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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2026 has been entered.
Response to Amendment
The amendment filed 03/17/2026 has been entered. Claims 1-11, 21-25, 27-28, and 30-31 remain pending in the application, claim 11 is withdrawn, claims 12-20, 26, and 29 are canceled, and claim 32 is added. Applicant’s amendments to the claims have not overcome the interpretation of the prior art rejection previously set forth in the Final Office Action mailed 11/17/2025.
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument with respect to claim 1. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Applicant argues on pages 9-11 that it is difficult to ascertain the precise location of the alleged bifurcation in the annotated version of fig. 15, and that the alleged “first end” and “second end” denoted on the figure are each pointing to two different lumen and the alleged “bifurcated portion” appears to point to a third separate lumen. Moreover, based on fig. 15, there is no clear evidence on the record that bifurcation ends extend distally from the same bifurcation point. The Office respectfully disagrees. Paragraph 53 discloses “Each conduit 48 defines a passage 50 that is separate from the internal volume 40. The passage 50 is open on a first end 52 into the inner lumen 46 and is open on a second end 54 into the space surrounding the filling structure 26” with respect to figure 2. Although figure 2 is a different embodiment than figure 15, they share the same elements of the conduits 48 and the passage 50, as well as the inner lumen 46. In figure 2, it is clear that the two conduits 48 extend from the bifurcated point which is the passage 50. The conduits 48 each have an end 52 that can be seen to extend distally from the bifurcated portion to the distal end of the inflatable fill structure 26 (see annotated figure 2 below). Therefore, the rejection is maintained.
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Applicant argues on pages 11-12 that Stone also has not been shown to teach a stent graft system “wherein the at least one inflatable fill structure comprises a plurality of inflatable fill structures” and cites to figures 16-18 to explain how the combination is problematic. The Office respectfully disagrees. The Office is NOT applying figures 16-18 to teach the plurality of inflatable fill structures. The Office cites to paragraph 66 which teaches “ In some embodiments, as described in more detail below, the internal volume 40 is separated into multiple chambers or compartments and the filling structure 26 includes multiple filling valves to allow each of the multiple chambers or compartments to be individually filled with the filling medium.” Although figure 14 does not explicitly disclose the multiple chambers or compartments, figure 14 does show a broken down version of the inflatable fill structure 26 with individual sections that read on the plurality of inflatable fill structures, when read in view of the teachings of paragraph 66. Therefore, the rejection is maintained.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32 lines 1-2 “wherein the ends form two fluidly connected lumen” is suggested to read “wherein the ends form two fluidly connected lumens” for better grammar.
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.
Claim 31 is 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 31 recites “the bifurcated portion” in lines 2 and 3, and is unclear if Applicant is reciting a single bifurcation portion of the bifurcation portions, or all of the bifurcated portions (plural) as previously introduced in claim 1. For the purposes of examination, the Office will interpret the claim to mean the bifurcated portions.
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.
Claims 1-3, 5, 9, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Ganpath et al. (US 2015/0148892) in view of Chobotov et al. (US PGPub 2009/0099649), hereinafter known as “Ganpath” and “Chobotov 649,” respectively.
With regards to claim 1, Ganpath discloses (Figures 21-22; although the figures are two different embodiments, the filling structure 806 of figure 22 is envisioned to be utilized in place of the filling structures 792/794/799 of figure 21 as paragraph 90 discloses “While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting in scope of the invention which is defined by the appended claims”) a stent graft system (figure 21) (paragraphs 57 and 77), comprising:
a stent graft 796/798 (paragraphs 57 and 77);
an inflatable fill structure 806 (paragraph 78) at least partially surrounding the stent graft 796/798 (paragraph 78), the inflatable fill structure 802 having a cavity that has a collapsed bifurcated shape when in an unfilled state and an expanded bifurcated shape when in a filled state (see annotated figure 22 below), wherein the inflatable fill structure 806 comprises two ends and bifurcated portions (see annotated figure 22 below); and
wherein the bifurcated portions are in fluid communication with the cavity and each other (see annotated figure 22 below – filling tab (FT) fills the lumen (L) of each leg 802/804 and thus the bifurcated portions are in fluid communication with the cavity and each other due to the single FT filling the entire filling structure 806 through the lumen L, there is no disclosure stating that the lumens are separate from each other and since they both share the same character “L,” it is interpreted that the lumen is shared across the bifurcated portions).
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Ganpath is silent to a cuff that is fillable and that is located outside of the inflatable fill structure.
