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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/10/23, 9/13/24, 1/7/25 were submitted in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Tomimatsu et al (US 10,350,214 hereafter Tomimatsu).
Tomimatsu teaches a pharmaceutical composition comprising at least 60 mg of the compound alectinib in free from as a daily dose (col. 5, lin. 50-55, claim 15). The formulation is oral (col. 7, lin. 55-65). Regarding the intended patient population and conditions treated, it is the position of the Examiner that such limitations are merely future intended uses for the pharmaceutical composition and do not distinguish over the prior art. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). The claims are drawn to a pharmaceutical composition comprising a range of a drug in an oral form. The prior art discloses the same compound in the same range, in the same form. The future intended purpose of the drug and to whom said drug formulation is administered is irrelevant to the patentability of the pharmaceutical composition claims. The claims are drawn to a composition and a composition is defined by its compositional components. These compositional components are taught by the prior art. Even if it were relevant, Tomimatsu is known to treat genetic ALK abnormalities that that manifest as cancers that metastasize (col. 1, lin. 21-35). These disclosures render the claims anticipated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618