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 .
Terminal Disclaimer
The terminal disclaimer filed on 04/28/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent 12385038 filed 02/24/2023 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Priority
2. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 02/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this submission of the information disclosure statement is being considered by the examiner.
Response to Amendment
4. The amendment filed 04/27/2026 has been entered. Currently, claims 1-14 remain pending in the application. Independent claims 1 was amended by Applicant without the addition of new matter. Additionally, claims 7-9 and 11 have amended to overcome previous claim interpretation as well as 112(B) rejections previously set forth in the Non-Final Office Action mailed 01/27/2026.
Response to Arguments
5. Applicant's arguments, see Remarks filed 04/27/2026 have been fully considered but they are not persuasive. Accordingly the prior art from the Non-Final Office Action mailed 01/27/2026 is maintained: Van De Graaf et al. (U.S. Patent Pub. No. 20170281401), Woehr et al. (U.S. Patent Pub. No. 20200188634), Mooney (U.S Patent No. 4659062), Zamberger (U.S. Patent Pub. No. 20200096071), Duchemin (U.S. Patent No. 3945625), Ebels et al. (U.S. Patent Pub. No. 20180014929).
6. Applicant makes the argument that “Applicant’s biasing element is capable of preloading the valve member towards both the opened position and the closed position. Notably, Woehr does not describe such bistably bias capability, since, in Woehr the spring only preloads the valve in a single direction, namely the closed position. ...Furthermore, Mooney’s bowed leaf springs are not the same as bow-shaped rods as claimed. Also similarly to Woehr, Mooney preloads in only one direction” (Remarks, Pages 8 to Page 10, Paragraph 4).
In response to applicant's argument (Remarks, Pages 8 to Page 10, Paragraph 4) that the references fail to show certain features of the invention of “both the opened position and the closed position”, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, claim 1 is interpreted based on broadest reasonable interpretation that bistably bias is provided by two-mirrored bows, as taught by Mooney. Moreover, leaf springs are construed as being rod shaped and capable of bowing and providing bias force to meet the claim limitation. Therefore, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the claim limitations of “bistably bias towards the open position or the closed position”. Examiner notes that such an amendment of --bistably bias towards both the opened position and [[or]] the closed position—would overcome and distinguish from both Woehr and Mooney for providing multidirectional throttle control.
7. Overall, Examiner notes that Applicant may further overcome the prior art of record by reciting additional positive limitations. For example, as shown in Applicant’s Figure 4A-4B the bowed rod end connects to the pivot member 410 at a central height portion of the pivot member 410. Moreover, negative limitations such as –not—or –without—to teach away from the prior art. Lastly, transitional phrases such as –consisting—and/or –consisting essentially of—in the preamble/body of the claim would prevent prior art combinations.
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, 7, and 11-14, as best understood given by the 35 USC 112(B) above, are rejected under 35 U.S.C. 103 as being unpatentable over Van De Graaf et al. (U.S. Patent Pub. No. 20170281401) in view of Woehr et al. (U.S. Patent Pub. No. 20200188634) and in further view of Mooney (U.S Patent No. 4659062).
Regarding claim 1, Van De Graaf discloses an implantable tube valve 100 (Paragraphs 24, 30, 43 and Figures 1-7 tube valve 100 for catheterization implanting comprising tube wall 113 with valve 120, pivot member 410, pivot shaft 415, and actuator 400 therein for pivoting valve 120 between open and closed position) for implanting in a human vessel, the tube valve 100 comprising: a tube 113, having an inner tube wall 111 and an outer tube wall 113 that extend between two axial tube ends; a valve member 120 that is connected to a pivot shaft 415supported by the tube 113, wherein the valve member 120 is pivotable between an open position and a closed position; an actuator 400 that is mounted (Paragraph 5 and Figure 4) on the outer tube wall; a pivot member 410 , mechanically coupled to the actuator 400 that is arranged for driving the pivot shaft 415 from the outer tube wall 113 by an actuation force from the actuator 400.
