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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-20 and 48-50 is/are pending. Claim(s) 11, 16-18, and 50 is/are withdrawn. Claim(s) 21-47 is/are canceled.
The Examiner notes claims 16 and 17 were amended without the changes being marked. See following Table I. It appears claim 16 was deleted and claim 18 duplicated so claim number in Table I were re-numbered incorrectly, while the duplication resulted in correct numbering again at claim 18. Claims will be treated with the numbering presented. Should Applicant choose to move the content back, proper claim mark-ups for amendments should be used.
Table I: Unmarked claim amendments
7/10/2026 Claims
3/13/2026 Claims
missing
16: the stents are self-expanding
16: the stents are balloon-expandable
17: the stents are balloon-expandable
17 and 18: the island graft includes a suture line that excludes a partial tubular lumen, whereby removal of the suture line opens the surgical segment at the island graft
18: the island graft includes a suture line that excludes a partial tubular lumen, whereby removal of the suture line opens the surgical segment at the island graft
Response to Arguments
Applicant’s arguments, filed 7/10/2026, with respect to claim objections have been fully considered and are persuasive. The claim objections of claims 3, 12, and 48 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 7/10/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-10, 12-16, 19-20, and 48-49 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant argues the amended language is not taught by the prior art. The Examine notes Schmitt teaches this language as detailed in the prior art rejection section below.
Applicant’s arguments with respect to claims 1, 12, 15, and 20 have been considered but are moot in view of the new grounds of rejection. The Examiner notes the change in prior art was necessitated by the Applicants amendments. Tani and Bruszewski are re-used, but in combination for claims 1, 12, 15, 20 in addition to claims 48-49 previously rejected under this combination. How this combination teaches the amended language is also detailed in the prior art rejection section below
Applicant’s Interview Request
A call was made to Emily Yasharpour on 8/25/2026 to discuss if an interview was being requested prior to examination. Applicant’s Representative indicated that an interview request would be considered after examination and any Office action issued in response to Applicant’s response on 7/10/2026.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
Claim 1, line 12 recites “a first side and second side”, which should be “a first side and a second side”.
Claim 20, line 6 recites “a first side and second side”, which should be “a first side and a second side”.
Appropriate correction is required.
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 1-10, 12-15, and 19 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.
Claim 1, line 15 and claim 20, line 9 and claim 48, line 23 each recites “fabric”. It is unclear if this is the same or different than the instance introduced earlier in the claim. For purposes of examination the Examiner considers this language to be “the fabric”.
Claim 1, line 16 and claim 20, line 10 and claim 48, line 24 each recites the limitation "the stitches". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “stitches formed by the removable sutures”.
Claim 1, line 17 and claim 20, line 11 and claim 48, line 25 each recites the limitation "the surface". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a surface”.
Claim(s) 2-10, 12-15, and 19 are rejected as dependent from a rejected claim.
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.
Claim(s) 1-10 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmitt, et al (Schmitt) (US 6,187,033 B1).
Regarding Claim 1, Schmitt teaches a vascular prosthesis (e.g. column 1, lines 4-10), comprising:
a) a major tubular component of fabric (e.g. Figure 3, #20), the major tubular component defining a longitudinal axis and having a length (these features are inherently present), and including a first open end and a second open end (e.g. Figure 3, longitudinal ends), the major tubular component defining a lumen extending from the first open end to the second open end of the major tubular component (e.g. Figure 3, there is inherently a lumen where the blood flows, #25);
b) a fenestration defined by the major tubular component between the first open end and the second open end (e.g. Figure 3, opening where #30 is connected), the fenestration having an area defined as an area that would be occupied by the major tubular component in the absence of the fenestration (this area is inherently present), and a length [of the fenestration] along the length of the lumen of the major tubular component and a width transverse to the length of the major tubular component (these features are inherently present), wherein the length of the fenestration is greater than the width of the fenestration (e.g. Figure 3); and
c) an island graft with a first side and a second side spanning the fenestration and attached to the major tubular component (e.g. Figure 3, #30; the first and second sides are two opposing sides), the island graft having greater surface area than the area of the fenestration (e.g. Figure 3);
d) wherein the island graft is coupled to the major tubular component of the fabric by removable sutures (e.g. column 6, lines 10-39; the sutures are removable because they are at least able to be cut away), such that removal of the stitches at the first side cause the island graft to be disproportionately raised from the surface of the major tubular component (when the removal of the stitches occurs at the first side the island graft would be able to be raised from the major tubular component as claimed; there is no requirement this function occur while finally implanted).
