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 .
Status of Claims
This office action is responsive to the amendment filed on 09/16/2025. As directed by the amendment: claims 1, 20, 25, 41, 45, 46 and 49 have been amended, claim 52 has been cancelled and new claim 54 has been added. Thus, claims 1, 6-9, 13, 15, 17, 19, 20, 25, 26, 35, 41, 45-47, 49, 51, 53 and 54 are presently pending in this application, and currently examined in the Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the stent graft system comprising first, second, and third grafts, an inflatable fill structure coupled to the first graft, and at least one inflatable support component coupled to the first graft, wherein the second and third grafts are configured to be inserted into a lumen of the first graft, and wherein the inflatable fill structure extends from the proximal end to the distal end of the first graft (claim 1), the stent graft system comprising first, second, and third grafts, an inflatable fill structure coupled to the first graft, and at least one inflatable support component coupled to the first graft, wherein the second and third grafts are configured to be inserted into a lumen of the first graft in a docking zone, wherein the inflatable fill structure extends from the proximal end to the distal end of the first graft, and further also surrounds at least portions of the second and third grafts that are outside the docking zone (claim 9), the stent graft system comprising first, second, and third grafts, an inflatable fill structure coupled to the first graft, and at least one inflatable support component coupled to the first graft, wherein the second and third grafts are configured to be inserted into a lumen of the first graft in a docking zone, wherein the inflatable fill structure extends from the proximal end to the distal end of the first graft, and a wire-wound stent, comprising a plurality of wire-wound rings, component coupled to a portion of the first graft in the docking zone (claim 13), the stent graft system comprising first, second, and third grafts, an inflatable fill structure coupled to the first graft, and at least one inflatable support component coupled to the first graft, wherein the second and third grafts are configured to be inserted into a lumen of the first graft in a docking zone, wherein the inflatable fill structure extends from the proximal end to the distal end of the first graft, and a wire-wound stent, comprising a single wire-wound stent, component coupled to a portion of the first graft in the docking zone (claim 15), the stent graft system comprising first, second, and third grafts, an inflatable fill structure coupled to the first graft, and at least one inflatable support component coupled to the first graft, wherein the second and third grafts are configured to be inserted into a lumen of the first graft, wherein the inflatable fill structure extends from the proximal end to the distal end of the first graft, and the inflatable fill structure is a bifurcated inflatable fill structure forming two lumens to receive the second and third grafts (claim 19), the stent graft system comprising first, second, and third grafts, an inflatable fill structure coupled to the first graft, and at least one inflatable support component coupled to the first graft, wherein the second and third grafts are configured to be inserted into a lumen of the first graft, wherein the inflatable fill structure extends from the proximal end to the distal end of the first graft, and second and third inflatable fill structures at least partially surrounding the second and third grafts, respectively, wherein the inflatable fill structure, the second inflatable fill structure and the third inflatable fill structure are separate fill structures (claim 20), the stent graft system comprising a graft forming a lumen, the graft having a docking zone configured to receive first and second stent graft limb extensions in its lumen, a first support component located on a first end of the graft, and a second support component located on a second end, and at the docking zone, of the graft, wherein each support component comprises a polymer ring surrounding the graft, wherein the second support component encircles both the first and second stent graft limb extensions; and a wire-wound stent forming a separate lumen within the graft lumen (claim 41), the stent graft system comprising a graft forming a lumen, the graft having a docking zone configured to receive first and second stent graft limb extensions in its lumen, a first support component located on a first end of the graft, and a second support component located on a second end, and at the docking zone, of the graft, wherein each support component comprises a polymer ring surrounding the graft, wherein the second support component encircles both the first and second stent graft limb extensions, a wire-wound stent forming a separate lumen within the graft lumen, and the graft further comprises inner sleeves or rings in the graft lumen that receive the first and second stent graft limb extensions (claim 45), and the stent graft system comprising a graft forming a lumen, the graft having a docking zone configured to receive first and second stent graft limb extensions in its lumen, a first support component located on a first end of the graft, and a second support component located on a second end, and at the docking zone, of the graft, wherein each support component comprises a polymer ring surrounding the graft, wherein the second support component encircles both the first and second stent graft limb extensions; a wire-wound stent forming a separate lumen within the graft lumen, and a second wire-wound stent forming a second separate lumen within the graft lumen (claim 54) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
