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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/24/2025 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 09/24/2025.
Status of the claims:
Claims 1, 3, 4, 7, 8, 23, and 34 are pending in the application.
Claim 1 is amended.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “two struts of a wire filament” in line 2, although the line does not rise to the level of being indefinite as the line is understood by the Examiner, based on Applicant’s disclosure, to mean “two struts of the plurality of interconnected struts formed by the wire filaments” as the “two struts” and the “wire filaments” are the same struts and wire filaments defined in claim 1, the Examiner suggests the line be amended to read “two struts of the plurality of the interconnected struts formed by the wire filaments” for the purpose of maintaining consistent language throughout the claims;
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.
The rejection of claims 1, 3, 4, 7, 8, 23, and 34 under U.S.C 35 112(a) for failing to comply with the written description requirement, recited in the previous action dated 03/25/2025 have been withdrawn in light of Applicant’s amendments filed on 09/24/2025. More specifically, the rejections of claim 1 for the recitation “the tubular filter membrane extends about an entire circumference of the tubular frame from the distal end to the proximal radiopaque marker” and for the recitation of “the single control wire is configured, in response to the proximal motion of the delivery catheter, to cause the delivery catheter to retract from and uncover the tubular frame” have been withdrawn as claim 1 has been amended to no longer require the tubular filter membrane to extend from the distal end and amended to no longer require the single control wire to cause the delivery catheter to retract; subsequently, the rejections of claims 3, 4, 7, 8, 23, and 34 have been withdrawn as the claims are no longer dependent on a claim rejected under 112(a).
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.
The rejection of claim 23 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 08/28/2024 have been withdrawn in light of the Applicant’s amendments filed 02/27/2025. Specifically, the rejection of claim 23, regarding the phrase "a bare metal leading cylindrical segment of the tubular frame extending axially and distally beyond the tubular filter membrane" in conjunction with limitations from previous claim 1, has been withdrawn as claim 1 no longer requires the tubular filter membrane to extend to the distal end of the frame. However, a new rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph with regard to claim 23 has been set forth below in light of Applicant’s amendments.
Claim 23 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.
Regarding claim 23, the phrase "bare metal struts with open sidewall windows between adjacent struts" renders the claim indefinite because it is unclear if the “bare metal struts” are the same as the “interconnected struts” defined in claim 1 and Applicant is further defining the plurality of interconnected struts to be metal, or if the “bare metal struts” are different from the “interconnected struts” such that the “interconnected struts” of claim 1 are not being further limited to be made of metal. For the purpose of examination, and based off of Applicant’s disclosure, the Examiner will read the “bare metal struts” to be same as the “interconnected struts”, wherein the interconnected struts are metal, and the metal interconnected struts, in the bare metal leading cylindrical segment, are bare.
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 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.
The rejection of claims 1, 3 – 4, 7 – 8, and 34 under U.S.C 35 103 with respect to Salahieh in view of Pigott, Club, and Jones, recited in the previous action dated 03/25/2025 have been withdrawn in light of the Applicant’s amendments filed 09/24/2025. Specifically, the rejection of claim 1, with respect to the combination of Salahieh, Pigott, Club, and Jones has been withdrawn because the combination does not anticipate or make obvious the distal radiopaque marker as recited in the current claim set.
Claims 1, 3 – 4, 7 – 8, 23, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 2005/0137696 A1) (previously cited), and in view of Pigott (WO 2016/011267 A1) (previously cited), Teitelbaum (US 2016/0158038 A1), and Brandies (US 2020/0268500 A1).
