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 Arguments
Applicant’s arguments, see the Appeal Brief filed 7/27/2026, with respect to the rejections of claims 1-9 under 35 U.S.C. 103 have been fully considered. Although the majority of the arguments presented were found not to be persuasive during the required Appeal Conference (see response below), the argument that the combination of Guo and Chebator (in the rejection of claim 1) renders the device of Guo unsuitable for its intended operation is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Chebator alone.
Applicant’s argument that the Examiner’s construction of “configured to” is unreasonably broad and improperly reads functional limitations out of claim 1 (see pages 8-11) is not persuasive.
Firstly, it is noted that Applicant’s assertion that the Office Action has set forth that the functional language has been “read out of the claim” is incorrect. The rejections previously and currently clearly set forth that the structures recited in the functional language – not the functional language itself – are not a part of the claimed invention. That is, the claims are directed only to a balloon protector and, therefore, the functionally recited “balloon catheter” and its components and the functionally-recited “guidewire” are not a part of the claimed balloon protector.
Regarding Applicant’s argument that one of ordinary skill in the art would understand that each “configured to” limitation of claim 1 requires a particular structure designed to perform the recited structure, it appears that the Applicant is arguing that the prior art must explicitly disclose that the functional limitation is performed. To this, the Examiner respectfully disagrees. One of ordinary skill in the art would recognize that a structure does not have to be explicitly described as performing a functional task (set forth by “configured to” language) if it is structurally capable of performing the task without additional intervention. In the present case, the balloon-covering section of Chebator is a tubular object and one of ordinary skill in the art would recognize that such a tubular object is “configured to” receive therein a balloon having a diameter smaller than the diameter of the tubular object’s lumen even though Chebator does not explicitly recite a “balloon” anywhere in their Specification.
If Applicant wishes for their claims to require operation with a balloon catheter, then the claims would need to be amended to positively recite the balloon catheter. For example, the preamble could be amended to be directed to “a system” comprising a balloon protector and a balloon catheter.
Applicant’s argument that the purpose of the balloon protector set forth in the specification (that it is used during shipping and preoperative handling and never inserted in the body – Para 49,55) should be read into the claim (see pages 11-13) is not persuasive. One of ordinary skill in the art would recognize that the phrase “balloon protector” could apply to a structure that is capable of protecting a balloon prior to insertion into the body or to a structure that is capable of protecting a balloon during insertion into the body; this is especially true since there are many prior art references where a balloon is covered (i.e. “protected”) until it reaches the intended target location in the body. Without claiming that the balloon protector is one that is not capable of entering the body or is only capable of being used outside the body, one of ordinary skill in the art would not limit the interpretation of a “balloon protector” to only this type of device. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s arguments directed to the previous rejections of claims 4-6 are moot in view of the present Office Action that indicates these claims as objected to but containing allowable subject matter.
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 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chebator et al. (PG PUB 2012/0083740).
Re claim 1, Chebator discloses a balloon protector 100 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted), comprising: a balloon-covering section 102+110 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-coated balloon” and “a balloon catheter” is not a part of the claimed invention; therefore, the balloon covering section of the claim 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 the lumen 108 of the balloon covering section is structurally capable of receiving a balloon having a diameter smaller than the lumen 108 therein), the balloon-covering section including a tip piece 110 of the balloon protector coupled to a distal-end portion (to the right in Fig 1) of a body piece 102 of the balloon protector (as seen in Fig 1; 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 of tip piece 110) having an inner-diameter taper (because tip piece 110 is structured to expand when an element 156 is extended therethrough, as seen in Fig 3B and described in Para 26, the tip piece 110 must have an inner-diameter taper that decreases in size in the distal direction) commensurate with an outer diameter of a distal shoulder of the balloon (as set forth above, “the balloon” is not a part of the claimed invention”; this limitation is met since one of ordinary skill in the art would recognize that the tapered portion of the tip piece 110 is structurally capable of receiving a distal shoulder of a balloon that is sized to be received therein), the inner-diameter taper of the tip piece configured to maintain concentricity between an opening 112 in a 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 (as set forth above, the “balloon catheter” is not a part of the claimed invention; therefore, “a shaft” having “a distal end” is also not a part of the claimed invention, nor is “a guidewire”; this limitation is met since one of ordinary skill in the art would recognize that the tip piece 110 is structurally capable of maintaining a concentricity between its opening 112 and an opening of a shaft sized to be received therein); and a tabbed section 116+116 proximal of the balloon-covering section (as seen in Fig 1), the tabbed section including a pair of tabs 116,116 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 (as set forth above, “the balloon” is not a part of the claimed invention; this limitation is met in view of Para 22 which discloses that the tabs 116,116 are pulled away from each other to split the balloon-covering section).
