DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 06/01/2026.
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 Objections
Claim 13 is objected to because of the following informalities: the second instance of the word “gap” in the claim appears to be misspelled as “cap”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 10-11, 13-14, and 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0215167 A1 to Belson (hereinafter “Belson”) (previously made of record by the Examiner).
Regarding claim 1, Belson discloses (see abstract; Figs. 1-5; and [0005]-[0008] & [0014]-[0025]) an embolic protection system (as shown in the Figures, see at least [0014]) comprising: an embolic protection device (EPD) (e.g., 40 in Fig. 4) including: an EPD shaft (48); a dual-hoop filter (42 + 44 + 50) provided at a distal end of the EPD shaft (see Fig. 4), the dual-hoop filter including a distal hoop (left-most hoop 50 in Fig. 40) provided at a distal end of the dual-hoop filter, a proximal hoop (right-most hoop 50 in Fig. 4) provided at a proximal end of the dual-hoop filter, and a filter material (42) coupled to the proximal hoop and the distal hoop (see Fig. 4 and [0020]-[0021]); and a filter actuator (16 - see [0017] and Fig. 1, see also [0021] stating that the embodiment of Fig. 4 may be combined with any of the devices described in Figs. 1-3 & 5) located at or towards a proximal end of the EPD (see Fig. 1 and [0017]), the filter actuator operable to selectively close the distal hoop and the proximal hoop of the dual-hoop filter (see Figs. 1/4 and [0017] & [0020]-[0021]), wherein in an open configuration with the proximal hoop and the distal hoop open, the filter material includes a proximal opening and a distal opening configured to enable a device to extend therethrough (see Fig. 4 & [0015]).
Regarding claim 10, Belson discloses (see abstract; Figs. 1-5; and [0005]-[0008] & [0014]-[0025]) an embolic protection device (EPD) (e.g., 40 in Fig. 4; see at least [0014]) comprising: an EPD shaft (48); a dual-hoop filter (42 + 44 + 50) provided at a distal end of the EPD shaft (see Fig. 4), the dual-hoop filter including a distal hoop (left-most hoop 50 in Fig. 40) provided at a distal end of the dual-hoop filter, a proximal hoop (right-most hoop 50 in Fig. 4) provided at a proximal end of the dual-hoop filter, and a filter material (42) coupled to the proximal hoop and the distal hoop (see Fig. 4 and [0020]-[0021]); the filter material forming an internal passage (see Fig. 4 and [0015]), and a particulate entrapment feature (inner layer 36 of two-layer structure, see Fig. 3 and [0019], see also [0021] stating that the embodiment of Fig. 4 may be combined with any of the devices described in Figs. 1-3 & 5), the particulate entrapment feature extending from the filter material (here, the filter material would comprise outer layer 36) into the internal passage to capture particulate material (see [0019], inner layer would by definition extend into the internal passage from the outer layer); and a filter actuator (16 - see [0017] and Fig. 1, see also [0021] stating that the embodiment of Fig. 4 may be combined with any of the devices described in Figs. 1-3 & 5) located at or towards a proximal end of the EPD (see Fig. 1 and [0017]), the filter actuator operable to selectively close the distal hoop and the proximal hoop of the dual-hoop filter (see Figs. 1/4 and [0017] & [0020]-[0021]).
