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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1, 4, 8, 10-12 and 39 in the reply filed on 05/14/2026 is acknowledged.
Status of Claims
Claims 1, 4, 8, 10-12, 14, 15, 28, 29, and 39-48 are pending and examined below.
Claim Objections
Regarding claims 14 and 47, the claims read “a thickness of approximately 5 to approximately 200 nm”. Please correct these claims to instead read ““a thickness of approximately 5 nm to approximately 200 nm” for consistency.
Regarding claim 39, the claim reads “a thickness of approximately 10 to approximately 20 nm”. Please correct this to read ““a thickness of approximately 10 nm to approximately 20 nm” for consistency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 8, 10-12, 14, 15, 28, 29, 40-43, 45-47 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2011/0093056 (Kaplan)
Regarding claim 1, Kaplan discloses a medical implant comprising:
an implant scaffold body (Fig. 1b)
a layer deposited on the implant scaffold body (¶0043, “tie layer”), the layer being a plasma polymerized polymer layer (¶0043, “plasma polymerization may be used to polymerize the tie layer onto a stent surface”)
Regarding claim 4, Kaplan disclose wherein the layer comprises Poly(L-lactide) (PLLA), Poly(D,L-lactide) (PDLLA), polycaprolactone (PCL), polyglycolide (PGA), poly(trimethylene carbonate), polydioxanone, or copolymers or mixtures thereof (¶0051, “poly(l-lactic acid))
Regarding claim 8, Kaplan discloses wherein the layer comprises a polymer comprising five methylene groups in its monomer structure (¶0051, “poly(ε-caprolactone)”
Regarding claim 10, Kaplan discloses wherein the layer is a primer layer (¶0043, wherein “tie layer” corresponds to a primer layer”), a coating layer formed on a primer layer (¶0043, “therapeutic agent is deposited onto the tie layer”), or a combination of a primer layer and coating layer
Regarding claim 11, Kaplan discloses wherien the coating layer comprises a therapeutic agent (¶0043, “therapeutic agent is deposited onto the tie layer”)
Regarding claim 12, Kaplan discloses wherein the therapeutic agent is everolimus, rapamycin, or another olumus-based drug (¶0052, “rapamycin”)
Regarding claim 14, Kaplan discloses wherein the layer is a bioresorbable layer (¶0050, “bioerodible polymers”) having a thickness of about 5nm to about 50nm (¶0047, wherein “about 100Å to about 300Å” is equivalent to 10nm to 30nm – which falls within the claimed range)
Regarding claim 15, Kaplan discloses wherein the bioresorbable layer (¶0050, “bioerodible polymers”) has a thickness of about 10nm to about 20nm (¶0047, wherein about 100Å to about 300Å is equivalent to 10nm to 30nm)
Regarding claim 28, Kaplan discloses wherein the layer (¶0028, “tie layer”) is synthesized directly on the medical implant (¶0028, “plasma polymerized tie layer may be applied to stent”)
Regarding claim 29, Kaplan discloses wherein the medical implant is at least one of a stent or a filter (Fig. 1B, stent 32)
Regarding claim 40, Kaplan discloses wherein the layer has a thickness of about 10nm (¶0047, wherein about 100Å to about 300Å is equivalent to about 10nm to about 30nm)
Regarding claim 41, Kaplan discloses wherein the layer is bioresorbable or bioabsorbable (¶0011, “bioerodible”)
Regarding claim 42, Kaplan discloses wherein the layer is formed from a monomer (¶0045, wherein “methane” corresponds to a monomer) dissolved in a solvent to form the plasma polymerized polymer layer (¶0047, “carrier solvent”)
Regarding claim 43, Kaplan discloses wherein the solvent comprises an aqueous solvent, an organic solvent, a liquid monomer, or combinations or mixtures thereof (¶0054, wherein “acetone” corresponds to an organic solvent”)
Regarding claim 45, Kaplan discloses wherein the layer comprises a ring opened polymer (¶0051, wherein “poly(ε-caprolactone)” corresponds to a ring-opened polymer)
