DETAILED ACTION
Status of Application
Receipt of the response to the restriction/election requirement, the amendments to the claims and applicant arguments/remarks, filed 07/29/2026, is acknowledged.
Claims 67-85 are pending in this action. Claim 66 has been cancelled. Because the applicant cancel claim 66 drawn to an immediate release film-coated tablet comprising 180-360 mg of 5-azacytidine and a pharmaceutically acceptable excipient(s), the restriction requirement as set forth in the Office action mailed on 05/29/2026 is hereby withdrawn. Claims 67-85 are currently under consideration.
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of U.S. Patent Application No. 17/984,939, filed November 10, 2022 and now abandoned, which is a continuation of U.S. Patent Application No. 17/533,033, filed November 22, 2021 and now issued as U.S. Patent No. 11,571,436, which is a continuation is a continuation of U.S. Patent Application No. 16/833,410, filed March 27, 2020 and now abandoned, which is a continuation of U.S. Patent Application No. 16/582,779, filed September 25, 2019 and now issued as U.S. Patent No. 10,646,503, which is a continuation of U.S. Patent Application No. 16/244,014, filed January 9, 2019 and now issued as U.S. Patent No. 10,463,683, which is a continuation of U.S. Patent Application No. 15/835,088, filed December 7, 2017 and now issued as U.S. Patent No. 10,220,050, which is a divisional of U.S. Patent Application No. 14/788,606, filed June 30, 2015 and now abandoned, which is a continuation of U.S. Patent Application No. 14,463,424, filed August 19, 2014 and now abandoned, which is a continuation of U.S. Patent Application No. 12/466,213, filed May 14, 2009 and now issued as U.S. Patent No. 8,846,628, which claims benefit of provisional U.S. Application No. 61/053,609, filed May 15, 2008, provisional U.S. Application No. 61/201,145, filed December 5, 2008, and provisional U.S. Application No. 61/157,875, filed March 5, 2009.
Inventorship
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.
Specification
The lengthy specification (96 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises references on publications and foreign applications (e.g., Para. 0007, 0012, 0013, 0020, 0076, 0081, 0083, 00100, 00102, 00105, 00122, 00129, 00158, 00162, 00164, 00176, 00178, 00188-00189, 00196, 00203, 00207, 00252, 00256, 00260, 00264). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises multiple acronyms without proper definition (e.g., Para. 00156; 00168). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The use of the trademarks/trade names/product names has been noted in this application (e.g., Para. 00144-00145, 00147, 00150, 00160, 00163, 0168-00169, 00214, Tables 3-5). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names/product names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The disclosure contains an embedded hyperlink and/or other form of browser-executable code (Para. 00179). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. MPEP 608.01.
Information Disclosure Statement
The information disclosure statements (38 pages), filed 10/25/2024 and 07/29/2026, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Applicant has submitted the oversized information disclosure statement without specifically pointing out where relevant material can be found in each of the references. As a result, the examiner has considered said oversized information disclosure statement to the extent permitted by the allotted time for such consideration and consistent with the MPEP.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statements fail to comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12. Regarding electronic document(s) retrieved from an online source, it is noted that the format for the citation of an electronic document should be similar to the format used for paper documents of the same type, with the addition of the information in the locations (internet, database, etc.) indicated. MPEP 707.05(e).
Further, the information disclosure statements fail to comply with 37 CFR 1.98(a)(2), which requires that any information disclosure statement includes a legible copy of (i) each foreign patent; and/or (ii) each publication or that portion which caused it to be listed. A copy of publication listed in an information disclosure statement is required to be provided, even if the publication was previously submitted to, or cited by the Office in an earlier application, unless: (1) The earlier application is properly identified in the information disclosure statement and is relied on for an earlier effective filing date under 35 U.S.C. 120; and (2) The information disclosure statement submitted in the earlier application complies with paragraphs (a) through (c) of this section. MPEP §609. In the present case, to expedite prosecution the examiner considered the legible copies of cited foreign patents and/or non-literature documents that have been submitted in parent applications. However, the legible copies of CZ114716 and/or CZ116297 are missing.
The information disclosure statements do not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or do not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 67 are objected to because of the following informalities:
Claim 67 comprises the typographic error “the 5-azacytidine” that needs to be corrected to “5-azacytidine”.
Claim 67 comprises the typographic error “comprising 180 mg to” that needs to be corrected to “comprising from 180 mg to”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 67-85 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 pre-AIA the applicant regards as the invention.
Claim 67 recites the term "substantially" that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, but teaches that “The term “substantially in the stomach” … means that at least about 99%, at least about 95%, at least about 90%, …, at least about 25%, at least about 20%, at least about 15%, or at least about 10% of the cytidine analog is released in the stomach” (Para. 0066). In the present case, it is unclear if said limitation implies that the claimed composition/tablet (to be used in the claimed method) substantially releases in a stomach at least 10% of 5-azacytidine? Therefore, the scope of the claim is not clear. Therefore, clarification is required.
Claim 67 discloses an immediate release formulation of 5-azacytidine in a form of film-coated tablet to be used for treatment for treating myelodysplastic syndrome and providing specific 5-azacytidine release (i.e., immediate release, substantially releases in a stomach), but it does so without including any materials that cause said results. The claims attempt to define the subject matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. To this point, it is noted that it is well known in the field that properties of multicomponent systems (e.g., compositions/products) depend on compounds included as well as on concentrations and/or distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/tabler. Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
Claims 68-85 are rejected as being dependent on rejected independent claim 67 and failing to cure the defect.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 67-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-37 of U.S. Patent No. 8,846,628.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the prior patent also claims: A method for treating myelodysplastic syndrome, the method comprising orally administering to a subject in need thereof a pharmaceutical composition in a form of coated tables and comprising 40-1000 mg of 5-azacytidine and at least one pharmaceutically acceptable excipient. Further, cited prior patent also teaches that 5-azacytidine in said formulations/tablets is absorbed substantially in the stomach. In the present case, the prior patent claims are merely broader than the instant claims that include additional limitations (e.g., 180-360 mg of 5-azacytidine, film-coated tablet, treatment schedule) and therefore are more specific.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches a large variety of compositions/tablets comprising 5-azacytidine as an active agent and their use for treatments cancers, e.g., myelogenous leukemia.
The prior art does not teach a method for treating myelodysplastic syndrome by orally administering to a patient in need thereof once daily (e.g., for 14 days) a film-coated tablet comprising 180-360 mg of 5-azacytidine and a pharmaceutical acceptable excipient(s), wherein said tablet provides an immediate release of 5-azacytidine substantially in the stomach. The applicant also teaches (see Declaration under 37 C.F.R. § 1.132, filed on 02/27/2014 in patent application 12/466,213) that immediate release film-coated tablets provide faster (i.e., in 0.5-1 hr after administering) a high concentration of 5-azacytidine in blood; allow delivering 5-azacytidine over a prolong period of time; have unexpected high antineoplastic activity, and can be used for treatment of cancer, disorders related to abnormal cell proliferation, hematologic disorders, immune disorders, among others.
Applicant is advised to clarify the claim language, the structure of the tablets to be used in the claimed methods, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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