Belson further discloses (claim 11) wherein the dual-hoop filter includes the filter material comprises a polymer mesh (see [0014]/[0019]); (claim 13) wherein the particulate entrapment feature defines a passage or gap in the dual-hoop filter between the particulate entrapment feature and the filter material, the passage or cap allowing a therapeutic device to pass therethrough when the therapeutic device is passed through the distal hoop and the proximal hoop of the dual- hoop filter (see [0019], the lumen of the filter defines a passage between the inner layer on the inferior side of the filter and the outer layer on the superior side of the filter to allow a therapeutic device to be passed therethrough); (claim 14) wherein at least one of the distal hoop and the proximal hoop is formed integrally with an actuation wire extending between the dual-hoop filter and the filter actuator (see [0017]/[0022]); (claim 17) wherein at least one of the distal hoop and the proximal hoop includes nitinol material and is pre-shaped to open in a round or oval configuration to conform to an aortic wall at a target treatment region (see Fig. 4, [0014], and [0021]); (claim 18) wherein a central portion of the dual-hoop filter, when opened, has a lower profile than both end portions of the dual-hoop filter when the distal hoop and the proximal hoop are open (see Fig. 4 and [0021], the waves/undulations would result in a given central portion having a lower profile when the extent of the wave is at its minimum versus at/near the end portions where the wave is at its maximum); (claim 19) wherein the EPD shaft includes a continuous braided polymer extrusion (the limitations of the claim are being treated as a product by process limitations. As set forth in MPEP 2113, "Even though product -by- process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product in the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985). Examiner notes since there was no evidence provided by the applicant that the process of extruding a continuous braided polymer imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitations are given little patentable weight); (claim 20) wherein the EPD shaft is a composite shaft and includes a distal shaft (46, Fig. 4) and a proximal shaft (48, Fig. 4); and (claim 21) wherein at least one of the distal hoop and the proximal hoop is an offset hoop wherein a proximal entry point of a proximal hoop wire of the proximal hoop is longitudinally offset along the EPD shaft from a proximal exit point of the proximal hoop wire and/or a distal entry point of a distal hoop wire of the distal hoop is longitudinally offset along the EPD shaft from a distal exit point of the distal hoop wire (see Fig. 4).
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.
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) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belson in view of US 2010/0036312 A1 to Krolik et al. (hereinafter “Krolik”) (previously made of record by the Examiner).
Belson discloses the invention substantially as claimed as discussed above, however, with respect to claims 15-16, Belson fails to specifically disclose wherein the filter actuator is a slider or slides to operate the hoops independently or simultaneously. However, in the same field of endeavor, Krolik discloses a known mechanism for deploying and retracting hoops (50) within the vasculature (90) by using a slider control (see [0038]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of combining prior art elements according to known methods to yield predictable results (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a proximal mechanism for manipulating a wire control to deploy/retract hoops in the vasculature, by using a slider as taught by Krolik. Further, it would have been obvious as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions with a reasonable expectation of success (see KSR above) to have provided individual sliders for each hoop or a single slider for both hoops simultaneously, as the only options for controlling two hoops with a slider mechanism are a) to have one slider per hoop, or b) to have a single slider operating booth hoops - a person of ordinary skill would have a reasonable expectation of success in arriving at either of the claimed options since these are the options available.
Claim(s) 1-5 and 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0137696 A1 to Salahieh et al. (hereinafter “Salahieh”) in view Belson.
Regarding claim 1, Salahieh discloses (see abstract; Figs. 1-13G; and [0029]-[0093]) an embolic protection system (500, Figs. 6A-13G) comprising: an embolic protection device (EPD) (520 + 510) including: an EPD shaft (510); a filter (520) provided at a distal end of the EPD shaft and a filter material (see [0055]) coupled to the filter; and a filter actuator (see [0072]) located at or towards a proximal end of the EPD, the filter actuator operable to selectively open or close the filter (see [0072]), wherein in an open configuration, the filter material includes a proximal opening and a distal opening configured to enable a device to extend therethrough (see Figs. 6B-C, 9, 13B-F).
Salahieh further discloses (claims 2-3) a dilator (balloon catheter 130) including an expandable tip (balloon) (see Fig. 3C and [0042]); (claim 4) a loading tool ("additional over-sheath", see [0071]); and (claim 5) an introducer sheath (600) (see Fig. 13A).
Salahieh fails to specifically disclose, with respect to claim 1, wherein the filter is a dual-hoop filter, the dual-hoop filter including a distal hoop provided at a distal end of the dual-hoop filter and a proximal hoop provided at a proximal end of the dual-hoop filter.
Belson discloses (see abstract; Figs. 1-5; and [0005]-[0008] & [0014]-[0025]) an embolic protection system (as shown in the Figures, see at least [0014]) comprising: an embolic protection device (EPD) (e.g., 40 in Fig. 4) including: an EPD shaft (48); a dual-hoop filter (42 + 44 + 50) provided at a distal end of the EPD shaft (see Fig. 4), the dual-hoop filter including a distal hoop (left-most hoop 50 in Fig. 40) provided at a distal end of the dual-hoop filter, a proximal hoop (right-most hoop 50 in Fig. 4) provided at a proximal end of the dual-hoop filter and a filter material (42) coupled to the proximal hoop and the distal hoop (see Fig. 4 and [0020]-[0021]); and a filter actuator (16 - see [0017] and Fig. 1, see also [0021] stating that the embodiment of Fig. 4 may be combined with any of the devices described in Figs. 1-3 & 5) located at or towards a proximal end of the EPD (see Fig. 1 and [0017]), the filter actuator operable to selectively close the distal hoop and the proximal hoop of the dual-hoop filter (see Figs. 1/4 and [0017] & [0020]-[0021]), in the same field of endeavor for the purpose of supporting the embolic protection device within the aortic arch (see [0021]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Salahieh's device with the proximal and distal hoops added to the filter, as taught by Belson, in order to support the embolic protection device within the aortic arch. In making the proposed combination, the proximal and distal hoops would, in their open configuration, still allow the filter of Salahieh to define proximal/distal openings for allowing a device to pass therethrough.
