DETAILED ACTION
The following Office Action is in response to the Amendment filed on November 7, 2025. Claims 1-7 and 9-21 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Concerning the “Rejections Under 35 U.S.C. § 112” section on pages 5-6 of the Applicant’s Response filed on November 7, 2025, the amendments to claim 1 to address the issues of indefiniteness have obviated the necessity of the rejection of the claim under 35 U.S.C. §112(b). Therefore, the rejection is withdrawn.
Response to Arguments
Concerning the “Rejections Under 35 U.S.C. § 103” section on pages 6-11 of the Applicant’s Response filed on November 7, 2025, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant first argues that the reference feature 102 are cuffs and not flanges. However, the examiner asserts that a flange may be interpreted as a rim, rib, or collar <thefreedictionary.com/flange>, wherein the cuff of the Rhodes reference may be interpreted as such structures.
The applicant then argues that the cuffs of the Rhodes reference are excluded when describing the sealing portions, arguing that the sealing covering of the Rhodes reference does not cover the cuffs. However, although the Rhodes reference may include a sealing covering that does not cover the cuff, this does not preclude the cuff from being interpreted as a sealing feature. It is apparent from the positioning of the cuff relative to the prosthesis and the statement that “The cuffs 102 of the prosthesis are preferably devoid of the covering mesh 100 in order to prevent the protrusion of the mesh into the origins of the renal arteries above the prosthesis and the protrusion of the mesh into the origins of the iliac arteries below the prosthesis” [emphasis added] (Column 11, Lines 38-42) that the cuffs are intended to be an anchor portion for the prosthesis in the neck of the aneurysm. Given the anchoring of the prosthesis in the neck of an aneurysm may contribute the creation of a seal for the prosthesis, and given the sealing feature of the Instant Application functions in the same manner, it is completely reasonable to interpret the cuff of the Rhodes reference as a sealing feature even if it does not include the mesh covering.
The applicant then argues that the cuffs of the Rhodes reference are not an inflatable structure and thus fails to teach an annular flange adapted to be filled with a hardenable fluid filling medium so that an inner surface of the at least one annular flange forms a generally tubular lumen in communication with the generally tubular lumen of the double walled fill structure to provide blood flow, further arguing that the Chobotov reference does not cure this deficiency because there is no motivation to convert the cuff of the Rhodes reference into a fillable flange for redundant sealing purposes. However, the examiner asserts that adding redundancies into medical devices is well known in the art to alleviate possible failures of medical devices. The Instant Application itself teaches prostheses having multiple redundancies in having multiple embodiments having multiple sealing features. Furthermore, the examiner asserts that the Rhodes reference includes multiple sealing features itself in including both the cuff for anchoring the prosthesis and in including the mesh covering for providing a seal within the body of the aneurysm. By modifying the cuff of the Rhodes reference to be a fillable flange as in the Chobotov reference, the combination has not created an additional redundancy, but has merely modified the redundancy of the Rhodes reference to optimize its functionality by allowing it to be a more conformable sealing medium. Therefore, the rejections of the claims under 35 U.S.C. §103(a) stand.
Claim Rejections - 35 USC § 103
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.
Claims 1-7, 9-16, and 18-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rhodes (US 5,665,117) in view of Chobotov et al. (US 2005/0090804, hereinafter Chobotov), and Kerr (US 2004/0073288).
Concerning claims 1, 3, 4, 7, 9, and 10, the Rhodes prior art reference teaches a system for treating an aneurysm (Figure 1; 20), said system comprising: at least a first double-walled filling structure having an outer wall (Figure 5; 78) and an inner wall (Figure 1; 70), wherein the filling structure is adapted to be filled with a fluid filling medium (Figure 5; 84), that may be hardenable, so that the outer wall conforms to an inside surface of the aneurysm and an inner surface of the inner wall forms a generally tubular lumen to provide blood flow; and a sealing feature (Figure 5; 30), the sealing feature forming a fluid seal between the filling structure and the aneurysm when the filling structure is filled with the fluid filling medium, thereby minimizing or preventing blood flow downstream of the seal (Column 9, Lines 13-37), wherein the sealing feature comprises a resilient frame comprising a plurality of resilient metals coupled to the inner wall of the filling structure biased to flex outward so as to facilitate outward expansion of the filling structure during deployment (Figure 5; 34, 36, 38) and wherein the sealing feature may additionally include the portions of the inner wall in which the resilient frame is connected to the inner wall (expanding, reinforced portions of the inner wall assist in forming a seal), and wherein the reference further teaches that the device may include additional sealing features (Column 11, Lines 7-36) including at least one annular flange about a neck region of the first filling structure and disposed in a neck of the aneurysm at the proximal end (Figure 14; 102), but it does not specifically teach the frame comprising a helical stent extending from a first end of the filling structure to an opposing second end of the filling structure, the annular flange being adapted to be filled with a hardenable fluid filling medium so that an inner surface of the at least one annular flange forms a generally tubular lumen in fluid communication with the generally tubular lumen of the first double-walled fill structure to provide blood flow, or the first filling structure comprising an upper layer of material disposed on a lower layer of material, wherein at least a portion of the upper layer is directly fixedly coupled with at least a portion of the lower layer of the material.
