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 with traverse of invention I (claims 1-18) in the reply filed on 03/31/26 is acknowledged. The traversal is on the ground(s) that the attorney does not believe the differences pointed out by the Examiner amount to a serious burden. While the restriction requirement was proper, in the interest of compact prosecution the Examiner has reconsidered and is withdrawing the restriction requirement of record.
Claim Objections
Claims 1, 3-4, 6-7, 10-11, 13, 15-16, 18 are objected to because of the following informalities:
Claims 1 and 11 are objected to for referring to “an elongate vessel wall engaging graft portion” but it is understood that there are missing hyphens and/or commas in this phrase.
Further, the claim is objected to for referring to “circumferentially spaced apart elongate recesses” for also appearing to be missing at least one hyphen.
Further, the claim is objected to for referring to “a corresponding elongate recess” when it is unclear how, if at all, this relates to the previously claimed “spaced apart elongate recesses”.
Claims 3 and 13 are objected to for referring to “a group of terminal portions” when it is unclear how, if at all, this relates to the previously claimed “terminal portions” of claim 1.
Claim 4 is objected to for referring to the tip comprising three “recesses”, when it is unclear how, if at all, this relates to the previously claimed “plurality of recesses”.
Further, the claim is unclear for referring to “the three elongate recesses” when it is unclear which of the plurality of recesses (if at all) these three recesses are relating to.
Further, the claim is unclear for claiming “a group of terminal portions” when it is unclear how, if at all, this relates to the previously claimed terminal portions.
Claims 6 and 15 are objected to for referring to “a terminal bend” when it is unclear how this relates to the previously claimed terminal bend.
Further, the claim is unclear for referring to “two adjacent struts” when it is unclear how this relates (if at all) to the previously claimed struts.
Claims 7 and 16 are objected to for claiming “portions of struts” when it is unclear how, if at all, this relates to the previously claimed “struts”, “adjacent struts”, and “portion” of two adjacent struts.
Further, the claims are unclear for referring to a “vessel wall” making it unclear how this relates (if at all) to the previously claimed “vessel wall engaging graft portion” or the vessel wall of the graft portion from claim 1.
Claim 10 is unclear for referring to there being a plurality of proximal release wires, when it is unclear how, if at all, this depends from the previously claimed “proximal release wire” of claim 9.
Claim 18 refers to “each of the three proximal release wire” but it appears “wire” is missing an “s”.
The claim is further unclear for referring to “the proximal release wire” when it is unclear which of the three proximal release wires is being referred to herein.
Appropriate correction is required.
Drawings
The drawings are objected to because the following numerals are present in the drawings, but not in the specification: 300, 220, 135, 430, 255, 265, 135’, 322, 600, 245.
Further, item 134 appears to be pointing towards two different items in figure 3b.
Further, item 130 appears to be pointing towards two different items in figures 3a-b.
Further, item “210” and “310” appear to both be representing “terminal portions”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 1-8, 11-17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley et al. (US 7909863 B2) hereinafter known as Hartley in view of Zhang et al. (CN 106913408 B) hereinafter known as Zhang.
Regarding claim 1 Hartley discloses an endovascular system comprising:
a stent-graft assembly (Figure 1 item 10) comprising:
an elongate vessel wall-engaging graft portion (Figure 1 item 12), and a proximal-end self-expanding stent (Figure 1 item 16; Abstract self-expanding z-stent) comprising a plurality of terminal portions (Figure 2 items 22, 28, 30), and
a deployment device (Figure 3 item 38) comprising:an elongate guide wire catheter adapted to be deployed over a guide wire (Figure 3 item 40; Column 3 lines 29-30 a nose-cone catheter is understood to inherently deploy over a guide wire)
a tip at a proximal end of the catheter with a proximal nose (Figure 3 item 42) and a distal receiving zone (Annotated Figure 3) comprising a plurality of circumferentially spaced-apart elongate stent-receiving locations (Annotated Figure 3), each stent-receiving location receiving at least one of the terminal portions of the stent-graft (Annotated Figure 3 shows the apices 22, 28, 30 being received at the circumferentially spaced, elongate stent-receiving locations), and
a trigger wire arrangement (Figure 3 item 44) retaining one terminal portion of the stent-graft within a corresponding stent-receiving location (Figure 3), and
wherein the retention of the terminal portions of the stent-graft within the stent-receiving location constrains against relative twisting between the stent-graft and the tip of the catheter (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Hartley discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example Column 1 lines 29-34, Column 2 lines 30-35, Column 3 lines 29-34 the apertures and trigger wires constraining the stacked apices of the stent are understood to constrain against relative twisting between the stent-graft and tip of the catheter by preventing from moving circumferentially around the tip),
but is silent with regards the distal receiving zone’s stent-receiving locations being recesses.
