DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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 1-12 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:
The claim recites the limitation "the external outer surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-9 are rejected due to their dependence on claim 1.
Regarding claim 2:
The claim recites the limitation "the top layer" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6:
The claim limitation “an active therapeutic agent” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “an active therapeutic agent” in line 9 of claim 1 (on which this claim depends) which raises a question of if two active therapeutic agents are required by the claim 6 or only one. For the sake of examination, the office has assumed that only one active therapeutic agent is required by the claim.
Regarding claim 9:
The claim recites the limitation "the hydrophobic polymer carrier" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10:
The claim recites the limitation "the coated catheter" in lines 7. There is insufficient antecedent basis for this limitation in the claim.
Claims 11-12 are rejected due to their dependence on claim 10.
Regarding claim 11:
The claim recites the limitation "the applying of the solutions to the catheter" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12:
The claim recites the limitation "the polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-2, 4-6, 8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080255508 A1 to Wang in view of US 20060085058 A1 to Rosenthal et al. (Rosenthal).
Regarding claim 1:
Wang discloses:
A balloon catheter (10 in figures 1-2c) comprising:
an expandable portion (12) on an elongated body (see length of 12 in figure 1) having a coating (see 22, 26 and 28 as shown in figure 2c) extending substantially about the external outer surface (outer surface of 12 as shown in figure 2c) of at least the expandable portion;
wherein the coating comprises:
a primer layer (22) on the surface of the expandable portion comprising at least one or more substantially hydrophilic compounds (¶0182 indicates that the adherent layer 22 can include polyethylene glycol which is a hydrophilic compound as indicated in the applicant’s disclosure on page 3 of the applicant’s specification),
a first layer (26) substantially overlying the primer layer and comprising an inclusion compound (¶0101 indicated layer 26 can include a therapeutic agent and optionally an additive or additives and the reference further indicates in ¶0173 the additives can include “(2-hydroxypropyl)-cyclodextrin” which is a derivative of hydroxypropyl-β- cyclodextrin which the applicant indicates is an inclusion compound as stated on page 3 of the applicant’s specification/disclosure);
a second layer (28) substantially overlying the first layer and comprising a mixture of an active therapeutic agent (see ¶0101 which indicates layer 28 can include a therapeutic agent) and the inclusion compound (¶0101 indicates layer 28 can include an additive which the reference indicates and the reference further indicates in ¶0173 the additives can include “(2-hydroxypropyl)-cyclodextrin” which is a derivative of hydroxypropyl-β- cyclodextrin which the applicant indicates is an inclusion compound as stated on page 3 of the applicant’s specification/disclosure).
Wang fails to disclose:
A second layer comprising a hydrophobic polymer
Rosenthal teaches:
A balloon catheter (see figure 1) that includes a balloon/expandable portion (116) with a catheter (105). The reference further indicates that a coating can include a biologically active material (active therapeutic agent) and a hydrophobic polymer (¶0091). The reference indicates this combination results in a controlled release coating (¶0091).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to further include a hydrophobic polymer in the second layer as taught by Rosenthal in order to control the release of the active therapeutic agent (Rosenthal, ¶0091).
Regarding claim 2:
Wang discloses:
The balloon catheter according to claim 1 wherein the active therapeutic agent of the top layer is selected from the group comprising sirolimus, everolimus, paclitaxel (¶0108 indicate the therapeutic agent (active therapeutic agent) can include paclitaxel) and taxol and including derivatives, hydrates, esters, salts, polymorphs or analogs thereof.
Regarding claim 4:
The balloon catheter according to claim 1 wherein and the total loading of the active therapeutic agent of the coating of the surface of the balloon is 1-3 µg/mm2 (¶0032 indicates the therapeutic agent can be between 1 to 20 µg/mm2).
Regarding claim 5:
Wang discloses:
The balloon catheter according to claim 1 wherein the at least one or more hydrophilic compound(s) of the primer layer is/are selected from the group comprising polyurethane acrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol (¶0030 indicates the adherent layer (primer layer 22) can include poly(ethylene glycol) oligo) and polyacrylic acid.
