DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Arguments
2. The species election reading on cancer is moot in light of the cancellation of claim 55, which has been cancelled, see Amendments to the Claims submitted January 28, 2026, see page 10.
3. Claims 1, 2, 9-13, 16-18, 21-26, 28, 32, 33, 35, 37, 40, 41, 43, 44 and 46-48 are pending.
Claims 46-48, drawn to non-elected inventions and non-elected species are withdrawn from examination.
Claims 3-8, 14, 15 and 55 have been cancelled.
Claims 1, 2, 9-13, 22-24, 40 and 41 have been amended.
Claims 1, 2, 9-13, 16-18, 21-26, 28, 32, 33, 35, 37, 40, 41, 43 and 44 with the species, NSCLC are examined on the merits.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 102
5. The rejection of claim(s) 1, 2, 17, 18, 25, 26, 43, 44 and 55 under 35 U.S.C. 102(a)(1) as being anticipated by Blake-Haskins et al., WO 2019/075032 A1 (published 18 April 2019/ IDS reference, Foreign Patent Document #1 submitted February 9, 2023) is withdrawn in light of the amendment to claim 1, see Amendments to the Claims submitted January 28, 2026. Claims 3-7, 14 and 55 have been cancelled.
Claim Rejections - 35 USC § 103
6. The rejection of claim(s) 1, 2, 9-13, 16-18, 21-26, 28, 32, 33, 35, 37, 40, 41, 43 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blake-Haskins et al., WO 2019/075032 A1 (published 18 April 2019/ IDS reference, Foreign Patent Document #1 submitted February 9, 2023), and further in view of Finlayson et al., WO 2017/136312 A1 (published 10 August 2017) is withdrawn in light of the amendment to claim 1 on page 2 and arguments presented in the Remarks on pages 14 and 15, see Amendments to the Claims and Remarks, respectively submitted January 28, 2026. Claims 3-8, 14, 15 and 55 have been cancelled.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 1, 2, 9-13, 16-18, 21-26, 28, 32, 33, 35, 37, 40, 41, 43 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blake-Haskins et al., WO 2019/075032 A1 (published 18 April 2019/ IDS reference, Foreign Patent Document #1 submitted February 9, 2023), and further in view of Finlayson et al., WO 2017/136312 A1 (published 10 August 2017) and Attiyeh et al., US 2019/0225689 A1 (effectively filed January 18, 2019). Blake-Haskins discloses a method of treating cancer comprising the administration of a poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor in combination with a PD-1 axis binding antagonist, radiotherapy or a chemotherapeutic agent, see abstract; pages 4-8; page 26, lines 16-22; and Example 1 on page 64. The method is implemented to treat non-small cell lung cancer (NSCLC), both locally advanced and metastatic NSCLC, see page 8, lines 4-10; page 21, lines 18-25; and page 59, lines 7-10.
The PARP inhibitor may be 0laparib or a pharmaceutically acceptable salt thereof, see page 2, lines 16-22; page 26, lines 16-22; and page 42, 2nd paragraph (para.).
The PD-1 antagonist is an anti-PD-1 antibody, pembrolizumab, see page 39, 1st para. The PD-1 antagonist can be administered at a flat dose ranging from 80 mg to 1600 mg, see para. bridging pages 61 and 62.
“A "chemotherapeutic agent" is a chemical compound useful in the treatment of cancer. Examples of chemotherapeutic agents include alkylating agents such as…a camptothecin (including the synthetic analogue topotecan (HYCAMTIN®), CPT-11 1 (irinotecan, CAMPTOSAR®), …pemetrexed; … bleomycins… dactinomycin, daunorubicin, …doxorubicin (including ADRIAMYCIN®, …paclitaxel (TAXOL®), albumin-engineered nanoparticle formulation of paclitaxel (ABRAXANE™), and doxetaxel (TAXOTERE®); … platinum analogs such as cisplatin and carboplatin;…platinum; etoposide (VP-16); …vincristine (ONCOVIN®); oxaliplatin; leucovovin; … daunomycin;”, see para. bridging pages 51-53.
“[T]he platinum- based chemotherapy is a platinum- based doublet. In some embodiments of this aspect, the platinum-based doublet is paclitaxel and carboplatin.”, see page 15, lines 17-23.
“A "platinum-based chemotherapy" as used herein, refers to a chemotherapy wherein at least one chemotherapeutic agent is a coordination complex of platinum. Exemplary platinum-based chemotherapy includes, without limitation, cisplatin, carboplatin, oxaliplatin, nedaplatin, gemcitabine in combination with cisplatin, carboplatin in combination with [pemetrexed].
A "platinum-based doublet” as used herein, refers to a chemotherapy comprising two and no more than two chemotherapeutic agents and wherein at least one chemotherapeutic agent is a coordination complex of platinum. Exemplary platinum- based doublet includes, without limitation, gemcitabine in combination with cisplatin, carboplatin in combination with pemetrexed.”, spanning pages 54 and 55.
“The practice of the method of this invention may be accomplished through various administration or dosing regimens. The compounds of the combination of the present invention can be administered intermittently, concurrently or sequentially. In an embodiment, the compounds of the combination of the present invention can be administered in a concurrent dosing regimen.”, see para. bridging pages 60 and 61.
Blake-Haskins does not teach the claimed method, wherein the radiotherapy is thoracic radiotherapy administered at a dose in the range of about 10 Gy to 100 Gy in one or more fractions or at a dose of about 60 Gy in 30 daily doses of 2 Gy, wherein the thoracic radiation therapy is standardized 3D conformational radiation (3DCRT) or intensity-modulated radiation therapy (IMRT). Blake-Haskins does not teach the NSCLC is unresectable, locally advanced, stage III NSCLC. Nor, does Blake-Haskins teach the claimed method, wherein treatment phases and maintenance phases implementing the taught therapeutic agents are administered in the order and dosages cited in claims 11-13, 16, 21-24, 32, 33, 35, 37, 40, 41, 43 and 44.
