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 Status
The amendment submitted on July 13th, 2026 has been entered. The amendment has presented no changes to the claims as previously presented. Claims 1-21 are currently pending. Claims 14-21 have been withdrawn from consideration in response to the restriction requirement mailed on May 14th, 2026. The election is considered to be without traverse due to the lack of arguments presented by applicant in the response received July 13th, 2026. As such claims 1-13 are currently under consideration.
Claim Objections
Claim 12 is objected to because of the following informalities: “a a hard material” should read –a hard material--. 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 10-13 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.
Claim 10 recites the limitation "the first lumen" and “the second lumen” in lines 1 and 2 respectively. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites the limitation “first lumen” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 11 and 13 is rejected based on its dependency upon a rejected claim (claims 10 and 12 respectively).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al. (U.S. Publication 2013/0197621) (embodiment 1).
Regarding claim 1, Ryan discloses a system (Fig. 2b) for use in accessing and treating a carotid artery, said system comprising: an arterial access sheath (110; embodiment 8A, 605) formed of an elongated body sized and shaped to be introduced into a common carotid artery (Fig. 2A shows elongate nature of 110 and introduction into CCA, i.e. common carotid artery), the arterial access sheath having an internal lumen (¶0157 inner lumen of sheath 605) that can receive blood flow (¶0135 establish and facilitate retrograde or reverse flow blood circulation..blood to flow…from the cerebral vasculature through the internal carotid artery and through the shunt 120); a shunt (815, 120, 615 that fluidly communicates with the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath (¶0135 shunt that provides a passageway for retrograde flow from the arterial access device to the venous return device); and a flow control assembly 125 mechanically attached to the pathway of the shunt (Fig. 2A shows mechanical attachment; Fig. 23A,23B show mechanical nature of attachment), wherein the flow control assembly includes a flow tube 120 fluidly connected to the shunt (Fig. 18 show fluidic connection to 815 and 615), the flow controller assembly further including a deformer structure 1710, the deformer structure movably positioned relative to the flow tube (Fig. 23A and 23B show movable positioning from unclamped to clamped state), wherein the deformer structure can be actuated to cause the deformer structure to physically interact with and deform the flow tube so as to constrict fluid flow through the flow tube (¶0228 valve 1710 controlled by the controller or controlled manually by the user; Fig. 23a-b show physical interaction with tube 120 to block main flow pathway).
Regarding claim 2, Ryan discloses the system of claim 1. Ryan further discloses the deformer structure physically interacts with the flow tube in a manner that varies a size of an internal lumen of the flow tube (Fig. 23A-B show variation in size of main lumen 1700).
Regarding claim 9, Ryan discloses the system of claim 1. Ryan further discloses the flow tube having a first internal lumen 1700 and a second internal lumen 1705 (both lumens internal to outer tubing that maintains the lumen on the internal side for fluid flow therethrough).
Regarding claim 10, Ryan discloses the system of claim 1. Ryan further discloses a first lumen 1700 that provides a larger flow rate (¶0228 secondary lumen can be longer and/or have a smaller diameter than the main lumen. Thus, the secondary lumen has higher flow resistance; higher flow resistance equates to lower flow rate) than a second lumen 1705.
Regarding claim 11, Ryan discloses the system of claim 10. Ryan further discloses the deformer structure 1710 can deform the first lumen 1700 (see Fig. 23A and 23B deforming 1700).
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al. (U.S. Publication 2013/0197621) (embodiment 2).
