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 Amendment
The amendment filed 13 May 2026 has been entered. Claims 1-7 are canceled and new claims 8-14 are pending. Interpretation under 35 U.S.C. 112(f) is withdrawn in light of the amendments to the claims.
Claim Objections
Claims 9-11 are objected to because of the following informalities:
Claim 9, line 2 “an ePTFE covering material” should be written out as “an expanded polytetrafluoroethylene (ePTFE) covering material” for clarity.
Claim 10, line 2 “is uncovered” should be “is uncovered by the ePTFE covering material” or similar for clarity.
Claim 11 currently includes two periods at the end of the claim.
Appropriate correction is required.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gleich (US 20200397320 A1--previously cited) in view of Yeo (US 20220287580 A1).
Regarding claim 8, Gleich teaches an implant for determining a pressure difference inside a body (Paragraph 0028, 0116-0118--the hepatic shunt device can comprise several pressure sensors, particularly for monitoring a pressure drop), comprising:
a stent (Hepatic shunt device 2200) comprising a helically wound wire section (First part 2201; paragraph 0116-- the first part 2201 of the wire structure has separate wires) including a first element connected to a second element (Fig. 11, paragraph 0116—wires of the wire structure);
a first pressure sensor coupled to the first element (First pressure sensor 2205 which is coupled to a wire; paragraph 0116) at a first end of the implant (at a first end, see Fig. 11), the first conductive element configured to wirelessly transmit a first pressure reading from the first pressure sensor; and
a second pressure sensor coupled to the second element (Further pressure sensor 2209 which is connected to neighboring wires; paragraph 0117) at a second end of the implant (at a second end, see Fig. 11), the second conductive element configured to wirelessly transmit a second pressure reading from the second pressure sensor.
Gleich generally teaches that the implant includes a reading system for wirelessly transmitting a pressure reading from the pressure sensors (Paragraph 0031-0034), where some such system must be present in the stent as the first and second pressure sensors enable real-time pressure monitoring (Paragraph 0119) and where the system includes coiled conductor loops (Paragraph 0141-- The technical simplest systems are coreless conductor loops for sending and receiving of magnetic fields. Coils are generally good enough for the sensor application).
However, Gleich does not explicitly disclose the a helically wound wire section including a first conductive element connected to a second conductive element via an insulating connector sheath, wherein the first pressure sensor is coupled to the first conductive element, the first conductive element configured to wirelessly transmit a first pressure reading from the first pressure sensor; and wherein the second pressure sensor is coupled to the second conductive element, the second conductive element configured to wirelessly transmit a second pressure reading from the second pressure sensor.
Yeo, in the same field of endeavor of a stent implant including a first and second sensor for measuring a pressure gradient, teaches that such a device may include a helically wound wire section including a first conductive element connected to a second conductive element via an insulating connector sheath (Paragraph 0038--The outer wall can be formed by a plurality of conductive loops 106 and nonconductive connectors 107 to achieve a conductive pathway resembling a solenoid and serving as an inductive antenna, wherein a first and second conductive loop can serve as the first and second conductive elements and a nonconductive connector may serve as an insulating connector sheath); where a first pressure sensor (Paragraph 0024, 0054; two sensors Fig. 1C, 1G, 8B, 12) is coupled to the first conductive element (Loop 106) at a first end of the implant (Paragraph 0054—each pressure sensor is located proximate the stent ends…), the first conductive element configured to wirelessly transmit a first pressure reading from the first pressure sensor (Paragraph 0019, 0038--the outer wall of the stent can comprise a plurality of conductive loops. Each of the conductive loops can be coupled to an adjacent conductive loop via a nonconductive connector. The outer wall can form an inductive antenna capable of being interrogated by a second external inductive antenna; paragraph 0042--placing a pressure sensor 115 at each end shares the stent 105 and forms two LC circuits with distinct resonant frequencies…placing a pressure sensor 115 at each end shares the stent 105 and forms two LC circuits with distinct resonant frequencies.); and a second pressure sensor (Paragraph 0024, 0054; two sensors, Fig. 1C, 1G, 8B, 12) is coupled to the second conductive element (Loop 106) at a second end of the implant (Paragraph 0054—each pressure sensor is located proximate the stent ends…), the second conductive element configured to wirelessly transmit a second pressure reading from the second pressure sensor (Paragraph 0019, 0038--the outer wall of the stent can comprise a plurality of conductive loops. Each of the conductive loops can be coupled to an adjacent conductive loop via a nonconductive connector. The outer wall can form an inductive antenna capable of being interrogated by a second external inductive antenna; paragraph 0042--placing a pressure sensor 115 at each end shares the stent 105 and forms two LC circuits with distinct resonant frequencies…placing a pressure sensor 115 at each end shares the stent 105 and forms two LC circuits with distinct resonant frequencies.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the implant of Gleich to include a helical antenna structure as described by Yeo as the helical section of Gleich in order to predictably improve the ability of the device to transmit data from the implanted device to an outside system for monitoring, wherein a coil of conductive loops is known in the art for such an application as disclosed by Gleich and wherein the particular structure and size of such a coil may be adapted to different sizes of stents as described by Yeo (Paragraph 0038) and wherein the inclusion of an insulating connector sheath may prevent shorting between adjacent loops of the coil to improve longevity of the device (Yeo, paragraph 0044). Such a structural modification is further supported by the second sensor of Gleich being connected to neighboring wires, such that it may be connected to each of the helical and woven sections via wires which neighbor one another at the transition between sections.
