DETAILED ACTION
America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for domestic priority under 35 USC §120 is acknowledged:
This application, filed 25-November-2024, is a continuation of application 17/827,066, filed 27-May-2022, and subsequently issued as US 12,152,833 B2.
This application will, therefore, be accorded a prima facie effective filing date of 17-May-2022.
Information Disclosure Statement
The information disclosure statement ID#1 submitted on 4-March-2025 (13 references) has been considered by the Examiner and made of record in the application file.
Claim Rejections - 35 USC §112
The following is a quotation of 35 USC §112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 is rejected under 35 USC §112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 6 recites “…said bidirectional flange…” [line1-2] where there is no precedent for a bidirectional flange in the claim or in base claim 4.
Double Patenting
Claims 1-14 are rejected for non-statutory double patenting:
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Current Application
US 12,152,833 B2 (Parent)
Claim 1: A temperature monitoring device, said device comprising:
a body, said body comprised of solid silicone;
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; and
a flexible bidirectional flange, said bidirectional flange integrally connected to said body.
Claim 1: A temperature monitoring device, said temperature monitoring device comprising:
a body, said body having a top end defined by a first width;
a bidirectional flange connected to said top end of said body, said bidirectional flange defined by a second width;
a circuit assembly located within said body, said circuit assembly comprising a first end and a second end, and said circuit assembly comprising temperature sensor configured to provide temperature data, said temperature sensor located on said second end, and said circuit assembly comprising a thermal break located between said first end and said temperature sensor; and
wherein said bidirectional flange is flexible, and said first width is narrower than said second width.
Claim 2: 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.
Claim 2: The temperature monitoring device of claim 1, wherein said body is comprised of silicone.
Claim 3: The temperature monitoring device of Claim 1, wherein said bidirectional flange is comprised of silicone.
Claim 3: The temperature monitoring device of claim 2, wherein said bidirectional flange is comprised of silicone.
Claim 4: A temperature monitoring device, said temperature monitoring device comprising:
a body, and
a circuit assembly located within said body,
said circuit assembly comprising a first end and a second end, and
said circuit assembly comprising temperature sensor configured to provide temperature data,
said temperature sensor located on said second end, and
said circuit assembly comprising a thermal break located between said first end and said temperature sensor.
Claim 4: The temperature monitoring device of claim 3, wherein said body and said bidirectional flange are formed from one volume of solid silicone.
Claim 5: The temperature monitoring device of Claim 4, wherein said body is comprised of silicone.
Claim 5: The temperature monitoring device of claim 1, wherein said circuit assembly further comprises memory storage, said memory storage configured to store a calibration factor associated with said sensor.
Claim 6: The temperature monitoring device of Claim 5, wherein said bidirectional flange is comprised of silicone.
Claim 6: The temperature monitoring device of claim 1, wherein said circuit assembly further comprises a light.
Claim 7: 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.
Claim 7: The temperature monitoring device of claim 1, wherein said circuit assembly is largely encased in a volume of solid silicone.
Claim 8: The temperature monitoring device of Claim 4, wherein said circuit assembly further comprises a light.
Claim 8: The temperature monitoring device of claim 1, wherein said body has the general shape of a triangular prism with a front face and a rear face, and said bidirectional flange extends from said front face to said rear face.
Claim 9: The temperature monitoring device of Claim 4, wherein said circuit assembly is largely encased in a volume of solid silicone.
Claim 9: The temperature monitoring device of claim 1, wherein said body has the general shape of a triangular prism with a front face and a rear face, and said bidirectional flange extends from said front face to said rear face.
Claim 10: 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.
Claim 10: The temperature monitoring device of claim 9, wherein said body and said bidirectional flange are comprised of solid silicone.
Claim 11: 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.
Claim 12: The temperature monitoring device of Claim 11, wherein said body and said bidirectional flange are comprised of solid silicone.
Claim 13: A temperature monitoring device comprising:
a solid silicone volume, said silicone volume comprising:
a body, said body having a generally triangular prism shape, said body having a front face, a rear face, a bottom side, a right side, and a left side, a first vertex between said bottom side and said right side, a second vertex between said bottom side and said left side, and a transected vertex between said right side and said left side;
a bidirectional flange, said bidirectional flange extending from said front face to said rear face along said transected vertex, said bidirectional flange comprising two underhangs; and
a circuit assembly located within said body, said circuit assembly comprising a temperature sensor.
