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 .
Current Status
This action is responsive to the amended claims of 12/22/2023. Claims 1-9 and 12-13 are pending. Claims 5-6 and 12-13 are withdrawn. Claims 1-4 and 7-9 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9) and compound 83
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in the reply filed on 04/30/2026 is acknowledged.
A search for the compound 83 did not retrieve prior art (see SEARCH 6 of the attached search notes). The search was extended to the species of independent claim 7 – no art was retrieved for these species. The search was further extended to the structure
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wherein A* is any chain or ring moiety – no art was retrieved for this genus.
The search was further extended to
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wherein Cy is any cycle; this retrieved one species:
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.
This species reads on claims 1-3 and 8-9.
The search was further extended to the species:
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,
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,
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,
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, and
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.
These species read on claims 1-4 and 8-9.
Claim 7 is found free of the prior art, thus, it is examined here.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/30/2026.
Claims 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/30/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 06/28/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/11/2024 and 05/21/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-4 and 7-9 are objected to because of the following informalities. Appropriate correction is required.
Claim 1: On Pg. 4 line 3 of the definition of Rb, please fix the typo “dicyclic” to “bicyclic”. On Pg. 4 line 4 of the definition of R, please fix the typo “carboxy” to “carboxyl”. On Pg. 4 second-to-last line of R, please fix the typo “heterocycloalkyllor” to “heterocycloalkyl or”. On Pg. 5 line 2, please fix the typo “methyl” to “methyl”. Dependent claims 1-4 and 8-9 are similarly objected to since they do not fix the issues.
Claim 3: In line 3, please fix the typo “there” to “thereof”. On Pg. 7 line 6 please fix the typo “benzimidazoly” to “benzimidazolyl”.
Claim 4: In line 11, please fix the typo “carboxy” to “carboxyl”.
Claims 2 and 7: please add a comma between each structure and a conjunction (e.g., “and”) before the final structure.
Claim 8: to improve grammar, please add “the” before “Amine compound,” since all of these compounds are introduced in the preceding scheme.
Claim 9: please strike the second occurrence of “a racemate” since this is a duplicate.
Examiner asks Applicant kindly check all claims (including withdrawn) for similar issues.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-4 and 7-9 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 claimed invention. This is a written description rejection.
MPEP 2163(I) states “The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005).”
Factors considered in making the determination as to whether the artisan would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art.
The Instant Disclosure:
Claim 1 is broadly drawn to any possible metabolite, metabolic precursor, or prodrug of Formula (I) wherein these terms are not limited to any defined structural subset. The dependent claims 2-4 and 8-9 do not provide any further limitations to these forms of Formula (I). Similarly claim 7 is drawn to defined compounds or a metabolite, metabolic precursor, or prodrug thereof with no further structural limitations given for these forms “thereof”. The claimed compounds are expected to have pharmacological utility in the treatment of diseases (withdrawn claims 12-13). This lack of structural definition does not allow the artisan to envisage the compounds which are part of the invention (see Factors (b) and (c) above).
The specification does not define the terms “metabolite,” metabolic precursor,” or “prodrug”. The specification provides synthetic schemes for the genus of Formula (I) (Pg. 26-27) and exemplary compounds (Pg. 27-59), but does not call out any exemplary metabolites, metabolic precursors, or prodrugs of the Formula (I). Thus, Factors (a) and (d), above, are not met.
MPEP 2163(II)(A)(2) states “The disclosure of an element may be critical where those of ordinary skill in the art would require it to understand that inventor was in possession of the invention… Amgen, Inc. v. Chugai Pharm.Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) ("it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it").” After review of the specification and claims, the Examiner finds that Applicants have not defined the metabolite, metabolic precursor, or prodrug of Formula (I) in a way that distinguishes it from other materials and Applicants have not described how to obtain such forms of Formula (I). Thus, it has not been demonstrated that the Applicant was in possession of the invention that is claimed. Moreover, as drafted, metabolite, metabolic precursor, or prodrug would encompass compounds which have not yet been discovered and/or those with uncharacterized metabolic pathways.
Level of Skill and Knowledge in the Art:
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a synthetic chemist and/or health practitioner with several years of professional experience. However, this factor is outweighed by the unpredictable nature of the pharmaceutical art. It is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which prodrugs exhibit the desired pharmacological activity (e.g. the ability to degrade GSPT1).
