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 .
Election/Restrictions
Claims 13-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2025.
Applicant’s election of claims 1-12, and 15-20 in the reply filed on 09/18/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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.
Claims 1-12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bakis et al. (US 20180125656 A1) in view of Deck et al. (US 20110230891 A1).
Regarding claim 1, Bakis discloses a delivery apparatus for an expandable, implantable medical device (prosthetic valve 14, Fig 1), the delivery apparatus comprising: a handle portion (handle 202, Fig 23); a shaft (main shaft 104, Fig 23) extending from the handle portion (202) (Fig 1); a delivery capsule (delivery sheath 106, Fig 18) configured to house the medical device (14) in a radially compressed state for delivery into a subject ([0099]); a rotatable component (gear 230, Fig 25) disposed in the handle portion (202) and operatively coupled to the delivery capsule (106) to produce axial movement of the delivery capsule (106) relative to the shaft (104) upon rotation of the rotatable component (230)([0123]; delivery sheath 106 surrounds the medical device and rotation of the motor causes rotation of gears 228 and 230 which produces relative axial motion between the sheath 106 and shaft 104); a motor (electric motor 226, Fig 25) disposed in the handle portion (202) and operatively coupled to the rotatable component (230) to produce rotation of the rotatable component (230) and corresponding axial movement of the delivery capsule (106) ([0123]).
Bakis is silent regarding a pull cord configured to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.
Deck teaches a delivery apparatus (Fig 1) comprising a pull cord (actuating element 7, Fig 1) configured to produce rotation of the rotatable component (rotor 6, Fig 1) and corresponding axial movement of the delivery capsule (insertion needle holder 2, Fig 1) when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component (pull cord 7 of device of Deck is structurally capable of being manually pulled and pushed to cause axial displacement of the needle holder 2 before locking mechanism prevent further use; [0026]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis to include similar actuating element as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014])
Regarding claim 2, Bakis/Deck discloses the delivery apparatus of claim 1. Bakis discloses wherein the shaft is a first shaft (104) and the delivery apparatus further comprises a second shaft (elongated shaft 110, Fig 9) extending through the first shaft (104), wherein the second shaft (110) has a proximal end portion operatively coupled to the rotatable component (230)([0123]; Fig 24) and a distal end portion operatively coupled to the delivery capsule ([0100]; claim 1) such that rotation of the rotatable component (230) rotates the second shaft (110) relative to the first shaft (104) and produces axial movement of the delivery capsule (106) ([0123]).
Regarding claim 4 Bakis/Deck discloses the delivery apparatus of claim 1. Bakis is silent wherein the handle portion comprises an opening for inserting the pull cord through the handle portion.
Deck teaches a delivery apparatus (Fig 1) wherein a handle portion (housing 1, Fig 1) comprises an opening (opening 1001, Annotated Fig 1) for inserting the pull cord (7) through the handle portion (1).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar openings in the handle as taught by Deck for the purpose of inserting the manual actuator (Fig 1; [0026])
Regarding claim 5, Bakis/Deck discloses the delivery apparatus of claim 4. Bakis is silent wherein the pull cord is configured to be pulled through the opening in a direction substantially perpendicular to a lengthwise axis of the handle portion to produce rotation of the rotatable component.
Deck teaches wherein the pull cord (7) is configured to be pulled through the opening (1001, Annotated Fig 1) in a direction (1003, Annotated Fig 1) substantially perpendicular to a lengthwise axis (1002, Annotated Fig 1) of the handle portion (1) to produce rotation of the rotatable component (6) ([0026]; device of deck is structurally capable of both pulling and pushing in the perpendicular direction; Annotated Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar pull cord orientation as taught by Deck to improve the ergonomic of the handle at the time of manual actuation ([0008]).
Regarding claim 6, Bakis/Deck discloses the delivery apparatus of claim 4. Bakis is silent wherein movement of the pull cord through the opening in a first direction rotates the rotatable component in a second direction to produce movement of the delivery capsule in a third, proximal direction, and movement of the pull cord through the opening in a fourth direction, opposite the first direction, rotates the rotatable component in a fifth direction, opposite the second direction to produce movement of the delivery capsule in a sixth, distal direction.
Deck teaches wherein the movement of the pull cord (7) through the opening (1001, Annotated Fig 1) in a first direction rotates (1004, Annotated Fig 1) the rotatable component in a second direction (counterclockwise direction of 6, Fig 1) to produce movement of the delivery capsule (2) in a third, proximal direction (1005, Annotated Fig 1), and movement of the pull cord (7) through the opening (1001, Annotated Fig 1) in a fourth direction (1006, Annotated Fig 1), opposite the first direction (1004, Annotated Fig 1), rotates the rotatable component (6) in a fifth direction (clockwise, Fig 1), opposite the second direction (counterclockwise) to produce movement of the delivery capsule (2) in a sixth, distal direction (1007, Annotated Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar pull cord actuation arrangement as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014]).
