DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s Amendment filed May 26, 2026 (hereinafter “05/26/26 Amendment") has been entered, and fully considered. In the 05/26/26 Amendment, claims 25, 29, 36, 37, 41, & 47 were amended, and claims 30, & 32-34 were cancelled (claims 1-24 were previously cancelled). No claims were newly added. Accordingly, claims 25-29, 31, & 35-49 are now pending in the application (and claims 48 & 49 remain withdrawn from consideration).
3. The 05/26/26 Amendment has overcome the objections to the Specification, Drawings, & Claims, as well as the claim rejections under §§ 112(b), 102, & 103 previously set forth in the Non-Final Office Action mailed 02/25/26 (“02/25/26 Action”).
4. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 103
5. 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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. Claims 25, 29, 38-42, 44, & 47 are rejected under 35 U.S.C. 103 as being unpatentable over EP 3 628 259 A1 to Pouletty (published 2020-04-01) (“Pouletty”) in view of U.S. 2017/0119407 to Scarpine et al. ("Scarpine").
8. Regarding claim 25, Pouletty teaches a medical device [medical device (10) - ¶[0045]; FIGS. 1, 7A-7D] for retrieving a thrombus from a vessel [e.g., ¶[0030] (“The proposed device is particularly suitable to remove thrombosis in arteries, fill aneurysms or deliver drugs to a tumor”)], comprising an attachment element [attachable functional unit (51) - ¶’s [0028]-[0030], [0051]; FIGS. 7A-7D], arranged at a distal end of the medical device [e.g., FIGS. 7A, 7C, 7D],
wherein the attachment element [(51)] is adapted to attach to a proximal face of the thrombus such that the thrombus is retrievable by exerting a pulling force on the attachment element [e.g., FIG. 7D illustrates unit (51) as, e.g., a “hook” that is capable of attaching to (via insertion in) a proximal face of a thrombus (as broadly as currently claimed, the proximal face of a thrombus is a part of the thrombus - and is therefore attached (with the rest of the thrombus) to the attachment element); see also ¶[0051] wherein the medical device [(10)] comprises a microrobot [e.g., ¶’s [0001], [0010] (“The medical device may be a micro robot for use in a body vessel. In particular, the medical device or micro robot may be suitable for application inside a human body”), & ¶[0043]] equipped with the attachment element [(51)]… wherein the microrobot further comprises a magnetic part [medical device (10) comprises a body part (11), which may comprise a magnetic part – see ¶’s [0010], [0027] (“The body part may comprise a magnetic part. This magnetic part is usable to guide the medical device by interaction with an external magnetic field. The magnetic part may be an inner core made of a magnetic material or comprising a magnetic material, magnetic micro- or nanoparticles in a matrix or a coating”); [0045], & [0049] (“The body part 11 of the medical device 10 has a magnetic part 14, which is attracted by the magnetic field 21”)] and a controlling line [recapture line (13) - ¶’s [0010], [0012], [0013], [0021] (“The recapture line of the medical device preferably comprises a transmission cable, to transmit energy and/or data, in particular light or electric signals from or to the medical device. The transmission cable could include two separate cables, one for delivery energy and data and one for receiving data. The transmission cable could also be a single cable to transmit energy and data and figure as a recapture line”), and [0034]] wherein the magnetic part is adapted to interact with an external magnetic field [¶[0027] (“The body part may comprise a magnetic part. This magnetic part is usable to guide the medical device by interaction with an external magnetic field”); and ¶[0049] (“A magnetic field generator 23 is generating a magnetic field 21 at the application site 25. The body part 11 of the medical device 10 has a magnetic part 14, which is attracted by the magnetic field 21. At the application site 25 the medical device 10 stays in place, held by the magnetic field 21 against force of the blood stream B. After performing any kind of action the magnetic field generator 23 is switched off and the magnetic field 21 collapses. The medical device is removed against the force of the blood stream B by pulling at the recapture line 13”)], and wherein the controlling line [recapture line (13)] is attachable or attached to a proximal part of the microrobot [e.g., ¶[0045] (“A recapture line 13 is attached to the body part 12. The recapture line 13 is used to pull the medical device 10”)].
SUCTION MECHANISM
Pouletty teaches that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions [e.g., ¶’s [0028] (“The medical device comprises preferably at least one functional unit such as a clamp, scalpel, drill, hook, stent, legs, caterpillar, propeller, detonator, camera or a sensor or a drug release component”); [0031], [0051]].
Pouletty does not explicitly teach:
the attachment element comprising a suction mechanism.
However, the use of suction together with a device distal segment configured for capturing/removing a thrombus was well known in the art, before the effective filing date of the claimed invention.
