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 .
Response to Amendment
The claims filed on June 11th, 2026 have been entered into the application. Claims 2- 21 are pending in the application. The amendments to the claims overcome the previous claim objections.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/611,454, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 2, from which claims 3-21 depend, recites “wherein the inner filter portion is separated from the outer scaffold portion by an intervening annular space in the fully deployed configuration along a length of the inner filter portion”. Additionally, claim 18 recites the limitation “a distal end sheet attached to the intermediate portion, wherein the distal end sheet is configured to block flow of embolic material through the intermediate portion”; and claim 19 recites the limitation “wherein the outer scaffold portion comprises distally extending loops of wires”. Application No. 62/611,454 filed December 28th, 2017 does not provide support for at least these limitations, and thus the claims will not be given the benefit of that priority. PCT/US2018/067143 filed December 21, 2018 provides support for the claimed limitations (Paragraphs 0014, 0015, 0023, 0025, and 0056). Thus, claims 2-21 are given the benefit of the priority date of December 21, 2018.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 2-3, 5-6, 8-13, 15, and 16 under 35 U.S.C. 103 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) has been withdrawn; specifically Cox does not teach an outer scaffold or wherein the outer scaffold middle portion is attached to the inner sheath distal end via the outer scaffold proximal end.
The rejection of claims 4 and 7 under 35 U.S.C. 103 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) and in further view of Haverkost et al. (US 2019/0343613) has been withdrawn; specifically Cox does not teach an outer scaffold or wherein the outer scaffold middle portion is attached to the inner sheath distal end via the outer scaffold proximal end.
The rejection of claim 17 under 35 U.S.C. 103 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of Belson (US 2012/0109182) has been withdrawn; specifically Cox does not teach an outer scaffold or wherein the outer scaffold middle portion is attached to the inner sheath distal end via the outer scaffold proximal end.
The rejection of claim 18 under 35 U.S.C. 103 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of McGowan et al. (US 2018/0289460) has been withdrawn; specifically Cox does not teach an outer scaffold or wherein the outer scaffold middle portion is attached to the inner sheath distal end via the outer scaffold proximal end.
The rejection of claim 19 under 35 U.S.C. 103 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of Rosenbluth et al. (WO 9956801) has been withdrawn; specifically Cox does not teach an outer scaffold or wherein the outer scaffold middle portion is attached to the inner sheath distal end via the outer scaffold proximal end.
The rejection of claim 20 under 35 U.S.C. 103 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of Groh (US 2016/0317276) has been withdrawn; specifically Cox does not teach an outer scaffold or wherein the outer scaffold middle portion is attached to the inner sheath distal end via the outer scaffold proximal end.
Claim(s) 2-3, 5-6, 8- 11, 15- 16, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739).
Regarding claims 2 and 21, Cox (Cox et al.) teaches an embolic material capture catheter (EPD 10)(abstract)(Figs. 1- 4) comprising:
An outer sheath (73) defining an outer sheath lumen (Paragraph 0042);
An inner sheath (proximal portion 18 of EPD 10) disposed in the outer sheath lumen (Paragraph 0042), having an inner sheath distal end (see annotated Fig. 1 below), and defining an inner sheath lumen that extends to the inner sheath distal end (Paragraphs 0029 and 0036); and
An embolic material capture element (filter portion 12) comprising a filter (Paragraph 0031), wherein the filter has an filter proximal end that is attached to the inner sheath distal end (see annotated Fig. 1 below)(Paragraph 0036), wherein the filter is adapted to, in the fully deployed configuration, interface with an inner surface of a blood vessel (Paragraph 0032), wherein the filter extends distally beyond the inner sheath distal end in the fully deployed configuration (see annotated Fig. 1 below) and wherein the embolic material capture element is adapted to block flow of embolic material through the blood vessel past the embolic material capture element (Paragraph 0029).