Regarding claims 1, 23, and 34, Salahieh discloses an embolic protection access system (embolic protection system 500 / sheath 510) (paragraphs [0074 – 0083] and Figs. 13B), comprising:
a guidewire (guidewire “G”) (paragraphs [0074 – 0083] and Figs. 13A-G)
a self-expandable, tubular frame (filter 520) (Examiner’s note: as stated in paragraph [0078] the filter comprises a self-expanding wire frame)
the tubular frame having a proximal end with a proximal opening ([proximal] interface 521 attached to the pullwire 540 shown in Fig. 13B and 13D) and a distal end with a distal opening ([distal] interface 521 not attached to the pullwire 540 shown in Fig. 13B and 13D),
wherein the tubular frame (filter 520) is formed from a plurality of woven wire filaments (wires in the Nitinol braid) (discussed in paragraph [0055] and Fig. 13B/D), wherein the plurality of woven wire filaments form a plurality of interconnected struts (wires of the Nitinol braid) along a length and an entire circumference of the tubular frame from the proximal end to the distal end (see Figs. 13B-G), wherein each of the plurality of interconnected struts are separated by a plurality of sidewall openings (windows / pores between the wires) spanning the length and the entire circumference (see Figs. 13B-G);
wherein the tubular frame is configured self-expand to a tubular configuration (paragraph [0078]) and to be delivered by a delivery catheter (embolic protection system 500 / sheath 510) over a guidewire (guidewire “G”) and through an access sheath (introducer sheath 602) (Examiner’s note: as stated in paragraphs [0077 – 0078] the guidewire is pushed through the sheath 602, and then the protection system 500/510 is advanced over the guidewire, therefore the protection system 500 / sheath 510 is advanced through the access sheath and over the guidewire; additionally, because the filter 520 is delivered by the sheath 510 and is controlled by the pullwire 540 (as stated in paragraphs [0079 – 0080]) then the pullwire 540 would also be advanced through the access sheath with the protection system 500 / sheath 510; additionally, Fig. 13B shows the pullwire 540 is advanced through the sheath 510 and Fig. 13C shows the pullwire 540 within the access sheath) such that, in an implanted configuration across an aortic arch (configuration shown in Fig. 13B), the proximal end resides on a plane that extends at a first non-normal angle to a longitudinal axis of the tubular frame (Examiner’s note: as shown in Fig. 13B the proximal end face is inclined at a non-normal angle to the longitudinal axis of the frame), such that the proximal end presents an inclined proximal face to facilitate recapture (paragraph [0086] and Fig. 13B) and the proximal end comprises a first portion (proximal most portion of the proximal end that is attached to the pullwire 540 shown in Fig. 13B) adjacent to and contacting a superior wall of the aortic arch and a diametrically opposite second portion (opposite end from the proximal most portion, not connected to the pullwire 540) with the first portion proximal of the second portion (Examiner’s note: although the embodiment of Fig. 13B does not expressly state that the more proximal end (i.e., the first portion) of the proximal end of the filter 520 (i.e., the tubular frame) is contacting the superior wall, Salahieh teaches an alternate deployed configuration for the filter 520 (i.e., tubular frame) in the embodiment of Fig. 9E(b) (discussed in paragraph [0066]), wherein the tapered tip (i.e., the first portion) of the proximal end of the filter 520 (i.e., tubular frame) extends towards the greater curvature, which means that the tapered tip (i.e., the first portion) of the proximal end will be in contact with the superior wall of the aortic arch instead of in contact with the inferior wall of the aortic arch. Therefore, because Salahieh teaches that the tubular frame can be configured with the tapered portion (i.e., the first portion) contacting the inferior wall or the superior wall of the aortic arch, it would be obvious to one of ordinary skill in the art to modify the filter 520 of the embodiment of Fig. 13B to have the tapered portion (i.e., the first portion) be in contact with the superior wall of the aortic arch; additionally, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known filter configuration for another, and the results of the substitution would have been predictable and resulted in the filter of the embodiment of Fig. 13 being suitably configured within the aortic arch in order to filter the blood flowing therethrough as intended);
