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 § 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.
Claims 1, 4-6 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbott et al. (US 2007/0073337).
Regarding claim 1, Abbott et al. disclose a device (103; Figure 21A) capable of being regarded as a stent (the device functions to connect tissue layers, as in Figure 19B, as does Applicant’s device - noting that Applicant’s device does not function as a traditional stent which holds open and/or dilates a vessel; therefore the device can be regarded as a stent inasmuch as Applicant’s), configured to maintain an open passage between body lumens within a patient to enable and facilitate the flow of fluids and materials between the body lumens during use within the patient (the device as seen in Figure 21A clearly has an open lumen along its central longitudinal axis which would enable and maintain passage of at least some fluids and/or materials), the stent comprising: an elongate body having a first retention member (303/306), a second retention member (304/307), and a saddle region (305) coupling the first retention member and the second retention member; wherein: a lumen is defined through and along the entire length of the elongate body, including through the first retention member, the saddle region, and the second retention member and maintained in an open configuration during use to enable flow of fluid through and along the entire length of the stent during use of the stent (unlabeled interior lumen along the central longitudinal axis is evident from Figure 21A - analogous to lumen 302 in other embodiments; some amount and type of fluid would be able to flow through this lumen as claimed); the diameter of each of the first retention member and the second retention member is greater than the diameter of the saddle region (the retention members have a larger outer diameter than the saddle region, either at portions 303 or 304, or taken across two opposing members 306 or 307 as evident from Figure 21A); at least one of the first or second retention member comprises a continuously circumferential flange (e.g. the portion at “301” in Figure 21A is part of the flange and extends continuously around a circumference; alternatively, the flanges 306 or 307 in Figures 17I and 17J, considered as fully disclosed for combination with the Figure 21A embodiment, are continuous members extending around a circumference) the saddle region is coupled at a first end thereof to an axial inner surface of the first retention member, and at a second end thereof to an axial inner surface of the second retention member (evident from Figure 21A - integral with the retention members at their axial inner surfaces in the same way as Applicant’s saddle region in Figure 2A); the saddle region is formed along its entire length of a coil imparting a bias force to the first retention member and the second retention member to apply a restoring force to tissue surfaces respectively apposed to the axial inner surface of the first retention member and the axial inner surface of the second retention member (the saddle region is a coiled spring capable of functioning as claimed - ¶[0185]); and the lumen is defined through the entire length of the body to be maintained in an open configuration upon deployment between body lumens within a patient to define an open flow passage between body lumens to facilitate longitudinal flow of fluid through the saddle region and between the body lumens during use within the patient (the lumen is shown to be unobstructed; no other disclosure specifically describes this lumen as obstructed, therefore it would be able to maintain a flow passage as claimed for at least some fluids other than blood). Abbott et al. further disclose another embodiment (Figure 17I) also readable by the above limitations having retention members (303 and 304) and a spring saddle region (305) as claimed. It is noted that the open, uncovered coil of Figure 17I would create a lumen as claimed since Applicant’s Figure 2A is apparently readable by the claims as well.
Regarding claim 4, the coil extends along an entire length of the saddle region (evident from Figure 21A).
Regarding claim 5, the coil is configured to apply tension between the first retention member and the second retention member (¶[0185]).
Regarding claim 6, the coil of Figure 17I, being a spring, would apply a laterally outward force as claimed since there are spaces between the coil loops.
Regarding claim 9, the saddle region comprises at least one curve (innumerable curved can be identified along the outer circumference of the coil).
Regarding claim 10 the first retention member, the second retention member and the coil are continuously formed of wire (Figure 17I; ¶[0177]).
Regarding claim 11, either the first retention member comprises a first surface substantially perpendicular to a longitudinal axis of the saddle region, the first surface configured to appose a first tissue, or the second retention member comprises a second surface substantially perpendicular to a longitudinal axis of the saddle region, the second surface configured to appose a second tissue, or both retention members comprise the first and second surface, respectively (members 306 or 307 can be regarded as being substantially perpendicular as claimed - also see ¶[0130]).
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 non-obviousness.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. (US 2010/0160847) in view of Rafiee et al. (US 2019/0231510).
