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 § 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) 1-5, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2014/0142505 A1) in view of Weber et al. (US 2006/0129179 A1) and in further view of Lee et al. (US 2010/0130926 A1).
With regard to claim 1, Lin discloses A medical delivery system (Fig. 4) comprising: a balloon catheter (any of 19/20/23); and an inflatable balloon (16) coupled to a portion of the balloon catheter (see Fig. 4), the inflatable balloon comprising a balloon wall at least partially defining an inflated volume of the inflatable balloon (walls 30/31/32), the balloon wall comprising a first balloon wall layer (31) and a second balloon wall layer (30), the first balloon wall layer comprising a Shore A durometer hardness value smaller than that of the second balloon wall layer ([0041]), and the first balloon wall layer being an inner layer of the balloon wall relative to the second balloon wall layer (see Fig. 4).
However, Lin does not disclose the specific material.
Weber teaches a multi-layer ballon catheter (Fig. 1, also see Fig. 1a, layers 32/34/36) that can be made of a styrenic block copolymer ([0067], claim 21).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of Lin with the styrenic block copolymer as taught by Weber for the purpose of providing suitable durable elastomeric material for a balloon catheter ([0067], claim 21). Further the substation of one material for another is well-known in the art and doe not alter the overall function of the device.
However, Lin/Weber do not teach the first balloon layer having a thickness greater than a thickness of the second balloon wall layer.
Lee teaches a balloon (Fig. 5) having a first balloon layer (520) and a second balloon layer (510), where the first balloon layer has a thickness greater than a thickness of the second balloon layer (See Fig. as well as [0012], indicating the outer layer being less than 20% of the total wall thickness). Further Lee teaches that the shore hardness of the outer thinner layer is greater than the thicker inner layer ([0009], [0012]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lin/Weber to having the first layer (inner layer) being thicker than the outer harder layer as taught by Lee for the purpose of contributing to fewer premature ruptures ([0019]).
With regard to claim 2, Lin discloses wherein the first balloon wall layer comprises a Shore A durometer hardness and the second balloon wall layer comprises a Shore A durometer hardness greater than the first layer ([0045]). While Lin does not explicitly disclose the specific shore A values, it would be prima facie obvious to optimize the hardness to be a first balloon wall layer with a Shore A durometer value of about 20 to about 45 and the second balloon wall layer comprises a Shore A durometer hardness value of about 25 to about 50 as doing so would not alter the over all function of the device ([0045]).
With regard to claim 3, Lin discloses wherein the balloon wall is the first balloon wall layer (32) and the second balloon wall layer (30).
With regard to claim 4, Lin discloses wherein the first balloon wall layer is about 70% to about 85% of a total thickness of the balloon wall (the first layer is coextruded and additional layers can be dip coated in which the dip coated layers would be much thinner than one that was coextruded). Thus while Lin does not explicitly disclose 70% to 85% it would be prima facie obvious to optimize the thickness of the layers as doing so would not alter the overall function of the device.
With regard to claim 5, Lin discloses the claimed invention except for the specific material.
Weber teaches wherein the styrenic block copolymer is one of styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS) or styrene-ethylene-butylene- styrene (SEBS) ([0067]).
With regard to claim 12, Lin discloses wherein at least one of the first balloon wall layer and the second balloon wall layer comprises polyurethane ([0044]).
With regard to claim 13, Lin discloses wherein the balloon wall comprises a third balloon wall layer (32), the third balloon wall layer being an inner balloon wall layer (see Fig. 4), the second balloon wall layer being an outer balloon wall layer (30), and the first balloon wall layer (31) being an intermediate balloon wall layer between the third balloon wall layer and the second balloon wall layer (see Fig. 4).
With regard to claim 14, Lin discloses wherein the first balloon wall layer (31) and the second balloon wall layer (30) and wherein the third balloon wall layer (32) comprises polyurethane ([0044]).
However, Lin does not disclose the specific material.
Weber teaches a multi-layer ballon catheter (Fig. 1, also see Fig. 1a, layers 32/34/36) that can be made of a styrenic block copolymer ([0067], claim 21).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of Lin with the styrenic block copolymer as taught by Weber for the purpose of providing suitable durable elastomeric material for a balloon catheter ([0067], claim 21). Further the substation of one material for another is well-known in the art and doe not alter the overall function of the device.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2014/0142505 A1) in view of Weber et al. (US 2006/0129179 A1) and in further view of Lee et al. (US 2010/0130926 A1) and Nizuka et al. (US 2001/0021429 A1).
With regard to claim 6, Lin/Weber/Lee teach the claimed invention except for the specific mol % of styrene monomers.
Nizuka teaches a medical balloon catheter wherein the styrenic block copolymer comprises about 5 mol % to about 15 mol % of styrene monomers ([0017]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of Lin/Weber/Lee with the styrene monomers as taught by Nizuka for the purpose obtaining the desired elasticity/hardness ([0017]).
Claim(s) 7-8, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2014/0142505 A1) in view of Weber et al. (US 2006/0129179 A1) and in further view of Lee et al. (US 2010/0130926 A1) and Burgmeier et al. (US 2005/0228429 A1).
With regard to claim 7-8 and 11, Lin/Weber/Lee teach the claimed invention except for a tackiness reducing agent.
Burgmeier teaches a balloon catheter (Fig. 8) that has a coating of PTFE to provide a low friction coating or tackiness reducing agent ([0103]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of Lin/Weber/Lee with the tackiness reducing agent of PTFE as taught by Burgmeier for the purpose of reducing the friction of the balloon catheter when employed in the body ([0103]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2014/0142505 A1) in view of Weber et al. (US 2006/0129179 A1) and in further view of Lee et al. (US 2010/0130926 A1) and Burgmeier et al. (US 2005/0228429 A1) and Allex et al. (US 2010/0234875 A1).
With regard to claim 9 and 10, Lin/Weber/Lee/Burgmeier teach the claimed invention except for a radiopaque filler.
Allex teaches coatings on a balloon catheter that further includes a radiopaque filler material ([0007], [0017], [0011]) comprising at least one of bismuth oxychloride (BiOCl), barium sulfate (BaSO4), and bismuth subcarbonate ((BiO)2CO3) ([0064], [0072]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of Lin/Weber/Lee/Burgmeier with the radiopaque filler as taught by Allex for the purpose of visualization of the catheter when it is being inserted ([0013]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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