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’s arguments with respect to claim(s) 1-7 and 11-15 have been considered but are moot because the new ground of rejection over Quijano et al. US 5609626.
Quijano et al. discloses a support (50 or 50a, figures 8, 9) extending radially inward from said wall and into said lumen (see annotated figure 8 below), said support is configured to engage the connector to couple said first tubular implantable medical device and said second tubular implantable devices together (engaged within the connected device, attached through the suture to support ring 50 or 50a for coupling with flanges 14, 16 to couple members 30 with sutures which pass through flanges 14, 16, 32 and support or spacer 50; column 8, lines 22-25; see annotated figures 8, 9 below), and said connector 10 establishes an anastomosis through said first implantable medical device 30 and said second implantable medical device 30 preventing flow of materials in a direction through walls of said first and second implantable medical devices (connector comprises a vascular graft, figure 3, allowing for blood flow therethrough, column 8, lines 27-28; blood flow passes through to provide anastomosis).
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Applicant’s arguments with respect to claim(s) 1, 2, 5, 6, 12 and 14 have been considered but are moot because the new ground of rejection over Porter, IV US 2019/0117226 in view of Hamer et al. US 8551157.
Porter, IV discloses a system comprising: a first tubular implantable medical device 100A (figure 17); a second tubular implantable medical device 100B (figure 17); and a connector 1600 separate from and configured to couple together said first tubular implantable medical device and said second tubular implantable medical device.
Hamer et al. teaches a method of coupling a tubular member 20 and second conduit or coupler 26, the tubular member comprising a wall (figure 3, wall 20) having a support 34 extending radially inward from the wall (figure 3) to couple with a connector attachment portion 36 (figure 4), the connector attachment portion 36 engages with protuberance 32 of the support and are therefore engaged and interlocked into the cuff, preventing or inhibiting from dislodgement (column 3, lines 33-51).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a support extending radially inward from said wall and into said lumen, as taught by Hamer et al. as a known substitute attachment in the art for connecting a tubular members with a connector or graft therebetween, to engage and lock with each other to prevent or inhibit dislodgement once placed in the desired location.
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(s) 1-7 and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quijano et al. US 5609626.
Regarding claims 1, 12, Quijano et al. discloses an implantable medical device system configured to form an anastomosis across cut ends of a body lumen (figures 9, 15, 16, connecting ends of blood vessel 40, 40a, 40b), said system comprising: a first tubular implantable medical device 30 (figures 9, 15); a second tubular implantable medical device 30 (figures 9, 15); and a connector 10 separate from and configured to couple together said first tubular implantable medical device and said second tubular implantable medical device (figures 9, 15); wherein said first tubular implantable medical device and said second tubular implantable medical device each include: tissue-engagement features configured to facilitate coupling of said first and second tubular implantable medical devices with respect to a body lumen (apertures 34 to receive sutures and secure to flange 32 of the tubular implantable medical device, figure 9, 15; column 7, lines 22-25); and a support (50 or 50a, figures 8, 9) extending radially inward from said wall and into said lumen (see annotated figure 8 below), said support is configured to engage the connector to couple said first tubular implantable medical device and said second tubular implantable devices together (engaged within the connected device, attached through the suture to support ring 50 or 50a for coupling with flanges 14, 16 to couple members 30 with sutures which pass through flanges 14, 16, 32 and support or spacer 50; column 8, lines 22-25; see annotated figures 8, 9 below), and said connector 10 establishes an anastomosis through said first implantable medical device 30 and said second implantable medical device 30 preventing flow of materials in a direction through walls of said first and second implantable medical devices (connector comprises a vascular graft, figure 3, allowing for blood flow therethrough, column 8, lines 27-28; blood flow passes through to provide anastomosis).
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Regarding claim 2, Quijano et al. discloses wherein: said tissue-engagement features are provided at a tissue-engaging region of each of said first and second implantable medical devices (figure 10, 16; engaged with vessel 40); and said support 50a is at a device-engaging region of each of said first and second implantable medical devices (support 50a for each first and second implantable medical device is engaged with flanges 14, 16 of the connector 10, respectively).
