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 6/9/2026.
Applicant’s election without traverse of Group I in the reply filed on 1/08/2026 is acknowledged.
Claims 1, 3-12, 14-18 are pending. Claims 2 and 13 have been cancelled.
Claims 3-12, 14-17 are withdrawn as being drawn to nonelected invention.
The following rejections are maintained. Response to arguetmsn follows.
This action is FINAL.
Withdrawn Objections and Rejections
The claim objections made in the previous office action is withdrawn based upon amendments to the claims.
The 35 USC 112b rejection and 35 USC 102 made in the previous office action is withdrawn based upon amendments to the claims.
The obviousness double patenting rejection made in the previous office action is withdrawn based upon the approval of the terminal disclaimer of 6/09/2026.
Maintained 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 and 18 are rejected 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) a gene combination which are products of nature as these oligonucleotides 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.
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]henomena 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 sequences which would include naturally occurring genes. This judicial exception is not integrated into a practical application because it conveys the same genetic information as the genes itself. 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 arguetmsn is provided below with response to arguments following. The reply asserts that the claims are drawn to gene combinations which were obtained using whole exome sequencing of renal cancer patient data (p. 9). The reply asserts that this required the inventive effort to combine the genes and that these are a specific gene combination than what is naturally occurring (p. 9). The reply asserts that the claims are integrated into a practical application (p. 9-10).
These arguments have been fully reviewed but have not been found persuasive.
Although the claims are drawn to a specific gene set combination, as noted in the response these genes are known in the prior art. As such these genes in the claims are the same as those that are naturally occurring. The fact that the genes are placed together in a “set” does not overcome the issue with regard to the fact that there is no structure that is not identical from nature. The reply provides that the claims are integrated because of the application to “human tumor grading”. However, the claims are drawn to a product and not a method. The structure of the claim do not require any more structure than the genes that are found in a naturally occurring population.
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.
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, 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
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