HAN (Han, H., AAPS PharmsciTech., 2000, 2, 1-11) describes that some prodrug forms are not chemically or structurally related to their active form, for example, both glucose
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and hypoxanthine
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are prodrug forms of hydrogen peroxide
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(Pg. 5 Table 1). In view of HAN, the artisan would not have sufficient guidance as to what a “prodrug” or “metabolic precursor” of Formula (I) encompasses.
FDA (FDA Drug Safety Communication: Reduced Effectiveness of Plavix (Clopidogrel) in Patients Who are Poor Metabolizers of the Drug, 2017, pp. 1-2) states that a prodrug, Plavix, was found to have reduced effectiveness in patients who are poor metabolizers of Plavix leading to reduced effectiveness (Pg. 1 P4). As a result, predictability of “prodrug” or “metabolic precursor” efficacy in the art is understood as a challenge facing the artisan.
ZHANG (Zhang & Tang, Acta Pharmaceutica Sinica B, 2018, 8(5), 721-732) discloses, in majority of cases, sites of metabolism are unpredictable and metabolites could have no pharmacological activity (Pg. 725 Right col. ¶2). Thus, the structure and efficacy of a “metabolite” of Formula (I) would be unpredictable to the artisan.
Without guidance as to what structures correspond to viable metabolites, metabolic precursors, and prodrugs of the Formula (I), Factors (e) and (f) are not met. This is especially true for instant claim 7 since there is no prior art for the claimed species.
Conclusions:
Due to the breadth of “metabolite, metabolic precursor, or prodrug” of Formula (I), the lack of direction given in the claims/specification regarding embodiments of such which show the desired activity, and the challenges in the art, the artisan would not be able to immediately envisage the breadth of the claimed forms of Formula (I).
Methods of making compounds, in general, are known to the artisan, however the instant disclosure does not inform the artisan of what combination of elements are present in the instant metabolites/prodrugs and if such form possesses the required pharmacological activity. Accordingly, the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to the artisan that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Thus, claims 1-4 and 7-9 are rejected as lacking written description for the full scope of “metabolite, metabolic precursor, or prodrug” of Formula (I). To overcome this rejection, Applicants are encouraged to strike “metabolite”, “metabolic precursor”, and “prodrug” from the claims.
Note: withdrawn claims 5-6 would be similarly rejected.
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 1-4 and 8-9 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.
Regarding claims 1-4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 1-4 each recite “preferably” multiple times; each time is unclear if the following limitation is required or is merely an exemplary embodiment (but not required). Thus, the metes and bounds of the claims are undefined rendering the claims indefinite. Dependent claims 8-9 are similarly rejected since they do not fix the underlying issue.
Note: withdrawn claims 5-6 would be similarly rejected.
In claim 1, on Pg. 4 the claim recites when R is “-O-C(O)-C6-12 heterocycloalkyl” it may be further substituted; however, R is not chosen from this moiety. The closest moiety R is chosen from is “-O-C(O)-3-9-membered heterocycloalkyl” (Pg. 4 lines 2-3 of R) but, these moieties differ in size since 9-members is the maximum size of the heterocycloalkyl. Further, by defining the heterocycle by C6-12, this leaves the number of heteroatoms open-ended and even the C6 heterocycle encompasses heterocycles with over 9 members. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 2-4 and 8-9 are similarly rejected since they do not fix the underlying issue.
In claim 3, in line 12 Rb is “silyl.” Silyl is understood as the radical
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(Pg. 2) evidenced by CID 139580 (PubChem, CID 139580, created 2004, pg. 1-14). There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites Rb is “Si1-3 alkyl” which is understood to encompass any alkyl bound to 1-3 Si atoms. Silyl does not fall within the recited genus. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
In claim 4, line 14, R is
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. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites R is “Si1-6 alkoxy” which is understood to encompass any alkoxyl bound to 1-6 Si atoms. The
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does not fall within the recited genus – Examiner interprets the structure as -O-Si(C1-4alkyl)1-3. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
In claim 4, line 13, R is
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. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites when R is O-C(O)-C1-6alkyl, R may be substituted with -O-C(O)-C1-6alkyl not -C(O)-O-C1-6alkyl as is shown in the structure above. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 3-4 recite species outside of the scope of parent claim 1, as described in ¶26-28 above. Thus, claims 3-4 do not properly further limit the claim they depend from.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by COTTENS (WO 2022/029138; pub. 10 Feb. 2022; provided IDS of 01/11/2024).
