NON-FINAL REJECTION
This application was filed on Apr. 24, 2024.
Claims 1-6, 13-19, 67, 74, 75, 103, 122, 123, as amended, are pending.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Apr. 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds, compositions, and kits; and the compound species of Example 51, having the structural formula,
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in the reply filed on June 3, 2026, is acknowledged.
Claims 2-6, 14-19, 74, and 103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 3, 2026.
Claims 1, 13, 67, 75, 122, and 123 are currently pending and under consideration.
Claim Rejections - 35 USC § 112(d) (Pre-AIA Fourth Paragraph)
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.
Claim 13 is 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.
Specifically, claim 13 recites compounds of claim 1, having the structural formula (I-1), wherein the variable groups are "as defined in claim 0."
However, "claim 0" does not exist. Furthermore, as recognized by MPEP § 608.01(n), multiple dependent claims must depend from claims previously set forth in the alternative only.
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 § 112(b) - Indefiniteness
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 67 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 pre-AIA the applicant regards as the invention.
Specifically, each claim must end with a period. See MPEP §608.01(m).
Claims 75, 122, and 123 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.
Specifically, claims 75, 122, and 123 recite a compound "selected from Examples 1-125," presumably referring to the compounds of Examples 1 through 125 disclosed by structural formula and IUPAC name throughout the specification.
However, the claims are to be complete in themselves. As recognized by MPEP § 2173.05(s), incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Therefore, a claim which refers to an external figure or table renders the metes and bounds of the claim indefinite.
This rejection can be overcome, for example, by amending the claims to expressly recite the compounds of Examples 1-125 by IUPAC name and/or structural formula.
Claims 1, 13, 67, 75, 122, and 123 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.
Specifically, claim 1 is drawn to compounds of formula (I-A), having the structural formula,
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wherein R2 is defined as "selected from the group of carbocycle and a monocyclic heterocyclic ring or a bicyclic or spirocyclic heterocyclic ring system bound through a carbon atom."
However, this phrasing is ambiguous because it is unclear (1) which of these moieties is "bound through a carbon atom" (e.g., only the bicyclic or spirocyclic heterocyclic ring system, or, alternately, all of the listed cyclic groups); and (2) whether the referenced carbon atom is of the R2 group, or of the central 6-membered ring.
Thus, compounds encompassed by the claims cannot be unambiguously distinguished from compounds excluded from the scope of the claims, rendering the metes and bounds of the claims indefinite.
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.
Claims 1, 13, 67, 75, 122, and 123 are rejected under 35 U.S.C. 103 as being unpatentable over Kaul et al. (WO 2021/222858, cited on PTO-892).
Kaul et al. disclose compounds which function as antagonists to human GPR39 protein, for use in pharmaceutical compositions and in methods of treatment of diseases including cardiovascular conditions, cancer, metabolic, gastrointestinal, liver, and respiratory diseases, and endocrine, hormone, hematological, and neurological disorders (abstract).
In particular, Kaul et al. exemplify the compound of Example 210 (p. 311), having the structural formula shown below, in comparison with the elected compound species:
Kaul et al. Example 210
Elected Compound (Example 51)
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The compound of Example 210 of Kaul et al. reads on formula (I-A) as recited by claims 1, 13, 67, 75, 122, and 123,
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,
wherein:
Z1, Z2, and Z3 are C;
X1 is 1,2,4-triazolyl substituted by methyl;
X2 is –C(O)-piperidinyl di-substituted by fluoro;
R2 is a monocyclic heterocyclic ring (pyrazolyl substituted by isopropyl); and
R2' is hydrogen.
The compounds of Kaul et al. are disclosed in a kit comprising:
a) one or more compositions comprising a pharmaceutically effective amount of the compound and a pharmaceutically acceptable carrier or excipient; and
b) instructions for administering the one or more compositions to a human in need
thereof (claim 104), as recited by claims 75 and 122.
As shown above, compound 210 of Kaul et al. differs from the elected compound species only in the orientation of the pyrazole ring.
However, compound 210 of Kaul et al. is disclosed as a species of formula (I-u) (claim 29), having the structural formula,
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wherein Z1, Z2, Z3, Y1, Y2, R1, R3, and R4 are defined identically to the claimed compounds; and R2 is selected from, e.g., a monocyclic heterocyclic ring (claim 1).
Further, the compounds of Kaul et al. are disclosed to have the identical mechanism of action as GPR39 antagonists and to be useful for treating the identical diseases and disorders as the claimed compounds.
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the compound of Example 210 of Kaul et al. by exchanging the positions of N1 and C3 of the pyrazole ring to arrive at the elected compound species (Example 51) with a reasonable expectation of success, because Kaul et al. disclose, teach, and suggest a monocyclic heterocyclic ring at R2 in any orientation.
In addition, positional isomers are prima facie obvious even in the absence of a teaching to modify. As recognized by MPEP § 2144.09, compounds which are positional isomers (i.e., having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that they possess the same properties. This expectation is then deemed the motivation for preparing the position isomers. See In re Wilder, 563 F.2d 457 (CCPA 1977). Compounds that differ only in the placement of substituents in a ring system are not patentable absent a showing of unexpected properties. See In Re Papesch, 315 F.2d 381 (CCPA 1963) and MPEP § 2144.09 (I).
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, 13, 75, and 122 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 41, 48-50, 55, 56, 79, 102, and 103 of copending Application No. 17/997,533 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims recite compounds and a subgenus which would anticipate the examined claims.
For example, the compound of Example 2, as recited by reference claim 102, reads on formula (I-A) as recited by examined claims 1, 13, 75, and 122, as shown below:
Reference compound (Example 2, claim 102)
Examined claims Formula (I-A)
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wherein Z1, Z2, and Z3 are each C;
X1 is
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, where Ra is hydrogen and R1 is –(CH2)n1-cyclopropyl, where n1 is 0;
X2 is
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, where Y1 and Y2 are each N, R3 is hydrogen, and R4 is C1-6 alkyl (propyl);
R2 is a monocyclic heterocyclic ring (pyrrolidinyl) substituted by C1-6 alkyl (isopropyl); and
R2' is hydrogen.
Furthermore, reference claims 1, 2, 41, 48-50, 55, 56, 79, and 103 are drawn to compounds of formula (I-1),
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wherein, for example:
Z1, Z2, and Z3 are C;
X1 is
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, where R1 is C1-6 alkyl (e.g., methyl);
Y1 is N, Y2 is C, and R3 and R4 are each hydrogen; and
R2 is a monocyclic heterocyclic ring (e.g., pyrazolyl) substituted by C1-6 alkyl (e.g., isopropyl).
Thus, the compound subgenus of formula (I-1) as recited by the reference claims falls within the scope of formula (I-A) as recited by the examined claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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