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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 04/13/2026. As directed by the amendment: claims 1, 19, 20, 25, 41, 46, 53 and 54 have been amended, and claims 9, 13, 15, 26 and 51 have been cancelled. Thus, claims 1, 6-8, 17, 19, 20, 25, 35, 41, 45-47, 49, 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 separately deployable first, second and third grafts, wherein the second and third grafts are inserted into a lumen of the first graft when deployed; at least one inflatable support component and an inflatable fill structure coupled to the first graft, wherein the inflatable fill structure extends from about a proximal to about a distal end of the first graft and is configured to form a seal in a proximal neck region of an aorta; a second inflatable fill structure at least partially surrounding the second graft, and a third inflatable fill structure at least partially surrounding the third graft, wherein the second and third inflatable fill structures are configured to expand within the aorta and surround at least partially the first graft (claim 25) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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.
Claim 25 is 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. Claim 25 depends from independent claim 1, which sets forth the parameter of the stent graft system comprising at least one inflatable support component and an inflatable fill structure coupled to the first graft, wherein the inflatable fill structure extends from about a proximal to about a distal end of the first graft and is configured to form a seal in a proximal neck region of an aorta; and claim 25 further sets forth the parameter of a second inflatable fill structure at least partially surrounding the second graft, and a third inflatable fill structure at least partially surrounding the third graft, wherein the second and third inflatable fill structures are configured to expand within the aorta and surround at least partially the first graft, however, this parameter was never mentioned, or suggested in the originally filed disclosure. Specifically, neither the originally filed specification, nor the original figures, mention, suggest or illustrate a stent graft system comprising separately deployable first, second and third grafts, wherein the second and third grafts are inserted into a lumen of the first graft when deployed; at least one inflatable support component and an inflatable fill structure coupled to the first graft, wherein the inflatable fill structure extends from about a proximal to about a distal end of the first graft and is configured to form a seal in a proximal neck region of an aorta; a second inflatable fill structure at least partially surrounding the second graft, and a third inflatable fill structure at least partially surrounding the third graft, wherein the second and third inflatable fill structures are configured to expand within the aorta and surround at least partially the first graft, as set forth in claim 25.
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 19, 20, 41, 45 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 19, ultimately depends from independent claim 1, which sets forth “an inflatable fill structure coupled to the first graft”, and claim 19 further sets forth the parameter of “further comprising a bifurcated inflatable fill structure”; however this parameter is found to be confusing since it is not clear if the “bifurcated inflatable fill structure” is the same structure as the “inflatable fill structure”, as set forth in claim 1, or if it is a completely separate and distinct fill structure. If it is the same inflatable fill structure, then it is suggested the claim be amended by deleting the words “further comprising” and replacing them with the words “wherein the inflatable fill structure is”; however, if the bifurcated inflatable fill structure is completely separate and distinct from the inflatable fill structure, as set forth in claim 1, then there would be new matter and drawing issues, since such a parameter has never been mentioned, suggested or illustrated in the originally filed disclosure. For the purpose of examination, as can be gleaned from the originally filed disclosure, the claim shall be interpreted as “the inflatable fill structure is a bifurcated inflatable fill structure”.
Regarding claim 20, which recites the limitation “the first inflatable fill structure, on lines 3-4; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested either: line 3 be amended by deleting the word “first”, or line 5 of claim 1 be amended to state “a first inflatable fill structure” (though this option may cause indefiniteness issues in other dependent claims).
Regarding claim 41, which recites the limitations “the graft lumen”, on the 4th to last line, and “the first and the second stent graft limb extensions” (emphasis added), on the 3rd – 2nd to last lines; there is insufficient antecedent basis for these limitations in the claim. In order to overcome this rejection, it is suggested the limitation on the 3rd – 2nd to last lines be amended by deleting the word “the” before the word “second”, such that the limitation states “the first and second stent graft limb extensions”; and regarding the limitation on the 4th to last line, either: amend the 4th to last line to state “the lumen of the graft”, or amend the 2nd line to state “a graft forming a graft lumen”.
