Prosecution Insights
Last updated: October 04, 2026
Application No. 18/933,413

SYSTEMS AND METHODS FOR TRANSFEMORAL CAROTID INTERVENTION

Non-Final OA §101§103§112§DP
Filed
Oct 31, 2024
Priority
Nov 03, 2023 — provisional 63/595,988 +1 more
Examiner
MARCETICH, ADAM M
Art Unit
Tech Center
Assignee
Silk Road Medical Inc.
OA Round
1 (Non-Final)
73%
Grant Probability
Favorable
1-2
OA Rounds
1y 0m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
993 granted / 1366 resolved
+12.7% vs TC avg
Strong +19% interview lift
Without
With
+18.8%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
49 currently pending
Career history
1390
Total Applications
across all art units

Statute-Specific Performance

§101
3.0%
-37.0% vs TC avg
§103
48.1%
+8.1% vs TC avg
§102
15.4%
-24.6% vs TC avg
§112
20.9%
-19.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1366 resolved cases

Office Action

§101 §103 §112 §DP
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 . Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description. Figs. 24A and 24B include an element number “2205” which appears to represent a rotor. However, the specification lacks element number “2205” and instead labels the rotors with a different number 2410 (¶ [0139], The rollers 2210 are also coupled to one or more rotors 2410). The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “2205” and “2410” have both been used to designate the rotors (Figs. 24A and 24B). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections The claims contain minor informalities. In claim 16, the language “… the arterial access device [[comprises]] comprising a distal sheath …” should be changed for clarity. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 1 calls for “… wherein the arterial access device includes a distal sheath [[which enters]] configured to enter the common carotid artery …” which should be revised to remove the common carotid artery from the claim scope. Applicant is recommended to use inferential language (e.g. configured to, adapted to or whereby) to avoid positively claiming the human body. Claims 2-15 are rejected for depending on a rejected parent claim. Claim Rejections - 35 USC § 112(b) 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 4 and 18 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 pre-AIA the applicant regards as the invention. Claim 4 calls for “… wherein each roller is coupled to a belt that forms an elongated pathway upon which each roller moves into contact with the tubing.” This feature appears to conflict with parent claim 3 because claim 3 calls for the language “… wherein the at least one roller includes a plurality of rollers, each roller of the plurality of rollers coupled to a rotor …” Figs. 24A and 24B describe different embodiments. Fig. 24A describes a pump comprising rollers fixed to a central rotor, while Fig. 24B describes rollers that connect to a belt and which move around a pair of rotors (¶ [0139]). Fig. 24A requires the rollers to remain fixed to the central rotor, while Fig. 24B requires the rollers to remain independent of the two rotors, such as in a caterpillar drive system. Claim 3 requires the rotors to couple to the rotor, which appears to preclude the rollers against coupling to a belt. Claim 18 recites similar language and depends on claim 17, which recites “…the plurality of rollers coupled to a rotor…” Claim 17 appears to contradict claim 18 for the same reasons discussed above. 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 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 of this title, 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 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. Claims 1, 2, 8, 9, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston; Natasha et al. (US 20220047267 A1). Regarding claim 1, Johnston discloses a system for use in accessing and treating a carotid artery (¶ [0013], improved methods, apparatus, and systems for performing transcarotid access, retrograde flow and flushing procedures, carotid angioplasty, and implantation of a carotid stent in the carotid arterial vasculature to reduce the risk of procedural and post-procedural emboli; ¶ [0021] In one aspect, there is disclosed a system for use in accessing and treating a carotid artery; ¶ [0067] FIG. 1A shows a first embodiment of a retrograde flow system 100); the system comprising: an arterial access device adapted to be introduced into a common carotid artery (¶ [0067], The retrograde flow system 100 includes an arterial access device 110 … The arterial access device 110 at least partially inserts into the common carotid artery CCA; ¶ [0068] In the embodiment of FIG. 1A, the arterial access device 110 accesses the common carotid artery CCA via a transcarotid approach); via a percutaneous access location in a groin of a patient (¶ [0070] FIG. 1C, the arterial access device 110 accesses the common carotid artery via a femoral approach … the arterial access device 110 approaches the CCA via a percutaneous puncture into the femoral artery FA, such as in the groin, and up the aortic arch