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 without traverse of fluorouracil in the reply filed on 06/17/2026 is acknowledged.
Claims 1-25 read on the elected species.
Priority
This application is a continuation of US patent 12011427, which claims priority to US provisional application 62/946,581.
The instant claims find support from the provisional application. Therefore, the effective filing date is 12/11/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12, and 14-24 are rejected under 35 U.S.C. 103 as being unpatentable over:
TAVAZOIE (WO Patent No. 2014/071067 A2),
in view of:
MARTINEZ (U.S. Patent No. 9,884,813 B1),
and in view of:
KEANE (Keane, Maccon. “FOLFIRI Therapy-14 day, NCCP Chemotherapy Regimen.” Published October 1, 2015),
as evidenced by:
FDA (“Camptosar (Irinotecan) Injection, intravenous infusion”, FDA, Published: December 2014),
and in view of:
AMERICAN CANCER SOCIETY (“What is Cancer Recurrence?”, American Cancer Society, Last Revised: February 12, 2016).
TAVAZOIE teaches a method of treating cancer in a subject in need by administering 0.01-100 mg/kg of B-GPA (page 22), which teaches all the limitations of claims 1-6 except the dosage.
TAVAZOIE teaches orally administering B-GPA (page 22), which teaches claims the oral route of administration of claim 1.
TAVAZOIE teaches administering one or more anti-cancer therapies, such as chemotherapeutic, radiotherapeutic, and anti-angiogenic agents, alone or in combination (page 22 lines 6-8), which teaches instant claims 7-8.
TAVAZOIE teaches surgery as part of a treatment regimen (page 1 lines 27 and 28), which teaches instant claims 8 and 14. TAVAZOIE further teaches the co-administration of two or more agents/therapies and teaches the first agent/therapy administered followed by a second agent/therapy administered (page 22 lines 9-11), which helps teach instant claims 7 and 8. TAVAZOIE teaches recurrence following surgery (the most common form of therapy), is a major problem and often the ultimate cause of death (page 1 lines 28 through page 2 lines 2); this helps teach claim 12.
TAVAZOIE also teaches therapeutic agents of fluorouracil, oxaliplatin, irinotecan, and folinic acid (page 3 lines 24 and 25), which teaches instant claims 9 and 10.
TAVAZOIE teaches that the subject is identified to have, or to be at risk of having, metastatic colon cancer (page 3 lines 28-29), which teaches instant claim 19.
TAVAZOIE teaches the cancer is metastatic colon cancer (page 2 lines 8-9), which teaches claims 16, 17, 18, and 19.
TAVAZOIE also teaches gastric cancer (page 5 line 24) and adenocarcinoma (page 9 line 31), which teaches claim 17.
TAVAZOIE teaches the colon cancer or metastatic colon cancer that is resistant to chemotherapeutics or targeted therapies (page 4 lines 4-7), which teaches instant claim 21.
TAVAZOIE teaches CKB as a marker of determining tumor activity (page 3 lines 7-16 and page 5 lines 7-16). TAVAZOIE teaches a method of decreasing the expression level or activity of CKB (page 3 line 9). TAVAZOIE also teaches a method of identifying a compound useful for treating colon cancer, which includes obtaining a test cell capable of expressing CKB, and later treating the colon cancer with a test compound, such as B-GPA (page 3 lines 7-16 and page 5 lines 7-16). TAVAZOIE teaches decreasing the level of CKB, which teaches the cancer must express CKB from instant claim 20.
TAVAZOIE does not teach B-GPA as a succinate salt or the 2:1 ratio, does not teach the dose amount and timings, and does not teach cancers which have progressed after treatment.
MARTINEZ teaches B-GPA as a treatment of cancer (column 1 line 36) and as a succinate salt as well as in a 2:1 ratio (table 18 and column 30 line 5), teaches instant claims 23 and 24.
MARTINEZ does not teach all of the limitations of each rejected claim.
