DETAILED ACTION
This action is in response to applicant's amendments filed 05/28/26.
The examiner acknowledges the amendments to the claims.
Claims 1-5, 8, 13-17, 19-21 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/28/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection set forth in this office action.
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 Objections
Claim 13 is objected to because of the following informalities: in line 2 “wherein constraining sleeve” should read as --wherein the constraining sleeve--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites “the portion” lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitations will be read as --the first portion--.
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 Douglas (U.S. Pub. No. 2012/0271410), cited in IDS filed 01/10/2025.
Regarding claim 1, Douglas discloses an endoprosthesis delivery system, comprising:
an expandable endoprosthesis having a first portion 324 and a second portion 310 (Figure 10);
a constraining sleeve 220 (Figure 5) overlapping the second portion 310 of the expandable endoprosthesis and configured to releasably constrain the second portion of the expandable endoprosthesis to a partially expanded configuration ([0108], [0127]);
a second sleeve 210 (Figures 2-3) overlapping the constraining sleeve 220 and the second portion 310 of the expandable endoprosthesis to constrain the second portion of the expandable endoprosthesis to a collapsed configuration ([0105], [0107]); and
a third sleeve 326 (Figures 6-8, 11, 13) overlapping the first portion 324 of the expandable endoprosthesis and configured to releasably constrain the first portion of the expandable endoprosthesis to a collapsed configuration ([0128]).
Regarding claim 2, Douglas discloses the endoprosthesis is self-expandable ([0088], [0096]).
Regarding claim 3, Douglas discloses the endoprosthesis is configured to be expanded with a secondary device (such as a balloon; [0088], [0096]).
Regarding claim 5, Douglas discloses the first portion 324 of the expandable endoprosthesis is configured to expand independent of the second portion 310 of the expandable endoprosthesis (Figures 6-9).
Regarding claim 8, Douglas discloses an endoprosthesis delivery system, comprising:
a catheter shaft 230 (Figures 12-13);
an expandable endoprosthesis 310/324 mounted on the catheter shaft ([0170]), the expandable endoprosthesis having a first portion 310 and a second portion 324 defined along a length of the expandable endoprosthesis;
a constraining sleeve 220 (Figure 5) overlapping the first portion 310 and configured to releasably constrain the first portion of the expandable endoprosthesis to a first portion partially expanded configuration ([0108], [0127]);
a second sleeve 210 (Figures 2-3) in series (having overlapping portions) with the constraining sleeve 220 such that the second sleeve overlaps the constraining sleeve and the first portion 310 of the expandable endoprosthesis and is configured to releasably constrain the first portion of the expandable endoprosthesis to a first portion delivery configuration ([0105], [0107]); and
a third sleeve 326 (Figures 6-8, 11, 13) in parallel (at least partially not overlapping) with the constraining sleeve 220 such that the third sleeve is longitudinally displaced from the constraining sleeve to overlap the second portion 324 of the endoprosthesis (Id.), the third sleeve being configured to releasably constrain the second portion of the expandable endoprosthesis to a second portion delivery configuration ([0128]).
Regarding claim 13, Douglas discloses the constraining sleeve 220 allows access to the (first) portion 310 of the expandable endoprosthesis when the (first) portion of the expandable endoprosthesis is at an intermediate diameter (Figure 5; when the first portion 310 is at a partially expanded/intermediate diameter when the constraining sleeve 220 is retracted).
Regarding claim 14, Douglas discloses further comprising a first guidewire 201 or 202 (Figure 2) associated with the expandable endoprosthesis.
Claims 1-5, 8, 13-14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaw (U.S. Pub. No. 2012/0130475), cited in IDS filed 01/10/2025.
