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 Objections
Claim 8 is objected to because of the following informalities: typo. Ll. 3 recites “thereby determining a degree or extraction or retraction of the tip…” and should be amended to recite “thereby determining a degree of extraction or retraction of the tip…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites, “A blood clot trimmer device configured to pass through a work channel that is releasably attachable to an existing endoscope or through a working channel of an existing endoscope…”, see ll. 1-3. In ll. 14-18, the claim further defines features of the releasably attachable work channel, but this limitation is recited in the alternative in ll. 1-3 as shown above. As such, it is unclear if the “releasably attachable work channel” is required or optional as set forth by Applicant. For examination purposes, this limitation has been interpreted as optional and the limitations of ll. 14-18 are thus interpreted as optional as well.
Claims 10-13 are drawn to limitations of the “releasably attachable work channel” and are thus interpreted as being optional as well.
As a result of dependence on claim 1, subsequent dependent claims 2-15 are rejected as indefinite as well.
Claim 16 is rejected as indefinite for the same reasons as claim 1, see above.
As a result of dependence on claim 16, subsequent dependent claims 17-19 are rejected as indefinite as well.
Regarding claim 8, the claim recites “movement of the motor causes movement of the guide wire and the tip connected to the guide wire with respect to the sheath, thereby determining degree or extraction or retraction of the tip with respect to the distal end of the sheath”, see ll. 1-4. It was set forth in claim 1, however, that the tip controller controls a degree of extraction or retraction of the tip with respect to the distal end of the sheath, see ll. 11-13. It is unclear if both the tip controller and motor are meant to provide this function. For examination purposes, claim 8 has been interpreted without the limitation “thereby determining degree or extraction or retraction of the tip with respect to the distal end of the sheath”, leaving this function tied to the tip controller as recited in claim 1.
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.
Claims 1 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (CN 210903226) (hereinafter Huang).
Regarding claims 1 and 16, Huang discloses a blood clot trimmer device configured to pass through a working channel of an existing endoscope (Abstract: “An endoscope blood clot crushing cleaner”; Figs. 1-3), the blood clot trimmer device being configured to trim blood clots and remove trimmed blood from a site internal to a patient body (Abstract), said blood clot trimmer device comprising: a flexible guide wire with a distal end and a proximal end (rotating drive connecting rod 12); a sheath configured to enable free passage of the guide wire therethrough, said sheath including a distal end and a proximal end (connecting rod sleeve 10); a flexible tip connected to the distal end of the guide wire, said tip configured to rotate and thereby trim blood clots (crushing net basket 13; pg. 4: “…then rotating the rotating the driving handle 9 by rotationally driving the connecting rod 12 the crushing net basket 13 rotating clot crushing body…”, as best understood, rotation of driving handle 9 drives rotation of crushing net basket 13 to trim blood clots); a tip controller connected to the proximal end of the guide wire and to the proximal end of the sheath, the tip controller configured to control a degree of extraction or retraction of the tip with respect to the distal end of the sheath (holding handle 8 and driving handle 9; pg. 4: “one hand holds the holding handle 8 and the other hand pushing forward rotating the driving handle 9 along the telescopic connecting rod 11 moves forward. at the same time the pushing rotating drive connecting rod 12 through the connecting sleeve 10 to move forward along the length direction of the outer sleeve 1, the crushing net basket 13 out of the outer sleeve 1, the crushing net basket 13 diastolic expansion… hold the pulled backwards rotating the driving handle 9, by rotationally driving the connecting rod 12 the crushing net basket 13 close into a connecting sleeve 10”, as best understood, pushing/pulling the driving handle 9 controls degree of extraction/retraction of tip 13 with respect to sheath 10).
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 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Takahashi et al. (US 2019/0321059) (hereinafter Takahashi).
Regarding claim 2, Huang does not disclose the tip has a diamond shape.
Takahashi, however, teaches a reentry catheter for treatment of occluded vessels (para. 2) wherein a tip of the device has a diamond shape (Fig. 22C; para. 165). Takahashi also teaches that the diamond shaped sections provide lower friction than square cross-sections when advanced through the vasculature (para. 167).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Huang such that the tip has a diamond shape. Making this modification would be useful for providing lower friction when advanced through the vasculature, as suggested by Takahashi.
Regarding claim 4, Huang does not disclose the tip is made of nitinol.
Takahashi, however, teaches that, with reference to FIGS. 32-34, the distal tip 552 of the catheter 550 can have a core member 556 therein configured to increase a bending stiffness of the distal tip 552. The core member 556 can be comprise any desired material or mix of materials, including without limitation nickel titanium (Nitinol), stainless steel, polymer material, or any other shape memory materials or suitable materials. In any embodiments, the core member 556 can increase the durability of the distal tip (para. 186).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Huang such that the tip is made of nitinol. Making this modification would be useful for increasing bending stiffness and durability of the tip, as taught by Takahashi.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Ressemann et al. (US 5501694) (hereinafter Ressemann).
Regarding claims 7-8, Huang does not disclose the blood clot trimmer device comprises a motor connected to the guide wire and a battery to provide power to the motor, wherein movement of the motor causes movement of the guide wire and the tip connected to the guide wire with respect to the sheath, further wherein operation of the motor is configured to rotate the tip.
