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 .
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.
Claim(s) 1, 7, 9 and 21-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess (US 20100312063) (embodiment of fig. 4) in view of Hess (US 20100312063) (embodiment of fig. 12a-12c) in further view of Stefanchik (US 20110295077).
With respect to claim 1, Hess teaches a surgical sealing device (e.g., 310, 314) (see fig. 4 below) configured to provide access to an interior of a natural body lumen or organ (see para. 75), the surgical sealing device comprising: a seal housing (314) having a plurality of ports (e.g., 341, 342, 343) and configured to be at least partially disposed within a natural body orifice (see fig. 4 below, para. 75), the plurality of ports comprising; a first port (e.g., any of 341, 342, 343) configured to allow ingress and egress of fluid between an interior volume of the natural body lumen or organ and an ambient environment (see para. 89-91), and a second port (another of 341, 342, 343) configured to form a seal around an instrument (e.g., see para. 91) inserted therethrough (see para. 91); and a retention element (e.g., 334, see fig. 4 below and para. 88) arranged on an exterior surface of the seal housing and configured to affix the seal housing to the natural body orifice (see fig. 4 below and para. 87-88).
PNG
media_image1.png
675
912
media_image1.png
Greyscale
Hess (embodiment of fig. 4) does not teach appear to teach wherein the retention element is deployable outside of the natural body lumen or organ; and the first port is configured to allow ingress and egress of fluid while in a first configuration and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration.
However, Hess further teaches another embodiment that includes a proximal retaining ring (270) that includes a proximal retention element (280) that is deployable outside of the natural body lumen or organ (see fig. 12c, 12a below, and note the location of 280, i.e.- deployable outside/above of the natural lumen) in order to provide an alternate equivalent retention element for the surgical sealing device that provides the same function of anchoring the surgical sealing device to tissue as desired (see para. 100 below, particularly, the last sentence).
PNG
media_image2.png
438
817
media_image2.png
Greyscale
PNG
media_image3.png
266
794
media_image3.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to try the modification of Hess (embodiment of fig. 4), wherein the retention element is deployable outside of the natural body lumen or organ, in view of Hess (embodiment as shown in fig. 12a-12c), as a matter of engineering design choice in order to provide an alternate equivalent retention element for the surgical sealing device that provides the same function of anchoring the surgical sealing device to tissue, as desired.
Stefanchik, also drawn to surgical sealing devices, teaches a port a self-seal (e.g., 28) with two configurations (e.g., with an instrument inserted and closed with an instrument removed, see para. 50, 57) wherein the first port is configured to allow ingress and egress of fluid while in a first configuration (see para. 50, 57) and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration (see para. 50, 57) in order to provide a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough or not (see para. 50, 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hess (embodiment of fig. 4) wherein the first port is configured to allow ingress and egress of fluid while in a first configuration and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration, in view of Stefanchik, as a matter of engineering design choice, in order to provide a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough or not.
As for claim 7, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the at least one retention element is a barb (e.g., 1100) extending from the exterior surface of the housing (see para. 87, 100).
As for claim 9, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the fluid comprises at least one gas or at least one liquid (see para. 91).
As for claim 21, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the seal housing comprises an outer body member (310) and an inner body (314) member removably coupled to the outer body member (see fig. 4 above), and wherein the first port and the second port are disposed within the inner body member (see fig. 4 above).
As for claim 22, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches surgical sealing device of claim 1, wherein the first port being configured to prevent the ingress and egress of fluid between the interior volume of the natural body lumen or organ and the ambient environment while in a second configuration comprises the first port being configured to prevent endoluminal escape of laparoscopic insufflated fluids (see para. 91 and Stefanchik para. 50, note that this device is able to perform this function).
As for claim 23, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the first port being configured to allow the ingress and egress of fluid between the interior volume of the natural body lumen or organ and the ambient environment while in a first configuration comprises the first port being configured to adjust breathable air inflow to offset smoke evacuation through one or more of the plurality of ports (see para. 91 and Stefanchik para. 50, note that this device is able to perform this function).
