DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 24 July 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 33-37 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. For example, claim 33 is multiply dependent, and depends from claim 31. Since claim 31 is also multiply dependent, claim 33 is in improper form. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim Rejections - 35 USC § 112 & 35 USC § 101 – Use Claims
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
Claims 52-53 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. This claims provide for the use of the kit, but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process the claims are intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 53-54 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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, 38-42, 44-50, and 51-53 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 and 52-53 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.).
Instant claims 38-42 recite limitations to the pH and acid present in the composition comprising the positively charged polymer. The acids present in the aqueous composition disclosed by Purcell et al. are trifluoroacetic acid and HCl (example 2) (though neither is described as a solvent, and thus not limited to this element). And the pH when contacting the positively charged polymer and the hyaluronic polymer can be 5 (example 10).
Instant claim 44 further limits the negatively charged polymer, and the sulfated hyaluronic acid disclosed by Purcell et al. reads upon the instantly recited negatively charged polymer.
Instant claims 45-50 recite limitations to the temperature-sensitive polymer (i.e. the poloxamer). The elected species (poloxamer) is taught by Bley, and thus the limitations recited by instant claims 45-48 are met. As for instant claims 49-50, these claims recite limitations to the amount present. Purcell et al. is silent as to the concentration. However, generally differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Instant claim 51 recites that the hydrogel supports a therapeutic molecule, and bioactive molecules are suggested for incorporation by Purcell et al. (paragraph [47]).
Response to Arguments
The Applicant argues that the prior art rejections are not proper for several reasons. The Applicant first states that the claims are directed to a spray-type hydrogel kit which is capable of gelation in a body temperature environment and effectively adhering to biological tissue. Specific polymers (as used in the working examples) are discussed. In contrast, the Applicant states that Purcell et al. does not disclose this mechanism or configuration for maximizing binding force using sulfated hyaluronate. And while crosslinking does occur in the preparation disclosed by Purcell et al., it is not directly related to electrostatic interaction. A fundamentally different mechanism of action ius used. Purcell et al. also does not suggest gelation in situ. As for Bley, this reference does not disclose the gelation mechanism either.
The Applicant also cites a publication, stating it shows that hyaluronic acid cannot form a gel when mixed with chitosan. The poloxamer and the sulfated hyaluronate provide for the desired gel.
The Applicant finally argues that there is no motivation to combine these two references, as Bley discloses the poloxamer solely as a solubility enhancer, whereas Purcell et al. does not disclose in situ electrostatic binding under physiological conditions.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. There are numerous arguments regarding he references not teaching the same mechanism of action for the gelation, or the same manner of application. It is noted that the features upon which applicant relies are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) & MPEP 2145.
With respect to the chitosan and hyaluronic acid gel, first it is noted that the publication is not provided. Thus, no evidence is presented to support the arguments. But regardless, the rejection is not based on chitosan and hyaluronic acid. And in fact the inclusion of chitosan was stated to be part of the allowable subject matter (see both the previous action and the below section of this action).
The Examiner also is not persuaded by the argument that there is no motivation to combine. Both references discuss penetration enhancers, and thus provides the nexus and rationale for the combination of the references.
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
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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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, Fereydoun Sajjadi can be reached at (571) 272-3311. 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.
/Brian Gulledge/Primary Examiner, Art Unit 1699
Prosecution Insights