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 .
Claim Status: Claims 1-8, 11-22 are pending.
Response to Arguments
Applicant's arguments filed on June 2, 2026 have been fully considered but they are not persuasive.
Re Claims 1 and 16, Applicant made an argument that Arevalos does not disclose “a sensor implant device comprising a sensor body, the sensor implant device configured for placement within the opening of the tissue wall and between the central flow portion of the shunt body and an inner wall of the opening of the tissue wall”. Applicant also stated that catheter 902 of Arevalos is not a shunt body and does not comprise a central flow portion. Applicant also argued that guidewire 901 is not positioned in a side-by-side orientation with the catheter 902 or the tissue stabilizer 904.
These arguments have been considered but are not persuasive.
The annotated figures 7 and 9 show the sensor implant device configured for placement within the opening of the tissue wall and between a central flow portion of the shunt body and an inner wall of the opening of the tissue wall. The figures also show catheter 902 with central flow portion within the catheter which reads on “a shunt body comprising a central portion”. Para. [0029], [0165], [0169] also discloses that oxygen saturation sensor is included in the guidewire tip, which reads on “a sensor implant device comprising a sensor body”.
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As shown in annotated fig. 7 and fig. 9, central flow portion and sensor implant device are positioned in a side-by-side orientation within the opening.
Re Claim 19, Applicant made an argument that the applied references do not disclose the limitation “a sensor body comprising one or more sensor components configured to provide sensor readings relating to one or more physiological parameters, the sensor body sized for placement within an opening of a tissue wall and between a shunt body and the tissue wall.”
This argument has been considered but is not persuasive.
Examiner would like to note that “the sensor body sized for placement within an opening of a tissue wall and between a shunt body and the tissue wall” is an intended use and that “a shunt body” is not positively recited nor required by the claim.
Arevalos discloses a guidewire that includes oxygen saturation sensor as disclosed in para. [0029], [0165], [0169], which reads on “a sensor body comprising one or more sensor components configured to provide sensor readings relating to one or more physiological parameters.” The size of the guide wire as shown in fig. 7 and fig. 9 is small enough to be placed within an opening of a tissue wall and between a shunt body and the tissue wall, and therefore the disclosure reads on the above claim language. Also, the size of the opening of a tissue wall and the size of a shunt body can be arbitrary that “the sensor body sized for placement within an opening of a tissue wall and between a shunt body and the tissue wall” can also be arbitrarily sized.
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 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.
Claims 1-8, 11-13 and 15-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arevalos et al (US 2019/0374254).
Regarding claims 1 and 16, Arevalos discloses a sensor implant system comprising: a shunt body 902 comprising a central flow portion configured for placement at least partially within an opening of a tissue wall 900; and a sensor implant device 901 comprising a sensor
body, see paragraph [0167], the sensor implant device configured for placement within the opening of the tissue wall and between the central flow portion of the shunt body and an inner wall of the opening of the tissue wall, see FIG. 9.
Regarding claims 2 and 17, Arevalos discloses the sensor implant device comprises one or more arms 1307 coupled to the sensor body.
Regarding claim 19, Arevalos discloses a sensor implant device comprising:
a sensor body comprising one or more sensor components configured to provide sensor readings relating to one or more physiological parameters (para. [0029], [0165], [0169], a guidewire that includes oxygen saturation sensor), the sensor body sized for placement within an opening of a tissue wall and between a shunt body and the tissue wall (fig. 13A, 13B, fig. 7, fig. 9); and one or more anchoring arms extending from the sensor body (para. [0187], fig. 13A-13C, one or more arms 1307. The device assembly disclosed herein 1300 includes a delivery catheter 3 1310, and the tissue stabilizer 1307, which is deployed from catheter 1, 1302, after its penetrating tip 1301 has crossed the septum tracking along a guidewire (not shown)).
Examiner would like to note that “the sensor body sized for placement within an opening of a tissue wall and between a shunt body and the tissue wall” is an intended use and that “a shunt body” is not positively recited nor required by the claim.