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However, regarding claim 1 Zhang teaches that a catheter’s stent-receiving location can include a plurality of elongate recesses (Figures 4-6 item 2711). Hartley and Zhang are involved in the same field of endeavor, namely stent graft delivery systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Hartley so that the stent-receiving locations of Hartley include recesses that fit the groups of stent apices 22, 28, 30, trigger wires 44 and apertures 43 of Hartley in order to further minimize the delivery profile of the device, and as an extra measure to ensure the elements stay in their stacked configuration during delivery, thus easing delivery to difficult to reach or tortuous patient vessels.
Regarding claim 2 the Hartley Zhang Combination teaches the system of claim 1 substantially as is claimed,
wherein Hartley further discloses the deployment device comprises a sheath with an initial position covering the stent-graft (Column 3 lines 23-25) and a retracted condition where the stent-graft is uncovered (Figures 1 ,3).
Regarding claim 3 the Hartley Zhang Combination teaches the system of claim 1 substantially as is claimed,
wherein Hartley further discloses each elongate [recess] receives a group of terminal portions (Annotated Figure 3 shows the stent-receiving locations receiving a group of three terminal portions of the stent; Column 3 lines 35-37).
Regarding claim 4 the Hartley Zhang Combination teaches the system of claim 2 substantially as is claimed,
wherein Hartley further discloses the [recesses] comprises three [recesses] (Annotated Figure 3 shows three stent-receiving locations), and each receives a group of terminal portions (Annotated Figure 3; Column 3 lines 35-37).
Regarding claim 5 the Hartley Zhang Combination teaches the system of claim 2 substantially as is claimed,
wherein Hartley further discloses the stent comprises terminal bends (Figures 2-3 items 20, 28, 30) and distal bends (Figure 2 item 24) joined by struts (Figure 2 item 20).
Regarding claim 6 the Hartley Zhang Combination teaches the system of claim 5 substantially as is claimed,
wherein Hartley further discloses each terminal portion comprises a terminal bend and a portion of each of two adjacent struts (Annotated Figure 3).
Regarding claim 7 the Hartley Zhang Combination teaches the system of claim 6 substantially as is claimed,
wherein Hartley further discloses the terminal portions include barbs projecting from portions of the struts (Figures 1-2 item 26) which are configured to anchor the stent-graft within a vessel wall (this is likewise stated as a functional limitation (see the explanation in the rejection to claim 1 above). The barbs of Hartley are understood to be capable of anchoring the stent-graft within a vessel wall if desired).
Regarding claim 8 the Hartley Zhang Combination teaches the system of claim 7 substantially as is claimed,
wherein Hartley further discloses the barbs are staggered with respect to each other (Figures 1-2; Column 3 lines 41-46).
Regarding claim 11 the Hartley Zhang Combination teaches the system of claim 1 substantially as is claimed,
wherein Hartley further discloses the circumferentially spaced elongate [recesses] comprise three [recesses] (Annotated Figure 3), and
wherein the deployment device comprises a sheath with an initial position covering the stent-graft (Column 3 lines 23-25) and a retracted condition where the stent-graft is uncovered (Figures 1 ,3).
Regarding claim 12 the Hartley Zhang Combination teaches the system of claim 11 substantially as is claimed,
wherein Hartley further discloses wherein the trigger wire arrangement comprises one proximal release wire for each of the three elongate [recesses] (Hartley Annotated Figure 3 shows three trigger wires 44, one for each stent-receiving location).
Regarding claim 13 see the rejection to claim 3 above.
Regarding claim 14 see the rejection to claim 5 above.
Regarding claim 15 see the rejection to claim 6 above.
Regarding claim 16 see the rejection to claim 7 above.
Regarding claim 17 see the rejection to claim 8 above.
Regarding claim 19 the Hartley Zhang Combination teaches the system of claim 1 substantially as is claimed,
wherein Hartley further discloses the stent-graft assembly is a medical device (Column 1 line 11),
there are one or more elongate [recesses] (Annotated Figure 3), and the trigger wire arrangement is a terminal portion retention arrangement (Annotated Figure 3; Column 3 lines 32-34).
Regarding claim 20 the Hartley Zhang Combination teaches the system of claim 19 substantially as is claimed,
wherein Hartley further discloses the terminal retention portion arrangement comprises one or more wires (Annotated Figure 3 item 44).
Claims 9-10, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley and Zhang as is applied above, further in view of Hartley et al. (US 20060142836 A1), hereinafter known as Hartley ‘836 and further in view of Weng (US 20090099640 A1).