Regarding claim 1, Braido et al. disclose a device capable of functioning as a stent (Figures 25 and 58 and 59 the device functions to connect tissue layers, as in Figure 19B, as does Applicant’s device - noting that Applicant’s device does not function as a traditional stent which holds open and/or dilates a vessel; therefore the device can be regarded as a stent inasmuch as Applicant’s) configured to maintain an open passage between body lumens within a patient to enable and facilitate the flow of fluids and materials between the body lumens during use within the patient (¶[0087]-[0090]), the device comprising: an elongate body (160/600; Figures 25 and 58 or 59) having a first retention member (160; Figure 25), a second retention member (member 160 at opposite end of 600), and a saddle region (600) coupling the first retention member and the second retention member; wherein: a lumen is defined through and along the entire length of the elongate body, including through the first retention member, the saddle region, and the second retention member and maintained in an open configuration during use to enable flow of fluid through and along the entire length of the stent during use of the stent (evident from ¶[0004], [0087]-[0090]); the diameter of each of the first retention member and the second retention member is greater than the diameter of the saddle region (evident from Figure 1); at least one of the first retention member and the second retention member comprise at least one continuously circumferential flange (numerous portion of member 160, e.g. 162, extend continuously around a circumference); the saddle region is coupled at a first end thereof to an axial inner surface (166) of the first retention member, and at a second end thereof to an axial inner surface (166) of the second retention member; the saddle region is formed, along its entire length, of a coil (620 or 630); and the lumen is defined through the entire length of the elongate body to be maintained in an open configuration upon deployment between body lumens within a patient to define an open flow passage between body lumens to facilitate longitudinal flow of fluid through the saddle region and between the body lumens during use within the patient (evident from ¶[0004], [0087]-[0090]).
Braido et al. fail to disclose that the coil imparts a bias force to the first retention member and the second retention member to apply a restoring force to tissue surfaces respectively apposed to the axial inner surface of the first retention member and the axial inner surface of the second retention member.
Rafiee et al. disclose a similar device for providing a conduit between vessels (¶[0068] of Rafiee et al.; ¶[0090] of Braido et al.) and further teaches providing a similar reinforcing coil (330 or 430) with a an elastic biasing force in order to allow the length of a saddle region to be adjustable (¶[0015], [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the coil of Braido et al. with the elastic biasing force of Rafiee et al. in order to allow the length of the saddle region to accommodate changes in length between the connected tissues.
Regarding claim 2, Braido et al. disclose that the first retention member comprises a first flange (formed by petals 170) and a second flange (formed by petals 171) configured to appose first and second surfaces of the first tissue (a tissue layer could be located in the gap between the flanges), wherein the second retention member comprises a third flange and a fourth flange configured to appose first and second surfaces of the second tissue, or both (the second retention member, also being another member 160, would also have opposing flanges formed by petals 170 and 171 as claimed).
Regarding claim 3, the first retention member comprises a mesh structure, or the second retention member comprises a mesh structure, or both retention members each comprise a mesh structure (the woven structure can be regarded as a mesh - ¶[0114] of Braido et al.).
Regarding claim 4, the coil extends along an entire length of the saddle region (Figures 58 and 59 of Braido et al.).
Regarding claim 5, the coil, being a spring as modified above, would be configured to apply tension between the first retention member and the second retention member.
Regarding claim 6, the coil, being a spring as modified above, would be configured to apply a laterally outward force between the first retention member and the second retention member.
Regarding claim 7, the saddle region comprises two or more coils (Figure 59 of Braido et al.).
Regarding claim 8, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the coaxial springs of different diameters (and therefore different spring constants) disclosed by Rafiee et al. (¶[0054]) within the saddle region of Braido et al. in order to provide a stronger biasing force when necessary.
Regarding claim 9, saddle region comprises at least one curve (as defined by the outer surface of the cylindrical saddle region or the coil(s) therein).
Regarding claim 10, the first retention member, the second retention member, and the coil are continuously formed of wire (¶[0114] of Braido et al.).
Regarding claim 11, either the first retention member comprises a first surface substantially perpendicular to a longitudinal axis of the saddle region, the first surface configured to appose a first tissue, or the second retention member comprises a second surface substantially perpendicular to a longitudinal axis of the saddle region, the second surface configured to appose a second tissue, or both retention members comprise the first and second surface, respectively (evident from Figure 25 of Braido et al.).
Claims 12-14 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. (US 2010/0160847) in view of Rafiee et al. (US 2019/0231510) and Goldsteen et al. (US 5,976,178).
Regarding claims 12-14 and 16-21, Braido et al. in view of Rafiee et al. make obvious the device as described above, including the limitations already addressed above.
Braido et al. disclose that the retention members comprise a woven wire structure (¶[0114]) but fails to specifically state that they are braided wire structure.
However, Goldsteen et al. disclose a similar device for creating a conduit between tissue layers (Abstract; Figure 16) and further teach that a similar retention member or flange (436) can be formed from braided wires (col. 12, lines 45-47; col. 19, lines 12-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Goldsteen et al. to have formed the flanges of the retention members of Braido et al. from braided wire as a suitable alternate means taught by the prior art for making a similar flange with a reasonable expectation of success for anchoring against tissue.
Response to Arguments
Applicant's arguments filed June 3rd 2026 have been fully considered but they are either not persuasive or are moot in view of the new grounds of rejection above. Applicant has argued that the retention members of Abbott et al. are separately deflectable portions which are not continuously circumferential. As at least recited in claim 1, the portion at “301” in Figure 21A has been cited as part of a retention member and it is cylindrical and therefore continuously circumferential. Furthermore, the flanges 306 or 307 in Figures 17I and 17J, considered as fully disclosed for combination with the Figure 21A embodiment, are continuous members extending around a circumference as well.
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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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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