DETAILED ACTION
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 .
Applicants' arguments, filed August 22, 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
1) Claims 1-11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Stankus et al. (US 7,824,601).
Stankus et al. disclose medical devices such as stents, including a fibrous layer comprising particles (Abstract). One embodiment of the invention includes a method of fabricating a tubular implantable medical device comprising: electrospinning a polymer fluid through a nozzle to form fibers of the polymer; depositing the fibers over a tubular support to form a tubular fibrous layer; and incorporating particles into the tubular fibrous layer. The medical device includes a stent. It is a cylindrical shaped device which function to hold open and sometimes expand a segment of a blood vessel or other anatomical lumen such as urinary tracts and bile ducts. Stents are often used in the treatment of atherosclerotic stenosis in blood vessels. It may be desirable for a stent to be biodegradable or bioerodible. In many treatment applications, the presence of a stent in a body may be necessary for a limited period of time until its intended function of, for example, maintaining vascular patency and/or drug delivery is accomplished. Therefore, stents fabricated from biodegradable polymers can be configured to completely erode only after the clinical need for them has ended. The stents are a tubular device with a fibrous layer comprising a network of polymer fibers. The fibrous layer may be disposed over a non-fibrous layer. The fibrous layer comprises a network of polymer fibers with particles, which would meet polymer fibers and polymer core. Suitable polymers for the fibrous layer include poly(L-lactide), poly(D,L-lactide), polyglycolide, polycaprolactone, polydioxanone, poly(trimethylene carbonate), poly(4-hydroxybutyrate), poly(ester amides) (PEA), polyurethanes, and copolymers thereof. In particular, poly(L-lactide-co-glycolide) can be used as a fiber material. In some embodiments the fibrous layer can have a coating with a synthetic or natural hydrogel. The hydrogel may include poly(ethylene glycol), poly(vinyl alcohol), polyvinylpyrrolidone, hyaluronan, collagen, gelatin, chitosan, alginate, aloe/pectin, cellulose, or polyNIPAAM. Actives used include anti-inflammatories, hormones and growth factors and vitamins. A support member is used and can be a tubular polymeric or metallic construct on which the fibrous material adheres. The metallic construct may be an alloy and include magnesium alloys. A medicated stent may be fabricated by coating the surface of either a metallic or polymeric scaffolding with a polymeric carrier that includes an active or bioactive agent or drug. Polymeric scaffolding may also serve as a carrier of an active agent or drug. The medicated sting may be coated with a metallic or polymeric scaffolding. Gold is used to coat a stent of the reference (Examples).
Stankus et al. differ from the instant claims insofar as it does not exemplify a stent with a metal support covered with polymer fibers and coated with a hydrogel.
However, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made a metal alloy support and coated the support with a fibrous layer and a hydrogel layer because it is suggested by Stankus et al.
In regards to the amount of lactide proportion, the polymer thickness would control drug release when the drug is in the polymer layer, making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of lactide coating on a support in order to yield the desired thickness and drug release. See MPEP 2144.05.
In regards to claim 11, the device comprises a polymer and hydrogel layer, therefore it would have been reasonable to conclude that the adhesive of the sleeve can adhere to balloon of a balloon catheter.
Response to Arguments
The Examiner submits that in regards to the support being expandable, Stankus discloses the implants disclosed therein are expandable. In regards to the sleeve, the claims recite that the sleeves are applied to the outer side of the expandable supporting structure. This would include a coating. Further the claims are broad and they do not specifically recite that the sleeves cannot be coatings. In regards to the supporting structure having a coating as well as a sleeve, Stankus discloses that the supporting structure has a coating. Stankus discloses that the fibrous layer may be applied over a nonporous layer. This would meet the limitations of the implant have a coating (non-fibrous layer) and a sleeve (fibrous layer). In regards to the order of making the expandable structure and the sleeve of the instant claims, the claims do not appear to recite the order of making each part. In regards to the figure, sleeves may also encompass coatings. Therefore the figures of Stankus does not teach away from the instant claims. In regards to the fibrous layer surrounding the support, Figure 4 indicates that surrounding the expandable support with a fibrous layer is contemplated.
2) Claims 1-2 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Stankus et al. (US 7,824,601) in view of Imwinkelried et al. (US 9,593,397).
Stankus et al. are discussed above and differ from the instant claims insofar as they do not disclose the magnesium alloy composition.
Imwinkelried et al. disclose An alloy and an implant having a three-dimensional structure based on such alloy. The alloy comprises a MgZnCa alloy containing nanosized precipitates being less noble than the Mg matrix alloy and having a Zn content ranging 0.1 wt. % Zn to 2 wt. % Zn and a calcium content ranging from 0.2 wt. % to 0.5 wt. %, and having less than 0.04 wt. % of one or more other elements with the remainder being Mg. The alloys are suitable for implants such as stents. The major goals are to control the degradation rate, to avoid the formation of gas bubbles during degradation and to avoid potentially harmful alloying elements. Therefore, a need exists for magnesium alloys with a homogenous degradation behavior whose rate of degradation can be controlled and/or tuned as desired.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used the magnesium alloy, MgZnCa, because it is a suitable alloy for stents and to control the degradation rate of the implant and avoiding potentially harmful alloying elements.
Response to Arguments
The Examiner submits that the response applied above are also applied here. Imwinkelried et al. cure the deficiencies of the instant claims by disclosing different magnesium alloys such as MgZnCa, are suitable alloys for stents. Therefore, the rejection is maintained.
Obvious-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1) Claims 1-11 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-16 and 18-19 of copending Application No. 17/779,535 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the sets of claims are coextensive insofar as they are both drawn to intraluminal endoprosthesis comprising a support structure, and polymer fibers. The instant claims differ from the copending claims insofar as they do not recite a method whereas the copending claims recite a method. However, it would have been obvious to have made the product of the instant claims with the method of the copending claims because the copending claims recite a method of making an intraluminal endoprosthesis, which the product of the instant claims is, and because the product made has the same components as the product of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Examiner submits that although the compositions of the copending claims do not recite hydrogel, the claims use the transitional language of “comprises” and therefore does not exclude hydrogels from being used in the recited method.
2) Claims 1-11 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/780,144 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the sets of claims are coextensive insofar as they are both drawn to intraluminal endoprosthesis comprising a support structure, polymer fibers to form a sleeve for the support and hydrogel fibers. The instant claims differ from the copending claims insofar the copending claims are more specific about the position of the sleeve. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Examiner submits that there appears to be no terminal disclaimer filed. Therefore the rejection is maintained.
Conclusion
Claims 1-11 and 13-16 are rejected.
No claims allowed.
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 LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612