However, in a similar field of endeavor of stent graft systems, Chobotov 649 teaches (Figures 1-14) a cuff 62 that is fillable (paragraphs 45-46 and 48) and that is located outside of the stent graft 12 (figure 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath to include the cuff as taught by Chobotov 649 for the purpose of sealing against the inside surface of a patient’s vessel (paragraph 6 of Chobotov 649).
The combination of Ganpath/Chobotov 649 results in Chobotov 649’s cuff 62 located on the outside and towards the upper end of Ganpath’s inflatable fill structure 806, similar to how the cuff 62 is located on the outside and towards the upper end of the medical device 10 of Chobotov 649. Therefore, a first end (Ganpath: see annotated figure 22 above) of the ends of the inflatable fill structure (Ganpath: 806) is closer to the bifurcated portions (Ganpath: see annotated figure 22 above) of the inflatable fill structure (Ganpath: 806) than to the cuff (Chobotov 649: 62).
With regards to claim 2, Ganpath further discloses wherein a portion of the cavity 802/804 is configured to receive a branch stent graft for connection to the stent graft (functional limitation – paragraph 78 – “Two leg regions 802, 804 help to seal around the leg extension scaffolds that are received by the docking scaffold” – therefore the portion of the cavity is capable of receiving a branch stent graft).
With regards to claim 3, as rejected above, it would be obvious to modify the stent graft system of Ganpath to include the cuff of Chobotov 649. Chobotov 649 further discloses wherein the cuff 62 is located at an end of the stent graft 12 (figure 1). Thus, when incorporating the cuff of Chobotov 649, the claimed limitation is considered obvious.
With regards to claim 5, Ganpath/Chobotov 649 disclose the stent graft system as claimed in claim 1. Ganpath further discloses a single inflatable channel (figure 22 – “FT” – filling tab that acts as a valve to allow filling of the filling structure; paragraph 61). Ganpath/Chobotov 649 are silent to further comprising: inflatable channels located at least partially around the stent graft and surrounded by the inflatable fill structure.
However, Chobotov 649 teaches (Figures 1-14) further comprising: inflatable channels 58 (paragraphs 44-46 and 48) located at least partially around the stent graft 12 (figure 13).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath/Chobotov 649 to include the inflatable channels as taught by Chobotov 649 for the purpose of accepting a hardenable fill or inflation material to provide structural rigidity to the main graft member when the network of inflatable channels is in an inflated state (paragraph 6 of Chobotov 649).
The combination of Ganpath/Chobotov 649 with the inflatable channels 58 of Chobotov 649 would result in the inflatable channels 58 of Chobotov 649 to be surrounded by the inflatable fill structure 806 of Ganpath due to the inflatable fill structure surrounding the stent graft 796/798 of Ganpath.
With regards to claim 9, Ganpath/Chobotov 649 disclose the stent graft system as claimed in claim 1. Ganpath/Chobotov 649 are silent to further comprising:
a longitudinal support structure anchored to an end of the inflatable fill structure and structurally coupled to the scaffold.
However, Chobotov 649 teaches (Figures 1-14) further comprising:
a longitudinal support structure 88 anchored to an end of the stent graft 12 (figures 8-10; paragraphs 65-67 - anchored via belts 86 in which the wire/rod 88 extends through to lock, or anchor, the belt 86 to an end of the stent graft 12 where stent 32B is located) and structurally coupled to the scaffold 32A.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath/Chobotov 649 to include the longitudinal support structure and scaffold mechanism of Chobotov 649 for the purpose of maintaining a small profile and avoiding engagement of the stents with a body lumen wall until deployment of the stents is initiated (paragraph 65 of Chobotov 649).
The combination of Ganpath/Chobotov 649 results in Chobotov 649’s longitudinal support structure 88 anchored to an end of the inflatable fill structure 806 of Ganpath, similar to how the longitudinal support structure 88 is anchored to an end of the medical device 10 of Chobotov 649.
With regards to claim 30, Ganpath/Chobotov 649 disclose wherein when the cuff is filled (Chobotov 649: 62; paragraph 45), a gap is between the cuff (Chobotov: 649: 62) and the stent graft (Ganpath: 796/798), and the inflatable fill structure (Ganpath: 806) fills the gap when inflated (the combination of Ganpath/Chobotov 649 allows the cuff 62 of Chobotov 649 to be placed around the outside of Ganpath’s inflatable fill structure 806, Ganpath’s inflatable fill structure 806 is placed around the outside of Ganpath’s stent graft 796/798. Therefore, there is a gap present between the cuff 62 of Chobotov 649 and the stent graft 796/798 of Ganpath, the gap being occupied by the inflatable fill structure 806 of Ganpath).
