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 .
Response to Amendment
The amendment filed 07/30/2025 has been entered. Claims 1-8, 18-20, and 30-38 remain pending in the application, and claims 9-17 and 21-29 are canceled. Applicant’s amendments to the claims have overcome the 112(b) rejections, however has not overcome the interpretation of the prior art rejection as previously set forth in the Non-Final Office Action mailed 04/30/2025.
Response to Arguments
Applicant's arguments filed 07/30/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 6-8 with respect to claims 1 and 18 that Johnson does not disclose the “proximal enclosure configured to enclose a proximal portion of a valve frame” and that the “proximal enclosure enclose[s] a proximal portion of a valve frame in a collapsed configuration during delivery.” The Office respectfully disagrees. It can be seen in figures 6-8 that that valve frame 30 is enclosed by the sheath 114, the proximal enclosure 132, and the distal enclosure 118. Figure 2 further shows a plurality of slots 238 on the proximal enclosure 132 that is disclosed in paragraph 74 to receive longitudinally-extending struts 72 of the valve frame 30. Any portion that is proximal of the distal end of the frame 30 is interpreted as the proximal portion of the frame 30.Thus, it can be interpretated that the proximal enclosure 132 is capable of enclosing a proximal portion of a valve frame due to the plurality of slots receiving portions of the valve frame 30. Therefore, the rejection is maintained.
The Office would like to make a note that claim 18 is written mostly functional apart from the core member, control unit comprising a control handle, an anchor expansion actuator coupled to the control handle, and a valve frame release actuator coupled to the control handle. Everything recited after “for” is functional, and therefore it can be interpreted that the anchor, the frame, the sheath, and the distal carrier assembly (comprising the proximal enclosure and distal enclosure recited in claim 19) is not a positively recited element of the system, not needing to be presently required. The control unit, anchor expansion actuator, and valve frame release actuator only need to be capable of performing the claimed function, and will be examined as such.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “control unit” in claims 1 and 18, “first control element” in claim 1, “second control element” in claim 1, “sheath control element” in claim 8, and “position control element” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4, 8, and 32-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (US PGPub 2017/0056169), hereinafter known as “Johnson.”
With regards to claim 1, Johnson discloses (Figures 1-21) a valve delivery device 100 (paragraph 60) comprising:
a distal carrier assembly (combination of 118/132) having a proximal enclosure 132 configured to enclose a proximal portion of a valve frame 72 of a valve prosthesis 30 (figures 5-8; paragraph 64; proximal enclosure 132, distal enclosure 118, and sheath 114 encloses the valve prosthesis 30; figure 2, paragraph 74 – slots 238 of proximal enclosure 132 receiving portions of the valve frame 30) in a collapsed configuration during delivery (figure 6; paragraph 75), the proximal enclosure 132 comprising a proximal tapered surface (where the 132 indicator line points to in figures 2-3; paragraph 73);
a sheath 114 configured to support a valve anchor 80/82 of the valve prosthesis 30 in the collapsed configuration during delivery (figure 6; paragraph 63), the sheath 114 being movable relative to the distal carrier assembly 118/132 to release the valve anchor 80/82 such that when the valve anchor 80/82 is released from the valve delivery device 100, the distal carrier assembly 118/132 can be moved to release the valve frame 72 (figures 6-11; paragraphs 82-88), and the sheath 114 being longitudinally slidable over the proximal tapered surface to axially align the sheath 114 with the proximal enclosure 132 (figures 2-3 and 6; paragraph 88); and
a control unit 110 (paragraphs 61-62; see Note below) operatively coupled to the distal carrier assembly 118/132 and the sheath 110 for actuation motion thereof, the control unit 110 comprising:
a first control element 501 (see Note below) configured to move the sheath 114 relative to the distal carrier assembly 118/132 for permitting the valve anchor to expand and for moving the sheath 114 over the proximal tapered surface of the proximal enclosure 132 to an axially aligned configuration after release of the valve anchor (paragraphs 88 and 91); and
a second control element 506 (see Note below) configured to actuate the proximal enclosure 132 and a distal enclosure 118 of the distal carrier assembly 118/132 for permitting expansion of the valve frame (paragraphs 75 and 97), wherein the distal enclosure 118 is distal to the proximal enclosure 132 and configured to enclose a distal portion of the valve frame 72 (figures 2-3 and 6-11; proximal enclosure 132, distal enclosure 118, and sheath 114 encloses the valve prosthesis 30).
Note – 112(f) interpretation – Applicant’s control unit is a handle actuator 500 that controls the operation of the delivery device 200 (Spec. [0044]); Johnson’s control unit 110 is similarly a handle that controls the operation of the device (figures 1 and 12-15; paragraphs 61-62); therefore both control units are equivalent in controlling the operation of the device.
