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.
Claims 2 and 4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation at least one G4 stabilizer selected from a group consisting of…, and the claim also recites preferably the G4 stabilizer is Pyridostatin which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 recites the broad recitation, the at least on histone deacetylase inhibitor is selected from a group consisting of…, and the claims also recites, preferably the histone deacetylase inhibitor is Panobinostat which is the narrower statement of the range/limitation.
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, 2, 9, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shammas et al. (Molecular Cancer Therapeutics, 2003).
Shammas et al. disclose a G-quadruplex (G4) stabilizer as a potential therapeutic for treating multiple myeloma. The compound taught is tetra(N-methyl-4-pyridyl)-porphyrin chloride (TMPγP4). Claims 9 and 10 are drawn to compositions, therefore the diagnosis of an individual as have a poor outcome, and the method for determining a poor outcome has not been given much patentable weight. As such, the instant claims are anticipated by the teaching of Shammas et al.
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) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shammas et al. in view of Schneekloth, Jr. et al. (US 10,604,499).
The instant claims further limit the composition of claims 1 to the inclusion of at least one nitrogen mustard.
Shammas et al. do not teach nitrogen mustards in there therapeutic for treating multiple myeloma; however, Schneekloth, Jr. et al. teach that G4-stabilizing molecules are useful in treating several types of cancer, including lymphoma and multiple myeloma (abstract; col. 11, lines 8-17). The reference further teaches additional chemotherapeutic agents that may be used as a combination therapy with the G4-stabilizing compounds, including nitrogen mustards, e.g., ifosfamide, chlorambucil, chlormethine, cyclophosphamide, and melphalan (col. 32, lines 42-60).
The instant claims are rendered obvious by the combined reference teachings, since Schneekloth, Jr. et al. that the G4-stabilizers can be used in combination with other therapeutics, such as nitrogen mustards, to treat cancer, including, inter alia, multiple myeloma. A person having ordinary skill in the art would have been able to incorporate such teachings into the therapeutic taught by Shammas et al. for treating multiple myeloma, with the reasonable intention of increasing the efficacy of treating such cancer.
Claims 3, 5, and 6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692
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