DETAILED ACTION
This action is in response to applicant's amendments filed 12/02/25.
The examiner acknowledges the amendments to the claims.
Claims 1-5, 8, 13-20 are pending in this application.
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 .
Response to Arguments
In light of Applicant’s amendments filed 12/02/25, new ground(s) of rejection is made below in view of Shaolian et al., hereinafter “Shaolian” (U.S. Pub. No. 2001/0007954) for claims 1-5, 8, 13, 14.
Applicant's arguments filed 12/02/25 regarding claims 15-20 have been fully considered but they are not persuasive.
Regarding claims 15-20, Applicant generally argues that Shaw fails to teach a sleeve positioned over the fenestrable material when the expandable endoprosthesis is in an unexpanded configuration, the sleeve configured to selectively allow access to the fenestrable material. However, the examiner acknowledges that Shaw does not disclose a sleeve positioned over the fenestrable material on expandable endoprosthesis 102 when the expandable endoprosthesis is in an unexpanded configuration, the sleeve configured to selectively allow access to the fenestrable material. Nonetheless, Shaw teaches a sleeve that is positioned over side branch component (stent-graft 400) when the side branch component is in an unexpanded, restrained configuration ([0042]). The examiner maintains that a skilled artisan would have found it obvious to modify the delivery system in Shaw by applying this teaching of the side branch component sleeve to the expandable endoprosthesis. Accordingly, another sleeve may be similarly positioned over the fenestrable material of the expandable endoprosthesis. In other words, one of ordinary skill in the art would have found it obvious to have another sleeve that is positioned over expandable endoprosthesis 102, and therefore positioned over the fenestrable material, to initially constrain the expandable endoprosthesis in a low-profile delivery configuration. This additional sleeve would facilitate advancement of the endoprosthesis through tortuous vasculature and would also be configured to selectively allow access to the fenestrable material when the sleeve is selectively retracted relative to the endoprosthesis.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “coupling member” in claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 8, 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaolian (U.S. Pub. No. 2001/0007954).
Regarding claim 1, Shaolian discloses an endoprosthesis delivery system, comprising:
an expandable endoprosthesis 76 (Figure 6; [0059]) having a first portion, a second portion, and a third portion (see annotated Figure 6 below);
a constraining sleeve (outer sheath 50; Figure 1) associated with the second portion of the expandable endoprosthesis and configured to releasably constrain the second portion of the expandable endoprosthesis to a partially expanded configuration (Figure 2; limb segment 70 of second portion is expanded when sheath 50 is retracted, while the remaining segment of the second portion is constrained within tubular housing 33);
a second sleeve (tubular housing 33; Figure 1) in parallel (at least partially not overlapping) with the constraining sleeve 50, the second sleeve configured to constrain the second portion of the expandable endoprosthesis to a collapsed configuration (Figure 2; the remaining segment of the second portion is constrained within tubular housing 33, while the limb segment 70 of the second portion is expanded); and
a third sleeve (middle core 40; Figures 1-2) in series (overlapping) with the constraining sleeve 50, the third sleeve configured to constrain at least one of the first portion (including limb 72) and the third portion (the third sleeve 40 is configured to constrain the first portion, as seen in Figure 6 below) of the expandable endoprosthesis to a collapsed configuration.
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Regarding claim 2, Shaolian discloses the endoprosthesis is self-expandable ([0057]-[0059]).
Regarding claim 3, Shaolian discloses the endoprosthesis is configured to be expanded with a secondary device (such as a spring, graft actuator, release wire; [0056], [0060], [0063]).
Regarding claim 5, Shaolian discloses wherein at least one of the first portion and the third portion of the expandable prosthesis is configured to expand independent of the second portion of the expandable endoprosthesis (the first portion, including limb 72 and as seen in annotated Figure 6 above, is able to expand independently of the second portion from a constrained configuration via selective retraction of middle core 40 as in Figure 4).
