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 .
Detailed Action
This application is a continuation of US application 17/045343, now US patent 12036222, filed October 5, 2020, which is a national stage application of PCT/US2019/025609, filed April 3, 2019, which claims benefit of provisional application 62/652565, filed April 4, 2018. Claims 21-30 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted September 24, 2024, is acknowledged wherein claims 1-19 are canceled and new claims 21-30 are introduced.
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.
Claims 26-30 are 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.
The aforementioned claims 26-30 all depend from independent claim 21, which claims a composition for treating cancer in a subject, comprising an EZH2 inhibitor, a PARP inhibitor, and a pharmaceutically acceptable carrier. In its broadest reasonable interpretation, this claim is interpreted as being infringed by a composition of matter composed of all three of these elements together. However, dependent claims 26 and 27 describe the EZH2 inhibitor and the PARP inhibitor as being provided in either the same or different pharmaceutically acceptable carriers. However, given that these claims depend from base claim 21, the discussion of a composition of matter as comprising compounds in different pharmaceutically acceptable carriers creates ambiguity as to the meaning of “pharmaceutical composition.” Similarly, claims 28-30 refer to the two active ingredients being formulated in either the same or separate administrative doses. It is unclear from the claims and the specification what the definition of “administrative dose” is and in what way two different active ingredients can be part of the same composition but two different administrative doses, rendering these claims indefinite.
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.
Claims 21-23 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. (Reference included with PTO-892)
Independent claim 21 claims a composition comprising and EZH2 inhibitor and a PARP inhibitor. Dependent claims 22 and 23 further specify the identity of the EZH2 inhibitor and PARP inhibitor.
Yamaguchi et al. discloses a study of the interaction of EZH2 and PARP in the context of cancer treatment. (p. 20-8 right column second paragraph) Inhibition of PARP in a breast cancer cell line was seen to enhance EZH2 function and lead to an increase in cancer stem cells. (p. 210 right column) Furthermore inhibiting EZH2 was seen to sensitize breast cancer cells to PARP inhibition. (p. 212 left column last paragraph – right column) The EZH2 inhibitor used was GSK343 and the PARP inhibitor used was olaparib.
While Yamaguchi et al. does not specifically disclose a pharmaceutical composition comprising both GSK343 and olaparib, it would have been obvious to one of ordinary skill in the art at the time of the invention to make such a composition comprising effective amounts of both active ingredients. One of ordinary skill in the art would have seen the disclosure of Yamaguchi as suggesting the combined administration of these two compounds as being useful at producing an enhanced antitumor effect, which would have suggested producing a single pharmaceutical composition for administering them together.
Regarding claims 26-30, as discussed under 35 USC 112(b), these claims are indefinite, and it is unclear how they would differentiate the claimed subject matter from any pharmaceutical composition comprising both active ingredients. Furthermore to the extent that these claims are taken as claiming an set of two different pharmaceutical dosage units that are somehow associated with one another, one of ordinary skill in the art would still have seen such a combination not be obvious as it merely represents the rearrangement of parts and still serves the same function of enabling one of ordinary skill in the art to administer both anticancer compounds to the same subject.
Therefore the invention taken as a whole is prima facie obvious.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaguchi et al. as applied to claims 21-23 and 26-30 above, and further in view of Hastak et al. (Reference included with PTO-892)
The disclosure of Yamaguchi et al. is discussed above. Yamaguchi et al. does not specifically disclose a composition further comprising a platinum drug. However, Hastak et al. discloses a study of the effect of gemcitabine, cisplatin, and a PARP inhibitor either alone or in combination against breast cancer cells. (p. 7971 left column second paragraph) The PARP inhibitor and cisplatin were found to have a synergistic effect in certain cell lines. (p. 7974 left column)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include cisplatin in the compositions mentioned in the previous rejection over Yamaguchi et al. alone. One of ordinary skill in the art would have expected based on the disclosure of Hastak et al. that this compound can have a synergistic effect with PARP inhibitors in certain cancer types.
Therefore the invention taken as a wholes is prima facie obvious.
