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
Pursuant to the preliminary amendment dated 2/14/2024, claim 2-8, 10-11, 13, 15-16, 19-22, 28, 32-34, 36, 38-45, 47-60, 62, 63, 65-74 and 76-81 are cancelled and claims 12, 14, 17, 23, 26, 29, 31, 37, 46 and 61 are amended. No claims are newly added.
Claims 1, 9, 12, 14, 17, 18, 23-27, 29-31, 35, 37, 46, 61, 64 and 75 are pending in the instant application and are examined on the merits herein.
Priority
The application claims benefit to provisional application US 63/435530 filed on 12/27/2022.
Information Disclosure Statement
The information disclosure statements (IDS) dated 3/26/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claims 12, 14, 17 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 64 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmeide et al. (WO 2009/056983A1, PTO-892).
Holmeide exemplifies the following chemical synthesis for preparing “PRB-2 MG”: (¶0130-0134)
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Accordingly, the instant claims are anticipated by the prior art.
Claim Rejections - 35 USC § 103
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 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 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.
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.
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, 9 and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Fensterbank et al. (J. Chem. Soc. Perkin I, 1999, PTO-892).
Fensterbank discloses a compound of formula 10 and a process for preparing compound 10 as follows: (Scheme 2)
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Fensterbank also discloses that owing to their remarkable properties, cyclam and its derivatives have received considerable attention as selective complexation agents. (p. 811, Col. 1)
Fensterbank does not teach a compound meeting the instant limitation that R5 is a C4-C25 alkyl group.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the propenyl (C3) group of Fensterbank to be a group of similar structure, such as a butenyl (C4) or pentenyl (C5), thereby arriving at the instant limitation of R5=C4-C25 alkyl group. The rationale to support a case of prima facie obviousness is that compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also MPEP § 2144.09.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 23-27, 29-31, 35, 37, 46 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Fensterbank et al. (J. Chem. Soc. Perkin I, 1999, PTO-892), in view of Oupicky et al. (US 2014/0243397A1, PTO-892).
The disclosure of Fensterbank is referenced as discussed above. Fensterbank does not teach a pharmaceutical composition comprising carriers, nucleic acids or a method for delivery of nucleic acids or a method of treating a disease.
Oupicky teaches that cyclams are used in pharmaceutical compositions comprising carriers and excipients, such as lipids, for use as a nucleic acid (i.e. DNA, shRNA, siRNA or microRNA) delivery agent, in methods of treating cancer. (¶0098-0099, 0134-0148)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the cyclam derivative of Fensterbank could be used within the scope of teachings of Oupicky, thereby arriving at the instant invention. One would expect that the cyclam derivative of Fensterbank, taught as effective for chelating other compounds, would function equivalently to the cyclam of Oupicky, for chelation and delivery of nucleic acids. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. 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 Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/DALE R MILLER/Primary Examiner, Art Unit 1693
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