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 .
Response to Amendment
The claims filed on June 15th, 2026 have been entered. Claims 1- 20 are pending in the application. Claims 13- 20 remain withdrawn for being drawn to an unelected invention. The amendments to the claims overcome the previous claim objections and the amendment to claims 1 and 5 overcome the previous 112(b) rejection.
Claim Objections
Claims 1- 4 are objected to because of the following informalities:
Claim 1, Line 9 states “surface directly contracts the second articulating element”, it is suggested to change this to “surface directly contacts the second articulating element”.
Claims 2- 4 are objected to for being dependent on or from objected claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1- 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 1, the limitation “the first articulating element surface directly contacts the second articulating element surface in the delivery state” is not described in the specification in such a way as to reasonably convey that the inventor or joint inventor had possession of the claimed invention. Although the first articulating element and the second articulating element are taught to be “separated as shown in Figure 17B” (Paragraph 0113) after the penetration of the stent graft wall, it is unclear if a surface of the first articulating element directly contacts a surface of the second articulating element in the delivery state. Furthermore, this limitation is not clearly demonstrated within the figures.
Claims 2- 4 are rejected for being dependent on or from rejected claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 3, 5- 8 and 10- 12 under 35 U.S.C. 103 over Bruzewski et al. (US 2008/0108987) in view of Arevalos et al. (US 2020/0289196) has been withdrawn in light of applicant’s amendments; specifically Bruzewski does not teach wherein the distal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state and/or the proximal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state.
Claim(s) 1- 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruzewski et al. (US 2008/0108987) in view of Arevalos et al. (US 2020/0289196).
Regarding claim 1, Bruzewski (Bruzewski et al.) teaches an in-situ fenestration device (100)(Figs. 1- 8)(abstract and Paragraph 0011) comprising: a fenestration catheter (130) extending along a longitudinal axis, a distal tip (326) extending from the fenestration catheter (see annotated Fig. 3 below), the fenestration catheter including a first articulating element (RF electrode 106), the first articulating element articulable about the longitudinal axis from a delivery state to a deployment state, configured to form a fenestration in a graft material at a fenestration site of a stent graft (Paragraphs 0024, 0026, and Paragraph 0039)(As Paragraph 0039 teaches that the electrode self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.).
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Bruzewski does not teach a second articulating element, the second articulating element articulable about the longitudinal axis from the delivery state to the deployment state, the second articulating element in the deployment state configured to form a fenestration in a graft material at a fenestration site of a stent graft, wherein the first articulating element includes a first articulating element surface, the second articulating element includes a second articulating element surface, the first articulating element surface directly contacts the second articulating element surface in the delivery state.
Arevalos (Arevalos et al.) teaches an in-situ cutting device (Figs. 24A- 24B)(abstract, Paragraph 0004) comprising a catheter (2401) extending along a longitudinal axis, a distal tip extending from the catheter (see annotated Fig. 24A below), the catheter including a first articulating element (electrode 2403) and a second articulating element (tissue stabilizer 2404), the first articulating element articulable about the longitudinal axis from a delivery state to a deployment state (Paragraphs 0013, 0019, and 0064)(As Paragraph 0064 teaches that the tissue cutter self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.), the second articulating element articulable about the longitudinal axis from a delivery state to a deployment state (Paragraphs 0015, 0019, and 0064)(As Paragraph 0064 teaches that the tissue stabilizer self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.), and the first articulating element and the second articulating element in the deployment state are configured to cut tissue in-situ (Paragraphs 0019, 0130, and 0164).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos, since Arevalos teaches that having a first and second articulating element allows for the elements to sandwich the part being cut and allows for it to be removed after the cutting occurs (Paragraphs 0019, 0086- 0093, and 0106).
The combination of Bruzewski and Arevalos does not teach wherein the first articulating element includes a first articulating element surface, the second articulating element includes a second articulating element surface, the first articulating element surface directly contacts the second articulating element surface in the delivery state.
