DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-34 and 38-39, drawn to a compound represented by the structure of formula I or a pharmaceutically acceptable salt or stereoisomer thereof; and a pharmaceutical composition comprising the therapeutically effective amount of the compound; and the following species:
Compound 66 having the structure of:
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as the elected compound species represented by the structure of formula I
are maintained.
Claims 40-46 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner determined that the prior art at the time of the present invention was such that it did not anticipate or render obvious the elected compound species:
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. In light of this discovery, the search was expanded to the subject matter of the full scope of the compound of the formula (I). Therefore, the restriction requirement among the compound species of Formula (I) as set forth in the Office action mailed on March 5, 2025 is hereby withdrawn. Claims 3, 6-9, 12-15, 19-21, 25-28, 30-31 and 33, directed to the compound species non-elected, hereby rejoined and fully examined for patentability.
Priority
The instant application 17/926,074 filed on November 17, 2022 is a 371 of PCT/US2021/033328 filed on May 20, 2021, which claims priority to, and the benefits of U.S. Provisional Application No.
63/028,011 filed on May 21, 2020.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on June 29, 2026, wherein claims 1 and 10 are amended; claims 2-13, 16-27, 30-34 and 38-46 are unchanged; and claims 14-15, 28-29 and 35-37 are canceled.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-13, 16-27, 30-34 and 38-46 are pending.
Claims 40-46 remain withdrawn.
Claims 1-13, 16-27, 30-34 and 38-39 are under examination.
Action Summary
Applicant's arguments filed on June 29, 2026 have been fully considered.
All rejections pertaining to claims 14-15, 28-29 and 35-37 are moot because the claims are cancelled in view of the amendments filed on June 29, 2026.
Claims 1-33 and 39 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 are maintained, but revisited and modified in view of the claim amendments.
Claim 1 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 is maintained, but revisited and modified in view of the claim amendments.
Claims 4 and 10 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 are withdrawn in view of the claim amendments. Specifically, the term “absent” is deleted from the claim language.
Applicant’s arguments, see page 29-31, filed on June 29, 2026, with respect to the rejection of claims 1-34 and 38-39 on the judicially-created basis that it contains an improper Markush grouping of alternatives have been fully considered and are persuasive. The rejection of claims 1-34 and 38-39 has been with withdrawn in view of the amendments. Particularly, the amendments change the scope of R2, R2’, R3, X, and W1, such that the compounds represented by a structure of formula I share the 3-(2,5-dioxo-3-(phenylamino)-2,5-dihydro-1H-pyrrol-1-yl) piperidine-2,6-dione moiety
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in common.
Claims 1-5, 10-11, 16-18, 21-32, 34, and 38-39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 27-32 and 38-42 of U.S. Patent No. 12,227,488 B2 (reference patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) are maintained, but revisited and modified in view of the claim amendments.
Claims 1-5, 10-11, 16-18, 21-32, 34, and 38-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-13, 15-16, 18-20, 24-25, 42, 46-47, 64, and 67-68 of copending Application No. 19/012,206 (reference application), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) are maintained, but revisited and modified in view of the claim amendments.
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 1-13, 16-27, 30-34 and 39 remain 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.
Instant claim 1 recites “[a] compound species represented by a structure of formula I:
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or a pharmaceutically acceptable salt or stereoisomer thereof: wherein…Y1 is
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…
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”. It is noted that multiple substituent(s) on different atoms can be joined together to form a cycloalkyl or heterocycloalkyl; However, the specification does not disclose a representative number of species that has one of these indicated substituent(s) joined together, for instance, there is no compound species composed of (h) at Y1 wherein R5 and R5’, when on different carbon atoms, together with the atoms to which they are attached form a (C3-C7)cycloalkyl group or 4- to 7-membered heterocycloalkyl group; or compound species composed of formula (d) at Y1 wherein R5 and R9 together with the atoms to which they are attached from a 4- to 7-membered heterocycloalkyl group.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.I "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5,2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure ..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
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. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004).
In the present case, applicant discloses compounds (1)-(89) (see [00128] of the specification); However, none of these compounds are composed of formula (h) at Y1 wherein R5 and R5’ on different carbon atoms together with the atoms to which they are attached form a (C3-C7)cycloalkyl group or 4- to 7-membered heterocycloalkyl group; and none of these compounds are composed of formula (d) at Y1 wherein R5 and R9 together with the atoms to which they are attached from a 4- to 7-membered heterocycloalkyl group.
In the absence of a sufficient variety of species to reflect the variation within the genus, it is not apparent that applicant was actually in possession of the entire genus of compound represented by a structure of formula I, including those that has two of the indicated substituent(s), joined together to from a cycloalkyl or heterocycloalkyl group based on the limited disclosure provided.
