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 .
Response to Amendment
The Amendment filed 10/15/25 has been entered. Claims 1, 6, 10- 12, 16 and 18 are amended. Claim 9 is canceled. Claim 21 is added. Claims 1- 8 and 10- 21 are being addressed by this Office Action.
Response to Arguments
Applicant’s Amendment has obviated the claim objections made in the Non-Final Office Action, mailed 6/17/25. As such, the claim objections made in the Non-Final Office Action, mailed 6/17/25 are withdrawn.
Applicant’s Amendment has obviated the rejections under 35 U.S.C. 112(b) made in the Non-Final Office Action, mailed 6/17/25. As such, the rejections under 35 U.S.C. 112(b) made in the Non-Final Office Action, mailed 6/17/25 are withdrawn.
Applicant’s arguments, see applicant’s Remarks, filed 10/15/25, with respect to the rejection(s) of claim(s) 1, 2, 4- 6 and 8- 10 under 35 U.S.C. 102(a) or alternatively under 103 under 35 U.S.C. 103 over Wensel have been fully considered and are persuasive because Wensel does not disclose the newly added limitation regarding such that the clot treatment device to elongates within the clot material outside the guide catheter. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wensel et al. (US Pat. No. 5,895,398). It is noted that the arguments against Wensel are directed to the elongating within the clot material outside the guide catheter feature upon which Wensel is relied.
Claim Objections
Claim 1 is objected to because of the following informalities: line 11- “elongates within the clot material outside the guide catheter” should be amended to - - elongates within the at least a portion of the clot material outside the guide catheter - - since it is clear that applicant is referring to the same at least a portion of the clot material recited in lines 8- 9, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 2- 8, 10- 15 and 21 are objected to because they depend off claim 1.
Claim 1 is objected to because of the following informalities: lines 13- 14- “the portion of the clot material at least partially into the guide catheter” should be amended to - - the at least a portion of the clot material at least partially into the guide catheter - - since it is clear that applicant is referring to the same at least a portion of the clot material recited in lines 8- 9, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 2- 8, 10- 15 and 21 are objected to because they depend off claim 1.
Claim 10 is objected to because of the following informalities: “wherein the method further comprises applying a vacuum through the guide catheter to aspirate at least a portion of the clot material into the guide catheter” should be amended to - - wherein the method further comprises applying a vacuum through the guide catheter to aspirate the at least a portion of the clot material into the guide catheter - - since it is clear that applicant is referring to the same at least a portion of the clot material recited in claim 1, lines 8- 9, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 11 is objected to because it depends off claim 10.
Claim 16 is objected to because of the following informalities: lines 16- 17- “retracting the clot treatment device at least partially through the clot material such that at least a portion of the clot material is captured by the clot treatment device” should be amended to - - retracting the clot treatment device at least partially through the clot material such that the at least a portion of the clot material is captured by the clot treatment device - - since it is clear that applicant is referring to the same at least a portion of the clot material recited in lines 7- 8, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claims 17- 20 are objected to because they depend off claim 16.
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.
Claim 19 is 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 19 recites “The method of claim 18 wherein the clot treatment device is a balloon.” However, claim 16, from which claim 18 depends, recites “wherein the clot treatment device comprises a porous structure that at least partially permits blood flow through the clot treatment device” in lines 4- 5. Since a balloon is an occlusive member and impermeable (See P. [0085] of applicant’s Specification), claim 19 contradicts claim 16 and as such, claim 19 is indefinite.
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.
Claim(s) 1- 3, 10- 15 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wensel et al. (US Pat. No. 5,895,398).