As one non-limiting example, Scarpine, in a similar field of endeavor, teaches a device distal segment (104) capable of interfacing with a thrombus [e.g., Abstract, ¶’s [0043]-[0045]].
In one embodiment, and with reference to FIG. 4A (provided below), Scarpine teaches an exemplary distal segment (104) that is capable of attaching to (via insertion in) a proximal face of a thrombus, comprising projections (402) disposed along and around the distal segment (104) [see ¶[0079] (“the projections include a plurality of projections 402 equally longitudinally spaced and circumferentially arranged around a longitudinal axis of the distal segment 104. Some or all of the projections 402 can be configured to slide distally through a thrombus within a blood vessel and to pull the thrombus when the elongate member 102 is retracted proximally”)].
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Scarpine further teaches that the distal segment (104) includes an array of ports (106) that allow for the application of aspiration while the distal segment (104) is in contact with the thrombus [¶[0082]; note also ¶[0044] (“The distal segment can be advanced into a thrombus, and positioned so that at least some of the ports are in the thrombus. When aspiration is applied through the ports, the thrombus can be pulled against the distal segment.”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pouletty such that the attachment element [attachable functional unit (51)] include a suction mechanism to facilitate/enhance securement of the thrombus to the functional unit (51) when the medical device (10) is withdrawn by pulling at the recapture line (13). The application of suction would be advantageous in that it would help the thrombus stay attached in the presence of the force of the blood stream working against the removal of the device.
NOTE: For clarity, the formulated rejection (above) is based on adding suction/suction ports to the attachable functional units (51) of Pouletty to facilitate/enhance securement of the functional units (51) to the thrombus.
In the alternative, however, Examiner notes that it would have also been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Pouletty to utilize the distal segment (104) of Scarpine (including the projections and ports) as an attachable functional unit, since such a modification amounts merely to the simple substitution of one known, art-recognized functional unit for another, yielding only predictable results [enabling attachment to (and removal of) a thrombus] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
9. Regarding claim 29, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Pouletty further teaches wherein the attachment element comprises a mechanical attachment mechanism [e.g., ¶’s [0028], [0051]].
10. Regarding claim 38, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Under the alternative modification of Pouletty described above (in the rejection of claim 25) in which Pouletty is modified to utilize the distal segment (104) of Scarpine (including the projections and ports) as an attachable functional unit, Scarpine further teaches an extension member extendable in an axial direction and adapted for generation of an axial force on the thrombus [[the projections (402) of distal segment (104), which engage the thrombus, each extend in a radial axial direction - ¶’s [0079]-[0083]].
11. Regarding claim 39, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Pouletty further teaches a sensor [e.g., ¶’s [0020], [0034], [0035]].
12. Regarding claim 40, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Under the alternative modification of Pouletty described above (in the rejection of claim 25) in which Pouletty is modified to utilize the distal segment (104) of Scarpine (including the projections and ports) as an attachable functional unit, Scarpine further teaches wherein the attachment element comprises a substantially flat surface adapted for attachment to the thrombus [the projections (402) of distal segment (104), which engage the thrombus, each include a substantially flat surface – as clearly seen in FIG. 4A].
13. Regarding claim 41, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Pouletty further teaches wherein a maximum extension in a direction (r) perpendicular to a longitudinal axis of the medical device is smaller than 3 mm when attached to the thrombus [see ¶[0036] (“The medical device has preferably a size of 8 - 2000 µm, preferably 50 - 1000 µm and more preferably 200 - 500 µm. The size may be a length, a diameter, or a longest dimension of the medical device”); Pouletty teaches that the medical device can have a maximum diameter of, e.g., 2000 µm (or 2 mm via conversion); Examiner notes that the diameter of the device body is in a direction perpendicular to its longitudinal axis].
14. Regarding claim 42, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Under the alternative modification of Pouletty described above (in the rejection of claim 25) in which Pouletty is modified to utilize the distal segment (104) of Scarpine (including the projections and ports) as an attachable functional unit, it is noted that the combination of Pouletty and Scarpine further teaches wherein the attachment element is smaller, in a direction (r) perpendicular to a longitudinal axis of the medical device, than a maximum size of the medical device, when attached to the thrombus [NOTE: Pouletty teaches that the medical device can have a maximum diameter of, e.g., 2000 µm (or 2 mm via conversion), and Scarpine teaches that a diameter of the attachment element [distal segment (104)] is less than 2 mm [see Scarpine, ¶[0056] (“For example, the distal segment 104 can have a maximum outer dimension (e.g., diameter) of 2 French (0.67 mm), 2.4 French (0.8 mm), 2.6 French (0.87 mm), 2.8 French (0.93 mm), or 3 French (1.0 mm)”)].