Regarding claim 7, Bakis/Deck discloses the delivery apparatus of claim 1. Bakis discloses wherein the motor (226) is an electrically actuated motor powered by at least one battery, which is housed in the handle portion ([0123]).
Regarding claim 8, Bakis/Deck discloses the delivery apparatus of claim 1. Bakis is silent wherein the pull cord is removable from the handle portion.
Deck teaches wherein the pull cord (7) is removable from the handle portion (1). (Pull cord 7 is removed functionally once the device is used once; [0011]: “A safeguard against unwanted re-use can be implemented by designing the drive mechanism to become locked after use. For example, actuating element can be designed to snap into position at the end of the driving motion.” )
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar locking mechanism functionally removing pull cord of further use at the end of the driving motion as taught by Deck for the purpose of indicating delivery of medical device and as safeguard against unwanted manipulation ([0011]).
Regarding claim 9, Bakis/Deck discloses the delivery apparatus of claim 1. Bakis discloses wherein the rotatable component (230) comprises a plurality of gear teeth (teeth of gear 230, Fig 25). Bakis is silent wherein the pull cord comprises a plurality of teeth that are configured to drivingly engage the gear teeth of the rotatable component.
Deck teaches wherein the pull cord (7) comprises a plurality of teeth (racks 8, Fig 1) that are configured to drivingly engage the gear teeth of the rotatable component (teeth of rotor 6, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar teeth engagement between the pull cord and the rotatable component as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014]).
Regarding claim 10, Bakis/Deck discloses the delivery apparatus of claim 9. Bakis discloses further comprising a drive gear (gear 228, Fig 25) coupled to the motor (226) and comprising a plurality teeth (teeth of gear 228, Fig 25) that engage the gear teeth of the rotatable component (teeth of gear 230).
Regarding claim 11, Bakis/Deck discloses the delivery apparatus of claim 9. Bakis is silent wherein the pull cord comprises at least one end portion without teeth.
Deck teaches wherein the pull cord comprises at least one end portion without teeth (proximal and distal end portions of pull cord 7 do not have teeth, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar dented pull cords having teeth in the central portion and no teeth at the ends as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014]).
Regarding claim 12, Bakis/Deck discloses the delivery apparatus of claim 1. Bakis is silent wherein the pull cord comprises a middle portion comprising a plurality of teeth and two end portions without teeth, the middle portion disposed between the two end portions.
Deck teaches wherein the pull cord (7) comprises a middle portion comprising a plurality of teeth and two end portions without teeth, the middle portion disposed between the two end portions (center portion of 7 comprise a plurality of teeth and is in-between the end portions without teeth, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar dented pull cords having teeth in the central portion and no teeth at the ends as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014]).
Regarding claim 15, Bakis discloses a delivery apparatus for an expandable, implantable medical device (prosthetic valve 14, Fig 1), the delivery apparatus comprising: a handle portion (handle 202, Fig 23); a delivery capsule (delivery sheath 106 Fig 18) configured to house the medical device (14) in a radially compressed state for delivery into a subject ([0099]); a rotatable component (gear 230, Fig 25) disposed in the handle portion (202) and operatively coupled to the delivery capsule (106) to produce axial movement of the delivery capsule (106) relative to the handle portion (202) upon rotation of the rotatable component (230)([0123]; delivery sheath 106 surrounds the medical device and rotation of the motor causes rotation of gears 228 and 230 which produces relative axial motion between the sheath 106 and the handle 202)
Bakis is silent regarding a pull cord configured to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.
Deck teaches a delivery apparatus (Fig 1) comprising a pull cord (actuating element 7, Fig 1) configured to produce rotation of the rotatable component (rotor 6, Fig 1) and corresponding axial movement of the delivery capsule (insertion needle holder 2, Fig 1) when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component (manual pulling and pushing force applied to the actuating element 7 cause axial displacement of the needle holder 2; [0026]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis to include similar actuating element as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014])
Regarding claim 16, Bakis/Deck discloses the delivery apparatus of claim 15. Bakis discloses further comprising a motor (electric motor 226, Fig 25) disposed in the handle portion (202) and operatively coupled to the rotatable component (230) to produce rotation of the rotatable component (230) and corresponding axial movement of the delivery capsule (106) ([0123]).
Regarding claim 17, Bakis/Deck discloses the delivery apparatus of claim 15. Bakis is silent wherein the handle portion comprises an opening for inserting the pull cord through the handle portion and wherein the pull cord is configured to be pulled through the opening in a direction substantially perpendicular to a lengthwise axis of the handle portion to produce rotation of the rotatable component.
Deck teaches a handle portion (housing 1, Fig 1) comprises an opening (opening 1001, Annotated Fig 1) for inserting the pull cord (7) through the handle portion (1) and wherein the pull cord (7) is configured to be pulled through the opening (1000, Annotated Fig 1) in a direction (1003, Annotated Fig 1) substantially perpendicular to a lengthwise axis (1002, Annotated Fig 1) of the handle (1) portion to produce rotation of the rotatable component (6) ([0026]; device of deck is structurally capable of both pulling and pushing in the perpendicular direction except when the locking mechanism activates; Annotated Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar pull cord orientation as taught by Deck to improve the ergonomic of the handle at the time of manual actuation ([0008]).
