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 Objections
Claims 3 and 4 are objected to because of the following informalities:
Claim 3 currently recites “a separation adjusting mechanism the distance between…” The previous deletion of “which controls” appears to create a typographical error. For examination purposes, a separation adjusting mechanism “which controls” or “configured to control” will be assumed.
Line 2 of claim 4 recites “patient with an , said method comprising the steps [[or]] of:”
Applicant is requested to review all the amendments for consistency. Claim 4 appears to be missing language and makes deletions of terms that were not in previous version of the claims.
Appropriate correction is required.
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 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0008557 to Lenker et al. (“Lenker”) in view of U.S. Patent Publication No. 2012/0065579 to Cully et al. (“Cully”).
Regarding claim 1, Lenker teaches a steerable endoluminal access device (Fig. 2) comprising an outer tube (106) characterized by a proximal end, a distal end, and a flexible region (130) at said distal end of the outer tube (Fig. 2), said flexible region also characterized by a proximal and a distal end (Fig. 2), and an inner tube (104) characterized by a proximal end and a distal end (Fig. 2), and a flexible region (136) near said distal end of the inner tube, said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally proximate the distal end of the outer tube, said inner tube longitudinally fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube ([0007]), and a hub assembly comprising a first fitting (118) disposed about the proximal end of the outer tube and a second fitting (116) disposed about the proximal end of the inner tube, said first fitting operable to be longitudinally fixed to the outer tube and said second fitting operable to be longitudinally fixed to the inner tube (the hubs are fixed to their respective tubes), but does not explicitly specify a compression-type fitting, although given the broadest reasonable interpretation, the fittings of Lenker can be construed as “compressing” their respective tubes, since they are attached.
In any case, Cully shows compression fittings (hubs 112, 114, 116, connected to associated tubes 106, 108, 110, via compression fittings [0082]) in a similar type of access device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the fittings of Lenker with the compression-type fittings of Cully, in order to obtain the predictable result of providing attachment of a fitting to tube in a medical context.
Regarding claim 2, Lenker teaches the steerable endoluminal access device of claim 1 as shown above, Lenker further teaching the flexible region of the outer tube comprises a segment of the outer tube which is snake-cut with a plurality of radially oriented slots (718) in the wall of the outer tube, said radially oriented slots being radially aligned along one side of the outer tube (Fig. 7A), and the flexible region of the inner tube comprises a segment of the inner tube with a longitudinally oriented slot (726), wherein said longitudinally oriented slot divides the flexible region of the inner tube into a first partial cylinder segment and a second partial cylinder segment (734/732, [0117]).
Regarding claim 4, Lenker teaches a method of accessing a lumen of a patient with an endoluminal access device, said method comprising the steps of providing an endoluminal access device (Fig. 2) comprising an outer tube (106) characterized by a proximal end, a distal end, and a flexible region (130) at said distal end of the outer tube (Fig. 2), said flexible region also characterized by a proximal and a distal end (Fig. 2), and an inner tube (104) characterized by a proximal end and a distal end (Fig. 2), and a flexible region (136) near said distal end of the inner tube (Fig. 2), said inner tube being disposed within the outer tube, extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally proximate the distal end of the outer tube, said inner tube longitudinally fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube ([0007]), inserting the endoluminal access device into a lumen of the patient and navigating the distal end of the endoluminal access device toward a target site within the patient ([0089]), securing a first fitting (118) about the proximal end of the outer tube such that the first compression fitting is longitudinally fixed to the outer tube, securing a second fitting (116) about the proximal end of the inner tube such that the second compression fitting is longitudinally fixed to the inner tube (the fittings are secured in at least the final product and the claim does not require the securement to occur after insertion into the patient), and manipulating the first fitting and second fitting to tension or compress the inner tube relative to the outer tube to cause deflection of the distal end of the endoluminal access device ([0007]), but does not explicitly specify a compression-type fitting.
Cully shows compression fittings (hubs 112, 114, 116, connected to associated tubes 106, 108, 110, via compression fittings [0082]) in a similar type of access device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the fittings of Lenker with the compression-type fittings of Cully, in order to obtain the predictable result of providing attachment of a fitting to tube in a medical context.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker and Cully as applied to claim 1 above, and further in view of U.S. Patent No. 5,007,914 to Schweigerling.
