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 .
Priority
This application, filed 10/30/2023 is a Continuation of 18119521, filed 03/09/2023.
18119521 is a Continuation of 17872745, filed 07/25/2022.
17872745 is a Continuation of 16697107, filed 11/26/2019.
16697107 is a Continuation of 15409912, filed 01/19/2017.
15409912 is a Continuation of 14687714, filed 04/15/2015.
14687714 Claims Priority from Provisional Application 62110278, filed 01/30/2015;
Provisional Application 62042756, filed 08/27/2014; Provisional Application 62042681, filed 08/27/2014; and from Provisional Application 61980540, filed 04/16/2014.
Status of Claims
Claims 1-20 are pending as of the response filed on 6/22/26. Claims 21-120 have been canceled.
Applicant’s election of the AKT inhibitor, perifosine, in the reply filed on 6/22/26 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 § 818.01(a)). The elected species reads on claims 1-12, 19, and 20.
Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/26.
In addition to the elected species, search and examination were extended to an additional species, the immunomodulator, lenalidomide; and the HDAC inhibitor ACY-1215, to provide compact prosecution, with the understanding that the species election is maintained.
Claims 1-12, 19, and 20 were examined and are rejected.
Claim Rejections-35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gallatin et. al., WO 2012125510 A1, publ. 9/20/2012.
Gallatin discloses combination therapies for the treatment of hematologic malignancies (title & abstract; para [0002]). Gallatin discloses treatment of chronic lymphocytic leukemia (CLL) or indolent non-Hodgkin’s lymphoma comprising administering an effective amount of the combination of a compound of formula (I”) shown below, and lenalidomide, with a pharmaceutical excipient (para [0069]):
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. The shown compound is (S)-2-(1-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one, and lenalidomide is a well-known immunomodulator. Regarding the claim recitations, “a synergistic combination”; “wherein the combination is synergistic as indicated by a combination index value that is less than 1”; “wherein the combination is synergistic as indicated by a combination index value that is less than 0.7”; “wherein the combination is synergistic as indicated by a combination index value that is less than 0.5”; “wherein the combination index value is assessed at 50% inhibition”; “wherein the combination index value is assessed at 50% growth inhibition”; “wherein the combination of the PI3K inhibitor and the second therapeutic agent is synergistic as indicated by a synergy score value of greater than 3”; and “wherein the combination of the PI3K inhibitor and the second therapeutic agent is synergistic as indicated by a synergy score value of greater than 3 for inhibition or growth inhibition”, Gallatin discloses the same combination as claimed for the treatment of cancer, CLL or indolent non-Hodgkin’s lymphoma. Therefore, the combination disclosed by Gallatin would have necessarily had the same characteristics as claimed. See MPEP 2112.01(II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Gallatin therefore anticipates the claims.
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Quayle et. al., WO 2015054355 A1 (publ. 4/16/2015, cited in the IDS; provisional appl. 61889207, filed on 10/10/2013, provides support to the limitations discussed below), as evidenced by Winkler et. al., Chemistry & Biology, vol. 20, pp. 1364-1374, publ. Nov. 2013 (cited in the IDS), and Santo et. al., Blood, vol. 119(11), pp. 2579-2589, publ. 2012 (cited in the IDS).
Quayle discloses HDAC inhibitors in combination with PI3K inhibitors, administered for treating non-Hodgkin’s lymphoma (NHL) (Title & Abstract; p. 1, line 28-p. 2, line 7). Quayle discloses the combination synergistically increases apoptosis of cells (p. 2, lines 8-9). Quayle discloses compositions and treating NHL in a subject in need thereof comprising administering a therapeutically effective amount of compound A and IPI-145 (p. 15, lines 6-11; p. 24, lines 22-24); compound A has the chemical structure shown below (p. 27, Ex. 1):
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. Compound A is also known as the HDAC inhibitor ACY-1215, as evidenced by Santo (Title & Abstract; Fig. 1A), and IPI-145 is structurally identical to (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one, as evidenced by Winkler (see p. 1366, Fig. 1A):
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. Quayle therefore discloses treatment of the same condition as encompassed by the claims, the hematological malignancy, NHL, comprising administering a therapeutically effective amount of the same combination as recited by the instant claims, (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one and the HDAC inhibitor, ACY-1215, to a subject in need thereof. Regarding the limitation in the claims, “a synergistic combination”; “wherein the combination is synergistic as indicated by a combination index value that is less than 1”; “wherein the combination is synergistic as indicated by a combination index value that is less than 0.7”; “wherein the combination is synergistic as indicated by a combination index value that is less than 0.5”; “wherein the combination index value is assessed at 50% inhibition”; “wherein the combination index value is assessed at 50% growth inhibition”; “wherein the combination of the PI3K inhibitor and the second therapeutic agent is synergistic as indicated by a synergy score value of greater than 3”; and “wherein the combination of the PI3K inhibitor and the second therapeutic agent is synergistic as indicated by a synergy score value of greater than 3 for inhibition or growth inhibition”, Quayle discloses administration of the same combination as claimed to treat a hematological malignancy, NHL. See MPEP 2112.01(II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Quayle as such anticipates the claims.
