RESPONSE TO AMENDMENT
This communication is responsive to the amendment filed 25 June-2026 with respect to application 18/958,757, filed 25-November-2024.
Applicant has amended claims 1, 4 and 6, and has added new claim 15.
Claims 1-15 are currently pending.
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 §103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3 are rejected under 35 USC §103 as unpatentable over Chen et al. (United States Patent Application Publication # US 2021/0016095 A1), hereinafter Chen, in view of Brown (United States Patent # US 2,012,741), and Sattler et al. (United States Patent # US 7,883,463 B2), hereinafter Sattler.
Consider claim 1: A temperature monitoring device, Chen discloses a multi-sensor composite ventricular electrode device comprising a temperature sensor, [Title; Abstract; Fig. 1-3, 6; Para. 0001, 0005-0009], said device comprising:
a body, said body comprised of solid silicone; a silicone catheter (2) which is the main body of the electrode [Fig. 1; Para. 0049-0051];
a temperature sensor located within said body, said temperature sensor in direct contact with said solid silicone, and said temperature sensor configured to collect temperature data associated with said solid silicone; a thermistor mounted on a PCB within the catheter body, and for measuring temperature of blood outside the catheter [Fig. 1-2; Para. 0008, 0011; 0065, 0074]; and
a flexible bidirectional flange, said bidirectional flange integrally connected to said body; a positioning anchor (bidirectional flange) made of silicone [Fig. 1; Para, 0007, 0049-0050]; said bidirectional flange comprising two underhangs that extend laterally in opposite directions beyond a top end of said body; Chen discloses the anchor portion (1), attached to the catheter body (2) may broadly be seen to comprise one or more underhangs which extend laterally on various sides of the body, but does not explicitly disclose two underhangs.
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This is known in analogous prior art however, and for example:
Brown discloses a combined thermometer and support, specifically designed to allow the thermometer to hang between two rails, and where the hanger (9) comprises two arms (11, 12) with two hooks (13, 14) (underhang) extending outward in opposite directions over the top end of the thermometer to engage a pair of parallel rails [Fig. 1-3; Col. 1, 1-42, Col. 2, 1-29].
Chen discloses that the catheter (body) and anchor (bidirectional flange) are made of silicone, where silicone is commonly known to be a flexible rubber-like material, but Chen does not explicitly disclose the silicone anchor to be flexible, or that the temperature sensor is in direct contact with the catheter body. These would have been obvious to an artisan, and also have been disclosed in analogous prior art; for example:
Sattler discloses a combination sensor for physiological parameters, intended to be worn behind the ear of a person, and comprising temperature monitoring sensors [Title; Abstract; Fig. 1-3; Col. 1, 12-13, 47-67] and specifically that the sensor carrier (11) may be embedded in a pliable plastic material (body), preferably in silicone, and which is adapted to the shape of a human ear [Fig, 3; Col. 2, 6-8], and where the pliable silicone body forms a flange-like projection to engage the ear [Fig. 3].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing for the invention for a positioning device comprise two arms with underhangs extending laterally in two directions to suspend a device below, as taught by Brown, and to embed temperature monitoring elements within a pliable silicone carrier, and where an extension of the flexible body acts to anchor the device to a user’s ear, as taught by Sattler, and applied to a multi-sensor composite ventricular electrode device comprising a temperature sensor as taught by Chen, in order to suspend the device from parallel rails, and where the pliable silicone material is durable, biocompatible, and resilient.
Consider claim 3 and as applied to claim 1: The temperature monitoring device of Claim 1, wherein said bidirectional flange is comprised of silicone. Sattler discloses use of a pliable plastic material, preferably silicone with an adapted shape [Col. 2; 6-8].
Claim 2 is rejected under 35 USC §103 as unpatentable over Chen et al. (United States Patent Application Publication # US 2021/0016095 A1), hereinafter Chen, Brown (United States Patent # US 2,012,741), and Sattler et al. (United States Patent # US 7,883,463 B2), hereinafter Sattler, further in view of Hartmann et al. (United States Patent Application Publication # US 2021/0207982 A1), hereinafter Hartmann.
Consider claim 2 and as applied to claim 1: The temperature monitoring device of Claim 1, wherein said device further comprises: memory storage, wherein said memory storage is located within said body, and said memory storage is configured to store calibration information unique to said temperature sensor.
Chen does not disclose that the temperature sensor unit comprises a memory.