AA into the target common carotid artery CCA); and receive blood flow from the common carotid artery via a distal region of the arterial access device (¶ [0067], When flow through the common carotid artery is blocked, the natural pressure gradient between the internal carotid artery and the venous system causes blood to flow in a retrograde or reverse direction RG (FIG. 2A) from the cerebral vasculature through the internal carotid artery and through the shunt 120 into the venous system); wherein the arterial access device includes a distal sheath which enters the common carotid artery (¶ [0090] The distal sheath 605 is adapted to be introduced through … a percutaneous puncture established, for example, using the Seldinger technique); a shunt fluidly connected to the arterial access device, wherein the shunt comprises tubing defining a blood flow pathway for blood to flow from the arterial access device to a return site (¶ [0067], [0087], shunt 120 which provides a passageway for retrograde flow from the arterial access device 110 to the venous return device 115; ¶ [0132] The shunt 120 can be formed of a single tube or multiple, connected tubes that provide fluid communication between the arterial access catheter 110 and the venous return catheter 115 to provide a pathway for retrograde blood flow therebetween); and a flow control assembly coupled to the shunt and adapted to assist blood flow through the shunt (¶ [0067], The flow control assembly 125 is adapted to regulate and/or monitor the retrograde flow from the common carotid artery to the internal jugular vein; ¶ [0138] The flow control assembly 125 interacts with the retrograde shunt 120 to regulate and/or monitor the retrograde flow rate from the common carotid artery to the venous return site); the flow control assembly including a pump that pumps blood through the shunt toward the return site (¶ [0142] FIG. 11 shows an example of the system 100 with a schematic representation of the flow control assembly 125 … including one or more pumps 1110; ¶ [0144], The pump 1110 can be a peristaltic tube pump or any type of pump including a positive displacement pump). Johnston does not explicitly disclose that the pump has at least one roller that interacts with the tubing of the shunt. However, Johnston calls for a peristaltic pump (¶ [0144]). As known in the art, a peristaltic pump operates by progressively deforming a flexible lumen in order to confine a small volume of fluid in a tube segment and the propel the fluid towards one end of the lumen. A skilled artisan would have been able to implement Johnston’s peristaltic pump with rollers that contact the shunt tubing, such as with a circular or linear peristaltic pump. Therefore, it would have been obvious to modify Johnston with rollers in order to construct a peristaltic pump according to Johnston’s guidelines. Regarding claim 16, Johnston discloses a method of treating a carotid artery (¶ [0013], improved methods, apparatus, and systems for performing transcarotid access; ¶ [0014] The disclosed methods, apparatus, and systems establish and facilitate retrograde or reverse flow blood circulation in the region of the carotid artery bifurcation; ¶ [0024] In another interrelated aspect of the current subject matter, a method of a transcarotid access and treatment system is disclosed); comprising: percutaneously accessing a femoral artery by inserting an arterial access device into the femoral artery through a puncture in the femoral artery (¶ [0070] FIG. 1C, the arterial access device 110 accesses the common carotid artery via a femoral approach … the arterial access device 110 approaches the CCA via a percutaneous puncture into the femoral artery FA, such as in the groin, and up the aortic arch AA into the target common carotid artery CCA); the arterial access device comprises a distal sheath (¶ [0090] The distal sheath 605 is adapted to be introduced through … a percutaneous puncture established, for example, using the Seldinger technique); introducing the distal sheath into a common carotid artery via an aortic arch (¶ [0090], In an alternate embodiment, the distal sheath is adapted to be introduced through a percutaneous puncture into the femoral artery, such as in the groin, and up the aortic arch AA into the target common carotid artery CCA); expanding a balloon on the distal sheath to occlude at least a portion of the common carotid artery to cause blood to flow in a retrograde direction from an internal carotid artery into the distal sheath (¶ [0074] FIG. 2B … A separate arterial occlusion device 112 with an occlusion element 129 can be used to occlude the common carotid artery CCA; ¶ [0075] FIG. 2C … wherein the arterial access device 110 is used for the purpose of creating an arterial-to-venous shunt as well as arterial occlusion using an occlusion element 129 (e.g., occlusion balloon); ¶ [0117] FIG. 8A … the distal sheath 605 includes an occlusion element 129 for occluding flow through, for example the common carotid artery); shunting blood from the sheath to a return site via a shunt fluidly coupled to