Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The office acknowledges Applicants filing of the response on 6/18/2026 in regards to the restriction election requirement mailed on 01/09/2026. Claims 1-12 have been canceled and new claims 13-18 have been added. The pending claims 13-18 are examined based on the merits herein.
Application Priority
This application filed 05/07/2024 is a Continuation of 18081390, filed 12/14/2022, 18081390 is a Continuation of 16842023, filed 04/07/2020, 16842023 is a Continuation of 15151601, filed 05/11/2016, now U.S. 10646468, 15151601 is a Divisional of 13816804, filed 02/13/2013, now U.S. 9365514, 13816804 is a National Stage entry of PCT/JP2011/068735, International Filing Date: 08/19/2011, claims foreign priority to 2010-185385, filed 08/20/2010.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 5/7/2024, 12/27/2024, 3/7/2025, 7/1/2025, 10/6/2025, 10/22/2025 and 5/27/2036 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 13-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wadai Kinoshita et al. (IDS: WO 2010/143664, filing date: June 09 2010, see AU2010259588 for English translation) in view of Shiozawa et al. (WO1992009275A1, see English translation)
Wadai Kinoshita teachings are to tetracyclic compounds, its salts, including hydrochloride salt (see abstract, p 73, lines 13-14).
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The reference is explicit in teaching the compound as instantly claimed
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Also see claim 6, p 655, lines 27-28,
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The reference teaches formulation of the pharmaceutical composition comprising the compound(s), a pharmaceutically acceptable carrier (See Abstract, p 103, lines 15-25) for oral use, e.g. tablets (p 104, lines 14-15), the stabilizing agent include dehydroacetic acid (see p 105, lines 2-5) and its use as an ALK inhibitor (p 104, line 8).
Wadai Kinoshita is not explicit in teaching the dissolution aid in the composition.
Shiozawa disclose developing a pharmaceutical preparation having excellent dissolution properties and a bitterness-masking action (p 2, lines 11-12). The reference teaches quick release coated preparation comprising pharmaceutical actives and surfactants (abstract). The reference is explicit in teaching using polyoxyethylene-polypropylene glycol, e.g. polyoxyethylene [160] polyoxypropylene [30] glycol (See p 3, lines 2, 7). It is further taught that the coated preparation of the present invention can be used as tablets and powders (p 6, line 13).
From Shiozawa a skilled artisan before the effective filing date of the invention would have found it obvious to use polyoxyethylene-polypropylene glycol surfactant, e.g. polyoxyethylene [160] polyoxypropylene [30] glycol in the composition comprising the tetracyclic compound of Wadai Kinoshita. A skilled artisan would have been motivated to add polyoxyethylene-polypropylene glycol surfactant with a reasonable expectation of success and to prepare coated tablets (for oral administration) having excellent dissolution properties and a bitterness-masking action. A skilled artisan would have been motivated to arrive at the claimed composition for therapeutic use as an ALK inhibitor. Thus claims 13-15 are addressed. As to claims 16-17, Wadai Kinoshita teaches salts of the tetracyclic compounds, including the hydrochloride salt. A person skilled in the art would have found it obvious to use the pharmaceutical salt of the compound of claim 13 with a reasonable amount of success and to improve dissolution and solubility. As to claim 18, Wadai Kinoshita teaches using stabilizing agents such as dehydroacetic acid in the pharmaceutical composition. It is noted that the claimed sodium dehydroacetate is the sodium salt of dehydroacetic acid. Hence a skilled artisan would have found it obvious to use the salt version to obtain similar or better stabilizing effects.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 13-17 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of U.S. 9365514 (‘514) or claims 1-16 of US 11433076 (‘076) or claims 1-24 of US 10350214 (’214) in view of Ohkouchi et al. (CA 2374760)
The instant claims are directed to:
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Claim 14 is limited to specific polymers, claim 15 to an oral administrable formulation, claims 16-17 are to salts of the compound of claim 13, 17 in particular to hydrochloride salt. Claim 18 is further comprises selective additives in the formulation.
‘514 reference claims are directed to a composition comprising a substance which is 9-Ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile or a salt thereof, a pharmaceutically acceptable carrier, and a dissolution aid, wherein the dissolution aid is sodium lauryl sulfate. Claim 2 is to an oral administrable formulation, claim 3 further comprising select organic polymers and claim 4 is to the water solubility of the substance.
‘076 reference claims are directed to a composition of the compound is 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b] carbazole-3-carbonitrile, including its hydrochloride salt. The dependent claims are limited to density, granule particle size, addition of disintegrating agents, solubilizing agent, sodium lauryl sulfate, binder, per unit formulation.