the tubular frame (filter 520) configured to receive a transcatheter aortic valve replacement (TAVR) delivery system (delivery system 100) into the proximal opening of the tubular frame and through the tubular frame and exiting out of the distal opening of the tubular frame (paragraphs [0080], [0088 – 0091], and Figs. 13F-G), the tubular frame configured to have a TAVR delivery catheter (sheath 110) of the TAVR delivery system positioned within and extending through the tubular frame over the guidewire when a compressed valve (replacement valve 20) and a valve support frame (expandable anchor 30) carried within the TAVR delivery catheter are positioned in a deployment location distal to the distal opening of the tubular frame (paragraphs [0030 – 0031], [0088 – 0091], and Figs. 13F-G);
a tubular filter membrane (membrane “M”) positioned over and supported by the tubular frame extending about the entire circumference of the tubular frame to the proximal end (paragraphs [0055], [0065 – 0066] and Fig. 9E) (Examiner’s note: although Salahieh does not expressly state that the filter 520 of the embodiment of Figs. 13A – 13G relied upon by the Examiner has the membrane “M” disclosed in the embodiment of the filter 520 of Fig. 9E, it would be obvious to modify the filter 520 of embodiment of Figs. 13A – 13G with the membrane of the filter device of Fig. 9E for the purpose of providing increased filtration and capturing of the embolic material. Moreover, as stated in paragraph [0055], the filter 520, which is same filter in Figs. 13A-G, can also comprise a permeable/porous membrane to assist in filtering. Therefore, Salahieh makes obvious the limitation above);
wherein the tubular filter membrane is configured to be positioned against and cover three great vessels of the aortic arch with the proximal end positioned on a downstream side of a left subclavian artery to deflect debris created by deployment of the compressed valve and the valve support frame away from the three great vessels (paragraph [0091] and Fig. 13G);
wherein the tubular filter membrane (membrane “M”) is configured to block a passage of the debris as small as 0.1 mm and greater away from the three great vessels (Examiner’s note: as stated in paragraph [0065] the membrane has a pore size of less than 100 μm which equates to less than 0.1mm. Because the pores are less than 100 μm then the pores will block all debris that has a diameter of 100 μm (i.e., 0.1mm) and greater);
a single control wire (pullwire 540) offset from the longitudinal axis and offset from the guidewire (guidewire “G”) extending proximally from the first portion (proximal most portion of the proximal end of the filter that is attached to the pullwire 540) of the proximal end of the tubular frame (Examiner’s note: as shown in Fig. 13B and 13D and stated in paragraph [0079] the pullwire 540 extends proximally from the proximal most end of the frame and is offset from the longitudinal axis of the tubular embolic protection filter and the guidewire “G”),
the single control wire (pullwire 540) abutting and directly coupled to the tubular frame and configured to remain tethered to and prevent proximal movement of the tubular frame such that proximal motion of the delivery catheter relative to the single control wire causes the delivery catheter (sheath 510) to retract from and uncover the tubular frame allowing the tubular frame to self-expand (Examiner’s note: as shown in Fig. 13B and 13D the pullwire 540 (i.e., the control wire) is directly connected to the tubular frame; and as stated in paragraph [0080] upon removal of the sheath 510 from the patient the pullwire extends through the sheath 602 (i.e., the pullwire is not removed), the pullwire 540 (i.e., the control wire) being used to maintain the filter (i.e., tubular frame) at the desired position, whereby the medical practitioner can leave the filter 520 without significant monitoring during the endovascular treatment. Therefore, the pullwire 540 (i.e., control wire) is configured to remain tethered to the frame during the procedure preventing proximal and distal movement of the tubular frame; alternately, because the pullwire 540 is said to keep the tubular frame / filter frame in the desired position it would be obvious for the pullwire 540 to have enough stiffness and tension so as to prevent both distal and proximal movement for the purpose of keeping the tubular frame / filter frame in the desired place. Furthermore, the pull wire 540 (i.e., the control wire) is not coupled to the delivery catheter such that the pullwire 540 (i.e., the control wire) interferes with the retraction of the sheath 510 (i.e., the delivery catheter)),
the single control wire configured to extend alongside a wall (inner wall) of the delivery catheter (embolic protection system 500 / sheath 510) during delivery of the tubular frame to the aortic arch (Examiner’s note: as shown in Fig. 13B the pullwire 540 (i.e., the control wire) extends along the inner wall of the sheath 510 while the filter 520 (i.e., tubular frame) is being deployed), and the single control wire further configured to extend between a wall (inner wall) of the access sheath (introducer sheath 602) and a wall (outer wall) of the TAVR delivery catheter (delivery sheath 110) during delivery of the compressed valve and the valve support frame (aortic valve 20 and expandable anchor 30) by the TAVR delivery catheter (delivery sheath 110) over the guidewire (guidewire “G”) and through the access sheath (introducer sheath 602) (paragraph [0088] Figs. 13E – 13G); and
