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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, which recite the term “optionally”, on line 7; however, this term renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention, or not. Furthermore, the term “fibering agent”, on line 7, is found to be confusing since it is not clear what exactly this term means; is it an agent that causes fibers/fibering, or is it specifically fibers in the polymer, or is it something else complete different. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention. Furthermore, line 8 recites the limitation(s) of either: “the proximal” and “the distal end portions”, or “the proximal and the distal end portions”; however, there is insufficient antecedent basis for this/these limitation(s) in the claim. In order to overcome this issue, and keep claim terminology consistent, it is suggested the above mentioned limitation(s) be amended to state either: “the proximal and distal end portions” or “the proximal end portion and the distal end portion”.
Regarding claims 6, 11 and 14, which recite the term “optionally”, on line 2 of claim 6, line 3 of claim 11 and lines 9 and 13 of claim 14; this term “optionally” renders the claims indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention, or not.
Regarding claim 7, which recites the limitation(s) of either: “the proximal” and “the distal end portions”, or “the proximal and the distal end portions”; however, there is insufficient antecedent basis for this/these limitation(s) in the claim. In order to overcome this rejection, and keep claim terminology consistent, it is suggested the above mentioned limitation(s) be amended to state either: “the proximal and distal end portions” or “the proximal end portion and the distal end portion”.
Regarding claim 9, which recites the parameter of “a concentration from 1 to 10mg/mm2 of coated surface, in particular from 2 to 5mg/mm2 of coated surface” (emphasis added); however, this parameter is found to be confusing since it is not clear which concentration range would actually be needed in order to meet the claimed invention. Specifically, would a concentration of 1mg/mm2 or 8 mg/mm2 meet the claimed invention, or does the concentration need to be within 2-5mg/mm2. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 1-13, 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, 7-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Banas et al. (US Patent No. 6,124,523), hereinafter Banas, in view of Nolting (US PG Pub. 2006/0210600).
Regarding claims 1-5, 7, 8 and 11, Banas discloses a stent (200), illustrated in Figure 9, comprising an expandable structural scaffold (210) 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 (216&218); a lining (212/214) arranged only at the central portion so that the central portion is covered by the lining and the end portions are free from the lining; wherein the lining (212/214) comprises an inner lining layer (212) covering a luminal surface of the central portion of the structural scaffold and an outer lining layer (214) covering an abluminal surface of the central portion of the structural scaffold; wherein the lining comprises a biocompatible thermoplastic polymer, specifically expanded polytetrafluoroethylene (ePTFE); wherein the central portion of the structural scaffold and the lining are drug-free (Column 12, Line 65 – Column 13, Line 30); but does not teach the proximal and distal end portions being coated with a drug-containing coating comprising a biodegradable polymer, a Limus drug and a second active agent.
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), and a second active agent 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 Banas, to be coated with a drug-containing coating comprising a biodegradable/bioerodable polymer, a Limus drug, specifically sirolimus (rapamycin), and a second active agent 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 9, Banas 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, specifically 2 to 5 mg/mm2, of coated surface, 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, specifically 2 to 5 mg/mm2, of coated surface, 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, or 2 to 5 mg/mm2, as opposed to any other concentration.
Regarding claim 10, Banas 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, Banas 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).
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Banas in view of Nolting as applied to claims 1 and 11 above, and further in view of Brodbeck et al. (US PG Pub. 2007/0179599), hereinafter Brodbeck.
Regarding claim 6, Banas 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 Banas 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.
Regarding claim 12, Banas in view of Nolting disclose the drug-eluting stent according to claim 11, but do not specifically disclose the second active agent is 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 heparin ([0018], about a quarter way down in the 3rd column).
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 second active agent, including heparin, since this is a well-known drug used in drug-eluting stent and is well-known anti-coagulant which would aid in reducing/preventing blood clots.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Banas in view of Nolting and Berg et al. (US Patent No. 5,464,650), hereinafter Berg.
Regarding claim 14, Banas discloses a method of manufacturing stent (200), illustrated in Figure 9, comprising providing an expandable structural scaffold (210) 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 (216&218); covering only the central portion of the structural scaffold with a lining (212/214) of a biocompatible thermoplastic polymer so that the end portions are free from the lining (Column 12, Line 65 – Column 13, Line 30); but does not teach preparing a coating solution comprising a biodegradable polymer, a Limus drug, and a solvent, 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 and a Limus drug (sirolimus/rapamycin) on distal and proximal portions of the stent, illustrated in Figures 1 and 2 (Nolting: [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 (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 Banas 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, as taught by Nolting, , thereby resulting in a method of manufacturing a drug-eluting stent.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Banas 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 disclosed in the IDS dated 07/27/2023, hereinafter Ballard.
Regarding claim 15, Banas in view of Nolting and Berg disclose the method of claim 14, wherein Banas further teaches the biocompatible thermoplastic polymer, of the lining (212/214), is PTFE (Banas: Column 13, Lines 6-9); but does not specifically disclose the covering/applying of the lining is performed 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 Banas 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.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/06/2026