Sattler discloses the storage of sensor reference values for determining an alarm condition [Col. 3, 4-9], but does not disclose the storage temperature calibration values. This was known in the prior art, however, and for example:
Hartmann, discloses an environment monitoring system where an environmental parameter, which may include temperature, is calibratable, and particularly a memory in which calibrated values are stored [Title; Abstract; Fig. 1, 7; Para. 0002, 0014-0018, 0026-0031].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing for the invention to individually generate calibration data for a temperature sensor, and to store the calibration data in the sensor device as taught by Hartmann, and applied to a multi-sensor composite ventricular electrode device comprising a temperature sensor as taught by Chen as modified by Brown and Sattler, in order to improve the accuracy of the sensor readings.
Claims 4-6, 8 and 15 are rejected under 35 USC §103 as unpatentable over Chen et al. (United States Patent Application Publication # US 2021/0016095 A1), hereinafter Chen, in view of Takeuchi (United States Patent Application Publication # US 2009/0080492 A1).
Consider claim 4: A temperature monitoring device, said temperature monitoring device Chen discloses a multi-sensor composite ventricular electrode device comprising a temperature sensor, [Title; Abstract; Fig. 1-3, 6; Para. 0001, 0005-0009], comprising:
a body, a silicone catheter (2) which is the main body of the electrode [Fig. 1; Para. 0049-0051]; and
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a circuit assembly located within said body, a printed circuit board (PCB) (circuit assembly) within a sensor compartment (3) [Fig. 1-2; Para. 0049-0052];
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said circuit assembly comprising a first end and a second end, wherein the PCB is shown to have a first end and a second end [Fig. 1-2]; and
said circuit assembly comprising temperature sensor configured to provide temperature data, the PCB comprising a thermistor operating as a temperature sensor [Fig. 2; Para. 0052, 0062];
said temperature sensor located on said second end, and
said circuit assembly comprising a thermal break, said break comprising a void in said circuit assembly, located between said first end and said temperature sensor.
Chen does not disclose that the temperature sensor is mounted at one end of the PCB, or the use of a thermal break or barrier between the sensor end and opposite end of the PCB. This was known in analogous prior art, however, and for example:
Takeuchi discloses a temperature sensor for use with an internal combustion engine comprising a signal processing circuit (17) on a ceramic substrate (17a) with an IC-chip (18) and connected to a sensor element (16) through a probe housing portion (12) wherein: “Only the conductor element and the sensor element are disposed in the inner space which becomes at a high temperature, while the signal-processing circuit including the IC-chip, which has a relatively low heat-resistivity is disposed inside the housing which is kept at a relatively low temperature. Therefore, the components of the temperature sensor are well protected from the high temperature without providing a complex heat-insulating structure.” The processing circuit is thus protected from excessive heat by providing space (broadly a void) between the sensor and circuit [Fig. 1-3; Para. 0022-0026].
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing for the invention, to provide a temperature sensor on one end of a circuit assembly and to mount circuit elements on opposing end of the assembly, with a space (void) between them, as taught by Scaboo, and applied to a multi-sensor composite ventricular electrode device comprising a temperature sensor as taught by Chen, in order to protect IC-chips from high temperatures generated or applied at the other end of the device.
Consider claim 5 and as applied to claim 4: The temperature monitoring device of Claim 4, wherein said body is comprised of silicone. Chen discloses a silicone catheter (2) which is the main body of the electrode [Fig. 1; Para. 0049-0051];
Consider claim 6 and as applied to claim 5: The temperature monitoring device of Claim 5, wherein said body comprises a bidirectional flange, said bidirectional flange is comprised of silicone. Chen discloses a positioning anchor (bidirectional flange) and made of silicone [Fig. 1; Para, 0007, 0049-0050];
Consider claim 8 and as applied to claim 4: The temperature monitoring device of Claim 4, wherein said circuit assembly further comprises a light. Chen discloses that the device comprises red and infrared LEDs [Fig. 1-2; Para. 0052].
Consider claim 15 and as applied to claim 5: The temperature monitoring device of Claim 5, wherein the silicone of said body traversed said thermal break. Chen discloses that the catheter body (2) may be made of silicone [Fig. 1; Para. 0007-0009, 0049-0052]. The space (void) between the circuit board and sensor element, would thus be silicone.
Claim 7 is rejected under 35 USC §103 as unpatentable over Chen et al. (United States Patent Application Publication # US 2021/0016095 A1), hereinafter Chen, and Takeuchi (United States Patent Application Publication # US 2009/0080492 A1), in view of Scaboo et al. (United States Patent Application Publication # US 2021/0096098 A1), hereinafter Scaboo.
Consider claim 7 and as applied to claim 4: The temperature monitoring device of Claim 4, wherein said circuit assembly further comprises memory storage, said memory storage configured to store a calibration factor associated with said sensor.
