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 .
Restriction
Applicant’s election with traverse of Species I in the reply filed on 4/16/2026 is acknowledged. The reasoning for Applicant’s traversal is that there would be no serious search burden if the species were examined together. As Applicant has not provided an explanation or reasoning for this statement, applicant’s arguments are not found persuasive.
Notes and Comments
Applicant’s arguments, filed 10/25/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Claim 11 is allowable, as previously indicated.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2 and 17-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The application does not have support for the limitation
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This limitation does not appear in the original application, neither expressly or implicitly.
Applicant’s arguments have been full considered but are not found persuasive. Applicant argues that the application provides an extensive list of A’s which are distinct from BC’s provided at paragraph 214 and Examples 1-3 that describes in each instance the synthesis of compounds where chemically reactive moiety “A” and “BC-solid lines” are different. There is no disclosure in the application to that would allow the artisan to believe that applicant had contemplated the specific genus of
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Although the application recites some examples of A wherein those examples do not fall under the scope of
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, the few examples provided do not represent the very large genus of
“a biologically active group or chemically reactive moiety” wherein A is not
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, which is a vast genus representing a myriad of biologically active groups or chemically moieties. The few examples presented in the application are not representative of this vast genus, and for this reason the artisan would not accept that applicant had envisioned the scope of “a biologically active group or chemically reactive moiety” except where the biologically active group or chemically reactive moiety has the above structure.
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.
Claims 2 and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over US20080020043 to Gingras. Gingris teaches a dendrimer conjugate comprising a central core having the following structure:
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Where each sphere may be:
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(Compound 25; Figure 9). This reads on applicant’s compound as follows:
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The encircled moiety corresponds to applicant’s A ~~ BC where the squiggly line is PEG with
3 discrete ethylene oxide residues terminating in a carboxylate group or a NH2 moiety (wherein A is a NH2) (paragraph 62). Each other arm corresponds to applicant’s ~~ BC= where each PEG with 4 discrete ethylene oxide residues corresponds to applicant’s squiggly line and each phenyl moiety corresponds to applicant’s BC. A is a NH2 moiety, as shown below
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Which is not
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The difference between the above structure and applicant’s structure is that in applicant’s structure, there are eight to seventy-two terminal ethylene oxide residues represented by the black line, wherein in the above structure, there are four terminal ethylene glycol residues.
It would have been obvious to one of skill in the art at the time the invention was made to optimize the number of terminal ethylene glycol residues, and in this way, would find the range of 4 to 12 ethylene oxide groups and 8 to 24 ethylene oxide groups through routine experimentation. The motivation for this is to improve the efficacy of the formulation. “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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 reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977) (MPEP 2144.09, II). “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).” (MPEP 2144.09, I).
Applicant’s arguments have been fully considered but are not found persuasive.
Regarding applicant’s argument that the references does not satisfy
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, the examiner’s response is that it does satisfy the above, as A is NH2.
Conclusion
Applicants’ amendment has necessitated the new grounds of rejection. THIS ACTION IS THEREFORE MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
June 24, 2026
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