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 .
DETAILED ACTION
Claims 1-17 are currently pending in the instant application. Claims 1-4, 6, 7 and 9-17 are rejected and claims 5 and 8 are objected in this Office Action.
I. Priority
The instant application claims benefit of US Provisional Application 63/524,863, filed on July 4, 2023.
II. Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 27, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
III. Rejections
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that 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 section102 of this title, 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 negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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 1-4, 6, 7 and 9-17 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Wolfgang, et al. (US 20131096946 A1). Applicants claim
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896
590
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The Scope and Content of the Prior Art (MPEP §2141.01)
Wolfgang, et al. teaches cyclodextrin-based polymers for therapeutic delivery. The prior art further teaches that another approach to the drug delivery problem is using “host/guest inclusion complexes between the therapeutic agent and cyclodextrins or derivatives thereof (see paragraph 0003). The prior art teaches that in a preferred embodiment, that CDP-cabazitaxel conjugate includes an inclusion complex between a taxane (e.g. cabazitaxel), attached or conjugated to the CDP, e.g., via a covalent linkage or via a linker such as a linker described herein and another molecule in the CDP (see paragraph 0007). The prior art teaches the species
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302
455
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wherein
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31
65
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is
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47
126
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and R1 is an optionally substituted straight alkyl chain (see example 28) and then also teaches
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327
649
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(see example 30).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Wolfgang, et al. and the instant invention is that the prior art broadly teaches that the CDP-cabazitaxel conjugate includes an inclusion complex between a taxane (e.g. cabazitaxel), attached or conjugated to the CDP, e.g., via a covalent linkage or via a linker such as a linker described herein and another molecule in the CDP.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
The prior art broadly teaches an inclusion complex comprising a carbazitaxel prodrug of formula I and a cyclodextrin which is included in the invention of a CDP-cabazitaxel conjugate. For example, it is obvious for one of ordinary skill in the art to prepare an inclusion complex comprising a CDP-cabazitaxel conjugate taught by the prior art with a reasonable expectation of success. The prior art teaches that cyclodextrins have unique physico-chemical properties such as good water solubility, low toxicity and low immune response and that when cyclodextrins form host/guest inclusion complexes with therapeutic molecules they alter the physical, chemical and/or biological properties of these guest molecules (see paragraph 0003). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare an inclusion complex comprising a CDP-cabazitaxel conjugate based on the teachings of the preferred embodiments in the prior art. A strong prima facie obviousness has been established.
IV. Objections
Dependent Claim Objections
Dependent Claims 5 and 8 are objected to as being dependent upon a rejected based claim. To overcome this objection, Applicant should rewrite said claims in an independent form and include the limitations of the base claim and any intervening claim.
V. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/ Primary Examiner, Art Unit 1626
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