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 Arguments
Applicant argues in the response filed 02/27/2026 that the claim amendments would overcome the previous claim objections and 112 rejections. The previous objections and 112 rejections have been withdrawn.
The applicant argues Cragg does not disclose that the lumen is sized and configured such that air is entrapped within the lumen when the guide wire is received in the lumen. However it is to be noted that the claim does not state how exactly the air is trapped. Further the claim is a device claim and therefore can be positively state the method step of trapping the air. Cragg does disclose a lumen which is sized to receive the guide wire. The device is not used in a vacuum and therefore air will be within the lumen. When the guide wire is moved into the lumen, air will be entrapped therein. Prior art Ashby/Michlitsch can provide evidence/teachings that air can be entrapped within a lumen when a guide wire is positioned therein. See rejections below.
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.
Claim Objections
Claim 16 is objected to because of the following informalities: the claim is a device claim and therefore cannot positively claim method steps/human tissue. In order to avoid any 101/112 issues line 5 should be amended to read “the air or liquids entrapped within the lumen are configured to be pushed…”. 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2, 5, 6, 8, 9, 26 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2002/0022822 to Cragg in view of U.S. Patent Publication 2003/0088269 to Ashby and/or U.S. Patent Publication 2006/0155330 to Michlitsch.
As to claim 2, Cragg discloses a guide member (paragraph 24, the access sheath can read on the guide member) configured to slide along a guide wire (54) and engageable with a surgical device (10/40), the guide member comprising: a tubular guide body (20) that is elongated along a longitudinal axis (figure 1a), the tubular guide body having an outer surface (figure 1a), a distal end (1a), an opening (figure 1a, where 70 extends from 24, figure 1a, paragraph 30) at the distal end, a proximal end (where 22 is located) opposite the distal end along the longitudinal axis, a lumen (paragraph 30, the dilator extends within 20) that extends along the longitudinal axis from the opening at the distal end toward the proximal end, and at least one aperture (60) that extends through the tubular guide body from the outer surface to the lumen, wherein the lumen is sized and configured to receive the guide wire (54, figure 1a) and guide a sealing device (30) to a puncture of a blood vessel (figure 1a) such that air is entrapped within the lumen when the guide wire is received in the lumen (paragraph 29, 30, see interpretation below); and a gripping member (22) coupled to the tubular guide body and grippable by a user (figure 1a, the handle or proximal end of the sheath can be gripped by the user), wherein the gripping member is positioned at or adjacent the proximal end of the tubular guide body and exterior to a proximal end of the surgical device (figure 1a, the proximal end 22 is proximal to the proximal end of 40/10), the gripping member extends outwardly relative to the tubular guide body (figure 1a, the proximal end has a lateral dimension more than the average outer diameter of the shaft 20), a first force applied to the gripping member moves the guide member relative to the guide wire and a surgical device in a proximal direction or a distal direction (paragraph 30, figure 1b, the sheath 20 is withdrawn so a force applied the proximal end, 22, can move the sheath 20 in a proximal direction along the guide wire 54), and a pulling force applied to the gripping member selectively moves the guide member away from the sealing device and proximally relative to the surgical device (figure 1b, paragraph 30, the sheath 20 can be removed by being pulled which will move the sheath 20 proximally away from 30/10/40, this pulling force can be applied to the proximal end 22). The claim is a device claim so will not be able to claim any method steps. Therefore any movement or forces will be functional limitations, which will be interpreted by if the structure can perform the function. The sheath 20 is removed from the canula (surgical device) 10 as well as the sealing material (sealing device) 30. The sheath 20 has a proximal end that has a widened section which can be gripped by a user and used to move the sheath. Therefore, Cragg will be able to read on the gripping member and the first force and pulling force.