KEANE teaches the dosages and timing of FOLFIRI therapy, which is a treatment of irinotecan, folinic acid, and fluorouracil (page 1). KEANE teaches irinotecan administered intravenously over 90 minutes with a dosage of 180 mg/m2 and concurrently administering 400 mg/m2 folinic acid over 2 hours, and then followed by administering about 2400 mg/m2 infusion of fluorouracil intravenously over 46 hours (page 1). KEANE also teaches irinotecan and the folinic acid can be infused at the same time by using a y-connector placed immediately before the injection site (page 1).
KEANE teaches repeating the FOLFIRI therapy of every 14 days (page 1). This helps reject claims 10-12.
KEANE does not teach all the limitations of each rejected claim.
FDA is relied upon for the beneficial teachings that FOLFIRI therapy is a well-known therapy consisting of irinotecan, folinic acid, and fluorouracil (page 1). FDA also corroborates the timings of the FOLFIRI therapy dosages (page 1).
AMERICAN CANCER SOCIETY teaches cancer recurrence, which is defined as cancer found after treatment (page 1). AMERICAN CANCER SOCIETY also teaches these types of cancer can progress (page 2). It is commonly known in the art that multiple and different rounds of treatment are required for recurrent cancers (page 2 and 3), which teaches instant claim 22.
AMERICAN CANCER SOCIETY does not teach all of the limitations of each rejected claim.
The instant claims 1-12 and 14-24 are prima facie obvious in light of the combination of references TAVAZOIE, MARTINEZ, KEANE (as evidenced by FDA), and AMERICAN CANCER SOCIETY.
The artisan would find obvious before the effective filing date of the claimed invention to tailor the dosages of B-GPA as taught by TAVAZOIE to arrive at the instantly claimed invention.
The artisan would be motivated to treat one or more of the metastatic gastrointestinal cancers of TAVAZOIE (see, above) with a dose tailored amount of the 0.01-100 mg/kg of B-GPA (TAVAZOIE page 22; page 2 lines 8-9; page 5 line 24; page 9 line 31; and page 4 lines 4-7). Doctors and Pharmacists regularly tailor doses of medicaments to achieve similar results in different patient populations based on patient size and body mass index. For example, a small child would be prescribed a very different dosage of B-GPA versus a full-grown adult. The artisan would be expected to optimize the dosage (concentration and how often said concentration is administered referred to as “dose tailoring”) of B-GPA, including the widely utilized B-GPA succinate salt in its commonly prescribed form of 2:1 B-GPA to succinate salt (MARTINEZ col. 1 line 36; and table 18 and column 30 line 5), to increase therapeutic efficacy in the normal course of tailoring a dosage to specific patient populations. See MPEP 2144.05 (II): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical”. Neither the specification nor the claims indicate the dosages of the instant claims are critical.
Furthermore, the artisan would be motivated to monitor the levels of CKB tumor biomarker during B-GPA treatment. The artisan would expect that B-GPA administration would be effectively treating the cancer if CKB levels fell during B-GPA treatment as CKB is understood to be a marker of determining tumor activity (TAVAZOIE page 3 lines 7-16 and page 5 lines 7-16).
Furthermore, the artisan would be motivated to add B-GPA to one or more of the commonly prescribed radiation and surgery anti-cancer therapies, especially for metastatic cancers and for cancers resistant to one or more therapeutic agents (TAVAZOIE page 1 lines 28 through page 2 lines 2; page 1 line 27-28; page 22 line 6-8; and AMERICAN CANCER SOCIETY pages 2-3). The artisan would expect that by adding the commonly prescribed B-GPA administration to at least one of surgery and radiation anti-cancer therapies, that the cancer disease progress would be more effectively controlled than without B-GPA (TAVAZOIE and MARTINEZ). Moreover, if surgery is chosen, then the artisan would be expected to follow the surgery with B-GPA administration since cancer recurrence after surgery is a common cause of death (TAVAZOIE page 1 lines 28 through page 2 lines 2).