Re claim 7, Chebator discloses that both the body piece and the tip piece of the balloon-covering section include a pair of opposing longitudinal lines of weakness 114+115 (although only one line 114+115 is shown in Fig 1, Para 22 discloses “diametrically opposed” lines), the balloon-covering section configured to split along each line of the lines of weakness (Para 22,26).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chebator et al. (PG PUB 2012/0083740) in view of Moyer (PG PUB 2006/0052749).
Re claim 8, Chebator discloses the balloon-covering section further including a transitional section (the entire section of body piece 102) configured to cover a proximal shoulder of the balloon (as set forth above, “the balloon” is not a part of the claimed invention; this limitation is met since one of ordinary skill in the art would recognize that the transitional section is structurally capable of covering a proximal shoulder of a balloon sized to be received therein), but does not disclose the transitional section having an outer-diameter flare from an immediately distal portion of the balloon-covering section to a distal end of the tabbed section configured to increase a distance between the tabs making the tabs easier to grasp. Moyer, however, teaches a balloon protector 10 (Fig 1) comprising a balloon covering section 30 (Fig 1) and a tabbed section 60+60 (labeled in Fig A below), wherein the balloon covering section includes an outer-diameter flare at a proximal end of the balloon covering section (as seen in Fig 1) from an immediately distal portion of the balloon-covering section to a distal end of the tabbed section (as seen in Fig 1 and seen in Fig A below) configured to increase a distance between the tab 60,60 making the tabs easier to grasp (as seen in Fig 1). Moyer teaches that providing an outer-diameter flare at the proximal end of the balloon covering section provides means for attaching the balloon covering section to the tabbed section (Para 18). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Chebator to include the proximal end of the balloon covering section (which is a part of the transitional section) with an outer diameter flare, as taught by Moyer, for the purpose of providing means for attaching the balloon covering section to the tabbed section (Para 18).
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Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chebator et al. (PG PUB 2012/0083740) in view of Nardeo (US Pat 6,796,991).
Re claim 9, Chebator discloses all the claimed features except that each tab of the pair of tabs includes an inner surface and an outer surface, the inner and outer surfaces of each tab are textured making the tabs easier to grasp. Nardeo, however, teaches a balloon protector 14 (Fig 2) comprising a balloon covering section 43+56 (Fig 2) and a tabbed section 40 (Fig 2), wherein the tabbed section includes a pair of tabs 42,42 (Fig 2,3) with each tab including an inner surface (facing to the right in Fig 3) and an outer surface (facing to the left in Fig 3) and with each of the surfaces being textured (via ridges 47, as seen in Fig 1-3) making the tabs easier to grasp (Col 6, Lines 25-30); Nardeo teaches that providing the tabs with inner and outer textured surfaces aids the physician in gripping the tabs, aids the physician in maneuvering the balloon protector, and provides the physician with greater leverage when splitting the sheath (Col 6, Lines 25-30 and Col 10, Lines 47-59). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Chebator to include each tab with a textured inner surface and a textured outer surface, as taught by Nardeo, for the purpose of aiding the physician in gripping the tabs, aiding the physician in maneuvering the balloon protector, and providing the physician with greater leverage when splitting the sheath (Col 6, Lines 25-30 and Col 10, Lines 47-59).
Allowable Subject Matter
Claims 3-6 are 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.
The following is a statement of reasons for the indication of allowable subject matter: Dependent claim 3 (upon which claims 4-6 depend) requires the tip piece to have an overlapping portion over the distal-end portion of the body piece, the overlapping portion having an outer diameter greater than an outer diameter of an immediately proximal portion of the balloon-covering section. Chebator does not include such an overlapping portion, nor would it have been obvious to one of ordinary skill in the art to modify Chebator to include an overlapping portion as doing so would render the outer surface of the balloon-covering section no longer smooth, which one of ordinary skill in the art would recognize as undesirable during the removal of the split balloon-covering section from the vasculature.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 5,167,634 to Corrigan Jr et al. and PG PUB 2016/0058983 to Poker appear to disclose balloon protectors substantially similar to that of claim 1.
Applicant's amendment in the 10/27/2025 claim filing necessitated the new grounds 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
