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 § 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) 1-4, 10-13 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson (US Patent 5,882,329) in view of Ulm (US PGPub 2015/0190156).
Regarding Claim 1, Patterson teaches a method of capturing a clot, the method comprising:
deploying a clot retrieval device (10) comprising (Figures 18A-18C; Column 17, Lines 5-17):
a delivery shaft (12; Figure 18C) having a distal delivery shaft end; and
a capturing basket (20; Figure 18C but the basket is taught as shearing body in Figures 14 and Column 16, lines 19-29) coupled to the distal delivery shaft end (12; Figure 14 and Figure 18C), wherein the capturing basket (Figure 14) comprises a first basket end (136; Figure 14), a second basket end (138; Figure 14), a plurality of cells defined by struts (132, 134; Figure 14), the struts (132 134) having strut ends that are connected to the first basket end (136) and the second basket end (138; Figure 14),
expanding the capturing basket on a side of the clot, between a vessel wall and the clot (Figure 18C); wherein expanding the capturing basket of the clot retrieval device allows for the clot to ingress laterally into the capturing basket of the clot retrieval device, thus capturing the clot (Column 17, Lines 17-25).
Patterson fails to disclose:
at least six body markers disposed on the capturing basket, wherein three of the at least six body markers are distributed around a distal portion of the capturing basket and three of the at least six body markers are distributed around a proximal portion of the capturing basket.
Ulm teaches a clot retrieval device (Abstract) comprising an expandable capturing basket (216; Figure 15A), with at least six body markers (244) disposed on the capturing basket (214), wherein three of the at least six body markers are distributed around a distal portion of the capturing basket (the distal portion is from 258C/D distally) and three of the at least six body markers are distributed around a proximal portion (the proximal portion is from 258A/B proximally) of the capturing basket (Figures 15A-15D; Paragraph 0164).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the capturing basket taught by Patterson, with 3 markers on the distal portion and 3 markers on the proximal portion, as taught by Ulm, for the advantage of allowing the surgeon to use the markers to determine the placement of the capturing basket and using the markers to determine whether the clot is located inside the capturing basket or whether the clot is collapsing the capturing basket (Paragraph 0164; Ulm).
Regarding Claim 2, the combination of references disclosed above teaches the method of claim 1 wherein Patterson teaches further comprising rotating the capturing basket to dislodge the clot from the vessel wall, thus capturing the clot (Column 17, Lines 17-25).
Regarding Claim 3, the combination of references disclosed above teaches the method of claim 2, wherein Patterson teaches rotating the device allows for controlled shearing of the clot and dislodging the clot from the vessel wall (Column 17, Lines 17-25).
Regarding Claim 4, the combination of references disclosed above teaches the method of claim 2, wherein Patterson teaches the delivery shaft (12) is rotated such that when the delivery shaft of the clot retrieval device is rotated torque is transferred through the delivery shaft to the capturing basket, such that the capturing basket is also rotated (Column 17, Lines 17-25).
Regarding Claim 10, the combination of references disclosed above teaches the method of claim 1, wherein Patterson teaches the clot comprises an embolus (Column 10, Lines 49-52).
Regarding Claim 11, Patterson teaches a method of capturing a clot, the method comprising:
deploying a clot retrieval device (10) comprising (Figures 18A-18C; Column 17, Lines 5-17):
a delivery shaft (12; Figure 18C) having a distal delivery shaft end; and
a capturing basket (20; Figure 18C but the basket is taught as shearing body in Figures 14 and Column 16, lines 19-29) coupled to the distal delivery shaft end (12; Figure 14 and Figure 18C), wherein the capturing basket (Figure 14) comprises a first basket end (136; Figure 14), a second basket end (138; Figure 14), a plurality of cells defined by struts (132, 134; Figure 14), the struts (132 134) having strut ends that are connected to the first basket end (136) and the second basket end (138; Figure 14),
expanding the capturing basket on a side of the clot, between a vessel wall and the clot (Figure 18C); wherein expanding the capturing basket of the clot retrieval device allows for the clot to ingress laterally into the capturing basket of the clot retrieval device (Column 17, Lines 17-25; Figures 18B-18C),
rotating the capturing basket to dislodge the clot from the vessel wall, thus capturing the clot (Column 17, Lines 17-25; Figure 18D).
Patterson fails to disclose:
at least six body markers disposed on the capturing basket, wherein three of the at least six body markers are distributed around a distal portion of the capturing basket and three of the at least six body markers are distributed around a proximal portion of the capturing basket.
Ulm teaches a clot retrieval device (Abstract) comprising an expandable capturing basket (216; Figure 15A), with at least six body markers (244) disposed on the capturing basket (214), wherein three of the at least six body markers are distributed around a distal portion of the capturing basket (the distal portion is from 258C/D distally) and three of the at least six body markers are distributed around a proximal portion (the proximal portion is from 258A/B proximally) of the capturing basket (Figures 15A-15D; Paragraph 0164).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the capturing basket taught by Patterson, with 3 markers on the distal portion and 3 markers on the proximal portion, as taught by Ulm, for the advantage of allowing the surgeon to use the markers to determine the placement of the capturing basket and using the markers to determine whether the clot is located inside the capturing basket or whether the clot is collapsing the capturing basket (Paragraph 0164; Ulm).