Regarding claims 1-3, COTTONS teaches N-((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-5-yl)methyl)-3-(1H-indol-3-yl)propenamide (Pg. 71 Example 28), reproduced below:
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. This reads on Formula (I) wherein X1 is CH, X2 is CH, X3 is CH, X4 is CH2, X5-7 are O, R10 is H, m is 1, X is methylene, n is 1, Q is -CH=CH-, Rb is 9-membered benzoheterocyclic
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. These species are recited in the required parts of claims 1-3. Since the “preferably” portions of claims 1-3 are unclear, the limitations after “preferably” are interpreted under the broadest reasonable interpretation to be optional/exemplary embodiments not required by the claim.
Regarding claim 9, COTTONS teaches a pharmaceutical composition comprising the above compound (Pg. 17 Line 18) for oral administration (Pg. 140 claim 49). Since the compound is formulated as a pharmaceutically acceptable composition for oral administration, the artisan would immediately envisage the composition further comprising an acceptable excipient/carrier.
Thus, COTTONS anticipates claims 1-3 and 9.
Claims 1-4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MULLER (WO 2010/053732).
Regarding claims 1-4, MULLER teaches multiple species which fall under instant Formula (I):
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(Pg. 119 claim 15),
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(Pg. 119 claim 15),
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(Pg. 119 claim 15),
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(Pg. 123 claim 19), and
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(Pg. 123 claim 19). These species all share the core structure wherein X1 is CH, X2 is CH, X3 is CH, X4 is CH2, X5-7 are O, R10 is H, m is 1, X is methylene, n is 1, Q is a bond, and Rb is phenyl. The R variable differs in each, respectively, as follows: R is amino & halogen Cl; 5-membered heteroaryl; 5-membered heterocycloalkyl, methyl & C1 alkyl substituted with 6-membered heterocycloalkyl; and halogen Cl & C2 alkyl substituted with 6-membered heterocycloalkyl.
Regarding claim 9, MULLER teaches a pharmaceutical composition comprising the compounds above and one or more pharmaceutically acceptable excipients or carriers, formulated for administration (Pg. 125 claim 21-23).
Thus, MULLER anticipates claims 1-4 and 9.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by COTTENS (WO 2022/029138; effectively filed 03 Aug. 2021; provided IDS of 01/11/2024).
The teachings of COTTENS are above (¶33), since the effectively filed date is the international filing date no priority document is cited.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome either of the COTTENS rejections because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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.
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 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over MULLER (WO 2010/053732) as applied to claim 1 above, further in view of CHAN (WO 2020/242960; pub. May 2020; provided IDS of 01/11/2024), in view of BECK (WO 2015/129926), and in view of FAHMAN (Fahman, A. E. & Albericio, F., Chemical Reviews, 2011, 111, 6557-6602).
Determining the Scope and Contents of the Prior Art:
MULLER teaches claim 1, above. MULLER also teaches a synthetic method for such compounds: e.g., for
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the reagents
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(Ra-(X)n-NH2) and
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(HO-C(O)-Q-Rb) are mixed with carbonyl diimidazole (CDI) in DMF, stirred, and reacted at room temperature – the solution is filtered and washed in ethyl acetate (combination with organic phase) and purified by HPLC (Pg. 91 ¶256).
CHAN teaches a compound analogous to Formula (I) and that of MULLER:
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(Pg. 158 Ex. 16). The synthesis involves the following Ra-(X)n-NH2 and HO-C(O)-Q-Rb reagents:
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(Pg. 158 ¶446); the reaction was performed in DMF with DIEA, HOBt, and EDAC, stirred, concentrated, and purified by HPLC (Pg. 156 ¶448).
BECK teaches carboxylic acid – amine coupling to create an amide by:
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wherein
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reads on HO-C(O)-Q-Rb wherein Q is a bond and Rb is C4 alkyl substituted by fluorines and the amine group is a functional-group analog of the instant amine group (Pg. 124 Ex. A294). The reaction mixture is stirred at room temperature, combined with organic phases (EtOAc), filtered (extracted), concentrated in vacuo, and purified (Pg. 124 Ex. A294).
FAHMAN teaches each of CDI (Pg. 6565 sect. 5.1), HOBt (Pg. 6561 Table 2), EDAC (Pg. 6592 Scheme 52), and HATU (Pg. 6592 Scheme 52) are known reagents for coupling amines and carboxylic acids to form amide linkages. Further, FAHMAN teaches there is no one “best” coupling reagent and multiple different reagents may be used within the same synthesis with factors such as reaction phase, manual or automatic synthesis, and functional groups present on the reactants leading the optimization of such syntheses (Pg. 6591 Sect. 16 ¶1). The entirety of FAHMAN provides extensive examples of how coupling reagents have been optimized for varying types of reactants and varying types of syntheses.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
MULLER does not utilize HATU, ACN, and TEA and does not teach concentration under pressure.
