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 .
Claims 20-25 are cancelled. Therefore, claims 1-19 and 26 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a 371 of PCT/US2022/033969 06/17/2022
PCT/US2022/033969 has PRO 63/305,907 02/02/2022
PCT/US2022/033969 has PRO 63/212,893 06/21/2021
Information Disclosure Statement
Applicant’s Information Disclosure Statement, filed on December 05, 2023 has been considered. Please refer to Applicant’s copy of the 1449 submitted herewith.
Compact Prosecution
In the interest of compact prosecution, the examiner attempted to reach out to applicants to suggest some Examiner’s Amendment to advance the prosecution of the case.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, 8-13 and 26 are rejected, under 35 U.S.C. 102(a)(1) as being anticipated by Yoshitaka ET AL: "COMBINATION THERAPY WITH PARP INHIBITOR AND STATIN FOR CASTRATION-RESISTANT AND TAXANE-RESISTANT PROSTATE CANCER" (cited in the IDS)
The instant claims are directed to a method of treating cancer in a patient in need thereof, the method comprising administering to the patient (i) a therapeutically effective amount of a poly (ADP-ribose) polymerase inhibitor (PARP inhibitor); and(ii) a therapeutically effective amount of a lipophilic statin. Dependent claims further limit the PARP inhibitor, the statin, the dosage, the type of cancer and the patent population.
Yoshitaka ET AL discloses combination therapy that anticipate the instant claims. Yoshitaka ET AL discloses the combination therapy with the PARP inhibitor olaparib and the statin simvastatin in the treatment of a pancreas type of cancer, showing a synergistic effect due to the ability of the statin of altering many gene expressions, being the biggest in the pathway of role of BRCA1 in DNA damage response.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-4, 8-14 and 26 are rejected, under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/033006 (cited in the IDS)
The instant claims are directed to a method of treating cancer in a patient in need thereof, the method comprising administering to the patient (i) a therapeutically effective amount of a poly (ADP-ribose) polymerase inhibitor (PARP inhibitor); and(ii) a therapeutically effective amount of a lipophilic statin. Dependent claims further limit the PARP inhibitor, the statin, the dosage, the type of cancer and the patent population.
WO 2006/033006 discloses combination therapy that anticipate the instant claims. WO 2006/033006 discloses 8-fluoro-2-(4- [(methylamino)methyl]pheny]}-1 ,3,4,5-tetrahydro-6H-azepino[5,4,3- cd] indol-6- one in the treatment of cancer, wherein the PARP inhibitor is used in a preferred embodiment in conjunction with a statin selected from the group consisting of Atovorstatin and Lovastatin.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8-19 and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable Yoshitaka et al (cited in IDS) in view of HEO YOUNG-A ET AL: "Olaparib Tablet: A Review in Ovarian Cancer Maintenance Therapy" (cited in IDS).
The instant claims are directed to a method of treating cancer in a patient in need thereof, the method comprising administering to the patient (i) a therapeutically effective amount of a poly (ADP-ribose) polymerase inhibitor (PARP inhibitor); and(ii) a therapeutically effective amount of a lipophilic statin. Dependent claims further limit the PARP inhibitor, the statin, the dosage, the type of cancer and the patent population.
Determination of the scope and contents of the prior art
Yoshitaka ET AL teaches combination therapy with the PARP inhibitor olaparib and the statin simvastatin in the treatment of a pancreas type of cancer, showing a synergistic effect due to the ability of the statin of altering many gene expressions, being the biggest in the pathway of role of BRCA1 in DNA damage response.
Yoshitaka ET AL does not teach platinum based therapy.
HEO YOUNG-A ET AL teach a therapy that uses Olaparib is co-administered with statin. HEO YOUNG-A ET AL also teach that the patients are with BARCA mutation. The reference also teach the use of Olaparib as maintenance therapy in patients with platinium-senstive ovarian cancer who have received platinum based chemotherapies.
Resolving the Level of Ordinary Skill in the Pertinent Art
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) the education level of active workers in the field.” Envtl. Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.3d 1376, 1381-82 (Fed. Cir. 1983)). The above factors are not exhaustive, but are a guide. Id.
In this case, the education level of the inventor and the education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, a person of ordinary skill in the art would likely have at least a college degree in the field of organic chemistry, with industry experience, i.e., a masters or doctorate level of skill and knowledge in the laboratory. Thus, the level of skill in the art is relatively high.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143. Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" — choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel. Here one or more of rationales (C) and (G) apply.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Yoshitaka et al and HEO YOUNG-A ET AL to create the instantly claimed invention. Yoshitaka ET AL teaches combination therapy with the PARP inhibitor olaparib and the statin simvastatin in the treatment of a pancreas type of cancer, showing a synergistic effect due to the ability of the statin of altering many gene expressions, being the biggest in the pathway of role of BRCA1 in DNA damage response. HEO YOUNG-A ET AL also teach that the patients are with BARCA mutation. The reference also teach the use of Olaparib as maintenance therapy in patients with platinium-senstive ovarian cancer who have received platinum based chemotherapies. In the absence of unexpected results, one skilled in the art would expect that the instant, one skilled in the art would have been motivated to incorporate the teaching in HEO YOUNG-A ET AL in the combination therapy in patients with platinium-senstive ovarian cancer who have received platinum based chemotherapies.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). See MPEP 2145, Section II. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Accordingly, claims 8-13 are rendered obvious in view of the references above. Applicant might consider providing evidence of unexpected results to overcome the rejection.
Objections
Claims 5-7 are object to for depending on 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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Kamal A Saeed/
Primary Examiner, Art Unit 1626