‘214 reference claims are directed to a pharmaceutical formulation comprising (i) a granule containing a compound, 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b] carbazole-3-carbonitrile or a salt thereof. The dependent claims are limited to specific amount of carmellose calcium disintegration agent, solubilizing agent, sodium lauryl sulfate, binder, mean granule particle diameter and a method of producing the formulation.
‘514 or ‘076 or ‘214 do not teach the specific polyoxyethylene polyoxypropylene block polymer in the composition.
Ohkouchi teach polyoxyethylene [160] polyoxypropylene [30] glycol and sodium lauryl sulfate are surfactants that are useful in the preparation of quickly disintegrating solids comprising active pharmaceutical agents (See p 23, lines 2-5).
A skilled artisan would have found it obvious to use one surfactant for another for e.g. sodium lauryl sulfate for polyoxyethylene polyoxypropylene polymer from Ohkouchi’s teachings in expectation of achieving reasonable amount of success. It is noted that the same agent can function as a surfactant or a solubilizer or a dissolution aid. Thus claims 13-14 would have been obvious over 514 reference claims and Ohkouchi. Claim 15 is addressed by the reference claim 2 and the prior art teachings. As to claims 16-17, it is within the skill of an artisan to use the salt of the compound, e.g. HCl salt in the composition in expectation of achieving similar or better solubility effects.
Claim 18 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of U.S. 9365514 (‘514) or claims 1-16 of US 11433076 (‘076) or claims 1-24 of US 10350214 (’214) in view of Shiozawa (WO1992009275) and further in view of Wadai Kinoshita et al. (IDS: WO 2010/143664, filing date: June 09 2010, see AU2010259588 for English translation)
The instant claims as above.
The reference claims ‘514, ‘076, ‘214 and the prior art teachings as above.
The above rejection is incorporated herein.
The reference claims and the cited art is not explicit in teaching the additive as in claim 18.
Wadai Kinoshita et al. teachings as discussed above.
As to claim 18, Wadai Kinoshita teaches using stabilizing agents such as dehydroacetic acid in the pharmaceutical composition. It is noted that the claimed sodium dehydroacetate is the sodium salt of dehydroacetic acid. Hence a skilled artisan would have found it obvious to use the salt version to obtain similar or better stabilizing effects.
Claims 13-17 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of US 10646468 (‘468) in view of Shiozawa et al. (WO1992009275A1, see English translation).
The instant claims as above.
‘468 reference claims are directed to a composition comprising 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile, or a salt thereof, a pharmaceutically acceptable carrier, and a dissolution aid selected from specific agents, claim 2 further comprising select organic polymers, claim 3 is to the water solubility of the substance and claim 4 is to an oral administrable formulation.
‘468 do not teach the specific polyoxyethylene polyoxypropylene block polymer in the composition.
Shiozawa et al. as above.
From Shiozawa a skilled artisan before the effective filing date of the invention would have found it obvious to use polyoxyethylene-polypropylene glycol surfactant, e.g. polyoxyethylene [160] polyoxypropylene [30] glycol in the composition comprising the tetracyclic compound of the reference claims. A skilled artisan would have been motivated to add polyoxyethylene-polypropylene glycol surfactant with a reasonable expectation of success and to prepare coated tablets (for oral administration) having excellent dissolution properties and a bitterness-masking action. Thus claims 13-14 would have been obvious over the reference claims and the prior art. Claims 15-16 would have been obvious over the reference claims 1, 2 and 4 and the prior art. As to claim 17, it is within the skill of an artisan to HCl salt of the compound in the composition because it is well known in the art to make HCl salt and in expectation of achieving similar or better solubility effects.
Claim 18 is rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-4 of US 10646468 (‘468) in view of Shiozawa et al. (WO1992009275A1, see English translation) and further in view of Wadai Kinoshita et al. (IDS: WO 2010/143664, filing date: June 09 2010, see AU2010259588 for English translation)
The instant claims as above.
The reference claims and the prior art teachings as above.
The above rejection is incorporated herein.
The reference claims and the cited art is not explicit in teaching the additive as in claim 18.
Wadai Kinoshita et al. teachings as discussed above.
As to claim 18, Wadai Kinoshita teaches using stabilizing agents such as dehydroacetic acid in the pharmaceutical composition. It is noted that the claimed sodium dehydroacetate is the sodium salt of dehydroacetic acid. Hence a skilled artisan would have found it obvious to use the salt version to obtain similar or better stabilizing effects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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