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 .
Election/Restrictions
Applicant's election with traverse of Group I with the addition of compound 009
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as the elected compound species in the reply filed on 04/20/2026 is acknowledged. The traversal is on the ground(s) that the pending claims necessarily possess unity, or that all pending claims are automatically entitled to examination based solely on the amendment and the asserted between elected compound 009 and compound 001. This is not found persuasive because the original election of species practice was based on the determination that multiple disclosed species were patentably distinct. Deletion of previously claimed embodiment does not, by itself, establish that all remaining claimed subject matter is directed to a single patentably indistinct inventive or otherwise eliminate the effect of the prior election.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Priority
The present invention claims priority to the following applications: Chinese Patent Application No. 202210101639.3 filed with China National Intellectual Property Administration on Jan. 27, 2022, and Chinese Patent Application No. 202210340109.4 filed with China National Intellectual Property Administration on Apr. 1, 2022, and Chinese Patent Application No. 202110706921 .X filed with China National Intellectual Property Administration on Jun. 24, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2023 has been considered by the examiner.
Status of Claims
Claims 1-6 and 10-19 are pending Claims 7-9 are canceled. Claims 6 and 18-19 are withdrawn. Claims 1-5 and 10-17 are examined in accordance to the elected species.
Claim Rejections - 35 USC § 103
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 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 1-5 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmed et al. (US11,787,834 B2) in view of Ai-Harbi et al. (Bioorganic Chemistry, 90 (2019) 103088, pages 1-9) and Song et al. (Bioorganic & Medicinal Chemistry, Letters, 2020, 126826, pages 1-7).
Ahmed teaches compounds of Formula (I), or a pharmaceutically acceptable salt thereof, as glucocorticoid receptor agonists, wherein the compound of Formula I, or pharmaceutically acceptable salt thereof is useful for treating autoimmune and inflammatory diseases, such as atopic dermatitis and rheumatoid arthritis. (See Abstract and lines 27-35 of column 1.) Moreover, Ahmed teaches a pharmaceutical composition comprising the compound of Formula I, or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable carrier, diluent, or excipient. (See lines 39-43 of column 12.) Ahmed further teaches compound 8
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as one of the compounds species of formula I. (See Table 18a columns 89/90.)
Ahmed does not teach the elected compound. The difference between Ahmed compound and the elected compound is as follow:
Ahmed Compound Elected Compound
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However, Al-Harbi teaches benzodioxole moiety is a privileged medicinal scaffold exhibiting numerous pharmacological activities, including anti-inflammatory activity. (See Abstract, last paragraph of the left column and second paragraph of the right column of page 1; and figure 1.) Moreover, Al-Harbi teaches benzodioxole derivatives have been investigated as anticancer agents because of their favorable bioavailability and low toxicity (See second paragraph of the left column of page 2.)
Song teaches medicinal chemists intentionally introduced benzodioxole into lead compound as a routine structure-activity technique (fig. 3 and page 2.)
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to select compound 8 of Ahmed as a suitable lead compound, because Ahmed teaches compound 8 as one of the specifically exemplified glucocorticoid receptor agonist compounds of formula I. Because Ahmed identifies compound 8 as a representative species of its disclosed glucocorticoid receptor agonists, one of ordinary skill in the art would have reasonably considered compound 8 as a suitable starting point or lead compound for further medicinal chemistry optimization. One of ordinary skill in the art would have been motivated to modify the terminal aromatic substituent of Ahmed’s selected compound 8 by incorporating the known 1,3-benzodioxole-containing aromatic pharmacophore taught by Al-Harbi, as further exemplified by Song, because Al-Harbi teaches that 1,3-benzodioxole moiety is a privileged medicinal scaffold exhibiting numerous pharmacological activities, including anti-inflammatory activity, and is deliberately incorporated into lead compounds to produce biologically active agents possessing favorable bioavailability and toxicity profiles. Song teaches that incorporation of a 1,3-benzodioxole group into lead compounds was routine structure-activity optimization strategy employed by medicinal chemist to obtain compound with improved biological properties. Accordingly, one of ordinary skill in the art would have had reason to modify Ahmed’s glucocorticoid receptor agonist by substituting the terminal aromatic pharmacophore with a known benzodioxole-containing aromatic system while retaining the remaining glucocorticoid receptor agonist scaffold, with a reasonable expectation of success of obtaining another biologically active glucocorticoid receptor agonist.
Conclusion
Claims 1-5 and 10-17 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEAN P CORNET/Primary Examiner, Art Unit 1628
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