Regarding claims 1 and 3-5, a system (Fig. 2b) for use in accessing and treating a carotid artery, said system comprising: an arterial access sheath (110; embodiment 8A, 605) formed of an elongated body sized and shaped to be introduced into a common carotid artery (Fig. 2A shows elongate nature of 110 and introduction into CCA, i.e. common carotid artery), the arterial access sheath having an internal lumen (¶0157 inner lumen of sheath 605) that can receive blood flow (¶0135 establish and facilitate retrograde or reverse flow blood circulation..blood to flow…from the cerebral vasculature through the internal carotid artery and through the shunt 120); a shunt (815, 120, 615 that fluidly communicates with the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath (¶0135 shunt that provides a passageway for retrograde flow from the arterial access device to the venous return device); and a flow control assembly 125 mechanically attached to the pathway of the shunt (Fig. 2A shows mechanical attachment; Fig. 23A,23B show mechanical nature of attachment), wherein the flow control assembly includes a flow tube 120 fluidly connected to the shunt (Fig. 18 show fluidic connection to 815 and 615), the flow controller assembly further including a deformer structure 2210, the deformer structure movably positioned relative to the flow tube (¶0273 movable blocking member 2310 that is slidably positioned in a housing 2315), wherein the deformer structure can be actuated to cause the deformer structure to physically interact with and deform the flow tube so as to constrict fluid flow through the flow tube (Claim 1) (¶0273 pressure increase pushes the plunger forward toward the shunt. The plunger in turn can push the anvil toward the thin walled segment of the shunt to pinch off the thin-walled segment of the shunt and prevent flow through the shunt) wherein the deformer structure is a slidable plate (Claim 3)(¶0273 slidably positioned in a housing), wherein the deformer structure has an edge than can be moved to contact the flow tube (Claim 4)(Fig. 44B shows edge in contact with thin-walled portion 2320), wherein the distal edge is slidable toward and away (¶0273 plunger in turn can push the anvil toward the thin walled segment…biasing member, such as spring, can urge the plunger and anvil toward the open position when there is no pressure in the fluid line) from the flow tube and wherein the distal edge forms a non-straight region (Fig. 44A and B show non-straight, curved, contact edge of 2310) (claim 5).
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.
Claim(s) 3, 6-8, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al. (U.S. Publication 2013/0197621) (embodiment 1) in view of Hamilton Sr. et al. (U.S. Patent No. 4,139,017).
Regarding claims 3, 6-8, and 12-13, Ryan discloses the system of claim 1. Ryan does not expressly disclose the deformer structure being a slidable plate, the flow control assembly further includes a backstop positioned to limit a range of movement of the deformer structure relative to the flow tube (Claim 6); wherein the backstop is positioned relative to the flow tube and the deformer structure such that the backstop prevents the deformer structure from completely occluding an internal lumen of the flow tube (Claim 7); wherein a position of the backstop relative to the flow tube and the deformer structure is adjustable (Claim 8), a first lumen being at least partially seated within a hard material that does not deform when the deformer structure is pressed against it (Claim 12), or the hard material being stainless steel (Claim 13).
However, Hamilton, in the same field of endeavor of flow control devices, discloses flow control assembly comprising a deformer structure 26 as a slidable plate (Col. 3 lines 52-56 clamping disc…slide reciprocally on the rod between the anvil and the knob), a backstop 28 positioned to limit a range of movement of the deformer structure relative to the flow tube (Col. 4 lines 55-68, to maintain the disc in position, the adjustment know is grasped and rotated toward the disk and into slidable and parallel abutting relationship with the bearing surface 39 of the claiming disc. The knob is controllably rotated or tightened, directing the clamping disc toward the anvil and applying pressure to the tube/ When it is desired to lessen the flow of fluid the knob is further rotated toward the anvil to bend and compress the tube in the groove and constrict the passage. The rate of flow may be controlled or regulated by varying the amount of tightness or degree of rotation of the adjustment knob and therefore the degree of compression of the tube; position of 28 limits range of movement of deformer structure in direction away from anvil) (Claim 6); wherein the backstop is positioned relative to the flow tube and the deformer structure such that the backstop prevents the deformer structure from completely occluding an internal lumen of the flow tube (Col. Lines 55-68 describes positioning of 28 which shows that the backstop can be positioned such that complete occlusion does not occur) (Claim 7); wherein a position of the backstop relative to the flow tube and the deformer structure is adjustable (Col. 4 lines 55-68 knob is controllably rotated or tightened…rate of flow may be controlled or regulated by varying the amount of tightness or degree of rotation of the adjustment knob) (Claim 8), wherein the lumen 10 is at least partially seated (seated within groove 23) within a hard material that does not deform when the deformer structure is pressed against it (Claim 12) (Col. 2 lines 61-68, the fluid flow control and mounting thereof is constructed of virtually any suitable material which is sufficiently strong to withstand the shear and bending forces applied thereto), wherein the hard material is stainless steel (Claim 13) (Col. 3 line 2 stainless steel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ryan to have substituted its deformer structure for the tube deforming structure of Hamilton including its backstop, slidable plate 26 and tube seating portion 2 for both the purpose of allowing varying degrees of flow rate control (Col. 4 lines 55-68 of Hamilton) and since these elements perform the same function of deforming flow tubing to control flow therethrough, simply substituting one tubing flow control means for another would yield the predictable result of allowing the flow through fluid tubing to be controlled. See MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Forberg (U.S. Patent No. 3,918,675) discloses a backstop that prevents full occlusion of tubing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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