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
Election/Restriction
Acknowledgement is made of Applicant’s election of Group I invention without traverse, and election without traverse of the species, compound 615 , in the reply filed on 07/15/2026.
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The elected species is a compound of Formula I, wherein
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Claims 35-48 and 51-56 read on the elected species.
Claims 49-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The elected species, racemic mixture of Compound 615 (CAS # 2222114-09-0, entered in STN Registry database on May 02, 2018), is rejected on the ground of double patenting. To practice compact prosecution, the examiner has extended the search and examination to non-elected species wherein the ABM moiety is
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, the CLM moiety is
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, and the linker moiety comprising O and CH2 as AL , i. e. CRL1RL2 wherein the RL1 and RL2 is H. The expanded non-elected species are rejected in following 35 USC103 section. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species. It should be noted that the prior art search/examination will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reconsidered. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reconsideration that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Status of Claims
Claims 35-56 are pending in instant application.
Claims 49-50 are withdrawn.
Claims 35-48 and 51-56 are currently under examination.
Priority
Instant application 18/772,066, filed July 12, 2024, is a continuation of U.S. Application No. 18/213,055, filed June 22, 2023, now U.S. Patent No. 12077509, which is a continuation of U.S. Application No. 17/539,679, filed December 1, 2021, now U.S. Patent No. 11,952,347, which is a continuation of U.S. Application No. 16/938,864, filed July 24, 2020, now U.S. Patent No. 11,236,051, which is a continuation of U.S. Application No. 16/577,901, filed September 20, 2019, now U.S. Patent No. 10,844,021, which is a divisional application of U.S. Application No. 15/730,728, filed October 11, 2017, now U.S. Patent No. 10,584,101, which claims priority to, and the benefit of, U.S. Provisional Application No. 62/406,888, filed October 11, 2016, and U.S. Provisional Application No. 62/528,385, filed July 3, 2017.
The elected species, racemic mixture of Compound 615 was not disclosed in U.S. provisional Application No. 62/406,888 and 62/528,385. Compound 615 is disclosed in U.S. Application No. 15/730,728, now U.S. Patent No. 10,584,101(See compound 615, Col. 115 ).
Information Disclosure Statement
The information disclosure statement filed 07/15/2026 is considered by the examiner.
The information disclosure statement filed 09/30/2024 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Drawings
The drawings filed on 07/12/2024 are objected to because the structures in Fig. 7 ( e.g. page 232-283 ) are blurry and illegible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Instant specification disclosed vast variety of compounds having complex chemical names and structure thereof. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Improper Markush Grouping
Claims 35-48 and 51-56 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, or disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use that flows from the substantial structural feature.
Claim 1 recites compound of Formula I comprising vast variety of subgenus alternatives of
binding moiety, linker, CLM moieties, and combination thereof wherein the Markush grouping of W1, Y , W2, AL , R, etc. and combination thereof embraces different chemical species that don’t belong to the same recognized chemical class and/or do not share substantial structural similarity. Dependent claims only further limit to improper Markush group of ABM moiety, linker moiety or CLM moiety while other moiety/subgroup remain improper Markush grouping.
Claim 1 recites variety of ABM moiety comprising combinations of different subgroups W1, Y3, W2 with further substitutions that do not belong to the same recognized chemical class or share substantial structural feature. Instant claims recite linker moiety comprising vast AL subgroups and R further substituted with vast variety of groups that do not belong to the same recognized chemical class or share substantial structural feature,
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The above findings demonstrate that not all members recited in instant Markush group belong to the same recognized physical and chemical class and the species fail to share a single structural similarity or any substantial structural feature. In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 35-48 and 51-56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the full-scope of claimed compound of Formula I. This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Independent claim 35 refers to compound of formula I with vast varieties of androgen receptor binding moieties, linker moieties and degron moieties further substituted with multiple W, Y, R groups. Dependent claims only further limit to improper Markush group of ABM moiety, linker moiety or CLM moiety while other moiety/subgroup remain improper Markush grouping. The Applicant is required to provide adequate written description and evidence of possession of the claimed genus, compound of Formula I and subgenus that align with the instantly claimed broad scope.
