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 .
Status of Claims
This office action is responsive to the amendment filed on 05/13/2026. As directed by the amendment: claims 1, 6, 7, 9-11, 13 and 14 have been amended, no claims have been cancelled and new claims 16-20 have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 1-13, 17 and 18, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 7-10, 13, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Evans et al. (WO 02/24247 A1), hereinafter Evans, in view of Nolting (US PG Pub. 2006/0210600), as previously disclosed.
Regarding claims 1, 2, 4, 5, 7 and 8, Evans discloses a stent (10), illustrated in Figure 1, comprising an expandable structural scaffold (20) configured to resist radial compression when disposed in a lumen of a patient, the structural scaffold comprising a central portion arranged between proximal and distal end portions (22a&22b), the structural scaffold (20) having an expanded condition and a compressed condition; a lining (22) arranged only at the central portion so that the central portion is covered by the lining (22) and the end portions (22a&22b) are free from the lining; wherein the lining (22) comprises a biocompatible thermoplastic polymer, specifically polytetrafluoroethylene (PTFE) and/or expanded polytetrafluoroethylene (ePTFE); wherein the central portion of the structural scaffold and the lining (22) are drug-free, and wherein when in the expanded condition, the structural scaffold (20) has a substantially constant diameter between proximal and distal ends (22a&22b) of the structural scaffold (20), illustrated in Figure 1 (Pgs.13-15); but does not teach the proximal and distal end portions being coated with a drug-containing coating comprising a biodegradable polymer and a Limus drug.
However, Nolting teaches a stent, in the same field of endeavor, which comprises a drug-containing coating, comprising a biodegradable/bioerodable polymer, a Limus drug, specifically sirolimus (rapamycin), on a luminal/abluminal/both surface(s) of distal and proximal portions of the stent and no drug-containing coating on a central portion (between the distal and proximal portions) of the stent, illustrated in Figures 1 and 2 ([0018] & [0021], Lines 3-5); the drug-containing coating on the distal and proximal portions aids in inhibiting stenosis at/adjacent the ends of the stent ([0001] & [0008]).
In view of the teachings of Nolting, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the proximal and distal end portions, of the stent of Evans, to be coated with a drug-containing coating comprising a biodegradable/bioerodable polymer and a Limus drug, specifically sirolimus (rapamycin), on a luminal/abluminal/both surface(s) of the distal and proximal portions, in order to aid in inhibiting stenosis at/adjacent the ends of the stent, as taught by Nolting, thereby resulting in a drug-eluting stent.
Regarding claim 3, Evans in view of Nolting disclose the drug-eluting stent according to claim 1, wherein Evans further teaches the structural scaffold (20) comprises a luminal surface and an abluminal surface, and wherein the lining (22) comprises an inner lining layer (22) covering the luminal surface of the central portion of the structural scaffold and/or an outer lining layer (22) covering the abluminal surface of the central portion of the structural scaffold, illustrated in Figures 2a-2c (Evans: Pg. 20, Last 7 Lines).
Regarding claims 9 and 18, Evans in view of Nolting disclose the stent according to claim 1, and though it is not specifically disclosed that the Limus drug has a concentration from 1 to 10 mg/mm2, more specifically 2 to 5 mg/mm2, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention determine an appropriate concentration of the Limus drug on the coated surface, including 1 to 10 mg/mm2, more specifically 2 to 5 mg/mm2, based on intended use, and/or specific patient need; and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the concentration of the Limus drug on the coated surface being 1 to 10 mg/mm2, more specifically 2 to 5 mg/mm2, as opposed to any other concentration.
Regarding claim 10, Evans in view of Nolting disclose the stent according to claim 1, and though it is not specifically disclosed that the biodegradable polymer and the Limus drug are in a weigh ratio from 1.7:1 to 3.5:1, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention determine an appropriate weigh ratio between the biodegradable polymer and the Limus drug, including from 1.7:1 to 3.5:1, based on manufacturing process(es), and/or intended use, and/or specific patient need; and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the drug-containing coating having a weigh ratio between the biodegradable polymer and the Limus drug being from 1.7:1 to 3.5:1, as opposed to any other ratio.