Response to Arguments
Applicant's arguments filed on June 29, 2026 with respect to the rejection of claims 1-33 and 39 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 have been fully considered but they are not persuasive.
All rejections pertaining to claims 28-29 are moot because the claims are cancelled in view of the claim amendments filed on June 29, 2026.
In this case, applicant amends instant claim 1 by deleting the following recitations:
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.
In Summary, applicant argues the clams have been amended, and that changes the scope of R6, R7, and R7’ specifically noted in the rejection under 35 U.S.C. § 112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph, and that overcomes the rejection of record.
In response, applicants’ arguments are not found persuasive. As noted in the rejection of record, the claims pertain to compounds represented by a structure of formula I:
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and the Y1 contains therein can be a wide variety of formulae, including the listed (a), (d), (h), (i), wherein multiple substituent(s) on different atoms can be joined together to form a cycloalkyl or heterocycloalkyl. There is lack of sufficient variety of species to reflect the variation within the genus to reasonably convey to a person skill in the art that applicant was in possession of the entire genus of compound represented by a structure of formula I.
While the examiner has made the effort by providing examples using the two R6 on different nitrogen atoms, R6 and R7 together, and R7 and R7’ on different carbon atoms, these groups are identified as examples for purpose of illustrating the concept that the claimed genus contains multiple substituent(s) on different atoms joined together, the representative groups are intended to demonstrate, at a minimum, the issues identified, and should not be construed as encompassing each and every issues in its entirety.
Given that the claimed genus still contains substantial structural variation where multiple substituent(s) on different atoms can be joined together, the disclosed species does not resolve the written description inquiry as these species are not sufficient to represent the full genus as broadly encompassed by instant claims. Therefore, the rejection of record has been maintained, but revisited and modified in view of the claim amendments.
Conclusion
Although the specification discloses compound (1)-(89), those compounds do not reasonably represent the full structural variation encompassed by Formula I as amended. In particular, the disclosed species do not exemplify the structurally distinct embodiments arising from the recited ring-forming alternatives, including Y, of formula (h) wherein R5 and R5’ located on different carbon atoms, together with atoms to which they are attached, form the recited cycloalkyl or heterocycloalkyl ring, or Y1 of formula (d) wherein R5 and R9 together with the atoms to which they attached from the recited cycloalkyl or heterocycloalkyl ring. These alternatives alter the connectivity and conformationally constrain portions of the molecule and therefore represent structural variation beyond merely substituting one conventional substituent for another on an otherwise exemplified scaffold.
The specification reports degradation data only for a subset of the compounds. For example, Table 3 provides GFP-IKZF2/IKZF1DC50 values for compounds 7, 8, 9, 16, 18, 20-23, 25-27, 30, 36, 44, 48, 60, 64-67, 73, and 80, while ¶ [00374] concludes IKZF2 or IKZF1. In view of the multiple independently variable structural alternatives permitted by Formula I and Y1, and the absence of representative species or other identifying characteristic reasonably demonstrating possession of these structurally distinct portions of the genus as amended, the disclosure does not reasonably convey to one of ordinary skill that Applicants possessed the entire scope of the presently claimed genus at the time of filing.
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.
Claim 1 is 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 claim 1, the term “adjacent” recites in the claims, for instance, in the phrase of”
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…
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” renders the claim indefinite, because the term “adjacent" is a relative term used to refer to something is located next to, bordering, or near a specific reference point or object. The term “adjacent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is not clear what is considered adjacent or non-adjacent atoms.
Response to Arguments
Applicant's arguments filed on June 29, 2026 with respect to the rejection of claim 1 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 have been fully considered but they are not persuasive.
In this case, applicant deletes the recitation of “R7 and R7’, when on adjacent atoms”; and that changes the scope of the claims.
In Summary, Applicant argues the term “adjacent” generally refers to the atoms that are directly bonded to each other; and uses water molecule (H2O) as an example to explain the ordinary meaning of “adjacent”. In particular, Applicant explains that the oxygen atom of H2O is adjacent to both hydrogen atoms, but the hydrogen atoms are not adjacent to each other because they are not directly bonded.