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.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallatin et. al., WO 2012125510 A1, publ. 9/20/2012, as applied to claims 1-10 and 12.
The disclosure of Gallatin as discussed previously is incorporated herein. Additionally, Gallatin teaches combination therapies involving administering a compound of formula (A) as shown below, an additional therapeutic agent, and a pharmaceutically acceptable excipient, for the treatment of cancer (para [0165]):
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. The S-enantiomer of the compound shown below is exemplified for formula (A) (para [0171]):
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; this compound is also known as (S)-2-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one. Gallatin teaches administering the compound of formula (A) above in combination with a therapeutically effective amount of an additional therapeutic agent, with perifosine included within the list of additional therapeutic agents (para [0194-0195], [0256]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the combination of the PI3K inhibitor, (S)-2-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one, and the AKT inhibitor, perifosine, for administering to treat cancer, in consideration of Gallatin. Gallatin teaches combination therapies for treating cancer, and exemplifies the PI3K inhibitor, (S)-2-(9H-purin-6-ylamino)propyl)-5-fluoro-3-phenylquinazolin-4(3H)-one, for combination with one or more chemotherapy agents. Perifosine is included as an additional chemotherapy agent for combination treatment. As such, one of ordinary skill in the art would have been motivated to have arrived at the combination treatment of the claims, and have had a reasonable expectation of success.
Claim Rejections-Nonstatutory 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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18-19 of U.S. Patent No. 12213983 B2 in view of Ren et. al., WO 2011008302 A1, publ. 1/20/2011, cited in the IDS. Both sets of claims encompass treating a malignancy by administering the following compound:
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(S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one. Furthermore, both sets of claims encompass administering the above compound in combination with a second agent, selected from an HDAC inhibitor or a MEK inhibitor (see patented claim 8 & instant claim 1). The difference between the claims is that the patented claims recite oral administration of (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one twice daily at a dose from about 25 mg. to about 75 mg., which is not explicitly recited by the instant claims. However, such a dosage and route of delivery would have been prima facie obvious in view of Ren. Ren teaches PI3K modulators for treating various diseases, including cancer, wherein oral administration is acceptable (title & abstract; para [00106]). Ren further teaches (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one as a PI3K modulator (para [00492], see compound 4904), and that an exemplary daily dose ranges from 0.5-100 mg. (para [00329]), from one to six times or more per day (para [00371]). As such, it would have been prima facie obvious to have adopted the dosing regime recited in the patented claims into the instant claims, in view of Ren, and have had a reasonable expectation of success. For these reasons, the instant and patented claims are not patentably distinct.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 95-98, 100, 103-111, and 113-117 of copending Application No. 18985776 in view of Ren et. al., WO 2011008302 A1, publ. 1/20/2011. Both sets of claims encompass treating a malignancy by administering the following compound:
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, (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one. Furthermore, both sets of claims encompass administering the above compound in combination with a second agent, selected from an HDAC inhibitor or a MEK inhibitor (see copending claim 103 & instant claim 1). The difference between the claims is that the copending claims recite oral administration of (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one twice daily at a dose from about 25 mg. to about 75 mg., which is not explicitly recited by the instant claims. However, such a dosage and route of delivery would have been prima facie obvious in view of Ren. Ren teaches PI3K modulators for treating various diseases, including cancer, wherein oral administration is acceptable (title & abstract; para [00106]). Ren further teaches (S)-3-(1-((9H-purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one as a PI3K modulator (para [00492], see compound 4904), and that an exemplary daily dose ranges from 0.5-100 mg. (para [00329]), from one to six times or more per day (para [00371]). As such, it would have been prima facie obvious to have adopted the dosing regime recited in the copending claims into the instant claims, in view of Ren, and have had a reasonable expectation of success. For these reasons, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
Information Disclosure Statement
The IDS filed on 4/17/26 has been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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