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 .
Election/Restrictions
Claims 13-18 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/23/2026.
Applicant’s election without traverse of Group I in the reply filed on 04/23/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 3, states “arranged to be placed in communication with”. It is unclear if the gas sensor is in communication with the vessel or can be placed in communication with the vessel. In other words, it is unclear if this is a required limitation of the claim. For examination purposes, it is interpreted as the gas sensor is in communication with the vessel. Further clarification and correction is required.
Claim 1, lines 2-3, states “for generating at least one of an electrical response signal or an optical response signal indicating an attribute associated with a particular biological specimen”. It is unclear whether the gas sensor or the biological specimen vessel is generating at least one of an electrical response signal or an optical response signal indicating an attribute associated with a particular biological specimen. For examination purposes, it is interpreted as the gas sensor generates an electrical or optical signal. Further clarification and correction is required.
Claim 1, lines 9-10, states “processing circuitry configured to place the at least one gas sensor and the individual vessel in communication with each other”. It is unclear how circuitry is placing a gas sensor (electrical device) in communication with an individual vessel (non-electrical device). For examination purposes, it is interpreted as the circuitry is going from the gas sensor to a processor.
Claims 2-12 are further rejected as they depend from Claim 1.
Claim 5, line 3, recites “an individual biological specimen vessel”. It is unclear if this is the same vessel as the “individual vessel of the at least one biological specimen vessel” or a different vessel entirely. Further clarification and correction is required. For examination purposes, it is interpreted as the individual vessel of claim 1.
Claims 6-8 are further rejected as they depend form Claim 5.
Claim 6, line 1, states “a vessel transporter”. It is unclear if this is the same vessel transporter as recited in Claim 5 or a different vessel transporter. Further clarification and correction is required. For examination purposes, it is interpreted as the vessel transporter from Claim 5.
Claim 6, lines 2-3, recite “at least one vessel in a series of vessels”. It is unclear if this is the same vessel as the “individual vessel of the at least one biological specimen vessel” or a different vessel entirely. Further clarification and correction is required. For examination purposes, it is interpreted as the individual vessel of claim 1.
Claim 7, line 1, states “a gas sensor transporter”. It is unclear if this is the same gas sensor transporter as recited in Claim 5 or a different gas sensor transporter. Further clarification and correction is required. For examination purposes, it is interpreted as the gas sensor transporter from Claim 5.
Claim 8, line 3, recites “an individual biological specimen vessel”. It is unclear if this is the same vessel as the “individual vessel of the at least one biological specimen vessel” or a different vessel entirely. Further clarification and correction is required. For examination purposes, it is interpreted as the individual vessel of claim 1.
Claim Rejections - 35 USC § 102
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.
Claims 1, 10, 12, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawasaki et al. (WO2018212029A1).
Regarding Claim 1, Kawasaki teaches the following:
An incubator with gas concentration sensors (para 3)(an incubation system for gas detection of at least one incubated biological specimen)
The culture chamber 20 is equipped with various sensors including a carbon dioxide sensor and nitrogen sensor (para 33)(at least one gas sensor in communication with at least one biological specimen vessel). Regarding the gas sensor generating at least one of an electrical response signal or an optical response signal indicating an attribute associated with a particular biological specimen, the purpose of a sensor is to generate a signal indicating a particular condition, therefore the sensor of Kawasaki meets this limitation.
The front space of the culture chamber is divided by four shelves, and twelve petri dishes filled with culture medium for culturing cells are placed on each shelf (para 35)(a temperature-controlled chamber, including within the chamber at least one shelf defining a plurality of receptacles, an individual receptacle sized and shaped for receiving an individual vessel of the at least one biological specimen vessel)
A microcomputer is linked to various sensors (para 60)(processing circuitry configured to place the at least one gas sensor and a processor in communication with each other)
Twelve petri dishes (individual vessels) filled with culture medium for culturing cells are placed on each shelf (para 35)(the individual vessel configured for carrying the particular biological specimen)
Determining, based on the attribute indicated by the at least one of an electrical response signal or an optical response signal, at least one of a presence of, or a chemical characteristic of, at least one target gas composition associated with the particular biological specimen are directed to the function of the apparatus and/or the manner of operating the apparatus and all of the structural limitations have been disclosed. The device of Kawasaki is capable of determining the presence of a target gas composition associated with a particular specimen as the sensor would be able to produce an electric or optical response signal based on the gas composition and as the sensor is linked to the microprocessor, would be able to determine the presence of said target gas composition absent clear evidence otherwise. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kawasaki (see MPEP §2114).
