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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
Double Patenting Rejections, MAINTAINED and NEW
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 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 1, 2, 4-6, 8, 10-14 and 16-22 remain rejected, and new claim 23 is also rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of (parent) U.S. Patent No. 9,573,935 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other. Inventor’s amendment and arguments have been carefully considered, but are not persuasive.
As outlined previously, patented claims 1 and 2 are drawn to a single compound: N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide or a salt thereof. (Diagramed in the patent’s specification at column 29, Example 5). The instant Markush claims drawn to compounds (claims 1, 2, 4-6, 8 and 16) encompass this compound. Note that the principle is well established in chemical cases, and in cases involving compositions of matter, that the disclosure of a species in a cited reference is sufficient to prevent a later applicant from obtaining a patent to the “generic claim.” In re Steenbock, 1936, C.D. 594, 473 O.G. 495.
Furthermore, US 9,573,935 B2, teaches that the patented compound is a member of a set of compounds which have Ax1 inhibitory activity and are therefore useful in preventing and/or treating Ax1-related diseases, such as cancer, kidney disease, etc., specifically, acute myeloid leukemia, chronic myeloid leukemia, etc. including metastatic cancer (column 1, line 15; column 22, line 6ff). The instant claims encompass this teaching. Note, however, that a claim to a method of using a compound, where an earlier patent claimed the compound and that patent’s specification disclosed the compound’s utility in the method, is not patentably distinct from the patented compound claim. (Sun Phar. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ 2d 1797 (Fed. Cir. 2010)).
Inventor has amended independent claim 1 to recite that the compound is a mixture of optical isomers. New dependent claim 23 (from claim 1) teaches that this mixture is a racemic mixture.
The examiner notes that the named compound, N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide or a salt thereof, of the cited art intrinsically encompasses optical isomers, including racemic mixtures. Simply explicitly stating what the cited art already intrinsically encompasses does not distinguish over the teachings of that art.
Claims 1-14, and 16-22 remain rejected, and new claim 23 is also rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10 and 16 of (parent) U.S. Patent No. 9,994,549 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other. Inventor’s amendment and arguments have been carefully considered, but are not persuasive.
As outlined previously, patented claims 9 and 10 teach Markush sets of compounds which substantially overlap the Markush set of compounds taught by instant compound claims 1-8 and 16. Patented claim 16 teaches a method of treating an Ax1-related disease comprising administering a member of the Markush set of compounds of claim 10. The specification of US 9,994,549 B2 explicitly teaches that the larger Markush group which encompasses these compounds have Ax1 inhibitory activity and are therefore useful in preventing and/or treating Ax1-related diseases, such as cancer, kidney disease, etc., specifically, acute myeloid leukemia, chronic myeloid leukemia, etc. including metastatic cancer (column 7, line 20; column 22, line 6ff). The instant claims encompass this teaching.
Finally, the patented method of treatment claim intrinsically requires a pharmaceutical composition be utilized in the method. That being the case, instant claim 9 is included in this rejection because its limitation is intrinsic to the prior art method.
Inventor has amended independent claim 1 to recite that the compound is a mixture of optical isomers. New dependent claim 23 (from claim 1) teaches that this mixture is a racemic mixture.
The examiner notes that the cited art intrinsically encompasses optical isomers, including racemic mixtures. Simply explicitly stating what the cited art already intrinsically encompasses does not distinguish over the teachings of that art.
Claims 10-14, and 17-22 remain rejected, and new claim 23 is also rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of (parent) U.S. Patent No. 10,208,022 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are essentially generic to the patented claims. Inventor’s amendment and arguments have been carefully considered, but are not persuasive.
As outlined previously, the patented claims are drawn to a method which encompasses a single compound: N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide. (Diagramed in the patent’s specification at column 29, Example 5). The Markush group of the instant method claims - which teach the same method - encompasses this compound. Note that the principle is well established in chemical cases, and in cases involving compositions of matter, that the disclosure of a species in a cited reference is sufficient to prevent a later applicant from obtaining a patent to the “generic claim.” In re Steenbock, 1936, C.D. 594, 473 O.G. 495.
Inventor has amended independent claim 1 to recite that the compound is a mixture of optical isomers. New dependent claim 23 (from claim 1) teaches that this mixture is a racemic mixture.
The examiner notes that the named compound, N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide, of the cited art intrinsically encompasses optical isomers, including racemic mixtures. Simply explicitly stating what the cited art already intrinsically encompasses does not distinguish over the teachings of that art.
Claim 9 remains rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of (parent) U.S. Patent No. 10,501,442 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is essentially generic to the patented claims. Inventor’s amendment and arguments have been carefully considered, but are not persuasive.
As outlined previously, the patented claims are drawn to a pharmaceutical composition which encompasses a single compound: N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide. (The compound is diagramed in patented claim 2.) The Markush group of the instant composition claim encompasses this compound. Note that the principle is well established in chemical cases, and in cases involving compositions of matter, that the disclosure of a species in a cited reference is sufficient to prevent a later applicant from obtaining a patent to the “generic claim.” In re Steenbock, 1936, C.D. 594, 473 O.G. 495.
Inventor has amended independent claim 1 to recite that the compound is a mixture of optical isomers.
The examiner notes that the named compound, N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide, of the cited art intrinsically encompasses optical isomers, including racemic mixtures. Simply explicitly stating what the cited art already intrinsically encompasses does not distinguish over the teachings of that art.
Claims 1, 2, 4-6, 8, 10-14 and 16-22 remain rejected, and new claim 23 is also rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7 and 8-12 of U.S. Patent No. 10,836,747 B2, cited in the IDS (applicant is ONO PHARMACEUTICAL CO., LTD). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim is essentially generic to the patented claims. Inventor’s amendment and arguments have been carefully considered, but are not persuasive.
As outlined previously, the patented claims are drawn to a compound (claim 1), pharmaceutical composition (claims 7) and methods of use (claims 8-12) which encompasses a single compound: the ethanesulfonate salt of N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide. (The free base of which is diagramed in the patent’s specification at column 18, Example 5, and the preparation of which is taught at column 20, Example 6.) This compound and its pharmaceutical composition and method of use are encompassed by the instant Markush group. Note that the principle is well established in chemical cases, and in cases involving compositions of matter, that the disclosure of a species in a cited reference is sufficient to prevent a later applicant from obtaining a patent to the “generic claim.” In re Steenbock, 1936, C.D. 594, 473 O.G. 495.
Inventor has amended independent claim 1 to recite that the compound is a mixture of optical isomers. New dependent claim 23 (from claim 1) teaches that this mixture is a racemic mixture.
The examiner notes that the named compound, the ethanesulfonate salt of N-{5-[(6,7,-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-phenyl-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide, of the cited art intrinsically encompasses optical isomers, including racemic mixtures. Simply explicitly stating what the cited art already intrinsically encompasses does not distinguish over the teachings of that art.
Allowable Subject Matter
Claim 15 remains allowed for reasons of record (3/2/2023).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 2/6/2026