15. Regarding claim 44, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
Pouletty further teaches a propulsion member [at least one drive] for generating an axial propulsion force [e.g., ¶’s [0018], [0019]].
16. Regarding claim 47, the combination of Pouletty and Scarpine teaches a system comprising the medical device according to claim 25 [see the rejection of claim 25 under § 103 above based on the combination of Pouletty/Scarpine which is incorporated herein], a controlling unit [Pouletty - e.g., ¶’s [0018], [0019], [0047]], and an imaging device [Pouletty - e.g., ¶[0024]], wherein the controlling unit is adapted to navigate the medical device to a target location in a vasculature [Pouletty - e.g., ¶’s [0018], [0019], [0047]].
17. Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pouletty and Scarpine, as applied to claim 25 above, and further in view of U.S. 6,514,273 to Voss et al. ("Voss").
18. Regarding claim 26, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty and Scarpine does not, however, teach:
wherein the attachment element comprises a biological attachment mechanism.
Voss, in a similar field of endeavor, teaches medical devices that are useful in treating thromboembolic disorders and for removal of foreign bodies in the vascular system [col. 1, ll. 6-10].
Voss teaches that it was known to coat the distal working end (or capture assembly) of a device with a biological thrombogenic material such as Thrombin [see col. 4, ll. 50-51; & col. 5, ll. 20-25 (“In the event the capture device 30 is treated with thrombogenic material, the same promotes the formation of the fibrin bonds to the thrombus. Generally, fibrin is a white insoluble fibrous protein formed from fibrinogen by the action of thrombin especially in the clotting of blood”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty and Scarpine such that the attachment element be coated with (and therefore comprise) a biological attachment mechanism such as a thrombogenic material (e.g., Thrombin) in order to promote formation of fibrin bonds to the thrombus, as explicitly taught by Voss [col. 5, ll. 20-33].
19. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pouletty and Scarpine, as applied to claim 25 above, and further in view of U.S. 2021/0186540 to Taff et al. (“Taff”).
20. Regarding claim 27, the combination of Pouletty and Scarpine teaches all of the
limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
While Pouletty teaches that the recapture line may be adapted to transmit energy [e.g., ¶’s [0021], [0034]], and that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions [e.g., ¶’s [0028], [0031], [0051]], the combination of Pouletty and Scarpine does not teach:
wherein the attachment element comprises electrical contacts attached or attachable to an electrical conductor and adapted to create attachment through tissue change induced by temperature increase and/or electrical current voltage.
Taff, in a similar field of endeavor, teaches medical devices and procedures, such as thrombectomy procedures for the removal of thrombi from blood vessels [e.g., ¶[0001]],
More particularly, Taff teaches a medical device [apparatus (20) - ¶[0107]] for retrieving a thrombus from a vessel [e.g., ¶[0093]] which includes an attachment element [shaft (26) comprising two electrically-conductive circumferential portions: an active electrode (28), and a reference electrode (30) - ¶[0109]; FIG. 1], arranged at a distal end of the medical device [FIG. 1]. Taff teaches that the attachment element is adapted to attach to a proximal face of the thrombus such that the thrombus is retrievable by exerting a pulling force on the attachment element [e.g., ¶’s [0094] & [0096]].
Taff further teaches wherein the attachment element comprises electrical contacts attached or attachable to an electrical conductor [electrodes (28, 30) - ¶’s [0109], [0118]] and adapted to create attachment through tissue change induced by temperature increase and/or electrical current voltage [e.g., ¶’s [0094], [0119] (“Via first electrically-conductive element 34 and second electrically-conductive element 38, power source 36 applies a voltage between the active electrode and the reference electrode, thus anchoring the thrombus to the active electrode via ionic attraction”)].
Given (as noted above) that Pouletty teaches that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty and Scarpine to utilize an art-recognized distal end configuration known to be effective in removing a thrombus from a blood vessel, including one wherein the attachment element comprises electrical contacts attached or attachable to an electrical conductor and adapted to create attachment through tissue change induced by electrical current voltage, as taught by Taff, since such a modification amounts merely to the simple substitution of one known, art-recognized functional unit for another, yielding only predictable results [enabling attachment to (and removal of) a thrombus] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
21. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pouletty and Scarpine, as applied to claim 25 above, and further in view of U.S. 2021/0128185 to Nguyen et al. (“Nguyen”).
22. Regarding claim 28, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty and Scarpine does not, however, teach:
wherein the attachment element comprises a chemical attachment mechanism.
