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 Arguments
Applicant’s arguments, filed 02/24/2026, with respect to the drawings have been fully considered and are persuasive. The objection of figure 5 has been withdrawn.
Applicant’s arguments, filed 02/24/2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of claims 2, 4, 5, 9, 11, 12, and 13 have been withdrawn.
Applicant’s arguments, filed 02/24/2026, with respect to the 35 USC 102(a)(1) rejection of claim 1 have been fully considered and are persuasive.
Applicant’s argument that Quadri discloses a replacement heart valve and not a replacement venous valve, and that Quadri fails to disclose the frame comprises a plurality of strut bridges that connect a subset of proximal peaks in one section to a subset of distal peaks in the other section as now required by amended claim 1 are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Case et al. (US Patent No. 8,038,708 B2).
Applicant’s arguments, filed 02/24/2026, with respect to 35 USC 103 rejection of claim 11 have been fully considered and are persuasive.
Applicant’s argument that Quadri discloses a replacement heart valve and not a replacement venous valve, and that Quadri fails to disclose the frame comprises a plurality of strut bridges that connect a subset of proximal peaks in one section to a subset of distal peaks in the other section as now required by amended claim 11 are persuasive. Further, applicant’s argument that Armer, Nitzan, and Gurovich fail to disclose a replacement venous valve and that such combination would not allow the skilled person to arrive at the frame comprises a plurality of strut bridges that connect a subset of proximal peaks in one section to a subset of distal peaks in the other section are persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Case et al. (US Patent No. 8,038,708 B2).
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, 3-5, 9, 11-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Case et al. (US Patent No. 8,038,708 B2).
Regarding claim 1, Case discloses an implantable compressible vein frame (Col. 4, lines 52-67, Fig. 1A, medical device 10), comprising: a first section formed from a first plurality of segments (see annotated Fig. 1A below, 44a); and a second section (see annotated Fig. 1A below, 44b) connected to the first section (44a) by a plurality of strut bridges (Col. 9, lines 2-5, see annotated Fig. 1A below), the second section formed from a second plurality of segments (see annotated Fig. 1A below, 44b), wherein the connected first section and second section form a hollow cylinder (Col. 8, lines 59-60, lumen 25); and wherein the first plurality of segments includes a first plurality of proximal peaks (see annotated Fig. 1A below) and a first plurality of distal peaks (see annotated Fig. 1A below) and the second plurality of segments includes a second plurality of proximal peaks (see annotated Fig. 1A below) and a second plurality of distal peaks (see annotated Fig. 1A below), and wherein the plurality of strut bridges (Col. 9, lines 2-5, see annotated Fig. 1A below) connects a first subset of the first plurality of proximal peaks to a second subset of the second plurality of distal peaks (see annotated Fig. 1A below).
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Regarding claim 3, Case discloses wherein each end of the cylinder (Col. 8, lines 59-60, lumen 25) has a flare (12,14) that anchors or hooks the frame to the natural tissue upon insertion (Col. 8, lines 40-47and 57-60).
Regarding claim 4, Case discloses further comprising a third body section (see annotated Fig. 1A above, 44c) connected to the second section (44b), the third section formed from a third plurality of segments (44c), wherein the connected second section (44b) and third section (44c) form a hollow cylinder (Col. 8, lines 59-60, lumen 25); and wherein the second plurality of segments (44b) includes the second plurality of proximal peaks (see annotated Fig. 1A above) and a the second plurality of distal peaks (see annotated Fig. 1A above) and the third plurality of segments includes a third plurality of proximal peaks (see annotated Fig. 1A above) and a third plurality of distal peaks (see annotated Fig. 1A above).
Regarding claim 5, Case discloses further comprising a fourth body section (see annotated Fig. 1A above, 44d) connected (Col.9, lines 29-32) to the third section (44c), the fourth section formed from a fourth plurality of segments (44d), wherein the connected third section and fourth section form a hollow cylinder (Col. 8, lines 59-60, lumen 25); and wherein the third plurality of segments (44c) includes the third plurality of proximal peaks (see annotated Fig. 1A above) and a the third plurality of distal peaks (see annotated Fig. 1A above), and the fourth plurality of segments (44d) includes a fourth plurality of proximal peaks (see annotated Fig. 1A above) and a fourth plurality of distal peaks (see annotated Fig. 1A above).
Regarding claim 9, Case discloses wherein the first section (44a) and the second section (44b) are self-expanding or assisted with a balloon inflation system (Col. 9, lines 6-10).
