DETAILED ACTION
This action is in response to Applicant’s submission dated March 26, 2026, in which Applicant elected the invention of Group I with traverse.
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 .
Information Disclosure Statement
The references contained in the IDS dated April 17, 2025 and August 30, 2024 are made of record.
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.
Claims 1-10 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 applicant regards as the invention.
i) Compositions by definition must contain two or more ingredients and here it appears that the composition of claim 1 is limited to glycerol being the sole ingredient of said composition. Correction is required.
Election/Restriction
Applicant traverses the restriction arguing that the reasoning offered by the Office is insufficient to sustain a requirement for restriction.
WO 2020/229446 discloses topical glycerol formulations for protecting skin and wounds by inhibiting the growth of harmful bacteria while nourishing and promoting the growth of commensal bacteria. As such, the person skilled in the art would expect that the topical wound-healing glycerol formulations from this reference would also support the growth of commensal bacteria. With regards to Group II, it is considered that in seeking a solution to the problem being addressed the skilled artisan would be motivated to combine the disclosure of WO 2020/162764 with WO 2020/229446 to arrive at a solution which is the same as the claimed invention with every expectation of success.
As such, Examiner maintains the restriction requirement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robinson, WO 2020/162764, which teaches surgical hydrogels prepared from N-succinyl chitosan cross-linked to aldehyde-derivatized dextrans as polymer in amounts of from 2 to 10% w/v and glycerol in amounts from 10 to 30%, preferably about 20%, the sterile formulations being used as post-surgical wound packing materials in the nasal cavity and/or sinus such as in the treatment of chronic sinusitis to prevent adhesions between mucosal surfaces, minimize ostial stenosis and granulation, control bleeding, prevent infections and aid in the healing process (Abstract; p. 1, line 1 to p. 5, line 34; p. 20, lines 9-17; p. 31, line 9 to p. 32, line 12; claims 1-30.
Claims 1-4, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ha, et al., A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery, International Forum of Allergy & Rhinology, Vol. 3(7), pp. 573-580 (2013), which teaches a gel prepared from succinyl-chitosan and dextran aldehyde and further comprising glycerol, which when applied following endoscopic sinus surgery to treat chronic rhinosinusitis was found to significantly improve sinus ostial patency and wound healing (Abstract; Section: Study design at p. 574; Figs. 2-5).
Claims 1-4, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by CHITOGEL, Endoscopic Sinus Surgery Kit, Medtronic, “Optimize the wound healing environment and patient comfort with Chitogel postoperative sinus dressing” (August 10, 2021), which teaches an enhanced postoperative sinus dressing and wound-healing gel formulation such as for treating chronic rhinosinusitis, the gel being prepared from succinyl chitosan, dextran aldehyde and glycerol, the gel having anti-adhesion, hemostatic and moisture retention properties, inhibits coagulation factors, minimizes ostial stenosis and reduces fibroblast migration, granulation tissue formation, oedema and crust formation (whole reference, in particular, pp. 2-4).
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.
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 non-obviousness.
Determining the scope and contents of the prior art.
Claims 5 and 9 are rejected under 35 U.S.C. § 103 as being unpatentable over CHITOGEL, Endoscopic Sinus Surgery Kit, Medtronic, “Optimize the wound healing environment and patient comfort with Chitogel postoperative sinus dressing” (August 10, 2021) in view of Ha, et al., A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery, International Forum of Allergy & Rhinology, Vol. 3(7), pp. 573-580 (2013).
See the anticipation rejections, supra, regarding what these two references disclose.
Ascertaining the difference between the prior art and the claims at issue.
Present claim 5 recites that the composition comprises at least 20% glycerol (v/v). Topical mucosal formulations routinely contain such amount of glycerol, such as discussed above in Robinson, WO 2020/162764. It is expected that the compositions of CHITOGEL, Endoscopic Sinus Surgery Kit, Medtronic, “Optimize the wound healing environment and patient comfort with Chitogel postoperative sinus dressing” (August 10, 2021) and Ha, et al., A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery, International Forum of Allergy & Rhinology, Vol. 3(7), pp. 573-580 (2013) would contain this amount of glycerol, or at least its inclusion would be plainly obvious.
Present claim 9 recite that the pathogenic bacteria are selected from Staphylococcus aureus and Pseudomonas aeruginosa. These are common and well known bacteria known to infect wounds for which salves and topical preparations for wounds are designed to aid their protection from as discussed, supra.
“Mere recitation of newly-discovered function or property, inherently possessed by things in prior art, does not cause claim drawn to those things to distinguish over prior art; Patent Office can require applicant to prove that subject matter shown to be in prior art does not possess characteristic relied on where it has reason to believe that functional limitation asserted to be critical for establishing novelty in claimed subject matter may be inherent characteristic of prior art; this burden of proof is applicable to product and process claims reasonably considered as possessing allegedly inherent characteristics.” In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here. The instant claims thus is reasonably expected to share the same properties as that taught in the references given the express equivalency teaching recited.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
In the absence of any substantiated unexpected property, which is relevant in comparison with the closest related art, then non-obviousness cannot be acknowledged.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
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