DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 09/24/25.
The examiner acknowledges the amendments to the claims.
Claims 2-21 are pending in this application.
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 7 is objected to because of the following informalities: in line 1 it recites “the stent structure comprise a side port” and should rather read as --the stent structure comprises a side port--. 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.
Claims 10, 11, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Broome (U.S. Pub. No. 2003/0208224).
Regarding claim 10, Broome discloses an embolic protection device comprising: a shaft 14 (Figure 1);
an embolic filter 44/36/26/22 mounted over the shaft, wherein the embolic filter comprises a port 22 for the passage of the shaft therethrough ([0008]), a porous mesh material 44 ([0014]) defining a collection chamber for captured emboli ([0018]), and a stent structure 36/26, wherein the embolic filter has a collapsed configuration and a deployed configuration; and
a conical structure 30/24 comprising a proximal end and a distal end, wherein the proximal end of the conical structure is slidably coupled to the shaft ([0008]) and the distal end of the conical structure is coupled to the stent structure ([0010]), wherein the conical structure has a collapsed configuration and a deployed configuration ([0010], [0011], [0019]).
Regarding claim 11, Broome discloses wherein the stent structure 36/26 comprises a framework (Figure 1).
Regarding claim 15, Broome discloses the conical structure 30/24 is integral with (connected to) the stent structure 36/26.
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.
Claims 2-4, 6, 8, 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bates (U.S. Pub. No. 2007/0142858) in view of Broome (U.S. Pub. No. 2003/0208224).
Regarding claim 2, Bates discloses a catheter (Figures 6A-6B; [0055]) comprising:
a shaft 21’ having a lumen ([0038]) and a distal portion (having balloon 27’ and stent 37’);
an embolic filter 50 ([0056]) mounted over the shaft, wherein the embolic filter comprises a port (similar to mounting ring 40 in Figures 4A-4B) for the passage of the shaft therethrough (see port surrounding shaft 21’; Figures 6A-6B), a porous mesh material defining a collection chamber for captured emboli ([0056]), and a stent structure 51 providing support to the porous mesh; and
an interventional element (balloon 27’ and stent 37’; [0052]) coupled directly to the distal portion of the shaft (Figures 6A-6B).
However, Bates does not disclose a conical structure comprising a proximal end and a distal end, wherein the proximal end of the conical structure is slidably coupled to the shaft and the distal end of the conical structure is coupled to the embolic filter.
In Figure 1, Broome teaches a conical structure 30/24 comprising a proximal end (near 24) and a distal end (near 32), wherein the proximal end of the conical structure is slidably coupled to a shaft 14 ([0008]) and the distal end of the conical structure is coupled to a stent structure 36/26 ([0010]), wherein the conical structure has a collapsed configuration and a deployed configuration ([0010], [0011], [0019]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Bates with a conical structure as claimed, as taught by Broome, in order to provide more support to the embolic filter and facilitate expansion and radial deployment and subsequent removal of the device in the lumen (Broome; [0010]).
Regarding claim 3, Bates as modified teaches the distal end of the conical structure is coupled to the embolic filter at the stent structure (at 32; Broome, Figure 1).
Regarding claim 4, Bates as modified teaches the stent structure 51comprises a framework (Bates; Figures 6A-6B).
Regarding claim 6, Bates as modified teaches the stent structure comprises a shape memory material (Bates; [0057]).
Regarding claim 8, Bates as modified teaches the conical structure is integral with the stent structure (Broome, Figure 1; 30/24 is integral with (connected to) the stent structure 36/26).
Regarding claim 17, Bates discloses a system comprising:
a catheter comprising a shaft 21’ and a distal portion (having balloon 27’ and stent 37’);
an embolic filter 50 ([0056]) mounted over the shaft, wherein the embolic filter comprises a port (similar to mounting ring 40 in Figures 4A-4B) for the passage of the shaft therethrough (see port surrounding shaft 21’; Figures 6A-6B), a porous mesh material defining a collection chamber for captured emboli ([0056]), and a stent structure 51, wherein the embolic filter has a collapsed configuration and a deployed configuration ([0057]);
an interventional element (balloon 27’ and stent 37’; [0052]) coupled directly to the distal portion of the shaft (Figures 6A-6B), and
a constraining sheath 24’ for delivering the catheter, the embolic filter, and the interventional element ([0057]).
However, Bates does not disclose a conical structure comprising a proximal end and a distal end, wherein the proximal end of the conical structure is slidably coupled to the shaft and the distal end of the conical structure is coupled to the stent structure, wherein the conical structure has a collapsed configuration and a deployed configuration.
