DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed September 8, 2025. Currently, claims 4-9 are pending. Claims 4-8 have been withdrawn as drawn to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
The 102 rejection over NEB has been withdrawn in view of the amendments to the claims to require particular buffers and enzymes and endonucleases.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-3 in the paper filed September 8, 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to foreign application CHINA 202210638902.2, filed June 7, 2022.
It is noted that a translation of the foreign document has not been received.
Drawings
The drawings are acceptable.
New Matter
Newly added Claim 9 is rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the amended claims, reference to “high activity Taq enzyme” is included. The amendment does not point to support for “high activity” Taq enzyme. However, the specification does not describe or discuss “high activity Taq enzyme”. Instead, the specification describes Taq polymerase. This description does not support high activity Taq enzyme. The concept of “high activity Taq enzyme” does not appear to be part of the originally filed invention. Therefore, “high activity Taq enzyme” constitutes new matter. Applicant is required to cancel the new matter in the reply 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.
Newly added Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, the rejected claim(s) do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
Briefly, Claim 9 is rejected because the claim is drawn to a primer and probe group. The claim then lists SEQ ID NO: 1-2, 5-11. Claim 9 is directed to a kit with PCR mix, buffer, Taq enzyme, labeling mixture, endonucleases and Buffer.
Claim 9 is directed to nucleic acid fragments from the goat genome, i.e. known naturally occurring nucleic acids. The specification teaches the SRY gene was JN561348, the GAPDH gene is NM_001190390 and PIS is on chromosome 1 NC_030808.1. These are naturally occurring nucleic acids. Such isolated nucleic acid molecules, that are identical to fragments of naturally occurring nucleic acid molecules are not patent eligible subject matter, i.e. they are judicial exceptions to patentable subject matter.
MPEP 2106.04(b)(II) discusses products of nature. The MPEP specifically discusses DNA, primers and probes. The isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). The MPEP further states the “product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.").” The Federal Circuit in Ambry Genetics reviewed “[t]he Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, the same length as the primer claims at issue here, suggesting that even short strands identical to those found in nature are not patent eligible. Compare ’492 patent col. 170 ll. 32–38, with ’282 patent col. 153 ll. 66–67.”
In the instant case, the claims, embrace probes and primers that are identical to naturally occurring gene fragments and clearly read on nature-based products that themselves do not exhibit markedly different characteristics from the naturally occurring gene. See e.g. Myriad in which one claim at issue was drawn to “[a]n isolated DNA having at least 15 nucleotides [an isolated DNA coding for a BRCA1 polypeptide having the amino acid sequence of SEQ ID NO: 2] (Myriad at 2113). The Court recognized that this claim, if valid, would have given Myriad exclusive right to isolate any strand of 15 or more nucleotides of an individual’s BRCA1 gene (paragraph bridging 2113 and 2114). This is directly analogous to the instant situation wherein Applicant’s claims cover probe and primer molecules that are fragments of a naturally occurring goat genome sequence. The Court held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”, and that “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2118). The Court found that while Myriad had located and sequenced an important gene, Myriad had not created anything, and that “separating that gene from its surrounding genetic material is not an act of invention” (page 2118). Consistent with the findings of the Court in Myriad, the Office finds that the primers and probe molecules embraced by the instant clams are not patent eligible compositions of matter regardless of whether or not they are isolated from the genome. The Guidelines indicate that a change in biological function or activity maybe a characteristic of an isolated product that can provide a marked difference sufficient to distinguish over a naturally occurring product. However, in this case, as in the Ambry case, the function of the nucleic acids is the same function as the relevant portion of the naturally occurring sequence. Just as in nature, primers and probes utilize the innate ability of DNA to bind to itself.
Having established that the claims include a naturally occurring product that is a judicial exception, it must now be determined whether or not the claims recite an element or combination of elements that amount to significantly more than that exception, and whether those additional elements also amount to significantly more for the other claimed exception(s), which ensures that the claim does not have a preemptive effect with respect to any of the recited exceptions. To determine whether a claim that includes a nature-based product limitation recites a “product of nature” exception, an analysis is performed in which it is first determined if a claim includes a nature-based product that has markedly different characteristics from the corresponding naturally occurring product, and if it does not, then it is determined whether or not other elements of the claim are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself (see the Interim Guidance on Patent Subject Matter Eligibility published 12/16/2014 in the Federal Register at pages 74618-74633). In order to be markedly different, the claimed product must possess at least one characteristic that is different from that of the counterpart.
