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) 45-47, 50-51, 53-57, 60-61, and 63-64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Axon (US 2019/0054217).
Regarding Claim 45, Axon discloses a clot filtering device (Figs. 1-7) comprising:
a body (combination of lid member 1, base member 2, and filter member 3, Figs. 1-7) comprising:
a first body portion (lid member 1, Figs. 1-7) having a top surface (upper wall 1a, Fig. 4);
a second body portion (base member 2, Figs. 1-7) having a bottom surface (lower wall 2a, Fig. 4) and being configured to form an internal cavity with the first body portion (1, Figs. 4-6; ¶ [0088]);
a first tube (inlet port 6, Figs. 1-7) in fluid communication with the body (1 and 2 and 3, Figs. 1-7); and
a second tube (outlet port 7, Figs. 1-7) in fluid communication with the body (1 and 2 and 3, Figs. 1-7);
wherein the first tube (6, Figs. 1-7) and the second tube (7, Figs. 1-7) are in fluid communication with each other through the internal cavity (¶ [0088]);
wherein the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7) define a cylindrical side wall (12, Figs. 1-7; the grooves 11 and 20 of the lid and base members accept edge regions of wall 12, and therefore the first and second body portion can be considered to define the side wall) having a diameter and an axial length (¶ [0087]);
wherein the top surface (1a, Fig. 4) and the bottom surface (2a, Fig. 4) are spaced apart from each other by the cylindrical side wall (12, Figs. 1-7);
a filter (basket 25, Fig. 5) located within the internal cavity of the body (1 and 2 and 3, Figs. 1-7) in between the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7), the filter (25, Fig. 5) comprising a plurality of openings (¶ [0089, 0094]);
wherein at least one of the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7) is transparent (¶ [0084]) to permit visualization of the filter (25, Fig. 5);
wherein the transparent one of the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7) comprises a grid to determine a size of a clot (¶ [0084, 0097]);
wherein a diameter of the cylindrical side wall (12, Figs. 1-7) is larger than an axial length of the cylindrical side wall to define a disc shape (see Figs. 1-7 showing the diameter is wider than the height/axial length of the wall; additionally, ¶ [0087] describes the wall as an annular wall, indicating it would be disc shaped).
Regarding Claim 53, Axon discloses a clot filtering device (Figs. 1-7) comprising:
a body (combination of lid member 1, base member 2, and filter member 3, Figs. 1-7) comprising:
a first body portion (lid member 1, Figs. 1-7);
a second body portion (base member 2, Figs. 1-7) being configured to form an internal cavity with the first body portion (1, Figs. 4-6; ¶ [0088]);
a first tube (inlet port 6, Figs. 1-7) in fluid communication with the body (1 and 2 and 3, Figs. 1-7); and
a second tube (outlet port 7, Figs. 1-7) in fluid communication with the body (1 and 2 and 3, Figs. 1-7);
wherein the first tube (6, Figs. 1-7) and the second tube (7, Figs. 1-7) are in fluid communication with each other through the internal cavity (¶ [0088]),
wherein the internal cavity has:
a depth (y-direction as seen in Fig. 5) defined as a first distance being transverse to a longitudinal axis of the body and being between the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7), and
a width (x-direction as seen in Fig. 5) defined as a second distance transverse to the depth and transverse to the longitudinal axis of the body (1 and 2 and 3, Figs. 1-7), the width being larger than the depth (see Figs. 1-7 showing the diameter is wider than the height/axial length of the wall; additionally, ¶ [0087] describes the wall as an annular wall, indicating the width is larger than the depth of the wall); and
a filter (basket 25, Fig. 5) being located within the internal cavity of the body (1 and 2 and 3, Figs. 1-7) in between the first tube (6, Figs. 1-7) and the second tube (7, Figs. 1-7; ¶ [0088-0089]), the filter (25, Fig. 5) comprising a plurality of openings (¶ [0089, 0094]).
Regarding Claims 46 and 56, Axon discloses the first tube (6, Figs. 1-7) is configured to be in fluid communication with an aspiration catheter (¶ [0046]).
Regarding Claims 47 and 57, Axon discloses the second tube (7, Figs. 1-7) is configured to be in fluid communication with a vacuum source (¶ [0046]).
Regarding Claims 50 and 60, Axon discloses each of the plurality of openings of the filter (25, Fig. 5) is less than or equal to about 1 mm (¶ [0094] indicates each opening has a width between 0.5 – 1 mm).
Regarding Claims 51 and 61, Axon discloses the clot filtering device (Figs. 1-7) is configured to reside within a sterile field (the device is fully capable of being used within a sterile field).
Regarding Claim 54, Axon discloses the first body portion (1, Figs. 1-7) comprises a top portion (upper surface 1a, Figs. 1-7) having a flat surface (¶ [0086] indicates the surface is generally planar, therefore generally flat), the second body portion (2, Figs. 1-7) comprises a bottom portion (lower wall 2a, Figs. 1-7) comprising a flat surface (¶ [0088]; indicates the surface is generally planar, therefore generally flat), and the filter (25, Fig. 5) is located between the top portion (1a, Figs. 1-7) and the bottom portion (2a, Figs. 1-7) and comprises a flat surface (top surface of 25, as seen in Fig. 7) parallel to the flat surfaces of the top (1a, Figs. 1-7) and bottom (2a, Figs. 1-7) portions.
