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 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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 32-35, 37-38 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Keer et al (UIS 2020/085848).
Keer et al discloses discloses the use of of (i) a cytidine deaminase (CDA) substrate drug (5-azacytidine (claim 21) or decitabine) and (ii) cedazuridine in the treatment of cancer (claim 1). The administering is preferably performed in one composition (claim 10). The pharmaceutical compositions may be formulated for sustained or controlled release ([073]), which are both controlled released formulations.
Where selection of one named species from a list of alternatives is all that is required to arrive at the instantly claimed subject matter, that species is anticipated. Ex Parte A., 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). See also In re Sivaramakrishnan, 213 USPQ 441 (CCPA 1982). Here, the release profiles is for the active is selected from a list of three alternatives, therefore all combinations of the immediately envisions and the three are considered anticipatory.
The compositions are preferably used in the treatment of leukemia, MDS, AML, CML
(see claims 1-6 or [0048]).
The compositions of the invention may be administered with further chemotherapeutic agents ([065]-[067]), i.a. cisplatin, doxorubicin.
Claim Rejections - 35 USC § 103
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.
Claims 1-38 are rejected under 35 U.S.C. 103 as being unpatentable over Keer et al (UIS 2020/085848) in view of Sands et al (US 2004/0162263) and Aleksandar et al (2015). Mini-tablets: a contemporary system for oral drug delivery in targeted patient groups. Expert Opinion on Drug Delivery, 12(1), 65–84).
Keer et al is discussed above and further teaches soft and hard gelatin capsules (paragraph 73).
One of ordinary skill in the art would understand that the capsules can be used an be smaller in size, but does not teach the specific components of the mini-capsules instantly claimed.
Sands et al teaches oral formulations of cytidine analogs, such as 5-azacytidine (¶ 12), with dillutents such as lactose monohydrate (¶ 57), retention enhancing excipients such as HPMC (¶ 120), and enteric coatings based on methacrylic acid which release based on a given pH threshold (¶ 97). The tablets are formed with active and filler, then seal coated with HPMC, and sealed with the enteric coating (¶¶ 322-326). The amount of active in the tablets is preferably between 0.1-20wt% of the entire tablet (¶ 41).
Aleksandar et al teaches mini-tablets were a known oral drug delivery system with improved benefits for overcoming therapeutic obstacles and use as multiple units modified release systems (Introduction).
It would have been obvious to one of ordinary skill in the art to modify the combined dosage form of Keer et al to include mini-tablets of Aleksandar et al, given their ability to improve multiple units modified release systems. It would then have been obvious to formulate the mini-tablets using known excipients, such as taught by Sands et al and to vary the amount of each excipient based on its disclosed function.
The dosage forms made obvious would be expected to be suitable for treatment of known conditions, such as disclosed by the references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
Prosecution Insights