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 .
Detailed Action
This is in response to the non-provisional application filed 10/09/2024.
Allowable Subject Matter
Claims 11-20 are allowed.
The following is an examiner’s statement of reasons for allowance: claim 11 recites with the radially expandable distal section of the funnel catheter while in the radially expanded state maintained at a positioned on a proximal side of the vessel bifurcation, advancing through the lumen of the funnel catheter the navigation device while the radially expandable section of the navigation device is in a radially constricted state; substantially aligning the radially expandable section of the navigation device with the radially expandable distal section of the funnel catheter in the radially expanded state; with the substantial alignment of the radially expandable section of the navigation device and the radially expandable distal section of the funnel catheter in the radially expanded state, activating the radially expandable section of the navigation device substantially filling the maximum inner diameter at the distal edge of the radially expandable distal section of the funnel catheter while in the radially expanded state; advancing in a distal direction past without catching on the vessel bifurcation the funnel catheter together with the activated radially expandable section of the navigation device in the radially enlarged state substantially filling the inner diameter of the radially expandable distal section of the funnel catheter; after passing distally of the vessel bifurcation, deactivating the radially expandable section of the navigation device transitioning to the radially constricted state; while the radially expandable section of the navigation device is in the radially constricted state, withdrawing the navigation device via the lumen of the funnel catheter while the funnel catheter is maintained in position within the vasculature.
The Office agrees the art of record fails to teach or suggest these features.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim Rejections - 35 USC § 102
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 5,092,839 (Kipperman)
Regarding claim 1, Kipperman discloses as shown in Figures 1-14, an endovascular medical system preventing catching at a bifurcated vessel during removal of a clot; wherein the endovascular medical system comprises: a funnel catheter (thrombectomy catheter 11, see col. 3, lines 39-48) having a proximal end and an opposite distal end defining a lumen therebetween; the funnel catheter having a radially expandable distal section including a free terminating distal edge; the radially expandable distal section of the funnel catheter being transitionable between a radially constricted state (Figure 6) and a radially expanded state (Figure 9); and the radially expandable distal section of the funnel catheter while in the radially expanded state has a maximum inner diameter at the free terminating distal edge; a navigation device (balloon catheter 13, see col. 3, lines 29-49) advanceable in the lumen of the funnel catheter; the navigation device comprises: a tapered distal section having a proximal end of maximum outer diameter and a distal end of minimum outer diameter; a proximal section; a radially expandable section interposed between the tapered distal section and the proximal section; the radially expandable section of the navigation device is transitionable between a radially constricted state (figure 11) and a radially expanded state (figure 13); wherein in the radially constricted state, the radially expandable section of the navigation device has an outer diameter slidable within the lumen of the funnel catheter; and wherein in the radially expanded state, the radially expandable section of the navigation device has a maximum outer diameter substantially equal to the maximum inner diameter at the free terminating distal edge of the radially expandable distal section of the funnel catheter while in the radially expanded state; See Figure 14; and a guidewire (guidewire 15) permanently secured to the tapered distal section, the guidewire having a distal portion projecting distally in a longitudinal direction beyond the distal end of the tapered distal section.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 7,220,269 (Ansel et al.)
Regarding claim 1, Ansel et al. discloses as shown in Figures 15-17, an endovascular medical system preventing catching at a bifurcated vessel during removal of a clot; wherein the endovascular medical system comprises: a funnel catheter (catheter 40, see col. 9, lines 29-55) having a proximal end and an opposite distal end defining a lumen therebetween; the funnel catheter having a radially expandable distal section including a free terminating distal edge; the radially expandable distal section of the funnel catheter being transitionable between a radially constricted state and a radially expanded state; see col. 9, lines 29-55 and Figures 15-17; and the radially expandable distal section of the funnel catheter while in the radially expanded state has a maximum inner diameter at the free terminating distal edge; a navigation device (catheter, shown in Figure 1) advanceable in the lumen of the funnel catheter; the navigation device comprises: a tapered distal section having a proximal end of maximum outer diameter and a distal end of minimum outer diameter; a proximal section; a radially expandable section (balloon occluder 34, see col. 10, 49-67) interposed between the tapered distal section and the proximal section; the radially expandable section of the navigation device is transitionable between a radially constricted state and a radially expanded state; wherein in the radially constricted state, the radially expandable section of the navigation device has an outer diameter slidable within the lumen of the funnel catheter; and wherein in the radially expanded state, the radially expandable section of the navigation device has a maximum outer diameter substantially equal to the maximum inner diameter at the free terminating distal edge of the radially expandable distal section of the funnel catheter while in the radially expanded state; See Figure 14; and a guidewire (guidewire 15) permanently secured to the tapered distal section, the guidewire having a distal portion projecting distally in a longitudinal direction beyond the distal end of the tapered distal section.
