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 § 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 (figs 1 and 3a) including a first shaft portion at 28 and a second shaft portion 10b (figs 1 and 3a) 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)), wherein a distal portion at of the balloon 54a is joined to a distal portion of the second shaft portion.
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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 31,50a 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], wherein a distal portion of the balloon is joined to a distal portion of the second shaft portion.
However, Katsurada fails to disclose the first shaft portion has a length in an axial direction of 1.5 cm or more.
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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, 22,15 wherein the first shaft portion 20,16 is more flexible than the second shaft portion [0023], wherein a distal portion of the balloon is joined to a distal portion of the second shaft portion. The inflation lumen 15,20,22 can have another configuration such as a single tube [0012]. However, Egerter fails to disclose the first shaft portion has a length in an axial direction of 1.5 cm or more.
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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].
Response to Arguments
Applicant's arguments filed 06/01/2026 have been fully considered but they are not persuasive.
In regard to applicant’s arguments states about Vreeman (page 5 of Remarks), that the amended language “clarifies that the balloon does not cover the first shaft portion, and that the first shaft portion 10 extends distally beyond the balloon's distal end.”. The examiner disagrees. For applicant’s convenience, the examiner provided above a labeled figure in the rejections with the claimed elements. Claim 1 set forth the amended language, there is no distinction within the claim were the set forth “portions” are designated beyond the plain definition from proximal and distal which can be taken arbitrarily. The claim also does not specifically state where one portion starts or ends from a proximal side to a distal side, but establishes a seemingly large section where the balloon seats on either first and second shaft portions. Therefore, Vreeman anticipates claim 1.
In regard to applicant’s arguments about “Similar to Vreeman, in Katsurada and Egerter, the balloon distal end covers the components that the Office identified as the first shaft portion. However, by this amendment, the structural 20 relationship where the entire length of the first shaft portion is located distally of the balloon joint is not taught or suggested by these references. Accordingly, one of ordinary skill in the art would have no motivation to modify the references and to move the balloon joint proximally to leave a long (> 1.5 cm), highly flexible shaft portion 25 extending distally beyond the balloon, as the prior art's configuration focuses on the balloon covering these distal members.”, the examiner disagrees. The examiner directs applicant to argument 1).
Also, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Vreeman discloses the claimed length. Calhoun teaches a range including a distal tip section length which would have been obvious to one of ordinary skill to modify the length that the distal tip extends and where the balloon will be located. There is not further distinction in the claim from a balloon covering and joined to the second shaft portion in the claim. Therefore, it meets the claimed limitation.
Conclusion
THIS ACTION IS MADE FINAL. 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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