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 with traverse of the species depicted in Figure 2A, Figures 9A-E, Figures 6A-D, Figure 17C, Figure 18A, and Figure 19B in the reply filed on 6/15/2026 is acknowledged. The traversal is on the grounds that the pending claims do currently claim the features of these species. This is not found persuasive because applicant must select between all possible species, regardless of their current inclusion in claim language in a proper restriction because claims can be amended to include more features. Thus, the features of the species above could be part of the claim language for this claim application.
The requirement is still deemed proper and is therefore made FINAL.
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 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 1-3, 6, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pate et al., US 20190133678, herein referred to as “Pate”.
Regarding claim 1, Pate discloses an in-situ fenestration device for locating a fenestration site and for forming a fenestration (Figures 2A-D and 12A-13B), the in-situ fenestration device comprising: first and second magnetic locators configured to magnetically mate in a mated position within a vasculature of a patient at the fenestration site (Figures 2A-D: adhesion elements 202 and 208 and [0021]: “the adhesion element may comprise a magnet configured to heat tissue by delivering electrical current”); and first and second heating elements configured to heat the first and second magnetic locators to form the fenestration at the fenestration site ([0021]: “the adhesion element may comprise a magnet configured to heat tissue by delivering electrical current” and Figures 13-B and [0022]: “Adhesion may be performed before, during, or after other procedures, such as fistula formation”).
Regarding claim 2, Pate discloses the in-situ fenestration device of claim 1, wherein the first and second heating elements are configured to demagnetize the first and second magnetic locators to change from the mated position to a released position ([0031]: “Upon completion of welding between the blood vessels (204, 210), the catheters (200, 206) may be removed.”).
Regarding claim 3, Pate discloses the in-situ fenestration device of claim 1, wherein the first magnetic locator is carried on a magnetic device configured to rotate from a delivery position to a deployment position where the first magnetic locator is facing the second magnetic locator ([0030]: “The adhesion elements (202, 208) may be configured to be attracted to each other when in proper axial and rotational alignment.” And [0031]: “Furthermore, in addition to bringing the catheters closer together and compressing tissue, a flat contact surface, such as contact surface (214), may allow a lateral magnetic coaption force to be generated and translated into an aligning torque, which may aid rotational alignment, as well as axial alignment, with an adhesion element of a second catheter.”).
Regarding claim 6, Pate discloses the in-situ fenestration device of claim 1, wherein the first and second magnetic locators are first and second permanent magnetic locators configured to demagnetize from heat generated by the first and second heating elements, respectively ([0044]: “The magnets described here throughout may be permanent magnets comprising one or more hard magnetic materials, such as but not limited to alloys of rare earth elements (e.g., samarium-cobalt magnets or neodymium magnets, such as N52 magnets) or alnico.” And [0050]: “After the vessels are brought toward each other and aligned, one or more adhesion elements may be activated to heat and denature tissue to fuse tissue together and form an adhesion between the two vessels. The catheters may then be removed.”).
Regarding claim 15, Pate discloses an in-situ fenestration device for locating a fenestration site and for forming a fenestration (Figures 6B and 12A-13B), the in-situ fenestration device comprising: first and second magnetic locators configured to magnetically mate in a mated position within a vasculature of a patient at the fenestration site (Figure 6B, see Figures 2A-D for reference), the first and second magnetic locators having first and second complimentary shapes, respectively, configured to align the first and second magnetic locators to magnetically mate in the mated position (Figure 6B); and first and second heating elements configured to heat the first and second magnetic locators to form the fenestration at the fenestration site (Figures 12A-13B and [0021]: “the adhesion element may comprise a magnet configured to heat tissue by delivering electrical current” and Figures 13-B and [0022]: “Adhesion may be performed before, during, or after other procedures, such as fistula formation”)..
Regarding claim 16, Pate discloses the in-situ fenestration device of claim 15, wherein the first and second complimentary shapes are first and second complimentary curved shapes, respectively (Figure 6B).
Regarding claim 17, Pate discloses the in-situ fenestration device of claim 16, wherein the first complimentary curved shape includes a convex surface and the second complimentary curved shape includes a concave surface (Figure 6B).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Pate (Figures 2A-D) in view of Embodiment B of Pate (Figure 6A).
Regarding claim 5, Embodiment A of Pate discloses the in-situ fenestration device of claim 1, but does not explicitly disclose a device wherein the first magnetic locator includes an end face and the second magnetic locator includes an indentation complementary in shape to the end face.
However, Embodiment B of Pate teaches an in-situ fenestration device wherein the first magnetic locator includes an end face and the second magnetic locator includes an indentation complementary in shape to the end face (Figure 6A).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Embodiment A of Pate so that the first magnetic locator includes an end face and the second magnetic locator includes an indentation complementary in shape to the end face as taught by Embodiment B of Pate to allow greater pressure to be applied to tissue between the two adhesion elements ([0036]).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Pate in view of Schenider, US 20140222046, herein referred to as “Schneider”.
