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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/05/2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 06/05/2026. As directed by the amendment: claims 1 and 6 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-19 are presently pending in this application, and currently examined in the Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 6, both of which set forth the parameter of “the stent elements comprise helically aligned adjacent rhombus shaped closed cells of equal size and shape” (emphasis added); however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed specification never specifically discloses that the adjacent rhombus shaped closed cells are of equal shape; in fact, the originally filed specification, in paragraph [0092], specifically mentions that “Stent elements may comprise various shapes and configurations” and that “stent may comprise multiple different cells having different cell shapes, orientations, and/or sizes”. Applicant argues, in the response dated 06/05/2026, that Figures 5A-5D show the above mentioned parameter; however, a figure cannot/does not show the precise degree of equality. Thus, Figures 5A-5D may show similar shaped/sized rhombus shaped closed cells, but that is not the same as specifically disclosing that the shape/size of the rhombus shaped closed cells are equal, as set forth in the claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 6, both of which set forth the parameter of “the stent elements are configured to have a radial resistive fore of 18 N/cm or more after implantation in the vein”, on lines 8-9 of claim 1 and lines 10-11 of claim 6; however, this parameter is found to be confusing since it is not clear what exact structure and/or chemical make-up would be needed in order to meet such a parameter. Specifically, the only time in the entire originally filed disclosure a radial resistive fore of 18 N/cm or more is mentioned is in paragraph [0078], which states “Typical balloon-expandable metal stents (BES) have a much higher radial resistive force, sometimes above 18 N/cm. The polymer, shape, cell pattern, thickness, and/or width of the stent elements may be configured to have a radial resistive force of 18 N/cm or more after implantation in the vein” (emphasis added ). However, nowhere in the entire originally filed disclosure is there any detail, explanation, or clarification as to what polymer, shape, cell pattern, thickness, and/or width, the stent elements/device would need in order to result in the stent elements/device being configured to have/having a radial resistive fore of 18 N/cm or more after implantation. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite. Additionally, lines 12-13 and 15-16 of claim 1, and lines 14-15 and 17-8 of claim 6 set forth the parameter of “struts forming sides of the rhombus shaped closed cells between the helically aligned adjacent rhombus shaped closed cells have a…” (emphasis added); however, this parameter is found to be confusing since it is not clear what structure/location of structure is actually being referred to. Specifically, is the above mentioned parameter just trying to refer to the struts which form the rhombus shaped closed cells, or is it specifically referring to struts at specific locations between certain adjacent closed cells, and if so, how are these struts different than the struts that from the rhombus shaped closed cells, or is it referring to some other completely different strut and/or strut location. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “struts forming sides of the helically aligned adjacent rhombus shaped closed cells have a…”, and it is suggested lines 12-13 and 15-16 of claim 1, and lines 14-15 and 17-8 of claim 6 be amended as such, in order to avoid confusion and clarify the claim language.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Papp et al. (US PG Pub. 2013/0268045), as previously disclosed, hereinafter Papp, in view of Douroumis et al. (WO 2016/116748 A1), as previously disclosed, hereinafter Douroumis.
Regarding claims 1-5, Papp discloses a device, illustrated in Figures 4, 5 and 8A-8C, for placement within a vein, comprising multiple, balloon-expandable, bioresorbable, venous stent elements (406,408,410) spaced such that the stent elements do not touch one another; wherein the stent elements are formed from a bioresorbable polymer material, specifically, poly(L-lactic acid) (PLLA), poly(D,L-lactic acid) (PDLLA), semicrystalline polylactide, polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), poly(iodinated desamino tyrosyl-tyrosine ethyl ester) carbonate, polycaprolactone (PCL), poly(hydroxybutyrate), poly(trimethylene carbonate), polyethylene terephthalate, polyvinyl pyrrolidone, or combinations thereof; wherein the stent elements are configured to provide temporary, rigid, radial support to the vein following balloon angioplasty wherein the stent elements are configured to have a radial resistive force of 18 N/cm or more after implantation in the vein, wherein the radial rigidity of the stent is slowly attenuated as its structural polymer is unlinked and metabolized such that the stent slowly becomes more flexible causing adaptation and remodeling of the vein and restoration of the vein's elasticity and further comprising a therapeutic drug to prevent/attenuates cell activation, cell proliferation, atherosclerotic changes and/or thrombosis, illustrated in Figure 30 ([0014]; [0021], Lines 1-2; [0090]; [0099] – [0101] & [0226]); wherein the stent elements comprise helically aligned adjacent rhombus shaped closed cells of equal size and shape, and having circular keyhole shaped corners, illustrated in Figures 4, 5, 8A-8C 23B, 26A and 26B ([0120] & [0243] – it is to be noted that Papp teaches that the adjacent rhombus shaped closed cells of equal size and shape to the same extent as taught in the originally filed disclosure of the current application at hand; and it also would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate shape/sizes and/or proportions for the adjacent rhombus shaped closed cells, including the closed cells being of equal size and shape, since a change in shape/form and/or size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04); but does not specifically disclose the struts, forming sides of the helically aligned adjacent rhombus shaped closed cells, have a thickness of 425 microns or more and a width of 425 microns or more.
