Prosecution Insights
Last updated: April 19, 2026
Application No. 18/374,283

IN-SITU FENESTRATION DEVICES WITH HEATED EXPANDABLE CONE

Non-Final OA §102§103§112
Filed
Sep 28, 2023
Examiner
DEMIE, TIGIST S
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Medtronic Vascular, Inc.
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
3y 3m
To Grant
97%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
322 granted / 428 resolved
+5.2% vs TC avg
Strong +22% interview lift
Without
With
+21.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
34 currently pending
Career history
462
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
46.7%
+6.7% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
18.6%
-21.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 428 resolved cases

Office Action

§102 §103 §112
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. 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 20 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 20 recites the limitation " the extending step includes advancing the expandable cone relative to the expandable cone " in line 1-2 . It is unclear to the Examiner how the expandable cone can move relative to itself. For examination purpose, the examiner is interpreting it to read as the extending step includes advancing the expandable cone relative to sheath. 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. Claims 1-4 , 8-11 and 13-14 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by AREVALOS et al. ( US 2019 / 0374254 ). Regarding claim 1 , AREVALOS discloses a n in-situ fenestration device comprising: a sheath (fig.14A-C; device 1400) including a proximal end (proximal end of device 1400) and a distal end (distal end of device 1400) ; and an expandable cone (fig.14A; cutter 1408, see also [0004]) including a proximal end (proximal end of cutter 1408) , a distal end (distal end of cutter 1408) , and a body extending (the body of cutter 1408) between the proximal end and the distal end (fig.14A) , the expandable cone includes a heating element ([0011]: “ the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element”) , the expandable cone is configured to expand from a crimped state within the sheath into an expanded state extending from the distal end of the sheath (fig.14A-C, see also [0004]) , and the heating element of the expandable cone is configured to be energized with an energy source to form a fenestration in a graft material at a fenestration site of a stent graft ([0011]: “ the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element”) . This feature of the device is capable of forming fenestration in a graft material of the stent graft. Examiner Note: While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, the device of AREVALOS is capable of performing the functions of the claimed invention. Regarding claim 2 , AREVALOS discloses t he in-situ fenestration device of claim 1, wherein the proximal end of the expandable cone has a proximal diameter and the distal end of the expandable cone has a distal diameter, the distal diameter is greater than the proximal diameter when the expandable cone is in the expanded state (fig.14A-C) . Regarding claim 3 , AREVALOS discloses t he in-situ fenestration device of claim 1, wherein the heating element is carried on the distal end of the expandable cone [0011] . Regarding claim 4 , AREVALOS discloses t he in-situ fenestration device of claim 1, wherein the heating element has a crimped shape in the crimped state (fig.14B) and an expanded shape in the expanded state (fig.14A) , the crimped shape is different than the expanded shape. The shape of the cutter 1408 is different in compressed and expandable state. Regarding claim 8 , AREVALOS discloses t he in-situ fenestration device of claim 1, wherein the energy source is an electrical energy source, a resistive energy source, or a radio frequency (RF) energy source [0011] . Regarding claim 9 , AREVALOS discloses t he in-situ fenestration device of claim 1, wherein the expandable cone is formed of a metal shape setting material ([0011]: “ cutter material comprises a shape memory alloy comprising: nickel-titanium; copper-aluminum-nickel; zinc-gold-copper; or a combination thereof.”) . Regarding claim 10 , AREVALOS discloses t he in-situ fenestration device of claim 4, wherein the expandable cone has a truncated conical shape in the expanded shape (fig.14A-C) . Regarding claim 11 , AREVALOS discloses t he in-situ fenestration device of claim 1, wherein the expandable cone is a carried on a catheter configured to retract and to advance the expandable cone relative to the sheath (fig.14A-C , see also [0189] ) . Regarding claim 13 , AREVALOS discloses an in-situ fenestration device comprising: a sheath (fig.14A-C; device 1400) including a proximal end (proximal end of device 1400) and a distal end (distal end of device 1400); and an expandable cone (fig.14A; cutter 1408, see also [0004]) including a proximal end (proximal end of cutter 1408), a distal end (distal end of cutter 1408), the expandable cone includes a heating element ([0011]: “ the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element”) , and the expandable cone is configured to expand from a crimped state within the sheath into an expanded state extending from the distal end of the sheath (fig.14A-C, see also [0004]), an energy source configured to energize the heating element of the expandable cone to form a fenestration in a graft material at a fenestration site of a stent graft ([0011]: “ the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element”) and a barb (fig.14A-B; penetrating tip 1401 with tines 1407) configured to gather and to remove the fenestrated material [0189] . Examiner Note: While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. In this case, the device of AREVALOS is capable of performing the functions of the claimed invention. Regarding claim 14 , AREVALOS discloses t he in-situ fenestration device of claim 13, wherein the barb is