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 .
Status of Claims
Claims 1-20 are pending in the instant application.
Claims 4-6 stand withdrawn from consideration.
Withdrawn Rejections/Objections
Beginning at Page 29 of Applicant’s remarks filed June 3rd, 2025, Applicant traverses the rejection of Claims 1-3 and 7-14 under 35 U.S.C. 112(a) on the basis that the Deng Declaration received December 3rd, 2025 provides sufficient evidence to enable the aforementioned claims. The examiner finds this persuasive. This rejection is hereby withdrawn.
Specification
For the reasons noted in the non-final rejection mailed June 3rd, 2025, the objection to the abstract is maintained. For clarity of the record, the objection is re-stated here:
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because it is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of Claims 1-3, 7-8, 11, 13, and 15-19 under 35 U.S.C. 103 as being unpatentable over Wu (WO2011/035077 A1; cited in non-final rejection mailed June 3rd, 2025; hereinafter referred to as Wu) in view of Martin et. al. (WO2004/080976 A1; cited in non-final rejection mailed June 3rd, 2025; hereinafter referred to as Martin) as evidenced by CAS Registry File (763113-22-0, entered into STN October 15th, 2004; obtained from the internet April 24th, 2025; cited in the non-final rejection mailed June 3rd, 2025; hereinafter referred to as CAS Registry File) is maintained.
Applicant has traversed this rejection on the basis that the cited references fail to establish a prima facie case of obviousness and that the claimed invention exhibits unexpected superior properties.
The examiner does not find this argument persuasive.
In particular, with respect to the Applicant’s assertion of unexpected superior properties, Applicant points to the Deng Declaration, which reports at Table 1 IC50 values against various cancer cell lines obtained from administration of Olaparib alone or in combination with compound 605B, which is the instantly elected species, received December 3rd, 2025. At Page 42, Third Paragraph, of Applicant’s remarks filed December 3rd, 2025, it is stated, “As shown in Table 1 of the Deng Declaration, the combination resulted in a ‘4.3-fold’ increase in efficacy in wild-type ovarian cancer cells and a ‘2.0-fold’ increase in wild type pancreatic cancer cells. Id. at ¶ 17. A skilled artisan, looking at Wu and Martin, would have no motivation to combine these agents for wild-type cancers because the biological rationale for PARP efficacy (synthetic lethality) is absent in that context. Indeed, Declarant affirms that ‘BRCA-wild-type cells possess functional DNA repair mechanisms that typically render them resistant to PARP inhibitors.’ Id. at ¶ 12.1. The finding that ‘Compound 605B effectively sensitizes wild-type BRCA cancers to PARP inhibition” is a surprising property that confers patentability. Id. at ¶ 20.”
This is not persuasive, as the data disclosed in the Deng Declaration do not sufficiently demonstrate the combination of 605B with Olaparib is more efficacious than Compound 605B alone. With respect to the motivation to combine the elected species with Olaparib, the motivation flows from the fact that Wu teaches the elected species as effective in treating cancers instantly claimed in Claim 1, and Martin teaches Olaparib as effective in treating cancers instantly claimed in Claim 1. As noted in the non-final rejection mailed June 3rd, 2025, per MPEP 2144.06, I., “"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)”.
As noted in the non-final rejection mailed June 3rd, 2025, Wu references the elected species of a compound of formula I as XC608. At Table 3 at Page 33, Wu reports IC50 values of XC608 in three cancer cell lines ranging from 1.05 to 7.11 µg/mL. This equates to a range of 2.82 to 19.14 µM (or, for consistence of units for comparison to the Deng Declaration, 2820 to 19140 nM). This range overlaps with the reported IC50 values at Table 1 for the combination of Olaparib and 605B, which is reported at 890 to 4489 nM. While the Examiner acknowledges different cell lines were tested, this underscores the fact that it has not been demonstrated that the claimed combination has not necessarily produced unexpected results compared to the administration of the elected species alone, which was known in the art, at the time of filing to be efficacious in treating a variety of cancers, as taught by Wu.
