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
In response to the amendment filed on 12/11/2025, Claims 9-11, 16-19, and 28 have been cancelled, and Claims 1-8, 12-15 and 20-27 are pending.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 12/11/2025 is acknowledged. Claims 20-21 has been withdrawn from further consideration and Claims 1-8, 12-15 and 22-27 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1708” has been used to designate both “external male threads” (Figure 113; Paragraph 0381 of instant specification PGPub) and “fixation tips” (Figure 117; Paragraph 0387 of instant specification PGPub). Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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 Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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) 22 and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGoldrick (US PGPub 2019/0021710).
Regarding Claim 22, McGoldrick teaches a vascular closure system for sealing an aperture in a wall of a body vessel (abstract), the system comprising:
a vascular closure device (100; Figure 1) (see also Figure 75) assembly comprising a closure pin (126; Figure 1A-B; Figure 17A-18A; Paragraph 0081 and Paragraph 0125), a flexible patch (106; Figure 1A-1B; Paragraph 0048), a scaffold (118; Figure 1A and Figure 2A) comprising a scaffold base (120) and scaffold neck (122) (Figures 2A and Figure 3A; Paragraph 0054) (see also Figure 74 in the which also disclose a base and neck for the scaffold), and an external fixation component (7301; Figures 7A-73B; Paragraph 0106), wherein the scaffold neck (as shown in Figure 74A) comprises multiple retaining tabs (7403) extending out of the scaffold neck (see Paragraph 0106-0107); and
a delivery device (500 as shown in Figure 5 and 7701 as shown in Figure 77) for delivery of the vascular closure device assembly (100) (see Paragraph 0110 which discusses using both in combination).
Regarding Claim 26, McGoldrick teaches the vascular closure system of claim 22, wherein the external fixation component (7301) has a cage-like structure (Figure 73A; Paragraph 0106).
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 (i.e., changing from AIA to pre-AIA ) 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, 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) 1-2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710) in view of Reynolds (US PGPub 2022/0110617).
Regarding Claim 1, McGoldrick teaches a vascular closure system for sealing an aperture in a wall of a body vessel, comprising:
an implantable closure device (100; Figure 1A; Paragraph 0048);
a delivery device (500) for delivery of the implantable closure device (100; Figure 5; Paragraph 0066); and
an introducer assembly comprising a sheath assembly (outer most sheath shown in Figure 1B, see Paragraph 0090 which discloses an introducer catheter) and a guidewire (202; Figure 1B).
McGoldrick fails to disclose:
a dilator assembly coaxially inside the sheath assembly.
Reynolds teaches a vessel closure system for sealing an aperture in a wall of a body vessel (abstract; see Figures 11A-11D), the system further comprising:
a dilator assembly (470; Figures 17A-17B; Paragraph 0146) disposed coaxially inside the sheath assembly (440; Figures 18 shows the sheath assembly and Figures 20A-20B shows the dilator assembly (470) being inserted into the sheath assembly; Paragraph 0150 and Paragraph 0153).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vascular closure system of McGoldrick to include a dilator assembly which is configured to be disposed coaxially inside the sheath assembly, as taught by Reynold, for the advantage of stretching the opening of the skin and access tract to allow placement of a closure device (Paragraph 0153; Reynolds).
Regarding Claim 2, the combination of references disclosed above teaches the vascular closure system of claim 1, McGoldrick teaches the implantable device (Figures 1A-1B and Figure 75) comprising:
an external fixation (126; Figure 1A-1B) disposed on the outside (116; Figure 1B) of the vessel wall (110; as seen in Figure 1B; Paragraph 0053) (see also Figures 75-76C; Paragraph 0110 which states that this element is on the outside of the vessel);
a scaffold (120; Figure 1B) disposed on the inside (108) of the vessel wall (110) and interfacing with the external fixation (126; Figure 1B) (see also Figures 75 in which the scaffold is the bottom plate), with at least a portion of the scaffold (120) disposed through an aperture (112; Figure 1B) in the vessel wall (110; as disclosed in Paragraph 0048); and
a patch (106) disposed on the inside (108) of the vessel wall (110) and sandwiched between the external fixation (126; Figures 1A-1B) and the scaffold (104), with the patch (106) substantially covering the full area of the aperture (112; Figures 1B), thereby sealing the aperture (112; Paragraph 0046 and 0084).
