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 .
Status of Claims
This office action is responsive to the amendment filed on 07/01/2026. As directed by the amendment: claims 1, 6 and 8 have been amended, no claims have been cancelled and new claims 10-17 have been added. Thus, claims 1-17 are presently pending in this application, and currently examined in the Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5 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.
Regarding claim 2, which recites the limitation “a raised rim”, on lines 1-2; this limitation is found to be confusing since it is not clear if this “raised rim” is the same structure as “a rim of the hub”, as first disclosed on line 13 of claim 1 (from which claim 2 depends), or if it is another separate, and distinct structure. If it is a different/separate and distinct structure, then it is further found to be confusing/unclear how exactly the hub has two rim structures, and/or how they would relate to the rim and the final structure of the delivery system; and the originally filed disclosure being completely silent regarding such structure, i.e. the hub having two separate and distinct rim structures. However, if they are the same structure, then it is suggested the above-mentioned limitation be amended to state “the rim”, in order to avoid confusion and keep claim terminology consistent.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berra et al. (US Patent No. 9,364,314), as previously disclosed, hereinafter Berra.
Regarding claims 1 and 11, Berra discloses an aortic prosthesis delivery system (5500), illustrated in Figures 55A and 56, comprising a distal handle (5530) having a proximal end and a distal end defining a longitudinal axis; a straight track (5540/5542) extending proximally from the distal handle (5530) and along the longitudinal axis; a hub (5510) at the straight track and slidable along the straight track (5540); an introducer sheath (5550) fixed to and extending distally from the hub (5510), whereby the introducer sheath (5550) extends distally from the distal handle (5530); a proximal handle (5520) proximal to the distal handle (5530) and longitudinally slidable along the straight track (5540), wherein the proximal handle (5520) defines, by an inside surface thereof, a helical track/interior thread that has a longitudinal travel length along the longitudinal axis, the proximal handle (5520) being rotatable about the longitudinal axis, and wherein the hub (5510) and the proximal handle (5520) are mated, whereby a raised rim (5512) of the hub (5510) is disposed within an interior space, i.e. the helical track/interior thread, of the proximal handle (5520) and rotation of the proximal handle (5520) about the hub (5510) causes longitudinal travel of the hub along a length of the longitudinal axis and the straight track (5540) relative to the proximal handle while the proximal handle (5520) remains fixed relative to the distal handle (5530), the length of travel of the hub being limited by the travel length of the helical track of the hub, the hub (5510) and the introducer sheath (5550) being proximally movable along the straight track (5540) by at least one of direct longitudinal force on the proximal handle (5520) and rotation of the proximal handle (5520) about the longitudinal axis, illustrated in Figures 55A-56 and 61 (Column 11, Line 62 – Column 12, Line 15 & Column 21, Line 65 – Column 22, Line 30 – to clarify, rim 5512, of hub 5510, is disposed within the interior space of proximal handle 5520 at/when the rim 5512 and helical track/interior thread, of proximal handle 5520, are engaged to longitudinally move hub 5510).
Regarding claim 2, Berra discloses the aortic prosthesis delivery system of claim 1, wherein the raised rim (5512) of the hub (5510) follows the helical track/interior thread of the proximal handle (5520) as the proximal handle is rotated about the longitudinal axis to thereby cause proximal movement of the hub (5510) and introducer sheath (5550), illustrated in Figures 55A, 56 and 61 (Column 22, Lines 6-29).
Regarding claim 3, Berra discloses the aortic prosthesis delivery system of claim 2, wherein the rim (5512) of the hub (5510) extends radially outward from the hub and from the longitudinal axis, and wherein the helical track/interior thread defines at least a portion of an interior space of the proximal handle (5520), illustrated in Figures 55A and 56 (Column 22, Lines 7-11).
Regarding claim 4, Berra discloses the aortic prosthesis delivery system of claim 3, wherein the hub (5510) is confined to the interior space of the proximal handle (5520), illustrated in Figures 55A and 56 (to clarify, the above-mentioned figures illustrate a portion of hub 5510 confined to the interior space of proximal handle 5520).
Regarding claim 5, Berra discloses the aortic prosthesis delivery system of claim 4, further including a guidewire catheter (5740/5742/5744) extending through the hub (5510), the distal handle (5530), the proximal handle (5520), and the introducer sheath (5550), illustrated in Figures 56 and 57A (Column 12, Lines 16-23, 29-35 & 64-65).