However, Blake-Haskins teaches study designs, wherein a treatment phase or chemotherapy treatment comprises administering a PD-L1 antibody in combination with chemotherapy; two different chemotherapeutic agents; or a non-PD-1 antibody with two types of chemotherapy. The maintenance treatment may be a combination of a PD-L1 antibody with a PARP inhibitor; a PARP inhibitor or a non-PD-L1 antibody, see Table 8 on page 72. Chemotherapy dosages cited in Table 9 overlap with those denoted in claims 21 and 32, see page 93.
Hence, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the both phases as set forth in claims 11-13, 16, 21-24, 32, 33, 35, 37, 40, 41, 43 and 44.
One of ordinary skill in the art would have been motivated to administer the treatment/chemotherapy phases and maintenances phases in the order, manner, cycles and dosages as noted in the claim limitations because “the skilled artisan will readily understand that numerous variations and modifications of…exemplary embodiments are possible without undue experimentation. All such variations and modifications are within the scope of the current teachings.”, see para. bridging pages 63 and 64. It is also known these claimed combinations of therapeutic agents can be arrived upon at the cited dosages with a reasonable expectation of success by teachings well known and noted herein that dosages of any pharmaceutical composition may be adjusted and optimized. And while the particular dosages of the chemotherapeutic agents differ, they overlap and one of ordinary skill in the art has been provided the general guidance. Moreover, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Finlayson teaches a combinatorial approach to treating cancer including implementing thoracic radiation at a dose “between about 10 to 100 Gy, such as from about 20 to 80 Gy about 30 to 70 Gy, or about 40 to 60 Gy. An external radiation dose may be administered in fractional doses, such as from 1 to 60 fractional doses, or from 5 to 30 fractional doses.
Radiation therapy (e.g. fractional doses) may be administered periodically, ... In certain embodiments, fractionized doses are administered with about 1.5 to about 2.5 Gy per fraction (e.g. about 1.5 Gy, 1.6 Gy, 1.7 Gy, 1.8 Gy, 1.9 Gy, 2.0 Gy, 2.1 Gy, 2.2 Gy, 2.3 Gy, 2.4 Gy, or 2.5 Gy per fractionized dose). Fractionated doses of radiation therapy may be administered at intervals. In certain embodiments, the fractionized doses are administered over a period of minutes, hours, or weeks such as 1 to 26 weeks, 1 to 15 weeks, or 2 to 12 weeks…In other embodiments, the radiation therapy is administered in a single dosage rather than in fractionized doses. For example, the single dose may be administered with about 1-30 Gy per dose, such as from 5-20 Gy or such as about 10-15 Gy.”, see entire document; and in particular, sections 00152 and 00153 spanning pages 52 and 53.
Attiyeh teaches treating “[a]dvanced solid tumor” refers to metastatic, unresectable, Stage III or Stage IV solid tumor.” with pembrolizumab (KEYTRUDA®), see page 5, section 0070; and page 7, section 0139. This particular type of cancer can be treated with focused radiation methods including IMRT, see page 8, section 0146. “The dosage of radiation applied using stereotactic radiosurgery may vary typically from 1 Gy to about 30 Gy, and may encompass intermediate ranges including, for example, from 1 to 5, 10, 15, 20, 25, up to 30 Gy in dosage…The dosage of radiation applied using fractionated stereotactic radiation may vary from range from 1 Gy to about 50 Gy, and may encompass intermediate ranges including, for example, from 1 to 5, 10, 15, 20, 25, 30, 40, up to 50 Gy in hypofractionated dosages. Intensity-modulated radiation therapy (IMRT) may also be used. IMRT is an advanced mode of high-precision three-dimensional conformal radiation therapy (3DCRT), which uses computer-controlled linear accelerators to deliver precise radiation dosages to a malignant tumor or specific areas within the tumor, the profile of each radiation beam is shaped to fit the profile of the target from a beam's eye view (BEV) using a multileaf collimator (MLC), thereby producing a number of beams. IMRT allows the radiation dosage to conform more precisely to the three-dimensional (3-D) shape of the tumor by modulating the intensity of the radiation beam in multiple small volumes. Accordingly, IMRT allows higher radiation dosages to be focused to regions within the tumor while minimizing the dosage to surrounding normal critical structures. IMRT improves the ability to conform the treatment volume to concave tumor shapes, for example, when the tumor is wrapped around a vulnerable structure, such as the spinal cord or a major organ or blood vessel. Suitable radiation sources for use as a cell conditioner include both solids and liquids.”, see page 8, section 0146.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the standard thoracic radiotherapy at the designated dosages for the treatment of NSCLC in combination with additional anti-cancer agents as taught within Finlyason (see abstract; page 66, section 00203; and entire document) and Attiyeh (see page 4, section 0036; page 7, section 0138; page 8, sections 0145 and 0146; and page 11, section 0222).
One of ordinary skill in the art would have been motivated to administer the radiotherapy in the order, manner and dosages set forth in the claims in combination with additional therapeutic agents because “[i]t should be understood that various modifications can be made without departing from [Finlayson].”, see page 89, section 00305. It is also known the fractions, dosages and schedule of radiotherapy with combinations of additional anti-cancer treatments can be arrived upon with a reasonable expectation of success by teachings well known and noted herein as one of ordinary skill in the art has been provided the general guidance. Moreover, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Conclusion
9. 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.
10. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
27 May 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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