Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
The remarks filed 06/04/2025 are acknowledged.
Claims 1-4 are canceled.
Claims 5-21 are pending.
Election/Restrictions
The Requirement for Restriction/Election mailed 02/07/2025 named species groups A, B, and C. The response to election/restriction filed 06/04/2025 named groups 1, 2, and 3. Group A, B, and C will be used here instead of Group 1, 2, and 3, respectively.
The election of: A. 1-(6,7-dihydro-5H-benzo[6,7]cyclohepta[1,2-c]pyridazin-3-yl)-N3-((7-(S)- pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo[7]annulene-2-yl)-1H-1,2,4-triazole-3,5-diamine, B. sequential, and C. between 1.0 mg/kg to 100 mg/kg in the response to election filed 06/04/2025 is acknowledged. In the response, Applicant argues that the species of Group A is a Markush group and thus, the election of a singular species is unnecessary. After examination, the examiner found that the species of Group A are alternately useable members and are a proper Markush group. For this reason, the requirement for the election of a species from Group A is withdrawn. After examination, the requirement for the species election of Groups B and C was found to be unnecessary because, for Group B, an art search for sequential administration resulted in results with both sequential and concurrent administration and, for Group C, an art search for a dose between 1.0 mg/kg to 100 mg/kg also resulted in results for a dose between 0.001 mg/kg to 100 mg/kg.
Therefore, claims 5-21 are under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application is a CON of 16/351,130, filed 03/12/2019, NOW ABANDONED, which is a CON of 15/077,648, filed 03/22/2016, NOW ABANDONED, which is a CON of 13/908,874 filed 06/03/2013, NOW ABANDONED, which is a DIV of 12/688,746 filed 01/15/2010, PAT 8546433, which claims the benefit of 61/145,448 filed 01/16/2009.
All claims examined here on their merits are given the benefit of 61/145,448 and are granted a filing date of 01/16/2009.
Information Disclosure Statement
The information disclosure statements submitted on 11/14/2022 and 12/27/2023 follow the provisions of 27 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The information disclosure statement filed 08/31/2021, with the exception of non-patent literature documents 23 and 58, follows the provisions of 27 CFR 1.98(a)(2). Accordingly, the information disclosure statement as a whole is being considered by the examiner but the non-compliant documents have not been considered. Non-patent literature document 23 is of such poor quality as to preclude consideration. Non-patent literature document 58 was not found among the non-patent literature documents filed in the instant or priority applications.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see page 98, line 20 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 12 and 20 recite the limitation “sub-cutaneous”. The spelling of subcutaneous in the claims is grammatically awkward. The examiner recommends amending the claim to read “subcutaneous.” Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation “…wherein the therapeutically effective amount of cytarabine is delivered by subcutaneous infusion”. There is insufficient antecedent basis for the limitation of this claim. The lack of antecedent basis arises from claim 20’s dependence on claim 15, which is dependent from claim 13. There is no mention of “cytarabine” in claim 13 or 15. For examination purposes, the Examiner has interpreted the ”cytarabine” as referring to the chemotherapeutic agent.
The Examiner presumes that it was intended for claim 20 to depend from claim 14, which does make reference to cytarabine. Thus, amending claim 20 to depend from claim 14 would overcome this rejection.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 5-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goff (WO2008083367; IDS filed 08/31/2021) in view of Camera et al., 2003 (instant PTO-892).
Regarding claims 5-21, Goff teaches a compound of formula (I) which encompasses the specific Axl inhibitors set forth in instant claims 5, 6, 13, and 21 and teaches a method of treating a disease or condition associated with Axl activity in a mammal, comprising administering to the mammal a therapeutically effective amount of a compound of formula (I) [see Goff claims 1 and 59] wherein the disease or condition is myeloid leukemia or lymphoma [see Goff claim 67], which has an overexpression of Axl [page 2, lines 20-23]. Goff also teaches that compound of formula (I) may be administered as an oral dose of between 0.001 mg/kg to 100 mg/kg in addition to one or more other therapeutic agents [page 121, lines 14-22, 26-28] and that the co-administration of another therapeutic agent can be either concurrently or sequentially [page 121, lines 20-32]. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
However, Goff does not specifically teach that the additional therapeutic agent is a chemotherapeutic agent or that the specific chemotherapeutic agent is cytarabine.
Camera teaches that Cytarabine (chemotherapeutic agent; Ara-C) is one of the most powerful cytotoxic drugs available for the treatment of acute leukemias and are the gold standard for induction therapy of acute myeloid leukemias (AML) [page 1, left column, first paragraph]. Camera further teaches that cytarabine is regularly injected subcutaneously in clinical treatment [page 1, left column, first paragraph] and that subcutaneous injection results in fewer gastrointestinal issues than venous infusion [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have picked among the various embodiments of Goff formula (I) to arrive at the claimed Axl inhibitor. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the Axl inhibitor of Goff with the chemotherapeutic agent of cytarabine, as taught by Camera, in order to treat AML. One would have been motivated to combine the Axl inhibitor of Goff with the cytarabine of Camera to treat AML because both are known to treat AML. This follows the logic of MPEP 2144.06 states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the Axl inhibitor and cytarabine for the same purpose of treating AML.
