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 .
Election/Restrictions
Applicant’s election without traverse of 1-11 in the reply filed on 7/23/26 is acknowledged. The claims that read on the elected species are 1-4. 6 and 9-11.
Claims 5, 7-8 and 12-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/23/26
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 6/3/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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)(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(s) 1-4, 6 and 11 is/are rejected under 35 U.S.C. 102(a2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Clevland et al. (WO 2021/113651).
With regards to instant claim 1 Cleland teaches dendrimers useful as nano carriers i.e., nano formulations (see pg. 18 lines 10-15) comprising a poly(amidoamine) (PAMAM) dendrimer conjugated to an active agent (see abstract) wherein the active agent is an anti-inflammatory agent- metformin (see pg. 67, lines 14-15) wherein the PAMAM dendrimer generation 4 PAMAM (as required by instant claims 2-3) wherein the linker is a carbamate bond (see pg. 17, lines 25+, as required by instant claim 6). With regards to instant claim 11, Cleland teaches the composition exist in a pharmaceutically acceptable carrier (see pg. 13, lines 14+)..
Therefore the claims are anticipated or in the alternative obvious at the time the invention was made as it would have been anticipated or obvious to have the nanoparticle comprising a PAMAM dendrimer generation 4 conjugated to an active agent metformin with a reasonable expectation of success.
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 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.
Claim(s) 1-4 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cleland et al. (WO 2021/113651) in view of Cleland et al. ( US 2021/0170040) .
Cleland ’651 is applied here as above. However fails to teach instant claim 9. Leland ‘040 With regards to instant claim 1 teaches dendrimers useful as nano carriers i.e., nano formulations (see 0070) comprising a poly(amidoamine) (PAMAM) dendrimer conjugated to an active agent (see abstract) wherein the active agent is an anti-inflammatory agent- metformin (see para 0227) wherein the PAMAM dendrimer generation 4 PAMAM (as required by instant claims 2-3, see abstract) wherein the linker is a carbamate bond (see 0067, 0083, as required by instant claim 6). With regards to instant claim 11, Cleland teaches the composition exist in a pharmaceutically acceptable carrier (see 0052).
However fails to teach as required by instant claims 9-10. Nonetheless teaches the nanoparticle comprises
PNG
media_image1.png
118
99
media_image1.png
Greyscale
wherein A is as shown above.
Although Cleland did not per se teach specifically the A conjugated to metformin as represented by claims 9-10. Nonetheless based on the teaching that the conjugated PAMAM dendrimer generation 4 PAMAM is capable of conjugating with, and active metformin as illustrated by the Figs 13B-15C.
Therefore it would have been obvious to one of ordinary skill in the art to have substituted polyethylene glycol with a carbamate bond with a reasonable expectation of success because the reference teaches so. And the expectation that the prior art elements will perform their expected functions to achieve the expected result.
No claims are 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 M-F 9am-6pm.
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, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 9/8/26
Prosecution Insights