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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/16/2025. As directed by the amendment: claims 1, 11, 15 and 16 have been amended and claim 24 has been added. Thus, claims 1-24 are presently pending in this application with claims 18-23 withdrawn.
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.
Claims 1, 3-6, 8, 9, 11, 13, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies et al. (US 20080183132 A1).
Regarding claim 1 Davies discloses (fig. 5a-5f) a composite medical balloon, comprising:
a base balloon layer 502 including first and second tapered portions and a barrel portion (center tubular portion of 502) therebetween (see fig. 5a and [0065]); and
a hybrid layer (512+514) over the base balloon layer (see fig. 5d-5e), the hybrid layer comprising a seamless tube (center tubular portion of 514) for covering the barrel portion (see fig. 5d and [0068]) and a spiral wrapping 512 for covering at least one of the first and second tapered portions (see fig. 5d and [0065]).
Regarding claim 3 Davies further discloses (fig. 5a-5f) the tube comprises a polyamide (see [0069]).
Regarding claim 4 Davies further discloses (fig. 5a-5f) the base balloon layer comprises a polyamide (see [0051]).
Regarding claim 5 Davies further discloses (fig. 5a-5f) the spiral wrapping 512 comprises a spirally wound ribbon of material extending from one end of the first or second tapered portion to another end of the corresponding tapered portion (see fig. 5d).
Regarding claim 6 Davies further discloses (fig. 5a-5f) the spiral wrapping 512 overlaps with the tube at a transition from the first or second tapered portion to the barrel portion (see fig. 5d-5e).
Regarding claim 8 Davies further discloses (fig. 5a-5f) a spiral wrapping 512 covering the other of the first or second tapered portions (see fig. 5d and [0065]).
Regarding claim 9 Davies further discloses (fig. 5a-5f) the tube (center tubular portion of 514) is substantially equal in length to a length of the barrel portion (center tubular portion of 502) of the base balloon layer 502 (see fig. 5d and [0068]).
Regarding claim 11 Davies discloses (fig. 5a-5f) a composite medical balloon, comprising:
a balloon 502 including first and second tapered portions and a barrel portion (center tubular portion of 502) therebetween (see fig. 5a and [0065]);
and a hybrid layer (512+514) adhesively (via 516) attached to the balloon (see [0068]), the hybrid layer comprising a tube (center tubular portion of 514) made of a first material (see [0068]) for covering the barrel portion (see fig. 5d and [0068]), a first spirally wrapped ribbon 512 made of a second material (see [0082]) for covering the first tapered portion (see fig. 5d and [0065]), and a second spirally wrapped ribbon (there are multiple of 512) made of the second material for covering the second tapered portion (see fig. 5d and [0065]);
wherein the first material is different from the second material (see [0068] and [0082]).
Regarding claim 13 Davies further discloses (fig. 5a-5f) the tube comprises a polyamide (see [0069]).
Regarding claim 14 Davies further discloses (fig. 5a-5f) the balloon comprises a polyamide (see [0051]).
Regarding claim 16 Davies further discloses (fig. 5a-5f) the tube (center tubular portion of 514) is substantially equal in length to a length of the barrel portion (center tubular portion of 502) of the base balloon layer 502 (see fig. 5d and [0068]).
Claims 1, 2, 10, 11, 17, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell et al. (US 20080033477 A1).
Regarding claim 1 Campbell discloses (fig. 2) a composite medical balloon, comprising:
a base balloon layer 38 including first and second tapered portions and a barrel portion (center tubular portion of 38) therebetween (see fig. 38 and [0022]); and
a hybrid layer (40+42+44) over the base balloon layer 38 (see fig. 2), the hybrid layer comprising a seamless tube 40 for covering the barrel portion (see fig. 2 and [0022]) and a spiral wrapping 42 for covering at least one of the first and second tapered portions (see fig. 2, [0022]; 42 is capable of covering at least one of the first and second tapered portions).
The language “a spiral wrapping for covering at least one of the first and second tapered portions” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Campbell meets the structural limitations of the claim, and the spiral wrapping 42 is capable of covering at least one of the first and second tapered portions.
Regarding claim 2 Campbell further discloses (fig. 2) the tube comprises an extruded or blow-molded material.
Regarding claim 10 Campbell further discloses (fig. 2) one or more fiber layers between the base balloon layer and the hybrid layer.
Regarding claim 11 Campbell discloses (fig. 2) a composite medical balloon, comprising:
a balloon 38 including first and second tapered portions and a barrel portion (center tubular portion of 38) therebetween (see fig. 38 and [0022]); and
a hybrid layer (40+42+44) adhesively attached to the balloon 38 (see fig. 2 and [0022]), the hybrid layer comprising a tube 40 made of a first material for covering the barrel portion (see fig. 2 and [0022]), a first spirally wrapped ribbon 42 made of a second material (see [0022]) for covering the first tapered portion (see fig. 2), and a second spirally wrapped ribbon 44 made of the second material (see [0022]) for covering the second tapered portion (see fig. 2);
wherein the first material is different from the second material (see [0022]).
The language “spiral wrapping for covering the tapered portion” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Campbell meets the structural limitations of the claim, and the spiral wrappings 42 and 44 are capable of covering the first and second tapered portions.
Regarding claim 17 Campbell further discloses (fig. 2) a fiber layer 39 between the balloon 38 and the hybrid layer (see fig. 2 and [0022]).
Regarding claim 24 Campbell further discloses (fig. 2) the first material imparts a first property (elastic) to the tube (see [0022]);
wherein the second material imparts a second property (adhesion) to the first tapered portion and the second tapered portion (see [0022]); and
wherein the first property is different from the second property (see [0022]).
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 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Pepper et al. (US 20100243135 A1).
Regarding claims 7 and 15, Campbell discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 11. Campbell is silent regarding the spiral wrapping comprises a polyether block amide.
However Pepper, in the same filed of endeavor, teaches (fig. 5C) a similar spiral wrapping tape 522, wherein the spiral wrapping comprises a polyether block amide (see [0078]).
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 Campbell to have the spiral wrapping comprises a polyether block amide as taught by Pepper, for the purpose of having a thermally weldable material to be able to heat set the device (see Pepper [0078]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell in view of Sridharan (US 20070138694 A1).
Regarding claim 12, Campbell discloses the claimed invention substantially as claimed, as set forth above for claim 11. Campbell further discloses one wind of the spiral wrapping overlapping an edge of the tube (see fig. 2).
Campbell is silent regarding the first spirally wrapped ribbon of material includes a plurality of overlapping winds.
Sridharan, in the same filed of endeavor, teaches (fig. 1B-7) a hybrid layer 33 comprising a first spirally wrapped ribbon of material (section 45 of another of the layers of 40) for covering the first tapered portion (see fig. 5 and [0028]-[0029]), and a second spirally wrapped ribbon of material (section 46 of a third of the layers of 40) for covering the second tapered portion (see fig. 5 and [0028]-[0029]); the first spirally wrapped ribbon of material includes a plurality of overlapping winds, (see fig. 5 and [0031]).
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 Campbell to have the first spirally wrapped ribbon of material includes a plurality of overlapping winds as taught by Sridharan, for the purpose of covering the whole section to increase adhesion.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771