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 04/29/2026. As directed by the amendment: claims 1, 5, 6, 9, 10, 13, 16, 17 and 19 have been amended, claim 4 has been cancelled and new claim 21 has been added. Thus, claims 1-3 and 5-21 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 branched stent graft comprising a coupling/fenestration window extending from a main body, the main body including a bare body stent portion secured to a proximal end of the main body and a distal body stent portion at least partially located distal the coupling/fenestration window, a loop stent portion, located in a surrounding region between the bare stent portion and the distal body stent portion, extending less than the main body circumference, wherein the bare body stent portion and the loop stent portion are connected with a proximal bridge portion circumferentially opposite and offset the coupling/fenestration window the loop stent portion and the distal body stent portion are connected with a distal bridge portion circumferentially opposite and offset the coupling/fenestration window (claim 13), and the branched stent graft comprising a coupling/fenestration window extending from a main body, the main body including a bare body stent portion secured to a proximal end of the main body and a distal body stent portion at least partially located distal the coupling/fenestration window, a loop stent portion, located in a surrounding region between the bare stent portion and the distal body stent portion, extending less than the main body circumference, the bare body stent portion and the loop stent portion are connected with a proximal bridge portion circumferentially opposite and offset the coupling/fenestration window the loop stent portion and the distal body stent portion are connected with a distal bridge portion circumferentially opposite and offset the coupling/fenestration window, and wherein the proximal bridge portion and the distal body stent portion are circumferentially aligned (claim 17) 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 Objections
Applicant is advised that should claim 16 or claim 21 be found allowable, the other of claim16 or claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 17 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 17 sets forth the parameter of “the proximal bridge portion and the distal body stent portion are circumferentially aligned”; however, this parameter was never mentioned, or suggested, 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 9-21 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, the last three lines of the claim set forth the parameter of “a peak of the proximal body stent and valleys of the support stent and the distal body stent are circumferentially aligned with a center of the coupling or the fenestration window”; however, this parameter is found to be confusing since it is not clear what structures are aligned in what way. Specifically, how exactly is the peak of the proximal body stent and the valleys of the support stent aligned, and/or how are the valleys of the support stent and the distal body stent aligned, and/or how is the peak of the proximal body stent and the distal body stent aligned; and which portions are actually circumferentially aligned with the center of the coupling/fenestration window. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “a peak of the proximal body stent, a valley of the support stent, and a valley of the distal body stent are circumferentially aligned with a center of the coupling or the fenestration window”; and amending the claim as such is suggested for clarification.
Regarding claim 13, which recites the limitation of “the bare stent portion”, on line 8; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, it is suggested the word “body” be added between the words “bare” and “stent” on line 8. Furthermore, lines 11-14 set forth the parameter(s) of “the bare body stent portion and the loop stent portion are connected with a proximal bridge portion circumferentially opposite and offset the coupling or the fenestration window the loop stent portion and the distal body stent portion are connected with a distal bridge portion circumferentially opposite and offset the coupling or the fenestration window” (emphasis added); however, this parameter(s) is/are confusing since it is not clear what exactly, structurally is meant by the term “offset”. Specifically, it is not clear how exactly the proximal and distal bridge portions are “offset” from the coupling/fenestration window; are they offset axially, laterally, circumferentially or offset in some other completely different way/direction. Additionally, if “offset” means circumferentially offset, then it would further be unclear what additional structural limitation this entails since it has already been set forth that the proximal and distal bridge portions are circumferentially opposite from the coupling/fenestration window. 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 17, which sets forth the parameter of “the proximal bridge portion and the distal body stent portion are circumferentially aligned”, however, this parameter is found to be confusing since it is not clear how exactly, structurally, the proximal bridge portion, which is a singular connecting portion, can be “circumferentially aligned” with the distal body stent portion, which is a circumferential portion; and the originally filed disclosure does not aid in clarifying such a parameter, in fact, being 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation disclosed in claim 19 can be found on lines 11-14 of independent claim 13. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arbefeuille (US PG Pub. 2019/0269497).
Regarding claims 9, 11 and 12, Arbefeuille discloses a branched stent graft (120), illustrated in Figure 7, comprising a main body aligning with a blood vessel in a radially expanded state and extending between proximal and distal ends; and a coupling (126/128) extending from the main body proximate; the main body including a proximal body stent (132) at least partially located between the proximal end of the main body and the coupling (126/128) and a distal body stent (DS) at least partially located distal the coupling (126/128), the proximal and distal body stents having proximal and distal body stent diameters, respectively, the main body including a surrounding region located between the proximal and distal body stents and extending along a main body circumference, the main body further including a wire form support stent (136) located in the surrounding region and configured to maintain the main body in an open state when aligned with the blood vessel, the support stent (136) having a support stent diameter, and a peak (PP) of the proximal body stent (132), a valley (VS) of the support stent (136), and a valley (VD) of the distal body stent (DS) are circumferentially aligned with a center of the coupling (126/128), illustrated in Figure 7 and modified figure 7, below.
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Regarding claim 10, Arbefeuille discloses the branched stent graft of claim 9, wherein a peak (PB) of a bare stent (BS) is circumferentially aligned with the center of the coupling (126/126), illustrated in Figure 7 and modified figure 7, above.
Allowable Subject Matter
Claims 1-3 and 5-8 are allowed.
Claim 13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Response to Arguments
Applicant’s arguments with respect to claim 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 06/25/2026