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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on August 8, 2025. Claims 2-23 are currently pending.
Specification
In view of the response filed on 8/8/2025 amending the specification to clarify the abstract the objections made against the abstract in the office action of 5/8/2025 have been withdrawn.
Claim Objections
In view of the amendment filed on 8/8/2025 amending the claim 5 to clarify the language the objections made against claim 5 in the office action of 5/8/2025 have been withdrawn.
Claims 12-18 and 21 are objected to because of the following informalities: Claim 12, line 13 should recite similar to –the at least one convex contact pad-- to provide proper antecedent basis. Appropriate correction is required. Claims 13-18 directly or indirectly depend from claim 12 and are also objected to for the reasons stated above regarding claim 12.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-18 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 12 and 21 recite “at least one strut of the plurality of elongate struts at least intermittently makes contact with a vessel wall of the blood vessel distal of the pump housing without requiring continuous contact between the at least one convex contact pad and the vessel wall” which is confusing on when the at the at least one strut with convex contact pad is contacting the vessel wall since a broad limitation “at least intermittently makes contact with a vessel wall of the blood vessel” which includes intermittently contact and continuous constant contact is followed by a narrower limitation within the same claim “without requiring continuous contact between the at least one convex contact pad and the vessel wall” which includes intermittent contact but does not include continuous constant contact, clarification is required. Claims 13-18 directly or indirectly depend from claim 12 and are also rejected to for the reasons stated above regarding claim 12. As best understood, for the purposes of examination the language of claims 12 and 21 has been interpreted to include at least intermittently makes contact with a vessel wall of the blood vessel.
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.
Claim(s) 2-8, 12-16, 18-19 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0128659 to Heuring et al. (Heuring) in view of US 2011/0303229 to Najafi et al. (Najafi) (both previously cited).
In reference to at least claim 2
Heuring discloses a method of operating a blood flow assist system (e.g. “circulatory support system”, para. [0002]), the method comprising: providing a pump (e.g. “intravascular pumping module”, para. [0096]) at a treatment location entirely within a blood vessel of a patient (e.g.” The following nonlimiting example discusses placement of the circulation and perfusion enhancement system in the descending aorta. However, in other embodiments, placement can be in any accessible vessel or chamber of sufficient size.”, para. [0098]), the pump including a pump housing disposed in a sheath (e.g. housing 114 disposed in sheath 140), an impeller disposed in the pump housing (e.g. impeller 115), and a plurality of elongate struts extending from the pump housing in a collapsed configuration (e.g. struts 121), removing the pump from the sheath (e.g. “The passage of the intravascular pumping module 80 through the sheath 140 is made possible with an obturator (not shown). As the obturator is held in place, the sheath 130 is then withdrawn, which in the case of a spring type support structure 120, the support members, or struts 121 then spring open and anchor the pump 110 in the descending aorta 98 or other vessel or chamber, “, para. [0201]), the plurality of elongate struts radially self- expanding to an expanded configuration (e.g. “which in the case of a spring type support structure 120, the support members, or struts 121 then spring open and anchor the pump 110 in the descending aorta 98 or other vessel or chamber, “, para. [0201]) in which at least one strut at least intermittently makes contact with a vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall (e.g. strut 121 contacts a vessel wall and maintains spacing of the pump, Fig. 1C); and rotating the impeller to pump blood (e.g. which permits the passage of blood 81'' into housing 114, as it is drawn into, pumped, or pulled into housing 114 by the rotation of impeller 115”, para. [100]).
However, Heuring does not explicitly teach each elongate strut of the plurality of struts including a convex contact pad at a distal end thereof; in which at least one convex contact pad at least intermittently makes contact with a vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall.
Najafi discloses an implant (e.g. anchor 10) with a plurality of convex contact pads (e.g. surfaces 36, para. [0038]), each convex contact pad being coupled with one of a plurality of structures (e.g. arms 26, para. [0024]).Najafi further discloses that “[T]he convex surfaces 36 of the tips 32 also act to reduce the force required to insert the anchor 10 through the septum wall 102, enhance the ability of the anchor 10 to navigate blood vessel curvatures, and reduce the likelihood that the anchor 10 will damage blood vessel walls.” (e.g. para. [0038]).
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 system of Heuring to include on the tips of the elongated struts convex contact pads, as taught by Najafi, in order to enhance the ability of the strut to navigate blood vessel curvature while reducing the likelihood of damage to the wall (‘229, para. [0038]).