the single control wire is configured to form an opening (opening of the filter 520 at the proximal end) configured to receive therethrough the TAVR delivery catheter (delivery sheath 110) over the guidewire during delivery of the compressed valve and the valve support frame (aortic valve 20 and expandable anchor 30) (Fig. 13F and 13G) (Examiner’s note: it should be understood that the pullwire 540 (i.e., the control wire) provides tension to the proximal end of the filter 520 (as stated in paragraph [0080]) and the tension pulls the proximal face open to some degree. Therefore, the single control wire is configured to form the opening. Furthermore, as shown in Fig. 13F and 13G the opening of the filter receives the delivery system 100).
However, Salahieh is silent regarding (i) [claim 1] wherein the tubular frame expands to a diameter of at least 20mm, (ii) [claim 23] a bare metal leading cylindrical segment of the tubular frame extending axially and distally beyond the tubular filter membrane and having bare metal struts with open sidewall windows between adjacent struts, (iii) [claim 1] a distal radiopaque marker at a distal portion of the tubular frame, (iv) a proximal radiopaque marker at the proximal end of the frame positioned on the downstream side of the left subclavian artery, (v) [claim 1] the tubular membrane extending from the distal radiopaque marker to the proximal marker, (vi) [claim 34] wherein the single control wire extends from the proximal marker, (vii) [claim 1] wherein the filter membrane comprises a plurality of electrospun fibers formed from a solution configured to be positioned against and cover three great vessels, and (viii) [claim 1] two or more ramped struts extending from the proximal end of the tubular frame offset from the longitudinal axis, the two or more ramped struts and the single control wire are configured to form the opening, and (ix) [claim 1] configured to be utilized to facilitate entry of the tubular frame into a distal end of the delivery catheter.
As to (i), there is no evidence of record that establishes that changing the diameter of expansion would result in a difference in function of the Salahieh device. Further, a person having ordinary skill in the art, being faced with modifying the filter of Salahieh, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter of expansion. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the diameter “may” be within the claimed range, and offering other acceptable ranges (e.g., 25 to 30 or to 35 or more mm, Specification at para. [0037]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result; and the both the claimed devices and the device of Salahieh are disclosed as being used in the same manner (i.e., being placed in the aortic arch) (Claim 1 of the Instant Application, and paragraphs [0074 – 0083] and Figs. 13B of Salahieh)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the expansion diameter to be within the claimed ranges an obvious matter of design choice within the skill of the art.
As to (ii), Pigott teaches, in the same field of endeavor, an embolic protection access system (embolic protection device 420) comprising a tubular frame (frame 422 a bare metal leading cylindrical segment of the tubular frame (frame 422; which equates to the filter 520 of Salahieh) extending axially and distally beyond a filter membrane (screen 426; which equates to the membrane “M” of Salahieh) (Examiner’s note: as shown in Fig. 11 and disclosed in paragraphs [0046] the screen 426 extends along the first diameter and not along the distal end (i.e., the cylindrical leading segment) of the frame 422), the bare metal leading segment having bare metal struts with open sidewall windows between adjacent struts (Fig. 11 and paragraph [0031]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the filter 520 of Salahieh such that a portion of the filter (i.e. the distal end portion — shown in annotated Fig. 13D of Salahieh) is not covered by the membrane, thereby having an exposed a bare metal cylindrical segment having bare metal struts with open sidewall windows, based on the teachings of Pigott, for the purpose of having the covering only where it is needed (i.e., extending along the branched arteries – discussed in paragraph [0005] and shown in Fig. 11 of Pigott), thereby requiring less material for the manufacturing process. It should be understood that the combination made above is such that only the distal portion, shown in annotated Fig. Fig. 13D, of the tubular frame is not covered by the membrane because that portion of the frame does not stretch across the vessels’ openings, and that the membraned covers the rest of the frame, from the proximal end of the distal end portion to the proximal end of the tubular frame.