Regarding claim 13, Evans in view of Nolting disclose the drug-eluting stent according to claim 1, and though it is not specifically disclosed that the structural scaffold has a length from 40 to 100 mm and the drug-coated proximal and distal end portions each have a length from 0.5 to 30 mm, these parameters are deemed to be a mere matter of normal design choice and/or intended use. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention determine an appropriate length for the structural scaffold and/or each of the proximal and distal end portions, including 40 to 100mm and 0.5 to 30mm, respectively, based on specific patient need; and such a modification would involve a mere change in the size of a component, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Regarding claim 16, Evans in view of Nolting disclose the drug eluting stent according to claim 1, wherein Evans further teaches the lining (22) further comprising a fibering agent, specifically polyethylene oxide (Evans: Table 2 on Pg. 17 & Pg. 18, 2nd Paragraph).
Claims 6, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Nolting as applied to claim 1 above, and further in view of Brodbeck et al. (US PG Pub. 2007/0179599), as previously disclosed, hereinafter Brodbeck.
Regarding claim 6, Evans in view of Nolting disclose the drug-eluting stent according to claim 1, but do not specifically disclose the biodegradable/bioerodable polymer is a poly a-hydroxy acid.
However, Brodbeck teaches that it is well known in the art that a poly a-hydroxy acid, specifically poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), poly-lactic acid, polyglycolic acid (PGA), and poly (lactide-co- glycolic acid) (PLGA), are biodegradable/bioerodable polymers.
In view of the teachings of Brodbeck, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to pick an appropriate biodegradable/bioerodable polymer, for the drug-containing coating of the stent of Evans in view of Nolting, including a poly a-hydroxy acid, specifically poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), poly-lactic acid, polyglycolic acid (PGA), or poly (lactide-co- glycolic acid) (PLGA); since these are well known biodegradable/bioerodable polymers in the art, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Regarding claims 11 and 12, Evans in view of Nolting disclose the drug-eluting stent according to claim 1, wherein Nolting further teaches the drug-containing coating further comprises a second active agent (Nolting:[0009]); but do not specifically disclose the second active agent is an anticoagulant agent, specifically heparin.
However, Brodbeck teaches a drug-eluting stent, in the same filed of endeavor, wherein multiple drugs/active agents can be used/coated on a medical device/stent, including an anticoagulant agent such as heparin ([0018], about a quarter way down in the 2nd and 3rd columns).
In view of the teachings of Brodbeck, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention for the second active agent, of the drug-containing coating of the drug-eluting stent of Evans in view of Nolting, to be an anticoagulant agent, specifically heparin, in order to reduce/prevent blood clots.
Claims 14, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Nolting and Berg et al. (US Patent No. 5,464,650), as previously disclosed, hereinafter Berg.
Regarding claims 14 and 20, Evans discloses a method of manufacturing stent (10), illustrated in Figure 1, comprising providing an expandable structural scaffold (20) configured to resist radial compression when disposed in a lumen of a patient, the structural scaffold comprising a central portion arranged between proximal and distal end portions (22a&22b), wherein the structural scaffold (20) has an expanded condition and a compressed condition, and when in the expanded condition, the structural scaffold (20) has a substantially constant diameter between proximal and distal ends of the structural scaffold; covering only the central portion of the structural scaffold with a lining (22) of a biocompatible thermoplastic polymer so that the end portions (22a&22b) are free from the lining, illustrated in Figure 1 (Pgs.13-15); but does not teach preparing a coating solution comprising a biodegradable polymer, a Limus drug, a solvent and a second active agent, and applying the coating solution to the proximal and distal end portions of the structural scaffold.