With respect to the lumen of the guide body is sized and configured such that air is entrapped within the lumen when the guide wire is received in the lumen, the lumen of Cragg is sized to allow the guidewire to be located within the lumen, and further, there is a bleed black indicator which allows for blood to enter the lumen, while the guidewire is in the lumen, when the guide body is within the blood vessel. Therefore air that exists in the lumen will be entrapped since the pressure from the blood entering the holes 60 can entrap the air. The lumen is hollow based on being a lumen and will have air in it since it is not being used in a vacuum. When the guide wire is positioned within the lumen, air can be trapped since another structure is within the lumen. When the guidewire is in the lumen, and extends out of the lumen, the air that is originally within the lumen will be entrapped since the guidewire is closing a hole of the lumen. Ashby teaches a similar device (delivery device, abstract) where a bleed back lumen is used as a vent tube (paragraph 55, 56, 59). Michlitsch teaches a similar device (sealing device, abstract) where any air can escape through an air vent when a device is positioned within a lumen (paragraph 46). Both Ashby and Michlitsch teaches and/or provides evidence that air gets trapped within bleed back lumens when a device is positioned therein, moved into the vascular, where fluid is then drawn into the lumen. It would have been known and/or obvious that the lumen of Cragg can be sized and configure to receive a guide wire and air can be entrapped within the lumen of Cragg when the guidewire is positioned therein in order venting out air that is contained within the lumen.
As to claim 5, with the device of Cragg and Ashby/Michlitsch above, Cragg disclose the proximal end of the tubular guide body includes a proximal opening (through 22, where 72 extends from, figure 1a) and the proximal opening permits the air or liquids entrapped within the lumen to vent out of the lumen (figure 1a). Both Ashby (figure 1, 3a,b, 17) and Michlitsch (16, figure 2) further teach the proximal opening.
As to claim 6, with the device of Cragg and Ashby/Michlitsch above, Cragg discloses the tubular guide body is configured to provide a visual indication of the guide wire position within the lumen (paragraph 29, 62). The guide wire extends proximal through the guide body as seen in figure 1a, which can provide visual indication. Additionally and/or alternatively, the bleed black indicator can be an visual indicator that there is blood, which will provide indication that the device is within the blood vessel, where the guide body is advanced over the guide wire, so the bleeding will provide indication on the guide wire positioned within the guide body, extending through the guide body, based on the blood. Both Ashby (figure 1, 3a,b, 17) and Michlitsch (16, figure 2) can further teach a visual indication.
As to claim 8, with the device of Cragg and Ashby/Michlitsch above, Cragg discloses the tubular guide body is configured to translate relative to the surgical device between a first position, where 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, the device is fully withdrawn).
As to claim 9, with the device of Cragg and Ashby/Michlitsch above, Cragg discloses a force applied to the gripping member causes the tubular guide body to translate relative to the surgical position between the first position and the second position (figure 1a-c). The withdrawal force is capable to cause the change in positions.
As to claim 26, with the device of Cragg and Ashby/Michlitsch above, Cragg discloses the proximal end of the tubular guide body and the gripping member are positioned proximal relative to a proximal most end of the surgical device in the first configuration and the second configuration (figure 1a-c).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2002/0022822 to Cragg in view of U.S. Patent Publication 2003/0088269 to Ashby and/or U.S. Patent Publication 2006/0155330 to Michlitsch as applied to claims 2, 5, 6, 8, 9, 26 above, and further in view of U.S. Patent Publication 2014/0172012 to Stanley.
As to claim 3, Cragg in view of Ashby/Michlitsch discloses the device above but is silent about the proximal end of the tubular guide body is a closed proximal end, wherein the closed proximal end has a proximal wall that extends at least partially along a transverse direction that is perpendicular to the longitudinal axis so as to define the closed proximal end. Cragg does disclose that the proximal end can have a seal (paragraph 31).
Stanley teaches a similar device (sealing device) where a proximal end of tubular guide body is a closed proximal end (figure 2, 142 can have a closed proximal end based on at least 160, paragraph 51), wherein the closed proximal end has a proximal wall (162) that extends at least partially along a transverse direction that is perpendicular to the longitudinal axis so as to define the closed proximal end for the purpose of comprising a valve at the proximal of the device (paragraph 51,52). The member 160 creates a closed proximal end where the guide wire of Cragg can still slide through. Further the member 160 can act like a valve or be the sealing member of Cragg. It would have been obvious to one of ordinary skill in the art before the effective fling date of the invention for the proximal end of the tubular guide body have a closed proximal end defined by a proximal wall that extends at least partially along a transverse direction that is perpendicular to the longitudinal axis in order for using a valve to help seal the proximal end of the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2002/0022822 to Cragg in view of U.S. Patent Publication 2003/0088269 to Ashby and/or U.S. Patent Publication 2006/0155330 to Michlitsch as applied to claims 2, 5, 6, 8, 9, 26 above, and further in view of U.S. Patent 6,042,601 to Smith.