Regarding claim 46, Kaplan discloses wherein the layer comprises a primer layer (¶0043, “tie layer”) and a coating layer (¶0043, “therapeutic agent in a polymer matrix”)
Regarding claim 47, Kaplan discloses a medical implant comprising:
an implant scaffold body (Fig. 1B);
a primer layer deposited on the implant scaffold body, the primer layer being a plasma polymerized polymer layer, the primer layer having a thickness of approximately 5 to approximately 200 nm (¶0047, wherein about 100Å to about 300Å is equivalent to about 10nm to about 30nm – this overlaps the claimed thickness)
wherein the primer layer comprises Poly(L-lactide) (PLLA), Poly(D,L-lactide) (PDLLA), polycaprolactone (PCL), polyglycolide (PGA), poly(trimethylene carbonate), polydioxanone, or copolymers or mixtures thereof (¶0051, “poly(l-lactic acid)); and
a coating layer applied directly on the primer layer, wherein the coating layer comprises a therapeutic agent (¶0043, “therapeutic agent is deposited onto the tie layer”);
wherein the medical implant is at least one of a stent or a filter (Fig. 1b, stent 32)
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.
Claim(s) 39, 44, and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0093056 (Kaplan) in view of US 2006/0093771 (Rypacek)
Regarding claim 39. Kaplan discloses wherein the layer is a primer layer (¶0043, “tie layer”), the primer layer having a thickness of approximately 10 to approximately 20 nm (¶0047, wherein “about 100Å to about 300Å” is equivalent to 10nm to 30nm – which touches the claimed range)
a coating layer applied directly on the primer layer, wherein the coating layer comprises a therapeutic agent (¶0043, “therapeutic agent is deposited onto the tie layer”)
Kaplan discloses a primer layer but doesn't explicitly teach or disclose wherein the primer layer comprises a Poly(D,L-lactide) (PDLLA), and Polycaprolactone (PCL) copolymer.
Rypacek discloses a primer layer comprising a Poly(D,L-lactide) (PDLLA), and Polycaprolactone (PCL) copolymer (¶0349, a copolymer poly(D,L-lactide-co-6-caprolactone with an LA/CL ratio 90/10, i.e. P(DLLA90CL10))
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the primer layer of Kaplan to comprise a PDLLA and PCL copolymer, as taught by Rypacek, in order to control the biologically active agent release from the polymer matrix (¶0084)
Regarding claim 44, Kaplan doesn't explicitly teach or disclose a solvent comprising caprolactone (CL), dioxanone, or combinations or mixture thereof
Rypacek discloses a solvent comprising caprolactone (CL), dioxanone, or combinations or mixture thereof (¶0349, wherein the copolymer is dissolved in a 0.3% dioxanone)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to dissolve the monomer of Kaplan in a solvent comprising caprolactone (CL), dioxanone, or combinations or mixture thereof, as taught by Rypacek, in order to form a homogenous mixture with the monomer.
Regarding claim 48, Kaplan discloses a primer layer (see rejection of claim 47) but doesn't explicitly teach or disclose wherein the primer layer comprises a Poly(D,L-lactide) (PDLLA), and Polycaprolactone (PCL) copolymer.
Rypacek discloses a Poly(D,L-lactide) (PDLLA), and Polycaprolactone (PCL) copolymer (¶0349, a copolymer poly(D,L-lactide-co-6-caprolactone with an LA/CL ratio 90/10, i.e. P(DLLA90CL10)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the layer of Kaplan with a solvent comprising caprolactone, dioxanone, or combinations or mixture thereof, as taught by Rypacek, in order to function as a drug diffusion barrier (¶0346)
Conclusion
Included below is relevant prior art that was considered but not relied upon for this office action:
2007/0071879 – Rypacek family
US 6,939,376 - discloses polymers used for the second polymer / therapeutic layer
2023/0039005 – ¶0091 discloses PLLA-co-PCL and PDLLA coating
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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