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 .
Claim Objections
Claims 1, 3, and 10-11 are objected to because of the following informalities: regarding claims 1 and 10-11, the bullet points “○” or “●” should be removed/deleted. Regarding claim 3, “ii” is listed twice. Appropriate correction is required.
Claims 34-35 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claims 34-35 has not been further treated on the merits.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6-8, 10, 22, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 27, 31, and 33-36 of U.S. Patent No. 11,878,973 B2 in view of Chan et al. US 2021/0171958 A1 (Chan) as applied to claims 1, 3, 8, 10, 22, and 40 below.
Claims 21, 27, 31, and 33-36 of the reference patent differ from the instantly claimed invention in that the claims of the reference patent do not explicitly recite the use of an instant agent (e.g., cisplatin, paclitaxel, etc.); however, this deficiency would have been obvious in view of the teachings of Chan for the reasons set forth herein below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 6-10, 19, 22, 24-33, and 38-40 are 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.
Regarding claim 1, the claim reads upon “an agent which can…of cancer cells”; however, one of ordinary skill in the art would not be apprised of the metes and bounds of the instant “agent” as the “agent” is only described in functional terms. The recitation(s) “sensitise the cancer cells…WRN inhibitor”, “prime the cancer cells…in cancer cells”, “create or increase MMR…in cancer cells”, “create or increase MSI-H…in cancer cells”, and/or “increase MMR…of cancer cells” is/are not sufficient to convey a chemical structure, chemical name or the like to the instantly claimed conjugate. There is nothing inherently wrong with defining some part of an invention in functional terms; however, a functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used. Functional descriptions of chemical compounds/compositions must be coupled with a known or disclosed correlation between function and structure. This deficiency is not cured in claims 2, 6-10, and 40.
Regarding claim 8, the phrase “such as” renders the claim indefinite because it is unclear whether the limitations after the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 9, the text “selected from MSS…or MGMG-methylated MSS (microsatellite stable) cancer” reads upon an improper Markush group as members of the group are listed in an alternative manner. When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if "wherein R is a material selected from the group consisting of A, B, C and D" is a proper limitation, then "wherein R is A, B, C or D" shall also be considered proper.
Regarding claim 19, the term “including” renders the claim indefinite because it is unclear whether the limitations after the term are part of the claimed invention. See MPEP § 2173.05(d). This deficiency is not cured in claims 28 and 38-39.
Regarding claim 22, the parenthetical phrase(s) “(e.g. doxorubicin hydrochloride)” and/or “(e.g. mitomycin A…particularly mitomycin C)” render(s) the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d). Further, the term “e.g.” and/or “particularly” renders the claim indefinite because it is unclear whether the limitations after the term are part of the claimed invention. See MPEP § 2173.05(d). Further still, claim 22 contains the trademark/trade name Camptosar®, Taxotere®, Adriamycin®, Rubex®, Adrucil®, Efudex®, Xeloda®, Platinol®, Paraplatin®, and Taxol®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the at least one chemotherapy agent and, accordingly, the identification/description is indefinite.
Regarding claims 24-27 and 29-33, the parenthetical phrase(s) “(at least one)” render(s) the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1, 3, 8, 10, 22, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. US 2021/0171958 A1 (Chan).
Claims 1, 3, 8, 10, and 40 are drawn to a method for treating cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a WRN inhibitor and
an agent which can
sensitise the cancer cells, for example for an improved response to treatment with a WRN inhibitor,
prime the cancer cells, for example, such priming may include triggering hypermutation status in cancer cells,
create or increase MMR deficiency in cancer cells,
create or increase MSI-H status in cancer cells, or
increase MMR heterogeneity of cancer cells, and optionally wherein the treatment further comprises administration of:
ii. a chemotherapy.
Claim 22 is drawn to a method of treating cancer in a subject in need thereof, in particular microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a WRN inhibitor in combination with a therapeutically effective amount of at least one chemotherapy agent selected from gemcitabine, camptothecin, irinotecan (Camptosar®), docetaxel (Taxotere®), doxorubicin (e.g. doxorubicin hydrochloride) (Adriamycin®, Rubex®), 5-fluorouracil (Adrucil®, Efudex®), capecitabine (Xeloda®), etoposide (Vepesid®), epirubicin (Ellence®, Pharmorubicin®), oxaliplatin (Eloxatin®), mitomycin (e.g. mitomycin A, mitomcyin B or mitomycin C, particularly mitomycin C), cisplatin (Platinol®), carboplatin (Paraplatin®), bleomycin and paclitaxel (Taxol®).
