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 05/15/25 has been entered. Claims 1-20 have been cancelled, and new claims 21-39 have been amended. Claims 21-39 are addressed in the following office action.
Claim Objections
Claims 21, 33-34, and 36 objected to because of the following informalities:
In claim 21, line 3: “the catheter” should be “the guide catheter”.
In claim 21, line 12: “a clot treatment” should be “a clot treatment device”.
In claim 33, line 1: “The clot treatment system” should be “The system”.
In claim 34, line 3: “the catheter” should be “the guide catheter”.
In claim 34, line 7: “generate vacuum” should be “generate vacuum pressure”.
In claim 34, line 11: “clot treatment” should be “clot treatment device”.
In claim 34, lines 13-14: “catheter, a shaft, and an expandable member having a proximal end portion secured to the shaft, and wherein” should be deleted.
In claim 36, line 1: “the syringe” should be “the pressure source comprising a syringe, wherein the syringe”.
Appropriate correction is required.
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.
Claims 21-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrison et al. (US 2013/0035628) which incorporates by reference Rosenbluth et al. (US 6,685,722).
Regarding claim 21, an invention relating to a device for removing obstructions in blood vessels, Garrison discloses (Figs. 1, 17, 22) a system for treating clot material in the vasculature of a patient (Abstract) [Note, certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment, and conversely various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination (Par. 0137)], the system comprising: a guide catheter (2010) defining a lumen [i.e. internal lumen] (Par. 0046) and having a distal end portion [i.e. the distal portion of element 2010 within CCA] (Fig. 1), wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material [i.e. the atrial access device is near or at the face of the occlusion] (Par. 0046, 0081, 0083, 0085); a syringe having a barrel [i.e. VacLok Syringe; Note applicant’s original disclosure details in paragraph 0038 a vacuum pressure source, the details of which are disclosed in U.S. Patent Application No. 16/536,185, filed August 8, 2019, and titled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS," which is incorporated herein by reference in its entirety. The incorporated reference details the trademark “VacLok” syringe by Merit Medical Sytem, Inc. in paragraph 0054 of the application’s original disclosure], wherein the syringe is actuatable to generate vacuum pressure in the barrel, wherein the barrel is configured to store the vacuum pressure, and wherein the syringe is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored in the barrel to the lumen to aspirate at least a first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137); and a clot treatment device (4100) [Note, it should be appreciated that other mechanical thrombectomy catheters may be used in a similar manner with the vascular access and reverse flow system as described above. Mechanical thrombectomy devices may include variations on the thrombus retrieval device described earlier. Rosenbluth et al. (US 6,685,722) is an exemplary device which is incorporated by reference in its entirety, and is referred to for the disclosure of the clot treatment device (Par. 0105)] comprising a delivery catheter (11 & 12; Fig. 1A), a shaft (24; Fig. 2A; Col. 12, line 25), and an expandable member (14; Fig. 1A) having a proximal end portion secured to the shaft [i.e. portion of elements 20; Fig. 2A inside the catheter in figure 1A ] (Col. 12, lines 19-21), wherein the expandable member includes a plurality of interconnected struts (20) forming a unitary structure [i.e. basket with pores and openings formed from helical wound wires and wire proximal portions acting as connecting members] movable between a compressed configuration within the delivery catheter and an expanded configuration outside the delivery catheter Col. 11, line 39-61 & Col. 12, lines 3-17, in the expanded configuration, the unitary structure comprises (a) a proximal conical region extending from the proximal end portion, (b) a cylindrical region extending from the proximal conical region, and (c) a distal conical region extending from the cylindrical region to a distal end portion [i.e. portion of elements 20 within element 30 (Figs. 2A-B)] of the expandable member (see annotated figure below), the clot treatment device is configured to be inserted through the guide catheter with the expandable member in the compressed configuration within the delivery catheter, the clot treatment device is configured to be moved to the expanded configuration outside the delivery catheter distal to the guide catheter, and the expandable member is configured to be retracted proximally in the expanded configuration to capture at least a second portion of the clot material that remains in the blood vessel after aspiration of the first portion of the clot material [Note, the language, “configured to/for" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "Configured for/to," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Garrison which incorporates by reference Rosenbluth meets the structural limitations of the claim] (Par. 0011, 0046, 0083, 0085, 0097, 0105, 0112, 0137) [see Rosenbluth’s Col. 18, lines 54-61].
