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
Status of the Claims
Claims 1-18 are pending. Claims 4-5, 11, and 15 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable.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.
35 U.S.C. § 102(a)(1) Rejections Maintained
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.
The rejection of claims 1-3, 6-10, 12-13, and 16-17 under 35 U.S.C. 102(a)(1) as being anticipated by Thies (US 2013/0274215 A1 published on October 17th 2013) is maintained.
Response to Applicant’s Arguments:
Applicant argues, in the response filed on June 26th 2026 that the compound of claim 1 differs from applicant’s compound genus in that it has a (=O) in the R8 position, wherein applicant allows for either an -H or -OH.
Regarding applicant’s argument, the compound upon which the 102 rejection was based, FT-1575-2, has the following illustrated structure:
PNG
media_image1.png
353
442
media_image1.png
Greyscale
.
It is acknowledged that the compound carries a carbonyl group in the R8 position. However, such a carbonyl would be recognized by one of ordinary skill in the art as a tautomer of the same chemical structure wherein R8 is an alcohol and a double bond is present. That is, the structure above would inherently be in equilibrium with its alcohol counterpart,
PNG
media_image2.png
348
430
media_image2.png
Greyscale
,
which is undoubtedly anticipatory of the compound presented in applicant’s generic structure. See MPEP § 2112.
As compound FT-1575-2 lies within the genus of compounds in claim 1, Thies remains anticipatory of applicant’s method, and the 102 rejections of claims 1-3, 6-10, 12-13, and 16-17 are maintained.
35 U.S.C. § 102(a)(1) Rejections Reiterated
Claim 1 is directed to a method for treating a fibrotic disease comprising administration of a compound of Formula (I):
PNG
media_image3.png
183
248
media_image3.png
Greyscale
.
Thies teaches the treatment of fibrosis via administration of compound FT-1575-2:
PNG
media_image2.png
348
430
media_image2.png
Greyscale
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.
35 U.S.C. § 103 Rejections Maintained
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 rejection of claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Thies is maintained.
As the 103 rejection of claim 14 relied on the reasoning in the 102 rejections above, it is maintained for the same reasons.
The rejection of claim 18 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) is maintained.
Applicant argues in the response filed on June 26th 2026 that one of ordinary skill in the art would not treat fibrosis using Oxy210, because Oxy210 is not recognized as an inhibitor of both Wnt and TGF, which Thies requires.
However, Thies very explicitly defines the motivation for such pathway inhibition. See Thies, paragraphs [0154] – [0156]:
Increased EMT/EnMT, prolonged myofibroblast activation, and increased deposition of extracellular matrix are features common to many fibroproliferative diseases, including but not limited to pulmonary fibrosis, liver fibrosis, kidney fibrosis, systemic sclerosis, and fibrosis arising from transplant rejection. The spectrum of affected organs, the usually progressive nature of the fibrotic process, the large number of affected persons, and the absence of effective treatment pose an enormous challenge when treating fibrotic diseases. Current treatments for fibrotic diseases typically target the inflammatory response, but there is accumulating evidence that the mechanisms driving fibrosis are distinct from those regulating inflammation. In fact, some studies suggest that ongoing inflammation reverses established and progressive fibrosis.
Accordingly, the present invention contemplates, in part, to provide compositions comprising inhibitors of cell signaling pathways that underlie the mechanism(s) of fibrosis that are common to most tissues, including without limitation, cell signaling pathways associated with EMT/EnMT, myofibroblast activation, and myofibroblast deposition of extracellular matrix. Without wishing to be bound to any particular theory, it is contemplated that fibrosis and fibroproliferative diseases can be more effectively prevented, reversed, treated, or ameliorated by inhibiting multiple signaling pathways associated with fibrosis.
Thus, by providing compositions that more effectively inhibit cell signaling pathways associated with EMT/EnMT, myofibroblast activation, and myofibroblast deposition of extracellular matrix, the present invention provides a much needed solution to a pandemic heath care crisis.
That is, one of ordinary skill in the art would have recognized that Thies’ approach was based on using a dual-pathway approach to inhibit epithelial-mesenchymal transition (EMT). In this regard, Oxy210 is recognized as a perfect candidate, as:
Oxy210 represents a substitution of a TGF-ß-signaling inhibitor
Oxy210 is a multi-pathway agent inhibiting both TGF-ß and hedgehog signaling
and most importantly,
The results of Theis’ anti-fibrosis methods rest entirely on the compounds’ activity in inhibiting EMT, upon which Oxy210 has been demonstrated to be effective (Stappenbeck, pg. 12).
One of ordinary skill in the art would thereby have a reasonable expectation of success in treating fibrosis with Oxy210, and the 103 rejection of claim 18 is maintained.
35 U.S.C. § 103 Rejection Over Claim 14 Reiterated
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.
35 U.S.C. § 103 Rejection Over Claim 18 Reiterated
Claim 18 is directed towards the treatment of fibrosis with applicant’s elected species, Oxy210:
PNG
media_image4.png
125
254
media_image4.png
Greyscale
.
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
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 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.
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, Jeffrey Lundgren can be reached at (571)272-5541. 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.
/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
