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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A in the reply filed on 11/3/25 is acknowledged.
Claims 9, 10 and 16-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/3/25.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 discloses “said support includes a support” on line 4. This language is indefinite as it is unclear whether “a support” is the same or different “a support” as disclosed in claim 1.
Claim 8 discloses “supports” on line 2. This language is indefinite as it is unclear whether the “support” is the same or different “a support” as disclosed in claim 1.
Claim 8 recites the limitation "with supports" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending such as “with the supports” to point out the supports are the same supports, as disclosed in claim 1.
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) 1-4 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tabur et al. US 2019/0343544.
Regarding claim 1, Tabur et al. discloses an implantable medical device system (for example, figure 3) configured to form an anastomosis across cut ends of a body lumen (figure 8, brings together in end to end fashion with an excised tissue portion 171, paragraph 0034, 0049), said system comprising: a first tubular implantable medical device (for example, see annotated figure 3 below, members 112); a second tubular implantable medical device (for example, see annotated figure 3 below, members 114); and a connector configured to couple said first tubular implantable medical device and said second tubular implantable medical device together (for example, see annotated figure 3 below, figure 5, connector or fasteners 152 for connecting the first and second tubular members, paragraph 0039); wherein said first tubular implantable medical device and said second tubular implantable medical device 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, see annotated figure 3 below, features 130, 164, paragraphs 0037, 0041, figure 3); and a support configured to facilitate coupling of said first and second tubular implantable devices together (figures 5, 9; first tubular member 112 having support or including a plurality of slots 135 and features 138; the second tubular members 114 each having a support or including a plurality of slots 154 and features 140, for example, see annotated figure 3 below).
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Regarding claim 2, Tabur et al. discloses wherein: said tissue-engagement features 130 are provided at a tissue-engaging region of each of said first and second implantable medical devices (figure 8, features 130, 164 affixed to tissue, paragraphs 0037, 0041); and said support includes a support at a device-engaging region of each of said first and second implantable medical devices (see annotated figure 9 below, portions 134, 136 engage).
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Regarding claim 3, Tabur et al. discloses wherein said tissue-engagement features comprise apertures (open apertures between tangs, figure 9).
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Regarding claim 4, Tabur 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 placed against apertures, figure 9; Examiner notes it would be configured to allow tissue to extend therethrough, as there are apertures adjacent the tissue).
Regarding claim 11, Tabur et al. further comprising a tether 125 coupling said first and second implantable medical devices together after the body lumen to which said first and second implantable medical devices are coupled has been cut between said first and second implantable medical devices (figure 8, tether 125 with hook tool 120 comprising hooks 124 engaged with the first tubular member to bring towards second tubular member in an end-to-end fashion, paragraph 0034).
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quijano et al. US 5609626.
Regarding claim 1, 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 configured to couple said first tubular implantable medical device and said second tubular implantable medical device together (figures 9, 15); wherein said first tubular implantable medical device and said second tubular implantable medical device 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 32 configured to facilitate coupling of said first and second tubular implantable devices together (flange 32 for coupling with connector flanges 14, 16, figure 9, 15).
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 32 includes a support at a device-engaging region of each of said first and second implantable medical devices (flanges 32 engage with flanges 14, 16 of the connector).
Regarding claim 3, Quijano et al. discloses wherein said tissue-engagement features comprise apertures (apertures 34, figures 6, 9)
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 claim 5, Quijano et al. discloses wherein said connector is a tubular connector (figure 2, connector 10 with bore 22 therethrough) formed separately from said first and second implantable medical devices (figures 2, 6, show individual connector and devices formed separately prior to being connected), and has a first end (flange 14) engageable with the support (flange 32) of said first implantable medical device and a second end (flange 16) engageable with the support (flange 32) of said second implantable medical device to couple said first and second implantable medical devices together (figure 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, connected on each end of the connector).
Claim(s) 1, 2, 5, 8, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Borghi US 2003/0088255.
Regarding claim 1, Borghi discloses an implantable medical device system configured to form an anastomosis across cut ends of a body lumen (figure 2, end portions 1 and 2 of vessel), said system comprising: a first tubular implantable medical device 11 (figure 1); a second tubular implantable medical device 24 (figure 1); and a connector 38 configured to couple said first tubular implantable medical device and said second tubular implantable medical device together (figure 2); wherein said first tubular implantable medical device and said second tubular implantable medical device include: tissue-engagement features configured to facilitate coupling of said first and second tubular implantable medical devices with respect to a body lumen (fixing hooks 17 and 30, figure 1); and a support (figure 1, supports 23 and 36 on first and second tubular medical device, respectively) configured to facilitate coupling of said first and second tubular implantable devices together (figure 2).
Regarding claim 2, Borghi discloses wherein: said tissue-engagement features are provided at a tissue-engaging region of each of said first and second implantable medical devices (figure 1, fixing hooks 17, 30 extend through vessel at a tissue engaging portion); and said support includes a support at a device-engaging region of each of said first and second implantable medical devices.
Regarding claim 5, Borghi discloses wherein said connector is a tubular connector formed separately from said first and second implantable medical devices (figure 1, tubular connectors shown separate from connector), and has a first end engageable with the support of said first implantable medical device and a second end engageable with the support of said second implantable medical device to couple said first and second implantable medical devices together (see annotated figure 2 below).
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Regarding claim 8, Borghi discloses 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).