*** Applicant argues, in the response dated 09/16/2025, that different aspects of different embodiments are illustrated in multiple figures; however, the drawing objections remain since no figure clearly shows all the parameters of a stent graft system as set forth for in claims 1, 9, 13, 15, 19, 20, 41 and 54. Specifically, none of the figures mentioned in the response illustrate an inflatable fill structure coupled to, and extending from a distal end to a proximal end of, the first graft; the only figures that illustrate this parameter (which is also the only support in the originally filed disclosure for this parameter) are Figures 20C-20E and 21C. However, none of these figures (20C-20E and 21C) also show/illustrate the other parameters set forth in the above mentioned claims.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 25 and 41 are objected to because of the following informalities: line 2 of claim 25 states “a second inflatable fills structure” (emphasis added); the word “fills” is thought to be grammatically incorrect in this instance, and it is suggested it be deleted and replaced with the word “fill”. Additionally, the 3rd to last line of claim 41 states “the second support component is encircles both the first and…” (emphasis added) the word “is” is thought to be grammatically incorrect in this instance, and it is suggested the word “is” be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6-9, 13, 15, 17, 19, 20, 25, 26, 35, 41, 45, 51, 53 and 54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, which sets forth, in part, a stent graft system comprising an inflatable fill structure coupled to the first graft, extending from a proximal to distal end of the first graft, and “at least one inflatable support component coupled to the fist graft” (emphasis added); however this parameter(s) was never mentioned in the originally filed disclosure. Specifically, neither the originally filed specification, nor any of the originally filed figures, mention or illustrate a stent graft system comprising an inflatable fill structure coupled to the first graft, extending from a proximal to distal end of the first graft, and further having at least one inflatable support component coupled to the fist graft.
Regarding claim 9, which ultimately depends from claim 1, which sets forth the inflatable fill structure extends from the proximal end to the distal end of the first graft, and claim 9 further sets forth “the inflatable fill structure, in an inflated state, surrounds at least portions of the second graft and the third graft that are outside of the docking zone”; however, this parameter was never mentioned in the originally filed disclosure. Specifically neither the originally filed specification, nor any of the originally filed figures, mention or illustrate a stent graft system comprising the inflatable fill structure extends from the proximal end to the distal end of the first graft, and further having the inflatable fill structure surround at least portions of the second and third grafts outside of the docking zone (which would be beyond the distal end of the first graft where the inflatable fill structure extends to).
Regarding claim 19, which ultimately depends from claim 1, which sets forth the inflatable fill structure extends from the proximal end to the distal end of the first graft, and claim 19 further sets forth “the inflatable fill structure is a bifurcated inflatable fill structure that in an inflated state, forms two lumens”; however, this parameter was never mentioned in the originally filed disclosure. Specifically neither the originally filed specification, nor any of the originally filed figures, mention or illustrate a stent graft system comprising the inflatable fill structure extends from the proximal end to the distal end of the first graft, and further having the inflatable fill structure be a bifurcated structure forming two lumen in an inflated state.
Regarding claim 41, which, on line 10, sets forth the parameter of “a wire-wound stent forming a separate lumen within the graft lumen”; however, this parameter was never mentioned in the originally filed disclosure.
Regarding claim 45, which depends from claim 41, which sets forth a wire-wound stent forming a separate lumen within the graft lumen, and claim 45 further sets forth “the graft further comprises inner sleeves or rings in the graft lumen that receive the first and second stent graft limb extensions”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, neither the originally filed specification, nor any of the originally filed figures, mention or illustrate a stent graft system comprising a wire-wound stent forming a separate lumen within the graft lumen, and the graft further comprising inner sleeves or rings in the graft lumen that receive the first and second stent graft limb extensions.