Nguyen, in a similar field of endeavor, teaches systems and methods to remove materials of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions [¶[0002]].
Nguyen further teaches that it was known to coat a portion of the device in communication with a thrombus (capturing portion) with, e.g., a hydrogel or adhesive that bonds to the thrombus in order to improve removal of the obstruction [e.g., ¶[0189] (“Another aspect applicable to variations of the devices can be to configure the devices (whether the traversing filament or the surrounding portion) for better adherence to the obstruction. One such mode includes the use of coatings that bond to certain clots (or other materials causing the obstruction.) For example, the wires may be coated with a hydrogel or adhesive that bonds to a thrombus. Accordingly, as the device secures about a clot, the combination of the additive and the mechanical structure of the device may improve the effectiveness of the device in removing the obstruction. Coatings may also be combined with the capturing portions or catheter to improve the ability of the device to encapsulate and remove the obstruction (e.g., a hydrophilic coating)”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty and Scarpine such that the attachment element be coated with (and therefore comprise) a chemical attachment mechanism such as, e.g., an adhesive, so as to provide the benefit/advantage of improving the effectiveness of the device in removing the obstruction, as taught by Nguyen.
23. Claims 31, 35, 36, 43, 45, & 46 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pouletty and Scarpine, as applied to claim 25 above, and further in view of U.S. 2008/0065012 to Hebert et al. (“Hebert”).
24. Regarding claim 31, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
While Pouletty teaches that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions [e.g., ¶’s [0028], [0031], [0051]], the combination of Pouletty and Scarpine does not teach:
an activation mechanism, wherein the attachment element has an activated state and a deactivated state, wherein in the deactivated state, the attachment element is adapted to not interact with a vessel wall or with the thrombus and in the activated state the attachment element is adapted to interact with the thrombus, wherein the activation mechanism is adapted to bring the attachment element at least from the deactivated state to the activated state.
Hebert, in a similar field of endeavor, teaches a device for retrieving a thrombus [clot (C)] from a vessel [vessel (V)], comprising an attachment element [four arms (102a, 102b, 102c, 102d) with adhesive provided thereon - ¶[0077]; FIGS. 5-8], arranged at a distal end of a medical device [FIG. 7], wherein the attachment element is adapted to attach to a proximal face of the thrombus such that the thrombus is retrievable by exerting a pulling force on the attachment element [¶’s [0077]-[0078]; FIGS. 5-8].
Hebert further teaches an activation mechanism [slidable tube (100) - ¶[0077]; FIGS. 5-8], wherein the attachment element [four arms (102a, 102b, 102c, 102d) with adhesive provided thereon] has an activated state [a deployed configuration - e.g., FIGS. 7, 8] and a deactivated state [a delivery configuration - e.g., FIG. 5], wherein in the deactivated state [delivery configuration - FIG. 5], the attachment element is adapted to not interact with a vessel wall or with the thrombus [see FIG. 5] and in the activated state [deployed configuration - e.g., FIGS. 7, 8] the attachment element is adapted to interact with the thrombus [clearly shown in FIGS. 7-8], wherein the activation mechanism [slidable tube (100)] is adapted to bring the attachment element at least from the deactivated state to the activated state [see, e.g., ¶[0077] (“When exposed from the sheath 104, either by movement of the sheath 104, tube 100, or both, the arms 102a-102d return to their open shape memory position as shown in FIGS. 6 and 7”)].
Given (as noted above) that Pouletty teaches that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty and Scarpine to utilize an art-recognized distal end configuration known to be effective in removing a thrombus from a blood vessel, including one having an activation mechanism, wherein the attachment element has an activated state and a deactivated state, wherein in the deactivated state, the attachment element is adapted to not interact with a vessel wall or with the thrombus and in the activated state the attachment element is adapted to interact with the thrombus, wherein the activation mechanism is adapted to bring the attachment element at least from the deactivated state to the activated state, all as taught by Hebert, since such a modification amounts merely to the simple substitution of one known, art-recognized functional unit for another, yielding only predictable results [enabling attachment to (and removal of) a thrombus] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
25. Regarding claim 35, the combination of Pouletty, Scarpine, & Hebert teaches all of the limitations of claim 31 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty & Scarpine was modified above (in the rejection of claim 31) to utilize the functional unit of Hebert. Hebert further teaches wherein the activation mechanism [slidable tube (100)] comprises a mechanism adapted to release at least the attachment element [the mechanism used to advance/retract tube (100)] from a storage area of the medical device [from the distal end of sheath (104)].
