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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 4/29/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 128 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 128 positively recites the limitation "the elongate rigidizing device" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Although it could be assumed in light of the instant Specification that “the elongate rigidizing device” may be “the rigidizing device” of claim 99, this is not necessarily required in light of the instant Specification, rendering the scope of the claim indeterminate as it is unclear what relationship(s) if any exist between or amongst “the elongate rigidizing device” and “the rigidizing device” and/or what is explicitly, implicitly, inherently, and/or inferentially required and/or excluded by “the elongate rigidizing device” recitation. For the purposes of examination on the merits "the elongate rigidizing device" recitation is being treated as reciting “the rigidizing device”.
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(s) 99-103, 105-113, and 128-129 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tilson et al. (WO 2020/018934 A1, hereinafter Tilson).
For claim 99, Tilson discloses a method of positioning a tool within a body lumen (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), comprising inter alia:
inserting a rigidizing device (609) and an outer tube (exterior of Fig 45D) into the body lumen while the rigidizing device is in a flexible configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), wherein the outer tube is positioned radially around the rigidizing device (exterior of 45D radially surrounds internally disposed 609), wherein the outer tube comprises one or more expandable channels therein (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]);
supplying vacuum or pressure to the rigidizing device to transition the rigidizing device from the flexible configuration to a rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]);
inserting a tool through a channel (655) of the one or more expandable channels while the rigidizing device is in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]); and
performing a medical procedure in the body lumen with the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 100, Tilson discloses the method of claim 99, further comprising inserting a guide through the channel of the one or more expandable channels while the rigidizing device is in the rigid configuration and prior to inserting the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 101, Tilson discloses the method of claim 100, further comprising: removing the tool from the guide (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]); and removing the guide from the channel (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 102, Tilson discloses the method of claim 101, wherein removing the guide from the channel causes the channel to collapse radially inwards (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 103, Tilson discloses the method of claim 100, wherein a shape of the rigidizing device in the rigid configuration remains fixed during inserting the guide (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 105, Tilson discloses the method of claim 100, wherein inserting the tool comprises inserting the tool such that the tool extends through a preset bend in a lumen of the guide and points towards a central axis of the rigidizing device (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 106, Tilson discloses the method of claim 100, wherein inserting the guide through the channel causes the channel to expand radially outwards from a collapsed configuration to an expanded configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 107, Tilson discloses the method of claim 100, wherein the guide has a higher stiffness than the rigidizing device in the flexible configuration and a lower stiffness than the rigidizing device in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 108, Tilson discloses the method of claim 99, wherein supplying the vacuum or pressure to the rigidizing device comprises supplying the vacuum or pressure to a wall of the rigidizing device (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 109, Tilson discloses the method of claim 99, wherein performing the medical procedure is performed while the rigidizing device is in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 110, Tilson discloses the method of claim 99, wherein the tool has a higher stiffness than the rigidizing device in the flexible configuration and a lower stiffness than the rigidizing device in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 111, Tilson discloses the method of claim 99, further comprising passing a scope through the rigidizing device while the rigidizing device is in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 112, Tilson discloses the method of claim 100, wherein a shape of the rigidizing device in the rigid configuration remains fixed during inserting the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 113, Tilson discloses the method of claim 99, further comprising selecting the channel of the one or more channels prior to inserting the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), wherein selecting the channel comprises selecting based upon a proximal marker indicating a distal circumferential position of the channel (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 128, Tilson discloses the method of claim 99, wherein the outer tube is permanently attached to the rigidizing device (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 129, Tilson discloses the method of claim 99, wherein the one or more expandable channels are in a lay-flat, radially collapsed state during insertion into the body lumen (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), and wherein inserting the tool through the channel causes the channel to radially expand from the lay-flat, radially collapsed state (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
Response to Arguments
Applicant's arguments filed 4/29/26 have been fully considered but they are not persuasive, wherein Applicant argues the following:
The Applicant submits that Tilson does not teach each and every feature recited in the claims. As amended, the claims recite, in part, inserting a rigidizing device and an outer tube into the body lumen while the rigidizing device is in a flexible configuration, wherein the outer tube is positioned radially around the rigidizing device, wherein the outer tube comprises one or more expandable channels therein; and inserting a tool through a channel of the one or more expandable channels while the rigidizing device is in the rigid configuration. The Office Action alleges that the exterior of FIG. 45D of Tilson is equivalent to the recited outer tube. However, FIG. 45D of Tilson shows the working channel 655 as being radially within the radial gap 611 (where pressure is supplied to rigidize the device). Thus, Tilson does not describe an outer tube (which includes one or more expandable channels) as being positioned radially around a rigidizing device, as recited. Therefore, Tilson does not teach each and every feature recited in the claims, and the claims cannot be anticipated by this reference.
In response the Examiner respectfully notes the following:
As set forth and cited hereinabove, Tilson explicitly discloses a rigidizing braid device 609 that is enclosed by an outer exterior layer tube shown in cross section in Fig 45D as the outermost layer, where the outer tube comprises one or more expandable channels therein . It appears Applicant is mischaracterizing the nature of the rejection when referencing 655.
