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 .
Claim Objections
Claim 1 is objected to because of the following informalities: lines 3-4 recite “a first end” and “a second end” while lines 5-6 recite “the first longitudinal end” (emphasis added) and “the second longitudinal end” (emphasis added). Furthermore, claim 4, which is dependent on claim 1, also recite “the first longitudinal end” (emphasis added) and “the second longitudinal end” (emphasis added). Examiner suggests that applicant amends “a first end” and “a second end” in lines 3-4 to read “the first longitudinal end” and “the second longitudinal end.” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: line 1 recites “The multibranch device of claim 1, wherein a portion of the wall defining
the recess is unsupported.”
Claim 17 is objected to because of the following informalities: line 1 recite “The method of claim 116.” Examiner suggests that applicant amends “The method of claim 116” to read “The method of claim 16” because claim 16 further claims a second portal and a third portal. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-6 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shahriari (US 2018/0098837, hereinafter “Shahriari”).
Referring to claim 1, Shahriari discloses a multibranch implantable device (FIGS. 1-8 and 12. FIG. 2 is reproduced below) comprising:
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a main body including a tubular element (12, 14 as shown in FIG. 2; para. [0043]) having wall defining a main lumen, the tubular element having a first end 86 defining a first opening into the main lumen and a second end 74 defining a second opening in the main lumen, the tubular element including at least one side branch portal (opening 120 of side branch component 16 as shown in FIGS. 1-3) defining an aperture 120 through the wall between the first longitudinal end and the second longitudinal end of the tubular element; and
at least one secondary body (branch components 16 as shown in FIGS. 1-3; paras. [0043], [0058], [0060]-[0064]) defining a secondary lumen, the at least one secondary body operable to be deployed with a portion of the secondary body positioned in the at least one side branch portal of the main body.
Referring to claim 2, Shahriari discloses the multibranch device of claim 1, wherein the at least one side branch portal (side branch component 16 as shown in FIGS. 1-3) has a first end and a second end, the secondary body being operable to be deployed such that the second end of the side branch portal is substantially contiguous with an outer surface of the main body (FIG. 2 shows opening 120, which is interpreted as second end of the side branch portal, of side branch component 16 is substantially contiguous with the inclined surface, which is an outer surface of the side branch component; para. [0063]: “As shown in FIGS. 4-6, each branch component 16 is positioned in the chamber 72 of the distal component 14 such that the passageway 150 is aligned with and covers one of the openings 120 defined in the distal component 14.”).
Referring to claim 3, Shahriari discloses the multibranch device of claim 1, wherein the first opening 74 of the first longitudinal end of the tubular element faces a first direction and the second end of the at least one side branch portal is facing substantially in the first direction when the main body is in a neutral, unbent configuration (see FIG. 2, which is reproduced above).
Referring to claim 4, Shahriari discloses the multibranch device of either claim 1, wherein the second opening 86 of the second longitudinal end of the tubular element faces a second direction and the second end of the at least one side branch portal 16 is facing substantially in the second direction when the main body is in a neutral, unbent configuration (see FIG. 2, which is reproduced above).
Referring to claim 5, Shahriari discloses the multibranch device of claim 1, wherein the wall of the main body defines a recess 110 (para. [0070]) proximate the at least one side branch portal 16 (see FIG. 2, which is reproduced above).
Referring to claim 6, Shahriari discloses the multibranch device of claim 1, wherein the main body further includes a stent coupled to the wall (frame 20 includes a plurality of self-expanding stents as shown in FIGS. 1-2; para. [0044]).
Referring to claim 8, Shahriari discloses the multibranch device of claim 1, wherein the at least one side branch portal includes a first portal, a second portal, and a third portal each having exterior openings positioned at a first longitudinal position along the main body (FIG. 8; para. [0057]: “The component 14 includes three openings 120 in the illustrative embodiment, but, in other embodiments, the component 14 may include additional or fewer openings.” Para. [0058]: “Each opening 120 in the proximal surface 100 is sized to receive a tubular conduit 18. As described in greater detail below, the plurality of branch components 16 of the device 10 are aligned with the openings 120 defined in the proximal surface 100.”).