With regards to claim 31, Ganpath further discloses wherein the first end extends from below the bifurcation portion to a second end of the ends of the inflatable fill structure, across the bifurcated portion, wherein the bifurcation portion is between the first end and the second end of the inflatable fill structure (see annotated figure 22 below).
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Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ganpath in view of Chobotov 649, and further in view of Chobotov (US PGPub 2010/0016943), hereinafter known as “Chobotov 943”.
With regards to claim 4, Ganpath/Chobotov 649 disclose the stent graft system as claimed in claim 1. Ganpath/Chobotov 649 are silent wherein the cuff has a tapered shape such that it is wider at one end than at an opposite end when filled with a fill medium.
However, in a similar field of endeavor of stent graft systems, Chobotov 943 teaches (Figure 1) wherein the cuff 16 conforms to the shape of the vessel within which it is deployed (paragraphs 122 and 217). Similarly, Applicant has disclosed in the instant specification that the cuff has a tapered shape to accommodate the shape of a proximal neck of an aneurysm (spec. [0068]).
Therefore, since both the instant invention and the prior art are directed to cuffs conforming to the shape of the vessel within which it is deployed, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cuff of Ganpath/Chobotov 649 to a tapering cuff as taught by Chobotov 943 since it has been held that discovering an optimum shape of a result-effective variable involves only routine skill in the art (MPEP 2144.05).
With regards to claim 7, Ganpath/Chobotov 649 disclose the stent graft system as claimed in claim 1. Ganpath/Chobotov 649 are silent wherein the inflatable fill structure is configured such that the cavity that is bifurcated is longer on one side of the bifurcation than on the other side of the bifurcation.
However, in a similar field of endeavor of stent graft systems, Chobotov 943 teaches (Figure 7) wherein the stent graft 116 is configured such that the cavity of the stent graft 116 that is bifurcated is longer on one side of the bifurcation 114 than on the other side of the bifurcation 115 (paragraph 167).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath/Chobotov 649 to include the different stent graft bifurcation lengths as taught by Chobotov 943 for the purpose of accommodating graft delivery system requirements and various clinical demands (paragraph 167 of Chobotov 943).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ganpath in view of Chobotov 649, and further in view of Herbowy et al. (US PGPub 2018/0028192), hereinafter known as “Herbowy.”
With regards to claim 6, Ganpath/Chobotov 649 disclose the stent graft system as claimed in claim 1. Ganpath/Chobotov 649 are silent wherein the cuff and the inflatable fill structure are separately fillable from each other to different pressures with fill medium.
However, in a similar field of endeavor of stent graft systems, Herbowy teaches (Figure 19C) wherein the cuff 582 and the inflatable fill structure 576 are separately fillable from each other to different pressures with fill medium (paragraph 150).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath/Chobotov 649 to include the separately fillable cuff and inflatable fill structure to different pressures of fill medium as taught by Herbowy for the purpose of monitoring the pressure between the inflatable fill structure and the aneurysm wall, thereby preventing over inflation in one region and underinflation in another region (paragraph 150 of Herbowy).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ganpath in view of Chobotov 649, and further in view of Schreck et al. (WO 2015/183489), hereinafter known as “Schreck.”
With regards to claim 8, Ganpath/Chobotov 649 disclose the stent graft system as claimed in claim 1. Ganpath/Chobotov 649 are silent to further comprising:
a scaffold located in the cavity at least partially in an area where a branch stent graft is insertable into the cavity;
wherein the scaffold is configured to provide structural support to the inflatable fill structure prior to the branch stent graft being received within the cavity.
However, in a similar field of endeavor of stent graft systems, Schreck teaches (Figure 17) a scaffold 1700 located in the cavity (paragraph 126; figure 17 – scaffold 1700 is located within the graft 1702 which is within the inflatable fill structure 1704) at least partially in an area where a branch stent graft is insertable into the cavity (scaffold 1700 is within the graft 1702 in which may receive the branch stent graft as disclosed in the figures 7A-7E embodiment);
wherein the scaffold 1700 is configured to provide structural support to the inflatable fill structure 1704 prior to the branch stent graft being received within the cavity (figures 17; paragraph -14; paragraph 126).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath/Chobotov 649 to include the scaffold mechanism as taught by Schreck for the purpose of providing support to the graft (paragraph 99 of Schreck).
With regards to claim 10, Ganpath/Chobotov 649 disclose the stent graft system of claim 1. Ganpath further discloses wherein the stent graft includes a branch stent graft 796/798. The combination is silent wherein the stent graft includes a main stent graft and a branch stent graft that are integrally formed, and the main stent graft includes a stent graft cavity.