In reference to at least claim 3
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses conveying electrical current to a motor by way of a tether (e.g. “power wire” 117) the motor operatively coupled with the impeller and the tether coupled to the pump, wherein rotating the impeller generates a thrust force, the tether opposing the thrush force (e.g. “Pump 110 is preferably powered by a motor 116, such as an electric motor 116', which rotates impeller 115. Impeller 115 may be mounted on a shaft supported by bearings, or magnetically or hydrodynamically levitated, for rotation within housing 114. A power wire 117 is associated with motor 116, and as will hereinafter described in greater detail, it extends from intravascular pumping module 80 to a point at which it may be associated with a power source, such as a battery (not shown).”, para. [0100]).
In reference to at least claim 4
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses percutaneously delivering the sheath to the treatment location (e.g. The sheath 140 is then passed over a guide-wire and then placed into position in the descending aorta 98 or other vessel or chamber, with the tip 141 (FIG. 1B) in the mid thoracic aorta, superior to splanchnic arteries.”, para. [0201]), and, subsequently, delivering the pump to the treatment location (e.g. “The intravascular pumping module 80 is then passed through the one-way valve into the sheath 140 to the tip 141 at the mid thoracic area.”, para. [0201]).
In reference to at least claim 5
Heuring modified by Najafi renders obvious a system according to claim 2. Najafi further discloses causing a portion of the contact pad to depress into the vessel wall (e.g. “When deployed within an opening in a wall, such as a septum of a heart, the convex surfaces of the distal tips and intermediate portions of the arms and legs serve to clamp the wall and thereby secure the anchor within the wall.”, para. [0007]; “With the arms 26 and legs 28 in their deployed configurations, the convex surfaces 36 and 44 of the arms 26 and legs 28 are axially aligned with each other, providing a clamping capability on the wall 102 as evident from FIGS. 2 and 3”, para. [0023]).
In reference to at least claim 6
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses removing the pump from the patient (e.g. “ The pump 110 and support structure 120, including support members 121, could be designed whereby pump 110 and support structure 120 could be removed with a catheter based removal device (not shown) which could collapse support members 121 and disengage them from their anchored configuration to permit the removal of them and pump 110, if desired, such as to replace or repair pump 110.”, para. [0206]).
In reference to at least claim 7
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses wherein removing the pump from the sheath comprises providing relative motion between the sheath and the pump (e.g. “the sheath 130 is then withdrawn, which in the case of a spring type support structure 120, the support members, or struts 121 then spring open and anchor the pump 110 in the descending aorta 98 or other vessel or chamber, or alternatively, if support structure 120 is a self-expanding stent 200, stent 200 springs open and anchors the pump 110 in the aorta 98 or other vessel or chamber.”, para. [0201]).
In reference to at least claim 8
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses collapsing the plurality of elongate struts (e.g. “support structure 120 could be removed with a catheter based removal device (not shown) which could collapse support members 121 and disengage them from their anchored configuration”, para. [0206]).
In reference to at least claim 12
Heuring discloses a method of operating a blood flow assist system (e.g. “circulatory support system”, para. [0002]), the method comprising: providing a pump (e.g. “intravascular pumping module”, para. [0096]) at a treatment location within a blood vessel of a patient (e.g.” The following nonlimiting example discusses placement of the circulation and perfusion enhancement system in the descending aorta. However, in other embodiments, placement can be in any accessible vessel or chamber of sufficient size.”, para. [0098]), the pump including a pump housing disposed in a sheath (e.g. housing 114 disposed in sheath 140), an impeller disposed in the pump housing (e.g. impeller 115), and a plurality of elongate struts having a proximal end disposed at a distal end of the pump housing and extending distally from the pump housing in a collapsed configuration (e.g. struts 121), a tether extending proximally from the pump (e.g. “power wire” 117); removing the pump from the sheath (e.g. “The passage of the intravascular pumping module 80 through the sheath 140 is made possible with an obturator (not shown). As the obturator is held in place, the sheath 130 is then withdrawn, which in the case of a spring type support structure 120, the support members, or struts 121 then spring open and anchor the pump 110 in the descending aorta 98 or other vessel or chamber, “, para. [0201]), the plurality of elongate struts radially self- expanding to an expanded configuration (e.g. “which in the case of a spring type support structure 120, the support members, or struts 121 then spring open and anchor the pump 110 in the descending aorta 98 or other vessel or chamber, “, para. [0201]) in which at least one strut at least intermittently makes contact with a vessel wall of the blood vessel to maintain spacing of the pump housing from the vessel wall distal of the pump housing (e.g. strut 121 contacts a vessel wall and maintains spacing of the pump, Fig. 1C); positioning the pump within the blood vessel such that the pump housing is surrounded by the vessel wall with an uninterrupted blood flow path disposed between the pump housing and the vessel wall and entirely around the pump housing, and such that the at least one strut extends along the vessel wall (e.g. pump is positioned within the vessel surrounded by the vessel wall, Figs. 1C, 1D); and rotating the impeller to pump blood proximally through the blood vessel (e.g. “other embodiments may reverse the flow through the device described in FIG. 9 such that the ports (88) farther from the pump (82) are inlet ports and the ports (86) closer to the pump (82) are outlet ports. This is the "pull" configuration.”, para. [0094], [0097]).
