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 .
Priority
This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/IB2021/060071, filed 10/30/2021, which claims the priority benefit of INDIA Application No. 202041032697, filed 10/30/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/12/2024, 03/14/2024, and 03/21/2024 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of the Application
Claims 1-16 are pending and are currently under examination.
Specification
The use of the terms Taxol and Taxotere, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 13 and 16 are objected to because of the following informalities: the repeated phrase “water for injection” appears twice in claim 13, line 2 and claim 16, line 2. Appropriate correction is required.
Claims 3 and 8 are objected to because of the following informalities: the term –or—appears to be missing before the word prochlorperazine in claims 3 and 8 line 2. Appropriate correction is required.
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 4, 6, 9, 13 and 16 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.
The term “like” in claim 4, line 3 and claim 9, line 2 is a relative term which renders the claim indefinite. The term “like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A skilled artisan would be unable to determine which excipients applicant intends as the claim is currently written.
This rejection can be overcome by amending the claim to read which excipients or surfactants are required by the claim.
The term “associated” in claim 4, line 2 and claim 9, line 2 is a relative term which renders the claim indefinite. The term “associated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The skilled artisan would be unable to determine if reducing the hypersensitivity reactions is limited to the patient or if it also extends to a caregiver preparing the cabazitaxel composition as the claims are currently written.
This rejection may be overcome by amending the claim language to reflect which hypersensitivity reactions are caused by which excipients.
The term “improving” in claim 6, line 1 is a relative term which renders the claim indefinite. The term “improving” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant fails to establish what the term “improving” is referring to in the instant claims with such specificity to allow a skilled artisan to determine what the alleged improvement is relative to.
Regarding claims 13 and 16, the phrase "and the like" renders the claims indefinite because the claims include elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claims unascertainable. See MPEP § 2173.05(d).
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, claims 13 and 16 recite the broad recitation sulfurous acid salts and parabens, and the claims also recite “(bisulfite, metabisulfite)” and “(methyl, propyl, butyl)”as a limitations which is the narrower statement of the range/limitation. The claims 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.
This rejection may be overcome by amending the claims to establish whether sulfurous acid salts and parabens mentioned in the claims are limited to the compounds named in the claims.
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.
(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.
Claims 1-3 and 6-8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bissery (US 2014/0056996 Al).
Bissery teaches an IV infusion dose regimen of cabazitaxel wherein premedication’s including antihistamines are administered by IV 30 minutes before the administration of cabazitaxel [0150]. Bissery further describes the solvent for cabazitaxel as a 13% methanol solution in water for injection [0145]. The teachings of Bissery anticipate the limitations of the instant claims where a patient is administered cabazitaxel in an aqueous composition after a premedication therapy
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 of this title, 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bissery (US 2014/0056996 Al) in view of Gupta (US 10,583,110 B2).
The instant claims are directed to a method of treatment in a patient by administering an aqueous composition of cabazitaxel and excipients after a premedication therapy free from antihistamines of dexchlorpheniramine, diphenhydramine, and prochlorperazine has been administered.
Bissery et al. teach an IV infusion dose regimen of cabazitaxel wherein premedication’s including antihistamines are administered by IV 30 minutes before the administration of cabazitaxel [0150]. Bissery discloses cabazitaxel supplied in a solution wherein an excipient is polysorbate 80 [0144]. Bissery further describes the solvent for cabazitaxel as a 13% methanol solution in water for injection [0145]. Bissery also teaches cabazitaxel may be administered parenterally, such as via intravenous administration and that a galenical form of cabazitaxel is suitable for administration by intravenous infusion in which the cabazitaxel is dissolved in water in the presence of excipients chosen from surfactants, cosolvents, glucose or sodium chloride [0019].
However, Bissery et al. fail to disclose the specific antihistamines of dexchlorpheniramine, diphenhydramine, prochlorperazine.
Gupta et al. teach the administration of cabazitaxel as a medication for the treatment of prostate cancer (Abstract). Gupta also teaches “used to prevent hypersensitivity to the cabazitaxel treatment include antihistamines, such as dexchloropheniramine (for example 5 mg), and diphenhydramine (for example 25 mg) or equivalent antihistamines; and corticosteroids, such as dexamethasone (for example 8 mg) or an equivalent steroid.” (sic) (col. 7, lines 1-6).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the instant application, to apply the teachings of Bissery of an aqueous composition of cabazitaxel with polysorbate 80 and ensuring any premedication including antihistamines occurs 30 minutes before administering cabazitaxel with the antihistamines of dexchlorpheniramine and diphenhydramine as disclosed by Gupta because a person of ordinary skill would have a reasonable expectation of success that doing so would avoid hypersensitivity in a patient in need of cabazitaxel. See MPEP 2144.05(II).
A person of ordinary skill in the art would have been motivated to avoid a hypersensitivity reaction by administering a premedication therapy 30 minutes prior to administering cabazitaxel to a patient in need thereof to avoid a hypersensitivity reaction when administering an aqueous composition of cabazitaxel by following the teachings of Bissery and Gupta. See MPEP 21444.06 and MPEP 2112.01.
Conclusion
All claims are rejected, no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNESTO VALLE JR whose telephone number is (703)756-5356. The examiner can normally be reached 0730-1700 M-F EST, 1st Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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