Regarding claim 12, Borghi discloses an implantable medical device system configured to form an anastomosis across cut ends of a body lumen (figure 2, end portions 1 and 2 of vessel), said system comprising: a first tubular implantable medical device 11 (figure 1); a second tubular implantable medical device 24 (figure 1); and a connector 38 configured to couple said first tubular implantable medical device and said second tubular implantable medical device together (figure 2); wherein said first tubular implantable medical device and said second tubular implantable medical device include: tissue-engagement features configured to facilitate coupling of said first and second tubular implantable medical devices with respect to a body lumen (fixing hooks 17 and 30, figure 1); and a support (figure 1, supports 23 and 36 on first and second tubular medical device, respectively) configured to facilitate coupling of said first and second tubular implantable devices together (figure 2), said connector establishes an anastomosis through said first implantable medical device and said second implantable devices preventing flow of materials in a direction through walls of said first and second implantable medical devices (figure 2, walls of device are made of any bio-compatible material such as an elastic material, placed around the vessels to prohibit flow out of the vessel to complete the anastomosis).
Regarding claim 14, Borghi discloses wherein said connector is a tubular connector formed separately from said first and second implantable medical devices (figure 1, tubular connectors shown separate from connector), and has a first end engageable with the support of said first implantable medical device and a second end engageable with the support of said second implantable medical device to couple said first and second implantable medical devices together (see annotated figure 2 below).
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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) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tabur et al. US 2019/0343544 in view of Greenhalgh US 2002/0087176.
Regarding claim 12, Tabur et al. discloses an implantable medical device system (for example, figure 3) comprising: a first tubular implantable medical device (for example, see annotated figure 3 below, members 112); a second tubular implantable medical device (for example, see annotated figure 3 below, members 114); and a connector configured to couple said first tubular implantable medical device and said second tubular implantable medical device together (for example, see annotated figure 3 below, figure 5, connector or fasteners 152 for connecting the first and second tubular members, paragraph 0039); wherein said first tubular implantable medical device and said second tubular implantable medical device include: tissue-engagement features configured to facilitate coupling of said first and second tubular implantable medical devices with (for example, see annotated figure 3 below, features 130, 164, paragraphs 0037, 0041, figure 3); and a support configured to facilitate engagement of said first and second implantable devices to couple said first and second implantable medical devices together (figures 5, 9; first tubular member 112 having support or including a plurality of slots 135 and features 138; the second tubular members 114 each having a support or including a plurality of slots 154 and features 140, for example, see annotated figure 3 below), and said connector establishes an anastomosis through said first implantable medical device and said second implantable medical device (figure 4, connector 138, 140, when connected by connector 152, first and second tubular members have complementary features to form a continuous tubular structure, paragraph 0034), but fails to explicitly disclose wherein the tubular connector is coated to prevent passage of materials through the wall thereof, or preventing flow of materials in a direction through walls of said first and second implantable medical devices.
Greenhalgh discloses an implantable medical device system for anastomosis at a tissue site (paragraph 0004), wherein a tubular member 22 is coated to prevent passage of materials through the wall thereof, or preventing flow of materials in a direction through walls of said first and second implantable medical devices (paragraph 0052, anastomosis device may comprise a membrane or silicone coating to seal and provide virtually zero permeability to seal the anastomosis).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Tabur et al. wherein the tubular connector is coated to prevent passage of materials through the wall thereof, as taught by Greenhalgh, to seal and provide virtually zero permeability to seal the anastomosis.
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Regarding claim 13, Tabur et al. discloses wherein said tissue-engagement features comprise apertures configured to allow at least one of a tissue connector or tissue to extend therethrough (tissue placed against apertures, see annotated figure 9 below; Examiner notes it would be configured to allow tissue to extend therethrough, as there are apertures adjacent the tissue).
Claim(s) 7 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quijano et al. US 5609626 in view of Greenhalgh US 2002/0087176.
Regarding claim 7 and 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 configured to couple said first tubular implantable medical device and said second tubular implantable medical device together (figures 9, 15); wherein said first tubular implantable medical device and said second tubular implantable medical device 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 32 configured to facilitate coupling of said first and second tubular implantable devices together (flange 32 for coupling with connector flanges 14, 16, figure 9, 15), as discussed above, but fails to disclose wherein the tubular connector is coated to prevent passage of materials through the wall connector thereof, or preventing flow of materials in a direction through walls of said first and second implantable medical devices.
Greenhalgh discloses an implantable medical device system for anastomosis at a tissue site (paragraph 0004), wherein a tubular member 22 is coated to prevent passage of materials through the wall thereof, or preventing flow of materials in a direction through walls of said first and second implantable medical devices (paragraph 0052, anastomosis device may comprise a membrane or silicone coating to seal and provide virtually zero permeability to seal the anastomosis).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Tabur et al. wherein the tubular connector is coated to prevent passage of materials through the wall thereof, as taught by Greenhalgh, as known in the art to provide virtually zero permeability to seal the anastomosis to prevent leaking.
Regarding claim 13, , Quijano et al. discloses wherein said tissue-engagement features comprise apertures 34 are configured to allow at least one of a tissue connector or tissue to extend therethrough (tissue connector 54 extend through aperture 34 to connect, figures 9, 15; column 7, lines 22-25).
Regarding claim 14, Quijano et al. discloses wherein said connector is a tubular connector (figure 2, connector 10 with bore 22 therethrough) formed separately from said first and second implantable medical devices (figures 2, 6, show individual connector and devices formed separately prior to being connected), and has a first end (flange 14) engageable with the support (flange 32) of said first implantable medical device and a second end (flange 16) engageable with the support (flange 32) of said second implantable medical device to couple said first and second implantable medical devices together (figure 9, 16).
Regarding claim 15, Quijano et al. discloses wherein the tubular connector is a stent (stent device 10) having a has a first end (flange 14) engageable with the support (flange 32) of said first implantable medical device and a second end (flange 16) engageable with the support (flange 32) of said second implantable medical device to couple said first and second implantable medical devices together (figure 9, 16).
Conclusion
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.
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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