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 .
Priority
This application is a 371 of PCT/EP2022/060546 (04/21/2022)
and claims foreign priority to EP 21169916.0 (04/22/2021).
Status
Rejections not reiterated in this action are withdrawn.
Election/Restrictions
Applicant's election with traverse of Group I, a product of formula (I), current claims 41-52, in the reply filed on 3/9/26 is acknowledged. The traversal is on the ground(s) that the office has not explained how unity was destroyed by the cited art. This is not found persuasive because unity was destroyed by both the cited art and the lack of a technical feature linking the claims that is a significant structural element.
The requirement is still deemed proper and is therefore made FINAL.
Applicant also elected the following species:
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determined to read on claims 41-52.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
New 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.
Claims 41-52 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 41 was amended with the following new language:
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which is ambiguous as to how the “proviso” applies to the claim scope. For example, claim 54 has species of
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where A is a-1 and B is b-1 (
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) where R3 is hydrogen, however the scope appears to conflict with the following new language:
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which could exclude compound 6 due to the proviso.
As a result, one of ordinary skill in the art would find the claim language confusing and ambiguous as to the limiting effect of the “proviso”. Therefore, claim 41 and those that depend therefrom are rejected as indefinite.
New 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.
Claims 41-52 are rejected under 35 U.S.C. 103 as being unpatentable over Durrenberger et al. (WO2017068089, cited in IDS 2026-07-29) in view of Gaba et al. (European Journal of Medicinal Chemistry 76 (2014), p. 494-505).
Durrenberger teaches ferroportin inhibitors including compound 127 (claims 1, 31) with the following structure:
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As well as a genus of formula (I) wherein the benzimidazole ring may be substituted by groups including phenyl and pyridyl (claim 1, p. 7-17) with utility in treating inflammation (claim 43, p. 67).
Durrenberger teaches a genus that encompasses the instant claims but does not teach species that anticipate. Durrenberger’s species differ from species in the instant claims such as compounds 18 and 19 by the substituent on the benzimidazole, either phenyl or pyridyl.
Gaba reviews the benzimidazole scaffold is known to be a core structure in anti-inflammatory agents (Title, Abstract). Gaba teaches the benzimidazole structure is substituted as follows while maintaining anti-inflammatory activity:
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Gaba teaches examples of anti-inflammation compounds with in vivo experimental data including the following (p. 496-407, Scheme 2):
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wherein the benzimidazole is substituted by phenyl and pyridyl.
According to MPEP 2144: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
In this case the Durrenberger teaches a genus encompassing the claimed compounds as well as species differing only by a substituent which Gaba teaches was a known modification of the same core structure that would result in compounds with the same utility of being anti-inflammatory. Thus, one of ordinary skill in the art would have been motivated to make the compounds within the scope of Durrenberger as guided by the substitutions taught as successful by Gaba and have a reasonable expectation of success to arrive at the instantly claimed compounds including compounds 18 and 19.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success and the claims are prima facie obvious.
New Double Patenting Rejection
Claims 41-52 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18694175 (reference application) in view of Durrenberger et al. (WO2017068089, cited in IDS 2026-07-29) in view of Gaba et al. (European Journal of Medicinal Chemistry 76 (2014), p. 494-505). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application in claim 9 has compounds such as compound 42 which anticipates and renders obvious the instant claims and would be prima facie obvious to one of ordinary skill in the art. MPEP 2144.09 (“Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).”). The claims are rendered obvious in view of the prior art for the same reasons provided in the 35 USC 103 rejection supra.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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