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Regarding the embolic material capture element having an insertion configuration, an intermediate deployment configuration, and a fully deployed configuration, as Cox teaches an outer sheath (73) and that the device in Fig. 1 is inserted within the outer sheath and compressed (Paragraphs 0029, 0042 and 0044) and that the embolic material capture element can self- expand (Paragraph 0030), therefore when the outer sheath is disposed over the embolic material capture element and until it is halfway over the embolic material capture element, it would be in an insertion configuration, when the outer sheath is over halfway pulled off of the embolic material capture element, it would partially expand and therefore assume an intermediate deployment configuration, and when the outer sheath is not on the embolic material capture element it would assume a fully deployed or expanded configuration, like the one shown in Figure 1.
Regarding wherein the inner sheath slidably disposed in the outer sheath lumen, as the outer sheath is taught to be provided over the embolic material capture element in deployment (Paragraphs 0042 and 0044), and as the outer sheath is withdrawn to deploy the element (Paragraph 0045), the inner sheath and the outer sheath are slidable relative to each other, and therefore when the outer sheath is held then when the inner sheath is pulled or pushed by a user, it slides within the outer sheath lumen.
Cox does not teach an outer scaffold, an inner filter, wherein the outer scaffold has an outer scaffold proximal end and an outer scaffold distal end and an outer scaffold middle portion extending between and attached directly to outers scaffold proximal end and the outer scaffold distal end, wherein the outer scaffold middle end is attached to the inner sheath distal end via the outer scaffold proximal end, wherein the inner filter has an inner filter proximal end that is attached to the inner sheath distal end, wherein the inner filter is separated from the outer scaffold by an intervening annular space in the fully deployed configured along a length of the inner filter, wherein the outer scaffold is adapted to, in the fully deployed configuration, interface with an inner surface of a blood vessel, wherein the outer scaffold extends distally beyond the inner sheath distal end in the fully deployed configuration, wherein the inner filter extends distally beyond the inner sheath distal end in the fully deployed configuration or (claim 21) wherein the outer scaffold proximal end is attached directly to the inner sheath distal end.
Brady (Brady et al.) teaches an embolic material capture catheter (Figs. 24a- 24c)(abstract) comprising: an outer sheath (25) defining an outer lumen (see Fig. 2e); an inner sheath having an inner sheath distal end (see annotated Fig. 24a below); and an embolic material capture element (engaging basket 551)(Paragraph 0554) wherein the embolic material capture element comprises an outer scaffold (outer member 552) and an inner filter (part of the inner braided tube 553)(Paragraph 0083), wherein the outer scaffold has an outer scaffold proximal end and an outer scaffold distal end and an outer scaffold middle portion extending between and attached directly to the outer scaffold proximal end and the outer scaffold distal end, wherein the outer scaffold middle end is attached to the inner sheath distal end via the outer scaffold proximal end and wherein the outer scaffold proximal end is attached directly to the inner sheath distal end (see annotated Fig. 24a below), wherein the inner filter portion is separated from the outer scaffold portion by an intervening annular space in a fully expanded configuration along a length of the inner filter portion (see annotated Fig. 24a below), wherein in the fully expanded configuration, the embolic material capture element interfaces with an inner surface of a blood vessel and is adapted to block flow of embolic material through the blood vessel past the embolic material capture element (Paragraph 0014).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
Regarding the inner filter, as discussed above, for the combination the outer scaffold of the combination surrounds the filter, therefore it is an inner filter.
Regarding claim 3, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
Regarding wherein the embolic material capture element is reconfigurable from the fully deployed configuration to a captured configuration in which the embolic material capture element is disposed in the outer sheath via proximal movement of the inner sheath relative to the outer sheath, Cox teaches this limitation since, as discussed above, Cox teaches that the outer sheath (73) covers the embolic material capture element during deployment (Paragraph 0029 and 0042), and Cox teaches that the outer sheath and the inner sheath slide relative to each other (Paragraph 0045) when the outer sheath lumen is held by a user, and the inner sheath is moved proximal relative to it, then the embolic material capture element enters into the capture configuration.
