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 .
Allowable Subject Matter
The indicated allowability of claim 7-8, 10 and 14 is withdrawn in view of the newly discovered reference(s) to Wang et al. U.S. Publication 2011/0202126 A1 and Weber et al. WO2004/069169 A2. Rejections based on the newly cited reference(s) follow.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4, line 3 includes the recitation “amorphous calcium magnesium phosphate” however, in the specification, the particles are amorphous magnesium phosphate or amorphous calcium phosphate not amorphous calcium magnesium phosphate. Appropriate correction is required.
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 3, 5-6, 8 and 10 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.
Claim 3 includes the limitation “wherein the material is selected from..,” however it is unclear which material is being referred back to in claim 1 as claim 1 was amended to further include a coating comprising a material. Therefore, claim 1 includes a stent having a material and a coating comprising a material. For examination purposes it is assumed the material referred to in claim 3 is regarding the stent material.
Claim 5 recites “wherein the material,” however, it is unclear which material is being referred to. In this case since the claim recites the material and the nanoparticles it is assumed the material is referring to the stent material.
Claim 6 recites the limitation “wherein the coating material” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: polylactic. Claim 8 includes the limitation and the nanocapsules co-glycolic acid. The specification provides support for “the stent may include a polyvinyl alcohol coating with polylactic-co-glycolic acid nanocapsules,” therefore the element polylactic is an omitted essential element.
Claim 10 recites the limitation “wherein the coating material” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 3-4, 6, 8-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. U.S. Publication 2011/0202126 A1 in view of Weber et al. WO2004/069169 A2.
Claim 1, Wang et al. discloses a stent 100 as seen in Figure 1A comprising a material 170 selected from a biocompatible material, a bioabsorbable material, and combinations thereof (p. 13, 15-17, 30, 52, 60-61, 63, 65, 139); particles selected from biocompatible amorphous particles, bioabsorbable amorphous particles and combinations thereof (particles formed from hydroxyapatite, see Wang et al. p. 52 which applicant discloses as an amorphous particle, see claim 4 below); and a coating comprising a material selected from a biocompatible material, a bioabsorbable material (p. 12, 29, 85 and 148) and a therapeutic agent in the coating (p. 12, 29). However, Wang et al. does not expressly disclose the therapeutic agents are encapsulated in a nanocapsules, wherein the nanocapsules are selected from the group of glycolic acid, lactic acid, lactic-co-glycolic acid, polylactic-co-glycolic acid, polycaprolactone, chitosan, and mixtures thereof and a therapeutic agent encapsulated in the nanocapsules. Weber et al. teaches a stent in the same field of endeavor (p. 12-13) formed of a polymer and having a biodegradable coating layer disposed over the surface of the stent, wherein the biodegradable coating comprises nanocapsules (p. 12-13, 62), the nanocapsules includes a drug and a wall formed from PGA, PLA, PCL, PLGA, chitosan (p. 26-27, 34) for the purpose of providing nanocapsules having a multilayer shell that is degradable to impart thickness and permeability to provide controlled drug release profile of the drug via the dissolution of the capsule walls (p. 27, 34, 42). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s coating containing a therapeutic drug to further include nanocapsules that contains the drugs as taught by Weber et al. for the purpose of providing a nanocapsule having a multilayer shell that impart thickness and is degradable to provide controlled release profile to the drugs and further protect the
Claim 3, Wang et al. discloses wherein the material is selected from the group including glycolic acid, lactic acid, lactic-co-glycolic acid, polylactic-co-glycolic acid, polycaprolactone, chitosan and combinations thereof (p. 60-61, 63, 139).
Claim 4, Wang et al. discloses wherein the particles are amorphous and are selected from the group of amorphous magnesium phosphate, amorphous calcium magnesium phosphate, hydroxyapatite, magnesium hydroxide, magnesium oxide and mixtures thereof (particles formed from hydroxyapatite, see Wang et al. p. 52 and 75).
Regarding Claim 6, Wang et al. does not expressly disclose the material for the coating is a polyvinyl alcohol. Weber et al. teaches a stent in the same field of endeavor (p. 12-13) formed of a polymer and having a biodegradable coating layer disposed over the surface of the stent and is formed from polyvinyl alcohol (p. 63) for the purpose of having a biocompatible material and can swell and soften inside the body to enhance the patient comfort (as evidenced by prior art Ronan et al. U. S. Patent 6060,534 (described in Weber, p. 64), see Ronan abstract and column 1, lines 54-61). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s coating to further include polyvinyl alcohol as taught by Weber et al. for the purpose of having a biocompatible material and can swell and soften inside the body to enhance the patient comfort.
Regarding Claim 8, Wang et al. does not expressly disclose wherein the material is polyvinyl alcohol and the nanocapsules are formed from polylactic-co-glycolic acid. Weber et al. teaches a stent in the same field of endeavor (p. 12-13) formed of a polymer and having a biodegradable coating layer disposed over the surface of the stent and is formed from polyvinyl alcohol (p. 63) for the purpose of having a biocompatible material and can swell and soften inside the body to enhance the patient comfort (as evidenced by prior art Ronan et al. U. S. Patent 6060,534 (described in Weber, p. 64), see Ronan abstract and column 1, lines 54-61) and wherein the biodegradable coating comprises nanocapsules (p. 12-13, 62), formed from polylactic-co-glycolic acid (p. 34) for the purpose of having nanocapsules having a biodegradable capsule wall and having controlled dissolution of the capsule walls of the nanocapsule (p. 34). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s coating to further include polyvinyl alcohol as taught by Weber et al. for the purpose of having a biocompatible material and can swell and soften inside the body to enhance the patient comfort and having nanocapsules formed from polylactic-co-glycolic acid for the purpose of having nanocapsules having a biodegradable capsule wall and having controlled dissolution of the capsule walls of the nanocapsule.
