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
Applicant’s election without traverse of group I and FAM19A2 mRNA in the reply filed on 04/21/2026 is acknowledged.
Claims 5 and 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/21/2026.
Drawings
The drawings filed 09/28/2023 are acceptable.
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 1-4, 6-7 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.
Claim 1 recites a method for detecting follicular thyroid cancer in a subject however the only active process steps are detecting expression of FAM19A2 in a biological sample derived from the subject. There is no active process steps of detecting follicular thyroid cancer and it is unclear if one necessarily accomplishes this by detecting FAM19A2. It is unclear if the claim is a method for detecting expression of FAM19A2 or a method for detecting follicular thyroid cancer. If the claim is intended to be a method for detecting follicular thyroid cancer, it would be remedial to recite an active process of detecting follicular thyroid cancer that is tied to the active process of expression of FAM19A2.
Claim 2 recites the limitation "the higher expression" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 2 depends from claim 1 and claim 1 does not require detecting a higher expression of FMA19A2.
Claim 4 recite wherein the expression of FAM19A2 is transcription into mRNA or mRNA precursor comprising exon 1 and 2 of FAM19A2 gene. This recitation renders the claim indefinite. It is unclear if the claim is requiring detecting exon 1 and exon 2 of FAM19A2 or if the claim is requiring detecting expression of FAM19A2 in which the gene during expression has exon 1 and exon 2. It is unclear what the limitations of claim 4 requires and how this limits the expression of FAM19A2.
Claims 3-4, 6-7 depend from claim 1 and are indefinite for the reasons applied to claim 1.
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 1-4, 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea and law of nature without significantly more.
Claim 1 recite a method for detecting follicular thyroid cancer. Claim 2 recites the higher expression of FAM19A2 in the subject than a reference value indicates a possibility that the subject has FTC. Claim 6 recites calculating expression of FAM19A2 as an absolute value or a relative value and comparing it with a cutoff value. The recitation of “detecting”, “calculating” and “comparing” encompass a mental process step which could be practiced in the mind. The practitioner necessarily needs to perform a comparison in order to determine that there is an elevated expression level in claim 2. For example the claims encompasses embodiments in which a practitioner evaluates a subject’s gene expression to ascertain that the expression level is elevated and indicative of follicular thyroid cancer.
The claims are directed to a law of nature. Claim 1 recites a method for detecting follicular thyroid cancer (FTC) and claim 2 recites the higher expression of FAM19A2 indicates a possibility that the subject has FTC. The claims recite a natural phenomenon which is a natural principle: an asserted correlation between elevated expression level and FTC. This conclusion is supported by the recited purposed of the claimed method as set forth in the preamble of claim 1 and recited in the wherein clause of claim 2.
These judicial exception are not integrated into a practical application because the steps recited in the claims in addition to the judicial exceptions are data gathering steps that do not apply or integrate the judicial exceptions in any way. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are data gathering steps recited at a high level of generality employing techniques that were well-established, routine and conventional at the time of the invention. The courts have recognized that amplifying nucleic acid sequences is a well-understood, routine, conventional activity in the life science arts when claimed in a merely generic matter. Here, the claims include steps of expression of mRNA and thyroid sample. Prior to the invention, Reyes (Cancer Biomarkers, 2019, 24:71-83) teaches obtaining thyroid samples from subject and detecting mRNA expression by microarray analysis, including analysis of FAM19A2 and Bathe (WO2021195727A1) teaches expression analysis of TAFA2 (FAM19A2) in thyroid samples (See para 7-8). This evidences that these steps were conventional at the time of the invention.
Claims 2, 6 further define the expression levels that are identified via the mental processes and thus only limit the judicial exceptions.
Claims 3-4 and 7, further limit the expression and sample, thus is a field of use limitation which does not amount to significantly more.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reyes (Cancer Biomarkers, 2019, 24: 71-83).
With regard to claim 1, 3, 6-7, Reyes teaches a method of gene expression profiling of papillary thyroid cancer. Reyes teaches the data was deposited in GSE3678 (see pg. 72). Reyes teaches thyroid samples were obtained from patients with thyroid cancer (see 2.2) (claim 7). Reyes teaches RNA amplification and cDNA analysis followed by hybridization to Affymetrix U133 plus 2.0 array (see 2.3) (detecting expression of FAM19A2) (claim 3). Reyes teaches expression analysis of the microarray data (See 2.4) (calculating expression of FAM19A2 as absolute or relative value and comparing to cutoff value) (claim 6). It is noted that claim 1 only active process step is detecting expression of FAM19A2 in a sample derived from a subject. The method of Reyes teaches detecting expression of FAM19A2 in a sample from a subject.
With regard to claim 2 and 4, Reyes teaches expression analysis of FAM19A2. Reyes in deposited data, GSE3678 teaches FAM19A2 is overexpressed. Probe position 241399_at which corresponds to FAM19A2 transcript has a value of 73.7249. Additionally because it is unclear what is encompassed by claim 4, claim 4 has been interpreted to require detecting expression of FAM19A2 which comprises exon 1 and exon 2, in the instant case FAM19A2 comprises exon 1 and exon 2. Additionally claim 2 only requires that expression indicates a possibility that the subject has FTC. A subject that has thyroid cancer will have a possibility of having FTC.
Claims 1-4 and 6-7 are rejected under 35 USC 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bathe (WO2021195787A1, published 10/7/2021 priority 4/3/2020).
Bathe teaches isolating RNA from a biological sample of a patient and determining RNA level to determine risk of PTC based on the level of expression of the genes (see para 7). Bathe teaches gene signature that comprises TAFA2 (FAM19A2) (see para 8). TAFA2 is another abbreviation for FAM19A2 gene. Bathe teaches the sample is a thyroid tissue sample (see para 59) (claim 7). Bathe teaches isolating RNA followed by RT-PCR, microarray analysis or RNAseq (see para 63-64) (claim 3-4). Bath teaches increased expression was determined (see para 135-136) (claim 2). Bathe teaches scores for gene signature for risk (see table 2) (calculating expression as a relative value and comparing to cutoff) (claim 6).
Additionally because it is unclear what is encompassed by claim 4, claim 4 has been interpreted to require detecting expression of FAM19A2, TAF2A, which comprises exon 1 and exon 2, in the instant case TAFA2 disclosed by Bathe comprises exon 1 and exon 2. Additionally claim 2 only requires that expression indicates a possibility that the subject has FTC. A subject that has thyroid cancer will have a possibility of having FTC.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
Prosecution Insights