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
Claims 1-51 are currently pending in the instant application. Claims 1-51 are rejected in this Office Action.
I. Priority
The instant application claims benefit of Foreign Application EPO 23382983.7, filed on September 27, 2023.
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II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 29, 2025 and March 5, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Rejections
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that 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 section102 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.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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 1-36 and 38-51 are rejected under 35 U.S.C. § 103 as being unpatentable over Barda, et al. (US 2024/0043451 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Barda, et al. teaches compounds of formula I
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such as
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435
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(see compound 38 on page 26) which are KRAS inhibitors.
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Barda, et al. and the instant invention it that the instant compounds can have a methyl group at position of variable R6 whereas the prior art’s compounds have a hydrogen at this position. So the difference would be Me vs. H.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
In In re Wood, 199 USPQ 137, it was well established that hydrogen and methyl are deemed obvious variants. Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As was stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups.
For example, it is obvious to prepare a compound substituted with a methyl when the art teaches the same compound substituted with a hydrogen with a reasonable expectation of success. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare adjacent homologs based on the teachings of the preferred embodiments in the prior art. A strong prima facie obviousness has been established.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-51 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 12,351,591 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because:
Applicants claim
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188
679
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Determining the Scope and Content of the Issued Patent
Claim 1 of the issued patent claims
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475
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593
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The issued patent also claims various species such as
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(see compound 138, columns 769-770) in issued patent claim 31.
Ascertaining the Differences Between the Instant Application and the Issued Patent
The difference between the prior art of Barda, et al. and the instant invention it that the instant compounds can have a methyl group at position of variable R6 whereas the prior art’s compounds have a hydrogen at this position. So the difference would be Me vs. H.
Finding Prima Facie Obviousness
In In re Wood, 199 USPQ 137, it was well established that hydrogen and methyl are deemed obvious variants. Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As was stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups.
For example, it is obvious to prepare a compound substituted with a methyl when the art teaches the same compound substituted with a hydrogen with a reasonable expectation of success. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare adjacent homologs based claims of the issued patent. A strong prima facie obviousness has been established. As a result, the claims are rejected under obviousness-type double patenting.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWQUIA JACKSON/ Primary Examiner, Art Unit 1626
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