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 .
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.
Response to Amendment
This action is in response to Applicant’s amendment received 7/28/2026. The amendments made to the claims do not place the application in condition for allowance for the reasons set forth below. Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. Applicant argues that Hall fails to disclose the end strut of the end row comprises a bend disposed between a free end section and a trough section as now recited in amended claims 1, 11, and 13. However, it is the examiner’s position that Hall discloses the end strut of the end row comprises a bend disposed between a free end section and a trough section as now recited in amended claims 1, 11, and 13 (see rejection and annotated figure below for details).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 11 has been amended to require the transition strut being disposed between an apex of the body row and a trough of the end row. However, the original specification describes the transition strut 222 is disposed between a trough 244 and an apex 245 of the body row 213 as originally claimed, not of the end row as amended (see also Figs. 3A-5B). Therefore, the limitation is considered new matter.
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 1-8, 10, 13-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hall et al. (US Pub. No. 2013/0184808).
Regarding claim 1, Hall discloses a vascular prosthesis (stent graft; see [0056]) comprising a support structure comprising a frame (wire 650 being shaped to form the frame, providing a support structure; see Figs. 6-7C), wherein the frame comprises an end row (bottom row) comprising a plurality of apexes (top 652s/652’s of the bottom row) and a plurality of troughs (bottom 652s/652’s of the bottom row), and a body row (row above bottom row) comprising a plurality of troughs (bottom 652s/652’s of the body row), and defining a transition strut disposed at an end of the body row (see annotated figure 6 below), wherein the transition strut of the body row is coupled to an end strut of the end row (see annotated figure below), wherein the transition strut is configured to position the body row axially away from the end row (see annotated figure 6 below), wherein the end row is axially offset from the body row when the support structure is radially crimped (since the end row is axially offset from the body row when the support structure is in the expanded state, the support structure is capable of being crimped such that the end row remains axially offset from the body row when the support structure is radially crimped), and wherein the end strut comprises a bend disposed between a free end section and a trough section (see annotated figure 6 below).
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Regarding claim 2, Hall discloses the transition strut positions the body row axially away from the end row over an arc extending along a portion of a circumference of the frame (see Fig. 6).
Regarding claim 3 Hall discloses the body row is angled relative to the end row (see Fig. 6, wherein the helical pattern presents rows that are angled relative to each other).
Regarding claim 4, Hall discloses the end strut is directed axially away from the body row (see annotated figure 6 above).
Regarding claim 5, Hall discloses the plurality of troughs of the end row are circumferentially aligned (see annotated figure 6 above).
Regarding claim 6, Hall discloses at least one of the plurality of troughs of the end row (at least one of the bottom 652’s) is axially offset from an adjacent trough of the plurality of troughs of the end row (see annotated Fig. 7C below), and wherein a shoulder of the at least one of the plurality of troughs of the end row is axially offset from a shoulder of the adjacent trough of the plurality of troughs of the end row when the frame is radially compressed (since the shoulders are axially offset in the expanded state, the shoulders are axially offset when the frame is radially compressed; see annotated Fig. 7C below and [0170] describing the frame of Fig. 6 may be configured as shown in Fig. 7C at one or both ends of the frame).
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Regarding claim 7, Hall discloses a height of at least one apex of the plurality of apexes of the end row (top 652’s) is shorter than a height of an adjacent apex of the plurality of apexes of the end row (see annotated Fig. 7C above and [0170] describing the frame of Fig. 6 may be configured as shown in Fig. 7C at one or both ends of the frame).
Regarding claim 8, Hall discloses the plurality of apexes of the end row are axially offset from the plurality of troughs of the body row (see annotated figure 6 above).
Regarding claim 10, Hall discloses a cover coupled to the support structure (see [0149], wherein Hall discloses the embodiment of Figs. 6-7C may also be coupled to any of the disclosed coverings), wherein the cover comprises a luminal layer (325) of rotational spun polytetrafluoroethylene (PTFE) fibers (see [0069], [0113]), an abluminal layer (330) of PTFE (see [0113]), and a tie layer (335) disposed between the luminal and abluminal layers (see Fig. 3B), wherein the support structure is at least partially disposed between the luminal and abluminal layers and coupled to the tie layer (see Fig. 3B, the exemplary support structure referenced as element 320 which equates to element 650 of Figs. 6-7C).
Regarding claim 13, Hall discloses a frame of a vascular support structure (wire 650 being shaped to form the frame, providing a vascular support structure; see Figs. 6-7C) comprising an end row (bottom row) comprising a plurality of apexes (top 652s/652’s of the bottom row), a plurality of troughs (bottom 652s/652’s of the bottom row), and an end strut (see Fig. 6), wherein the end strut of the end row comprises a bend disposed between a free-end section and a trough section (see annotated figure 6 above), a body row (row above bottom row) comprising a plurality of troughs (bottom 652s/652’s of the body row), and a transition strut disposed between the end row and the body row (see annotated figure 6 above), wherein the transition strut is configured to position the body row axially away from the end row (see annotated figure 6 above), and wherein the end row is axially offset from the body row when the support structure is radially compressed (since the end row is axially offset from the body row when the support structure is in the expanded state, it is capable of being radially compressed such that the end row remains axially offset from the body row when the support structure is radially compressed).