Regarding claim 54, which sets forth the “system of claim 41, further comprises a second wire-wound stent forming a second separate lumen within the graft lumen”; however, this parameter was never mentioned in the originally filed disclosure.
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 9, 41, 45, 51, 53 and 54 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.
Regarding claim 9, which ultimately depends from claim 1, which sets forth the inflatable fill structure extends from the proximal end to the distal end of the first graft, and claim 9 further sets forth “the inflatable fill structure, in an inflated state, surrounds at least portions of the second graft and the third graft that are outside of the docking zone”; however, this parameter is found to be confusing since it is not clear how exactly the inflatable fill structure can extend from the proximal end to the distal end of the first graft, but also surround at least portions of the second and third grafts outside of the docking zone. Specifically, how can the inflatable fill structure end at the distal end of the first graft, but then also extend beyond the distal end of the first graft to a portion outside the docking zone to surround portions of the second and third grafts; and neither the originally filed specification, nor the originally filed figures, aid in clarifying this parameter since it is not shown in any of the figures and the originally filed specification is completely silent regarding such a parameter. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 41, which, on line 10, sets forth the parameter of “a wire-wound stent forming a separate lumen within the graft lumen”; however, this parameter is found to be confusing since it is not clear what exact structure this parameter entails. Specifically, it is not clear what exactly is meant by, structurally and/or location-wise, “a separate lumen”, and what exact structure comprises the “wire-wound stent”; is the wire wound stent part of the graft, or is it part of the first and/or second support components, or is it part of the first or second stent graft limb extensions, or is it a completely separate, and different, structure altogether. It is to be noted that neither the originally filed specification, nor the originally filed figures, aid in clarifying this parameter since it is not shown in any of the figures and the originally filed specification is completely silent regarding such a parameter; therefore, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 45, which depends from claim 41, which sets forth a wire-wound stent forming a separate lumen within the graft lumen, and claim 45 further sets forth “the graft further comprises inner sleeves or rings in the graft lumen that receive the first and second stent graft limb extensions”; however, this parameter is found to be confusing since it is not clear, structurally, how the graft lumen can have a wire-wound stent forming a separate lumen therewithin while also comprising inner sleeves or rings therewithin to receive the first and second stent graft limb extensions. It is to be noted that neither the originally filed specification, nor the originally filed figures, aid in clarifying this parameter since it is not shown in any of the figures and the originally filed specification is completely silent regarding such a parameter; therefore, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 51, which recites the limitation “the seal component”, on line 1; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what exact structure “the seal component” is, and/or how it relates to the final structure of the stent graft system. Furthermore, lines 1-2 recite the limitation “support component”, is this support component the same structure as the “at least one inflatable support component” (as first set forth on line 6 of claim 1, from which claim 51 depends), or is it a different and separate structure/support component. If it is the same structure/support component, then it is suggested the words “the at least one inflatable” be added before the word “support” on line 1, in order to keep claim terminology consistent and avoid confusion; however, if this is a different and separate structure/support component, then it is further found to be unclear what exact structure this support component entails, and/or how it relates to the final structure of the stent graft system. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 53, which recites the limitation “the support component”, on line 1; there is insufficient antecedent basis for this limitation in the claim. In order to overcome the rejection, avoid confusion, and keep claim terminology consistent, it is suggested the words “the at least one inflatable” be added before the word “support” on line 1.