As to claim 11, Cragg in view of Ashby/Michlitsch discloses the device above but is silent about the gripping member is a tab that extends from the tubular guide body.
Smith teaches a similar device (deliver device) having a gripping member comprising a tab (32, col. 5 ll. 23-25, figure 3) that extends outwardly from the tubular guide body for the purpose of helping the user grasp the handle. The wings 32 can read on tabs that can be poisoned on the similar hub of Cragg that will allow the user to easily grasp the hub/handle. It would have been obvious to one of ordinary skill in the art before the effective filing date to use tabs in the device of Cragg in order for allowing the user ease of handling the guide.
Claims 12, 16, 17, 19, 27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2002/0022822 to Cragg in view of U.S. Patent 6,042,601 to Smith, U.S. Patent Publication 2003/0088269 to Ashby and/or U.S. Patent Publication 2006/0155330 to Michlitsch.
As to claim 12, Cragg discloses a guide member (paragraph 24, the access sheath can read on the guide member) configured to slide along a guide wire (54) and being engageable with a surgical device (10/40), the guide member comprising: a tubular guide body (20) that is elongated along a longitudinal axis (figure 1a), the tubular guide body having an outer surface (figure 1a), a distal end (24), an opening (where 70 extends from, figure 1a) at the distal end, a proximal end (where 22 is located) opposite the distal end along the longitudinal axis, a lumen (paragraph 30, the dilator extends within 20) that extends along the longitudinal axis from the opening at the distal end toward the proximal end, at least one aperture (60) that extends through the tubular guide body from the outer surface to the lumen, and a length (figure 1a) that extends from the proximal end to the distal end along the longitudinal axis, wherein the lumen is sized and configured to receive the guide wire and guide a sealing component (30, figure 1a) such that air is entrapped within the lumen when the guide wire is received in the lumen (paragraph 29, 30, see interpretation below), wherein the length of the tubular guide body is greater than a length of the surgical device (figure 1a), a gripping member (22) extending from at or adjacent the proximal end of the tubular guide body and grippable by a user (figure 1a), wherein a pulling force applied to the gripping member moves the guide member along the guide wire in a proximal direction or a distal direction relative to the guide wire and surgical device, away from the sealing component (paragraph 30, figure 1b, the sheath 20 is withdrawn so a force applied the proximal end, 22, can move the sheath 20 in a proximal direction along the guide wire 54), wherein the gripping member and proximal end are positioned exterior and proximal relative to a proximal-most end of the surgical device (figure 1) but is silent that the gripping member is a tab extending outwardly from the tubular guide body.
With respect to the lumen of the guide body is sized and configured such that air is entrapped within the lumen when the guide wire is received in the lumen, the lumen of Cragg is sized to allow the guidewire to be located within the lumen, and further, there is a bleed black indicator which allows for blood to enter the lumen, while the guidewire is in the lumen, when the guide body is within the blood vessel. Therefore air that exists in the lumen will be entrapped since the pressure from the blood entering the holes 60 can entrap the air. The lumen is hollow based on being a lumen and will have air in it since it is not being used in a vacuum. When the guide wire is positioned within the lumen, air can be trapped since another structure is within the lumen. When the guidewire is in the lumen, and extends out of the lumen, the air that is originally within the lumen will be entrapped since the guidewire is closing a hole of the lumen. Ashby teaches a similar device (delivery device, abstract) where a bleed back lumen is used as a vent tube (paragraph 55, 56, 59). Michlitsch teaches a similar device (sealing device, abstract) where any air can escape through an air vent when a device is positioned within a lumen (paragraph 46). Both Ashby and Michlitsch teaches and/or provides evidence that air gets trapped within bleed back lumens when a device is positioned therein, moved into the vascular, where fluid is then drawn into the lumen. It would have been known and/or obvious that the lumen of Cragg can be sized and configure to receive a guide wire and air can be entrapped within the lumen of Cragg when the guidewire is positioned therein in order venting out air that is contained within the lumen.