Regarding Claim 12, the combination of references disclosed above teaches the method of claim 11, wherein Patterson teaches rotating the device allows for controlled shearing of the clot and dislodging the clot from the vessel wall (Column 17, Lines 17-25).
Regarding Claim 13, the combination of references disclosed above teaches the method of claim 11, wherein Patterson teaches the delivery shaft (12) is rotated such that when the delivery shaft (12) of the clot retrieval device is rotated torque is transferred through the delivery shaft to the capturing basket, such that the capturing basket is also rotated (Column 17, Lines 17-25; Figure 18D).
Regarding Claim 19, the combination of references disclosed above teaches the method of claim 11, wherein Patterson teaches the clot comprises an embolus(Column 10, Lines 49-52).
Regarding Claim 20, Patterson teaches a method of capturing a clot, the method comprising:
deploying a clot retrieval device (10) comprising (Figures 18A-18C; Column 17, Lines 5-17):
a delivery shaft (12; Figure 18C) having a distal delivery shaft end; and
a capturing basket (20; Figure 18C but the basket is taught as shearing body in Figures 14 and Column 16, lines 19-29) coupled to the distal delivery shaft end (12; Figure 14 and Figure 18C), wherein the capturing basket (Figure 14) comprises a first basket end (136; Figure 14), a second basket end (138; Figure 14), a plurality of cells defined by struts (132, 134; Figure 14), the struts (132 134) having strut ends that are connected to the first basket end (136) and the second basket end (138; Figure 14),
expanding the capturing basket on a side of the clot, between a vessel wall and the clot (Figure 18C); wherein expanding the capturing basket of the clot retrieval device allows for the clot to ingress laterally into the capturing basket of the clot retrieval device, thus capturing the clot (Column 17, Lines 17-25).
Patterson fails to disclose:
at least four body markers disposed on the capturing basket, wherein three of the at least four body markers are distributed around a distal portion of the capturing basket and two of the at least four body markers are distributed around a proximal portion of the capturing basket.
Ulm teaches a clot retrieval device (Abstract) comprising an expandable capturing basket (216; Figure 15A), with at least four body markers (244) disposed on the capturing basket (214), wherein three of the at least four body markers are distributed around a distal portion of the capturing basket (the distal portion is from 258C/D distally) and two of the at least four body markers are distributed around a proximal portion (the proximal portion is from 258A/B proximally) of the capturing basket (Figures 15A-15D; Paragraph 0164).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the capturing basket taught by Patterson, with 3 markers on the distal portion and 3 markers on the proximal portion, as taught by Ulm, for the advantage of allowing the surgeon to use the markers to determine the placement of the capturing basket and using the markers to determine whether the clot is located inside the capturing basket or whether the clot is collapsing the capturing basket (Paragraph 0164; Ulm).
Claim(s) 5-6 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patterson (US Patent 5,882,329) in view of Ulm (US PGPub 2015/0190156) as applied to claim 1 and 14 above, and further in view of Morrison (US PGPub 2020/0155293))
Regarding Claim 5-6 and 14-15, the combination of references disclosed above teaches the method of claim 1 and 11, but fails to disclose wherein three of the at least six body markers are evenly distributed around a distal portion of the capturing basket and three of the at least six body markers are evenly distributed around a proximal portion of the capturing basket.
Morrison teaches an embolism removal device (abstract) wherein the capture basket (1900; Figure 50) has a plurality of markers which are offset relative to one another equally, by 120 degrees (Paragraph 0177). The Examiner notes that Morrison does teach two capturing baskets (Figure 56) which each have three markers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the each of the proximal set of markers and distal set of markers, taught by Ulm, to be spaced evenly or 120 degree apart on the capturing basket of Patterson, as taught by Morrison, for the advantage that the capturing basket can be imaged in any orientation along the 360 degree axis, especially while the capturing basket is rotating.
Allowable Subject Matter
Claims 7-9 and 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The combination of references disclosed above fails to disclose:
Regarding Claim 7: the method of claim 1 further comprising visualizing and monitoring a distance between the body markers on either the distal portion, the proximal portion, or both of the capturing basket, wherein when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket are stationary, the clot is retained in the capturing basket, and when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket changes, the clot is escaping.
Regarding Claim 8: the method of claim 7, wherein when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket increases, the clot is escaping.
Regarding Claim 9: the method of claim 7, wherein when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket decreases, the clot is escaping.
Regarding Claim 16: the method of claim 11 further comprising visualizing and monitoring a distance between the body markers on either the distal portion, the proximal portion, or both of the capturing basket, wherein when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket are stationary, the clot is retained in the capturing basket, and when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket changes, the clot is escaping.
Regarding Claim 17: the method of claim 15, wherein when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket increases, the clot is escaping.
Regarding Claim 18: the method of claim 15, wherein when the distance of the body markers on either the distal portion, the proximal portion, or both of the capturing basket decreases, the clot is escaping.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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