Regarding claim 54, which depends from claim 41, which sets forth the stent graft system comprises a wire-wound stent forming a separate lumen within the graft lumen, and claim 54 further sets forth the stent graft system “further comprising a second wire-wound stent forming a second separate lumen within the graft lumen”; however, this parameter is found to be confusing since it is not clear what exact structure this parameter entails. Specifically, as mentioned above in regard to claim 41, it is not clear what exactly is meant by, structurally and/or location-wise, a separate lumen, and what exact structure comprises the “second wire-wound stent”; is the second wire-wound stent part of the graft, or is it part of the first and/or second support components, or is it part of the first or second stent graft limb extensions, or is it part of the same structure which comprises the wire-wound stent, or is it a completely separate, and different, structure altogether. It is to be noted that neither the originally filed specification, nor the originally filed figures, aid in clarifying this parameter since it is not shown in any of the figures and the originally filed specification is completely silent regarding such a parameter; therefore, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 41, 45 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chobotov (US PG Pub. 2015/0088244), as previously disclosed, hereinafter Chobotov’ 244.
Regarding claim 41, Chobotov’ 244 discloses a stent graft system (110), illustrated in Figures 1-4A, comprising a graft (12) forming a lumen (20); a first support component (28A), located on a first end (14) of the graft, and a second support component (28B), located on a second end (16) of the graft, each of the support components (28A&28B) being embedded in the graft and comprising a polymer ring surrounding the graft, the graft (12) having an external surface (18) that faces away from the lumen, wherein the second support component (28B) is located at a docking zone configured to receive first and second stent graft limb extensions (118&120), a wire-wound stent (22) forming a separate lumen within the graft lumen, and wherein the second support component (28B) encircles both the first and second stent graft limb extensions (118&120) in a configuration of the system where the first and second stent graft limb extensions are placed in the graft lumen, illustrated in Figures 1-4A ([0032], Lines 4-8; [0038], Lines 1-5; [0042]; [0044] & [0064]).
Regarding claim 45, Chobotov’ 244 discloses the stent graft system of claim 41, wherein the graft further comprises inner sleeves/layers in the graft lumen that receive the first and second stent graft limb extensions ([0058]).
Regarding claim 54, Chobotov’ 244 discloses the stent graft system of claim 41, further comprising a second wire-wound stent (300) forming a second separate lumen within the graft lumen (20), illustrated in Figure 4A ([0044] & [0047], Lines 1-7).
Claim Rejections - 35 USC § 102/103
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.
Claims 1, 6-8, 17, 20, 25, 46, 47, 49 and 53 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Evans et al. (US PG Pub. 2009/0319029), as previously disclosed, hereinafter Evans.
Regarding claims 1, 6, 7 and 53, Evans discloses a stent graft system, illustrated in Figures 4D-4L, comprising a first graft (210), having a proximal end and a distal end, at least one inflatable support component/stent circumferentially coupled to the first graft at the distal end (i.e. distal portion of the stent of stent-graft 210), an anchor/stent coupled to the first graft (i.e. proximal portion of the stent of stent-graft 210); a second graft (216); a third graft (228); and an inflatable fill structure (208) coupled to, and at least partially surrounding the first graft (210), wherein each of the first, second, and third grafts are separate grafts before being deployed and each comprises at least one lumen; wherein the second graft (216) and the third graft (228) are configured to be inserted into the lumen of the first graft (210) when deployed, and wherein the inflatable fill structure (208) extends from the proximal end to the distal end of the first graft (210), is configured to form a seal in a proximal neck region of an aorta, and to expand within and contact an aorta wall, illustrated in Figures 4D-4L ([0067], Lines 13-17; [0075] – [0078]; [0080], Lines 8-10 & [0081] – To clarify, scaffold 210 is a stent-graft, thus the graft portion is considered the “first graft”, the stent portion at the distal end of the scaffold is considered the “at least one inflatable support component”, wherein the stent is inflated by inflatable balloon 206, and the stent portion at the proximal end is considered the “anchor”. Also, inflatable fill structure 208 is said to “cover most of scaffold 210” and it is also stated that “more…of the scaffold 210 may be covered by the filling structure 208” than what is illustrated, thus, it is inherent and/or it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate length for the inflatable fill structure, including extending from the proximal end to the distal end of the first graft; and it is also to be noted that either the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the inflatable fill structure extending from the proximal end to distal end of the first graft, as opposed to extending for any other length).