In response to applicant’s argument that a person of skill in the art would readily understand “adjacent” refers to atoms that are directly bonded to each other, and that permits a person of ordinary skill in the art to determine which R substituents are adjacent or on adjacent atom. To the extent that Applicant’s position is accepted and the term “adjacent” in the claim language refers to atoms directly bonded to one another. A person skilled in the art reading the depicted formulae in view of the “adjacent” definition proposed by the Applicant, for example,
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, which contains R5 and R5’ at multiple locations and some R5/R5’ pair appears to be attached to the same atom. The R5 and R5’ substituents attached to the same atom are not themselves “on adjacent atoms” under Applicant’s proposed definition, because they are on the same atom and are not directly bonded. The R5 and R5’ substituents on different atoms are also not considered “on adjacent atoms” because they are also not directly bonded. Therefore, under Applicant's H2O analogy, it does not explain which occurrences of R5 and R5' in the claimed structures are subject to the "when on adjacent atoms" provision rather than the “when on different carbon atoms” provision. Same logic is applicable to other substituents, for example, instant claim 1 also recites “two adjacent R10 groups taken together” in the phrase of “R8 is … optionally and independently substituted by one or more identical or different groups selected from R10 … wherein two adjacent R10 groups taken together with the respective to which each is attached from an aryl”. In other words, one or more R10 substituted on the R8 group are also not considered “adjacent” under Applicant’s proposed definition, because R10 substituents are not directly bond to one another; instead, they are directly bond to the R8 group, and that is not considered “adjacent” under applicant’s H2O analogy. Thus, based upon applicant’s proposed definition of “adjacent”, it is also not clear which occurrences of R10 in the claimed structure is “adjacent”. In view of the foregoing, one of ordinary skill in the art would not be reasonably apprised of the scope of the compound represented by a structure of formula I.
Therefore, the rejection is maintained for the same reasons of record and for the reasons set forth herein but revisited and modified in view of the claim amendments.
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 1-5, 10-11, 16-18, 21-27, 30-32, 34, and 38-39 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 27-32 and 38-42 of U.S. Patent No. 12,227,488 B2 (reference patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of reference patent are drawn to a compound that falls within the scope of the claimed invention. For instance, the claims of the reference patent are drawn to compound having the structure of:
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(see e.g., claim 38);
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(see e.g., claim 20); and
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(see e.g., claim 31). The claims of the reference patent are also drawn to pharmaceutical composition comprising a therapeutically effective amount of the compound or pharmaceutically acceptable salt or stereoisomer thereof, and a pharmaceutically acceptable carrier.
The claims of reference patent do not teach the elected compound 66 and compound 9.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical (see e.g., p. 3148-3149). Patani et al. further teaches a list of bioisosteres of the amide bond shown below:
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(see e.g., Table 48). Patani et al. further teaches classical bioisosteres benzene and pyridine resulted in analogues with
retention of biological activity within different series of pharmacological agents (see e.g., p. 3158, left column, “E. Ring Equivalents”). Patani et al. further teaches fluorine, hydroxyl, amino and methyl are monovalent group of isosteres for replacements for hydrogen based on Grimm’s Hydride Displacement Law (see e.g., p. 3152, left column, “4. Fluorine and Hydroxyl, Amino, or Methyl Groups as
Replacements for Hydrogen (Grimm’s Hydride Displacement Law)”, 1st paragraph; Table 12).
To the extent that the claimed compound is compound 66, the difference between the compound 159 of the reference patent and the claimed compound 66 is that the reference patent contains the reverse amide (-CONH-) shown below (see shaded):
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. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound 159 of the reference patent and then modify said compound by replacing the reverse amide (-CONH-) with a methyleneamino (-CH2NH-) based on the nonclassical bioisosteres of the amide bond taught by Patani et al. One would have been motivated to do so, because Patani et al. teaches reversed amide (-CONH-) and methyleneamino (-CH2NH-) are nonclassical bioisosteres that can be interchanged in medicinal chemistry to arrive compound with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound 159 of reference patent would have exerted the same or substantially similar activity as compound 159; and therefore, said modified compound would successfully incorporate into a pharmaceutical composition with a pharmaceutically acceptable carrier without any appreciable loss of activity.
To the extent that the claimed compound is compound 9, the difference between the compound 153 of the reference patent and the claimed compound 9 is that the reference patent contains the phenyl rather than pyridine and methyl rather than hydrogen shown below (see shaded):
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. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound 153 of the reference patent and then modify said compound by replacing the hydrogen with methyl and phenyl and pyridine based on the classical bioisosteres taught by Patani et al. to arrive at the claimed invention. One would have been motivated to do so, because Patani et al. teaches phenyl and pyridine, and methyl and hydrogen are classical bioisosteres that can be interchanged in medicinal chemistry to arrive compound with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound 153 of reference patent would have exerted the same or substantially similar activity as compound 153; and therefore, said modified compound would successfully incorporate into a pharmaceutical composition with a pharmaceutically acceptable carrier without any appreciable loss of activity.