However, Van De Graaf fails to explicitly disclose (1) at least one biasing element that is connected to the pivot member and arranged for preloading the pivot member to bistably bias the valve member towards the open position or the closed position; wherein the biasing element comprises a bowed rod in a mirrored fashion; (2) there are at least two bow-shaped rods that are interconnected at both ends in a mirrored fashion
Woehr teaches an analogous implantable tube valve (Paragraphs 9, 25, 80, 230, 491-495, and Figure 15, IV catheter implantable tube with valve member 120) wherein at least one biasing element 240 (Paragraphs 9, 25, 80, 230, 491-492, and Figure 15, bowed elliptical-mirror coil spring 240 to impart a proximally directed axial force vector to the nose section 150 of the valve actuator to open and close valve 120 with a pivot member to attach the spring 240 to a securing device 124 against the nose section 150 and provide a directional biasing) that is connected to an analogous pivot member (Paragraph 80) and arranged for preloading the analogous pivot member (Paragraph 80) to bistably bias the analogous valve member 120 towards the analogous open position (Paragraphs 494-495 and Figure 16) or the analogous closed position (Paragraphs 494-495 and Figure 17); wherein the biasing element 240 comprises a bowed rod 240 in a mirrored fashion.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the pivot member of Van De Graaf, so that there is at least one biasing element that is connected to the pivot member and arranged for preloading the pivot member to bistably bias the valve member towards the open position or the closed position; wherein the biasing element comprises a bowed rod in a mirrored fashion, as taught by Woehr, in order to provide an improved implantable tube valve with an enhanced pivot member that is biasingly adjustable via an elliptical bowed spring shape to impart force onto the valve member to desirably control movement of the valve member from an open or closed position via directional biasing (Woehr, Paragraphs 9, 25, 80, 230, 491-493)
However, the combination of Van De Graaf in view of Woehr fails to explicitly disclose (2) there are at least two bow-shaped rods that are interconnected at both ends in a mirrored fashion.
Mooney teaches an analogous valve member (Col. 9, lines 21-45 and Figure 9, valve with elliptical spring 61 formed by two bowed leaf springs 63a,63b joined at ends 64 in mirrored fashion to apply force to valve) wherein the analogous biasing element 61 comprises at least two bow-shaped rods 63a,63b that are interconnected at both ends 64 in an analogous mirrored fashion.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the singular bowed biasing element of Van De Graaf in view of Woehr, so that the biasing element comprises at least two bow-shaped rods that are interconnected at both ends in a mirrored fashion, as taught by Mooney, in order to provide an improved implantable tube valve with an enhanced biasing element formed of two interconnected leaf springs for desirable resilience and force throughout both rods forming the bow (Mooney, Col. 9, lines 21-45).
Regarding claim 5, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above and further discloses wherein the biasing element (Woehr, Paragraphs 9, 25, 80, 230, 491-495, and Figure 15, biasing spring 240 is an integrally formed part as the spring 240 is attached within the tube; Mooney, Col. 9, lines 21-45 and Figure 9, leaf springs 631,63b are integrally formed and attached ) is an integrally formed part.
Regarding claim 7, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above. Van De Graaf further discloses wherein the tube 113 comprises a cavity (Paragraphs 24, 30-32, 43 and Figures 4-5 and 7, cam 410 on outer tube wall 113 with cavity between outer tube wall 113 and inner tube wall 111 to connect cam 410 with pivot shaft 415 to internal valve 120, thereby enclosing a portion of the pivot shaft 415 of cam 410 therebetween) between the inner 111 and outer tube 113 wall, for enclosing at least the pivot member 410.
Regarding claim 11, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above and further discloses wherein the actuator (Paragraphs 24, 30-32 and Figures 5A-5B, actuator 400 with cam 410, tension wires M1,M2, detent wire D, and heating circuit 425 for providing actuation force onto pivot shaft 415) comprises a heating circuit425 arranged for heating at least one tension wire M1, M2, D by means of an electrical current through the tension wire M1, M2, D, the tension wire M1, M2, D being attached between (Figure 5B) the heating circuit 425 and the pivot member 410 so that by heating the tension wire M1, M2, D, provides an actuation force on the pivot member 410.