MPEP 2163 II states; “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above)”. While applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. “A representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” MPEP 2163 II.
Instant specification discloses about 625 compounds (See Figs 2-7 ), wherein most of them do not have OR’ in CLM moiety covalently joined to the linker group, wherein R’ is cycloalkyl, aryl, heteroaryl, and heterocyclyl as claimed. The W2 group in the ABM moiety of disclosed compounds were limited to specific heterocycles as recited in claim 42. There are no embodiments in linker moiety comprising NR13, wherein R13 is C3-11 cycloalkyl, aryl, heteroaryl, C3-11 heterocyclyl, etc. Instant disclosed working examples do not represent the structural variations in compound of Formula I and do not commensurate with the scope of genus/subgenus claimed. One of skilled in the art would not recognize from the disclosure that the applicant was in possession of full scope of compound of Formula I.
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.
Claims 35-48 and 51-56 are 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.
Claim 35 recites RL1 and RL2 in linker moiety, “where RL1 and RL2 are linked to form a cycloalkyl or a heterocycle moiety). It’s not clear how RL1 and RL2 are linked to form the cycloalkyl or heterocycle moiety. Claim 35 recites OR’ in CLM moiety covalently joined to the linker group. It’s not clear it’s O or R’ that’s covalently joined to the linker group. A person of ordinary skilled in the art would not be apprised the scope of compound of Formula I because the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claims 36-44 and 51-56 are rejected due to dependency on claim 1.
Claim 36 recites
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. However, there is no definition for R22 and R23 groups.
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, 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.
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.
Claims 35-48 and 51-56 are rejected under 35 U.S.C. 103 as being unpatentable over Crews et al. ( US 2015/0291562 A1, hereafter Crew ’562, published on 10/15/2015), in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176, Bioisosterism: A Rational Approach in Drug Design).
Crew ’562 discloses bifunctional or proteolysis targeting chimeric (PROTAC) imide-based compounds that contain a ligand which binds to the cereblon E3 ubiquitin ligase (CLM) and a moiety which binds a target protein (e.g. androgen receptor, AR), which affect degradation (and inhibition) of target protein (See abstract, [0010]-[0017], [0219], Table 1, claims 1-7 and 14-16). Crew ’562 discloses bifunctional compound has a common structure comprising: PTM-L-CLM, wherein PTM is a protein target moiety that binds to a target protein or a target polypeptide, wherein the PTM is chemically linked to the CLM through the linker group, wherein the CLM comprises a chemical group derived from an imide, a phthalimido group, or an analog or derivative thereof(See [0012]-[0016], [0304]-[0310]).
Regarding claims 37-44, Crew ’562 discloses exemplary androgen receptors as PTM moieties (See [0114], [0219]), e.g.
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which reads on instant ABM except W2 in Crew ’562 is phenyl vs heteroaryl in instant claims.
Regarding claims 45-48, Crew ’562 discloses variety of CLM moieties ( See [0050]-[0062], [0101]). It’s noted R is OR’ wherein R’ is cycloalkyl reads on instant R and R’ .
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Regarding claims 51-55 , Crew ’562 discloses linker moiety comprising substituted amine, alkylene, aryl, or heterocycle group that are linked to the CLM and/or PTM( See [0102]-[0113]). Please note CRL1RL2 reads on instant CRL1RL2, NRL3 wherein is RL3 is H , or NHC1-8 alkyl reads on instant NRL3 , C3-11 heterocyclyl also reads on instant AL.
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Regarding claim 56, Crew ’562 discloses pharmaceutical composition comprising the bifunctional/PROTAC compound and pharmaceutically acceptable carrier ( See [0229]-[0233]).
Crew ’562 discloses compound 11 that has very similar PTM moiety and CLM moiety as the elected species ( See [0487], [0503], Table 1). The linker moiety in Crew ’562 Compound 11 read on instant claimed linker moiety wherein AL is CH2 and O.