However, Heuring does not explicitly teach each elongate strut of the plurality of struts including a convex contact pad at a distal end thereof; in which at least one convex contact pad at least intermittently makes contact with a vessel wall without requiring continuous contact between the at least one convex contact pad and the vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall and being free of hooks.
Najafi discloses an implant (e.g. anchor 10) with a plurality of convex contact pads (e.g. surfaces 36, para. [0038]), each convex contact pad being coupled with one of a plurality of structures (e.g. arms 26, para. [0024]).Najafi further discloses that “[T]he convex surfaces 36 of the tips 32 also act to reduce the force required to insert the anchor 10 through the septum wall 102, enhance the ability of the anchor 10 to navigate blood vessel curvatures, and reduce the likelihood that the anchor 10 will damage blood vessel walls.” (e.g. para. [0038]).
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 system of Heuring to include on the tips of the elongated struts convex contact pads, as taught by Najafi, in order to enhance the ability of the strut to navigate blood vessel curvature while reducing the likelihood of damage to the wall (‘229, para. [0038]).
In reference to at least claim 13
Heuring modified by Najafi renders obvious a system according to claim 12. Heuring further discloses percutaneously delivering the sheath to the treatment location (e.g. The sheath 140 is then passed over a guide-wire and then placed into position in the descending aorta 98 or other vessel or chamber, with the tip 141 (FIG. 1B) in the mid thoracic aorta, superior to splanchnic arteries.”, para. [0201]), and, subsequently, delivering the pump to the treatment location (e.g. “The intravascular pumping module 80 is then passed through the one-way valve into the sheath 140 to the tip 141 at the mid thoracic area.”, para. [0201]).
In reference to at least claim 14
Heuring modified by Najafi renders obvious a system according to claim 12. Heuring further discloses removing the pump from the patient (e.g. “ The pump 110 and support structure 120, including support members 121, could be designed whereby pump 110 and support structure 120 could be removed with a catheter based removal device (not shown) which could collapse support members 121 and disengage them from their anchored configuration to permit the removal of them and pump 110, if desired, such as to replace or repair pump 110.”, para. [0206]).
In reference to at least claim 15
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses conveying electrical current to a motor by way of the tether which comprises a conductor (e.g. “power wire” 117), the motor operatively coupled with the impeller and the tether coupled to the pump(e.g. “Pump 110 is preferably powered by a motor 116, such as an electric motor 116', which rotates impeller 115. Impeller 115 may be mounted on a shaft supported by bearings, or magnetically or hydrodynamically levitated, for rotation within housing 114. A power wire 117 is associated with motor 116, and as will hereinafter described in greater detail, it extends from intravascular pumping module 80 to a point at which it may be associated with a power source, such as a battery (not shown).”, para. [0100]).
In reference to at least claim 16
Heuring modified by Najafi renders obvious a system according to claim 2. The modified structure of Heuring with Najafi discloses convex contact pad being on the ends of the struts, i.e. each elongate strut of the plurality of elongate struts includes a convex contact pad at a distal end thereof, see rejection of claim 12 above.
In reference to at least claim 18
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses that the support structure with the struts secures the pump to the vessel (e.g. “a transluminally deliverable support structure 120 which secures, or anchors, pump 110 within the descending aorta 98 or other vessel or chamber.”, para. [0098]; “As will be hereinafter described in greater detail, support structure 120 anchors pump 110 within descending aorta 98 or other vessel or chamber for long or short term use”, para. [0105]), therefore the modified device with convex contact pads located on the ends of the struts would apply sufficient force to the vessel wall of the blood vessel to depress a portion of the contact pad into the vessel wall such that a surrounding portion of the vessel wall is radially inward from the contact pad.
In reference to at least claim 19
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses wherein the tether extends proximally from the pump (e.g. power wire 117 extends proximally from the pump, Figs. 1B-1C), wherein rotating the impeller to pump blood comprises pumping blood proximally through the blood vessel (e.g. “other embodiments may reverse the flow through the device described in FIG. 9 such that the ports (88) farther from the pump (82) are inlet ports and the ports (86) closer to the pump (82) are outlet ports. This is the "pull" configuration.”, para. [0094], [0097]).