Regarding claim 1, Shaw discloses an endoprosthesis delivery system (Figures 7A-7C; [0054]-[0056]), comprising:
an expandable endoprosthesis 702 having a first (distal) portion and a second (proximal) portion;
a constraining sleeve 704a (Figure 7C) overlapping the second (proximal) portion of the expandable endoprosthesis and configured to releasably constrain the second portion of the expandable endoprosthesis to a partially expanded configuration ([0054]);
a second sleeve 718 (Figure 7A) overlapping the constraining sleeve 704a and the second (proximal) portion of the expandable endoprosthesis to constrain the second portion of the expandable endoprosthesis to a collapsed configuration ([0055]); and
a third sleeve 704b (Figure 7B) overlapping the first (distal) portion of the expandable endoprosthesis and configured to releasably constrain the first portion of the expandable endoprosthesis to a (partially) collapsed configuration ([0054]).
Regarding claim 2, Shaw discloses the endoprosthesis is self-expandable ([0053]).
Regarding claim 3, Shaw discloses the endoprosthesis is configured to be expanded with a secondary device (such as coupling members 714a-b, 722; [0054]-[0056]).
Regarding claim 4, Shaw discloses the constraining sleeve 704a including a coupling member 714a (Figure 7C; [0054]) configured to disengage from the constraining sleeve to release the constraining sleeve from the second (proximal) portion of the endoprosthesis (Id.).
Regarding claim 5, Shaw discloses the first (distal) portion of the expandable endoprosthesis is configured to expand independent of the second (proximal) portion of the expandable endoprosthesis (via coupling member 714b; [0041], [0054]).
Regarding claim 8, Shaw discloses an endoprosthesis delivery system, comprising:
a catheter shaft 110 (Figure 1);
an expandable endoprosthesis 702 mounted on the catheter shaft (Figure 7A), the expandable endoprosthesis having a first (proximal) portion and a second (distal) portion defined along a length of the expandable endoprosthesis;
a constraining sleeve 704a (Figure 7C) overlapping the first (proximal) portion and configured to releasably constrain the first portion of the expandable endoprosthesis to a first portion partially expanded configuration ([0054]);
a second sleeve 718 (Figure 7A) in series (having overlapping portions) with the constraining sleeve 704a such that the second sleeve overlaps the constraining sleeve and the first (proximal) portion of the expandable endoprosthesis and is configured to releasably constrain the first portion of the expandable endoprosthesis to a first portion delivery configuration ([0055]); and
a third sleeve 704b (Figure 7B) in parallel (at least partially not overlapping) with the constraining sleeve 704a such that the third sleeve is longitudinally displaced from the constraining sleeve to overlap the second (distal) portion of the endoprosthesis (for instance, when third sleeve is 704b is expanded, the third sleeve will be longitudinally displaced and forms a space between the constraining sleeve and the third sleeve, since a target portion of the endoprosthesis may be exposed between the adjacent sleeves; ([0076], similar to sleeves 304a-b in Figures 3-4), the third sleeve being configured to releasably constrain the second portion of the expandable endoprosthesis to a second portion delivery configuration ([0054]).
Regarding claim 13, Shaw discloses the constraining sleeve 704a allows access to the (first, proximal) portion of the expandable endoprosthesis when the (first, proximal) portion of the expandable endoprosthesis is at an intermediate diameter ([0054]).
Regarding claim 14, Shaw discloses further comprising a first guidewire (722, 714a-b may be considered guidewires; [0039]) associated with the expandable endoprosthesis.
Regarding claim 21, Shaw discloses the third sleeve 704b is longitudinally displaced from the constraining sleeve so as to form a space between the constraining sleeve 704a and the third sleeve (for instance, when third sleeve is 704b is expanded, the third sleeve will be longitudinally displaced and forms a space between the constraining sleeve and the third sleeve, since a target portion of the endoprosthesis may be exposed between the adjacent sleeves; ([0076], similar to sleeves 304a-b in Figures 3-4).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Douglas (U.S. Pub. No. 2012/0271410) in view of Norris (U.S. Pub. No. 2013/0245742).
Regarding claim 4, Douglas discloses the claimed invention, as discussed above, except for the constraining sleeve 220 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 ([0044]-[0050]).
It would have been obvious to one of ordinary skill before the effective filing date to modify Douglas to have a coupling member as claimed, as taught by Norris, in order to facilitate selective and controlled deployment of the endoprosthesis (Id.).
Claims 15-17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw ‘478 (U.S. Pub. No. 2012/0130478) in view of Douglas (U.S. Pub. No. 2012/0271410).
