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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/18/26 has been entered.
Claim 18 has been added by Applicant.
Claims 1, 2, and 5-18 are pending.
Claims 1, 5, and 7 have been amended.
Claims 1, 2, and 5-18 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Action contains New Rejections Necessitated by Amendments.
Rejections Withdrawn
All previous rejections are withdrawn.
New Rejections
Claim Rejections - 35 USC § 112
Claims 1, 2, and 5-18 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.
Claims 1, 2, and 5-18 are rejected because both claim 1 and claim 18 recite “…a regular caloric intake…a regular caloric intake…the regular caloric intake is between 1200 Kcal and 3000 Kcal per day….” Noting claims 1 and 18 both recite two regular caloric intakes prior to reciting “the regular caloric intake”, it is unclear which regular caloric intake is the regular caloric intake that is between 1200 Kcal and 3000 Kcal per day. There is insufficient antecedent basis for “the regular caloric intake” in the claims. In an effort to expedite prosecution, it is noted the following amendment to claims 1 and 18 could obviate this rejection: “…a regular caloric intake… the regular caloric intake…the regular caloric intake is between 1200 Kcal and 3000 Kcal per day….”
Claim Rejections - 35 USC § 103
Claim(s) 1-5, 7, 8, 10, 11, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rivoltini et al (US 2022/0338522 A1; 10/27/22) in view of Hellmann et al (NEJM, 2019, 381(21): 2020-2031).
Rivoltini et al teaches a nutrition plan/method for patients suffering from neoplasia applicable on a 3 or 4-week basis before, during, and after administration of anticancer treatments such as immunotherapy, chemotherapy, and radiation therapy ([0001], in particular). The nutrition plan/method of Rivoltini et al comprises an administered food preparation with a low caloric content of most preferably 300-600 Kcal/day for enhancing the effect of anticancer treatments in patients suffering from neoplasia ([0021] and claim 22, in particular). The 300-600 Kcal/day diet of Rivoltini et al is a 50-75% reduction in caloric intake, as compared to a 1200 regular caloric intake diet. Rivoltini et al further teaches the nutrition plan is administered as a therapeutic adjuvant for 5 consecutive days and can be repeated on a 3 or 4-week basis ([0052], in particular). Rivoltini et al further teaches patients suffering from neoplasia means subjects that have been diagnosed with a malignant tumor of any type, at any stage of growth, and includes patients with breast cancer, colorectal cancer, lung cancer, prostate cancer, melanoma, and leukemia ([0020], in particular). Rivoltini et al teaches the low caloric treatment treats cancer by reducing cancer cell uptake of metabolites ([0008], in particular).
Rivoltini et al does not specifically teach the administered daily doses of 300-600 Kcal/day diet are administered on subsequent days as “a first part which a regular caloric intake is reduced by 30% to 70% and a second part in which a regular caloric intake is reduced by 40 to 97%” wherein a regular caloric intake is between 1200-3000 Kcal per day. Further, Rivoltini et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor or a CTLA-4 inhibitor. However, these deficiencies are made up in the teachings of Hellmann et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success to perform a method comprising administering the low calorie diet at just any dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to cancer patients of Rivoltini et al before, during, and after immunotherapy because Rivoltini et al teaches administering the low calorie diet at doses between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to subjects with cancer before, during, and after immunotherapy. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering a low-calorie diet at a dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis of Rivoltini et al. For example, administering the 5 consecutive day diet of Rivoltini et al (which comprises a “first part” and “second part” that are both 300-600 Kcal/day) on weeks 1 and 3 administers a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 2 times after respective periods of from 5 to 60 days.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with lung cancer Rivoltini et by performing said method comprising administering the combination of the nutrition plan (a low caloric content of 300-600 Kcal/day as a therapeutic adjuvant for 5 consecutive days that is repeated on a 3 or 4-week basis) and immunotherapy of Rivoltini et al wherein the immunotherapy is a combination of the immunotherapeutic checkpoint inhibitors nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor) 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). This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention. 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
Claim(s) 1, 2, 5, 6, 8, 10, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rivoltini et al (US 2022/0338522 A1; 10/27/22) in view of Paz-Ares et al (NEJM, 2018, 379(21): 2040-2051).