As for claim 24, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the first port being configured to allow the ingress and egress of fluid between the interior volume of the natural body lumen or organ and the ambient environment while in a first configuration comprises the first port being configured to allow the ingress of breathable air to a lung and the egress of exhaled air from the lung (see para. 74-75 Stefanchik para. 50, note that this device is able to perform this function).
As for claim 25, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the retention element is configured to be disengaged from the natural body orifice prior to removal of the surgical sealing device from the natural body orifice (see para. 78, 120, note reference to releasable and reuseable).
As for claim 26, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the retention element being configured to affix the seal housing to the natural body orifice comprises the retention element being configured to maintain a position of the seal housing relative to the natural body orifice during movement of the natural body orifice (see para. 78, 87, 100 and note that this device is capable of performing this function).
As for claim 27, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, further teaches the surgical sealing device of claim 1, wherein the seal housing is configured to be entirely positioned within the natural body orifice (see para. 75 and note the section regarding placing the sealing device endoscopically).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess (US 20100312063) (embodiment of fig. 4), Hess (US 20100312063) (embodiment of fig. 12a-12c) and Stefanchik (US 20110295077), as applied to claim 1 above, in view of Stellon (US 20100298646).
As for claims 2-4, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, does not appear to teach wherein the first port is operatively connected to a valve arranged outside of the seal housing; wherein the valve has at least one monitored parameter which is used to control a fluid transfer rate through the first port; and wherein the at least one monitored parameter comprises one or more of a fluid transfer pressure, a fluid transfer volume, or a fluid transfer direction.
Stellon, also drawn to surgical sealing devices, teaches wherein the first port (e.g., any of 16, 18, 20) is operatively connected to a valve (60, 62) arranged outside of the seal housing (see para. 31 and fig. 7); wherein the valve has at least one monitored parameter (e.g., by user with use of the valve/stopcock) which is used to control a fluid transfer rate through the first port (see para. 31); and wherein the at least one monitored parameter comprises one or more of a fluid transfer pressure, a fluid transfer volume, or a fluid transfer direction (e.g., the purpose of the valve/stopcock is to control at least the volume and direction of the fluid transfer), in order to selectively and controllably provide insufflation gas through the sealing devices (see para. 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, wherein the first port is operatively connected to a valve arranged outside of the seal housing; wherein the valve has at least one monitored parameter which is used to control a fluid transfer rate through the first port; and wherein the at least one monitored parameter comprises one or more of a fluid transfer pressure, a fluid transfer volume, or a fluid transfer direction, in view of Stellon, in order to selectively provide insufflation gas through the sealing devices.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess (US 20100312063) (embodiment of fig. 4), Hess (US 20100312063) (embodiment of fig. 12a-12c) and Stefanchik (US 20110295077), as applied to claim 1 above, in view of Rabin (US 20090326518).
As for claim 10, Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik (US 20110295077), does not appear to teach wherein the surgical sealing device further comprises a control system configured to control the ingress and egress of fluid to create a pressure differential between the interior volume of the natural body orifice and the ambient environment.
Rabin also drawn to devices for manipulating body tissues and organs (see abstract), teaches wherein a control system (e.g., pump) is configured to control the ingress and egress of fluid to create a pressure differential between the interior volume of the natural body orifice and the ambient environment (see abstract and para. 73) in order to controllably apply or reduce insufflation pressure as needed during a procedure (see abstract, para. 16, 73).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hess (embodiment of fig. 4), as modified by Hess (embodiment of fig. 12a-12c) and Stefanchik, to include a control system configured to control the ingress and egress of fluid to create a pressure differential between the interior volume of the natural body orifice and the ambient environment, in view of Rabin, in order to controllably apply or reduce insufflation pressure as needed during a procedure.
