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 .
Claims 1-5, 8-11, 14-29, are pending in this application.
Claims 6-7, 12-13, 30-35, are deleted.
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 27, 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.
The claim requires reading table 1, from the specification into it, contrary to several precedent decisions by the US courts. Adding the compounds to the claim will obviate the rejection.
Claim Rejections - 35 USC § 102
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 1-5, 10-11, 14-16, 18-21, 23-29, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al., WO2020/211872, which teaches the following compounds and compositions thereof, useful for treating FXR related diseases:
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, wherein R1, R2 are halogen, substituted alkyl, substituted alkoxyl; L is optionally substituted phenylene, 6-memebered heteroaryl; X is 5-memebered heteroaryl, substituted by oxo; m is 0-2; n is 1-2; p, q, are 0 (Ra, Rb are absent) or p, q, are 1, (wherein Ra, Rb, may form a bridge with the carbons they are attached). See the attached abstract.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 8-9, are rejected under 35 U.S.C. 103(a) as being unpatentable over Xu et al., WO2020/211872, alone or in view of Patani et al., Chem. Rev. (1996) 96, pp. 3147-3149.
Xu et al., teaches as set forth above under anticipatory rejection. In claims 8-9, applicant replaced H with F at one of Ra, Rb. From the substituents on L (phenylene) in the prior art, it is clear that H and F are equivalents.
Also, the invention is obvious in view of Patani et al., which teaches H and F are bioisosteres equivalents, and that it is a routine practice in the art to replace H with F. The prior art teaches the advantages of replacing H with F in pharmaceuticals. See the entire document, particularly, page 3149, C1, last two ¶s.
In the instant invention H and F are equivalents because, they are claimed as such, e.g. at positions R1 and R2.
A showing of sufficiently close structural relationship is enough to create an expectation of similar properties, in light of the totality of prior arts, that the new compound will have "similar properties" to the old. Motivation is found in the expectation that similar compounds will have similar properties. A disclosure of new property does not defeat such expectation. Dillon, 16 USPQ2d, 1897 (Fed Cir, 1990). In the instant and the prior art, the compounds are FXR modulators.
As held in KSR Int. Co. v. Teleflex Inc, 550 U.S. 82 USPQ2d 1385 (2007), “when a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, 103 likely bars its patentability. For the same reason if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
In the instant, it is not beyond the ordinary skill of a Scientist to use conventional technique in replacing one equivalent with another at the time the invention was made. This is deemed invention of reasoning, not of creativity, KSR.
Having known the compounds are equivalents and are expected to have similar chemical and biological properties, a POSA would have known and be motivated to make the substitution at the time the invention was made. There is reasonable expectation of success because such substitution is a routine practice in the art.
The claims are not allowable over the combination of the prior arts and knowledge well-known in the art.
Objection
Claims 17, 22, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form, including all of the limitations of the base claim and any intervening claims.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625 October 10, 2025