Smith teaches a similar device (deliver device) having a gripping member extending from the proximal end of body and comprising a tab (col. 5 ll. 23-25, figure 3) that extends outwardly from the tubular guide body for the purpose of helping the user grasp the handle. The wings 32 can read on tabs that can be poisoned on the similar hub of Cragg that will allow the user to easily grasp the hub/handle. The wings 32 are positioned at the proximal end of base 28. The proximal end positioned can be applied to Cragg. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the gripping member tabs positioned at the proximal end of the tubular guide body in the device of Cragg in order for helping the user grasp the handle.
As to claim 16, with the device of Cragg, Ashby/Michlitsch, and Smith above, Cragg the proximal end of the tubular guide body includes a proximal opening (through 22, where 72 extends from, figure 1a) and the air or liquids entrapped are pushed ahead of the guide of the guide wire as the guide wire is moved proximally within the lumen (figure 1a). The bleed back lumen with the proximal opening allows for air/fluid to be pushed ahead of the guide wire. Both Ashby (figure 1, 3a,b, 17) and Michlitsch (16, figure 2) further teach the proximal opening in which air or liquid entrapped within the lumen can be pushed ahead of the guide wire.
As to claim 17, with the device of Cragg, Ashby/Michlitsch, and Smith above, Cragg discloses the tubular guide body is configured to provide a visual indication of the guide wire position within the lumen (paragraph 29, 62). The guide wire extends proximal through the guide body as seen in figure 1a, which can provide visual indication. Additionally and/or alternatively, the bleed black indicator can be an visual indicator that there is blood, which will provide indication that the device is within the blood vessel, where the guide body is advanced over the guide wire, so the bleeding will provide indication on the guide wire positioned within the guide body, extending through the guide body, based on the blood. Both Ashby (figure 1, 3a,b, 17) and Michlitsch (16, figure 2) can further teach a visual indication.
As to claim 19, with the device of Cragg, Ashby/Michlitsch, and Smith above, Cragg discloses the tubular guide body is configured to translate relative to the surgical device between a first position, where 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, the device is fully withdrawn).
As to claim 27, with the device of Cragg, Ashby/Michlitsch, and Smith above, Cragg discloses in a third configuration, the guide member translates proximally relative to the guide wire and the surgical device and is removed from the surgical device (figure 1b,c, paragraph 32, 35).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2002/0022822 to Cragg in view of U.S. Patent 6,042,601 to Smith, U.S. Patent Publication 2003/0088269 to Ashby and/or U.S. Patent Publication 2006/0155330 to Michlitsch as applied to claims 12, 16, 17, 19, 27 above, and further in view of U.S. Patent Publication 2014/0172012 to Stanley.
As to claim 14, Cragg in view of Smith and Ashby/Michlitsch discloses the device above but is silent about the proximal end of the tubular guide body is a closed proximal end, wherein the closed proximal end has a proximal wall that extends at least partially along a transverse direction that is perpendicular to the longitudinal axis so as to define the closed proximal end. Cragg does disclose that the proximal end can have a seal (paragraph 31).
Stanley teaches a similar device (sealing device) where a proximal end of tubular guide body is a closed proximal end (figure 2, 142 can have a closed proximal end based on at least 160, paragraph 51), wherein the closed proximal end has a proximal wall (162) that extends at least partially along a transverse direction that is perpendicular to the longitudinal axis so as to define the closed proximal end for the purpose of comprising a valve at the proximal of the device (paragraph 51,52). The member 160 creates a closed proximal end where the guide wire of Cragg can still slide through. Further the member 160 can act like a valve or be the sealing member of Cragg. It would have been obvious to one of ordinary skill in the art before the effective fling date of the invention for the proximal end of the tubular guide body have a closed proximal end defined by a proximal wall that extends at least partially along a transverse direction that is perpendicular to the longitudinal axis in order for using a valve to help seal the proximal end of the device.