Regarding claim 5, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
The combination further teaches wherein outer scaffold has an outer scaffold outer surface that extends between the outer scaffold proximal end and the outer scaffold distal end (see annotated Fig. 24a of Brady below).
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Regarding the outer scaffold outer surface being disposable distal to the outer sheath with the embolic material capture element in the insertion configuration, as discussed above, Cox teaches that the outer sheath (73) covers the embolic material capture element during deployment (Paragraph 0029 and 0042), and Cox teaches that the outer sheath and the inner sheath slide relative to each other (Paragraph 0045) and the insertion configuration is considered to be from when the outer sheath is fully covering the embolic material capture element to when it has been partially pulled back, revealing the outer scaffold outer surface of the embolic material capture element of the combination. Therefore, the outer scaffold outer surface is disposable distal to the outer sheath with the embolic material capture element in the insertion configuration.
Regarding claim 6, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
The combination further teaches wherein the embolic material capture element comprises a shape- memory material (Brady, Paragraphs 0065 and 0622).
Regarding claims 8 and 9, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
The combination further teaches wherein the outer scaffold distal end has an annular configuration that provides an outer scaffold distal end circular opening (distal junction 555)(see annotated Fig. 24a of Brady below).
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Cox further teaches wherein the inner sheath accommodates insertion of a treatment catheter (TAVR catheter) into the inner sheath lumen and advancement of a distal end portion of the treatment catheter through the embolic material capture element central lumen to a position distal to the outer scaffold distal end in the fully deployed configuration (see Fig. 5); the distal end portion of the treatment catheter is adapted to accomplish a surgical task, wherein the embolic material capture element is adapted to, in the fully deployed configuration, interface with a patient’s aorta and substantially block flow of embolic material through the patient’s aorta past the embolic material capture element, and the treatment catheter is adapted to deploy a prosthetic aortic valve (Paragraphs 0045- 0047)(A TAVR catheter is known in the art to deliver a prosthetic aortic valve.).
Regarding claim 10, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
Cox further teaches wherein the inner filter comprises a filtering membrane adapted to filter embolic material from blood flowing through the filtering membrane (Paragraphs 0029- 0031).
Regarding claim 11, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
Cox further teaches the embolic material capture catheter adapted to be coupled with an embolic material extraction device operable to draw embolic material through the inner sheath lumen while the embolic material capture element is in the fully deployed configuration (Paragraph 0037)(It is noted that an embolic extraction device is a known term and structure in the art which requires suction or vacuum to remove the material.).
Regarding claim 13, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
The combination further teaches wherein the embolic material capture element comprises a connection cone; and the inner filter has an inner filter distal end that is coupled with the outer scaffold distal end via the connection cone (see annotated Fig. 24a of Brady below).
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Regarding claim 14, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold, connection cone, and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
Regarding wherein the connection cone is configured to capture embolic material from blood flowing through the connection cone, as this language is functional, the structure of the connection cone only needs to be able to accomplish the function, therefore as the connection cone of the combination is a part of the embolic material capture element and as blood and embolic material flows into the connection cone of the combination and is captured through the inner filter membrane (Cox, Paragraph 0037; Brady, Paragraph 0021), the connection cone of the combination captures embolic material from blood flowing through the connection cone.
Regarding claim 15, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold, connection cone, and inner filter portion, as discussed above.
The combination does not teach wherein the connection cone is nonporous.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the intermediate portion of the combination to be nonporous. Since one of ordinary skill in the art would recognize that one has two options, a material that is porous or a material that is nonporous. Thus, a nonporous connection cone would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 16, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold, connection cone, and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
The combination further teaches wherein the connection cone has a conical shape configured to direct blood flow into the inner filter portion (see annotated Fig. 24a of Brady below)(As this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as the connection cone has the same structure as the claim limitation, it would accomplish the same function as set forth in the claim.).
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Claim(s) 4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739), as applied to claim 2 above, in further view of Haverkost et al. (US 2019/0343613).
