DETAILED ACTION
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant's election with traverse of Group II (claims 29-53) and the species of chitosan, sulfated hyaluronic acid, and poloxamer in the reply filed on 20 January 2026 is acknowledged. The traversal is on the ground(s) that the amendment to the claims to require sulfated hyaluronate establishes a common inventive feature across the claims. This is not found persuasive because such a feature is known, as shown by the obviousness rejection below. The requirement is still deemed proper and is therefore made FINAL. Claims 1-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 33-42 and 44-53 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
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.
Claims 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Purcell et al. (US Patent Application Publication 2018/0311364) in view of Bley (US Patent Application Publication 2006/0222690)
Purcell et al. discloses hydrogels prepared by mixing a cross-linking peptide and hyaluronic acid, a sulfated hyaluronic acid, or a sulfonated hyaluronic acid (abstract). The sulfated hyaluronic acid reads upon the instantly recited negatively charged polymer. Purcell et al. discloses that the structure of the cross-linking peptide has a thiol group on one end and an amine group on the other end (example 3), and this reads upon the instantly recited positively charged polymer.
Purcell et al. discloses the preparation of the gel by first preparing a hyaluronate component and a peptide component, and then mixing each (example 4). Purcell et al. suggests the inclusion of penetration enhancers in the composition (paragraph [51]), but does not teach specific enhancers. So as such there are no temperature sensitive polymers disclosed.
Purcell et al. also does not state how the penetration enhancer is incorporated into the composition (i.e. added into the peptide component, the hyaluronate component, or added after hydrogel formation). With respect to this element, this is a difference of how the ingredients are mixed. And selection of any order of mixing ingredients is prima facie obvi-ous. See MPEP 2144.04(IV)(C).
As for the temperature sensitive polymer, Bley discloses dermal delivery using penetration enhancers (abstract), and useful enhancers include poloxamer (claim 3). This is the elected species of temperature sensitive polymer. Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used poloxamer as the penetration enhancer in the composition disclosed by Purcell et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Thus, independent instant claim 29 is prima facie obvious.
Instant claims 30-32 recite limitations to the use of the composition. The claims are directed to the product, and not the use. But the use steps recited appear to be steps which would be able to be achieved by the taught composition. Per the disclosure of Purcell et al., it is sprayable (paragraph [49]), it forms a gel when mixed (example 3), and does not need special temperatures in order to gel (id.).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter. The closest prior art is considered above cited Purcell et al. This reference does not suggest the inclusion of chitosan as the positively charged polymer. And doing so would not be prima facie obvious. This polymer is positively charged (has amine groups), and these would be expected to interfere with the cross-linking with the peptide taught by Purcell et al. Since this peptide-hyaluronate crosslinking is a required element of the disclosed gel, one of ordinary skill in the art would not add chitosan to sulfated hyaluronic acid.
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699