Teachings of Rivoltini et al are discussed above.
Rivoltini et al does not specifically teach the administered daily doses of 300-600 Kcal/day diet are administered on subsequent days as “a first part which a regular caloric intake is reduced by 30% to 70% and a second part in which a regular caloric intake is reduced by 40 to 97%” wherein a regular caloric intake is between 1200-3000 Kcal per day. Further, Rivoltini et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor. However, these deficiencies are made up in the teachings of Paz-Ares et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success to perform a method comprising administering the low calorie diet at just any dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to cancer patients of Rivoltini et al before, during, and after immunotherapy because Rivoltini et al teaches administering the low calorie diet at doses between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to subjects with cancer before, during, and after immunotherapy. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering a low-calorie diet at a dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis of Rivoltini et al. For example, administering the 5 consecutive day diet of Rivoltini et al (which comprises a “first part” and “second part” that are both 300-600 Kcal/day) on weeks 1 and 3 administers a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 2 times after respective periods of from 5 to 60 days.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with lung cancer comprising administering the combination of the nutrition plan (a low caloric content of 300-600 Kcal/day as a therapeutic adjuvant for 5 consecutive days that is repeated on a 3 or 4-week basis) and immunotherapy of Rivoltini et al wherein the immunotherapy is the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) in combination with carboplatin and the topoisomerase inhibitor paclitaxel 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention. 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
Claim(s) 1, 2, 5, 6, 8-10, 13, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rivoltini et al (US 2022/0338522 A1; 10/27/22) in view of Loi et al (Lancet Oncol, 2019, 20: 371-382).
Teachings of Rivoltini et al are discussed above.
Rivoltini et al does not specifically teach the administered daily doses of 300-600 Kcal/day diet are administered on subsequent days as “a first part which a regular caloric intake is reduced by 30% to 70% and a second part in which a regular caloric intake is reduced by 40 to 97%” wherein a regular caloric intake is between 1200-3000 Kcal per day. Further, Rivoltini et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor. However, these deficiencies are made up in the teachings of Loi et al.
The abstract of Loi et al teaches subjects 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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success to perform a method comprising administering the low calorie diet at just any dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to cancer patients of Rivoltini et al before, during, and after immunotherapy because Rivoltini et al teaches administering the low calorie diet at doses between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to subjects with cancer before, during, and after immunotherapy. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering a low-calorie diet at a dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis of Rivoltini et al. For example, administering the 5 consecutive day diet of Rivoltini et al (which comprises a “first part” and “second part” that are both 300-600 Kcal/day) on weeks 1 and 3 administers a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 2 times after respective periods of from 5 to 60 days.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with trastuzumab-resistant breast cancer comprising administering the combination of the nutrition plan (a low caloric content of 300-600 Kcal/day as a therapeutic adjuvant for 5 consecutive days that is repeated on a 3 or 4-week basis) and immunotherapy of Rivoltini et al wherein the immunotherapy is the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) in combination with trastuzumab because Loi et al teaches subjects 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention. 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
Claim(s) 1, 2, 5, 6, 8-10, 12, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rivoltini et al (US 2022/0338522 A1; 10/27/22) in view of Tolcher et al (Clin Cancer Res, 2017, 23(18): 5349-5537).
Teachings of Rivoltini et al are discussed above.
