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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/12/2026 has been entered.
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 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skold – US 20080268495.
As to claim 15, first embodiment of Skold teaches a heating device 85 for testing a biological sample (fig.9 and [0079]: a device for preparing a biological sample for analysis, wherein the device includes has two retaining members 85 that are capable of conducting heat from one or more heat sources), comprising: a heat source operable to generate heat to heat a biological sample ([0079]), a transfer element 89 can be used to load and retrieve the biological sample, wherein the transfer element 89 is distinct from the heating device 85 ([0079-0080]: a transfer element 89 can be used to load and retrieve the sample); and
This embodiment of Skold further teaches the biological sample being at least partially contained within a removable enclosure 89 distinct from the heating device 85, an enclosure interface associated with the heat source, wherein the enclosure interface is configured to interface with the enclosure 89 such that heat is transferred from the heat source 85 to the enclosure 89 by conduction (fluid samples can be introduced into a container for retaining the sample during heating. The container has a shape that allows uniform heating of the fluid sample; The container can also be in one of a parallelepiped, a cylinder or other suitable shape, as shown in FIG. 3; The sample container can also be configured for easy access to the sample after heating, as the heating can in some instances change the sample from having fluid characteristics to solid characteristics ([0061]); The sample container can be formed of a material (material corresponds to “enclosure interface”) that permits effective heat transfer through the container, such as a metal ([0062, 0079-0080]); hence, the transfer element 89 also corresponds to “removable enclosure”; thus “the biological sample being at least partially contained within a removable enclosure distinct from the heating device; an enclosure interface associated with the heat source, wherein the enclosure interface is configured to interface with the enclosure such that heat is transferred from the heat source to the enclosure by conduction”).
Note that: Para. 0061 teaches fluid samples can be introduced into a container for retaining the sample during heating. The container can be any suitable shape as shown in fig.3. The container 1 (left side) of fig.3 has a shape of parallelepiped is similar to shape of transfer element 89 shown in fig.9. Hence, transfer element 89 is an enclosure containing a biological sample. Para. 0080 states a transfer element 89 can be used to load and retrieve the sample. Fig.9 shows that a transfer element or enclosure 89 is transferred/transported toward heating space between members 85. After heating, the enclosure is retrieved/removed from the heating space. Thus, the enclosure 89 also corresponds to “removable enclosure”. Thus, transfer element and removable enclosure are equivalent structures.
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Claim Rejections - 35 USC § 103
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 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 24 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Skold – US 20080268495 and further in view of Gwynn – US 20130132006.
As to claim 24, modified Skold does not explicitly teach the heat source comprises at least one of a resistance heater, an induction heater, a radiant heater, a convection heater, a thermoelectric heater, or a heat spreader.
Gwynn teaches heat sources i.e. resistance heaters, thermoelectric devices are used ([0672]).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify heat source of modified Skold with teachings of Gwynn to include the heat source comprises at least one of a resistance heater, an induction heater, a radiant heater, a convection heater, a thermoelectric heater, or a heat spreader, to provide the heat that is transferred to reaction vessel to heat sample inside the reaction vessel ([0650, 0672]).
Claims 16-19 and 25 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Skold – US 20080268495 and further in view of Hillebrand – US 20130130257.
As to claims 16-18, first embodiment of Skold does not explicitly teach a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample at less than or equal to about 2 degrees C/s.
Since another embodiment of Skold teach a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample ([0072, 0077]), it would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify device 81 of Skold to include a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample at any desired temperature rate i.e. at less than or equal to about 2 degrees C/s (as recited in claim 16); the controller is operable to control heat generation by the heat source to heat the biological sample from about 0.5-1.5 degrees C/s (as recited in claim 17); the controller is operable to control heat generation by the heat source to heat the biological sample from about 0.8-1.2 degrees C/s (as recited in claim 18), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (i.e. temperature rate of heating) involves only routine skill in the art based on particular temperature rate requirements per application. In re Aller, 105 USPQ 233 (CCPA 1955).