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Regarding claim 22, Garrison discloses the system of claim 21. Garrison further discloses wherein the clot treatment device further comprises a distal tip coupled to the distal end portion of the expandable member [i.e. nose cone 30 mounted on the distal end of the receptacle, see incorporated reference Rosenbluth figure 2A and column 13, lines 1-10].
Regarding claim 23, Garrison discloses the system of claim 22. Garrison further discloses wherein the distal tip is configured to abut a distal end of the delivery catheter when the expandable member is in the compressed configuration within the delivery catheter [i.e. nose cone abuts a distal end of catheter tip member 28 while the receptacle is in a substantially straight configuration in the catheter, see incorporated reference Rosenbluth figure 2A and column 13, lines 1-10].
Regarding claim 24, Garrison discloses the system of claim 21. Garrison further discloses wherein the struts of the expandable member form first cells in the proximal conical region and second cells in the distal conical region, and wherein the first cells are larger than the second cells [see incorporated reference Rosenbluth figure 1A and column 11, lines 54-67].
Regarding claim 25. Garrison discloses the system of claim 21. Garrison further discloses wherein the shaft is a first shaft, and wherein the clot treatment device further comprises a second shaft extending through the first shaft and coupled to the distal end portion of the expandable member [i.e. the guidewire GW extending through proximal actuator shaft 24 and coupled to the distal portion via nose cone 30; see incorporated reference Rosenbluth figure 1A and column 18, line 42].
Regarding claim 26, Garrison discloses the system of claim 21. Garrison further discloses (Fig. 17) wherein the syringe is fluidly coupled to the lumen of the guide catheter via a valve (3325) [Note, the active aspiration source of VacLok Syringe is fluidly coupled to the lumen of the arterial access device via the valve (Par. 0082-0083 & 0085)], wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel (Par. 0011, 0083, 0085, 0112, 0137).
Regarding claim 27, Garrison discloses the system of claim 26. Garrison further discloses wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137).
Regarding claim 28, Garrison discloses the system of claim 21. Garrison further discloses wherein the expandable member is further configured to be retracted in the expanded configuration into the lumen of the guide catheter with the captured second portion of the clot material (Par. 0097) [Note, Garrison describes withdrawing an expandable member of the clot treatment device to capture some clot material and being withdrawn into the arterial access sheath, and this would be done with the expandable member of Rosenbluth’s device. It would be withdrawn into the sheath in the expanded configuration to accommodate the captured clot material within the expandable member] (Par. 0097) [see Rosenbluth’s Col. 18, lines 54-61].
Regarding claim 29, Garrison discloses the system of claim 21. Garrison further discloses wherein the struts of the expandable member are configured to self-expand from the compressed configuration to the expanded configuration when the expandable member is outside the delivery catheter [i.e. preformed wire members self-recoil when relieved of the surrounding retrain of the catheter; see Rosenbluth’s column 12, lines 10-17].
Regarding claim 30, Garrison discloses the system of claim 21. Garrison further discloses wherein the struts of the clot treatment device include a shape memory material [see Rosenbluth’s column 12, lines 3-5).
Regarding claim 31, Garrison discloses the system of claim 21. Garrison further discloses wherein the syringe is a vacuum-pressure locking syringe (Par. 0085).
Regarding claim 32, Garrison discloses the system of claim 21. Garrison is capable of retrieving the clot material comprising a pulmonary embolism [Note, the thrombectomy device can be 80-120 cm which is more than long enough to reach a pulmonary embolism (Par. 0094)].
Regarding claim 33, Garrison discloses the clot treatment system of claim 21. Garrison is capable of retrieving the clot material comprising a deep vein thrombosis [Note, the thrombectomy device can be 80-120 cm which is more than long enough to reach a deep vein thrombosis (Par. 0094)].
