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 .
CONTINUING DATA
This application has PRO 63/374,137 08/31/2022
FOREIGN APPLICATIONS
PCTIB2022060652 11/04/2022
Claims 1-21 are pending.
Drawings
The drawings are objected to because Figure 1, 3, 5, and 9-12 contain pixelated or illegible matter. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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 19 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 19 depends from claim 1 and recites that the subject is not being treated with any compound that is metabolized by cytidine deaminase. Decitabine is inactivated by CDA. See WO2021173598A1, paragraph [0004]. Decitabine is a CDA substrate drug. See WO2021173598A1, paragraph [0079]. Claim 19 is unclear because claim 1 requires that decitabine is administered, while claim 19 appears to require that decitabine is not administered. Thus, it is unclear whether claim 19 was intended to mean that the subject was not previously treated with a compound that is metabolized by cytidine deaminase.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 depends from claim 1 and recites that the subject is not being treated with any compound that is metabolized by cytidine deaminase. Decitabine is inactivated by CDA. See WO2021173598A1, paragraph [0004]. Decitabine is a CDA substrate drug. See WO2021173598A1, paragraph [0079]. Thus, claim 19 appears to exclude administration of decitabine while claim 1 requires it. Claim 19 fails to include all the limitations of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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) 1-2, 5-11, 15, and 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT05403450, June 22, cited on IDS.
NCT05403450 teaches administration of oral decitabine/cedazuridine in combination with tolinapant (as the only compounds administered in the study) for relapsed/refractory peripheral T-cell lymphoma. See title. Tolinapant is administered orally once daily on days 1-7 and 15-21 of each 28 day cycle. Decitabine/cedazuridine is administered orally. Pages 2-3, Arms. Patients to be treated include the following on page 4:
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The combination of decitabine, cedazuridine, and tolinapant meets the limitation of a pharmaceutical composition comprising the three because the claim does not require that all three are contained within one dosage form or as a single agent. The specification describes decitabine/cedazuridine as a single agent in paragraph [0083], but all three of decitabine, cedazuridine, and tolinapant are never described as a single dosage form and are used in different dosing schedules, so claim 21 in view of the specification is interpreted to include combinations which are not present in a single dosage form.
Claim(s) 1-2, 5-11, 15, 17, 19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poligone (“Trial in Progress…” poster, cited on IDS).
Poligone teaches treatment of relapsed/refractory T-cell lymphoma using the combination of tolinapant with oral decitabine/cedazuridine (as the only compounds given in the study). See title and background. Subtypes are as follows:
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Oral decitabine/cedazuridine is given on days 1-5. Tolinapant 120 mg/day is given on days 1-7 and 15-21. See Study Schema.
The combination of decitabine, cedazuridine, and tolinapant meets the limitation of a pharmaceutical composition comprising the three because the claim does not require that all three are contained within one dosage form or as a single agent. The specification describes decitabine/cedazuridine as a single agent in paragraph [0083], but all three of decitabine, cedazuridine, and tolinapant are never described as a single dosage form and are used in different dosing schedules, so claim 21 in view of the specification is interpreted to include combinations which are not present in a single dosage form.
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 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.
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) 1-6, 12, 15-18, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Organesian (WO 2021173598A1, September 2, 2021, cited on IDS) in view of Ternyila (FDA Grants Orphan Drug Designation to Tolinapant for Treatment of T-Cell Lymphomas, internet article https://www.targetedonc.com/view/fda-grants-orphan-drug-designation-to-tolinapant-for-treatment-of-t-cell-lymphomas, September 1, 2020), Samaniego (“Preliminary Results of ASTX660…” cited on IDS) and Ward (“Combining the IAP Antagonist Tolinapant…”, November 5, 2021, cited on IDS).
Organesian teaches the combination of decitabine and cedazuridine in a solid oral dosage form. See title. The composition comprises 100 mg cedazuridine and 35 mg decitabine (claims 9-10). T-cell lymphoma is treated (claim 27). The composition is administered MTWThF (5 days). See claim 31. Decitabine is used to treat MDS [0004]. Pretreatment with an additional therapeutic agent is optional [0090], which includes a subject which has been previously treated or a subject which has not been previously treated.
Organesian does not teach administration of tolinapant along with the decitabine and cedazuridine.
Ternyila teaches that oral tolinapant is used to treat T-cell lymphoma such as peripheral T-cell lymphoma and cutaneous T-cell lymphoma. Phase 1 includes a dose-escalation stage and administration was every other week. See page 1. Patients received between 15 and 270 mg/day. See page 2.
Samaniego teaches that ASTX660 (tolinapant) shows activity against relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma. See Conclusion and Title.
Ward teaches that decitabine enhances the activity of tolinapant in the context of T-cell lymphoma (Conclusions).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat T-cell lymphoma using the combination of decitabine, cedazuridine, and tolinapant because all three are known for treating T-cell lymphoma. See MPEP 2144.06: “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.” The combination of decitabine and cedazuridine is used to treat T-cell lymphoma, tolinapant shows activity against T-cell lymphoma, and decitabine enhances the activity of tolinapant, so the skilled artisan would have had a reasonable expectation that a combination of all three would be useful for treating T-cell lymphoma. The skilled artisan would have optimized the dose of tolinapant starting at 15 mg/day as taught by Ternyila and escalating the dose until the best results were observed. It would have been obvious to one of ordinary skill in the art at the time the application was filed to treat a subject who was previously treated with decitabine because decitabine is used to treat MDS.
