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 § 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, 2, 4 – 10, and 12 – 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruszewski et al (US 2012/0271401 A1).
Regarding claims 1, 2, 4, 5, Bruszewski discloses a method (abstract, paragraphs [0030], [0062 – 0066], and Figs. 11 – 13,18, and 22 – 27) comprising:
tracking a stent graft (stent graft 100) in a delivery state within a stent graft cover (outer sleeve 210) along a first guidewire (first guidewire 220) to a deployment site within an aorta (paragraphs [0064 – 0065] and Figs. 11,13,22 – 23), the stent graft defines a side opening (external coupling 120) (paragraph [0063] and Figs. 13,18);
extending a second guidewire (second guidewire 222) through the side opening (external coupling 120) and [claim 2] extending the second guidewire into a branch vessel of the aorta (paragraphs [0052], [0064 – 0066], and Fig. 18,22,23,24); and
retracting the stent graft cover (outer sleeve 210) to retract a second guidewire lumen (side tube 224) of the second guidewire (second guidewire 222) (Examiner’s note: as shown in Fig. 13 the side tube 224 (i.e., the second guidewire lumen) extends distally from the tip of the system when the outer sleeve 210 (i.e., the stent graft cover) is fully extended, and when the outer sleeve 210 (i.e., the stent graft cover) is retracted, as shown in Fig. 18 and described in paragraph [0057], the external coupling 120 is reoriented thus retracting (i.e., pulling proximally) the side tube 224 (i.e., the second guidewire lumen) relative to its initial position);
[claim 4] wherein the retracting step deploys the stent graft (stent graft 100) at the deployment site (paragraphs [0066 – 0067]);
[claim 5] wherein the stent graft cover (outer sleeve 210) and the second guidewire lumen (side tube 224) are attached (paragraphs [0047], [0057], and Fig. 11) (Examiner’s note: the outer sleeve 210 (i.e., the second guidewire lumen) and side tube 224 (i.e., the second guidewire lumen) are attached via the proximal portion 250).
Regarding claims 1, 2, 4, and 5, (alternate interpretation – changes italicized below) Bruszewski discloses a method (abstract, paragraphs [0030], [0062 – 0066], and Figs. 11 – 13,18, and 22 – 27) comprising:
tracking a stent graft (stent graft 100) in a delivery state within a stent graft cover (outer sleeve 210) along a first guidewire (first guidewire 220) to a deployment site within an aorta (paragraphs [0064 – 0065] and Figs. 11,13,22 – 23), the stent graft defines a side opening (external coupling 120) (paragraph [0063] and Figs. 13,18);
extending a second guidewire (second guidewire 222) through the side opening (external coupling 120) and [claim 2] extending the second guidewire into a branch vessel of the aorta (paragraphs [0052], [0064 – 0066], and Fig. 18,22,23,24); and
retracting the stent graft cover (outer sleeve 210) to retract a second guidewire lumen (lumen of outer sleeve 210) of the second guidewire (second guidewire 222) (Examiner’s note: the second guidewire 222 extends through the outer sleeve, therefore the lumen of the outer sleeve 210 (i.e., the stent graft cover) is a second guidewire lumen; and as the outer sleeve 210 (i.e., the stent graft cover) is retracted so is its lumen (i.e., the second guidewire lumen));
[claim 4] wherein the retracting step deploys the stent graft (stent graft 100) at the deployment site (paragraphs [0066 – 0067]);
[claim 5] wherein the stent graft cover (outer sleeve 210) and the second guidewire lumen (lumen of outer sleeve 210) are attached (Examiner’s note: the outer sleeve 210 (i.e., the stent graft cover) comprises its lumen (i.e., the second guidewire lumen), thus the outer sleeve 210 (i.e., the stent graft cover) and its lumen (i.e., the second guidewire lumen) are attached).
