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 of Group I (claims 1-10) in the reply filed on 07/16/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Therefore claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable
generic or linking claim.
Claim Objections
Claim 1 is/are objected to due to the following informalities:
In claim 1, line 12, “the API” should be corrected to “the water-soluble API” for claim language consistency.
Claim Rejections - 35 USC § 102
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 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) 1, 2, 4 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chappa et al. (US 20120100187 A1).
Regarding claim 1, Chappa discloses an implantable or indwelling medical device (cross section 304 in Fig. 3; it is set forth in [0013] that Fig. 3 is a cross-sectional view of a medical device) to deliver sustained release of an active pharmaceutical ingredient (API) (active agent delivered includes peptides [0026]) by non-Fickian diffusion across (it is set forth in the Specification the non-Fickian diffusion is achieved by employing multiple layers and using pressure by layered polymeric coatings, therefore it is interpreted that the device of Chappa releases active agent by non Fickian diffusion since the device of Chappa comprises multiple layers as set forth below) a top coating (top layer 316 in Fig. 3), the implantable or indwelling medical device comprising:
a medical device surface (substrate 310 in Fig. 3);
a primary coating on the medical device surface (combination of primer layer 312 and expandable layer 314 in Fig. 3), wherein the primary coating comprises:
a coating matrix (expandable layer 314 in Fig. 3 is disposed on primer layer 312); and
a water-soluble API within the coating matrix (expandable layer 314 includes active agent [0056]; active agent delivered includes hydrophilic molecules like peptides [0026]); and
wherein the top coating is disposed on the primary coating (top coating 316 is seen in Fig. 3 to be disposed over layer 314, since primer layer 312 with layer 314 makes the primary coating, it is interpreted that coating 316 is therefore disposed over the primary coating), wherein the top coating comprises an inert polymer (top layer 316 include polyethylene-co-vinyl acetate [0056]),
wherein in response to water crossing the top coating into the coating matrix, the water-soluble API is released from the coating matrix and the primary coating swells to create a pressure that drives the API across the top coating (The layer can physically expand due to build-up in pressure that otherwise occur due to the ingress of fluids into the layer. The top layer is configured to allow expansion of expandable layer [0028]).
Regarding claim 2, Chappa disclosed all limitations of claim 1. Chappa further discloses wherein the primary coating and the top coating are solvent-cast (solvents is used in order to form coating solutions for deposition of the primer layer 112, expandable layer 114, and top layer 116 [0053])
Regarding claim 4, Chappa disclosed all limitations of claim 1. Chappa further discloses wherein the inert polymer of the top coating comprises polyethylene-co-vinyl acetate (top layer 316 include polyethylene-co-vinyl acetate [0056]).
Regarding claim 9, Chappa disclosed all limitations of claim 1. Chappa further discloses wherein the medical device surface comprises an outer surface of an intravenous or arterial catheter (medical device is used in conjunction with arterial catheter [0064]; it is set forth in Fig. 1 which is another embodiment of Chappa that the coiled body 104 of device 100 comprises layer 114 as the outer most surface in Fig. 2, and therefore it is interpreted that top layer 316 forms the outer surface of device of Chappa in Fig. 3).
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 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chappa et al. (US 20120100187 A1) and Santerre (US 20100055068 A1).
Regarding claim 3, Chappa disclosed all limitations of claim 1. Chappa further discloses wherein the water-soluble API is uniformly dispersed in the coating matrix (the active agent is dispersed within the expandable layer 114 throughout the layer in Fig. 1 [0049]; it is interpreted the expandable layers of Fig. 1 and Fig. 3 are equatable since the two expandable layers perform similar function of storing and delivering active agent), but fails to explicitly disclose wherein the water-soluble API is not covalently or ionically bound to the coating matrix.
However, Santerre teaches an implantable medical device with a grafted polymer that controls the release of therapeutic agent from the device [0185].
Santerre further teaches the grafted polymer forming a complex with an active agent via non-covalent interactions [0157]. One of ordinary skill in the art teaches the active agent of the embodiment in Fig. 3 of Chappa to be configured to be non-covalently bound to the layer 314 as taught by Santerre.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the medical device of Chappa to include wherein the water-soluble API is not covalently or ionically bound to the coating matrix as taught by Santerre since such a modification enables the device of Chappa to provide concentration effect and mechanical properties necessary for a particular application [Santerre, 0161].
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chappa et al. (US 20120100187 A1) and in further view of Belt (US 20230183596 A1).
Regarding claim 5, Chappa disclosed all limitations of claim 5. However, Chappa failed to explicitly disclose wherein the coating matrix comprises a non-ionic polyurethane.
