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 information disclosure statements (IDS) submitted on 7/26/23;11/13/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-3, 5-14, 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madsen et al. (US 2009/0012208) (“Madsen”). Madsen discloses:
(claim 1,13,14) a urinary catheter kit [0162-0163] comprising: an aqueous lubricant composition comprising water and at least one polyether-polyurethane thermogelling copolymer P1, and a urinary catheter with an external coating of thermogelling copolymer P2 comprising at least ether units. (claim 5) the thermogelling copolymer P1 and the thermogelling copolymer P2 comprise polyethylene oxide and polypropylene oxide units. (claim 3) the thermogelling copolymer P2 comprises at least ether units and units selected from urethane units, ester units, and mixtures thereof.
[0030,0033], see abstract [0046,0057]
Claim 2: the urinary catheter is immersed in the aqueous lubricating composition. [0162-0163]
Claim 6,16: the thermogelling copolymer P1 has a polyethylene oxide content of from 50 to 99% (70-95%) by weight based on the total weight of the copolymer. [0104-0105]
Claim 7,17: the aqueous lubricant composition comprises from 1 to 20% (2-15%) by dry weight of thermogelling copolymer(s) P1, based on the total weight of the aqueous lubricating composition. [0104-0105]
Claim 8,18: the aqueous lubricant composition further comprises glycerin in an amount of from 1 to 30% by weight based on the total weight of the aqueous lubricating composition. [0092,0141]
Claim 9,10: the copolymer coating is applied by dipping and drying the catheter in a composition comprising the thermogelling copolymer P2 or by extrusion of a composition comprising said thermogelling copolymer P2. [0136,0152-0154]
Claim 11,19: the catheter has two, preferably identical, layers of thermogelling copolymer P2 coating. [0153]
Claim 12: the catheter is made of olefinic thermoplastic material, and the olefinic thermoplastic material is previously activated by plasma or previously coated with a primer coat before being coated with the thermogelling copolymer P2. [0046,0137,0155]
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 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.
Claims 4, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen.
Madsen discloses the invention as substantially claimed but does not directly disclose the viscosity of the thermogelling copolymers. The copolymers comprising polyethylene oxide and polypropylene oxide units is found in Madsen [0030,0033], see abstract [0046,0057]. Thus, the viscosity at 25°C of 5 to 100 mPa.s, (10 to 80 mPa.s) is a known and measurable value to one skilled in the art.
Conclusion
Any 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