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 .
Response to Arguments
Applicant's arguments filed 05/06/26 have been fully considered but they are not persuasive.
On page 7 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully disagrees, noting amendments do not correct the objections of record.
On page 7 regarding drawing objections, Applicant argues amendments overcome the drawing objections of record.
The Examiner respectfully agrees and withdraws drawing objections.
On pages 7-8 regarding 112f claim interpretation, Applicant argues amendments prevent the Examiner from interpreting claim 1 under 112f.
The Examiner respectfully disagrees, noting the term has not been removed from the claim, so the claims remain under 112f interpretation.
On pages 8-9 regarding prior art rejections, Applicant argues that modifying Vardi would require substantial redesign and render the final resulting device inoperable, destroying the principle of operation of the prior art rejections. Applicant argues Zedler’s bare wire stent is conflated improperly with Vardi’s stent graft. Applicant argues Zedler does not teach a fenestration through a covering material as claim 1 requires and argues the covering material disposed on the wire frame would block the open-cell functionality of Zedler.
The Examiner respectfully notes no evidence in the record that utilizing a two-balloon delivery catheter would render Vardi inoperable or destroy any principle of operation, making this unpersuasive. Regarding suggestions that Zedler’s “bare wire stent” is conflated with Vardi’s stent graft, the Examiner cannot find any part of the rejection of record or the claims which mentions a bare stent, making this argument unclear. Similarly, suggestions that Zedler does not teach a fenestration through a covering material or blocking open cells of Zedler are equally unclear since it is Vardi’s system which is being modified (not Zedler), and Vardi’s device already includes the supposedly missing fenestration. The Examiner accordingly finds these arguments unpersuasive.
On page 10 Applicant argues further that modification of Vardi’s single balloon delivery system to use a dual-balloon delivery system would require a “complete redesign” of the stent graft, since it requires the fenestration to be aligned precisely with the branch vessel. Applicant argues Zedler’s dual-balloon system must work with a bare stent and not with isolated fenestrations through a covered graft. Thus the modification to use Zedler with Vardi’s covered graft would remove Zelder’s “core design premise” and so this constitutes substantial redesign and change of principle of operation. Applicant also notes no motivation to combine Zedler’s catheter with the covered stent since the covering material would interfere.
The Examiner respectfully disagrees, again noting no evidence in the record supporting the suggestion that anything of Vardi would require any redesign at all, let alone one that is so substantial that one of ordinary skill would not understand how to achieve it. Suggestions that a branch vessel would have to be aligned with the delivery device are not an outlandish principle as Applicant suggests, but rather as simple as fitting openings together. The Examiner understands a person of ordinary skill in the art would understand how to align openings and/or guidewires. Arguments regarding Zedler’s dual-balloon system not being operable with a stent that is not bare are unsupported, since there does not appear to be any reason or evidence presented in the response as to why the covering of Vardi would present any problems at all in the context of the system. Additionally, arguments regarding Zedler’s “core design premise” are unclear, since Zedler is not being modified in any way (Vardi is the reference being modified). These arguments are accordingly unpersuasive.
On pages 10-11 Applicant argues further that adding Bassoe’s wrap/sheath to the combination is improper, since Bassoe’s sheath is designed to control expansion of a hybrid stent’s self-expanding mid-portion. Applicant argues further that the Examiner cannot combine the prior art as suggested since the references have different structures and mechanisms of function, and since there is no evidence from the prior art itself for the modifications.
The Examiner respectfully disagrees, noting that simply providing a statement saying that Bassoe’s sheath is designed to control expansion does not appear to present any argument or evidence as to why this would be improper to add to the Vardi Zedler Combination. Additionally, the Examiner reminds Applicant that modification of a prior art reference need not be present in the reference itself, but also wishes to note confusion, since both Zedler and Bassoe actually do provide that evidence within their text (and it is/was presented in the rejection of record). This argument is accordingly unpersuasive.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to for referring to “the distal end portion of the catheter”, “the proximal end portion of the stent graft device”, and “the distal end portion of the stent graft device” with improper antecedent basis.
Appropriate correction is required.
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: “release mechanism” in claims 1 and 5. The specification describes this as “a removeable wrap or sheath”.
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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardi et al. (US 6210429 B1) hereinafter known as Vardi in view of Zedler et al. (US 6494905 B1) hereinafter known as Zedler, further in view of Bassoe (US 20050004647 A1).
