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 .
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 30, 2026 has been entered. Claims 1-4, 6-9, and 11-27 are pending in the application with claims 12-25 being withdrawn from further consideration. Response to applicant's arguments can be found at the end of this office action.
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 1-4, 6, 9, 11, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Parr (U.S. Patent Application Publication No. 20180280671) in view of Bar-Cohen et al. (U.S. Patent No. 5855565; hereinafter “Bar-Cohen”) and White et al. (U.S. Patent No. 9808650; hereinafter “White”).
Regarding claim 1, Parr discloses a blood flow regulating device for a vessel (Figs. 2A-2D; paras. [0052]-[0064]), comprising:
a delivery catheter (204) extending along a longitudinal axis; and
a vessel shaping device (202) having a retracted configuration in the delivery catheter (para. [0053]) and an expanded configuration out of the delivery catheter (para. [0053]), the vessel shaping device being arranged to expand to the expanded configuration along a transverse axis, perpendicular to the longitudinal axis of the delivery catheter (Figs. 2A-2C), to reshape the vessel to a flattened configuration (para. [0064]), the vessel shaping device comprising:
a frame including a first arm (206) extending transversely outward from the longitudinal axis to define a first apex (Figs. 2A-2C; para. [0055]), and a second arm (208) extending transversely outward from the longitudinal axis in an opposite direction from the first arm to define a second apex (Figs. 2A-2C; para. [0055]).
The device of Parr discloses the invention substantially as claimed, except for proximal ends of the first and second arm being coupled to a proximal collar and distal ends of the first and second arm being coupled to a distal collar.
Bar-Cohen, a reference in the vascular dilator field of endeavor, teaches coupling a proximal end of the first arm (50) and a proximal end of the second arm (50) to a proximal collar (56), and a distal end of the first arm and a distal end of the second arm are coupled to a distal collar (57; Figs. 1-2) to secure the arms to a catheter for stable, uniform expansion of the arms during use (col. 4, ll. 33-64).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the frame such that a proximal end of the first arm and a proximal end of the second arm are coupled to a proximal collar, and a distal end of the first arm and a distal end of the second arm are coupled to a distal collar, in view of Bar-Cohen, in order to uniformly deform a blood vessel by uniformly expanding the arms.
The modified device discloses the invention substantially as claimed, except for the device including first and second stability members.
White, a reference in the vascular treatment catheter field of endeavor, teaches providing an expandable device with
a first stability member (76) extending across a first apex of a fist arm (66) from a proximal portion of the first arm to a distal portion of the first arm, wherein the first stability member is coupled to the proximal portion of the first arm between the first apex and the proximal collar and coupled to the distal portion of the first arm between the first apex and the distal collar (Fig. 14; col. 14, ll. 8-19), and
a second stability member (76) extending across a second apex of a second arm (66) from a proximal portion of the second arm to a distal portion of the second arm, wherein the second stability member is coupled to the proximal portion of the second arm between the second apex and the proximal collar and coupled to the distal portion of the second arm between the second apex and the distal collar (Fig. 14; col. 14, ll. 8-19)
in order to provide structural support to the first arm and second arm during use (col. 14, ll. 15-19).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified device with first and second stability members, as taught by White, in order to provide structural support to the first and second arms to maintain the expanded shape of the device during a procedure.
Regarding claim 2, Parr discloses wherein the flattened configuration of the vessel defines an extended transverse diameter, a reduced lateral diameter, and a smaller cross-sectional area than the cross-sectional area of the vessel in a resting configuration (para. [0064]).
Regarding claim 3, Parr discloses wherein the vessel shaping device is self-expanding to the expanded configuration (para. [0063]).
Regarding claim 4, Parr discloses wherein the vessel shaping device is formed from Nitinol (para. [0041]).
Regarding claim 6, Parr discloses wherein the vessel shaping device further comprises a tubular member (202) coupled to the frame (Figs. 2A-2C; para. [0054]).