Regarding claim 8, Evans discloses the stent graft system of claim 6, wherein the inflatable fill structure (208), when deployed, at least partially surrounds proximal ends of the second graft (216) and a third graft (228) that are docked within the lumen of the first graft (210), illustrated in Figures 4I-4L ([0079]).
Regarding claim 17, Evans discloses the stent graft system of claim 6, wherein the inflatable fill structure (208) forms a funnel shape in an inflated state, illustrated in Figures 4E-4L.
Regarding claim 20, Evans discloses the stent graft system of claim 1, further comprising a second inflatable fill structure (218) at least partially surrounding the second graft (216), and a third inflatable fill structure (230) at least partially surrounding the third graft (228); the first, second, and third inflatable fill structures (208,218,230) are separate inflatable fill structures that are configured to expand within an aorta when deployed, illustrated in Figures 4H-4L ([0075]; [0078] & [0081]).
Regarding claim 25, Evans discloses the stent graft system of claim 1, further comprising a second inflatable fill structure (218) at least partially surrounding the second graft (216), and a third inflatable fill structure (230) at least partially surrounding the third graft (228), wherein the second and third inflatable fill structures (218&230) are configured to expand within an aorta and surround at least partially the first graft (210) when deployed, illustrated in Figures 4K and 4L.
Regarding claims 46 and 49, Evans discloses a system, illustrated in Figures 4D-4L, 15A and 15B, comprising a first limb stent graft (216) and a second limb stent graft (218); and a proximal extension inflatable fill structure (208 & 210/602), configured to form a seal (via portion 208) in a proximal neck region of an aorta when the proximal extension inflatable fill structure is inflated; and configured to form a dual lumen (606 & 608) when the proximal extension inflatable fill structure is inflated, wherein the dual lumen is configured to receive the first and second limb stent grafts; and wherein each of the first limb stent graft (216) and the second limb stent graft (218) are separate grafts before being deployed and each comprises a single lumen; and when deployed, the first limb stent graft and the second limb stent graft are coupled together, wherein the dual lumen comprises two side-by-side lumens (606 & 608) extending independently along a longitudinal axis of the proximal extension inflatable fill structure, and the first and second limb stent grafts are placed in the separate lumens (606 & 608) in the proximal extension inflatable fill structure, illustrated in Figures 4D-4L, 15A and 15B ([0075] – [0078]; [0081] & [0094]). It is inherent and/or obvious to one having ordinary skill in the art before the effective filing date of the invention for the docketing scaffold (210) of the inflatable fill structure (208 & 210), of the embodiment illustrated in Figures 4D-4L, to comprise divider (604) thereby creating dual/side-by-side lumen (606 & 608), as illustrated in Figures 15A and 15B, in order to keep the first and second limb stent grafts from taking up more room/cross-sectional area than allotted, when expanded, as disclosed by Evans.
Regarding claim 47, Evans discloses the system of claim 46, further comprising an anchor (501) coupled to the proximal extension inflatable fill structure (208 & 210/602, illustrated in Figure 14A; it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to couple an anchor (501) to the docking scaffold (210/602), in order to aid in anchoring the system ([0093]).
Claims 13 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Evans as applied to claims 1 and 25 above, and in view of Palmaz (US Patent No. 4,733,665), as previously disclosed.
Regarding claim 13, Evans discloses the stent graft system of claim 1, wherein the second graft (216) and a third graft (228) dock within the lumen of the first graft (210) in a docking zone; and the first graft (210) comprises a wire-wound stent component coupled to a portion of the first graft in the docking zone, illustrated in Figures 4I-4L ([0067], Lines 13-17 & [0075], Line 12); and though it does not specifically disclose the wire-wound stent component comprises a plurality of wire-wound rings, Evans does state that the wire-wound stent may be one such as described by Palmaz - US Patent No. 4,733,665 (Evans: [0068], Lines 5-8 & [0075], Lines 17-19). Palmaz illustrates, in Figures 1A-2B, wire-wound stent components comprising a plurality of wire-wound rings. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the wire-wound stent component, of the stent graft system of Evans, to comprise a plurality of wire-wound rings, as taught by Palmaz, since Evans states the wire-wound stent component can be one such as described by Palmaz.