Regarding Claim 2, the island graft is radially raised from the area of the fenestration (e.g. Figure 3).
Regarding Claim 3, the major tubular component defines corrugations that extend transversely to the length of the lumen of the major tubular component from the first open end to the second open end of the major tubular component (e.g. Figure 3).
Regarding Claim 5, the island graft or its attachment to the major tubular component causes at least a portion of the major tubular component to be arcuate (e.g. Figure 3).
Regarding Claim 4, the island graft defines corrugations that extend parallel to the longitudinal axis of the major tubular component (e.g. Figure 3), whereby the island graft is expandable in a lateral direction relative to the longitudinal axis (e.g. Figure 3, column 5, lines 16-23; the materials are flexible and thus expandable).
Regarding Claim 6, there is a collar surrounding a circumference of the major tubular graft and distal to the island graft (e.g. Figure 3; column 6, lines 10-39; the suture line forms a collar around a circumference of the major tubular graft; likewise #16 also forms a collar).
Regarding Claim 7, there is an island graft collar circumscribing a perimeter defined by the island graft (e.g. Figure 3; column 6, lines 10-39; the suture line forms a collar).
Regarding Claim 8, the island graft defines corrugations that are concentric (e.g. Figure 3), whereby the island graft is collapsible in a radial direction (e.g. column 5, lines 16-23; the materials are flexible and thus collapsible).
Regarding Claim 9, the island graft is radially raised from the fenestration (e.g. Figure 3), and wherein the island graft defines pleats that extend radially away from a center of the fenestration, whereby the island graft is collapsible (e.g. Figure 3; column 5, lines 16-23; the materials are flexible and thus collapsible).
Regarding Claim 10, the island graft defines an opening (e.g. Figure 3, at connection to the major tubular component, where blood flows into the island graft).
Regarding Claim 12, the major tubular component includes
a) a surgical segment defining the fenestration (e.g. annotated Figure 3 below); and
b) an endovascular segment extending from the surgical segment (e.g. annotated Figure 3 below),
the surgical segment and the endovascular stent graft segment, thereby forming a juncture between the surgical segment and the endovascular segment (e.g. annotated Figure 3 below), and defining a lumen (e.g. Figure 3, #25; column 6, lines 10-39), the fenestration being closer to the juncture than to at least one of the first open end and the second open end (e.g. annotated Figure 3 below).
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Annotated Figure 3, Schmitt
Regarding Claim 13, there is a collar extending circumferentially about the major tubular component and interposed between the surgical segment and the endovascular segment (e.g. annotated Figure 3 above; shaded corrugation ring).
Regarding Claim 14, the surgical segment is corrugated (e.g. Figure 3) and at least semi-rigid (as broadly claimed, the device holds its structure sufficiently to function as a blood vessel (e.g. abstract) and is rigid enough to maintain this structure and thus is considered semi-rigid).
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.
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.
Claims 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tani (US 2012/0071960 A1) in view of Bruszewski, et al (Bruszewski) (US 2010/0268327 A1).