Regarding Claim 15, McCormick teaches the vascular closure system of claim 1, wherein the delivery device comprises:
a first shaft (500; Figure 5; Paragraph 0110), a second shaft (external shaft 7703; Figure 77; Paragraph 0110), and a third shaft (shoe pusher; Figure 77; Paragraph 0111), wherein each shaft is releasably coupled to a component of the implantable closure device for moving the implantable closure device into position at the aperture (as described in Paragraph 0110-0111).
Claim(s) 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710) in view of Reynolds (US PGPub 2022/0110617) as applied to claim 1 above, and further in view of Grant (US PGPub 2017/0333014).
Regarding Claim 3, the combination of references disclosed above teaches the vascular closure system of claim 1, McGoldrick teaches wherein the delivery device comprises:
a first shaft (500; Figure 5; Paragraph 0110), a second shaft (external shaft 7703; Figure 77; Paragraph 0110), and a third shaft (shoe pusher; Figure 77; Paragraph 0111), wherein each shaft is releasably coupled to a component of the implantable closure device for moving the implantable closure device into position at the aperture (as described in Paragraph 0110-0111);
wherein at least one shaft of the first (500), second (7703), and third shafts (shoe pusher) is disposed concentrically within at least one other shaft of the first, second, and third shafts (Paragraph 0110-0111), and
a cannula assembly (2202) for holding the implantable closure device prior to positioning the implantable closure device at the aperture (Figures 21A-22; Paragraph 0093)
The combination of references disclosed above fails to disclose:
a handle, comprising:
three cams disposed in linear arrangement with a first cam disposed adjacent to the distal end of the handle, a second cam disposed proximally from the first cam, and a third cam disposed proximally from the second cam, the three cams at least partially forming the outer structure of the handle, wherein each of the three cams interacts with a corresponding first hub, second hub, and third hub disposed radially inward of each cam.
Grant teaches a vascular closure system (abstract; Figure 1) comprising:
a handle, comprising:
two cams (sheath cam and back cam; Figures 14-17; Paragraph 0130-0131) disposed in linear arrangement with a first cam (sheath cam; Figure 15) disposed adjacent to the distal end of the handle, a second cam (back cam; Figure 17) disposed proximally from the first cam (Figures 14-17), the two cams at least partially forming the outer structure of the handle (as shown in Figures 14-16), wherein each of the cams interacts with a corresponding hub (sheath hub, retainer sleeve hub, push tube hub; Paragraph 0031) disposed radially inward of each cam (Paragraph 0128 and 0131).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of the combination of references to include the cam/hub/handle teachings of Grant for the advantage of using the markings on the cylindrical handle to accurately deploy the medical device and the advantage of not needing linear slideable actuators which would be limited in their precision since the hubs can be rotated many times about the circumference.
Grant fails to explicitly disclose a third cam/hub arrangement for the third shaft on the handle.
Since the combination of references discloses above the claimed invention except for a third cam for the third shaft, It would have been obvious to one having ordinary skill in the art at the time the invention was made to add a third cam to actuate a third shaft, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding Claim 4, the combination of references disclosed above teaches the vascular closure system of claim 3, Grant teaches wherein each of the cams comprises a hollow cylinder comprising ridges parallel to the axis of the cylinder on the outer surface of the cylinder (as seen in Figure 14; also Paragraph 0131 states that the lines can be engravings).
Regarding Claim 5, the combination of referenced disclosed above teaches the vascular closure system of claim 4, wherein Grant teaches
wherein each of the first cam, the second cam, and the third cam comprises a helical track on the inner surface of each cylinder (Figures 13 and 16, and
wherein each of the first hub, the second hub, and the third hub comprises two cam follower protrusions to interface with the helical tracks of each of the first cam, second cam, and third cam to convert rotational movement of the cams into linear movement of the hubs (as disclosed in Paragraph 0047; Figure 16).
Regarding Claim 6, the combination of references disclosed above teaches the vascular closure system of claim 5, wherein Grant teaches the rotational movement of the cams is converted into rotational movement of the hubs (Paragraph 0010, 0047, and 0164).
Regarding Claim 7, the combination of references disclosed above teaches the vascular closure system of claim 3, wherein Grant teaches the handle comprises at least one cam lock (3) for releasably stopping movement of at least one cam, wherein the cam lock comprises a depressible button (Figure 16; Paragraph 0131).