Regarding claim 26, Evans discloses the stent graft system of claim 25, wherein each of the second and the third grafts (216 & 228) comprise a wire-wound stent component, illustrated in Figures 4J-4L ([0067], Lines 13-17 & [0078], Lines 15 and 5th to last Line); and though it does not specifically disclose the wire-wound stent component comprises a plurality of wire-wound rings, Evans does state that the wire-wound stent may be one such as described by Palmaz - US Patent No. 4,733,665 (Evans: [0068], Lines 5-8; [0075], Lines 17-19 & [0078], Lines 18-19 and last three Lines). Palmaz illustrates, in Figures 1A-2B, wire-wound stent components comprising a plurality of wire-wound rings. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the wire-wound stent components, of the stent graft system of Evans, to comprise a plurality of wire-wound rings, as taught by Palmaz, since Evans states the wire-wound stent components can be one such as described by Palmaz.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Evans as applied to claim 1 above, and in view of Boneau (US Patent No. 5,292,331), as previously disclosed.
Regarding claim 15, Evans discloses the stent graft system of claim 1, wherein the second graft (216) and a third graft (228) dock within the lumen of the first graft (210) in a docking zone; the first graft (210) comprises a wire-wound stent ring coupled to a portion of the first graft in the docking zone, illustrated in Figures 4I-4L ([0067], Lines 13-17 & [0075], Line 12); and though it does not specifically disclose the wire-wound stent ring comprises a single ring of wire-wound stent, Evans does state that the wire-wound stent ring may be one such as described by Boneau - US Patent No. 5,292,331 (Evans: [0068], Lines 5-8 & [0075], Lines 17-20). Boneau illustrates, in Figures 1-6, a wire-wound stent ring comprising a single ring of wire-wound stent. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the wire-wound stent ring, of the stent graft system of Evans, to comprise a single ring of wire-wound stent, as taught by Boneau, since Evans states the wire-wound stent ring can be one such as described by Boneau.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Evans as applied to claim 1 above, and in view of Jalisi (US PG Pub. 2002/0123795), as previously disclosed.
Regarding claim 35, Evans discloses the stent graft system of claim 1, wherein the first graft (210) comprises a stent component ([0067], Lines 13-17 & [0075], Line 12); but does not specifically disclose the stent component is a laminated stent component.
However, Jalisi teaches a laminated stent component comprising a metallic substrate material and at least one metallic cladding material layer; the benefit of having such a laminated stent component allows for a combinate of desired material properties such as strength, ductility and/or radiopacity ([0008]).
In view of the teachings of Jalisi, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the stent component, of the stent graft system of Evans, to be a laminated stent component, in order to provide the stent component with a combinate of desired material properties such as strength, ductility and/or radiopacity, as taught by Jalisi.
Response to Arguments
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive. Applicant states “Chobotov’244 has not been shown to teach a system comprising…” and then goes on to recite claim 41, however does not provide any detail and/or specific instances/parameters which Chobotov’244 does not teach. As detailed above, in the rejection section, Chobotov’244 teaches all the structural limitations set forth in claim 41, and therefore the rejection stands. Applicant goes on the argue the rejection of claim 1, and insinuates the prior art of Evans does not teach the newly added parameter of “at least one inflatable support component”. Examiner respectfully disagrees with Applicant’s assertion. As explained above in the rejection section, the stent portion, at the distal end of the graft, is considered the “at least one inflatable support component”, and the stent is considered to be an inflatable support component since it is inflated by inflatable balloon 206. Thus, the rejection of independent claim 1 as being unpatentable over the prior art of Evans is deemed to be proper since all the structural limitations are met; therefore, the rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774