Referring to claim 9, Shahriari discloses the multibranch device of claim 1, wherein the at least one side branch portal includes a first portal, a second portal, and a third portal each having an exterior opening, each exterior opening being positioned at one of at least two longitudinal positions along the main body. (FIG. 8; para. [0057]: “The component 14 includes three openings 120 in the illustrative embodiment, but, in other embodiments, the component 14 may include additional or fewer openings.” Para. [0058]: “Each opening 120 in the proximal surface 100 is sized to receive a tubular conduit 18. As described in greater detail below, the plurality of branch components 16 of the device 10 are aligned with the openings 120 defined in the proximal surface 100.”).
Claim(s) 10-11, 16-18 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnault De La Menardiere et al. (US 2007/0167955, hereinafter “Arnault”).
Referring to claim 10, Arnault discloses a method of deploying an endoprosthesis at a target site having a main lumen and a first branch lumen (FIGS. 8A-8H; paras. [0125]-[0139]), the method comprising:
advancing a main body 4 (FIG. 8B; para. [0126]) of a multibranch stent graft (FIGS. 8D-8H) toward the main lumen of the target site, the main body having a first portion (FIG. 8C shows a first portion is deployed from catheter 32) and a second portion (FIG. 8C shows a second portion is within catheter 32), the main body defining a first portal (FIG. 8H shows the main body has three portals.) operable to provide fluidic access from the main body to a first side branch extending from the target site when the main body is deployed at the target site (FIG. 8H);
partially deploying the first portion of the main body in the main lumen of the target site (FIG. 8C shows the first portion is deployed from catheter 32; para. [0131]: “Once the distal end of catheter portion 32 is operatively positioned within the aortic arch 5, outer sheath 38 is retracted by manually pulling on fitting 50 (see FIG. 3A) to expose the proximal end of nose cone 46 of inner member 42 and to partially deploy the distal portion of the main or aortic lumen 4 of stent graft 2 within the ascending aorta, as shown in FIG. 8C.”) ;
advancing a first articulatable wire 154 (FIG. 8C) through the first portal and into the first branch lumen (para. [0133]);
partially deploying the second portion of the main body in the main lumen of the target site (FIG. 8D; paras. [0133]-[0134]);
fully deploying the first portion and the second portion of the main body (FIGS. 8E-8F; para. [0134]);
advancing a first side branch body 6a (FIG. 8C; para. [0133]) along the first articulatable wire 154 into the first branch lumen of the target site; and
deploying the first side branch body 6a in the first branch lumen of the target site (FIG. 8C; para. [0133]).
Referring to claim 11, Arnault discloses the method of claim 10, wherein the first portal 6a has a first end (free end of side branch 6a as shown in FIG. 8H) and a second end, the second end being substantially contiguous with an outer surface of the main body 4 (FIG. 8H shows the second end, which is opposite from the first end, is located near the outer surface of the main body).
Referring to claim 13, Arnault discloses the method of claim 10, wherein the first portal is positioned such that the first portal from the first end to the second end is retrograde relative to fluid flow through the main body (FIG. 8H shows the first portal 6a is position such that the direction from the first end (free end of portal 6a) to the second end (the portion that coupled to the opening in the wall of main body 4) is retrograde with the direction of blood flow) .
Referring to claim 16, Arnault discloses the method of claim 10, wherein the main body 4 includes a second portal and a third portal (FIGS. 8C-8F; FIG. 8D is reproduced below; para. [0132]: “While the various side branch lumens 6a, 6b and 6c of stent graft 4 may be deployed serially (one at a time)”), the method further comprising:
advancing a second articulatable wire 154 through the second portal and into a second branch lumen 7b of the target site;
advancing a third articulatable wire 154 through the third portal and into a third branch lumen 7c of the target site;
advancing a second side branch body 6b along the second articulatable wire into the second branch lumen 7b of the target site; and
advancing a third side branch body 6c along the third articulatable wire 154 into the third branch lumen 7c of the target site.
