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) 20-39, 41 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neilan et al. (USPGPub 2017/0203011).
Regarding claim 20-22 and 25,Neilan teaches that it is known to coat medical devices such as stents (cover figure) with a carboxylic acid coating (claim 2) for the purpose of further attaching bioactive compounds which may include rapamycin among other [0066] wherein the drug is intended to be released from the medical device in vivo. Neilan further teaches a coating thickness similar to that claimed [0032] but fails to teach a coating thickness that reads upon the current claims. However, those of ordinary skill in the art would readily recognize that as stated by Neilan, “advantageously the functionalized surface is thin” presumably providing a reduced profile to the exterior of the medical device which will then be pushed through the vascular system, in the case of a stent wherein Neilan further indicates that this thickness can be optimized, especially as relates to stents. Therefore, in the absence of criticality of the specific coating thickness 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 control/optimize the coating thickness of Neilan as guided by Neilan in order to control the coating thickness profile of the functionalization coating of Neilan. Neilan further teaches wherein the reaction that may be employed between active agents and carboxylic acid coatings may result in a Lewis adduct [0072] wherein the lower active agent molecules would form the adduct and additional coating above that would not be in contact with the functionalization coating and would therefore not form an adduct. Neilan further teaches wherein the surface to be treated with a carboxylic acid solution [0104] applied to a metal oxide surface [0074].
Regarding claim 23, Neilan does not require the use of a polymeric matrix for his biomolecule layer [0068-0069]
Regarding claim 24, Neilan teaches the use of several of the carboxylic acids claimed [0077] for his functionalization.
Regarding claim 26, Neilan further teaches wherein the reaction that may be employed between active agents and carboxylic acid coatings may result in a Lewis adduct [0072].
Regarding claim 27-28, Neilan further teaches wherein the medical device to be coated may be a balloon [0078] or a stent [0033-0034].
Regarding claim 29, Neilan further teaches wherein the bioactive agent may further comprise an excipient [0121].
Regarding claims 30-32, 35, Neilan teaches that it is known to coat medical devices such as stents (cover figure) with a carboxylic acid coating (claim 2) for the purpose of further attaching bioactive compounds which may include rapamycin among other [0066] wherein the drug is intended to be released from the medical device in vivo. Neilan further teaches a coating thickness similar to that claimed [0032] but fails to teach a coating thickness that reads upon the current claims. However, those of ordinary skill in the art would readily recognize that as stated by Neilan, “advantageously the functionalized surface is thin” presumably providing a reduced profile to the exterior of the medical device which will then be pushed through the vascular system, in the case of a stent wherein Neilan further indicates that this thickness can be optimized, especially as relates to stents. Therefore, in the absence of criticality of the specific coating thickness 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 control/optimize the coating thickness of Neilan as guided by Neilan in order to control the coating thickness profile of the functionalization coating of Neilan. Neilan further teaches wherein the reaction that may be employed between active agents and carboxylic acid coatings may result in a Lewis adduct [0072] wherein the lower active agent molecules would form the adduct and additional coating above that would not be in contact with the functionalization coating and would therefore not form an adduct. Neilan further teaches wherein the surface to be treated with a carboxylic acid solution [0104] applied to a metal oxide surface [0074].
Regarding claim 33, Neilan does not require the use of a polymeric matrix for his biomolecule layer [0068-0069]
Regarding claim 34, Neilan teaches the use of several of the carboxylic acids claimed [0077] for his functionalization.
Regarding claim 36, Neilan further teaches wherein the reaction that may be employed between active agents and carboxylic acid coatings may result in a Lewis adduct [0072].
Regarding claims 37-38, Neilan further teaches wherein the medical device to be coated may be a balloon [0078] or a stent [0033-0034].
Regarding claim 39, Neilan further teaches wherein the bioactive agent may further comprise an excipient [0121].
Regarding claims 41 and 43 , Neilan further teaches wherein the surface to be treated with a carboxylic acid solution [0104] applied to a metal oxide surface [0074].
