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 .
Applicant’s amendment and response filed on 12/24/2025 has been received and entered into the case.
Claims 2-4 and 6-11 have been canceled, claim 12 is newly added, and claims 1, 5 and 12 have been considered on the merits. All arguments have been considered.
Response to Amendment
The claim rejections under 35 USC 35 U.S.C. 112(a) and (b) have been withdrawn due to the instant amendment.
The claim rejection under 35 USC 101 to claims 6 and 10 has been withdrawn due to the instant amendment.
The claim rejection under 35 USC 102 has been withdrawn due to the instant amendment.
It is noted that the following claim rejection under 35 U.S.C. 103 has been modified to address the newly added claim (claim 12).
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) 1, 5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (of record).
Lei et al. teach a method of treating liver fibrosis induced by carbon tetrachloride (CCl4) injection in an animal model by administering siRNA against Hic-5, i.e. a Hic-5 inhibitor (Abstract; Fig. 3D-H; p.114).
Regarding the limitation directed to NASH, while the BDL as well as CCl4 induced liver fibrosis taught by Lei et al. are considered meet the NASH, Lei et al. do not particularly teach the limitation. While the CCl4 induced liver fibrosis of Lei et al. is not considered to represent NASH, however, it would have been obvious to a person skilled in the art to use the method of administering siRNA against Hic-5 to a patient having NASH with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because one skilled in the art would recognize that the reduction of fibrosis is produced by knocking down Hic-5 by according to Lei et al. indicating that the progression of liver injury caused by CCl4 to liver fibrosis is decreased by knockout of Hic-5. Thus, it would have been obvious for one skilled in the art to try to use the method of knocking out Hic-5 in a patient having NASH without liver fibrosis (i.e. early stage of fatty liver/NASH) in order to attenuate progression of NASH into liver fibrosis.
Regarding claim 12, the method taught by Lei et al. utilize siRNA against Hic-5 and thus, meet the limitation.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments with respect to the 102 rejection have been fully considered and are persuasive. The 102 rejection has been withdrawn.
As applicant established that the liver fibrosis and NASH are two different conditions and the arguments were persuasive to overcome the 102 rejection.
Regarding the 103 rejection, applicant alleged that the gene expression, e.g. TAZ, is highly expressed in liver of NASH model but absent in liver of CCl4 model; or Lei et al. do not teach that Hic-5 is upregulated in fatty liver. It is noted that the 103 rejection has been presented under the interpretation that CCl4 model of Lei et al. is different from NASH, and the teaching of Lei et al. is not relied upon any assumption that Hic-5 is upregulated in fatty liver. Rather, the claim rejection reasoned that one would reduce the expression of Hic-5 in NASH patients in order to prevent the progress of NASH to liver fibrosis as liver fibrosis is mediated by Hic-5 according to Lei et al. As NASH is defined by hepatic steatosis, inflammation, hepatocellular injury and fibrosis, one skilled in the art recognize that inhibiting Hic-5 attenuates liver fibrosis would be beneficial in treating NASH patients to attenuate liver fibrosis.
It is noted that Hic-5 deficiency attenuates hepatic stellate cell (HSC) activation and HSC activation leads to upregulation of Hic-5 by TGF-b according to Lei et al. (Background & Aim). It is also known in the art that the activation of HSC is also a key pathophysiology of NASH (Marcher et al. 2019; Scientific Reports). This teaching further supports the Examiner’s position that one skilled in the art would use the method of Lei et al. for the patients having NASH to attenuate liver fibrosis.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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, JAMES SCHULTZ can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAEYOON KIM/ Primary Examiner, Art Unit 1631