In reference to at least claim 21
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses wherein, in the expanded configuration, the convex contact pad at least intermittently makes contact with the vessel wall without requiring continuous contact between the convex contact pad and the vessel wall (e.g. struts 121 at least intermittently makes contact with a vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall, Fig. 1C);.
In reference to at least claim 22
Heuring modified by Najafi renders obvious a system according to claim 2. Najafi further discloses wherein the convex contact pad is free of hooks (e.g. no hooks present on the surfaces “convex contact pads”, 36, para. [0038]), .
In reference to at least claim 23
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring further discloses positioning the pump within the blood vessel such that the pump housing is surrounded by and spaced from the vessel wall by an uninterrupted blood flow channel and such that the plurality of elongate struts extends along the vessel wall (e.g. pump is positioned within the vessel surrounded by the vessel wall, Figs. 1C, 1D).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0128659 to Heuring et al. (Heuring) in view of US 2011/0303229 to Najafi et al. (Najafi) as applied to claim 2 further in view of US 2018/0311421 to Tuseth et al. (Tuseth) (previously cited).
In reference to at least claim 9
Heuring modified by Najafi renders obvious a system according to claim 2. Heuring discloses being able to collapse the struts (e.g. “If the deployment is not satisfactory, hold the device in place by tension on the snare wire and advance the sheath to collapse the struts back to their pre-deployment configuration.”, para. [0202]; “whereby pump 110 and support structure 120 could be removed with a catheter based removal device (not shown) which could collapse support members 121 and disengage them from their anchored configuration to permit the removal of them and pump 110,”, para. [0206]).
However, Heuring modified by Najafi does not disclose wherein each strut of the plurality of elongate struts comprises a knee, wherein collapsing the plurality of elongate struts comprises engaging each knee with a distal end of the sheath.
Tuseth discloses a pump (e.g. intracorporeal device 300 includes a pump housing 320), the pump including a pump housing (e.g. pump housing 320) disposed in a sheath (e.g. “The ventricular assist system is preferably delivered and implanted using a transcatheter system”, therefore it is inherent that the intracorporeal device that includes the pump is disposed within a sheath, para. [0003]), an impeller disposed in the pump housing (e.g. impeller, para. [0086]), and a plurality of elongate struts (e.g. fixing means 302 containing support arms 306) extending from the pump housing in a collapsed configuration (e.g. “members/support arms 306 are re-positioned into a “delivery” position, wherein the pump docking members/support arms 306 are arranged substantially parallel with the longitudinal axis of the intracorporeal device 300”, the delivery position includes a collapsed configuration of the support arms 306, para. [0082]), each elongate strut of the plurality of struts including a convex contact pad at a distal end thereof (e.g. support arm 306 includes a convex contact pad, Fig. 3), the plurality of elongate struts radially self- expanding to an expanded configuration in which at least one convex contact pad at least intermittently makes contact with a vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall (e.g. “FIG. 3 illustrates the fixing means 302 in a “deployed” position, wherein the number of pump docking members/support arms 306 are splayed out substantially perpendicular to the longitudinal axis of the intracorporeal device 300. These pump docking members/support arms 306, in use, abut a portion of the anatomical wall 4”, para. [0080]) to maintain spacing of the pump from the vessel wall (e.g. “The number of pump docking members/support arms 306 act as a tissue shield and pump protector, since the wall of the aorta is held away from the intracorporeal device 300”, para. [0081]), wherein each strut of the plurality of elongate struts comprises a knee, wherein collapsing the plurality of elongate struts comprises engaging each knee with a distal end of the sheath (e.g. “members/support arms 306 are re-positioned into a “delivery” position, wherein the pump docking members/support arms 306 are arranged substantially parallel with the longitudinal axis of the intracorporeal device 300”, the support arms 306 can be collapsed into a “delivery” position, para. [0082]).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Heuring modified by Najafi to include each strut of the plurality of elongate struts comprises a knee, wherein collapsing the plurality of elongate struts comprises engaging each knee with a distal end of the sheath, as taught by Tuseth, to provide an element that further aids in bending of the strut when collapsing the struts and distributes pressure so that the anatomical wall is not damaged (‘421, para. [0080]).
Claim(s) 10-11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0128659 to Heuring et al. (Heuring) in view of US 2011/0303229 to Najafi et al. (Najafi) as applied to claim 2 and 12 further in view of US Patent No. 7,303,526 to Sharkey et al. (Sharkey) (previously cited).