In support therefor, Tilson explicitly states and evidentiarily demonstrates at least the following (emphasis added):
[0153] In general, described herein are rigidizing devices (e.g., overtubes) that are configured to aid in transporting a scope (e.g., endoscope) or other medical instrument through a curved or looped portion of the body (e.g., a vessel). The rigidizing devices can be long, thin, and hollow and can transition quickly from a flexible configuration (i.e., one that is relaxed, limp, or floppy) to a rigid configuration (i.e., one that is stiff and/or holds the shape it is in when it is rigidized). A plurality of layers (e.g., coiled or reinforced layers, slip layers, braided layers, bladder layers and/or sealing sheaths) can together form the wall of the rigidizing devices. The rigidizing devices can transition from the flexible configuration to the rigid configuration, for example, by applying a vacuum or pressure to the wall of the rigidizing device or within the wall of the rigidizing device. With the vacuum or pressure removed, the layers can easily shear or move relative to each other. With the vacuum or pressure applied, the layers can transition to a condition in which they exhibit substantially enhanced ability to resist shear, movement, bending, and buckling, thereby providing system rigidization.
[0154] The rigidizing devices described herein can provide rigidization for a variety of medical applications, including catheters, sheaths, scopes (e.g., endoscopes), wires, or laparoscopic instruments. The rigidizing devices can function as a separate add-on device or can be integrated into the body of catheters, sheaths, scopes, wires, or laparoscopic instruments. The devices described herein can also provide rigidization for non-medical structures.
[0159] In some embodiments, the braid layer 209 (or any braid layer described herein) can be configured such that the rigidizing devices described herein have a high stiffness ratio (i.e., the ratio of the stiffness in the rigid configuration, such as when vacuum or pressure is applied, to stiffness in the flexible configuration, such as when vacuum or pressure is not applied). For example, the stiffness ratio can be greater than 5, such as greater than 6, greater than 9, greater than 9, or greater than 10. Referring to Table 1 below, six vacuum rigidizing devices (samples A-F) were built and tested over a length of 4” and a deflection of ½” for cantilevered bending stiffnesses at atmospheric pressure (flexible configuration) and under vacuum (rigid configuration). As shown, lowering the braid angles raises the stiffness of the rigidized devices. Samples E and F show, in particular, the stiffness difference between a braid at a typical torque angle (sample E, 47.7 degrees and rigid stiffness of 0.529lbf) and a braid with a lower angle (sample F, 27.2 degrees, and a rigid stiffness of 1.455 lbf). As is also shown in Table 1, rigidizing devices with lower angles (e.g., angles under 45 degrees or 35 degrees, such as samples A-D and F) can have a much higher stiffness ratio (e.g., ratio of greater than 5, greater than 6, greater than 9, or greater than 10) than rigidizing devices with higher angles (e.g., angles of 45 degrees or above, such as sample F), which can have a stiffness ratio of under 5. It can also be observed from Table 1 that both samples A and B have a stiffness ratio above 5. Sample B, at a 14.9 degree braid angle, has a lower stiffness ratio but a higher absolute stiffness than sample because the strands of sample B are oriented close to the longitudinal axis (and therefore sample B has a higher stiffness in the flexible configuration).
[0169] In use, vacuum or pressure can be supplied between the walls of the rigidizing devices described herein, causing the braided layer and neighboring layer(s) to constrict and/or separate to transition between flexible and rigid configurations. The rigidizing devices described herein can thus advantageously transition from very flexible to very stiff upon activation by the user. When a vacuum or pressure is applied, the braids or strands can radially constrict or expand to become mechanically fixed or locked in place relative to one another. As a result, the rigidizing device can go from a flexible configuration to a rigid configuration when vacuum or pressure is applied (thereby fixing the rigidizing device in the shape that the rigidizing device was in just prior to application of the vacuum or pressure).
[0192] The rigidizing devices described herein can toggle between the rigid and flexible configurations quickly, and in some embodiments with an indefinite number of transition cycles. As interventional medical devices are made longer and inserted deeper into the human body, and as they are expected to do more exacting therapeutic procedures, there is an increased need for precision and control. Selectively rigidizing devices (e.g., overtubes) as described herein can advantageously provide both the benefits of flexibility (when needed) and the benefits of stiffness (when needed). Further, the rigidizing devices described herein can be used, for example, with classic endoscopes, colonoscopes, robotic systems, and/or navigation systems, such as those described in International Patent Application No. PCT/US2016/050290, filed September 2, 2016, titled“DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” the entirety of which is incorporated by referenced herein.
[0265] In some embodiments, the distal end section of the rigidizing devices described herein can include an element for local tissue stabilization, such as suction, a balloon or a cage element. For example, referring to Figures 45A-45D, in one embodiment, a rigidizing device 600 can include a balloon 666 and a balloon inflation lumen or tube 667 extending thereto. As shown in Figures 45B-45D (the outer layers have been removed in 6B-6C for clarity), the balloon inflation tube 667 can extend alongside the working channel 655 (and thus within the radial gap 611 between the slip layer 613 and the first braid layer 609). As shown in Figures 45B-45C, the inflation tube 667 can be configured to include a service loop 668 that can change lengths (i.e., straighten as in Fig 45B or obtain a greater bend as in 45C) to accommodate bending of the rigidizing device 600. In some embodiments, the balloon inflation tube can be spiraled about its axis to accommodate bending. In some embodiments, a vacuum rigidizing device can include a balloon inflation tube between the innermost layer and the braid, between the braid and the outer layer, radially inwards of the inner layer, or radially outwards of the outer layer. In some embodiments, a pressure rigidizing device can include an inflation lumen in the pressure gap, between the bladder and braid, between the braid and outer layer, radially inwards if the inner layer, or radially outwards of the outer layer. For example, the inflation lumen can be positioned similar to as described herein with respect to working channels and/or cables.
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Tilson Fig 45 showing rigidizing device 600 cross section, wherein exterior-most outer tube layer(s) radially surround interior, including rigidizing braid 609
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/Primary Examiner, Art Unit 3791
Prosecution Insights