Neither Chen nor Takeuchi specifically discloses storage of calibration factors in memory, but this is known in analogous prior art, and for example:
Scaboo discloses a wireless sensor, comprising a temperature sensor, comprising a circuit board (2101) (PCB) on which as temperature sensing element (2103) is placed on one end, and a thermal barrier (3702) on the second end [Title, Abstract, Fig. 37A-37D; Para. 0002, 0005, 0016,0274], and particularly that the wireless sensing device comprises a memory, and that temperature calibration values may be stored in the memory [Para. 0197-0199].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing for the invention, to provide a memory in the processing circuit, containing temperature calibration values , as taught by Scaboo, and applied to a multi-sensor composite ventricular electrode device comprising a temperature sensor as taught by Chen as modified by Takeuchi, in order to improve accuracy to the sensed measurements over the design range.
Claim 9 is rejected under 35 USC §103 as unpatentable over Chen et al. (United States Patent Application Publication # US 2021/0016095 A1), hereinafter Chen, and Takeuchi (United States Patent Application Publication # US 2009/0080492 A1), and further Sattler et al. (United States Patent # US 7,883,463 B2), hereinafter Sattler.
Consider claim 9 and as applied to claim 4: The temperature monitoring device of Claim 4, wherein said circuit assembly is largely encased in a volume of solid silicone.
Chen discloses that the catheter (body) and anchor (bidirectional flange) are made of silicone, but does not disclose that the circuit assembly is encased in solid silicone. These is known in analogous prior art, and for example:
Sattler discloses a combination sensor for physiological parameters, intended to be worn behind the ear of a person, and comprising temperature monitoring sensors [Title; Abstract; Fig. 1-3; Col. 1, 12-13, 47-67] and specifically that the sensor carrier (11) may be embedded in a pliable plastic material (body), preferably in silicone, and which is adapted to the shape of a human ear [Fig, 3; Col. 2, 6-8], and where the pliable silicone body forms a flange-like projection to engage the ear [Fig. 3].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing for the invention to embed temperature monitoring elements within a pliable silicone carrier, and where an extension of the flexible body acts to anchor the device to a user’s ear, as taught by Sattler, and applied to a multi-sensor composite ventricular electrode device comprising a temperature sensor as taught by Chen, as modified by Takeuchi, where the pliable silicone material is durable, biocompatible, and resilient.
Claims 10-12 are rejected under 35 USC §103 as unpatentable over Chen et al. (United States Patent Application Publication # US 2021/0016095 A1), hereinafter Chen, and Takeuchi (United States Patent Application Publication # US 2009/0080492 A1), and further in view of Booth (United Kingdom Patent Application Publication # GB 2523576 A).
Consider claim 10 and as applied to claim 4: The temperature monitoring device of Claim 4, wherein said body has the general shape of a triangular prism with a front face and a rear face.
Chen and Takeuchi both teach a device with an elongate body with a circular cross-section. Other shapes are known in analogous prior art, however, and for example:
Booth discloses a thermometer (temperature monitoring device) comprising a base (10) which may be formed from an elongate extrusion of a resilient plastic material, the base having first and second end (face) and a wider front side which tapers to the rear, and with clip (flange) portions on the rear, thus with a general triangular prism shape when the clip portions are not expanded outward [Title; Abstract; Fig. 1; Page 1, 6-8; Page 3, 20 to Page 4, 14].
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of effective filing for the invention for a thermometer base to have a generally triangular prism shape, in elongate form, with first and second ends, a wider front side, and a narrower rear side with gripping projections as taught by Booth, and applied to a thermometer and support as taught by Chen, as modified by Takeuchi, allowing the thermometer to be removably attached to objects such as a shelf edge.
Consider claim 11 and as applied to claim 4: The temperature monitoring device of Claim 4, wherein said body has the general shape of a triangular prism with a front face and a rear face, and a bidirectional flange extends from said front face to said rear face. This claim is rejected based on the same citations and analysis as for claim 10 previously.
Consider claim 12 and as applied to claim 11: The temperature monitoring device of Claim 11, wherein said body and said bidirectional flange are comprised of solid silicone. Chen discloses a silicone catheter (2) (body,) and a positioning anchor (bidirectional flange) also made of silicone [Fig. 1; Para. 0049-0051].
