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 .
Status of the Claims
Claims 1-24, 29, 30, 32, and 34 are pending.
Claims 3-24 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 2, 29, 30, 32, and 34 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to methods of administering compounds of formula I to human subjects suffering from diseases involving uPAR/FPRs receptors, which in dependent claim 2 is identified as including systemic sclerosis. Claims 29 and 30 define compositions containing particular compounds of Formula I. Claims 32 and 34 define methods of treating particular diseases including systemic sclerosis with a composition according to Claim 28.
Response to Amendment
Applicants amendments to Claim 1 has addressed the issues raised by the Examiner in the previous office action concerning compliance with 35 USC 112(a) and 35 USC 112(b).
These rejections are therefore WITHDRAWN.
Applicants amendments to Claim 1 specifying that the patient population to be treated by the administration of any of the Markush-type listing of alternative compounds is a human subject has overcome the rejection of Claims 1, 25, 28-30, and 32 as being anticipated by Johnson.
This rejection has therefore been WITHDRAWN.
Applicants amendments to Claim 1, specifying that the Markush-type listing of alternative compounds no longer includes either of the 6-tert-butyl-2-[ (3-tert-butyl-5-chloro-2-hydroxy-6-methylphenyl )methyl]-4-chloro-3-methylphenol or 2-(2,5-dihydroxy-4-methylphenyl)-5-methylbenzene-1,4-diol recited by Zudaire as angiogenesis inhibitors suitable for use in a treatment of scleroderma has overcome the rejection of Claims 1, 2, and 25 over the combined teachings of Zudaire and Sugiyama.
This rejection is therefore WITHDRAWN.
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.
Claims 1, 2, 29, 30, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over White (U.S. PGPub. 2009/0192220) in view of Sugiyama (U.S. PGPub. 2017/0368131).
White indicates that compounds which are ACAT inhibitors also serve to act as inhibitors of angiogenesis. [0016; 0019-20; 0023; 0071-72]. White describes the compound bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane, synonymous with the 6,6’-methylenebis(2-(tert-butyl)-4-methylphenol of the instant claims, is just such an antiangiogenic ACAT inhibitor. “Table 1,” Pg.6. White indicates that these ACAT inhibitors may be administered by any suitable route, such as by the oral delivery of liquid solution formulations containing appropriate excipients for the chosen route of delivery. [0075-80].
However, White does not specifically enumerate systemic sclerosis, also known as scleroderma, among these angiogenesis related diseases capable of being treated by the administration of an antiangiogenic ACAT inhibitor.
This is cured by the teachings of Sugiyama, which indicates that scleroderma is treatable by the administration of agents which inhibit angiogenesis. [0002].
It therefore would have been prima facie obvious to have used bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane, synonymous with the 6,6’-methylenebis(2-(tert-butyl)-4-methylphenol of the instant claims taught as angiogenesis inhibitors by White in the treatment of scleroderma per the instant claims, owing to the fact that the art recognizes inhibition of angiogenesis is useful in the treatment of scleroderma, while also acknowledging that the compounds of the prior art are taught to be useful in the inhibition of angiogenesis.
Response to Arguments
Applicant's arguments filed 28 November 2025 have been fully considered but they are not persuasive.
Applicants argue that nothing of the art relied upon by the examiner establishes that a skilled artisan would have any reasonable expectation that the administration of a known angiogenic inhibitor such as the bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane of White would treat scleroderma by modifying the activity of uPAR/FPRs. Applicants argument on this point misstates the obviousness analysis in a number of ways. Applicants are reminded that the reason or motivation to modify a prior art reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). Applicants claims are to the treatment of a disease modulated by uPAR/FPRs, among which applicants claims specifically enumerate scleroderma, by the administration of any compound including the bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane of White. While the art of record may not have described the capacity of the bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane of White to modulate uPAR/FPRs, applicants are reminded that products of identical chemical composition cannot have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. In addition, applicants are reminded that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render an otherwise obvious method patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Here, the art indicates that the bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane of White is a known angiogenesis inhibitor, and the teachings of Sugiyama establish that the inhibition of angiogenesis treats scleroderma. Nothing more is required to establish a prima facie case of obviousness.
Applicants assertion that there is no reasonable expectation of success in utilizing this angiogenesis inhibitor in the treatment of scleroderma lacks the supporting evidence necessary to call into question the enablement of the prior art, and is unpersuasive as a result. Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness), see also In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)(the arguments of counsel cannot take the place of evidence in the record). The art of record demonstrates that he bis(2-hydroxy-3-tert-butyl-5-methylphenyl)methane of White is a known angiogenesis inhibitor, and the teachings of Sugiyama establish that the inhibition of angiogenesis treats scleroderma. Applicants offer no objective evidence to rebut the presumption of operability the prior art of record possesses, and their arguments fail to persuade as a result.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614