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 3/03/2026.
Applicant's election with traverse of KCNA3 in the reply filed on 7/08/2025 is acknowledged. The traversal is on the ground(s) that there is no under search burden (p. 1). This is not found persuasive because the requirement for species is under the national stage application requirements which do not require a search burden.
The requirement is still deemed proper and is therefore made FINAL.
It is noted that the claims have been amended to require both NR2E1 and KCNA3 and therefore changing the species.
Claim 15-23 are pending. Claims 1-14 have been cancelled.
The following rejections are maintained with response to arguments following.
This action is FINAL.
Withdrawn Rejections and Objections
The Claim Objections made in the previous office action is withdrawn based upon amendments to the claims.
The improper marksuh rejection, 35 USC 112b, 35 USC 102 and 35 USC 103 made in the previous office action is withdrawn based upon amendments to the claims.
Maintained Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method of treating bladder cancer comprising obtaining a sample from a subject, measuring the level of methylation at a CpG site in KCNA3, identifying the subject having an increased level of methylation and administering a treatment for bladder cancer.
The claims are drawn to a very large genus of examining and comparing any CpG site increased methylation levels in any sample from any subject. The specification states that when unmethylation or hypermethylation occurs the expression of the gene is increased (p 7). The specification teaches that KCNA3 is unmethylated (p. 10) and as such based upon the definition of page 7 the expression of the gene is increased. The specification has not provided that methylation levels of KCNA3 is identified in any sample or any subject and administration of treatment for bladder cancer.
Based upon the description in the specification although the skilled artisan could readily use a methylation analysis for comparison, the artisan would first need to determine if it functionally detectable of origin or tissue type based upon the compassion of any number of CpG sites in KCNA3 and any number of methylation/unmethylation sites in a vast array of potential cells or tissue samples. The specification has not provided written support for the structures with the recited functionality.
Further, the art does not provide guidance to sufficiently describe relevant identifying characteristics or functional attributes that would distinguish different members of the claimed genus. In the instant case it is not clear that the functionality can be extrapolated to non-human individuals or in any sample based upon any methylome atlas. This finding is supported by Feng (PNAS 2010 Vol 107 No 19 pages 8689-8694). Specifically, Feng teaches that although DNA methylation likely has a conserved role in gene silencing, the levels and patterns of DNA methylation appear to vary drastically among different organisms (abstract).
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that "Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed." (See: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.) In the instant case, the specification fails to teach the necessary common attributes or features of the methylation of molecules to any methylome atlas in view of the species disclosed. As such, one of skill in the art would not recognize that applicant was in possession of the genus encompassed by the broadly claimed invention.
Response to Arguments and 37 CFR 1.132
The reply traverses the rejection. The reply does not provide any specific arguments. The declaration states that higher copy number of methylation of KCNA3 and NR2E1 provide stronger cancer specific methylation (p. 1). The declaration states that urine samples were collected from healthy and bladder cancer patients (p. 1-2). The declaration states that the combination of the two genes enhances detection sensitivity (p 2-3). The statements in the declaration have been considered but is not persuasive based upon the difference in scope. First it is noted that claim 15 is drawn to any control, whereas the declaration provides data based upon patients that do not have bladder cancer. Further the declaration is based upon only patients with bladder cancer or without bladder cancer, however, does not provide guidance to patients that are only suspected of having bladder cancer and diagnosis. Furhtermore the data provided is based upon urine measurements, however, the declaration does not provide support for the claimed “any sample”.
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 15-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract step without significantly more. The claim(s) recite(s) the judicial exception of an abstract step of “identifying the subject”. This judicial exception is not integrated into a practical application because the claims require steps of measuring the level of methylation it does not provide a step to integrate the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not integrate the judicial exception to steps that are not considered routine and conventional steps.
These judicial exceptions are not integrated into a practical application because the claims only recite the abstract ideas and routine and convention steps, wherein the routine and convention steps does not integrate the judicial expectation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are considered general and routine knowledge in the prior art as exemplified by the prior (as discussed below).
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, an abstract idea.
The step of identifying is considered an abstract idea as it would encompass looking at data
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the steps require only routine and convention steps and does not integrate the judicial exception to a practical application. Step d is drawn to administering however, the step is not integrated because regardless of step c the subject is administered a treatment.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No as the claims do not require any elements that integrate the judicial exception.
The steps that are not considered judicial expectations are the steps of determining methylation and treating a subject with a bladder cancer treatment. Feber et al. (US Patent Application Publication 2018/0305765 October 25, 2018) teaches obtaining a sample from a subject (para 265). Feber et al. teaches measuring the level of methylation of a CpG sites in KCNA3 (table 1). Feber et al. teaches identifying increased level of methylation at the CpG site relative to the control (para 98-102, 148-165, and Table 1). Feber et al. teaches treating the subject with a treatment for bladder cancer (para 173-178). Although Feber et al. does not teach NR2E1, the detection of a gene that is naturally occurring using general methylation assays such as those taught by the specification would be routine steps of naturally occurring data from genes.
The dependent claims only limit the claims to well-known samples and method steps to well-known methylation assays.
These methods are considered generic recitations of general methods of expression determination that do not overcome the rejection.
Response to Arguments
The reply traverses the rejection. The reply does not provide any particular arguments and as such the claim rejections have been maintained for the reasoning set forth above.
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
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