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 67-87 are currently pending. Claims 67 and 72 are independent.
Priority
The instant application claims priority as follows:
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Election/Restrictions
Applicant’s election without traverse of Group I, claims 67-73, in the reply filed on November 14, 2025 is acknowledged. Applicant’s election of the species of formula (I),
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, is also acknowledged.
Claims 74-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/14/2025.
The elected species was searched and applicable art was not identified. The entire scope of claims 67-73 has been examined in accordance with Markush search practice. See MPEP 803.02.
The only issues found for claims 67-73 have been raised in the rejections below.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 67-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-23 and 25 of the of U.S. Patent No. 10,329,320. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same art specific subject matter. Claims 1-6, 8-23 and 25 of the ‘320 anticipate the present claims. Particularly, patented claim 17 is of the same scope as, and fully anticipates claim 71. Additionally, see the compounds in patented claim 23, at columns 159 and 160.
Claims 67-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 17 and 23-28 of U.S. Patent No. 11,124,538. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compounds as claimed in the instant claims, and the method of using the compounds, as claimed in the patented claims. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compounds and their utility, which is the same utility disclosed in this application; and the instant claims claim the same compounds. Patented claim 17 encompasses the same exact scope of compounds. Patented claim 23 recites compound species that read on the instant claims. See columns 183 and 185.
This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Claim 72 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 56 of U.S. Patent No. 10,246,482. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 56 of the patent teaches compounds of formula (Ia) in which the compound is of formula
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.
While patented claim 56 depicts the isomer of formula
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, what was patented in claim 56 is the formula
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. Based on the file wrapper, the allowed structures for patented claim 56 (original claim 58) are the following:
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This is further clarified by patented claim 56 being dependent of claim 33, which discloses the formula:
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. No examiner’s amendment or Rule 312 amendment was made to original claim 58 (patented claim 56). Thus, the compound of the patented claim anticipates the instant claim.
In addition, claim 72 would have been obvious in view of what is covered by the formula (Ia) of claim 33 of the patent. What is covered by patented claim 33 was exemplified in Example 12, compound 13, of the patent. It would have been prima facie obvious to one of ordinary skill in the art to select the compound Examples from the disclosure of the invention claimed in the patent since these are the embodiments that provide support to and fall within the scope of the claims of the patent.
This rejection is proper under MPEP 804 II. B. 2. (a):
Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because ONLY "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
In addition, if the printed version would be correct, the claimed compound would be a stereoisomer of the patented compound, and thus, would have very close structural similarity and the same utility as the patented compound. One of ordinary skill in the art would have been motivated to use the claimed stereoisomeric compound with the expectation that compounds similar in structure will have similar properties. It is well known that compounds that are isomeric with compounds of the prior art are unpatentable unless they possess some unobvious or unexpected beneficial property not possessed by the prior art compounds. See In re Schechter and LaForge, 98 USPQ 144, 150. See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.) This rejection is in accordance with MPEP 2144.09.
Claim 72 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 10,745,436. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compound of formula
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as claimed in instant claim 72, and the method of using said compound, as in patented claim 17. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compound and its utility, which is the same utility disclosed in this application. This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Claim 72 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,149,057. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compound of formula
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as claimed in instant claim 72, and the method of using said compound, as in patented claim 17. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compound and its utility, which is the same utility disclosed in this application. This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Claim 72 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 11,780,875. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compound of formula
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as claimed in instant claim 72, and the method of using said compound, as in patented claim 14. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compound and its utility, which is the same utility disclosed in this application. This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Claim 72 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,473,327. Although the claims at issue are not identical, they are not patentably distinct from each other because there is no patentable distinction between the compound of formula
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as claimed in instant claim 72, and the method of using said compound, as in patented claim 14. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use]. The claims of the patent disclose the compound and its utility, which is the same utility disclosed in this application. This rejection is also proper under the recent court decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ 2d 1797. The claims of a later patent were invalid for obviousness-type double patenting because the earlier patent claimed the compound and disclosed its utility in the specification, and the later patent claimed a method of using the patented compound for the use described in the specification of the earlier patent.
Statutory DP
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 71 is are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 17 of prior U.S. Patent No. 10,329,320. This is a statutory double patenting rejection.
Conclusion
Claims 67-73 are rejected. No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached on Monday-Friday 9:30am-5:30pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1626 01/23/2025