Regarding claim 3, Lenker and Cully teach the steerable endoluminal access device of claim 1 as shown above, but do not teach the separation adjusting mechanism.
Schweigerling teaches a separation adjusting mechanism (Fig. 7, forceps 33, see claim interpretation above) which controls the distance between a first fitting (11) and a second fitting (13). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the forceps-type of the separation adjusting mechanism into the device of Lenker and Cully in order to provide distance between the inserted catheter and the user’s hand to avoid contamination of the user’s hand through blood spray or other body fluid exposure (column 1, lines 20-32).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2006/0047222 to Heuser in view of U.S. Patent Publication No. 2009/0306472 to Filipi et al. (“Filipi”).
Regarding claim 4, Heuser teaches a method of accessing a lumen of a patient with an endoluminal access device, said method comprising the steps of providing an endoluminal access device (Fig. 2) comprising an outer tube (26) characterized by a proximal end, a distal end, and a flexible region (28, given that the 26 is a wire, flexibility given the broadest reasonable interpretation is assumed) at said distal end of the outer tube, said flexible region also characterized by a proximal and a distal end (Fig. 2), and an inner tube (12) characterized by a proximal end and a distal end, and a flexible region (14, given that 12 is a wire, flexibility given the broadest reasonable interpretation is assumed) near said distal end of the inner tube (Fig. 2), said inner tube being disposed within the outer tube (Fig. 2), extending from the proximal end of the outer tube to the distal end of the outer tube, and terminating distally proximate the distal end of the outer tube (Fig. 2), said inner tube longitudinally fixed to the outer tube at a point in the outer tube proximate the distal end of the flexible region of the outer tube (once 60/62 are connected), and inserting the endoluminal access device into a lumen of the patient and navigating the distal end of the endoluminal access device toward a target site within the patient (Figs. 3-4), securing a first compression fitting (54) about the proximal end of the outer tube such that the first compression fitting is longitudinally fixed to the outer tube, securing a second compression fitting (50) about the proximal end of the inner tube such that the second compression fitting is longitudinally fixed to the inner tube, manipulating the first compression fitting and second compression fitting to tension or compress the inner tube relative to the outer tube to cause deflection of the distal end of the endoluminal access device ([0020]), but does not teach the fitting being a compression fitting.
Filipi teaches a compression fitting (400, Fig. 19A). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted the fittings of Heuser with the compression-type fitting of Filipi, in order to obtain the predictable result of providing releasable attachment of a handle to tube in a medical context.
Regarding claim 5, Heuser and Filip teach the method of claim 4 as shown above, Heuser further teaching the steps of: after the step of inserting the endoluminal access device, removing the first compression fitting from the proximal end of the outer tube and removing the second compression fitting from the proximal end of the inner tube ([0011], the handles of Heuser are designed to be removable) and inserting a catheter into the lumen of the patient over or through the endoluminal access device (Fig. 6, catheter 58 is inserted into the patient over the wire [0019]).
Response to Arguments
The drawings were received on 12/18/2025. These drawings are acceptable.
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to specification objections have been fully considered and are persuasive. The specification objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant's arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues that the fittings of Lenker are not compression fittings, however such an argument is moot since the compression fittings have been shown by Cully. Applicant argues that Cully does not depict compression fittings, however explicit depictions are not required, especially since compression fittings are explicitly recited in paragraph [0082] of Cully. Regarding claims 1 and 4, Applicant argues that Cully is not a similar device. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both are medical devices that are inserted into the body, and Cully is only being relied upon for the fittings and not other aspects of the device. Furthermore regarding claim 1, Applicant argues that there is no reason to combine Lenker and Cully since there is no reason to make the tubes and hubs of Lender removable. Examiner submits that there is no requirement for removability in claim 1. The rejections stand.
Regarding new claim 5, a new rejection has been made for claims 4 and 5 in view of Heuser and Filipi in response to the new limitations introduced in claim 5.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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