In Figure 1, Broome teaches a conical structure 30/24 comprising a proximal end (near 24) and a distal end (near 32), wherein the proximal end of the conical structure is slidably coupled to a shaft 14 ([0008]) and the distal end of the conical structure is coupled to a stent structure 36/26 ([0010]), wherein the conical structure has a collapsed configuration and a deployed configuration ([0010], [0011], [0019]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Bates with a conical structure as claimed, as taught by Broome, in order to provide more support to the embolic filter and facilitate expansion and radial deployment and subsequent removal of the device in the lumen (Broome; [0010]). It is noted that when the combination is made, the constraining sheath would also deliver the conical structure since it is coupled to the shaft.
Regarding claims 18-19, Bates as modified teaches retraction of the constraining sheath 24’ places the embolic filter and the conical structure in the deployed configuration (Bates; [0057]; also see [0017] of Broome).
Regarding claims 20-21, Bates as modified teaches distal advancement of the constraining sheath 24’ places the embolic filter and the conical structure in the collapsed configuration (Bates, [0058]; also see [0019] of Broome).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bates (U.S. Pub. No. 2007/0142858) in view of Broome (U.S. Pub. No. 2003/0208224), as applied to claim 4 above, and further in view of Khosravi (U.S. Patent No. 6,129,739).
Regarding claim 5, Bates as modified teaches the claimed invention, as discussed above, including the framework comprises a plurality of longitudinal struts and a hoop (struts 51 and hoop 53 in Bates Figures 6A-6B; also see struts 36 and hoop 26 in Broome, Figure 1), but not a plurality of hoops.
In Figure 6, Khosravi teaches an embolic filter with multiple hoops 53, 54 which help to prevent the filter from bunching during retrieval (col. 3, lines 42-44).
It would have been obvious to one of ordinary skill before the effective filing date to provide the framework of Bates as modified with a plurality of hoops, as taught by Khosravi, to ensure that emboli are retained and prevent the filter from bunching (Id.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bates (U.S. Pub. No. 2007/0142858) in view of Broome (U.S. Pub. No. 2003/0208224), as applied to claim 2 above, and further in view of Fawzi (U.S. Pub. No. 2006/0287668).
Regarding claim 7, Bates as modified teaches the claimed invention, as discussed above, except for the stent structure comprises a side port, wherein the side port is configured to allow for the passage of a second catheter.
Fawzi teaches a stent structure 60 with at least one closeable side port capable of introduction of a second catheter (see port through which 32 passes in Figure 6A).
It would have been obvious to one of ordinary skill before the effective filing date to further modify Bates as modified with a side port as claimed, as taught by Fawzi, to allow introduction of a tool that facilitates anchoring or maintaining a position of the filter (Fawzi; [0032])
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bates (U.S. Pub. No. 2007/0142858) in view of Broome (U.S. Pub. No. 2003/0208224), as applied to claim 2 above, and further in view of Ladd (U.S. Pub. No. 2004/0006364).
Regarding claim 9, Bates as modified teaches the claimed invention, as discussed above, including the conical structure having a plurality of arms 30 (Broome; Figure 1); except for arms being curved.
In Figure 1, Ladd teaches a conical portion of a filter having curved arms 46 which shapes the outer surface of the conical section such that the arms may be pressed firmly against a wall of a vessel when the filter is deployed ([0029]) while not damaging the wall of the vessel ([0012]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Bates as modified such that the arms are curved, as taught by Ladd, in order to secure the filter against the wall of a vessel in an atraumatic manner (Id.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Broome (U.S. Pub. No. 2003/0208224) in view of Khosravi (U.S. Patent No. 6,129,739).
Regarding claim 12, Broome discloses the claimed invention, as discussed above, including the framework comprises a plurality of longitudinal struts and a hoop (struts 36 and hoop 26 in Broome, Figure 1), but not a plurality of hoops.
In Figure 6, Khosravi teaches an embolic filter with multiple hoops 53, 54 which help to prevent the filter from bunching during retrieval (col. 3, lines 42-44).
It would have been obvious to one of ordinary skill before the effective filing date to provide the framework of Broome with a plurality of hoops, as taught by Khosravi, to ensure that emboli are retained and prevent the filter from bunching (Id.).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Broome (U.S. Pub. No. 2003/0208224).