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.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,092,839 (Kipperman) in view of U.S. Patent Publication Number 2004/0064089 (Kesten et al.), U.S. Patent Publication Number 2002/0065507 (Zadno-Azizi et al.)
Regarding claims 2-4, Kipperman discloses the radially expandable section of the navigation device comprises: a polymer outer jacket secured between the proximal section and the distal section of the navigation device defining an inner cavity. See col. 2, lines 8-17.
Kipperman fails to disclose the polymer is complaint.
Kesten et al., from the same field of endeavor teaches a similar system as shown in Figure 1, wherein a radially expandable section of a navigation device is made of complaint material. See paragraph [0050].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting polymer of the radially expandable section disclosed by Kipperman for the complaint material taught by Kesten et al., because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Zadno-Azizi et al., from the same filed of endeavor teaches a similar system as shown in Figure 43, 44 a radially expandable mechanical structure (coil 1080, see paragraph [0257]) disposed in the inner cavity; the radially expandable mechanical structure is transitionable between a radially constricted state and a radially expanded state; wherein transitioning of the radially expandable mechanical structure between the radially constricted state and the radially expanded state is controllable via a mechanical activation device (elongate member 1082 or second elongate member 1086, see paragraph [0257]), wherein the mechanical activation device is a pull wire (elongate member 1082 is disclosed as weldable to the coil which means it is necessary metal in the form of a usually very flexible thread or slender rod, or more simply a wire, the Office interprets it as a pull wire because it is capable of being pulled) secured at a distal end to either the guidewire or the tapered distal section of the navigation device, wherein the radially expandable mechanical structure is a coil or braided structure.
It would have been obvious to one for ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting the system disclosed by Kipperman by substituting the means for inflating balloon catheter 13 for the coil 1080 and elongate member 1082 or second elongate member 1086 taught by Zadno-Azizi et al. because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,092,839 (Kipperman) in view of U.S. Patent Publication Number 2004/0064089 (Kesten et al.), U.S. Patent Publication Number 2002/0065507 (Zadno-Azizi et al.) as applied to claim 2 above, and further in view of U.S. Patent Publication Number 2003/0100915 (Quint)
Regarding claim 5, Kipperman wherein the compliant polymer outer jacket is substantially uniform in radial thickness in a longitudinal direction.
Quint et al., from the same field of endeavor teaches a similar system as shown in Figure 1, wherein the compliant polymer outer jacket is substantially uniform in radial thickness in a longitudinal direction. See paragraph [0024].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting thickness of the outer jacket disclosed by Kipperman for the thickness of the outer jacket taught by Quint et al., because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 6, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,092,839 (Kipperman) in view of U.S. Patent Publication Number 2004/0064089 (Kesten et
Regarding claims 6, 7 Kipperman discloses the radially expandable section of the navigation device comprises: a polymer outer jacket secured between the proximal section and the distal section of the navigation device defining an inner cavity, wherein the polymer outer jacket is transitionable from the radially constricted state to the radially expandable state by fluidically controlling a volume of inflation medium in the interior cavity; wherein the interior cavity is in fluid communication with at least one lumen defined in the proximal section, wherein the at least one lumen comprises a single lumen in fluid communication with the interior cavity for bi-directional flow of the inflation medium to and from the interior cavity. See col. 2, lines 8-17 and col. 3, lines 29-48.