However, in a similar field of endeavor of stent graft systems, Schreck teaches (Figures 7A-7E) wherein the stent graft 700 includes a main stent graft 700 and a branch stent graft (stent shown within the ipsilateral leg 706 in figure 7A-7B) that are integrally formed, and the main stent graft 700 includes a stent graft cavity (where 708 points to in figures 7A-7B) for receiving a second branch stent graft 714 (paragraphs 106-108).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Ganpath/Chobotov 649 to include a main stent graft integrally formed with the branch stent graft and including a stent graft cavity for receiving the second branch stent graft as taught by Schreck for the purpose of selectively excluding/sealing different sections of the aneurysm.
Claims 21-25, 27-28 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Stone et al. (WO 2017/117068), hereinafter known as “Stone,” in view of Schreck.
With regards to claim 21, Stone discloses (Figures 14-15) a stent graft system (figure 14; paragraph 75), comprising:
a stent graft 22 (paragraph 52); and
at least one inflatable fill structure 26 (paragraph 75) at least partially surrounding the stent graft 22 (paragraph 53), the inflatable fill structure 26 having at least one cavity 46 (paragraphs 53 and 77; figure 15), wherein the at least one inflatable fill structure 26 comprises two ends and a bifurcated portion (see annotated figure 15 below – bottom-most branches of the inflatable fill structure 26 is interpreted as the bifurcated portion);
wherein the ends extend distally from the bifurcated portion to a distal end of the inflatable fill structure 26 (see annotated figure 15 below).
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Stone is silent to a cuff that is fillable and that is located outside of the at least one inflatable fill structure.
However, in a similar field of endeavor of stent graft systems, Schreck teaches (Figure 57) a cuff 5704a that is fillable (paragraph 206) and that is located outside of the stent graft 5708 (figure 57).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent graft system of Stone to include the cuff as taught by Schreck for the purpose of sealing against the inside surface of a patient’s vessel (paragraph 206 of Schreck).
With regards to claim 22, Stone further discloses wherein the at least one cavity 46 comprises multiple discrete cavities 48 (paragraph 75; figure 15 – top-most cavities 48 branching out from cavity 46).
With regards to claim 23, Stone further discloses wherein the at least one cavity 46 comprises a branched cavity 46 (paragraph 75; figure 15 – top-most cavities 48 branching out from the branched cavity 46).
With regards to claim 24, Stone further discloses wherein the at least one cavity 46 comprises cavities 48 configured to provide access to multiple arteries (paragraph 75; figure 14 – multiple cavities 48 provide access to the renal arteries 12a/12b and the iliac arteries 14a/14b).
With regards to claim 25, Stone further discloses wherein the at least one cavity 46 comprises cavities 48 configured for fluid communication with various arteries such as iliac 14a/14b and renal 12a/12b arteries (paragraph 75; figure 14 – multiple cavities 48 provide access to the renal arteries 12a/12b and the iliac arteries 14a/14b).
With regards to claim 27, Stone further discloses comprising branch stent grafts 28/25 configured for anchoring to iliac 14a/14b and renal arteries 12a/12b (figure 14 – see second endoluminal prosthesis 58; paragraphs 42 and 58).
With regards to claim 28, Stone/Chobotov 649 disclose the stent graft system as claimed in claim 21. Stone/Chobotov 649 are silent to wherein the at least one inflatable fill structure comprises a plurality of inflatable fill structures with regards to the figures 14-15 embodiment of Stone.
However, Stone teaches wherein the at least one inflatable fill structure 26 comprises a plurality of inflatable fill structures 40 (paragraph 66 – “the internal volume 40 is separated into multiple chambers or compartments and the filling structure 26 includes multiple filling valves to allow each of the multiple chambers or compartments to be individually filled with the filling medium”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 14-15 embodiment of Stone/Chobotov 649 to include the plurality of inflatable fill structures comprising the inflatable fill structure as taught by Stone for the purpose of keeping the internal volumes of the filling structures fluidly isolated from each other and filled independently to match the particular patient geometry being treated (paragraphs 80-81 of Stone).
With regards to claim 32, Stone further discloses wherein the ends form two fluidly connected lumen 48 extending from the bifurcation (see annotated figure 15 above; paragraph 53 – “Each conduit 48 defines a passage 50 that is separate from the internal volume 40. The passage 50 is open on a first end 52 into the inner lumen 46 and is open on a second end 54 into the space surrounding the filling structure 26” – although this paragraph is in relation to figure 2, the common elements of the passage 50 and conduits 48 are disclosed in which are similar to that of figure 15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 05/21/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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