the distal sheath (¶ [0067], [0087], shunt 120 which provides a passageway for retrograde flow from the arterial access device 110 to the venous return device 115; ¶ [0132] The shunt 120 can be formed of a single tube or multiple, connected tubes that provide fluid communication between the arterial access catheter 110 and the venous return catheter 115 to provide a pathway for retrograde blood flow therebetween); and assisting blood flow through the shunt using a pump to pump blood through the shunt toward the return site (¶ [0142] FIG. 11 shows an example of the system 100 with a schematic representation of the flow control assembly 125 … including one or more pumps 1110; ¶ [0144], The pump 1110 can be a peristaltic tube pump or any type of pump including a positive displacement pump). Johnston does not explicitly disclose that the pump includes a roller. However, Johnston calls for a peristaltic pump (¶ [0144]). Regarding the rationale and motivation to implement Johnston’s peristaltic pump with one or more rollers, see the discussion of claim 1 above. Regarding claims 2, 8, 9 and 13, Johnston discloses a system and method wherein the percutaneous access location is in a femoral vein (¶ [0070] FIG. 1C, the arterial access device 110 accesses the common carotid artery via a femoral approach … the arterial access device 110 approaches the CCA via a percutaneous puncture into the femoral artery FA, such as in the groin, and up the aortic arch AA into the target common carotid artery CCA); further comprising a dilator formed of an elongated body sized and shaped to be inserted into the arterial access device; wherein the dilator has a first tapered region at a distal location of the dilator (¶ [0089] FIG. 6A shows an exemplary embodiment of the arterial access device 110, which comprises a distal sheath 605 … The arterial access device may also comprise a dilator 645 with a tapered tip 650); wherein the arterial access device further comprises an expandable balloon on a distal region of the sheath, the expandable balloon adapted to occlude the common carotid artery (¶ [0068], An occlusion element 129, such as an expandable balloon, can be used to occlude the common carotid artery CCA at a location proximal of the distal end of the arterial access device 110. The occlusion element 129 can be located on the arterial access device 110 or it can be located on a separate device; ¶ [0117] FIG. 8A … the distal sheath 605 includes an occlusion element 129). Claims 3, 5-7, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston; Natasha et al. (US 20220047267 A1) in view of Petersen; Craig et al. (US 20140127063 A1). Regarding claims 3, 5-7, 17 and 19-20, Johnston does not explicitly disclose a plurality of rollers, a rotor and adjustable degree of occlusion. Petersen discloses roller pumps used in medical devices (¶ [0001], [0007], [0018], FIG. 1. The roller pump 20); comprising at least one roller that interacts with a tubing; wherein the at least one roller includes a plurality of rollers, each roller of the plurality of rollers coupled to a rotor that rotates to successively move each roller into contact with the tubing (¶ [0018], In general terms, the roller pump 20 is configured to maintain a length of flexible tubing 30 between the stator frame 26 and one or more rollers 32 provided with the roller head assembly 24 … the roller(s) 32 travels along the tubing 30, thereby pushing a fluid medium through the tubing 30); wherein the tubing of the shunt extends along a pathway having a predetermined shape, wherein the predetermined shape is straight or curved (¶ [0025], The flange 112 extends from the base 110 to define a raceway 114 having an inner arcuate receiving surface 116 against which the flexible tubing 30 (FIG. 1) is disposed as described below); wherein a rigid structure extends along a portion of the tubing in a side-by-side relationship such that the tubing conforms to the shape of the structure; wherein a relative position between the roller and the tubing can be adjusted to adjust a degree of occlusion that the roller achieves relative to an internal lumen of the tubing (¶ [0039], In effect, an occlusion zone or distance 250 is established between each of the rollers 32 and the receiving surface 116, with the distance (or "level" of occlusion) 250 being adjustable as described below; ¶ [0042] The level or amount of occlusion (i.e., the radial distance 250 (FIG. 6) between the rollers 32 and raceway receiving surface 116) can be changed in the occlusion adjustment mode of operation. With reference to FIGS. 5A and 7, occlusion adjustment is effectuated by a user rotating the actuator knob 120). Petersen enables a caregiver or operator to adjust the pump’s occlusion without stopping the pump (¶ [0044] Any level or amount of occlusion … can be selected or effectuated by a user. Notably, occlusion adjustment steps can be performed while the roller pump 20 is simultaneously and continuously operating to pump a fluid medium …eliminates the need for the user (e.g., perfusionist) to stop the pump every time occlusion