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 22nd, 2026, have been entered. Claims 1-16 remain pending in the Application. The claim amendments overcome the previous claim objections.
Response to Arguments
Applicant's arguments filed June 22nd, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that Eli (Pub. No. 2019/0000604) does not disclose the newly added claim limitations because the center pocket of 220 does not have edges that are connected to the perimeter of the material 214 that is connected to the rails 216 and instead the edges of 220 connected to a central portion of 214, and that further, the three 220s do not extend away from the material 214 because interior portions of the 220s are connected back to an inner region of 214. Examiner respectfully disagrees. First, the claim language “connected to” does not require direct contact between the pouch edge and the rail, as intervening materials can “connect” two objects. Further, the central 220 does extend away from the rails 216 and material 214 in both a lateral and longitudinal direction, as shown in FIG. 2, and the connection between the 220s returning to 214 before extending outward does not contradict any claimed limitations.
Second, Applicant argues that Eli does not disclose the claim limitations in claim 6 of “applying force via the extension arm to press the frame and the entire perimeter of the sheet-like material against the sidewall” and in claim 8 of “mitigating eddy current generation in the tubular structure and generate laminar flow by interacting with turbulent fluid flowing in the tubular structure along a surface of the pouch” because Eli does not state that these functions are carried out. Examiner respectfully disagrees. Both claim limitations are part of “configured to” clauses, which only require that the claimed structure is capable of carrying out that function. Since the extension arm 204 is capable of pressing 214, 216, and 220 against the sidewall, and since the structure is capable of mitigating eddy currents and generating laminar flow in the tubular structure, Eli satisfies the claim limitations.
Third, Applicant argues that Eli does not disclose 220 and 214 can be made of a continuous material because 220 are connected to 214. Examiner respectfully disagrees. A continuous material requires no interruption, and the connections between 220 and 214 are not interruptions, as they form a single surface between the two filter materials.
Fourth, Applicant argues that Eli does not disclose “using the extension arm to press the frame against a sidewall of a tubular structure.” Examiner respectfully disagrees. As pointed out in the Non-Final Rejection dated March 20th, 2026, [0095] and [0355] disclose the connecting portion presses the deflector screen against the aortic arch using fluid pressure, and [0217] discloses forming a seal around the perimeter of the screen. Eli thereby discloses that the extension arm 204, which is used to place the device within the aortic arch, is pressing the filter (which includes the frame around the filter) into the aortic arch.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eli (Pub. No. 2019/0000604).
Regarding claim 1, Eli discloses an apparatus (200; [0163]; FIG. 2) comprising:
a frame (216) having respective rails (FIG. 2: left and right sides of 200) connecting proximal and distal ends of the frame (FIG. 2: the sides of 216 connect the proximal and distal ends of 216) and forming an enclosed region between the rails (206); and
a filter (214 and 220) including:
a sheet-like material (214) connected to the rails at a perimeter of the sheet-like material (FIG. 2: 214 connects to 216 on either side, and at the perimeter of 214), and configured to filter material passing through the enclosed region between the rails ([0171] 214 filters blood and particles); and
a pouch (the three 220s form a pouch with three pockets) including filter material having respective edges ([0171] 220 filters blood and particles), a first one of the edges connected a portion of the perimeter of the sheet-like material that is connected to one of the rails to (“connected” does not require direct contact, as an intervening object can bridge the gap between two connected objects, and FIG. 2 shows the right-side 220 making contact with a first right side of 216), and a second one of the edges connected to a portion of the perimeter of the sheet-like material that is connected to the other one of the rails (FIG. 2: the left-side 220 makes contact with the other 216), and having a central portion extending from each of the edges (FIG. 2: the center pocket of 220 extends from the sides of 210) and away from the sheet-like material and the enclosed region (FIG. 2: the center pocket of 220 extends away from 214), therein forming the pouch having an open end (224) with a further edge thereof connecting the respective edges (FIG. 2: the sides of 220 form an edge which connects one side of 210 to the other) and having a closed end (226) bound by the filter material and a portion of the sheet-like material extending between the edges of the filter material (FIG. 2: 226 are formed by 214 and 220).
Regarding claim 2, Eli further discloses the pouch is configured to filter particles from fluid flowing into the open end toward the closed end ([0172] the open ends 224 are upstream and the closed ends 226 are downstream).
Regarding claim 3, Eli further discloses the central portion has a further edge that connects the respective edges of the filter material and forms an entry to the open end (FIG. 2: the open edges of 224 connect one side of 216 to the other).
Regarding claim 4, Eli further discloses the filter material of the central portion is also formed of the sheet-like material ([0171] 214 and 220 are formed of the same material).
Regarding claim 5, Eli further discloses an extension arm (202 and 204) having a proximal end (202) and a distal end (204), the frame being coupled to the distal end of the extension arm (FIG. 2: 204 is coupled to 216).
