DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed October 27, 2025 has been entered. Claims 1-21 are currently pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7-8, and 19 of U.S. Patent No. 11,547,549. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including: a tubular aortic component, tunnel graft, proximal stent, and distal stent, including the tunnel graft being disposed within the tubular aortic component. The difference between claims 1-2 of the application and claims 1, 6, and 7-8, and 19 of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of claims 1, 6, and 7-8, and 19 of the patent is in effect a “species” of the “generic” invention of claims 1-2. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-2 are anticipated by claims 1, 6, and 7-8, and 19 of the patent, they are not patentably distinct from claims 1-2. Claim 16 is disclosed by claim 7 of the patent.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18-19 of U.S. Patent No. 9,592,112. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent and the instant application are claiming common subject matter including: a tubular aortic component, tunnel graft, proximal stent, and distal stent, including the tunnel graft being disposed within the tubular aortic component. The difference between claims 1-2 of the application and claims 1 and 18-19 of the patent lies in the fact that the patent claims include many more elements and are thus much more specific. Thus, the invention of claims 1 and 18-19 of the patent is in effect a “species” of the “generic” invention of claims 1-2. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-2 are anticipated by claims 1 and 18-19 of the patent, they are not patentably distinct from claims 1-2.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 14, and 17-20 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Greenberg et al. (AU 2010254599, hereinafter “Greenberg”).
Regarding claim 1, Greenberg discloses an aortic graft assembly, comprising:
a) a tubular aortic component (14) that includes a proximal end and a distal end connected by a wall of the tubular aortic component, the wall defining a wall aperture (32) that is between the proximal and distal ends, the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis (boat or bath shaped and supported by wire framework 40 which also has a proximal end extending perpendicular to a major longitudinal axis of the tubular aortic component – Figs 5-6; page 6, lines 1-14);
b) a tunnel graft (combination of open portion defined by recess wall 34 and tubes 44) connected to the wall of the tubular aortic component (14) and extending from the wall aperture (32) toward the proximal end of the tubular aortic component, the tunnel graft disposed within the tubular aortic component (page 6, lines 13-14), the tunnel graft having a proximal end and a distal end, the distal end being at the wall aperture of the tubular aortic component, and distal of the proximal end of the wall aperture, and wherein the tunnel graft includes an open portion (open portion defined by recess wall 34 forming recess lumen 35 - Figs 3-4) at the wall aperture (32), the open portion defining a proximal end, and a tubular portion (defined by at least one of tubes 44) extending proximally from the open portion of the tunnel graft, the tubular portion defining a proximal end, and a distal end at the proximal end of the open portion (page 6, ln 1-14);
c) a proximal stent (30) that supports the proximal end of the tubular aortic component (page 5, lines 31-32; see annotated Fig below); and
d) a distal stent (30) that supports the distal end of the tubular aortic component (page 5, lines 31-32; see annotated Figs 1-2 below).
[AltContent: textbox (Proximal end of wall aperture extending perpendicular to major longitudinal axis of tubular aortic component)]
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[AltContent: textbox (Distal end of tunnel graft connected to a distal end of the wall aperture and extending from wall aperture toward proximal end of the tubular aortic component)]
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Regarding claim 2, wherein the tubular portion (at least one of tubes 44) is secured to the tubular aortic component (14) (page 6, lines 13-14).
Regarding claim 14, wherein the proximal end of the tubular portion (at least one of tubes 44) has a geometric center that is distinct from a geometric center of the tubular aortic component (14), wherein a line defined by the geometric centers of the proximal end of the tubular portion and the tubular aortic component in a plane of the proximal end of the tubular portion is at a positive angle from a line defined by the geometric center of the tubular aortic component and a point along a centerline bisecting the wall aperture and parallel to the major longitudinal axis of the tubular aortic component, the point being in the same plane as the geometric centers of the proximal end of the tubular portion and the tubular aortic component (geometric center of tubular portion of tunnel graft is offset from the geometric center of the tubular aortic component, which lies along the central longitudinal axis of lumen 28; Fig 4).
Regarding claim 17, wherein the tubular portion is a first tubular portion (one of the pair of tubes 44), and further including a second tubular portion (other of the pair of tubes 44) of the tunnel graft extending proximally from the open portion of the tunnel graft, wherein the second tubular portion defines a proximal end, and a distal end at the proximal end of the open portion (pair of tubes 44; page 6, lines 13-14).
Regarding claim 18, wherein the second tubular portion is of about equal length to the first tubular portion (pair of tubes 44; page 6, lines 13-14; Fig 6).
Regarding claim 19, wherein the second tubular portion is parallel to the first tubular portion (pair of tubes 44; page 6, lines 13-14; Fig 6).
Regarding claim 20, wherein the first and second tubular portions are each distinct and integrally complete tubular portions (pair of tubes 44; page 6, lines 13-14; Fig 6).
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 3-4 and 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenberg (AU 2010254599), as applied to claims 1 and 20 above, further in view of Hartley et al. (US 2011/0257731, hereinafter “Hartley”).
