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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/09/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bukart et al. (US 2009/0182413) in view of Ramzipoor et al. (US 2010/0042202).
Regarding claim 1 and 4-5, Bukart et al. discloses device for placement within a blood vessel to maintain or enhance blood flow through the blood vessel (60, FIGs 6A-8, [0050-0056]), the device comprising: multiple balloon-expandable, vascular stent elements configured to be implanted in the blood vessel as a stent (See multiple segments formed in FIG 6B, [0050] discloses 60 is balloon expandable); wherein the stent elements are separated and spaced such that after implantation the stent elements do not touch one another at a target location during skeletal movement (FIG 6B and 8 show the stent elements are spaced apart and not touching. [0052] discloses that “distance between adjacent rings may be desired”. Although connected by polymeric covering 66, the stent elements are physically separated by a gap distance and to do not touch) and such that bending of the blood vessel at the target location during skeletal movement is accommodated by bending of spaces between the stent elements (Because the space between the stent elements is formed of a flexible polymeric material, bending is allowed at these spaces on order for the device to form to the shape of the vasculature, [0013]); wherein the stent elements comprise a closed cell pattern comprising diamond-shaped closed cells (FIG 6A shows the closed cell pattern and diamond shaped closed cells 63d, [0050]); wherein the closed cell pattern of the stent elements, and the spaces between the stent elements are configured to provide high radial force at the blood vessel wall while still preserving patency of the lumen during bending of the blood vessel ([0013] discloses the stent elements allow the construction of a stent having good flexibility and a useful resistance to forces that may be applied to the device in vivo such as torsional forces, bending forces, axial tension or compression, or radial compression); and wherein the closed cell pattern of the stent elements and the spaces between the stent elements are configured such that axial compression of both the stent elements and the spaces between the separated stent elements absorb axial compression of the blood vessel during skeletal movement ([0013] discloses the stent elements allow the construction of a stent having good flexibility and a useful resistance to forces that may be applied to the device in vivo such as torsional forces, bending forces, axial tension or compression, or radial compression) such that the blood vessel at the target location remains preserved without kinking or collusion during skeletal movement (The device is at least configured such that having a spacing between rigid elements of the stent facilitates the preservation of the target blood vessel and minimizes kinking or occlusion due to the bendability in between stent elements).
Bukart et al. is silent regarding the stent elements are formed from a bioresorbable polymer material comprising poly(L-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), poly(D,L-lactic acid) (PDLLA), semi crystalline polylactide, polyglycolic acid (PGA), poly(l actic-co-glycolic acid) (PLGA), poly(iodinated desamino tyrosyl-tyrosine ethyl ester) carbonate, polycaprolactone (PCL), sali cylate based polymer, polydioxanone (PDS), poly(hydroxybutyrate), poly(hydroxybutyrate- co-val erate), polyorthoester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), poly(iodinated desaminotyrosyl-tyrosine ethyl ester) carbonate, polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyalkylene oxalates, polyphosphazenes, polyiminocarbonates, and aliphatic polycarbonates, fibrin, fibrinogen, cellulose, starch, collagen, polyurethane including polycarbonate urethanes, polyethylene, polyethylene terephthalate, ethylene vinyl acetate, ethylene vinyl alcohol, silicone including polysiloxanes and substituted polysiloxanes, polyethylene oxide, polybutylene terephthalate-co-PEG, PCL-co-PEG, PLA-co-PEG, PLLA-co- PCL, polyacrylates, polyvinyl pyrrolidone, polyacrylamide, or combinations thereof, and wherein the radial rigidity of the stent is slowly attenuated as its structural polymer is unlinked and metabolized, the such that the stent slowly becomes more flexible causing adaptation and remodeling of the vein and restoration of the vein's elasticity.
However, Ramzipoor et al. teaches in the same field of endeavor a device (190, FIG 19, [0075]) for placement within a blood vessel (Abstract) to maintain or enhance blood flow through the blood vessel ([0040-0041]. It is understood that the function of a stent is to improve blood flow through the vessel), the device comprising: multiple balloon-expandable, bioresorbable, vascular stent elements (Segments 194, which are balloon expandable [0046, 0059-0061] and bioresorbable, abstract, [0041-0042, 0066, 0075]) configured to be implanted in the blood vessel as a stent (FIG 10 shows an exemplary vessel lumen 88, [0060-0062]); wherein the stent elements are formed from a bioresorbable polymer material ([0071 and 0075]); the bioresorbable polymer material comprising ([0071] discloses at least one of the following) poly(L-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), poly(D,L-lactic acid) (PDLLA), semi crystalline polylactide, polyglycolic acid (PGA), poly(l actic-co-glycolic acid) (PLGA), poly(iodinated desamino tyrosyl-tyrosine ethyl ester) carbonate, polycaprolactone (PCL), sali cylate based polymer, polydioxanone (PDS), poly(hydroxybutyrate), poly(hydroxybutyrate- co-val erate), polyorthoester, polyanhydride, poly(glycolic acid-co-trimethylene carbonate), poly(iodinated desaminotyrosyl-tyrosine ethyl ester) carbonate, polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyalkylene oxalates, polyphosphazenes, polyiminocarbonates, and aliphatic polycarbonates, fibrin, fibrinogen, cellulose, starch, collagen, polyurethane including polycarbonate urethanes, polyethylene, polyethylene terephthalate, ethylene vinyl acetate, ethylene vinyl alcohol, silicone including polysiloxanes and substituted polysiloxanes, polyethylene oxide, polybutylene terephthalate-co-PEG, PCL-co-PEG, PLA-co-PEG, PLLA-co- PCL, polyacrylates, polyvinyl pyrrolidone, polyacrylamide, or combinations thereof, and wherein the radial rigidity of the stent is slowly attenuated as its structural polymer is unlinked and metabolized (Due to the device being made of a bioabsorbable material, it is understood that the stent degrades over time by degradation of the polymers), the such that the stent slowly becomes more flexible (Becoming more flexible is a result of the gradual dissolving of the stent polymer material) causing adaptation and remodeling of the vein and restoration of the vein's elasticity (the preceding limitations are interpreted as functional language wherein the disclosed device is at least capable of having such an effect on the surrounding vessel tissue).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the material of the stent elements of Bukart et al. to be a bioabsorbable polymeric material comprising at least polyethelyene such that the radial rigidity of the stent is slowly attenuated as its structural polymer is unlinked and metabolized, the such that the stent slowly becomes more flexible causing adaptation and remodeling of the vein and restoration of the vein's elasticity, as taught by Ramzipoor, for the purpose of altering the structural characteristics of the stent over time within the body to achieve a desired patency of the target lumen.
Response to Arguments
Applicant's arguments filed 06/09/2026 have been fully considered but they are not persuasive. Applicant argues on page 5 that “Bukart describes a stent with flexible webs connecting adjacent stent
Elements” and therefore “fails to teach or suggest stent elements that are separated and spaced as these stent elements are connected by the flexible web”. However, it is the examiners position that being spaced apart by a flexible web still constitutes the stent elements themselves being “separated and spaced”. In the device of Burkart, there is no direct mechanical contact between any segments of adjacent stent elements. See FIG 8 which shows elements 62 being devoid of any direct contact with one another. Further, the full imitations of the claim states that “the stent elements are separated and spaced such that after implantation the stent elements do not touch one another at a target location during skeletal movement”. This limitation can be met regardless of if there is a polymeric coating surrounding the device or not. The stent elements of Burkart are separate and spaced such that they do not touch one another after implantation due to the axial spacing between elements 62. Therefore, applicants’ argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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