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 § 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) 1-2, 4-5, 6-9, and 10-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0116715 A1 to Khosravi (hereinafter “Khosravi”).
Regarding claim 1, Khosravi discloses (see abstract; Figs. 2A-8B; and [0032]-[0063]; see also [0003] incorporating by reference to US application serial 09/470,857 which issued as US Patent 6,129,739 to Khosravi (hereinafter "K2"); see Figs. 2A-8 and Col. 4, line 40 - Col. 9, line 60 of K2) an embolic protection system (see at least [0037]) comprising: an embolic protection device (EPD) including: an EPD shaft (54, Fig. 5A); a dual-hoop filter provided at a distal end of the EPD shaft (Khosravi discloses a single hoop (56) filter (57) at the distal end of the shaft in Fig. 5A and also discloses a single hoop filter in Fig. 2A; K2 discloses the same single hoop filter at Fig. 2A and also discloses the use of a dual-hoop filter at Figs. 6-8 and Col. 8, line 15 - Col. 9, line 32), 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 (K2 discloses two hoops 53/54 at the proximal and distal ends of the dual-hoop filter); and a filter actuator (proximal end of guidewire 51, see [0052]) located at or towards a proximal end of the EPD, the filter actuator operable to selectively open or close the distal hoop and the proximal hoop of the dual-hoop filter (see [0052] of Khosravi and Col. 7, lines 12-22 & Col. 8, lines 29-31 of K2).
Khosravi further discloses (claim 2) a dilator (63, Fig. 5A); (claim 4) a loading tool (50); and (claim 5) an introducer sheath (61, see also [0051]).
Regarding claim 6, Khosravi discloses (see abstract; Figs. 2A-8B; and [0032]-[0063]; see also [0003] incorporating by reference to US application serial 09/470,857 which issued as US Patent 6,129,739 to Khosravi (hereinafter "K2"); see Figs. 2A-8 and Col. 4, line 40 - Col. 9, line 60 of K2) a method of deploying an embolic protection device (EPD) into a vasculature of a patient (see Figs. 6A-C and [0051]-[0053]), the method comprising: establishing access to the vasculature (see [0051]); introducing a guide wire (51) into the vasculature to assist with guidance of the embolic protection device through the vasculature (see [0051]); advancing the embolic protection device into the vasculature and over the guide wire toward a target treatment region (see [0051]), wherein the embolic protection device comprises an EPD shaft (54, Fig. 5A); a dual-hoop filter provided at a distal end of the EPD shaft (Khosravi discloses a single hoop (56) filter (57) at the distal end of the shaft in Fig. 5A and also discloses a single hoop filter in Fig. 2A; K2 discloses the same single hoop filter at Fig. 2A and also discloses the use of a dual-hoop filter at Figs. 6-8 and Col. 8, line 15 - Col. 9, line 32), 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 (K2 discloses two hoops 53/54 at the proximal and distal ends of the dual-hoop filter); and a filter actuator (proximal end of guidewire 51, see [0052]) located at or towards a proximal end of the EPD, the filter actuator operable to selectively open or close the distal hoop and the proximal hoop of the dual-hoop filter (see [0052] of Khosravi and Col. 7, lines 12-22 & Col. 8, lines 29-31 of K2); actuating the filter actuator thereby radially expanding at least one of the distal hoop and the proximal hoop of the dual-hoop filter to lie against a vessel wall at the target treatment region (see Fig. 6B and [0052]); and capturing emboli in the dual-hoop filter (see [0053]).
Khosravi further discloses (claim 7) further comprising inserting a therapeutic device through the dual-hoop filter and advancing the therapeutic device toward the target treatment region (see [0052]); (claim 8) wherein the target treatment region comprises an aortic valve (see Fig. 6B and [0052]); and (claim 9) 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 [0053]).
Regarding claim 10, Khosravi discloses (see abstract; Figs. 2A-8B; and [0032]-[0063]; see also [0003] incorporating by reference to US application serial 09/470,857 which issued as US Patent 6,129,739 to Khosravi (hereinafter "K2"); see Figs. 2A-8 and Col. 4, line 40 - Col. 9, line 60 of K2) an embolic protection device (EPD) including: an EPD shaft (54, Fig. 5A); a dual-hoop filter provided at a distal end of the EPD shaft (Khosravi discloses a single hoop (56) filter (57) at the distal end of the shaft in Fig. 5A and also discloses a single hoop filter in Fig. 2A; K2 discloses the same single hoop filter at Fig. 2A and also discloses the use of a dual-hoop filter at Figs. 6-8 and Col. 8, line 15 - Col. 9, line 32), 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 (K2 discloses two hoops 53/54 at the proximal and distal ends of the dual-hoop filter); and a filter actuator (proximal end of guidewire 51, see [0052]) located at or towards a proximal end of the EPD, the filter actuator operable to selectively open or close the distal hoop and the proximal hoop of the dual-hoop filter (see [0052] of Khosravi and Col. 7, lines 12-22 & Col. 8, lines 29-31 of K2).
Khosravi further discloses (claim 11) wherein the dual-hoop filter includes a polymer mesh (see [0040]); (claim 12) wherein the dual-hoop filter includes a particulate entrapment feature (see Figs. 5B/6B and [0052]); (claim 13) the particulate entrapment feature defines a passage or gap in the dual-hoop filter fully capable of 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 Figs. 5B/6B and [0052]); (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 Col. 8, lines 19-33 of K2); (claim 15) wherein the filter actuator includes a distal slider to operate the distal hoop, and a proximal slider to operate the proximal hoop (see Col. 7, lines 13-25 of K2, it is within the scope of the disclosed invention that the distal hoop can be operated by sliding the sheath relative to the guidewire, whereas the proximal hoop can be operated by further sliding of the guidewire relative to the sheath in the opposite direction, thus making different elements sliding responsible for operating the distal and proximal hoops); (claim 16) wherein the filter actuator includes a single slider to operate the distal hoop and the proximal hoop simultaneously (see [0052] of Khosravi and Col. 7, lines 12-22 & Col. 8, lines 29-31 of K2); (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. 5B and [0041]/[0052]); (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. 6 of K2); (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 (55) and a proximal shaft (54) (see Fig. 5A); and (claim 21) wherein at least one of the distal hoop and the proximal hoop is an offset hoop (see Fig. 7 of K2).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khosravi in view of US 2023/0346536 A1 to Kleshinksi et al. (hereinafter “Kleshinski”).
Khosravi discloses the invention substantially as claimed as set forth above, however with respect to claim 3, Khosravi fails to specifically disclose wherein the dilator includes an expandable tip. Kleshinksi discloses, in the same field of endeavor of embolic filters, an embolic filter system comprising a tapered dilator tip which is expandable for the purpose of facilitating entry through an arteriotomy (see abstract and [0015]). 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 Khosravi’s device with the expandable dilator tip of Kleshinski in order to facilitate entry through an arteriotomy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing filter systems that have multiple hoops.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771