Note – 112(f) interpretation – Applicant’s first control element 520 is a knob or button configured to move the sheath (Spec. [0044-0045]; claim 1); Johnson’s first control element 501 is a knob used to move the sheath 114 relative to the distal carrier assembly 118/132 (paragraphs 88 and 91); therefore both first control elements are equivalent in controlling the sheath.
Note – 112(f) interpretation – Applicant’s second control element 522 is a knob or button that actuates the distal carrier assembly (Spec. [0044-0045]; claim 1); Johnson’s second control element 506 is a knob actuating the distal carrier assembly 118/132 for permitting expansion of the valve frame 72 (paragraphs 75 and 97); therefore both second control elements are equivalent in in actuating the distal carrier assembly for permitting expansion of the valve frame.
With regards to claim 4, Johnson discloses wherein the distal enclosure 118 is movable relative to the proximal enclosure 132 and configured to enclose the distal portion of the valve frame 70 during delivery and release from the distal carrier assembly 118/132 (paragraph 75; figures 6-8 - proximal enclosure 132, distal enclosure 118, and sheath 114 encloses the valve prosthesis 30).
With regards to claim 8, Johnson discloses further comprising a sheath control element 502 configured to enable a surgeon to permit expansion of the valve anchor (paragraphs 92-96 – rotation of knob controllably expands the implant 30) and a position control element 512 configured to enable the surgeon to control a longitudinal position of the valve anchor during placement of the valve anchor in a patient (paragraphs 98-100 – “sleigh 512 is configured to move proximally within the housing 500 and distally back into the housing 500. Thus, by pulling the sleigh 512 proximally relative to the housing 500 to a proximal position shown in FIG. 16, the inner retention shaft 124, locking shaft 122, and nose cone shaft 130, and thus the nose cone 118 and inner retention member 132, can be pulled proximally in one motion” – implant 30 is constrained within the distal carrier assembly 118/132 and therefore also moves proximally/distally in coordination with the sleigh 512).
112(f) interpretation – Applicant’s sheath control element 522 is a knob or button that permits expansion of the valve anchor [spec. 0044-0045]; Johnson sheath control element 502 is a knob that controls expansion of the implant 30 (paragraphs 92-96); therefore both sheath control elements are equivalent in being knobs and permitting expansion of the valve anchor.
112(f) interpretation - Applicant’s position control element 520 is a knob or button that controls a rotational or longitudinal position of the valve anchor [spec. 0044-0045]; Johnson’s position control element 512 is a sleigh that slides proximally and distally to control movement of the device (paragraphs 98-100); therefore both position control elements are equivalent in controlling a longitudinal position of the valve anchor.
With regards to claim 32, Johnson discloses wherein the proximal enclosure 132 of the distal carrier assembly 118/132 is separable relative to the distal enclosure 118 of the distal carrier assembly (paragraphs 75-76 and 88 – proximal/distal movement of either the proximal enclosure 132 or the distal enclosure 118 relative to each other).
With regards to claim 33, Johnson discloses wherein the proximal enclosure 132 further comprises an abutment surface at a distal end portion of the proximal tapered surface, the abutment surface having a radius equal to a radius of the sheath 114 (paragraph 88; see annotated figure 3 below; figure 6 displays the sheath 114 in contact with the abutment surface to ensure full closure, thus resulting in equal radii of the abutment surface and the sheath 114).
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With regards to claim 34, Johnson discloses wherein the abutment surface is configured to align an outer surface of the proximal enclosure 132 with an outer surface of the sheath 114 (see annotated figure 3 above and figure 6; paragraph 88).
With regards to claim 35, Johnson discloses wherein the proximal enclosure 132 comprises circumferential nodes (circumferential ridges that extend between the slots 238; figures 2-4) that taper from the abutment surface in the proximal direction, and the circumferential nodes are configured to guide the sheath 114 towards the abutment surface as the sheath 114 longitudinally slides over the proximal tapered surface (paragraph 88; see annotated figure 3 above and figure 6 for alignment of the sheath 114 and the abutment surface).
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 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 2-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Zhang (US PGPub 2016/0015512), hereinafter known as “Zhang 512.”
With regards to claims 2-3 and 5, Johnson discloses the valve delivery device as claimed in claim 1. Johnson is silent wherein a link mechanism is slidable along the valve anchor, the valve anchor comprising an engagement area whereat the link mechanism can be engaged and constrained from further sliding movement (claim 2); wherein the link mechanism comprises a suture that is slidably coupled to the valve anchor and fixedly coupled to the valve frame (claim 3); and wherein the link mechanism is coupled to the valve frame at a substantially fixed position when the valve frame is engaged by the distal carrier assembly, prior to release of the valve frame therefrom (claim 5).
