DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This action is in response to the amendment filed on 10/30/2025. Claims 1-9, 12-24, and 26 are pending. Claims 1, 13, and 20 are independent. Claims 10, 11, and 25 are canceled. Claims 13-19, 23, and 24 are withdrawn.
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.
Claim Rejections - 35 USC § 103
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, 20-22, and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Leopold et al. (US Pub. No.:2002/0029077) in view of Stenzel et al. (US Pub. No.: 2003/0212410).
Regarding claim 1, Leopold discloses a deployment system for a transvascular endoluminal device, the system comprising: a catheter (136, Fig. 9C and Para. [0106]) having a proximal end (Fig. 9C); an expandable endoluminal device (106, Figs. 9B, 10A, and 11A) positioned about the catheter and rearward of the proximal end of the catheter (Fig. 9C), the expandable endoluminal device having at least one target portion (a first arbitrary portion / target portion adjacent to the stitch line at the first lateral opening defined below), the expandable endoluminal device positioned on the catheter and configured to be transvascularly delivered to a target site via the catheter (Figs. 9B, 10A, and 11A); a first sleeve (a first restraining member 102, Figs. 3-4B and 9C and Para. [0106]) wrapped circumferentially about the expandable endoluminal device to maintain a first portion of the endoluminal device in a first collapsed configuration (Fig. 9C), wherein the first sleeve is configured to remain implanted with the expandable endoluminal device (at least Para. [0070] and Fig. 4A, the first sleeve is configured to remain implanted with the expandable endoluminal device because it is fixed to the endoluminal device), wherein the first sleeve includes a first lateral opening (a lateral opening 116/118 of the sleeve for the control lines to extend through, Fig. 4B and 9C) for positioned adjacent to and configured to expose the at least one target portion of the expandable endoluminal device upon release of the first sleeve; a second sleeve (a second restraining member, Para. [0106], “multiple restraining members”) distinct from the first sleeve and releasably wrapped circumferentially about the expandable endoluminal device to maintain a second portion of the endoluminal device in a second collapsed configuration (Fig. 9C and Para. [0106]), and at least one of the first sleeve and the second sleeve are configured to cover the at least one target portion in the first collapsed configuration and the second collapsed configuration and expose the at least one target portion in response 14to expansion of a corresponding sleeve of the at least one of the first sleeve and the second sleeve relative to the at least one target portion (Figs. 9C and 1-4B and Para. [0106]); and a deployment line (104, Figs. 1-4B, 9B, 10A, and 11A) coupled to the first sleeve, wherein the deployment line extends through at least a portion of the catheter (Fig. 9B). However, Campbell does not disclose that a second sleeve releasable wrapped circumferentially about the expandable endoluminal device to maintain a second portion of the endoluminal device in a second collapsed configuration. However, Leopold does not specifically disclose that the first and second sleeves are separate.
Stenzel teaches, in the same field of endeavor (endoluminal device deployment system), a system comprising a first sleeve and a second sleeve (sleeves 12 and 14, Figs. 1-2 and Paras. [0038]-[0045]; alternatively, sleeves 50 and 51, Figs. 10-13, and Paras. [0052]-[0053]) releasably wrapping around an expandable endoluminal device; wherein the second sleeve is separate from the first sleeve.
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Leopold to have the second sleeve to be separate from the first sleeve as taught by Stenzel in order to obtain the advantage of expanding one sleeve without affecting the expansion of the other sleeve.
Regarding claim 2, Leopold discloses that the at least one target portion includes a first target portion arranged (the first arbitrary portion / target portion adjacent to the stitch line at the proximal side of the device/stent similar to what is shown in Fig. 4 of the instant application) with the first portion of the endoluminal device and a second target portion (the second arbitrary portion / target portion adjacent to the stitch line at the distal side of device/stent and misaligned with the first arbitrary portion / target portion along the stitch line similar to what is shown in Fig. 4 of the instant application).
Regarding claim 3, in the modified system of Leopold in view of Stenzel, the first sleeve and the second sleeve are configured to expose the first target portion and the second target portion to vasculature in response to expansion of the first sleeve and the second sleeve (Leopold, Para. [0106]).
Regarding claim 4, in the modified system of Leopold in view of Stenzel, the first sleeve is configured to allow expansion of the first portion of the endoluminal device to a first larger diameter and the second sleeve is configured to allow expansion of the second portion of the endoluminal device a second larger diameter (Leopold, Para. [0106]).
