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
The amendment filed 09/18/2025 is entered. With regard to the Office action mailed 03/06/2025:
The objections to the specification/claims for failure to comply with 37 CFR 1.831-1.835 is withdrawn in view of the submission of the Substitute Sequence Listing and the amendments to the specification and claims providing appropriate sequence identifiers (SEQ ID NOs).
The objection to the specification regarding hyperlinks is withdrawn in view of the amendment to the specification.
The answer in response to the requirement for information under 37 CFR 1.105 is not adequate; this will be addressed below.
The rejections set forth under 35 USC 112(b) are moot as the rejected claims have been cancelled.
The rejection under 35 USC 102(a)(1) is maintained and reiterated below; applicant’s remarks will be addressed following the rejections.
The rejection under 35 USC 103 is moot as the rejected claims have been cancelled.
The rejection under 35 USC 101 is maintained and reiterated below; applicant’s remarks will be addressed following the rejections.
Requirement for Information (37 CFR 1.105)
In the previous Office action, the Examiner asked whether or not SEQ ID NOs 3 and 4 are found naturally in the genome of at least one member of the species Mastacembelus armatus. Based on Applicant’s answer (and applicant’s arguments to the rejection under 35 USC 101), Applicant appears to have not fully understood the question.
The Examiner wants to know whether the sequences of SEQ ID NOs 3 and 4 are found within the larger sequence of the Mastacembelus armatus genome. Or, to put it in Applicant’s terms, do the sequences of SEQ ID NOs 3 and 4 "match natural nucleic acids" found in Mastacembelus armatus? Applicant is required to answer this query in response to this Office action.
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.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) primers, which are fragments of naturally-occurring polynucleotides. See MPEP 2106.04(b), citing University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113; USPQ2d 1241, 1244 (Fed. Cir. 2014).
This judicial exception is not integrated into a practical application because the claim recites no additional elements beyond the primers per se. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as noted, there are no additional elements beyond the primers per se.
Evidence that the recited primers occur in naturally-occurring polynucleotides is found in GenBank accession number NC_046642.1 (previously cited).
GenBank accession number NC_046642.1 discloses a sequence from chromosome 10 of Mastacembelus armatus. Within this sequence can be found Applicant’s SEQ ID NO: 7 and 8:
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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.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Per MPEP 2153.01(a): “A disclosure made within the grace period is not prior art under AIA 35 U.S.C. 102(a)(1) if it is apparent from the disclosure itself that it is an inventor-originated disclosure. Specifically, Office personnel may not apply a disclosure as prior art under AIA 35 U.S.C. 102(a)(1) if the disclosure: (1) was made one year or less before the effective filing date of the claimed invention; (2) names the inventor or a joint inventor as an author or an inventor; and (3) does not name additional persons as authors on a printed publication or joint inventors on a patent.”
In this case, authors Yuwei Feng and Yuxin Wu are not listed as inventors on the application. Moreover, the article indicates Yuwei Feng contributed “supervision” and Yuxin Wu contributed “conceptualization”; see page 5, “CRediT authorship contribution statement”.
Applicant may overcome this rejection by either submitting a translation of the certified priority document as noted above, or submitting a declaration under 37 CFR 1.130(a), or by claim amendments.
Claims 1-4, 7, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al (Aquaculture 571:739498; available online 21 March 2023).
Regarding claims 1 and 2, Qin disclosed these primer pairs (see Table S4 of the Supplementary Material following the main article).
Regarding claims 3 and 9, Qin used these primers to amplify DNA prepared from Mastacembelus armatus, analyzed the amplification products by gel electrophoresis, and determined the subject was a female if one band was detected, or a female if two bands were detected. See figure 1.
Regarding claims 4 and 10, DNA was extracted with a DNA extraction kit. See page 2, section 2.1.
Regarding claim 7, Qin detected bands of these sizes. See figure 1.
Response to Arguments
Applicant's arguments filed 09/18/2025 have been fully considered but they are not persuasive. Regarding the rejection under 35 USC 101, Applicant argues:
Primer pair 1 (SEQ.ID NO.1 and 2) and primer pair 1 (SEQ.ID NO.3 and 4) are not naturally present in Mastacembelus armatus but are artificially synthesized tools. The primers of claim 2 are artificially designed and chemically synthesized oligonucleotide chains, whose sequences have been screened and optimized for specific amplification of target genes. Among them, the length of primer SEQ ID NO.3 is 22 bp, which is artificially optimized and different from the long-chain DNA in the natural genome. Although some sequences may match natural nucleic acids, their physical forms (such as single-stranded structure and specific length) and application scenarios (in vitro molecular detection) are not naturally occurring, and they are not naturally present in organisms. They are "products of human intellectual activity" and fall within the patentable subject matter as defined in Title 35, United States Code, Section 101.
This argument is not persuasive. It does not matter how the primers were made, or that they were screened and/or optimized for some particular purpose. As claimed, they are structurally indistinct from fragments of naturally occurring polynucleotides, and thus they are not patent eligible.
As to the rejection under 35 USC 102, Applicant argues:
In response, the applicant supplements and provides the DAS code of the priority document for this application: 541E. If you still cannot overcome this issue, the applicant is willing to subsequently provide a certified English translation of the priority document; or provide a statement signed by authors YUWEI FENG and YUXIN WU waiving the right to authorship of this invention application.
This argument is not persuasive. The issue is not obtaining the priority document. The priority document is already in the application file. The issue is that there is no certified English translation of said document. Providing a certified translation would perfect Applicant’s foreign priority claim and antedate the Qin reference. Alternatively, if applicable, Applicant could file a declaration averring that the subject matter relied upon from the Qin reference was solely the work of one or more of the named inventors on the application.
Conclusion
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 SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
1 As for claim 1, a similar analysis did not return evidence that SEQ ID NO: 3 is found within a naturally-occurring sequence. SEQ ID NO: 4 was found in an unrelated species. Thus, while SEQ ID NO:4 per se would be subject to the same rejection, SEQ ID NO:3 would not be.