DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claim(s) 1-20 is/are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/23/2026 has been entered.
Response to Arguments
Applicant’s arguments, filed 4/23/2026, with respect to the 35 USC 112(a) rejections have been fully considered and are persuasive. The 35 USC 112(a) rejections of claims 13-16 has/have been withdrawn due to the Applicant’s amendments.
With respect to the 35 USC 112(b) rejections, Applicants arguments filed on 4/23/2026 have been fully considered, but they are not persuasive as noted below.
Applicant argues that because some claim language using terms of degree has been found definite, the rejected claim language is definite (Applicant's Response on 4/23/2026, herein "Response", page 10). The Examiner notes the cited prior claim language is "substantial pitch" in the context of what amount of pitch is substantial enough to achieve the need of the claim". Here, "approximately" is used with numerical values to create a range of values. Understanding a threshold amount is needed for some event to occur is quite different from knowing the bounds of a range that are intended for the instant invention. For these numerical values, it is unclear because Applicant's disclosure does not provide how large or small the standard deviation is. It could be any range of values. There is simply no way to know what range "approximately" encompasses in the current Application's situation. Therefore, the language remains indefinite and the 35 USC 112(b) rejection is maintained.
In Applicant's example in Figure 18 (Response, page 11), the angle shown is exactly 180 degrees because it is a cross section. Therefore, this Figure does not support any particular bounds or range size as it supports only what is shown, 180 degrees.
With respect to Applicant's comment regarding "personal knowledge" (Response, page 11), no such reasoning was/is used by the Examiner.
With respect to Applicant's argument regarding a lack of a separate rejection for each claim (Response, page 12), the Examiner notes the issue is the same for every rejected claim and thus there is no need to repeat the same reasoning numerous times.
With respect to Applicant's argument regarding disclosure of the term "approximately" (Response, page 12), the Examiner notes there is no issue regarding disclosure (i.e. 35 USC 112(a) rejection). Thus, this argument is moot. However, the Examiner notes as discussed supra, the disclosed language does not solve the indefiniteness issue.
With respect to the prior art, Applicants arguments filed on 4/23/2026 have been fully considered, but they are not persuasive as noted below.
Applicant argues Erickson does not teach "using guidewires" or "placement [of the guidewires] in a pre-delivery state" (Response, page 13). This argument is directed to the following claim language in claim 11: "the first main graft body in a collapsed pre-delivery state receives a first hollow guide wire through at least a portion of the first lumen of the first main graft body, and through the first lateral opening in the wall portion of the first main graft body". As claimed, this language describes what happens when the first main graft body is in its collapsed pre-delivery state, which is how it's used/functions, rather than a positive recitation of the guidewire being within the lumen of the first main graft body while the first main graft body is in a collapsed pre-delivery state. Therefore, as worded, Erickson meets what is claimed.
In response to applicant's argument that placement of the guidewires during the pre-delivery state, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues there are no details provided regarding the modification of Erickson based on Mayberry (Response, page 14). Applicant further cites embodiments of Figures 12 and 14 and notes in these embodiments the guidewire is placed over rather than through the graft. As noted supra, the language in question describes how the guide wire is used/functions. Further, how the claimed limitations are met is described below in the prior art rejection section.
Applicant argues the guidewire would enter Erickson first through the main body and exit through a side opening and that in Mayberry the guidewire would enter the side opening first and exit through the main body (Response, page 14). The Examiner notes this comment is speculation. Further, Applicant does not provide any reasoning why placing the guidewire as taught by Mayberry would cause the device of Erickson to no longer function as intended when being delivered in the combination's manner. How the claimed limitations are met is described below in the prior art rejection section.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 8,221,494 in view of Mayberry, et al (Mayberry) (US 2008/0172122 A1).
Claims 1 and 11-12 are claimed by claim 3, but claim 3 fails to claim the catheter and the second guidewire.
Mayberry teaches delivery of a stent graft using a catheter, a hollow guide wire, and multiple guide wires (e.g. [0016], [0069]).
Mayberry is concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the ‘494 patent’s claims such that there are first and second hollow guidewires placed as claimed as taught by Mayberry in order to provide a means to allow for subsequent access to the patient’s anatomy and the implant (e.g. Mayberry, [0073]).
Claims 2-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 8,221,494 in view of Mayberry, et al (Mayberry) (US 2008/0172122 A1) and further in view of Erickson, et al (Erickson) (US 2007/0055350 A1).