Regarding claim 12, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above and further discloses wherein the tension wire M1, M2, D is mechanically connected to at least two respective terminals (Paragraph 43 and Figure 6) of the heating circuit 425 at one end, to provide a current running therethrough, and mechanically connected to the pivot member 410 (Paragraph 43 and Figures 6-7) at another end, so that the current runs through the tension wire M1, M2, D without branching off to the pivot member 410.
Regarding claim 13, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above and further discloses wherein the at least one tension wire M1, M2, D is coupled to a connector 413 (Paragraphs 40, 43 and Figures 5A-5B, connector 413 mounted within cam 410 having pivot shaft 415 ), and wherein the connector410 is mounted in the pivot member 410.
Regarding claim 14, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above and further discloses wherein the at least one tension wire M1, M2, D is coupled to a connector 413 (Paragraphs 40, 43 and Figures 5A-5B, connector 413 mounted within cam 410 having pivot shaft 415 ), said connector 413 mounted in the pivot member 410.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Van De Graaf et al. (U.S. Patent Pub. No. 20170281401) in view of Woehr et al. (U.S. Patent Pub. No. 20200188634) in further view of Mooney (U.S Patent No. 4659062), as applied to claim 1, and in further view of Zamberger (U.S. Patent Pub. No. 20200096071).
Regarding claim 2, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above but fails to explicitly disclose wherein each bow-shaped rod has a middle section with an increased bending stiffness with respect to a distal end and a proximal end section bending stiffness.
Zamberger teaches an analogous biasing rod 1 (Paragraph 48 and Figure 1, leaf spring rod 1 with middle having increased bending stiffness and thickness than ends 3a,3b) has a middle section with an increased bending stiffness with respect to a distal end 3b and a proximal end 3b section bending stiffness.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a material thickness of each bow-shaped rod of Van De Graaf in view of Woehr in view of Mooney, so that the rod has a middle section with an increased bending stiffness with respect to a distal end and a proximal end section bending stiffness, as taught by Zamberger, in order to provide an improved implantable tube valve with an enhanced biasing rod member with a non-uniform stiffness and thickness throughout the leaf spring rod for desirable greater resisting bowing forces located centrally during bending (Zamberger, Paragraph 48).
Regarding claim 3, the combination of Van De Graaf in view of Woehr in view of Mooney in view of Zamberger discloses the invention as described above and further discloses wherein each bow shaped rod (Woehr, Paragraphs 9, 25, 80, 230, 491-495, and Figure 15, biasing spring 240 is an integrally formed part as the spring 240 is attached within the tube; Mooney, Col. 9, lines 21-45 and Figure 9, leaf springs 631,63b are integrally formed and attached ) has a middle section cross-sectional area (Zamberger , Paragraph 48 and Figure 1) which is larger than a cross-sectional area of any end section of each bow shaped rod.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Van De Graaf et al. (U.S. Patent Pub. No. 20170281401) in view of Woehr et al. (U.S. Patent Pub. No. 20200188634) in further view of Mooney (U.S Patent No. 4659062), as applied to claim 1, and in further view of Duchemin (U.S. Patent No. 3945625).
Regarding claim 4, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above but fails to explicitly disclose wherein the biasing element is a planar structure with a constant thickness.
Duchemin teaches an analogous biasing element rod 1 (Col. 1, lines 64-65 and Figure 1, leaf 1 has a perimeter that is substantially constant and a wall thickness that is substantially constant, thereby providing a planar side of the leaf) is a planar structure with a constant thickness.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a material thickness of each bow-shaped biasing rod of Van De Graaf in view of Woehr in view of Mooney, so that the rod of the biasing element is a planar structure with a constant thickness, as taught by Duchemin, in order to provide an improved implantable tube valve with an enhanced biasing rod member with a uniform thickness throughout the leaf spring rod for desirable constant resilient bowing forces throughout bending (Duchemin, Col. 1, lines 64-65).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Van De Graaf et al. (U.S. Patent Pub. No. 20170281401) in view of Woehr et al. (U.S. Patent Pub. No. 20200188634) in further view of Mooney (U.S Patent No. 4659062), as applied to claim 1, and in further view of Ebels et al. (U.S. Patent Pub. No. 20180014929).