Kipperman fails to disclose the polymer is complaint.
Kesten et al., from the same field of endeavor teaches a similar system as shown in Figure 1, wherein a radially expandable section of a navigation device is made of complaint material. See paragraph [0050].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting polymer of the radially expandable section disclosed by Kipperman for the complaint material taught by Kesten et al., because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,092,839 (Kipperman) in view of U.S. Patent Publication Number 2004/0064089 (Kesten et al.) as applied to claim 6 above, and further in view of U.S. Patent Publication Number 2015/0216533 (Hray et al.)
Regarding claim 8, Kipperman fails to disclose wherein the at least one lumen comprises: an inlet lumen for unidirectional flow of the contrast medium into the interior cavity; and an outlet lumen for unidirectional flow of the contrast medium from the interior cavity.
Pal et al., from the same field of endeavor teaches a similar system as shown n Figure 2, where the system includes at least one lumen comprises: an inlet lumen for unidirectional flow of the contrast medium into the interior cavity; and an outlet lumen for unidirectional flow of the contrast medium from the interior cavity for the purpose of introducing contrast fluid. See paragraph [0034].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman to include the contrast lumen taught by Pal et al. in order to introduce contrast lumen into the system, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,092,839 (Kipperman) in view of U.S. Patent Publication Number 2004/0064089 (Kesten et al.), U.S. Patent Publication Number 2002/0065507 (Zadno-Azizi et al.) U.S. Patent Publication Number 2008/0097509 (Beyar)
Regarding claims 9, 10 Kipperman discloses the radially expandable section of the navigation device comprises: a polymer outer jacket secured between the proximal section and the distal section of the navigation device defining an inner cavity. See col. 2, lines 8-17.
Kipperman fails to disclose the polymer is complaint.
Kesten et al., from the same field of endeavor teaches a similar system as shown in Figure 1, wherein a radially expandable section of a navigation device is made of complaint material. See paragraph [0050].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting polymer of the radially expandable section disclosed by Kipperman for the complaint material taught by Kesten et al., because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Zadno-Azizi et al., from the same filed of endeavor teaches a similar system as shown in Figure 43, 44 a radially expandable mechanical structure (coil 1080, see paragraph [0257]) disposed in the inner cavity; the radially expandable mechanical structure is transitionable between a radially constricted state and a radially expanded state; wherein transitioning of the radially expandable mechanical structure between the radially constricted state and the radially expanded state is controllable via a mechanical activation device (elongate member 1082 or second elongate member 1086, see paragraph [0257]), wherein the mechanical activation device is a pull wire (elongate member 1082 is disclosed as weldable to the coil which means it is necessary metal in the form of a usually very flexible thread or slender rod, or more simply a wire, the Office interprets it as a pull wire because it is capable of being pulled) secured at a distal end to either the guidewire or the tapered distal section of the navigation device, wherein the radially expandable mechanical structure is a coil or braided structure, wherein the mechanical activation device is a pull wire having a proximal end and an opposite distal end; the pull wire extending longitudinally through the interior cavity of the compliant polymer outer layer with the distal end of the pull wire secured to either the guidewire or the tapered distal section of the navigation device.
It would have been obvious to one for ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting the system disclosed by Kipperman by substituting the means for inflating balloon catheter 13 for the coil 1080 and elongate member 1082 or second elongate member 1086 taught by Zadno-Azizi et al. because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Kipperman wherein the compliant polymer outer jacket has non-uniform in radial thickness in a longitudinal direction.
Beyar et al., from the same field of endeavor teaches a similar system as shown in Figure 1, wherein the compliant polymer outer jacket is substantially non-uniform in radial thickness in a longitudinal direction for the purpose expanding the expandable section in a non-spherical shape. See paragraph [0109].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Kipperman by substituting thickness of the outer jacket disclosed by Kipperman for the thickness of the outer jacket taught by Beyar et al., because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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