Therefore, the claimed invention is rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant's arguments filed on June 29, 2026 with respect to the rejection of claims 1-5, 10-11, 16-18, 21-32, 34, and 38-39 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 27-32 and 38-42 of U.S. Patent No. 12,227,488 B2 (reference patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) have been fully considered.
All rejections pertaining to claims 28-29 are moot because the claims are cancelled in view of the claim amendments filed on June 29, 2026.
Applicant requests the double patenting rejections be held in abeyance. Given that applicant did not put forth any arguments against the nonstatutory double patenting rejection noted above, the rejection has been maintained for the same reasons of record and for the reasons set forth herein.
Claims 1-5, 10-11, 16-18, 21-27, 30-32, 34, and 38-39 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-13, 15-16, 18-20, 24-25, 42, 46-47, 64, and 67-68 of copending Application No. 19/012,206 (reference application), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of reference application are drawn to numerous compound species that fall within the scope of claimed invention. For instance, the claims of the reference application are drawn to a compound having the structure of:
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; and
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(see e.g., claim 67). The claims of the reference application are further drawn to a pharmaceutical composition comprising the compound or pharmaceutically acceptable salt or stereoisomer thereof, and a pharmaceutically acceptable carrier. For instance, compound 97 is a compound represented by a structure of formula I:
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, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein
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is
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; X is -NH-; Y1 is
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(i.e.,
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, wherein
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is
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; n1 is 0; R9 and R9’ are independently hydrogen; n2 is 1 and R6 is hydrogen; n3 is 1 and R6 is methyl; n1 is 0; R8 is
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.
The claims of reference patent do not teach the elected compound 66 and compound 9.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical (see e.g., p. 3148-3149). Patani et al. further teaches a list of bioisosteres of the amide bond shown below:
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290
474
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(see e.g., Table 48). Patani et al. further teaches classical bioisosteres benzene and pyridine resulted in analogues with
retention of biological activity within different series of pharmacological agents (see e.g., p. 3158, left column, “E. Ring Equivalents”). Patani et al. further teaches fluorine, hydroxyl, amino and methyl are monovalent group of isosteres for replacements for hydrogen based on Grimm’s Hydride Displacement Law (see e.g., p. 3152, left column, “4. Fluorine and Hydroxyl, Amino, or Methyl Groups as
Replacements for Hydrogen (Grimm’s Hydride Displacement Law)”, 1st paragraph; Table 12).
To the extent that the claimed compound is compound 66, the difference between the compound 159 of the reference patent and the claimed compound 66 is that the reference patent contains the reverse amide (-CONH-) shown below (see shaded):
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338
429
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. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound 159 of the reference patent and then modify said compound by replacing the reverse amide (-CONH-) with a methyleneamino (-CH2NH-) based on the nonclassical bioisosteres of the amide bond taught by Patani et al. One would have been motivated to do so, because Patani et al. teaches reversed amide (-CONH-) and methyleneamino (-CH2NH-) are nonclassical bioisosteres that can be interchanged in medicinal chemistry to arrive compound with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound 159 of reference patent would have exerted the same or substantially similar activity as compound 159; and therefore, said modified compound would successfully incorporate into a pharmaceutical composition with a pharmaceutically acceptable carrier without any appreciable loss of activity.
To the extent that the claimed compound is compound 9, the difference between the compound 153 of the reference patent and the claimed compound 9 is that the reference patent contains the phenyl rather than pyridine and methyl rather than hydrogen shown below (see shaded):
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294
384
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. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound 153 of the reference patent and then modify said compound by replacing the hydrogen with methyl and phenyl and pyridine based on the classical bioisosteres taught by Patani et al. to arrive at the claimed invention. One would have been motivated to do so, because Patani et al. teaches phenyl and pyridine, and methyl and hydrogen are classical bioisosteres that can be interchanged in medicinal chemistry to arrive compound with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound 153 of reference patent would have exerted the same or substantially similar activity as compound 153; and therefore, said modified compound would successfully incorporate into a pharmaceutical composition with a pharmaceutically acceptable carrier without any appreciable loss of activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on June 29, 2026 with respect to the provisional rejection of claims 1-5, 10-11, 16-18, 21-32, 34, and 38-39 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-13, 15-16, 18-20, 24-25, 42, 46-47, 64, and 67-68 of copending Application No. 19/012,206 (reference application), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) have been fully considered.
All rejections pertaining to claims 28-29 are moot because the claims are cancelled in view of the claim amendments filed on June 29, 2026.
Applicant requests the double patenting rejections be held in abeyance. Given that applicant did not put forth any arguments against the nonstatutory double patenting rejection noted above, the rejection has been maintained for the same reasons of record and for the reasons set forth herein.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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