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 .
Claims 1-10 are pending in the instant application. Claims 3-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1, 2, 9, and 10 are rejected.
Information Disclosure Statements
The information disclosure statements filed on January 22, 2026 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election of Group I, claims 1, 2, 9, and 10, in the response filed on January 22, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The restriction requirement is still deemed proper and is hereby made final.
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, 2, 9, and 10 are rejected under 35 U.S.C. 103 as being obvious over Parsons et al. U.S. Patent No. 11,299,491 (cited on IDS filed on January 22, 2026).
The applied reference has a common joint inventor (i.e., Parsons) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
The 35 U.S.C. 102(a)(2) critical reference date of the U.S. patent is entitled to the benefit of the filing date of the provisional application (No. 62/768,802) under 35 U.S.C. 119(e) since the provisional application properly supports the subject matter relied upon to make the rejection in compliance with 35 U.S.C. 112 (pre-AIA ), first paragraph. See MPEP 2136.03 III.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
U.S. Patent No. 11,299,491 discloses a process of preparing a compound of Formula (4a) or
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496
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(see column 56).
The reference discloses using 2 equivalents of (+)-DBTA instead of 3 molar equivalents as in the process of the instant claims.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to try different molar equivalents of (+)-DBTA and to arrive at the process of the claims with a reasonable expectation of success. The motivation would have been to find the optimal reaction conditions for the process. Thus, a prima facie case of obviousness has been established.
Further, the courts have stated that a change in process conditions of an old process does not impart patentability in the absence of unexpected results. In re Boesch, 205 USPQ 215 (1980). In re Aller et al. (CCPA 1955) 220 F2d 454.
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, 2, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 27 of U.S. Patent No. 12,473,281. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 12,473,281 claims admixing the compound of Formula (4) with (+)-DBTA and 2-methyltetrahydrofuran to provide a composition of Formula (4a). Also, it is disclosed in the reference that (+)-2,3-dibenzolyl-D-tartaric acid (2.0 eq) is added to 1.0 eq. of Compound 4 and 7:5 2-MeTHF/heptane (12 vol) is used (see columns 47-49).
The reference discloses using 2 equivalents of (+)-DBTA instead of 3 molar equivalents as in the process of the instant claims.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to try different molar equivalents of (+)-DBTA and to arrive at the process of the claims with a reasonable expectation of success. The motivation would have been to find the optimal reaction conditions for the process. Thus, a prima facie case of obviousness has been established.
Further, the courts have stated that a change in process conditions of an old process does not impart patentability in the absence of unexpected results. In re Boesch, 205 USPQ 215 (1980). In re Aller et al. (CCPA 1955) 220 F2d 454.
Claims 1, 2, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,299,491. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 11,299,491 claims the compound of Formula (4a) that is prepared in the instant claims. Also, it is disclosed in the reference that (+)-2,3-dibenzolyl-D-tartaric acid (2.0 eq) is added to 1.0 eq. of Compound 4 and 7:5 2-MeTHF/heptane (12 vol) is used (see columns 56-57).
The reference discloses using 2 equivalents of (+)-DBTA instead of 3 molar equivalents as in the process of the instant claims.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to try different molar equivalents of (+)-DBTA and to arrive at the process of the claims with a reasonable expectation of success. The motivation would have been to find the optimal reaction conditions for the process. Thus, a prima facie case of obviousness has been established.
Further, the courts have stated that a change in process conditions of an old process does not impart patentability in the absence of unexpected results. In re Boesch, 205 USPQ 215 (1980). In re Aller et al. (CCPA 1955) 220 F2d 454.
Claims 1, 2, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,391,691. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 12,391,691 claims a process for preparing a composition of Formula (4a) comprising reacting a compound of Formula (4) with a compound of Formula (B1) or (+)-DBTA in the presence of 2-methyltetrahydrofuran to form the composition of Formula (4a). It is further claimed that heptane is added to the solution to provide a suspension of the composition of Formula (4a) (see claim 5). Also, it is disclosed in the reference that (+)-2,3-dibenzolyl-D-tartaric acid (2.0 eq) is added to 1.0 eq. of Compound 4 and 7:5 2-MeTHF/heptane (12 vol) is used (see columns 55-56).
The reference discloses using 2 equivalents of (+)-DBTA instead of 3 molar equivalents as in the process of the instant claims.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to try different molar equivalents of (+)-DBTA and to arrive at the process of the claims with a reasonable expectation of success. The motivation would have been to find the optimal reaction conditions for the process. Thus, a prima facie case of obviousness has been established.
Further, the courts have stated that a change in process conditions of an old process does not impart patentability in the absence of unexpected results. In re Boesch, 205 USPQ 215 (1980). In re Aller et al. (CCPA 1955) 220 F2d 454.
Claims 1, 2, 9, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 9, and 10 of U.S. Patent No. 12,391,689. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 12,391,689 claims a composition comprising a compound of Formula (4) and a compound of Formula B. It is further claimed that the composition further comprises 2-methyltetrahydrofuran. Also, it is disclosed in the reference that (+)-2,3-dibenzolyl-D-tartaric acid (2.0 eq) is added to 1.0 eq. of Compound 4 and 7:5 2-MeTHF/heptane (12 vol) is used (see columns 54-55).
The reference discloses using 2 equivalents of (+)-DBTA instead of 3 molar equivalents as in the process of the instant claims.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to try different molar equivalents of (+)-DBTA and to arrive at the process of the claims with a reasonable expectation of success. The motivation would have been to find the optimal reaction conditions for the process. Thus, a prima facie case of obviousness has been established.
Further, the courts have stated that a change in process conditions of an old process does not impart patentability in the absence of unexpected results. In re Boesch, 205 USPQ 215 (1980). In re Aller et al. (CCPA 1955) 220 F2d 454.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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