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 .
Acknowledgments
This office action is in response to the reply filed on 9/24/26. In the reply, the applicant elected Group I and the species of claim 16 without traverse. Applicant amended claims claims 13, 21; canceled claim 22; added new claim 23. Claims 1-3, 6-21, 23 are pending with claims 14-15, 17-20 and 23 being withdrawn. New claim 23 also withdrawn from election by original presentation.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/25/26 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. The factual inquiries 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.
7. Claims 1-3, 6-13, 16, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Reitz et al. (US 2011/0275587) (“Reitz”) in view of Spearman et al. (US 2016/0184564) (“Spearman”).
Reitz discloses: A medicated gel [0017], comprising: a sterile viscous gel having a viscosity sufficient to be maintained within a paranasal sinus cavity or nasal passage after insertion [0013,0015-0017]; and a medication dispersed in the sterile viscous gel [0017], the medication comprises mometasone furoate or mometasone furoate monohydrate [0021].
Wherein Reitz does disclose the viscous medicated gel adhering to the paranasal sinus cavity ([0013,0015-0017]), Reitz does not directly disclose chitosan in the viscous gel helping with this feature. Spearman, in the analogous art, teaches a similar intranasal delivery device, the nasal delivery device including a thickening agent (chitosan [0047]); carrier and support compositions such as hydrogels composed of chitosan [0102, 0105-0107]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added chitosan to the sterile viscous gel to increase adherence of the gel to the paranasal sinus cavity as taught by Reitz [0013,0015-0017] and Spearman [0072,0047,0102,0105-0107].
Reitz/Spearman discloses the invention as substantially claimed, including the sterile viscous gel in combination with one or more carbomer polymers [0019] (Spearman [0047]) and (claim 11) anti-inflammatory medications [0021]. The sterile viscous gel contains ibuprofen, diclofenac, naproxen, ketoprofen or meloxicam) are simply more narrow examples of the above disclosed by Reitz (i.e., anti-inflammatory medications), therefore obvious.
Reitz further discloses:
the sterile viscous gel is selected from the group consisting of: hydroxyethyl cellulose, hypromellose, methlycellulose, carboxymethlycellulose and other cellulose type polymers. [0013,0019]
the sterile viscous gel contains time release lipid matrix microspheres. [0022]
a viscosity of the gel is between 10 and 300,000 centipoise. [0013]
the medication is selected from the group consisting of: tobramycin, gentamicin, vancomycin, ceftriaxone, ceftazidime, clindamycin, levofloxacin, ciprofloxacin, mupirocin, azithromycin, clarithromycin, polymyxin B, colistin, sulfamethoxazole/trimethoprim and ertapenem. [0021]
the medication is selected from the group consisting of: Penicillins; Cephalosporins; Tetracyclines; Macrolides; Quinolones; Fluoroquinolones; Aminoglycosides; Carbapenems; Sulfonamides; Glycopeptides and Polymyxins. [0021]
the medication is selected from the group consisting of: Fluconazole, Itraconazole, Voriconazole, Posaconazole, Isoconazole, Amphotericin B, Amphotericin B Liposome, and Amphotericin B Lipid Complex. [0021]
the medication is selected from the group consisting of: betamethasone, fluticasone furoate, fluticasone propionate, ciclesonide, hydrocortisone, budesonide, mometasone furoate and mometasone furoate monohydrate. [0021]
the sterile viscous gel contains methylglyoxal, Vitamin D3, Vitamin A, silver or gold ions or colloidal suspensions, ethylenediaminetetraacetic acid (EDTA), hyaluronic acid (HA), xylitol, bromelain, quercetin, herbal extracts, or essential oils. [0013]
claim 13: A method of delivering the medicated gel of claim 1 into the paranasal sinus cavity or nasal passage, the method comprising: depositing the medicated gel into the paranasal sinus cavity and onto surrounding tissues. [0018,0020]
claim 16: Reitz/Spearman discloses the invention as substantially claimed, including, from Spearman, depositing the medicated gel by applying the medicated gel with pre-soaked pledgets or swabs, and spreading the gel with a swab applicator directly onto the paranasal sinus cavity or nasal passage. [0049,0052].
Claim 21: the medicated gel is diluted with saline prior to being deposited into the paranasal sinus cavity and onto the surrounding tissues [0049,0098] (Reitz also discloses the gel medication in a water soluble formula [0017].
ConclusionAny inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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, Kevin Sirmons can be reached at 571-272-4965. 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783
