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.
Claim(s) 15, 17, 19, 21-22, 24-27, 29-34 and 36 is/are rejected under 35 U.S.C. 103 as being obvious over Sarasam et al. (US8642063) in view of Yamashita et al. (USPGPub 2015/0328369).
Regarding claims 15, 17, 19, 21-22, 24-27, 33-34 and 36, Sarasam teaches that it is known to coat stents (claim 19) and balloons (claim 11) with a layer consisting of pyrolytic carbon (see Coating Uniformity and Durability section) followed by a layer consisting of paclitaxel (claim 1). Further, although Sarasam does not state that the carbon layer is hydrolyzed as claimed, it is noted in the current specification that the hydrolysis occurs in such a manner “that once exposed to the atmosphere, the carbon layer may become hydrolyzed and/or hydroxylized, that is that there may be formed C-OOH carboxylic functional groups within the carbon layer”. Therefore reasonably because Sarasam does not teach the avoidance of exposure to air or common atmospheric conditions, it is reasonably implicit that this action would necessarily proceed in the invention of Sarasam without steps being taken to prevent it and the product of Sarasam would also have C-OOH groups present on the surface as claimed. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. Inherency is not established by probabilities or possibilities. In re Robertson, 49 USPQ2d 1949 (1999). Further it is noted that Sarasam teaches that the elastomer topcoat of his invention is “positioned over and covering at least a portion of the first layer” wherein “each coating layer can be applied to a portion of a surface or can be applied continuously over the entire surface” (col. 7, line 63 through col. 8, line 12). Therefore reasonably Sarasam reasonably implies that all of the layer of therapeutic agent provided must be covered and only a portion of that layer need be covered such that in at least some area the drug layer of Sarasam may be the outermost layer over the coating surface in the coated medical device ready for implantation. The teachings of Sarasam are as shown above. Sarasam fails to teach wherein the layer of paclitaxel comprises an excipient such as urea. However, Yamashita teaches that it is known to incorporate urea into paclitaxel drugs layers for the coating of balloon catheters [0117]. 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 the urea of Yamashita in the paclitaxel layers of Sarasam for coating medical balloon catheters as a use of a known excipient addition technique applied to a similar device having the same type of drug layer with no excipient to improve those devices in the same way.
Regarding claims 29-32, urea is known to speed up the release of drugs when employed as an excipient which is also acknowledged by the current specification.
Response to Arguments
Regarding the applicants’ arguments it is noted that no claims are currently rejected under 102 and as such, generally the provided 102 arguments are moot. However, within those arguments the applicant notes that Sarasam’s silence on the hydrolyzation of the pyrolytic carbon of does not necessarily always lead to the claimed first layer. The applicant goes on to say that it is possible to form the pyrolytic carbon of Sarasam without exposure to carbon. The examiner agrees that it is possible under certain circumstances, but it must be acknowledged that these circumstances would require additional steps to be taken that would include avoiding standard conditions involving air existing within Earth’s atmosphere generally in all locations wherein steps are not taken to remove it. In the case of Sarasam, there is no teaching of the removal of air from his process after the formation of the pyrolytic carbon and therefore it is reasonably implied that it is present. It is a requirement of the examination that the examiner consider what is both literally stated and implied by the references. If it is the position of the applicant that the prior art does not reasonably imply that air was present or that there is evidence that air was removed from the process of Sarasam leading to a different product than that claimed, then the examiner would consider those arguments. However, they are not present in the current response to the examiner’s rejection.
Further the applicant argues that there is no reason to modify Sarasam with Yamashita because Sarasam already controls the release of material from his invention through the use of a release layer. However, it is reasonable for prior art to control the release of drugs in more than one way in order to provide complex release profiles. Factually the release of drugs from the medical device is already controlled in a plurality of way other than just through the use of a release layer. Release is controlled by the material chosen and the processes used to coat them onto the surfaces of the implant including the plurality of layers employed. Further, the exclusion of materials and impurities further affects release profiles. As such, Sarasam controls the release of drugs in a plurality of ways already and providing an additional control release mechanism is not precluded by the invention of Sarasam and is shown to be obvious herein in view of Yamashita as argued by the examiner.
Conclusion
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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/ANDREW J BOWMAN/Examiner, Art Unit 1717