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 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Geng et al. (USPGPub 2015/0273109) in view of Meyer-Kobbe et al. (USPGPub 2020/0139017) and Wadsworth et al. (USPGPub 2020/0330647).
Regarding claims 1 and 12, Geng teaches coating a magnesium alloy stent or orthopaedic implant [0012] with silk fibroin [0014-0016] which may further comprise a magnesium oxide layer between and the coating layer [0019] and wherein the transition layer may have a thickness in the range claimed [0040]. Further it is noted that Geng further teaches wherein the polymeric coating layer may comprise mixtures of polymers [0016]. Geng fails to teach wherein the coating layer comprises polydopamine. However, Meyer-Kobbe teaches that polydopamine is a known substitute for poly(L-lactide) and a plurality of other polymers employed as the polymeric layers for the coating of magnesium stents (see claims 1 and 2). 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 all or a portion of the polymer of Geng which may be silk fibroin which may be used in combination with poly(l-lactide) with polydopamine as guided by Meyer-Kobbe as a simple substitution of one known polymer for the coating of magnesium implants for another wherein the results of the substitution would be predictable and expected to succeed based upon the teachings of Meyer-Kobbe. Further the current claims would read upon separating the single coating step of providing the layer of Geng in view of Meyer-Kobbe into two steps wherein the Court has long held that the mere splitting of one process step into two wherein the processes are substantially identical or equivalent in terms of function, manner and result is held to not patentably distinguish the processes. See Ex parte Rubin, 128 USPQ 440 (Bd. Pat. App. 1959). See also In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results). Geng in view of Meyer-Kobbe fails to teach wherein the polymer further comprises cellulose nanocrystal. However, Wadsworth teaches to incorporate cellulose nanocrystals into biocompatible coatings for medical devices [0155]. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the cellulose nanocrystal of Wadsworth and the implantable coating of Geng according to the known combining method of including agents in the coatings already provided by Geng alone wherein the results of the combination would have been predictable based upon the teachings of Wadsworth.
Regarding claim 10, the Wadsworth teaches using 5% CNC compared to the alginate polymer that it is combined with which would read upon using “about … 3wt%”.
Regarding claim 11, the examiner argued above that the combination of two layers of the current application may be the same as the singular layer of Geng. Further Geng teaches wherein the overall coating thickness would read upon the coating thickness claimed for the combination of both coatings. Further the coating process of Geng may be repeated many times or broken down many arbitrary times or referenced in such a way that many layers could read upon one layer. As such, the breakdown of the thickness of the layers does not seemingly distinguish the product of the current claims over the prior art of Geng without reasonably some unexpected result arising from dividing the coating arbitrarily over two thickness instead of many wherein the sum may be the same and read upon the currently claimed range.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Geng et al. (USPGPub 2015/0273109) in view of Meyer-Kobbe et al. (USPGPub 2020/0139017) and Wadsworth et al. (USPGPub 2020/0330647) as applied to claims 1 and 10-12 above and further in view of Sasaki et al. (USPGPub 2018/0264180).
Regarding claims 7-9, the teachings of Geng in view of Meyer-Kobbe and Wadsworth are a shown above. Geng in view of Meyer-Kobbe and Wadsworth teaches the use of magnesium alloys but fails to explicitly teach those cited herein. However, Sasaki teaches that AZ31 is a known magnesium alloy used for the manufacture of stents (title)[0199]. 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 AZ31 of Sasaki for the magnesium alloy of Geng in view of Meyer-Kobbe and Wadsworth as a simple substitution of one known magnesium alloy for the purposes of forming stents for another wherein the substitution would provide predictable results with an expectation of success based upon the teachings of Sasaki.
Response to Arguments
The applicant argues that Geng fails to teach the entirety of the claim limitations wherein the Court has long held that arguments attacking a single reference for failing to teach limitations provided in a 103-type obviousness rejection by a plurality of references is insufficient for overcoming a prima facie case of obviousness.
As relates to the teachings of Meyer-Kobbe as to the replacement of poly-l-lactide with polydopamine the list provided by Meyer-Kobbe does reasonably support the replacement of one polymer with the other as asserted. It may be reasoned from the laundry list of Meyer-Kobbe that the choice of polymer may largely be inconsequential or may fall within a very large grouping. If it is the position of the applicant that this is not the case with their invention, then arguments should be made with regards to the value of polydopamine in their invention and the unexpected results provided. Otherwise, it would seem that the choice of polymer is also largely inconsequential in the current application and as such replacement would also be reasonable there.
Further the applicant argues that Meyer-Kobbe teaches away from placing his coating on an oxide layer but this statement is not supported. Placing a coating directly on a stent surface, wherein it is noted that most common stent metals including titanium, stainless and nitinol all form oxide layers in air, does not in anyway teach away from placing a coating on an oxide layer of a surface and those of ordinary skill in the art would recognize that this is largely what takes place in the art even when not stated. A teaching away is not merely a statement of doing something that is not identical. It is a teaching that would explicitly lead one to avoid performing an operation. Further Meyer-Kobbe was not applied for the manner in which it provides it layers. It was cited for the known possibility of substitution of polymers in the art. If the manner in which Meyer-Kobbe uses these materials makes them non-substitutable then that would seemingly be pertinent but the manner in which Meyer-Kobbe provides other layers is largely non-pertinent. The layer structure of the device argued was provided by Geng.
As relates to the use of Wadsworth, the applicant argues that Wadsworth is related meniscus implants and Geng is related to stents and therefore the teachings of each are not pertinent to the other. However, Geng is related to orthopedic implants primarily [0002] which would read upon meniscus implants. Stents are a minor area of the invention of Geng. The examiner even cited in the action that Geng teaches orthopedic implants. As relates to the results of the combination being predictable based upon the teachings of Wadswoth, Wadsworth teaches a specific desire to include nanocrystalline cellulose into orthopedic implants comprising polymers. These teachings would strongly indicate to one of ordinary skill in the art that such inclusion could take place in other orthopedic implants comprising polymers and that the outcome would be predictable. A lack of teaching of these similarities would seemingly make it more difficult to assume that outcomes would be similar but as the overlap between the arts applied becomes greater, so too should the predictability of combining these arts. The applicant makes reference to Geng very narrowly as related to cardiovascular implants but when the Geng reference is taken as a whole, Geng is primarily drawn to the same over-arching type of implants used in the same bodily locations and comprising some of the same types of materials. As such, the extent of overlap of these arts makes their combination substantially more predictable than set forth by the applicant.
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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/ANDREW J BOWMAN/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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