DETAILED ACTION
The following Office Action is in response to the Amendment filed on December 22, 2025. Claims 1, 5, and 22-39 are currently pending.
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 .
Response to Arguments
Concerning the “Rejection of Claims under 35 U.S.C. § 102” section on page 8 of the Applicant’s Response filed on December 22, 2025, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5, 6, 22, 30-35, and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuseth et al. (US 2017/0196565).
Concerning claim 1, the Tuseth et al. prior art reference teaches a shunt device capable of being used for shunting between a first blood vessel and a second blood vessel (Figure 1-14F; 1), the shunt device comprising: a shunt conduit (Figure 1; 2) sized to provide a blood flow pathway between a first opening in a first wall portion of the first blood vessel (Figure 14E; W2) and a second opening in a second wall portion of the second blood vessel (Figure 14E; W1); a first pair of anchors coupled to a first side of the shunt conduit (Figure 8; 3A) each of the first pair of anchors sized for placement within the first blood vessel, each of the first pair of anchors having a free end adapted to deflect towards the first wall portion to anchor to an inner surface of the first blood vessel (Figure 9A; 3A); and a second pair of anchors coupled to a second side of the shunt conduit (Figure 8; 3B), each of the second pair of anchors sized for placement within the second vessel to anchor the shunt conduit to an inner surface of the second blood vessel, each of the second pair of anchors being longer than each of the first pair of anchors (Figure 8; 3A, 3B) and having a free end adapted to deflect towards the second wall portion (Figure 9A; 3B), and wherein the second pair of anchors (Figure 9A; 3B) are rotationally perpendicular relative to the first pair of anchors with respect to an axis of the shunt conduit (Figure 9A; 3B).
Concerning claim 5, the Tuseth reference teaches the shunt device of claim 1, wherein the shunt conduit has an adjustable length ([¶ 0123], shunt is capable of extending radially, which would result in a shortening longitudinal length).
Concerning claim 6, the Tuseth reference teaches the shunt device of claim 1, wherein the first blood vessel and the second blood vessel are capable of being generally perpendicular orientations with respect to each other (shunt device is capable of being inserted between two perpendicular blood vessels).
Concerning claim 22, the Tuseth reference teaches the shunt device of claim 1, wherein the shunt conduit comprises a first end (Figure 8; distal end of 2), a second end (Figure 8; proximal end of 2), and a midpoint between the first end and the second end (Figure 8; midline of 2), and wherein each of the second pair of anchors is coupled to the midpoint of the shunt conduit and each of the first pair of anchors is coupled to the first end of the shunt conduit (Figure 8; struts attached to anchors 3B forming the diamond shape of the conduit couple the anchors to the midpoint of the shunt conduit).
Concerning claim 30, the Tuseth et al. prior art reference teaches a shunt device capable of being used for shunting between a first blood vessel and a second blood vessel (Figure 1-14F; 1), the shunt device comprising: a shunt conduit (Figure 1; 2) sized to provide a blood flow pathway between a first opening in a first wall portion of the first blood vessel (Figure 14E; W2) and a second opening in a second wall portion of the second blood vessel (Figure 14E; W1); a first flange coupled to a first side of the shunt conduit and sized for placement within the first blood vessel to anchor the shunt conduit to an inner surface of the first blood vessel (Figure 9A; 3A); and a second flange coupled to a second side of the shunt conduit and sized for placement outside the first blood vessel (Figure 9A; 3B).
Concerning claim 31, the Tuseth reference teaches the shunt device of claim 30, wherein the second flange (Figure 9A; 3B) is rotationally perpendicular relative to the first flange with respect to an axis of the shunt conduit (Figure 9A; 3A).
Concerning claim 32, the Tuseth reference teaches the shunt device of claim 30, wherein the first flange comprises a pair of anchors (Figure 9A; 3A), each of the first pair of anchors having a free end adapted to deflect towards the first wall portion to anchor to an inner surface of the first blood vessel.
Concerning claim 33, the Tuseth reference teaches the shunt device of claim 32, wherein the second flange comprises a second pair of anchors (Figure 9A; 3B), each of the second pair of anchors being longer than each of the first pair of anchors and having a free end adapted to deflect towards the second wall portion to anchor to an inner surface of the second blood vessel.
