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 Group A drawn to Fig. 3A in the reply filed on 12/18/2025 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 12/18/2025.
Claim 4 is also withdrawn as being directed to the nonelected species of Group B and 8-10 are also withdrawn as being drawn to nonelected species of Group C/D.
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, 2, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,308,342 to Sepetka et al. (“Sepetka”).
Regarding claim 1, Sepetka teaches a catheter comprising an elongate tubular body (12) having a proximal end portion and a distal end portion (Fig. 2), the elongate tubular body comprising: an inner liner (19/20/21) comprising a first surface (inner surface of 19/20/21) and a second surface (outer surface of 19/20/21), the first surface defining a lumen of the elongate tubular body (lumen of 12), and one or more outer layers (18) over the second surface of the inner liner, wherein the inner liner comprises a first thickness (thickness of segment 19) at the proximal end portion of the elongate tubular body and a second thickness (thickness of segment 21) at the distal end portion of the elongate tubular body, the second thickness being smaller than the first thickness (column 3, lines 23-24, the thickness of segment 20 is smaller than the thickness of segment 19, and in column 3, lines 46-47, the thickness of segment 21 is smaller than the thickness of segment 20, therefore the second thickness 21 is smaller than the first thickness 19; Examiner notes that the disclosure regarding the relative thicknesses of segments 19-21 in Sepetka is clear despite Fig. 2 appearing to show segment 21 being thicker than segment 20).
Regarding claim 2, Sepetka teaches the catheter of claim 1 as shown above, Sepetka further teaching the second surface of the inner liner defines a first outer diameter at the proximal end portion of the elongate tubular body and a second outer diameter at the distal end portion of the elongate tubular body, the second outer diameter being smaller than the first outer diameter (given that the thickness of the distal portion is smaller than the thickness of the proximal portion as shown above regarding claim 1, the corresponding diameters the distal portion would also be smaller than the proximal portion).
Regarding claim 3, Sepetka teaches the catheter of claim 2 as shown above, Sepetka further teaching the first outer diameter defined by the second surface of the inner liner at the proximal end portion is substantially constant, the second outer diameter defined by the second surface of the inner liner at the distal end portion is substantially constant (claim 1, section (b), all the segments have a constant wall thickness and thereby constant outer diameters), and the second surface of the inner liner further comprises a transition section (20) having a tapering function from the first outer diameter to the second outer diameter (column 3, lines 29-31).
Regarding claim 5, Sepetka teaches the catheter of claim 2 as shown above, Sepetka further teaching the first surface of the inner liner defines a diameter of the lumen substantially constant between the proximal end portion and the distal end portion of the elongate tubular body (column 3, lines 59-61).
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.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sepetka in view of U.S. Patent No. 4,323,071 to Simpson et al. (“Simpson”).
Regarding claim 6, Sepetka teaches the catheter of claim 2 as shown above, and although Sepetka discloses the use of a polymer, does not explicitly mention PTFE.
Simpson teaches an inner liner (22) is constructed from a material comprising PTFE (column 3, lines 45-47). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used PTFE as the material for the inner liner of Sepetka as taught by Simpson to yield the predictable result of providing an inner liner having a low coefficient of friction and high flexibility to facilitate movement as would be necessary to suit particular therapeutic applications.
Regarding claim 7, Sepetka and Simpson teach the catheter of claim 6 as shown above, Sepetka further teaching the first outer diameter defined by the second surface of the inner liner at the proximal end portion is substantially constant, the second outer diameter defined by the second surface of the inner liner at the distal end portion is substantially constant (claim 1, section (b), all the segments have a constant wall thickness and thereby constant outer diameters), and the second surface of the inner liner further comprises a transition section (20) having a tapering function from the first outer diameter to the second outer diameter (column 3, lines 29-31).
Conclusion
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783