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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Note
In claim 5, the Examiner presumes that claim “4” was struck (though it is difficult to see), and that claim 5 now only depends from claim 3.
Claim Rejections - 35 USC § 112
Claims 11-13, 15 and 22-23 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.
Each of these claims depends from a claim that has been cancelled. As such, no interpretation of these claims is possible without making unwarranted assumptions, and these claims have not been further treated on the merits.
Claims 12, 20, 24 and 25 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.
As set forth in MPEP 2173.05(s), claims are to be complete in themselves. Reference to Table 2 is not permitted, since what is in Table 2 can be inserted directly into the claim.
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 1-3, 5, 7, 10, 17-19 and 28 are 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) a purported natural correlation between mutations that reduce the pore size of sodium leak channel NALCN and the presence, progression, stage and/or metastasis of cancer. This judicial exception is not integrated into a practical application because the additional elements (analyzing a tumor sample, determining the presence of a mutation compared to a reference, determining whether the mutation causes a reduction in pore size, computational modeling) are considered to be extra-solution activity (i.e. data gathering). See MPEP 2106.05(g).
Regarding claim 18, as set forth in MPEP 2106.04(d)(2), in order for “treatment” to be sufficient to integrate the judicial exception into a practical application, the treatment must actually be administered (nor merely “selected”). In addition, the treatment must be “particular”.
Regarding claim 28, merely implementing the method on a general purpose computer is not sufficient to integrate the judicial exception into a practical application; see MPEP 2106.05(f)(2) and 2106.05(b)(I).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited in the claims (i.e., those elements which are not part of the natural correlation itself, including the particular mutations or cancer types recited in the claims) were well-known, routine and conventional in the field of molecular diagnostics.
For example, Heider (US 2022/0017891, paragraph [0028]) disclosed obtaining and analyzing tumor samples for mutations compared to germline DNA obtained from the same subject.
Smart (Journal of Molecular Graphics, 14:354-360 (1996), IDS reference) disclosed computational modeling to determine pore dimensions.
Hughes (US 12,637,716) disclosed calculating a risk score for cancer (column 46, lines 50-56).
Wang (J. Gen. Physiol. 109:491-507 (1997)) disclosed determining ion-selectivity filter radius of a pore (see abstract: “Relative permeabilities were determined for all of the monovalent cations and anions…The relationship between the relative cation permeability and hydrated radius was modeled.”).
Williams (US 2023/0366030) disclosed selecting treatment based on presence or absence of mutations (paragraph [0083]).
Because the additionally recited elements of the claims (i.e. beyond the natural correlation) neither serve to integrate the natural correlation into a practical application nor amount to significantly more than the natural correlation itself, the claims are not patent eligible under 35 USC 101.
Claims 24 and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) “reagents” for detection of one or more mutations. This would encompass primers that are nothing more than fragments of the natural polynucleotides that contain such mutations. As discussed at MPEP 2106.04(b), such primers are patent ineligible (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 there are no additionally recited elements required by the claims. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additionally recited elements required by the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iamshanova (bioRxiv 13 August 2020, pages 1-22, IDS ref).
Iamshanova identified NALCN upregulation (thus, greater activity) during cancer progression and noted that NALCN was observed “only in highly aggressive [prostate cancer] cell lines, with little or no expression in weakly metastatic cells”. See first paragraph under “Results and Discussion”, page 4.
It would therefore have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application, based on Iamshanova’s findings, to use increased expression of NALCN (the numerical value of which can be considered a “risk score”) as a biomarker for prognosis of cancer.
Conclusion
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.
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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
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