Regarding claims 6, 7 and 15, Berra discloses a method for treating an aortic aneurysm comprising the steps of delivering an aortic prosthesis that is radially constrained within a distal end of an introducer sheath through an artery to an aortic aneurysm of a patient, whereby a distal end of the introducer sheath is proximal to the aneurysm; rotating a proximal handle (5520) proximal to and abutting a distal handle (5530), and that is mated to a hub (5510) at a helical track/interior thread defined by an interior surface of the proximal handle (5520), the hub (5510) being fixed to a proximal end of the introducer sheath (5550) and wherein a rim (5512) of the hub (5510) is disposed within an interior space/inside surface, i.e. the helical track/interior thread, of the proximal handle (5520), such that rotating the proximal handle (5520) includes engaging the helical track/interior thread defined by the interior space/inside surface of the proximal handle (5520), thereby causing the hub (5510) to travel proximately along a straight track (5540) extending within the proximal handle (5520), whereby the introducer sheath (5550) is at least partially retracted from the aortic prosthesis at the aortic aneurysm, thereby causing the prosthesis to be at least partially released from radial constraint by the introducer sheath (5550), and further including the step of applying proximal longitudinal force to the proximal handle (5520), thereby causing the hub (5510) to slide proximally along the straight track (5540) and the introducer sheath (5550) to further retract from the stent graft, illustrated in Figures 55A-56 and 61 (Column 5, Line 65 – Column 6, Line 8; Column 11, Line 62 – Column 12, Line 15 & Column 21, Line 65 – Column 22, Line 52 - to clarify, rim 5512, of hub 5510, is disposed within the interior space of proximal handle 5520 at/when the rim 5512 and helical track/interior thread, of proximal handle 5520, are engaged to longitudinally move hub 5510).
Regarding claims 8 and 9, Berra discloses the method of claims 7, wherein the aortic prosthesis defines a fenestration (open end of contralateral leg) and further including the step of rotationally orienting the aortic prosthesis to align the fenestration with an arterial branch, and wherein the step of applying proximal longitudinal force to the proximal handle is conducted after aligning the fenestration of the aortic prosthesis with the arterial branch (Column 19, Lines 23-47).
Regarding claim 10, Berra discloses the system of claim 1, wherein the hub (5510) and the introducer sheath (5550) are proximally movable along the straight track (5540) by direct longitudinal force without rotation on the proximal handle (Column 22, Lines 15-30).
Regarding claim 12, Berra discloses the system of claim 1, wherein the length of longitudinal travel of the hub (5510) along the longitudinal axis is further limited by a length of the straight track (5540), illustrated in Figures 55A and 56 (Column 11, Line 62 – Column 12, Line 15).
Regarding claim 13, Berra discloses the system of claim 1, wherein the introducer sheath (5550) is configured to be partially retracted by rotation of the proximal handle (5520) while the proximal handle abuts the distal handle (5530), and further retracted by proximal movement of the proximal handle (5520) along the straight track (5540), illustrated in Figures 55A-56 (Column 21, Line 65 – Column 22, Line 30).
Regarding claim 14, Berra discloses the method of claim 6, further including the step of moving the hub (5510) and the introducer sheath (5550) proximally along the straight track (5540) by applying direct longitudinal force without rotating the proximal handle (Column 22, Lines 15-30).
Regarding claim 16, Berra discloses the method of claim 6, further including the step of limiting the longitudinal travel of the hub (5510) along the longitudinal axis by a length of the straight track (5540), illustrated in Figures 55A and 56 (Column 11, Line 62 – Column 12, Line 15).
Regarding claim 17, Berra discloses the method of claim 6, further including the steps of partially retracting the introducer sheath (5550) by rotating the proximal handle (5520) while the proximal handle abuts the distal handle (5530), and further retracting the introducer sheath (5550) by pulling the proximal handle (5520) proximally along the straight track (5540), illustrated in Figures 55A-56 (Column 21, Line 65 – Column 22, Line 30).
Response to Arguments
Applicant's arguments filed 07/01/2026 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 1, and those claims that depend from it, as being unpatentable over the prior art of Berra, stating Berra does not teach the newly added parameter of “a rim of the hub is disposed within an interior space of the proximal handle”. Examiner respectfully disagrees with Applicant’s assertion. As explained in the rejection section above, the rim/raised rim (5512), of the hub (5510), is disposed within the interior space of the proximal handle (5520) at/when the rim (5512) and the helical track/interior thread, of the proximal handle (5520), engage to longitudinally move the hub (5510). To clarify, the rim/raised rim (5512), which is used to move the hub (5510), engages the helical track/interior thread, which is located on the inner surface/space of the proximal handle (5520); thereby, the rim/raised rim (5512), of the hub (5510), is disposed within an interior space of the proximal handle (5520), as currently set forth in independent claim 1. Therefore, the rejection of independent claim 1, and those claims that depend from it, as being unpatentable over the prior art of Berra, is deemed to be proper, since all the structural limitations set forth in the claim are taught by Berra; hence, the rejection(s) stand(s).
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774
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