Regarding claim 1, Wensel discloses a method of treating clot material at least partially restricting blood flow through a blood vessel, the method comprising:
advancing a clot treatment device (30) (Figs. 2a- 2e, 10a- 11) to the clot material (22) (Figs. 2a- 2e) in the blood vessel (20) (Figs. 2a- 2e) through a guide catheter (12, 116, 110) (Figs. 2a- 2f, 11) (See Figs. 2a, 2b) (Col. 8, l. 17- 23 - - In practice, the introducing catheter 110 is inserted through a large vessel and through the vascular system to a position near a clot in an occluded artery under fluoroscopic guidance. The catheter 12, is then inserted through port 112 and through the introducing catheter such that the distal end of the catheter 12 has passed the distal end 116 of the introducing catheter);
expanding the clot treatment device (30) within the blood vessel (20) such that at least a portion of the clot treatment device (30) expands distal to the clot material (22) within the blood vessel (20) (See Fig. 2c) (Col. 8, l. 23- 27 - - The catheter 12 is then translated across the clot. The coil 30 and insertion mandrel 16 are then inserted into the catheter 12. The insertion mandrel is then translated through the catheter 12 until the coil 30 is deployed in the vessel); and
retracting the clot treatment device (30) at least partially through the clot material (22) such that at least a portion of the clot material (22) is captured by the clot treatment device (30), and such that the clot treatment device (30) elongates within the clot material (22) outside the guide catheter (12, 116, 110) (See Fig. 2e) (Col. 3, l. 22- 24; Col. 7, l. 59- 67; Col. 8, l. 27- 28 - - FIG. 2e is a schematic illustration of the removal of a clot via a clot capture coil illustrating the corkscrewing and ensnaring effect of the coil within the viscoelastic clot; The clot is then retrieved by translating the insertion mandrel along with the catheter proximally. When the clot capture coil is pulled proximally the clot becomes ensnared. Additionally, while pulling proximally on the insertion mandrel, the coil is rotated by rotating the insertion mandrel to transfix the clot by corkscrewing the clot into the coils. The viscoelastic properties of the clot allow the clot to be captured within the side coils and to be pulled down using the most distal coils as a capture cup; The insertion mandrel is then translated proximally to ensnare the clot within the coil and then the catheter; it is noted that pulling proximally, rotating and corkscrewing the viscoelastic coil elongates the clot treatment device (30) within the clot material (22) as shown in Fig. 2e); and
further retracting the clot treatment device (30) and the portion of the clot material (22) at least partially into the guide catheter (12, 116, 110) (Col. 8, l. 28- 35 - - then the catheter, coil and clot are translated toward the distal end 116 of the introducing catheter 110. Once the clot and the coil are at the distal end 116, suction is applied via port 114 to suck part of the clot into the distal end 116. The suction helps to keep the clot within the coil. Then the introducing catheter 110, the catheter 12, the clot and the coil 30 are removed from the patient).
Regarding claim 2, Wensel further discloses wherein expanding the clot treatment device (30) includes expanding a plurality of radially-extending portions of the clot treatment device (30) such that at least one of the of radially-extending portions is expanded distal to the clot material (22) (See Fig. 2c) (Col. 5, l. 22- 28 - - A different coil configuration is illustrated in FIGS. 2a-2f … The coil is conically shaped with the diameter of the coils decreasing distally to the free end 32; it is noted each separate coil has a component that extends in the radial direction).
Regarding claim 3, Wensel further discloses wherein expanding the clot treatment device (30) includes allowing the clot treatment device (30) to self expand (Col. 2, l. 35- 40 - - The clot capture coil is made out of a solid elastic or superelastic material which has shape memory. The elasticity or superelasticity of the coil allows it to be deformed within the catheter and then to reform its original coil configuration when the coil is moved outside of the catheter lumen).
Regarding claim 10, Wensel further discloses wherein the method further comprises applying a vacuum through the guide catheter (12, 116, 110) to aspirate at least a portion of the clot material (22) into the guide catheter (12, 116, 110) (Col. 8, l. 28- 35 - - then the catheter, coil and clot are translated toward the distal end 116 of the introducing catheter 110. Once the clot and the coil are at the distal end 116, suction is applied via port 114 to suck part of the clot into the distal end 116. The suction helps to keep the clot within the coil. Then the introducing catheter 110, the catheter 12, the clot and the coil 30 are removed from the patient).
Regarding claim 21, Wensel further discloses wherein the clot treatment device (30) comprises a porous structure (See Fig. 2c - - showing coil having openings or pores through which blood can flow).
Claim(s) 11- 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wensel et al. (US Pat. No. 5,895,398) in view of Dubrul et al. (US Pub. No. 2010/0030256 A1). Dubrul is cited in the IDS filed 8/01/23.