Claim 11: A temperature monitoring device comprising:
a solid silicone volume, said silicone volume comprising:
a body, said body having a generally triangular prism shape, said body having a front face, a rear face, a bottom side, a right side, and a left side, a first vertex between said bottom side and said right side, a second vertex between said bottom side and said left side, and a transected vertex between said right side and said left side;
a bidirectional flange, said bidirectional flange extending from said front face to said rear face along said transected vertex, said bidirectional flange comprising two underhangs;
a circuit assembly located within said body, said circuit assembly comprising a temperature sensor in direct contact with said solid silicone volume, and said temperature sensor configured to provide data related to the temperature of the solid silicone volume;
wherein said bidirectional flange is flexible and has a width greater than the width of said transected vertex.
Claim 14: The temperature monitoring device of Claim 13, wherein said circuit assembly further comprises memory storage, said memory storage configured to store calibration information unique to said temperature sensor.
Claim 12: The temperature monitoring device of claim 11, wherein said circuit assembly further comprises memory storage, said memory storage configured to store calibration information unique to said temperature sensor.
Claims 1-14 are rejected on the ground of non-statutory double patenting as unpatentable over claims 1-12 of Dutro (United States Patent # US 12,152,833 B2), hereinafter Parent.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Consider independent claim 1: Parent, claims 1, 2 and 11, recite or suggest all of the limitations of independent claim 1.
Consider claim 2 and as applied to claim 1: The additional limitations of this claim are taught by Parent claims 1 and 5.
Consider claim 3 and as applied to claim 1: The additional limitations of this claim are taught by Parent claim 3.
Consider independent claim 4: Parent, claim 1, recites or suggests all of the limitations of independent claim 4.
Consider claim 5 and as applied to claim 4: The additional limitations of this claim are taught by Parent claim 2.
Consider claim 6 and as applied to claim 5: The additional limitations of this claim are taught by Parent claim 3.
Consider claim 7 and as applied to claim 4: The additional limitations of this claim are taught by Parent claim 5.
Consider claim 8 and as applied to claim 4: The additional limitations of this claim are taught by Parent claim 6.
Consider claim 9 and as applied to claim 4: The additional limitations of this claim are taught by Parent claim 7.
Consider claim 10 and as applied to claim 4: The additional limitations of this claim are taught by Parent claims 8 and 9.
Consider claim 11 and as applied to claim 4: The additional limitations of this claim are taught by Parent claims 8 and 9.
Consider claim 12 and as applied to claim 11: The additional limitations of this claim are taught by Parent claims 9 and 10.
Consider independent claim 13: Parent, claim 11, recites or suggests all of the limitations of independent claim 1.
Consider claim 14 and as applied to claim 13: The additional limitations of this claim are taught by Parent claim 12.
Claim Rejections - 35 USC §103
The following is a quotation of 35 USC §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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 USC §102 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 USC §102(b)(2)(C) for any potential 35 USC §102(a)(2) prior art against the later invention.
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 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];
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 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, 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 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 Sattler, in order to improve the accuracy of the sensor readings.
Claims 4-8 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 Scaboo et al. (United States Patent Application Publication # US 2021/0096098 A1), hereinafter Scaboo.
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
PNG
media_image1.png
142
467
media_image1.png
Greyscale
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];
PNG
media_image2.png
173
439
media_image2.png
Greyscale
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 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:
Scaboo discloses a wireless sensor, comprising a temperature sensor, and which particularly comprises 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].
PNG
media_image3.png
159
454
media_image3.png
Greyscale
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 a heat barrier on the opposing end of the assembly, 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 the sensor 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 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 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. Scaboo discloses that the wireless sensing device comprises a memory, and that temperature calibration values may be stored in the memory [Para. 0197-0199].
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].
Claims 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 Scaboo et al. (United States Patent Application Publication # US 2021/0096098 A1), hereinafter Scaboo; 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 temperature sensor 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 Scaboo, 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 Scaboo et al. (United States Patent Application Publication # US 2021/0096098 A1), hereinafter Scaboo; 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 Scaboo 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].
PNG
media_image4.png
395
488
media_image4.png
Greyscale
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 Scaboo, 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 recite allowable subject matter as follows:
Claims 13 and 14 are rejected for non-statutory double patenting with respect to Parent, (issued patent # US 12,152,833 B2), but would be allowable should a terminal disclaimer be filed and approved, or if amended such that they are sufficiently distinguished from the Parent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Brainard (U.S. Patent # US 2,012,741 A) disclosing a combined thermometer and support.
Belke et al. (U.S. Patent Application Publication # US 2002/0148636 A1) disclosing the wireless sensing of a closed environment and devices thereof.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call (800)786-9199 (IN USA OR CANADA) or (571)272-1000.
/STEPHEN R BURGDORF/ Examiner, Art Unit 2685
Prosecution Insights