DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Terminal Disclaimer
The terminal disclaimer filed on 7/29/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent No. 12023237 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
The amendments, dated 7/29/2026, have overcome:
The objection to claim 7;
The rejection(s) of claim(s) 3, 6-9, 11-12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The rejection of claim(s) 2-3, 8-10, 13 under pre-AIA 35 U.S.C. 102(b) based on Greenberg et al. (US 2006/0247761 A1 – as previously cited);
The rejection of claim(s) 11 under pre-AIA 35 U.S.C. 103(a) based on Greenberg et al. (US 2006/0247761 A1 – as previously cited) in view of Hartley et al. (US 2006/0287704 A1 – as previously cited);
The rejection of claim(s) 12 under pre-AIA 35 U.S.C. 103(a) based on Greenberg et al. (US 2006/0247761 A1 – as previously cited) in view of Reesemann et al (US 2001/0014823 A1 – as previously cited);
The rejection of claim(s) 14-15 under pre-AIA 35 U.S.C. 103(a) based on Greenberg et al. (US 2006/0247761 A1 – as previously cited) in view of Stelter et al. (US 2001/0037142 A1 – as previously cited);
The rejection of claim(s) 2-12, 14-15 based on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-9 of U.S. Patent No. 12,023,237 (as previously cited).
The aforementioned objections/ rejections have been withdrawn.
Please note: Applicant provided no arguments/ remarks concerning the priority date of the claim(s). The priority date for claim 4 (and those that depend therefrom) has been modified (as seen below) due to amendments to the claim but are otherwise maintained.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Specifically, 61/623151 fails to provide support for: the first and second bifurcated stent grafts with an extension stent graft therebetween (as required by claim 2). Claim(s) 2, 8-13 are awarded a priority date of May 14, 2012 (the filing date of application 61/646637).
Specifically, 61/623151, 61/646637, 61/716315, 61/716326, 61/716292, 61/720803 fail to provide support for: a four part debranching stent graft comprising: first and second bifurcated stent grafts (each including a bifurcation), an extension stent graft, AND a second extension stent (as required by claim 3) OR a main body stent graft (as required by claim 14). Claim(s) 3, 14-15 are awarded a priority date of December 5, 2012 (the filing date of application 13/706086).
Specifically, 61/623151, 61/646637 fail to provide support for: a first bifurcated stent graft/ main body stent graft limb having a diameter at the second end in a range from about 14 mm to about 18 mm, wherein the first leg has a diameter ranging from about 8 mm to about 12 mm, wherein the second leg has a diameter ranging from about 6 mm to about 10 mm, wherein the diameter of the first leg is about 2 mm greater than the diameter of the second leg (as required by claim 4). Claim(s) 4-7, are awarded a priority date of October 19, 2012 (the filing date of 61/716292).
Claim Objections
Claim(s) 13 is/are objected to because of the following informalities:
Within claim 13, lines 1-2: “a length of the first leg of the second bifurcated stent graft” should be replaced with --the length of the first leg of the second bifurcated stent graft-- (in order to properly link back to claim 2, lines 10-11).
Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-3, 8-10, 13-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stelter et al. (US 2001/0037142 A1 – as previously cited) in view of Greenberg et al. (US 2006/0247761 A1 – as previously cited).
With respect to claim(s) 2-3:
Stelter et al. discloses the invention substantially as claimed. Specifically, Stelter et al. discloses a debranching stent graft, as can be seen in fig. 7, comprising:
an extension stent graft (leg 16), as can be seen in fig. 3, having a first end (closer to portion 58) and a second end (closer to portion 56) (paragraphs [0030, 0034]); and
a second bifurcated stent graft (main stent graft device 12), as can be seen in fig. 1, having a second bifurcation (bifurcation 26) defining a first leg (contralateral stump 24) and a second leg (ipsilateral leg 22) (paragraph [0031]), wherein the second bifurcated stent graft (main stent graft device 12) has a first end (closer to the bottom of the page in fig. 1) and a second end (closer to the top of the page in fig. 1), wherein the first leg of the second bifurcated stent graft (contralateral stump 24 of main stent graft device 12) is coupled to the second end of the extension stent graft (end of leg 16 closer to portion 56), and wherein a length (about 50 mm) of the extension stent graft (leg 16) is greater than a length (about 35 mm) of the first leg of the second bifurcated stent graft (contralateral stump 24 of main stent graft device 12) (paragraphs [0031, 0034]).
However, Stelter et al. does not disclose:
the debranching stent graft to comprise a first bifurcated stent graft having a first bifurcation defining a first leg and a second leg each extending away from the first bifurcation, wherein the first bifurcated stent graft has a first end and a second end and the first end (closer to portion 58) of the extension stent graft (leg 16) being coupled to the second end of the first bifurcated stent graft (as required by claim 2); nor
a second extension stent graft having a first end and a second end, wherein the second end of the second extension stent graft is coupled to the second leg of the first bifurcated stent graft (as required by claim 3).
