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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 24th 2025 has been entered.
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, 2, 4-6, and 9-20 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); 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 2, the first retention member comprises a first flange and a second flange configured to appose first and second surfaces of the first tissue, 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 (both retention members have 2 flanges, 306 or 307, configured as claimed and evident from Figure 21A).
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]).
Regarding claim 12, Abbott et al. disclose a device (103; Figure 21A) capable of being regarded as a stent as claimed (see remarks above in regard to claim 1), comprising: a hollow body having a constrained configuration (as in Figure 3A) and an unconstrained configuration (Figure 21A), the hollow body in the unconstrained configuration comprising a first retention member (303/306), a second retention member (304/307), and a central region (305) therebetween, wherein the central region comprises along its entire length a coil (305) configured to, when deflected, generate a force to return towards a predetermined position (¶[0114], [0185]; the coil can be a spring which would function as claimed), the ends of the coil positioned along the central region (coil ends at the ends of the central region are considered to be positioned along the central region since claim 12 requires a singular coil to extend along the entire length of the central region); wherein a lumen is defined through the first retention member, the saddle region, the second retention member and the coil to extend along the entire length of the stent and to be maintained in an open configuration during use to provide an open flow path through and along the length of the stent so that fluids may move through the stent and between the body lumens (a lumen as claimed is clearly shown extending along the central longitudinal axis in Figure 21A; 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 central 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 13, as modified above, the coil would be configured to apply tension between the first retention member and the second retention member.
Regarding claim 14, 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 15, the first retention member, the second retention member and the coil are continuously formed of wire (Figure 17I; ¶[0177]).
Regarding claim 16, Abbott et al. disclose a device (103; Figure 21A) capable of being regarded as a stent (see remarks above in regard to claim 1), comprising: a first retention member (303/306) configured to appose a first tissue layer; a second retention member (304/307) configured to appose a second tissue layer; and a saddle region (portion of the central lumen extending within the coil 305) extending between and coupling the first retention member and the second retention member (Applicant has not disclosed a coil extending around a physical structure which couples the retention members, therefore a region of space can be regarded as the saddle region as claimed); a coil (305) extending along an entire length of the saddle region and around a diameter and along the circumference of the saddle region and configured to bias the first retention member and the second retention member together when the coil is not in a relaxed configuration to affect a spacing between the first tissue layer and the second tissue layer (¶[0114], [0185]; the coil can be a spring which would function as claimed); wherein a lumen is defined through the first retention member, the saddle region, the second retention member, and the coil to extend along the entire length of the stent to provide a flow path through the stent so that fluids may move through the stent (evident from Figure 21A; 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 17, the coil of either embodiment, being a spring, would be configured to apply tension between the first retention member and the second retention member.
Regarding claim 18, the coil of Figure 17I or the concentric coils provided in view of Figures 23A-C, being a spring as modified above, would apply a laterally outward force as claimed since there are spaces between the coil loops.
Regarding claim 19, the first retention member, the second retention member and the coil are continuously formed of wire (Figure 17I; ¶[0177]).
Regarding claim 20, the coil would extend along an entire length of the saddle region (evident from Figure 17I; members 303 and 304 are considered as part of a respective retention member and therefore the coil of Figure 21A also extends along the entire length of the saddle region).
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 3, 6, 7, 8, 14, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott et al. (US 2007/0073337).
Regarding claim 3, Abbott et al. fail to disclose that 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. However Abbott et al. disclose that a braided suture can be attached to a retention member in order to help retrieve the device (¶[0194]-[0197]; Figures 25A-25D)
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 one of the retention members with a braided suture (which can be regarded as a mesh) in order to help retrieve the device if necessary.
Regarding claim 6, Abbott et al. fail to disclose that the coil is configured to apply a laterally outward force between the first retention member and the second retention member. However, Abbott et al. disclose numerous embodiments of the coil having openings between coil loops (Figures 17I, 23A, 23C and 24D). Abbott et al. further disclose that various properties of the coil including pitch may be adjusted in order to create the appropriate compressive force for a particular treatment site (¶[0185]). Therefore, 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 (which is a spring) with openings between the coil loops in order to allow adjustment of the compressive force applied to tissue at a treatment site. With this modification, the coil would be configured to apply a laterally outward force between the first retention member and the second retention member if compressed and then released.
Regarding claim 7, Abbott et al. fail to disclose that the saddle region comprises two or more coils.
However, Abbott et al. disclose that the saddle region of other embodiments may be formed of multiple coaxial coils (Figures 23A-C) which allows application of a greater compressive force to tissue layers (¶[0188]).
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 Figure 21A as two coaxial coils in order to allow a greater compressive force to be applied to tissue layers when necessary.
