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 .1
This application has been reassigned from Examiner Shterengarts to Examiner William Lee, in Art Unit 1623. In order to expedite accurate processing of the application papers, all future correspondence with the office should reflect this change.
Status of Claims
Claims 1-7 are pending.
Election/Restrictions
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 10, 2026.
Applicant’s election without traverse of Group I, claims 1-6 in the reply filed on April 10, 2026 is acknowledged. The examined claims are directed to administering ebastine to a subject in need.
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CAS Reg. No. 90729-43-4
Ebastine is a known H1 antihistamine allergy medication and also known to increase cancer cell sensitivity to chemotherapeutic cancer drugs. See Applicant’s specification, page 4, lines 6-13.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 17, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “symptoms”, and the claim also recites “such as suppressing weight
gain and improving impaired glucose tolerance” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Further, regarding claim 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable Lim and Kim, EZH2 as a Potential Target for NAFLD Therapy. Int. J. Mol. Sci. 2020, 21, 8617, in view of Li et al. Antihistamine Drug Ebastine inhibits cancer growth by targeting Polycomb Group Protein EZH2, Mol Cancer Ther. 2020 October ; 19(10): 2023–2033.
Both Li and Lim & Kim are cited on the PTO-892 form.
Regarding claims 1 and 5, Lim and Kim teach Enhancer of zeste homolog 2 (EZH2) is a potential target for non-alcoholic fatty livery disease (NAFLD) therapy of a subject in need. See Title and Abstract. Lim and Kim teach that EZH2 has a critical role in liver inflammation and fibrosis (using a streptozotocin administered STAM NASH (non-alcoholic steatohepatitis) mouse model), as EZH2 expression causes liver inflammation and insulin secretion impairment, “resulting in a phenotype resembling advanced type 2 diabetes.” See page 5, last paragraph.
Lim and Kim state STAM NASH mice serve as a model of human NAFLD, from steatosis to fibrosis, where treatment with EZH2 inhibitors (EPZ-6438 or UNC1999) decreases the mRNA expression of inflammatory cytokines and fibrosis markers; Lim and Kim concludes EZH2 overexpression drives NAFLD progression, where pharmacologic inhibition of EZH2 could be a promising strategy for treating NAFLD. See bottom of page 5 bridging to top of page 6. See also Figure 2 on page 6, noting EZH2 inhibition of NAFLD, as well as progression of normal liver to NAFLD, to NASH to liver cirrhosis.
While teaching the subject in need of claims 1 and 5 (fatty liver and diabetes), Lim and Kim does not the administration of ebastine to the claimed subject in need.
To address this, Li et al. teaches “[w]e discovered an anti-histamine drug, ebastine, as a novel EZH2 inhibitor by targeting EZH2 transcription and subsequently downregulating EZH2 protein level. . . .” See Abstract. Additionally, Li teaches in “addition to ebastine, its metabolite, carebastine, also found to be elevated in the tumor of mice treated with ebastine and demonstrated to reduce EZH2 protein level. . . . “ See page 11, middle paragraph.
Prior to the filing of the present patent application, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) following the teachings of Lim and Kim to treat the claimed fatty liver and diabetes subjects in need via EZH2 inhibition, and based on Li teaching ebastine is a EZH2 inhibitor, as claimed (e.g., MPEP 2143 (a) combining prior art elements of Lim and Kim according to the method of EZH2 inhibition per Li to yield predictable results). The PHOSITA would have had a reasonable expectation of success because the cited prior art teach the claimed elements of the treatment of the claimed subject in need with the claimed sole compound, ebastine, via the mechanism of EZH2 inhibition.
Regarding claims 2 and 3, Lim and Kim teach the particular species of fatty liver disease, non-alcoholic fatty liver disease (NAFLD) via EZH2 inhibition. See Abstract as well as multiple instances throughout Lim and Kim. Further, Lim and Kim teach a species of NAFLD, non-alcoholic steatohepatitis (NASH). See page 1, bottom of page. Further, see bottom of page 5 bridging to top of page 6, noting STAM NASH mouse models treated with EZH2 inhibitors to decrease mRNA expression of inflammatory cytokines and fibrosis markers. See also Figure 2 noting NAFLD treated by EZH2 inhibition and progression of NAFLD to NASH.
Regarding claim 4, Lim and Kim teach the association of liver fibrosis with NAFLD pathogenesis, caused by inflammatory cytokines, mitochondrial dysfunction and oxidative stress. See page 1 first paragraph, Section Introduction.
Regarding claim 6 and the limitations of symptoms ameliorated, Lim and Kim teach and suggests treatment of diabetes, where it notes in a STAM NASH mouse model had liver inflammation and insulin secretion impairment resulting in a phenotype resembling advanced type 2 diabetes, where mice models were treated with EZH2 inhibitors. See bottom of page 5 bridging to top of page 6. With regard to the limitation of weight loss (suppression of weight gain), Lim and Kim note the association of weight with NAFLD, where weight loss is a known NAFLD management strategy. See bottom of page 1 bridging to top of page 2. Further it is known that treatment of type 2 diabetes is associated with improved glucose tolerance. Thus, treatment of NAFLD via drug therapy as claimed would provide an effect of ameliorating symptoms, in particular, suppressing weight gain and improved glucose tolerance.
Conclusion and Correspondence
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 FOREIGN APPLICATIONS
KOREA, REPUBLIC OF 10-2023-0023711 02/22/2023
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