However, Douroumis teaches a device for placement within a vein, wherein the struts have a thickness of more than 425 microns, and a width of more than 425 microns (Pg. 9, Lines 9-18: specifically Lines 9-10 & 17 & Pg. 10, Lines 18-20 & 24).
In view of the teachings of Douroumis, it would have been obvious and well within the capability of to one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate thickness and an appropriate width for the struts, of the stents elements of the device of Papp, including a thickness of 425 microns or more and a width of 425 microns or more, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim(s), nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the struts of the stent elements have a thickness of 425 microns or more and a width of 425 microns or more, as opposed to any other valve/size.
Claims 6-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Papp in view of Werneth et al. (WO 2016/191754 A1), as previously disclosed, hereinafter Werneth, Byrne et al. (WO 2018/052878 A1), as previously disclosed, hereinafter Byrne and Douroumis.
Regarding claims 6-11, Papp discloses a method for maintaining or enhancing blood flow through a vein/peripheral vessel comprising implanting a balloon-expandable multi-element venous stent within a vein/peripheral vessel at a target location, wherein the venous stent comprises multiple bioresorbable venous stent elements (351, 352, 353/406, 408, 410) spaced such that the stent elements do not touch one another; wherein the venous stent is expanded using a balloon (350/400) to a larger diameter at the target location, illustrated in Figures 5 and 8A-8C ([0014]; [0020]; [0099], Lines 1-3 & [0148] – [0151] – it is to be noted that Papp states the device/stent can be implanted into/used to treat peripheral vessels, which include/encompass veins, thereby meeting the claimed limitation of the stent being implanted within a vein); wherein the stent elements are formed from a bioresorbable polymer material, specifically, poly(L-lactic acid) (PLLA), poly(D,L-lactic acid) (PDLLA), semicrystalline polylactide, polyglycolic acid (PGA), poly(lactic-co-glycolic acid) (PLGA), poly(iodinated desamino tyrosyl-tyrosine ethyl ester) carbonate, polycaprolactone (PCL), poly(hydroxybutyrate), poly(trimethylene carbonate), polyethylene terephthalate, polyvinyl pyrrolidone, or combinations thereof ([0226]); wherein the stent elements are configured to provide temporary, rigid, radial support to the vein following implantation wherein the stent elements are configured to have a radial resistive force of 18 N/cm or more after implantation in the vein, wherein the radial rigidity of the stent is slowly attenuated as its structural polymer is unlinked and metabolized such that the stent slowly becomes more flexible causing adaptation and remodeling of the vein and restoration of the vein's elasticity and further comprising a therapeutic drug to prevent/attenuates cell activation, cell proliferation, atherosclerotic changes and/or thrombosis, illustrated in Figure 30 ([0014]; [0021], Lines 1-2; [0090]; [0099] – [0101] & [0226]); wherein the stent elements comprise helically aligned adjacent rhombus shaped closed cells of equal size and shape, and having circular keyhole shaped corners, illustrated in Figures 4, 5, 8A-8C 23B, 26A and 26B ([0120] & [0243] – it is to be noted that Papp teaches that the adjacent rhombus shaped closed cells of equal size and shape to the same extent as taught in the originally filed disclosure of the current application at hand; and it also would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine appropriate shape/sizes and/or proportions for the adjacent rhombus shaped closed cells, including the closed cells being of equal size and shape, since a change in shape/form and/or size is generally recognized as being within the level of ordinary skill in the art, see MPEP 2144.04); but does not specifically disclose the venous stent is expanded to a diameter 2.5% or more larger than the diameter of the vein at the target location, and that the struts, forming sides of the helically aligned adjacent rhombus shaped closed cells, have a thickness of 425 microns or more and a width of 425 microns or more.
