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) 1-15 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sos (U.S. Patent No. 10,231,751).
Regarding claim 1, Sos discloses a system (FIG. 11) comprising:
a medical device (100) comprising:
an elongated support member (150);
an expandable element (110) disposed around the elongated support member (FIG. 11: 110 is disposed around 150), the expandable element including a basket (FIG. 11: 110 is a capture basket) configured to receive one or more pieces of a thrombus through a proximal mouth defined by the basket (FIG. 11: 110 is capable of receiving thrombi through 130);
a stationary element (134a and 134b; FIGs. 18-18C), wherein a proximal end of the stationary element and a distal end of the stationary element are coupled to the elongated support member (FIG. 18A: the distal ends of 134a and 134b are coupled to 110, and then to 150, while the proximal ends of 134a and 134b are coupled to 150 through the proximal handle end of 100); and
a movable element (201) disposed radially inward from the stationary element (FIG. 19A: 201 are radially inward of the guide wires 134a and 134b), the movable element configured to move relative to the stationary element to macerate the thrombus (FIGs. 19A-19B: 201 move relative 134a and 134b to macerate the thrombus); and
a delivery catheter (170) defining a delivery catheter inner lumen (FIG. 18A),
wherein the medical device is configured to be received in the delivery catheter inner lumen when the expandable element, the stationary element, and the movable element are in a delivery configuration (C12:L28-39: most elements of 100 are housed within 170 while being delivered, except for the dilator tip 120; this includes 110, 210, and 134a and 134b while in the delivery configuration; FIG. 2B), and
wherein at least the stationary element is configured to self-expand to a deployed configuration when extended distally from the delivery catheter (C19:L37-46: the guide wires 134a and 134b facilitate the expansion of 200, which can be done upon deployment from 170).
Regarding claim 2, Sos further discloses the stationary element is configured to expand to define a volume within the stationary element (FIG. 19A: the guide wires 134a and 134b expand to form a volume between), and wherein the movable element is configured to move within the volume defined by the stationary element (FIGs. 19A-19B: 201 are capable of moving within the volume defined by 134a and 134b).
Regarding claim 3, Sos further discloses in the deployed configuration, a central portion of the stationary element between the proximal end of the stationary element and the distal end of the stationary element is expanded radially outward from the elongated support member (FIG. 19A: the central portion of 134a and 134b is radially outward of 150).
Regarding claim 4, Sos further discloses in the deployed configuration, the central portion of the stationary element defines a greatest diameter that is greater than or equal to a greatest diameter defined by the proximal mouth of the expandable element (FIG. 19A: the central portion of 134a and 134b has a greater diameter than the diameter of 201).
Regarding claim 5, Sos further discloses the medical device further comprises a rotatable tube (208) disposed around the elongated support member (FIG. 21A: 208 is around 150), wherein the rotatable tube is coupled to a distal end of the movable element (FIG. 201A: 208 is directly coupled to the proximal end of 201, and is thereby coupled to the distal end of 201), the rotatable tube being configured to rotate about a longitudinal axis of the elongated support member to rotate the movable element relative to the stationary element (C20:L25-29: 208 can be rotated to cause 200 to rotate relative to 134a and 134b; FIGs. 21A-21C).
Regarding claim 6, Sos further discloses a length of the stationary element is 50-150 mm (FIG. 6A: 134a and 134b are held against a ruler in mm, where the measurement of their length from where they attach to 130 to where they get to 140 is around 75 mm), the length being measured from the proximal end of the stationary element to the distal end of the stationary element (FIG. 6A: the distal end of 134a and 134b is the point of attachment to 130, while the proximal end of 134a and 134b can be defined as the portion from where 134a and 134b enter 140 onwards).
Regarding claim 7, Sos further discloses the medical device further comprises an actuator (100b) at a proximal portion of the medical device (FIG. 6B), the actuator configured to receive user input for controlling rotation of the movable element (C14:L59-C15:L15: the handle has buttons and controls for making user inputs to rotate 201).
Regarding claim 8, Sos further discloses the stationary element is configured to segment the thrombus into smaller pieces as the thrombus moves through the stationary element (FIGs. 18A-18C: 134a and 134b are wires which are capable of cutting through a thrombus as the thrombus moves through them).
