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 .
Receipt and entry of the response dated 3/31/2026 is acknowledged.
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 1-3, 5-8, 10-13, 15-22 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. This rejection is maintained for reasons set forth in the Office Action dated 10/2/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 3/31/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) written description for a claimed invention may be provided in a variety of ways; 2) the specification describes a number of block copolymers and segments thereof having the recited structural requirements.
Regarding 1), such is true. However, as set forth previously, the instant specification fails to provide a “reduction to practice” or a complete invention that is commensurate in scope with the claims. The breadth of the claims has been previously explained, and the amendments to the independent claim do not narrow the scope of the claimed micelles or methods in any significant way. That is, a “polycationic segment” is assumed to be “protonated” (H+), the hydrophobic segments (e.g. PCL) assumed to interact and the hydrophilic segment (e.g. PEG) to form a surrounding shell (e.g. Fig. 1). The claims still encompass preparing the claimed compositions and performing the claimed methods with any block copolymer that might have a hydrophobic segment coupled with either a “polycationic segment” or a hydrophilic segment. The fact remains the only composition disclosed that meets the structural and functional requirements of the claims is plasmid DNA in a micelle formed from PCL-b-P2VP (polycation) and PCL-b-PEG (hydrophilic). Such micelles (termed PIHC in the instant specification) could transform bacteria with the plasmid DNA, but functional (e.g. gene expression) transformation or transfection of any nucleic acid into eukaryotic cells was not established. No micelles were formed from any other block copolymers or any other type of nucleic acid (e.g. RNA, ssDNA).
Regarding 2), the claims are not directed to block copolymers or their recited segments, as detailed above. Rather, the recited block copolymers must perform the functional aspects of the claims in forming “a core” or “polyplex” with a nucleic acid, and then further complete the claimed micelle by forming “a matrix” with the two hydrophobic segments. Further, the claimed methods require the micelles to function as transformation or transfection reagents in any type of cell with any type of nucleic acid. Other than the specific pairing of PCL-b-P2VP and PCL-b-PEG with plasmid DNA, the specification and prior art do not provide any further support for the claimed genus of micelles and methods. The Examiner agrees that the specification supports micelles, and methods of making and using the micelles, that comprise PCL-b-P2VP and PCL-b-PEG; however, no claim is limited to such micelles.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638
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