Regarding Claim 55, Axon discloses the first tube (6, Figs. 1-7) connects to the top portion (1a, Figs. 1-7; the first tube connects to the top portion through the base, filter, and lid portions) and the second tube (7, Figs. 1-7) connects to the bottom portion (2a, Figs. 1-7) such that the flow of fluid from the first tube (6, Figs. 1-7) into the internal cavity flows across the flat surface of the filter (25, Fig. 5) toward the second tube (7, Figs. 1-7; ¶ [0088]).
Regarding Claims 63 and 64, Axon discloses wherein at least one of the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7) is transparent (¶ [0084]) to permit visualization of the filter (25, Fig. 5), wherein the transparent one of the first body portion (1, Figs. 1-7) and the second body portion (2, Figs. 1-7) comprises a grid to determine a size of a clot (¶ [0084, 0097]).
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.
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) 48 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axon (US 2019/0054217) in view of Tannoury et al (US 2019/0343724).
Regarding Claims 48 and 58, the rejection of Claims 45 and 53 set forth above can be reinterpreted such that the first tube is considered the combination of the inlet port 6 and the tubing connected to the inlet port that connects the inlet port to an instrument conduit (¶ [0046]), and the second tube is considered the combination of the outlet port 7 and the tubing connected to the outlet port that connects the outlet port to a suction source (¶ [0046]).
Therefore, Axon further discloses the first tube (6 and tubing, Figs. 1-7; ¶ [0046]) is configured to be positioned between the body (1 and 2 and 3, Figs. 1-7) and an aspiration catheter (¶ [0046]), and the second tube (7 and tubing, Figs. 1-7; ¶ [0046]) is configured to be positioned between the body (1 and 2 and 3, Figs. 1-7) and a vacuum source (¶ [0046]).
Axon is silent whether a length of the first tube is no more than about 50% of a length of the second tube.
Tannoury teaches a medical tubing system, thus being in the same field of endeavor, where the length of the first tube (inlet tubing 12, Fig. 1) is no more than about 50% of a length of the second tube (outlet tubing 13, Fig. 1; ¶ [0032]) to reduce the amount of tubing used.
Therefore, 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 length of the first tube of Axon to be no more than about 50% of a length of the second tube, as taught by Tannoury, to reduce the amount of tubing used, which would be beneficial when used with the device of Axon to minimize tubing within the sterile field.
Claim(s) 49 and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axon (US 2019/0054217) in view of Delmage et al (US 2011/0017667).
Regarding Claims 49 and 59, the rejection of Claims 45 and 53 set forth above can be reinterpreted such that the first tube is considered the combination of the inlet port 6 and the tubing connected to the inlet port that connects the inlet port to an instrument conduit (¶ [0046]), and the second tube is considered the combination of the outlet port 7 and the tubing connected to the outlet port that connects the outlet port to a suction source (¶ [0046]).
Axon is silent regarding a clamp positioned along the first tube, the clamp configured to restrict fluid flow along the first tube.
Delmage teaches a medical tubing system, thus being in the same field of endeavor, with a clamp positioned along a blood inlet tube (¶ [0017]) configured to restrict fluid flow along the blood inlet tube to control when the patient’s blood is flowing through the tubing (¶ [0017]).
Therefore, it would have been obvious to modify the device of Axon to include a clamp positioned along the first tube, as taught by Delmage, to allow a user to control when the patient’s blood is flowing through the tubing (as motivated by Delmage ¶ [0017]).
Claim(s) 52 and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axon (US 2019/0054217) in view of Deville et al (US 10531883).
Regarding Claims 52 and 62, Axon is silent regarding a valve being configured to selectively permit fluid communication with at least one of atmosphere or a vacuum source, wherein the body further comprises a button configurated to permit a user to manually actuate the valve.
Deville teaches an aspiration thrombectomy system, thus being in the same field of endeavor, with a valve (214, Fig. 18) being configured to selectively (Col. 5 lines 5-25) permit fluid communication with at least one of atmosphere or a vacuum source (Col. 25 lines 1-50), wherein the body further comprises a button (bleed switch, Col. 25 lines 25-30) configurated to permit a user to manually actuate the valve (214, Fig. 18; Col. 25 lines 1-50). This allows the surgeon to inspect the clot caught within the chamber without blood obscuring the clot (Col. 25 lines 1-50).
Therefore, it would have been obvious to modify the device of Axon to include a valve being configured to selectively permit fluid communication with at least one of atmosphere or a vacuum source, wherein the body further comprises a button configurated to permit a user to manually actuate the valve, as taught by Deville, to allow a surgeon to inspect a clot captured within the body without blood obscuring the clot (as motivated by Deville Col. 25 lines 1-50).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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