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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/17/2026 has been entered.
Response to Arguments
Applicant argues in the response filed 08/17/2026 that amendments would overcome the claim objection, and 102/103 prior art rejections. The previous objection and 102/103 rejections have been withdrawn.
The applicant argues the double patenting rejection be held in abeyance until allowable claims or subject matter are otherwise identified. The examiner acknowledges the request but the double patenting rejections are still made below.
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 2-6, 11, 12, 14, 15, 19, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,555,727. Although the claims at issue are not identical, they are not patentably distinct from each other because, with respect to the instant application’s claim 2, the reference patent claims a vascular closure system comprising a sealing device (claim 1) configured to seal a puncture of a blood vessel, a delivery assembly (claim 1) that releasably holds the sealing device, a guide wire (claim 1) positionable in the blood vessel, a guide member (claim 1) configured to slide along the guide wire through the delivery assembly, the guide member comprising a tubular guide body (claim 1, the moveable guide body has a lumen which will read on the tubular guide body) that is elongated along a longitudinal axis (claim 1), the tubular guide body having an outer surface (the body will inherently have an outer surface opposite the lumen), a distal end (claim 1), a proximal end opposite the distal end along the longitudinal axis (claim 1), a lumen (claim 1) that extends along the longitudinal axis from the distal end toward the proximal end, wherein the lumen is sized to receive the guide wire such that air is entrapped within the lumen when the guide wire is received in the lumen (the lumen does receive the guide wire as well as having the claimed structure, therefore can perform the function of entrapping air when the guide wire is received within the lumen); wherein the tubular guide body is configured to extend at least partially through and guide the sealing device to the puncture of the blood vessel (claim 1), and a force applied to the guide member selectively moves the tubular guide member away from the sealing device and proximally relative the surgical device (claim 1).
As to the instant application’s claim 3, see reference patent claim 1.
As to the instant application’s claim 4, see reference patent claim 1.
As to the instant application’s claim 5, 6, see reference patent claim 6. The proximal opening can allow air/liquids to vent out.
As to the instant application’s claim 11, see reference patent claim 9.
As to the instant application’s claim 12, the reference patent claims a vascular closure system comprising a sealing device (claim 15) configured to seal a puncture of a blood vessel, a delivery assembly (claim 15) that releasably holds the sealing device, a guide wire (claim 15) positionable in the blood vessel, a guide member (claim 15) configured to slide along the guide wire and at least partially within the delivery assembly, the guide member comprising a tubular guide body (claim 15, the moveable guide body has a lumen which will read on the tubular guide body) that is elongated along a longitudinal axis (claim 15), the tubular guide body having an outer surface (the body will inherently have an outer surface opposite the lumen), a distal end (claim 15), a proximal end opposite the distal end along the longitudinal axis (claim 15), a lumen (claim 15) that extends along the longitudinal axis from the distal end toward the proximal end, at least one aperture that extends through the tubular guide body from the outer surface to the lumen (claim 15), wherein the lumen is sized to receive the guide wire such that air is entrapped within the lumen when the guide wire is received in the lumen (the lumen does receive the guide wire as well as having the claimed structure, therefore can perform the function of entrapping air when the guide wire is received within the lumen); the lumen is configured to guide the sealing device to the puncture of the blood vessel (claim 15), the length of the tubular guide body is greater than a length of the delivery assembly (claim 17).
As to the instant application’s claim 14, see reference patent claim 15.
As to the instant application’s claim 15, see reference patent claim 15.
As to the instant application’s claim 19, see reference patent claim 15.
As to the instant application’s claim 28, see reference patent claim 1.
