DETAILED ACTION
Claims 16-33 are currently pending. Claims 16-21 and 25-26 are currently under examination.
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 .
Examiner’s Note
Applicant's amendments and arguments filed 01/27/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 01/27/2026, it is noted that claims 16-21 and 25 have been amended and no new matter or claims have been added.
Modified Rejection:
The following rejection is modified based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 102
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.
Claim(s) 16-21 and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0228617 (Applicant provided).
Regarding claims 16-17 and 25-26, the limitation of a medical device, comprising a coating on at least a portion of the surface thereof, wherein the coating comprises at least one limus substance in non-encapsulated crystalline form, and wherein the at least one crystalline non-encapsulated limus substance: was applied directly from a solution containing a water-miscible organic solvent or a mixture of water-miscible organic solvent and water, optionally drying the at least one limus substance applied as solution according to (i) was slowed down or restricted and wherein the organic solvent is selected from a group including methanol and ethanol is met by the ‘617 publication teaching balloon catheters having a polymer free coating on the balloon surface, said coating comprising at least one limus substance in crystalline form (abstract). The medical device is taught to be an angioplasty balloon catheter [0013]. The limus drug is taught to be zotarolimus [0014]. The limus drugs are brought to crystallization in suitable solvent in a known way [0015]. The limus substance can be dissolved in a polar organic solvent such as ethanol and then the solution can be mixed with the apolar solvent, so that either a supersaturated solution is formed the supersaturated or true solution is applied to the balloon in the absence of crystals and is crystallized there, wherein the balloon surface is further dried or optionally dried [0018] Example 2. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The ‘617 publication teaches angioplasty balloon catheter with a polymer free coating comprising at least one limus substance in an un-encapsuled crystalline form (claim 1), thus teaching the structure of claim 1.
Regarding claim 18, the limitation of the coating further comprises one or more antioxidants selected from a group including butylated hydroxytoluene is met by the ‘617 publication teaching sirolimus and butylhydroxytoluene crystallized and applied to a balloon catheter [0037].
Regarding claim 19, the limitation of the coating further comprises one or more excipients and/or additives is met by the ‘617 publication teaching additional excipients and/or additives, excluding polymers, is applied (claim 7).
Regarding claim 20, the limitation of characterized in that the excipients are antioxidants in proportions of greater than 5 wt% of the limus substance is met by the ‘617 publication teaching the excipients are antioxidants in proportions of greater than 5 wt% of the limus substance (claim 8).
Regarding claim 21, the limitation of characterized in that the excipients are fatty acid salts in the range of 0.5-50 wt% of the limus substance is met by the ‘617 publication teaching the excipients are fatty acid salts in the range of 0.5-50 wt% of the limus substance (claim 9).
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.
Claims 16-17, 19-21 and 26 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,539,369. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘369 patent are directed to angioplasty balloon catheter containing a coating of unencapsulated crystalline limus substance applied to the surface, wherein the coating may include overlapping amounts of excipients such as antioxidants and fatty acid salts, thus teaching the same claimed structure.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
112:
Applicant argues the 112 rejections have been overcome by claim amendments.
In response, Applicant’s amendments have overcome the previously applied 112(b) rejection and thus are withdrawn.
102:
Applicant argues the instant claims have been amended to state “excluding non-polar solvent”. The ‘617 publication (Peters) requires an apolar organic solvent [0015]. To be able to achieve an adequate dose on the balloon surface, solvent mixtures of at least one polar organic solvent and at least one apolar organic solvent may be used. One skilled in the ‘617 publication would understand it fails to disclose excluding an apolar organic solvent form its solvent mixture. Applicant argues the non-polar solvent is essential to achieve sufficient crystallization on the balloon.
In response, the instant claims are product claims. Applicant is arguing the use of a solvent in the process or making the coating, wherein the solvent is not present in the final product but removed through drying. The product claimed is a medical device comprising a coating on at least a portion of the surface where the coating comprises at least one limus substance in non-encapsulated crystalline form. The ‘617 publication is directed to an angioplasty balloon catheter with a polymer free coating on the balloon surface comprising at least one limus substance in an unencapsulated crystalline form (claim 1). Thus the ‘617 publication teaches the claimed structure. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The ‘617 publication teaches angioplasty balloon catheter with a polymer free coating comprising at least one limus substance in an un-encapsuled crystalline form (claim 1), thus teaching the structure of claim 1 wherein the solvent is not present in the final coating.
Applicant argues the ‘617 publication mixtures include ethyl acetate/heptane which evaporate very quickly causing Limus substance to dry very rapidly. The crystallization thereof not as complete as with Limus 3. Due to the delayed drying of Limus 3 almost complete crystallization takes place. This can be demonstrated with dissolution test. Applicant references data.
In response, Attorney’s arguments cannot take the place of factual evidence where in evidence is required. Applicant provides data for dissolution tests in the arguments however has not provided such data in the declaration nor is a portion of the instant specification referenced. Further it is noted that Applicant references delayed drying as a means for the results presented, however in the instant claims delayed or slowed down drying is optional and not required. Thus the presented results are not commensurate in scope with the instant claim.
Double Patenting:
Applicant argues the current claims exclude non-polar solvents. The ‘369 patent requires an “apolar organic solvent”. The ‘369 patent fails to teach at least the exclusion of a non-polar solvent as required by the claims.
In response, the instant claims are product claims. Applicant is arguing the use of a solvent in the process or making the coating, wherein the solvent is not present in the final product but removed through drying. The product claimed is a medical device comprising a coating on at least a portion of the surface where the coating comprises at least one limus substance in non-encapsulated crystalline form. The ‘369 patent is directed to an angioplasty balloon catheter with a polymer free coating on the balloon surface comprising at least one limus substance in an unencapsulated crystalline form (claim 1). Thus the ‘369 patent teaches the claimed structure. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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