DETAILED ACTION
The following Office Action is in response to the Amendment filed on March 10, 2026. Claims 1-4 and 6-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Concerning the “Claim Rejections Under 35 U.S.C. §103” section on pages 6-9 of the Applicant’s Response filed on March 10, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant first argues that the McKenzie reference fails to teach or suggest transvascular delivery within the meaning of amended claim 1, arguing that the embolic device of the McKenzie reference is instead intended for use with a bypass machine and intended to be surgically implanted in conjunction with the use of a bypass machine. However, the examiner asserts that the use of the claimed invention in transvacular delivery is an intended use limitation, wherein a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, there are no structural differences between the snowshoe diverter of the McKenzie reference and the claimed embolic protection device. The applicant’s arguments are primarily focused on the intended use of the McKenzie reference, but has not provided any arguments as to how the snowshoe diverter of McKenzie would be incapable of transvascular delivery. Furthermore, it is noted that the applicant has too narrowly interpreted the term “transvascular delivery”. The applicant assumes that “transvascular delivery” must entail percutaneous delivery to the aortic arch through a neighboring vessel. However, the term “transvascular” may be simply defined as being “across the wall of a blood vessel” <en.wiktionary.org/wiki/transvascular>, wherein given the snowshoe diverter of the McKenzie reference is delivered across the wall of a blood vessel, it may be interpreted as being for “transvascular delivery to an aortic arch” when given its broadest reasonable interpretation.
The applicant then argues that the examiner mischaracterizes the McKenzie reference by overlooking the actual closest embodiment to the claimed protection device, arguing that other embodiments of the McKenzie reference show transvascular delivery, while the snow shoe diverter of the embodiment of Figures 5 and 14 are intended for direct surgical implantation. However, again, the examiner asserts that the applicant is arguing the intended use of the device, but does not argue any structural differences between the prior art and the claimed invention.
Lastly, the applicant argues that the modifications suggested by the Office Action in view of Johnson are erroneous given the modification from clearly open heart to a transvascular approach and the moving or altering of implementation and use of the snowshoe diverter. However, the examiner asserts that the applicant is mischaracterizing the modification. The examiner has not suggested a change in the delivery method of the McKenzie as suggested by the applicant. The modification is merely modifying the frame of the snowshoe diverter of the McKenzie reference to include the connection area of Johnson to facilitate deployment, repositioning, and removal of the protection unit, wherein such deployment, repositioning, and removal of the protection unit of the McKenzie reference may still be necessary even in an open heart procedure ([¶ 0075]; “the aortic diverter 200 is left in position for four to ten minutes then removed”). The applicant continues to argue that the snowshoe diverter is not designed for what the applicant interprets as transvascular delivery but fails to address any deficiencies in the specific structure of the combination which would make the device incapable of transvascular delivery or how an interpretation of a delivery of the device across a blood vessel as being transvascular is unreasonable. Therefore, the rejections of the claims under 35 U.S.C. §103 stand.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-4 and 6-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McKenzie et al. (US 2002/0077596, hereinafter McKenzie) in view of Johnson et al. (US 2006/0241675, hereinafter Johnson).
Concerning claim 1, the McKenzie et al. prior art reference teaches a collapsible embolic protection device capable of transvascular delivery to an aortic arch (Figure 14; 200), said protection device comprising: a delivery unit (Figure 14A; 304) and a protection unit (Figure 14A; 200) comprising a selectively permeable material ([¶ 0011]), a support frame provided in the form of a wire (Figure 21; 317), wherein said support frame has a distal end capable of being arranged in a direction of an ascending aorta and a proximal portion capable of being arranged in a direction of a descending aorta, depending on how the support frame is deployed by the operator (Figure 14; 200), wherein said protection unit has a collapsed delivery state during transvascular delivery to the aortic arch ([¶ 0079], collapsible to permit loading and delivery through a standard cannula, wherein delivering through the cannula may be interpreted as ‘transvascular’ given the protection unit is being deployed across a blood vessel) and an expanded state when in use within the aortic arch ([¶ 0079], expanded state = biased open position), wherein said protection unit in said expanded state extends substantially planar in a longitudinal direction of said collapsible embolic protection device (Figure 14; 200); a perimeter of said support frame, in the expanded state of said protection unit, is shaped to releasably engage with vessel tissue of the aortic arch (Figure 14; 306), such that said selectively permeable material covers a plurality of side branch vessel ostia (Figure 14; 200); said selectively permeable material is attached to said support frame such that said support member surrounds the entire perimeter of said selectively permeable material and expands said selectively permeable material along a length and width into a non-tubular shape, said selectively permeable material allows blood to pass into said plurality of side branch vessels but prevents embolic material in the blood from entering said plurality of side branch vessels during a medical procedure ([¶ 0014, 0079]), and wherein at least said distal end of said support frame is shaped to facilitate a collapse of said support frame in said collapsed delivery state by bending two branches of the support frame towards each other (Figure 21; frame 317 includes two branches that meet at distal end of the protection unit, said two branches capable of bending to collapse [¶ 0079]), but it does not specifically teach a connection area which is part of said wire and arranged at a perimeter of said proximal portion and configured for attachment to said delivery unit.
