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 .
Status of Claims
This office action is responsive to the amendment filed on 10/16/2025. As directed by the amendment: claims 1 and 6 have been amended, no claims have been cancelled and new claims 12-19 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” (emphasis added) and “stent may comprise multiple different cells having different cell shapes, orientations, and/or sizes” (emphasis added).
Regarding claims 11-19, all of which depend from independent claim 6 which, in part, sets 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”; and claims 11-19 further set forth different veins, i.e. femoral vein, popliteal vein, fibular vein etc., where the balloon-expandable multi-element venous stent is implanted, however these parameters have never been mentioned in the originally filed disclosure. Specifically, the originally filed disclosure does not mention, or suggest, implanting stent elements, which are configured to have a radial resistive fore of 18 N/cm or more after implantation in a vein, wherein the vein: is a femoral vein (claim 12), is a popliteal vein (claim 13), is an anterior or posterior tibial vein (claim 14), is a fibular vein (claim 15), is a peroneal vein (claim 16), is a great or small saphenous vein (claim 17), is a superior vena cava, brachiocephalic vein, iliac vein, renal vein, or ovarian vein (claim 18), and is a subclavical vein, subscapular vein, axillary vein, cephalic vein, medial cubital vein, basalic vein, median antebrachial vein, radial vein, ulnar vein, brachial vein, splenic vein, superior mesenteric vein, inferior vena cava, azygos vein, internal or external jugular vein, vertebral vein, uterine vein, or pelvic vein (claim 19).
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/chemical make-up would be needed in order to meet the 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 disclosure is there any detail, explanation, or clarification as to what polymer, shape, cell pattern, thickness, and/or width, of the stent elements, would result in the stent elements being configured to have 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, or is it referring to some other completely different struts and/or struts at different locations. 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 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.
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 § 102/103
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.
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, 4, 6, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Papp et al. (US Pg Pub. 2014/0046431), hereinafter Papp.
Regarding claims 1, 3 and 4, Papp discloses a device, illustrated in Figures 4-6, for placement within a vein, comprising multiple, balloon-expandable, bioresorbable, venous stent elements (341-347/351-353) spaced such that the stent elements do not touch one another; wherein the stent elements comprise helically aligned adjacent rhombus shaped closed cells of equal size and shape; 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), or combinations thereof; wherein the stent elements are configured to provide temporary, rigid, radial support to the vein following balloon angioplasty, 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; wherein struts forming sides of the rhombus shaped closed cells have a thickness and width of approximately 425 microns; and the stent elements being configured to have a radial resistive force of 18 N/cm or more after impanation, illustrated in Figures 4-6 ([0015] – [0017]; [0060], Lines 1-2; [0062] – [0064]; [0075], Lines 6-7 & [0171]). To clarify, Papp states the width and thickness of the struts can be 400 microns, which is considered to be “approximately 425 microns”, as claimed, since the originally filed specification of the current application at hand does not provide a specific, quantitative, standard for the term “approximately”; and/or it 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 an appropriate width and thickness for the struts including approximately 425 microns or more, as claimed, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05). Additionally, even though Papp does not specifically state the stent elements are configured to have a radial resistive force of 18 N/cm or more after impanation, all the structural limitations set forth in the claims including specific polymers, shape, cell pattern, strut width, and strut thickness are taught by Papp and therefore the stent elements would be configured to, i.e. have the physical/structural ability to, have a radial resistive force of 18 N/cm or more after impanation (It is to be noted that the only description/explanation of the device having a radial resistive force of 18 N/cm or more after impanation in the originally filed specification of the current application at hand states “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”; thus it is deemed that any device that has the polymer, shape, cell pattern, strut thickness, and/or strut width as set forth in the claim(s) would meet the parameter of being “configured to have a radial resistive force of 18 N/cm or more after impanation”).
