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.
Claims 1-4, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (PG PUB 2008/0208128) in view of Chebator et al. (PG PUB 2012/0083740).
Re claim 1, Guo discloses a balloon protector (as seen in Fig 10), comprising: a balloon-covering section 2+100+ the distal section of 102 (labeled in Fig A below) configured to cover a drug-coated balloon of a balloon catheter (it is noted that the italicized text constitutes functional language and, therefore, “a drug-covered balloon” and “a balloon catheter” are not a part of the claimed invention; therefore, the balloon covering section only has to be structurally capable of covering a balloon of a balloon catheter; one of ordinary skill in the art would recognize that this limitation is met since a balloon having a diameter smaller than the lumen of the balloon-covering section could be received therein), the balloon-covering section including a tip piece 100 (Fig 10,11) of the balloon protector coupled to a distal-end portion 4 (Fig 11) of a body piece 2 (Fig 10) of the balloon protector (as seen in Fig 10,11); and a tabbed section (the proximal portion of 102 labeled in Fig A below) proximal of the balloon-covering section (as seen in Fig A below), the tabbed section including a pair of tabs 106,106 (Fig 10) configured to be continuously pulled away from each other to progressively split the balloon protector along the balloon-covering section until the balloon protector is completely peeled off the balloon (it is noted that the italicized text constitutes functional language and, therefore, “the balloon” is not a part of the claimed invention; this limitation is met in view of Para 103), wherein the tip piece has an opening (labeled in Fig A below) in a distal end of the tip piece (as seen in Fig A below). Guo does not disclose that the tip piece has a tapered portion having an inner diameter taper commensurate with an outer diameter of a distal shoulder of the balloon, the inner-diameter taper of the tip piece configured to maintain concentricity between the opening in the distal end of the tip piece and an opening in a distal end of a shaft of the balloon catheter for threading a guidewire therethrough.
Chebator, however, teaches a balloon protector 100 (Fig 1) configured to split along its entire length (via perforations 114+115, Fig 1; Para 22) and comprising a balloon-covering section 102+110 (Fig 1) including a body piece 102 (Fig 1) and a tip piece 110 (Fig 1) coupled to the body piece (Para 21, “the penetrating portion 110 is fixedly secured to, or monolithically formed with, the body portion 102”), wherein the tip piece has a tapered portion (the entirety thereof), as seen in Fig 1; Para 21, “distally tapered penetrating portion 110”) having an inner diameter taper (as seen in Fig 1) and an opening 112 (Fig 1) at the distal end of the tip piece (as seen in Fig 1). Chebator teaches that providing the tip piece with a tapered portion having an inner-diameter taper enlarges an opening formed in target tissue during advancement of the balloon protector while minimizing trauma to the target tissue (Para 21,26). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Guo to include the tip piece with a tapered portion having an inner diameter taper, as taught by Chebator, for the purpose of enlarging an opening formed in target tissue during advancement of the balloon protector while minimizing trauma to the target tissue (Para 21,26).
As set forth above, “a drug-coated balloon of a balloon catheter” is not a part of the claimed invention. Therefore, modifying the tip piece of Guo to have an inner diameter taper (as taught by Chebator) would result in an inner-diameter taper commensurate with an outer diameter of a distal shoulder of the balloon (it is noted that the italicized text constitutes functional language; this limitation is met since one of ordinary skill in the art would recognize that a balloon having a distal shoulder with a diameter smaller than that of the inner-diameter taper could be placed within the tapered portion) and the inner-diameter taper of the tip piece being configured to maintain concentricity between the opening of the tip piece and an opening in a distal end of a shaft of the balloon catheter for threading a guidewire therethrough (it is noted that the italicized text constitutes functional language and, therefore, “a guidewire” is not a part of the claimed invention; this limitation is met because one of ordinary skill in the art would recognize that, because the tip piece has an opening, a shaft having a diameter less than that of the lumen of the tip piece and a guidewire therein could be placed within the tapered portion).
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Re claim 3, Guo discloses that the tip piece has an overlapping portion (the portion of tip piece 110 that lies over section 130 of body piece 102, seen in Fig 11 but not labeled; labeled in Fig 12 and described in Para 114) over the distal-end portion of the body piece having an outer diameter greater than an outer diameter of an immediately proximal portion 132 (seen in Fig 11 but not labeled; labeled in Fig 12) of the balloon-covering section (as seen in Fig 11, the outer diameter of the tip piece 110 covering portion 130 is larger than the outer diameter of portion 132), the outer diameter of the overlapping portion of the tip piece configured to provide a stop to prevent insertion of the balloon catheter into an introducer sheath while the balloon protector is covering the balloon (it is noted that the italicized text constitutes functional language and, therefore, “an introducer sheath” is not a part of the claimed invention; this limitation is met in view of Fig 11, which shows that the proximal end of the overlapping portion extends radially above the outer surface of the balloon-covering section to such a degree that it could be used as a stop for the distal end of an introducer sheath).
