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 Amendment
This action is entered in response to Applicant's amendment and reply of 2/17/26. The claims 1-32 are pending. The claims 1, 9, and 21 are amended. Claims 9-32 are withdrawn.
Response to Arguments
The telephonic interview of 1/22/26 discussed proposed amendments. After further review, Examiner disagrees the amendments overcome the previous rejection for the reasons discussed below.
Applicant’s arguments, filed 2/17/26 with respect to the rejections of claims 1, 3-6 under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin (US2009/0062901) have been fully considered but they are not persuasive. Applicant argues, “the tube is naturally biased to the retracted configuration via elasticity of the elastic fibers to the tube” is not taught by the prior art. Examiner disagrees, where the claims need to clarify that the tube is biased to the retracted configuration by the structure of the tube itself. Where the elastin in the valve of McGuckin can provide at least some minimal force in retracting the overall device by the nature of elastin. Where McGuckin teaches the contraction of the device is desirable to bring the vessel wall radially inward ([0061]).
With regard to claim 6, Applicant argues, the asserted retention legs of McGuckin (teeth 28) are not “arranged against a surface of the tube prior to expansion of the tube”. Examiner disagrees, as stated in the rejection below, the legs 28 are arranged against a surface by being in the same plane as the surface of the tube in the delivery configuration as shown in Fig. 6 in another embodiment. Examiner further states, the teeth 28 are interpreted as being against the surface when looking down the longitudinal axis the components are adjacent each other and interpreted as being against each other.
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 and 3-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin (US2009/0062901).
Regarding claim 1, McGuckin discloses a closure device for repairing a vein valve insufficiency ([0003]), the closure device comprising:
a tube (valve 40 having a cylindrical shape, see Fig. 2) formed of extracellular matrix ([0079]), comprising elastin fibers (the valve is composed of intestinal submucosa which contains elastin fibers, [0079]), wherein the tube is radially expandable from a retracted configuration to an expanded configuration ([0060]), wherein the tube is naturally biased to the retracted configuration via elasticity of the elastic fibers of the tube ([0061] states “the device is contracted to bring the vessel wall radially inward”; where the valve is part of the device and contains elastin fibers that by the nature of the elastin in some part contribute to the device being biased back to the retracted configuration by its elasticity after expansion in the same manner as claimed); and
one or more anchoring elements (28) configured to anchor the tube to a vessel wall of a vessel upon expansion of the tube to the expanded configuration wherein the tube circumferentially contacts the vessel wall of the vessel and is anchored thereto by the one or more anchoring elements ([0047], [0060]); and
wherein retraction of the tube to the retracted configuration draws the vessel wall of the vessel radially inward to repair the vein valve insufficiency ([0061], [0003]).
Regarding claim 3, McGuckin discloses the closure device of claim 1, wherein the one or more anchoring elements comprise a plurality of retention members (tips 29) configured to pierce the vessel wall of the vessel ([0047]).
Regarding claim 4, McGuckin discloses the closure device of claim 3, wherein the plurality of retention members comprise one or more retention legs (teeth 28a) extending from a base (base of strut 22 that extends to strut 32, see Fig. 1) configured to be engaged with the tube (struts 18/22/32 are engaged with the valve 40, [0051, see Fig. 1]), wherein expansion of the tube causes the one or more retention legs to pierce the vessel wall of the vessel ([0060]).
Regarding claim 5, McGuckin discloses the closure device of claim 4, wherein the one or more retention legs comprise a first retention leg and a second retention leg, wherein the first retention leg and the second retention leg diverge from one another as the first retention leg and the second retention leg are advanced through the vessel wall of the vessel (see Figs. 3A-3B, [0060]).
Regarding claim 6, the closure device of claim 4, wherein the one or more retention legs are arranged against a surface of the tube prior to expansion of the tube (the legs 28 are arranged against a surface by being in the same plane as the surface of the tube in the delivery configuration as shown in Fig. 6 in another embodiment), and where expansion of the tube causes the one or more retention legs to extend away from the surface of the tube (expansion out of the delivery configuration causes the legs 28 to extend away from the valve 40, see Fig. 1).
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.
Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin (US2009/0062901) in view of Firstenberg (US2017/0056213).