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 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 9 of U.S. Patent No. 12036222. (cited in PTO-892, herein referred to as ‘222) Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘222 claims a method comprising coadministering an EZH2 inhibitor with a PARP inhibitor to a patient. Furthermore claims 1 and 6 specify the same particular EZH2 and PARP inhibitors recited by present claims 32 and 33, and claims 8 and 9 of ‘222 claim methods further comprising administering one of the same platinum chemotherapeutic agents recited in present claims 24 and 25. While the claims of ‘222 claim methods of treatment rather than pharmaceutical compositions, one of ordinary skill in the art would have seen the disclosure of a process comprising administering two or three pharmaceutical active ingredients together to suggest making a single pharmaceutical composition comprising all of the individual active ingredients, in order to more conveniently administer them together to a subject.
Regarding claims 26-30, as discussed under 35 USC 112(b), these claims are indefinite, and it is unclear how they would differentiate the claimed subject matter from any pharmaceutical composition comprising both active ingredients. Furthermore to the extent that these claims are taken as claiming an set of two different pharmaceutical dosage units that are somehow associated with one another, one of ordinary skill in the art would still have seen such a combination not be obvious as it merely represents the rearrangement of parts and still serves the same function of enabling one of ordinary skill in the art to administer both anticancer compounds to the same subject.
Claims 21 and 23-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 8 of U.S. Patent No. 10987353 (Cited in PTO-892, herein referred to as ‘353) in view of Yamaguchi et al. (Reference included with PTO-892)
Claim 1 of ‘353 claims a method of treating cancer in a subject comprising administering to the subject the EZH2 inhibitor CPI-1205, which is one of the compounds recited in present claim 32. While the claims of ‘353 do not include a method further comprising administering a PARP inhibitor such as Olaparib, as discussed previous under 35 USC 103, Yamaguchi et al. discloses synergism between Olaparib and an EZH2 inhibitor, suggesting that these two compounds would be beneficial to administer together. One of ordinary skill in the art would have therefore found it to be obvious to make a pharmaceutical composition comprising both of these two compounds, for the purpose of administering them together to treat cancer in a patient.
Regarding claims 24 and 25, claims 7 and 8 of ‘353 further specify administering one of the claimed platinum compounds to the subject. Regarding claims 26-30, as discussed under 35 USC 112(b), these claims are indefinite, and it is unclear how they would differentiate the claimed subject matter from any pharmaceutical composition comprising both active ingredients. Furthermore to the extent that these claims are taken as claiming an set of two different pharmaceutical dosage units that are somehow associated with one another, one of ordinary skill in the art would still have seen such a combination not be obvious as it merely represents the rearrangement of parts and still serves the same function of enabling one of ordinary skill in the art to administer both anticancer compounds to the same subject.
Claims 21-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 8 of U.S. Patent No. 12629364 (Cited in PTO-892, herein referred to as ‘364) in view of Yamaguchi et al. (Reference included with PTO-892)
Claim 1 of ‘364 claims a method of treating cancer in a subject comprising administering to the subject the EZH2 inhibitor GSK126, which is one of the compounds recited in present claim 32. While the claims of ‘364 do not include a method further comprising administering a PARP inhibitor such as Olaparib, as discussed previous under 35 USC 103, Yamaguchi et al. discloses synergism between Olaparib and an EZH2 inhibitor, suggesting that these two compounds would be beneficial to administer together. One of ordinary skill in the art would have therefore found it to be obvious to make a pharmaceutical composition comprising both of these two compounds, for the purpose of administering them together to treat cancer in a patient.
Regarding claims 24 and 25, claims 7 and 8 of ‘364 further specify administering one of the claimed platinum compounds to the subject. Regarding claims 26-30, as discussed under 35 USC 112(b), these claims are indefinite, and it is unclear how they would differentiate the claimed subject matter from any pharmaceutical composition comprising both active ingredients. Furthermore to the extent that these claims are taken as claiming an set of two different pharmaceutical dosage units that are somehow associated with one another, one of ordinary skill in the art would still have seen such a combination not be obvious as it merely represents the rearrangement of parts and still serves the same function of enabling one of ordinary skill in the art to administer both anticancer compounds to the same subject.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 9/25/2026