Claim(s) 1, 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weisenburgh (US 20100312064) in view of Hess (US 20100312063) and further in view of Stefanchik (US 20110295077).
With respect to claims 1, 5 and 7, Weisenburgh teaches a surgical sealing device (e.g., 20) configured to provide access to an interior of a body lumen (see fig. 1 below, para. 53), the surgical sealing device comprising: a retention element (40) arranged on an exterior surface of the seal housing and configured to affix the seal housing to tissue (see fig. 1 below, para. 58, 61, 62 below), wherein the retention element is deployable outside of the body lumen or organ (see fig. 1 below and note the location of 44); and further teaches wherein the retention element is deployable inside of the body lumen or organ (see fig. 1 below and note the location of 42, see fig. 1 below); wherein the at least one retention element is a barb (e.g., 44) extending from the exterior surface of the housing (see para. fig. 1 below, para. 61-62 below).
PNG
media_image4.png
188
786
media_image4.png
Greyscale
PNG
media_image5.png
372
450
media_image5.png
Greyscale
PNG
media_image6.png
650
796
media_image6.png
Greyscale
Weisenburgh does teach the incorporation of ports/seals (see para. 56-57) but does not appear to explicitly teach the surgical sealing device configured to provide access to an interior of a natural body lumen or organ; the retention element configured to affix the seal housing to the natural body orifice; a seal housing having a plurality of ports and configured to be at least partially disposed within a natural body orifice, the plurality of ports comprising: a first port configured to allow ingress and egress of fluid while in a first configuration and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration, and a second port configured to form a seal around an instrument inserted therethrough.
Hess, also drawn to surgical sealing devices (e.g., 310, 314) (see fig. 4 below), teaches the sealing device is configured to provide access to an interior of a natural body lumen or organ (see para. 75 above) or an incision, the surgical sealing device comprising: a seal housing (314) having a plurality of ports (e.g., 341, 342, 343) and configured to be at least partially disposed within a natural body orifice (see fig. 4 below, para. 75 below), the plurality of ports comprising; a first port (e.g., any of 341, 342, 343) configured to control ingress and egress of fluid between an interior volume of the natural body lumen or organ and an ambient environment (see para. 89-91), and a second port (another of 341, 342, 343) configured to form a seal around an instrument (e.g., see para. 91) inserted therethrough (see para. 91); and a retention element (e.g., see fig. 12a and 12c above) arranged on an exterior surface of the seal housing and configured to affix the seal housing to the natural body orifice (see para. 75 and 87-88) in order to provide an access device that is capable of use within any opening within a body and that is able to maintain a sterile environment when an instrument is inserted therethrough (see para. 75 and 91) as is well-known in the art.
It would have been obvious to one of effective filing date of the invention to design Weisenburgh wherein the surgical sealing device configured to provide access to an interior of a natural body lumen or organ; the retention element configured to affix the seal housing to the natural body orifice; and to include a seal housing having a plurality of ports and configured to be at least partially disposed within a natural body orifice, the plurality of ports comprising: a first port configured to control ingress and egress of fluid between an interior volume of the natural body lumen or organ and an ambient environment, and a second port configured to form a seal around an instrument inserted therethrough, in view of Hess, as a matter of engineering design choice in order to provide a surgical sealing device that is capable of use within any opening within a body and that is able to maintain a sterile environment when an instrument is inserted therethrough as is well-known in the art.
Stefanchik, also drawn to surgical sealing devices, teaches a port a self-seal (e.g., 28) with two configurations (e.g., with an instrument inserted and closed with an instrument removed, see para. 50, 57) wherein the first port is configured to allow ingress and egress of fluid while in a first configuration (see para. 50, 57) and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration (see para. 50, 57) in order to provide a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough or not (see para. 50, 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Weisenburgh, as modified by Hess, wherein the first port is configured to allow ingress and egress of fluid while in a first configuration and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration, in view of Stefanchik, as a matter of engineering design choice, in order to provide a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough or not.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hess (US 20100312063) (embodiment of fig. 4), in view of Hess (embodiment of fig. 14), in further view of Fischvogt (US 20140194696) and in further view of Stefanchik (US 20110295077).
