DETAILED ACTION
Status of Application
Claims 1-27, filed 10/15/2025, are pending in this application. Claims 1-27 are currently under consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of U.S. Patent Application No. 18/383,389, filed October 24, 2023 and now issued as U.S. Patent No. 12,208,166, which a continuation of U.S. Patent Application No. 17/355,781, filed June 23, 2021 and now issued as U.S. Patent No. 11,793,759, which a continuation of U.S. Patent Application No. 17/103,468, filed November 24, 2020 now issued as U.S. Patent No. 11,571,388.
Applicant’s statement that not later than the effective filing date of the claimed invention the subject matter disclosed in the reference by Dykstra et al. (US 2019/0365729) and the claimed invention were owned by Iterion Therapeutics (as filed for applicant 17/355,781) is acknowledged.
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 (35 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 multiple acronyms without proper definition, e.g., Wnt (Pages 1, 11), WNT (Pages 6, 17, 22), HFA (Page 19), API (Page 23, 24, 26, 30), PSI (Page 25), DSC (Page 25), WFI (Page 30), VWR, EMD (Page 31). 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 has been noted in this application (e.g., Page 20). 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 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.
Information Disclosure Statement
The information disclosure statement, filed 03/20/2025, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Claim Objections
Claims 20-24, 26-27 are objected to because of the following informalities:
It is suggested that in claim 20 the limitation "at storage at a temperature of between 5 °C and 25 °C" should be corrected to "during a storage at a temperature of 5-25 °C" for clarity. Similar is applied to claims 21-23.
In claim 24 the limitation “in a mammal in need thereof comprising administering” needs to be corrected to “in a mammal in need thereof, the method comprising administering” for clarity.
Claim 26 comprises the typographic error “claim 1 wherein” that needs to be corrected to “claim 1, wherein”.
Claims 26-27 comprise the typographic error “the tegavivint” that needs to be corrected to “tegavivint”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(1)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The present claims are directed to pharmaceutical formulations that can be lyophilized and comprise particles of tegavivint or a pharmaceutically acceptable salt thereof; wherein said particles have a median particle diameter D50 ≤ 500 nm and D90 ≤ 1.0 micron; a poloxamer and stabilizers selected from the group consisting of sucrose, trehalose, and sorbitol (claims 1, 3); wherein said formulations are stable for at least three months during the storage at 5-25 oC (claims 20-23), and wherein tegavivint is prepared from Form I or Form IV polymorphs as a starting material. Specification defines “a stable formulation” as a formulation, wherein said active ingredient does not lose more than 20% of its activity during the storage (Page 10).
The written description requirement for a claimed genus (here as tegavivint or a pharmaceutically acceptable salt thereof) may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. MPEP §2163.
In the present case, it is noted that the only examples of using specific polymorphic forms of tegavivint, i.e., Form I and Form IV polymorphs, in combination with poloxamer/disintegrant and sucrose/trehalose/sorbitol as stabilizers as a starting material for preparation of stable pharmaceutical formulations as claimed are provided.
Therefore, it is examiner’s position that the instant specification lends support for the lyophilized formulations comprising tegavivint, wherein said formulations are prepared by using a starting material consisting of tegavivint Form I and/or Form IV polymorphs in combination with poloxamer/disintegrant and stabilizers/sucrose/trehalose/sorbitol. For the reasons provided supra, applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations (i.e., a starting material is Form I and Form II) using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 13-17 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 13 recites the term "about" 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, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 14-17. Clarification is required.
Claim 14 recites the limitation "temperature of between about 40 oC and about 60 oC” that is not reasonably clear. In the present case, it is noted that the term "between" means that the temperature cannot be 40 oC or 60 oC, however, by using the term "about" the claim does allow the temperature to be 40 oC or 60 oC. Therefore, the metes and bounds of the claim cannot be determined. Similar is applied to claim 16. Clarification is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-27 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-27 of prior U.S. Patent No. 11,793,759.
In the present case, it is noted that claims 1-27 of the instant application are substantial duplicates of claims 1-27 of prior patent 11,793,759 despite a slight difference in wording. This is a statutory double patenting rejection.
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 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-21 of U.S. Patent No. 11,571,388; (2) claims 1-22 of U.S. Patent No. 11,602,501; (3) claims 1-16 of U.S. Patent No. 11,964,054; (4) claims 1-26 of U.S. Patent No. 12,208,166; and (5) claims 1-17 of U.S. Patent No. 12,491,162.
Although the conflicting claims are not identical, they are not patentably distinct from each other because prior patents also claim: A formulation comprising particles of tegavivint or pharmaceutically acceptable salt thereof, wherein said particles have D50 ≤ 500 nm, and D90 ≤ 1 micron, and wherein said formulation also comprises a poloxamer and at least one stabilizer selected from the group consisting of sucrose, trehalose and sorbitol, and wherein said formulation is used for a treatment of cancer. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in the said prior patents.
Claims 1, 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8 of U.S. Patent No. 11,266,637.
Although the conflicting claims are not identical, they are not patentably distinct from each other because prior patents also claim: A formulation comprising particles of tegavivint or pharmaceutically acceptable salt thereof, wherein said particles have D50 ≤ 500 nm, and D90 ≤ 1 micron, and wherein said formulation also comprises a poloxamer and sorbitol, and wherein said formulation is used for a treatment of cancer. In the present case, the prior patent claims are merely broader than instant independent claims (i.e., claims 1 and 3) that include additional limitations (i.e., D50, D90, poloxamer, stabilizers, prepared from Form I or form IV) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in the said prior patent.
Claims 1-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/405,894.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on that copending application, since the referenced copending applications and the instant application are claiming common subject matter, as follows: A formulation comprising particles of Form I or Form IV polymorph of tegavivint or pharmaceutically acceptable salt, ester, amide, stereoisomer or geometric isomer thereof, wherein said particles have D90 ≤ 0.2 micron, D50 ≤ 120 nm (claims 1-2); wherein said formulation is anhydrous (claim 7); is stable for 3-18 months (claims 8-11); comprises a poloxamer and at least one stabilizer selected from the group consisting of sucrose, trehalose and sorbitol (claims 12-18); and wherein tegavivint is Form I polymorph or Form IV polymorph (claims 19-20); and said composition can be used for cancer treatment (claim 21). In the present case, the copending application independent claim is merely broader than instant independent claims (i.e., claims 1 and 3) that include additional limitations (i.e., D50, D90, poloxamer, stabilizers) and therefore are more specific. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Correspondence
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
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 8/17/26
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