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
Receipt is acknowledged of the Information Disclosure Statement filed 9/6/24; 3/7/25 and 10/22/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Status of Claims
Claims 1-7 are pending and under examination in this office action.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita et al. (US 9,126,931)
With regards to instant claim 1, Kinoshita et al. teach a compound represented by formula
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see compound FR4, col. 449,lines 26 +) in a crystalline form.
However Kinoshita et al. fail to teach the specific process, nonetheless teaches the process of preparing in as much to result in the claimed compound (see col. 428, lines 13+) It would have been obvious to one of ordinary skill in the art to have formed the crystalline with a reasonable expectation of success by practice the method with modification to result in the claimed process..
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 - 7 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 16 of U.S. Patent 11,433,076, 10,350,214 (claims 1-24). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
Both sets of claims recite the same compound ie., 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride (see patented claim 14) wherein when the patented specification is used as a dictionary it describes the compound is a crystal (see Fig. I) wherein the process involves adding the compound represented by formula (I) drop wise in a solution mixture of ethanol and hydrochloric acid (containing 1 mole equivalent or more of hydrochloric acid to the compound and prepares as recited in col. 28, lines 62+.
Thus, the process of making is a set of precursor of the patented claims and therefore are part of the obvious variation of the instant claims.
In view of the foregoing, the patented claims and the current application claims are obvious variations
Claim 1 -7 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 4 of U.S. Patent 10,774,0067. although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
Both sets of claims refer to the same compound having the structure as
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or the compound name as 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride. Per Examiners interpretation no distinguishing factor between the name and the patented claimed compound. The method of preparing, when the specification was used as a dictionary, it teaches the process recited by the instant claims. Therefore one of ordinary skill in the art would have been motivated to use the process taught by the specification of the instant to practice the instant claimed method
. Thus, the process of making is a set of precursor of the patented claims and therefore are part of the obvious variation of the instant claims. In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claim 1 -7 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 9 of U.S. Patent 11, 098,037. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The claims of the patent are directed to the process for preparing Alectinib hydrochloride, comprising the steps of: a) contacting Alectinib with a solvent selected from alcohols, halogenated solvents, and mixtures thereof; b) adding hydrochloric acid to the reaction mixture of step a); and c) isolating Alectinib hydrochloride
The claims of the instant are directed to a process of making a form III crystal of 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile, comprising adding a solution containing 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile dropwise to a liquid mixture of ethanol and hydrochloric acid, which contains 1 molar equivalent or more of hydrochloric acid relative to the 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile
When one of ordinary skill in the art considers the patented specification col. 22, teaches the preparation of alectinib having the same chemical name with that of the instant claim, therefore one of ordinary skill in the art would have been motivated to practice the preparation to result in the instant claims.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claim 1 -7 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 13 of U.S. Patent 11, 939,322. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
The patented claims are to a method of manufacturing
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. The method of manufacturing can reasonable result in the claimed compound. Once the compound is the same and the process of manufacturing because the patentability of the product does not depend on its method of production.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached on M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615
6/91/26
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