Regarding Claim 9, Wang et al. discloses a representative sphere diameter of the particles is between 1 nm and 1 micrometer (p. 101 and 150).
Claim 11, Wang et al. discloses the therapeutic agent is selected from the group including consisting of antiproliferative agents, anti-inflammatory agents and combinations thereof (p. 148).
Claim 12, 13, Wang et al. does not expressly disclose wherein the therapeutic agent is selected from the group including consisting of Paclitaxel and Curcumin. Weber et al. teaches a stent in the same field of endeavor (p. 12-13) formed of a polymer and having a biodegradable coating layer disposed over the surface of the stent, wherein the biodegradable coating comprises nanocapsules (p. 12-13, 62), the nanocapsules includes a drug including paclitaxel (p. 7, 44 and 48) for the purpose of mitigating restenosis (p. 48). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s therapeutic agent to further include paclitaxel as taught by Weber for the purpose of mitigating restenosis and narrowing of vessels.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. U.S. Publication 2011/0202126 A1 in view of Weber et al. WO 2004/069169 A2 and further in view of Gale et al. U.S. Publication 2007/0282431 A1 and further in view Bein et al. WO 2017/025359 A1.
Claim 5, Wang et al. discloses wherein the stent 100 as seen in Figures 1-2B is formed from a biocompatible, bioabsorbable material (p. 13, 15-17, 30, 52, 60-61, 63, 65, 139) and the particles is an amorphous material (hydroxyapatite, see p. 52). However, Wang et al. does not expressly disclose the stent is formed from polylactic-co-glycolic acid. Gale et al. teaches a stent in the same field of endeavor comprising a stent body formed from a biocompatible and bioabsorable material 230 (p. 12, 45) wherein the material is PLGA (p. 160-163) for the purpose of having a stent that is bioabsorable polymer that is configured to completely erode (p. 12) and the stent further includes particles 220 formed from an amorphous material (p. 64). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s stent formed of a bioabsorable and biocompatible polymeric material to further comprise of polylactic-co-glycolic acid as taught by Gale et al. for the purpose of having a stent that is bioabsorable polymer that is configured to completely erode. However, Wang et al. does not expressly disclose the particles are amorphous magnesium phosphate. Bein et al. teaches a stent in the same field of endeavor for drug delivery, wherein the stent comprises a coating having a plurality of nanoparticles with a therapeutic agent (page 6, lines 25-27 and page 7, lines 1-4 and 7 and page 8, lines 7-10), wherein the nanoparticles are formed from magnesium phosphate (page 8, lines 14-19) for the purpose of using magnesium phosphate for the diagnosis and treatment of cancer (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s particles to further include particles formed of amorphous magnesium phosphate as taught by Bein for the purpose of using magnesium phosphate for the diagnosis and treatment of cancer (abstract).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. U.S. Publication 2011/0202126 A1 in view of Weber et al. WO 2004/069169 A2 and further in view of Holzer et al. CA 2843097 A1.
Claim 10, Wang et al. does not expressly disclose the coating material is a polyvinyl alcohol filament with a diameter of 100 nm to 500 nm. Holzer et al. teaches a stent 100 in the same field of endeavor comprising a polymer (page 24, lines 20-31 and page 37, lines 12-31) and a coating 104 comprising PVA (see page 68, lines 24-27) for the purpose of having a porous structure is elastic, biocompatible and exhibit mechanical strength and capable of releasing embedded pharmaceuticals at a controlled rate (page 37, lines 11-33) comprising a drug (page 26, lines 1-10 and page 35, lines 1-10 and page 46, lines 17-33 and page 50, lines 1-26 and page 54, lines 1-25) in the form of a fiber having a diameter 40 nm to 40 microns (page 32, lines 1-15 and page 34, lines 1-20 and page 40, lines 3-12 and page 41, lines 16-30), wherein the smaller the fiber size, the less porous surface area dedicated to the stent surface, having less surface coverage wherein the fiber size allow for easy diffusion through the coating and facilitate growth of cells therein (page 32, lines 17-33). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s coating to further include a polyvinyl alcohol filament with a diameter of 100 nm to 500 nm as taught by Holzer et al. for the purpose of having a porous structure is elastic, biocompatible and exhibit mechanical strength and capable of releasing embedded pharmaceuticals at a controlled rate and having a small diameter filament for the coating to allow for easy diffusion through the coating and facilitate growth of cells therein.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. U.S. Publication 2011/0202126 A1 in view of Weber et al. WO 2004/069169 A2 and further in view of Stankus et al. U.S. Publication 2010/0324645 A1.
Claim 14, Wang et al does not expressly disclose a therapeutic agent concentration of 50 µg/cm2 to 150 µg/cm2. Stankus et al. teaches a implantable device in the same field of endeavor comprising a coating formed from poly vinyl alcohol (p. 39, 46 and 49) and a drug in the form of an anti-proliferative, anti-inflammatory, antithrombotic in the coating (p. 53), wherein the drug has a concentration between 15 to 1500 mg/cm2 (p. 21-22) for the purpose of having a drug at a concentration necessary to inhibit and prevent restenosis (p. 41). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s therapeutic agent to have a concentration of 50 mg/cm2 to 150 mg/cm2 as taught by Stankus et al. for the purpose of having a drug at a concentration necessary to inhibit and prevent restenosis.
Conclusion
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774