Regarding claim 15, Shaw ‘478 discloses an endoprosthesis delivery system, comprising:
an expandable endoprosthesis 102 (Figure 3; [0054]) including a graft ([0031]), the graft having a portion comprised of a fenestrable material ([0030], [0038], [0039]), at least a portion of the fenestrable material defining a side branch portal (through which side branch stent-graft may be delivered; Figure 7, [0039]-[0040]);
a side branch component 400 (Figure 7, [0046]) configured to be exposed upon access to the fenestrable material and fenestration of the fenestrable material, the side branch component further configured for delivery through the side branch portal ([0039]-[0041]).
However, Shaw ‘478 does not disclose a sleeve positioned over the side branch portal when the expandable endoprosthesis is in an unexpanded configuration, the sleeve configured to selectively allow access to the side branch portal.
Douglas teaches in Figures 1-2 having a sleeve 210 positioned over a side branch portal (through which branch graft assembly 320 extends) when an expandable endoprosthesis 310/324 is in an unexpanded configuration, the sleeve configured to selectively allow access to the side branch portal.
It would have been obvious to one of ordinary skill before the effective filing date to modify the graft in Shaw ‘478 such a sleeve is positioned over the side branch portal when the expandable endoprosthesis is in an unexpanded configuration, the sleeve configured to selectively allow access to the side branch portal, as taught by Douglas since doing so may prevent expansion of a side branch component and facilitate delivery of the endoprosthesis in a low profile through the vasculature (Douglas; [0105]).
Regarding claim 16, Shaw ‘478 as modified teaches an endoluminal tool 300 (Shaw ‘478; Figure 3, [0039]) configured to fenestrate the fenestrable material.
Regarding claim 17, Shaw ‘478 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 (as in Figure 5 of Douglas).
Regarding claim 19, Shaw ‘478 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; [0042]) of Shaw ‘478).
Regarding claim 20, Shaw ‘478 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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 13-14, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8 of U.S. Patent No. 11,147,698, and in view of Shaw (U.S. Pub. No. 2012/0130475). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that the application claims are encompassed by the patent claim(s), wherein the application claims include features that are merely obvious, as discussed and taught by Shaw above, which facilitate accurate delivery of the endoprosthesis (Shaw; [0007]). For instance, regarding claim 1, the patent claim 1 recites an expandable endoprosthesis having a first portion (distal portion) and a second portion (proximal portion), a constraining sleeve (secondary sleeve) overlapping the second portion of the expandable endoprosthesis and configured to releasably constrain the second portion of the expandable endoprosthesis to a partially expanded configuration, a second sleeve (first primary sleeve) overlapping the constraining sleeve and the second portion of the expandable endoprosthesis to constrain the second portion of the expandable endoprosthesis to a collapsed configuration, and a third sleeve (second primary sleeve) overlapping the first portion of the expandable endoprosthesis and configured to releasably constrain the first portion of the expandable endoprosthesis to a collapsed configuration.
Claims 1-5, 8, 13-14, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 13-14, 20-21 of U.S. Patent No. 11,969,369 in view of Shaw (U.S. Pub. No. 2012/0130475). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that the application claims are encompassed by the patent claim(s), wherein the application claims include features that are merely obvious, as discussed and taught by Shaw above, which facilitate accurate delivery of the endoprosthesis (Shaw; [0007]). For instance, regarding claim 1, the patent claim 1 recites an expandable endoprosthesis having a first portion (distal portion) and a second portion (proximal portion), a constraining sleeve (secondary sleeve) overlapping the second portion of the expandable endoprosthesis and configured to releasably constrain the second portion of the expandable endoprosthesis to a partially expanded configuration, a second sleeve (first primary sleeve) overlapping the constraining sleeve and the second portion of the expandable endoprosthesis to constrain the second portion of the expandable endoprosthesis to a collapsed configuration, and a third sleeve (second primary sleeve) overlapping the first portion of the expandable endoprosthesis and configured to releasably constrain the first portion of the expandable endoprosthesis to a collapsed configuration.
Conclusion
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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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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