Rivoltini et al does not specifically teach the administered daily doses of 300-600 Kcal/day diet are administered on subsequent days as “a first part which a regular caloric intake is reduced by 30% to 70% and a second part in which a regular caloric intake is reduced by 40 to 97%” wherein a regular caloric intake is between 1200-3000 Kcal per day. Further, Rivoltini et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor. However, these deficiencies are made up in the teachings of Tolcher et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success to perform a method comprising administering the low calorie diet at just any dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to cancer patients of Rivoltini et al before, during, and after immunotherapy because Rivoltini et al teaches administering the low calorie diet at doses between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to subjects with cancer before, during, and after immunotherapy. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering a low-calorie diet at a dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis of Rivoltini et al. For example, administering the 5 consecutive day diet of Rivoltini et al (which comprises a “first part” and “second part” that are both 300-600 Kcal/day) on weeks 1 and 3 administers a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 2 times after respective periods of from 5 to 60 days.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat just any subject with lung cancer comprising administering the combination of the nutrition plan (a low caloric content of 300-600 Kcal/day as a therapeutic adjuvant for 5 consecutive days that is repeated on a 3 or 4-week basis) and immunotherapy of Rivoltini et al wherein the immunotherapy is the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) in combination with a 4-1BB agonist because Tolcher et al teaches subjects with lung cancer receive therapeutic benefit by being administered a combination of the immunotherapeutic checkpoint inhibitor pembrolizumab (PD-1 inhibitor) and a 4-1BB agonist. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention. 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
Claim(s) 1, 2, 8, 10 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rivoltini et al (US 2022/0338522 A1; 10/27/22) in view of Sen et al (Journal of Thoracic Oncology, 2019, 14(12): 2152-2163).
Teachings of Rivoltini et al are discussed above.
Rivoltini et al does not specifically teach the administered daily doses of 300-600 Kcal/day diet are administered on subsequent days as “a first part which a regular caloric intake is reduced by 30% to 70% and a second part in which a regular caloric intake is reduced by 40 to 97%” wherein a regular caloric intake is between 1200-3000 Kcal per day. Further, Rivoltini et al does not specifically teach methods wherein administered immunotherapy is a PD-L1 inhibitor. However, these deficiencies are made up in the teachings of Sen et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success to perform a method comprising administering the low calorie diet at just any dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to cancer patients of Rivoltini et al before, during, and after immunotherapy because Rivoltini et al teaches administering the low calorie diet at doses between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis to subjects with cancer before, during, and after immunotherapy. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering a low-calorie diet at a dose between 300-600 Kcal/day for 5 consecutive days repeated on a 3 or 4-week basis of Rivoltini et al. For example, administering the 5 consecutive day diet of Rivoltini et al (which comprises a “first part” and “second part” that are both 300-600 Kcal/day) on weeks 1 and 3 administers a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 2 times after respective periods of from 5 to 60 days.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat just any subject with lung cancer comprising administering the combination of the nutrition plan (a low caloric content of 300-600 Kcal/day as a therapeutic adjuvant for 5 consecutive days that is repeated on a 3 or 4-week basis) and immunotherapy of Rivoltini et al wherein the immunotherapy is an immunotherapeutic checkpoint inhibitor anti-PD-L1 antibody of Sen et al in combination with the CHK1 inhibitor SRA737 and the antimetabolite gemcitabine 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention. 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, 5, 7, 8, 10, 11, and 16-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nencioni et al (Nature Reviews, 2018, 18: 707-719; 9/30/22 IDS) in view of Hellmann et al (NEJM, 2019, 381(21): 2020-2031).
Nencioni et al teaches fasting or fasting-mimicking diets (FMDs) lead to alterations in growth factors and metabolite levels, generating environments that can improve the effects of cancer therapies by reducing the capability of cancer cells to adapt and survive (Abstract, in particular). Nencioni et al further teaches fasting or FMDs increase resistance of chemotherapy in normal but not cancer cells and promote regeneration in normal tissues, which could help prevent detrimental and potentially life-threatening side effects of treatments (Abstract, in particular). Nencioni et al further teaches that while fasting is hardly tolerated by patients, animal and clinical studies show cycles of low-calorie FMDs are feasible and overall safe (Abstract, in particular). Nencioni et al further proposes the combination of FMDs with chemotherapy, immunotherapy or other treatments represents a potentially promising strategy to increase treatment efficacy, prevent resistance acquisition and reduce side effects (Abstract, in particular). Nencioni et al further teaches FMDs are typically 300-1,000 kcal/day, 3 monthly cycles of a 5-day FMD was well tolerated and reduced IGF1 levels in healthy subjects, and fasting and FMDs have typically been administered for 1-5 days every 3-4 weeks (right column on page 708, in particular). The 300-1,000 Kcal/day diet of Nencioni et al is a 67-90% reduction in caloric intake, as compared to a 3000 regular caloric intake diet.
