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
Claims 1-18, 28 and 39 are pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-11, drawn to a composition comprising a hydrogel, and the species of:
polyethylene glycol (PEG) for the species of biocompatible polymer, and
2-furoic acid and 6-maleimidohexanoic acid for the species of reactants.
in the reply filed on 6/30/26 is acknowledged.
Upon reconsideration, the election of a species of reactants (b) is withdrawn.
Claims 12-18, 28 and 39 are withdrawn as being drawn to a nonelected invention.
Claims 1-11 are under consideration to the extent that the composition comprises the elected species of PEG.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 3/6/24 and 1/30/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 7 is objected to because of the following informalities: The group of biocompatible polymers recited in claim 7 should be linked by “or” instead of “and” to clarify that not all of the polymers are required. Appropriate correction is required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 2012/0035531) in view of Hayes et al. (WO 2019/014549).
Zhao et al. teach compositions and methods to release drugs from a polymer matrix upon demand without degrading the matrix (e.g. abstract). Zhao et al. teach a composition comprising: a polymer matrix, which may be a hydrogel (e.g. Claims 1 and 18; Examples), comprising a linker and a therapeutic species coupled to the hydrogel (e.g. paragraph 0052, Claim 9), wherein the linker is configured to undergo a reversible retrograde cleavage reaction to release the therapeutic species from the hydrogel upon exposure to a triggering event (e.g. paragraph 0054, 0062).
Zhao et al. do not teach that the liker comprises a Diels-Alder cyclo-addition reaction product. This is made up for by the teachings of Hayes et al.
Hayes et al. teach a composition comprising a nanoparticle, a therapeutic species, and a linker joining the nanoparticle to the therapeutic species, wherein the linker joining the nanoparticle to the therapeutic species comprises a Diels-Alder cyclo-addition reaction product (e.g. abstract). Hayes et al. teach that when the transferred energy is sufficient to activate (or initiate) a retro (or reverse) Diels-Alder reaction, the result is severing of the linker and decoupling and release of the therapeutic species from the nanoparticle (e.g. page 8, lines 5-17; claim 18). Hayes et al. teach that there is a need for improved compositions and methods for targeted delivery of therapeutic and/or diagnostic species (e.g. page 1, lines 17-22). Hayes et al. teach that by varying the Diels-Alder cyclo-addition product in the linker group, breaking up or cleaving of the Diels-Alder cyclo-addition product (and concomitant decoupling of the therapeutic species and the nanoparticle) can be "tuned" to occur at different temperatures (e.g. page 16, lines 7-22).
Regarding Claim 1, it would have been obvious to one of ordinary skill in the art at the time of filing to select the Diels-Alder cyclo-addition reaction product linker of Hayes et al. for use with the hydrogels of Zhao et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions are useful for drug delivery and comprise a linker and a therapeutic species, and one of ordinary skill would have been motivated in order to provide the benefits of “tuned” delivery as disclosed by Hayes et al. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007).
Regarding Claim 2, Zhao et al. teach that the bioactive agents maybe be encapsulated within the polymer matrix (e.g. paragraph 0059).
Regarding Claims 3-5, the limitations are directed to a method of using the claimed composition and do not further limit the composition itself. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The composition of claim 1 is met by the teachings of Zhao et al. and Hayes et al. as described supra.
Regarding Claims 6 and 7, Zhao et al. teach that the polymer matrix comprises polyethylene glycol (e.g. paragraph 0024).
Regarding Claim 8, Zhao et al. teach that the therapeutic may be small molecule, nucleic acid, and a peptide (e.g. paragraph 0037, 0039, 0041). Hayes et al. teach that the therapeutic may be small molecule, nucleic acid, a peptide, and a microRNA mimic (e.g. Claims 10 and 11).
Regarding Claims 9-11, Hayes et al. teach that the Diels-Alder cyclo-addition reaction product is a reaction product of a dienophile and a furan, and that the dienophile may be a substituted or unsubstituted alkene or alkyn (e.g. page 15, lines 21-30; Claim 14).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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, David Blanchard can be reached on 571-272-0827. 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.
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
Prosecution Insights