Regarding claim 54, which recites the limitation “the graft lumen, on line 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested either: line 2 be amended to state “the lumen of the graft”, or line 2 of claim 41 be amended to state “a graft forming a graft lumen”.
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 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chobotov (US PG Pub. 2015/0088244), as previously disclosed.
Regarding claim 41, Chobotov 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 (22/26) maintaining an opening within the lumen (20) of the graft (12), 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; [0035]; [0038], Lines 1-5; [0042]; [0044] & [0064]).
Regarding claim 45, Chobotov 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]).
Claims 46, 47 and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al. (US PG Pub. 2009/0319029), as previously disclosed, hereinafter Evans.
Regarding claims 46, 47 and 49, Evans discloses a system, illustrated in Figures 4G-4L and 7A-7C, comprising a first limb stent graft (216/320) and a second limb stent graft (228/320), each having a lumen and being separate grafts before deployment; and a proximal extension inflatable fill structure/docking scaffold (208/324), configured to form a seal in a proximal neck region of an aorta when the proximal extension inflatable fill structure is inflated; an anchor (210) coupled to the proximal extension inflatable fill structure (208), illustrated in Figures 4G-4L; wherein, when inflated, the proximal extension inflatable fill structure/docking scaffold (208/324) is configured to form a dual lumen, comprising two side-by-side fluidly separate lumens extending independently along a longitudinal axis of the proximal extension inflatable fill structure, such that the first and second limb stent grafts (216 & 228/320) are placed in the dual lumen/fluidly separate lumens and coupled together, illustrated in Figures 4J-4L and 7C ([0074]; [0075]; [0079] & [0088] – to clarify, sealing element 322, which is within the proximal extension inflatable fill structure/docking scaffold 208/324, creates the dual/two side-by-side fluidly separate lumens, as illustrated in Figure 7C).
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.
Claims 1, 6-8, 17, 19, 20, 25 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Schreck et al. (US PG Pub. 2017/0239035), hereinafter Schreck.
Regarding claims 1 and 6, Schreck discloses a stent graft system, illustrated in Figures 8A-8D, comprising a first graft (800) having a proximal end and a distal end; a second graft (812a); a third graft (812b), an inflatable fill structure (802), at least partially surrounding and coupled to the first graft (800), wherein each of the first graft (800), the second graft (812a), and the third graft (812b) are separate grafts before being deployed and each comprises at least one lumen, such that the second and third grafts (812a,b) are configured to be inserted into the lumen of the first graft when deployed; the inflatable fill structure (802) extends from about the proximal end to about the distal end of the first graft and is configured to expand within and contact an aorta wall to form a seal in a proximal neck region of an aorta, illustrated in Figures 8A-8D ([0109] – [0112]); and at least one inflatable support component (1806/2206), fillable with a fill medium to radially expand, coupled to the first graft (1802/2202), as illustrated in the embodiments of Figures 18 and 22, the inflatable support component (1806/2206) aids in supporting and/or sealing the graft when implanted ([0127] & [0131]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the embodiment of stent graft system of Figures 8A-8D to further comprise at least one inflatable support component, fillable with a fill medium to radially expand, coupled to the first graft, in order to aid in supporting and/or sealing the first graft when implanted.
Regarding claim 7, Schreck discloses the stent graft system of claim 1, further comprising an anchor (2214) coupled to the first graft (2202), illustrated in Figure 22, the anchor providing fixation of the graft/system in the aorta ([0131], Last 2 Lines); it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the embodiment of stent graft system of Figures 8A-8D to further comprise an anchor coupled to the first graft, in order to provide fixation of the first graft/system in the aorta.
