DETAILED ACTION
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 the Claims
The Office Action is in response to the application filed October 19, 2023. Claims 1, 4, 7, and 9-23 are being examined on the merits herein.
Objection
Claim 20, “metasticized” is misspelled. Corrective action is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7, 11-14, 16, and 21 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Polvino (US PG-PUB 2008/0207640 A1) of record.
Polvino teaches subjects that have cancer also commonly have cachexia. Cachexia is a progressive loss of body weight, which is mainly due to loss of fat and skeletal muscle. Survival of cancer patients is directly related to the total weight loss and also the rate of weight loss. Polvino teaches methods of inhibiting and reversing cachexia in subjects that have cancer. Specifically, the instant invention provides methods for treating a patient with cancer cachexia by administering to the subject a growth hormone secretagogue [0304].
Polvino teaches subjects were separated into groups and administered a placebo or RC-1291 (Formula III). Each group was administered the appropriate number of capsules. The capsules were microcrystalline cellulose, magnesium stearate and RC-1291 HCl (25 mg) in a hard gelatin capsule. The placebo capsule was microcrystalline cellulose in a hard gelatin capsule. The RC-1291 groups received 50 mg or 100 mg of RC-1291 daily [0337].
Polvino demonstrates in Example 3, both the lean body mass and total body weight increase in subjects administered RC-1291 (anamorelin) as compared to a control group [0304].
Polvino provides the results in FIGS. 10, 11, and 12. Total body mass and lean body mass were measured for subjects described in Example 1 (see FIGS. 10, and 11, respectively.) Lean body mass and total body mass were measured by dual-energy x-ray absorptiometry (DEXA). Total body weight was measured for subjects described in Example 2 (see, FIG. 12) [0343]. The results presented in FIGS. 10, 11 and 12 demonstrate that subjects administered RC-1291 (anamorelin) not only halted the change in lean body mass and total body weight, but that these subjects gained lean body mass and total body weight (Example 3) [0344].
Polvino teaches treating weight loss and increasing total body mass and lean mass in a human cancer patient with the administration of 100mg anamorelin.
Polvino teaches a 12-week study [0088].
Polvino teaches one hour before breakfast subjects were administered the two capsules after fasting during the night [0330].
Polvino teaches wherein treatment of the solid-tumor cancer is selected from lung, colon, or rectal cancer (claim 45).
Polvino is silent on the patient receiving chemo- or radiotherapy, thereby meeting the limitations of claim 21.
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Claims 1, 4, 9, 18, and 22-23 are rejected 35 U.S.C. 102 (a)(1) as being anticipated by Garcia (Support Care Cancer, 2013) of record.
Garcia teaches anamorelin, an oral mimetic of ghrelin, has been shown to increase body weight and anabolic hormone levels in healthy volunteers and is being investigated to treat cancer cachexia (abstract; page 133, Figure 1).
This multicenter, double-blind, placebo-controlled, crossover study evaluated the effects of anamorelin in 16 patients with different cancers and cachexia. Patients were randomly assigned to anamorelin 50 mg/day or placebo for 3 days (Abstract; Methods, page 130, column 2).
Anamorelin significantly increased body weight compared with placebo (0.77 kg vs. -0.33 kg). Food intake increased compared with placebo (Abstract; page 132, column 1, “Body Weight Gain”).
Anamorelin showed significant metabolic, clinical, and patient-rated effects in cancer cachexia.
Patients were recruited at seven sites across the United States. Men and women aged ≥18 years were eligible if they had a histologically confirmed diagnosis of incurable cancer and involuntary loss of body weight of ≥5 % (excluding perioperative and edematous weight loss) within the past 6 months. Patients also had to have an estimated life expectancy of >3 months and an Eastern Cooperative Oncology Group (ECOG) performance status 0–2 (i.e., at least ambulatory and capable of all self-care; up and about ≥50 % of waking hours) (page 130, column 2, “Patients" section).
Garcia study discloses that subjects having received concomitant chemotherapy with a highly emetogenic agent (Hesketh rating>3) [23] within 1 week of study admission were also disqualifying (page 131, column 1, lines 3-6).
Patients enrolled in the study were diagnosed with varying cancer types including breast, colon, lung neoplasm, Non-Hodgkin’s lymphoma, prostate, and rectal (page 132, Table 1).
Garcia discloses a series of exploratory patient reported symptoms were administered. Mean-adjusted ASAS total scores showed a positive, statistically significant impact after 3 days of treatment with anamorelin at 50 mg/day (change from a mean baseline of 66.44 to a mean endpoint of 73.80 for anamorelin compared with 66.44 to 67.44 for placebo, p<0.002; 95 % CI, 3.5–10.3; Fig. 4 and Online Resource, Table S1). Among individual questionnaire items, patients reported significant improvement in appetite (from a mean baseline of 4.00, increasing by 2.67 with anamorelin and 0.50 with placebo, p00.011; 95 % CI, 0.7–3.3; Online Resource, Table S1). The mean-adjusted total score for FACIT-F significantly improved with 3 days of anamorelin treatment, increasing from 95.38 at baseline to 107.33 for anamorelin, compared with an increase from 95.38 to 101.69 with placebo (p00.018; 95 % CI, 1.8–11.3; Fig. 4 and Online Resource, Table S2).
Garcia teaches patient-reported symptom measures, including the FACIT-F, have been shown to be strongly predictive of outcomes, including survival in cancer patients who have cachexia. Patients demonstrated improvement in anorexia and cachexia (page 131, column 1, 3rd full ¶). Improvement in anorexia meets the limitation of treating fatigue resulting from cancer cachexia (clam 4), wherein the fatigue is caused by anorexia (claim 9).
Mean total BACRI-7 scores showed a positive trend after 3 days of treatment, with a 34.54-point difference in improvement at the end of the anamorelin treatment period compared with the placebo period (p00.12; 95 % CI, −6.7 to 81.8; Fig. 4 and Online Resource, Table S3). Among individual questionnaire items, appetite was not significantly different between treatments after 3 days (p00.240); however, significantly more patients reported greater enjoyment from eating when receiving anamorelin compared with placebo (p00.046; Online Resource, Table S3) (page 133-134 bridging paragraphs).
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
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 of this title, 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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Polvino (US PG-PUB 2008/0207640 A1) of record as applied to claims 1, 7, 11-14, 16, and 21 in the 102 (a)(1) rejection above.
Polvino is discussed above.
Polvino teaches a 12-week therapeutic period [0088].
Polvino does not teach a 13-to-24-week therapeutic period as required by the limitations of claim 17.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known of the use of anamorelin for the treatment of a patient with cancer cachexia for a 12-week period as taught by Polvino and envisioned increasing the therapeutic window. The length of the therapeutic period is considered to be a parameter that is within the purview of the skilled artisan to modify and optimize based on the results observed, absent some demonstration of unexpected results from the claimed parameters.
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1, 4, 7, 9, and 11-23 are not allowed.
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627