Concerning claim 34, the Tuseth reference teaches the shunt device of claim 33, wherein the second pair of anchors (Figure 9A; 3B) is rotationally perpendicular relative to the first pair of anchors (Figure 9A; 3A) with respect to an axis of the shunt conduit.
Concerning claim 35, the Tuseth reference teaches the shunt device of claim 33, wherein the shunt conduit comprises a first end (Figure 8; distal end of 2), a second end (Figure 8; proximal end of 2), and a midpoint between the first end and the second end (Figure 8; midline of 2), and wherein each of the second pair of anchors is coupled to the midpoint of the shunt conduit and each of the first pair of anchors is coupled to the first end of the shunt conduit (Figure 8; struts attached to anchors 3A, 3B forming the diamond shape of the conduit couple the anchors to the midpoint of the shunt conduit).
Concerning claim 39, the Tuseth reference teaches the shunt device of claim 30, wherein the first flange comprises a first pair of anchors (Figure 9A; 3A) and a second pair of anchors (Figure 9A; 4A), each of the first pair of anchors having a free end adapted to deflect perpendicularly relative to the shunt conduit and each of the second pair of anchors having a free end adapted to deflect perpendicularly relative to the shunt conduit, wherein the second pair of anchors is rotationally perpendicular relative to the first pair of anchors with respect to an axis of the shunt conduit.
Claim(s) 24-26, 30, and 37-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuck et al. (US 2022/0096253, hereinafter Tuck).
Concerning claim 24, the Tuck et al. prior art reference teaches a shunt device capable of shunting fluid between a first blood vessel and a second blood vessel (Figures 1-4; 100), the shunt device comprising: a first shunt conduit (Figure 4; conduit defined between flanges 422 and 424 of retention member 402) sized for placement at least partially within a first wall portion of the first blood vessel to provide a blood flow pathway between a first opening in the first wall portion of the first blood vessel (Figure 4; 308) and a second opening in a second wall portion of the second blood vessel (Figure 4; 310); a first flange coupled to a first side of the first shunt conduit and sized for placement within the first blood vessel (Figure 4; 422), the first flange having a biased circular shape and being axially compressible and radially expandable to anchor the first shunt conduit to an inner surface of the first blood vessel (Figures 2AB); and a second flange coupled to a second side of the first shunt conduit and sized for placement outside the first blood vessel (Figure 4; 424), the second flange having the biased circular shape and being axially compressible and radially expandable (Figures 2AB).
Concerning claim 25, the Tuck reference teaches the shunt device of claim 24, wherein the second flange is sized for placement within the second blood vessel, and wherein the second flange is capable of anchoring the first shunt conduit to an inner surface of the second blood vessel.
Concerning claim 26, the Tuck reference teaches the shunt device of claim 24, wherein the second flange is adapted to anchor the first shunt conduit to an outer surface of the first blood vessel (Figure 4; 308), the shunt device further comprising: a second shunt conduit coupled to the second flange and sized for placement between the first blood vessel and the second blood vessel (Figure 4; 106), to extend the blood flow pathway; a third shunt conduit sized for placement at least partially within the second wall portion of the second blood vessel to extend the blood flow pathway (Figure 4; conduit defined between flanges 426 and 428 of retention member 404); a third flange coupled between the second shunt conduit and the third shunt conduit to anchor the third shunt conduit to an outer surface of the second blood vessel (Figure 4; 426); and a fourth flange coupled to the third shunt conduit and sized for placement within the second blood vessel to anchor the third shunt conduit to an inner surface of the second blood vessel (Figure 4; 428).
Concerning claim 30, the Tuck et al. prior art reference teaches a shunt device capable of shunting fluid between a first blood vessel and a second blood vessel (Figures 1-4; 100), the shunt device comprising: a shunt conduit (Figure 4; conduit defined between flanges 422 and 424 of retention member 402) sized to provide a blood flow pathway between a first opening in the first wall portion of the first blood vessel (Figure 4; 308) and a second opening in a second wall portion of the second blood vessel (Figure 4; 310); a first flange coupled to a first side of the shunt conduit and sized for placement within the first blood vessel to anchor the shunt conduit to an inner surface of the first blood vessel (Figure 4; 422); and a second flange coupled to a second side of the first shunt conduit and sized for placement outside the first blood vessel (Figure 4; 424).