Furthermore, the artisan would be motivated to add one or more of the commonly prescribed therapeutic agents: folinic acid, fluoruracil, irinotecan, and/or oxaliplatin anti-cancer therapies in addition to administering B-GPA to the treatment of any metastatic cancers (TAVAZOIE page 1 lines 28 through page 2 lines 2; page 1 line 27-28; page 22 line 6-8; and AMERICAN CANCER SOCIETY pages 2-3). The artisan would expect that by adding these additional anti-cancer therapeutic agents in the commonly prescribed/FDA-approved dosages (which match those of claims 9-10) (KEANE page 1) that that the metastatic disease progress would be more effectively controlled.
Claim(s) 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over
TAVAZOIE (WO Patent No. 2014/071067 A2),
in view of:
MARTINEZ (U.S. Patent No. 9,884,813 B1),
and in view of:
KEANE (Keane, Maccon. “FOLFIRI Therapy-14 day, NCCP Chemotherapy Regimen.” Published October 1, 2015),
as evidenced by:
FDA (“Camptosar (Irinotecan) Injection, intravenous infusion”, FDA, Published: December 2014),
and in view of:
AMERICAN CANCER SOCIETY (“What is Cancer Recurrence?”, American Cancer Society, Last Revised: February 12, 2016)
and in view of:
Pavlidis (Pavlidis and Pavlidis, “Role of Bevacizumab in colorectal cancer growth and its adverse effects: a review”, World Journal of Gastroenterology, August 21, 2013).
Claims 1-12, and 14-24 are taught above.
Pavlidis teaches that Bevacizumab is currently used in combination with other chemotherapies to manage colorectal cancer (Abstract). This helps teach claim 13.
Additionally, the artisan would have found it obvious to combine Bevacizumab, with FOLFIRI therapy (taught in KEANE), which are known to treat colorectal cancers. It is prima facie obvious to combine one colorectal cancer treatment with another in order to form a composition to be used for the very same purpose (treating colorectal cancers). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 13 and 25.
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 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,011,427 B2 in view of TAVAZOIE (WO Patent No. 2014/071067 A2), and Pavlidis (Pavlidis and Pavlidis, “Role of Bevacizumab in colorectal cancer growth and its adverse effects: a review”, World Journal of Gastroenterology, August 21, 2013).
Although the reference claims are not identical to the instant claims, the reference claims in view of Pavlidis teaches the instant claims.
Ref claim 1 teaches instant claim 1 except for the oral route of administration.
TAVAZOIE teaches orally administering B-GPA (page 22), which teaches claims the oral route of administration of instant claim 1.
Ref claim 4 teaches instant claim 7.
Ref claim 5 teaches instant claim 8.
Ref claim 6 teaches instant claim 9.
Ref claim 7 teaches instant claim 10.
Ref claim 8 teaches instant claim 11.
Ref claim 9 teaches instant claim 12.
Ref claim 10 teaches instant claim 14.
Ref claim 11 teaches instant claim 15.
Ref claim 13 teaches instant claim 16.
Ref claim 14 teaches instant claims 17 and 18.
Ref claim 16 teaches instant claim 19.
Ref claim 15 teaches instant claim 20.
Ref claim 17 teaches instant claim 21.
Ref claim 18 teaches instant claim 22.
Ref claims 19-20 teaches instant claims 23-24.
The ref claims do not teach Bevacizumab.
Pavlidis teaches that Bevacizumab is currently used in combination with other chemotherapies to manage colorectal cancer (Abstract). This helps teach claim 13.
Additionally, the artisan would have found it obvious to combine Bevacizumab, with folinic acid, fluorouracil, irinotecan (ref claims 6-8) , which are known to treat colorectal cancers. It is prima facie obvious to combine one colorectal cancer treatment with another in order to form a composition to be used for the very same purpose (treating colorectal cancers). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This teaches claims 13 and 25.
Conclusion
No claims are allowed as currently written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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