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, 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 in view of U.S. Patent Publication 2005/0107826 to Zhu and in view of U.S. Patent Publication 2013/0035702 to Heneveld.
As to claim 2, the reference patent claims a guide member (claim 1) configured to slide along a guide wire and engageable with a surgical device, 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 and configured to receive the guide wire (claim 1) and guide a sealing device to a puncture of a blood vessel (claim 1) 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); and a gripping member (claim 8) coupled to the tubular guide body, wherein a first force applied to the gripping member moves the guide member relative to the guide wire and the surgical device in a proximal direction or a distal direction (claim 8) and a pulling force applied to the gripping member selectively moves the tubular guide member away from the sealing device and proximally relative the surgical device (claim 1, 8, a force is applied to the gripping member to move it relative to the sealing device and delivery assembly) but is silent about the opening at the distal end and the at least one aperture that extends through the tubular guide body from the outer surface to the lumen, and the gripping member is grippable by a user, positioned at or adjacent to the proximal end of the tubular guide body, exterior to the proximal end of the surgical device, and extends outwardly from the tubular guide body.
Zhu teaches a similar device (device for closing a wound) having a guide member (32) with an opening at the distal end (figure 4, where 58 extends through) and the at least one aperture (60) that extends through the tubular guide body from the outer surface to the lumen for the purpose to allow the guide wire to slide therethrough and to allow a vacuum to be applied to allow for blood to pass therethrough which aids in positioning of the device (paragraph 88). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the guide body of the reference patent have an opening at the distal end and the apertures in order to allow for blood to pass therethrough which aids in positioning of the device.
Heneveld teaches a similar device (deliver device) the gripping member is grippable by a user, positioned at or adjacent to the proximal end of the tubular guide body, exterior to the proximal end of the surgical device, and extends outwardly from the tubular guide body (paragraph 56, figure 1b) for the purpose of facilitating ease of handling of the guide tube. 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, positioned at the proximal end of the tubular guide body, exterior to the surgical device, and extends outwardly from the tubular guide body in order for of facilitating ease of handling of the guide tube.
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, see reference patent claim 6. The proximal opening can allow air/liquids to vent out.
As to the instant application’s claim 6, see Zhu (68, paragraph 88). The view port can allow for visual indication of blood which will indicate the presence of the proper positioning of the guide wire.
As to the instant application’s claim 11, see Cragg (figure 1b, paragraph 56).
As to the instant application’s claim 28, see reference patent claim 1.
Claims 2-6, 11, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,576,663 in view of in view of U.S. Patent Publication 2005/010726 to Zhu and in view of U.S. Patent Publication 2013/0035702 to Heneveld.
With respect to the instant application’s claim 2, the reference patent claims a guide member (claim 1) configured to slide along a guide wire and engageable with a surgical device (sealing device), the guide member comprising: a tubular guide body (claim 1, the guide member is elongate along a longitudinal axis and has a lumen extending along the axis, therefore can be tubular), which that is elongated along a longitudinal axis (claim 1), the tubular guide body having an outer surface (claim 1, the member 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, a lumen that extends along the longitudinal axis from the distal end toward the proximal end, and at least one aperture that extends through the tubular guide body from the outer surface to the lumen (claim 8), wherein the lumen is sized and configured to receive the guide wire (claim 1) and guide a sealing device (claim 1) to a puncture of a blood vessel 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); and a gripping member (claim 1) extending outwardly from the tubular guide body, wherein a first force applied to the gripping member moves the guide member relative to the guide wire and the surgical device in a proximal direction or a distal direction (claim 1), a pulling force applied to the gripping member selectively moves the tubular guide member away from the sealing device and proximally relative to the surgical device (claim 1, 8, a force is applied to the gripping member to move it relative to the sealing device and delivery assembly) but is silent about the opening at the distal end and the gripping member is grippable by a user, positioned at or adjacent to the proximal end of the tubular guide body, exterior to a proximal end of the surgical device.