However, the Chobotov reference teaches a system for treating an aneurysm (Figure 9; 10), wherein the reference further teaches a sealing feature in the form of an annular cuff or flange (Figure 9; 56), wherein the annular flange is adapted to be filled with a fluid medium such that the inner surface of the filling structure forms a generally tubular lumen to provide blood flow ([¶ 0082]), wherein the first filling structure comprises an upper layer of material disposed on a lower layer of material, wherein at least a portion of the upper layer is directly fixedly coupled with at least a portion of the lower layer of material ([¶ 0082], may be formed of one or more fusible layers, wherein the layers must be directly fixedly coupled in order to be fusible).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the annular flange of the Rhodes reference be adapted to be filled with a hardenable fluid filling medium as in the Chobotov reference to create a more conformable sealing medium to provide the seal against the lumen wall (Chobotov; [¶ 0094]). It would be further obvious to have the first filling structure of the Rhodes reference include the upper layer of material and the lower layer of material as in the Chobotov reference to provide a method of incorporating additional sealing features such as connectors or frames (Chobotov; [¶ 0083])
Furthermore, the Kerr reference teaches a system for treating an aneurysm (Figure 1; 10) which includes a resilient frame or frames coupled with an inside surface of the tubular structure of the system, wherein the system may include a plurality of axially spaced apart stents or may instead be a helical stent extending from a first end of the structure to an opposing second end of the structure (Figure 13; 56 |[¶ 0077], [¶ 0109]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the resilient frame of the Rhodes reference be a helical stent extending from a first end of the structure to an opposing second end of the structure as in the Kerr reference given the Kerr reference teaches that such a helical stent is an alternative to axially spaced apart ring shaped stents that provides greater outwardly directed radial forces on the filling structure (Kerr; [¶ 0077]).
Concerning claim 2, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 1, wherein the resilient frame will provide a first region of the first filling structure having a first compliance where the frame interfaces the inner wall and a second region of the first filling structure having a second compliance different than the first compliance (outer wall will have a different compliance than the reinforced inner wall).
Concerning claims 5 and 6, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 1, wherein the Chobotov reference teaches that the filling structure and the sealing feature may be formed of ePTFE (Chobotov; [¶ 0082]), which is a thrombogenic material.
Concerning claim 11, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 5, wherein the Rhodes reference further teaches the first filling structure having a main body with a main body width (Figure 5; 24) and the sealing feature comprising a narrow neck coupled with a main body, the narrow neck region having a width less than the main body width (Figure 5; 30).
Concerning claim 12, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 5, wherein the narrow neck width is capable of being approximately 2% to approximately 20% of the main body width depending on how much fluid is added to the filling structure and the amount of expansion of the sealing feature (i.e. the narrow neck is closed to its narrow extreme, and the body is inflated to its absolute wide extreme).
Concerning claims 13, 14, 18, and 20, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 1, wherein the Rhodes reference further teaches that the annular flange may have a tapered shoulder region, winged region, or head region on an upper portion of the filling structure which flares or progressively decreases inwardly from an upper portion of the first filling structure to a lower portion of the first filling structure (Figure 14; 102 | Column 11, Lines 7-36).
Concerning claims 15, 16, and 21, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 1, wherein the Chobotov reference further teaches that the annular flange of the sealing feature may comprise an upper filling region formed by a seal defining the upper filling region and a lower filling region of the filling structure (Figure 9; 57, 58, 60), the upper and lower filling regions in fluid communication with one another, wherein the upper filling region holds a smaller volume of filling medium than the lower filling structures, and wherein the cuff directly below the upper filling region, which may be defined as a first flange, may be interpreted as a second flange, having a thickness that is different from the first flange.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the Rhodes, Chobotov, and Kerr combination include the upper and lower filling regions, therein defining a first flange and a second flange, to help prevent kinking and twisting of the device when it is deployed within angled or tortuous anatomies as well as during remodeling of body passageways (Chobotov; [¶ 0090]).
Concerning claim 19, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 5, wherein the Chobotov reference further teaches the at least one annular flange being adapted to radially expand when filled with a hardenable filling medium (Chobotov; [¶ 0094]))
Claim 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rhodes (US 5,665,117) in view of Chobotov et al. (US 2005/0090804, hereinafter Chobotov), and Kerr (US 2004/0073288) as applied to claims 1-7, 9-16, and 18-21 above, and further in view of Taylor et al. (US 2008/0039923, hereinafter Taylor).
Concerning claim 17, the combination of the Rhodes, Chobotov, and Kerr references as discussed above teaches the system of claim 1, but does not teach the sealing feature comprising an arm in fluid communication with the region filled with the hardenable filling medium.
However, the Taylor reference teaches a system for treating an aneurysm (Figure 1; 10) comprising a double walled filling structure having an outer wall (Figure 2; 30) and an inner wall (Figure 2; 20), wherein the filling structure may be filled with a filling medium so that the outer wall conforms to the inside surface of an aneurysm, wherein the reference further includes a sealing feature including an arm in fluid communication with the region filled with the filling medium (Figure 1; 16, 18).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of invention to have the sealing feature of the Rhodes, Chovotov, and Kerr combination include the arm in fluid communication with the region filled with filling medium of the Taylor reference to allow the system to be positioned within an aneurysm near renal arteries or other lateral arteries and assist in maintaining a position of the system (Taylor; [¶ 0062]).
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 1/21/2026