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The main difference of Crew’562 compound and instant claimed formula I is the W2 group in ABM moiety: phenyl ring vs heteroaryl (e.g. pyridine, pyrimidine, etc.) which is classical bioisosteric modification within general knowledge of SAR study to a skilled artisan.
Patani et al. teaches bioisosterism for the rational modification of lead compounds. Patani et al. teaches classical bioisosteres, e.g. CH, N, O, defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (See p. 3148-3149), and ring equivalent wherein CH on phenyl ring was replaced with N (See p 3158-3160).
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have 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).
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant application to explore more bifunctional/ PROTAC androgen receptor modulator comprising androgen receptor binding moiety, linker moiety, degron /CLM moiety and combination thereof, based on collective teachings of Crew ’562 , together with optimization based on general knowledge of structure similarity and bioisosteric modification taught by Patani, and arrive at instantly claimed invention with reasonable expectation of success. At the time the instant application was filed, it was already known that bifunctional compound comprising variety of PTM moiety, CLM moiety and linker moiety could be made and used as androgen receptor degrader as taught by Crew ’562.
One of ordinary skilled in the art would have had reasonable expectations of success in producing the claimed invention based on combined teaching of prior art and general knowledge of structure similarity/ bioisosteric modification and bifunctional degraders . Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 autoprocessed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 35-48 and 51-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12077509.
Reference claims are drawn to bifunctional compound and composition thereof that’s the stereospecific isomer of instant elected species, wherein the W1,Y, W2 , AL, R, R’, etc. read on instant claims.
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Reference compound is encompassed by instant compound of Formula I, thus anticipating instant claimed invention. Instant application is continuation of reference application, thus no 35 USC 121 shield.
Claims 35-36, 38-42 and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,952,347.
Reference claims are directed to bifunctional compound that’s very similar to instant compound of Formula I,
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W1 is
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, aryl substituted by one halogen and one CN;
Y3 moiety between W1 and Q is O ;
Y moiety between W2 and Q is NRY2 and C=O;
Q is a 6-membered alicyclic-substituted ring;
W2 is unsubstituted heteroaryl.
AL is CH2 and heterocyclyl;
The main difference of reference compound is Q is six-membered alicyclic ring versus instant four-membered alicyclic ring.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have 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). Reference 6-membered alicyclic- ring is considered as homologation of instant four-membered alicyclic ring. Please note prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979), See MPEP 2144.09 III.
Claims 35-36, 38-44 and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11964945B2.
Reference claims are drawn to bifunctional compound and composition thereof that’s very similar to instant claimed compound of Formula I, wherein the W1,Y, W2 , R, etc. read on instant claims except Q is six-membered alicyclic ring versus instant four-membered alicyclic ring.
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have 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). Please note prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979), See MPEP 2144.09 III.
Claims 35-36, 38-44 and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,844,021.
Reference claims are directed to a method of treating prostate cancer in a subject comprising administering bifunctional compound that’s very similar to instant compound of Formula I,
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, aryl substituted by one halogen and one CN;
Y3 moiety between W1 and Q is O ;
Y moiety between W2 and Q is NRY2 and C=O;
Q is a 6-membered alicyclic-substituted with RQ, wherein RQ is H;
W2 is unsubstituted heteroaryl, e.g. pyrimidine.
AL is CH2 and C3-11 heterocyclyl;
The main difference of reference compound is Q is six-membered alicyclic ring versus instant four-membered alicyclic ring.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have 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). Please note prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979), See MPEP 2144.09 III.
Claims 35, 38-44 and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,584,101.
Reference claims are drawn to bifunctional compound that’s very similar to instant compound of Formula I, for e.g.
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, aryl substituted by one halogen and one CN;
Y3 moiety between W1 and Q is O ;
Y moiety between W2 and Q is NRY2 and C=O;
Q is a 6-membered alicyclic-substituted ring;
W2 is unsubstituted heteroaryl, e.g. pyrimidine.
AL is CH2 and C3-11 heterocyclyl;
The main difference of reference compound is Q is six-membered alicyclic ring versus instant four-membered alicyclic ring.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have 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). Please note prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979), See MPEP 2144.09 III.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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