adjustment is desired). One would be motivated to modify Johnston with Petersen’s plural rollers, rotor and adjustable occlusion so that the pump can continue operating even when it needs to be adjusted. Petersen also explains how to construct a peristaltic pump suitable for propelling blood through an extracorporeal system (¶ [0002]). Therefore, it would have been obvious to modify Johnston with Petersen’s plural rollers, rotor and adjustable occlusion in order to implement a peristaltic pump according to Johnston’s suggestion, and to configure the pump to be adjusted during its operation. Claims 3, 4, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston; Natasha et al. (US 20220047267 A1) in view of Ferme; Philippe et al. (US 20150110655 A1). Regarding claims 3, 4, 17 and 18, Johnston does not explicitly disclose plural rollers and also lacks a belt that forms an elongated pathway. Ferme discloses a peristaltic pump for a dialysis machine (¶ [0002], [0029], a linear peristaltic pump 1); comprising at least one roller that interacts with a tubing; wherein the at least one roller includes a plurality of rollers, each roller of the plurality of rollers coupled to a rotor that rotates to successively move each roller into contact with the tubing (¶ [0030] The peristaltic pump 1 also comprises a force application system 2, the system having a plurality of presser members 7 and drive means for moving said presser members 7 enabling said presser members to be moved while pressed against the tube in order to deform it against said pump body 3; ¶ [0044] The loop element 6 comprises a drive belt arranged in a loop around the cylinders 8. One of the cylinders 8 is driven by a motor 81 so that said cylinder forms a cylinder suitable for driving the belt around said cylinders); wherein each roller is coupled to a belt that forms an elongated pathway upon which each roller moves into contact with the tubing (¶ [0043] Said drive means for moving the presser members 7 include a loop element 6 that connects the presser members 7 to one another, and two rotary cylinders 8, positioned inside and at opposite ends of said loop element 6). Ferme describes how to construct a peristaltic pump that is suitable for propelling blood through an extracorporeal system. One would be motivated to modify Johnston with Ferme’s plural rollers and belt since Johnston calls for a peristaltic pump (¶ [0144], The pump 1110 can be a peristaltic tube pump). Therefore, it would have been obvious to modify Johnston with Ferme’s plural rollers and belt in order to implement Johnston’s pump with a known peristaltic pump. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Johnston; Natasha et al. (US 20220047267 A1) in view of Mehrabi; Azadeh (US 20240341781 A1). Regarding claim 10, Johnston lacks a second tapered region. Mehrabi discloses a crossing catheter system (¶ [0002], [0008], [0017], [0143] FIG. 1 shows a crossing catheter system 1 including a support catheter 2); comprising an arterial access device (¶ [0143] FIG. 1 … support catheter 2); and a dilator shaped to be inserted into the arterial access device (¶ [0143], dilator 3); wherein the dilator has a first tapered region at a distal location of the dilator, wherein the dilator has a second tapered region at a distal location of the dilator (¶ [0146] FIG. 4 shows an embodiment of a distal dilator end 32. The distal dilator end 32 has at least three different segments 37, 38, 39; ¶ [0147] The distal dilator end 32 has three or four intermediate segments 38, a first intermediate segment 381, a second intermediate segment 382, a third intermediate segment 383 and an optional fourth intermediate segment 384). Mehrabi provides a plurality of sizes in a single dilator so that a surgeon can select one of several diameters (¶ [0031], This enables the operator to individually adapt the distal dilator end to the specific requirements needed during an operation). One would be motivated to modify Johnston with Mehrabi’s second tapered region so that a surgeon can dilate a vessel with one of several intermediate diameters. Therefore, it would have been obvious to modify Johnston with Mehrabi’s second tapered region in order for a surgeon to more finely adjust a vessel diameter. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston; Natasha et al. (US 20220047267 A1) in view of Bakos, Gregory J. et al. (US 20050070949 A1). Regarding claims 11 and 12, Johnston lacks an optical marker that aligns with a landmark. Bakos discloses a dilator device (¶ [0002], [0008], [0019], [0021] FIG. 2 shows a dilator 18 of the present invention); comprising an optical marker; wherein the dilator has an optical marker on a proximal region of the dilator (¶ [0041] FIG. 5 also shows plurality of markings 43 for the physician to select and position the desired dilating diameter in the area of stricture 61 during the procedure; ¶ [0044] FIG. 7B … While viewing plurality of markings 43 for reference, dilator 18 is advanced into stricture 61 causing dilation to first outer diameter D1. Plurality of markings 43 may delineate the boundaries