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 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wensel et al. (US 2008/0262487).
Regarding claim 1, Wensel discloses a method for removing an obstruction from a bodily lumen (FIGs 1a-1f, wherein clot 22 is the obstruction and artery 20 is the bodily lumen), the method comprising: obtaining a treatment system (10, [0043]) comprising an elongated shaft (12) defining a lumen extending therethrough (14, [0043-0044]) and a treatment device (16/18, FIG 1a) comprising a manipulation member (16) and an interventional element (18) at a distal portion of the manipulation member (FIG 1c-1f, [0043-0047]), the interventional element comprising a resilient wire formed into a coil ([0047]) having a plurality of windings adjacent to one another along a longitudinal dimension of the interventional element (FIGs 1a and 1c show the plurality of windings of the coil along the longitudinal direction), wherein the interventional element is positioned within the lumen of the elongated shaft at a distal portion of the elongated shaft in a radially compressed configuration (FIG 1b, [0062]) in which the windings are circumferentially aligned with one another about the longitudinal dimension (The dimension of the winding when the coil is inserted within catheter 12 are defined by the inner diameter of the lumen. In the radially compressed delivery profile, the winding all conform to the same diameter and therefore are circumferentially aligned. FIG 1b shows the aligned windings in the delivery state despite having various diameters in the expanded state of FIG 1a); distally advancing the distal portion of the elongated shaft through the bodily lumen to a treatment location at or adjacent to the obstruction (FIG 1a-1b shows 12 advanced towards and then through obstruction 22); releasing the interventional element from the lumen of the elongated shaft such that the interventional element transitions from the radially compressed configuration to a radially expanded configuration (FIG 1c, [0018 and 0063]) in which the windings are circumferentially offset from one another about the longitudinal dimension (FIG 1c shows the windings being offset because they each have a different circumference); engaging the obstruction with the interventional element in the radially expanded configuration (FIG 1d-1e); and proximally withdrawing the manipulation member to proximally withdraw the interventional element and engaged obstruction from the bodily lumen (FIG 1f, [0021 and 0065]).
Regarding claim 6, Wensel discloses the plurality of windings comprises three windings angularly offset from one another about a circumference of the interventional element by about 120 degrees (FIG 1a shows at least 8 complete loops formed by the wire of 18. Therefore, there can be taken at least three segments which form windings that are offset by about 120 degrees about the circumference of the interventional element).
Regarding claim 7, Wensel discloses the plurality of windings comprises four windings angularly offset from one another about a circumference of the interventional element by about 90 degrees (FIG 1a shows at least 8 complete loops formed by the wire of 18. Therefore, there can be taken at least four segments which form windings that are offset by about 90 degrees about the circumference of the interventional element).
Regarding claim 8, Wensel discloses the plurality of windings comprises five windings angularly offset from one another about a circumference of the interventional element by about 72 degrees (FIG 1a shows at least 8 complete loops formed by the wire of 18. Therefore, there can be taken at least five segments which form windings that are offset by about 72 degrees about the circumference of the interventional element).
Regarding claim 9, Wensel discloses the resilient wire forms the manipulation member ([0049] discloses “The distal end of the barrel-shaped coil is permanently connected to the distal end 24 of the insertion mandrel” and [0046-0047] disclose both the resilient wire and the manipulation member can be made from nitinol. This is interpreted as meeting the limitation of the wire forming the manipulation member because they are integrally attached and formed from the same material).
Regarding claim 10, Wensel discloses each of the windings defines an opening (Open space formed by the coils), and wherein the manipulation member extends through the opening of at least one of the windings (FIG 1a and 1c show that 16 passes through the opening of each of the windings).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 2-5 and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wensel et al. (US 2008/0262487) in view of Yair et al. (US 2022/0110736).
Regarding claim 2, Wensel discloses the invention substantially as claimed, as set forth above for claim 1.
Wensel is silent regarding each of the windings is defined by a perimeter comprising a first region and a second region, and wherein each of the first regions is closer to the central longitudinal axis in the radially compressed state than in the radially expanded state and each of the second regions is farther from the central longitudinal axis in the radially compressed state than in the radially expanded state.