As to (iii) – (vi), Teitelbaum teaches, in the same field of endeavor, an embolic protection delivery device (flow diverter 500) (paragraphs [0018], [0036], and Fig. 11) comprising a tubular frame (flow diversion device 500) having a radiopaque marker (marker 520) at a proximal end (proximal end 525) and distal radiopaque marker (marker 550) at a distal end of a filter membrane (base layer 535; which equates to the filter membrane “M” of Salahieh) (paragraphs [0036 – 0037] and Fig. 11), and wherein the tubular frame (flow diversion device 500) has a bare metal leading cylindrical segment (distal end 530 – which is free of the base layer 535; which equates to the bare metal leading segment of Salahieh in view of Pigott). Teitelbaum, teaches wherein the distal radiopaque marker at the distal end of the filter membrane (base layer 535), and at the proximal end, is for the purpose of allowing an operator to precisely place the stent frame 510 at a particular treatment site (paragraphs [0036 – 0037]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the filter of Salahieh to incorporate the proximal and distal radiopaque markers, as taught by Teitelbaum, for the purpose of allowing an operator to precisely place the stent frame 510 at a particular treatment site (paragraphs [0036 – 0037] – Teitelbaum). With respect to (v) and (vi) it would further be obvious to position the proximal radio-opaque marker on the downstream side of the left subclavian artery such that the single control wire (pullwire 540 – Salahieh) extends from the radio-opaque marker for the purpose of showing the operator the orientation of the filter within the body with respect to the single control wire (pullwire 540 – Salahieh) and the release mechanism for the filter (i.e. the connection point of the singular control wire), such that knowing the orientation of the filter with respect to the control wire and the release mechanism allows the operator to make accurate positional adjustments to the tubular frame (filter 520 – Salahieh) so that the tubular frame (filter 520 – Salahieh) is placed in the most optimized orientation and position. Thus, the combination of Salahieh, Pigott, and Teitelbaum makes obvious wherein the tubular filter membrane extends from the distal radiopaque marker to the proximal radiopaque marker at the distal end of the tubular frame.
As to (vii – ix), Brandies teaches, in the same field of endeavor, an embolic protection device (aortic protection device 500) placed within the aorta, the device comprising a tubular embolic frame (first / inner layer mesh 501; which is equated to the frame of the filter 520 of Salahieh) having a tubular self-expandable filter frame formed of a plurality of filaments (braiding of first / inner layer mesh 501) (paragraphs [0304 – 0317] and Figs. 5A – 5C) with a filter membrane (second / outer layer mesh 502; which equates to the membrane “M” of Salahieh) wherein the filter membrane comprises a plurality of electrospun fibers (Examiner’s note: as recited in paragraph [0014] the second mesh is made out a flexible material and as stated in paragraphs [0059] and [0158] the flexible material is an electro spun polymer thread; therefore, the second mesh (i.e., the filter membrane) is made out of electro spun fibers). Additionally, Brandies teaches, in a separate embodiment, an embolic protection device (aortic protection device 200) placed within the aorta, the device comprising a tubular embolic frame (mesh 221) with an open distal end (proximal ring 213) and an open proximal end (distal end 220) connected to a single control wire (first wire 217) extending proximally from, and directly attached to, the proximal end (distal end 220) offset from the longitudinal axis of the filter frame and two ramped struts (connecting wires 218A/B), which form the opening of the device via tension placed thereon, for the purpose of assisting in the withdrawing of the tubular filter frame (mesh 212) into the catheter 216 (which equates to the sheath 510 of Salahieh) (paragraphs [0169], [0177], [0181 – 0183], and Fig. 2B).