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 .
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.
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 10-15 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 10 recites, “sliding a clear balloon protector over the waist portion; applying adhesive at the proximal portion of the waist portion, wherein the flared end of the fiber braid allows seepage of the adhesive under the fiber braid onto an unexposed region of the waist portion; sliding an additional balloon protector proximally over the waist portion and the catheter shaft to squeeze out excess adhesive and prevent adhesive wicking; curing the adhesive with the additional balloon protector in place; and removing the additional balloon protector to expose an adhesive step at a proximal end of the fiber braid.” It is unclear as to whether the clear balloon protector is applied over the proximal or another waist portion of the balloon and whether that clear balloon protector is covered by the additional balloon protector during curing, which could affect the structural limitations of the recited product. For purposes of examination it is presumed Applicant meant to recite that the clear balloon protector is placed upon the distal end as recited in claim 1.
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 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies, Jr. et al. (US 20130131709) in view of Ryan et al. (US 5108416).
As to claim 1, Davies discloses a medical balloon (Abstract). Davies discloses that the balloon comprises of: a catheter shaft 208; a balloon comprises a cone portion 104, a waist portion 102, and a body portion 106; a fiber braid layer 43, 44; an adhesive layer 126 placed under the fiber braid layer to where the proximal and distal waist portions are covered with adhesive and the fiber braid layer (Abstract; Fig. 2, 4, 12, 13, 24; ¶61; 81-83).
Davies fails to specifically teach or disclose whether the waist portions can have a protector/sleeve over the waist portions. Ryan discloses a stent introducer system (Abstract). Ryan discloses that it is known and conventional in the art to place sleeves 32, 38) on the proximal and distal waist portions of a balloon so as to prevent axial movement of a stent toward either the proximal or distal end of a catheter (C6, L26-40; Fig. 7A, 7B, 7B). Davies discloses that the sleeves may be adhesively bonded (Id.). It would have been obvious to modify the product of Davies to include proximal and distal sleeves over the proximal and distal waist portions and would have been motivated to do so because Ryan teaches that the use of such sleeves prevents the axial movement of a stent toward either the proximal or distal end of the catheter.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Here, the products of the references as combined comprises the same structure recited by claim 1.
As to claim 2, the product of claim 1 is taught as seen above. Davies discloses that the adhesive is a non-heat curing adhesive (¶61).
As to claim 6, the product of claim 1 is taught as seen above. Davies discloses that the fibers may comprise of ultra high molecular weight polyethylene (¶64).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies, Jr. et al. (US 20130131709) and Ryan et al. (US 5108416) as applied to claims 1, 2 and 6 above, and further in view of Tilson (US 20140066896).
As to claim 3, the product of claim 2 is taught as seen above. Tilson teaches applying a non-heat curing thermoset adhesive (paragraph [0158]: wherein the adhesive 208 can be a UV curing adhesive) to the waist portion (narrowest portion of shell 678) of the balloon (figure 3B, item 678; paragraph [0113]: wherein the shell 678 can be used as a balloon; paragraph [0156]: wherein the adhesive is applied to the waist portion of the balloon via the fibers; paragraph [0115]) to adhesively bond (paragraph [0156]) an inner surface of the fiber (figure 3B, item 86a and 86b; paragraph [0118]; paragraph [0157]) to an outer surface of the waist portion (paragraph [0156]). It would have been obvious to one of ordinary skill in the art at the time of filing to use the UV curable adhesive of Tilson in the product taught by the above references as combined because one of ordinary skill in the art would have been able to carry out such a substitution to achieve the predictable result of providing a known successful and conventional adhesive for bonding a fiber braid to a balloon. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies, Jr. et al. (US 20130131709) and Ryan et al. (US 5108416) as applied to claims 1, 2 and 6 above, and further in view of Aggerholm (US 20150297871).
As to claim 7-8, the product of claim 1 is taught as seen above. The above references as combined fail to teach or disclose that the balloon comprises of a poly(ether-block-amide). Aggerholm discloses a catheter (Abstract). Aggerholm discloses that the balloon of the catheter may comprise of a polyamide in the form of a poly(ether-block-amide) (¶32). It would have been obvious to one of ordinary skill in the art at the time of filing to use the poly(ether-block-amide) of Aggerholm in the product taught by the above references as combined because one of ordinary skill in the art would have been able to carry out such a substitution to achieve the predictable result of providing a known successful and conventional material to use as a balloon in a catheter. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies, Jr. et al. (US 20130131709) and Ryan et al. (US 5108416) as applied to claims 1, 2 and 6 above, and further in view of Laguna (US 20040006359).
As to claim 9, the product of claim 1 is taught as seen above. The above references as combined fail to teach or disclose if the catheter comprise of a dual lumen catheter shaft. Laguna discloses a balloon catheter (Abstract). Laguna discloses that it is known and conventional in the art to use a dual lumen structure in a balloon catheter (¶24). It would have been obvious to one of ordinary skill in the art at the time of filing to use the dual lumen catheter of Laguna in the product taught by the above references as combined because one of ordinary skill in the art would have been able to carry out such a substitution to achieve the predictable result of providing a known successful and conventional lumen structure for use in a balloon catheter. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Allowable Subject Matter
Claims 4-5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 10-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 4 recites that the adhesive curing of the fiber braid results in a step being formed between the fiber braid and the waist portion. None of the prior art teaches or discloses a catheter wherein the fiber braid bonded to the balloon is retracted from the end of the waist portion to form a step between said fiber braid and the waist portion.
Claim 10 recites that an adhesive step is formed at proximal end of the fiber braid on the proximal portion of the waist portion. None of the prior art teaches or discloses a catheter wherein an adhesive step is formed at the proximal end of the fiber braid on the proximal portion of the waist portion of the balloon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER C CAILLOUET whose telephone number is (571)270-3968. The examiner can normally be reached M-F 9AM-5PM EST.
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/CHRISTOPHER C CAILLOUET/ Examiner, Art Unit 1745
/GEORGE R KOCH/ Primary Examiner, Art Unit 1745
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