However, Nolting teaches a method of manufacturing a stent, in the same field of endeavor, which comprises a drug-containing coating, comprising a biodegradable/bioerodable polymer, a Limus drug (sirolimus/rapamycin) and a second active agent on distal and proximal portions of the stent, illustrated in Figures 1 and 2 (Nolting: [0009]; [0018] & [0021], Lines 3-5); the drug-containing coating on the distal and proximal portions aids in inhibiting stenosis at/adjacent the ends of the stent and releasing multiple different drugs/agents (Nolting: [0001] & [0008]). Furthermore, Berg teaches that it is well-known in the art of manufacturing a coated stent for the coating solution comprising a solvent, in addition to a polymer and drug; the solvent aids in dissolving the polymer and drug into a solution to apply to the stent (Berg: Column 2, Lines 24-36 & Column 3, Lines 52-65).
In view of the teachings of Nolting and Berg, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of Evans to further comprise creating a coating solution comprising a biodegradable polymer, a Limus drug, and a solvent (the solvent aiding in dissolving the polymer and drug into a solution, as taught by Berg), and applying the coating solution to the proximal and distal end portions of the structural scaffold, in order to aid in inhibiting stenosis at/adjacent the ends of the stent and releasing multiple different drugs/agents, as taught by Nolting, thereby resulting in a method of manufacturing a drug-eluting stent.
Regarding claim 19, Evans in view of Nolting and Berg disclose the method of claim 14, and though it is not specifically disclosed that the structural scaffold has a length from 40 to 200 mm and the drug-coated proximal and distal end portions each have a length from 0.5 to 30 mm, these parameters are deemed to be a mere matter of normal design choice and/or intended use. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention determine an appropriate length for the structural scaffold and/or each of the proximal and distal end portions, including 40 to 200mm and 0.5 to 30mm, respectively, based on specific patient need; and such a modification would involve a mere change in the size of a component, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Nolting and Berg as applied to claim 14 above, and further in view of Ballard et al. (US PG Pub. 2016/0296351), as previously disclosed, hereinafter Ballard.
Regarding claim 15, Evans in view of Nolting and Berg disclose the method of claim 14, wherein Evans further teaches the biocompatible thermoplastic polymer of the lining (22) is PTFE (Evans: Pg. 15, Table 1); but does not specifically disclose covering/applying the lining by electrospinning.
However, Ballard teaches a method of applying a PTFE lining to a stent by electrospinning; such a process allows for control of the thickness, density, porosity and other characteristics of the lining ([0025]).
In view of the teachings of Ballard, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of Evans in view of Nolting and Berg to further comprise covering/applying the lining by electrospinning, since electrospinning allows for control of the thickness, density, porosity and other characteristics of the lining, as taught by Ballard.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Nolting as applied to claim 1 above, and further in view of Ballard.
Regarding claim 17, Evans in view of Nolting disclose the drug eluting stent according to claim 1, wherein Evans further teaches the biocompatible thermoplastic polymer is PTFE (Evans: Pg. 15, Table 1); but does not specifically disclose the PTFE is electrospun.
However, Ballard teaches a drug eluting stent (100), in the same field of endeavor, comprising a lining (210/220) of electrospun PTFE, illustrated in Figure 2A ([0035] & [0037]); the process of electrospinning allows for control of the thickness, density, porosity and other characteristics of the lining ([0025]).
In view of the teachings of Ballard, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the PTFE thermoplastic polymer, of the lining of the drug eluting stent of Evans in view of Nolting, to be electrospun PTFE, since electrospinning allows for control of the thickness, density, porosity and other characteristics of the lining, as taught by Ballard.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendments, Examiner now cites the prior art of Evans, in addition to the prior art of Nolting and Berg; rejecting independent claim 1, and those claims that depend from it, as being unpatentable over Evans in view of Nolting, and rejecting independent claim 14, and those claims that depend from it, as being unpatentable over Evans in view of Nolting and Berg.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/25/2026
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