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
The Amendments and Remarks filed 12/8/25 in response to the Office Action of 6/6/25 are acknowledged and have been entered.
Claim 17 has been added by Applicant.
Claims 1, 2, and 4-17 are pending.
Claims 1 and 4 have been amended by Applicant.
Claims 1, 2, and 4-17 are currently under examination.
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 following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Rejections Withdrawn
All previous rejections are withdrawn. In response to whether the Rivoltini et al rejection starting on the bottom of page 5 of the Office Action was intended to be a rejection under 35 U.S.C. 102(a)(2) or 35 U.S.C. 103, the rejection was intended to be a rejection under 35 U.S.C. 103.
Claim Interpretation
Pending claim 1 is set-forth below:
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While claim 1 recites a patient is subjected to a “reduced” caloric intake of between 1200 Kcal and 3000 Kcal, a “regular” caloric intake is 1200-3000 Kcal/day (lines 8-9 on page 9 of the instant specification). However, 1200-3000 Kcal/day is “reduced” as compared to a higher caloric intake. Pending claim 1 broadly encompasses a method of administering just any immunotherapeutic agent to just any cancer patient that is subjected to a month of caloric intake that is 1200-3000 Kcal/day.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 103
Claims 1, 2, 4-6, 8-11, 13, 16, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Loi et al (Lancet Oncol, 2019, 20: 371-382) in view of Survillo et al (Rocz Panstw Zakl Hig, 2013, 64(3): 225-233) and Geirsdottir et al (Food & Nutrition Research, 2008, 52(1)(1856): 1-6).
The abstract of Loi et al teaches patients with trastuzumab-resistant breast cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and the EGFR targeted immunotherapeutic inhibitor trastuzumab (Abstract, in particular).
Loi et al does not specifically teach patients are subjected to a particular caloric intake. However, these deficiencies are made up in the teachings of Survillo et al and Geirsdottir et al.
Survillo et al teaches the average caloric intake of 100 patients with breast, lung, or bone and soft tissue cancer was found to be 1608 +/-436 kcal/day (Table 2, in particular).
Geirsdottir et al teaches the average caloric intake of 30 patients with lung, colon, or breast cancer undergoing chemotherapy was found to be 1905 +/- 500 kcal/day (Table 4, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to administer a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and the EGFR inhibitor trastuzumab to just any patient with trastuzumab-resistant breast cancer, including patients subjected to years of caloric intake of Survillo et al or Geirsdottir et al, because Loi et al teaches patients with trastuzumab-resistant breast cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and the EGFR inhibitor trastuzumab (Abstract, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4-8, 10-11, 16, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hellmann et al (NEJM, 2019, 381(21): 2020-2031) in view of Survillo et al (Rocz Panstw Zakl Hig, 2013, 64(3): 225-233) and Geirsdottir et al (Food & Nutrition Research, 2008, 52(1)(1856): 1-6).
The abstract of Hellmann et al teaches subjects with lung cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitors nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor).
Hellmann et al does not specifically teach patients are subjected to a particular caloric intake. However, these deficiencies are made up in the teachings of Survillo et al and Geirsdottir et al.
Survillo et al teaches the average caloric intake of 100 patients with breast, lung, or bone and soft tissue cancer was found to be 1608 +/-436 kcal/day (Table 2, in particular).
Geirsdottir et al teaches the average caloric intake of 30 patients with lung, colon, or breast cancer undergoing chemotherapy was found to be 1905 +/- 500 kcal/day (Table 4, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to administer a combination of the immunotherapeutic checkpoint inhibitors nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor) to just any patient with lung cancer, including patients subjected to years of caloric intake of Survillo et al or Geirsdottir et al, because Hellmann et al teaches subjects with lung cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitors nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4-6, 8, 10, 12, 16, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tolcher et al (Clin Cancer Res, 2017, 23(18): 5349-5537) in view of Survillo et al (Rocz Panstw Zakl Hig, 2013, 64(3): 225-233) and Geirsdottir et al (Food & Nutrition Research, 2008, 52(1)(1856): 1-6).
The abstract of Tolcher et al teaches subjects with cancer, such as lung cancer, receive therapeutic benefit (both complete response and partial response) by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and a 4-1BB agonist (Abstract and page 5353, in particular).
Tolcher et al does not specifically teach patients are subjected to a particular caloric intake. However, these deficiencies are made up in the teachings of Survillo et al and Geirsdottir et al.
Survillo et al teaches the average caloric intake of 100 patients with breast, lung, or bone and soft tissue cancer was found to be 1608 +/-436 kcal/day (Table 2, in particular).
