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 is/are pending.
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 2-7 and 11-14 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.
Claims 2-6 each recites the limitation "the second deploying step". 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 step of deploying the first bridging stent graft and/or the second bridging stent graft”. Alternatively, Applicant can introduce first and second deploying steps in claim 1, for example as “first, deploying a first modular stent device …” and “second, deploying a first bridging stent graft …”.
Claim 7 recites the limitation "the first deploying step". 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 step of deploying the first modular stent device”. Alternatively, Applicant can introduce first and second deploying steps in claim 1, for example as “first, deploying a first modular stent device …” and “second, deploying a first bridging stent graft …”.
Claim 11 recites “the main body” twice. It is unclear which main body is being referred back to. For purposes of examination the Examiner considers this language to be “the main body of the second modular stent device”.
Claim 12 recites “the bypass gate”. It is unclear which bypass gate is being referred back to. For purposes of examination the Examiner considers this language to be “the bypass gate of the second modular stent device”.
Claim 12 recites the limitation "the third deploying step". 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 step of deploying the second modular stent device”. Alternatively, Applicant can introduce the third deploying step in claim 11, for example as “third, deploying a second modular stent device …”.
Claim 14 recites the limitation "the fourth deploying step". 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 step of deploying the third bridging stent graft”. Alternatively, Applicant can introduce the fourth deploying step in claim 13, for example as “fourth, deploying a third bridging stent graft”.
Claim(s) 13 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.
For anatomical locations, see Applicant’s Figure 3 and [0058].
Claim(s) 1-9 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (US 2013/0274861 A1).
Regarding Claim 1, Kelly teaches a method of deploying a modular multibranch stent assembly (e.g. Figure 6, [0159]-[0160]), the method comprising:
deploying a first modular stent device in an ascending aorta (e.g. Figure 6, the device is located in the ascending aorta and aortic arch and thus must have been delivered to the claimed location), the first modular stent device including a main body, a bypass gate extending from the main body, and a bifurcated contra limb extending from the main body, the bifurcated contra limb including a first distal limb and a second distal limb (e.g. annotated Figure 6(1) below); and
deploying a first bridging stent graft in the first distal limb and/or a second bridging stent graft in the second distal limb (e.g. annotated Figure 6(1) below).
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Annotated Figure 6(1), Kelly
Regarding Claim 2, the second deploying step includes deploying the first bridging stent graft in the first distal limb and the second bridging stent graft in the second distal limb (e.g. annotated Figure 6(1) above).
Regarding Claim 3, the second deploying step includes deploying the first bridging stent in the first distal limb and a left common carotid artery (e.g. annotated Figure 6(1) above).
Regarding Claim 4, the second deploying step includes deploying the second bridging stent graft in the second distal limb and a brachiocephalic artery (e.g. annotated Figure 6(1) above).
Regarding Claim 5, the first bridging stent graft contacts the second bridging stent graft after the second deploying step (e.g. annotated Figure 6(1) above).
Regarding Claim 6, the first bridging stent graft contacts the bypass gate after the second deploying step (e.g. annotated Figure 6(1) above).
Regarding Claim 7, the bypass gate extends beyond a distal end of the bifurcated contra limb after the first deploying step (e.g. annotated Figure 6(1) above; where distal is away from the heart).
Regarding Claim 8, the first distal limb is connected to the second distal limb at a septum (e.g. annotated Figure 6(1) above; the details of element #1000 shown in Figures 10A-10B; Figure 10B and [0175] show the bifurcation of the bifurcated contra limb).
Regarding Claim 9, the method includes deploying a tube graft in the bypass gate (e.g. annotated Figure 6(2) below).
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Annotated Figure 6(2), Kelly
Regarding Claim 15, Kelly teaches a method of deploying a modular multibranch stent assembly (discussed supra for claim 1), the method comprising:
delivering a first modular stent device in a delivery position within a delivery system to an ascending aorta (discussed supra for claim 1), the first modular stent device including a main body, a bypass gate extending from the main body, and a bifurcated contra limb extending from the main body, the bifurcated contra limb including a first distal limb and a second distal limb (discussed supra for claim 1);
deploying the first modular stent device in the ascending aorta in a deployed position (discussed supra for claim 1);
deploying a first bridging stent graft in the first distal limb and a left common carotid artery (discussed supra for claim 3); and
deploying a second bridging stent graft in the second distal limb and a brachiocephalic artery (discussed supra for claim 4).
Regarding Claim 16, the method includes expanding the first bridging stent from a delivery position to a deployed position to be anchored within the second distal limb and the left common carotid artery (discussed supra for claims 1 and 3).
Regarding Claim 17, the method includes expanding the second bridging stent from a delivery position to a deployed position to be anchored within the first distal limb and the brachiocephalic artery (discussed supra for claims 1 and 4).
Regarding Claim 18, Kelly teaches a method of deploying a modular multibranch stent assembly (discussed supra for claim 1), the method comprising:
deploying a first modular stent device in an ascending aorta during a first stage (discussed supra for claim 1), the first modular stent device including a main body, a bypass gate extending from the main body, and a bifurcated contra limb extending from the main body, the bifurcated contra limb including a first distal limb and a second distal limb (discussed supra for claim 1); and
deploying a first bridging stent graft in the first distal limb in a second stage (discussed supra for claim 1); and
deploying a second bridging stent graft in the second distal limb in a third stage (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.