Regarding claim 18, Bakis/Deck discloses the delivery apparatus of claim 15. Bakis discloses wherein the rotatable component (230) comprises a plurality of gear teeth (teeth of gear 230, Fig 25). Bakis is silent wherein the pull cord comprises a plurality of teeth that are configured to drivingly engage the gear teeth of the rotatable component, and wherein the pull cord comprises at least one end portion without teeth.
Deck teaches wherein the pull cord (7) comprises a plurality of teeth (racks 8, Fig 1) that are configured to drivingly engage the gear teeth of the rotatable component (teeth of rotor 6, Fig 1) and wherein the pull cord comprises at least one end portion without teeth (proximal and distal end portions of pull cord 7 do not have teeth, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar dented pull cords having teeth in the central portion and no teeth at the ends as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014]).
Regarding claim 18, Bakis/Deck discloses the delivery apparatus of claim 18. Bakis is silent wherein the pull cord comprises a middle portion comprising the plurality of teeth and two end portions without teeth, the middle portion disposed between the two end portions.
Deck teaches wherein the pull cord (7) comprises a middle portion comprising a plurality of teeth and two end portions without teeth, the middle portion disposed between the two end portions (center portion of 7 comprise a plurality of teeth and is in-between the end portions without teeth, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis/Deck with similar dented pull cords having teeth in the central portion and no teeth at the ends as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014]).
Regarding claim 20, Bakis discloses a medical apparatus for insertion into a subject, the medical apparatus comprising: a handle portion (handle 202, Fig 23); a moveable component (main shaft 104, Fig 23) configured to be inserted into the subject; a rotatable component (gear 230, Fig 25) disposed in the handle portion (202) and operatively coupled to the moveable component (104) to produce axial movement of the moveable component (104) relative to the handle portion (202) upon rotation of the rotatable component (230). Bakis is silent regarding a pull cord configured to produce rotation of the rotatable component and corresponding axial movement of the moveable component when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.
Deck teaches a pull cord (actuating element 7, Fig 1) configured to produce rotation of the rotatable component (rotor 6, Fig 1) and corresponding axial movement of the moveable component (insertion needle holder 2, Fig 1) when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component (pull cord 7 of device of Deck is structurally capable of being manually pulled and pushed to cause axial displacement of the needle holder 2 before locking mechanism prevent further use; [0026]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis to include similar actuating element as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014])
Regarding claim 1, Bakis discloses a delivery apparatus for an expandable, implantable medical device (prosthetic valve 14, Fig 1), the delivery apparatus comprising: a handle portion (handle 202, Fig 23); a shaft (shaft assembly 104+110, Fig 23) extending from the handle portion (202) (Fig 1); a delivery capsule (delivery sheath 106, Fig 18) configured to house the medical device (14) in a radially compressed state for delivery into a subject ([0099]); a rotatable component (gear 230, Fig 25) disposed in the handle portion (202) and operatively coupled to the delivery capsule (106) to produce axial movement of the delivery capsule (106) relative to the shaft (104+110) upon rotation of the rotatable component (230)([0123]; delivery sheath 106 surrounds the medical device and rotation of the motor causes rotation of gears 228 and 230 which produces relative axial motion between the sheath 106 and shaft assembly 104+110); a motor (electric motor 226, Fig 25) disposed in the handle portion (202) and operatively coupled to the rotatable component (230) to produce rotation of the rotatable component (230) and corresponding axial movement of the delivery capsule (106) ([0123]);
Bakis is silent regarding a pull cord configured to produce rotation of the rotatable component and corresponding axial movement of the delivery capsule when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component.
Deck teaches a delivery apparatus (Fig 1) comprising a pull cord (actuating element 7, Fig 1) configured to produce rotation of the rotatable component (rotor 6, Fig 1) and corresponding axial movement of the delivery capsule (insertion needle holder 2, Fig 1) when a manual pulling force is applied to the pull cord to pull the pull cord relative to the rotatable component (pull cord 7 of device of Deck is structurally capable of being manually pulled and pushed to cause axial displacement of the needle holder 2 before locking mechanism prevent further use; [0026]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Bakis to include similar actuating element as taught by Deck for the purpose of engaging the rotatable element to convert the driving motion of the actuating element, which extends transversely to the delivery direction, into a linear motion to cause axial motion of the delivery capsule by manual means (abstract; [0014])
Regarding claim 3, Bakis/Deck discloses the delivery apparatus of claim 1. Bakis discloses wherein the delivery capsule (106) is connected to a distal end portion of the shaft (104+110) ([0099]) and the rotatable component (230) is operatively coupled to a proximal end portion of the shaft (104+110) such that rotation of the rotatable component (230) produces axial movement of the shaft (nut 150 component of shaft 104+110) and the delivery capsule (106)([0115]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783