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 .
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/17/2023, 5/23/2024, 9/22/2025, and 02/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowe (WO 2020123338 A1).
Regarding Claim 1, Rowe teaches a sensor implant system (par. 121-122, figs. 16A-C) comprising:
a shunt implant (1620) comprising a central flow portion configured to maintain an opening through a tissue wall(fig. 16A); and
a sensor implant device (#1627 fig. 16A, see par. 121: "the sensor 1610 comprises or is associated with one or more projections 1627 configured or designed to hold or secure the sensor 1610 to the shunt structure 1620") comprising: a shunt body configured to fit at least partially within the central flow portion (structures #1627 of D1 fit within the central flow, see par. 122:" ... showing the sensor 1610 disposed in the flow path 1603 of the shunt structure") of the shunt implant; and
a sensor coupled to the shunt body (par.121; figs. 16A, C).
Regarding Claim 2, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor is configured to extend at least partially over the opening through the tissue wall (figs. 14B, 15, 16A).
Regarding Claim 3, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor is configured to extend at least partially over the tissue wall (figs. 14B, 15, 16A).
Regarding Claim 4, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the sensor is coupled to the shunt body via an arm extending from the shunt body (arm #1527 fig. 15).
Regarding Claim 5, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the shunt body comprises a wire loop (1621) having a proximal portion configured to assume a first width within the central flow portion of the shunt implant and having a distal portion configured to expand to a second width beyond the central flow portion of the shunt implant, and wherein the second width is greater than the first width (figure 16c).
Regarding Claim 6, Rowe teaches the sensor implant system of claim 5. Rowe further teaches wherein the wire loop is configured to expand to the second width beyond a first side of the tissue wall (figure 17), and wherein the sensor (1610) is configured to extend beyond a second side of the tissue wall (figure 16B and 17).
Regarding Claim 7, Rowe teaches the sensor implant system of claim 5. Rowe further teaches wherein the proximal portion of the wire loop is configured to be situated at least partially within the central flow portion of the shunt implant (figure 16B and 17).
Regarding Claim 8, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the shunt body comprises a coil (paragraph [0117 and 0140]) having a proximal portion configured to form a first width within the central flow portion of the shunt implant and having a distal portion configured to form a second width beyond the central flow portion of the shunt implant, and wherein the second width is greater than the first width (figure 16c).
Regarding Claim 9, Rowe teaches the sensor implant system of claim 8. Rowe further teaches wherein the shunt body is configured to form the second width beyond a first side of the tissue wall(figure 17), and wherein the sensor (1610) is configured to extend beyond a second side of the tissue wall (figure 16B and 17).
Regarding Claim 10, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the shunt body has an hourglass shape in which a midsection of the shunt body has a first diameter and the shunt body expands to a second diameter at a first end of the shunt body and at a second end of the shunt body, wherein the second diameter is greater than the first diameter (figure 16B).
Regarding Claim 11, Rowe teaches the sensor implant system of claim 10. Rowe further teaches wherein the shunt body comprises a sensor dock (1625) at the first end, and wherein the sensor is configured to couple to the shunt body at the sensor dock (figure 16B).
Regarding Claim 12, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the shunt body has a partial cylindrical form (1622) with a gap separating a first end of the shunt body from a second end of the shunt body (fig. 16B).
Regarding Claim 13, Rowe teaches the sensor implant system of claim 1. Rowe further teaches wherein the shunt body comprises multiple anchoring arms (1621) configured to mate with the shunt implant (16C).
Regarding Claim 14, Rowe teaches the sensor implant system of claim 13. Rowe further teaches wherein each of the anchoring arms couples to a tether (1662) interconnecting the sensor and the anchoring arms (figure 16c).
Regarding Claim 15, Rowe teaches the sensor implant system of claim 14. Rowe further teaches wherein the tether is configured to extend the sensor at least partially over the tissue wall (fig. 17).
Regarding Claim 16, Rowe teaches the sensor implant system of claim 1. Rowe further teaches, a coupling arm (1522) interconnecting the sensor and the shunt body, wherein the coupling arm comprise a network of struts forming diamond shaped cells (figure 15).
Regarding Claim 17, Rowe teaches a method comprising:
delivering a shunt implant (1620) to an opening in a tissue wall, the shunt implant comprising a central flow portion configured to maintain the opening (paragraph [0070 and 0089]);
delivering a sensor implant device to the opening in the tissue wall (paragraph [0070 and 0089]);
the sensor implant device comprising:
a shunt body configured to fit at least partially within the central flow portion (structures #1627 of D1 fit within the central flow, see par. 122:" ... showing the sensor 1610 disposed in the flow path 1603 of the shunt structure") of the shunt implant; and
a sensor coupled to the shunt body(par.121; figs. 16A, C); and
rotating the sensor implant device to adjust a position of the sensor (paragraph [0076]).
Regarding Claim 18, Rowe teaches the method of claim 17. Rowe further teaches wherein the shunt body comprises a wire loop (1621) having a proximal portion configured to assume a first width within the central flow portion of the shunt implant and having a distal portion configured to expand to a second width beyond the central flow portion of the shunt implant, and wherein the second width is greater than the first width (figure 16c).
Regarding Claim 19, Rowe teaches a sensor implant device comprising: a shunt body (1620) configured to fit at least partially within a central flow portion of a shunt implant (#1627 fig. 16A, see par. 121: "the sensor 1610 comprises or is associated with one or more projections 1627 configured or designed to hold or secure the sensor 1610 to the shunt structure 1620"); and a sensor coupled to the shunt body (par.121; figs. 16A, C).
Regarding Claim 20, Rowe teaches the sensor implant system of claim 19. Rowe further teaches wherein the shunt body has an hourglass shape in which a midsection of the shunt body has a first diameter and the shunt body expands to a second diameter at a first end of the shunt body and at a second end of the shunt body, wherein the second diameter is greater than the first diameter (figure 16B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20080071178 A1 and US 20160045165 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781