However, Belt teaches coating composition is made into a well adhering hydrophilic coating on a surface of a polymer substrate [0017].
Belt further teaches the hydrophilic polymer is a non-ionic polymer and polyurethane [0052]. One of ordinary skill in the art teaches layer 314 of Chappa is to be configured to comprise non-ionic polyurethane as taught by Belt.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention, to modify the medical device of Chappa to include wherein the coating matrix comprises a non-ionic polyurethane as taught by Belt since such a modification enables the device of Chappa to have affinity for water and other polar liquids [Belt, 0052].
Claim 6 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Chappa et al. (US 20120100187 A1) and in further view of Belt (US 20230183596 A1) and Garey (US 20100104880 A1).
Regarding claim 6, Chappa as modified by Belt disclosed all limitations of claim 5. However, Chappa as modified by Belt failed to explicitly disclose wherein the coating matrix comprises an aromatic-polyether polyurethane, an aromatic-polycarbonate polyurethane, an aliphatic-polyether polyurethane, or an aliphatic-polycarbonate polyurethane.
However, Garey teaches article surface 12 is coated with a layer of polycar polycarbonate-polyurethane copolymer which is impregnated with drugs [0135].
Gary further teaches polycarbonate-based polyurethane copolymers such as aliphatic polycarbonate-polyurethane copolymers [0129]. One of ordinary skill in the art teaches the layer 314 of Chappa to be configured to comprise aliphatic polycarbonate-polyurethane as taught by Garey.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention, to modify the medical device of Chappa as modified by Belt to include wherein the coating matrix comprises an aromatic-polyether polyurethane, an aromatic-polycarbonate polyurethane, an aliphatic-polyether polyurethane, or an aliphatic-polycarbonate polyurethane as taught by Garey since such a modification enables the device of Chappa to provide excellent resistance to all of the various degradation phenomena and conditions that can occur inside the body [Garey, 0129].
Claims 7, 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Chappa et al. (US 20120100187 A1) in Fig. 3 and in further view of the embodiment of Chappa in Fig. 4.
Regarding claim 7, Chappa in the embodiment of Fig. 3 disclosed all limitations of claim 1. Chappa however failed to explicitly disclose in the embodiment of Fig.3 wherein the primary coating has a thickness of at least 15 micrometers.
However, Chappa teaches in the embodiment of Fig. 4 the primer layer 404 is between 1 to 5 microns thick [0057]. Chappa further teaches expandable layer 406 is between 5 to 100 microns thick [0058]. One of ordinary skill in the art teaches the primer layer 312 and expandable layer 314 of the embodiment of Fig. 3 of Chappa is to be configured according to the ranges taught by the embodiment of Fig. 4 to achieve a thickness of at least 15 micrometers (since combination of layer 312 and 314 makes the primary coating).
Therefore, it would have been obvious to one of ordinary skill, prior to the effective filing date of the invention to modify the medical device of Chappa in the embodiment of Fig. 3 to include wherein the primary coating has a thickness of at least 15 micrometers as taught by the embodiment of Fig. 4 since such a modification enables the device of Chappa to optimize dimension to allow the medical device to be positioned as desired within the body of a patient [0003].
Regarding claim 8, Chappa in the embodiment of Fig. 3 disclosed all limitations of claim 1. Chappa however failed to explicitly disclose in the embodiment of Fig.3 wherein the top coating has a thickness less than 15 micrometers.
However, Chappa in the embodiment of Fig. 4 teaches he top layer 408 can be from about 1 micron to about 50 microns thick [0059]. One of ordinary skill in the art teaches the top coating 316 of the embodiment of Fig. 3 of Chappa is to be configured according to the ranges taught by the embodiment of Fig. 4 to achieve a thickness less than 15 micrometers.
Therefore, it would have been obvious to one of ordinary skill, prior to the effective filing date of the invention to modify the medical device of Chappa in the embodiment of Fig. 3 to include wherein the top coating has a thickness less than 15 micrometers as taught by the embodiment of Fig. 4 since such a modification enables the device of Chappa to optimize dimension to allow the medical device to be positioned as desired within the body of a patient [0003].
Regarding claim 10, the embodiment of Fig. 3 of Chappa as modified by the embodiment of Fig. 4 of Chappa disclosed all limitations of claim 7. The embodiment of Fig. 3 further discloses wherein the medical device surface comprises polyurethane (substrate polymer includes polyurethanes [0061]).
Conclusion
The prior art of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20200282177 A1 (Farrell) – related to a hydrophilic medical device.
US 20150182527 A1 (Pendleton) – related to an implantable medical device.
US 20080188836 A1 (Weber) – related to a nanoporous medical device.
US 20060052757 A1 (Fischer) – related to an implantable medical device.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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