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Salahieh to incorporate two ramped struts, as taught by Brandies, for the purpose of assisting in the withdrawing of the tubular filter frame (paragraph [0181] – Brandies). Furthermore, it should be understood that Salahieh and Brandies are known references in the art that teach an aortic embolic filter (abstract, paragraphs [0029], [0074 – 0088], and Figs. 13A – 13F – Salahieh ; abstract, paragraphs [0028], [0058], [0158], [0304 – 0317], and Figs. 5A-C – Brandies); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one method of forming an aortic filter membrane for another (i.e., making the membrane “M” of Salahieh via electrospinning the fibers), and the results of the substitution would have been predictable and resulted in the modified filter membrane “M” of Salahieh being able to operate as intended to capture embolic debris / prevent embolic debris from entering the great vessels of the aortic arch. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Annotated Figure 13D of Salahieh
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Regarding claims 3 and 4, as discussed above, it would have been obvious to modify the medical device of Salahieh in view of Pigott, Teitelbaum, and Brandies. Additionally, Salahieh further discloses wherein the proximal end includes a plurality of eyelets (see annotated Fig. 13D – Salahieh); and wherein an eyelet of the plurality of eyelets is formed by an apex at a junction of two struts of the wire filament (Examiner’s note: a strut is defined as a metal wire that provides structural support; with that said, Salahieh teaches, in paragraph [0055] and shown in annotated Fig. 13D the frame is made up of Nitinol wires (i.e., metal wires that provide structural support); therefore the filter (i.e., tubular frame) is made up of wire struts, where the struts form an apex at the proximal end as shown in annotated Fig. 13D – Salahieh).
Regarding claim 7, as discussed above, it would have been obvious to modify the medical device of Salahieh in view of Pigott, Teitelbaum, and Brandies. Additionally, Salahieh discloses comprising the tubular delivery catheter (sheath 510 – Salahieh), and the tubular frame (filter 520 – Salahieh) is carried in a reduced cross-sectional configuration (configuration when compressed in sheath 510) within the delivery catheter (Examiner’s note: as disclosed in paragraph [0072] the filter 520 is collapsed within the sheath 510 during delivery, therefore the filter is carried in a reduced cross-sectional configuration within the delivery catheter).
Regarding claim 8, as discussed above, the combination of Salahieh in view of Pigott, Teitelbaum, and Brandies teaches the device of claim 1.
However, the combination of Salahieh in view of Pigott, Teitelbaum, and Brandies is silent regarding (i) the diameter of the delivery catheter.
As to the above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Salahieh to have a diameter of a 13.5 Fr catheter since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the delivery catheter of Salahieh would not operate differently with the claimed diameter, and since the delivery catheter of both Salahieh and the Instant Application are used within the aortic arch (Fig. 13B and 13D – Salahieh ; paragraph [0039] – Instant Specification) then the delivery catheter of Salahieh would function appropriately having the claimed diameter.
Response to Arguments
Applicant’s arguments, filed 09/24/2025, with respect to the rejection of claims 1, 3, 4, 7, 8, 23, and 34 under Salahieh, Pigott, Club, and Jones have been considered but are moot as the arguments are directed to Applicant’s amendments and the Affidavit filed on 09/24/2025, and the previous rejection of the claims has been withdrawn in light of said amendments and said Affidavit. Specifically, the rejections were withdrawn because the combination of Salahieh, Pigott, Club, and Jones does not teach the distal radiopaque marker in the distal portion of the tubular frame, wherein the tubular membrane extends from the distal radiopaque marker to the proximal radiopaque marker; furthermore, Clubb does not make obvious the electrospun fibers based on Applicant’s Affidavit. It is noted that a new rejection has been made over Salahieh in view of Brandies and Teitelbaum. The teachings of Brandies and Teitelbaum are relied upon for teaching the newly added limitations as discussed above.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771