Claim(s) 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gleich in view of Yeo, further in view of Sanati (US 20060265041 A1).
Regarding claim 9, the combination of Gleich and Yeo teaches the implant according to claim 8. Gleich additionally teaches wherein the helically wound wire section is at least partially covered by a covering material (Paragraph 0116-- the first part 2201 is lined by using PTFE (polytetrafluoroethylene)).
However, Gleich fails to explicitly disclose the covering material is ePTFE.
Sanati, in the same field of endeavor of a stent device having a helical coil and a covered section and an uncovered section (Paragraph 0048-0049), teaches that a stent may include a covered section which is covered by an ePTFE covering (Paragraph 0049).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the implant of Gleich, which utilizes a PTFE covering, to use an ePTFE covering as disclosed by Sanati as a matter of simple substitution of known elements in the art, where both materials are substantially elastic and capable of preventing tangling of outside elements with the structures of the stent by providing a smooth surface to the outside of the stent (see Sanati, paragraph 0049).
Regarding claim 10, the combination of Gleich, Yeo, and Sanati teaches the implant according to claim 9. Gleich additionally teaches wherein the helically wound wire section (First part 2201) is connected to a woven wire section (Second part 2202; paragraph 0116-- in the second part 2202 of the wire structure 2203 the wires are interwoven), and wherein the woven wire section is uncovered (Paragraph 0116-- a first part 2201 surrounded by a lining material and a bare second part 2202).
Regarding claim 11, the combination of Gleich, Yeo, and Sanati teaches the implant according to claim 10. Gleich additionally teaches wherein the helically wound wire section is formed from a shape memory material (Paragraph 0012, 0085, 0107-- can be manufactured from wire material, e.g. Nitinol for its high flexibility and good bio-compatibility).
Regarding claim 12, the combination of Gleich, Yeo, and Sanati teaches the implant according to claim 10. Gleich additionally teaches wherein the first pressure sensor is coupled to the helically wound wire section at the first end of the implant, and wherein the second pressure sensor is coupled to the woven wire section at the second end of the implant (Paragraph 0116; Fig. 11—see position of first and last sensors at each end).
Regarding claim 13, the combination of Gleich, Yeo, and Sanati teaches the implant according to claim 12. Gleich generally teaches that the helically wound wire section is coupled to the woven wire section (see structure in Fig. 11).
However, Gleich is silent regarding a second insulating connector sheath.
Yeo additionally teaches comprising a second insulating connector sheath coupling wire elements together (Paragraph 0038--The outer wall can be formed by a plurality of conductive loops 106 and nonconductive connectors 107 to achieve a conductive pathway resembling a solenoid and serving as an inductive antenna, wherein a first and second conductive loop can serve as the first and second conductive elements and a nonconductive connector may serve as an insulating connector sheath).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the implant of Gleich to include the second insulating connector as described by Yeo as the helical section of Gleich in order to predictably improve the longevity of the device by preventing shorting between adjacent wires (Yeo, paragraph 0044).
Regarding claim 14, the combination of Gleich, Yeo, and Sanati teaches the implant according to claim 13. Gleich additionally teaches wherein the implant is configured as a stent graft for a transjugular intrahepatic portosystemic shunt (TIPS), and wherein the first pressure sensor and the second pressure sensor are configured to measure a portal pressure gradient (Paragraph 0112, 0116-0118—transjugular intrahepatic portosystemic shunts (TIPS)… the hepatic shunt device can comprise several pressure sensors, particularly for monitoring a pressure drop).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
While the Gleich reference is still applied, new citations of the reference along with the newly cited references of Yeo and Sanati are used to teach all limitations of the claims.
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.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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