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Referring to claim 17, Arnault discloses the method of claim 16, wherein the first side branch body 6a is deployed prior to deploying the second side branch body 6b and the third branch body 6c (para. [0132]: “While the various side branch lumens 6a, 6b and 6c of stent graft 4 may be deployed serially (one at a time)”).
Referring to claim 18, Arnault discloses the method of claim 16, wherein exterior openings of each of the first portal, second portal, and third portal are each positioned at a first longitudinal position along the main body (FIG. 8H shows the portals are located along the longitudinal axis of the main body).
Referring to claim 20, Arnault discloses the method of claim 10, further comprising adjusting an inner curve of the main body prior to fully deploying the first portion and the second portion of the main body (para. [0131]: “With partial deployment of stent graft 2, i.e., main aortic lumen 4 is maintained in a stretched or tensioned state, arterial blood flow exiting from aortic valve 10 flows through and around main lumen 4. It is important to note that with main lumen 4 in this partially deployed state, stent graft 2 can be easily repositioned within the vasculature as it is not yet engaged with the vessel walls and, thus, is not subject to the frictional resistance that contact with the walls would cause, not to mention the avoidance of the resulting endothelial damage and/or plaque embolization which is likely to occur.” Examiner notes that reposition of the stent graft in the aorta arch from one location to another location means that the curvature of the stent graft will be changed based on new location in the aorta arch).
Referring to claim 21, Arnault discloses the method of claim 16, wherein each of the side branch bodies are deployed substantially simultaneously (para. [0132]: “While the various side branch lumens 6a, 6b and 6c of stent graft 4 may be deployed serially (one at a time) in any order or parallelly (simultaneously) together”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahriari in view of Arbefeuille et al. (US 2014/0039597, hereinafter “Arbefeuille”) and Parodi et al. (US 2016/0081787, hereinafter “Parodi”).
Referring to claim 7, Shahriari discloses the multibranch device of claim 1, but fails to disclose a portion of the wall defining the recess is unsupported.
Referring again to claim 7, however, in the same field of endeavor, which is a multibranch implantable device, Arbefeuille discloses a main body includes a recess portion (the portion at lead lines 22, 28 and 26 as shown in FIG. 1B) and the recess portion is unsupported. Furthermore, Parodi discloses a portion of the wall, which side branches are coupled to the main body, has no stent to support (FIGS. 1-1A; FIG. 1A is reproduced below).
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Referring still to claim 7, apparently, one of ordinary skill in the art would understand that no stent is present at the portion where the side branch is coupled to the wall of the main body, in order to avoid interference with blood flow between the main body and the side branch. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the device of Shahriari such that the inclined portion of the recess portion 110 has no stent to ensure that there is no interference with blood flow between the main body and the side branch.
Claim(s) 10-14 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahriari (US 2018/0098837, hereinafter “Shahriari”) in view of Greenberg et al. (US 2012/0323300, hereinafter “Greenberg”).
Referring to claim 10, Shahriari discloses a method of deploying an endoprosthesis at a target site having a main lumen and a first branch lumen (FIGS. 7-8 and 12; paras. [0065]-[0069] and [0076]-[0081]), the method comprising:
advancing a main body (stent graft 10 as shown in FIGS. 2 and 12; paras. [0043] and [0076]) of a multibranch stent graft 18 (FIGS. 7-8 and 12) toward the main lumen of the target site, the main body having a first portion (FIG. 7, which is reproduced and annotated below, shows a first portion is deployed from catheter 32) and a second portion (see annotated figure below), the main body defining a first portal (see annotated figure below) operable to provide fluidic access from the main body to a first side branch extending from the target site when the main body is deployed at the target site (FIGS. 7-8 and 12);
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partially deploying the first portion of the main body in the main lumen of the target site (FIG. 7; para. [0066]: “As shown in FIG. 7, the proximal section 28 of the proximal component 12 remains in the compressed position when the device 10 is initially deployed.”) ;
advancing a first articulatable wire 196 (FIGS. 7-8) through the first portal and into the first branch lumen (paras. [0067]-[0068]) ;
fully deploying the first portion and the second portion of the main body (para. [0069]: “To do so, the trigger wire 58 of the restraint 50 is withdrawn from the loops 62, 64 of the reducing ties 52, 54, 56. When released, the self-expanding frame 20 of the main body 40 of the component 12 expands to outward to the position shown in FIG. 8. In the expanded position, the main body 40 engages the walls of the ascending aorta 190.”);
advancing a first side branch body 18 (FIGS. 7-8; paras. [0067]-[0068]) along the first articulatable wire 196 into the first branch lumen of the target site; and
deploying the first side branch body 18 in the first branch lumen of the target site 18 (FIGS. 7-8; paras. [0067]-[0068]).