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.
Double Patenting Rejections over U.S. Patent No. 8,546,433
Claims 5-11, 13-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-7 of U.S. Patent No. 8,546,433 (‘433) in view of Goff (WO 2008083367; IDS filed 08/31/2021).
Regarding claims 5-11, 13-19, and 21 of the instant application, claim 1 of ‘433 teaches a method for treating or managing cancer associated with Axl catalytic activity in a patient in need thereof, wherein the method comprises administering to the patient a therapeutically effective amount of an Axl inhibitor selected from 1-(6,7-dihydro-5H-benzo [6,7]cyclohepta[1,2-c]pyridazin-3- yl)-N3-(7-(pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo[7] annulene-2-yl)-1H-1,2,4-triazole-3,5-diamine, an isolated stereoisomer or mixture thereof or a tautomer or mixture thereof, or a pharmaceutically acceptable salt or N-oxide thereof; and a therapeutically effective amount of one or more chemotherapeutic agents, claims 2 and 3 of ‘433 teach specific Axl inhibitors which meet the specific limitations of instant claims 6 and 21, claim 5 of ‘433 teaches that the chemotherapeutic agent is cytarabine, claim 6 of ‘433 teaches that the Axl inhibitor and the one or more chemotherapeutic agents are administered concurrently, as set forth in instant claims 7 and 17, and claim 7 of ‘433 teaches that the Axl inhibitor and the one or more chemotherapeutic agents are administered sequentially, as set forth in instant claim 8.
However, ‘433 does not specifically teach that the cancer is AML or that the Axl inhibitor is administered orally or at a specific dosing.
Goff teaches a compound of formula (I) which encompasses the specific Axl inhibitors set forth in instant claim 5, 6, 13, and 21 and teaches a method of treating a disease or condition associated with Axl activity in a mammal, comprising administering to the mammal a therapeutically effective amount of a compound of formula (I) [see Goff claims 1 and 59] wherein the disease or condition is myeloid leukemia or lymphoma [see Goff claim 67], which has an overexpression of Axl [page 2, lines 20-23]. Goff also teaches that compound of formula (I) may be administered as an oral dose of between 0.001 mg/kg to 100 mg/kg in addition to one or more other therapeutic agents [page 121, lines 14-22, 26-28] and that the co-administration of another therapeutic agent can be either concurrently or sequentially [page 121, lines 20-32].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have picked among the various embodiments of Goff formula (I) to arrive at the same Axl inhibitor of ‘433. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the Axl inhibitor and cytarabine of ‘433 to treat AML, and administered the Axl inhibitor orally at the specific dosing, because Goff teaches that Axl inhibitors identical to those of ‘433 can be used to treat AML when administered orally at the specific dosing. Therefore, there would be a reasonable expectation of success in treating AML with the Axl inhibitor and cytarabine of ‘433.
Claims 5-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-7 of U.S. Patent No. 8,546,433 (‘433) in view of Goff (WO 2008083367; IDS filed 08/31/2021), as applied to claims 5-11, 13-19, and 21 above, and further in view of Camera et al., 2003 (instant PTO-892).
The teachings of ‘433 and Goff are above.
However, ‘433 and Goff do not specifically teach that the cytarabine is administered by subcutaneous infusion.
Regarding claims 12 and 20, Camera teaches that Cytarabine (chemotherapeutic agent; Ara-C) is one of the most powerful cytotoxic drugs available for the treatment of acute leukemias and are the gold standard for induction therapy of acute myeloid leukemias (AML) [page 1, left column, first paragraph]. Camera further teaches that cytarabine is regularly injected subcutaneously in clinical treatment [page 1, left column, first paragraph] and that subcutaneous injection results in fewer gastrointestinal issues than venous infusion [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the cytarabine of ‘433 by subcutaneous infusion as taught by Camera. One would have been motivated to administer the cytarabine subcutaneously because Camera teaches that cytarabine is regularly injected subcutaneously in clinical treatment [page 1, left column, first paragraph] and that subcutaneous injection results in fewer gastrointestinal issues than venous infusion. Additionally, because administering cytarabine subcutaneously is a known parameter in the art, there would be a reasonable expectation of success.
Double Patenting Rejections over U.S. Patent No. 8,741,898
Claims 5-6, and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-9, and 13-14 of U.S. Patent No. 8,741,898 (‘898) in view of Camera et al., 2003 (instant PTO-892).