Regarding claim 9, Sos further discloses the medical device further comprises a proximal end cap (214) and a movable element support structure (208) on the elongated support member, the proximal end of the stationary element coupled to the elongated support member via the proximal end cap (FIG. 11: 214 is coupled to 150, and 134a and 134b are coupled to 214 through the proximal handle) and the proximal end of the movable element rotatably coupled to the elongated support member via the movable element support structure (FIG. 11: the proximal end of 200 is rotatably coupled to 208, which is coupled to 150 through the proximal handle), and wherein the proximal end cap and the movable element support structure are at least partially coextensive along the elongated support member (FIG. 11: 214 and 208 are coextensive).
Regarding claim 10, Sos further discloses a retrieval catheter (140; FIGs. 2A-2J) defining a retrieval catheter lumen (FIG. 2D) and including a funnel at a distal portion of the retrieval catheter (C13:L10-19: the distal end of 140 can be flared to accommodate the retraction of 110 and CL), the retrieval catheter configured to compress at least the stationary element and the movable element when the medical device is withdrawn proximally into the retrieval catheter lumen (C13:L10-19: 110 can be retracted into and constrained by 140, which also includes retracting and compressing 134a, 134b, and 201).
Regarding claim 11, Sos further discloses the movable element is configured to self-expand to a deployed configuration when extended distally from the delivery catheter (C18:L1-8: 201 can be made of nitinol, which is capable of self-expanding to a shape memory position when deployed).
Regarding claim 12, Sos further discloses the stationary element comprises a plurality of arms extending along the elongated support member (FIG. 18A: 134a and 134b are a plurality of arms extending along 150).
Regarding claim 13, Sos further discloses the plurality of arms of the stationary element comprises a first plurality of arms (FIG. 18A: 134a and 134b are a plurality of arms extending along 150), and wherein the movable element comprises a second plurality of arms extending along the elongated support member (FIG. 18A: 201 are a plurality of arms extending along 150).
Regarding claim 14, Sos further discloses at least one arm of the second plurality of arms defines a parabolic shape (FIG. 19A: 201 define a parabolic wave shape).
Regarding claim 15, Sos further discloses the medical device further comprises a rotatable tube (208) disposed around the elongated support member (FIG. 21A: 208 is around 150), wherein the rotatable tube is coupled to a distal end of each arm of the second plurality of arms (FIG. 201A: 208 is directly coupled to the proximal end of 201, and is thereby coupled to the distal end of 201), the rotatable tube being configured to rotate about a longitudinal axis of the elongated support member to rotate the movable element relative to the stationary element (C20:L25-29: 208 can be rotated to cause 200 to rotate relative to 134a and 134b; FIGs. 21A-21C).
Regarding claim 17, Sos discloses a system (FIG. 11) comprising:
a medical device (100) comprising:
an elongated support member (150);
an expandable element (110) disposed around the elongated support member (FIG. 11: 110 is disposed around 150), the expandable element including a basket (FIG. 11: 110 is a capture basket) configured to receive one or more pieces of a thrombus through a proximal mouth defined by the basket (FIG. 11: 110 is capable of receiving thrombi through 130);
a stationary element (134a and 134b; FIGs. 18-18C), wherein a proximal end of the stationary element and a distal end of the stationary element are coupled to the elongated support member (FIG. 18A: the distal ends of 134a and 134b are coupled to 110, and then to 150, while the proximal ends of 134a and 134b are coupled to 150 through the proximal handle end of 100); and
a movable element (201) disposed radially inward from the stationary element (FIG. 19A: 201 are radially inward of the guide wires 134a and 134b), the movable element configured to move relative to the stationary element to macerate the thrombus (FIGs. 19A-19B: 201 move relative 134a and 134b to macerate the thrombus); and
a delivery catheter (170) defining a delivery catheter inner lumen (FIG. 18A),
wherein the medical device is configured to be received in the delivery catheter inner lumen when the expandable element, the stationary element, and the movable element are in a delivery configuration (C12:L28-39: most elements of 100 are housed within 170 while being delivered, except for the dilator tip 120; this includes 110, 210, and 134a and 134b while in the delivery configuration; FIG. 2B),
wherein at least the stationary element is configured to expand to a deployed configuration to define a volume within the stationary element (C19:L37-46: the guide wires 134a and 134b facilitate the expansion of 200, which can be done upon deployment from 170), and
wherein the movable element is configured to move within the volume defined by the stationary element (FIGs. 19A-19B: 201 are capable of moving within the volume defined by 134a and 134b).