Regarding Claim 48, Tani teaches a vascular prosthesis (e.g. abstract, Figure 1), comprising:
a) a major tubular component of fabric (e.g. Figure 1), the major tubular component defining a longitudinal axis and having a length (these features are inherently present), and including a first open end and a second open end (e.g. Figure 1, longitudinal ends), the major tubular component defining a lumen extending from the first open end to the second open end of the major tubular component (e.g. Figure 1, [0035], there is inherently a lumen since the device is a blood vessel replacement), wherein the major tubular component includes
i). an endovascular stent graft segment (e.g. annotated Figure 1 below), the endovascular stent graft segment including a luminal graft component and as stent component (e.g. Figure 1, [0036]; graft #16, (zig-zag) stents #18), wherein the stent component of the endovascular stent segment includes stents that are anchored to the graft component (e.g. Figure 1), and
ii). a surgical segment defining at least one fenestration (e.g. annotated Figure 1 below), the fenestration having an area defined as an area that would be occupied by the major tubular component in the absence of the fenestration (e.g. annotated Figure 1 below), and a length along the length of the lumen of the major tubular complex and a width transverse to the length of the major tubular component (e.g. annotated Figure 1 below), wherein the length of the fenestration is greater than the width of the fenestration (e.g. Figure 1), and wherein the endovascular stent graft segment and the surgical segment define a juncture (e.g. annotated Figure 1 below) and the fenestration is closer to the juncture than at least one of the first open end of the major tubular component and the second open end of the major tubular component (e.g. annotated Figure 1 below).
Tani discloses the invention substantially as claimed but fails to teach:
b) at least one island graft separately spanning each of the at least one fenestrations and attached to the surgical segment, at least a portion of the at least one island graft having greater surface area than the area of the fenestration it spans, wherein the island graft is coupled to the major tubular component of fabric by removable sutures, such that removal of the stitches at the first side cause the island graft to be disproportionately raised from the surface of the major tubular component.
Bruszewski teaches b) at least one island graft (e.g. annotated Figure 10(1) below) separately spanning each of the at least one fenestrations (e.g. annotated Figure 10(1) below) and attached to the surgical segment (e.g. annotated Figures 10(1) below), at least a portion of the at least one island graft having greater surface area than the area of the fenestration it spans (e.g. Figure 10; the island graft’s radial thickness surface area of the combined inner and outer surfaces is greater than the surface area of the radial thickness of the fenestration; as broadly, claimed, any surface of the fenestration meets the claimed limitation), wherein the island graft is coupled to the major tubular component of the fabric by removable sutures (e.g. column 6, lines 10-39; the sutures are removable because they are at least able to be cut away), such that removal of the stitches at the first side cause the island graft to be disproportionately raised from the surface of the major tubular component (when the removal of the stitches occurs at the first side the island graft would be able to be raised from the major tubular component as claimed; there is no requirement this function occur while finally implanted).
Tani and Bruszewski are concerned with the same field of endeavor as the claimed invention, namely stent grafts having multiple segments and a lateral fenestration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tani by incorporating the island graft as taught by Bruszewski as it is combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)). Here, the results are predictable because each claimed element performs in the same manner in the combination as it does separately. Specifically, the major tubular component supports the anatomy and provides an opening for branch graft(s) and the island graft provides a support coupling for a particular branch.
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Annotated Figure 1, Tani
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Annotated Figure 10(1), Bruszewski
Regarding Claim 49, wherein the surgical segment is corrugated (e.g. Tani, Figure 1).
Regarding Claim 20, the combination of Tani and Bruszewski teaches a hybrid vascular prosthesis (e.g. Tani, abstract, Figure 1), comprising:
a) a surgical segment (e.g. Tani, annotated Figure 1 above), the surgical segment having a proximal end and a distal end (the longitudinal ends of the surgical segment), at least a portion of the distal end of the surgical segment having an increased diameter relative to the remainder of the surgical segment adjacent the endovascular stent graft segment (e.g. Tani, Figure 1, the corrugated structure has alternating diameters thereby meeting the claimed diameter differences); and
b) an endovascular stent graft segment (e.g. Tani, annotated Figure 1 above) having a graft component and a stent component fixed to the graft component (e.g. Tani, Figure 1, [0036]; graft #16, (zig-zag) stents #18), and extending from the distal end of the surgical segment (e.g. Tani, Figure 1), the surgical segment and the endovascular stent graft segment together defining a lumen (e.g. Tani, Figure 1).
