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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/02/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 16 have been considered but are not persuasive. Applicants’ arguments on page 9-10 are pertaining to the problem being solved by the device of Whayne being different than that of the present invention. However, the device of Ward is in the field of the inventor’s endeavor and Whayne is only relied upon to teach an alternative shape and material of wire fins. Applicant argues that the wire fin and wings of the modified device would not be capable of generating a concentrated 15-pound force to effectively pinch off the aorta against the spine. However, this capability is not a recited limitation of the claim. 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). Further, the device of Ward is taught to be capable of the desired aortic compression and modifying the number of wings and the material would not remove this property.
Applicants’ arguments on pages 11-12 regarding the rejection of claims 6, 11, and 12 are addressed in the response above pertaining to claim 1.
In response to applicant's argument on pages 12-14 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., tensioning to create structural rigidity capable of transmitting 15 pounds of crushing force to occlude the aorta) 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). Claims 13-15 simply require an internal shaft comprised of a plurality of articulable segments that allow at least portions of the internal shaft to bend and internal tension wires attached to segments of said internal shaft and configured to change a stiffness of said internal shaft in response to tensioning said internal wires. These features are taught by Cuscuna as a mechanism for controlling steering of the device. The different uses and applications of the device being steered is not pertinent to whether or not it would have been obvious to form a steerable shaft using articulating segments and internal wires. This construction is commonly known in the art and does not require an inventive step to arrive at the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4, 7, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 5,716,386) in view of Whayne (US 2008/0114288).
Regarding claim 1, Ward discloses a device (20/20’, FIGs 1-9) for trans-esophageal aortic flow control (FIG 9 shows compression of aorta 50 from within esophagus 46), comprising: an esophageal tube (22/22’) having a distal end (End shown in FIG 1-3) and a proximal end (end near handle member shown in FIGs 1-2); an anchoring device (32) adjacent the distal end of the esophageal tube (FIG 2) and configured to secure placement of the distal end of the esophageal tube in a patient's stomach (FIG 6, col 11 lines 26-40); and an actuator (24’, 36, 44, 40, 28) configured to apply a compressive force posteriorly in the patient's esophagus in a direction of the patient's aorta at a location in the patient's aorta that is proximal to the patient's diaphragm to at least partially occlude the patient's aorta at said location (FIG 9 shows that in use, the device is positioned such that 24’ extends posteriorly to compress the aorta. Col 12 lines 1-11 also disclose the device being used in this manner), said actuator further comprising a deformable wire fin (36) formed of a shape-memory material (Col 11 lines 53-67 discloses 36 is made of spring steel) and extensible from the esophageal tube (See change in position between FIGs 5 and 4), wherein said wire fin is configured to deform upon extension from said esophageal tube into a memory shape having an outwardly extending wing defining a compression edge extending transverse to a longitudinal axis of the esophageal tube (As shown in cross section of FIG 9, at least some dimension of the bow 36 which forms movable portion 24’ has an edge extending transverse to a longitudinal axis of the tube).
Ward is silent regarding the wire fin having a plurality of outwardly extending wings defining a compression edge extending transverse to a longitudinal axis of the esophageal tube and material of the wire fin being Nitinol and being configured to deform into a predetermined memory shape upon extension from said esophageal tube.
However, Whayne teaches a deployable wire fin (Both of 216, [0168-0169], FIG 9C-9D) expandable to contact the anatomy into which they are deployed ([0169] discloses deployment against the esophagus) and having a plurality of outwardly extending wings (see two strands 216) defining a compression edge extending transverse to a longitudinal axis of the tube (Wherein 210 is the tube and FIG 9D shows a longitudinal axis of the ube. See annotated FIG 9C below defining a compression edge transverse to this longitudinal axis), the material of the wire fin being Nitinol ([0165] disclose the use of nitinol or spring steel) and being configured to deform into a predetermined memory shape upon extension ([0165-0166] discloses “ In some variations, the strands 216 assume a preshaped configuration upon deployment of the device…. For elastic or resilient strand configurations, the strands 216 have an expanded preshaped orientation”). Whayne further disclose the wire fin being enclosed in balloon 212, similar to the construction of Ward which comprises balloon 25 and wire fin 36.
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the wire fin of Ward with the two outwardly extending wings made of Nitinol and be configured to deform into a predetermined memory shape upon extension, as taught by Whayne, because Ward teaches that spring steel and Nitinol are interchangeable materials The substitution of one material known in the art for another would have resulted in the predictable result o of expanding to a shaped configuration for applying pressure or support on a treatment tissue of the patient. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). The use of Nitinol has the advantage of deploying to a predetermined shape such that the exact amount of pressure being applied is consistent and known prior to deployment of the device. Further, the use of two extending wings instead of the single extending wing of Ward would provide the predictable result of creating a surface edge to apply a compressive force to the target tissue that is equally as capable as the single wing design of Ward.