However, Yair teaches in the same field of endeavor of embolus capturing (abstract) an interventional element (35, FIG 7A-C, [0122]) comprising a resilient wire formed into a coil (filament 36, FIG 7A-7B showing the coil shape, [0124]) having a plurality of windings (41, 42, 43, FIG 7B-7C, [0125]) along a central longitudinal axis (40, FIG 7C), each of the windings is defined by a perimeter (See perimeter forming each loop in FIG 7C) comprising a first region (The outer perimeter of each winding 41, 42, 43 that lies roughly in the outer dashed ring below is interpreted as the first region) and a second region (Each segment respectively of 41, 42, 43 that falls within the dashed inner ring below is interpreted as the second region), and wherein in the radially expanded state, each of the first regions is further from the central longitudinal axis (The first regions are formed by portions which expand to a position furthest from central axis 40) and each of the second regions is closer to the central longitudinal axis (The second regions are formed by portions which expand to a position closest to central axis 40). Yair also teaches an embodiment where the first and second winding are centered on the central longitudinal axis (FIG 9A-9B) equivalent to the arrangement taught by Wensel.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the shape of the coil of Wensel with that taught by Yair, such that it comprises the plurality of windings having a first and second regions positioned closer or further from the central axis, because both shapes are disclosed as equivalent structures for providing an obstruction grasping interventional element and substitution of one for the other would have resulted in the predictable result of allowing for the interventional element to expand to a shape configured to remove an obstruction from the target blood vessel. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). The device as modified meets the limitations of the claim because in the radially compressed state, the first regions are closer to the central longitudinal axis than when expanded and the second regions are further from the central longitudinal axis than when expanded.
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Regarding claim 3, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 2. The device as modified by Yair further discloses the first regions are configured to move away from the central longitudinal axis and the second regions are configured to move towards the central longitudinal axis as the interventional element transitions from the radially compressed state to the radially expanded state (Due to the flexible construction of the windings, the device is at least configured to move in the claimed manner as the first region reached a more radially outward position and the second region moved to an inner position).
Regarding claim 4, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 2. The device as modified by Yair further discloses each of the first regions and each of the second regions extends circumferentially about the central longitudinal axis (As demonstrated in the annotated FIG 7C above).
Regarding claim 5, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 2. The device as modified by Yair further discloses when the interventional element is in the radially expanded state (Such as in FIG 7C), all or a portion of the first region of one of the windings does not circumferentially overlap the first region of another of the windings (At least a portion of each of the first regions does not overlap the adjacent first region of another winding).
Regarding claim 11, Wensel discloses a method for removing an obstruction from a bodily lumen (FIGs 1a-1f, wherein clot 22 is the obstruction and artery 20 is the bodily lumen), the method comprising: obtaining a treatment system (10, [0043]) comprising an elongated shaft (12) defining a lumen extending therethrough (14, [0043-0044]) and a treatment device (16/18, FIG 1a) comprising a manipulation member (16) and an interventional element (18) at a distal portion of the manipulation member (FIG 1c-1f, [0043-0047]), the interventional element comprising a resilient wire formed into a coil ([0047]) having a first winding and a second winding (FIG 1a and 1c show at least 8 full coil loops, wherein any two segments of loops can be taken as a first and second winding) adjacent the first winding along a central longitudinal axis of the interventional element (FIGs 1a and 1c show the plurality of windings of the coil along the longitudinal direction), wherein the interventional element is positioned within the lumen of the elongated shaft at a distal portion of the elongated shaft in a radially compressed configuration (FIG 1b, [0062]) in which the first and second windings are centered about the central longitudinal axis (The dimension of the winding when the coil is inserted within catheter 12 are defined by the inner diameter of the lumen. In the radially compressed delivery profile, the winding all conform to the same diameter and therefore are circumferentially aligned. FIG 1b shows the aligned windings in the delivery state despite having various diameters in the expanded state of FIG 1a); distally advancing the distal portion of the elongated shaft through the bodily lumen to a treatment location at or adjacent to the obstruction (FIG 1a-1b shows 12 advanced towards and then through obstruction 22); releasing the interventional element from the lumen of the elongated shaft such that the interventional element transitions from the radially compressed configuration to a radially expanded configuration (FIG 1c, [0018 and 0063]); engaging the obstruction with the interventional element in the radially expanded configuration (FIG 1d-1e); and proximally withdrawing the manipulation member to proximally withdraw the interventional element and engaged obstruction from the bodily lumen (FIG 1f, [0021 and 0065]).