Regarding claim 34, an invention relating to a device for removing obstructions in blood vessels, Garrison discloses (Figs. 1, 17, 22) a system for treating clot material in the vasculature of a patient (Abstract) [Note, certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment, and conversely various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination (Par. 0137)], the system comprising: a guide catheter (2010) defining a lumen [i.e. internal lumen] (Par. 0046) and having a distal end portion [i.e. the distal portion of element 2010 within CCA] (Fig. 1), wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material [i.e. the atrial access device is near or at the face of the occlusion] (Par. 0046, 0081, 0083, 0085); a pressure source [i.e. VacLok Syringe; Note applicant’s original disclosure details in paragraph 0038 a vacuum pressure source, the details of which are disclosed in U.S. Patent Application No. 16/536,185, filed August 8, 2019, and titled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS," which is incorporated herein by reference in its entirety. The incorporated reference details the trademark “VacLok” syringe by Merit Medical Sytem, Inc. in paragraph 0054 of the application’s original disclosure] configured to generate vacuum and to store the vacuum pressure, wherein the pressure source is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored therein to the lumen to aspirate at least a first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137); and a clot treatment device (4100) [Note, it should be appreciated that other mechanical thrombectomy catheters may be used in a similar manner with the vascular access and reverse flow system as described above. Mechanical thrombectomy devices may include variations on the thrombus retrieval device described earlier. Rosenbluth et al. (US 6,685,722) is an exemplary device which is incorporated by reference in its entirety, and is referred to for the disclosure of the clot treatment device (Par. 0105)] comprising a delivery catheter (11 & 12; Fig. 1A), a shaft (24; Fig. 2A; Col. 12, line 25), and an expandable member (14; Fig. 1A) having a proximal end portion secured to the shaft [i.e. portion of elements 20; Fig. 2A inside the catheter in figure 1A ] (Col. 12, lines 19-21), wherein the expandable member includes a plurality of interconnected struts (20) forming a unitary structure [i.e. basket with pores and openings formed from helical wound wires and wire proximal portions acting as connecting members] movable between a compressed configuration within the delivery catheter and an expanded configuration outside the delivery catheter (Col. 11, line 39-61 & Col. 12, lines 3-17), in the expanded configuration, the unitary structure comprises (a) a proximal conical region extending from the proximal end portion, (b) a cylindrical region extending from the proximal conical region, and (c) a distal conical region extending from the cylindrical region to a distal end portion [i.e. portion of elements 20 within element 30 (Figs. 2A-B)] of the expandable member (see annotated figure below), the clot treatment device is configured to be inserted through the guide catheter with the expandable member in the compressed configuration within the delivery catheter, the clot treatment device is configured to be moved to the expanded configuration outside the delivery catheter distal to the guide catheter, and the expandable member is configured to be retracted proximally in the expanded configuration to capture at least a second portion of the clot material that remains in the blood vessel after aspiration of the first portion of the clot material [Note, the language, “configured to/for" merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "Configured for/to," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Garrison which incorporates by reference Rosenbluth meets the structural limitations of the claim] (Par. 0011, 0046, 0083, 0085, 0097, 0105, 0112, 0137) [see Rosenbluth’s Col. 18, lines 54-61].
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Regarding claim 35, Garrison discloses the system of claim 34. Garrison further discloses wherein the clot treatment device further comprises a distal tip coupled to the distal end portion of the expandable member, and wherein the distal tip is configured to abut a distal end of the delivery catheter when the expandable member is in the compressed configuration within the delivery catheter [i.e. nose cone 30 mounted on the distal end of the receptacle, and abuts a distal end of catheter tip member 28 while the receptacle is in a substantially straight configuration in the catheter, see incorporated reference Rosenbluth figure 2A and column 13, lines 1-10].
Regarding claim 36, Garrison discloses the system of claim 34. Garrison further discloses (Fig. 17) wherein the pressure source comprises a syringe [i.e. VacLok Syringe], wherein the syringe is fluidly coupled to the lumen of the guide catheter via a valve (3325) [Note, the active aspiration source of VacLok Syringe is fluidly coupled to the lumen of the arterial access device via the valve (Par. 0082-0083 & 0085)], wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel (Par. 0083), wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137).
Regarding claim 37, Garrison discloses the system of claim 34. Garrison further discloses wherein the clot material comprises a pulmonary embolism or deep vein thrombosis [Note, the thrombectomy device can be 80-120 cm which is more than long enough to reach a pulmonary embolism (Par. 0094)].
Regarding claim 38, Garrison discloses the system of claim 34. Garrison further discloses wherein the expandable member is further configured to be retracted in the expanded configuration into the lumen of the guide catheter with the captured second portion of the clot material (Par. 0097) [Note, Garrison describes withdrawing an expandable member of the clot treatment device to capture some clot material and being withdrawn into the arterial access sheath, and this would be done with the expandable member of Rosenbluth’s device. It would be withdrawn into the sheath in the expanded configuration to accommodate the captured clot material within the expandable member] (Par. 0097) [see Rosenbluth’s Col. 18, lines 54-61].
