Prosecution Insights
Last updated: July 17, 2026
Application No. 17/811,737

DEFLECTABLE SHAFTS FOR DELIVERY SYSTEMS

Final Rejection §102§103
Filed
Jul 11, 2022
Priority
Jan 16, 2020 — provisional 62/962,026 +1 more
Examiner
DUDDEN, TERESA MARIE
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
2 (Final)
42%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allowance Rate
10 granted / 24 resolved
-28.3% vs TC avg
Strong +40% interview lift
Without
With
+40.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
24 currently pending
Career history
70
Total Applications
across all art units

Statute-Specific Performance

§103
92.9%
+52.9% vs TC avg
§102
4.4%
-35.6% vs TC avg
§112
1.7%
-38.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 24 resolved cases

Office Action

§102 §103
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 Arguments Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive. Regarding claim 1, Applicant argues due to the optional pull wire lumen (¶ [0129]) the pull tether does not variably move towards the first set of bi-directional cuts or towards the second set of bi-directional cuts. The examiner would like to point out the use of the word “may” makes the language an optional requirement, the cited art does not need to support the limitation. Further, the use of the word “or” indicating the pull tether needs to only move toward one set of the two sets of bi-directional cuts. Even if the optional pull wire lumen is used, the pull tether would move towards the nearest set of bi-directional cuts, as is well known in the art. As the pull tether is retracted, causing the hypotube to deflect, it moves toward (or in the general direction of) the wall of the hypotube. Applicant’s arguments with respect to claim(s) 16-19 and 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claim Status The drawing objection has been overcome. Claims 1-25 are examined below. 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: a deflection mechanism in claim 13 a release mechanism in claims 15 and 23 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. Claim(s) 1-5 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper (US 2019/0008640 A1). Regarding claim 1, Cooper teaches a delivery system for an implant (10, delivery system, fig. 1), the delivery system comprising: an elongate shaft (12, shaft assemble, fig. 1) having a length and having: an implant retention area (16, implant retention area, fig. 2A) for retaining the implant, a hypotube (136, rail hypotube, fig. 6A) extending along the length of the elongate shaft and having a proximal portion (see annotated fig. 13, below) and a distal portion (see annotated fig. 13, below), and including a first set of bi-directional cuts aligned longitudinally along a first side of the hypotube (slots, ¶ [0157]) and a second set of bi-directional cuts aligned longitudinally along a second side of the hypotube that is opposite the first side (slots, ¶ [0157]), and two longitudinally extending spines each positioned on opposite sides of the hypotube between the first set of bi-directional cuts and the second set of bi-directional cuts (backbones, ¶ [0157]), and a pull tether (138, distal pull wires, fig. 6B) extending along the length of the elongate shaft and having a distal portion (see annotated fig. 6B, below) and a proximal portion (see annotated fig. 6B, below) and an intermediate portion (see annotated fig. 6B, below), with the distal portion of the pull tether coupled to a portion of the elongate shaft (¶ [0128]) such that the intermediate portion of the pull tether may variably move towards the first set of bi-directional cuts or towards the second set of bi-directional cuts (fig. 6B, as the pull tether is retracted, causing the hypotube to deflect, it moves toward (or in the general direction of) the wall of the hypotube), and the pull tether configured to be pulled to deflect the hypotube (¶ [0184]). PNG media_image1.png 280 841 media_image1.png Greyscale PNG media_image2.png 306 366 media_image2.png Greyscale Regarding claim 2, Cooper further teaches the distal portion of the pull tether is coupled to the portion of the elongate shaft such that the intermediate portion of the pull tether is aligned with at least one of the two longitudinally extending spines (¶ [0128], fig. 6B). Regarding claim 3, Cooper further teaches the distal portion of the pull tether is coupled to a point on the distal portion of the hypotube that is longitudinally aligned with one of the two longitudinally extending spines (¶ [0128]). Regarding claim 4, Cooper further teaches the point is on a sidewall of the hypotube (¶ [0128]). Regarding claim 5, Cooper further teaches the hypotube is configured to deflect in two directions in a single plane (235, distal slotted hypotube section, fig. 