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 .
DETAILED ACTION
Election of Species and Status of the Claims
Applicant’s election with traverse of
Oxy210 as the ‘single specific compound’
Metabolic dysfunction-associated steatotic liver disease as the ‘single fibrotic disease’
Oral administration as the ‘single method of administration’
Resmetirom as the ‘single additional therapeutic’
in the response filed on October 10th 2025 is acknowledged.
Applicant argues that 25-hydroxycholesterol is outside the scope of Formula (I) because R1 and R1’ must include at least one OH group. Applicant’s argument is found persuasive and Dahlman there does not serve as prior art. However, additional 102 art remains (see below), and the election of species requirement is thereby maintained.
Claims 1-18 are pending. Claims 4-5 (directed towards fibrotic diseases with nonelected causes), 11 (directed towards a nonelected method of administration), and 15 (directed towards nonelected species of additional therapeutic) are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1-3, 6-10, 12-14, and 16-18 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on October 16th 2024, September 27th 2023, and April 26th 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
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.
Claims 1-3, 6-10, 12-13, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thies (US 2013/0274215 A1 published on October 17th 2013).
Claim 1 is directed to a method for treating a fibrotic disease comprising administration of a compound of Formula (I):
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Thies teaches the treatment of fibrosis via administration of 20α-Hydroxycholesterol:
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Thies (pg. 22, claim 1; pg. 23 claims 17-18; Figure 29).
Thies thereby anticipates claim 1.
Claims 2-3 limit the fibrosis of claim 1 to one such as liver fibrosis, and are anticipated by Thies, who teaches the treatment of liver fibrosis (Thies, pg. 23, claim 14).
Claim 6 is directed towards the method of claim 1 wherein the compound is administered after a fibrotic lesion has been developed. Thies teaches a method of reducing fibrosis (Thies, pg. 22, claim 1), which necessitates that a fibrotic lesion has been developed. Thies thereby anticipates claim 6.
Claim 7 requires that, in the method of claim 1, the compound inhibits expression of extracellular proteins associated with tissue fibrosis. Thies teaches the inhibition of TGF-ß signaling (Thies, pg. 22, claim 1), anticipating claim 7.
Claim 8 limits the dosage of claim 1 to 1 microgram/kg to 1 gram/kg body weight administered once a day or multiple times per day. Claim 8 is anticipated by Thies, who teaches dosage of 0.1 to 0.5 mg/kg body weight per day (Thies, pg. 18).
Claim 9 limits the form of the compound administered in claim 1 to one such as a pill. Thies teaches administration in pill form (Thies, pg. 17), anticipating claim 9.
Claim 10 limits the administration in the method of claim 1 to be by injection, infusion, instillation, inhalation, or ingestion. Thies teaches oral forms (Thies, pg. 17), which are administered via ingestion. Thies thereby anticipates claim 10.
Claim 12 limits the method of claim 1 to systemic administration. Thies teaches oral forms of administration (Thies, pg. 17), which are by their nature systemic. Thies thereby anticipates claim 12.
Claim 13 is directed towards the method of claim 1 further comprising administration of an additional therapeutic agent. Thies teaches administration of an additional therapeutic agent (Thies, pg. 19), anticipating claim 13.
Claims 16-17 require that the subject in claim 1 is a human. Thies teaches human subjects (Thies, pg. 7), anticipating claims 16-17.
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Thies.
Claim 14 limits the additional therapeutic agent administered in claim 13 to an anti-fibrotic agent. For the teachings of Thies as they are relevant to claim 13, see the above 102 rejection over Thies. Regarding the co-administration of an antifibrotic agent, while Thies does not explicitly teach co-administration of an antifibrotic agent, one of ordinary skill in the art would have a reasonable expectation of success in administering an anti-fibrotic agent as the “additional therapeutic agent” in Thies’ method for treating fibrosis, because anti-fibrotic agents are known in the art for said purpose. Claim 14 is thereby prima facie obvious.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Thies in view of Stappenbeck (Stappenbeck et al. Inhibition of Non-Small Cell Lung Cancer Cells by Oxy210, an Oxysterol-Derivative that Antagonizes TGFβ and Hedgehog Signaling. Cells. 2019 Oct 22;8(10):1297).
Claim 18 is directed towards the treatment of fibrosis with applicant’s elected species, Oxy210:
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Thies teaches the treatment of fibrosis via administration of inhibitors of TGF-ß (Thies, pg. 22, claim 1). Thies does not explicitly teach the administration of Oxy210, but one of ordinary skill in the art would have a reasonable expectation of success in treating fibrosis with Oxy210, because it is known in the art as an inhibitor of TGF-ß (Stappenbeck, Abstract). Claim 18 is thereby prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629