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 .
Election/Restrictions
Applicant’s election without traverse of species a) figure 1, claims 1-3, 5-7 in the reply filed on 12/29/2025 is acknowledged.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
In response to applicant’s remarks about generic claims, the examiner agrees claims 1-3, 5-6 are generic.
Claim Rejections - 35 USC § 102
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.
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 Vreeman et al (US 20080300539 A1).
Regarding claims 1, Vreeman discloses a balloon catheter comprising:
a shaft 10 including a first shaft portion at 28 and a second shaft portion 10b located on a proximal side of the first shaft portion 28 (fig 3a); and
a balloon 8 covering and joined to the second shaft portion (fig 3a), wherein the first shaft portion is more flexible than the second shaft portion [0023], and has a length in an axial direction of 1.5 cm or more ([0027] (15-200mm equal to 1.5 cm- 20cm)).
Regarding claim 7, Vreeman discloses the first shaft portion 28 and the second shaft portion 10 are integrally formed (figs 4a-4d); a first lumen 129,29 and a second lumen 120 are formed in the shaft, the first lumen 129 penetrating from a proximal side of the second shaft portion 10 to a distal end of the first shaft portion 29, the second lumen 120 extending from the proximal side of the second shaft portion to an inside of the balloon 8 and communicating with the balloon (fig 3a); and an outer diameter of the first shaft portion is smaller than an outer diameter of the second shaft portion.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 are rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al. (US 2017/0071613 A1) in view of Calhoun et al (US 20200206482 A1).
Regarding claim 1, Katsurada discloses a balloon catheter 10 comprising:
a shaft 30 including a first shaft portion at 22A,60,80A and a second shaft portion 31 located on a proximal side of the first shaft portion (fig 1); and
a balloon 20A covering and joined to the second shaft portion at 23, wherein the first shaft portion is more flexible ([0028] formed from a resin) than the second shaft portion [0025].
Katsurada set forth in [0010-0011, 0013] that the first shaft portion, specifically the joining portion between inner shaft, balloon and tip can be extended based on balloon, inner shaft and tip preference to avoid balloon detachment [0046]. However, Katsurada fails to disclose the first shaft portion has a length in an axial direction of 1.5 cm or more.
Calhoun teaches a balloon catheter 500 (figs 20-20C) including a shaft 502,506,508 including a first shaft portion at 518 and a second shaft portion 508 located on a proximal side of the first shaft portion (fig 20); and
a balloon 520 covering and joined to the second shaft portion at 522 (fig 20C), wherein the first shaft portion is more flexible than the second shaft portion [0045].
Calhoun further teaches in [0173, 0175] the distal tip section extends 5-7mm (.5-.7cm) enhancing access to the artery around tight turns due to the extended tip. Calhoun also teaches in [0006] that balloon detaches from the inner tube as prior art, therefore with the extension of the first shaft portion will help prevent detachment.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Katsurada’s catheter with the tip extension of Calhoun since such modification would enhance maneuverability within an artery and prevent balloon detachment from inner tube. Additionally, the first shaft portion length is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al. (US 2017/0071613 A1) in view of Calhoun et al (US 20200206482 A1), and further in view of Duchamp et al (US 7141059 B2).
Regarding claims 2-3, Katsurada discloses an outer layer of the first shaft portion (at 22A,60,80A) and an outer layer of the second shaft portion 31 are each formed of a resin [0025,0028]. However, it fails to disclose a resin material of the outer layer of the first shaft portion has a Shore hardness of D47 or less, or D40 or less.
Duchamp teaches a first shaft portion (distal tip member; col 2 line 60- col. 2 line 23) (figures 6-7) including an outer layer of the first shaft portion 15,41,40 each formed of a resin; and a resin material of the outer layer of the first shaft portion 15,41,40 has a Shore hardness of D40 or less, or D40 or less. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Katsurada/Calhoun with Duchamp’s resin durometer since such modification is taught old and well known in the art of resins for providing a soft, flexible, and atraumatic distal end to the catheter.
Claims 1, 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Egerter (US 20200269023 A1) in view of Katsurada et al. (US 2017/0071613 A1) and Calhoun et al (US 20200206482 A1).
Regarding claim 1, Egerter discloses a balloon catheter 10 comprising:
a shaft including a first shaft portion 20,16 and a second shaft portion 14 located on a proximal side of the first shaft portion 20,16; and
a balloon 12 covering and joined to the second shaft portion 14, wherein the first shaft portion 20,16 is more flexible than the second shaft portion [0023]. However, Egerter fails to disclose the first shaft portion has a length in an axial direction of 1.5 cm or more.
Katsurada teaches a balloon catheter, [0010-0011, 0013], that the first shaft portion 22A,60,80A, specifically the joining portion between inner shaft, balloon and tip can be extended based on balloon, inner shaft and tip preference to avoid balloon detachment [0046].
Calhoun teaches in [0173, 0175] the distal tip section extends 5-7mm (.5-.7cm) enhancing access to the artery around tight turns due to the extended tip. Calhoun also teaches in [0006] that balloon detaches from the inner tube as prior art, therefore with the extension of the first shaft portion will help prevent detachment.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Egerter’s catheter with the tip extension of Katsurada and Calhoun since such modification would enhance maneuverability within an artery and prevent balloon detachment from inner tube. Additionally, the first shaft portion length is deemed matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results.
Regarding claim 5, Egerter discloses wherein a hydrophilic coating 16,54 is formed on at least a distal side of an outer peripheral surface of the first shaft portion (figures 2-3).
Regarding claim 6, Egerter discloses the hydrophilic coating 16,54 is formed on the outer peripheral surface of a distal portion of the first shaft portion (figures 2-3); and a coefficient of friction of the outer peripheral surface of the first shaft portion at a position proximal of the hydrophilic coating is higher than a coefficient of friction of the hydrophilic coating [0030].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783