Re claim 4, Guo discloses that the tip piece includes a longitudinal gap 114 (Fig 11; wherein lines 114 are “skived”, Para 94) on each side of two opposing sides of the balloon protector (Para 94), the longitudinal gap having a length greater than or equal to that of the overlapping portion of the tip piece allowing the distal-end portion of the body piece to be split through a distal end of the body piece without an increase in applied peel force (as seen in Fig 11, the gap 114 extends the entire length of the tip piece 100; as seen in Fig 11, the overlapping portion (that which lies over section 130) does not extend the entire length of the tip piece 100; therefore, the length of gap 114 is longer than that of the overlapping portion).
Re claim 7, Guo discloses that both the body piece and the tip piece of the balloon-covering section include a pair of opposing longitudinal lines of weakness 104+114 (Fig 10,11) aligned with the tabs (as seen in Fig 10), the balloon-covering section configured to split along each line of the lines of weakness (Para 103).
Re claim 8, Guo discloses that the balloon-covering section further including a transitional section (labeled in Fig A above) configured to cover a proximal shoulder of the balloon (it is noted that the italicized text is functional language; this limitation is met since one of ordinary skill in the art would recognize that the balloon-covering section is of a size such that a balloon having a diameter smaller than that of the lumen of the balloon-covering section could be inserted into the balloon-covering section such that a proximal shoulder of the balloon is aligned with the transitional section), the transitional section having an outer-diameter flare (as seen in Fig A above) from an immediately distal portion of the balloon-covering section (labeled in annotated Fig A above) to a distal end of the tabbed section (labeled in annotated Fig A above) configured to increase a distance between the tabs making the tabs easier to grasp (as seen in Fig 10).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (PG PUB 2008/0208128)/Chebator et al. (PG PUB 2012/0083740) in view of Forde et al. (PG PUB 2008/0082083).
Re claim 5, Guo discloses that the length of each of the longitudinal gaps is greater than the length of the overlapping portion of the tip piece (since the gap 114 extends the entire length of tip piece 100 but the overlapping portion only resides over section 130 of the body piece which is not as long as the tip piece 100). Guo does not disclose that this arrangement forms a respective through hole between a distal end of each of the longitudinal gaps and the distal end of the body piece. Forde, however, teaches a balloon protector 10 (Fig 1 with the tip piece 60 of Fig 5 in place of the tip piece 12 of Fig 1) comprising a balloon-covering section 14+60 (Fig 1,5) comprising a tip piece 60 (Fig 5) and a body piece 14 (Fig 1), wherein the tip piece includes a longitudinal gap 68,69 (Fig 5) on each side of two opposing sides (as seen in Fig 5, Para 32), wherein a through hole (although multiple holes 64,66 are shown in Fig 5, it is the distal-most hole 64,66 of Fig 5 that reads on the “through hole”) is formed just proximal to the distal end of the longitudinal gap (as seen in Fig 5); Forde teaches that the provision of through holes 64,66 within longitudinal gaps 68,69 aides in tearing of the longitudinal gap (Para 32). Therefore, it would have been obvious to modify Guo/Chebator to include a through hole just proximal to the distal end of the longitudinal gap, as taught by Forde, for the purpose of aiding in tearing of the longitudinal gap (Para 32). The through hole being located just proximal to the distal end of the Guo’s longitudinal gap 114 would result in the through hole being located between the distal end of the longitudinal gap and the distal end of the body piece, as claimed, since the distal end of the body piece 102 lies substantially proximal to the distal end of the tip 100 while the distal end of the longitudinal gap resides at the distal end of the tip 100.
Re claim 6, Guo/Chebator as modified by Forde in the rejection of claim 5 above discloses all the claimed features with Forde teaching that the through hole is configured to provide a break in the applied peel force when splitting the balloon protector along the balloon-covering section, the break signaling splitting through the distal end of the body piece (since, as set forth in the rejection of claim 5 above, the through hole would be located distal to the distal end of the body piece).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (PG PUB 2008/0208128)/Chebator et al. (PG PUB 2012/0083740) in view of Poker et al. (PG PUB 2016/0058983).
Re claim 9, Guo discloses that each tab of the pair of tabs includes an inner surface (labeled in Fig A above) and an outer surface (labeled in Fig A above) but does not explicitly disclose that the inner and outer surfaces of each tab are textured making the tabs easier to grasp. Poker, however, teaches a balloon protector 2 (Fig 1) comprising a pair of tabs 6,6 (Fig 1), each tab having two textured surfaces 10,10 (Fig 1; Para 37) making the tabs easier to grasp (Para 37) for the purpose of enhancing gripability and preventing fingers from sliding off of the tabs when pulling them (Para 37). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Butler to include the inner and outer surfaces of each tab such that they are textured, as taught by Poker, for the purpose of enhancing gripability and preventing fingers from sliding off the tabs when pulling them (Para 37).
Response to Arguments
Applicant’s arguments filed 10/27/2025 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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783