Nencioni et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor or a CTLA-4 inhibitor. However, these deficiencies are made up in the teachings of Hellmann et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with lung cancer comprising administering the combination of an FMD of Nencioni et al (such as a low caloric 300-1,000 kcal/day diet of 3 monthly cycles of a 5-day FMD) and immunotherapy of Nencioni et al wherein the immunotherapy is a combination of the immunotherapeutic checkpoint inhibitors nivolumab (PD-1 inhibitor) and ipilimumab (CTLA-4 inhibitor) because Nencioni et al proposes the combination of FMDs with chemotherapy, immunotherapy or other treatments represents a potentially promising strategy to increase treatment efficacy, prevent resistance acquisition and reduce side effects and 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). This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention.
Cited references do not specifically teach the administered daily doses of 300-1,000 kcal/day diet are administered on subsequent days as “a first part with regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%”; however, one would have been motivated with an expectation of success to administer 3 monthly cycles of the low calorie diet at just any dose between 300-1,000 kcal/day for 5 days per cycle because Nencioni et al teaches administering the low calorie FMD diet at doses between 300-1,000 kcal/day. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering 3 monthly cycles of a low-calorie diet at a dose between 300-1000 Kcal/day for 5 consecutive days Nencioni et al.
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, 5, 6, 8, 10, and 15-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nencioni et al (Nature Reviews, 2018, 18: 707-719; 9/30/22 IDS) in view of Paz-Ares et al (NEJM, 2018, 379(21): 2040-2051).
Teachings of Nencioni et al are discussed above.
Nencioni et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor. However, these deficiencies are made up in the teachings of Paz-Ares et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with lung cancer comprising administering the combination of an FMD of Nencioni et al (such as a low caloric 300-1,000 kcal/day diet of 3 monthly cycles of a 5-day FMD) and immunotherapy of Nencioni et al wherein the immunotherapy is a combination of pembrolizumab (PD-1 inhibitor), carboplatin, and the topoisomerase inhibitor paclitaxel because Nencioni et al proposes the combination of FMDs with chemotherapy, immunotherapy or other treatments represents a potentially promising strategy to increase treatment efficacy, prevent resistance acquisition and reduce side effects and 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention.
Cited references do not specifically teach the administered daily doses of 300-1,000 kcal/day diet are administered on subsequent days as “a first part with regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%”; however, one would have been motivated with an expectation of success to administer 3 monthly cycles of the low calorie diet at just any dose between 300-1,000 kcal/day for 5 days per cycle because Nencioni et al teaches administering the low calorie FMD diet at doses between 300-1,000 kcal/day. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering 3 monthly cycles of a low-calorie diet at a dose between 300-1000 Kcal/day for 5 consecutive days Nencioni et al.
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, 5, 6, 8-10, 13, and 16-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nencioni et al (Nature Reviews, 2018, 18: 707-719; 9/30/22 IDS) in view of Loi et al (Lancet Oncol, 2019, 20: 371-382).
Teachings of Nencioni et al are discussed above.
Nencioni et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor. However, these deficiencies are made up in the teachings of Loi et al.
The abstract of Loi et al teaches subjects 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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with trastuzumab-resistant breast cancer comprising administering the combination of an FMD of Nencioni et al (such as a low caloric 300-1,000 kcal/day diet of 3 monthly cycles of a 5-day FMD) and immunotherapy of Nencioni et al wherein the immunotherapy is a combination of pembrolizumab (PD-1 inhibitor and the EGFR inhibitor trastuzumab because Nencioni et al proposes the combination of FMDs with chemotherapy, immunotherapy or other treatments represents a potentially promising strategy to increase treatment efficacy, prevent resistance acquisition and reduce side effects and Loi et al teaches subjects 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention.