Regarding claim 6 – 10 and 12 – 14, Bruszewski discloses a method (abstract, paragraphs [0030], [0062 – 0066], and Figs. 11 – 13,18, and 22 – 27) comprising:
tracking a stent graft (stent graft 100) in a delivery state within a stent graft cover (outer sleeve 210) along a first guidewire (first guidewire 220) to a deployment site within an aorta (paragraphs [0064 – 0065] and Figs. 11,13,22 – 23), the stent graft defines a side opening (external coupling 120) (paragraph [0063] and Figs. 13,18);
extending a second guidewire (second guidewire 222) through the side opening (external coupling 120) (paragraphs [0052], [0064 – 0066], and Fig. 18,22,23,24); and
retracting the stent graft cover (outer sleeve 210) via a handle (proximal portion 250) to retract a second guidewire lumen (side tube 224) of the second guidewire (second guidewire 222) (Examiner’s note: as shown in Fig. 13 the side tube 224 (i.e., the second guidewire lumen) extends distally from the tip of the system when the outer sleeve 210 (i.e., the stent graft cover) is fully extended, and when the outer sleeve 210 (i.e., the stent graft cover) is retracted, as shown in Fig. 18 and described in paragraph [0057], the external coupling 120 is reoriented thus retracting (i.e., pulling proximally) the side tube 224 (i.e., the second guidewire lumen) relative to its initial position);
[claims 7 and 8] wherein the handle (proximal portion 250) is operatively connected to the stent graft cover (outer sleeve 210) and includes a slider (slider 254) (paragraphs [0047], [0057], and Figs. 11,18A,19A);
[claims 9 and 10] wherein the retracting step includes sliding and rotating the slider (slider 254) to retract the stent graft cover (outer sleeve 210) (paragraphs [0057], [0059], and Figs. 18A,19A);
[claim 12] wherein the stent graft cover (outer sleeve 210) and the second guidewire lumen (side tube 224) are attached to a hub (slider 254) (Examiner’s note: both the outer sleeve 210 (i.e., the stent graft cover) and the side tube 224 (i.e., the second guidewire lumen) are coupled to the proximal portion 250 which comprises the slider 254 (i.e., the hub), therefore both components are either directly or indirectly attached to the slider 254 (i.e., the hub));
[claim 13] wherein the secondary guidewire lumen (side tube 224) retracts as the hub (slider 254) slides linearly (Examiner’s note: as discussed in paragraphs [0057] and [0059] the slider 254 (i.e., the hub) retracts the outer sleeve 210 when slid linearly in the proximal direction; and as discussed above, as the outer sleeve 210 retracts proximally the side tube 224 (i.e., the secondary guidewire lumen) is retracted proximally relative to its original position);
[claim 14] wherein the first guidewire (guidewire 220) extends through a main lumen port (proximal opening of the lumen of outer sleeve 210) configured to move with the hub (slider 254) (Examiner’s note: the first guidewire extends through the opening of the lumen of the outer sleeve 210 (i.e., a main lumen port) and the outer sleeve 210 moves with the slider 254; thus, the proximal opening of the lumen of the outer sleeve 210 (i.e., a main lumen port) moves with the hub).
Regarding claims 15 – 17, Bruszewski discloses a method (abstract, paragraphs [0030], [0062 – 0066], and Figs. 11 – 13,18, and 22 – 27) comprising:
tracking a stent graft (stent graft 100) in a delivery state within a stent graft cover (outer sleeve 210) along a first guidewire (first guidewire 220) to a deployment site within an aorta (paragraphs [0064 – 0065] and Figs. 11,13,22 – 23), the stent graft defines a side opening (external coupling 120) (paragraph [0063] and Figs. 13,18);
extending a second guidewire (second guidewire 222) through the side opening and [claim 17] into a branch vessel of the aorta (external coupling 120) (paragraphs [0052], [0064 – 0066], and Fig. 18,22,23,24); and
and simultaneously retracting the stent graft cover (outer sleeve 210) and a second guidewire lumen (side tube 224) of the second guidewire (second guidewire 222) (Examiner’s note: as shown in Fig. 13 the side tube 224 (i.e., the second guidewire lumen) extends distally from the tip of the system when the outer sleeve 210 (i.e., the stent graft cover) is fully extended, and when the outer sleeve 210 (i.e., the stent graft cover) is retracted, as shown in Fig. 18 and described in paragraph [0057], the external coupling 120 is reoriented thus retracting (i.e., pulling proximally) the side tube 224 (i.e., the second guidewire lumen) relative to its initial position; therefore, both the outer sleeve 210 (i.e., the stent graft cover) and the side tube 224 (i.e., the second guidewire lumen) are retracted simultaneously);
[claim 16] wherein the extending step occurs before the tracking step (paragraphs [0052], [0065], and Fig. 11).
Regarding claims 15 – 17, (alternate interpretation – changes italicized below) Bruszewski discloses a method (abstract, paragraphs [0030], [0062 – 0066], and Figs. 11 – 13,18, and 22 – 27) comprising:
tracking a stent graft (stent graft 100) in a delivery state within a stent graft cover (outer sleeve 210) along a first guidewire (first guidewire 220) to a deployment site within an aorta (paragraphs [0064 – 0065] and Figs. 11,13,22 – 23), the stent graft defines a side opening (mobile external coupling 120) (paragraph [0063] and Figs. 13,18);
extending a second guidewire (second guidewire 222) through the side opening (external coupling 120) and [claim 17] extending the second guidewire into a branch vessel of the aorta (paragraphs [0052], [0064 – 0066], and Fig. 18,22,23,24); and
simultaneously retracting the stent graft cover (outer sleeve 210) and a second guidewire lumen (lumen of outer sleeve 210) of the second guidewire (second guidewire 222) (Examiner’s note: the second guidewire 222 extends through the outer sleeve, therefore the lumen of the outer sleeve 210 (i.e., the stent graft cover) is a second guidewire lumen; and as the outer sleeve 210 (i.e., the stent graft cover) is retracted so is its lumen (i.e., the second guidewire lumen));
[claim 16] wherein the extending step occurs before the tracking step (paragraphs [0052], [0065], and Fig. 11).