Regarding claims 11- 13 and 15, Wensel discloses the method of claim 1, Wensel further disclosing
(claim 11) wherein applying the vacuum includes fluid communication with the guide catheter (12, 116, 110) (Col. 8, l. 28- 35 - - then the catheter, coil and clot are translated toward the distal end 116 of the introducing catheter 110. Once the clot and the coil are at the distal end 116, suction is applied via port 114 to suck part of the clot into the distal end 116. The suction helps to keep the clot within the coil. Then the introducing catheter 110, the catheter 12, the clot and the coil 30 are removed from the patient). But Wensel does not disclose
(claim 11) a syringe as claimed;
(claims 12- 13 and 15) a guide member as claimed.
However, Dubrul teaches a method of treating clot material at least partially restricting blood flow in the same field of endeavor (P. [0265])
(claim 11) wherein applying the vacuum includes activating a syringe in fluid communication with the guide catheter (60) (Figs. 9, 13) (Ps. [0149], [0152] - - catheter 60 extending from a proximal catheter end 62 to a distal catheter end 64. A radially collapsible funnel element 66 extends from distal catheter end 64; To remove occlusion 40, the user may pull on guide wire 10 causing expandable element 38 to drive occlusion 40 towards funnel 66; a suction force may be created in tube 82, typically using a vacuum syringe attached to fitting 84, and thus in a vacuum space 112 created between distal catheter end 64 and shaft 50 as shown in FIG. 18A);
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the method step of applying a vacuum through the guide catheter to aspirate at least a portion of the clot material into the guide catheter associated with Wensel in order to include a syringe as taught by Dubrul because a syringe would predictably apply a suction force in order drive a clot towards the guide catheter (Dubrul - - P. [0152]).
Modified Wensel does not disclose
(claims 12- 13 and 15) a guide member as claimed.
However, Dubrul teaches a method of treating clot material at least partially restricting blood flow in the same field of endeavor (P. [0265])
(claim 12) wherein advancing the clot treatment device includes advancing the clot treatment device through a guide catheter (60), and wherein the method further comprises: expanding a guide member (66) (Figs. 9, 12, 17- 18) coupled to a distal end portion (64) (Figs. 9, 9A, 18A) of the guide catheter (60); and retracting the clot treatment device (16, sometimes referred to as 38) (Figs. 1- 2, 6- 7, 16- 18) toward the guide member (66) and toward the guide catheter (60) (Figs. 17, 18) (Ps. [0141], [0149], [0152] - - A braided expandable element 16; A radially collapsible funnel element 66 extends from distal catheter end 64. Funnel element 66 is preferably a braided funnel element having a normally radially expanded state, shown in solid lines in FIG. 9, and a radially collapsed state, shown in dashed lines in FIG. 9; To permit funnel element 66 to expand, tearaway sleeve 92 is pulled proximally as indicated by arrows 106…To remove occlusion 40, the user may pull on guide wire 10 causing expandable element 38 to drive occlusion 40 towards funnel 66; it is noted that although the clot treatment device taught by Dubrul is not explicitly shown as contracting in order to enter the guide member and/or guide catheter, Wensel specifically teaches contracting the clot treatment device so as to enter the guide catheter such that Wensel in view of Dubrul encompasses and/or makes obvious retracting the clot treatment device associated with Wensel through the guide member and into the guide catheter);
(claim 13) wherein expanding the guide member (66) includes expanding the guide member (66) into apposition with a wall of the blood vessel to block blood flow past the guide member (60) (See Figs. 17, 18) (P. [0172] - - In the case of expanding the funnel and trying to occlude blood, it is important is that the funnel has an outward radial force onto the vessel so that it in fact occludes the vessel and stops blood flow);
(claim 15) wherein the guide member (66) has a tapered or funnel shape for guiding the clot material (40) into a distal opening in the guide catheter (60) (Ps. [0149], [0152], [0159] - - radially collapsible funnel element 66; To remove occlusion 40, the user may pull on guide wire 10 causing expandable element 38 to drive occlusion 40 towards funnel 66; a suction force may be created in tube 82, typically using a vacuum syringe attached to fitting 84, and thus in a vacuum space 112 created between distal catheter end 64 and shaft 50 as shown in FIG. 18A. Depending upon the composition of occlusion 40, the occlusion may be drawn completely into tube 82; the funnel shape shown in FIG. 28, to occlude blood flow to stop emboli from flowing downstream).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the method step of retracting the clot treatment device into the guide catheter associated with Wensel in order to include providing an expandable funnel-shaped guide member, expanding the expandable funnel-shaped guide member in apposition with a blood vessel wall and retracting the clot treatment device through the expandable funnel-shaped guide member according to the teachings of Dubrul because it would provide a radially expanded, passageway sealing state of said blood flow blocking element used for completely blocking passage of material around the outside of said catheter, thereby preventing emboli from flowing downstream (Dubrul - - Ps. [0028], [0159]).
