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 in the reply filed on April 1, 2026, is acknowledged.
Claim 1 and its dependent claims do not read on the elected species. Species A is shown in Figs. 2-3, and as shown, there is no means by which the extension device is removable from about the shaft of the catheter without withdrawing the catheter proximally through the lumen of the extension device. This feature is shown in Figs 5A-5F (elements 514 and 516), which is directed to Species C. Therefore, claims 1-6 do not read on the elected species and are withdrawn.
Claim 7 and its dependent claims also fail to read on the elected species. Claim 7 requires “wherein the extension device is removable from about the shaft of the first medical device without drawing the shaft proximally through the lumens of the inner and outer members”. This is not shown in Figs. 2-3, but rather, is limited to elements 514 and 516 in Figs. 5A-5F and Species C. Therefore, claims 7-11 do not read on the elected species and are withdrawn.
Claim 14 is similar to claims 1 and 7 in that it requires removing the extension device from about the shaft of the catheter while the catheter remains within the working channel of the endoscope. Again, this is not shown in Figs. 2-3. The limitation is shown in Figs. 5A-5F, which is Species C.
Claim 15 requires “wherein the placing step comprises placing the extension device about the shaft after inserting the catheter into the patient.” This is not shown in Figs. 2-3. There is no explanation as to how this can be done with the embodiment as the handle of the catheter is larger than the extension device (see Fig. 2). The only embodiment where this appears feasible is Species C, Figs. 5A-5F.
Claims 12-13 are addressed on the merits below.
Claims 1-11 and 14-15 are withdrawn as being directed to non-elected species.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 12 is rejected under 35 U.S.C. 102a1/a2 as being anticipated by Suda (US 2008/0242925).
Regarding Claim 12, Suda discloses:
A method of extending a length of a working channel, comprising:
inserting an endoscope having a working channel (5) into a patient (see Paragraph 0037);
inserting a catheter (26) into the patient through the working channel;
placing an extension device (22 including sections 28 and 29) having a lumen extending therethrough about a shaft of the catheter (see Figs. 3 and 5 showing 22 with a lumen extending about the shaft of 26);
attaching the extension device to a proximal end of the working channel (see Fig. 1 showing the extension device attached to the proximal end of the working channel at 5a);
attaching the catheter to a proximal end of the extension device (see Fig. 2 showing 26 attaching at the proximal end of 22 near 29b);
adjusting the extension device to a desired position that corresponds to an adjustable length of the extension device (32 is used to adjust the length of the extension device as shown in Fig. 3); and
locking the extension device at the desired position (32 is a fixing screw that is tightened to lock the device in the desired position).
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.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Dimitriou et al. (US 2007/0270640) in view of McWeeney et al. (US 2012/0116248).
Regarding Claim 12, Dimitriou discloses:
A method of extending a length of a working channel, comprising:
inserting an endoscope having a working channel into a patient (see Paragraph 0010 discussing inserting an endoscope into a body cavity or organ where the scope includes a working channel);
inserting a tool into the patient through the working channel (see Paragraphs 0059-0060 discussing inserting tools through the endoscope);
placing an extension device (30) having a lumen extending therethrough about a shaft of the tool (see Fig. 10 showing the tool 114 is mounted and extends through the extension device; see Paragraphs 0073-0074);
attaching the extension device to a proximal end of the working channel (see Figs. 1-2, for example, showing 30 attached to the proximal end of the channel at 42);
attaching the catheter to a proximal end of the extension device (see Fig. 10 showing 118, the handle of the tool 114, attached to the proximal end of 30);
adjusting the extension device to a desired position that corresponds to an adjustable length of the extension device (see Fig. 5, for example, and Paragraph 0044 describing the selectively adjustable nature of the coupling); and
locking the extension device at the desired position (see Fig. 2 and Paragraph 0046 for example describing locking the extension device in the desired position).
Dimitriou does not explicitly disclose that the tool is a catheter. Catheters are well-known tools in the art. McWeeney teaches a similar extension device (see Fig. 1) using a catheter 14 with an endoscope for delivering a needle (see Paragraph 0069, for example). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Dimitriou’s method to include a catheter. Such a modification takes a well-known tool and incorporates it into a known method to yield predictable results. Catheters are frequently used with endoscopes for fluid delivery or for delivering other tools, as is the case with guide catheters.
Regarding Claim 13, Dimitriou does not explicitly disclose wherein adjusting the extension device to a desired position is such that a distal tip of the catheter extends at most 8 centimeters from a distal end of the endoscope. McWeeney teaches limiting the maximum distance of the distal tip to 8 cm (see Paragraph 0072). The Examiner also notes that changes in size or relative size are generally obvious when a person having ordinary skill in the art would have a reasonable expectation of success. Here, extending the tool or catheter too far beyond the endoscope would likely lead to the tool being outside the scope’s field of view. When this occurs, the user can no longer see the tool and it could harm the patient.
Conclusion
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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