Regarding claim 11, Case discloses a method of manufacturing (Col. 4, lines 36-48) an implantable compressible vein frame (Col. 4, lines 52-67, Fig. 1A, medical device 10), comprising: forming a first section from a first plurality of segments (see annotated Fig. 1A above, 44a); forming a second section (see annotated Fig. 1A above, 44b) connected to the first section (see annotated Fig. 1A above), the second section formed from a second plurality of segments (44b), wherein the connected first section (44a) and second section (44b) form a hollow cylinder (Col. 8, lines 59-60, lumen 25), each end of the cylinder being flared (Fig. 1A, flared ends 12 and 14); wherein the first plurality of segments (44a) includes a first plurality of proximal peaks (see annotated Fig. 1A above) and a first plurality of distal peaks (see annotated Fig. 1A above), and the second plurality of segments (44b) includes a second plurality of proximal peaks (see annotated Fig. 1A above) and a second plurality of distal peaks (see annotated Fig. 1A above) providing stability and ability to compress the structure (Col. 9, lines 6-10); wherein the first section (44a) and second section (44b) are connected by a plurality of strut bridges (Col. 9, lines 2-5, see annotated Fig. 1A above), and wherein the plurality of strut bridges connects a first subset of the first plurality of proximal peaks to a second subset of the second plurality of distal peaks (see annotated Fig. 1A above).
Regarding claim 12, Case discloses further comprising forming a third body section (see annotated Fig. 1A above, 44c) connected to the second section (44b), the third section formed from a third plurality of segments (44c), wherein the connected second section and third section form a hollow cylinder (Col. 8, lines 59-60, lumen 25); and wherein the second plurality of segments (44b) includes the second plurality of proximal peaks (see annotated Fig. 1A above) and the second plurality of distal peaks (see annotated Fig. 1A above), and the third plurality of segments (44c) includes a third plurality of proximal peaks (see annotated Fig. 1A above) and a second third plurality of distal peaks (see annotated Fig. 1A above).
Regarding claim 13, Case discloses further comprising forming a fourth body section (see annotated Fig. 1A above, 44d) connected (Col.9, lines 29-32) to the third section (44c), the fourth section formed from a fourth plurality of segments (44d), wherein the connected third section (44c) and fourth section (44d) form a hollow cylinder (25); and wherein the third plurality of segments (44c) includes a third plurality of proximal peaks (see annotated Fig. 1A above) and a third plurality of distal peaks (see annotated Fig. 1A above) and the fourth plurality of segments (44d) includes a fourth plurality of proximal peaks (see annotated Fig. 1A above) and a fourth plurality of distal peaks (see annotated Fig. 1A above).
Regarding claim 15, Case discloses wherein the plurality of strut bridges (Col. 9, lines 2-5, see annotated Fig. 1A above) connects every alternating pair of the first plurality of proximal peaks and the second plurality of distal peaks (see annotated Fig. 1A above).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US Patent No. 8,038,708 B2).
Regarding claim 2, Case discloses wherein each end of the cylinder has a flare (Fig. 1A, flared ends 12 and 14) wherein the hollow cylinder (Col. 8, lines 59-60, lumen 25) is compressible to 12 Fr-16 Fr (Col. 13, lines 9-13 and 35-40). Case fails to disclose wherein the flare is between about 2 mm to about 10 mm from the beginning of the flare to the end of the flare. There is no evidence of record that established that changing the flare length would result in a difference of function of the Case device. Further, a person having ordinary skill in the art, being faced with modifying the flare length of Case would have reasonable expectation of success in making such a modification and it appears the valve would function as intended being given the claimed flare length. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating the flare length “can be” within the claimed range (Paragraph [0136]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flare length of Case to be between about 2 mm to about 10 mm as an obvious matter of design choice within the level of skill in the art.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US Patent No. 8,038,708 B2), as applied to claim 1 above, and further in view of Tabor et al. (US PG Pub No. 2021/0315693).
Regarding claim 6, Case fails to disclose further comprising two to sixteen crowns formed on each of the first section and the second section to aid compressibility. Tabor also discloses a replacement venous valve (Paragraph [0051], Fig. 1 stent 10) with a first section (Fig. 1, first end 12) and a second section (Fig. 1, second end 14) connected by strut bridges (Fig. 1, longitudinal post 16). Tabor teaches further comprising two to sixteen crowns (Paragraph [0057], Fig.1) formed on each of the first section (Fig. 1, first end 12 has 6 crowns) and the second section (Fig. 1, second end has 12 crowns) to aid compressibility. Therefore, 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 Case’s replacement venous valve further comprising two to sixteen crowns formed on each of the first section and the second section to aid compressibility, as taught by Tabor, for attachment to the tissue valve (Paragraphs [0057 and 0062]).
Regarding claim 7, Case in view of Tabor fails to disclose further comprising anchors or hooks along the cylinder and at the crowns. Tabor further teaches further comprising anchors or hooks (Fig. 1, eyelet 19) along the cylinder (10) and at the crowns (14). Therefore, 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 Case’s replacement venous valve further comprising anchors or hooks along the cylinder and at the crowns, as taught by Tabor, for attachment to the tissue (Paragraph [0057]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US Patent No. 8,038,708 B2), as applied to claim 4 above, and further in view of Sirhan et al. (US PG Pub No. 2023/0201014 A1).