Regarding claim 18, Sos further discloses in the deployed configuration, a central portion of the stationary element between the proximal end of the stationary element and the distal end of the stationary element is expanded radially outward from the elongated support member (FIG. 19A: the central portion of 134a and 134b is radially outward of 150), and wherein the central portion of the stationary element defines a greatest diameter that is greater than or equal to a greatest diameter defined by the proximal mouth of the expandable element (FIG. 19A: the central portion of 134a and 134b has a greater diameter than the diameter of 201).
Regarding claim 19, Sos discloses a system (FIG. 11) comprising:
a medical device (100) comprising:
an elongated support member (150);
an expandable element (110) disposed around the elongated support member (FIG. 11: 110 is disposed around 150), the expandable element including a basket (FIG. 11: 110 is a capture basket) configured to receive one or more pieces of a thrombus through a proximal mouth defined by the basket (FIG. 11: 110 is capable of receiving thrombi through 130);
a stationary element (134a and 134b; FIGs. 18-18C), wherein a proximal end of the stationary element and a distal end of the stationary element are coupled to the elongated support member (FIG. 18A: the distal ends of 134a and 134b are coupled to 110, and then to 150, while the proximal ends of 134a and 134b are coupled to 150 through the proximal handle end of 100); and
a movable element (201) disposed radially inward from the stationary element (FIG. 19A: 201 are radially inward of the guide wires 134a and 134b), the movable element configured to move relative to the stationary element to macerate the thrombus (FIGs. 19A-19B: 201 move relative 134a and 134b to macerate the thrombus); and
a delivery catheter (170) defining a delivery catheter inner lumen (FIG. 18A),
wherein the medical device is configured to be received in the delivery catheter inner lumen when the expandable element, the stationary element, and the movable element are in a delivery configuration (C12:L28-39: most elements of 100 are housed within 170 while being delivered, except for the dilator tip 120; this includes 110, 210, and 134a and 134b while in the delivery configuration; FIG. 2B),
wherein at least the stationary element is configured to expand to a deployed configuration (C19:L37-46: the guide wires 134a and 134b facilitate the expansion of 200, which can be done upon deployment from 170),
wherein in the deployed configuration, a central portion of the stationary element between the proximal end of the stationary element and the distal end of the stationary element is expanded radially outward from the elongated support member (FIG. 19A: the central portion of 134a and 134b is radially outward of 150), and
wherein the central portion of the stationary element defines a greatest diameter that is greater than or equal to a greatest diameter defined by the proximal mouth of the expandable element (FIG. 19A: the central portion of 134a and 134b has a greater diameter than the diameter of 201).
Regarding claim 20, Sos further discloses the medical device further comprises an actuator (100b) at a proximal portion of the medical device (FIG. 6B), the actuator configured to receive user input for controlling rotation of the movable element (C14:L59-C15:L15: the handle has buttons and controls for making user inputs to rotate 201).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sos in view of Sutton et al. (U.S. Patent No. 10,448,969).
Regarding claim 16, Sos discloses the invention as claimed in claim 15, as discussed above. Sos does not disclose the rotatable tube defines a plurality of slots, each of the plurality of slots being configured to receive and retain a respective arm of the second plurality of arms.
Sutton et al. teaches in the same field of endeavor of clot removal devices, and discloses a catheter (FIG. 8; C9:L65-C10:L13) comprising a macerator (822) comprising a plurality of arms (FIG. 8) and a rotatable tube (826) comprising a plurality of slots (FIG. 8), each of the plurality of slots being configured to receive and retain a respective arm of the plurality of arms (FIG. 8: the slots in 826 each receive a respective 834) for the purpose of allowing greater control over the deployment of each respective arm (C9:L65-C10:L13).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the rotatable tube of Sos to have a plurality of slots, as taught by Sutton et al., for the purpose of allowing greater control over the deployment of each respective arm.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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