13). The phrase “the hypotube is configured to deflect in two directions in a single plane” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the two sets of bi-directional cuts and two spines of the distal slotted hypotube section is considered to be capable of deflecting in two direction in a single plane. Regarding claim 12, Cooper further teaches the implant retention area is positioned distal of the distal portion of the hypotube (fig. 2B). Regarding claim 13, Cooper further teaches the proximal portion of the pull tether is coupled to a deflection mechanism (206, distal pull wire knob, fig. 17) configured to pull the pull tether to deflect the hypotube (¶ [0206]). Regarding claim 14, Cooper further teaches a handle (14, handle, fig. 1) coupled to a proximal portion of the elongate shaft (11, proximal end, fig. 1). Regarding claim 15, Cooper further teaches a release mechanism (210, outer sheath knob, fig. 17, ¶ [0209]) configured to release the implant from the implant retention area (¶ [0209]). 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooper (US 2019/0008640 A1) in view of Rottenberg (US 2014/0031843 A1). Regarding claim 6, Cooper further teaches the hypotube includes a cut pattern positioned proximal of the first set of bi-directional cuts and the second set of bi-directional cuts (233, proximal slotted hypotube section). Cooper fails to teach a cut pattering providing at least three directions of deflection. However, Rottenberg teaches a hypotube that includes a cut pattern providing at least three directions of deflection (figs. 3-4C, ¶ [0036]-[0037]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Cooper to include a cut pattern providing at least three directions of deflection as taught by Rottenberg in order to provide multi-axis flexibility of the hypotube (¶ [0037], Rottenberg). Regarding claim 7, Cooper fails to teach the cut pattern that provides at least three direction of deflection includes a plurality of longitudinally staggered cuts. However, Rottenberg further teaches a plurality of longitudinally staggered cuts (fig. 3). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Cooper to include a plurality of longitudinally staggered cuts in the cut pattern that provides at least three direction of deflection as taught by Rottenberg in order to provide multi-axis flexibility of the hypotube (¶ [0037], Rottenberg). Regarding claim 8, Cooper fails to teach equal flexibility of the hypotube. However, Rottenberg further teaches the cut pattern that provides at least three directions of deflection (fig. 3) is configured to provide equal flexibility of the hypotube in all radial planes of deflection. The phrase “the cut pattern that provides at least three directions of deflection is configured to provide equal flexibility of the hypotube in all radial planes of deflection” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the cut pattern of the hypotube in fig. 3 is considered to be capable of providing equal flexibility of the hypotube in all radial planes of deflection. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Cooper to include equal flexibility of the hypotube as taught by Rottenberg in order to provide multi-axis flexibility of the hypotube (¶ [0037], Rottenberg). Regarding claim 9, Cooper fails to teach the cut pattern that provides at least three directions of deflection is configured to transmit torque about a longitudinal axis of the hypotube. However, Rottenberg further teaches the cut pattern that provides at least three directions of deflection (fig. 3) is configured to transmit torque about a longitudinal axis of the hypotube. The phrase “the cut pattern that provides at least three directions of deflection is configured to transmit torque about a longitudinal axis of the hypotube ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the cut pattern of the hypotube in fig. 3 is considered to be capable of transmitting torque about a longitudinal axis of the hypotube. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Cooper to include the cut pattern that provides at least three directions of deflection is configured to transmit torque about a longitudinal axis of the hypotube as taught by Rottenberg in order to provide multi-axis flexibility of the hypotube (¶ [0037], Rottenberg). Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooper (US 2019/0008640 A1). Regarding claim 10, a first embodiment of Cooper fails to teach varied cut thicknesses. However, a second embodiment of Cooper teaches the first set of bi-directional cuts and the second set of bi-directional cuts are each configured to have varied cut thicknesses (¶ [0152]-[0153] teaches having curved slots and slots of differing thicknesses). