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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-17 is/are pending. Claim(s) 11-17 is/are withdrawn. Claim(s) 1-10 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 4/22/2026, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 1 and 8 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 4/22/2026, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-10 has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 4/22/2026 have been fully considered but they are not persuasive.
Applicant argues Edwin does not address atrial septal defects, sinus venosus atrial septal defects, the right atrium, the superior vena cava, the atrial roof, anomalous pulmonary venous drainage, or any intracardiac application (Applicant's Response on 4/22/2026, herein "Response", page 6).
In response to applicant's argument that the prior art does not teach the claimed placement anatomical locations, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues Edwin teaches a uniform diameter and thus fails to teach "the asymmetric three-zone geometry" of claim 1 that requires three diameters along the device's length (Response, page 7). Applicant cites a portion of Edwin teaching flared ends (Response, page 7). Flared ends mean the device has multiple diameters rather than a uniform diameter. Further, cited Figure 4 of Edwin clearly has more than one diameter and thus is not uniform in diameter along the entire length of the device. Further, as cited in annotated Figure 4, d1 > d2 > d3. Applicant's arguments do not address this rejection.
Applicant argues Edwin does not teach the claimed flow directions relative to the patient's anatomy, such that one flow path is within the device and another is around the exterior of the device (Response, page 7). Applicant does not argue the cited openings in the end meshes, which are able to allow for blood transverse to the device.
In response to applicant's argument that Edwin does not teach the claimed flow directions relative to the patient's anatomy, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues Edwin does not teach the mesh rims as claimed (Response, page 8). Applicant argues Edwin does not teach a mesh rim that protrudes beyond a defined covered second-end portion (Response, page 8). As shown in annotated Figure 4 in the 10/22/2025 Office action, there is a mesh rim extending from the second end (annotated Figure 4).
Applicant argues Edwin does not teach "a rim configured for atrial-roof anchoring" (Response, page 8).
In response to applicant's argument that Edwin does not teach a rim configured for atrial-roof anchoring, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues Edwin does not teach "a rim configured for anchoring to the SVC wall above the right atrium" (Response, page 8).
In response to applicant's argument that Edwin does not teach "a rim configured for anchoring to the SVC wall above the right atrium", a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues Edwin fails to teach "an opening in the cover distal from the skirt" (Response, page 8). Applicant does not argue the cited openings in the end meshes, which are able to allow for blood transverse to the device.
In response to applicant's argument that Edwin fails to teach "an opening in the cover distal from the skirt", a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 and 5-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwin, et al (Edwin) (US 6,245,099 B1).
Regarding Claim 1, Edwin teaches a sinus venosus atrial septal defect stent having a tubular body (e.g. Figure 4), and comprising:
a first end defining a proximal opening surrounded by a radially expandable skirt (e.g. annotated Figure 4 below) comprising a self-expanding mesh (e.g. column 7, lines 4-16), the skirt having a first diameter (e.g. annotated Figure 4 below, d1), the first end including a first exposed mesh rim disposed adjacent the skirt (e.g. annotated Figure 4 below) that is configured to anchor to the roof of the right atrium adjacent an entry site of a superior vena cava (e.g. Figure 4, the open mesh structure of each end provides a location for tissue to grow into);
a central conduit extending away from the skirt (e.g. annotated Figure 4 below), the self-expanding mesh covered by a cover along the central conduit (column 10, line 59 to column 11, line 5, the cover is the ePTFE layers in the noted section), the central conduit defining an opening in the cover distal from the skirt (e.g. Figure 4, luminal space, the central conduit in fluid communication with the proximal opening (e.g. Figures 4-5, the lumen), the central conduit having a central diameter that is less than the first diameter (e.g. annotated Figure 4 below, central diameter is d3), the central conduit configured to be located in the superior vena cava (the device is able to be placed in the claimed location), the central portion having a longitudinal axis (there is inherently such an axis present); and
a second end defining a distal opening, distal from the first end and joined with the central conduit (e.g. annotated Figure 4 below), the second end including a second diameter (e.g. annotated Figure 4 below, d2) that is greater than the central diameter but less than the first diameter (e.g. annotated Figure 4 below), the second end including a second end portion covered by the cover (e.g. annotated Figure 4 below), and a second exposed mesh rim that protrudes beyond the second end portion covered by the cover (e.g. annotated Figure 4 below), the second exposed mesh rim configured to anchor to the wall of the superior vena cava above the right atrium (e.g. Figure 4, the open mesh structure of each end provides a location for tissue to grow into);
wherein the first end, central conduit and second end are arranged to provide a first flow path for blood from the superior vena cava into the right atrium generally along the longitudinal axis and through the first end, central conduit and second end, and simultaneously provide a second flow path for blood around the central conduit, generally transverse to the longitudinal axis, from a pulmonary vein through an atrial septal defect and into a left atrium (blood is able to flow through the central lumen and can also flow through the openings in the mesh ends and the device can be placed in the claimed relative positions).