Regarding claims 3-4, Greenberg discloses the invention substantially as claimed, as shown above. However, Greenberg fails to disclose the tubular portions include stents. Hartley discloses a similar aortic graft assembly discloses a similar aortic graft assembly (Figs 1-4B; para [0036-0042]) comprising a tubular aortic component (4) and a tunnel graft and teaches the tunnel graft comprises a first tubular portion (34) and a second tubular portion (36) each extending from an open portion (30) of the tubular aortic component. Hartley additionally teaches each of the tubular portions (34, 36) of the tunnel graft includes a stent with proximal and distal apices connected by struts (42) (para [0041]). Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Additionally, Greenberg recognizes the benefit of a plurality of self-expanding stents (30) along the tubular portion of the tubular aortic graft from the proximal to distal end thereof (Figs 1-2; page 5, lines 31-32 of Greenberg). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Greenberg such that the tubular portion (at least one of tubes 44) comprised a stent at proximal and distal ends of the tubular portion for the purpose of providing structure and support to the tubular portion of the tubular aortic graft.
Regarding claim 21, Greenberg discloses the invention substantially as claimed, as shown above. However, Greenberg fails to disclose the tubular portions share a common wall of a first graft material that partition a conduit of a second graft material, the first and second graft materials defining, at least in part, the first tubular portion and the second tubular portion. Hartley discloses a similar aortic graft assembly discloses a similar aortic graft assembly (Figs 5-7; para [0043-0049]) comprising a tubular aortic component (52) and a tunnel graft and teaches the tunnel graft comprises a first tubular portion (78) and a second tubular portion (80) each extending from an open portion (76) of the tubular aortic component, wherein the second tubular portion is of about equal length to the first tubular portion, wherein the second tubular portion is parallel to the first tubular portion, wherein the first and second tubular portions are each distinct and integrally complete tubular portions, and wherein the tubular portions share a common wall of a first graft material that partition a conduit of a second graft material, the first and second graft materials defining, at least in part, the first tubular portion and the second tubular portion (Fig 6). Hartley teaches first and second tubular portions allow the stent graft to be positioned into adjacent branch vessels (Fig 8; para [0050-0051]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Greenberg such that the tubular portions shared a common wall of a first graft material that partition a conduit of a second graft material, the first and second graft materials defining, at least in part, the first tubular portion and the second tubular portion, as taught by Hartley, for the purpose of further supporting a structure capable of accessing adjacent branch vessels.
Claims 5-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenberg (AU 2010254599) and Hartley (US 2011/0257731), as applied to claim 4 above, further in view of Roeder et al. (US 2009/0306763, hereinafter “Roeder”).
Regarding claims 5 and 7, Greenberg and Hartley disclose the invention substantially as claimed, as shown above. However, Hartley fails to disclose at least one stent includes at least one barb. Roeder discloses a similar aortic graft assembly and teaches one or more stents (706, 708, 710) “may include one or more barbed projections configured to help anchor the device” (para [0050]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Greenberg and Hartley such that at least one stent, including a central stent, had at least one barb to help anchor the device, as taught by Roeder.
Regarding claim 6, as noted above it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Additionally, Greenberg recognizes the benefit of a plurality of self-expanding stents (30) along the tubular portion of the tubular aortic graft from the proximal to distal end thereof, including a plurality of stents between proximal and distal ends thereof (Figs 1-2; page 5, lines 31-32 of Greenberg). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Greenberg such that the tubular portion (at least one of tubes 44) comprised a stent at proximal and distal ends of the tubular portion, including at least one stent between proximal and distal stents, for the purpose of providing structure and support to the tubular portion of the tubular aortic graft.
Regarding claim 8, Greenberg and Hartley disclose the invention substantially as claimed, as shown above. However, they fail to disclose the material of the stents. Roeder teaches it is known in the art that stents are formed of “nitinol or another allow wire” (para [0004]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Greenberg and Hartley such that the stents of the tubular portion included nitinol, since it is an old and well known material for forming self-expandable stents.
Regarding claims 9-10, Greenberg and Hartley disclose the invention substantially as claimed, as shown above. Furthermore, Hartley teaches the distal end of the tubular portion is generally conical (portion 32) and has a diameter greater than that of the proximal end of the tubular portion (portion dividing into the first and second tubular portions 34, 36) (Fig 2; para [0038]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to further modify Greenberg such that the distal end of the tubular portion was generally conical and has a diameter greater than that of the proximal end of the tubular portion, as taught by Hartley, to further support the connection between the first and second tubular portions of the tunnel graft to the tubular aortic component.
Regarding claim 11, Greenberg and Hartley disclose the tubular portion has a major longitudinal axis that is parallel to the major longitudinal axis of the tubular aortic component (see at least Greenberg Figs 2, 4, 6).
Regarding claim 12, Greenberg and Hartley disclose the proximal end of the tubular portion is distal to the proximal end of the tubular aortic component (Fig 6).