Regarding claim 2, Ward/Whayne disclose the invention substantially as claimed, as set forth above for claim 1. Ward further discloses said actuator is positioned on said esophageal tube proximally to the anchoring device (FIG 2) by a sufficient distance to cause the actuator to be aligned with a portion of the patient's esophagus that is distal to an intersection of the patient's esophagus and the patient's diaphragm when the anchoring device is positioned inside of the patient's stomach (This limitation is interpreted as being met, see positioning relative to the anatomy in FIG 2 and 9 and the disclosure stating that with the anchoring device 32 positioned in the stomach, actuator 24 is positioned to apply a force through the esophagus to the aorta).
Regarding claims 4, Ward/Whayne disclose the invention substantially as claimed, as set forth above for claim 1. Ward further discloses said actuator further comprises a compression balloon extensible from an exterior of said esophageal tube (Flexible sheath 44 which surrounds wire fin 36 forms a compression balloon, FIG 4).
Regarding claim 7, Ward/Whayne disclose the invention substantially as claimed, as set forth above for claim 1. Ward further discloses a cover (44) extending over and extendable upon extension of said actuator (Flexible sheath 44 which surrounds wire fin 36 forms a cover, FIG 4), wherein said cover defines a top edge extending transverse to a longitudinal axis of the esophageal tube (See FIG 9; at least some surface of the cover defines an edge extending transverse to a longitudinal axis of the tube).
Regarding claim 10, Ward/Whayne disclose the invention substantially as claimed, as set forth above for claim 1. Ward further discloses said anchoring device further comprising a gastric balloon (32 is a gastric balloon, FIG 6).
Regarding claim 16, Ward discloses a device (20/20’, FIGs 1-9) for trans-esophageal aortic flow control (FIG 9 shows compression of aorta 50 from within esophagus 46), comprising: an esophageal tube (22/22’) having a distal end (End shown in FIG 1-3) and a proximal end (end near handle member shown in FIGs 1-2); an anchoring device (32) adjacent the distal end of the esophageal tube (FIG 2) and configured to secure placement of the distal end of the esophageal tube in a patient's stomach (FIG 6, col 11 lines 26-40); and an actuator (24’, 36, 44, 40, 28) configured to apply a compressive force posteriorly in the patient's esophagus in a direction of the patient's aorta (FIG 9 shows that in use, the device is positioned such that 24’ extends posteriorly to compress the aorta. Col 12 lines 1-11 also disclose the device being used in this manner), wherein said actuator is positioned on said esophageal tube proximally to the anchoring device (FIG 2) by a sufficient distance to cause the actuator to be aligned with a portion of the patient's esophagus that is distal to an intersection of the patient's esophagus and the patient's diaphragm when the anchoring device is positioned inside of the patient's stomach (This limitation is interpreted as being met, see positioning relative to the anatomy in FIG 2 and 9 and the disclosure stating that with the anchoring device 32 positioned in the stomach, actuator 24 is positioned to apply a force through the esophagus to the aorta), said actuator further comprising a deformable wire fin (36) formed of a shape-memory material (Col 11 lines 53-67 discloses 36 is made of spring steel) and extensible from the esophageal tube (See change in position between FIGs 5 and 4), wherein said wire fin is configured to deform upon extension from said esophageal tube into a memory shape having an outwardly extending wing defining a compression edge extending transverse to a longitudinal axis of the esophageal tube (As shown in cross section of FIG 9, at least some dimension of the bow 36 which forms movable portion 24’ has an edge extending transverse to a longitudinal axis of the tube).
Ward is silent regarding the wire fin having a plurality of outwardly extending wings defining a compression edge extending transverse to a longitudinal axis of the esophageal tube and material of the wire fin being Nitinol and being configured to deform into a predetermined memory shape upon extension from said esophageal tube.
However, Whayne teaches a deployable wire fin (Both of 216, [0168-0169], FIG 9C-9D) expandable to contact the anatomy into which they are deployed ([0169] discloses deployment against the esophagus) and having a plurality of outwardly extending wings (see two strands 216) defining a compression edge extending transverse to a longitudinal axis of the tube (Wherein 210 is the tube and FIG 9D shows a longitudinal axis of the ube. See annotated FIG 9C above defining a compression edge transverse to this longitudinal axis), the material of the wire fin being Nitinol ([0165] disclose the use of nitinol or spring steel) and being configured to deform into a predetermined memory shape upon extension ([0165-0166] discloses “ In some variations, the strands 216 assume a preshaped configuration upon deployment of the device…. For elastic or resilient strand configurations, the strands 216 have an expanded preshaped orientation”). Whayne further disclose the wire fin being enclosed in balloon 212, similar to the construction of Ward which comprises balloon 25 and wire fin 36.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the wire fin of Ward with the two outwardly extending wings made of Nitinol and be configured to deform into a predetermined memory shape upon extension, as taught by Whayne, because Ward teaches that spring steel and Nitinol are interchangeable materials The substitution of one material known in the art for another would have resulted in the predictable result o of expanding to a shaped configuration for applying pressure or support on a treatment tissue of the patient. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). The use of Nitinol has the advantage of deploying to a predetermined shape such that the exact amount of pressure being applied is consistent and known prior to deployment of the device. Further, the use of two extending wings instead of the single extending wing of Ward would provide the predictable result of creating a surface edge to apply a compressive force to the target tissue that is equally as capable as the single wing design of Ward.
