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 .
Power of Attorney
The informal power of attorney has not been accepted. See paper mailed 5/14/2025.
Applicants’ amendment
Applicants’ amendment filed 8/6/2025 has been received and entered. Claims 1, 4, 7, 8 11 and 12 have been amended, claims 5 and 6 have been cancelled.
Claims 1-4, 7-12 are pending
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 1/22/2025 was acknowledged, and was found that examination of all the groups can be done without serious burden. Accordingly, the restriction requirement was withdrawn.
Claims 1-12 drawn to a method of analyzing precursor RNA, an information processing apparatus to perform the method and non-transitory medium containing a computer program are currently under examination.
Priority
This application filed 8/5/2021 is a 371 national stage filing of PCT/JP2020/004901 filed 2/7/2020 and claim benefit to foreign applications JP2019-021463 filed 2/8/2019 and JP2019-21279 filed 11/29/2019.
Receipt was acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 8/5/2021.
No comment on the summary is provided in Applicants remarks.
Information Disclosure Statement
It was noted that the listing of references in the specification is not a proper information disclosure statement. See for example starting in [0004] and throughout the specification.
No new IDS nor comment has been made in Applicants remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Response to Applicants Comments
Applicants indicate that no comment will be made on the examiner’s evaluation, and that alternative construction post allowance are maintained.
In response, it is noted that claim 4 has deleted these embodiments, and viewing no arguments or specific comments, the analysis provided for ‘an acquisition unit configured’, ‘an analysis unit configured’, ‘a search unit configured’ and ‘an output unit configured’ are not of issue in the pending claims.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7-11 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 is withdrawn.
Amendments to the claims to remove the particular limitations of units and modules has addressed the basis of the rejection.
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 1-4, 7-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim analysis
The claims have been amended and still are generally directed to a method which analyzes the effect of compounds on RNA splicing. More specifically, the claims have removed the different modules and units for analysis and added in more detail the splice patterns which are to be assessed in RNA processing to mRNA. Given the guidance of the specification, the claims require analyzing precursor mRNA for splice variation, assessing the ability of a substance to alter the observed splice variation.
Dependent claims recite that the compounds be Kampo medicine or Juzen-taiho-to. The claims also provide for an apparatus and a non-transitory medium which provides the instructions required of the analysis. In view of the teaching of the specification the invention is based in part on the observation that Kampo medicine and Juzen-taiho-to affect RNA splicing in eukaryotic cells, thought the broadest claims encompass any substance.
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a process and product. Here the method of analysis of RNA splice information can be stored on a non-transitory medium or practiced with an apparatus.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of accessing sequence data for splice variants which were produced in the presence or absence of a substance which may or may not affect splicing. The steps to assess different variants can be practiced by aligning and comparing sequences to arrive at the identification of variant sequences and are considered instructional steps for determining the presences or absences of possible splice variants. The judicial exception is a set of instructions for analysis of sequence data and appear to be a Mental Processes, that is concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Here the evaluation of splice variation can be determined by observation of the data. The breadth of ‘acquisition’ ‘analysis’, search’’ and ‘output’ encompasses non-transformative visual assessment of data, possibly coupled to prior knowledge for the affect of a substance on splicing. This breadth does not impose a meaningful limit on the claim scope, such that all others are not precluded from using the natural principle of observing changes in splicing under different conditions with various substances. Although the claims recite the use of an apparatus or CRM to practice the analysis, they do not appear to integrate a judicial exception into a practical application; for example, merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f). The steps required of the analysis are very generally recited, the combination of which together reasonably interpreted as mere data gathering and analysis. Computing, constructing datasets and using statistical models if needed for quantitation was well understood, conventional, and routinely performed in the art at the time the application was filed. The claims appear to fall into the category of Mathematical Concepts to the extent quantitation is required, as it applies the use of statistics and mathematical relationships in the analysis, and also into the category of mental processes, as concepts performed in the human mind (including an observation, evaluation, judgment, opinion) because there is no apparent complexity to or amount of data that is collected and analyzed as presently claimed.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims do not have an additional element to which the judicial exception is applied. It simply requires having or obtaining the data from some source and analyzing the data to determine if any changes are observable. This judicial exception requires steps recited at high level of generality and are only stored on a non-transitory, and is not found to be a practical application of the judicial exception as broadly set forth.
For step 2B of the 101 analysis, claims 4 and 12 provide for products, however these do not appear to be new or unique devices rather appear to be a general purpose computer and/or memory source for the analysis instructions. As such, the claims do not provide for any additional element to consider under step 2B beyond using a general purpose computer to analyze possible splice variant data. It is noted that in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process." Here, for the products the claimed method of analysis of claim 1 can be practiced using a computer, howe there is not specialized computer needed, nor do method steps of analysis appear to materially affect the computer function given the evidence of record. While the instruction are stored on a medium and could be implemented on a computer, together the steps do not appear to result in significantly more than a means to compare sequences of possible variants. The judicial exception of the method as claimed can be performed by hand and in light of the previous claims to a computer medium and in light of the teaching of the specification on a computer.
Response to Applicants arguments
Applicants argue that the claims inherently provide an improvement over the art, noting [0047] for enabling exons to be joined properly.
In response, the claims are directed to a method of research and observation and do not require any inherent outcome as argued. While Kempo medicine may alter RNA processing, the claims simply require observing any possible changes which can be assessed by observing the removal state as required of the claims.
As noted previously, one way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 7, 8, 11 rejected under 35 U.S.C. 102(a) as being anticipated by Salton et al. is withdrawn.
Response to Applicants arguments
It is agreed that the amendments to the claims provide for limitations which are not disclosed by the teaching of Salton et al. which only provide an overview that pre-mRNA splicing is a fundamental process in mammalian gene expression and alternative RNA splicing plays a considerable role in generating protein diversity.
Conclusion
No claim is 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.
In addition to Salton et al, Nishi et al is evidence that the analysis in deconstructing the traditional Japanese medicine “Kampo” and providing detailed analysis of compounds, metabolites and pharmacological profile. In review, while Kampo is well known and an area of active research, there is no evidence that it would affect RNA splicing, nor in review of the various compounds comprised in Kampo that any of them were known to have an affect on RNA splicing as required of the dependent claims. While there appears to be a wide variety of compounds and proteins known to affect RNA splicing, there does not appear to be any knowledge or motivation to analyze Kampo for possible affects (as clearly provide in Okada et al. 2023).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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/Joseph Woitach/Primary Examiner, Art Unit 1687