Regarding claim 8, Case fails to disclose wherein the radial strength can be 17-20 N, depending on the number of sections and crowns. Sirhan also discloses a replacement venous valve (Paragraph [0039], Fig. 1, endoluminal prosthesis 10), with a first section (Fig. 1, zig zag rings 14) and a second section (Fig. 1, zig zag rings 14) connected by strut bridges (Fig. 1, 44). Sirhan teaches wherein the radial strength can be 0.03 - .95 N/mm stent length (Paragraph [0152],), depending on the number of sections and crowns (Paragraph [0077]). Therefore, 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 Case’s replacement venous valve wherein the radial strength can be 0.03 - .95 N/mm stent length, as taught by Sirhan, in order to provide crush resistance (Paragraph [0005]). However, Case as modified by Sirhan fails to disclose the radial strength can be 17-20 N. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the radial strength from 0.03 - .95 N/mm as taught by Sirhan to 17-20 N as claimed, 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. In re Aller, 105 USPQ 233.
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US Patent No. 8,038,708 B2), as applied to claims 1 and 11 above, and further in view of Murphy et al. (US PG Pub No. 2020/0060814 A1).
Regarding claim 10, Case fails to disclose wherein the first section and second section are covered with a material including a fabric or coating. Murphy also discloses a replacement venous valve (Figs.1 and 4, prosthesis 10), a first section (Fig. 4, section 20), and a second section (Fig. 4, section 21). Murphy teaches wherein the first section (20) and second section (21) are covered with a material including a fabric or coating (Paragraph [0069], Fig 1, tissue 12). Therefore, 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 Case’s replacement venous valve wherein the first section and second section are covered with a material including a fabric or coating, as taught by Murphy, in order to in order to match the native anatomy (Paragraph [0083]).
Regarding claim 14, Case fails to disclose placing a replacement valve leaflet within the first and second sections, the replacement valve leaflet including a leaflet, a wall, and an inflow skirt. Murphy also discloses a replacement venous valve (Figs. 1 and 4, prosthesis 10), a first section (Fig. 4, section 20), and a second section (Fig. 4, section 21). Murphy teaches further, comprising placing a replacement valve leaflet (Fig. 4, leaflet 14) within the first (20) and second sections (21), the replacement valve leaflet including a leaflet (14), a wall (Fig. 4, wall 40), and an inflow skirt (Fig. 4, skirt 12). Therefore, 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 Case’s replacement venous valve by placing a replacement valve leaflet within the first and second sections, the replacement valve leaflet including a leaflet, a wall, and an inflow skirt, as taught by Murphy, in order to match the native anatomy (Paragraph [0083]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Case et al. (US Patent No. 8,038,708 B2), as applied to claim 1 above, and further in view of Chanduszko (US PG Pub No. 2018/0214286).
Regarding claim 16, Case fails to disclose wherein the plurality of strut bridges connects every alternating third pair of the first plurality of proximal peaks and the second plurality of distal peaks. Chanduszko also discloses a replacement venous valve (Paragraph [0004], Fig. 1A, stent 100), strut bridges (Fig. 1A, b1-bridges 114), and proximal and distal peaks (Paragraph [0032], v4-vertexes 108). Chanduszko teaches wherein the plurality of strut bridges (114) connects pairs, depending on attributes such as flexibility (Paragraph [0004]), of the first plurality of proximal peaks (108) and the second plurality of distal peaks (108). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the connection points of Case’s strut bridges as taught by Chanduszko in order to achieve the desired flexibility of the valve (Paragraph [0004]). Chanduszko fails to explicitly teach the plurality of strut bridges connects every alternating third pair. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made wherein the plurality of strut bridges connects every alternating third pair of the first plurality of proximal peaks and the second plurality of distal peaks 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. In re Aller, 105 USPQ 233.
Regarding claim 17, Case fails to disclose wherein the plurality of strut bridges connects every alternating fourth pair of the first plurality of proximal peaks and the second plurality of distal peaks. Chanduszko also discloses a replacement venous valve (Paragraph [0004], Fig. 1A, stent 100), strut bridges (Fig. 1A, b1-bridges 114), and proximal and distal peaks (Paragraph [0032], v4-vertexes 108). Chanduszko teaches wherein the plurality of strut bridges (114) connects pairs, depending on attributes such as flexibility (Paragraph [0004]), of the first plurality of proximal peaks (108) and the second plurality of distal peaks (108). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the connection points of Case’s strut bridges as taught by Chanduszko in order to achieve the desired flexibility of the valve (Paragraph [0004]). Chanduszko fails to explicitly disclose the plurality of strut bridges connects every alternating fourth pair. It would have been obvious to one having ordinary skill in the art at the time the invention was made wherein the plurality of strut bridges connects every alternating fourth pair of the first plurality of proximal peaks and the second plurality of distal peaks 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. In re Aller, 105 USPQ 233.
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.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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