A microcomputer is linked to various sensors (para 60)(transceiver circuitry for transmitting the at least one of an electrical response signal or an optical response signal or the determined presence or chemical characteristic to a location outside the chamber).
Regarding Claim 10, Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki further teaches temperature control device 40 (thermostat) for adjusting the temperature of the air inside the culture chamber 20 (which regulates the temperature of the fluid within the chamber).
Regarding Claim 12, Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki further teaches a microcomputer is linked to various sensors (para 60)(wired connection for providing a wired communication between the gas sensor and a remote receiver).
Regarding Claim 19, Kawasaki teaches the following:
An incubator with gas concentration sensors (para 3)(a biological specimen incubator)
The front space of the culture chamber is divided by four shelves, and twelve petri dishes filled with culture medium for culturing cells are placed on each shelf (para 35)(a incubator chamber, including within the chamber a plurality of shelves, an individual shelf defining a respective plurality of receptacles for receiving biological specimen vessels)
The culture chamber 20 is equipped with various sensors including a carbon dioxide sensor and nitrogen sensor (para 33)(a gas sensor locatable in communication with an individual one of the biological specimen vessels for obtaining a measurement of a concentration of a specified gas component or composition associated with biological specimen in the individual one of the specimen vessels). The measurement based on an electro-chemical detection characteristic or an electro-optical detection characteristic measured by the gas sensor within the chamber is how the gas sensor would operate and therefore meets the claim.
A microcomputer is linked to various sensors (para 60)(providing a reading of the measurement at a location outside of the incubator)
Regarding Claim 20, Kawasaki teaches all of the limitations of Claim 19 (see above). Moving the gas sensor from a first biological specimen vessel within a receptacle of a first shelf towards a second biological specimen vessel within a receptacle of a second shelf is directed to the function of the apparatus and/or the manner of operating the apparatus and all of the structural limitations have been disclosed. The device of Kawasaki is capable of having the gas sensor moved. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kawasaki (see MPEP §2114).
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al. (WO2018212029A1) in view of Buller et al. (EP3404420A1).
Regarding Claim 2, Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki further teaches carbon dioxide concentration sensor are located in the culture chamber (page 48)(the at least one gas sensor is enclosed by the chamber).
Kawasaki does not explicitly teach the at least one gas sensor to be carried with the at least one shelf.
Buller teaches a laboratory incubator 1, here a CO2 incubator, which is a microprocessor
controlled instrument designed for cell culture (para 117). Buller further teaches shelf 52 containing the gas sensors 54 (para 131)(the at least one gas sensor is carried with the at least one shelf).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawasaki and locate the at least one gas sensor on the shelf. One would have been motivated to make this modification as the gas sensors 54 may contain a digitizer to generate measurement data from the measured signals (para 131) and the sensors being located on the shelf would allow a more accurate reading of the gas directly next to the cell culture.
Regarding Claim 3, Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki does not teach the at least one gas sensor to include a plurality of gas sensors.
Buller teaches shelf 52 containing the gas sensors 54 (para 131). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawasaki to have a plurality of gas sensors as taught by Buller. One would have been motivated to make this modification as the gas sensors 54 may contain a digitizer to generate measurement data from the measured signals (para 131) and having a plurality of sensors would allow a more accurate reading of the gas concentrations.
Regarding the gas sensors locatable in communication with a respective receptacle of the plurality of receptacles, the sensor are inserted into the incubator and therefore would be locatable to be in communication with a respective receptacle.
Regarding Claim 4, Kawasaki in view of Buller teach all of the limitations of Claim 3 (see above). Buller further teaches the shelf contains the gas sensors and a (second) control apparatus 4", as well as a communication apparatus 5 and the temperature sensors 53 and the gas sensors 54 may contain a digitizer to generate measurement data from the measured signals (para 131)(electrical circuity in wired or wireless communication with the gas sensor in communication with the individual receptacle).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al. (WO2018212029A1) in view of Bhimani et al. (EP1624303A2).
