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
Applicant’s arguments, filed 7/28/2025, have been fully considered but they are not deemed to be fully persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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, 11, 17-20 and 22 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. There is insufficient written description for “wherein the terminal moiety and A have orthogonal reactivity” as it appears in claim 2. The term “orthogonal reactivity”
has more than one meaning in chemistry, with its definition broadening over time. It evolved from a specific concept for protecting groups into a general principle for designing complex chemical systems. Some practioners use the term to refer to different functional groups on a single molecule that are protected by different protecting groups, each protecting group can be removed independently under a unique set of reaction conditions without affecting the others, while others use the term to refer to two or more distinct chemical reactions can be performed simultaneously without one interfering with the other. The reactive partners in one reaction are completely unreactive towards the partners in the other, allowing for multiple selective bond-forming events, while still others use the term to refer to chemical reactions can be performed inside a living organism without disrupting native biochemical processes. As there is no universally art recognized meaning for this term, and as the application has to given a definition for what the term means within the context of the present invention, except for the recitation of the term “orthogonal” in the application (pages 12, 15, 36, and 74 of the as-filed application), there is no definition provided in the application of this term or description of what species fall under this term. Further, there is no disclosure in the as-filed application that A and the terminal moiety specifically have orthogonal reactivity. For these reasons, the artisan would not accept that applicant had possession of the invention at the time of filing.
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 2, 17-20 and 22 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 recitation in claim 2 “wherein the terminal moiety and A have orthogonal reactivity” is unclear. The term “orthogonal reactivity.” There is more than one meaning of “orthogonal reactivity” in chemistry, with its definition broadening over time. It evolved from a specific concept for protecting groups into a general principle for designing complex chemical systems. Some practioners use the term to refer to different functional groups on a single molecule that are protected by different protecting groups, each protecting group can be removed independently under a unique set of reaction conditions without affecting the others, while others use the term to refer to two or more distinct chemical reactions can be performed simultaneously without one interfering with the other. The reactive partners in one reaction are completely unreactive towards the partners in the other, allowing for multiple selective bond-forming events, while still others use the term to refer to chemical reactions can be performed inside a living organism without disrupting native biochemical processes. As there is no universally art recognized meaning for this term, it’s unclear what “wherein the terminal moiety and A have orthogonal reactivity,” and how “orthogonal reactivity” limits the claimed invention.
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, 17-20 and 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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1429
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Where each sphere may be:
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148
179
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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 4 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. In this structure, the terminal moiety and A would be independent and do not interfere with each other (“wherein the terminal moiety and A have orthogonal reactivity”).
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 as the claims recite “the terminal moiety and A have orthogonal reactivity,” which closes the scope of the present claims to exclude symmetrical structures, the examiner’s response is that lack of symmetrical symmetry is not in the claims, nor does the recitation “the terminal moiety and A have orthogonal reactivity” exclude symmetrical structure. There is no standard art-recognized meaning of “orthogonal reactivity” in the art, nor is the term described in applicant’s application. Under one use of the term in the art, the term can mean chemical reactions or groups of reactants that are independent and do not interfere with each other when performed in the same system. As stated above, in the prior art structure, the terminal moiety and A would be independent and do not interfere with each other (“wherein the terminal moiety and A have orthogonal reactivity”).
Conclusion
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.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
September 6, 2025