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 1, 4-9, 11, 16, 18, 19, 22, 24-26, 28, 30, and 32-34 are pending in the instant application. Claim 32 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1, 4-9, 11, 16, 18, 19, 22, 24-26, 28, 30, 33, and 34 are rejected.
Information Disclosure Statements
The information disclosure statements filed on February 2, 2024 and April 8, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Drawings
The drawings are objected to because the font in Figure 13 is difficult to read and appears to be cut off in Figure 13C. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 4-9, 11, 16, 18, 19, 22, 24-26, 28, 30, 33, and 34, is acknowledged. The restriction requirement is still deemed proper and is hereby made final.
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.
Claims 1, 4-9, 11, 16, 18, 19, 22, 24-26, 28, 30, 33, and 34 are rejected are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/106721 A1 in view of Wright et al. (Neuro-oncology, 2015, vol. 17, no. 12, pages 1620-1627).
WO 2008/106721 A1 discloses that folinic acid (FA) is typically administered alongside 5-fluoruracil (5-FU) to treat cancer, but that they cannot be co-administered in the same injection as they are chemically incompatible. As a solution to this problem, the reference discloses an injectable aqueous solution for parenteral administration with pH 5-8 comprising 5-50 mg/ml 5-Fluorouracil, 1-15 mg/ml calcium folinate, and 10-300 mg/ml cyclodextrins, such as 2-hydroxypropyl-β-cyclodextrin or Heptakis(6-O-sulfo)-ß-cyclodextrin sodium (see abstract; Examples 1-8; claims). Analogues of 5-FU, such as 5-fluoro-2-dcoxyuridinc (5-FUdr) may also be used in the compositions (see page 2, line 32). The compositions are demonstrated to treat cancers, including cancers of the breast and colon, and they are shown to have increased anticancer efficacy compared to 5-FU/FA compositions which do not have cyclodextrin present. It is disclosed in the reference that the “therapeutically effective dose level for any particular patient will depend upon a variety of factors including: the cancer being treated and the severity of the cancer, the age, body weight, general health, sex and diet of the patient, the time of administration, the route of administration, the duration of the treatment, drugs used in combination or coincidental with the treatment, together with other related factors well known in medicine.” See page 16, lines 28-33. It is also disclosed that methods of treatment according to the invention may be applied in conjugation with conventional therapy, such as radiotherapy or chemotherapy. See page 19, lines 1-3.
WO 2008/106721 A1 does not disclose that the above compositions can be used specifically to treat and/or prevent a cancer of the brain and/or central nervous system in a subject in need thereof.
Wright et al. (see abstract; table 2; p. 1626, col. 1, par 2) shows that the administration of i.v. bolus 5-FU for treatment of recurrent ependymoma in children is well tolerated and possesses antitumor activity.
Wright et al. does not disclose a composition comprising (i) 5-FU, a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable analogue thereof; (ii) folinic acid, or a pharmaceutically acceptable salt thereof; and (iii) a cyclodextrin, or a pharmaceutically acceptable salt thereof.
Since it is known in the art that 5-FU can be used for the treatment of ependymoma and WO 2008/106721 A1 discloses that the injectable aqueous solutions comprising (i) 5-FU, (ii) folinic acid, or a pharmaceutically acceptable salt thereof and (iii) a cyclodextrin, or a pharmaceutically acceptable salt thereof can be used to treat various types of cancer, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to use an injectable aqueous solution disclosed in WO 2008/106721 A1 in a method of treating and/or preventing a cancer of the brain, such as ependymoma, and/or central nervous system in a subject in need thereof and to arrive at the method of the instant claims with a reasonable expectation of success. The motivation would have been to find additional cancers which can be treated or prevented (e.g., secondary tumors can spread to the brain from other parts of the body) using the compositions disclosed in WO 2008/106721 A1.
Thus, a prima facie case of obviousness has been established.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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