Regarding claim 6, Salahieh discloses (see abstract; Figs. 1-13G; and [0029]-[0093]) a method of deploying an embolic protection device (EPD) (520 + 510) into a vasculature of a patient (see at least [0074]), the method comprising: establishing access to the vasculature (see [0075]); introducing a guide wire into the vasculature to assist with guidance of the embolic protection device through the vasculature (see [0075] and Fig. 13B); advancing the embolic protection device into the vasculature and over the guide wire toward a target treatment region (see [0078] and Fig. 13B), wherein the embolic protection device comprises an EPD shaft (510); a filter (520) provided at a distal end of the EPD shaft and a filter material (see [0055]) coupled to the filter; and a filter actuator (see [0072]) located at or towards a proximal end of the EPD, the filter actuator operable to selectively open or close the filter (see [0072]), actuating the filter actuator thereby radially expanding the filter to lie against a vessel wall at the target treatment region (see Figs. 6A/9B/13B and [0078]-[0079]); inserting a therapeutic device (100) through a proximal opening in the filter material, through an internal passage formed by the filter material, and through a distal opening in the filter material (see Fig. 13F and [0088]); and capturing emboli in the filter (see [0091]).
Salahieh fails to specifically disclose, with respect to claim 6, wherein the filter is a dual-hoop filter, the dual-hoop filter including a distal hoop provided at a distal end of the dual-hoop filter and a proximal hoop provided at a proximal end of the dual-hoop filter.
Belson discloses (see abstract; Figs. 1-5; and [0005]-[0008] & [0014]-[0025]) an embolic protection system (as shown in the Figures, see at least [0014]) comprising: an embolic protection device (EPD) (e.g., 40 in Fig. 4) including: an EPD shaft (48); a dual-hoop filter (42 + 44 + 50) provided at a distal end of the EPD shaft (see Fig. 4), the dual-hoop filter including a distal hoop (left-most hoop 50 in Fig. 40) provided at a distal end of the dual-hoop filter, a proximal hoop (right-most hoop 50 in Fig. 4) provided at a proximal end of the dual-hoop filter and a filter material (42) coupled to the proximal hoop and the distal hoop (see Fig. 4 and [0020]-[0021]); and a filter actuator (16 - see [0017] and Fig. 1, see also [0021] stating that the embodiment of Fig. 4 may be combined with any of the devices described in Figs. 1-3 & 5) located at or towards a proximal end of the EPD (see Fig. 1 and [0017]), the filter actuator operable to selectively close the distal hoop and the proximal hoop of the dual-hoop filter (see Figs. 1/4 and [0017] & [0020]-[0021]), in the same field of endeavor for the purpose of supporting the embolic protection device within the aortic arch (see [0021]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Salahieh's device in the claimed method with the proximal and distal hoops added to the filter, as taught by Belson, in order to support the embolic protection device within the aortic arch. In making the proposed combination, the proximal and distal hoops would, in their open configuration, still allow the filter of Salahieh to define proximal/distal openings for allowing a device to pass therethrough.
The combination of Salahieh and Belson as discussed above for the reasons set forth above would further disclose (claim 7) wherein the therapeutic device is advanced through the dual-hoop filter and toward the target treatment region (see Figs. 6C/13F of Salahieh); (claim 8) wherein the target treatment region comprises an aortic valve (see [0074] and Figs. 13B-G of Salahieh); and (claim 9) further comprising, after a withdrawal of the therapeutic device through the dual-hoop filter, closing at least one of the distal hoop and the proximal hoop of the dual-hoop filter (see [0086]-[0087] & [0092] of Salahieh).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11 and 13-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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