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
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 1-7, 10-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Marashi et al (2008/0147001).
Regarding claim 1, Al-Marashi et al disclose a catheter (10) comprising a metal hypotube (48 – Figures 14 and 15 and para. [0047], for example) and a polymer outer jacket (para. [0052], for example) over the hypotube. Note that outer catheter body may also be made of a polymer (para. [0028], for example). The hypotube is configured to bend with varying flexibility along the length of the hypotube (para. [0047] and [0066], for example). The hypotube defines a rapid exchange joint (18 – Figures 14 and 15) in an intermediate portion of the hypotube.
Regarding claim 2, there is a guidewire tube (26) comprising a proximal portion positioned at least partially in the rapid exchange joint (Figure 14) to allow a guidewire to pass from the inside of the hypotube to the rapid exchange joint opening to the outside of the catheter proximal of the rapid exchange joint opening (Figures 1 and 14, for example). Regarding claim 3, the guidewire tube comprises a skived section defining a smooth diameter transition between the polymer outer jacket and a location where a portion of the guidewire tube extends into the rapid exchange joint when the proximal portion of the guidewire tube (26) is attached to the hypotube (48) as seen in Figure 15. Regarding claims 4-6, Al-Marashi et al disclose the flexibility may be constructed as desired by varying the pitch with gradual or stepped transitions (para. [0066], for example). Regarding claim 7, Al-Marashi et al disclose providing a plurality of holes (or cuts) in one or more patterns to vary the flexibility along the length of the hypotube. See Figures 2-13 and associated description and paragraph [0066]. Regarding claim 8, Al-Marashi et al disclose a variety of patterns of holes/cuts that may be provided along the length of the hypotube such that the flexibility may be varied along the length (para. [0049] and [0066], for example. Regarding claim 10, Al-Marashi et al teach the rapid exchange joint may be provided towards the distal end of the hypotube (para. [0020], and Figure 1, for example) or may be provided distal to the hypotube (para. [0064]).
Regarding claim 11, Al-Marashi et al disclose the catheter as addressed with respect to claim 1 above and further disclose the steps of cutting a rapid exchange joint opening in the metal hypotube and polymer jacket.
Regarding claims 12 and 13, see Figures 14 and 15 and associated discussion. Regarding claim 14, Al-Marashi et al disclose forming laser cut patterns to afford variable stiffness, as desired, along the length of the hypotube. See, for example, paragraphs [0049] and [0066]. Regarding claim 15, Al-Marashi et al specifically disclose the variable stiffness along the length of the hypotube may be made with gradual transitions to vary the flexibility along the length of the hypotube (para. [0066]). Regarding claim 16, Al-Marashi et al disclose laser-cutting holes/patterns into the hypotube to provide a varying flexibility along the length of the hypotube (para. [0049] and [0066], for example). Regarding claim 17, Al-Marashi et al disclose laser-cutting holes in a variety of patterns to provide varying flexibility along the length of the hypotube (para. [0049] and [0066], for example). Regarding claim 20, see discussion of claim 10 above.
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Al-Marashi et al (2008/0147001).
Al-Marashi et al fail to disclose the exact dimensions for the opening for the rapid exchange joint. The examiner maintains that one of ordinary skill in the art would recognize the appropriate size of the opening that would be sufficient to allow passage of a guidewire while not compromising the integrity of the hypotube. While not necessarily to scale, Figures 10-13 show various openings for the rapid exchange joint which are depicted as being much smaller than 80% of the inner diameter of the hypotube.
To have provided the Al-Marashi et al with any reasonable sized opening for the rapid exchange joint to allow for the passage of a guidewire would have been an obvious design consideration for one of ordinary skill in the art.
Claims 1, 9, 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al (2015/0209104) in view of the teaching of Al-Marashi et al (2008/0147001).
Regarding claim 1, Tran et al provide a catheter comprising a metal hypotube and a polymer jacket over the hypotube (Abstract, for example) with the catheter device comprising a variable flexibility along the length of the catheter. Tran et al also disclose a guidewire for use with the catheter, but fail to expressly disclose a rapid exchange joint opening for receiving the guidewire in the hypotube. Also, the Tran et al device does not have the hypotube extend the majority of the length of the catheter.
Al-Marashi et al, as addressed previously, disclose a flexible catheter and specifically teach that it is known to provide the catheter with a metal hypotube surrounded by a polymer outer jacket, and a rapid exchange joint opening in the hypotube to accept a guidewire for guiding the catheter. The hypotube has cuts/holes along the length thereof to provide variable flexibility along the length of the hypotube. See above discussion with respect to the 35 USC 102 rejection.
To have provided the Tran et al device with a hypotube along substantially the entire length of the catheter with cuts/holes to afford flexibility, and a rapid exchange joint opening for receiving a guidewire to guide the catheter would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Al-Marashi et al fairly teach it is known to provide flexible catheters with a variable stiffness hypotube structure and a rapid exchange joint for receiving a guidewire to guide the catheter to a desired location.
Regarding claim 9, Tran et al teach that it is known to provide the catheter with electrodes (Abstract, for example) and also provide a separate polymer tube (132) for housing the wires connected to the electrodes as the wires extend through the hypotube. See, for example, paragraphs [0027-0028].
Regarding claim 11, see above discussion of claim 1 which provides the motivation for providing the Al-Marashi et al teaching with the Tran et al device. Both Al-Marashi et al and Tran et al discuss the method of making the device, which method is inherent to the structure disclosed. Regarding claim 19, Tran et al again teach that it is known to provide a separate polymer tube for housing wires that are connected to electrodes at the distal end of the catheter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stigall et al (2020/0214665) discloses a catheter comprising a hypotube having a varying flexibility and a rapid exchange port near the distal end of the catheter device. Swanson (5,605,543) disclose another hypotube catheter device having holes of different patterns cut into the hypotube to vary the flexibility along the length of the catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/March 25, 2026