found insufficient to place the instantly examined claims in condition for allowance. Applicant’s amendments to claims 20 and 27 have obviated the rejections under 35 USC 112. In view of applicant’s amendment to claim 20, the rejection under 35 USC 103 has been withdrawn. However, the rejection under 35 USC 101 is maintained, with modification(s) as necessitated by amendment.
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 20-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (e.g., law of nature) without significantly more.
Claims 20-45 are drawn to a method for processing or analyzing a tissue sample, comprising: (a) subjecting a first portion of a tissue sample of a subject to cytological analysis that indicates that said first portion of said tissue sample is cytologically indeterminate, wherein said tissue sample comprises a thyroid tissue sample; (b) upon determining that said first portion of said tissue sample is cytologically indeterminate, sequencing a plurality of gene expression products obtained or derived from a second portion of said tissue sample to yield a plurality of sequencing reads, wherein said plurality of gene expression products comprises one or more fusion transcripts and one or more messenger ribonucleic acid (mRNA) transcripts, and wherein said plurality of sequencing reads comprises a set of fusion transcript-derived sequencing reads and a set of mRNA transcript-derived sequencing reads; (c) detecting a presence or an absence of a TRK gene fusion and a RET gene fusion in said second portion of said tissue sample, wherein said detecting comprises processing said plurality of sequencing reads to generate a classification of said second portion of said tissue sample as being a malignant thyroid tissue sample, wherein said processing comprises distinguishing between benign thyroid tissue samples and malignant thyroid tissue samples, wherein said classification has a sensitivity of at least 90% and a specificity of at least 60%. The essence of the claimed invention is the discovery of an asserted relationship between presence or absence of a TRK gene fusion and a RET gene fusion in a thyroid tissue sample and a malignant or benign classification of said thyroid tissue sample. However, assuming such an asserted relationship exists, it is not a statutory invention under 35 U.S.C. 101, instead it is a phenomenon of nature, i.e., a law of nature, discovered by Applicant. Laws of nature are not considered to be patentable subject matter (see e.g., MPEP 2106.04). The U.S. Supreme Court has found that if a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. A patent, for example, could not simply recite a law of nature and then add the instruction “apply the law” (Mayo Collaborative Services v. Prometheus Laboratories Inc., 101 USPQ2d 1961 (U.S. 2012)).
The recited law of nature (i.e., the recited relationship between presence or absence of a TRK gene fusion and a RET gene fusion in a thyroid tissue sample and a malignant or benign classification of said thyroid tissue sample) is not integrated into a practical application. Specifically, steps (a)-(b) and “detecting a presence or an absence of a TRK gene fusion and a RET gene fusion” in step (c) are mere data gathering steps (i.e., steps to gather information regarding the presence or absence of a TRK gene fusion and a RET gene fusion in a thyroid tissue sample) that are necessary for using the recited law of nature. The wherein clauses in step (c) merely utilize the recited law of nature to get a malignant or benign classification of the thyroid tissue sample based on presence or absence of a TRK gene fusion and a RET gene fusion. Thus, steps (a)-(c) of the claimed method do not integrate the recited law of nature into a practical application, and the claims are directed to the recited law of nature which is a judicial exception.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (i.e., law of nature). As discussed above with respect to integration of the law of nature into a practical application, steps (a)-(b) and “detecting a presence or an absence of a TRK gene fusion and a RET gene fusion” in step (c) are mere data gathering steps (i.e., steps to gather information regarding the presence or absence of a TRK gene fusion and a RET gene fusion in a thyroid tissue sample) that are necessary for using the recited law of nature, and thus do not amount to significantly more than the law of nature. Furthermore, all the steps recited in the claims in addition to the judicial exception are well-understood, purely conventional and routine in the art, as evidenced by the 103 rejection presented in the previous Office action and as evidenced by the following two references to prove that detecting a TRK gene fusion in a tissue sample via sequencing is also conventional and routine in the art: (1) Vaishnavi et al. (Nat. Med. 2013, 19:1469-1472); (2) Drilon et al. (Ann. Oncol. 2016, 27:920-926). Accordingly, claims 20-45 are not patent eligible.
Allowable Subject Matter
4. Claim 47 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
5. Applicant’s arguments (as filed on 3/9/2026) directed at the rejection under 35 USC 101 have been fully considered but are found to be unpersuasive.
Applicant submits that “amended claim 20 as a whole recites additional elements beyond an alleged judicial exception that serve to impose a meaningful limit on the judicial exception by integrating the alleged judicial exception into a practical application that pertains to an improvement to the field of diagnostics” (see page 8 of applicant’s response filed 3/9/2026).
This is not found persuasive because amended claim 20 as a whole does not recite anything that integrates the recited law of nature into a practical application (as discussed in the rejection above), unlike newly added claim 47 which recites a further step of administering a therapeutic intervention comprising “a surgery” to the subject upon using the recited law of nature to identify the tissue sample from the subject as a “malignant” thyroid tissue sample and thus integrates the recited law of nature into a practical application (see MPEP 2106.04(d)(2)).
Applicant argues that “[amended] claim 20 recites a combination of elements that were not routine or conventional at the time of filing” because “none of the [previously] cited references meet all elements of the claim” (see page 9 of applicant’s response filed 3/9/2026).
This is not found persuasive because: all the elements of the previously presented claim 20 were routine or conventional at the time of filing as discussed in the previous Office action, and the newly added feature of detecting a TRK gene fusion in a tissue sample via sequencing was also routine or conventional at the time of filing as evidenced by the following references: (1) Vaishnavi et al. (Nat. Med. 2013, 19:1469-1472); (2) Drilon et al. (Ann. Oncol. 2016, 27:920-926).
Conclusion
6. 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 KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
Prosecution Insights