Resseemann, however, teaches an atherectomy device (Abstract; Fig. 1) wherein the device comprises a motor connected to the guide wire and a battery to provide power to the motor, wherein movement of the motor causes movement of the guide wire and the tip connected to the guide wire with respect to the sheath, further wherein operation of the motor is configured to rotate the tip (Fig. 1, motor 24, rotatable drive shaft 26, batteries 28; Col. 5, ll. 52-60: “The drive assembly 12 generally comprises an electric motor 24 having a hollow, rotatable drive shaft 26, a power source 28, illustrated as a plurality of batteries electrically connected in series, for energizing the motor 24, and a control switch 30 connected electrically between the motor 24 and the power source 28 such that actuation of the control switch 30 allows current to flow between the power source 28 and the motor 24, thereby causing the drive shaft 26 to rotate”). Resseemann also teaches that for example, the motor 24 may be similar to the brushless direct current motor available from Transicoil Inc. of Valley Forge, Pa., model number U-222285, which can reach speeds of 100,000 revolutions per minute. By rotating the drive shaft 26 at this speed, more efficient removal of occlusion material may be achieved because the intravascular treatment may take less time (Col. 6, ll. 1-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Huang such that the blood clot trimmer device comprises a motor connected to the guide wire and a battery to provide power to the motor, wherein movement of the motor causes movement of the guide wire and the tip connected to the guide wire with respect to the sheath, further wherein operation of the motor is configured to rotate the tip. Making this modification would be useful for achieving rotation speeds wherein more efficient removal of occlusion material may be achieved because the intravascular treatment may take less time, as taught by Resseemann.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Opie (WO 2005/112780).
Regarding claim 9, Huang does not disclose the blood clot trimmer device is manually operated via user rotation of a threaded handle rotating along a threaded rod.
Opie, however, teaches a percutaneous harvesting device (Abstract) wherein moving PVT (perivascular cutting tool) 104 or 600 through the subcutaneous body tissue requires a certain amount of torque and/or pressure to force a PVT through the body tissue surrounding the blood vessel. To assist in advancing a PVT, an optional torque handle (or simply "handle") 902 can be attached to PCT 104 or 600 opposite the cutting head. Torque handle 902 is designed to fit into an adult human hand and is preferably a rod or tube made from extruded plastic (for example, Lexan 12, high density polyethylene, acetal, Nylon, ABS are all plastics that could be used) or any suitable material, and includes a connector 904 to connect to the PVT 104 and a shaft 906. In one embodiment connector 904 comprises threads on the rod or tube that threadingly connect to the PVT. Optionally a handgrip 908 can be attached to or formed in handle 902 to further assist in operation of the PVT (para. 63, with reference to Fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Huang such that the blood clot trimmer device is manually operated via user rotation of a threaded handle rotating along a threaded rod. Making this modification would be useful for providing hand-driven torque for advancing the device through body tissue, as taught by Opie.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Gamba et al. (WO 2023/168336) (hereinafter Gamba).
Regarding claim 14, Examiner first notes that this claim has an effective filing date of 01/25/2024 since the priority documents (US provisional app. no. 63/225,596 and PCT/IL2022/050811) do not appear to provide support for a two-part handle comprising a reusable unit and a disposable unit, wherein the reusable unit comprises the motor and a power source, and wherein the disposable unit comprises the flexible guide wire, the sheath, the flexible tip and the tip controller.
Huang does not disclose a two-part handle comprising a reusable unit and a disposable unit, wherein the reusable unit comprises the motor and a power source, and wherein the disposable unit comprises the flexible guide wire, the sheath, the flexible tip and the tip controller.
Gamba, however, teaches device for removing material from a patient (Abstract) wherein in some implementations, the handle assembly 106 can be split between a disposable and a reusable assembly. For example, the catheter body 104 and catheter hub 124 along with all the distal elements and collection assembly 112 can be disposable while the majority of the handle assembly 106 can be a durable assembly. In this manner, the user can connect the disposable and reusable portions, perform the operation, and then dispose of the catheter assembly while cleaning and reusing the handle assembly 106 (para. 191). Examiner notes that the reusable handle assembly 106 comprises a motor 416 and power source 134, see Fig. 5.
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Huang to include a two-part handle comprising a reusable unit and a disposable unit, wherein the reusable unit comprises the motor and a power source, and wherein the disposable unit comprises the flexible guide wire, the sheath, the flexible tip and the tip controller. Making this modification would be useful such that the user can connect the disposable and reusable portions, perform the operation, and then dispose of the catheter assembly while cleaning and reusing the handle assembly, as taught by Gamba.
Allowable Subject Matter
Claims 3, 5-6, 15, and 17-20 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 following is a statement of reasons for the indication of allowable subject matter: In the closest prior art, Huang does not disclose the tip has a duck-foot shape (claim 3); the tip controller comprises scale marks to indicate options for changing location of the tip with respect to the sheath (claim 5); the reusable unit comprises a protruding shaft, and the disposable unit comprises a corresponding groove configured to house the protruding shaft, wherein when the motor rotates, the shaft rotates, which in turn rotates the walls of the groove, which are connected to the guide wire, which is forced to rotate thereby forcing the flexible tip to rotate and trim blood clots (claim 15); moving a tip location lock along scale marks on the tip controller, thereby determining the degree of extraction or retraction of the tip with respect to the distal end of the sheath (claim 17), in combination with other limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Palestrant (US 5030201) discloses an expandable atherectomy catheter wherein A motor is coupled to the proximal end of the rotatable catheter for rotating the cutting head to remove the atheromatous plaque or blood clot (Abstract).
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792