Regarding claim 39, Garrison discloses the system of claim 34. Garrison further discloses wherein the struts of the expandable member are configured to self-expand from the compressed configuration to the expanded configuration when the expandable member is outside the delivery catheter [i.e. preformed wire members self-recoil when relieved of the surrounding retrain of the catheter; see Rosenbluth’s column 12, lines 10-17].
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-10 of U.S. Patent No. 11,864,779 in view of Garrison et al. (US 2013/0035628).
Claims
19/066,855
21
22
23
24
25
26
Claims
US Patent No
11,864,779
1
1
1
1
1
1
Claims
19/066,855
27
28
29
30
31
32
Claims
US Patent No
11,864,779
1
1
9
10
1
1
Claims
19/066,855
33
34
35
36
37
38
Claims
US Patent No
11,864,779
1
1
1
1
1
1
Claims
19/066,855
39
Claims
US Patent No
11,864,779
9
Claim 1 of Patent No. 11,864,779 fails to claim a guide catheter defining a lumen and having a distal end portion, wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material; a syringe having a barrel, wherein the syringe is actuatable to generate vacuum pressure in the barrel, wherein the barrel is configured to store the vacuum pressure, and wherein the syringe is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored in the barrel to the lumen to aspirate at least a first portion of the clot material into the lumen [In Claim 21 of application 19/066,855]. Note, Claim 1 of Patent No. 11,864,779 does not explicitly claim the clot treatment device is configured to be inserted through the guide catheter with the expandable member in the compressed configuration within the delivery catheter, the clot treatment device is configured to be moved to the expanded configuration outside the delivery catheter distal to the guide catheter, and the expandable member is configured to be retracted proximally in the expanded configuration to capture at least a second portion of the clot material that remains in the blood vessel after aspiration of the first portion of the clot material [In Claim 21 of application 19/066,855]. However, these are functional limitations that the claimed structure is capable of performing. Also, Claim 1 of Patent No. 11,864,779 fails to claim the syringe is fluidly coupled to the lumen of the guide catheter via a valve, wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel [In Claim 26 of application 19/066,855]; wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen [In Claim 27 of application 19/066,855]; and wherein the syringe is a vacuum-pressure locking syringe [In Claim 31 of application 19/066,855]. Note, Claim 1 of Patent No. 11,864,779 does not explicitly claim the expandable member is further configured to be retracted in the expanded configuration into the lumen of the guide catheter with the captured second portion of the clot material [In Claim 28 of application 19/066,855], the clot material comprises a pulmonary embolism [In Claim 32 of application 19/066,855], and wherein the clot material comprises a deep vein thrombosis [In Claim 33 of application 19/066,855]. However, these are functional limitations, and the claimed structure capable of performing the described function and is capable of retrieving the specified clot material.
In the same field of endeavor, which are devices for removing obstructions in blood vessels, Garrison teaches (Figs. 1, 17, 22) a guide catheter (2010) defining a lumen [i.e. internal lumen] (Par. 0046) and having a distal end portion [i.e. the distal portion of element 2010 within CCA] (Fig. 1), wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material [i.e. the atrial access device is near or at the face of the occlusion] (Par. 0046, 0081, 0083, 0085); a syringe having a barrel [i.e. VacLok Syringe; Note applicant’s original disclosure details in paragraph 0038 a vacuum pressure source, the details of which are disclosed in U.S. Patent Application No. 16/536,185, filed August 8, 2019, and titled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS," which is incorporated herein by reference in its entirety. The incorporated reference details the trademark “VacLok” syringe by Merit Medical Sytem, Inc. in paragraph 0054 of the application’s original disclosure], wherein the syringe is actuatable to generate vacuum pressure in the barrel, wherein the barrel is configured to store the vacuum pressure, and wherein the syringe is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored in the barrel to the lumen to aspirate at least a first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137); the syringe is fluidly coupled to the lumen of the guide catheter via a valve (3325) [Note, the active aspiration source of VacLok Syringe is fluidly coupled to the lumen of the arterial access device via the valve (Par. 0082-0083 & 0085)], wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel (Par. 0011, 0083, 0085, 0112, 0137); wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137); and wherein the syringe is a vacuum-pressure locking syringe (Par. 0085).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Patent No. 11,864,779 to have a guide catheter defining a lumen and having a distal end portion, wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material; a syringe having a barrel, wherein the syringe is actuatable to generate vacuum pressure in the barrel, wherein the barrel is configured to store the vacuum pressure, and wherein the syringe is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored in the barrel to the lumen to aspirate at least a first portion of the clot material into the lumen; the syringe is fluidly coupled to the lumen of the guide catheter via a valve, wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel; wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen; and wherein the syringe is a vacuum-pressure locking syringe. Doing so would aid in the removal of the clot and reduce the risk of emboli (Par. 0006), as taught by Garrison.
