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 § 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.
Claim 41 is 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 41, the phrase "for example" (e.g.) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-3, 21, 34, 35, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 9,745,314).
Wang et al. disclose MDM2 inhibitors and methods of treating diseases and conditions wherein inhibition of an interaction between p53 and MDM2 provides a benefit (abstract). The reference discloses the same compounds (MDM2 inhibitors) recited in the instant claims, and teaches that the compounds can be used to treat diseases, including, inter alia, acute myeloid leukemia, multiple myeloma, and myelodysplastic syndrome. The MDM2 inhibitors disclosed by Wang et al. may be administered with a second therapeutic agent, together as a single dose or separately as multi-unit doses. The MDM2 inhibitor, in particular, may be administered in an amount of about 0.005 to about 500 mg per dose (col. 3, line 45 to col. 7, line 35; col. 19 to col.23).
The second therapeutic agent, which may be an anti-cancer agent, includes alkylating agents, anti-tumor antibiotics, anti-inflammatory drugs, anti-metabolites, and adoptive immunotherapy agents. The reference expressly mentions dexamethasone, an anti-inflammatory drug, and cytarabine, and anti-metabolite (col. 27 to col. 28). This disclosure anticipates the instant claims.
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.
Claim(s) 5, 18, 19, 22-24, 26, 29, 30, 33, 36, 41, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 9,745,314).
The instant claims further limit the treatment method recited by the instant claims to a specific AML-MCR or MDS disease, wherein the disease or treatment has relapsed, to a combination of the compound of formula I with specific secondary therapeutics, such as 5-azacitidine, pomalidomide, thalidomide, or lenalidomide, and to specific doses and treatment cycles.
The specific compounds mentioned above are not expressly mentioned by Wang et al., however, the compounds are known alkylating agents, and/or immunomodulating agents useful in anti-cancer treatments. Since Wang et al. teach that such classes of compounds may be combined with the MDM2 inhibitors taught therein, a person having ordinary skill in the art would have found it obvious to use known compounds, such as those recited herein, in the combination therapy suggested by Wang et al.
With regard to specific doses and treatment cycles recited in the claims, such parameters are found to be obvious absent unexpected results, as an artisan, e.g., a skilled physician, would base treatment cycles, doses, etc., based on the type of disease being treated, the stage or level of disease, patient body size, tolerance to the drugs, etc. Therefore, the instant claims are found to be obvious in view of the teaching of Wang et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692
Prosecution Insights