Regarding claim 6:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Wang and Rosenthal:
The balloon catheter according to claim 1, wherein the second layer comprises a homogeneous mixture of the hydrophobic polymer (see the hydrophobic polymer in Rosenthal incorporated into Wang om the claim 1 rejection above), an active therapeutic agent and the inclusion compound (see the active therapeutic agent and the inclusion compound of Wang indicated in the claim 1 rejection above).
Regarding claim 8:
Wang discloses:
The balloon catheter according to claim 1wherein the inclusion compound is chitosan, p-cyclodextrin, hydroxypropyl-β-cyclodextrin (¶0101 in Wang indicates the additive/inclusion compound can include “(2-hydroxypropyl)-cyclodextrin” which is a derivative of hydroxypropyl-β- cyclodextrin), hydroxypropyl-y-cyclodextrin, hydroxyethyl cellulose, carboxymethyl cellulose, iopromide and derivatives thereof and dextran.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080255508 A1 to Wang in view of US 20060085058 A1 to Rosenthal et al. (Rosenthal) as applied to claim 1 above, and further in view of WO 9955396 A1 to Chudzik et al. (Chudzik).
Regarding claim 3:
Wang and Rosenthal fails to disclose:
The balloon catheter according to claim 1wherein the mass ratio of inclusion compound and hydrophobic polymer is 1:1-1:10,
Chudzik teaches:
A bioactive agent release coating that include a hydrophobic polymer (page 4, lines 15-25). The reference further teaches that the concentration/amount of hydrophobic polymer in the coating can be changed based on the desired release rate of the bioactive agent in the coating (page 4, lines 15-25). This teaches that the amount or concentration of the hydrophobic polymer in the coating is a results effective variable to control the release of the bioactive agent (therapeutic agent).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang and Rosenthal to have a mass ratio of inclusion compound and hydrophobic polymer is 1:1-1:10 since it is known that the hydrophobic polymer is a results effective variable as taught by Chudzik to control the release of the therapeutic agent (Chudzik, page 4, lines 15-25). It would have been obvious to change the amount of hydrophobic polymer in the coating to achieve this ration in order to control the release of the therapeutic agent.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080255508 A1 to Wang in view of US 20060085058 A1 to Rosenthal et al. (Rosenthal) as applied to claim 1 above, and further in view of WO 9811828 A1 to Sahatjian et al. (Sahatjian).
Regarding claim 7:
Wang and Rosenthal fails to disclose:
The balloon catheter according to claim 1 wherein the second layer comprises microspheres having the active therapeutic agent encapsulated therein.
Sahatjian teaches:
A balloon catheter (see figure 2) that includes a balloon (51) and catheter (see catheter extending through the balloon 51). The reference further teaches that active therapeutic agents (drugs) can be incapsulated within microspheres in order to prolong the time of drug delivery (page 3, lines 30-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang and Rosenthal to further microspheres encapsulating the active therapeutic agent as taught by Sahatjian in order to prolong the time of drug delivery (Sahatjian, page 3, lines 30-35).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080255508 A1 to Wang in view of US 20060085058 A1 to Rosenthal et al. (Rosenthal) as applied to claim 1 above, and further in view of EP 1254674 A1 to Alt.
Regarding claim 3:
Wang and Rosenthal fails to disclose:
The balloon catheter according to claim 1wherein the said the hydrophobic polymer carrier is selected from polylactic acid, polylactide hexalactide and polyglycolide lactide and has a molecular weight of 1-100 kDa.
Alt teaches:
A balloon catheter (figure 1) that includes a coating made from multiple components including polylactic acid with a molecular weight of 30 kDa (¶0022). This molecular weight of the polylactic acid in the coating yields a uniform coating (column 4, lines 1-5/¶0020).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang and Rosenthal to replace the hydrophobic polymer added by Rosenthal with polylactic acid with a molecular weight of 30 kDa as taught by Alt in order to yield a uniform coating (Alt, column 4, lines 1-5/¶0020).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080255508 A1 to Wang in view of US 20060085058 A1 to Rosenthal et al. (Rosenthal) and US 6306144 B1 to Sydney et al. (Sydney).