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of a first embodiment of Cooper to include varied cut thicknesses as taught by a second embodiment of Cooper since it is a simple substitution of one known element for another to obtain predictable results. Regarding claim 11, a first embodiment of Cooper fails to teach the first set of bi-directional cuts and the second set of bi-directional cuts are each configured to have cuts curved such that an entire interior area of the cuts contacts simultaneously. However, a second embodiment of Cooper teaches the first set of bi-directional cuts and the second set of bi-directional cuts are each configured to have cuts curved such that an entire interior area of the cuts contacts simultaneously. ¶ [0152]-[0153] of Cooper teaches having curved slots. ¶ [0078] of the instant application states the interior area of this rounded oval shape would contact simultaneously. Further, the phrase “the first set of bi-directional cuts and the second set of bi-directional cuts are each configured to have cuts curved such that an entire interior area of the cuts contacts simultaneously” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the curved slots of slot pair 222 in fig. 12A is considered to be capable of the entire interior area of the cuts contacting simultaneously. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of a first embodiment of Cooper to include curved cuts such that an entire interior area of the cuts contacts simultaneously as taught by a second embodiment of Cooper since it is a simple substitution of one known element for another to obtain predictable results. Claim(s) 16-19 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 2012/0277730 A1) in view of Corcoran (US 2006/0241564 A1). Regarding claim 16, Salahieh teaches a delivery system for an implant (600, steerable delivery system, fig. 28), the delivery system comprising: an elongate shaft having a length (see annotated fig. 28, below) and having: an implant retention area for retaining the implant (260, medical device, fig. 14, it is inherent an implant delivery device would have an implant retention area to hold the implant until surgeons are ready to deploy the device), a first hypotube (36, inner tubular element, fig. 2A) extending along the length of the elongate shaft and including a proximal end (35, proximal portion, fig. 2a) and a distal end (37, distal end, fig. 2a), and a plurality of cuts configured to allow the first hypotube to deflect in a first direction (512, interrupted slots, fig. 2c), a second hypotube (34, outer tubular element, fig. 2a) including a distal portion (37, distal end, fig. 2a) and a proximal portion (35, proximal portion, fig. 2a), the distal portion extending over the first hypotube (fig. 2a) and including a plurality of cuts configured to allow the second hypotube to deflect in a second direction that is opposite the first direction (510, interrupted slots, fig. 2c, ¶ [0070]), and the proximal portion including a plurality of cuts (60, overlapping slots, fig. 3, ¶ [0089]) configured to allow the proximal portion (35, proximal portion, fig. 2a) to deflect in both the first direction and the second direction. The phrase “the proximal portion . . . configured to allow the proximal portion to deflect in both the first direction and the second direction ” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the proximal portion is considered to be capable of deflecting in both the first and second directions. PNG media_image3.png 596 522 media_image3.png Greyscale Salahieh fails to teach the proximal portion being positioned proximal of the proximal end of the first hypotube. However, Corcoran teaches a steerable catheter assembly that includes the proximal portion of the outer tube being positioned proximally of the proximal end of the inner tube (fig. 6). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the orientations of the first and second hypotubes of Salahieh to include the proximal portion being positioned proximal of the proximal end of the first hypotube as taught by Corcoran since it is obvious to try, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). There are a finite number of options, either the proximal portion is positioned proximally or distally of the proximal end of the first hypotube. Regarding claim 17, Salahieh further teaches the first hypotube is configured to impede the distal portion of the second hypotube from deflecting in the first direction. The first and second hypotubes have the same configuration described in the instant application ¶ [0071] thus would function as intended. Further, the phrase “the first hypotube is configured to impede the distal portion of the second hypotube from deflecting in the first direction” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the inner tubular element is considered to be capable