However, in a similar field of endeavor of heart valve prosthesis delivery, Zhang 512 teaches (Figures 1-7) wherein a link mechanism 60 (suture loop, paragraphs 72, 82, and 91) is slidable along the valve anchor (paragraph 72 and 91), the valve anchor 140/150 (alternatively 10 in figure 1 to show the link mechanism 60) comprising an engagement area (figure 1; paragraph 72 – “engagement position” - lumen 50 within leg member 30) whereat the link mechanism 60 can be engaged and constrained from further sliding movement (suture 60 can only slide within the lumen 50 of the leg member 30);
wherein the link mechanism 60 comprises a suture 60 that is slidably coupled to the valve anchor 140/150 (alternatively 10 in figure 1 to show the suture 60) and fixedly coupled to the valve frame 170 (alternatively 15 in figure 1) (paragraphs 43, 70, 72, 82, and 91); and
wherein the link mechanism 60 is coupled to the valve frame 170 at a substantially fixed position (paragraphs 43, 70, and 72 – “suture loop is fixed to the support frame and movably attached to the leg member”) when the valve frame 170 is engaged by the distal carrier assembly 110, prior to release of the valve frame 170 therefrom (figure 1 shows the link mechanism 60 attached to the valve frame 10, paragraph 91 discloses the attachment of the valve frame to the link mechanism prior to movements of the first 110 and second 120 sheaths to deploy the valve prosthesis).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the implant of Johnson for the heart valve prosthesis of Zhang 512. The difference between the prior art and the claimed invention is that Johnson does not teach a link mechanism. Zhang 512 teaches (see Figs. 1-7) a similar heart valve prosthesis comprising a link mechanism. Accordingly, the prior art references teach that it is known that the heart valve prosthesis of Johnson and the heart valve prosthesis of Zhang 512 are elements that are functional equivalents for providing pumping of blood of the heart. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the heart valve prosthesis taught by Zhang 512 for the heart valve prosthesis of Johnson because both elements were known equivalents for providing and would have resulted in the predictable results of providing pumping of blood to the heart.
Claims 6-7 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Macoviak et al. (US PGPub 2009/0043381), hereinafter known as “Macoviak.”
With regards to claims 6-7, Johnson discloses the device as claimed in claim 1. Johnson is silent wherein the device comprises a system length of less than 4 feet as recited in claim 6, or less than 3 feet as recited in claim 7.
However, in a similar field of endeavor of heart valve prosthesis delivery, Macoviak teaches wherein the device comprises a system length of less than 3 feet (paragraph 12 – “These devices, systems and methods may be applied by any established beating heart or open heart direct surgical approach using relatively short catheters or tools, e.g., less than approximately 80 cm in length, or with standard surgical tools” – 80 cm equals 2.62 feet, which is less than 3 feet).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system length of Johnson to be less than 3 feet as taught by Macoviak for the purpose of enabling improved control of the device.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Zhang (US 2010/0249916), hereinafter known as “Zhang 916.”
With regards to claim 30, Johnson discloses the delivery device as claimed in claim 1. Johnson is silent wherein the first control element slides to move the sheath relative to the distal carrier assembly.
Zhang 916 teaches in an alternative embodiment wherein the control unit may comprise one or more dial portions wherein individual movable components of the implantation device (e.g., first sheath, second sheath, track wires, locking wires, pusher wires) may be moved proximally or distally by rotating a dial; and it is understood that a single implantation device control unit may comprise both rotational control elements such as the threaded sections, and control elements such as switches and handles that are moved along the longitudinal axis (paragraph 267).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first control element of Johnson to include wherein the first control element is also slidable as taught by Zhang 916 for the purpose of increased efficiency by applying a single implantation device control unit to comprise of both rotational and slidable control elements (paragraph 267 of Zhang 916).
With regards to claim 31, Johnson further discloses wherein the first control element 501 rotates in a first direction to release a plurality of graspers from the valve anchor to permit disengagement of the anchor (paragraphs 83-84, 88 and 91 – functional limitation – knob 501 is rotatable to translate the sheath 114, therefore once the implant 30 is uncovered, a plurality of grasper members can disengage from the anchor).
Claims 18-19 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Zhang 916.