In any event, Hillebrand teaches a concept of: sample (situated in receptacle) is heated up at approximately 1.5-2° C./s ([0006]).
Since another embodiment of Skold teach a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample ([0072, 0077]), it would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify device 81 of Skold to include a controller in communication with the heat source and operable to control heat generation by the heat source to heat a biological sample at any desired temperature rate i.e. at less than or equal to about 2 degrees C/s (as recited in claim 16); the controller is operable to control heat generation by the heat source to heat the biological sample from about 0.5-1.5 degrees C/s (as recited in claim 17); the controller is operable to control heat generation by the heat source to heat the biological sample from about 0.8-1.2 degrees C/s (as recited in claim 18), for rapid PCR technology ([0006]).
As to claim 25, first embodiment of Skold does not explicitly teach a thermal sensor in communication with the controller, the thermal sensor being operable to sense a temperature associated with the heat source.
Skold teaches another embodiment, wherein a thermal sensor (or heat sensor 23) in communication with the controller 25, the thermal sensor 23 being operable to sense a temperature associated with the heat source 15; The heat controller 25 optionally has a timer to regulate the on time of the heating element 15, or to regulate the amount of time that heat is delivered to the sample (fig.5, [0072, 0077]).
Since device 81 of Skold includes a sensor can sense the temperature of the heating members 85 and ensure that the temperature does not become too high ([0080]), it would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify device 81 of Skold to include a thermal sensor in communication with the controller, the thermal sensor being operable to sense a temperature associated with the heat source (as recited in claim 25); a timer in communication with the controller and operable to provide time data to the controller, wherein the controller controls the heater to provide heat for a predetermined incubation time period (as recited in claim 19), to ensure that the temperature does not become too high ([0080]).
As to claim 19, claim 19 is rejected as reasons stated in the rejection of claim 25.
Claims 20-23 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Skold and Hillebrand and further in view of Catanzaro – US 20110165595.
As to claims 20 and 22-23, while the first embodiment of Skold further teach a sensor can sense the temperature of the members 85; the sensor can be an IR camera or a thermocouple or other suitable sensor ([0080]), it does not explicitly teach a thermal sensor in communication with the controller, the thermal sensor being operable to sense a temperature associated with the biological sample, wherein the controller controls heat generation by the heat source based on the temperature.
Catanzaro teaches a thermal sensor 830 in communication with controller 850, the thermal sensor 830 being operable to sense a temperature associated with biological sample (i.e. blood sample), wherein the controller 850 controls heat generation by the heat source 820 based on the temperature ([0142]).
Catanzaro further teaches the thermal sensor 830 comprises at least one of a contact sensor or a non-contact sensor; a non-contact thermopile device may be used so as to provide optical sensing of the temperature based on conversion of thermal energy to electrical energy ([0146]; note that thermopile is an electronic device that converts thermal energy into electrical energy. It is composed of several thermocouples connected usually in series or, less commonly, in parallel).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify device 81 of Skold to include a thermal sensor in communication with the controller, the thermal sensor being operable to sense a temperature associated with the biological sample, wherein the controller controls heat generation by the heat source based on the temperature (as recited in claim 20); the thermal sensor comprises at least one of a contact sensor or a non-contact sensor (as recited in claim 22); the thermal sensor comprises at least one of an optical thermal sensor, an infrared thermal sensor, a thermocouple, a thermistor, or a resistance temperature detector (RTD) (as recited in claim 23), to heat sample to the desired target temperature ([0142]).
As to claim 21, the first embodiment of Skold does not explicitly teach the temperature associated with the biological sample is a temperature of at least a portion of the enclosure.
Catanzaro teaches a thermal sensor 830 in communication with controller 850, the thermal sensor 830 being operable to sense a temperature associated with biological sample (i.e. blood sample), wherein the controller 850 controls heat generation by the heat source 820 based on the temperature ([0142]).
