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
Claims 14-28 are pending in the application. Claims 14-28 are rejected. Claims 14 and 23 are objected to.
Restriction/Election of Species
Applicant’s election without traverse of “metarrestin” (structure from paragraph [0222] of instant specification reproduced below) for a species of a compound of formula (I) in the reply filed on March 27, 2026 is acknowledged.
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The absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse. See MPEP § 818.01.
Pursuant to MPEP § 803.02, the Markush claims that read on the elected species were examined fully with respect to the elected species. Upon examination, the elected species was found to be anticipated or rendered obvious by prior art; therefore, the Markush claim and claims to the elected species will be rejected. The claim(s) and subject matter that do not read on the elected species have NOT been examined and searched by the examiner.
Priority
This application is labeled as a divisional of 17/055,256, filed on November 13, 2020, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2019/032461, filed on May 15, 2019, which claims benefit of Provisional Application No. 62/671,964, filed on May 15, 2018.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on June 6, 2024 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claims 14 and 23 are objected to because of the following informalities:
Claim 14 should be amended to recite the expression “....or a pharmaceutically acceptable salt thereof,...” after the recited generic formula for a compound of formula (I) (i.e., before the recited variable definitions) for sake of clarity. In addition, the original instance of this expression in the claim should be canceled.
Claim 23 should be amended to include the word “the” before “compound of formula (I)” for sake of clarity and consistency.
Appropriate correction is required.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14-28 are rejected under 35 U.S.C. § 103 as being unpatentable over Oliva et al. (U.S. Patent No. 9,877,966 B1; January 30, 2018) in view of Vareedayah et al. (Mo Med. 2018, May-Jun, 115(3):230-235).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Oliva et al. teach Compound 2 having the following chemical structure (see e.g., Table 4, columns 29 and 30):
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Regarding instant claim 14, the above prior art Compound 2 is encompassed by variable definitions of the instantly claimed compound of formula (I), wherein R1 is hydroxycycloalkyl; R2 is phenyl; R3 is phenyl; and R4 is arylalkyl (i.e., “an alkyl group linked to a C6-C10 aryl ring and further linked to a molecule via the alkyl group” as disclosed in paragraph [0161] of the instant specification). Oliva et al. also teach “a method of treating or preventing cancer comprising administering to a patient in need thereof a therapeutically effective amount of [the prior art invention]” e.g., Compound 2. See e.g., column 19, lines 57-61. Oliva et al. also teach methods of treating cancer in humans wherein “the cancer is [preferably] a metastatic cancer.” See e.g., column 19, lines 66 and 67. Oliva et al. further teach the cancer may be “pancreatic cancer” or “pancreatic carcinoma.” See e.g., column 20, lines 37 and 56.
Regarding instant claim 15, the above prior art Compound 2 corresponds to the chemical structure for “metarrestin.”
Regarding instant claim 16, Oliva et al. teach “coadministering to a patient in need thereof an effective amount of a radiation treatment and a compound or salt of the invention” (e.g., Compound 2). See e.g., column 22, lines 56-60.
Regarding instant claims 20, 22 and 23, Oliva et al. teach methods “comprising coadministering to a patient in need thereof an effective amount of an anticancer agent and a compound or salt of the invention” (e.g., Compound 2). See e.g., column 20, line 67 and column 21, lines 1 and 2. Oliva et al. further teach the term coadministering includes “sequential as well as coextensive administration of two or more drug compounds” (i.e., sequential or simultaneous administration). See e.g., column 21, lines 49-55.
Regarding instant claim 28, Oliva et al. teach dosages “such as from about 0.2 to about 80 mg/kg” which is encompassed by the instantly claimed dosage. See e.g., column 22, lines 31 and 32.
Note that instant claims 17, 24, 26 and 27 are drawn towards non-limiting characteristics that would necessarily result from employing the instantly claimed methods. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004). “[W]hen considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005). In addition, “[p]roducts of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01(II).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 14 and 19, Oliva et al. does not specifically teach a method for treating pancreatic adenocarcinoma or metastatic pancreatic adenocarcinoma. However, as stated above, Oliva et al. does teach methods for treating, for instance, “pancreatic cancer” or “pancreatic carcinoma.” See e.g., column 20, lines 37 and 56. In addition, Vareedayah et al. teach that “[t]he term ‘pancreatic cancer’ is typically used to refer to pancreatic adenocarcinoma. [...] [and that] [m]ore than 95% of malignant neoplasms of the pancreas arise from the exocrine portions of the gland (ductal and acinar cells), and demonstrate features consistent with adenocarcinoma.” See e.g., page 230. Vareedayah et al. also teach that “[a]pproximately 80% of [pancreatic cancer] patients have regional spread or metastatic disease at the time of diagnosis.” See e.g., page 230. Note that the disclosure of Vareedayah et al. focuses on pancreatic adenocarcinoma. See e.g., page 230.