Cited references do not specifically teach the administered daily doses of 300-1,000 kcal/day diet are administered on subsequent days as “a first part with regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%”; however, one would have been motivated with an expectation of success to administer 3 monthly cycles of the low calorie diet at just any dose between 300-1,000 kcal/day for 5 days per cycle because Nencioni et al teaches administering the low calorie FMD diet at doses between 300-1,000 kcal/day. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering 3 monthly cycles of a low-calorie diet at a dose between 300-1000 Kcal/day for 5 consecutive days Nencioni et al.
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, 5, 6, 8-10, 12, and 16-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nencioni et al (Nature Reviews, 2018, 18: 707-719; 9/30/22 IDS) in view of Tolcher et al (Clin Cancer Res, 2017, 23(18): 5349-5537).
Teachings of Nencioni et al are discussed above.
Nencioni et al does not specifically teach methods wherein administered immunotherapy is a PD-1 inhibitor. However, these deficiencies are made up in the teachings of Tolcher et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with lung cancer comprising administering the combination of an FMD of Nencioni et al (such as a low caloric 300-1,000 kcal/day diet of 3 monthly cycles of a 5-day FMD) and immunotherapy of Nencioni et al wherein the immunotherapy is a combination of pembrolizumab (PD-1 inhibitor) and a 4-1BB agonist because Nencioni et al proposes the combination of FMDs with chemotherapy, immunotherapy or other treatments represents a potentially promising strategy to increase treatment efficacy, prevent resistance acquisition and reduce side effects and 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention.
Cited references do not specifically teach the administered daily doses of 300-1,000 kcal/day diet are administered on subsequent days as “a first part with regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%”; however, one would have been motivated with an expectation of success to administer 3 monthly cycles of the low calorie diet at just any dose between 300-1,000 kcal/day for 5 days per cycle because Nencioni et al teaches administering the low calorie FMD diet at doses between 300-1,000 kcal/day. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering 3 monthly cycles of a low-calorie diet at a dose between 300-1000 Kcal/day for 5 consecutive days Nencioni et al.
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, 8, 10 and 14-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Nencioni et al (Nature Reviews, 2018, 18: 707-719; 9/30/22 IDS) in view of Sen et al (Journal of Thoracic Oncology, 2019, 14(12): 2152-2163).
Teachings of Nencioni et al are discussed above.
Nencioni et al does not specifically teach methods wherein administered immunotherapy is a PD-L1 inhibitor. However, these deficiencies are made up in the teachings of Sen et al.
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).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, treat a subject with lung cancer comprising administering the combination of an FMD of Nencioni et al (such as a low caloric 300-1,000 kcal/day diet of 3 monthly cycles of a 5-day FMD) and immunotherapy of Nencioni et al wherein the immunotherapy is a combination of anti-PD-L1 antibody, the CHK1 inhibitor SRA737, and the antimetabolite gemcitabine because Nencioni et al proposes the combination of FMDs with chemotherapy, immunotherapy or other treatments represents a potentially promising strategy to increase treatment efficacy, prevent resistance acquisition and reduce side effects and 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. This is an example of (i) combining prior art elements according to known methods to yield predictable results, (ii) a simple substitution of one known element for another to obtain predictable results, and (iii) some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to combine the prior art reference teachings to arrive at the claimed invention.
Cited references do not specifically teach the administered daily doses of 300-1,000 kcal/day diet are administered on subsequent days as “a first part with regular caloric intake reduced by 30% to 70% and a second part with a regular caloric intake reduced by 40 to 97%”; however, one would have been motivated with an expectation of success to administer 3 monthly cycles of the low calorie diet at just any dose between 300-1,000 kcal/day for 5 days per cycle because Nencioni et al teaches administering the low calorie FMD diet at doses between 300-1,000 kcal/day. In the case (such as this) where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Recited steps of administering a reduced caloric intake cycle as a “first part” and a “second part” that is repeated from 1 to 30 times after respective periods of from 5 to 60 days encompass, or at least overlap, methods of administering 3 monthly cycles of a low-calorie diet at a dose between 300-1000 Kcal/day for 5 consecutive days Nencioni et al.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN E AEDER/Primary Examiner, Art Unit 1642
Prosecution Insights