Regarding claims 4 and 7, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
The combination of Cox and Brady does not teach in the first embodiment (claim 4) further comprising a dilator assembly, wherein the outer scaffold distal end is secured to a distal end portion of the dilator assembly in the insertion configuration; the dilator assembly is operable to release the outer scaffold distal end to reconfigure the embolic material capture element from the insertion configuration to the intermediate deployment configuration; the dilator assembly extends through the inner sheath lumen and is removable from the inner sheath lumen following release of the outer scaffold distal end via proximal extraction of from the inner sheath lumen; and the embolic material capture element conforms to an outer surface of the dilator assembly from the proximal end portion of the embolic material capture element to the distal end portion of the embolic material capture element when the embolic material capture element is in the insertion configuration or (claim 7) further comprising a dilator assembly, wherein the outer scaffold distal end is secured to a distal end portion of the dilator assembly in the insertion configuration; the dilator assembly is operable to release the outer scaffold distal end to reconfigure the embolic material capture element from the insertion configuration to the intermediate deployment configuration; the dilator assembly extends through the inner sheath lumen and is removable from the inner sheath lumen following release of the outer scaffold distal end via proximal extraction from the inner sheath lumen; and the embolic material capture element is retained in the insertion configuration at least partially via axial tension imparted into the outer scaffold via the dilator assembly.
Haverkost (Haverkost et al.) teaches a similar embolic material capture catheter (200)(Figs. 7- 15)(abstract) comprising a sheath (340), an embolic material capture element (104)(Paragraphs 0075 and 0077), and a dilator assembly (dilator shaft 220)(Paragraph 0071) wherein the distal end portion of the embolic material capture element is secured to a distal end portion of the dilator assembly in the insertion configuration (see annotated Fig. 11 below)(In Paragraph 0075, Haverkost teaches that the dilator assembly is able to be secured within the catheter, in Paragraph 0077, Haverkost teaches that the dilator assembly has the embolic material capture element disposed around it. Therefore, when in the insertion configuration, with the sheath disposed over the dilator assembly and the embolic material, the distal end portion of the embolic material capture element is secured to a distal end portion of the dilator assembly through friction and through the compression of the sheath.); the dilator assembly is operable to release the distal end portion of the embolic material capture element during reconfiguration of the embolic material capture element from the insertion configuration to the intermediate deployment configuration (In Paragraph 0077, Haverkost teaches that the dilator assembly expands the embolic material capture element after the device has been inserted, therefore, the dilator assembly releases the distal end portion through pushing it away and removing it from the outer surface of the dilator assembly.); the dilator assembly extends through the inner sheath lumen and is removable from the inner sheath lumen following release of the distal end portion of the embolic material capture element via proximal extraction of from the inner sheath lumen (see Fig. 13)(Paragraph 0077); and the embolic material capture element conforms to an outer surface of the dilator assembly from the proximal end portion of the embolic material capture element to the distal end portion of the embolic material capture element when the embolic material capture element is in the insertion configuration (see annotated Fig. 11 below)(For purposes of examination, the configuration shown within Fig. 11 represents a part of the insertion configuration, it is understood that the insertion configuration, however, would have the sheath extend over the dilation assembly and the embolic material capture element, as Fig. 11 is with the dilator shaft advanced (Paragraph 0037).).
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It would have been obvious before the effective filing date to modify the device of the combination to have the dilator assembly as taught by Haverkost, since Cox teaches that the embolic capture element can be “actively expanded using conventional techniques known in the art” (Paragraph 0045) and Haverkost teaches an active means for deployment.
Regarding wherein the embolic material capture element is retained in the insertion configuration at least partially via axial tension imparted into the outer scaffold via the dilator assembly, with the combination of Cox, Brady, and Haverkost, the dilator assembly would be placed within the inner sheath and extending out of it to interact with the outer scaffold of the embolic material capture element of the combination that extends past the distal end of the inner sheath. Therefore, when the element is within a compressed configuration, that of the insertion configuration, the dilator assembly imparts axial tension upon it, since the dilator takes up space while in the compressed configuration and therefore presses the outer scaffold of the embolic material capture element against the outer sheath.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739), as applied claim 2, in further view of Macoviak et al. (US 6,361,545).