Regarding Claim 5, Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki does not teach a vessel transporter or a gas sensor transporter communicatively coupled with the processing circuitry to move at least one of the at least one gas sensor or an individual biological specimen vessel to be in communication with each other.
Bhimani teaches an in vitro diagnostic system for reading information using a control system (Abstract). Bhimani further teaches the diagnostic system comprises a rotary table 30 (vessel transporter) having in an upper surface a circular array of openings 32 for receiving vials 34 (individual biological specimen vessel) containing fluid, such as blood plasma, that is to be diagnostically tested and control circuitry that may comprise a microprocessor or CPU (not shown) is situated in a housing 38 and is programmed to control operation of the diagnostic system and to perform diagnostic testing on the fluids in the vials 34. (para 35)(a vessel transporter communicatively coupled with the processing circuitry to move at least one of the at least one gas sensor or an individual biological specimen vessel to be in communication with each other).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawasaki with the rotary table as taught by Bhimani. One would have been motivated to make this modification as it would allow the sensor means to examine the vials and the control circuitry to use the data provided by the sensor means to output the results of the test (para 35).
Regarding Claim 6, Kawasaki in view of Bhimani teaches all of the limitations of Claim 5 (see above). Bhimani further teaches the rotary table 30 (vessel transporter including a carousel for moving the individual vessels along a carousel route) having in an upper surface a circular array of openings 32 for receiving vials 34 (individual biological specimen vessel)(para 35) and as the rotary table rotates, the vials are brought within communication with the sensor means.
Regarding Claim 7, Kawasaki in view of Bhimani teaches all of the limitations of Claim 5 (see above). Bhimani further teaches a second carousel 40 (gas sensor transporter) which includes readers 42 (sensors) that communicate data to the control circuitry and rotates around to be in communication with the vials 34 (para 35)(gas sensor transporter configured to move the at least one gas sensor towards an individual receptacle of the plurality of receptacles.
Regarding Claim 8, Kawasaki in view of Bhimani teaches all of the limitations of Claim 5 (see above). Bhimani further teaches control circuitry that may comprise a microprocessor or CPU (not shown) is situated in a housing 38 and is programmed to control operation of the diagnostic system and to perform diagnostic testing on the fluids in the vials 34 and the system includes sensor means 44 that examines the test fluid in a vial 34 after reagent has been added to the vial, and the control circuitry then uses data provided by the sensor means to output the results of the diagnostic test that has been performed. Given the combination of Kawasaki’s incubator device and gas sensor with the rotary table and circuitry of Bhimani, the device would identify the individual biological specimen vessel, place the identified biological specimen vessel in communication with the gas sensor, and obtain a measurement of a concentration of a specified gas component.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al. (WO2018212029A1) in view of Hawrylenko et al. (US11253827B2).
Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki does not teach an agitator coupled to the shelf for moving the shelf for agitating the biological specimen vessels.
Hawrylenko teaches a laboratory shaker for shaking or mixing samples containing fluids (col 1, lines 13-15). Hawrylenko further teaches the shaker to be placed or fixed on a work surface or installed in another device, e.g. an incubator for cell cultures or microbial applications and typically, the samples are liquids, e.g. cell cultures, biofuels or blood samples, and are contained in vessels (col 1, lines 42-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the shaker as taught by Hawrylenko to the incubator as taught by Kawasaki. One would have been motivated to make this addition as Hawrylenko teaches the shaker to be place in other devices such as an incubator for the mixing of cell cultures (col 1, lines 42-50).
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki et al. (WO2018212029A1) in view of Afshar et al. (US20210238532A1).
Kawasaki teaches all of the limitations of Claim 1 (see above). Kawasaki does not explicitly teach the transceiver circuitry to include a wireless transmitter for providing wireless communication between the gas sensor and a remote receiver.
Afshar teaches a system for automated cell culturing (Abstract). Afshar further teaches a radio (wireless transmitter) configured to electronically communicate with a computing device (remote receiver) and the radio is configured to send to the computing device a wireless signal associated with a measurement (providing wireless communication between a sensor and a remote receiver)(para 99).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kawasaki with the wireless radio as taught by Afshar. One would have been motivated to make this modification as Afshar teaches it as a suitable wat to relay information of a cell culture while in an incubator and it would have been an effective way of relay signals.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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