Zhu teaches a similar device (device for closing a wound) having a guide member (32) with an opening at the distal end (figure 4, where 58 extends through) for the purpose to allow the guide wire to slide therethrough which aids in positioning of the device (paragraph 88). It is to be noted Zhu also teaches the limitations at least one aperture (60) that extends through the tubular guide body from the outer surface to the lumen which can teach the ltimaiton in the instant application’s claim 1. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the guide body of the reference patent have an opening at the distal end (and the apertures in order to allow for blood to pass therethrough) in order for aiding in positioning of the device.
Heneveld teaches a similar device (deliver device) the gripping member is 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. 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
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. Zhu teaches the aperture which can allow the reference patent claim chain from claim 6, to read on the instant application’s claim 4.
As to the instant application’s claim 5, see reference patent claim 8. The proximal opening can allow air/liquid to vent out.
As to the instant application’s claim 6, see Zhu (68, paragraph 88). The view port can allow for visual indication of blood which will indicate the presence of the proper positioning of the guide wire.
As to the instant application’s claim 11, see Cragg (figure 1b, paragraph 56).
As to the instant application’s claim 28, see reference patent claim 1.
Claims 8, 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 2005/010726 to Zhu and in view of U.S. Patent Publication 2013/0035702 to Heneveld as applied to claims 2-6, 11, 28, and further in view of U.S. Patent Publication 2002/0022822 to Cragg.
As to claim 8, the reference patent as modified Zhu and Heneveld discloses the device 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 as modified by Zhu and Heneveld 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 9, see reference patent claim 1. A force as claimed in the claim 1 can move the gripping member between the positions.
As to the instant application’s claim 26, see Cragg (figure 1b,c, paragraph 32, 35). Cragg can further teach the third position.
Claims 8, 9, 26, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,576,663 in view of U.S. Patent Publication 2005/010726 to Zhu and in view of U.S. Patent Publication 2013/0035702 to Heneveld as applied to claims 2-6, 11, 28, and further in view of U.S. Patent Publication 2002/0022822 to Cragg.
As to claim 8, the reference patent as modified Zhu and Heneveld discloses the device 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 as modified by Zhu and Heneveld 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 9, see reference patent claim 1. A force as claimed in the claim 1 can move the gripping member between the positions.
As to the instant application’s claim 26, see Cragg (figure 1b,c, paragraph 32, 35). Cragg can further teach the third position.
Claims 12, 14-17, 19, 27, 29 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 2005/010726 to Zhu, in view of U.S. Patent Publication 2013/0035702 to Heneveld, and in view of U.S. Patent Publication 2002/0022822 to Cragg.
As to the instant application’s claim 12, the reference patent claims a guide member (claim 1) configured to slide along a guide wire and being engageable with a surgical device, 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 and configured to receive the guide wire (claim 1) and guide a sealing component (claim 1) 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); and a gripping member (claim 8) coupled to the tubular guide body, wherein a pulling force applied to the gripping member moves the guide member along the guide wire in a proximal direction or a distal direction relative to the guide wire and surgical device and away from the sealing component (claim 1, 8, a force is applied to the gripping member to move it relative to the sealing device and delivery assembly) but is silent about the opening at the distal end and the at least one aperture that extends through the tubular guide body from the outer surface to the lumen, a length that extends from the proximal to the distal along the longitudinal axis (of the tubular guide body) is greater than a length of the surgical device, and the gripping member is a tab that extends outwardly from the tubular guide body, grippable by a user, positioned at or adjacent to the proximal end of the tubular guide body, exterior to the proximal end of the surgical device.
Zhu teaches a similar device (device for closing a wound) having a guide member (32) with an opening at the distal end (figure 4, where 58 extends through) and the at least one aperture (60) that extends through the tubular guide body from the outer surface to the lumen for the purpose to allow the guide wire to slide therethrough and to allow a vacuum to be applied to allow for blood to pass therethrough which aids in positioning of the device (paragraph 88). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the guide body of the reference patent have an opening at the distal end and the apertures in order to allow for blood to pass therethrough which aids in positioning of the device.
Heneveld teaches a similar device (deliver device) having a gripping member is tab (24, paragraph 56) grippable by a user, positioned at or adjacent to the proximal end of the tubular guide body, exterior to the proximal end of the surgical device, and extends outwardly from the tubular guide body (paragraph 56, figure 1b) for the purpose of facilitating ease of handling of the guide tube. 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, positioned at the proximal end of the tubular guide body, exterior to the surgical device, and extends outwardly from the tubular guide body in order for of facilitating ease of handling of the guide tube.
