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
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 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gupta et al. (WO/2010/104760).
Regarding claims 1, 3 and 5, Gupta teaches that it is known to impregnate polyurethane catheters [0011][0036] with a nitric oxide releasing compound mixed with polyurethane (Tecoflex) in a solvent, wherein Gupta further shows wherein the dip coated layers may further comprise chlorhexidine diacetate [0039] and therein after the layer is dried by removing the solvent [0036]. This singular reads upon the combined steps of the current claims. Further the polyurethane of Gupta would be both undegraded and free of solvent after drying. Further still, the polyurethane coating comprising chlorhexidine of Gupta would read upon both the solvent impregnation material of the current claims and the polyurethane coating material of the current claims.
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 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 2, 4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (WO2010/104760) as applied to claims 1, 3 and 5 above and further in view of Herrmann et al. (USPGPub 2004/0171589).
Regarding claims 2, 4 and 6-8, the teachings of Gupta are as shown above. Gupta fails to teach wherein the nitric oxide releasing element is either of those claimed. However, Herrmann teaches that both of the compounds claimed are known to be used as nitric oxide releasing elements in the production of medical catheters [0135]. 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 either of the nitric oxide releasing agents employed in the production of catheters by Herrmann in the invention of Gupta as a simple substitute for one known nitric oxide releasing agent for another employed in catheter manufacture for another wherein the results would be predictable. See KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Response to Arguments
The applicant argues that the catheters of Gupta are extruded from a material comprising polyurethane, SNP and chlorhexidine and that this process used would form a product that it distinct from one that would be formed by solvent impregnation as claimed herein. However, the applicant’s statements are misleading. The examiner cited multiple paragraphs that the current response does not acknowledge including especially paragraphs [0036] and [0039]. The examiner acknowledges that Gupta does provide polyurethane, SNP and chlorohexidine by extrusion but is also noted that within [0036] and [0039], Gupta also teaches providing SNP, polyurethane and chlorhexidine solutions wherein in [0036] Gupta explicitly states that “extrusions were then dip coated” and goes on to describe a similar composition to that described above. As such, while the examiner does agree that Gupta does teach providing extrusions wherein polyurethane, SNP and chlorohexidine are present, Gupta additionally teaches the claimed impregnation using a solvent wherein it is further noted that the current claims do not exclude the use of a pre-impregnated catheter.
The applicant further argues that an impregnated catheter body inherently possesses a concentration gradient and therefore the catheter of Gupta is structurally different than the one claimed. However, the examiner notes that because Gupta follows the same impregnation step claimed, the prior art impregnated device would reasonably function in the same manner and be the same. Further it is noted that the current claims do not preclude the use of an impregnated catheter. Further, if it the intent of the applicant to claim a catheter having a gradient impregnation it would be appropriate to claim this concept because it is not present in the current claims. Further the applicants arguments stating that impregnated catheters necessarily have concentration gradients appears to be mere conjecture. Factually, the examiner found evidence to refute both the applicant’s assertion that extruded catheters provide uniform drug distribution while impregnated catheters do not within a single reference (see provided reference Dai et al., CN10250033). Dai specifically teaches that extruded medical devices with drugs present in the extrusion mixture are known to provide “uneven distribution of medicine” [0003] and in order to resolve this the prior art provides their alternative solution that provides “uniform distribution of medicine” [0004] using a solvent impregnation method. As such, there is at least conflicting information present in the art that sheds doubt on the inherency arguments of the applicant.
All other arguments provided are in relation to supposed deficiencies present in the prior art of record wherein it is the position of the examiner that the prior art of record is not deficient as described above and as such the current claims should remain properly rejected as they currently are.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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