Wensel is silent regarding the first and second windings being eccentrically disposed about the central longitudinal axis.
However, Yair teaches in the same field of endeavor of embolus capturing (abstract) an interventional element (35, FIG 7A-C, [0122]) comprising a resilient wire formed into a coil (filament 36, FIG 7A-7B showing the coil shape, [0124]) having a first winding (41) and a second winding (42, FIG 7B-7C, [0125]) along a central longitudinal axis (40, FIG 7C), wherein in the radially expanded configuration (Configuration shown in FIG 7A-7C), the first and second windings are eccentrically disposed about the central longitudinal axis (See offset in FIG 7C, [0125]). Yair also teaches an embodiment where the first and second winding are centered on the central longitudinal axis (FIG 9A-9B) equivalent to the arrangement taught by Wensel.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the shape of the coil of Wensel with that taught by Yair, such that it comprising the first and second windings being eccentrically disposed about the central longitudinal axis, because both shapes are disclosed as equivalent structures for providing an obstruction grasping interventional element and substitution of one for the other would have resulted in the predictable result of allowing for the interventional element to expand to a shape configured to remove an obstruction from the target blood vessel. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 12, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 11. The device as modified by Yair further discloses each of the first and second windings has a first length and second length diametrically opposed to the first length, and wherein, the first lengths are positioned further from the central longitudinal axis in the radially expanded configuration than in the radially compressed configuration and the second lengths are positioned closer to the central longitudinal axis in the radially expanded configuration than in the radially compressed configuration (See annotated FIG 7C below).
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Regarding claim 13, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 12. The device as modified by Yair further discloses when the interventional element is in the radially expanded configuration (As shown above in FIG 7C), the first lengths are positioned further from the central longitudinal axis than the second lengths (Wherein 40 is the central longitudinal axis and the annotated FIG shows the first lengths being positioned further from 40 than the second lengths).
Regarding claim 14, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 12. The device as modified by Yair further discloses when the interventional element is in the radially expanded configuration (As shown in FIG 7C), a maximum outer diameter of the interventional element defined between the first length of the first winding and the first length of the second winding is greater than a local outer diameter of the interventional element defined at any given location along the central longitudinal axis (The combined diameter formed between the first length of the first and second windings is greater than the diameter of a single winding alone, FIG 7C).
Regarding claim 15, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 12. The device as modified by Yair further discloses when the interventional element is in the radially expanded configuration (As shown in FIG 7C), a maximum outer diameter of the interventional element defined between the first length of the first winding and the first length of the second winding is greater than at least one of a first radial distance defined between the first and second lengths of the first winding (FIG 7C shows that a distance between the first length segments of the first and second winding is greater than a radius defined by the first winding along i.e. a distance between the first and second length segments of the first winding) or a second radial distance defined between the first and second lengths of the second winding.
Regarding claim 16-17, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 12. The device as modified by Yair further discloses at least one of the first length of the first winding or the first length of the second winding has a greater radius of curvature and arc length than the second length of the respective winding (See first length of the second winding above in FIG 7C, which has a greater radius of curvature and a greater arc length than the second length of the second winding).
Regarding claim 18, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 11. Wensel further discloses the resilient wire forms the manipulation member ([0049] discloses “The distal end of the barrel-shaped coil is permanently connected to the distal end 24 of the insertion mandrel” and [0046-0047] disclose both the resilient wire and the manipulation member can be made from nitinol. This is interpreted as meeting the limitation of the wire forming the manipulation member because they are integrally attached and formed from the same material).
Regarding claim 19, Wensel/Yair disclose the invention substantially as claimed, as set forth above for claim 11. Wensel further discloses each of the first and second windings defines an opening (Open space formed by the coils), and wherein the manipulation member extends through the openings of the first and second windings (FIG 1a and 1c show that 16 passes through the opening of each of the windings).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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