Regarding claim 13, Greenberg and Hartley disclose the invention substantially as claimed, as shown above. Greenberg fails to specifically teach the proximal end of the tubular portion is coterminous with the proximal end of the tubular aortic component. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination such that the respective lengths were modified such that the proximal end of the tubular portion is coterminous with the proximal end of the tubular aortic component for the purpose of providing a better fit of the tubular aortic component and tunnel graft with different anatomical variations of the vasculature or desired target areas of the vasculature and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenberg (AU 2010254599), as applied to claim 14 above. Greenberg discloses the invention substantially as claimed, as shown above, but fails to disclose an exact value of the angle. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify Greenberg to have the angle selected from the group consisting of ±10°, ±20°, ±30°, ±45, ±90°, ±120°, ±135°, ±160°, ±170° and 180° in order to size the graft appropriately for the intended implantation site since Applicant has placed no criticality on the angle having the specific dimension as evidenced by the wide range of values for the angle and since modifying Greenberg to have the specified dimension would not adversely affect the function of the device. The courts have recognized that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984)). Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Greenberg to have the angle selected from the group consisting of ±10°, ±20°, ±30°, ±45, ±90°, ±120°, ±135°, ±160°, ±170° and 180°, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenberg (AU 2010254599, hereinafter “Greenburg AU”), as applied to claim 1 above, further in view of Greenberg et al. (US 2006/0247761, hereinafter “Greenberg US2006”). Greenberg AU discloses the invention substantially as claimed, as shown above. However, Greenberg AU fails to disclose at least one radiopaque marker as claimed. Greenberg US2006 discloses a similar aortic graft assembly and teaches “Gold markers (not shown) are preferably attached to the prosthesis 110 in various locations to indicate the position and orientation of the prosthesis 110 under a fluoroscope.” (para [0151]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Greenberg AU to further include at least one radiopaque marker at least one of the proximal end of the tunnel graft and the distal end of the tubular portion of the tunnel graft for the purpose of indicating the position and orientation of the prosthesis under a fluoroscope and assist with proper positioning and deployment.
Response to Arguments
Applicant's arguments filed October 27, 2025, with respect to the rejections of the claims on the ground of nonstatutory double patenting have been fully considered but they are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments filed October 27, 2025 have been fully considered but they are not persuasive.
Applicant argues Greenberg (AU 2010254599) fails to teach or disclose "the wall defining a wall aperture that is between the proximal and distal ends [of the tubular aortic component], the wall aperture having a proximal end and a distal end, the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis[.]" Applicant argues that although wire basket (40) shows a proximal end extending perpendicular to a major longitudinal axis of the tubular aortic component, the wire basket (40) is not the opening of Greenberg and does not define the window of Greenberg. Thus, Applicant argues the wire basket does not define the window or wall aperture has a perpendicular proximal end as claimed. Applicant additionally argues Figure 2 shows a curvilinear edge of the window. The Examiner respectfully disagrees and notes Figures 2 and 6 clearly show the wall aperture has at least a portion of the proximal end extending perpendicularly, as detailed above. Furthermore, since the recess 32 of the graft material is stitched to framework 40 along the edge thereof, it follows that the recess 32 of the graft material will have the same perpendicular edge of the framework 40.
Applicant additionally argues Fig 6 of Greenberg does not truly show the window in the hybrid graft, but only shows a section view and argues the elongate recess is not the opening in the outer graft, but rather the window is shown to overhang a portion of the elongate recess when comparing the views of Fig 2 and Fig 6. Finally, Applicant argues Fig 3 of Greenberg shows tubular portions 44 which are sewn to the recess wall 34 are not perpendicular and instead are sewn at an angle to accommodate the curved boat/tub shape of the recess wall. The Examiner respectfully maintains Figs 3 and 6 show the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component when viewed orthogonally to the major longitudinal axis. Or at least shows the proximal end of the wall aperture extending perpendicular to a major longitudinal axis of the tubular aortic component along at least a portion of a length of the proximal end thereof when viewed orthogonally to the major longitudinal axis. The proximal end clearly extends perpendicularly to the major longitudinal axis along the circumference of the graft. See also Applicant’s Figure 1C showing the proximal end extending perpendicularly to the major longitudinal axis along the circumference of the graft, but also showing an arc due to the tubular nature of the graft.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Duggal et al. (US 2010/0106240) discloses a wall aperture that has a proximal end extending in a perpendicular direction and teaches “The sleeve and stent windows 68, 78 may be rectangular as depicted in FIGS. 6A-6C, or they may be round, oval, or any other shape.” (para [0072]).
Berra et al. (US 2007/0233229) discloses a wall aperture that has a proximal end extending in a perpendicular direction (Figs 4A-D) and teaches “to form these windows, graft material 110 having a length sufficient to span an aneurysmal sac 18 and enable sealing of the stent graft 100 with aortic wall tissue at either side thereof is further processed by cutting three generally rectangular or circular segments out of its tubular wall 108.” (para [0035]).
THIS ACTION IS MADE FINAL. 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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771