Arevalos teaches in a second embodiment an in-situ cutting device (Figs. 28A- 28K)(abstract, Paragraph 0004) comprising a catheter (2801) extending along a longitudinal axis, a distal tip extending from the catheter (see annotated Fig. 28K below), the catheter including a first articulating element (electrode 2803) and a second articulating element (tissue stabilizer 2804), the first articulating element articulable about the longitudinal axis from a delivery state to a deployment state (Paragraphs 0013, 0019, and 0064)(As Paragraph 0064 teaches that the tissue cutter self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.), the second articulating element articulable about the longitudinal axis from a delivery state to a deployment state (Paragraphs 0015, 0019, and 0064)(As Paragraph 0064 teaches that the tissue stabilizer self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.), and the first articulating element and the second articulating element in the deployment state are configured to cut tissue in-situ (Paragraphs 0019, 0130, and 0164), and wherein the first articulating element includes a first articulating element surface, the second articulating element includes a second articulating element surface (see annotated Fig. 28K below).
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Regarding wherein the first articulating element surface directly contacts the second articulating element surface in the delivery state, for purposes of examination the delivery state is herein considered where the device is being withdrawn to deliver the captured tissue and the deployment state is when the device is being reinserted, therefore as Arevalos teaches that the first articulating element surface directly contacts the second articulating element surface in this state (Paragraph 0150- 0151) then the second embodiment of Arevalos teaches this limitation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first articulating element and the second articulating element of the combination to have a first articulating element surface and a second articulating element surface directly contacting in the delivery state as taught by Arevalos, since Arevalos teaches that this configuration allows for the delivery catheter to capture all of the elements in a single motion and allows for efficient deployment and capture (Paragraphs 0150- 0151).
Regarding claim 2, Bruzewski and Arevalos make obvious the device as discussed above, including the first and second articulating elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding wherein the distal element has a distal element elliptical profile and the proximal element has a proximal element elliptical profile, Arevalos teaches that the first articulating element (electrode 2403) and the second articulating element (tissue stabilizer 2404) can have an oval profile (Paragraph 0016). As an oval shape is known in the art to be elliptical, the combination teaches this limitation.
Regarding claim 4, Bruzewski and Arevalos make obvious the device as discussed above, including the first and second articulating elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches w wherein the first articulating element (electrode 2403) and the second articulating element (tissue stabilizer 2404) are spaced apart in the deployment state (Arevalos, see annotated Fig. 24B below).
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Claim(s) 3 and 5- 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bruzewski et al. (US 2008/0108987) in view of Arevalos et al. (US 2020/0289196), as applied to claim 5 above, in further view of Long et al. (US 2010/0049190).
Regarding claim 3, Bruzewski and Arevalos make obvious the device as discussed above, including the first and second articulating elements.
The combination does not teach wherein the first articulating element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state and the second articulating element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state.
Long (Long et al.) teaches an abrading device (400)(abstract and Paragraph 0071)(Figs. 11A- 11D) comprising a catheter (106) extending along a longitudinal axis, a proximal tip extending from the catheter (see annotated Fig. 11A below), the catheter including a distal element (first canopy electrode 402a) and a proximal element (second canopy electrode 402b), the distal element articulable about the longitudinal axis from a delivery state to a deployment state, the proximal element articulable about the longitudinal axis from a delivery state to a deployment state, and the distal element and the proximal element in the deployment state are configured to cut tissue (Paragraph 0071- 0074) wherein the distal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state and wherein the proximal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state (see annotated Fig. 11A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distal element and the proximal element as taught by the combination to be oblique relative to the longitudinal axis of the fenestration catheter in the delivery state as taught by Long, as Long teaches an alternative way for the distal and proximal elements to expand in situ (Paragraph 0071- 0074) and the combination teaches that the distal and proximal elements expand (Paragraphs 0016 and 0064).
Regarding claims 5 and 9, Bruzewski (Bruzewski et al.) teaches an in-situ fenestration device (100)(Figs. 1- 8)(abstract and Paragraph 0011) comprising: a fenestration catheter (130) extending along a longitudinal axis, a distal tip (326) extending from the fenestration catheter (see annotated Fig. 3 below), the fenestration catheter including a distal element (RF electrode 106) articulable about the longitudinal axis from a delivery state to a deployment state (As Paragraph 0039 teaches that the electrode self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion), and configured to form a fenestration in a graft material at a fenestration site of a stent graft (Paragraphs 0024, 0026, and Paragraph 0039).
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Regarding the distal element having a distal element delivery cross sectional profile in the delivery state relative the longitudinal axis and a distal element delivery cross sectional profile in the deployment state relative the longitudinal axis, the distal element deployment cross sectional profile is larger than the distal element delivery cross sectional profile, as Bruzewski teaches in Paragraph 0039 that the distal element is expandable, and that the distal element has a cross sectional profile, then when the distal element is in the deployment state it would have a larger cross sectional profile compared to its delivery cross sectional profile.