Regarding claim 9, Parr discloses the invention substantially as claimed, except for movement of the tubular member in one of a proximal direction or a distal direction further expands the vessel shaping device along the transverse axis.
Bar-Cohen teaches configuring a tubular member (98; Figs. 7-8) to move in one of a proximal direction or a distal direction to further expand a vessel shaping device along a transverse axis to prevent the device from buckling during use (col. 5, ll. 36-43).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the tubular member such that movement of the tubular member or an actuator rod in one of a proximal direction or a distal direction further expands the vessel shaping device along the transverse axis, in view of Bar-Cohen, to prevent buckling of the device while expanding a blood vessel.
Regarding claim 11, White discloses wherein the first stability member or the second stability member extends transversely inward towards the central longitudinal axis (Fig. 14).
Regarding claim 26, the modified device discloses the invention substantially as claimed, except for the vessel shaping device further comprising an actuator rod.
Bar-Cohen teaches providing a vessel shaping device with an actuator rod (42) engaged with a tubular member (24; Figs. 1-2) to provide controlled dilation of a vessel (col. 3, ln. 66 – col. 4, ll. 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the vessel shaping device with an actuator rod slidably engaged with the tubular member, in view of Bar-Cohen, to provide increased control over expansion of the vessel shaping device to achieve a desired amount of vessel reshaping.
Regarding claim 27, Bar-Cohen further discloses wherein movement of the actuator rod in one of a proximal direction or a distal direction further expands the vessel shaping device along the transverse axis (col. 3, ln. 66 – col. 4, ll. 5).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Parr in view of Bar-Cohen and White, as applied to claim 6 above, and further in view of Farley et al. (U.S. Patent Application Publication No. 20110202047; hereinafter “Farley”).
Regarding claim 7, Parr discloses the invention substantially as claimed, except for the tubular member being fixedly attached to a distal collar and slidably engaged with a proximal collar.
Bar-Cohen teaches fixedly attaching a tubular member (98) to a distal collar (Figs. 7-8) and slidably engaged with a proximal collar (102) to prevent the device from buckling during use (col. 5, ll. 36-43).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the tubular member such that the tubular member is fixedly attached to a distal collar and slidably engaged with the proximal collar, in view of Bar-Cohen, to prevent buckling of the device while expanding a blood vessel.
The modified device discloses the invention substantially as claimed, except for the distal collar defining an atraumatic tip.
Farley, a reference in the vascular treatment catheter field of endeavor, teaches configuring a distal collar (36; Fig. 6) to define an atraumatic tip for the catheter as it is navigated through a vein (para. [0069]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the distal collar to define an atraumatic tip, in view of Farley, to prevent harming the patient’s vasculature during use.
Regarding claim 8, Parr discloses the invention substantially as claimed, except for the tubular member being slidably engaged with a distal collar and fixedly attached to the proximal collar.
Bar-Cohen configuring a tubular member (24) to be slidably engaged with a distal collar (58) and fixedly attached to a proximal collar (56; Figs. 1-2) to secure arms to a catheter for stable, uniform expansion of the arms during use (col. 4, ll. 33-64).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the tubular member to be slidably engaged with a distal collar and fixedly attached to a proximal collar, in view of Bar-Cohen, in order to uniformly deform a blood vessel by uniformly expanding the arms.
The modified device discloses the invention substantially as claimed, except for a distal end of the tubular member defining an atraumatic tip.
Farley, a reference in the vascular treatment catheter field of endeavor, teaches configuring a distal end (36) of a tubular member (34; Fig. 7) to define an atraumatic tip for the catheter as it is navigated through a vein (para. [0069]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure a distal end of the tubular member to define an atraumatic tip, in view of Farley, to prevent harming the patient’s vasculature during use.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-9, 11, and 26-27 have been considered but are moot because the new grounds of rejection over combinations with Smith, as presented above in this Office Action, do 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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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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