Regarding claim 9 the Hartley Zhang Combination teaches the system of claim 6 substantially as is claimed,
wherein Hartley further discloses a proximal release wire (Figure 3 item 44),
wherein the proximal release wire retains proximal portions of each of the groups of the terminal portions (Column 3 lines 32-34),
but is silent with regards to the trigger wire arrangement comprising a distal release wire with details of its two ends and their locations, or details of the proximal release wire’s ends and locations.
However, regarding claim 9 Hartley ‘836 teaches a stent-graft system which includes a stent-graft assembly which includes a proximal end stent (Figures 3-4 item 27) with terminal portions (Figure 12 item 51), a deployment device (Figure 12 item 40) with a proximal nose (Figure 12 item 46) and a distal receiving zone with spaced apart elongate recesses (Figure 12 item 56) and a trigger wire arrangement to retain the terminal portions in a receiving zone (Figure 12 item 50), and
a distal release wire mechanism ([0013] distal trigger wire arrangement) with a first actuation end at a distal end of the deployment device ([0013] means at the distal end of the catheter to release the trigger wire arrangement), which retains distal portions of each of the groups of terminal portions ([0013], [0063])
and a proximal release wire mechanism ([0014] trigger wire arrangement) with a second actuation end at the distal end of the deployment device ([0014]),
Further, regarding claim 9 Weng teaches that a proximal end of a catheter can include a handle (Figure 5 distal end 5),
and that wire release mechanisms for actuating stent deployment can have wire ends terminating within a catheter tip that holds a medical device (Figures 3, 5 item 42 at the left side of the figure), and their other ends terminating at the handle (Figures 3, 5 item 42 at the right side of the figure).
Hartley and Weng are involved in the same field of endeavor, namely catheter delivery systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Hartley Zhang Hartley ‘836 Combination so that the catheter includes a handle as is taught by Weng in order to allow the cardiac interventionalist to appropriately hold and control delivery of the stent-graft of the Combination. Further, it would have been obvious to one of ordinary skill to have the release wire mechanisms have their proximal end within the proximal tip of the catheter and the distal end at the handle as is taught by Weng since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case a person of ordinary skill would find it obvious to the wire to have terminal ends in any location within the delivery device as long as the release mechanism is able to function.
Regarding claim 10 the Hartley Zhang Hartley ‘836 Weng Combination teaches the system of claim 9 substantially as is claimed,
wherein Hartley further discloses the trigger wire arrangement comprises a plurality of proximal release wires (Figure 3 item 44 shows three trigger wires; Column 3 line 32 there are four trigger wires 44).
Regarding claim 18 the Hartley Zhang Combination teaches the system of claim 12 substantially as is claimed,
wherein Hartley further discloses each of the three proximal release wires (Figure 3 item 44) retains proximal portions of each of the groups of the terminal portions (Column 3 lines 32-34),
but is silent with regards to the trigger wire arrangement comprising a distal release wire with details of its two ends and their locations, or details of the proximal release wire’s ends and locations.
However, regarding claim 18 Hartley ‘836 teaches a stent-graft system which includes a stent-graft assembly which includes a proximal end stent (Figures 3-4 item 27) with terminal portions (Figure 12 item 51), a deployment device (Figure 12 item 40) with a proximal nose (Figure 12 item 46) and a distal receiving zone with spaced apart elongate recesses (Figure 12 item 56) and a trigger wire arrangement to retain the terminal portions in a receiving zone (Figure 12 item 50), and
a distal release wire mechanism ([0013] distal trigger wire arrangement) with a first actuation end at a distal end of the deployment device ([0013] means at the distal end of the catheter to release the trigger wire arrangement), which retains distal portions of each of the groups of terminal portions ([0013], [0063])
and a proximal release wire mechanism ([0014] trigger wire arrangement) with a second actuation end at the distal end of the deployment device ([0014]),
Further, regarding claim 18 Weng teaches that a proximal end of a catheter can include a handle (Figure 5 distal end 5),
and that wire release mechanisms for actuating stent deployment can have wire ends terminating within a catheter tip that holds a medical device (Figures 3, 5 item 42 at the left side of the figure), and their other ends terminating at the handle (Figures 3, 5 item 42 at the right side of the figure).
Hartley and Weng are involved in the same field of endeavor, namely catheter delivery systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Hartley Zhang Hartley ‘836 Combination so that the catheter includes a handle as is taught by Weng in order to allow the cardiac interventionalist to appropriately hold and control delivery of the stent-graft of the Combination. Further, it would have been obvious to one of ordinary skill to have the release wire mechanisms have their proximal end within the proximal tip of the catheter and the distal end at the handle as is taught by Weng since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case a person of ordinary skill would find it obvious to the wire to have terminal ends in any location within the delivery device as long as the release mechanism is able to function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/17/26
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