In reference to at least claims 10-11 and 17
Heuring modified by Najafi renders obvious a system according to claim 2 and 12. However, Heuring modified by Najafi does not disclose wherein each elongate strut of the plurality of elongate struts includes an inflection zone disposed between a distal end and a proximal end of the elongate strut, wherein the inflection zone of each strut spaces the distal end of the strut from an inner wall of the sheath in the collapsed configuration. It was well-known the art before the effective filing date of the claimed invention to provide inflection zones on an elongate strut which spaces a distal end of the strut from an inner wall of a delivery sheath as evidence by Sharkey (e.g. elongate strut include anchoring hooks 14C which have inflection zones spacing a distal end of the anchoring hooks from the inner wall of a delivery catheter, Figs. 3A-3B, see annotated figure below). 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 system of Heuring modified by Najafi to include inflection zones to space the distal end of the strut from an inner wall of the sheath in the collapsed configuration as such technique was known in the art and would have yielded the predictable result of reducing any snagging between the contact pads and the delivery sheath.
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Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0128659 to Heuring et al. (Heuring) in view of US 2011/0303229 to Najafi et al. (Najafi) as applied to claim 19 further in view of US2006/0036127 to Delgado, III (Delgado).
In reference to at least claims 20
Heuring modified by Najafi renders obvious a system according to claim 19. Heuring further discloses a tether (e.g. “power wire” 117) but does not explicitly teach extending the tether outside a body of the patient through a peripheral blood vessel of the patient.
Delgado discloses a left ventricle pump (e.g. 110) that includes a tether (e.g. power wire 117) that is extends outside a body of the patient through a peripheral blood vessel of the patient (e.g. “portion 118 of power wire 117 extending outwardly from graft 131. As will be hereinafter described in greater detail, the graft 131 is connected or anastomosed to the patient's femoral artery 10 “, para. [0040]-[0041], [0044]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Heuring modified by Najafi to include extending the tether outside a body of the patient through a peripheral blood vessel of the patient, as taught by Delgado, to provide a biocompatible arrangement for the power wire that provides a requisite seal reducing leaks (‘127, para. [0040]).
Response to Arguments
III. Claim Rejections under 35 USC 102
Applicant’s arguments, see pg. 6-9, filed 8/8/2025, with respect to the 102 rejections using Tuseth for claims 2 and 12 have been fully considered and are persuasive in view of the claim amendments requiring the device to be located “entirely within a blood vessel of a patient” and “positioning the pump within the blood vessel such that the pump housing is surrounded by the vessel wall with an uninterrupted blood flow path disposed between the pump housing and the vessel wall and entirely around the pump housing, and such that the at least one strut extends along the vessel wall.”. The 102 rejections using Tuseth for claims 2-10 and 12-16 has been withdrawn.
IV. Claim Rejections under 35 USC 103
A. Independent Claim 2
Applicant's arguments filed 8/8/2025 regarding the 103 rejection against claim 2 using Heuring have been fully considered but they are not persuasive. Applicant argues “The skilled artisan would understand that the convex surfaces 36, 44 cooperate on opposing sides of the wall 102 in Najafi to provide the clamping force described above, which would not be suitable for Heuring’s device, which does not provide a clamping force across a vessel wall. Indeed, as noted above, the hooks of Heuring can be used to anchor the pump in place within a blood vessel. There is no teaching in Najafi that the convex surfaces 36, 44 would be able to provide such an anchoring function from only one side of a blood vessel wall, nor any teaching in Najafi that the convex surfaces 36, 44 would be suitable for use with a pump that is disposed entirely within a blood vessel.”, pg. 9 of the response filed 8/8/2025. This is not persuasive. Heuring teaches that a small hook or similar anchoring structure may be used in the struts of the impeller device, see para. [0113]. Najafi teaches struts for placement in the cardiovascular system wherein the struts have convex tissue-contact surfaces, which provide the benefit of enhancing the ability of the anchor to navigate blood vessel curvatures, and reduce the likelihood of the anchor causing damage to the blood vessel walls. One of ordinary skill in the art would recognize the convex end surfaces of Najafi’s atrial septum device as a reasonable substitution for the small hooks of Heuring’s anchoring device because Heuring teaches that small hooks or similar anchoring elements may be used in the struts and, furthermore, Najafi indicates that the convex surfaces prevent damage to blood vessels. One of ordinary skill in the art would expect that such a substitution would be successful in anchoring Heuring’s device in a blood vessel because Heuring teaches that the struts spring outwardly, thereby anchoring to the vessel wall by means of outward forces upon the blood vessel.
B. Dependent Claims 3-8, 11 and 17
Applicant has not provided separate arguments for claims 3-8,11 and 17 and instead argues allowability based on their dependency from claims 2 and 12 which have already been addressed above.
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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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796