Regarding Claim 8, the combination of references disclosed above teaches the vascular closure system of claim 1, wherein Grant teaches the closure system further comprises a packaging tray and lid assembly containing the delivery device and implantable closure device (Figure 3; Paragraph 0042), the packaging tray and lid assembly comprising:
a packaging tray for holding the delivery device and a packaging funnel (Figure 3); and
a packaging lid releasably coupled to the packaging tray to retain the delivery device (Paragraph 0129),
wherein the packaging funnel contains the implantable closure device, wherein the packaging funnel is positioned at the distal end of the delivery device, and wherein one, two, or all three of (i), (ii), and (iii) as follows applies:
the packaging tray comprises a rectangular exterior and an interior shaped to match the external shape of the delivery device and the packaging funnel (Figure 3),
the packaging lid comprises a plurality of protrusions that are releasably pressed into a plurality of indentations on the outer rim of the upper surface of the packaging tray, and
the packaging funnel comprises a mouth, a tapered stem, a spout, and a lever connected to the spout via a hinge for releasably coupling the packaging funnel to a portion of the delivery device (Paragraph 0042; Figure 3).
It would have been obvious to one of ordinary skill in the art to modify the combination of references to include a packaging tray as taught by Grant since medical devices are well known to need sterile storage.
Regarding Claim 14, the combination of references disclosed above teach the vascular closure system of claim 3, wherein McGoldrick teaches wherein the cannula assembly (Figures 21A) comprises:
a cannula body (2102; Figure 21A) comprising a hollow cylindrical body, a flange (2104) at the distal end of the cannula body, and a protrusion (2106) on the distal surface of the flange (Figures 21A-21C; Paragraph 0090-0093);
a cannula tube (2202) comprising a hollow cylinder disposed within the interior lumen of the cannula body (Figure 21A; Paragraph 0090); and
a cannula cap (second offset surface or third s) disposed at the proximal end of the cannula body (Paragraph 0092).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710) in view of Reynolds (US PGPub 2022/0110617) as applied to claim 1 above, and further in view of Grant (US PGPub 2017/0333014) and Matsumoto (US Patent 4,610,665).
Regarding Claim 12, the combination of references teaches the vascular closure system of claim 1, but fails to disclose wherein the sheath assembly comprises:
a sheath shaft comprising a hollow cylinder and evenly spaced distance markings on the exterior surface of the hollow cylinder;
a sheath hub comprising a proximal mouth opening, a distal primary opening connected to the proximal end of the sheath shaft, and a flush tube opening disposed at an angle from the distal primary opening;
a flush tube connected to the flush tube opening;
a three-way stopcock valve connected to the distal end of the flush tube; and
a sheath seal disposed within the proximal mouth opening of the sheath hub, the sheath seal comprising a flexible polymeric disc with a linear slit disposed in the center of the flexible polymeric disc.
Grant teaches a vascular closure device comprising a sheath assembly comprising:
a sheath shaft comprising a hollow cylinder and evenly spaced distance markings on the exterior surface of the hollow cylinder (Figure 9B; Paragraph 0126);
a sheath hub comprising a proximal mouth opening, a distal primary opening connected to the proximal end of the sheath shaft (Figure 9B; Paragraph 0128), and
a sheath seal (hemostasis valve) disposed within the proximal mouth opening of the sheath hub, the sheath seal comprising a flexible polymeric disc with a linear slit disposed in the center of the flexible polymeric disc (Figure 9B).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the sheath taught by the combination of references with the sheath as taught by Grant since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the sheath of Grant provides the advantage of making a tight seal around medical devices disposed within the sheath and providing indicia on the outside of the shaft for determining penetration depth.
The combination of references disclosed above fails to disclose:
the sheath seal is polymeric;
a flush tube opening disposed at an angle from the distal primary opening;
a flush tube connected to the flush tube opening;
a three-way stopcock valve connected to the distal end of the flush tube
Matsumoto teaches a medical instrument comprising:
the sheath seal is (16; Figure 4) polymeric (Column 1, Lines 40-41);
a flush tube opening (which is connected to element 34) disposed at an angle from the distal primary opening (primary opening is distal tip of 13, closest to element 32, 32B, and 31; Figure 8);
a flush tube (34) connected to the flush tube opening (Figure 8);
a three-way stopcock valve (34A) connected to the distal end of the flush tube (34; Figure 9).