Claims 11-14 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2013/0274861 A1) as discussed supra, alone.
Regarding Claim 11, the embodiment of Figure 6 discloses the invention substantially as claimed but fails to teach the method includes deploying a second modular stent device in the bypass gate, the second modular stent device includes a main body, a bypass gate extending from the main body, and an artery branch extending from the main body.
Kelly teaches in Figure 3 a device having a second modular stent device in the bypass gate, the second modular stent device includes a main body, a bypass gate extending from the main body, and an artery branch extending from the main body in addition to the first modular stent device (e.g. annotated Figure 3 below). Kelly teaches placing the device of Figure 3 into the proximal aorta (e.g. [0138]) and the invention is intended to provide a much more versatile approach that can handle an almost infinite anatomic configurative without customized graft construction (e.g. [0242]).
Each cited teaching of Kelly is concerned with the same field of endeavor as the claimed invention, namely stent grafts having multiple branches and methods of placing them in the ascending aorta/aortic arch and its branches.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kelly’s Figure 6 by incorporating the second modular stent device as taught in the embodiment of Figure 3 in order to provide a much more versatile approach that can handle an almost infinite anatomic configurative without customized graft construction (e.g. [0242]).
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Annotated Figure 3, Kelly
Regarding Claim 12, the main body of the second modular stent device is located within the bypass gate after the third deploying step (e.g. annotated Figure 3 above; [0038], the second modular stent device (extension) is delivered in a separate catheter into a previously delivery portion of the device).
Regarding Claim 13, deploying a third bridging stent in the artery branch of the second modular stent device (e.g. annotated Figure 3 above).
Regarding Claim 14, Kelly discloses the invention substantially as claimed but fails to teach the fourth deploying step includes deploying the third bridging stent in a left subclavian artery.
Kelly teaches the invention is intended to provide a much more versatile approach that can handle an almost infinite anatomic configurative without customized graft construction (e.g. [0242]). Further, as discussed supra for claims 3-4, the first and second bridging stent grafts are placed in the brachiocephalic artery and the carotid artery. The left subclavian artery is downstream of these two arteries.
Each cited teaching of Kelly is concerned with the same field of endeavor as the claimed invention, namely stent grafts having multiple branches and methods of placing them in the ascending aorta/aortic arch and its branches.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kelly such that the third bridging stent graft is placed in the left subclavian artery because Kelly teaches the branches are placed as needed by the anatomy (e.g. [0242]) and because the third bridging stent graft of the second modular stent device (which is further downstream along the length of the combined first and second modular stent graft devices) is closer to the left subclavian artery and the upstream branches have already been treated with branches (as noted supra).
Regarding Claims 19-20, Kelly discloses the invention substantially as claimed but fails to teach each of the second stage and the third stage is later than the first stage.
Kelly teaches the embodiment of Figure 6 includes debranching stent graft #1000 (e.g. Figure 10B) and describes the use of debranching stent graft #1100 (e.g. Figure 11B) being deployed into an already implanted device #400 (e.g. [0200]).
Each cited teaching of Kelly is concerned with the same field of endeavor as the claimed invention, namely stent grafts having multiple branches and methods of placing them in the ascending aorta/aortic arch and its branches.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of implanting the device of Figure 6 by incorporating steps such that each of the second stage and the third stage is later than the first stage 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, elements #400 and #1100 are connected together as shown and described and route the blood flow in the same manner as disclosed and shown in Figure 6.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US 2013/0274861 A1) as discussed supra and further in view of Taheri (US 6,723,116 B2).
Regarding Claim 10, Kelly discloses the invention substantially as claimed but fails to teach the method includes inserting a bypass between a left common carotid artery and a left subclavian artery.
Taheri teaches a method of placing a stent graft in an ascending aorta/aortic arch (e.g. Figures 11-12) where there is also a step of inserting a bypass between a left common carotid artery and a left subclavian artery (e.g. Figure 12, #402; column 9, line 48 to column 10, line 23).
Taheri and Kelly are concerned with the same field of endeavor as the claimed invention, namely methods of placing a stent graft in an ascending aorta/aortic arch.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kelly by incorporating a step of inserting a bypass between a left common carotid artery and a left subclavian artery as taught by Taheri in order to provide a means to repair an aneurysm of the aortic arch or ascending/descending aorta in which the diseased section is excised and replaced (e.g. Taheri, column 4, lines 12-24; column 9, line 48 to column 10, line 23).
Relevant Prior Art
US 2019/0083229 A1 to Varga and US 2017/0340461 A1 to Varga each teaches a modular stent graft for placement in the ascending aorta/aortic arch (e.g. Figure 1).
US 2018/0153677 A1 to Perkins, et al teaches a modular stent graft for placement in the ascending aorta/aortic arch and a method of delivering this device (e.g. Figures 12-26).
US 2017/0296324 A1 to Argentine teaches a modular stent graft for placement in the ascending aorta/aortic arch and a method of delivering this device (e.g. Figures 1, 4-5, 7-8).
US 2007/0250154 A1 to Greenberg, et al teaches a modular stent graft for placement in the ascending aorta/aortic arch and a method of delivering this device (e.g. Figures 1, 15C-M).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. 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 4/27/2026
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