With regards to claim 18, Johnson discloses (Figures 1-21) a heart valve prosthesis delivery device control system 100 (paragraph 60) comprising:
a core member 130 (paragraph 68; figure 3);
a control unit 110 (see Note below) comprising a control handle (any area that a user can grab on the control unit 110 is a control handle) configured to permit step-wise release of an anchor and a frame of a valve prosthesis 30 (paragraphs 61 and 90-100 – functional limitation – control unit is capable of permitting set-wise release of an anchor and a frame of a valve prosthesis due to the features on the control unit 110);
an anchor expansion actuator 501 coupled to the control handle for (i) longitudinally sliding a sheath 114 over a proximal tapered surface (where the 132 indicator line points to in figures 2-3; paragraph 73) of a proximal enclosure 132 of a distal carrier assembly 118/132 to axially align the sheath 114 with the proximal enclosure 132 (paragraphs 88 and 91), the proximal enclosure 132 enclosing a proximal portion of the frame 30 in a collapsed configuration (figure 6) during delivery (figure 6 - proximal enclosure 132, distal enclosure 118, and sheath 114 encloses the valve prosthesis; it is interpreted that any portion proximal to the distal end of the frame 30 is interpreted as the proximal portion of the frame 30) and (ii) moving the sheath 114 relative to the anchor to expose the anchor and permit expansion of the anchor relative to the sheath 114 and being rotatable relative to the control handle for disengaging a plurality of grasper members from the anchor to permit disengagement of the anchor from the control system 100 (paragraphs 83-84, 88 and 91 – functional limitation – knob 501 is capable of performing the claimed functions due to the knob 501 being rotatable to translate the sheath 114, therefore once the implant 30 is uncovered, a plurality of grasper members can disengage from the anchor); and
a valve frame release actuator 502 coupled to the control handle for permitting expansion of the frame from the distal carrier assembly 118/132 coupled to the core member 130 (paragraphs 92-96 – functional limitation – valve frame release actuator 502 is capable of permitting expansion of the frame from the distal carrier assembly due to rotation of the knob 502); and
Note – 112(f) interpretation – Applicant’s control unit is a handle actuator 500 that controls the operation of the delivery device 200 (Spec. [0044]); Johnson’s control unit 110 is similarly a handle that controls the operation of the device (figures 1 and 12-15; paragraphs 61-62); therefore both control units are equivalent in controlling the operation of the device.
Johnson is silent wherein the anchor expansion actuator is slidable relative to the control handle.
However, Zhang 916 teaches in an alternative embodiment wherein the control unit may comprise one or more dial portions wherein individual movable components of the implantation device (e.g., first sheath, second sheath, track wires, locking wires, pusher wires) may be moved proximally or distally by rotating a dial; and it is understood that a single implantation device control unit may comprise both rotational control elements such as the threaded sections, and control elements such as switches and handles that are moved along the longitudinal axis (paragraph 267).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchor expansion actuator of Johnson to include wherein the anchor expansion actuator is also slidable relative to the control handle as taught by Zhang 916 for the purpose of increased efficiency by applying a single implantation device control unit to comprise of both rotational and slidable control elements (paragraph 267 of Zhang 916).
With regards to claim 19, Johnson further discloses wherein the distal carrier assembly 118/132 further comprises a distal enclosure 118 that is movable relative to the proximal enclosure 132 and configured to enclose a distal portion of the valve frame 30 during delivery and release from the distal carrier assembly 118/132 (paragraph 75; figures 6-8 - proximal enclosure 132, distal enclosure 118, and sheath 114 encloses the valve prosthesis).
With regards to claim 36, Johnson further discloses wherein the proximal tapered surface comprises circumferential nodes (circumferential ridges that extend between the slots 238; figures 2-4) configured to contact an inner surface of the sheath 114 as the sheath 114 longitudinally slides over the proximal tapered surface (paragraph 88; see annotated figure 3 below; figure 6 displays the sheath 114 in contact with the abutment surface to ensure full closure).
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With regards to claim 37, Johnson further discloses wherein the proximal tapered surface further comprises circumferential cavities 238 between the circumferential nodes (figures 2-4; paragraph 74).
With regards to claim 38, Johnson further discloses wherein an outer surface of the proximal enclosure 132 is aligned with an outer surface of the sheath 114 when the sheath 114 is axially aligned with the proximal enclosure 132 (paragraph 88; see annotated figure 3 above; figure 6 displays the sheath 114 in contact with the abutment surface to ensure full closure).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Zhang 916, and further in view of Macoviak.
With regards to claim 20, Johnson/Zhang 916 disclose the control system as claimed in claim 18. Johnson/Zhang 916 are silent wherein the control system comprises a system length of less than 3 feet.
However, in a similar field of endeavor of heart valve prosthesis delivery, Macoviak teaches wherein the control system comprises a system length of less than 3 feet (paragraph 12 – “These devices, systems and methods may be applied by any established beating heart or open heart direct surgical approach using relatively short catheters or tools, e.g., less than approximately 80 cm in length, or with standard surgical tools” – 80 cm equals 2.62 feet, which is less than 3 feet).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system length of Johnson/Zhang 916 to be less than 3 feet as taught by Macoviak for the purpose of enabling improved control of the device.
Conclusion
THIS ACTION IS MADE FINAL. 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 10/27/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771