Regarding claim 8, Schreck discloses the stent graft system of claim 6, wherein the inflatable fill structure (802), when deployed, at least partially surrounds proximal ends of the second and third grafts (812a,b) that are docked within the lumen of the first graft (800), illustrated in Figure 8D ([0112]).
Regarding claim 17, Schreck discloses the stent graft system of claim 6, and though it is not specifically disclosed that the inflatable fill structure forms a funnel shape in an inflated state, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape for the inflatable fill structure, in an inflated state, including a funnel shape, since doing so amounts to a mere change in shape/from of a known structure, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the inflatable fill structure forming a funnel shape in an inflated state, as opposed to forming/having any other shape/form.
Regarding claim 19, Schreck discloses the stent graft system of claim 6, wherein the inflatable fill structure (802) is a bifurcated inflatable fill structure, illustrated in Figure 8D.
Regarding claim 20, Schreck discloses the stent graft system of claim 1, further comprising a second inflatable fill structure (2206f) at least partially surrounding the second graft, and a third inflatable fill structure (2206g) at least partially surrounding the third graft; wherein the first inflatable fill structure (2204), the second inflatable fill structure (2206f), and the third inflatable fill structure (2206g) are separate inflatable fill structures that are configured to expand within the aorta when deployed, illustrated in Figure 22, the second and third inflatable fill structures aid in sealing the second and third grafts in the iliac arteries ([0131], Last 2 Lines); therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the embodiment of stent graft system of Figures 8A-8D to further comprise second and third inflatable fill structures at least partially surrounding the second and third grafts, respectively, in order to aid in sealing the second and third grafts in the iliac arteries.
Regarding claim 25, Schreck discloses the stent graft system of claim 1, further comprising a second inflatable fill structure (802a) at least partially surrounding the second graft (812a), and a third inflatable fill structure (802b) at least partially surrounding the third graft (812b); wherein the second and third inflatable fill structures (802a,b) are configured to expand within the aorta and surround, at least partially, the first graft (800) when deployed, illustrated in Figure 8D and modified figure 8D, below.
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Regarding claim 53, Schreck discloses the system of claim 1, wherein the at least one support component (1806/2206) is coupled to the first graft (1802/2202) at the distal end, illustrated in Figures 18 and 22. It is further noted that it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate location for the at least one support component, including at a distal end of the first graft, since doing so amounts to a mere matter of rearranging of a known part of an invention, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Schreck as applied to claim 1 above, and in view of Jalisi (US PG Pub. 2002/0123795), as previously disclosed.
Regarding claim 35, Schreck discloses the stent graft system of claim 1, wherein the first graft (2202) comprises a stent component (2214), illustrated in Figure 22, the stent component providing fixation of the graft/system in the aorta ([0131], Last 2 Lines); thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first graft, of the embodiment of stent graft system of Figures 8A-8D, to comprise a stent component, in order to provide fixation of the first graft/system in the aorta. However, Schreck 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 Schreck, 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.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Chobotov as applied to claim 41 above, and in view of Schreck.
Regarding claim 54, Chobotov discloses the stent graft system of claim 41, but does not specifically disclose a second wire-wound stent maintaining an opening within the lumen of the graft.
However, Schreck teaches a stent graft system, illustrated in Figure 21, in the same field of endeavor, comprising a graft (2102) having multiple/two wire-wound stents (2106), which aid in supporting the graft (2102), illustrated in Figure 21 ([0130]).
In view of the teachings of Schreck, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the stent graft system of Chobotov to further comprise a second wire-wound stent maintaining an opening within the lumen of the graft, and aid in supporting the graft, as taught by Chobotov’244; and doing so amounts to a mere matter of duplication of the essential working parts, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Schreck, and/or uses different embodiments of previously presented art; rejecting independent claim 1 as being unpatentable over Schreck, rejecting independent claim 41 as being unpatentable over Chobotov, and rejecting independent claim 46 as being unpatentable over Evans.
Conclusion
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 05/21/2026
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