It is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the seal of Grant using the materials as taught by Matsumoto, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the sheath of Grant to include a flush tube opening and a three-way stopcock valve for the advantage of an indication of blood flow back and for the advantage of providing structure for introducing medication to the patient.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710) in view of Reynolds (US PGPub 2022/0110617) as applied to claim 2 above, and further in view of Matsumoto (US Patent 4,610,665)
Regarding Claim 13, the combination of references disclosed above teaches the vascular closure system of claim 2, wherein Reynolds teaches the dilator assembly (Figures 17A-17B) comprises:
a dilator shaft (456) comprising a hollow cylinder (Paragraph 0147) with a tapered distal end (457; Figures 17A-17B);
a dilator hub (458) comprising a proximal mouth opening (Figure 17A), two spring clips (459) that can be releasably coupled with the sheath hub (418; Figures 20A-20B);
Reynolds fails to disclose a dilator insert comprising a cylindrical body and a narrowed interior lumen.
Matsumoto teaches a medical instrument (Figures 1-7, 10, 13-15, 17, 19-25B) having a hub (Figure 1-7, Figure 10) attached to shafts (Figures 1-7, 10, 13-15, 17, 19-25B). Specifically in Figure 10, Matsumoto teaches a hub (41) attached to a shaft (43) for housing a guidewire (49), in which the hub (41) comprises an insert (16) comprising a cylindrical body and a narrowed interior lumen (18) for the purpose of maintaining a liquid-tight state (Column 5, Lines 10-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the dilator hub taught by Reynolds to include the teachings of Matsumoto for the advantage of maintaining a liquid-tight state with medical devices disposed within the dilator.
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710) as applied to claim 22 above, and further in view of Grant (US PGPub 2017/0333014)
Regarding Claim 23, McGoldrick teaches the vascular closure system of claim 22, but fails to disclose wherein the delivery device for delivery of the vascular closure device comprises one or more rotatable fixation cams.
Grant teaches a vascular closure system (abstract; Figure 1) comprising: a handle, comprising one or more rotatable fixation cams (sheath cam and back cam; Figures 14-17; Paragraph 0130-0131)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of the combination of references to include the cam/hub/handle teachings of Grant for the advantage of not needing slidable actuators which would be limited in their precision since the hubs can be rotated many times about the circumference.
Regarding Claim 24, the combination of references disclosed above teaches the vascular closure system of claim 23, wherein Grant teaches the one or more rotatable fixation cams are rotatable to perform one, two, or all three of (i), (ii), and (iii) as follows: (i) retract an introducer sheath, (ii) push the external fixation component toward the scaffold and snap onto the scaffold, and (iii) deploy a guidewire hole blocking pin and release the vascular closure device (Paragraph 0007, 0010, 0047, 0130, and 0131).
Regarding Claim 25, the combination of references disclosed above teaches the vascular closure system of claim 23, wherein Grant teaches the one or more rotatable fixation cams comprises one or more cams rotatable to push a guidewire pin into the scaffold and simultaneously detach the scaffold from a bayonet of a delivery shaft of the delivery device (Paragraph 0047, 0128, 0131).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710), as applied to claim 22 above, and further in view of Reynolds (US PGPub 2022/0110617).
Regarding Claim 27, McGoldrick teaches the vascular closure system of claim 22, wherein the delivery device ((500; Figure 5) and (7701; Figure 77)) for delivery of the vascular closure device assembly comprises:
one or more shafts each releasably coupled to a component of the vascular closure device assembly for moving the implantable vascular closure device assembly into position (Paragraph 0110); and
an introducer assembly comprising a sheath assembly (as disclosed in Paragraph 0090), and a guidewire (202; Figure 1B; Paragraph 0094)).
McGoldrick fails to disclose:
a dilator assembly coaxially inside the sheath assembly.
Reynolds teaches a vessel closure system for sealing an aperture in a wall of a body vessel (abstract; see Figures 11A-11D), the system further comprising:
a dilator assembly (470; Figures 17A-17B; Paragraph 0146) disposed coaxially inside the sheath assembly (440; Figures 18 shows the sheath assembly and Figures 20A-20B shows the dilator assembly (470) being inserted into the sheath assembly; Paragraph 0150 and Paragraph 0153).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the vascular closure system of McGoldrick to include a dilator assembly which is configured to be disposed coaxially inside the sheath assembly, as taught by Reynold, for the advantage of stretching the opening of the skin and access tract to allow placement of a closure device (Paragraph 0153; Reynolds).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771