Regarding instant claims 5-6, and 12-14, claim 1 of ‘898 teaches a method of relieving or arresting the development of a disease of condition associated with Axl activity in a mammal, wherein a manifestation of the disease or condition is solid or liquid tumor formation in the mammal and wherein the method comprises administering to the mammal a therapeutically effective amount of a compound of formula (I). Formula (I) encompasses the specific Axl inhibitors set forth in instant claim 5, 6, 13, and 21. Claim 4 of ‘898 teaches the method of claim 1 wherein the disease of condition is alleviated by a decrease in Axl activity. Claim 7 of ‘898 teaches the method of claim 4, wherein a manifestation of the disease or condition is liquid tumor formation in said mammal. Claim 8 teaches the method of claim 7, wherein the disease or condition is myeloid leukemia or lymphoma. Claim 9 of ‘898 teaches a method of relieving or arresting the development of a disease or condition associated with Axl activity in a mammal, wherein the method comprises administering to the mammal a therapeutically effective amount of a 1-(6,7-dihydro-5H-benzo[6,7]cyclohepta[1,2-c]pyridazin-3-yl)-N3-(7-(pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo[7]annulene-2-yl)-1H-1,2,4-triazole-3,5-diamine, as a free base, a pharmaceutically acceptable salt thereof or an N-oxide
thereof; or a therapeutically effective amount of 1-(6,7-dihydro-5H-benzo[6,7]cyclohepta[1,2-c ]pyridazin-3-yl)-N3-(7-(S)-(pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo[7]annulene-2-yl)-1H-1,2,4-triazole-3,5-diamine, as a free base, a pharmaceutically acceptable salt thereof or an N-oxide thereof. Claim 13 of ‘898 teaches the method of claim 9, wherein a manifestation of the disease or condition is liquid tumor formation in said mammal. Claim 14 of ‘898 teaches the method of claim 13, wherein the disease or condition is myeloid leukemia or lymphoma.
However, ‘898 does not specifically teach administering the Axl inhibitor in combination with a chemotherapeutic agent or that the specific chemotherapeutic agent is cytarabine.
Camera teaches that Cytarabine (chemotherapeutic agent; Ara-C) is one of the most powerful cytotoxic drugs available for the treatment of acute leukemias and are the gold standard for induction therapy of acute myeloid leukemias (AML) [page 1, left column, first paragraph]. Camera further teaches that cytarabine is regularly injected subcutaneously in clinical treatment [page 1, left column, first paragraph] and that subcutaneous injection results in fewer gastrointestinal issues than venous infusion [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the Axl inhibitor of ‘898 with the chemotherapeutic agent of cytarabine, as taught by Camera, in order to treat AML. One would have been motivated to combine the Axl inhibitor of ‘898 with the cytarabine of Camera to treat AML because both are known to treat AML. This follows the logic of
MPEP 2144.06 states “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it would have been obvious to combine the Axl inhibitor and cytarabine for the same purpose of treating AML.
Claims 5-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-9, and 13-14 of U.S. Patent No. 8,741,898 (‘898) in view of Camera et al., 2003 (instant PTO-892), as applied to claims 5-6, and 12-14 above, and further in view of Goff (WO 2008083367; IDS filed 08/31/2021).
The teachings of ‘898 and Camera are above.
However, ‘898 and Camera do not specifically teach that the Axl inhibitor and cytarabine are administered concurrently or sequentially, that the Axl inhibitor is administered orally, or that the Axl inhibitor is administered in a dosing regimen between 0.001 mg/kg to 100 mg/kg or 1.0 mg/kg to 100 mg/kg for the duration of treatment.
Goff teaches a compound of formula (I), which encompasses the specific Axl inhibitors set forth in ‘898, and teaches a method of treating a disease or condition associated with Axl activity in a mammal, comprising administering to the mammal a therapeutically effective amount of a compound of formula (I) [see Goff claims 1 and 59] wherein the disease or condition is myeloid leukemia or lymphoma [see Goff claim 67], which has an overexpression of Axl [page 2, lines 20-23]. Goff also teaches that compound of formula (I) may be administered as an oral dose of between 0.001 mg/kg to 100 mg/kg in addition to one or more other therapeutic agents [page 121, lines 14-22, 26-28] and that the co-administration of another therapeutic agent can be either concurrently or sequentially [page 121, lines 20-32]. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have picked among the various embodiments of Goff formula (I) to arrive at the claimed Axl inhibitors of ‘898. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the Axl inhibitor and cytarabine, as taught by ‘898 and Camera, concurrently or sequentially, administered the Axl inhibitor orally, and administered the Axl inhibitor in a dosing regimen between 0.001 mg/kg to 100 mg/kg or 1.0 mg/kg to 100 mg/kg for the duration of treatment, as taught by Goff. One would have been motivated to have administered the Axl inhibitor and cytarabine concurrently or sequentially, administered the Axl inhibitor orally, and administered the Axl inhibitor in a dosing regimen between 0.001 mg/kg to 100 mg/kg or 1.0 mg/kg to 100 mg/kg for the duration of treatment because Goff teaches that identical Axl inhibitors to those of ‘898 may be administered as an oral dose of between 0.001 mg/kg to 100 mg/kg in combination with one or more other therapeutic agents and that the co-administration of another therapeutic agent can be either concurrently or sequentially. Therefore, since these are known parameters in the art, there would be a reasonable expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675