Regarding claim 6, Eli further discloses the extension arm and the frame are configured and arranged to seal the entire perimeter of the sheet-like material of the filter around an opening in a sidewall of a tubular structure that extends longitudinally along a length ([0095] and [0355] the connecting portion presses the deflector screen against the aortic arch using the fluid pressure, which [0217] discloses forms a seal around the perimeter of the screen), by applying force via the extension arm to press the frame and the entire perimeter of the sheet-like material against the sidewall ([0095] the force comes from the connecting portion, and presses the device against the wall of the aortic arch).
Regarding claim 7, Eli further discloses the pouch is configured to arch into a cross section of the tubular structure with the perimeter of the sheet-like material sealed around the opening ([0217] the device seals the aortic arch, [0175] forcing the blood through 220).
Regarding claim 8, Eli further discloses the pouch is configured to mitigate eddy current generation in the tubular structure and generate laminar flow by interacting with turbulent fluid flowing in the tubular structure along a surface of the pouch ([0173-175] 220 block the lumen of the aorta and force blood to flow through the filter pockets, which the present Specification states on Page 2, line 28, to Page 3, line 6, will mitigate undesirable fluid flow characteristics and generate laminar flow).
Regarding claim 9, Eli further discloses the sheet-like material and the filter material of the pouch are made of a continuous sheet-like material (FIG. 2: 214 and 220 are continuous with no disruptions).
Regarding claim 10, Eli further discloses the rails have different shapes (FIG. 2: the sides of 216 are opposite images of each other).
Regarding claim 11, Eli further discloses one or more struts (218) connected to a portion of the frame (FIG. 2: 218 connect with 216) and configured to enhance the stiffness of the frame portion to which they are connected ([0170] 218 stiffen 214).
Regarding claim 12, Eli further discloses the frame is asymmetrical (FIG. 2: the frame includes the rails 216 and the struts 218, which make the overall frame asymmetric around any potential axis) and different portions of the frame exhibit different flexural rigidity characteristics relative to other portions of the frame ([0170] 218 traverse an area of 214, which change the stiffness of 214 in selected areas relative to the rest of 214).
Regarding claim 13, Eli discloses a method ([0173-175]; FIG. 2) comprising:
providing a frame (216) having respective rails (FIG. 2: left and right sides of 200) connecting proximal and distal ends of the frame (FIG. 2: the sides of 216 connect the proximal and distal ends of 216) and forming an enclosed region between the rails (206); and
providing a filter (214 and 220) including:
a sheet-like material (214) connected to the rails at a perimeter of the sheet-like material (FIG. 2: 214 connects to 216 on either side, and at the perimeter of 214), and configured to filter material passing through the enclosed region between the rails ([0171] 214 filters blood and particles); and
a pouch (the three 220s form a pouch with three pockets) including filter material having respective edges ([0171] 220 filters blood and particles), a first one of the edges connected a portion of the perimeter of the sheet-like material that is connected to one of the rails to (“connected” does not require direct contact, as an intervening object can bridge the gap between two connected objects, and FIG. 2 shows the right-side 220 making contact with a first right side of 216), and a second one of the edges connected to a portion of the perimeter of the sheet-like material that is connected to the other one of the rails (FIG. 2: the left-side 220 makes contact with the other 216), and having a central portion extending from each of the edges (FIG. 2: the center pocket of 220 extends from the sides of 210) and away from the sheet-like material and the enclosed region (FIG. 2: the center pocket of 220 extends away from 214), therein forming the pouch having an open end (224) with a further edge thereof connecting the respective edges (FIG. 2: the sides of 220 form an edge which connects one side of 210 to the other) and having a closed end (226) bound by the filter material and a portion of the sheet-like material extending between the edges of the filter material (FIG. 2: 226 are formed by 214 and 220).
filtering material passing through the enclosed region between the rails ([0173] 220 filter particles as blood passes between the sides of 210); and
utilizing the pouch, filtering particles from fluid flowing into the open end toward the closed end ([0171-172] the open ends 224 are upstream and the closed ends 226 are downstream, enabling the capture of particles).
Regarding claim 14, Eli further discloses using the fluid flowing into the open end toward the closed end to apply pressure to the frame for sealing the perimeter of the sheet-like material to an opening in a sidewall with which the frame is engaged ([0095] and [0355] the connecting portion presses the deflector screen against the aortic arch using the fluid pressure, which [0217] discloses forms a seal around the perimeter of the screen).
Regarding claim 15, Eli further discloses providing the frame includes providing an extension arm (202 and 204) having a proximal end (202) and a distal end (204), the frame being coupled to the distal end of the extension arm (FIG. 2: 204 is coupled to 216), further including using the extension arm to press the frame against a sidewall of a tubular structure ([0095] and [0355] the connecting portion presses the deflector screen against the aortic arch using the fluid pressure, which [0217] discloses forms a seal around the perimeter of the screen).
Regarding claim 16, Eli further discloses including deploying the frame and extension arm into the tubular structure using a catheter ([0052] the method of deploying 200 involves using a catheter delivery system).
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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