26. Regarding claim 36, the combination of Pouletty, Scarpine, & Hebert teaches all of the limitations of claim 31 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty & Scarpine was modified above (in the rejection of claim 31) to utilize the functional unit of Hebert. Hebert further teaches wherein the activation mechanism [slidable tube (100)] comprises an activatable material [slidable tube (100) comprises a shape memory tube such as Nitinol (see ¶[0077]), which is a known, activatable shape memory alloy (SMA)].
27. Regarding claim 43, the combination of Pouletty, Scarpine, & Hebert teaches all of the limitations of claim 31 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty & Scarpine was modified above (in the rejection of claim 31) to utilize the functional unit of Hebert. Hebert does not teach:
wherein the attachment element is configured such that a maximum size in a direction perpendicular to a longitudinal axis of the medical device differs by less than 10% between the activated and the deactivated state.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty, Scarpine, & Hebert such that the arms (102a, 102b, 102c, 102d) of the functional unit of Hebert be configured so that a maximum size in a direction perpendicular to a longitudinal axis of the medical device differs by less than 10% between the activated (deployed configuration) and the deactivated state (delivery configuration) since the Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
28. Regarding claim 45, the combination of Pouletty and Scarpine teaches all of the limitations of claim 25 for the reasons set forth in detail (above) in the Office Action.
While Pouletty teaches that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions [e.g., ¶’s [0028], [0031], [0051]], the combination of Pouletty and Scarpine does not teach:
[the device] further comprising at least one drag member.
Hebert, in a similar field of endeavor, teaches a device for retrieving a thrombus [clot (C)] from a vessel [vessel (V)], comprising an attachment element [four arms (102a, 102b, 102c, 102d) with adhesive provided thereon - ¶[0077]; FIGS. 5-8], arranged at a distal end of a medical device [FIG. 7], wherein the attachment element is adapted to attach to a proximal face of the thrombus such that the thrombus is retrievable by exerting a pulling force on the attachment element [¶’s [0077]-[0078]; FIGS. 5-8].
Hebert further teaches at least one drag member [Hebert teaches that an expandable mesh structure (broadly, a “drag member”) may be used with the arms [e.g., ¶[0081]; FIGS. 14A-14C].
Given (as noted above) that Pouletty teaches that the attachment element [attachable functional unit (51)] may take a variety of forms, and perform a variety of functions, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty and Scarpine to utilize an art-recognized distal end configuration known to be effective in removing a thrombus from a blood vessel, including, e.g., that of Hebert which comprises, inter alia, at least one drag member, since such a modification amounts merely to the simple substitution of one known, art-recognized functional unit for another, yielding only predictable results [enabling attachment to (and removal of) a thrombus] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
29. Regarding claim 46, the combination of Pouletty, Scarpine, & Hebert teaches all of the limitations of claim 35 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty & Scarpine was modified above (in the rejection of claim 31) to utilize the functional unit of Hebert. Hebert further teaches wherein the activation mechanism comprises an activatable material [slidable tube (100) comprises a shape memory tube such as Nitinol (see ¶[0077]), which is a known, activatable shape memory alloy (SMA)].
30. Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Pouletty, Scarpine, & Hebert, as applied to claim 31 above, and further in view of U.S. 2004/0111095 to Gordon et al. (“Gordon”).
31. Regarding claim 37, the combination of Pouletty, Scarpine, & Hebert teaches all of the limitations of claim 31 for the reasons set forth in detail (above) in the Office Action.
The combination of Pouletty & Scarpine was modified above (in the rejection of claim 31) to utilize the functional unit of Hebert.
The combination of Pouletty, Scarpine, & Hebert does not, however, teach:
wherein the activation mechanism [tube (100) of Hebert] comprises a protection layer.
Gordon, in a similar field of endeavor, teaches that it was known in the art for an actuation mechanism [a push rod] to include a hydrophilic or Teflon® coating [a protective layer] to provide sufficient lubricity of the mechanism [e.g., ¶’s [0029]-[0030]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Pouletty, Scarpine, & Hebert such that the activation mechanism [tube (100) of Hebert] comprises a protection layer such as, e.g., Teflon® to sufficient lubricity of the mechanism [(100)] for facilitating axial translation during deployment/withdrawal of the attachment element [four arms (102a, 102b, 102c, 102d)].
Response to Arguments
32. As noted above, the 05/26/26 Amendment has overcome the objections to the Specification, Drawings, & Claims, as well as the claim rejections under §§ 112(b), 102, & 103 previously set forth in the 02/25/26 Action.
33. New grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Conclusion
34. Applicant's amendment necessitated the new ground(s) of rejection presented in this
Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is
reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
35. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617. The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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