Regarding claim 12, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture element as taught by Cox to have the outer scaffold and the intervening annular space separating the filter from the scaffold as taught by Brady, since Brady teaches that the outer scaffold engages the vessel during a procedure (Paragraph 0014) and the dual layer design scaffolds “the inner lumen of the engager”, filters “out fragments”, and facilitates a “very space efficient design” (Paragraph 0021).
The combination further teaches in the current embodiment the outer scaffold portion (Brady, 552) comprises one or more members (Brady, struts 557) that contacts a wall of a vessel along which embolic material is blocked from traversing (Brady, Paragraphs 0014 and 0021).
Cox further teaches wherein the inner filter is configured to prevent emboli of different sizes from passing through the filter (Paragraph 0031).
The combination of Cox and Brady does not teach wherein the inner filter is configured to prevent emboli of greater than 150 microns from passing through the inner filter.
Macoviak (Macoviak et al.) teaches an embolic material capture catheter (perfusion filter catheter 100)(Fig. 1-3) with an outer sheath (outer tube 124), an inner sheath (catheter shaft 104) and an embolic material capture element (embolic filter assembly 102) with a frame (filter support structure 114) and a filter membrane (filter screen 112), the filter membrane having a porosity of 1 to 100 micrometers (Column 7, Lines 1- 4).
It would have been obvious to one of ordinary skill in the art to modify the porosity of the inner filter portion of the combination to be between 1 to 100 micrometers as taught by Macoviak, since Macoviak teaches that this porosity is used to capture macroemboli and microemboli (Column 7, Lines 1-4) and that macroemboli larger than 100 micrometers can cause strokes and it is preferable to filter out these particles to improve the outcome of surgery (Column 1, Lines 49- 57).
Regarding the inner filter being configured to prevent emboli of greater than 150 microns from passing through the inner filter, as the porosity of the filter is less than 150 microns (A micrometer is one micron), the inner filter would filter out particles that are greater than the size of the pores, which includes values greater than 150 microns.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739), as applied to claim 2 above, in further view of Belson (US 2012/0109182).
Regarding claim 17, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
The combination of Cox and Brady does not teach wherein the outer scaffold portion, the intermediate portion, and the inner filter portion are portions of an integrally formed braided wire member.
Belson teaches a similar embolic material capture element (embolic protection device 100)(Paragraph 0020) placed within an aorta (abstract) through which a treatment catheter can be passed through (Paragraph 0023). The embolic material capture element is composed of an outer scaffold portion (cylindrical outer structure 102), an intermediate portion (upstream end 108), and an inner filter portion (inner structure 104), wherein each are portions of an integrally formed braided wire member (Paragraph 0021).
It would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the outer scaffold portion, the intermediate portion and the inner filter portion of the combination to be an integrally formed braided member as taught by Belson. Since one of ordinary skill in the art would recognize that one has two options, to have each portion be formed of non-integrally formed materials, or to have each portion be formed of an integrally formed material, such as a braided wire member as taught by Belson. Thus, the outer scaffold portion, the intermediate portion and the inner filter portion being portions of an integrally formed braided wire member would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739), as applied to claim 2 above, in further view of McGowan et al. (US 2018/0289460).
Regarding claim 18, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
The combination of Cox and Brady does not teach the embolic material capture catheter further comprising a distal end sheet attached to the intermediate portion, wherein the distal end sheet is configured to block flow of embolic material through the intermediate portion.
