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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Stamler et al. (US6232434) in view of Wang et al. (US6673053).
Regarding claims 1-2 and 6-10, Stamler teaches that it is known to incorporate compounds such as S-nitroso-N-acetylpenicillamine into polymers (Example 9) for the purpose of coating tubular articles (Example 8) and medical tubing including catheters (col. 1, lines 11-28) in order to deliver NO in the human body (col. 2, lines 4-6). Stamler fails to teach wherein the number of carbon atoms provided in his embodiments reads upon the range of 5 to 20 carbon atoms. However, Stamler further teaches that it was known in the prior art to provide S-nitroso penicillamine without complexing it to a polymer as well (col. 1, lines 37-53). It is noted that Stamler does not teach against the use of nitric oxide providing compounds that are not bound. Stamler instead notes advantages of nitric oxide agents bound to polymers and the ability of them to release nitric oxide over a longer period of time while at the same time reasonably indicating that nitric oxide compounds such as S-nitroso penicillamine alone are capable of releasing more nitric oxide more quickly. (col. 1, lines 29-53). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include S-nitroso penicillamine of Stamler that is not bound to polymers to the invention of Stamler comprising S-nitroso penicillamine bound to polymers in order to provide both a larger, quick release of nitric oxide in combination with a sustained release of nitric oxide by the invention of Stamler. Stamler fails to teach wherein the coating further comprises silicone oil. However, Wang teaches that it is known to coat medical device such as catheters (see Background of Invention) with silicone oil as an anti-block agent (claim 3) in order to prevent sticking of the catheter to other surfaces. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to
Incorporate the silicone oil of Wang into the invention of Stamler in order to provide the described anti-blocking/sticking properties of Wang in the invention of Stamler.
Regarding claim 3, the teachings of Stamler in view of Wang are as shown above. Stamler in view of Wang fails to teach the amount of NO releasing agent used relative to the weight of the tubing. However, those of ordinary skill in the art would readily recognize that the amount of NO agent provided would directly control the amount of NO released in the invention of Stamler. Therefore in the absence of criticality of the specific weight range of NO releasing agent relative to the tubing of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of NO releasing agent employed in order to optimize the amount of NO released from the implant of Stamler. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Stamler et al. (US6232434) in view of Wang et al. (US6673053) as applied to claims 1-3 and 6-10 above and further in view of Di Caprio et al. (US6123712).
Regarding claim 4, the teachings of Stamler in view of Wang are as shown above. Stamler in view of Wang fails to teach wherein the catheter is made from a thermoplastic elastomer. However, Di Caprio teaches that it is known to form medical catheters from thermoplastic elastomers (col. 7, lines 22-31). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the catheter material of Stamler in view of Wang with the catheter material of Di Caprio as simple substitution of one catheter material for another wherein the substitution would be expected to be successful based upon the teachings of Di Caprio.
Response to Arguments
The applicant argues that Stamler’s nitric oxide releasing polymers do not read upon the 5 to 20 carbon atom S-nitroso thiol compounds of Stamler. This may or may not be true depending on the length of the polymer formed but this point is largely irrelevant. The examiner did not cite the polymers comprising S-nitroso thiol groups as the nitric oxide releasing agents of Stamler. The examiner explicitly stated that Stamler also teaches that those in the art are known to use specific compounds such as S-nitroso-N-acetylpenicillamine. The current claim does not state that the coating consists of S-nitroso thiol compounds. The claim states that the composition comprises a nitric oxide releasing agent wherein the nitric oxide releasing agent consists of an S-nitroso thiol compound. As such, the composition may comprise a whole host of other materials other than the nitric oxide releasing agent, said host not limited in any way by the claims. As such, the language provided by the applicant defines that when the applicant refers to “the nitric oxide releasing agent”, said agent is limited to a singular S-nitroso thiol compound. However, this does not limit the claimed composition from using other S-nitroso thiol compounds. Further the examiner described in detail why one of ordinary skill in the art would include S-nitroso-N-acetylpenicillamine in the invention of Stamler as a small molecule but the applicant did not address this point which is a primary point in the rejection of the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah-Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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