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.
Response to Amendment
The Response filed November 4, 2025 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 Claims 1-4, 6-9, and 11-27 are pending in the application with claims 12-25 being withdrawn from further consideration. The previous rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Cleef (U.S. Patent No. 5792155).
Regarding claim 1, Van Cleef discloses a blood flow regulating device for a vessel (Fig. 8), comprising:
a delivery catheter (“catheter;” col. 6, ll. 9-46) extending along a longitudinal axis; and
a vessel shaping device (Fig. 8) having a retracted configuration in the delivery catheter (col. 6, ll. 24-26) and an expanded configuration out of the delivery catheter (col. 6, ll. 41-46), 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, to reshape the vessel to a flattened configuration (col. 5, ll. 31-34), the vessel shaping device comprising
a frame (Fig. 8) including a first arm extending transversely outward from the longitudinal axis to define a first apex (30), and a second arm extending transversely outward from the longitudinal axis in an opposite direction from the first arm to define a second apex (31), a proximal end of the first arm and a proximal end of the second arm are coupled to a proximal collar (portions of first and second arms including “tapped holes” at vertex (34); Fig. 8; col. 5, ll. 34-38), and a distal end of the first arm and a distal end of the second arm are coupled to a distal collar (portions of first and second arms including “tapped holes” at vertex (35); Fig. 8; col. 5, ll. 34-38), and
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a first stability member (32) extending across the first apex from a proximal portion of the first arm to a distal portion of the first arm (e.g., presser rod (32) extends in a proximal to distal direction; Fig. 8), and a second stability member (33) extending across the second apex from a proximal portion of the second arm to a distal portion of the second arm (e.g., presser rod (32) extends in a proximal to distal direction; Fig 8).
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Regarding claim 2,. Van Cleef 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 (col. 3, ln. 51 – col. 4, ln. 6).
Regarding claim 11, Van Cleef discloses wherein the first stability member or the second stability member extends transversely inward towards the central longitudinal axis (e.g., thickness of presser rods (32, 33) is defined by each rod extending transversely inward towards the central longitudinal axis; Fig. 8).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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”).
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.
Bar-Cohen teaches providing a vessel shaping device with a first stability member (60) extending across a first apex (54) from a proximal portion of a first arm (52) to a distal portion of the first arm (Fig. 2), and a second stability member (60) extending across a second apex (54) from a proximal portion of a second arm (52) to a distal portion of the second arm (Fig. 2) to provide rigidity and uniformity of contraction to the device (col. 4, ll. 37-44).
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 device with a first stability member extending across the first apex from a proximal portion of the first arm to a distal portion of the first arm, and a second stability member extending across the second apex from a proximal portion of the second arm to a distal portion of the second arm, in view of Bar-Cohen, in order to uniformly deform a blood vessel by uniformly contracting the device and to provide rigidity to prevent buckling of the device during use.
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, Bar-Cohen discloses wherein the first stability member or the second stability member extends transversely inward towards the central longitudinal axis (e.g., thickness of guide pins (60) is defined by each pin extending transversely inward towards the central longitudinal axis; Figs. 3-4).
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, 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 filed November 4, 2025 have been fully considered but they are not persuasive.
On pages 7-9 of the Response, Applicant argues that Van Cleef does not anticipate the claimed invention. These arguments are not persuasive.
On page 8 of the Response, Applicant argues that Van Cleef does not disclose a frame with “a first arm extending transversely outward from the longitudinal axis to define a first apex, and a second arm extending transversely outward from the longitudinal axis in an opposite direction from the first arm to define a second apex, 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,” as recited in claim 1. (Response pg. 8). This argument is not persuasive.
As can be seen in Fig. 8 of Van Cleef, annotated below, spreader element (29) includes a first arm extending transversely relative to threaded rod (36) to form a first apex (30) and a second arm extending transversely relative to threaded rod (6) to form a second apex (31).