Further, Claim 1 is silent with respect to any limitations regarding the amounts of the compound of formula I and the amount of the PARP inhibitor. To this end, the Applicant has failed in demonstrating that the claimed combination produces unexpected results over administration of a compound of formula I, alone.
Finally, Applicant’s statement beginning at Page 40, Last Paragraph of the remarks that, “Declarant further attests in the Deng Declaration that PARP inhibitors are mechanistically linked to BRCA mutations (synthetic lethality) and indicated for, and expected to work in, patients with defects in homologous recombination repair (e.g. BRCA mutations) such that there is no expectation that a PARP inhibitor would be effective, let alone synergistic, in BRCA Wild-Type cancers” is not persuasive. Claim 1 recites no limitations with respect to the cancer being a BRCA Wild-Type or a BRCA mutant cancer. Therefore, the broadest reasonable interpretation of the claim would include treatment of BRCA mutant cancers, for which Martin establishes Olaparib as effective in treating.
Taken together, Applicant’s assertion of unexpected results is insufficient to demonstrate the claimed combination is more effective in treating cancer than administration of the elected species alone. As both the elected species and Olaparib were known in the art at the time of filing to be effective in treating cancer, their combination would have been obvious as noted above.
The rejection of Claims 9-10, 14, and 20 under 35 U.S.C. 103 as being unpatentable over Wu in view of Martin in further view of O’Shaugnessy (“Pemetrexed: An Active New Agent for Breast Cancer”, Seminars in Oncology, 29, 6, 57-62, 2002; cited in non-final rejection mailed June 3rd, 2025; hereinafter referred to as O’Shaugnessy)” is maintained.
Applicant has traversed this rejection citing the same rationale as the above rejection. Therefore, for the reasons detailed above, and those noted in the previous office action, this rejection is maintained. For clarity of the record, the rationale for this rejection is revisited below.
As noted above, the limitations of Claim 1, from which Claims 9 and 10 depend, are obviated by Wu in view of Martin.
Wu in view of Martin does not teach further administration of a chemotherapeutic agent.
At the Abstract, O’Shaugnessy teaches pemetrexed, as recited in Cliam 10, as providing on-cross-resistant cytotoxic activity against breast cancers.
At Page 62, Second Paragraph, O’Shaugnessy teaches pemetrexed shows promise in adjuvant treatment of breast cancer.
As the combination of the elected species with a poly(ADP)-ribose polymerase inhibitor is obviated by Wu in view of Martin, O’Shaugnessy’s establishment in the art of pemetrexed in adjuvant treatment of breast cancer obviates the limitations recited in Claims 9 and 10 as well as a composition thereof as recited in Claim 20. The administration of a chemotherapeutic agent following administration of this combination would have been prima facie obvious to a person having ordinary skill in the art, as per MPEP 2144.06, I., “"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)”.
Taken together, this would result in the practice of Claims 9-10, 14, and 20 with reasonable expectation of success.
The following rejections are necessitated by amendment:
Claim Rejections - 35 USC § 112
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.
Claims 11-12 are 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 11 fails to further limit the subject matter of Claim 1, from which it depends. Claim 1 is drawn to a method for treating a cancer selected from breast cancer, colon cancer, ovarian cancer, or pancreatic cancer. Claim 11 expands the scope of Claim 1 by reciting the limitation that the cancer is a solid cancer selected from cancers beyond breast, colon, ovarian, or pancreatic, including lung, prostate, brain, skin, bladder, gastrointestinal, head and neck, gastric, neurologic, renal, and liver cancers.
Claim 12 fails to further limit the subject matter of Claim 1, from which it depends. Claim 1 is drawn to a method for treating a cancer selected from breast cancer, colon cancer, ovarian cancer, or pancreatic cancer. Claim 12 expands the scope of Claim 1 by reciting the limitation that the cancer is a hematological cancer selected from the group consisting of lymphocytic leukemia, myeloid leukemia, non-Hodgkin lymphoma, and Hodgkin lymphoma.
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.
Conclusion
Claims 1-3 and 7-20 are rejected.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624