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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on November 17, 2025 is acknowledged.
Claims 1-3, 5-6, and 8-19 are pending in this application.
Claims 1-3, 6, and 8-19 have been amended.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-17) in the reply filed on November 17, 2025 is acknowledged. The traversal is on the ground(s) that there is no search burden.
After further consideration, the election/restriction is withdrawn.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on May 2, 2023 is acknowledged. A signed copy is attached to this office action.
Specification
The disclosure is objected to because of the following informalities: the specification recites the acronym SMDI for saturated methylene diphenyl diisocyanate. The acronym is not defined in the specification, however, it is an art recognized acronym. Therefore, an amendment to the specification to define the term is not considered new matter.
Appropriate correction is required.
-Claim Objections
Claims 1 and 5 is objected to because of the following informalities:
Claim 1 has been amended to recite “an aqueous carrier comprising water” however, an aqueous carrier inherently comprises water therefore, the recitation is redundant.
Claim 1 recites the acronym SMDI for saturated methylene diphenyl diisocyanate. The acronym is not defined in the specification, however, it is a well-known art recognized acronym (see objection to the specification). When an acronym appears in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “saturated methylene diphenyl diisocyanate (SMDI)” and then recite only the acronym in subsequent reiterations. Appropriate correction is required.
Regarding claim 5, the Markush group comprises water, which are stated above, is redundant. It is suggested Applicant amend claim 6 to depend from claim 1.
Appropriate correction is required.
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, 5-6, 8-19 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.
Regarding claim 1, component b recites “a linear PEG/PPG triblock copolymer and polypropylene glycol (PPG)-SMDI copolymer”, such as ExpertGel 312 or 412. The claim also requires that a polymer defined as component a is a linear PEG/PPG triblock copolymer, such as poloxamer 407. The compositions Expertgel 312 or 412 comprise Poloxamer 407 or 338 coupled to PPG-SMDI copolymer. However, as currently claimed, it is unclear if component b is intended to be the coupled copolymer or simply additional poloxamer 407 and a PPG-SMDI copolymer. After a review of the specification, the Examiner has interpreted component b to be linear PEG/PPG triblock copolymer coupled to PPG-SMDI copolymer. Clarification and amendment are requested.
Regarding claim 10, the phrase "for example (e.g.)" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding claim 10, the recitation of the term “highly” is a relative term which renders the claim indefinite. The term “highly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is suggested the claim be amended to recite “wherein the polyacrylic acid or polyacrylate polymer is a crosslinked polymer having a viscosity of 29,000 to 40,000 mPas.”
Allowable Subject Matter
The claims are free of the prior art. Applicant’s attention is directed to the Claim objections and the 35 USC 112 rejections above.
The closest prior art is that of Wang et al. (WO 2020/211859; cited on ISR dated May 2, 2023) which discloses a hydrogel drug delivery composition comprising a therapeutic agent and a poloxamer (abstract). Poloxamers are nonionic triblock copolymers composed of a central hydrophobic chain of polyoxypropylene (poly(propylene oxide)) flanked by two hydrophilic chains of polyoxyethylene (poly(ethylene oxide)). Poloxamer 407 (Pluronic F127 “PF127”) is preferred (paragraphs 0010-0013).
The hydrogel is disclosed as being thermoresponsive (paragraph 0007).
The preparation of the BIO-loaded thermoresponsive hydrogel discloses PF 127 hydrogel formulations with 20% polymer concentration. The PF127 was dissolved in a PBS (phosphate buffer solution), which is an aqueous solution.
Wang discloses the thermoresponsive hydrogel formulations comprising Poloxamer 407 which has been modified to be capable of adhering to bones and teeth used as a drug delivery composition in the treatment of dental diseases such as periodontitis (paragraph 0018-0024). The poloxamer is modified by pyrophosphate, bisphosphonate, dopamine, acidic peptide or tetracycline groups(paragraph 0010).
Wang, however, does not disclose a linear PEG/PPG triblock copolymer coupled to a polypropylene glycol (PPG)-SMDI copolymer.
The instant specification discloses the instant formulation (combination of poloxamer and poloxamer coupled to a PPG/SMDI copolymer results in enhanced gel strength (Example 11).
There is no disclosure within the prior art suggesting that the SMDI copolymer according to component (b) of claim 1 had such properties on hydrogels.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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