Regarding claim 1 Vardi discloses a medical device system comprising:
a catheter (Figure 5) comprising an elongate shaft (54) with an opening defining a longitudinal axis (see Figure 5 where the opening receives guidewire 36),
a stent graft device (12) releasably coupled to a distal end portion of the catheter (Figure 4), the stent being constructed of a wire framework and a covering material disposed thereon and covering the wire framework (Column 5, lines 29-30 incorporates US 5653743 to Martin by reference. See Martin who teaches a wire framework stent 3 with a covering material 2 (Figure 1)),
wherein the stent graft includes a proximal portion (26), distal portion (28), and mid-body portion disposed therebetween (see Figure 4, the area between 26, 28);
wherein the mid-body portion of the stent graft defines a fenestration through the wire framework and covering material (16), and
wherein a proximal end portion of the stent graft is configured to expand in response to inflation of the proximal balloon member, and wherein the distal end portion of the stent graft is configured to expand in response to inflation of the distal balloon member (Figure 2; Column 4 lines 12-16, Column 5 lines 9-14),
but is silent with regards to the catheter including a proximal and distal balloon member which are spaced from one another with a space between the balloons that is in fluid communication with the shaft’s lumen,
the proximal portion of the stent graft being disposed on the proximal balloon and the distal portion of the stent graft being disposed on the distal balloon member with the fenestration being radially and longitudinally aligned with the opening defined by the shaft of the catheter,
and there being a first release mechanism that when activated, removes a localized radial constraint of the mid-body portion to allow it to self-expand radially.
However, regarding claim 1 Zedler teaches a catheter which includes an elongate shaft (2) with an opening (5) that extends between a spaced apart proximal (1.1) and distal balloon (1.2) member which are attached to the distal end portion of the shaft (Figure 2), so a proximal portion of a stent device is disposed on the proximal balloon member and a distal portion of a stent device is disposed on the distal balloon member (Figure 2 shows stent item 8 positioned around the two balloons 1.1, 1.2) with a fenestration (13) of the stent being radially and longitudinally aligned with the opening of the catheter shaft (5) which is in fluid communication with the shaft lumen (Figure 2),
and wherein a proximal end portion of the stent graft is configured to expand in response to inflation of the proximal balloon member, and wherein the distal end portion of the stent graft is configured to expand in response to inflation of the distal balloon member (Figure 2; Column 4 lines 12-16, Column 5 lines 9-14). Vardi and Zedler are involved in the same field of endeavor, namely bifurcated stent grafts and delivery systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Vardi to utilize multiple balloons to deliver the stent graft as is taught by Zedler in order to ensure as accurate of positioning as is possible (Zedler Column 1 lines 32-41) while achieving a consistent load (Zedler Column 2 lines 1-3).
Further, regarding claim 1 Bassoe teaches a stent in which a first release mechanism ([0009], an outer sheath), that when activated, removes a localized radial constraint of the stent’s mid-body portion to allow it to radially self-expand ([0009] outer sheath controls expansion of the self-expanding part of the stent; Abstract, the middle part of the stent 21 self-expands). Vardi and Bassoe are involved in the same field of endeavor, namely stent delivery mechanisms. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Vardi Zedler Combination so that the mid-portion of the stent self-expands via a localized radial constraint as is taught by Bassoe in order to achieve the benefits of hybrid stents known in the art, of both flexibility and accuracy of placement ([0006]).
Regarding claim 3 the Vardi Zedler Bassoe Combination teaches the system of claim 1 substantially as is claimed,
wherein Zedler further teaches a wire (4) slidably disposable in the first lumen (Figures 1-2) and extendable through the opening in the shaft and fenestration in the stent graft (Figures 1-2).
Regarding claim 4 the Vardi Zedler Bassoe Combination teaches the system of claim 1 substantially as is claimed,
but is silent with regards to the materials of the mid-body, proximal, and distal portions of the wire framework.
However, regarding claim 4 Bassoe teaches the mid-body portion framework can comprise Nitinol struts ([0024]) and the proximal and distal portions can comprise stainless steel struts ([0024]). Vardi and Bassoe are involved in the same field of endeavor, namely stent delivery mechanisms. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Vardi Zedler Bassoe Combination so that the mid-portion of the stent is made of a self-expandable material like Nitinol and has proximal and distal end portions made of non-self-expandable stainless steel as is taught by Bassoe in order to achieve the benefits of hybrid stents known in the art, of both flexibility and accuracy of placement ([0006]).
Claims 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardi, Zedler, and Bassoe as is applied above, further in view of Vardi et al. (US 20010003161 A1) hereinafter known as Vardi ‘161.