Claims 2-3 are claimed by claim 5, but claim 5 fails to claim the catheter, the second guidewire, and the opposing positions of the openings.
Mayberry teaches delivery of a stent graft using a catheter, a hollow guide wire, and multiple guide wires (e.g. [0016], [0069]).
Mayberry is concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the ‘494 patent’s claims such that there are first and second hollow guidewires placed as claimed as taught by Mayberry in order to provide a means to allow for subsequent access to the patient’s anatomy and the implant (e.g. Mayberry, [0073]).
The combination of claim 5 and Mayberry claims the invention substantially as claimed but fails to claim the opposing positions of the openings.
Erickson teaches a stent graft having lateral openings positioned approximately 180o apart (e.g. Figures 1-2).
Erickson are concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of the ‘494 patent and Mayberry such that the lateral openings are approximately 180o apart from each other as taught by Erickson in order to match anatomy with branching vessels that are approximately 180o apart (e.g. Erickson, [0071]).
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 8,672,989 in view of Erickson, et al (Erickson) (US 2007/0055350 A1).
Claims 1 and 11 are claimed by claim 6, but claim 6 fails to claim the opposing positions of the openings.
Erickson teaches a stent graft having lateral openings positioned approximately 180o apart (e.g. Figures 1-2).
Erickson is concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the ‘989 patent such that the lateral openings are approximately 180o apart from each other as taught by Erickson in order to match anatomy with branching vessels that are approximately 180o apart (e.g. Erickson, [0071]).
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 8,672,989 in view of Erickson, et al (Erickson) (US 2007/0055350 A1) and Mayberry, et al (Mayberry) (US 2008/0172122 A1).
Claim 12 is claimed by claim 6, but claim 6 fails to claim the opposing positions of the openings and the second guidewire.
Erickson teaches a stent graft having lateral openings positioned approximately 180o apart (e.g. Figures 1-2).
Erickson is concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the ‘989 patent such that the lateral openings are approximately 180o apart from each other as taught by Erickson in order to match anatomy with branching vessels that are approximately 180o apart (e.g. Erickson, [0071]).
The combination of ‘989 and Erickson substantially claims the invention of claim 12, but fails to teach the second guidewire as claimed.
Mayberry teaches delivery of a stent graft using a catheter, a hollow guide wire, and multiple guide wires (e.g. [0016], [0069]).
Mayberry is concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of the ‘989 patent’s claims and Erickson such that there are first and second hollow guidewires placed as claimed as taught by Mayberry in order to provide a means to allow for subsequent access to the patient’s anatomy and the implant (e.g. Mayberry, [0073]).
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 1-20 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 pre-AIA the applicant regards as the invention.
The term "approximately" in each of claims 1-6, 11, 13, 15-17, and 19-20 is a relative term which renders the claim indefinite. The term "approximately" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of " approximately” (such as standard deviation or another metric). Therefore, this term is indefinite.
Claim(s) 7-10, 12, 14, and 18 are rejected as dependent from a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 11-12 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Erickson, et al (Erickson) (US 2007/0055350 A1).
Regarding Claim 11, Erickson teaches an endoluminal prosthesis (e.g. Figures 1-2), comprising:
a first main graft body (e.g. Figures 1C-1D, #101) having a first lumen extending axially therethrough (e.g. Figures 1C-1D);
a second main graft body (e.g. Figures 1C-1D, #151) having a second lumen extending axially therethrough (e.g. Figures 1C-1D);
a first lateral opening (e.g. annotated Figure 1C(1) below) extending through a wall portion of the first main graft body (e.g. Figure 1D), the first lateral opening defining a first dimension (e.g. Figure 1D, width across the opening as shown);
a second lateral opening (e.g. annotated Figure 1C(1) below) extending through the wall portion of the first main graft body (e.g. Figure 1D), the second lateral opening positioned approximately one hundred eighty degrees opposite the first lateral opening (e.g. Figures 1C-1D) and defining a second dimension (e.g. Figure 1D, width across the opening as shown) larger than the first dimension (e.g. annotated Figures 1C-1D below); and
wherein the first main graft body in a collapsed pre-delivery state (e.g. [0064], [0016], [0018]) receives a first hollow guidewire through at least a portion of the first lumen of the first main graft body, and through the first lateral opening in the wall portion of the first main graft body (as each of the first lumen, the first lateral opening, and the second lateral opening are holes and large enough for a side branch to be placed through/in (e.g. Figures 3-4), they are large enough for a hollow guidewire to be placed through each opening)
wherein the first dimension is different from the second dimension (e.g. Figures 1C-D, the second dimension is greater than the first dimension), and
wherein the second main graft body is configured to be positioned within the first lumen of the first main graft body (e.g. Figures 1C-1D, 1E).
