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
Applicant’s election without traverse of Group I in the reply filed on 10/21/2025 is acknowledged. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/21/2025. The requirement is deemed proper and is therefore made FINAL.
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.
Claim 8 and its dependent claims 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. Claim 8 recites the limitation "the actuation shafts" in line 6. There is insufficient antecedent basis for this limitation as claim 8, line 3 recites “one or more actuation shafts” and does not mandate a plurality of actuation shafts. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, and 6-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Calomeni et al. (Pub. No. US 2019/0029854 A1; hereinafter “Calomeni”).
Calomeni discloses the following regarding claim 1: a delivery apparatus for implantation of a prosthetic heart valve, the delivery apparatus comprising: a handle housing (18); a release mechanism (78) mounted on the handle housing (Fig. 1); and a gear assembly (155, 157) comprising one or more pinion gears (157) and an indicator gear (155); wherein actuation of the release mechanism causes rotation of the one or more pinion gears and the indicator gear (paras. 0079-0083, 0087-0099); wherein each pinion gear is connected to a proximal end portion of a corresponding actuation shaft (132) (Fig. 10), wherein rotation of the pinion gear causes rotation of the corresponding actuation shaft such that a distal end portion of the actuation shaft can be connected to or released from the prosthetic heart valve (via the intermediate connection elements) (Figs. 1-4, 10; paras. 0079-0083, 0087-0092, 0094-0099); wherein the indicator gear is operably connected to an indicator tab (button mechanism) (paras. 0075-0076, 0099), wherein rotation of the indicator gear causes the indicator tab to move between a first position (locked) and a second position (unlocked) relative to the handle housing (paras. 0075-0076, 0099) such that when the indicator tab is at the first position, the one or more actuation shafts are connected to the prosthetic heart valve (when the delivery device is in a locked configuration and connected to the heart valve) (paras. 0075-0076, 0099), and when the indicator tab is at the second position, the one or more actuation shafts are released from the prosthetic heart valve (when the delivery device is in an unlocked configuration and disconnected from the heart valve) (paras. 0055-0060, 0070-0076, 0099, 0104).
Calomeni discloses the following regarding claim 2: the delivery apparatus of claim 1, wherein the indicator gear is connected to a proximal end portion of an indicator shaft (134) (Fig. 10), wherein a distal end portion of the indicator shaft is connected to the indicator tab (Fig. 10; paras. 0075-0076, 0099), wherein rotation of the indicator gear causes rotation of the indicator shaft about its axial axis (paras. 0079-0076, 0087-0099).
Calomeni discloses the following regarding claim 4: the delivery apparatus of claim 1, wherein the indicator tab extends into a slot (opening that holds the button mechanism when it is pressed radially inward) on the handle housing such that movement of the indicator tab relative to the handle housing can be visualized (paras. 0075-0076).
Calomeni discloses the following regarding claim 6: the delivery apparatus of claim 1, wherein the gear assembly comprises a driver gear (156) operably coupled to the one or more pinion gears and the indicator gear (Figs. 8-10) such that rotation of the driver gear causes corresponding rotation of the one or more pinion gears and the indicator gear (paras. 0072-0078, 0082-0084).
Calomeni discloses the following regarding claim 7: the delivery apparatus of claim 6, wherein the release mechanism comprises a knob (122) coupled to the driver gear such that rotation of the knob relative to the handle housing causes corresponding rotation of the driver gear (paras. 0072-0078, 0082-0084).
Calomeni discloses the following regarding claim 8: a delivery apparatus for implanting a prosthetic heart valve, comprising: a handle (18); and one or more actuation shafts (134), each having a proximal end portion connected to the handle (Figs. 8-10) and a distal end portion that is releasably couplable to the prosthetic heart valve (via the intermediate connection elements) (Figs. 1-4, 10; paras. 0079-0083, 0087-0092, 0094-0099); wherein the handle comprises a housing (82) and a release mechanism (78) mounted on the housing (Figs. 2-3), wherein actuation of the release mechanism can cause the distal end portion of the actuation shafts to be connected to or released from the prosthetic heart valve (paras. 0079-0083, 0087-0099); wherein the handle further comprises an indicator tab (button mechanism) configured to indicate whether the one or more actuation shafts are connected to or released from the prosthetic heart valve (paras. 0075-0076, 0099, 0104).
Calomeni discloses the following regarding claim 9: the delivery apparatus of claim 8, wherein the indicator tab is moveable between a first position (locked) and a second position (unlocked) relative to the housing such that when the indicator tab is at the first position, the one or more actuation shafts are connected to the prosthetic heart valve (when the delivery device is in a locked configuration and connected to the heart valve) (paras. 0075-0076, 0099), and when the indicator tab is at the second position, the one or more actuation shafts are released from the prosthetic heart valve (when the delivery device is in an unlocked configuration and disconnected from the heart valve) (paras. 0055-0060, 0070-0076, 0099, 0104).