However, the Johnson et al. prior art reference teaches an embolic protection device for transvascular delivery to a vessel, said protection device comprising: a delivery unit (Figure 71A; 712, snare may be used for both deployment/delivery and retrieval [¶ 0123, 0128]) and a protection unit comprising a selectively permeable material (Figure 69D; 100), a support frame provided in the form of a wire (Figure 16A; 105, 110 together form a support frame | or may be singular wire looped around Figure 21; 105 | [¶ 0081]), wherein said support frame has a distal end (Figure 16A; 104) and a proximal portion (Figure 16A; 130) and a connection area which is part of said wire (Figure 72A; 240 | [¶ 0128] additionally teaches that the delivery unit may be integral to the wire, therein having said retrieval feature be an integral connection area) arranged at a perimeter of said proximal portion and configured for attachment to said delivery unit (Figure 72A; 240); wherein: said protection unit has a collapsed delivery state (Figure 69C; 100) and an expanded state (Figure 69D; 100); a perimeter of said support frame, in the expanded state of said protection unit is shaped to releasably engage with vessel tissue (Figure 16A; 10), and wherein at least said distal end of said support frame is shaped to facilitate a collapse of said support frame into said collapsed delivery state by bending two branches of the support frame towards each other (Figure 2A; 105, 110 define elongate members that form the frame, wherein the distal ends of said elongate members define two branches that bend and deflect towards each other to collapse the entire frame, therein being shaped to facilitate collapse of the support frame).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the protection unit of the McKenzie reference include the connection area of the Johnson reference to allow the protection unit to be deployed fully into the aorta and to further allow repositioning and removal which may be accomplished from either end of the device (McKenzie; [¶ 0043]).
Concerning claim 2, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference further teaches the protection unit including a stem (Figure 22; 181a) connected to said support frame (Figure 22; 105) and extends towards said connection area (Figure 21; 102) for connecting said device to said delivery unit ([¶ 0081]); and said stem connected directly to said support frame at a proximal end of the perimeter of the support frame, wherein said connection area is configured to be connected to said delivery unit after the collapsible embolic protection device has been arranged in said vessel during said medical procedure (Figure 74A; 240, 712 | [¶ 0128]).
Concerning claim 3, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 2, wherein the Johnson reference further teaches said stem being isolated from said selectively permeable material (Johnson; Figure 16A; 240).
Concerning claim 4, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference further teaches the delivery unit being permanently attached to said connection area (Johnson; [¶ 0128]).
Concerning claim 6, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference further teaches said connection area being a single connection area on said support frame (Johnson; Figure 16B; 102).
Concerning claim 7, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference further teaches said wire forming a loop (McKenzie; Figure 21; 317).
Concerning claim 8, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference further teaches said connection area being arranged directly on said periphery of said support frame (Johnson; Figure 21; 102).
Concerning claim 9, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference further teaches said delivery unit being arranged at an angle with said support frame in a longitudinal direction of the embolic protection device (McKenzie; Figure 14; 304) such that a force may be applied through said delivery unit onto the embolic protection device toward a wall of the aortic arch (McKenzie; [¶ 0011]).
Concerning claim 10, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference teaches that the connection area may be integral to said support frame (Johnson; [¶ 0081]).
Concerning claim 11, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference further teaches the protection unit being sized and shaped to extend across an apex of the aortic arch (McKenzie; Figure 14).
Concerning claim 12, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference further teaches said wire, which forms said perimeter of said support frame, comprising two branches of said wire that are joined at said connection area (Figure 21; frame 317 includes two branches that meet at distal end of the protection unit and also connect at the proximal end where the handle is positioned).
Concerning claims 13-15, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference further teaches that said selectively permeable material may be formed of a mesh of metallic strands or filaments, therein being a rigid, non-elastic material which is non-conformable to ostia of aortic side branch vessels (Johnson; [¶ 0105]), wherein it would be obvious to have the combination be formed of metallic strands given this is a known material for forming a filter mesh.
Concerning claim 16, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference teaches that the permeable material may have any number of shapes and configurations (McKenzie; [¶ 0011]), but does not specifically teach the permeable material being molded in a heat setting process to set a desired shape.
However, the examiner notes that this is a product-by-process limitation because the product is being defined by terms of the method or process by which it is made. Product-by-process claims are not limited to manipulations of the recited steps, only to the structure implied by the steps. Thus, the molding of the permeable material in a heat setting process to a set desired shape does not have patentable weight. Because the permeable material of the Johnson reference includes the same claimed structure and the method of achieving said structure is irrelevant, the claimed invention is not distinguished from the combination of the McKenzie and Johnson references.
Concerning claim 17 and 18, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference further teaches said wire being shaped into a tongue at a distal end (McKenzie; Figure 21; 317) said tongue having a smaller width than the rest of the support frame.
Concerning claim 19, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the Johnson reference further teaches said wire being shaped into a tongue at a distal end (Johnson; Figure 16A; 104 or equivalent Figure 21; 102) said tongue having a smaller width than the rest of the support frame (Johnson; Figure 16A; 122), wherein said tongue has an angle deviating from the longitudinal plane of said protection unit (Figure 16A; 104), wherein it would be further obvious to have the distal end of the frame of the McKenzie reference have an angle deviating from the longitudinal plane of said protection unit as in the Johnson reference to incorporate an additional connection area or retrieval feature at the distal end.
Concerning claim 20, the combination of the McKenzie and Johnson references as discussed above teaches the device according to claim 1, wherein the McKenzie reference further teaches that said substantially planar shape may be in a shape that may be interpreted as a flat cupped shape (McKenzie; Figure 15A; 200).
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 3/25/2026
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