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.
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 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bruszewski et al (US 2012/0271401 A1).
Regarding claims 3 and 11, as discussed above, Bruszewski discloses the method of claims 1 and 6, comprising the step of extending the second guidewire (second guidewire 222) through a branched vessel of the aorta (paragraphs [0052], [0064 – 0066], and Fig. 18,22,23,24)
However, Bruszewski is silent regarding (i) [claims 3 and 11] wherein the branch vessel is a left subclavian artery.
As to the above, Bruszewski teaches in paragraph [0063] wherein the stent graft 100 can be placed within the aorta such that the mobile external couplings 120 (i.e., the side opening), through which the second guidewire 222 extends, can be deployed in any of the other branched arteries including the left subclavian artery 316 for the purpose of treating an aneurysm that affects the left subclavian artery. Additionally, when treating the left subclavian artery with the mobile external coupling 120 of the stent graft, it would be obvious to one of ordinary skill in the art to deliver the mobile external coupling 120 to the left subclavian artery in the same manner as previously discussed for delivering the mobile external coupling 120 to the brachiocephalic truck 308 (shown in Fig. 24) by extending the second guidewire 222 through the left subclavian artery for the purpose of tracking the mobile external coupling 120 to left subclavian artery.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Bruszewski to incorporate the step of extending the second guidewire to the left subclavian artery for the purpose of deploying the mobile external coupling to the left subclavian artery for the purpose of treating the left subclavian artery, as taught by Bruszewski.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bruszewski et al (US 2012/0271401 A1), as applied to claim 15 above, and further in view of Leanna et al (US 2007/0270931 A1).
Regarding claim 18, as discussed above, Bruszewski discloses the method of claim 15.
However, Bruszewski is silent regarding (i) pull-loading the stent graft.
As to the above, Leanna teaches a method of loading a stent into a delivery system via pulling the stent into the sent cover (outer tubular member 60; which equates to the outer sleeve 210 of Bruszewski) (abstract, paragraphs [0033 – 0034], [0036], and Figs. 3,4).
The Examiner notes that the method step of pull-loading a stent / implant into a delivery system is a known method step for loading the stent / implant into the delivery system and that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one known method for another known method, as taught and suggested by Leanna, for loading an implant into a delivery system since the results of the substitution would have been predictable and resulted in the device operating as intended. Therefore, the simple substitution of one known element for another producing a predictable result renders the claim obvious. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bruszewski et al (US 2012/0271401 A1) in view of Leanna et al (US 2007/0270931 A1), as applied to claim 18 above, and further in view of Mayberry et al (US 2011/0054587 A1).
Regarding claims 19 and 20, as discussed above, the combination of Bruszewski and Leanna teach the method claim 18.
However, the combination of Bruszewski and Leanna is silent regarding (i) [claim 19] pre-loading the second guidewire lumen through the side opening and (ii) [claim 20] wherein the pre-loading step occurs before the pull-loading step
As to the above, Mayberry teaches a system and a method of delivering a stent graft into a branched vessel (abstract, paragraphs [0171 – 0174], and Figs. 18,19) comprising pre-loading a first guidewire lumen and second guidewire lumen (guidewires 310,312 – which extend over pre-wired guidewires and are thus lumens ; which equate to side tube 224 of Bruszewski) through the stent graft side openings (branches ; which equate to the mobile external coupling 120 of Bruszewski) before the stent graft (endoluminal prosthesis 300) has been loaded into the delivery system (paragraphs [0163], [0171], [0172], and Fig. 18).
The Examiner notes that the method step of pre-loading the side openings of a branched stent graft with the secondary guidewire lumens is a known method step for preparing the stent / implant for delivery into the body and that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one known method for another known method, as taught and suggested by Mayberry, for extending guidewire lumens through side openings of a branched stent graft since the results of the substitution would have been predictable and resulted in the device operating as intended. Therefore, the simple substitution of one known element for another producing a predictable result renders the claim obvious. KSR, 550 U.S. at, 82 USPQ2d at 1396. With respect to (ii), the combination of Bruszewski, Leanna, and Mayberry encompasses pre-loading the second guidewire lumen through the side opening before loading the stent graft into the stent graft cover and thus prior to the pull-loading step; thus the combination encompasses the limitations above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hartley et al (US 2004/0230287 A1), Quadri (US 2005/015444 A1), Greenan (US 2007/0233220 A1), Argentine et al (US 2013/0298692 A1), Maggard et al (US 2013/0289693 A1), Perkins (US 2018/0153677 A1), and Roeder et al (US 2019/0201223 A1) all teach a method of tracking a stent graft within a stent graft cover along a first and second guidewire and retracting the stent graft cover to retract a lumen through which the second guidewire extends.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771