Regarding claim 8, the combination of Van De Graaf in view of Woehr in view of Mooney discloses the invention as described above but fails to explicitly disclose wherein the pivot member is curved, having a curvature following a contour of the inner tube wall to limit a lateral extension of the implantable tube valve.
Ebels teaches an analogous implantable tube valve 11 (Paragraph 40 and Figures 1 and 6, heart tube valve 11 with pivot member 13 allowing for valve members 31,33 to pivot therefrom, wherein the pivot member 13 is curved within inner surface of tube wall 13, thereby limiting lateral extension of valve 11) wherein the analogous pivot member 13 is curved, having a curvature following a contour of the analogous inner tube wall 13 to limit a lateral extension of the analogous implantable tube valve 11.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify a shape of the pivot member of Van De Graaf in view of Woehr in view of Mooney, so that the pivot member is curved, having a curvature following a contour of the inner tube wall to limit a lateral extension of the implantable tube valve, as taught by Ebels, in order to provide an improved implantable tube valve with an enhanced pivot member that is curved with the tubing to increase streamlined flow characteristics through the valve with low turbulence (Ebels ,Paragraph 40).
Allowable Subject Matter
Claims 6 and 9-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 6 would be allowable for disclosing wherein the biasing element comprises at least one cylindrically rounded end engageable with a cylindrically rounded cutout on the pivot member to form a rotatable connection.
An embodiment of Figure 25 of Woehr teaches an analogous biasing element 256 (Paragraph 506, leaf spring 256 with ends that are radiused) comprising rounded end of the analogous biasing member256.
Based on the structures of embodiment of Figure 25 of Woehr it would be improper hindsight to modify Van De Graaf in view of Woehr in view of Mooney so that cylindrically rounded end engageable with a cylindrically rounded cutout on the pivot member to form a rotatable connection. One of ordinary skill would instead be drawn to the structure of Van De Graaf, Woehr, and Mooney wherein the biasing elements ends are rounded and are pivotable with the pivot member, but the pivot member is explicitly described or shown to also have a rounded cut-out to receive the biasing element rounded ends. Therefore the combination of features is considered to be allowable.
Claim 9 would be allowable for disclosing wherein the pivot member comprises at least two opposing mounts radially extending from the pivot shaft for transferring the actuation force from the actuator to the pivot shaft.
Van De Graaf teaches wherein the pivot member 410 (Paragraphs 23, 30, 43 and Figures 6-7) comprises at least two opposing mounts for transferring the actuation force from the actuator 400 to the pivot shaft 415.
Based on the structures of Van De Graaf it would be improper hindsight to modify Van De Graaf in view of Woehr in view of Mooney so that there are two opposing mounts radially extending from the pivot shaft. One of ordinary skill would instead be drawn to the structure of Van De Graaf wherein the two mounts of the pivot member receive the tension wires of the actuation mechanism, but Van De Graaf does not explicitly describe or show a position of the mounts as radial from pivot shaft. Therefore the combination of features is considered to be allowable.
Claim 10 would be allowable for disclosing wherein the pivot member comprises at least one mount radially extending from the pivot shaft for transferring the preload force from the biasing element to the pivot shaft.
Woehr teaches the pivot member (Paragraphs 9, 25, 80, 230, 491-492, and Figure 15, bowed elliptical-mirror coil spring 240 to impart a proximally directed axial force vector to the nose section 150 of the valve actuator to open and close valve 120 with a pivot member to attach the spring 240 to a securing device 124 against the nose section 150) transferring the preload force from the biasing element 240.
Based on the structures of embodiment of Woehr it would be improper hindsight to modify Van De Graaf in view of Woehr in view of Mooney so that there is at least one mount radially extending from the pivot shaft for transferring the preload force from the biasing element to the pivot shaft. One of ordinary skill would instead be drawn to the structure of Van De Graaf, Woehr, and Mooney wherein the biasing element is pivotally mounted, but there is no explicit mention or showing the mounts being radially positioned. Therefore the combination of features is considered to be allowable.
Conclusion
17. THIS ACTION IS MADE FINAL. 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.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached on +1(571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
Prosecution Insights