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 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) 1-6, 9-13, 15-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Radojici (US 10695484 B1).
Regarding claim 1, Radojici discloses a wireless monitoring system comprising:
a controller (17, column 12 lines 46-48) configured to be positioned external to a subject (fig. 2B); and
a shunt device (84, column 7 lines 35-36, column 19 lines 19-24) configured to be implanted within the subject (fig. 11, column 7 lines 30-36), the shunt device having a pump chamber (20, fig. 5A, column 7 lines 47-53) and a pair of limbs (12A, 29, figs. 5A and 11, column 7 lines 47-53), the pump chamber or the pair of limbs (12A, 29) comprising: one or more wireless sensors (42, fig. 7, column 7 line 8) communicatively coupled to the controller (17, column 6 line 52, column 9 lines 31-39), at least one or more wireless sensors configured to output a signal indicative of a total volume, a glucose amount, or an oxygenation within a fluid flowing in contact with the pump chamber or at least one of the pair of limbs wherein the one or more wireless sensors wirelessly transmit data to the controller (column 9 line 20 – column 10 line 6).
Regarding claim 2, Radojici discloses the system of claim 1 and further discloses wherein the one or more wireless sensors (42, fig. 7, column 7 line 8) include at least one sensor configured to output a signal indicative of an acidity or basicity of the fluid in contact with the pump chamber or in contact with at least one of the pair of limbs (column 9 lines 48-50).
Regarding claim 3, Radojici discloses the system of claim 1 and further discloses wherein the one or more wireless sensors (42, fig. 7, column 7 line 8) include at least one sensor configured to output a signal indicative of a temperature of the fluid in contact with the pump chamber or in contact with at least one of the pair of limbs (column 9 lines 48-51).
Regarding claim 4, Radojici discloses the system of claim 1 and further discloses wherein the shunt device is a peritoneovenous shunt configured to fluidly couple a peritoneal cavity to a venous system of the subject (84, column 7 lines 35-36, column 19 lines 19-24).
Regarding claim 5, Radojici discloses the system of claim 1 and further discloses wherein the shunt device is a pleuro-peritoneal shunt configured to fluidly couple a pleural cavity to a peritoneal cavity of the subject (84, column 7 lines 35-36, column 19 lines 19-24).
Regarding claim 6, Radojici discloses the system of claim 1 and further discloses wherein the one or more wireless sensors (42, fig. 7, column 7 line 8) further include a pressure sensor positioned within the pump chamber or within at least one of the pair of limbs (column 9 lines 48-51).
Regarding claim 9, Radojici discloses the system of claim 1 and further discloses comprising a display device (18) communicatively coupled to the controller, wherein the controller displays the data on the display device (fig. 2A, column 12 lines 52-57).
Regarding claim 10, Radojici discloses the system of claim 1 and further discloses wherein the controller compares the data to a predetermined range and generates an alert when the controller determines the data is outside of predetermined range (column 10 lines 36-42).
Regarding claim 11, Radojici discloses a pleuro-peritoneal shunt assembly for fluidly coupling a pleural cavity to a peritoneal cavity of a subject (column 7 lines 35-36, column 19 lines 19-26), the pleuro-peritoneal shunt assembly comprising:
a controller (17, column 12 lines 46-48) configured to be positioned external to the subject (fig. 2B),
a pleuro-peritoneal shunt device configured to be embedded within the subject (fig. 11, column 7 lines 30-36) and in wireless communication with the controller (17, column 6 line 52, column 9 lines 31-39), the pleuro-peritoneal shunt device comprising:
a pair of limbs (12A, 29, figs. 5A and 11, column 7 lines 47-53), and
a pump chamber (20, fig. 5A, column 7 lines 47-53), one of the pair of limbs fluidly coupled to one side of the pump chamber and the other one of the pair of limbs fluidly coupled to an opposite side of the pump chamber (figs. 5A and 11), the pump chamber or the pair of limbs (12A, 29) comprising:
one or more wireless sensors (42, fig. 7, column 7 line 8) communicatively coupled to the controller, at least one of the one or more wireless sensors configured to output a signal indicative of a total volume, a glucose amount, or an oxygenation of a fluid in contact with the pump chamber or in contact with one of the pair of limbs,
wherein the one or more wireless sensors wirelessly transmit a plurality of data to the controller (column 9 line 20 – column 10 line 6).
Regarding claim 12, Radojici discloses the assembly of claim 11 and further discloses wherein the one or more wireless sensors (42, fig. 7, column 7 line 8) communicatively coupled to the controller further include at least one sensor configured to output a signal indicative of an acidity or basicity of the fluid in contact with the pump chamber or in contact with at least one of the pair of limbs (column 9 lines 48-50).