Concerning claim 37, the Tuck reference teaches the shunt device of claim 30, wherein the second flange is sized for placement within the second blood vessel, and wherein the second flange is capable of anchoring the first shunt conduit to an inner surface of the second blood vessel.
Concerning claim 38, the Tuck reference teaches the shunt device of claim 37, wherein the second flange is adapted to anchor the first shunt conduit to an outer surface of the first blood vessel (Figure 4; 308), the shunt device further comprising: a second shunt conduit coupled to the second flange and sized for placement between the first blood vessel and the second blood vessel (Figure 4; 106), to extend the blood flow pathway; a third shunt conduit sized for placement at least partially within the second wall portion of the second blood vessel to extend the blood flow pathway (Figure 4; conduit defined between flanges 426 and 428 of retention member 404); a third flange coupled between the second shunt conduit and the third shunt conduit to anchor the third shunt conduit to an outer surface of the second blood vessel (Figure 4; 426); and a fourth flange coupled to the third shunt conduit and sized for placement within the second blood vessel to anchor the third shunt conduit to an inner surface of the second blood vessel (Figure 4; 428).
Claim(s) 24 and 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coleman et al. (US 2010/0114128, hereinafter Coleman).
Concerning claim 24, the Coleman et al. prior art reference teaches a shunt device capable of shunting fluid between a first blood vessel and a second blood vessel (Figures 1-10; 10), the shunt device comprising: a first shunt conduit (Figure 1; 13) sized for placement at least partially within a first wall portion of the first blood vessel (Figure 45C; 150a) to provide a blood flow pathway between a first opening in the first wall portion of the first blood vessel and a second opening in a second wall portion of the second blood vessel (Figure 45C; 150c); a first flange coupled to a first side of the first shunt conduit and sized for placement within the first blood vessel (Figure 4; 16a), the first flange having a biased circular shape and being axially compressible and radially expandable to anchor the first shunt conduit to an inner surface of the first blood vessel (Figures 2-3); and a second flange coupled to a second side of the first shunt conduit and sized for placement outside the first blood vessel (Figure 4; 16b), the second flange having the biased circular shape and being axially compressible and radially expandable (Figures 2-3).
Concerning claim 27, the Coleman reference teaches the shunt device of claim 24, further comprising: a first stoper adjacent the first flange to axially compress the first flange (Figure 23; 224); and a second stopper adjacent to the second flange to axially compress the second flange (Figure 23; 228).
Concerning claim 28, the Coleman reference teaches the shunt device of claim 24, further comprising a threaded member adapted to twist to cause compression of the first flange and the second flange (Figure 19; 237).
Concerning claim 29, the Coleman reference teaches the shunt device of claim 24, further comprising a threaded member adapted to twist to adjust a size of the blood flow pathway of the first shunt conduit (Figure 9; 334).
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) 23 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuseth et al. (US 2017/0196565) in view of Tuck et al. (US 2022/0096253, hereinafter Tuck).
Concerning claims 23 and 36, the Tuseth reference teaches the shunt device of claims 22 and 35, but does not specifically teach each of the second pair of anchors being coupled to an internal surface of the shunt conduit.
However, the Tuck reference teaches a shunt device similar to that of the Tuseth reference, wherein the Tuck reference teaches the shunt device comprising a shunt conduit (Figure 3; 106) including an internal surface (Figure 3; 108) and an outer covering (Figure 3; 114) and a first anchor (Figure 2B; 202) and a second anchor (Figure 2B; 204), wherein the second anchor is coupled to the internal surface of the shunt conduit (Figure 2B; 208).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the shunt conduit of the Tuseth reference include an outer covering and internal surface as in the Tuck reference, with the second pair of anchors of the Tuseth reference being coupled to the internal surface as in the Tuck reference to prevent the tissue from snagging, catching, or otherwise engaging portions of the shunt conduit in a manner that may interfere with a desired operation (Tuck; [¶ 0043]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Aguirre reference (US 2011/0118765) teaches a shunt device including rotationally offset first and second anchors, the second anchors being longer than the first; and the Brenneman et al. reference (US 2007/0249985) and Binmoeller et al. reference (US 2008/0243151) teach shunt devices including a first pair of anchors that deflect towards an opposite end and a second pair of anchors that deflect towards an opposite end, the second anchors being longer than the first.
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.
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, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN T TON/Examiner, Art Unit 3771 3/7/2026