McGowan (McGowan et al.) teaches a similar embolic material capture catheter (guide catheter 120)(abstract)(Figs. 1- 5) with an inner catheter (guide catheter 120) and an embolic material capture element (400) comprising a filter portion (filter material 119), a scaffold portion, wherein the filter portion is separated from the scaffold portion by an intervening annular space, and an intermediate portion connecting the filter portion with the scaffold portion (see annotated Fig. 8 below), with a distal end sheet (covering material 114) attached to the intermediate portion (Paragraph 0046)(see Fig. 8), wherein the distal end sheet is configured to block flow of embolic material through the intermediate portion (Paragraphs 0037 and 0048).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the embolic material capture catheter of the combination to have a distal end sheet attached to the intermediate portion as taught McGowan, since McGowan teaches that the distal end sheet allows for the fluid passing through the device to flow through the center and aids to guide it to be filtered (Paragraph 0039).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739), as applied to claim 2 above, in further view of Rosenbluth et al. (WO 9956801).
Regarding claim 19, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
The combination of Cox and Brady does not teach wherein the outer scaffold portion comprises distally extending loops of wires configured for atraumatic engagement of the blood vessel inner surface.
Rosenbluth (Rosenbluth et al.) teaches an embolic material capture element (400)(Fig. 5)(Page 19, Lines 9- 27) with a scaffold (spokes 402) and a filter (fabric cover 404). The scaffold comprises atraumatic loops (410) formed on its distal end to atraumatically engage the vessel (Page 19, Lines 20- 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distal end of the outer scaffold of the combination to have atraumatic loops as taught by Rosenbluth, since Rosenbluth teaches that the loops “prevent vascular trauma” (Page 19, Line 22).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2013/082555) in view of Brady et al. (US 2013/0345739), as applied to claim 2 above, in further view of Groh (US 2016/0317276).
Regarding claim 20, Cox and Brady make obvious the embolic material capture catheter including the outer scaffold and inner filter portion, as discussed above.
The combination of Cox and Brady does not teach wherein a middle portion of the outer scaffold portion has a middle portion external diameter in the fully deployed configuration; the distal end portion of the outer scaffold portion has a distal end portion external diameter in the fully deployed configuration; and the middle portion external diameter is less than the distal end portion external diameter.
Groh teaches an embolic material capture catheter (100)(abstract)(Figs. 1- 10) with an outer sheath (retention sleeve 106), an inner sheath (elongated main tube 104) defining an inner sheath lumen (112), and an embolic material blocking element (108) with a filter membrane (136) and an outer scaffold (struts 134, circumferential edge members 130, 132), wherein a middle portion of the outer scaffold portion has a middle portion external diameter in the fully deployed configuration; the distal end portion of the outer scaffold portion has a distal end portion external diameter in the fully deployed configuration; and the middle portion external diameter is less than the distal end portion external diameter (see annotated Fig. 7 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shape of the outer scaffold of the combination to have the shape as taught by Groh, since Groh teaches that this shape “serves to guide captured embolic material” to be captured and taken away by the lumen of the catheter (Paragraph 0063).
Response to Arguments
Regarding applicant’s arguments filed June 11th, 2026, with respect to the 35 U.S.C. 103 rejection of claims 2-3, 5-6, 8-13, 15, and 16 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545), the 35 U.S.C. 103 rejection of claims 4 and 7 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) and in further view of Haverkost et al. (US 2019/0343613), the 35 U.S.C. 103 rejection of claim 17 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of Belson (US 2012/0109182), the 35 U.S.C. 103 rejection of claim 18 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of McGowan et al. (US 2018/0289460), the 35 U.S.C. 103 rejection of claim 19 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of Rosenbluth et al. (WO 9956801), and the 35 U.S.C. 103 rejection of claim 20 over Cox et al. (WO 2013/082555) in view of Macoviak et al. (US 6,361,545) in further view of Groh (US 2016/0317276) have been fully considered but are moot since, as discussed above, the previous prior art rejection was withdrawn in view of applicant’s amendments. However, it is noted that Cox, Macoviak, Haverkost, Belson, McGowan, Rosenbluth, and Groh are still relied upon for limitations not argued.
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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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