a needle barb (fig.14A-B, see also [0189] . Claim Rejections - 35 USC § 103 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 . Claim(s) 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over AREVALOS et al. ( US 2019/0374254) in view of BRUSZEWSKI (US 2009/0264977) . Regarding claim 15 , AREVALOS discloses the method comprising: delivering an expandable cone in a crimped state within a sheath to the fenestration site (fig.14A-C) , an expandable cone (fig.14A; cutter 1408, see also [0004]) including a proximal end (proximal end of cutter 1408), a distal end (distal end of cutter 1408), the expandable cone includes a heating element ([0011]: “ the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element”) , a sheath (fig.14A-C; device 1400) including a proximal end (proximal end of device 1400) and a distal end (distal end of device 1400) ; extending the expandable cone from the distal end of the sheath to transition the expandable cone from the crimped state into an expanded state (fig.14A-C, see also [0189]) ; and energizing the heating element of the expandable cone in the expanded state with an energy source to cut ([0011]: “ the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element”) . However, AREVALOS does not disclose energizing the heating element of the expandable cone in the expanded state with an energy source to form the fenestration in the graft material at the fenestration site of the stent graft and fenestrated material and a method of forming a fenestration in a graft material at a fenestration site of a stent graft . BRUSZEWSKI teaches a similar device that includes cutting radiofrequency plasma catheter assembly comprises electrodes (abstract). BRUSZEWSKI teaches energizing the heating element of the expandable cone in the expanded state with an energy source to form the fenestration in the graft material at the fenestration site of the stent graft and fenestrated material (fig.7B, see also [0063]). BRUSZEWSKI also teaches method of forming a fenestration in a graft material at a fenestration site of a stent graft (fig. 7B). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the method of AREVALOS with a method of forming a fenestration in a graft material at a fenestration site of a stent graft by energizing heating element as taught by BRUSZEWSKI for the purpose of using the device for different treatments including forming fenestration on graft material when needed . Regarding claim 16 , AREVALOS / BRUSZEWSKI teaches t he method of claim 15 further comprising gathering the fenestrated material with a barb (fig.14B of AREVALOS ) . Regarding claim 17 , AREVALOS/ BRUSZEWSKI teaches t he method of claim 16 further comprising removing the fenestrated material through the sheath (fig.14B, see also [0189] of AREVALOS ) . Regarding claim 18 , AREVALOS/ BRUSZEWSKI teaches t he method of claim 15 further comprising piercing the fenestrated material with a needle barb (fig.14A-B; penetrating tip 1401 with a plurality of tines 1407 of AREVALOS ) . Regarding claim 19 , AREVALOS/ BRUSZEWSKI teaches t he method of claim 15, wherein the extending step includes retracting the sheath relative to the expandable cone ( [0007] of AREVALOS) . Regarding claim 20 , AREVALOS/ BRUSZEWSKI teaches t he method of claim 15, wherein the extending step includes advancing the expandable cone relative to the expandable cone . Based on the interpretation stated above, cutter 1408 advances relative to delivery catheter 1410 (14A of AREVALOS ) . Claim 5-7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over AREVALOS et al. ( US 2019/0374254) . Regarding claim 5 -7 and 12 , In this specific e mbodiment AREVALOS does not teach wherein the crimped shape has a waveform profile; wherein the crimped shape has an overlapping, spiral profile ; wherein the crimped shape has a saddle profile and wherein the expandable cone is formed of a metal mesh material. In general teaching , AREVALOS teaches the cutter comprises various material such as shape memory alloy comprising: nickel-titanium; copper-aluminum-nickel; zinc-gold-copper; or a combination thereof. In some embodiments, the cutter comprises: a wire mesh [0004]. AREVALOS also teaches the cutter comprises various shapes including one or more collapsible wave forms. a collapsible hole saw configuration; a collapsible, open-end cylinder-shape configuration; a collapsible, open-end barrel-shape configuration; a collapsible, open-end box-shape configuration; a collapsible, open-end cone-shaped configuration; or a combination thereof. The expandable cutter is configured to have an expanded cross-sectional shape generally comprising: a circle; a square; a rectangle; a triangle; an oval; or a polygon [0007]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the first embodiment (14A-C) with various distal end shapes of the device and various material including a metal mesh material as taught by AREVALOS for the purpose of having the desired configuration of the device for the desired treatment. Furthermore, such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey , 149 USPQ 47 (CCPA 1976) and also it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin , 125 USPQ 416. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TIGIST S DEMIE whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5345 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday 8am-5Pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Joseph Stoklosa can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-2721213 . 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. /TIGIST S DEMIE/ Primary Examiner, Art Unit 3794
Read full office action

Prosecution Timeline

Sep 28, 2023
Application Filed
Mar 27, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
75%
Grant Probability
97%
With Interview (+21.6%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 428 resolved cases by this examiner. Grant probability derived from career allow rate.

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