of impeding the distal portion of the second hypotube from deflecting in the first direction. Regarding claim 18, Salahieh further teaches the first hypotube is coupled to a pull tether (604, actuator, fig. 28) configured to be pulled proximally to deflect the second hypotube (¶ [0121]). Regarding claim 19, Salahieh further teaches the distal end of the first hypotube is coupled to a distal end of the second hypotube (38, fixation location, fig. 2a, ¶ [0069]). Regarding claim 24, the first embodiment of Salahieh fails to teach a plurality of teeth configured to fit into recesses. However, a second embodiment of Salahieh teaches a plurality of teeth configured to fit into recesses (300, 302, interlocking elements, fig. 15). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of the first embodiment of Salahieh to include a plurality of teeth as taught by a second embodiment of Salahieh in order to allow for axial compression of the hypotube and prevent movement along a first axis (¶ [0108], Salahieh). Regarding claim 25, Salahieh further teaches the first hypotube includes a single spine (506, spine, fig. 2c) positioned between the plurality of cuts of the first hypotube, and the distal portion of the second hypotube includes a single spine (508, spine, fig. 2c) positioned between the plurality of cuts of the second hypotube at a position that is 180 degrees from the single spine of the first hypotube (¶ [0070]). Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Corcoran and Cooper (US 2019/0008640 A1). Regarding claim 20, Salahieh and Corcoran fail to teach twos sets of bi-directional cuts on opposing sides and two spines. However, Cooper teaches a steerable rail delivery system that includes the plurality of cuts of the proximal portion of the second hypotube include a first set of bi-directional cuts aligned longitudinally along a first side of the second hypotube (213, slot pairs, fig. 11, ¶ [0151]) and a second set of bi-directional cuts aligned longitudinally along a second side of the second hypotube that is opposite the first side (213, slot pairs, fig. 11, ¶ [0151]), and two longitudinally extending spines are each positioned on opposite sides of the second hypotube between the first set of bi-directional cuts and the second set of bi-directional cuts (215, backbones, fig. 11, ¶ [0151]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Salahieh and Corcoran to include teaching of Cooper since it is a simple substitution of one known element for another to obtain predictable results. Regarding claim 21, Salahieh further teaches the plurality of cuts of the proximal portion of the second hypotube are positioned distal a portion of the elongate shaft (see annotated fig. 28, below) that has a greater stiffness than the proximal portion of the second hypotube (it is stiffer due to the lack of cuts). PNG media_image4.png 596 522 media_image4.png Greyscale Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh in view of Corcoran and Cooper as applied to claim 21 above, and further in view of Liu (US 2012/0239142 A1). Regarding claim 22, Salahieh, Corcoran and Cooper fail to teach a torque shaft configured to move a sheath. However, Liu teaches implant delivery device that includes a torque shaft (108, torque shaft catheter, fig. 18) configured to move a sheath (106, sheath, fig. 20) for covering the implant retention area (¶ [0110]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Salahieh, Corcoran and Cooper to include a torque shaft as taught by Liu in order to move the sheath relative to the prosthetic valve in a precise and controlled manner (¶ [0117], Liu). Regarding claim 23, Salahieh, Corcoran and Cooper fail to teach a release mechanism configured to rotate the torque shaft. However, Liu further teaches a release mechanism configured to rotate the torque shaft (¶ [0110]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Salahieh, Corcoran and Cooper to include a release mechanism configured to rotate the torque shaft as taught by Liu in order to move the sheath relative to the prosthetic valve in a precise and controlled manner (¶ [0117], Liu). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /T.M.D./Examiner, Art Unit 3774 /THOMAS C BARRETT/SPE, Art Unit 3799
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Prosecution Timeline

Jul 11, 2022
Application Filed
Oct 24, 2025
Non-Final Rejection mailed — §102, §103
Jan 26, 2026
Response Filed
May 05, 2026
Final Rejection (signed) — §102, §103
Jun 11, 2026
Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
42%
Grant Probability
82%
With Interview (+40.0%)
3y 10m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 24 resolved cases by this examiner. Grant probability derived from career allowance rate.

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