The size of the guide wire as shown in fig. 7 and fig. 9 is small enough to be placed within an opening of a tissue wall and between a shunt body and the tissue wall, and therefore the disclosure reads on the above claim language. Also, the size of the opening of a tissue wall and the size of a shunt body can be arbitrary that “the sensor body sized for placement within an opening of a tissue wall and between a shunt body and the tissue wall” can also be arbitrarily sized.
Regarding claims 3 and 18, Arevalos discloses the one or more arms are configured to pierce the tissue wall, see paragraph [0187] and FIG. 13B.
Regarding claim 4, Arevalos discloses the one or more arms are configured to attach to the central flow portion of the shunt body, see paragraph [0187].
Regarding claim 5, Arevalos discloses the sensor implant device comprises a first set of two arms 1307 extending from an upper portion of the sensor body and a second set of two arms 1307 extending from a lower portion of the sensor body.
Regarding claim 6, Arevalos discloses the one or more arms 1307 are generally curved, see FIG. 13B.
Regarding claim 7, Arevalos discloses the one or more arms 1307 extend from an upper portion of the sensor body, and wherein the one or more arms 1307 have a convex curvature when viewed from above the upper portion of the sensor body, see FIG. 13B.
Regarding claim 8, Arevalos discloses the sensor implant device further comprises a sleeve 1301 encircling at least portion of the sensor body, and wherein the one or more arms 1307 extend from the sleeve.
Regarding claim 11, Arevalos discloses the shunt body is expandable from a compressed form to an expanded form, see paragraph [0187].
Regarding claim 12, Arevalos discloses the shunt body is configured to maintain the expanded form following expansion, see paragraph [0187].
Regarding claim 13, Arevalos discloses the shunt body has an hourglass shape in which a midsection of the shunt body1302 is configured for placement within the opening of the tissue wall 1320 and wherein the shunt body comprises a flared first end 1307 and a flared second end 1308 configured to extend out of the opening of the tissue wall, see FIG. 13B.
Regarding claim 15, Arevalos discloses the shunt body comprises a retaining device 904 configured to wrap at least partially around the sensor body, see paragraph [0166].
Regarding claim 20, Arevalos discloses a sleeve 1301 encircling at least portion of the sensor body, and wherein the one or more anchoring arms 1307 extend from the sleeve, see paragraph [0187].
Regarding claim 21, Arevalos discloses that the sensor implant device is configured for placement outside the shunt body (para. [0169], oxygen saturation sensor is incorporated into the guidewire and the guidewire is delivered outside of the shunt body to different anatomical region to confirm the anatomical location; para. [0013], [0017], advancing a guidewire therethrough to a left atrium and removing the guidewire from the subject).
Regarding claim 22, Arevalos discloses delivering the sensor implant device outside the shunt body (para. [0169], oxygen saturation sensor is incorporated into the guidewire and the guidewire is delivered outside of the shunt body to different anatomical region to confirm the anatomical location; para. [0013], [0017], advancing a guidewire therethrough to a left atrium and removing the guidewire from the subject).
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 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Arevalos et al (US 2019/0374254) as applied to claim 1 above, and further in view of Browd et al (US 2017/0209056).
Regarding claim 14, Arevalos meets all of the claimed limitation except for the sensor implant device comprises a first sensor component configured to obtain measurements at a first side of the tissue wall and a second sensor component configured to obtain measurements at a second side of the tissue wall.
Browd teaches providing a first sensor assembly 106a at a first side of a fluid flow device and a second sensor assembly 106b at a second side of the fluid flow device.
One of ordinary skill in the art would have found it obvious to use the dual sensor location arrangement for measuring fluid through a catheter as taught by Browd for measuring the fluid flow through the shunt body 902 central flow portion because the teaching of Browd
suggests using two sensor locations for measuring fluid flow between the two sensors. Since the fluid flow across the tissue wall occurs at the shunt body 902, the skilled artisan would have found it obvious to position first and second sensors on each side of the wall to measure fluid flow through the wall.
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 VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, September 30, 2026Examiner, Art Unit 3792
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