Regarding claim 14, Wensel in view of Dubrul discloses the method of claim 12, Wensel does not disclose
(claim 14) wherein the guide member is a balloon.
However, Dubrul teaches a method of treating clot material at least partially restricting blood flow in the same field of endeavor (P. [0265])
(claim 14) wherein the guide member (296) (Figs. 52- 54) is a balloon (Ps. [0191], [0193] - - Another aspect of the invention relates to a funnel shaped balloon; A balloon funnel catheter 290 is shown in FIGS. 52-54. Catheter 290 includes a shaft 292 having a distal end 294 to which an annular balloon 296 is secured. Balloon 296 extends past distal end 294. Balloon 296 defines a central open region 298 aligned with a main lumen 300 of shaft 292. Shaft 292 also includes inflation lumen 302 opening into the interior 304 of balloon 296. Balloon 296 moves between the uninflated, radially contracted state of FIG. 52 and the inflated, radially expanded state of FIGS. 53 and 54. Open region 298 is funnel shaped when balloon 296 is in the inflated, radially expanded state).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute the balloon expandable funnel-shaped guide member in the embodiment of Figs. 52- 54 (P. [0193] - - A balloon funnel catheter 290 is shown in FIGS. 52-54) for the braided expandable funnel-shaped guide member in the embodiment of Figs. 9, 17- 18 (P. [0149] - - Funnel element 66 is preferably a braided funnel element), since the substitution would have yielded predictable results, namely, radially expanding into a tapered, funnel shape in order to block passage of clot material around the outside of the catheter and to permit the clot material to pass therethrough (Dubrul - - Ps. [0027], [0028]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Allowable Subject Matter
Claims 4- 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the applicable claim informalities and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 16- 18 and 20 would be allowable if rewritten to overcome applicable claim informalities, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 19 would be allowable if rewritten to overcome applicable claim informalities and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Regarding claim 16, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the clot treatment device comprises a porous structure that at least partially permits blood flow through the clot treatment device … expanding the clot treatment device within the blood vessel such that the clot treatment device includes a plurality of radially-extending portions and at least one cylindrical portion between a pair of the plurality of radially-extending portions, wherein the plurality of radially-extending portions have a greater diameter than the cylindrical portion, and wherein the plurality of radially-extending portions have a length along a longitudinal axis of the clot treatment device that is different than a length of the cylindrical portion; and retracting the clot treatment device at least partially through the clot material such that at least a portion of the clot material is captured by the clot treatment device.
Wensel (US Pub. No. 2006/0282111) does not teach or suggest, alone or in combination, wherein the clot treatment device comprises a porous structure that at least partially permits blood flow through the clot treatment device (See applicant’s Remarks, filed 10/15/25).
The closest cited reference Wensel et al. (US Pat. No. 5,895,398) teaches a viscoelastic coil (30) (Figs. 2a- 2e, 11) and does not teach or suggest, alone or in combination, expanding the clot treatment device within the blood vessel such that the clot treatment device includes a plurality of radially-extending portions and at least one cylindrical portion between a pair of the plurality of radially-extending portions, wherein the plurality of radially-extending portions have a greater diameter than the cylindrical portion, and wherein the plurality of radially-extending portions have a length along a longitudinal axis of the clot treatment device that is different than a length of the cylindrical portion.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771