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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/30/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 7/30/26. The claims 1-32 are pending. The claims 1, 9, and 21 are amended. Claims 9-32 are withdrawn.
Response to Arguments
Applicant’s arguments, filed 7/30/26 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 and the amendments overcome the previous rejection. However, a new grounds of rejection has been made in view of Densford (US2007/0050012) in view of McGuckin (US2009/0062901).
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 1, 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Densford (US2007/0050012) in view of McGuckin (US2009/0062901).
Regarding claim 1, Densford discloses a closure device for repairing a vein valve insufficiency ([0028]), the closure device comprising:
a structure (body of prosthesis 30, prosthesis 30 is annularly disposed over the delivery device 20 to be expanded, see Fig. 4A, [0033]) having a body formed of extracellular matrix (medical device is formed of a “naturally derived resorbable or remoldable material” such as “collagenous extracellular matrix (ECM) materials, such as submucosa, [0052]), comprising elastin fibers (submucosa is a dense layer of connective tissue that contains elastin fibers, [0052]), wherein the structure is radially expandable from a retracted configuration to an expanded configuration ([0014]), wherein the structure is naturally biased to the retracted configuration via the body of the structure itself (prosthesis is formed of extracellular matrix with elastin would act as claimed, since the prosthesis is radially expanded to have the fasteners 34 pierce the vessel wall, [0037], the elasticity of the prothesis 30 would be biased to the unexpanded natural state); and
one or more anchoring elements (fasteners 34) configured to anchor the structure to a vessel wall of a vessel upon expansion of the structure to the expanded configuration ([0030]) wherein the structure circumferentially contacts the vessel wall of the vessel and is anchored thereto by the one or more anchoring elements (prosthesis contacts the wall of the vessel annularly by being around the delivery device and being intended to act as a native valve that is circumferentially around vessel, [0004], [0033], and is anchored as described in [0037]); and
wherein retraction of the structure to the retracted configuration draws the vessel wall of the vessel radially inward to repair the vein valve insufficiency (this is the method of treatment for venous valve insufficiency by contracting the vessel wall for leaflet apposition, [0007]).
If Applicant should disagree, that Densford discloses retraction of the structure to a retracted configuration draws the vessel wall of the vessel radially inward to repair the vein valve insufficiency. Densford teaches venous valve treatment by having the valves in apposition ([0007]). McGuckin further teaches a treatment of vein insufficiency ([0025]) with a vascular device 10 that is inflated by a balloon, and after the balloon has been deflated the device contracted to bring the vessel wall radially inwardly ([0061]). 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 closure device of Densford to retract to a retracted configuration to draw the vessel wall radially inward as taught by McGuckin in order to ensure the leaflets of the valve are in apposition to restore proper venous valve function ([0063] of McGuckin).
Densford, does not explicitly disclose the closure device being a tube. McGuckin teaches a vascular device for the same purpose, where the valve is formed as tube by being conically shaped (see Fig. 2, [0077]). 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 valve of Densford for the tubular valve of McGuckin, since the substitution would have yielded the same predictable result of providing a replacement valve for treatment of vein insufficiency that engages a wall of the vessel.
Regarding claim 3, Densford as modified by McGuckin makes obvious the closure device of claim 1, Densford further discloses wherein the one or more anchoring elements comprise a plurality of retention members (individual fasteners 34, [0031], see Fig. 4B) configured to pierce the vessel wall of the vessel ([0047]).
Regarding claim 4, Densford as modified by McGuckin makes obvious the closure device of claim 3, Densford further discloses wherein the plurality of retention members comprise one or more retention legs (barbs of the tail portion 34b, [0031]) extending from a base (head portion 34a, [0031]) configured to be engaged with the tube ([0033]), wherein expansion of the tube causes the one or more retention legs to pierce the vessel wall of the vessel ([0031]).
Regarding claim 5, Densford as modified by McGuckin makes obvious the closure device of claim 4, Densford further discloses wherein the one or more retention legs comprise a first retention leg and a second retention leg (the barb of the tail portion 34b can include one or more protuberances, where a first protuberance is the first retention leg, and a second protuberance is a second retention leg, [0031]), 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 (the protuberances project outwardly at different angles, [0031]).
Regarding claim 6, Densford as modified by McGuckin makes obvious the closure device of claim 4, Densford further discloses wherein the one or more retention legs are arranged against a surface of the tube prior to expansion of the tube (fasteners 34 are arranged against the surface of the prosthesis 30 by the prosthesis 30 being atop the fasteners 34, [0030]), and where expansion of the tube causes the one or more retention legs to extend away from the surface of the tube (expansion outward has the fasteners 34 extend through the surface of the prosthesis 30 and therefore away from the surface of the tube, [0030]).
Regarding claim 7, Densford as modified by McGuckin makes obvious the closure device of claim 1, Densford further discloses wherein the one or more anchoring elements comprise a plurality of retention members (individual fasteners 34, [0031], see Fig. 4B) comprising:
a retention leg (tip of the tail 34b) having a needle-like tip (pointed tip of the tail 34b that pierces, [0037]);
a base (head 34a) coupled to a proximal end of the retention leg (see Fig. 4B); and
an expandable shield (triangular part of the barb projecting away from the tip of the tail 34b that embeds defined by protuberances, [0031], see Fig. 4B) coupled to the needle-like tip (see Fig. 4B), 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 ([0031]), such that the vessel wall of the vessel becomes positioned between the base and the expandable shield (see Fig. 4B), wherein the expandable shield is configured to be compressed to be advanced through the vessel wall of the vessel (protuberances of the barbs are interpreted as being compressed when forced to penetrate through the vessel wall, there would be some force between the tissue and the protuberances of the barb 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 outwardly projecting protuberances are for resisting back out of the barb as described in claim 18, where the underside of the protuberances would have a force exerted on it when resisting back out that is interpreted as being capable of expanding the barb by the protuberances moving outwardly).
Claims 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable Densford (US2007/0050012) in view of McGuckin (US2009/0062901), as applied to claims 1 and 4, and further in view of Firstenberg (US2017/0056213).
Regarding claim 2, Densford as modified by McGuckin makes obvious 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 Densford/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, Densford as modified by McGuckin makes obvious 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).
Conclusion
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.
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, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MIKAIL A MANNAN/Examiner, Art Unit 3774
Prosecution Insights