Greenberg et al. teaches a debranching stent graft (modular prosthesis), as can be seen in fig. 15b, comprising:
a first bifurcated stent graft (iliac extension 409) having a first bifurcation defining a first leg (section of iliac extension 409 below hypogastric artery 406 within fig. 15b) and a second leg (helical prosthetic branch 408) each extending away from the first bifurcation, wherein the first bifurcated stent graft (iliac extension 409) has a first end (closer to the bottom of the page in fig. 15b) and a second end (end closer to intervening prosthetic module 403) (paragraphs [0168-0169]);
an extension stent graft (intervening prosthetic module 403) having a first end (closer to/ within iliac extension 409) and a second end (closer to/ within iliac limbs 407), wherein the first end of the extension stent graft end of intervening prosthetic module 403 closer to/ within iliac extension 409) is coupled to the second end (end closer to intervening prosthetic module 403) of the first bifurcated stent graft (iliac extension 409) (paragraphs [0168-0169]);
a second bifurcated stent graft (bifurcated endoluminal prosthesis 400) having a second bifurcation defining a first leg (iliac limb closer to the right side of the page in fig. 15b) and a second leg (iliac limbs 407 within the iliac arteries 404, 405), wherein the second bifurcated stent graft (bifurcated endoluminal prosthesis 400) has a first end (closer to the bottom of the page in fig. 15b) and a second end (closer to the top of the page in fig. 15b), wherein the first leg (iliac limb closer to the right side of the page in fig. 15b) of the second bifurcated stent graft (bifurcated endoluminal prosthesis 400) is coupled to the second end (closer to/ within iliac limbs 407) of the extension stent graft (intervening prosthetic module 403) (paragraphs [0168-0169]);
a second extension stent graft (hypogastric branch extension 410) having a first end (closer to the bottom of the page in fig. 15b) and a second end (closer to the top of the page in fig. 15b), wherein the second end (closer to the top of the page in fig. 15b) of the second extension stent graft (hypogastric branch extension 410) is coupled to the second leg (helical prosthetic branch 408) of the first bifurcated stent graft (iliac extension 409) (paragraph [0168]).
The first bifurcated stent graft (iliac extension 409) and second extension stent graft (hypogastric branch extension 410) allows the debranching stent graft (modular prosthesis) to treat aneurysms which extend into the iliac and hypogastric arteries while preserving blood to the hypogastric arteries (paragraph [0010-0011]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the first bifurcated stent graft (iliac extension 409) and second extension stent graft (hypogastric branch extension 410), as taught by Greenberg et al., as part of the modular system of the debranching stent graft such that it will connect with the first end (closer to portion 58) of the extension stent graft (leg 16), as disclosed by Stelter et al., in order allow for the treatment of aneurysms which may extend into the iliac or hypogastric arteries while still preserving blood flow into both the lower iliac and hypogastric arteries.
With respect to claim 8:
Wherein the first end of the extension stent graft (end leg 16 closer to portion 58), as disclosed by Stelter et al., is coupled to the second end (end closer to intervening prosthetic module 403) of the first bifurcated stent graft (iliac extension 409), as disclosed by Stelter et al. as modified by Greenberg et al. (as discussed above) via passive fixation (Stelter et al. paragraphs [0008-0009]), and wherein the first leg of the second bifurcated stent graft (contralateral stump 24 of main stent graft device 12), as disclosed by Stelter et al., is coupled to the second end of the extension stent graft (leg 16) via passive fixation (friction fit) (Stelter et al. paragraphs [0008-0009]).
With respect to claim 9:
Wherein the first leg of the second bifurcated stent graft (contralateral stump 24 of main stent graft device 12), as disclosed by Stelter et al., is configured to be (is capable of being) positioned entirely within an aneurysmal sac.
With respect to claim 10:
Wherein both the first end of the extension stent graft (end leg 16 closer to portion 58) and the second end of the extension stent graft (end leg 16 closer to portion 56), as disclosed by Stelter et al., are configured to be (is capable of being) positioned entirely within an aneurysmal sac.
With respect to claim 13:
Wherein the length (about 35 mm) of the first leg of the second bifurcated stent graft (contralateral stump 24 of main stent graft device 12) is less than a length (about 80 mm) of the second leg of the second bifurcated stent graft (ipsilateral leg 22 of main stent graft device 12), as disclosed by Stelter et al. (Stelter et al. paragraph [0031]).