Regarding Claim 1, the combination of Tani and Bruszewski teaches a vascular prosthesis (e.g. Tani, abstract, Figure 1), comprising:
a) a major tubular component of fabric (e.g. Tani, Figure 1), the major tubular component defining a longitudinal axis and having a length (these features are inherently present), and including a first open end and a second open end (e.g. Tani, Figure 1, longitudinal ends), the major tubular component defining a lumen extending from the first open end to the second open end of the major tubular component (e.g. Tani, Figure 1, [0035], there is inherently a lumen since the device is a blood vessel replacement);
b) a fenestration defined by the major tubular component between the first open end and the second open end (e.g. Tani, Figure 1, where #22a is located and Bruszewski, Figure 10, the opening into which the island graft is attached), the fenestration having an area defined as an area that would be occupied by the major tubular component in the absence of the fenestration (this area is inherently present), and a length along the length of the lumen of the major tubular component and a width transverse to the length of the major tubular component (these features are inherently present), wherein the length of the fenestration is greater than the width of the fenestration (e.g. Tani, Figure 1 and Bruszewski, Figure 10); and
c) an island graft with a first side and a second side spanning the fenestration and attached to the major tubular component (e.g. Bruszewski, annotated Figure 10(1) above; the first and second sides are two opposing sides), the island graft having greater surface area than the area of the fenestration (e.g. Bruszewski, Figure 10; the island graft’s radial thickness surface area of the combined inner and outer surfaces is greater than the surface area of the radial thickness of the fenestration; as broadly, claimed, any surface of the fenestration meets the claimed limitation);
d) wherein the island graft is coupled to the major tubular component of the fabric by removable sutures (e.g. Bruszewski, column 6, lines 10-39; the sutures are removable because they are at least able to be cut away), such that removal of the stitches at the first side cause the island graft to be disproportionately raised from the surface of the major tubular component (when the removal of the stitches occurs at the first side the island graft would be able to be raised from the major tubular component as claimed; there is no requirement this function occur while finally implanted).
Regarding Claim 12, the major tubular component includes
a) a surgical segment defining the fenestration (e.g. Tani, annotated Figure 1 above); and
b) an endovascular segment extending from the surgical segment (e.g. Tani, Figure 1),
the surgical segment and the endovascular stent graft segment, thereby forming a juncture between the surgical segment and the endovascular segment (e.g. Tani, Figure 1, where the two segments are connected to each other), and defining a lumen (e.g. Tani, abstract, since it’s a blood vessel it has a lumen where the blood flows), the fenestration being closer to the juncture than to at least one of the first open end and the second open end (e.g. Tani, Figure 1).
Regarding Claim 15, the endovascular segment includes a graft component and a stent component (e.g. Tani, Figure 1, [0036]; graft #16, (zig-zag) stents #18), and wherein the stent component of the endovascular stent segment includes stents that are anchored to the graft component (e.g. Tani, Figure 1).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt, et al (Schmitt) (US 6,187,033 B1) as discussed supra and further in view of Anidjar, et al (Anidjar) (US 6,036,723).
Regarding Claim 19, Schmitt discloses the invention substantially as claimed but fails to teach the island graft includes a removable clamp that excludes a partial tubular lumen, whereby removal of the clamp opens the surgical segment at the island graft.
Anidjar teaches a clamp used on branching vessels (e.g. Figures 10-11, column 9, lines 4-14).
Anidjar and Schmitt are concerned with the same field of endeavor as the claimed invention, namely branching grafts.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmitt by incorporating the removable clamp as taught by Anidjar in order to selectively block blood flow prior to branch placement, which prevents leakage in the vascular system (e.g. Anidjar, column 9, lines 4-14).
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, JERRAH EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/25/2026
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