Shahriari discloses the invention substantially as claimed except for disclosing the step of partially deploying the second portion of the main body, which is a portion of the distal portion 14 as shown in the annotated figure above, in the main lumen of the target site.
However, in the same field of endeavor, which is a method of deploying an endoprosthesis to an aorta arch having a main lumen and side branch lumens, Greenberg discloses prosthetic device includes mechanical constraints of the type known in the art and the mechanical constraints can be selectively released by activating one or more of the trigger wires (para. [0046]). Greenberg further discloses the mechanical constraints are located along the length of the prosthetic device to maintain the endovascular prosthetic device in a fully or partially collapsed configuration prior to and during deployment of the endovascular prosthetic device 302 (para. [0047]: “In FIG. 3, the proximal end of the stent graft is shown fully deployed and the distal end of the stent graft is shown partially deployed. In many applications, two or more trigger wires attach the stent graft proximally and one trigger wire attaches the stent graft distally, although only two proximal trigger wires are illustrated in the drawing figure.”).
In view of Greenberg’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided restraints to the distal end of Shahriari device to allow the surgeon to reposition the entire device to a desired location while the entire device is in a partial deployment. One of ordinary skill in the art would motivate to perform this step because in a partially deployed state, the device can be easily repositioned within the vasculature as it is not yet engaged with the vessel walls and, thus, is not subject to the frictional resistance that contact with the walls would cause endothelial damage.
Referring to claim 11, Shahriari/Greenberg discloses the method of claim 10, wherein the first portal 16 (Shahriari: FIGS. 2-3 and 8) has a first end and a second end, the second end being substantially contiguous with an outer surface of the main body.
Referring to claim 12, Shahriari/Greenberg discloses the method of claim 10, wherein the main body defines a main body longitudinal axis and the first portal defines a first portal longitudinal axis, wherein the main body longitudinal axis and the first portal longitudinal axis are substantially parallel (Shahriari: FIG. 2, which is reproduced and annotated above. The figure shows the longitudinal axis of the branch component 16 is parallel with the longitudinal axis of main body).
Referring to claim 13, Shahriari/Greenberg discloses the method of claim 10, wherein the first portal is positioned such that the first portal from the first end to the second end is retrograde relative to fluid flow through the main body (Shahriari: opening 120 and branch component 16 as shown in FIG. 7-8).
Referring to claim 14, Shahriari/Greenberg the method of claim 10, wherein walls of the main body defines a recess 110 (Shahriari: FIGS. 2 and 8. FIG. 2, which is reproduced and annotated above) proximate the first portal such that when the first articulatable wire 196 and the first side branch body 18 are advanced, the recess provides clearance for the first articulatable wire and first side branch body to exit the first portal without kinking.