Response to Arguments
The applicant argues that the examiner fails to show that the optimized variation in coating thickness “affects device profile in any clinically meaningful way”. It remains the position of the examiner that coating thickness would affect both the deployment and retention of the device and this is clearly understood using a basic understanding of the technology provided and logic. The device is deployed through vascular pathways and must be pushed through those pathways. As such, a wider device (i.e. same device, thicker coating) necessarily presses more on the wall of the vascular pathway through which it is being deployed. Obviously there is some limit to how large the coating can be or the device would rupture the vascular pathway during deployment due to high coating thickness. Further, logically the coating thickness must exist at least at some level to perform its intended function. Therefore adjusting coating thickness within that range would directly affect the deployment of the device. Additionally the devices are held in place by the expansion pressure of the device, wherein the coating thickness would apply additional pressure for the same device size or less depending on coating thickness. It is not to say that this difference it “clinically significant” in a manner such that vast changes would be expected with very small scale changes in coating thickness. However, optimization does not require vast changes. Only a slight change of 1nm that would have an effect in a preferred direction would be considered a very minor optimization. Factually, the Court has established that the burden is on the applicant to show that a variation in range is critical wherein that is the difference between the prior art and the current application. Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). ) “Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies.” See In re Becket, 88 F.2d 684 (CCPA 1937). Further it is noted that the range cited by the applicant regarding Neilan is 10-200nm is inaccurate. Explicitly Neilan states “for instance having a depth around 10 nanometres”. This is not 10-200nm. This is a specific preference around 10nm, which covers a reasonable distance on both sides of 10 nm. In this case, with the overall range being about 10-200nm, it cannot be explicitly stated that 2.2 nm as claimed does not read on the claimed range. However, because it was not explicitly stated that examiner chose to reject the claims using obviousness rationale rather than anticipation rationale in order to address the matter regardless. However, reasonably the applicant should address why 2.2nm is not “about 10nm” in this case, with a broad range claimed.
Further the examiner argued that the result effective variable would affect deployment and retention of the medical device but did not address how this would affect the functioning of the device after deployment. However it is noted that Neilan addresses this himself. Neilan clearly states that excessive amounts of the acid is known to “increase the RSD of the amount of drug applied” [0114] with a minimal amount being necessary to “provide the stated benefits of enhanced drug retention and greater uniformity across the stent” [0118]. Therefore the it is clearly established both by the examiner and by Neilan otherwise that the amount (thickness) of acid applied is a result effective variable.
Further the applicant argues that Neilan teaches away from the claimed coating thickness due to his desire for a uniform surface that would be applied by multiple coating layers. However, Neilan also establishes that “it is not necessary to have an even coating of acid on the stent surface” [0118]. As such, Neilan may in some embodiments prefer a thicker more uniform coating but does not teach away from less uniform coatings.
Further the applicant argues that Neilan fails to teach a “two-layer bioactive agent structure” wherein the applicant further states:
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Below is paragraph [0072] of Neilan:
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Not only does Neilan teach the layer organization claimed, the disclosure of Neilan contains a word-for-word duplicate portion of the description of the layer organization that the applicant states as being “the significance of this two-layer structure”. Seemingly by the applicants own admission, Neilan teaches exactly what the applicant claims to be significant.
As relates to claim 30, the applicant argues that Neilan is silent as to the exclusion of “excess” carboxylic acid. However, stated above, the applicant argues against the “excess” of Neilan by arguing that Neilan teaches a range of 100-170nm of coating thickness. In one example this is true but this is not the stated range of Neilan. Neilan teaches about 10nm in one embodiment. As such, this may reasonably read upon the 2.2nm described by the applicant. However, further still the term “excess” is not truly defined in the current specification. The specification generally guides that around 100nm or more is considered excessive [0092] wherein Neilan teach far less. Further it is also noted that the current specification “0.4 to 10 up to 22 nanometres, in most case just one molecule thick” [0104]. Seemingly even the applicant acknowledges that Neilan teaches the formation of thicknesses that are implicitly in the understood single molecular thickness range.
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
/ROBERT S WALTERS JR/Primary Examiner, Art Unit 1717
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