Claim 1 of Patent No. 11,864,779 fails to claim a guide catheter defining a lumen and having a distal end portion, wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material; a pressure source configured to generate vacuum and to store the vacuum pressure, wherein the pressure source is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored therein to the lumen to aspirate at least a first portion of the clot material into the lumen [In Claim 34 of application 19/066,855]. Note, Claim 1 of Patent No. 11,864,779 does not explicitly claim the clot treatment device is configured to be inserted through the guide catheter with the expandable member in the compressed configuration within the delivery catheter, the clot treatment device is configured to be moved to the expanded configuration outside the delivery catheter distal to the guide catheter, and the expandable member is configured to be retracted proximally in the expanded configuration to capture at least a second portion of the clot material that remains in the blood vessel after aspiration of the first portion of the clot material [In Claim 34 of application 19/066,855]. However, these are functional limitations that the claimed structure is capable of performing. Also, Claim 1 of Patent No. 11,864,779 fails to claim the syringe is fluidly coupled to the lumen of the guide catheter via a valve, wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel, wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen [In Claim 36 of application 19/066,855]. Note, Claim 1 of Patent No. 11,864,779 does not explicitly claim the clot material comprises a pulmonary embolism or deep vein thrombosis [In Claim 37 of application 19/066,855], and wherein the expandable member is further configured to be retracted in the expanded configuration into the lumen of the guide catheter with the captured second portion of the clot material [In Claim 38 of application 19/066,855]. However, these are functional limitations, and the claimed structure capable of performing the described function and is capable of retrieving the specified clot material.
In the same field of endeavor, which are devices for removing obstructions in blood vessels, Garrison teaches (Figs. 1, 17, 22) a guide catheter (2010) defining a lumen [i.e. internal lumen] (Par. 0046) and having a distal end portion [i.e. the distal portion of element 2010 within CCA] (Fig. 1), wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material [i.e. the atrial access device is near or at the face of the occlusion] (Par. 0046, 0081, 0083, 0085); a pressure source [i.e. VacLok Syringe; Note applicant’s original disclosure details in paragraph 0038 a vacuum pressure source, the details of which are disclosed in U.S. Patent Application No. 16/536,185, filed August 8, 2019, and titled "SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED DEVICES AND METHODS," which is incorporated herein by reference in its entirety. The incorporated reference details the trademark “VacLok” syringe by Merit Medical Sytem, Inc. in paragraph 0054 of the application’s original disclosure] configured to generate vacuum and to store the vacuum pressure, wherein the pressure source is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored therein to the lumen to aspirate at least a first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137); the syringe [i.e. VacLok Syringe] is fluidly coupled to the lumen of the guide catheter via a valve (3325) [Note, the active aspiration source of VacLok Syringe is fluidly coupled to the lumen of the arterial access device via the valve (Par. 0082-0083 & 0085)], wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel (Par. 0083), wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen (Par. 0011, 0083, 0085, 0112, 0137).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Patent No. 11,864,779 to have a guide catheter defining a lumen and having a distal end portion, wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the guide catheter is positioned proximate to the clot material; a pressure source configured to generate vacuum and to store the vacuum pressure, wherein the pressure source is configured to be fluidly coupled to the lumen of the guide catheter to apply the vacuum pressure stored therein to the lumen to aspirate at least a first portion of the clot material into the lumen; the syringe is fluidly coupled to the lumen of the guide catheter via a valve, wherein the valve is movable between (a) a first position that inhibits fluid flow from the lumen of the guide catheter to the barrel and (b) a second position that permits fluid flow from the lumen of the guide catheter to the barrel, wherein the syringe is configured to be actuated to generate the vacuum pressure in the barrel with the valve in the first position, and wherein the valve is movable from the first position to the second position while the vacuum pressure is stored in the barrel, thereby applying the vacuum pressure to the lumen of the guide catheter to aspirate the first portion of the clot material into the lumen. Doing so would aid in the removal of the clot and reduce the risk of emboli (Par. 0006), as taught by Garrison.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
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/CHIMA U IGBOKO/Examiner, Art Unit 3771