Regarding claim 5 Vardi discloses a method of deploying a stent graft delivery device (12) in an artery (Figure 1 item 8, Column 1 line 9) with a branch vessel (Figure 1 item 7), the method comprising:
advancing the system of claim 1 (see the explanation/rejection to claim 1 above, in the Vardi Zedler Combination) in the artery until the distal end of portion of the catheter and stent graft device are positioned at a location of the branch vessel (Figures 4-5),
but is silent with actuating a first release mechanism to allow the mid-body portion to radially self-expand, and then confirming the fenestration is in alignment with the branch vessel, and after confirming, causing the proximal and distal portions to radially self-expand to contact the artery both proximally and distally of the branch vessel.
However, regarding claim 5 Bassoe further teaches a method of deploying a stent device (20) which includes actuating a first release mechanism ([0009] outer sheath) to allow the stent’s mid-body portion (Figure 9 item 21) to radially self-expand (Abstract, [0030]),
and subsequently inflating proximal (32) and distal balloon members (33) to cause the proximal (22) and distal end portions (23) of the stent graft to radially expand into contact with the artery both proximally and distally of the branch vessel (Abstract, Figure 10, [0030]). Vardi and Bassoe are involved in the same field of endeavor, namely stent delivery mechanisms. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Vardi Zedler Combination so that the method of deployment includes both a self-expanding mid-portion and balloon-expandable proximal and distal portions as is taught by Bassoe in order to achieve the benefits of hybrid stents known in the art, of both flexibility and accuracy of placement ([0006]).
Further, regarding claim 5 Vardi ‘161 teaches a method of delivery of a stent device in which alignment of a fenestration with a branch vessel is confirmed ([0013]). Vardi and Vardi ‘161 are involved in the same field of endeavor, namely delivery of stent devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Vardi Zedler Bassoe Combination to ensure the method includes confirming alignment of the device during deployment as is taught by Vardi ‘161 in order to ensure the device is properly located, thus ensuring safety for the patient. The Examiner notes Bassoe acknowledges that the point of expanding the mid-portion of the stent first before expanding end portions is done to allow accurate placement ([0004]-[0007]), so the confirmation of this alignment would have been obvious to one of ordinary skill.
Regarding claim 7 the Varzi Zedler Bassoe Vardi ‘161 Combination teaches the method of claim 5 substantially as is claimed,
wherein the Combination further teaches the confirming the fenestration is in alignment comprises:
advancing a wire into the shaft’s lumen and visually confirming under fluoroscopy that the wire passes out of the shaft’s opening, through the fenestration, and into the branch vessel (Vardi Figures 1-5 shows the guidewire 36 through the lumen of the catheter 48 and through the stent graft’s fenestration 16 and into the branch 7; Zedler Figures 1-2 show the guidewire 4 extending through the opening 5 in the shaft of the catheter 2 and through fenestration (defined by items 13, 15) of the stent 8 and into the branch vessel 10.1; and wherein Vardi further teaches these steps are done under x-ray imaging (Abstract), Zedler further teaches the guidewire includes x-ray markers in order to monitor position during delivery (Column 2 lines 61-64), Bassoe teaches fluoroscopy can be used to image locations along the delivery catheter and stent to confirm a precise desired location ([0029]-[0030]), and Vardi ‘161 teaches performing stent delivery to a branch under fluoroscopy ([0013]).).
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardi, Zedler, Bassoe, Vardi ‘161 as is applied above, further in view of Baim et al. (US 20090171430 A1) hereinafter known as Baim.
Regarding claim 6 the Vardi Zedler Bassoe Vardi ‘161 Combination teaches the method of claim 5 substantially as is claimed,
wherein the Combination teaches the confirming the fenestration is in alignment comprises:
visually confirming stent delivery under fluoroscopy (Vardi Figures 1-5 shows the guidewire 36 through the lumen of the catheter 48 and through the stent graft’s fenestration 16 and into the branch 7; Zedler Figures 1-2 show the guidewire 4 extending through the opening 5 in the shaft of the catheter 2 and through fenestration (defined by items 13, 15) of the stent 8 and into the branch vessel 10.1; and wherein Vardi further teaches these steps are done under x-ray imaging (Abstract), Zedler further teaches the guidewire includes x-ray markers in order to monitor position during delivery (Column 2 lines 61-64), Bassoe teaches fluoroscopy can be used to image locations along the delivery catheter and stent to confirm a precise desired location ([0029]-[0030]), and Vardi ‘161 teaches performing stent delivery to a branch under fluoroscopy ([0013]).).
but is silent with regards to the method including injecting contrast agent into the shaft’s lumen in place of guidewire visualization.
However, regarding claim 6 Baim teaches contrast agent can be used to help in imaging stent position during delivery ([0072]). Vardi and Baim are involved in the same field of endeavor, namely stent delivery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of confirming placement so that it utilized contrast agent as is taught by Baim since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/18/26
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