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 .
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1 is objected to for referring to “the space”, and “the distal end portion of the catheter” with improper antecedent basis.
Claim 2 is objected to for referring to ‘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.
Drawings
Figures 1-3 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
The drawings are objected to because they refer to items A, B, and C which are not present in the specification. 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 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 claim 2. 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
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3 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.
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
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,
and 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.
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). 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).
Regarding claim 3 the Vardi Zedler 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).
Claims 2, 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vardi and Zedler as is applied above, further in view of Bassoe (US 20050004647 A1).
Regarding claim 2 the Vardi Zedler Combination teaches the system of claim 1 substantially as is claimed,
wherein Zedler further teaches 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 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 2 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 4 the Vardi Zedler 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 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 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
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 02/04/26