Regarding claims 6, 8 and 9, 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 (341-347/351-353) spaced such that the stent elements do not touch one another; the stent elements comprise helically aligned adjacent rhombus shaped closed cells of equal size and shape; wherein the venous stent is expanded using a balloon (350) to a larger diameter at the target location, illustrated in Figures 4-6; 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), or combinations thereof; wherein the stent elements are configured to provide temporary, rigid, radial support to the vein following implantation, 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; wherein struts forming sides of the rhombus shaped closed cells have a thickness and width of approximately 425 microns; and the stent elements being configured to have a radial resistive force of 18 N/cm or more after impanation, illustrated in Figures 4-6 ([0015] – [0017]; [0060], Lines 1-2; [0062] – [0064]; [0075], Lines 6-7; [0097] – [ 0099] & [0171]). To clarify, 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. Additionally, Papp also states the width and thickness of the struts can be 400 microns, which is considered to be “approximately 425 microns”, as claimed, since the originally filed specification of the current application at hand does not provide a specific, quantitative, standard for the term “approximately”; and/or it 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 an appropriate width and thickness for the struts including approximately 425 microns or more, as claimed, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (see MPEP 2144.05). Furthermore, even though Papp does not specifically state the stent elements are configured to have a radial resistive force of 18 N/cm or more after impanation, all the structural limitations set forth in the claims including specific polymers, shape, cell pattern, strut width, and strut thickness are taught by Papp and therefore the stent elements would be configured to, i.e. have the physical/structural ability to, have a radial resistive force of 18 N/cm or more after impanation (It is to be noted that the only description/explanation of the device having a radial resistive force of 18 N/cm or more after impanation in the originally filed specification of the current application at hand states “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”; thus it is deemed that any device that has the polymer, shape, cell pattern, strut thickness, and/or strut width as set forth in the claim(s) would meet the parameter of being “configured to have a radial resistive force of 18 N/cm or more after impanation”).
Claims 2, 5, 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Papp as applied to claims 1 and 6 above, and in view of Papp et al. (US Pg Pub. 2013/0268045), as previously disclosed, hereinafter Papp’045.
Regarding claims 2 and 7, Papp discloses the device and method of claims 1 and 6, further comprising a therapeutic drug ([0007]); but does not specifically disclose the therapeutic drug prevents or attenuates inflammation, cell dysfunction, cell activation, cell proliferation, neointimal formation, thickening, late atherosclerotic change or thrombosis.
However, Papp’045 teaches a device, in the same field of endeavor, wherein the device comprises a therapeutic drug which prevents or attenuates cell proliferation, neointimal formation, and/or thickening ([0221]).
In view of the teachings of Papp’045, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the therapeutic drug, of the device and method of Papp, to prevent or attenuate cell proliferation, neointimal formation, and/or thickening, in order to prevent/limit stenosis.
Regarding claims 5 and 10, Papp discloses the device and method of claims 1 and 6, but does not specifically disclose the rhombus shaped closed cells have circular keyhole shaped corners.
However, Papp’045 teaches a device, in the same field of endeavor, comprising rhombus shaped closed cells have circular keyhole shaped corners, illustrated in Figures 26A and 26B.
In view of the teachings of Papp’045, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the rhombus shaped closed cells, of the device and method of Papp, to have circular keyhole shaped corners, as taught by Papp’045, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Papp as applied to claim 6 above, and in view of Werneth et al. (WO 2016/191754 A1), as previously disclosed, hereinafter Werneth, and Byrne et al. (WO 2018/052878 A1), as previously disclosed, hereinafter Byrne.
Regarding claim 11, Papp discloses the method of claim 6, 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.
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). Additionally, 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).
In view of the teachings of Werneth and Byrne, 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.
Claims 12, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Papp as applied to claim 6 above, and in view of McGuckin, Jr. (US Pg Pub. 2015/0245851), hereinafter McGuckin.
Regarding claims 12, 13 and 17, Papp discloses the method of claim 6, wherein the device/stent elements are implanted in a peripheral blood vessel ([0062]), 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, 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 as applied to claim 6 above, and in view of Hirose et al. (US Patent No. 5,449,342), as disclosed in the IDS dated 11/11/2022, hereinafter Hirose.
Regarding claims 12, 18 and 19, Papp discloses the method of claim 6, wherein the device/stent elements are implanted in a peripheral blood vessel ([0062]), 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, 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.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Papp.
Regarding claims 14-16, Papp discloses the method of claim 6, wherein the device/stent elements are implanted in a peripheral blood vessel ([0062]), and though Papp does 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, 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.
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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, Jerrah Edwards can be reached at 408-918-7557. 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.
/DINAH BARIA/Primary Examiner, Art Unit 3774