Referring to claim 16, Shahriari/Greenberg discloses the method of claim 10, wherein the main body includes a second portal and a third portal (FIG. 8; para. [0057]: “The component 14 includes three openings 120 in the illustrative embodiment, but, in other embodiments, the component 14 may include additional or fewer openings.” Para. [0058]: “Each opening 120 in the proximal surface 100 is sized to receive a tubular conduit 18. As described in greater detail below, the plurality of branch components 16 of the device 10 are aligned with the openings 120 defined in the proximal surface 100.”), the method further comprising:
advancing a second articulatable wire 196 through the second portal and into a second branch lumen 186 (FIG. 8) of the target site;
advancing a third articulatable wire 196 through the third portal and into a third branch lumen 188 of the target site (in view of the disclosure in paragraph [0057] one of ordinary skill in the art would understand that Shahriari inherently teaches this step);
advancing a second side branch body 18 along the second articulatable wire into the second branch lumen 186 of the target site; and
advancing a third side branch body 18 along the third articulatable wire 196 into the third branch lumen 188 of the target site (in view of the disclosure in paragraph [0057] one of ordinary skill in the art would understand that Shahriari inherently teaches this step)
Referring to claim 17, Shahriari/Greenberg discloses the method of claim 16, wherein the first side branch body 18 is deployed prior to deploying the second side branch body 18 and the third branch body 18 (examiner notes that deployment of the side branch components 18 in serial of simultaneous is well known in the art. Extrinsic evidence Arnault (US 2007/0167955) discloses “While the various side branch lumens 6a, 6b and 6c of stent graft 4 may be deployed serially (one at a time) in any order or parallelly (simultaneously) together” (para. [0132])).
Referring to claim 18, Shahriari/Greenberg discloses the method of claim 16, wherein exterior openings of each of the first portal, second portal, and third portal are each positioned at a first longitudinal position along the main body (FIG. 2 shows each portal (120 and 16) is located along the longitudinal axis of the main body).
Referring to claim 19, Shahriari/Greenberg discloses the method of claim 16, wherein exterior openings of each of the first portal, second portal, and third portal each having an exterior opening, each exterior opening being positioned at one of at least two longitudinal positions along the main body (FIGS. 2 and 8 shows each portal (120 and 16) having an exterior opening, each exterior opening being positioned at one of at least two longitudinal positions along the main body).
Referring to claim 20, Shahriari/Greenberg discloses the method of claim 10, further comprising adjusting an inner curve of the main body prior to fully deploying the first portion and the second portion of the main body (Examiner notes that reposition of the stent graft in the aorta arch from one location to another location means that the curvature of the stent graft will be changed based on new location in the aorta arch).
Referring to claim 21, Shahriari/Greenberg discloses the method of claim 16, wherein each of the side branch bodies 18 are deployed substantially simultaneously (examiner notes that deployment of the side branch component 18 in serial of simultaneous is well known in the art. Extrinsic evidence Arnault (US 2007/0167955) discloses “While the various side branch lumens 6a, 6b and 6c of stent graft 4 may be deployed serially (one at a time) in any order or parallelly (simultaneously) together” (para. [0132])).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shahriari in view of Greenberg et al. as applied to claim 10 above and further in view Arbefeuille et al. (US 2014/0039597, hereinafter “Arbefeuille”) and Parodi et al. (US 2016/0081787, hereinafter “Parodi”).
Referring to claim 15, Shahriari/Greenberg discloses the multibranch device of claim 10, and the main body includes a stent coupled to the wall but fails to disclose a portion of the wall defining the recess does not include the stent.
Referring again to claim 15, however, in the same field of endeavor, which is a multibranch implantable device, Arbefeuille discloses a main body includes a recess portion (the portion at lead lines 22, 28 and 26 as shown in FIG. 1B) and the recess portion is unsupported. Furthermore, Parodi discloses a portion of the wall, which side branches are coupled to the main body, has no stent to support (FIGS. 1-1A; FIG. 1A is reproduced below).
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Referring still to claim 15, apparently, one of ordinary skill in the art would understand that no stent is present at the portion where the side branch is coupled to the wall of the main body, in order to avoid interference with blood flow between the main body and the side branch. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the device of Shahriari such that the inclined portion of the recess portion 110 has no stent to ensure that there is no interference with blood flow between the main body and the side branch.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771