Regarding claim 2, McGuckin discloses the closure device of claim 1; yet, is silent regarding wherein the one or more anchoring elements comprise a cell adhesion molecule coated on an outside surface of the tube, wherein the cell adhesion molecule chemically reacts to adhere the tube to the vessel wall of the vessel. Firstenberg teaches an implant that is an expandable stent 40 for use in the cardiovascular system ([0049]). The stent 40 having a coating 50 that covers micropillars 54 (interpreted as the anchoring elements) and the coating can include proteins (interpreted as cell adhesion molecule) for engaging the tissue wall in a biochemical manner ([0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchoring elements and tube of the implant of McGuckin to be coated with a cell adhesion molecule as taught by Firstenberg in order to further interlock the tissue and prevent migration of the implant over time ([0057] of Firstenberg).
Regarding claim 8, McGuckin discloses the closure device of claim 4; yet, is silent regarding wherein the plurality of retention members are formed from extracellular matrix. Firstenberg teaches an implant that is an expandable stent 40 for use in the cardiovascular system ([0049]). The stent 40 having a coating 50 that covers micropillars 54 (interpreted as the retention members) and the coating can include cells which would comprise extracellular matrix for engaging the tissue wall in a biochemical manner ([0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the retention members to be formed of extracellular matrix as taught by Firstenberg in order to further interlock the tissue and prevent migration of the implant over time ([0057] of Firstenberg).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McGuckin (US2009/0062901) in view of Wholey (US5234448).
Regarding claim 7, the closure device of claim 1; yet, is silent regarding wherein the one or more anchoring elements comprise a plurality of retention members comprising:
a retention leg having a needle-like tip;
a base coupled to a proximal end of the retention leg; and
an expandable shield coupled to the needle-like tip, wherein the needle-like tip and the expandable shield are configured to be advanced through the vessel wall of the vessel upon expansion of the tube to the expanded configuration, such that the vessel wall of the vessel becomes positioned between the base and the expandable shield, wherein the expandable shield is configured to be compressed to be advanced through the vessel wall of the vessel and is configured to expand after passing through the vessel wall of the vessel to trap the vessel wall of the vessel between the base and the expandable shield.
Wholey teaches one or more anchoring elements (barbs 10) for embedding in tissue (C3:L10-11). The barbs comprising: a retention leg (stem 11) having a needle-like tip (point tip of barb 12 that pierces, C2:L44-45);
a base (part of implant that stem 11 connects to, C3:L2-4) coupled to a proximal end of the retention leg; and
an expandable shield (triangular part of barb 12 that embeds, C2:L44-45) coupled to the needle-like tip.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the one or more anchoring elements being barbs with a triangular shape of Wholey for the one or more anchoring elements of McGuckin, since the substitution would have yielded the same predictable result of an anchoring element for piercing and retaining the position of the implant in tissue. Where the stem 11 of the anchoring element would be connected to the strut (base) of McGuckin the same manner.
Where the modified invention of McGuckin with Wholey further teaches wherein the needle-like tip and the expandable shield are configured to be advanced through the vessel wall of the vessel upon expansion of the tube to the expanded configuration (McGuckin teaches expansion of the tube in Figs. 3A-3B, where the substituted anchoring element with the expandable shield as taught by Wholey would be advanced through the vessel wall in the same manner), such that the vessel wall of the vessel becomes positioned between the base and the expandable shield (the anchoring element of Wholey would be embedded into the tissue and therefore the vessel wall would be positioned between the base and the expandable shield, C3:L10-11), wherein the expandable shield is configured to be compressed to be advanced through the vessel wall of the vessel (the expandable shield/triangular part of barb 12 as taught by Wholey is interpreted as being compressed when forced to penetrate the vessel wall, there would be some force between the tissue and the triangular part of the barb 12 that causes some amount of compression) and is configured to expand after passing through the vessel wall of the vessel to trap the vessel wall of the vessel between the base and the expandable shield (the expandable shield/triangular part of barb 12 as taught by Wholey is interpreted as being expanded after passing through the vessel wall by the device of McGuckin collapsing back to the retracted configuration by its natural bias, the underside of the triangular barbs facing the base would have a force exerted on it that is interpreted as being capable of expanding the barb 12).
Conclusion
THIS ACTION IS MADE FINAL. 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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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