Bruzewski does not teach a proximal element articulable about the longitudinal axis from a delivery state to a deployment state, the proximal element having a proximal element delivery cross sectional profile in the deployment state relative the longitudinal axis, the proximal element deployment cross sectional profile is larger than the proximal element delivery cross sectional profile, and the proximal element configured to form a fenestration in a graft material at a fenestration site of a stent graft or wherein the distal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state and/or the proximal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state, the distal and proximal elements are constrained within an outer diameter of the fenestration catheter in the delivery state.
Arevalos (Arevalos et al.) teaches an in-situ cutting device (Figs. 24A- 24B)(abstract, Paragraph 0004) comprising a catheter (2401) extending along a longitudinal axis, a distal tip extending from the catheter (see annotated Fig. 24A below), the catheter including a distal element (electrode 2403) and a proximal element (tissue stabilizer 2404), the distal articulable about the longitudinal axis from a delivery state to a deployment state (Paragraphs 0013, 0019, and 0064)(As Paragraph 0064 teaches that the tissue cutter self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.), the proximal element articulable about the longitudinal axis from a delivery state to a deployment state (Paragraphs 0015, 0019, and 0064)(As Paragraph 0064 teaches that the tissue stabilizer self-expands, then the delivery state is when the electrode is not expanded, and the deployment state is when it is, therefore it is articulating about the longitudinal axis through expansion.), the distal element and the proximal element in the deployment state are configured to cut tissue in-situ (Paragraphs 0019, 0130, and 0164), and the distal and proximal elements are constrained within an outer diameter of the fenestration catheter in the delivery catheter (As Paragraphs 0066, 0108, and 0150 teach that the elements are disposed and compressed within the catheter, then the elements are constrained within the outer diameter of the catheter).
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Regarding the distal element having a distal element delivery cross sectional profile in the delivery state relative the longitudinal axis and a distal element delivery cross sectional profile in the deployment state relative the longitudinal axis, the distal element deployment cross sectional profile is larger than the distal element delivery cross sectional profile, as Arevalos teaches in Paragraphs 0016 and 0064 that the distal element (electrode 2403) is expandable, and that the distal element has a cross sectional profile, then when the distal element is in the deployment state it would have a larger cross sectional profile compared to its delivery cross sectional profile.
Regarding the proximal element having a proximal element delivery cross sectional profile in the delivery state relative the longitudinal axis and a proximal element delivery cross sectional profile in the deployment state relative the longitudinal axis, the proximal element deployment cross sectional profile is larger than the proximal element delivery cross sectional profile, as Arevalos teaches in Paragraphs 0016 and 0064 that the proximal element (tissue stabilizer 2404) is expandable, and that the proximal element has a cross sectional profile, then when the proximal element is in the deployment state it would have a larger cross sectional profile compared to its delivery cross sectional profile.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos, since Arevalos teaches that having a first and second articulating element allows for the elements to sandwich the part being cut and allows for it to be removed after the cutting occurs (Paragraphs 0019, 0086- 0093, and 0106).
The combination does not teach wherein the distal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state and/or the proximal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state, the distal and proximal elements are constrained within an outer diameter of the fenestration catheter in the delivery state.
Long (Long et al.) teaches an abrading device (400)(abstract and Paragraph 0071)(Figs. 11A- 11D) comprising a catheter (106) extending along a longitudinal axis, a proximal tip extending from the catheter (see annotated Fig. 11A below), the catheter including a distal element (first canopy electrode 402a) and a proximal element (second canopy electrode 402b), the distal element articulable about the longitudinal axis from a delivery state to a deployment state, the proximal element articulable about the longitudinal axis from a delivery state to a deployment state, and the distal element and the proximal element in the deployment state are configured to cut tissue (Paragraph 0071- 0074) wherein the distal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state and wherein the proximal element is oblique relative to the longitudinal axis of the fenestration catheter in the delivery state (see annotated Fig. 11A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distal element and the proximal element as taught by the combination to be oblique relative to the longitudinal axis of the fenestration catheter in the delivery state as taught by Long, as Long teaches an alternative way for the distal and proximal elements to expand in situ (Paragraph 0071- 0074) and the combination teaches that the distal and proximal elements expand (Paragraphs 0016 and 0064).