In the instant case, Claim 9 recites additional elements, i.e. kit comprising PCR Mix, Buffer, Taq Enzyme, labeling mixture, endonucleases and Ligation Buffer. The kit limitation provides no significant addition to the judicial exceptions already claimed that would prevent the claims from having a pre-emptive effect on the use of the judicial exception. The presence of a “tube" in a composition comprising a nucleic acid is entirely conventional and does not represent a modification that amounts to something significantly more than the judicial exception. The fact that these natural products are organized into a kit with an intended use adds nothing to the judicial exceptions that would distinguish them from the naturally occurring material. The kit must be considered in the context of whether or not the combination can provide some way of ensuring it does not limit the public’s access to the naturally occurring material. That does not occur in this case because the naturally occurring material exists as a distinct entity within the kit, and is not integrated in terms of form or function with any other element of the kit.
The naturally occurring nucleic acids and the additional PCR mix, buffers, endonucleases and DNA ligation Buffer do not occur together in nature, so there is no naturally occurring counterpart mixture for comparison, and so the claimed mixture is compared to its naturally occurring components. The enzymes, endonucleases and ligases are naturally occurring, so neither components would be eligible as claimed on their own. As written, the claim does not require the components of the kit have been mixed together, thus the claimed kit as a whole does not display markedly different characteristics compared to the naturally occurring counterparts (see 101 Examples 10, claim 1 and Example 28, claim 3, for example).
Therefore, the claims are properly rejected under 35 USC 101 as being drawn to patent-ineligible subject matter.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Newly added Claim 9 is 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 pre-AIA the applicant regards as the invention.
Claim 9 is directed to 5 pairs of specific primers: SRY F and SRY R, for example. The claim then recites “shown as SEQ ID NO: 1”. The metes and bounds of “shown in” are unclear. It is unclear whether the claims are directed to a primer comprising SEQ ID NO: 1, a primer consisting of SEQ ID NO: 1 or a fragment of SEQ ID NO: 1, for example. The metes and bounds of the claimed invention are unclear.
Response to Arguments
The response traverses the rejection. The response asserts “shown in SEQ ID NO: 1” limits the sequences in the claims to identical sequences. This attorney statement does not render the claim definite. In the event applicant intended the claims to be primers consisting of SEQ ID NO: 1-2, 5-11, the claims should be amended to require and clarify the limitations. Thus, for the reasons above and those already of record, the rejection is maintained.
Claim 9 contains trademark/trade names to reagents. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe buffers and PCR mixes and, accordingly, the identification/description is indefinite. Gold Star Super PCR Mix is a trademark. A search of the art did not provide any information about “Golden” Star Super mix. T4DNA ligation Buffer is also not found in the art. The art teaches a T4DNA ligase buffer that does not have a set composition. Correction is required.
The term “high-activity Taq” in claim 9 is a relative term which renders the claim indefinite. The term “high activity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Simon et al. (Animal Genetics, Immunogenetics, Molecular Genetic and Functional Genomics, Stichting International Foundation for Animal Genetics, Vol. 51, pages 439-448, February 14, 2020) teaches genomic features of the polled intersex syndrome variant in goats. Simon teaches a structural variant consisting of a deletion with a total length of 10,159bp and an inversely inverted 480kb duplicated segment of a region. Simon identifies wild-type primers, variant 1 and 2 primers and sex linked primers (namely AMELXY, not SRY) for a multiplex amplification (see Supplemental Table 4). The start position of the primers for the wildtype are Chr1:129424628-12925025 which is the positions identified in Figure 1 of the instant application. While the primers appear directed to the same size variants and the same region of Chromosome 1, the prior art does not teach the claimed probe or the collection of primers.
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Li et al. (bioRxiv preprint doi: 10.1101/2021.12.20.473573, “Fine Mapping of goat polledness variant in six Chinese native breeds, December 21, 2021) teaches left fusion and right fusion for gRBPR2 and glbpf3 (see Figure 2). The breakpoints are 129424780-150818100 and 150,342,286-129,434,940 which are the same regions as the instant variants. While the primers appear directed to the same size variants and the same region of Chromosome 1, the prior art does not teach the claimed probe or the collection of primers.
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Applicant's amendment necessitated the new ground(s) of rejection presented in
this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
February 5, 2026