Regarding claims 3 and 13, Quijano et al. discloses wherein said tissue-engagement features comprise apertures (apertures 34, 36, figures 6, 9) configured to allow at least one of a tissue connector or tissue to extend therethrough (tissue connector sutures 54 may pass through, additionally apertures are sized and shaped to allow tissue ingrowth therethrough).
Regarding claim 4, Quijano et al. discloses wherein said tissue-engagement features are configured to allow at least one of a tissue connector or tissue to extend therethrough to anchor said first and second implantable medical devices with respect to the body lumen (tissue connector or sutures extend through aperture 34 to connect, figures 9, 15; column 7, lines 22-25).
Regarding claims 5 and 14, Quijano et al. discloses wherein said connector is a tubular connector (figure 2, connector 10 with bore 22 therethrough), and has a first end (flange 14) engageable with the support (50 or 50a) of said first implantable medical device and a second end (flange 16) engageable with the support (50 or 50a) of said second implantable medical device to couple said first and second implantable medical devices together (figures 8, 9, 16).
Regarding claim 6, Quijano et al. discloses wherein said tubular connector 10 couples said first and second implantable medical devices together (figure 9, 15) with supports of said first and second implantable medical device spaced apart from each other (figure 9, 15, supports 50 or 50a connected on each opposite end of the connector).
Regarding claim 7, Quijano et al. discloses wherein the tubular connector 10 is coated to prevent passage of materials through the wall thereof (coated with a vascular graft, figure 3, allowing for blood flow therethrough, column 8, lines 27-28; blood flow passes through to provide anastomosis).
Regarding claim 11, Quijano et al. discloses further comprising a tether coupling said first and second implantable medical devices together after the body lumen (sutures pass through flanges of the first and second tubular implantable medical devices and connector and support 50 to couple the device within the vessel 40; column 8, lines 59-65; Examiner notes the sutures may be considered a tether as it secures the connector and devices within the vessel, as a tether may be defined as “a rope, chain, cable or other line for restraining or securing an object” -yourdictionary.com).
Regarding claim 15, Quijano et al. discloses wherein the tubular connector 10 is a stent (stent device 10, column 8, line 3) having a first end engageable with said support of said first implantable medical device and a second end engageable with said support of said second implantable medical device (figure 9; engaged with intermediate support ring 50, 50a).
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, 2, 5, 6, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Porter, IV US 2019/0117226 in view of Hamer et al. US 8551157.
Regarding claims 1 and 12, Porter, IV discloses an implantable medical device system configured to form an anastomosis across cut ends of a body lumen (fixation system 108 configured for placement across cut ends, fixation system secures the connector to prevent separation or reduce or eliminate leakage at an anastomosis site, the connector may be of any suitable dimension for the particular anastomosis, paragraph 0028, 0035; Examiner notes the structure of the device would be configured to perform an anastomosis), said system comprising: a first tubular implantable medical device 100A (figure 17); a second tubular implantable medical device 100B (figure 17); and a connector 1600 separate from and configured to couple together said first tubular implantable medical device and said second tubular implantable medical device (paragraph 0027, device 100 selectively connected to section 1600); wherein said first tubular implantable medical device and said second tubular implantable medical device each include: tissue-engagement features configured to facilitate coupling of said first and second tubular implantable medical devices with respect to a body lumen (for example, figure 2, barbs 202 extending outwardly of a flange to come into contact with the interior surface of the vessel wall); a wall defining a lumen (wall of tubular body 102, paragraph 0026, figure 1A, 17); and a support 110, said support is configured to engage the connector to couple said first tubular implantable medical device and said second tubular implantable medical devices together (selectively attach the coupler 1600 to each the first and second tubular bodies 100A, 100B, figure 17, paragraph 0026, 0050), said connector establishes an anastomosis through said first implantable device and said second implantable medical device preventing flow of materials in a direction through the walls of said first and second implantable medical devices (materials or blood flow through the first and second tubular bodies through the connector graft once placed to allow for a bypass between the vessels).