Regarding claim 5, in the modified system of Leopold in view of Stenzel, the first sleeve and the second sleeve are configured to expand independently (Leopold, Para. [0106]; Also see Stenzel, Paras. [0038]-[0045] or Paras. [0052]-[0053]).
Regarding claim 6, in the modified system of Leopold in view of Stenzel, the at least one target portion is a fenestratable portion of the endoluminal device fully capable to fenestrate by an endoluminal tool after partial or fully implantation of the endoluminal device (the target graft portion of Leopold is considered as a fenestratable portion of the endoluminal device and is fully capable to be fenestrated by an endoluminal tool after partial or fully implantation of the endoluminal device depending on the endoluminal tool and the method implantation and creating the hole)
Regarding claim 7, in the modified system of Leopold in view of Stenzel, the target portion is fully capable to facilitate install of branching stent grafts to the endoluminal device (the target portion of Leopold is fully capable to facilitate install of branching stent grafts to the endoluminal device depending on the structure and/or size of the branching stent grafts and method of implantation)
Regarding claim 8, in the modified system of Leopold in view of Stenzel, the first sleeve and the second sleeve are coupled together to act as one individual sleeve (Leopold, Para. [0106] and Fig. 9C, when both the proximal and distal ends/sides are deployed simultaneously, the first sheath and second sheath are considered to be coupled together via the device/stent to act as one individual sheath for deploying the proximal and distal ends/sides together)
Regarding claim 9, in the modified system of Leopold in view of Stenzel, the first sleeve includes a first portion and a second portion (the joining edges of the first sheath similar to what is shown in Fig. 1 of Leopold) and the first portion of the first sleeve is releasably coupled to the second portion of the first sleeve to define a first seam (Leopold, Paras. [0071] and [0106], a seam on the first sheath similar to seam formed with 104 threaded through 102 as shown in Fig. 1 of Leopold) and the second sleeve includes a first portion and a second portion (the joining edges of the first sheath similar to what is shown in Fig. 1 of Leopold) and the first portion of the second sleeve is releasably coupled to the second portion of the second sleeve to define a second seam (Leopold, Paras. [0071] and [0106], a seam on the first sheath similar to seam formed with 104 threaded through 102 as shown in Fig. 1 of Leopold)
Regarding claim 21, in the modified system of Leopold in view of Stenzel, the first sleeve includes parallel edges (Leopold, Fig. 1), wherein, when the first sleeve is released and remains implanted, at least one of the at least one target portion is positioned between the parallel edges such that the at least one target portion is exposed (Figs. 1, 10A, and 11A and Para. [0070]).
Regarding claim 22, in the modified system of Leopold in view of Stenzel, the first sleeve is fully capable to be interposed between a vessel wall and the expandable endoluminal device following implantation (Leopold, Figs. 1-4B and 10A, the first sleeve is fully capable to be interposed between a vessel wall and the expandable endoluminal device following implantation because the first sleeve is attached to the expandable endoluminal device).
Regarding claim 26, Leopold discloses that the catheter includes a side wall having an aperture defined therethrough, wherein the aperture is spaced from the expandable endoluminal device, and wherein the deployment line extends through the aperture (Paras. [0106] and [0108] and Figs. 9C and 10A).
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Leopold et al. (US Pub. No.:2002/0029077) in view of Stenzel et al. (US Pub. No.: 2003/0212410) as applied to claim 1 above, and further in view of Greenberg et al. (US Pub. No.: 2006/0004433)
Regarding claim 12, Leopold in view of Stenzel discloses substantially all the limitations of the claims as taught above. However, neither Leopold nor Stenzel discloses that the at least one target portion is a lateral opening in the endoluminal device.
Greenberg teaches, in the same field of endeavor (stent graft), at least one target portion (67, Fig. 4) covered by a sheath (23, Figs. 1-2) is a lateral opening in the endoluminal device.
At the time of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the at least one target portion of Leopold in view of Stenzel to be a lateral opening in the endoluminal device as taught by Greenberg in order to access to other blood vessels (Greenberg, Para. [0036]).
Allowable Subject Matter
Claim 20 is allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 12, 21, 22, and 26 have been considered but are moot in view of new ground(s) of rejection.
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 JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771