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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1- 12, drawn to an in-situ fenestration device, classified in A61F2002/061.
II. Claims 13- 20, drawn to a method of forming a fenestration in a graft material at a fenestration site of a stent graft, classified in A61F2/954.
The inventions are independent or distinct, each from the other because:
Inventions Group I and Group II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process as claimed can be practiced by another and materially different apparatus or by hand, claim 13 does not require the elliptical shaped elements as required by the product.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (for example, searching different
classes/subclasses or electronic resources, or employing different search queries) :
Group I apparatus claims require searching CPC A61F2002/061, other similar CPC
groups, and cutting art, focusing on device structure and
catheter assemblies. Group II method claims require search CPC A61F2/954 and
procedure- focused art on in-situ fenestration protocols (including
RF/laser/ultrasound), which employs different queries and databases and is not likely
to be uncovered by structural device searches. The prior art applicable to the
apparatus is not likely to be applicable to the method steps and vice versa.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Matthew Jakubowski on February 11th, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13- 20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 1- 12 are objected to because of the following informalities:
Claim 1, Line 5 states “articulable the longitudinal”, it is suggested to change this to “articulable about the longitudinal”.
Claims 2- 4 are objected to for being dependent on objected claim 1.
Claim 5, Lines 4 states “articulable the longitudinal”, it is suggested to change this to “articulable about the longitudinal”.
Claim 5, Lines 5-6 states “articulable the longitudinal”, it is suggested to change this to “articulable about the longitudinal”.
Claims 6 -12 are objected to for being dependent on objected claim 5.
Claim 9, Lines 1- 2 states “oblique the longitudinal axis”, it is suggested to change this to “oblique relative to the longitudinal axis”.
Claim 9, Line 3 states “oblique the longitudinal axis”, it is suggested to change this to “oblique relative to the longitudinal axis”.
Claim 10, Line 1 states “parallel a first”, it is suggested to change this to “parallel to a first”.
Claim 10, Line 2 states “parallel a second”, it is suggested to change this to “parallel to a second”.
Appropriate correction is required.
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.
Claims 1- 12 are 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 1, Line 3 recites the limitation “a proximal tip”, it is unclear whether applicant is intending for the “proximal tip” to be referring to the tip that is facing the user, as set forth in applicant’s definition of proximal in Applicant’s specification, Paragraph 0032, or if applicant is intending for the proximal tip limitation to be referring to the tip that is facing away from the user, in which the proximal tip would be the distal most tip of the device. For purposes of examination, the proximal tip is herein interpreted as the distal most tip of the device.
Claim 5 is rejected for similar reasons related to the limitation “proximal tip” as recited in Line 3.
Claims 2- 4 and 6- 12 are rejected for being dependent on rejected claim 1 or rejected claim 5.
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.
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(s) 1- 8 and 10- 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).
Regarding claim 1, Bruzewski (Bruzewski et al.) teaches an in-situ fenestration device ()(Figs. 1- 8)(abstract and Paragraph 0011) comprising: a fenestration catheter (130) extending along a longitudinal axis, a proximal 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.
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 proximal 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).
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 claims 3 and 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 wherein the first articulating element (electrode 2403) and the second articulating element (tissue stabilizer 2404) contact in the delivery state (As Arevalos teaches that the first and second articulating elements are indirectly connected during delivery (Paragraph 0128), then the first and second articulating elements indirectly contact each other when within the delivery state.) and 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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Regarding claim 5, Bruzewski (Bruzewski et al.) teaches an in-situ fenestration device ()(Figs. 1- 8)(abstract and Paragraph 0011) comprising: a fenestration catheter (130) extending along a longitudinal axis, a proximal 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.
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 proximal 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.), and the distal element and the proximal element in the deployment state are configured to cut tissue in-situ (Paragraphs 0019, 0130, and 0164).
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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).
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 proximal tip (326) is configured to push through an initial fenestration (opening 328) of the graft material (Paragraph 0052)(see Fig. 3).
Claim(s) 9 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 9, Bruzewski and Arevalos make obvious the device as discussed above, including the proximal and distal elements.
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 wherein the proximal 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Danek et al. (US 2009/0143705) teaches a similar device for creating an opening within the body (abstract and Paragraphs 0140- 0142).
White (US 7,662,150) teaches a similar device for creating an opening within the body (abstract and Column 3, Line 60- Column 4, Line 6).
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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771