Regarding claim 7, Pate discloses an in-situ fenestration device for locating a fenestration site and for forming a fenestration (Figures 2A-D and 12A-13B), the in-situ fenestration device comprising: a catheter having a bendable distal portion (Figures 2A-D: catheter 200), and a magnetic device carrying a first magnetic locator (Figures 2A-D: adhesion element 202), the bendable distal portion configured to bend such that the magnetic device transitions from a delivery position to a deployment position ([0030]: “The adhesion elements (202, 208) may be configured to be attracted to each other when in proper axial and rotational alignment.” And [0031]: “Furthermore, in addition to bringing the catheters closer together and compressing tissue, a flat contact surface, such as contact surface (214), may allow a lateral magnetic coaption force to be generated and translated into an aligning torque, which may aid rotational alignment, as well as axial alignment, with an adhesion element of a second catheter.”); a second magnetic locator (Figures 2A-D: adhesion element 208), the first and second magnetic locators configured to magnetically mate in a mated position within a vasculature of a patient at the fenestration site (Figures 2C-D); and first and second heating elements configured to heat the first and second magnetic locators to form the fenestration at the fenestration site ( Figures 12A-13B and [0021]: “the adhesion element may comprise a magnet configured to heat tissue by delivering electrical current” and Figures 13-B and [0022]: “Adhesion may be performed before, during, or after other procedures, such as fistula formation”). Pate does not explicitly disclose a device comprising a catheter having a trench, and a portion configured to bend such that the magnetic device transitions from a delivery position to a deployment position through the trench and about a pivot axis.
However, Schneider teaches a device (Figure 1) comprising a catheter having a trench (Figure 4), and a portion configured to bend such that the device transitions from a delivery position to a deployment position through the trench and about a pivot axis (Figures 4-5). In combination with Pate, the device is a magnetic device.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Pate so that the catheter has a trench and a portion configured to bend such that the device transitions from a delivery position to a deployment position through the trench and about a pivot axis as taught by Cosentino so that end of the device can be controlled by a user to an open or closed position (Schneider [0009]).
Regarding claim 8, Pate in view of Schneider discloses the in-situ fenestration device of claim 7, and Pate further discloses a device wherein the first and second magnetic locators face each other when the magnetic device is in the deployment position (Figures 2A-D).
Regarding claim 9, Pate in view of Schneider discloses the in-situ fenestration device of claim 7, and Pate further discloses a device wherein the magnetic device is fixedly connected to a fixing portion of the bendable distal portion (Figures 2A-D).
Regarding claim 10, Pate in view of Schneider discloses the in-situ fenestration device of claim 7, and Pate further discloses a device further comprising first magnetic locator device including the magnetic device (Figures 2A-D: adhesion element 202), a first sheath including the bendable distal portion ([0008]: “For example, the first catheter may comprise a distal portion, an inner proximal portion, and an outer proximal portion. The outer proximal portion may be slidable relative to the distal portion.), and a first catheter configured to track through the first sheath to an advanced position where the bendable distal portion extends beyond the first sheath ([0008]: “For example, the first catheter may comprise a distal portion, an inner proximal portion, and an outer proximal portion. The outer proximal portion may be slidable relative to the distal portion. The distal portion may have a retracted configuration and an extended configuration. The distal portion may be configured to extend away from the outer proximal portion when moved from the retracted configuration to the extended configuration.”).
Regarding claim 11, Pate in view of Schneider discloses the in-situ fenestration device of claim 7, and Pate further discloses a device further comprising second magnetic locator device including the second magnetic locator (Figures 2A-D: adhesion element 208), a second sheath, and a second catheter configured to track through the second sheath to an advanced position where the second magnetic locator extends beyond the second sheath ([0008]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pate in view of Schenider, further in view of Reid et al., US 20210353274, herein referred to as “Reid”.
Regarding claim 12, Pate in view of Schneider discloses the in-situ fenestration device of claim 7, but does not explicitly disclose a device wherein the bendable distal portion includes bellows configured to bend bendable distal portion from the delivery position to the deployment position.
However, Reid teaches a device wherein the bendable distal portion includes bellows configured to bend bendable distal portion from the delivery position to the deployment position (Figures 3C-D and [0054]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Pate so that the bendable distal portion includes bellows configured to bend bendable distal portion from the delivery position to the deployment position as taught by Reid to stabilize the distal end of the catheter (Reid [0054]).
Regarding claim 13, Pate in view of Schneider and Reid discloses the in-situ fenestration device of claim 12, and Reid further discloses a device wherein the bendable distal portion includes a distal end section (Figures 3C-D: first cuff 56), a middle section including the bellows (Figures 3C-D: membrane 60’), and a proximal end section (Figures 3C-D: second cuff 54), and the distal and/or proximal end sections do not include the bellows (Figures 3C-D).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Pate so that the bendable distal portion includes a distal end section, a middle section including the bellows, and a proximal end section, and the distal and/or proximal end sections do not include the bellows as taught by Reid to stabilize the distal end of the catheter (Reid [0054]).
Regarding claim 14, Pate in view of Schneider and Reid discloses the in-situ fenestration device of claim 12, and Reid further discloses a device with bellows (Figures 3C-D). In combination with Schneider, the trench of Schneider terminates the bellows because the bellows section is where the bending occurs.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Pate so that the bendable distal portion includes bellows as taught by Reid to stabilize the distal end of the catheter (Reid [0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
/N.W.R./Examiner, Art Unit 3794