Regarding claim 14, Hall discloses the transition strut positions the body row axially away from the end row over an arc radius extending along a portion of a circumference of the frame (see annotated figure 6 above).
Regarding claim 15, Hall discloses the transition strut is coupled to an end strut of the end row (see annotated figure 6 above).
Regarding claim 16, Hall discloses the frame further comprises a radiopaque marker configured to couple the transition strut to the end strut of the end row (see [0171] disclosing a radiopaque marker may be crimped around the end 656 in such a manner as to couple the end 656 to the frame).
Regarding claim 17, Hall discloses the plurality of troughs of the end row are circumferentially aligned (see annotated figure 6 above).
Regarding claim 18, Hall discloses at least one of the plurality of troughs (at least one of the bottom 652’s) of the end row (bottom row) is axially offset from an adjacent trough of the plurality of troughs of the end row (see annotated Fig. 7C above), and wherein a shoulder of the at least one of the plurality of troughs of the end row is free from contact with a shoulder of the adjacent trough of the plurality of troughs of the end row when the frame is radially compressed (since the shoulders are axially offset in the expanded state, the shoulders are axially offset when the frame is radially compressed and thereby free from contact with each other; see annotated Fig. 7C above and [0170] describing the frame of Fig. 6 may be configured as shown in Fig. 7C at one or both ends of the frame).
Regarding claim 20, Hall discloses the frame further comprises any one of a coiled wire and a laser cut tube (wire 650 being wound in a helical pattern, thereby comprises a coiled wire; see Figs. 6, 7B, [0170], [0323]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US Pub. No. 2013/0184808).
Hall discloses the support structure/frame further comprises an expanded diameter (see [0151]) and a radial compressed diameter (see [0151]). Hall is silent as to the amount the radial compressed diameter is relative to the expanded diameter, thereby fails to disclose the radial compressed diameter ranges from 20% to 100% of the expanded diameter.
However, Hall does disclose devices of a certain diameter or constrained profile are more feasible for delivery at certain vascular or other access points than others and a frame may be configured to be crimped into a particular profile to enable potential access at various or desired access points (see [0151]). Therefore, a person of ordinary skill in the art, being faced with modifying the compressed diameter relative to the expanded diameter, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter percentage range. Applicant has not disclosed that the claimed range solves any stated problem or is used for any particular purpose, indicating that the radial compressed diameter “can” range from 20% to 100% of the expanded diameter (see [0045] and [0049]), and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the radial compressed diameter of Hall’s support structure/frame to range from 20% to 100% of the expanded diameter as an obvious matter of design choice within the level of skill in the art.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US Pub. No. 2013/0184808) in view of Rowe et al. (US Pub. No. 2019/0060092).
Regarding claim 11, Hall discloses a vascular prosthesis (stent graft; see [0056]) comprising a support structure comprising a first end portion of a coil (wire 650 being wound in a helical pattern, each row being a coil; see Figs. 6-7C) comprising an end row (bottom row) comprising a plurality of apexes (top 652s/652’s of the bottom row), a plurality of troughs (bottom 652s/652’s of the bottom row), and an end strut (see Fig. 6), wherein the end strut comprises a bend disposed between a free-end section and a trough section (see annotated figure 6 above), a body row (row above bottom row) comprising a plurality of apexes (top 652s/652’s of the body row), a plurality of troughs (bottom 652s/652’s of the body row), and a plurality of struts (struts in between 652s/652’s), each strut disposed between an adjacent apex and an adjacent trough (see Fig. 6), wherein the body row defines a transition strut disposed between an end apex of the body row and an end trough of the end row (see Fig. 6), wherein the transition strut is configured to position the body row axially away from the end row (see annotated figure 6 above), and wherein the end row is axially offset from the body row when the support structure is radially compressed (since the end row is axially offset from the body row when the support structure is in the expanded state, it is capable of being radially compressed such that the end row remains axially offset from the body row when the support structure is radially compressed), and a cover coupled to the support structure (see [0149], wherein Hall discloses the embodiment of Figs. 6-7C may also be coupled to any of the disclosed coverings).
Hall fails to disclose the transition strut is longer than each of the plurality of struts. Rowe also discloses a vascular prosthesis (500) comprising a transition strut (520) between two rows of struts (see Fig. 5). Rowe teaches the transition strut (520) is longer than each of the plurality of non-transition struts (see Fig, 5 and paragraph [0032]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Hall’s transition strut longer than each of the plurality of struts in the body row in order to permit an attachment point having a longer weld length which ensures the structural strength of the device is not adversely compromised as taught by Rowe (see paragraph [0026]).
Regarding claim 12, Hall as modified discloses the transition strut positions the body row axially away from the end row over an arc extending along a portion of a circumference of the support structure (see annotated figure 6 above).
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 MELANIE TYSON whose telephone number is (571)272-9062. The examiner can normally be reached M-F 8:00 AM - 4:00 PM (ET).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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