However, Werneth teaches a method of maintaining blood flow through a vein, wherein the venous stent is expanded to a diameter 2.5% or more larger than the diameter of the vein at the target location (Werneth: [0056], 4th – 3rd to Last Lines & [0060], Step 206-210). Moreover, Byrne teaches an expandable implant/stent, which has a diameter, in an expanded configuration, that is larger than the diameter of the vessel which it is implanted in, in order to provide a traction fit within the vessel (Byrne: [0018], Last 2 Lines). Additionally, Douroumis teaches a device for placement within a vein, wherein the struts have a thickness of more than 425 microns, and a width of more than 425 microns (Douroumis: Pg. 9, Lines 9-18: specifically Lines 9-10 & 17 & Pg. 10, Lines 18-20 & 24).
In view of the teachings of Werneth, Byrne and Douroumis, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of Papp to include expanding the venous stent to a diameter 2.5% or more larger than the diameter of the vein at the target location, as taught by Werneth, in order to provide a traction fit for the stent within the vein/peripheral vessel, as taught by Byrne; and it further would have been obvious and well within the capability of to one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate thickness and an appropriate width for the struts, of the stents elements of the method of Papp, including a thickness of 425 microns or more and a width of 425 microns or more, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claim(s), nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the struts of the stent elements have a thickness of 425 microns or more and a width of 425 microns or more, as opposed to any other valve/size.
Regarding claims 14-16, Papp in view of Werneth, Byrne and Douroumis disclose the method of claim 6, wherein Papp teaches the device/stent elements are implanted in a peripheral vessel (Papp: [0099], Lines 1-3); and though it is not specifically disclose the peripheral vessel is an anterior/posterior tibial vein, and/or a fibular vein, and/or a peroneal vein, it is well-known in the art that the general/broader term of a peripheral vessel includes/encompasses all veins located outside of the heart and main torso, i.e. veins in arms, legs, hands, feet etc. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the step of implanting in a peripheral blood vessel, of the method of Papp in view of Werneth, Byrne and Douroumis, to include implanting in an anterior/posterior tibial vein, and/or a fibular vein, and/or a peroneal vein, based on the patient’s specific need.
Claims 12, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Papp in view of Werneth, Byrne and Douroumis as applied to claim 6 above, and further in view of McGuckin, Jr. (US Pg Pub. 2015/0245851), as previously disclosed, hereinafter McGuckin.
Regarding claims 12, 13 and 17, Papp in view of Werneth, Byrne and Douroumis disclose the method of claim 6, wherein Papp teaches the device/stent elements are implanted in a peripheral vessel (Papp: [0099], Lines 1-3); but does not specifically disclose the peripheral vessel is a femoral vein, and/or a popliteal vein, and/or a great/small saphenous vein.
However, McGuckin teaches that it is well-known that a peripheral vessel can include/encompass a femoral vein, and/or a popliteal vein, and/or a saphenous vein ([0062], Last 2 Lines).
In view of the teachings of McGuckin, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the step of implanting in a peripheral blood vessel, of the method of Papp in view of Werneth, Byrne and Douroumis, to include implanting in a femoral vein, and/or a popliteal vein, and/or a saphenous vein, since these veins are known to be included in the general/broader term of a peripheral vessel, as taught by McGuckin, and based on the patient’s specific need.
Claims 12, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Papp in view of Werneth, Byrne and Douroumis as applied to claim 6 above, and further in view of Hirose et al. (US Patent No. 5,449,342), as previously disclosed, hereinafter Hirose.
Regarding claims 12, 18 and 19, Papp in view of Werneth, Byrne and Douroumis disclose the method of claim 6, wherein Papp teaches the device/stent elements are implanted in peripheral vessels (Papp: [0099], Lines 1-3); but does not specifically disclose the peripheral vessel is a femoral vein, and/or an iliac vein, and/or a subclavical/subclavian vein.
However, Hirose teaches that it is well-known that a peripheral blood vessel can include/encompass a femoral vein, and/or an iliac vein, and/or a subclavical/subclavian vein (Column 3, Lines 39-43).
In view of the teachings of Hirose, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the step of implanting in a peripheral blood vessel, of the method of Papp in view of Werneth, Byrne and Douroumis, to include implanting in a femoral vein, and/or an iliac vein, and/or a subclavical/subclavian vein, since these veins are known to be included in the general/broader term of a peripheral blood vessel, as taught by Hirose, and based on the patient’s specific need.
Response to Arguments
Applicant’s arguments with respect to independent claims 1 and 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 08/13/2026
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