With respect to claim 8, Hess teaches a surgical sealing device (e.g., 310, 314) (see fig. 4 below) configured to provide access to an interior of a natural body lumen or organ (see para. 75), the surgical sealing device comprising: a seal housing (314) having a plurality of ports (e.g., 341, 342, 343) and configured to be at least partially disposed within a natural body orifice (see fig. 4 below, para. 75), the plurality of ports comprising; a first port (e.g., any of 341, 342, 343) configured to control ingress and egress of fluid between an interior volume of the natural body lumen or organ and an ambient environment (see para. 89-91), and a second port (another of 341, 342, 343) configured to form a seal around an instrument (e.g., see para. 91) inserted therethrough (see para. 91); and a retention element (e.g., 334, see fig. 4 below and para. 88) arranged on an exterior surface of the seal housing and configured to affix the seal housing to the natural body orifice (see fig. 4 below and para. 87-88).
PNG
media_image1.png
675
912
media_image1.png
Greyscale
Hess (embodiment of fig. 4) does not teach wherein the retention element is deployable outside of the natural body lumen or organ; or wherein the at least one retention element is a balloon configured to be selectively inflated to contact an internal or an external surface of the natural body orifice and secure the housing thereto; and the first port is configured to allow ingress and egress of fluid while in a first configuration and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration.
Hess (embodiment of fig. 14) teaches wherein the at least one retention element is a balloon (e.g., 1430) configured to be selectively inflated to contact an internal or an external surface of the natural body orifice and secure the housing thereto, in order to provide an alternative equivalent mechanism to anchor the device in place during the procedure (see para. 103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hess (embodiment of fig. 4) wherein the at least one retention element is a balloon configured to be selectively inflated to contact an internal or an external surface of the natural body orifice and secure the housing thereto, as a matter of engineering design choice, in view of Hess (embodiment of fig. 14), in order to provide an alternative equivalent mechanism that provides the same function of anchoring the device to tissue/ in place during the procedure.
Fischvogt, also drawn to surgical sealing devices, teaches the use of inflatable retention elements (114, 116- see fig. 6), in particular, wherein the retention element is deployable outside (e.g., above, not within) of the natural body lumen or organ (see fig. 6) in order to provide an alternative equivalent mechanism that provides the same function of anchoring the device to tissue/ in place during the procedure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hess (embodiment of fig. 4) wherein the retention element is deployable outside of the natural body lumen or organ, as a matter of engineering design choice, in view of Fischvogt, in order to provide an alternative equivalent mechanism that provides the same function of anchoring the device to tissue/ in place during the procedure.
Stefanchik, also drawn to surgical sealing devices, teaches a port a self-seal (e.g., 28) with two configurations (e.g., with an instrument inserted and closed with an instrument removed, see para. 50, 57) wherein the first port is configured to allow ingress and egress of fluid while in a first configuration (see para. 50, 57) and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration (see para. 50, 57) in order to provide a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough or not (see para. 50, 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hess (embodiment of fig. 4) wherein the first port is configured to allow ingress and egress of fluid while in a first configuration and the first port is configured to prevent the ingress and egress if fluid between the interior volume of the natural body lumen and the ambient environment while in a second configuration, in view of Stefanchik, as a matter of engineering design choice, in order to provide a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough or not.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection has been presented in view of the amendment to claim 1. As detailed in the rejections to claims 1-5, 7-10 and 21-27 above, Stefanchik is provided to teach a known self-sealing port that will predictably maintain a fluid-tight seal whether an instrument is inserted therethrough and selection of such seal is an obvious matter of engineering design choice depending on the use of the device.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TARA ROSE E CARTER/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773