Claim(s) 6, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 5,716,386) in view of Whayne (US 2008/0114288), further in view of Ward (US 6,296,654).
Regarding claim 6, Ward/Whayne discloses the invention substantially as claimed, as set forth above for claim.
Ward is silent regarding a second compression balloon extensible from an exterior of said esophageal tube.
However, Ward ‘654 teaches a device (90, FIGs 18-18) for trans-esophageal aortic flow control (abstract) comprising an esophageal tube (108) and a plurality of compression balloons configured to laterally stabilize the esophageal tube in the patient's esophagus (FIG 17 shows at least 86 and 88, which are configured to restrict the lateral movement of the tube within the esophagus. Col 13 lines 15-31 discloses the members contacting the esophagus and “imparting rigid positioning” of the tube within the esophagus).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Ward to comprise a second compression balloon extensible from an exterior of said esophageal tube, as taught by Ward ‘654, for the purpose of increasing the stability and positioning of the device within the esophagus to maintain lateral positioning an ensure proper alignment of the actuator with the aorta.
Regarding claims 11-12, Ward/whayne discloses the invention substantially as claimed, as set forth above for claim 10.
Ward is silent regarding a plurality of proximal anchoring devices positioned adjacent or proximal to the actuator and configured to laterally stabilize the esophageal tube in the patient's esophagus wherein said plurality of proximal anchoring devices further comprise balloons extensible in a direction that is orthogonal to a direction of force application from the actuator.
However, Ward ‘654 teaches a device (90, FIGs 18-18) for trans-esophageal aortic flow control (abstract) comprising an esophageal tube (108) and a plurality of proximal anchoring devices configured to laterally stabilize the esophageal tube in the patient's esophagus (FIG 17 shows at least 86 and 88, which are configured to restrict the lateral movement of the tube within the esophagus. Col 13 lines 15-31 discloses the members contacting the esophagus and “imparting rigid positioning” of the tube within the esophagus), said plurality of proximal anchoring devices further comprise balloons (‘inflatable cuff’ is interpreted as a balloon) extensible in a direction that is orthogonal to a direction of force application from the actuator (Because each of the balloons exerts a radial force around the longitudinal axis, at least some direction of extension of the proximal anchoring devices is orthogonal for a force direction of the compression balloon).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Ward to comprise a plurality of anchoring balloons extensible in a direction that is orthogonal to a direction of force application from the actuator to laterally stabilize the esophageal tube in the patient's esophagus, as taught by Ward ‘654, for the purpose of increasing the stability and positioning of the device within the esophagus to maintain lateral positioning an ensure proper alignment of the actuator with the aorta.
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (US 5,716,386) in view of Whayne (US 2008/0114288), further in view of Cuscuna et al. (US 2019/0117193).
Regarding claims 13-15, Ward/Whayne discloses the invention substantially as claimed, as set forth above for claim 1.
Ward is silent regarding said esophageal tube further comprising an internal shaft comprised of a plurality of articulable segments wherein said articulable segments are configured to engage one another so as to allow at least portions of the internal shaft to bend, said device further comprising internal tension wires attached to segments of said internal shaft and configured to change a stiffness of said internal shaft in response to tensioning said internal wires.
However, Cuscuna et al. discloses a steerable tube (10) configured for insertion within an esophagus ([0002]; transesophageal probe) further comprising an internal shaft (10b, FIG 1, [0016]) comprised of a plurality of articulable segments (11, [0016]) wherein said articulable segments are configured to engage one another so as to allow at least portions of the internal shaft to bend (FIGs 4-5, [0019-0020]), said device further comprising internal tension wires (Control cables 40-42’, [0016 and 0022-0023], FIGs 8-9) attached to segments of said internal shaft (At anchor points 32, 34, 36, 38) and configured to change a stiffness of said internal shaft in response to tensioning said internal wires (Tensioning the wires changes the stiffness by bending the inner shaft and holding a bent position or relaxing to allow for relative flexibility).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Ward such that it comprises an articulable inner shaft and a plurality of tension wires to control said articulation, as taught by Cuscuna, for the purpose of providing the device with a means for steering the tube to position the actuation at a desired position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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