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Annotated Figures 1C(1), Erickson
Regarding Claim 12, the first main graft body is configured to receive a second hollow guidewire through at least a portion of the first lumen of the first main graft body, and through the second lateral opening in the wall portion of the first main graft body (as each of the first lumen, the first lateral opening, and the second lateral opening are holes and large enough for a side branch to be placed through/in (e.g. Figures 3-4), they are large enough for a hollow guidewire to be placed through each opening).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-10 and 17-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Erickson, et al (Erickson) (US 2007/0055350 A1) as discussed supra and further in view of Mayberry, et al (Mayberry) (US 2008/0172122 A1).
Regarding Claim 1, Erickson teaches an endoluminal prosthesis system (discussed supra for claim 11 and e.g. [0016], [0018]), comprising:
a delivery catheter having a flexible catheter body (e.g. [0016], [0018], at least the balloon portion is flexible), a proximal end, and a distal end (the catheter inherently has these ends);
an endoluminal prosthesis (discussed supra for claim 11) comprising:
a first main graft body having a first lumen extending axially therethrough (e.g. Figures 1-2);
a first lateral opening extending through a wall portion of the first main graft body (e.g. annotated Figures 1C-1D below), the first lateral opening defining a first dimension (e.g. Figure 1D, width across the opening as shown);
a second lateral opening extending through the wall portion of the first main graft body (e.g. annotated Figures 1C-1D below), the second lateral opening positioned approximately one hundred eighty degrees opposite the first lateral opening (e.g. Figures 1C-1D) and defining a second dimension (e.g. Figure 1D, width across the opening as shown) larger than the first dimension (e.g. annotated Figures 1C-1D below).
Erickson discloses the invention substantially as claimed but fails to teach the first and second hollow guidewires and their claimed placement.
Mayberry teaches a first hollow guidewire (e.g. [0016]) advanced from the proximal end of the flexible catheter body through at least a portion of the flexible catheter body, through at least a portion of the first lumen of the first main graft body, and then through the first lateral opening in the wall portion of the first main graft body (e.g. [0016]; Figure 9, the hollow guidewire is guided from one branch to the main body to the other branch and thus passes through a portion of the lumen of the main body prior to the second branch, which meets what is intended by the claimed language; however, as claimed, the first hollow guidewire need only be able to be advanced in the manner claimed (use/function)) when the first main graft body is in a collapsed, pre-delivery state within the flexible catheter body (e.g. [0016]); and
a hollow guidewire (e.g. [0016]) advanced from the proximal end of the flexible catheter body through at least a portion of the flexible catheter body, through at least a portion of the first lumen of the first main graft body, and through the second lateral opening in the wall portion of the first main graft body (e.g. [0016]) when the first main graft body is in the collapsed, pre-delivery state within the flexible catheter body (e.g. [0016]).
Mayberry further teaches the use of first and second guide wires (e.g. [0069]).
Mayberry and Erickson are concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Erickson such that there are first and second hollow guidewires placed as claimed as taught by Mayberry in order to provide a means to allow for subsequent access to the patient’s anatomy and the implant (e.g. Mayberry, [0073]).
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Annotated Figures 1C-1D, Erickson
Regarding Claim 2, the second dimension is approximately four times larger than the first dimension (as broadly claimed and disclosed in Applicant’s specification, “approximately” does not have any particular bounds, thus, the dimensions of Erickson are considered to meet the claimed relationship).
Regarding Claim 3, when the endoluminal prosthesis is in a deployed state, the first lateral opening is approximately axially aligned with a first vessel and the second lateral opening is axially offset from a second vessel (e.g. Erickson, Figure 2; the Examiner notes this location is the same as disclosed by Applicant in Figure 23).
