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 .
Priority
This application claims priority from application 16/585,722, filed 09/27/2019
Status of Claims
Claims 1-8, 10-16, and 21-25 are pending.
Claims 14-16 and 21-25 have been withdrawn from consideration.
Claims 9 and 17-20 have been cancelled.
Election/Restrictions
Applicant elected Invention I (Method of Using), Species 3 (Figures 1-4 and 6), and Sub-species B (Figure 11) without traverse on 04/03/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tube graft within the main docking lumen such that the tube graft seals against the main graft and the outer surfaces of the first and second internal sleeves must be shown or the feature(s) canceled from the claim(s). (The broad configuration of Claim 8 seems capable of being disclosed based on the configurations of the inner sleeves as shown in Figures 1-4 and 6, but the more specific configuration of claims 11-13 do not appear to be shown because Figures 10, 11, and 14 all show the tube graft as being positioned fully below the second sleeve and only in contact with the second sleeve’s outer surface and the inner surface of the main graft/main lumen).
No new matter should be entered.
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 Rejections - 35 USC § 112
The previous 112 rejection has been withdrawn in view of the applicant’s amendments.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 5-8, and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mehta US 2017/0319359 A.
1. Mehta discloses a method comprising: deploying a docking graft within an ascending aorta (Figure 4I), the docking graft comprising:
a main graft (130 Figure 1) defining a main lumen (largest inner opening surrounding/containing all inner structures Figure 1);
a first internal lumen (left most lumen in 140 Figure 1) within the main lumen;
a second internal lumen (second from the left in 140 Figure 1) within the main lumen (Figure 1); and
a main docking lumen (largest inner opening containing/surrounding 150 and the right two lumens 140 abutting the left two lumens 140 Figure 1) within the main lumen (Figure 1);
deploying a first bridging stent graft (452 Figure 4F) within the first internal lumen;
deploying a second bridging stent (454 Figure 4F) graft within the second internal lumen;
deploying a tube graft (410/458 [0053] discloses that extension 450 is connected to the end of the initial graft tube 410, wherein once it is attached a single tubular graft 410/458 is formed and deployed Figure 4H) within the main docking lumen such that the tube graft overlaps and is anchored along an entire length of the main docking lumen (by interpreting the tube graft as including both portions 410 and 450 the tube graft inherently extends the entire length of the main docking lumen as shown in Figure 1, additionally [0053] discloses that the previously identified tube graft 450 can also extend along the entire length of the main docking lumen thereby overlapping a portion of the inner surface).
2. Mehta discloses deploying the first bridging stent graft further comprises deploying the first bridging stent graft in a brachiocephalic artery (452 into 426 Figure 4F).
3. Mehta discloses the deploying the second bridging stent graft further comprises deploying the second bridging stent graft in a vessel selected from the group consisting of a left subclavian artery and a left common carotid artery (454 into 430 Figure 4F).
5. Mehta discloses the first internal lumen is defined by a first internal sleeve (left most sleeve 140 Figure 1) and the second internal lumen is defined by a second internal sleeve (the second from the left sleeve 140 Figure 1).
6. Mehta discloses the main docking lumen has a proximal opening at a proximal end of the docking graft (bottom of Figure 1) that is defined by an inner surface of the main graft and outer surfaces of the first internal sleeve and the second internal sleeve (Figure 1 shows the larger main docking lumen extending about the inner surface of the docking graft and abutting the outer surfaces of the left two internal sleeves but is considered to contain the right two sleeves and tube graft 150).
7. Mehta discloses the main docking lumen has a distal opening at a distal end of the docking graft (top of Figure 1) that is defined by the internal surface of the main graft and the outer surfaces of the first internal sleeve and the second internal sleeve (Figure 1 shows the larger main docking lumen extending about the inner surface of the docking graft and abutting the outer surfaces of the left two internal sleeves but is considered to contain the right two sleeves and tube graft 150).
8. Mehta discloses a method comprising: deploying a docking graft within an ascending aorta (Figure 4I), the docking graft comprising:
a main graft (130 Figure 1) defining a main lumen (largest inner opening Figure 1 surrounding/containing all inner structures);
a first internal sleeve (left most graft 140 Figure 1);
a second internal sleeve (second from the left most graft 140 Figure 1); and
a main docking lumen (largest inner opening containing 150 and the right two lumens 140 abutting the left two lumens 140 Figure 1) within the main lumen (Figure 1), the first internal sleeve and the second internal sleeve extending between a proximal end and a distal end of the docking graft (Figure 1);
deploying a first bridging stent graft (452 Figure 4F) within the first internal sleeve (Figure 4F);
deploying a second bridging stent graft (454 Figure 4F) within the second internal sleeve (Figure 4F); and
deploying a tube graft (as explained above the tube graft 458 is connected to portion 410 defining a single tube graft shown in Figure 4H) within the main docking lumen such that the tube graft seals against the main graft and the outer surfaces of the first and second internal sleeves. (Figure 4H shows the first end 410 of the tube graft contacts and seals against the outer surfaces of the sleeves and the inner surface of the main graft).
10. Mehta discloses the deploying the first bridging stent graft comprises deploying a graft of the first bridging stent graft within the first internal sleeve (452 into 412 Figure 4F [0051]).
11. Mehta discloses the deploying the first bridging stent graft further comprises locating the first branch graft in a brachiocephalic artery (452 into 426 Figure 4F).
12. Mehta discloses the deploying the first bridging stent graft further comprises introducing the first bridging stent graft via supra aortic access (452 into 426 Figure 4A-F).
13. Mehta discloses the introducing the first bridging stent graft via supra aortic access comprises:
introducing a guide wire (422 into 426 Figure 4E) through a right subclavian artery and advancing the guidewire into a distal opening of the first internal sleeve ([0049] discloses the guidewire can be advanced either direction); and
advancing a delivery system (442 Figure 4E and [0021]) comprising the first bridging stent graft into the brachiocephalic artery and the first internal sleeve over the guidewire (452 into 426 Figures 4D-F).
Claim Rejections - 35 USC § 103
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehta in view of Hartley US 10,231,822 B2.
Mehta discloses the invention substantially as claimed being described above. However, Mehta does not disclose the step of providing a bypass graft between left subclavian artery and a left common carotid artery.
Hartley teaches the use of a preparatory step of providing an anastomosis 102 is provided between the common carotid artery 98 and the left subclavian 100 (Figure 6 7:5-7) in the same field of endeavor for the purpose of increasing the operators ability to access the implant site from other approaches/angles.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the step of providing the bypass graft between left subclavian artery and a left common carotid artery taught by Hartley with the method of Mehra in order to provide the operator with increased access points during the surgery.
Response to Arguments
Applicant's arguments filed 12/16/2025 have been fully considered but they are not persuasive. The applicant argues that Mehta does not disclose a tube graft overlaps and is anchored along an entire length of the main docking lumen. The applicant points to tubular member portions 410 as preventing the tube graft of Mehta from reading on this limitation. This is not persuasive because Mehta has been interpreted such that the tubular portions 410 and 458 combine to make the tube graft. As stated above [0053] discloses that extension 450 is connected to the end of the initial graft tube 410, wherein once it is attached a single tubular graft 410/458 is formed and deployed Figure 4H. This provides a tube graft that overlaps and is anchored to the entire length of the main docking lumen as shown in Figure 1.
This interpretation also applies to claim 8, because the tube graft formed from 410 and 458 is shown as contacting and thereby sealing along the outer surfaces of the first two sleeves and the inner surface of the main graft.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774