Regarding claim 6, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding wherein the distal element has a distal element elliptical profile and the proximal element has a proximal element elliptical profile, Arevalos teaches that the distal element (electrode 2403) and the proximal element (tissue stabilizer 2404) can have an oval profile (Paragraph 0016). As an oval shape is known in the art to be elliptical, the combination teaches this limitation.
Regarding claim 7, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the distal element (electrode 2403) includes a distal heating element (cathode 2403b)(Arevalos, Paragraph 0128) and the proximal element (tissue stabilizer 2404) includes a proximal heating element (ring 2404b)(Arevalos, Paragraph 0128)(Paragraph 0074).
Regarding the elements being configured to heat the graft material at the fenestration site of the stent graft to form the fenestration, as Bruzewski teaches that the elements are within a device configured to form a fenestration in a stent graft (abstract and Paragraph 0060), and Arevalos teaches that the elements heat up to cut an opening (Paragraph 0074), then the elements of the combination are capable to heat the graft material at the fenestration site of the stent graft to form the fenestration.
Regarding claim 8, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the distal element (electrode 2403) and the proximal element (tissue stabilizer 2404) contact in the delivery state (As Arevalos teaches that the distal and proximal elements are indirectly connected during delivery (Paragraph 0128), then the distal and proximal elements indirectly contact each other when within the delivery state.) and wherein the distal element (electrode 2403) and the proximal element (tissue stabilizer 2404) are spaced apart in the deployment state (see annotated Fig. 24B below).
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Regarding claim 10, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination further teaches wherein the distal element (Arevalos, electrode 2403) is parallel to a first portion of the graft material in the deployment state and the proximal element (Arevalos, tissue stabilizer 2404) is parallel to a second portion of the graft material in the deployment state (see annotated Fig. 24A of Arevalos below).
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Regarding claim 11, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the cutting element as taught by Bruzewski to be the first and second articulating elements as taught by Arevalos for the purpose of cutting a hole within a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one cutting element for another because both elements are disclosed as equivalent structures for cutting an opening into a graft or tissue (Bruzewski, Paragraphs 0024, 0026, and 0039; Arevalos, 0019, 0130, and 0164) and substitution of one for the other would have resulted in the predictable result of providing a means for cutting an opening in-situ. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Bruzewski further teaches wherein the fenestration catheter is configured to track a guidewire (120)(Paragraphs 0036, 0053, and 0057)(see Fig. 1 and Fig. 3).
The combination further teaches wherein the distal element (electrode 2403) defines a distal element aperture configured to receive the guidewire, and the proximal element (tissue stabilizer 2404) defines a proximal element aperture configured to receive the guidewire (see annotated Fig. 24B of Arevalos below).
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Regarding claim 12, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
Bruzewski further teaches wherein the distal tip (326) is configured to push through an initial fenestration (opening 328) of the graft material (Paragraph 0052)(see Fig. 3).
Response to Arguments
Applicant's arguments filed June 15th, 2026 have been fully considered but they are not persuasive.
Applicant’s argument, see Pages 7-8, regarding that the prior art does not teach the newly added claim limitation of claim 1 has been fully considered but is not persuaded. As discussed above, Arevalos teaches this limitation within a second embodiment, since the delivery state is herein considered where the device is being withdrawn to deliver the captured tissue and the deployment state is when the device is being reinserted, therefore as Arevalos teaches that the first articulating element surface directly contacts the second articulating element surface in this state (Paragraph 0150- 0151) then the second embodiment of Arevalos teaches this limitation.
Applicant’s argument, see Pages 7-9, regarding the non-circular distal and proximal elements has been fully considered but is not persuasive as this limitation is not claimed within claim 5 and therefore is not applicable to the current claims.
Applicant’s argument, see Pages 8-9, regarding that Arevalos does not teach the distal and proximal elements constrained within an outer diameter of a fenestration catheter in the delivery state have been fully considered but is not persuasive. As discussed above, Arevalos teaches this limitation, since Paragraphs 0066, 0108, and 0150 teach that the elements are disposed and compressed within the catheter and therefore within the outside diameter of the catheter.
Applicant’s argument, see Pages 9- 10, regarding that Long does not teach the oblique relationship to the longitudinal axis has been fully considered but is not persuasive. As discussed above, Long teaches this limitation.
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 LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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