Regarding instant claim 18, Oliva et al. does not teach stage I, II, III, or IV pancreatic adenocarcinoma. However, Vareedayah et al. teach the staging of pancreatic cancer as designated by the American Joint Committee on Cancer. See e.g., Table 1. Vareedayah et al. also teach that “[o]nce the diagnosis of pancreatic cancer has been made...patients are often placed into one of four distinct groups, which determines treatment plan” (i.e., stage I, II, III or IV). See e.g., page 233.
Regarding instant claim 21, Oliva et al. does not teach administering gemcitabine to a human. However, Vareedayah et al. teach gemcitabine as a recommended chemotherapeutic treatment for patients with metastatic pancreatic adenocarcinoma. See e.g., page 234.
Regarding instant claim 25, Oliva et al. does not teach that one or more pancreatic adenocarcinoma tumor(s) has been removed from the human by surgery. However, Vareedayah et al. teach patients with stage I (i.e., “clearly resectable”) pancreatic cancer “should be referred as soon as possible to a surgeon, to determine if they are candidates for resection based on other medical comorbidities.” See e.g., page 233. Vareedayah et al. also teach that “[s]urgery is the only treatment modality for pancreatic cancer that is potentially curative.” See e.g., page 233.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 14, 18 and 19, it would, therefore, have been obvious to a person of ordinary skill in the art to arrive at the instantly claimed methods based on the combined teachings of Oliva et al. and Vareedayah et al. A person of ordinary skill in the art would expect- in treating metastatic pancreatic cancer/carcinoma patients with, for instance, Compound 2 as taught by Oliva et al.- to encounter a large subset of patients with pancreatic adenocarcinoma as Vareedayah et al. teaches “95% of malignant neoplasms of the pancreas...demonstrate features consistent with adenocarcinoma.” See e.g., page 230. Furthermore, it is within the ability of a skilled artisan to categorize a patient diagnosed with pancreatic adenocarcinoma into one of the four pancreatic cancer stages (discussed above) to determine an appropriate treatment plan. Therefore, at least in the interest of providing an effective treatment strategy for a large subset of the pancreatic cancer patient population, a skilled artisan would be motivated to employ the instantly claimed methods.
Regarding instant claim 21, it would, therefore, have been obvious to a person of ordinary skill in the art to further administer gemcitabine with, for instance, Compound 2 as taught by Oliva et al. to a patient with pancreatic cancer/adenocarcinoma. At least in the interest of improving the prognosis for a patient undergoing treatment for pancreatic adenocarcinoma, a skilled artisan would be motivated to follow the “[c]urrent recommendations for treatment of patients with metastatic disease” and administer “gemcitabine plus nab-paclitaxel or gemcitabine alone (based on the patient’s performance status).” See e.g., page 234.
Regarding instant claim 25, it would, therefore, have been obvious to a person of ordinary skill in the art to administer Compound 2, as taught by Oliva et al., to a pancreatic adenocarcinoma patient who has undergone surgery to remove one or more tumor(s). Considering that Vareedayah et al. teach the “prognosis for pancreatic cancer remains poor, even after potentially curative surgery” (see e.g., page 234), a skilled artisan would be motivated to administer Compound 2 to a patient after surgery as adjuvant therapy with the goal of preventing recurrence of pancreatic cancer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,663,521 (May 30, 2017) in view of Oliva et al. (U.S. Patent No. 9,877,966 B1; January 30, 2018) and Vareedayah et al. (Mo Med. 2018, May-Jun, 115(3):230-235).
Claims 1-19 of U.S. Patent No. 9,663,521 (“’521”) are drawn to the instantly claimed compound of formula (I) and compositions thereof. For instance, the compound as recited in claim 19 of ‘521 corresponds to Applicant’s instantly elected species (i.e., metarrestin). With respect to the fact that the claims of the patent are drawn to compounds and compositions while the instant claims are drawn to methods of treating a pancreatic adenocarcinoma in a human, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell, 547 F.3d 1378. For example, ‘521 discloses a method of treating metastatic cancer, such as pancreatic cancer. See column 17, line 58 and column 18, line 29. Therefore, claims 1-19 of ‘521 are generic to subject matter discussed above under 35 U.S.C. § 103 as being obvious. Accordingly, instant claims 14-28 would have been obvious in view of claims 1-19 of ‘521 for the same reasons discussed under 35 U.S.C. § 103, which rationale is incorporated here by reference.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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