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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 07/11/2024, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
I. Claims 285-293are rejected under 35 U.S.C. 103 as being unpatentable over Lin (WO2021/226546A1).
For claim 285-291:
Lin teaches the following compound:
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, wherein R1 is recited alkyl and trifluoro alkyl groups, for example 1,1,dimethylethyl, trifluoromethyl etc.; R2 is 1,1-dimethylethyl, R3 is gamma-lactamyl; R4 is
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or
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[see Fig. 10; claims 11, 15, 25].
Above compound with the above definitions reads applicants compound.
Difference is that Lin silent on exemplifying the applicants compound(s).
However, Lin described and provided enough guidance, therefore, a skilled person in the art can understand and arrived at applicants compound with a reasonable expectation of success.
For claim 292:
Lin is silent on claimed 6-membered hetero ring for R8. However, Lin teaches gamma-lactamyl, which is 5-membered hetero ring. So, difference is in the -CH2- in the ring and these are adjacent homologs. The MPEP 2144.09 states that “Compounds which are….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). Please note that adjacent homologs are considered to be obvious absent unexpected results. In re Henze, 85 USPQ 261, 263, CCPA 1950. Also explore MPEP 2144.09.
For claim 293:
Lin is silent on substituted azetidinyl. However, claimed substitutions are common chemical groups in the art. For example, H can be replaced with methyl groups, which is obvious modification according to established case law, see below:
The issue of patentability over the replacement of alkyl groups for hydrogen or vice versa has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that "one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious - at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound - at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results - at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds could be prepared by the same method as taught by the prior art and have the same utility as the compounds taught by the prior art.
MPEP 2144.09 (VII) states "A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)."
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual chemical moieties in the compound were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
A modification of prior art teachings is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to modifiy their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the art are not distinct from that of the present invention.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed compound with a reasonable expectation of success.
II. Claims 294-304 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (WO2021/226546A1).
For claim 294:
Lin teaches the following compound:
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, wherein X is -CH2-, R6 (reads applicants R5) is aryl, heteroaryl, substituted aryl or substituted heteroaryl; wherein R’ and R” (reads applicants R2) are interconnected [see claim 32 and 49].
The above reads applicants claimed compound with the recited variables.
Differences between Lin and instant claim are as follows:
(i) Lin is silent on exemplifying applicants compound, wherein R2 is azetidinyl or substituted azetidinyl, pyrrolidinyl, or substituted pyrrolidonyl.
(ii) Lin is silent on applicants R6 group.
With regard to (i) of above, Lin recognized and teach these specific substitutions on structurally similar compounds [see Fig. 10; claims 11, 15, 25]. Therefore, it is obvious to extrapolate these substitutions on structurally similar compounds, since Lin provided guidance or description on preparing these compounds.
With regard to (ii) of above, Lin teaches H, whereas claim requires alkyl group.
Above difference is nothing but replacing H with methyl group. However, the issue of patentability over the replacement of alkyl groups for hydrogen or vice versa has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that "one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious - at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound - at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results - at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds could be prepared by the same method as taught by the prior art and have the same utility as the compounds taught by the prior art.
MPEP 2144.09 (VII) states "A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)."
For claim 295-296:
Lin teaches R6 is aryl, heteroaryl, substituted aryl or substituted heteroaryl and teach fluoro-substituted phenyl ring [see claims 34-36].
For claims 297:
See the reasoning provided under For claim 294 above.
For claim 298:
See For claim 294 above.
For claim 299:
Lin teaches 5-membered ring for applicants R8 group, whereas claims require 6 membered ring. So, difference is in the -CH2- in the ring and so, these are adjacent homologs. The MPEP 2144.09 states that “Compounds which are….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). Please note that adjacent homologs are considered to be obvious absent unexpected results. In re Henze, 85 USPQ 261, 263, CCPA 1950. Also explore MPEP 2144.09.
For claim 300-304:
The recited compounds differ from the teachings of Lin in the substituents on the core structure. However, all these substituents are recognized and well described in Lin. Therefore, a skilled person in the art would be motivated to make these compounds based on the guidance and methodology to make these compounds in the teachings of Lin, and arrive at applicants compounds with a reasonable expectation of success.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual chemical moieties in the compound were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
A modification of prior art teachings is only proper if a person of ordinary skill in the art (POSA) at the time of the invention, faced with the same problem, would have been motivated to modifiy their teachings with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here, the technical fields and problems addressed by the art are not distinct from that of the present invention.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed compound with a reasonable expectation of success.
Nonstatutory Double Patenting Rejection
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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 285-293are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application# 18/777,100 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Claims of copending application teaches the following compound:
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In the above compound, is R6 C1-3 alkyl, which reads applicants R1; if R5 C1-3 alkyl, which reads applicants t-butyl group; if R3 and R4 forms 3-6-membered spiro ring, which reads R9 and R10;
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group reads applicants R8; and
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reads applicants R2.
Or
Claim 20 of US copending application teaches the following compound:
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The above compound is also silent on applicants t-butyl group for R6.
So, the difference is that claims of copending application does not teach applicants t-butyl group for R6.
Above difference is nothing but replacing H with methyl group. However, the issue of patentability over the replacement of alkyl groups for hydrogen or vice versa has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that "one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious - at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound - at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results - at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification).
The motivation to make a substitution of an alkyl group for hydrogen stems from the fact that a person having ordinary skill in the art would expect that the compounds could be prepared by the same method as taught by the prior art and have the same utility as the compounds taught by the prior art.
MPEP 2144.09 (VII) states "A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)."
Accordingly, claims are obvious over the claims of US copending application.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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