Claims 2-6, 8, 9, 11, 12, 19, 26, 28, 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,576,663. Although the claims at issue are not identical, they are not patentably distinct from each other because, with respect to the instant application’s claim 2, the reference patent claims a vascular closure system comprising a sealing device (claim 1) configured to seal a puncture of a blood vessel, a delivery assembly (claim 1) that releasably holds the sealing device, a guide wire (claim 1) positionable in the blood vessel, a guide member (claim 1) configured to slide along the guide wire through the delivery assembly, the guide member comprising a tubular guide body (claim 1, the moveable guide body has a lumen which will read on the tubular guide body) that is elongated along a longitudinal axis (claim 1), the tubular guide body having an outer surface (the body will inherently have an outer surface opposite the lumen), a distal end (claim 1), a proximal end opposite the distal end along the longitudinal axis (claim 1), a lumen (claim 1) that extends along the longitudinal axis from the distal end toward the proximal end, wherein the lumen is sized to receive the guide wire such that air is entrapped within the lumen when the guide wire is received in the lumen (the lumen does receive the guide wire as well as having the claimed structure, therefore can perform the function of entrapping air when the guide wire is received within the lumen); wherein the tubular guide body is configured to extend at least partially through and guide the sealing device to the puncture of the blood vessel (claim 1), and a force applied to the guide member selectively moves the tubular guide member away from the sealing device and proximally relative the surgical device (claim 1).
As to the instant application’s claim 3, see reference patent claim 5.
As to the instant application’s claim 4, see reference patent claim 6.
As to the instant application’s claim 5, 6, see reference patent claim 8. The proximal opening can allow air/liquids to vent out.
As to the instant application’s claim 8, see reference patent claim 11.
As to the instant application’s claim 9, see reference patent claim 1, 11.
As to the instant application’s claim 11, see reference patent claim 1.
As to the instant application’s claim 12, the reference patent claims a vascular closure system comprising a sealing device (claim 15) configured to seal a puncture of a blood vessel, a delivery assembly (claim 15) that releasably holds the sealing device, a guide wire (claim 15) positionable in the blood vessel, a guide member (claim 15) configured to slide along the guide wire and at least partially within the delivery assembly, the guide member comprising a tubular guide body (claim 15, the moveable guide body has a lumen which will read on the tubular guide body) that is elongated along a longitudinal axis (claim 15), the tubular guide body having an outer surface (the body will inherently have an outer surface opposite the lumen), a distal end (claim 15), a proximal end opposite the distal end along the longitudinal axis (claim 15), a lumen (claim 15) that extends along the longitudinal axis from the distal end toward the proximal end, at least one aperture that extends through the tubular guide body from the outer surface to the lumen (claim 15), wherein the lumen is sized to receive the guide wire such that air is entrapped within the lumen when the guide wire is received in the lumen (the lumen does receive the guide wire as well as have the claimed structure, therefore can perform the function of entrapping air when the guide wire is received within the lumen); the lumen is configured to guide the sealing device to the puncture of the blood vessel (claim 15), the length of the tubular guide body is greater than a length of the delivery assembly (claim 17).
As to the instant application’s claim 19, see reference patent claim 15.
As to the instant application’s claim 26, see reference patent claim 1.
As to the instant application’s claim 28, see reference patent claim 1.
As to the instant application’s claim 30, see reference patent claim 15.
Claims 8, 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,555,727 in view of U.S. Patent Publication 2002/0022822 to Cragg.
As to claim 8, the reference patent claims the device above but is silent about the tubular guide body is configured to translate relative to the surgical device between a first position, wherein the distal end of the tubular guide body extends through a distal-most end of the surgical device, and a second position, where the tubular guide body does not extend through the distal-most end of the surgical device.
Cragg teaches a similar device (sealing device, abstract) having a tubular guide body configured to translate relative to the surgical device between a first position, wherein the distal end of the tubular guide body extends through a distal-most end of the surgical device (figure 1a), and a second position, where the tubular guide body does not extend through the distal-most end of the surgical device (figure 1b,c) in order for allowing access to the blood vessel and aid in positioning of the sealing component. It would have been obvious to one of ordinary skill in the art before the effective filing date to for the reference patent have the tubular guide body be configured to translate relative to the surgical device between a first position, wherein the distal end of the tubular guide body extends through a distal-most end of the surgical device, and a second position, where the tubular guide body does not extend through the distal-most end of the surgical device in order for allowing access to the blood vessel and aid in positioning of the sealing component.
As to the instant application’s claim 27, Cragg teaches the third configuration which can the removal (figure 1b,c, paragraph 32, 35) in order to allow placement of the sealing device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent comprise the third configuration in order to allow placement of the sealing device.