Allowable Subject Matter
Claims 13 and 14 are allowed:
Response to Arguments
Applicant’s arguments filed on 25 June-2026 have been carefully and fully considered by the Examiner, and responses are provided as follow:
Consider Applicant remarks with respect to allowable subject matter [Remarks; Page 5]: A terminal disclaimer with respect to US patent # US 12,152,833 B2 (Parent), having been filed and accepted, claims 13 and 14 are allowed
Consider Applicant remarks with respect to new claim 15 [Remarks; Page 6]: Applicant remarks have considered, but are moot; this claim has not been previously examined. The claim is now rejected under 35 USC §103 as unpatentable over Chen (US 2021/0016095 A1) and Takeuchi (2009/0080492 A1), based on citations and analysis presented in this Office action.
Consider Applicant remarks with respect to rejection of Claim 6 under 35 USC §112(b) as indefinite [Remarks; Page 6]: Amendment of this claim obviates this rejection, and the rejection has been withdrawn.
Consider Applicant remarks with respect to rejection of Claims 1-14 for non-statutory double patenting with respect to Dutro (US 12,152,833 B2/Parent) [Remarks; Page 6]: The filing, and acceptance of, a terminal disclaimer obviates this rejection, and the rejection has been withdrawn.
Consider Applicant remarks with respect to rejection of Claims 1 and 3 under 35 USC §103 over Chen (US 2021/0016095 A1) and Sattler (US 7,883,463 B2) [Remarks; Page 6-7]:
Regarding independent claim 1: Applicant remarks have been considered, but are rendered moot by a new rejection of the claim under 35 USC §103 over Chen, Brown (US 2,012,741) and Sattler, wherein the amended claims are taught by brown.
Regarding claim 3: No separate or additional arguments are made with respect to this claim, and allowability asserted based on the alleged allowability of base claim 1. This claim is now rejected under 35 USC §103 over Chen, Brown and Sattler, based on the new rejection of the base claim, and on the particular citations and analysis presented in this Office action.
Consider Applicant remarks with respect to rejection of Claim 2 under 35 USC §103 over Chen, Sattler and Hartmann (US 2021/0207982 A1) [Remarks; Page 7]: No separate or additional arguments are made with respect to this claim, and allowability asserted based on the alleged allowability of base claim 1. This claim is now rejected under 35 USC §103 over Chen, Brown, Sattler and Hartmann, based on the new rejection of the base claim, and on the particular citations and analysis presented in this Office action.
Consider Applicant remarks with respect to rejection of Claims 4-8 under 35 USC §103 over Chen and Scaboo (US 2021/0096098 A1) [Remarks; Page 7]:
Regarding independent claim 4: Applicant remarks have been considered, but are rendered moot by a new rejection of the claim under 35 USC §103 over Chen and Takeuchi (US 2009/0080492 A1), wherein the amended claims are suggested by the anchor element of Chen and further taught by Takeuchi based on the citations and analysis presented in this Office action
Regarding claims 5, 6 and 8: No separate or additional arguments are made with respect to these claims, and allowability asserted based on the alleged allowability of base claim 4. These claims are now also rejected under 35 USC §103 over Chen and Takeuchi, based on the new rejection of the base claim, and on the particular citations and analysis presented in this Office action.
Regarding claim 7: No separate or additional arguments are made with respect to this claim, and allowability asserted based on the alleged allowability of base claim 4. This claim is now rejected under 35 USC §103 over Chen, Takeuchi and Scaboo, based on the new rejection of the base claim, and on the particular citations and analysis presented in this Office action.
Consider Applicant remarks with respect to rejection of Claim 9 under 35 USC §103 over Chen, Scaboo and Sattler [Remarks; Page 7]: No separate or additional arguments are made with respect to this claim, and allowability asserted based on the alleged allowability of base claim 4. This claim is now rejected under 35 USC §103 over Chen, Takeuchi and Sattler, based on the new rejection of the base claim, and on the particular citations and analysis presented in this Office action.
Consider Applicant remarks with respect to rejection of Claims 10-12 under 35 USC §103 over Chen, Scaboo and Booth (GB 2523576 A) [Remarks; Page 7]: No separate or additional arguments are made with respect to these claims, and allowability asserted based on the alleged allowability of base claim 4. These claims are now also rejected under 35 USC §103 over Chen, Takeuchi and Booth, based on the new rejection of the base claim, and on the particular citations and analysis presented in this Office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Shindo et al. (U.S. Patent # US 6,048,095 A) disclosing an external connection mechanism of temperature-measuring type for printed circuit board.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to STEPHEN R BURGDORF whose telephone number is (571)270-7328. The Examiner can normally be reached on Monday and Friday at 11:00 AM to 8:00 PM EST/EDT.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Quan-Zhen Wang can be reached at (571)272-3114. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/STEPHEN R BURGDORF/ Examiner, Art Unit 2685
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