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 .
This action is in response to papers filed 12/15/2025.
Applicant’s election of Group II and the species of miR-4443 in the reply filed on 7/24/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-6, 13-17 and 19-20 are pending. CLiams 1-6 and 19-20 are withdrawn as being drawn to a nonelected invention.
It is noted that the elected species of MiR 4443 has been cancelled and as such the next species will be examined. As such claims 16-17 have been rejoined.
Claims 7-12 and 18 have been cancelled.
The following rejections for Claims 13-17 are modified or newly applied as necessary by amendment. Response to arguments follows.
This action is FINAL.
Claim interpretation
The claims are drawn to a kit. The kit requires “reagents necessary to determine in a sample…”. Therefore the claims are interpreted as requiring “reagents”. It is noted that the recited ratios of biomarkers do not necessarily limit the reagents required by the kit.
Withdrawn Rejections
The 35 USC 112b and 35 USC 112d and 35 USC 102 rejections made in the previous office action is withdrawn based upon amendments to the claims.
Modified 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 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. The claim(s) recite(s) reagents that can encompass reagents such as miRNAs and water which represent fragments of naturally occurring nucleic acids. This judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the structures do not include anything other than a component that is found in nature. The recitation samples encompasses fragments of products of nature.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106.
Regarding judicial exceptions, “[p]phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II. The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, (2013).
The claimed invention is directed to naturally occurring fragments of a naturally occurring nucleic acids as the claims encompass fragments of the samples that are naturally occurring. These molecules are not patent eligible, whether isolated or not, pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics Inc., US (June 13, 2013). The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. This judicial exception is not integrated into a practical application because they convey the same genetic information as their naturally occurring counterparts. In Myriad v. Ambry CAFC 2014-1361,1366, December 17, 2014, the CAFC further (regarding a claim directed to a pair of primers) stated “In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the probe or primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here—the probe hybridizes to its complementary nucleotide sequence. Thus, just as in nature, probes utilize the innate ability of DNA to bind to itself.”
Response to arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following. The reply asserts that the claim has ben amended to recite that the reagents necessary to determine the ratio of expression levels of at least one biomarker from miRNA pairs consisting of particular miRNA pairs (p. 6). The reply asserts that there is nothing natural about providing reagents necessary to determine the ratios (p. 6).
This argument has been review but have not been found persuasive.
The reply appears to asserts that the “the reagents necessary to determine the ratio” would require structure that is not naturally occurring. However, the structure claims is broad as it only requires reagents that would be capable of determining a ratio. Ratios are mathematical components and therefore do not limit a structure of reagents. It appears that the reagents are based upon compositions that are used in the techniques listed in claim 13. Regents therefore would encompass any of these types of reagents including water, buffer, polymerases, for example. As such the claims broadly encompass components that are not different from those naturally occurring.
Newly Applied Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US Patent Application 2012/0045748 Fub 23, 2012)
With regard to claim 13,16-17 Wilson et al. teaches reagents for assaying to determine ratios of miR21 and miR106a (see 179-181). As such Wilson et al teaches “reagents necessary to determine”. With regard to the preamble, this is interpreted as the intended use of the claims. As Wilson et al teaches the claimed structure it would be capable of the recited intended use of “necessary to determine”.
With regard to claims 14-15 Wilson teaches urine and tissue samples (para 223). It is further noted that the sample is not included in the kit, rather only the reagents and as such the samples are not required by the structures of the kit.
Conclusion
No claims are allowed.
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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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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 at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682