Claims 9, 26, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,555,727 in view of U.S. Patent Publication 2002/0022822 to Cragg as applied to claim 8 above and further in view of U.S. Patent Publication 2013/0035702 to Heneveld.
As to claims 9, 26 the reference patent as modified by Cragg is directed to the device above including the gripping member (claim 8, 9) but is silent about the gripping member is positioned at or adjacent the proximal end of the tubular guide body, exterior to a proximal end of the surgical device, where the proximal end of the tubular guide body and the gripping member are positioned proximal relative to a proximal-most end of the delivery assembly in the first and second configuration.
Heneveld teaches a similar device (delivery device) having a gripping member grippable by a user, positioned at or adjacent the proximal end of the tubular guide body, exterior to the proximal end of the surgical device (paragraph 56, figure 1b) for the purpose of facilitating ease of handling of the guide tube. Further, the proximal end of the tubular guide body and the gripping member are positioned proximal relative to a proximal-most end of the delivery assembly in the first and second configuration (figure 1b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the gripping member of the reference patent be grippable by a user and positioned at the proximal end of the tubular guide body, exterior to the surgical device in order for of facilitating ease of handling of the guide tube.
Claims 16, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,555,727 in view of U.S. Patent Publication 2006/0155330 to Michlitsch.
As to the instant application’s claim 16, 17, the reference patent is directed to the device above but is silent about the proximal end of the tubular guide body includes a proximal opening, the lumen is sized and configured such that during use the air or liquids entrapped within the lumen are pushed ahead of the guide wire as the guide is moved proximally within the lumen which can provide a visual indication of the guide wire positioned within the lumen.
Michlitsch teaches a similar device (closure device, abstract) having the proximal end of the tubular guide body includes a proximal opening, the lumen is sized and configured such that during use the air or liquids entrapped within the lumen are pushed ahead of the guide wire as the guide is moved proximally within the lumen which can provide a visual indication of the guide wire positioned within the lumen (paragraph 46, figure 4a) for the purpose of venting the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the proximal opening in the reference patent in order to be able to vent the device.
Claims 16, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,576,663 in view of U.S. Patent Publication 2006/0155330 to Michlitsch.
As to the instant application’s claim 16, 17, the reference patent is directed to the device above but is silent about the proximal end of the tubular guide body includes a proximal opening, the lumen is sized and configured such that during use the air or liquids entrapped within the lumen are pushed ahead of the guide wire as the guide is moved proximally within the lumen which can provide a visual indication of the guide wire positioned within the lumen.
Michlitsch teaches a similar device (closure device, abstract) having a proximal opening, the lumen is sized and configured such that during use the air or liquids entrapped within the lumen are pushed ahead of the guide wire as the guide is moved proximally within the lumen which can provide a visual indication of the guide wire positioned within the lumen (paragraph 46, figure 4a) for the purpose of venting the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the proximal opening in the reference patent in order to be able to vent the device.
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,576,663 in view of U.S. Patent Publication 2002/0022822 to Cragg.
As to the instant application’s claim 27, the reference patent is directed to the device above but is silent about the third configuration.
Cragg teaches the third configuration which can the removal (figure 1b,c, paragraph 32, 35) in order to allow placement of the sealing device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the reference patent comprise the third configuration in order to allow placement of the sealing device.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,555,727 in view of U.S. Patent 6,042,601 to Smith.
As to claim 30, the reference patent is directed to the device including the guide member moves along the guide wire in a proximal direction or a distal direction relative the guide wire and the delivery assembly, and awa from the sealing device (claim 15) above but is silent about the gripping member.
Smith teaches a similar device (closure device) having a gripping member (32) extending from at or adjacent a proximal end of a tubular guide body and grippable by a user, the gripping member is a tab (figure 3) that extends outwardly from the tubular guide body, a pulling force applied to the gripping member moves the guide member along the guide, the gripping member and proximal end are positioned exterior and proximal relative to a proximal-most end of the delivery assembly (figure 3) for the purpose of allowing the user to grasp the device to be able to actuate the device (col. 5 ll. 21-36). It would have been obvious to one of ordinary skill in the art before the effective filing date for the reference patent have the gripping member in order for the user to grasp the device to be able to actuate the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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