Regarding claim 13, Broome discloses the claimed invention, as discussed above, except for the stent structure comprises a shape memory material. However, Broome teaches the conical structure struts 30 being made of a shape memory material ([0011]; Nitinol). It would have been obvious to one of ordinary skill before the effective filing date to modify the stent structure to also comprise a shape memory material such as Nitinol since it is preferred for its ability to undergo substantially bending or flexing with relatively little residual strain (Id.).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Broome (U.S. Pub. No. 2003/0208224) in view of Fawzi (U.S. Pub. No. 2006/0287668).
Regarding claim 14, Broome discloses the claimed invention, as discussed above, except for the stent structure comprises a side port, wherein the side port is configured to allow for the passage of a second catheter.
Fawzi teaches a stent structure 60 with at least one closeable side port capable of introduction of a second catheter (see port through which 32 passes in Figure 6A).
It would have been obvious to one of ordinary skill before the effective filing date to further modify Bates as modified with a side port as claimed, as taught by Fawzi, to allow introduction of a tool that facilitates anchoring or maintaining a position of the filter (Fawzi; [0032]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Broome (U.S. Pub. No. 2003/0208224).
Regarding claim 16, Broome discloses the claimed invention, as discussed above, including the conical structure having a plurality of arms 30 (Broome; Figure 1); except for arms being curved.
In Figure 1, Ladd teaches a conical portion of a filter having curved arms 46 which shapes the outer surface of the conical section such that the arms may be pressed firmly against a wall of a vessel when the filter is deployed ([0029]) while not damaging the wall of the vessel ([0012]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Bates as modified such that the arms are curved, as taught by Ladd, in order to secure the filter against the wall of a vessel in an atraumatic manner (Id.).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-4, 6, 8, 10-11, 13, 15, 17-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23 of U.S. Patent No. 12,076,224 in view of Broome (U.S. Pub. No. 2003/0208224). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements in the claim are to be found in the patent claims, except for features that are merely obvious (as discussed above). Broome teaches an embolic filter with a conical structure 30/24 comprising a proximal end and a distal end, wherein the proximal end of the conical structure is slidably coupled to the shaft ([0008]) and the distal end of the conical structure is coupled to the stent structure ([0010]), wherein the conical structure has a collapsed configuration and a deployed configuration ([0010], [0011], [0019]). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Broome, in order to provide more support to the embolic filter and facilitate expansion and radial deployment and subsequent removal of the device in the lumen (Broome; [0010]).
Claims 5 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23 of U.S. Patent No. 12,076,224 in view of Broome (U.S. Pub. No. 2003/0208224), as applied to claims 4 and 11 above, and further in view of Khosravi (U.S. Patent No. 6,129,739). The patent claims and Broome teach the claimed invention, as discussed above, except for features that are merely obvious.
In Figure 6, Khosravi teaches an embolic filter with multiple hoops 53, 54 which help to prevent the filter from bunching during retrieval (col. 3, lines 42-44). It would have been obvious to one of ordinary skill before the effective filing date to provide the framework of Broome and the patent claims with a plurality of hoops, as taught by Khosravi, to ensure that emboli are retained and prevent the filter from bunching (Id.).
Claims 7 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23 of U.S. Patent No. 12,076,224 in view of Broome (U.S. Pub. No. 2003/0208224), as applied to claims 2 and 10 above, and further in view of Fawzi (U.S. Pub. No. 2006/0287668). The patent claims and Broome teach the claimed invention, as discussed above, except for features that are merely obvious.
Fawzi teaches a stent structure 60 with at least one closeable side port capable of introduction of a second catheter (see port through which 32 passes in Figure 6A). It would have been obvious to one of ordinary skill before the effective filing date to further modify the patent claims and Broome with a side port as claimed, as taught by Fawzi, to allow introduction of a tool that facilitates anchoring or maintaining a position of the filter (Fawzi; [0032]).
Claims 9 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23 of U.S. Patent No. 12,076,224 in view of Broome (U.S. Pub. No. 2003/0208224), as applied to claims 2 and 10 above, and further in view of Ladd (U.S. Pub. No. 2004/0006364). The patent claims and Broome teach the claimed invention, as discussed above, except for features that are merely obvious.
In Figure 1, Ladd teaches a conical portion of a filter having curved arms 46 which shapes the outer surface of the conical section such that the arms may be pressed firmly against a wall of a vessel when the filter is deployed ([0029]) while not damaging the wall of the vessel ([0012]). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Broome such that the arms are curved, as taught by Ladd, in order to secure the filter against the wall of a vessel in an atraumatic manner (Id.).
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771