Regarding claim 8, Abbott et al. disclose providing a coil with multiple spring constants (22A; ¶[0186]) and adjusting the spring constant of a coil in order to adjust the compressive force applied to tissue (¶[0185]). Therefore, 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 two coils with different spring constants in order to adjust the compressive force applied to tissue to a particular desired amount.
Regarding claim 14, Abbott et al. fail to disclose that the coil of Figure 21A is configured to apply a laterally outward force between the first retention member and the second retention member. However, Abbott et al. disclose numerous embodiments of the coil having openings between coil loops (Figures 17I, 23A, 23C and 24D). Abbott et al. further disclose that various properties of the coil including pitch may be adjusted in order to create the appropriate compressive force for a particular treatment site (¶[0185]). Therefore, 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 (being a spring as modified above) with openings between the coil loops in order to allow adjustment of the compressive force applied to tissue at a treatment site. With this modification, the coil would be configured to apply a laterally outward force between the first retention member and the second retention member if compressed and then released.
Regarding claim 16, in an alternative interpretation, Abbott et al. fail to disclose both a saddle region and a coil for the above embodiment.
However, Abbott et al. disclose that the saddle region of other embodiments may be formed of multiple coaxial spring coils (Figures 23A-C) which allows application of a greater compressive force to tissue layers (¶[0188]).
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 Figure 21A as two coaxial coils in order to allow a greater compressive force to be applied to tissue layers when necessary. With this modification, the inner coil could be considered as the claimed saddle region and the outer coil can be considered as the claimed coil.
Regarding claim 17, the coil, being a spring, would be configured to apply tension between the first retention member and the second retention member.
Regarding claim 18, in view of the alternative interpretation, the coils provided from Figures 23A-C are springs and would apply a laterally outward force as claimed since there are spaces between the coil loops. In the first interpretation, Abbott et al. fail to disclose that the coil of Figure 21A is configured to apply a laterally outward force between the first retention member and the second retention member. However, Abbott et al. disclose numerous embodiments of the coil having openings between coil loops (Figures 17I, 23A, 23C and 24D). Abbott et al. further disclose that various properties of the coil including pitch may be adjusted in order to create the appropriate compressive force for a particular treatment site (¶[0185]). Therefore, 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 (being a spring as modified above) with openings between the coil loops in order to allow adjustment of the compressive force applied to tissue at a treatment site. With this modification, the coil would be configured to apply a laterally outward force between the first retention member and the second retention member if compressed and then released.
Regarding claim 20, the coil would extend along an entire length of the saddle region (members 303 and 304 are considered as part of a respective retention member and therefore the outer coil extends along the entire length of the saddle region).
Response to Arguments
Applicant's arguments filed November 24th 2025 have been fully considered but they are not persuasive. Applicant has again argued that the device of Abbott et al. is intended to block the flow of materials and/or close a PFO and could not allow the sustained fluid flow as claimed. The amended claims do not appear provide any substantive change to how the claimed device functions as compared the previously filed claims. Therefore, Examiner’s response in the Office action dated August 4th 2025 is largely repeated here. A lumen which is narrow enough to block the passage of blood cells would still be wide enough to allow the flow of at least some fluids including water. Although it is agreed that Abbott et al. disclose closing of a PFO and prevention of blood shunting therethrough, they make no mention of completely plugging the disclosed lumens. Unless a lumen is described or at least depicted as being completely closed by some structure(s), it must be assumed that some amount of fluid passage can occur as claimed; a fact that was confirmed with patent quality assurance specialists on one occasion and a supervisory patent examiner on another occasion who reviewed this issue. Applicant’s claims do not require the lumen to allow a sustained flow of blood or sustained drainage of a gastrointestinal tract (a function that the narrow lumen of Abbott et al. might prevent but further consideration would be needed). Applicant has argued that Abbott et al. is not analogous art. Applicant’s invention is not only directed to creating a fluid shunt. It is also largely directed to joining tissue layers (see for example ¶[0040] of Applicant’s specification). The clips of Abbott et al. and others like it are intended to join tissue layers separating body lumens or cavities for a variety of reasons (¶[0010], [0227]-[0231]) and would therefore be reasonably pertinent to the problem faced by the inventor. Applicant has argued that the coil (305) of Abbott et al. is limited to the central portion of the body (301) and does not extend along the entire length of the body and therefore does not meet the limitations of the independent claims. As explained above, members 303 and 304 of Abbott et al. can be considered as part of the claimed retention members. There is no recitation requiring the coil to extend along the entire length of the body; rather, the independent claims only require the coil to extend along the entire length of the saddle region or central region. Furthermore, Figure 17I shows the coil extending the entire length between radially expanded retention structures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771