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Annotated Figure 4, Edwin
Regarding Claim 5, the central diameter is less than half the first diameter (e.g. Figure 1, as broadly claimed, when the central diameter is that in the collapsed configuration, this limitation is met; when the central diameter is that in the collapsed configuration the relative diameter requirements in claim 1 are also met).
Regarding Claim 6, the central diameter is less than half the second diameter (e.g. Figure 1, as broadly claimed, when the central diameter is that in the collapsed configuration, this limitation is met).
Regarding Claim 7, the central conduit includes an interior lumen and an exterior surface (e.g. Figures 4-5), wherein the blood in the first flow path passes through the interior lumen (e.g. column 1, lines 35-48; since the stent replaces the vessel, the blood flows through the lumen of the stent); and the blood in the second flow path passes across the exterior surface (when blood flows through the mesh, it will reach the exterior surface of the stent).
Regarding Claim 8, the first end, central conduit and second end form an hourglass shaped tubular body (e.g. Figure 4).
Regarding Claim 9, the second end includes a second end length (e.g. Figure 4); and the second exposed mesh rim is at least half the second end length (e.g. annotated Figure 4 above) and anchor the superior vena cava (anchoring is discussed supra for claim 1).
Claim Rejections - 35 USC § 103
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Functional language and intended use language is presented in italicized font.
Claims 2-3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwin, et al (Edwin) (US 6,245,099 B1) as discussed supra and further in view of Alanbeai (US 2019/0083076).
Regarding Claim 2, Edwin discloses the invention substantially as claimed but fails to teach the central conduit defines a fenestration through the cover so as to provide fluid communication between an interior of the central conduit and an exterior of the central conduit.
Alanbeai teaches a stent graft having a central conduit that defines a fenestration through the cover (e.g. Figure 1A, #128, [0035]) so as to provide fluid communication between an interior of the central conduit and an exterior of the central conduit (e.g. [0035]).
Alanbeai and Edwin are concerned with the same field of endeavor as the claimed invention, namely stent grafts having uncovered mesh ends.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edwin’s stent to have the fenestration in the cover as taught by Alanbeai in order to provide for side branch stenting in case of the need for extra support or for bifurcating drainage (e.g. Alanbeai, [0035]).
Regarding Claim 3, the fenestration is between 1 mm and 10 mm in dimension (e.g. Alanbeai, [0035]).
Regarding Claim 10, Edwin discloses the invention substantially as claimed but fails to teach the ratio of the first diameter to the second diameter to the central diameter is between 10:6:3 and 3:2:1.
Alanbeai teaches a device having a first diameter (Alanbeai D3, [0026]), a second diameter (Alanbeai D1, [0037]), and a central diameter (Alanbeai D2, [0026]), where the first diameter to the second diameter to the central diameter is between 10:6:3 and 3:2:1 (e.g. Alanbeai, [0026], [0037], when D3 = 40 mm, D2 = 26.27 mm, D3 = 13.33 mm).
Alanbeai and Edwin are concerned with the same field of endeavor as the claimed invention, namely stent grafts having uncovered mesh ends.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edwin by incorporating the relative diameters as taught by Alanbeai as it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwin, et al (Edwin) (US 6,245,099 B1) as discussed supra and further in view of Schaeffer, et al (Schaeffer) (US 2005/0149166 A1).
Regarding Claim 4, Edwin teaches the skirt includes a transition portion that transitions to the central conduit (e.g. annotated Figure 4 above); the transition portion has a transition diameter less than the first diameter and greater than the central diameter (the outer diameter of the skirt in the transition portion is greater than the inner diameter of the stent in the central conduit).
Edwin discloses the invention substantially as claimed but fails to teach a radiopaque marker is disposed on the transition portion to enable monitoring of the positioning of the stent in the right atrium.
Schaeffer teaches a stent graft having radiopaque markers (e.g. [0076], Figure 5) placed at the end portions and along the body of the stent graft (e.g. [0076]).
Schaeffer and Edwin are concerned with the same field of endeavor as the claimed invention, namely stent grafts.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Edwin such that there is a radiopaque marker is disposed on the transition portion as taught by Schaeffer in order to aid in alignment of the stent graft while implanting the stent graft (e.g. Schaeffer, [0076], [0090]).
Conclusion
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 6/26/2026
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