With respect to claim 14:
Further comprising:
a main body stent graft (attachment tube 14), as disclosed by Stelter et al., as can be seen in fig. 2, having a first end (end 48) and a second end (end 46) (Stelter et al. paragraphs [0030, 0032]), wherein the first end of the main body stent graft (end 48 of attachment tube 14) is coupled to the second end of the second bifurcated stent graft (end of main stent graft device 12 closer to the top of the page in fig. 1).
With respect to claim 15:
Wherein the first end of the main body stent graft (end 48 of attachment tube 14), as disclosed by Stelter et al., is coupled to the second end of the second bifurcated stent graft (end of main stent graft device 12 closer to the top of the page in fig. 1) via passive fixation (friction fit) (Stelter et al. paragraphs [0008-0009]).
Claim(s) 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stelter et al. (US 2001/0037142 A1 – as previously cited) as modified by Greenberg et al. (US 2006/0247761 A1 – as previously cited) as applied to claim(s) 2-3, 8-10, 13-15 above, and further in view of Hartley et al. (US 2006/0287704 A1 – as previously cited).
With respect to claim(s) 11:
Stelter et al. as modified by Greenberg et al. discloses the invention substantially as claimed, as discussed above. However, Stelter et al. as modified by Greenberg et al. does not disclose the diameters of the first bifurcated stent graft (iliac extension 409), specifically, a diameter of the second end (end closer to intervening prosthetic module 403) of the first bifurcated stent graft (iliac extension 409) is greater than each of a diameter of the first leg (section of iliac extension 409 below hypogastric artery 406 within fig. 15b) and a diameter of the second leg (helical prosthetic branch 408) (as required by claim 11).
Hartley et al. teaches a stent graft, as can be seen in figs. 3 and 8A-8F, configured to be positioned within an iliac bifurcation (where the aneurysm doesn’t extend into the external iliac artery). The second end (at proximal end 70) has a diameter or 12 mm, and the first and second legs have diameters of 8mm and 10 mm and (paragraphs [0039, 0041, 0050]).
It would have been obvious to one having ordinary skill of the art at the time the invention was made to use the dimensions (diameter) of the stent graft, as taught by Hartley et al., for the dimensions (diameter) of the first bifurcated stent graft (iliac extension 409), as disclosed by Stelter et al. as modified by Greenberg et al., as the two structures are positioned intended to be positioned within the same area of the body (at the iliac bifurcation), and the dimensions, as taught by Hartley et al., allow for the treatment when the aneurysm does not extend into the external iliac artery (Hartley paragraph [0050]).
Claim(s) 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stelter et al. (US 2001/0037142 A1 – as previously cited) as modified by Greenberg et al. (US 2006/0247761 A1 – as previously cited) as applied to claim(s) 2-3, 8-10, 13-15 above, and further in view of Reesemann et al (US 2001/0014823 A1 – as previously cited).
With respect to claim(s) 12:
Stelter et al. as modified by Greenberg et al. discloses the invention substantially as claimed, as discussed above. However, Stelter et al. as modified by Greenberg et al. does not disclose a length of the first leg (section of iliac extension 409 below hypogastric artery 406 within fig. 15b) of the first bifurcated stent graft (iliac extension 409) is equal to a length of the second leg (helical prosthetic branch 408) of the first bifurcated stent graft (iliac extension 409) (as required by claim 12).
Ressemann et al. teaches a stent graft, as can be seen in figs. 7-8 and 14-15, configured to be positioned within an iliac bifurcation (where the aneurysm doesn’t extend into the external iliac artery). The branches of the stent graft have the same length (the length of the internal iliac leg 52 and the lower portion of the common/ external iliac leg 56), as can be seen in figs. 14-15.
It would have been obvious to one having ordinary skill of the art at the time the invention was made to use the dimensions (length) of the stent graft, as taught by Ressemann et al., for the dimensions (lengths) of the legs of the first bifurcated stent graft (iliac extension 409), as disclosed by Stelter et al. as modified by Greenberg et al., as the two structures are positioned intended to be positioned within the same area of the body (at the iliac bifurcation), and as such should have the same/ similar dimensions therefor.
Allowable Subject Matter
Claim(s) 4-7 and 16 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 4:
A debranching stent graft (as required by claim 2) wherein the diameters of the first and second legs of the first bifurcated stent graft are within the claimed range in addition to the large diameter claimed of the second end of the first bifurcated stent graft (this is in direct conflict to all of the art used in pending office action which has similar dimension for one of the legs of the first bifurcated stent graft and the second end of the first bifurcated stent graft).
With respect to claim 16:
A debranching stent graft (as required by claim 2) wherein the diameters of the first and second legs of the first bifurcated stent graft are the same (this is in direct conflict to all of the art used in pending office action which all specifically disclose diameters of different diameters for the internal and external iliac arteries).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