Calomeni discloses the following regarding claim 10: the delivery apparatus of claim 8, further comprising one or more support sleeves (132), wherein each actuation shaft extends through a lumen of a corresponding support sleeve (Figs. 2, 6-9), wherein the distal end portion of each actuation shaft and a distal end portion of the corresponding support sleeve are configured to interface with a corresponding actuator (80) of the prosthetic heart valve (Figs. 2-3, 6-9; paras. 0079-0083, 0087-0099).
Calomeni discloses the following regarding claim 11: the delivery apparatus of claim 10, wherein the handle further comprises an expansion mechanism (156) mounted on the housing (Figs. 5-10), wherein the expansion mechanism is connected to the proximal end portion of each actuation shaft and a proximal end portion of each support sleeve (Figs. 5-10), wherein actuation of the expansion mechanism can cause axial movement of the one or more actuation shafts relative to the corresponding support sleeves so as to actuate the actuators of the prosthetic heart valve for radial expansion or compression of the prosthetic heart valve (paras. 0079-0083, 0087-0099).
Calomeni discloses the following regarding claim 12: the delivery apparatus of claim 10, further comprising an intermediate shaft (14), wherein the one or more actuation shafts and the corresponding support sleeves extend through one or more lumens of the intermediate shaft (Figs. 1-4).
Calomeni discloses the following regarding claim 13: the delivery apparatus of claim 12, further comprising an inner shaft (12) and a nose cone (para. 0049) connected to a distal end portion of the inner shaft (Fig. 1), wherein the inner shaft extends through a nosecone lumen of the intermediate shaft (lumen of element 14) (Figs. 1-4).
Calomeni discloses the following regarding claim 14: the delivery apparatus of claim 13, wherein the handle further comprises a nosecone mechanism (part of nosecone attached to element 12) mounted on the housing (Fig. 1; para. 0049), wherein a proximal end portion of the inner shaft is connected to the nosecone mechanism such that actuation of the nosecone mechanism can cause axial movement of the inner shaft relative to the intermediate shaft (Fig. 1; para. 0049).
Calomeni discloses the following regarding claim 15: the delivery apparatus of claim 12, further comprising an outer shaft (120), wherein the intermediate shaft extends through a lumen of the outer shaft (Figs. 1, 7-10), wherein a distal end portion of the outer shaft is configured to retain the prosthetic heart valve in a radially compressed configuration (paras. 0079-0083, 0087-0099).
Calomeni discloses the following regarding claim 16: the delivery apparatus of claim 15, wherein the handle further comprises a deployment mechanism (162) mounted on the housing (Fig. 10), wherein the deployment mechanism is coupled to a proximal end portion of the intermediate shaft and a proximal end portion of the outer shaft (Figs. 8-10), wherein actuation of the deployment mechanism can result in relative axial movement between the intermediate shaft and the outer shaft so as to allow the distal end portion of the outer shaft to cover or expose the prosthetic heart valve (paras. 0079-0083, 0087-0099).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni in view of Khuu et al. (Pub. No.: US 2018/0071488 A1; hereinafter “Khuu”).
Calomeni discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the indicator tab connected to a nut threadably coupled to the distal end portion of the indicator shaft, wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft. Khuu teaches that it is well known in the art that a delivery apparatus for a heart valve comprises a nut (830) threadably coupled to a distal end portion of an indicator shaft (840), wherein rotation of the indicator shaft causes axial movement of the nut relative to the indicator shaft (paras. 0105-0109), for the purpose of securing the components of the delivery apparatus and preventing unwanted axial movement. It would have been obvious to one having ordinary skill in the art to modify the device of Calomeni to comprise a nut, as taught by Khuu, in order to secure the components of the delivery apparatus and prevent unwanted axial movement. Such a modification would be made with a reasonable expectation of success.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni in view of Andreas et al. (Pub. No.: US 2005/0149159 A1; hereinafter “Andreas”).
Calomeni discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the handle housing comprising a plurality of graduation marks adjacent to the slot to indicate a location of the indictor tab between the first and second positions. Andreas teaches that it is well known in the art that a delivery apparatus comprises information graduation marks (paras. 0024, 0063-0065, 0073-0078), for the purpose of allowing the user to more easily acquire information regarding the position of and placement of the delivery device and its components. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Calomeni to comprise markings to indicate the location of the indicator tab, as per the teachings of Andreas, in order to allow the user to more easily acquire information regarding the position of and placement of the delivery device and its components. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774