The combination of decitabine, cedazuridine, and tolinapant meets the limitation of a pharmaceutical composition comprising the three because the claim does not require that all three are contained within one dosage form or as a single agent. The specification describes decitabine/cedazuridine as a single agent in paragraph [0083], but all three of decitabine, cedazuridine, and tolinapant are never described as a single dosage form and are used in different dosing schedules, so claim 21 in view of the specification is interpreted to include combinations which are not present in a single dosage form.
Claim(s) 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Organesian in view of Samaniego and Ward as applied to claim 1-2, 5-6, 12, 17-18, and 20-21 above, and further in view of Pule (US 20170066827A1).
Organesian, Samaniego, Ward, and Ternyila teach as set forth above, but do not teach specifically the types of T-cell lymphomas recited in claims 5-14.
Pule teaches that T-cell lymphomas include peripheral T-cell lymphoma [0249] including not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma {AITL) [0254]; anaplastic large cell lymphoma [0266]; enteropathy-associated T-cell lymphoma [0276]; hepatosplenic T-cell lymphoma [0284]; cutaneous T-cell lymphoma [0290] including mycosis fungoides and Sezary syndrome [02929]; or acute lymphoblastic leukemias [0081].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to use the combination of decitabine, cedazuridine, and tolinapant for treatment of T-cell lymphomas recited in the current claims because the individual elements or pairs of elements of the combination are used for treating T-cell lymphomas generally and peripheral T-cell lymphoma and cutaneous T-cell lymphoma particularly, and Pule teaches the types of T-cell lymphomas. The skilled artisan would have had a reasonable expectation of success because the members of the combination are known for treating T-cell lymphomas generally individually or in pairs, and certain types of T-cell lymphomas particularly.
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 1-6, 12, 15-18, and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,224,610 in view of Organesian, Ternyila, Samaniego, and Ward.
The ‘610 patent claims a method of treating lymphoma using a combination of decitabine at 5-15 mg and cedazuridine at 40-1000 mg. Claims 1-7.
The ‘610 patent does not claim addition of tolinapant.
Organesian teaches the combination of decitabine and cedazuridine in a solid oral dosage form. See title. The composition comprises 100 mg cedazuridine and 35 mg decitabine (claims 9-10). T-cell lymphoma is treated (claim 27). The composition is administered MTWThF (5 days). See claim 31. Decitabine is used to treat MDS [0004]. Pretreatment with an additional therapeutic agent is optional [0090], which includes a subject which has been previously treated or a subject which has not been previously treated.
Ternyila teaches that oral tolinapant is used to treat T-cell lymphoma such as peripheral T-cell lymphoma and cutaneous T-cell lymphoma. Phase 1 includes a dose-escalation stage and administration was every other week. See page 1. Patients received between 15 and 270 mg/day. See page 2.
Samaniego teaches that ASTX660 (tolinapant) shows activity against relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma. See Conclusion and Title.
Ward teaches that decitabine enhances the activity of tolinapant in the context of T-cell lymphoma (Conclusions).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the ‘610 method with the addition of tolinapant because the combination of decitabine and cedazuridine is used to treat lymphoma, particularly T-cell lymphoma, and tolinapant is used to treat T-cell lymphoma. See MPEP 2144.06: “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.”
The combination of decitabine, cedazuridine, and tolinapant meets the limitation of a pharmaceutical composition comprising the three because the claim does not require that all three are contained within one dosage form or as a single agent. The specification describes decitabine/cedazuridine as a single agent in paragraph [0083], but all three of decitabine, cedazuridine, and tolinapant are never described as a single dosage form and are used in different dosing schedules, so claim 21 in view of the specification is interpreted to include combinations which are not present in a single dosage form.
Claims 5-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,224,610 in view of Organesian, Ternyila, Samaniego, and Ward; and further in view of Pule.
The ‘610 patent claims as set forth above, and Organesian, Ternyila, Samaniego, and Ward teach as set forth above, but do not teach all the different types of T-cell lymphomas recited in the current claims.
Pule teaches that T-cell lymphomas include peripheral T-cell lymphoma [0249] including not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma {AITL) [0254]; anaplastic large cell lymphoma [0266]; enteropathy-associated T-cell lymphoma [0276]; hepatosplenic T-cell lymphoma [0284]; cutaneous T-cell lymphoma [0290] including mycosis fungoides and Sezary syndrome [02929]; or acute lymphoblastic leukemias [0081].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the proposed combination of decitabine, cedazuridine, and tolinapant for treatment of T-cell lymphomas recited in the current claims because the individual elements or pairs of elements of the combination are used for treating T-cell lymphomas generally and peripheral T-cell lymphoma and cutaneous T-cell lymphoma particularly, and Pule teaches the types of T-cell lymphomas. The skilled artisan would have had a reasonable expectation of success because the members of the combination are known for treating T-cell lymphomas generally individually or in pairs, and certain types of T-cell lymphomas particularly.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693