DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of a random copolymer of the formula
PNG
media_image1.png
151
336
media_image1.png
Greyscale
wherein each of R3, R4a, and R4b is methyl; the initiator I’ (I’I’) is
PNG
media_image2.png
434
637
media_image2.png
Greyscale
s is 9; R¹ is LG¹ (a linking group); R²ᵃ is L²ᵃ-A²ᵃ and R²ᵇ is L²ᵇ-A²ᵇ (each of L²ᵃ and L²ᵇ is a cleavable linker and each of A²ᵃ and A²ᵇ is a functional agent); each of x, y¹ᵃ and, y¹ᵇ is independently an integer of from 1 to 1000 (claims 1-3, 8-16, and 23-25) in the reply filed on May 4, 2026 is acknowledged.
Claims 4-7, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 4, 2026.
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 1-3, 8-16, and 23-25 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.
Claim 1 recites the following:
“ZW is a zwitterionic moiety “;
“I is an initiator fragment and I′ is a radical scavenger, such that the combination of I-I′ is an initiator, I1 ”;
“I2 is an initiator”;
“each of L1 and L2 is a linker”; and
“each of LG1 and LG2 is a linking group”.
Each of these limitations recites the variable in terms of its function rather than its structure. A claim term is functional when it recites a feature “by what it does rather than by what it is” (e.g., as evidenced by its specific structure or specific ingredients). MPEP 2173.05(g)(citations omitted). “[W]hen claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” MPEP 2173.05(g) (citations omitted). Here reciting the above-listed elements of the claimed subject matter in terms of their respective function alone renders the scope of the claims unascertainable.
Applicant states, a “zwitterionic moiety” refers to a compound having both a positive and a negative charge (para.0028, pre-grant publication US 2024/0197810). Examples suitable for the claimed random copolymer include phosphorylcholine and those in prior art references incorporated by reference into the disclosure (id.). However these are but examples, and the claim term “zwitterionic moiety” includes any compound that has both a positive and a negative charge, unlimited in structure, size, or other attributes, and includes those yet to be discovered as suitable for the claimed random copolymer. The disclosure expressly states the compounds it refers to are but examples. Claims 1-3, 8, and 12-16 are directed to random copolymer of Formula I wherein the zwitterionic moiety is unlimited in structure.
Applicant states, the “‘initiator’ refers to a compound capable of initiating a polymerization using the comonomers of the present invention” wherein the polymerization can be a conventional free radical polymerization or a controlled/living radical polymerization, such as Atom Transfer Radical Polymerization (ATRP), …” (para.0029, US 2024/0197810). “When the initiator is suitable for ATRP, it contains a labile bond which can homolytically cleave to form an initiator fragment, I, being a radical capable of initiating a radical polymerization, and a radical scavenger, I′, which reacts with the radical of the growing polymer chain to reversibly terminate the polymerization. The radical scavenger I′ is typically a halogen, but can also be an organic moiety, such as a nitrile.” (Id. (emphasis added)) In other words there is no ascertainable structural limitation for the fragment I, and the radical scavenger I’, and therefore I1. Claim 1 recites “alternatively, I’ is selected from the group consisting of H and C1-6 alkyl”, which does not limit the scavenger I’ due to the “alternatively”.
Similarly claim 1 simply recites “I2 is an initiator”. Any compound of any structure which could initiate polymerization under any condition for any monomer, possibly of M1 and M2, qualifies as an I2.
Claims 1-3, 8-14, and 23-25 are directed to random copolymer of Formula I wherein the “initiator”, the fragment I, the radical scavenger I’, and initiators I1 and I2 are unlimited in structure. Claim 15 limits only the radical scavenger I’ to a halogen. Claim 16 limits only the initiator I1 by specific structures. But claim 16 recites initiators I1 (including the elected species), which are compounds, without any means of identifying the fragment I or the radical scavenger I’ or how the initiator forms the copolymer.
Regarding “each of L1 and L2 is a linker” in claim 1, the disclosure states, a “linker” is “a chemical moiety that links two groups together” (para.0030, US 2024/0197810). In other words there is no ascertainable structural limitation on each of L1 and L2. Claims 1-3, 8-16, and 23-25 are directed to random copolymer of Formula I wherein each of L1 and L2 is unlimited in structure. Claims 12 and 13 define them solely in terms of cleaving mechanisms.
Regarding “each of LG1 and LG2 is a linking group” in claim 1, the disclosure states, a “linking group” is “a functional group capable of forming a covalent linkage consisting of one or more bonds to a bioactive agent” (para.0030, US 2024/0197810). Table 1 lists “[n]onlimiting examples” (id.). In other words any functional group that can form a covalent bond to any bioactive agent is a linking group as defined herein, and there is no ascertainable chemical structure of the linking groups. Claims 1-3, 8-16, and 23-25 are directed to random copolymer of Formula I wherein each of LG1 and LG2 is unlimited in structure.
Here the claims are directed to random copolymers of Formula I defined with a combination of all these elements which are recited in terms of their respective function alone in forming the random copolymer, a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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, Ali Soroush can be reached at (571)272-9925. 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.
/H. SARAH PARK/Primary Examiner, Art Unit 1614
Prosecution Insights