Regarding claim 10:
Wang discloses:
A method of coating a balloon catheter (10 in figures 1-2c) comprising:
applying to the surface of a balloon catheter (12) a first solution (solution for the primer layer 22) comprising at least one more of the group consisting of from ethanol, acetone, isopropanol, propanol, ethyl acetate, dichloromethane, tetrahydrofuran, acetonitrile and one or more hydrophilic compounds selected from the group consisting of polyurethane acrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol (¶0182 indicates that the adherent layer 22 can include polyethylene glycol which is a hydrophilic compound as indicated in the applicant’s disclosure on page 3 of the applicant’s specification) and polyacrylic acid,
applying to the coated catheter a second solution (solution for layer 26) comprising at least one or more solvents in the group comprising ethanol, water, acetone (¶0034 indicates the additive (inclusion compound) can be soluble in water, ethanol, isopropanol or acetone) and isopropanol into which an inclusion compound (additive as indicated in ¶0034) has been dissolved;
applying to the coated catheter a third solution (solution for layer 28) comprising a therapeutic compound (see ¶0101 which indicates layer 28 can include a therapeutic agent), and a solvent, said solvent selected from the group comprising ethanol, water, acetone, isopropanol, dichloromethane, trichloromethane and tetrahydrofuran (¶0101 indicates layer 28 can include an additive and ¶0034 indicates the additive can be soluble in water, ethanol, isopropanol or acetone).
Wang fails to disclose:
Curing the coated catheter under hot air or ultraviolet light,
drying the coated catheter and
applying to the coated catheter a third solution comprising a polymer solution.
Sydney teaches:
A balloon catheter (see figure 2) that includes coatings and that the coating can be during by heat or ultraviolet light for a short period of time (see column 5, lines 30-40).
Rosenthal teaches:
A balloon catheter (see figure 1) that includes a balloon/expandable portion (116) with a catheter (105). The reference further indicates that a coating can include a biologically active material (active therapeutic agent) and a hydrophobic polymer (¶0091). The reference indicates this combination results in a controlled release coating (¶0091).
Regarding the limitation “Curing the coated catheter under hot air or ultraviolet light, drying the coated catheter and ”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to further include steps of curing the solution for each applying step in Wang with UV light as taught by Sydney in order to cure the coating after they are applied.
Regarding the limitation “applying to the coated catheter a third solution comprising a polymer solution”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to further include a hydrophobic polymer (polymer solution) in the second layer (as part of the third solution) as taught by Rosenthal in order to control the release of the active therapeutic agent (Rosenthal, ¶0091).
Regarding claim 11:
Wang discloses:
The method of coating a balloon catheter according to claim 10 wherein the applying of the solutions to the catheter is performed by dipping, spraying or brushing the solutions thereon (¶0067 indicates the coating is applied by dipping).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080255508 A1 to Wang in view of US 20060085058 A1 to Rosenthal et al. (Rosenthal) and US 6306144 B1 to Sydney et al. (Sydney) as applied to claim 10 above, and further in view of WO 9811828 A1 to Sahatjian et al. (Sahatjian).
Regarding claim 12:
Wang and Rosenthal fails to disclose:
The method of coating a balloon catheter according to claim 10 wherein microspheres are formed by aggregation of the therapeutic compound, the polymer and the inclusion compound.
Sahatjian teaches:
A balloon catheter (see figure 2) that includes a balloon (51) and catheter (see catheter extending through the balloon 51). The reference further teaches that active therapeutic agents (drugs) can be incapsulated within microspheres in order to prolong the time of drug delivery (page 3, lines 30-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, Rosenthal and Sydney to further microspheres encapsulating the active therapeutic agent as taught by Sahatjian in order to prolong the time of drug delivery (Sahatjian, page 3, lines 30-35).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20040220665-A1
Hossainy
See the coating including taxol, esters or paclitaxel
WO-0032255-A1
KAMATH
See the coating including paclitaxel
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/WESLEY G HARRIS/Examiner, Art Unit 3783