Chan features methods to treat cancer having ARID1A mutations and cancers with mutations in other subunits of the BAF complex [0002]. The invention also features methods to treat cancer having a mismatch repair deficiency (MMRd), e.g., in a subject in need thereof. In some embodiments, the methods described therein are useful in the treatment of cancer in combination with immunotherapies. In some embodiments, the cancer has a microsatellite instability (MSI)-positive or MSI-high (MSI-H) phenotype [0008]. In some embodiments, the MSI-positive phenotype is characterized by the presence of an MSI at least one of the mononucleotide or dinucleotide markers selected from the group consisting of BAT25, BAT26, D2S123, D5S346, and D17S250.
Chan teaches that in some embodiments, the cancer is an MSI-positive cancer, an MSI-H cancer, an adrenocortical carcinoma, a bladder carcinoma, a breast carcinoma, a cervical squamous cell carcinoma, an endocervical adenocarcinoma, a cholangiocarcinoma, a chronic lymphocytic leukemia, a colorectal cancer (e.g., a colon adenocarcinoma), a cutaneous T-cell lymphoma, a lymphoid neoplasm diffuse large B-cell lymphoma, an esophageal carcinoma, a glioblastoma multiforme, a head and neck squamous cell carcinoma, a kidney chromophobe, a kidney renal papillary cell carcinoma, an acute myeloid leukemia, a lower-grade glioma, a liver hepatocellular carcinoma, a lung adenocarcinoma, a lung squamous cell carcinoma, a mesothelioma, a nasopharyngeal carcinoma, an ovarian cancer (e.g., an ovarian serous cystadenocarcinoma), a pancreatic adenocarcinoma, a pheochromocytoma, paraganglioma, a prostate adenocarcinoma, a rectal adenocarcinoma, a sarcoma, a skin cutaneous melanoma, a stomach adenocarcinoma, a testicular germ cell tumor, a thyroid carcinoma, a thymoma, an uterine corpus endometrial carcinoma, an uterine carcinosarcoma, an uveal melanoma, a pediatric acute myeloid leukemia, a pediatric neuroblastoma, or a pediatric high-risk Wilms tumor [0016].
Chan teaches that an agent that reduces the level and/or activity of WRN in a cell in a subject as described therein, can be administered alone or in combination with an additional anti-cancer therapy [0130]. The anti-cancer therapy may be an additional therapeutic agent (e.g., other agents that treat cancer or symptoms associated therewith) or in combination with other types of therapies to treat cancer (e.g., radiological therapies or surgical procedures). In some embodiments, the second therapeutic agent is selected based on tumor type, tumor tissue of origin, tumor stage, or mutation status. In combination treatments, the dosages of one or more of the therapeutic agents may be reduced from standard dosages when administered alone. Chan teaches that in some embodiments, the anti-cancer therapy is a chemotherapeutic agent (e.g., a cytotoxic agent or other chemical compound useful in the treatment of cancer) [0133]. Non-limiting examples of chemotherapeutic agents include cisplatin and 6-thioguanine. Further examples of chemotherapeutic agents include doxorubicin and taxoids, e.g., TAXOL® (paclitaxel; Bristol-Myers Squibb Oncology, Princeton, N.J.)
Thus, Chan teaches or reasonably suggests a method of treating cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a WRN inhibitor. See [0002], [0008], [0016]. Chan teaches or reasonably suggests the administration of the WRN inhibitor in combination with an additional anti-cancer therapy. Chan teaches or reasonably suggests that the anti-cancer therapy may be an additional therapeutic agent(s) (e.g., cisplatin, 6-thioguanine, paclitaxel, and/or doxorubicin, etc.) or in combination with other types of therapies to treat cancer (e.g., radiological therapies). See [0130], [0133]. Chan teaches or reasonably suggests that the method may be used to treat an adrenocortical carcinoma, a breast carcinoma, a colorectal cancer (e.g., a colon adenocarcinoma), or an esophageal carcinoma. See [0016]. Chan teaches or reasonably suggests all of the instantly claimed elements.
Chan differs from the instantly claimed invention in that Chan does not explicitly teach the administration of a WRN inhibitor and an additional anticancer agent to a subject in need thereof in a singular embodiment; however, this deficiency would have been prima facie.
In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
It would have been obvious to administer a WRN inhibitor of Chan in combination with an additional anticancer therapy disclosed by Chan such as cisplatin or paclitaxel to an instant subject in need thereof (e.g., a subject having a breast carcinoma). Use of materials in combination, each of which is known to function for intended purpose, is generally held to be prima facie obvious as the idea of combining them flows logically from their having been individually taught in the prior art. Thus, claims 1, 3, 8, 10, 22, and 40 would have been obvious based upon the preponderance of evidence.
Conclusion
Claims 1-11, 19, 22, 24-35, and 38-40 are pending. Claims 1-3, 6-10, 19, 22, 24-33, and 38-40 are rejected. Claims 4-5 and 11 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. Claims 34-35 are objected to. No claims are allowed.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/