Geirsdottir et al teaches the average caloric intake of 30 patients with lung, colon, or breast cancer undergoing chemotherapy was found to be 1905 +/- 500 kcal/day (Table 4, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to administer a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and a 4-1BB agonist to just any patient with lung cancer, including patients subjected to years of caloric intake of Survillo et al or Geirsdottir et al, because Tolcher et al teaches subjects with cancer, such as lung cancer, receive therapeutic benefit (both complete response and partial response) by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and a 4-1BB agonist (Abstract and page 5353, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4-6, 8, 10, 15, 16, and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Paz-Ares et al (NEJM, 2018, 379(21): 2040-2051) in view of Survillo et al (Rocz Panstw Zakl Hig, 2013, 64(3): 225-233) and Geirsdottir et al (Food & Nutrition Research, 2008, 52(1)(1856): 1-6).
The abstract of Paz-Ares et al teaches subjects with lung cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor), carboplatin, and the topoisomerase inhibitor paclitaxel (Abstract, in particular).
Paz-Ares et al does not specifically teach patients are subjected to a particular caloric intake. However, these deficiencies are made up in the teachings of Survillo et al and Geirsdottir et al.
Survillo et al teaches the average caloric intake of 100 patients with breast, lung, or bone and soft tissue cancer was found to be 1608 +/-436 kcal/day (Table 2, in particular).
Geirsdottir et al teaches the average caloric intake of 30 patients with lung, colon, or breast cancer undergoing chemotherapy was found to be 1905 +/- 500 kcal/day (Table 4, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to administer a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor), carboplatin, and the topoisomerase inhibitor paclitaxel to just any patient with lung cancer, including patients subjected to years of caloric intake of Survillo et al or Geirsdottir et al, because Paz-Ares et al teaches subjects with lung cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor), carboplatin, and the topoisomerase inhibitor paclitaxel (Abstract, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claims 1, 2, 4, 8, 10, and 14-17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sen et al (Journal of Thoracic Oncology, 2019, 14(12): 2152-2163) in view of Survillo et al (Rocz Panstw Zakl Hig, 2013, 64(3): 225-233) and Geirsdottir et al (Food & Nutrition Research, 2008, 52(1)(1856): 1-6).
Sen et al teaches subjects lung cancer receive therapeutic benefit by being administered a combination of an immunotherapeutic checkpoint inhibitor anti-PD-L1 antibody, the CHK1 inhibitor SRA737, and the antimetabolite gemcitabine (Figure 4, in particular).
Sen et al does not specifically teach patients are subjected to a particular caloric intake. However, these deficiencies are made up in the teachings of Survillo et al and Geirsdottir et al.
Survillo et al teaches the average caloric intake of 100 patients with breast, lung, or bone and soft tissue cancer was found to be 1608 +/-436 kcal/day (Table 2, in particular).
Geirsdottir et al teaches the average caloric intake of 30 patients with lung, colon, or breast cancer undergoing chemotherapy was found to be 1905 +/- 500 kcal/day (Table 4, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to administer a combination of an immunotherapeutic checkpoint inhibitor anti-PD-L1 antibody, the CHK1 inhibitor SRA737, and the antimetabolite gemcitabine to just any patient with lung cancer, including patients subjected to years of caloric intake of Survillo et al or Geirsdottir et al, because Sen et al teaches subjects lung cancer receive therapeutic benefit by being administered a combination of an immunotherapeutic checkpoint inhibitor anti-PD-L1 antibody, the CHK1 inhibitor SRA737, and the antimetabolite gemcitabine (Figure 4, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 112
Claims 1, 2, and 4-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a NEW MATTER rejection.
Claim 1 recites a method for treating cancer in a patient comprising subjecting the patient to a first reduced caloric intake cycle of between 1200 Kcal and 3000 Kcal and at least one immunotherapeutic agent, wherein said first reduced caloric intake comprises a first part with a regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%, and wherein the first reduced caloric intake cycle is repeated from 1 to 30 times after respective periods of from 5 to 60 days. The instant specification discloses a “regular” caloric intake is 1200-3000 Kcal/day (lines 8-9 on page 9 of the instant specification). Descriptions of a method for treating cancer in a patient comprising subjecting the patient to a first reduced caloric intake cycle of between 1200 Kcal and 3000 Kcal and at least one immunotherapeutic agent, wherein said first reduced caloric intake comprises a first part with a regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%, and wherein the first reduced caloric intake cycle is repeated from 1 to 30 times after respective periods of from 5 to 60 days are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
Conclusion
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.
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642