Regarding claim 13, Radojici discloses the assembly of claim 11 and further discloses wherein the one or more wireless sensors (42, fig. 7, column 7 line 8) communicatively coupled to the controller further include a pressure sensor positioned within the pump chamber or within at least one of the pair of limbs (column 9 lines 48-51).
Regarding claim 15, Radojici discloses the assembly of claim 11 and further discloses wherein the one or more wireless sensors (42, fig. 7, column 7 line 8) include at least one sensor configured to output a signal indicative of a temperature of the fluid in contact with the pump chamber or in contact with at least one of the pair of limbs (column 9 lines 48-51).
Regarding claim 16, Radojici discloses the assembly of claim 11 and further discloses wherein a display device (18) is communicatively coupled to the controller, wherein the controller displays the data on the display device (fig. 2A, column 12 lines 52-57).
Regarding claim 17, Radojici discloses a peritoneovenous shunt assembly for fluidly coupling a peritoneal cavity to a venous system of a subject, the peritoneovenous shunt assembly (column 7 lines 35-36, column 19 lines 19-26, column 17 lines 46-54) comprising:
a controller (17, column 12 lines 46-48) configured to be positioned external to the subject (fig. 2B),
a peritoneovenous shunt device configured to be embedded within the subject (fig. 11, column 7 lines 30-36) and in wireless communication with the controller (17, column 6 line 52, column 9 lines 31-39), the peritoneovenous shunt device comprising:
a pair of limbs (12A, 29, figs. 5A and 11, column 7 lines 47-53), and
a pump chamber (20, fig. 5A, column 7 lines 47-53), one of the pair of limbs fluidly coupled to one side of the pump chamber and the other one of the pair of limbs fluidly coupled to an opposite side of the pump chamber (figs. 5A and 11), the pump chamber or the pair of limbs (12A, 29) comprising:
one or more wireless sensors (42, fig. 7, column 7 line 8) communicatively coupled to the controller, at least one of the one or more wireless sensors configured to output a signal indicative of a total volume, a glucose amount, or an oxygenation of a fluid within the pump chamber or within at least one of the pair of limbs,
wherein the one or more wireless sensors wirelessly transmit a plurality of data to the controller (column 9 line 20 – column 10 line 6).
Regarding claim 18, Radojici discloses the assembly of claim 17 and further discloses wherein the one or more wireless sensors communicatively coupled to the controller further comprise: at least one sensor configured to output a signal indicative of an acidity or basicity of the fluid within the pump chamber or within at least one of the pair of limbs; a pressure sensor positioned within the pump chamber or within the at least one of the pair of limbs; and at least one sensor configured to output a signal indicative of a temperature of the fluid within the pump chamber or within at least one of the pair of limbs (column 9 lines 41-67).
Regarding claim 20, Radojici discloses the assembly of claim 17 and further discloses wherein a display device (18) is communicatively coupled to the controller, wherein the controller displays the data on the display device (fig. 2A, column 12 lines 52-57).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7, 14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radojici (US 10695484 B1) in view of Sauder (US 20180235523 A1).
Regarding claims 7, 14, and 19, Radojici discloses the system of claim and the assemblies of claim 11 and 17. However, Radojici fails to disclose wherein the one or more wireless sensors further include a pair of flow sensors, one of the pair of flow sensors is within one of the pair of limbs and the other one of the pair of flow sensors is within the other one of the pair of limbs to output a signal indicative of a differential fluid flow data.
Sauder teaches a bodily fluid monitoring system with wireless sensors wherein one sensor is in one location and another sensor is in another location to output a signal indicative of a differential fluid flow data (para. [0051]).
Radojici already teaches a flow sensor disposed in one of the limbs (column 9 lines 48-51). The substitution of one known element (generic flow sensor as shown in Radojici) for another known element (differential flow sensor as shown in Saunder) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of a generic flow sensor for two sensors in different locations would have yielded predictable results, namely, a method of detecting a flow rate. MPEP 2143.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radojici (US 10695484 B1) in view of Burnett et al. (US 20150011855 A1).
Regarding claim 8, Radojici discloses the system of claim 1. However, Radojici fails to disclose wherein the one or more wireless sensors are charged using inductive charging positioned external to the subject.
Burnett teaches an implantable sensor within peritoneal fluid charged using inductive charging positioned external to the subject (para. [0058, 0061], claim 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Radojici and incorporate the wireless induction charging of Burnett to maximize the life of the implant (para. [0061]).
Conclusion
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 30 July 2026
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