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 .
Election/Restrictions
Applicant’s election of Group I, in the reply filed on 06/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8-20 are withdrawn from further consideration pursuant to 3. 37 CFR 1.142(b) as being drawn to a nonelected invention or nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/09/2026.
Claim Objections
Claim 7 is objected to because of the following informalities: typo graphical error in syntax, “the first barrel portion and the second barrel portion, when the first implant portion is coupled to the second implant portion, together form an oval-shaped barrel configured to fit at least partially within the orifice”. Appropriate correction is required.
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) 1-2, 4-7, 21-26, and 28-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bairdo et al. US 20160045165 A1, herein referred to as Bairdo.
Regarding claim 1, Bairdo discloses a method ([0174]) comprising: delivering a first implant (Fig 21c, 6000) to an orifice of a chamber of a heart ([0006]); anchoring the first implant at the orifice (Fig 21d); delivering a sensor device (Fig 21d, 6200) to the orifice (Fig 21d); and anchoring the sensor device at the orifice ([0165]).
Regarding claim 2, Bairdo discloses further comprising: delivering an expansion balloon to the orifice ([0005]); and inflating the expansion balloon to expand the first implant from a compressed form to an expanded form ([0173]).
Regarding claim 4, Bairdo discloses a method ([0174]) comprising: delivering a first implant (Fig 3a, 310) to an orifice of a chamber of a heart ([0006]); anchoring the first implant at the orifice (Fig 21d); delivering a sensor device (Fig 21d, 6200) to the orifice ([0174]); and anchoring the sensor device at the orifice ([0165]); further comprising: delivering a second implant to the orifice (Fig 21d), the second implant (Fig 21c, 6000) having a barrel portion configured to form a fluid conduit (center of stent forms a blood flow conduit); and attaching the first implant to the second implant ([0174]).
Regarding claim 5, Bairdo discloses wherein the first implant is C-shaped and comprises a first end portion and a second end portion (Fig 3a, 310), each of the first end portion and the second end portion configured to attach to the second implant [0111].
Regarding claim 6, discloses a method ([0174]) comprising: delivering a first implant (Fig 3a, 310) to an orifice of a chamber of a heart ([0006]); anchoring the first implant at the orifice (Fig 21d); delivering a sensor device (Fig 21d, 6200) to the orifice ([0174]); and anchoring the sensor device at the orifice ([0165]); further comprising: delivering a second implant to the orifice (Fig 21d), wherein the first implant comprises a first implant portion and a second implant portion (Figs 21d and 3a), the first implant portion and the second implant portion are configured to be coupled together (111), and the sensor device is configured to be coupled to the first wire implant portion (Fig 3a).
Regarding claim 7, Bairdo discloses wherein the first implant portion comprises a first barrel portion (Fog 20a, 100) and the second implant portion comprises a second barrel portion (Fog 20a, 5000), and the first barrel portion and the second barrel portion, when the first implant portion is coupled to the second implant portion ([0156]), together form an oval-shaped barrel configured to fit at least partially within the orifice (Fig 20a).
Regarding claim 21, Bairdo discloses a method of monitoring one or more physiological parameters of a patient ([0174]), the method comprising: forming an opening through a tissue wall of a heart ([0161]); percutaneously delivering a sensor (Fig 20b, 5300) to the opening ([0102]); anchoring the sensor at the opening (Fig 20); percutaneously delivering a shunt (6000) to the opening (Fig 21a-b); and anchoring the shunt at the opening (Fig 21a-b).
Regarding claim 22, Bairdo discloses wherein the sensor (Fig 21c, 6400) is coupled to an expandable implant (6000), the method further comprising anchoring the expandable implant at the opening (Fig 21d).
Regarding claim 23, Bairdo discloses wherein anchoring the sensor at the opening involves expanding the expandable implant into contact with tissue at the opening [0160].
Regarding claim 24, Bairdo discloses wherein the sensor (Fig 15b, 1402) is coupled to the expandable implant via a tether (Fig 15a, 1403b; [0138]).
Regarding claim 25, Bairdo discloses wherein the expandable implant comprises one or more anchoring arms (Fig 15a, 1403b; [0138]).
Regarding claim 26, Bairdo discloses wherein the shunt is delivered to the opening after the sensor and the expandable implant are anchored at the opening [0138].
Regarding claim 28, Bairdo discloses wherein the sensor is coupled to an implant (Fig 1, 102) having a curved form to curve around and grasp a side of the opening (Fig 20a).
Regarding claim 29, Bairdo discloses wherein the sensor (1402) is coupled to an implant having anchoring arms configured to couple to the shunt (Fig 15a, 1403b; [0138]).
Regarding claim 30, Bairdo discloses wherein the shunt forms a central flow portion to facilitate flow through the opening ([0097]), and wherein the implant is configured to form an extension of the shunt to expand the central flow portion formed by the shunt [0101].
Regarding claim 31, Bairdo discloses a method of monitoring one or more physiological parameters of a patient [0174], the method comprising: forming an opening through a tissue wall of a heart ([0161]); percutaneously delivering a sensor (Fig 20b, 5300) and an implant (5000) to the opening ([0102]); percutaneously delivering a shunt (5000) to the opening ([0102]); and anchoring the shunt at the opening (Fig 21a-b).
Regarding claim 32, Bairdo discloses wherein the sensor is coupled to an implant having anchoring arms configured to couple to the shunt (Fig 15a, 1403b; [0138]).
Regarding claim 33, Bairdo discloses wherein the shunt forms a central flow portion to facilitate flow through the opening [0101], and wherein the implant is configured to form an extension of the shunt to expand the central flow portion formed by the shunt (Fig 20a).
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.
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.
Claim(s) 2 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bairdo in view of Fahey et al. US 20210085935 A1, herein referred to as Fahey.
Regarding claim 3, Bairdo discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches further comprising delivering a second implant (Fig 21c, 6300) to the orifice (Fig 21d), the second implant configured to fit at least partially within an inner lumen of the first implant (Fig 21c, [0163]), but does not explicitly disclose a second implant further comprising one or more anchoring arms configured to extend at least partially over the first implant to anchor with a tissue wall.
However, in the same field of endeavor, Fahey discloses a method of implanting delivering a first implant (Fig 19b-c, 1710) to an orifice of a chamber of a heart [0068]; anchoring the first implant at the orifice [0191-0192]; delivering a sensor device (Fig 28a-d, 2850; [0289]) to the orifice ([0289]); a second implant further comprising one or more anchoring arms (Fig 17b-c, 1752) configured to extend at least partially over the first implant to anchor with a tissue wall [01541].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Bairdo to incorporate the steps wherein a second implant further comprising one or more anchoring arms configured to extend at least partially over the first implant to anchor with a tissue wall, as taught and suggested by Fahey, in order to allow the implant to interface with an actuation/delivery system for delivery purposes (Fahey [0154]).
Regarding claim 27, Bairdo the invention substantially as claimed and as discussed above with respect to claim 21, but does not disclose wherein the shunt comprises one or more distal arms and one or more proximal arms.
However, in the same field of endeavor, Fahey also teaches wherein the shunt (Figs 8a-c; 800) comprises one or more distal arms (824) and one or more proximal arms (826). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Bairdo to incorporate the steps wherein the shunt comprises one or more distal arms and one or more proximal arms, as taught and suggested by Fahey in order to secure the implant in place (Fahey [0107]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
McNamara et al. US 10413284 B2 discloses an atrial pressure regulation with control, sensing, monitoring and therapy delivery.
VanTassel et al. US 20180338824 A1 discloses filter apparatus for ostium of left atrial appendage
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/A.F./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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