Cragg teaches a similar device (sealing device) where a length of a tubular guide body (20) is greater than a length of a surgical device (10) in order to allow for access to the blood vessel and positioning of the sealing component (paragraph 24-27). The sheath 20 extends through and extends longer than the delivery cannula 10 which helps to provide access to the blood vessel and position the sealing component 30 in place. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the length of the reference patent tubular guide body be greater than the length of the surgical device in order to allow for access to the blood vessel and positioning of the sealing component.
As to the instant application’s claim 14, see reference patent claim 1.
As to the instant application’s claim 15, see reference patent claim 1.
As to the instant applications’ claim 16, see reference patent claim 6. The proximal opening will allow entrapped air/liquids to vent out.
As to the instant application’s claim 17, see Zhu (68, paragraph 88). The view port can allow for visual indication of blood which will indicate the presence of the proper positioning of the guide wire.
As to the instant application’s claim 19, see Cragg (figure 1a,b).
As to the instant application’s claim 27, see Cragg (figure 1b,c, paragraph 32, 35).
As to the instant application’s claim 29, see reference patent claim 1.
Claims 12, 14-17, 19, 27, 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,576,663 in view of in view of U.S. Patent Publication 2005/010726 to Zhu, in view of U.S. Patent Publication 2013/0035702 to Heneveld, and in view of U.S. Patent Publication 2002/0022822 to Cragg
With respect to the instant application’s claim 12, the reference patent claims a guide member (claim 1) configured to slide along a guide wire and engageable with a surgical device (sealing device), the guide member comprising: a tubular guide body (claim 1, the guide member is elongate along a longitudinal axis and has a lumen extending along the axis, therefore can be tubular), that is elongated along a longitudinal axis (claim 1), the tubular guide body having an outer surface (claim 1, the member 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, a lumen that extends along the longitudinal axis from the distal end toward the proximal end, and at least one aperture that extends through the tubular guide body from the outer surface to the lumen (claim 8), wherein the lumen is sized and configured to receive the guide wire (claim 1) and guide a sealing device (claim 1) 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); and a gripping member (claim 1) extending outwardly from the tubular guide body, wherein a pulling force applied to the gripping member moves the guide member along the guide wire in a proximal direction or a distal direction relative to the guide wire and surgical device, and away from the sealing component (claim 1, 8, a force is applied to the gripping member to move it relative to the sealing device and delivery assembly) but is silent about the opening at the distal end and the gripping member is grippable by a user, has a length greater than a length of the surgical device, positioned at or adjacent to the proximal end of the tubular guide body, exterior and proximal relative to a proximal-most end of the surgical device.
Zhu teaches a similar device (device for closing a wound) having a guide member (32) with an opening at the distal end (figure 4, where 58 extends through) for the purpose to allow the guide wire to slide therethrough which aids in positioning of the device (paragraph 88). It is to be noted Zhu also teaches the limitations at least one aperture (60) that extends through the tubular guide body from the outer surface to the lumen which can teach the ltimaiton in the instant application’s claim 1. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the guide body of the reference patent have an opening at the distal end (and the apertures in order to allow for blood to pass therethrough) in order for aiding in positioning of the device.
Heneveld teaches a similar device (deliver device) the gripping member is 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. 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.
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 as modified by Zhu and Heneveld 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 14, see reference patent claim 5.
As to the instant application’s claim 15, see reference patent claim 6. Zhu teaches the aperture which can allow the reference patent claim chain from claim 6, to read on the instant application’s claim 4.
As to the instant application’s claim 16, see reference patent claim 8. The proximal opening will allow air/liquids to vent out.
As to the instant application’s claim 17, see Zhu (68, paragraph 88). The view port can allow for visual indication of blood which will indicate the presence of the proper positioning of the guide wire
As to the instant application’s claim 19, see Cragg (figure 1a,b,).
As to the instant application’s claim 27, see Cragg (figure 1b,c, paragraph 32, 35).
As to the instant application’s claim 28, see reference patent claim 1.
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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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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