Regarding Claim 4, there is a second main graft body positioned within the first lumen (e.g. Erickson, Figure 1D), the second main graft body having a second lumen extending axially therethrough (e.g. Erickson, Figure 1D);
a third lateral opening (e.g. Erickson, annotated Figures 1C-1D above) extending through a wall portion of the second main graft body (e.g. Erickson, Figures 1C-D), the third lateral opening defining a third dimension (e.g. Erickson, Figures 1C-D);
a fourth lateral opening (e.g. Erickson, annotated Figures 1C-1D above) extending through the wall portion of the second main graft body (e.g. Erickson, Figures 1C-D), the fourth lateral opening positioned approximately one hundred eighty degrees opposite the third lateral opening (e.g. Erickson, Figures 1C-D) and defining a fourth dimension (e.g. Erickson, Figures 1C-D) larger than the third dimension (e.g. Erickson, Figures 1C-D).
Erickson discloses the invention substantially as claimed but fails to teach:
a third hollow guidewire advanced from the proximal end of the flexible catheter body through at least a portion of the flexible catheter body, through at least a portion of the second lumen of the second main graft body, and through the third lateral opening in the wall portion of the second main graft body when the second main graft body is in a collapsed, pre-delivery state within the flexible catheter body; and
a fourth hollow guidewire advanced from the proximal end of the flexible catheter body through at least a portion of the flexible catheter body, through at least a portion of the second lumen of the second main graft body, and through the fourth lateral opening in the wall portion of the second main graft body when the second main graft body is in the collapsed, pre-delivery state within the flexible catheter body.
Mayberry teaches hollow guidewires and using multiple guidewires (discussed supra for claim 1).
Mayberry and Erickson are concerned with the same field of endeavor as the claimed invention, namely branched stent grafts delivered via catheters.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of Erickson and Mayberry such that there are third and fourth guide wires placed as claimed to provide a means to allow for subsequent access to the patient’s anatomy and the implant (e.g. Mayberry, [0073]) and as it has been held that duplication of parts requires only routine skill in the art, as no new or unexpected results will result from the additional part (MPEP 2144.04 (VI)(B)).
Regarding Claim 5, the fourth dimension is approximately four times larger than the third dimension (as broadly claimed and disclosed in Applicant’s specification, “approximately” does not have any particular bounds, thus, the dimensions of Erickson are considered to meet the claimed relationship).
Regarding Claim 6, when the endoluminal prosthesis is in the deployed state, the third lateral opening is approximately axially aligned with the second vessel, and the fourth lateral opening is axially offset from the first vessel (e.g. Erickson, Figure 2; the Examiner notes this location is the same as disclosed by Applicant in Figure 23).
Regarding Claim 7, the first lateral opening and the fourth lateral opening are axially offset and are configured to receive an expansion device (e.g. Erickson, Figure 2; the Examiner notes this location is the same as disclosed by Applicant in Figure 23; expansion via delivery catheter components).
Regarding Claim 8, the first lateral opening and the fourth lateral opening are axially offset and are configured to receive an expansion device (e.g. Erickson, Figure 2; the Examiner notes this location is the same as disclosed by Applicant in Figure 23; expansion via delivery catheter components).
Regarding Claim 9, the expansion device comprises a balloon (e.g. Erickson, [0016], [0018]).
Regarding Claim 10, the expansion device comprises a stent (e.g. Erickson, Figures 1-2, [0064]-[0065], self-expanding stent).
Regarding Claim 17, the combination of Erickson and Mayberry teaches an endoluminal prosthesis system (discussed supra for claim 1), comprising:
a delivery catheter (discussed supra for claim 1) comprising:
a flexible catheter body with a proximal end, and a distal end (discussed supra for claim 1);
a first passage extending through at least a portion of the flexible catheter body (e.g. Mayberry, Figure 6, passage holding #144);
a second passage extending through at least a portion of the flexible catheter body (e.g. Mayberry as discussed supra for claim 1, the passage that the second hollow guide wire passes through); and
a third passage extending through at least a portion of the flexible catheter body (e.g. Mayberry as discussed supra for claim 1, the passage that the third hollow guide wire passes through);
an endoluminal prosthesis (discussed supra for claim 1) comprising:
a first main graft body having a first lumen extending axially therethrough (discussed supra for claim 1);
a first lateral opening extending through a wall portion of the first main graft body, the first lateral opening defining a first dimension (discussed supra for claim 1); and
a second lateral opening extending through the wall portion of the first main graft body, the second lateral opening positioned approximately one hundred eighty degrees opposite the first lateral opening and defining a second dimension larger than the first dimension (discussed supra for claim 1); and
a first hollow guidewire advanced through the first passage, through at least a portion of the first lumen of the first main graft body, and through the first lateral opening in the wall portion of the first main graft body when the first main graft body is in a collapsed, pre-delivery state within the flexible catheter body (discussed supra for claim 1).