Porter, IV discloses the support for attaching the coupler and may comprise any suitable system for connecting the first and second tubular members 100A, 100B with the connector graft 100 (paragraph 0027), the support may have a channel to receive and secure a mating protrusion, coupled by a mechanical fastener or through adhesive or bonding process, but fails to explicitly disclose a support extending radially inward from said wall and into said lumen.
Hamer et al. teaches a method of coupling a tubular member 20 and second conduit or coupler 26, the tubular member comprising a wall (figure 3, wall 20) having a support 34 extending radially inward from the wall (figure 3) to couple with a connector attachment portion 36 (figure 4), the connector attachment portion 36 engages with protuberance 32 of the support and are therefore engaged and interlocked into the cuff, preventing or inhibiting from dislodgement (column 3, lines 33-51).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a support extending radially inward from said wall and into said lumen, as taught by Hamer et al. as a known substitute attachment in the art for connecting a tubular members with a connector or graft therebetween, to engage and lock with each other to prevent or inhibit dislodgement once placed in the desired location.
Regarding claim 2, Porter, IV in combination discloses wherein: said tissue-engagement features are provided at a tissue-engaging region of each of said first and second implantable medical devices (tissue engaging region adjacent the vessel 402, figure 17); and said support is at a device-engaging region of each of said first and second implantable medical devices (support 110 at device 1600 engaging region, figure 17).
Regarding claims 5 and 14, Porter, IV in combination discloses wherein said connector is a tubular connector (graft connector 1600, figure 17) and has a first end engageable with the support 110 of said first implantable medical device and a second end engageable with the support 220 of said second implantable medical device to couple said first and second implantable medical devices together (figure 17, paragraph 0050, first and second medical device linked together by the connector 1600).
Regarding claim 6, Porter, IV in combination discloses wherein said tubular connector couples said first and second implantable medical devices together with supports of said first and second implantable medical device spaced apart from each other (supports 110 on opposite sides of connector 1600, figure 17).
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to disclose in combination with the claim limitations wherein said tubular connector couples said first and second implantable medical devices together with said supports of said first and second implantable medical device abuttingly engaging each other.
Quijano et al. US 5609626 discloses a tubular stent connector 10 being placed between first and second medical devices 30, the supports engaging the first and second implantable medical devices on opposite ends of the stent connector. Abuttingly engaging the first and second supports 50, 50a of the first and second implantable medical device would destroy the anastomosis function, as the tubular stent connector and graft would be unable to be attached therebetween.
Porter, IV US 2019/0117226 discloses tubular connectors being placed between first and second medical devices for providing bypass channels or connection between anastomosis. This providing space between the first and second medical devices supports and therefore the supports. It would not have been obvious to one having ordinary skill in the art to provide supports that abuttingly engage, as there would be no need for the tubular connector therebetween and would destroy the anastomosis function.
Borghi US 2003/0088255 discloses an implantable medical device system (figure 2) configured to form an anastomosis across cut ends of a body lumen (figure 2, end portions 1 and 2 of vessel), wherein said tubular connector couples said first and second implantable medical devices together with supports of said first and second implantable medical device abuttingly engaging each other (figure 2, supports 23 and 36 are abuttingly engaged), but fails to disclose a support extending radially inward from said wall and into said lumen, said support is configured to engage the connector to couple said first tubular implantable medical device and said second tubular implantable medical device together. The first and second implantable medical devices comprise a support extending radially inward (30 to engage vessel, figure 2), however, the support is not configured to engage the connector to couple said first tubular implantable medical device and said second tubular implantable medical device together. Support portions 23 and 36 are extending radially outward (figure 2). It would not be obvious to modify Borghi to have a radially inward supports to engage the connector and couple the first and second tubular medical devices together, as it would require the connector 38 to be placed on the inside of the vessel, and thereby destroying the reference.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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