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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
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)(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) 20 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yue (US 20120041175 A1, of record). This rejection is maintained for reasons made of record in the Office Actions dated 3/27/2025, 7/14/2025 and for reasons set forth below.
Yue teaches methods of measuring Rubicon gene expression, either the Rubicon protein or mRNA, in a biological sample (¶’s [0076]-[0077]). As a practical application of such measurement of Rubicon expression, Yue teaches a correlation between increased Rubicon expression and a decrease in autophagy. Yue teaches that a decrease in autophagy is associated with many age-related and inflammatory diseases (¶’s [0034]-[0035], [0244]-[0251]). This teaching of a positive correlation between increased Rubicon expression and age-related symptoms or disease is considered to be a teaching of the recitation of a mental process to asses “risk” carried out by the skilled artisan in instant claim 20. Such mental process steps are considered abstract ideas (MPEP 2106.04(a)(2) III), not a positive method step, and thus not given significant patentable weight for the purposes of prior art interpretation.
The instant specification provides no limiting definition of the claimed “organ fibrosis”. Thus, the term is considered to encompass the accumulation of fibrous or scar tissue, typically due to chronic inflammation. One such example is in IBD, e.g. Crohn’s disease, which accumulates scar tissue in the intestines due to chronic inflammation. Yue et al teach their invention is used for the rick detection of chronic inflammatory diseases such as Crohn’s disease or hypertrophic scarring (raised, thickened scars) (¶’s [0070], [0245], [0248]-[0249]).
The biological sample may be from a subject and compared to controls (¶ [0161], Fig. 6, Fig. 16). Yue teaches administration of agents that decrease the activity of, or bind to, Rubicon in order to treat age-related diseases (abstract, ¶ [0052], [0071], [0132]-[0133]).
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) Yue does not teach organ fibrosis; 2) Yue does not provide a motivation or reasonable expectation of success.
Regarding 1) such is not convincing. The organ fibrosis limitation has been addressed above.
Regarding 2), Yue et al provides a literal motivation by teaching their invention to be useful in the detection of risk and treatment of the diseases cited. Regarding expectation of success, prior art is assumed to be enabling absent evidence to the contrary. Applicants have provided no such evidence that the skilled artisan could not practice the claimed invention given the disclosure of Yue et al. The claimed testing methods do not require the use of any animal models or clinical results of an effective treatment. Further, the claimed methods do not require any efficacious treatment, only administration. Finally it is noted the instant specification is devoid of any in vivo results that lead to an efficacious treatment of an organ fibrosis by administration of a molecule that suppresses a Rubicon gene or protein function. Therefore, the instant specification does not provide any innovation or improvement upon the teachings of Yue et al regarding the “administering” step of the instant method.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638