Regarding Claim 18, there is a second hollow guidewire advanced through the second passage (discussed supra for claims 1 and 17), through at least a portion of the first lumen of the first main graft body, and through the second lateral opening in the wall portion of the first main graft body when the first main graft body is in the collapsed, pre-delivery state within the flexible catheter body (discussed supra for claims 1 and 17); and
a third hollow guidewire advanced through the third passage (discussed supra for claims 4 and 17), and through at least a portion of the first lumen of the first main graft body when the first main graft body is in the collapsed, pre-delivery state within the flexible catheter body (discussed supra for claims 4 and 17).
Regarding Claim 19, when the endoluminal prosthesis is in a deployed state, the first lateral opening is approximately axially aligned with a first vessel and the second lateral opening is axially offset from a second vessel (discussed supra for claims 3 and 6-8).
Regarding Claim 20, the second dimension is approximately four times larger than the first dimension (discussed supra for claims 2 and 5).
Claim(s) 13-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Erickson, et al (Erickson) (US 2007/0055350 A1) as discussed supra and further in view of Vardi, et al (Vardi) US 2003/0028233 A1.
Regarding Claim 13, Erickson discloses the invention substantially as claimed but fails to teach there is a third lateral opening extending through a wall portion of the second main graft body, the third lateral opening defining a third dimension;
a fourth lateral opening extending through the wall portion of the second main graft body, the fourth lateral opening positioned approximately one hundred eighty degrees opposite the third lateral opening and defining a fourth dimension larger than the third dimension; and
the second main graft body is configured to collapse into a pre-delivery state () and receive a third hollow guidewire through at least a portion of the second lumen of the second main graft body, and through the third lateral opening in the wall portion of the first main graft body.
Vardi teaches a branch stent placed in a lateral opening (e.g. Figures 7A-8, #40), the branch stent (second main graft body) having a third lateral opening extending through a wall portion of the second main graft body (e.g. Figure 8, one of the diamond cells), the third lateral opening defining a third dimension (the minor axis of the diamond);
a fourth lateral opening extending through the wall portion of the second main graft body, the fourth lateral opening positioned approximately one hundred eighty degrees opposite the third lateral opening (e.g. Figure 8, one of the diamond cells, located 180o opposite the third opening) and defining a fourth dimension larger than the third dimension (the major axis of the diamond); and
the second main graft body is configured to collapse into a pre-delivery state (e.g. configuration in Figure 7A) and receive a third hollow guidewire through at least a portion of the second lumen of the second main graft body, and through the third lateral opening in the wall portion of the first main graft body (each of the second lumen, the third lateral opening, and the fourth lateral opening are holes large enough for a hollow guidewire to be placed through each opening).
Vardi and Erickson are concerned with the same field of endeavor as the claimed invention, namely stent grafts having lateral side openings and branch stents.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Erickson such that the second main graft body is that as taught by Vardi as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of branch device placed to support a branching artery and direct blood flow (e.g. Erickson, [0046], [0301] and Vardi, [0009].
Regarding Claim 14, the second main graft body is configured to receive a fourth hollow guidewire through at least a portion of the second lumen of the first main graft body, and through the fourth lateral opening in the wall portion of the second main graft body (each of the second lumen, the third lateral opening, and the fourth lateral opening are holes large enough for a hollow guidewire to be placed through each opening).
Regarding Claim 15, when the endoluminal prosthesis is in a deployed state:
the first lateral opening is approximately axially aligned with a first vessel;
the second lateral opening is axially offset from a second vessel;
the third lateral opening is approximately aligned with the second vessel; and
the fourth lateral opening is axially offset from the first vessel (e.g. Erickson, Figure2, Vardi, Figure 8).
Regarding Claim 16, the second dimension is approximately four times larger than the first dimension (as broadly claimed and disclosed in Applicant’s specification, “approximately” does not have any particular bounds, thus, the dimensions of Erickson are considered to meet the claimed relationship) and the fourth dimension is approximately four times larger than the third dimension (as broadly claimed and disclosed in Applicant’s specification, “approximately” does not have any particular bounds, thus, the dimensions of Erickson are considered to meet the claimed relationship).
Conclusion
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 5/29/2026
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