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 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.
Claims 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.
Claims 1, 11, 16-17 recites the limitation "the cutting guidewire device". There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 11-16 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by US 2009/0228020 hereinafter Wallace.
In regards to Claim 1: A device for creating an in-situ fenestration in a graft material of a stent graft at a fenestration site (Wallace, Paragraph 25; Figure 2A & 2B Items 6 & 8), the cutting guidewire device comprising:
an outer member forming a lumen (Wallace, Paragraph 25; Figure 3E Item 6); and
an inner member situated within the lumen of the outer member (Wallace, Paragraph 25; Figure 3E Item 14),
the outer member includes one or more cutters configured to change from a delivery position to a cutting position via axial movement of the outer member and/or the inner member (Wallace, Figures 3B vs. 3E), the one or more cutters in the cutting position are configured to create the in-situ fenestration in the graft material of the stent graft at the fenestration site (Wallace Paragraph 25; Figure 3E Item 16).
In regards to Claim 2: wherein the outer member includes one or more struts carrying the one or more cutters (Wallace, Paragraph 33; Figure 11C item 60).
In regards to Claim 3: wherein the one or more cutters are one or more electrodes (Wallace, Paragraph 27; Figure 4B Item 6 & 96; “electrically coupled to the RF generator (92) by a different lead (100) is a fenestration element (94) coupled to the distal end of the inner sheath instrument (6)”).
In regards to Claim 7: wherein the inner member is an inner wire including a distal tip configured to pierce the graft material at the fenestration site (Wallace, Paragraph 28; “dilator punch”).
In regards to Claim 11: A device for creating an in-situ fenestration in a graft material of a stent graft at a fenestration site, the cutting guidewire device comprising:
an outer member including a proximal end and a distal end (Wallace, Figure 3E Item 6; Paragraph 25) and one or more struts extending therebetween, the one or more struts carrying one or more cutters (Wallace, Paragraph 5; “Guidewire”); and
an inner member situated within the outer member (Wallace, Figure 3E Item 14; Paragraph 25),
the one or more struts (Wallace, Paragraph 5; “Guidewire”) are configured to change from a delivery position to a cutting position via axial movement of the outer member and/or the inner member, the one or more cutters in the cutting position are configured to create the in-situ fenestration in the graft material of the stent graft at the fenestration site, the one or more cutters are spaced apart from the inner member in the cutting position (Wallace, Figure 3A & 3E).
In regards to Claim 12: wherein the one or more struts are bent in the cutting position (Wallace, Figure 3E).
In regards to Claim 13: wherein the one or more struts include one or more tapered portions (Wallace, Paragraph 28).
In regards to Claim 14: wherein the one or more struts are linear in the delivery position (Wallace, Figure 3A).
In regards to Claim 15: wherein the proximal end includes a transverse cutting pattern configured for flexing in the delivery position (Wallace, Paragraph 3; Figure 11C. Item 60).
In regards to Claim 16: A method of deploying a device at a fenestration site to form a fenestration in a graft material of a stent graft (Wallace, Paragraph 25; Figure 3E Items 6 & 14), the method comprises:
delivering a distal tip of the cutting guidewire device to the fenestration site (Wallace, Paragraph 29);
penetrating the graft material of the stent graft at the fenestration site with the distal tip (Wallace, Paragraph 28; “Punch”); and
creating the fenestration at the fenestration site with one or more cutters of the cutting guidewire device (Wallace, Paragraph 28)
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 (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 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 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.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0228020 hereinafter Wallace in view of 2014/0163664 hereinafter Goldsmith.
In regards to Claim 4: Wallace teaches all of claim 1 & 2, but does not teach wherein the one or more blades are friction fit to the one or more struts.
Goldsmith teaches wherein the one or more blades are friction fit to the one or more struts (Goldsmith, Paragraph 2118).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the blade taught in Goldsmith to the in-situ graft fenestration device of Wallace, the motivation being to provide a tool to make alterations and puncture the stent.
In regards to Claim 5: A modified Wallace teaches all of claim 1, 2, & 4, and wherein the one or more blades are friction fit to the one or more struts (Goldsmith, Paragraph 2118).
In regard to Claim 6: A modified Wallace teaches all of claims 1, 2, & 4, and an outer sheath configured to cover the one or more blades when the outer member is in the delivery position (Wallace, Paragraph 24; Figure 2A Item 8)
Claim(s) 8-10 & 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0228020 hereinafter Wallace in view of US 5,676,670 hereinafter Kim.
In regards to Claim 8: Wallace teaches all of claims 7 & 1, but does not teach wherein the inner member includes a retaining shoulder and the outer member includes a proximal stop and a distal stop, the inner member is in a delivery position when the retaining shoulder contacts the proximal stop, and the inner member is configured to change into a deployment position.
Kim teaches wherein the inner member includes a retaining shoulder and the outer member includes a proximal stop and a distal stop, the inner member is in a delivery position when the retaining shoulder contacts the proximal stop, and the inner member is configured to change into a deployment position (Kim, Figure 28 Item 126; Column 21 Lines 36-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the retaining shoulder taught in Kim to the in-situ graft fenestration device taught by Wallace, the motivation being to provide a structure that ensures the inner member does not slip too far into the outer member.
In regards to Claim 9: A modified Wallace teaches all of claims 8, 7, & 1, and wherein the distal tip extends beyond the outer member in the deployment position (Wallace, Figure 2A Items 6 vs. 8).
In regards to Claim 10: A modified Wallace teaches all of claims 8, 7, & 1, and wherein the retaining shoulder contacts the distal stop when the inner member is in the deployment position (Kim, Column 13 Lines 8-20; Figure 28).
In regards to Claim 17: Wallace teaches all of Claim 16, but does not teach wherein the cutting guidewire device includes an outer member including one or more struts carrying the one or more cutters and an inner member situated within the outer member.
Kim teaches wherein the cutting guidewire device includes an outer member including one or more struts carrying the one or more cutters and an inner member situated within the outer member (Kim, Figure 28 Items 134, 124, & 400).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the device structure taught in Kim to the in-situ graft fenestration device taught by Wallace, the motivation being to provide a device that can puncture a fenestration graft to better match the structure of the installation site.
In regards to claim 18: A modified Wallace teaches all of claim 17 & 16, and aligning the one or more cutters with the graft material, compressing the outer member to urge the one or more struts carrying the one or more cutters outward, and activating the one or more cutters to create the fenestration (Kim, Figure 32-38; Steps shown in figures).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the steps for puncture and installation taught in Kim to the in-situ graft fenestration device taught in Wallace, the motivation being to provide a device that can puncture a fenestration graft to better match the structure of the installation site.
In regards to Claim 19: A modified Wallace teaches all of claims 18, 17, & 16, and wherein the one or more cutters are one or more electrodes, and the activating step includes energizing the one or more electrodes to create the fenestration (Wallace, Paragraph 27).
In regards to Claim 20: A modified Wallace teaches all of 18, 17, & 16, and comprising retracting the distal tip into the outer member after the aligning step (Kim, Figure 38 & 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the steps for retraction taught in Kim to the in-situ graft fenestration device taught in Wallace, the motivation being to provide a device that can puncture a fenestration graft to better match the structure of the installation site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOE R DIETZ whose telephone number is (571)272-1135. The examiner can normally be reached Mon-Fri 8am - 5pm.
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/N.R.D./Patent Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791