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
Claims 27, 29 and 35-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9 June 2026. Applicant provided no basis for traversal and therefore this election is treated as without traverse.
With respect to claims 1 and 35 being present in multiple groups, the examiner notes that these claims are effectively linking claims. The examiner is not aware of any prohibition on such claims in Lack of Unity practice and in the absence of any citation to such, the requirement is maintained.
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.
Claim(s) 1-4, 8, 17-18 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 6,692,484 to Karpiel et al. (Karpiel hereinafter).
Regarding claim 1, Karpiel teaches a multi-lumen catheter comprising a catheter body (12 see e.g. Fig. 14) comprising opposing proximal (left) and distal (right) end portions, a first expandable member (14) and a second expandable member (18) longitudinally spaced from the first, a primary lumen (24) extending longitudinally open at opposing ends thereof, with a distal end (at 62 in Fig. 14) is distal of the first and second expandable members, and an additional lumen (16, 20) supplying the expandable members (col. 12, ln. 32-36).
Regarding claim 2, Karpiel teaches that the second expandable member (18) is distal of the first (see Fig. 14) and has a longitudinally extending length smaller than that of the first.
Regarding claim 3, Karpiel teaches that the first expandable member may comprise PET (col. 67, ln. 60-66) and the second may comprise silicone rubber (col. 7, ln. 5-14). These materials have the specified durometers.
Regarding claim 4, Karpiel teaches a fully expanded state of the first and second balloons (Fig. 14) such that the second diameter is larger than the first.
Regarding claim 8, Karpiel teaches that the catheter body is sized and configured for placement through a transductal opening in a biliary tree (see col. 8, ln. 27-49).
Regarding claim 17, Karpiel teaches that the first expandable member may comprise PET (col. 67, ln. 60-66) and the second may comprise silicone rubber (col. 7, ln. 5-14). Karpiel further teaches an elongated shape (of 14) and a spherical shape (of 18, see applicant’s specification in paragraph 93 for applicable definition of spherical: a round, 2-dimensional shape).
Regarding claim 18, Karpiel teaches sphincter dilation (see e.g. Fig. 3) and the claimed size (claim 25).
Regarding claim 21, Karpiel teaches a rotational inflation device (62, rotational read as rotatable herein) provided by the at least one additional lumen (20) in fluid communication with the second expandable member (18).
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(s) 5-7, 9, 16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karpiel.
Regarding claims 5-6, Karpiel is silent to the particular dimensions recited in these claims. However, it has been held that where the difference between the prior art is solely one of relative dimensions and there is no criticality thereof, a prima facie case of obviousness is present (MPEP 2144.04 IV. A). Accordingly, it would have been obvious at the time of the effective filing date of the application to use the dimensions of claim 6 as has been held by the courts.
Regarding claim 7, Karpiel teaches independent operation of the expandable members (14, 18, see previous citations). Karpiel does not teach valves providing this functionality. The examiner takes Official Notice that valves are well-known and conventional for controlling fluid flows generally (e.g. as in USPC class 251) and have been commercially available in catheters prior to the effective filing date of the application. It would therefore have been obvious and conventional to use such valves to control fluid in the catheter of Karpiel as is well-known and conventional in the art.
Regarding claim 9, Karpiel teaches a syringe and passage of liquid (at least via 20) and a medical device (endoscope 30).
Regarding claim 16, Karpiel teaches radiopaque markers (48, 50), but does not explicitly teach their use with the embodiment of Fig. 14. Karpiel teaches that such markers provide visual position information to a user of the catheter during use (col. 7, ln. 66, through col. 8, ln. 8). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use radiopaque markers with the embodiment of Fig. 14 in order to provide visual position information during use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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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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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 3 September 2026
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