Regarding claim 8, Shaolian discloses an endoprosthesis delivery system, comprising:
a catheter shaft 30 (Figure 1; [0047]);
an expandable endoprosthesis 76 (Figure 6; [0059]) mounted on the catheter shaft, at least a portion of the expandable endoprosthesis at least partially constrained by a constraining sleeve (outer sheath 50; Figure 1), wherein the constraining sleeve is configured to releasably constrain the portion of the expandable endoprosthesis to a partially expanded configuration (Figure 2; limb segment 70 of second portion is expanded, while the remaining segment of the second portion is constrained within tubular housing 33);
a second sleeve (tubular housing 33; Figure 1) in parallel (at least partially not overlapping) with the constraining sleeve 50; and
a third sleeve (middle core 40; Figures 1-2) in series (overlapping) with the constraining sleeve 50.
Regarding claim 13, Shaolian discloses the constraining sleeve 50 allows access to the portion of the expandable endoprosthesis when the portion of the expandable endoprosthesis is at an intermediate diameter (see intermediate diameter or width of exposed segment 70 in Figure 2 before fully expanded to the diameter shown in Figure 7).
Regarding claim 14, Shaolian discloses a first guidewire ([0045], [0047]) associated with the expandable prosthesis.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Shaolian (U.S. Pub. No. 2001/0007954) in view of Norris (U.S. Pub. No. 2013/0245742).
Regarding claim 4, Shaolian discloses the claimed invention, as discussed above, except for the constraining sleeve 50 including a coupling member configured to disengage from the constraining sleeve to release the constraining sleeve from the second portion of the endoprosthesis.
In the same field of art, namely endoprosthesis delivery systems, Norris teaches a sleeve 104 (Figures 1-2) including a coupling member 124 configured to disengage from the sleeve to release the sleeve from a second portion of the endoprosthesis (paras [0044]-[0050]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Shaolian to have a coupling member as claimed, as taught by Norris, in order to facilitate selective and controlled deployment of the endoprosthesis (Id.).
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (U.S. Pub. No. 2012/0130478).
Regarding claim 15, Shaw discloses an endoprosthesis delivery system, comprising:
an expandable endoprosthesis 102 (para [0054]) including a graft (para [0031]), the graft having a portion comprised of a fenestrable material (paras [0030], [0038], [0039]);
a side branch component 400 (Figure 7, para [0046]) configured to be exposed upon access to the fenestrable material and fenestration of the fenestrable material.
However, Shaw does not disclose a sleeve positioned over the fenestrable material when the expandable endoprosthesis is in an unexpanded configuration, the sleeve configured to selectively allow access to the fenestrable material.
Shaw teaches that the side branch component is a stent-graft 400 with a sleeve positioned over when the side branch component is in an unexpanded configuration (para [0042]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the graft in Shaw such that a sleeve is similarly positioned over the graft fenestrable material when in an unexpanded configuration, since doing so may facilitate delivery in a low profile through the vasculature (Id.). It is noted that when the combination is made, a skilled artisan would understand that the sleeve would be configured to selectively allow access to the fenestrable material.
Regarding claim 16, Shaw as modified teaches an endoluminal tool 300 (Figure 3, para [0039]) configured to fenestrate the fenestrable material.
Regarding claim 17, Shaw as modified teaches the sleeve allows access to the fenestrable material when the expandable endoprosthesis is at least partially expanded. As discussed above, it is noted that a skilled artisan would understand that the sleeve would be configured to selectively allow access to the fenestrable material, and therefore allow access when at least partially expanded.
Regarding claim 18, Shaw as modified teaches at least a portion of the fenestrable material defines a side branch portal (through which 400 passes; Figure 7), and the side branch component 400 is configured for delivery through the side branch portal (paras [0039]-[0040]).
Regarding claim 19, Shaw as modified teaches the side branch component 400 is configured to expand through the side branch portal independent of expansion of the expandable endoprosthesis (via removal of restraining sleeve; para [0042]).
Regarding claim 20, Shaw as modified teaches the expandable endoprosthesis is configured to expand to a full expanded configuration upon release of the sleeve (with full withdrawal of the sleeve, the endoprosthesis would be fully unconstrained and have full expansion).
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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771