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 .
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.
Claims 1-2, 5, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,100,992 to Cohn et al. (Cited on IDS).
As to claims 1, 5, and 13, Cohn discloses a medical device wherein at least a portion of the device comprises a polyurethane amide represented by the following:
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Derived from diisocyanates such as hexamethylene diisocyanate or 4,4-diphenylmethane diisocyanate, macroglycols such as poly(alkylene glycols) to provide flexibility, and dicarboxylic acids (9:24-10:69, Examples).
As to claim 2, Cohn discloses wherein the X and Y-substituents of the formula are derived from amines to enhance blood compatibility (12:34-39, Examples 9-10).
As to claims 14-18, Cohn discloses wherein the polyurethane amide polymeric materials are molded into solid surgical aids and biomedical devices (13:55-6), a coating (14:14-16), and further contain additives such as antibiotics and anti-thrombogenic agents (Claim 15).
Claims 1, 4-5, 7, 13, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2023/0295375 to McGrail et al.
As to claims 1 and 13, McGrail discloses biomedical devices (0194) wherein at least a portion of the device may be coated or formed from a (meth)acrylate functionalized amide containing oligomer that is the reaction product of xylylene diisocyanate and an oligoester amide diol and 2-hydroxyethyl acrylate wherein the reaction product contains urethane groups and amide groups and is represented by the following (Example 3, 0253):
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As to claim 4, McGrail discloses a reaction product of the above urethane amide polymer and hydroxy-functional (meth)acrylamide (0022, 0067, 0152, 0157).
As to claim 5, McGrail teaches isophorone diisocyanate or toluene diisocyanate as reaction partners (0109).
As to claim 7, McGrail teaches polyether polyols are added to prepare (meth)acrylamide functionalized urethane-amide oligomers (Example 6, 0256).
As to claim 20, McGrail discloses three-dimensional articles by additive manufacturing comprising the acrylate-functionalized urethane amide oligomer (0020).
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 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over by U.S. Patent Pub. No. 2023/0295375 to McGrail et al. in view of U.S. Patent Pub. No.2022/002371 to Paulus
As to claims 2 and 8, McGrail discloses biomedical devices (0194) wherein at least a portion of the device may be coated or formed from a (meth)acrylate functionalized amide containing oligomer that is the reaction product of xylylene diisocyanate and an oligoester amide diol and 2-hydroxyethyl acrylate wherein the reaction product contains urethane groups and amide groups and is represented by the following (Example 3, 0253):
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McGrail does not teach the addition of an amine reaction component.
However, within the same field of endeavor Paulus discloses acryloxy-functionalized polyurethanes that include diamino reaction partners including amine-terminated polyalkylene diols (0163).
At the time of filing it would have been obvious to a person of ordinary skill in the art to include the diamine component of Paulus within the reaction of McGrail to reduce tackiness of the coating and increase hardness (0166).
Claims 3-4, 6, 9-10, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over by U.S. Patent Pub. No. 2023/0295375 to McGrail et al. in view of U.S. Patent Pub. No. 2007/0043205 to Dias et al.
As to claims 3-4, 6, 14-16, and 20, McGrail discloses biomedical devices (0194) wherein at least a portion of the device may be coated or formed from a (meth)acrylate functionalized amide containing oligomer that is the reaction product of xylylene diisocyanate and an oligoester amide diol and 2-hydroxyethyl acrylate wherein the reaction product contains urethane groups and amide groups and is represented by the following (Example 3, 0253):
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McGrail does not teach the addition of a thioether, dithiol, or polyfunctional thiol component.
However, Dias within the same field of endeavor teaches curable compositions for medical devices, coatings, and 3-D printing process applications (0091, 0093) comprising a thiol-end reaction of a acrylate-terminated urethane oligomer (same as McGrail) and polythiol compounds (0031-0039), preferably trimethylolpropane tris(3-mercaptopropionate) or pentaerythritol tetrakis(3-mercaptopropionate (0108-0110) or polypropylene ether glycol bis(mercaptopropionate) (0031).
At the time of filing it would have been obvious to a person of ordinary skill in the art react the acrylate functional urethane amide of McGrail as taught in Dias because they have low toxicity due to avoidance of toxic acrylates and show improved compatibility with biological tissue (0093).
As to claims 9-10 and 19, the combination of McGrail in view of Dias teach a thiolene (Michael addition) reaction of acrylate functionalized urethane amides with chain terminating polythiols. This process is substantially identical to the process of the instant application. Therefore, the reaction of McGrail in view of Dais would contain mixtures of products that meet formula I of the instant claims.
As to claims 17-18, McGrail discloses the addition of additives (0186).
Allowable Subject Matter
Claims 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MICHAEL L LEONARD/Primary Examiner, Art Unit 1763