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 Claim(s) 11, 17-18, and 50 is/are withdrawn. Claim(s) 21-47 is/are canceled.
Election/Restrictions
Applicant’s election without traverse of Species 1-1, 2-2, 3-1, and 4-1 in the reply filed on 3/13/2026 is acknowledged.
Claims 11, 17-18, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/13/2026.
Claim Objections
Claims 3, 12, and 48 are objected to because of the following informalities:
Claim 3, line 2 recites “of lumen”, which should be “of the lumen”.
Claim 12, line 6 recites “first open and second open end”, which should be “first open end and second open end”.
Claim 48, line 8 recites “as stent component”, which should be “a stent component”.
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, 12-16, 19-20, and 48-49 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 9 and Claim 3, line 2 recites “the length of the lumen”. 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 lumen having a length and extending” where defined in line 4. Claim 48, line 12 has this same issue, which has the same interpretation applied to claim 48, line 4.
Claim 3, lines 3-4 recites “a first open end” of the major tubular component. It is unclear if this is the same or a different first open end as that already introduced in claim 1 from which claim 3 depends. For purposes of examination the Examiner considers this language to be “the first open end”.
Claim 3, line 4 recites “a second open end” of the major tubular component. It is unclear if this is the same or a different second open end as that already introduced in claim 1 from which claim 3 depends. For purposes of examination the Examiner considers this language to be “the second open end”.
Claim 20, line 4 recites “the endovascular stent graft segment”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an endovascular stent graft segment”. The Examiner notes since this is the first instance, this correction will need to be accompanied by a change in line 6 to “the” endovascular stent graft segment.
Claim 48, lines 14-15 recites “the second endovascular stent graft segment”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “the endovascular stent graft segment” referring to that introduced in line 7.
Claim(s) 2, 4-10, 12-16, 19, and 49 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 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 spanning the fenestration and attached to the major tubular component (e.g. Figure 3, #30), the island graft having greater surface area than the area of the fenestration (e.g. Figure 3).
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 lumen of the major tubular component from a first open end to a 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 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(s) 1-2, 6-7, 12-13, 15-16, 20, and 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruszewski, et al (Bruszewski) (US 2010/0268327 A1).
Regarding Claim 1, Bruszewski teaches a vascular prosthesis (e.g. abstract; Figure 10), comprising:
a) a major tubular component of fabric (e.g. annotated Figure 10(1) below, [0029]), 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 10, 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. [0029], blood flow pathway);
b) a fenestration defined by the major tubular component between the first open end and the second open end (e.g. annotated Figure 10(1) below, opening where the island graft is connected to the major tubular component), 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 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 10, the opening is oblong); and
c) an island graft spanning the fenestration and attached to the major tubular component (e.g. annotated Figure 10(1) below), the island graft having greater surface area than the area of the fenestration (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).
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Annotated Figure 10(1), Bruszewski
Regarding Claim 2, the island graft is radially raised from the area of the fenestration (e.g. Figure 10).
Regarding Claim 6, there is a collar surrounding a circumference of the major tubular graft and distal to the island graft (e.g. Figure 10, one of #s 104 located at the distal end of the major tubular component).
Regarding Claim 7, there is including an island graft collar circumscribing a perimeter defined by the island graft (e.g. Figure 10, #162 closest to the major tubular component).
Regarding Claim 12, the major tubular component includes
a) a surgical segment defining the fenestration (e.g. annotated Figure 10(2) below); and
b) an endovascular segment extending from the surgical segment (e.g. annotated Figure 10(2) 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 10(2) below), and defining a lumen (discussed supra for claim 1), the fenestration being closer to the juncture than to at least one of the first open and the second open end (e.g. annotated Figure 10(2) below).
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Annotated Figure 10(2), Bruszewski
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 10(2) above).
Regarding Claim 15, the endovascular segment includes a graft component (e.g. annotated Figure 10(2) above, #102) and a stent component (e.g. annotated Figure 10(2) above, #104), and wherein the stent component of the endovascular stent segment includes stents that are anchored to the graft component (e.g. Figure 10(2) above).
Regarding Claim 16, the stents are self-expanding (e.g. [0029], at least nitinol).
Regarding Claim 20, Schmitt teaches a hybrid vascular prosthesis (discussed supra for claim 1), comprising:
a) a surgical segment (discussed supra for claim 12), 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. Figure 10, the maximum diameter areas (where #s 104 are radially outward of #102) are greater than the remainder of the diameter in this segment); and
b) an endovascular stent graft segment (discussed supra for claim 12) having a graft component and a stent component fixed to the graft component (discussed supra for claim 15), and extending from the distal end of the surgical segment (e.g. annotated Figure 10(2) above), the surgical segment and the endovascular stent graft segment together defining a lumen (lumen as discussed supra for claim 1).
Regarding Claim 48, Bruszewski teaches a vascular prosthesis (discussed supra for claim 1), comprising:
a) a major tubular component of fabric (discussed supra for claim 1), the major tubular component defining a longitudinal axis and having a length (discussed supra for claim 1), and including a first open end and a second open end (discussed supra for claim 1), the major tubular component defining a lumen extending from the first open end to the second open end of the major tubular component (discussed supra for claim 1), wherein the major tubular component includes
i). an endovascular stent graft segment (discussed supra for claim 14), the endovascular stent graft segment including a luminal graft component (discussed supra for claim 15) and as stent component (discussed supra for claim 15), wherein the stent component of the endovascular stent segment includes stents that are anchored to the graft component (discussed supra for claim 15), and
ii). a surgical segment defining at least one fenestration (discussed supra for claim 12), the fenestration having an area defined as an area that would be occupied by the major tubular component in the absence of the fenestration (discussed supra for claim 1), and a length [of the fenestration] along the length of the lumen and a width transverse to the length of the major tubular component (discussed supra for claim 1), wherein the length of the fenestration is greater than the width of the fenestration (discussed supra for claim 14), and wherein the [second] endovascular stent graft segment and the surgical segment define a juncture (discussed supra for claim 12) 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 (discussed supra for claim 12); and
b) at least one island graft (discussed supra for claim 1) separately spanning each of the at least one fenestrations (discussed supra for claim 1) and attached to the surgical segment (e.g. annotated Figures 10(1) and 10(2) above), at least a portion of the at least one island graft having greater surface area than the area of the fenestration it spans (discussed supra for claim 1).
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.
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).
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 [of the fenestration] along the length of the lumen 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 [second] 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.
Bruszewski teaches b) at least one island graft (discussed supra for claim 1 under Bruszewski*) separately spanning each of the at least one fenestrations (discussed supra for claim 1 under Bruszewski) and attached to the surgical segment (discussed supra for claim 48 under Bruszewski), at least a portion of the at least one island graft having greater surface area than the area of the fenestration it spans (discussed supra for claim 1 under Bruszewski).
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.
* under Bruszewski refers to the 35 USC 102 rejections under Bruszewski detailed above
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Annotated Figure 1, Tani
Regarding Claim 49, wherein the surgical segment is corrugated (e.g. Tani, Figure 1).
Relevant Prior Art
US 2003/0135257 A1 to Taheri teaches a vascular prosthesis having a major tubular component and an island graft (e.g. Figures 2A-C, 6).
US 2019/0269497 A1 to Arbefeuille teaches a vascular prosthesis having a major tubular component and an island graft (e.g. Figures 1, 6, 10).
US 6,773,457 B2 to Ivancev, et al teaches a vascular prosthesis having a major tubular component and an island graft, where there are surgical and stent-graft segments (e.g. Figure 2).
Conclusion
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.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 4/2/2026