of diameter D1 and may also indicate its numerical value); wherein when the optical marker aligns with a landmark of an access device, the first tapered region fully extends from a distal tip of the arterial access device; wherein alignment between the optical marker and the landmark of the arterial access device indicates to a user that a location where the dilator begins to taper is aligned with a distal most end of arterial access device (¶ [0049] Another useful feature of the dilator 18 is that it provides one with the ability to dilate to more than one diameter with a single introduction of the device, and with precision. This is made possible by the ability to see plurality of markings 43 from inside transparent segment 21 to identify a particular dilating diameter); Bakos discloses a plurality of regularly spaced markings (¶ [0041], [0044], [0049]). A skilled artisan would have been able to modify Johnston with Bakos’s multiple markers by arranging Bakos’s markers on Johnston’s dilator. In this way, a surgeon will be able to estimate how much of the dilator extends from the sheath, and which of the dilator’s various diameters are deployed from the sheath. One would be motivated to modify Johnston with Bakos’s aligned optical marker in order for a surgeon to dilate a vessel to a selected diameter or degree. Therefore, it would have been obvious to modify Johnston with Bakos’s aligned optical marker in order to selectively dilate a blood vessel. Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston; Natasha et al. (US 20220047267 A1) in view of Kastenhofer, Gerhard (US 20020022824 A1). Regarding claims 14 and 15, Johnston does not explicitly disclose an outer jacket co-axially positioned over an inner layer. Kastenhofer discloses an interventional catheter constituting a sheath (¶ [0001], [0010], [0023] The interventional catheter shown in FIG. 1 comprises a catheter tube 1); comprising an expandable balloon on a distal region of the sheath (¶ [0028] Over the distal portion of the catheter tube I is positioned a balloon 7); wherein the sheath is formed of an outer jacket co-axially positioned over an inner layer (¶ [0029] A tube 9 is arranged over the catheter tube 1); and wherein a distal portion of the balloon is connected to one of the outer jacket or the inner layer and a proximal portion of the balloon is connected to the other of the outer jacket or the inner layer; wherein a distal portion of the balloon is connected to the inner layer (¶ [0028] Over the distal portion of the catheter tube I is positioned a balloon 7 the distal end 8 of which sealingly surrounds the outer layer 3 of catheter tube 1, for example by welding); and a proximal portion of the balloon is connected to the outer jacket (¶ [0029], The proximal end 11 of the balloon 7 is welded onto the distal end of tube 9); Kastenhofer describes how to construct an inflation lumen for a balloon (¶ [0029] A tube 9 is arranged over the catheter tube 1, at a radial distance thereof, thus defining an inflation lumen 10 for the balloon 7). One would be motivated to modify Johnston with Kastenhofer’s outer jacket and inner layer so that Johnston’s balloon can be inflated. Therefore, it would have been obvious to modify Johnston with Kastenhofer’s outer jacket and inner layer in order to construct a sheath and balloon having an inflation lumen. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claim 1 is rejected over the following patents: Reference Claims cited against pending claim 1 Criado; Enrique et al. US 8784355 B2 1, 13, 15 Criado; Enrique et al. US 10426885 B2 1, 12, 14 Criado; Enrique et al. US 10709832 B2 1, 13, 15 Each of the cited patents claims a system for use in accessing and treating a carotid artery comprising an arterial access device, a shunt comprising tubing and a flow control assembly. Each of these patents also claims a roller pump which implies that the pump includes a roller that interacts with the tubing of the shunt. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pattison; C. Phillip US 6010520 A Lee, Jeong S. et al. US 20030055448 A1 Bakos, Gregory J. et al. US 20050070949 A1 Strong; Jeffery John et al. US 20070240817 A1 Gelbart; Daniel et al. US 20120271096 A1 Aman; Michael et al. US 20140148651 A1 Repka; William James et al. US 20180161486 A1 Mehrabi; Azadeh US 20240341781 A1 Any inquiry concerning this communication or earlier communications from the examiner should be directed to: Tel 571-272-2590 Fax 571-273-2590 Email Adam.Marcetich@uspto.gov The Examiner can be reached 8am-4pm Mon-Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Adam Marcetich/ Primary Examiner, Art Unit 3781
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Prosecution Timeline

Oct 31, 2024
Application Filed
Aug 10, 2026
Non-Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
73%
Grant Probability
92%
With Interview (+18.8%)
2y 11m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1366 resolved cases by this examiner. Grant probability derived from career allowance rate.

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