CHAN’s compound teaches Rb is phenyl substituted by R C3 cycloalkyl further substituted with CF3 – the instant R C3 cycloalkyl cannot be further substituted. CHAN does not utilize HATU, ACN, and TEA.
BECK does not teach a compound of Formula (I) or the instant Ra-(X)n-NH2 reactant.
FAHMAN does not teach compounds of Formula (I).
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of synthetic schemes useful for coupling carboxylic acids and amines to create amides and possesses the technical knowledge necessary to make adjustments to the reagents to optimize/enhance the reaction. Said artisan has also reviewed the problems in the art regarding such couplings and is familiar with commonly used coupling reagents widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references MULLER in view each of: CHAN, BECK, and FAHMAN.
The artisan would be motivated to utilize the synthetic teachings of MULLER, CHAN, BECK, and FAHMAN to optimize a synthetic scheme for compounds of Formula (I). Since MULLER, CHAN, and BECK each teach a different set of reagents for carboxylic acid – amine coupling and since FAHMAN teaches each of these sets of reagents are known to induce such coupling (Pg. 6565 sect. 5.1, Pg. 6561 Table 2, & Pg. 6592 Scheme 52), the artisan would recognize these sets of coupling reagents as obvious variants, especially in view of FAHMAN’s teaching that there is more than one way to induce such coupling and multiple reagents may be used for the same reaction (Pg. 6591 Sect. 16 ¶1). Since all of the references teach successful synthesis of amide couplings by such reagents the artisan would have a reasonable expectation of success in utilizing any of them to perform the instant reaction, including HATU, ACN, and TEA as taught by BECK (Pg. 124 Ex. A294).
Further, since MULLER and CHAN both utilize a carboxylic acid reactant and an amine reactant, but use different coupling agents, the artisan would have a reasonable expectation that different sets of reagents work in such reaction.
Regarding the other step of concentration under reduced pressure, the artisan would have a reasonable expectation of success in concentrating the product this way in view of BECK (Pg. 124 Ex. A294). The artisan would be motivated to concentrate the product to have a stronger/more effective product since the compound of Formula (I) is meant for pharmaceutical administration (MULLER Pg. 125 claim 21-23).
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 auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 9 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-10 of copending Application No. 18/861,308 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 6 recites compounds FDAB 18-99, 102-104, 106, 108-113, 117-124, 131, 134-137, 139, 141-149, 152, 154, 156-159, 172-174, 176-177, 180-181, 184, and 186. The compounds area chosen from the same genus as instant Formula (I), wherein Ra-(X)n-NH-C(O) is chosen from:
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118
264
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,
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112
266
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, or
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121
260
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. The Q of the reference species is chosen from a bond, -C≡C-, or -C=C-. The Rb of the reference species ranges from aryl, cycloalkyl, alkyl, alkoxy, alkenyl, heteroaryl, benzoheterocyclics, tricyclic carbon rings wherein R is chosen from alky, alkoxy, aryl, amino, hydroxy, cyano, -N(R8)(R9), halogen, heterocycles, deuterium – each of Rb and R fall within the instant size limitations. The species are exemplified by
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135
365
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wherein X1 is CH, X2 is CF, X3 is CH, X4 is CH2, X5-7 are O, R10 is H, m is 1, X is methylene, n is 1, Q is bond, Rb is phenyl, and R is amino. Reference claim 6 recites species of reference claims 1 and 4. Reference claims 7-8 recite methods of use thereof – to practice the method the practitioner must be in possession of the compound. Reference claims 9-10 recite a pharmaceutical composition thereof for various routes of administration – the artisan would immediately envisage an acceptable excipient.
Thus, the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4 and 7-9 are rejected.
Note: Claim 7 is found free of the prior art: the close art is MULLER or COTTONS, above. The species of MULLER and COTTONS do not teach or suggest wherein Q is -C≡C- nor the exact Rb structures of the species of instant claim 7.
Further, the above NSDP reference teaches species analogous to instant claim 7; however, none of the instant species are fluorinated at X1, X2, or X3. Further, there is no species in the reference where all 3 of these variables are not fluorinated. Thus, the NSDP reference does not anticipate or make obvious the instant species of claim 7.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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