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Also, Van Cleef further discloses that tapped holes are provided in spreader element (29) at vertices (34, 35) to receive threaded rod (36; col. 5, ll. 34-38). Thus, the portions of the spreader element including the tapped holes form distal and proximal collars at vertices (34, 35), respectively, to allow the spreader element to receive the threaded rod.
Therefore, Van Cleef discloses the first and second arms, as recited in claim 1.
On pages 8-9 of the Response, Applicant argues that Van Cleef does not disclose “a first stability member extending across the first apex from a proximal portion of the first arm to a distal portion of the first arm, and a second stability member extending across the second apex from a proximal portion of the second arm to a distal portion of the second arm,” as recited in claim 1. (Response pg. 8-9). This argument is not persuasive.
As can be seen in Fig. 8 of Van Cleef, annotated below, the spreader element (29) includes a first and second presser arms (32, 33) extending in a proximal to distal direction. Van Cleef also disclose that the presser arms apply a force along the length of a vessel (col. 5, ll. 40-43).
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Thus, each presser arm (32, 33) stabilizes the spreader element by applying a force along the length of the spreader element and extends across (i.e., from one side to the opposite side of) a respective apex (30,31). Further, each presser arm (32, 33) extends in a proximal to distal direction from (i.e., having a starting point at/near) proximal portions of the first and second arms to (i.e., in the direction of) distal portions of the first and second arms).
Therefore, Van Cleef discloses first and second stability elements as recited in claim 1.
Applicant’s further argument that Van Cleef does not disclose “two points of connection and spanning the apex itself,” (Response pg. 9) is not persuasive because such structural feature is not recited in the rejected claims. 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).
For the reasons above, Examiner maintains that Van Cleef discloses each and every limitation recited in claim 1 and anticipates the claim.
On pages 9-11 of the Response, Applicant argues that the proposed combination of Parr in view of Bar-Cohen does not render obvious the claimed invention. These arguments are not persuasive.
On pages 9-11 of the Response, Applicant argues that Bar-Cohen does not disclose “a first stability member extending across the first apex from a proximal portion of the first arm to a distal portion of the first arm, and a second stability member extending across the second apex from a proximal portion of the second arm to a distal portion of the second arm,” as recited in claim 1. (Response pp. 9-11). This argument is not persuasive.
As can be seen in Fig. 2 of Bar-Cohen, annotated below, guide pins (60) extend in a proximal to distal direction along the length of expander (30) to provide rigidity and uniformity of contraction to the expander (col. 4, ll. 37-44).
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Thus, each guide pin (60) stabilizes the expander and extends across (i.e., from one side to the opposite side of) a respective apex (54). Further, each guide pin (60) extends in a proximal to distal direction from (i.e., having a starting point at/near) proximal portions of the first and second arms to (i.e., in the direction of) distal portions of the first and second arms.
Applicant’s argument that the guide pins of Bar-Cohen “do not extend across any apex” (Response pg. 11) is not persuasive, because in the view of the device depicted in Fig. 2 of Bar-Cohen the guide pins extend from one side of apex (54) to an opposite side of the apex.
Applicant’s argument that the guide pins of Bar-Cohen do not “connect a proximal portion of a wing (50) to a distal portion of that same arm,” (Response pg. 11) is not persuasive because such structural feature is not recited in the rejected claims. 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).
For the reasons above, Examiner maintains that the proposed combination of Parr and Bar-Cohen meets each and every limitation recited in claim 1.
For all the reasons above, Examiner maintains that the claimed invention is not allowable over the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jayaraman (U.S. Patent No. 5755781) disclosing a stent delivery device with an expandable frame (Figs. 16-18);
Allen (U.S. Patent Application Publication No. 20010016770) disclosing a stent having reinforcement struts extending across apexes (Figs. 7A-7L);
McNamara et al. (U.S. Patent Application Publication No. 20070055366) disclosing a stent having webs extending across apexes (Fig. 3B-4J).
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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan Hollm Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771