Since another embodiment of Skold teaches a concept of: biological samples 7 are introduced into a filler 9, which has a shape that allows for uniform heating of the sample; the filler 9 preferably has a similar dielectric constant and electrical conductivity as the biological sample in order to facilitate the uniform heating; hence, filler 9 also corresponds to “enclosure” ([0056]), it would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify device 81 of Skold to include the temperature associated with the biological sample is a temperature of at least a portion of the enclosure, because a portion of the enclosure and the biological samples has a similar dielectric constant and electrical conductivity to facilitate the uniform heating ([0056] of another embodiment of Skold).
In an alternative, claims 1 and 26 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Joris – US 20220291246 and further in view of Skold – US 20080268495.
As to claims 1 and 26, Joris teach a biological sample processing system for analyzing tissue samples using an imaging system including a microscope, wherein the biological sample processing system comprises a heating device 24 for testing a biological sample on tissue slide 34; biological sample 36 fixed on the tissue slide 34; a lid rotatably coupled to the base via a hinge/coupling 13; tissue slide holder (11) is coupled to microfluidic cartridge holder (9) via a coupling (13) allowing the microfluidic cartridge and the tissue support/slide 34 to be mounted and removed from the sample processing unit in an opened position (abstract; [0001, 0054, 0064-0065]: removable tissue/sample slide).
Joris does not explicitly teach a heat source operable to generate heat to heat a biological sample, the biological sample being at least partially contained within a removable enclosure distinct from the heating device; and an enclosure interface associated with the heat source, wherein the enclosure interface is configured to interface with the enclosure such that heat is transferred from the heat source to the enclosure by conduction.
Skold teaches a heat source 15 operable to generate heat to heat a biological sample (fig.4, [0072]), the biological sample being at least partially contained within an enclosure (or container) distinct from the heating device 15 (fig.4, [0072]); and an enclosure interface associated with the heat source 15, wherein the enclosure interface is configured to interface with the enclosure (or container) such that heat is transferred from the heat source 15 to the enclosure (or container) by conduction ([0072]: the biological sample (optionally in a container) is introduced into the chamber 13 via the opening 17, and an inner wall 19 of the chamber 13 contacts the biological sample, or a container that holds it. The chamber 13 presents a large heat transfer surface in relation to its volume and is very close to the sample. The inner wall 19 is formed of a material that is capable of conducting heat to the sample; hence, the inner wall 19 of the chamber 13 corresponds to “an enclosure interface”; the sample container can also be configured for easy access to the sample after heating, as the heating can in some instances change the sample from having fluid characteristics to solid characteristics ([0061]); the sample container can be formed of a material that permits effective heat transfer through the container, such as a metal ([0062]); thus “an enclosure interface associated with the heat source, wherein the enclosure interface is configured to interface with the enclosure such that heat is transferred from the heat source to the enclosure by conduction”).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the biological sample processing system of Joris with teachings of Skold to include a heat source operable to generate heat to heat a biological sample, the biological sample being at least partially contained within a removable enclosure distinct from the heating device; and an enclosure interface associated with the heat source, wherein the enclosure interface is configured to interface with the enclosure such that heat is transferred from the heat source to the enclosure by conduction, for preparing a biological sample for analysis, wherein the biological sample to adopt a shape to permit rapid and uniform heating (abstract, [0061, 0072]).
Claim 27 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Joris and Skold, and further in view of Salter – US 20060000296.
As to claim 27, modified Joris does not explicitly teach a sensor associated with at least one of the base or the lid, the sensor being operable to determine whether the enclosure is present.
Salter teaches a concept of a weight detecting sensor 195 mounted on surface of receptacle that is directly below container 24 to detect the weight of the resting container 24, such as piezoelectric pressure sensitive devices, as shown in FIG. 5 ([0040]). Salter also teaches container detector 96 can be a touch or pressure sensitive device mounted about the internal surfaces 73 of the receptacle 44 so that a container 24 inserted into the receptacle 44 comes in contact with the detector 96. A suitable touch sensor comprises a contact switch or electrical resistance device that generates a signal on being touched by a container 24 ([0031]).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify base of the biological sample processing system of modified Joris with teachings of Salter to include a sensor associated with at least one of the base or the lid, the sensor being operable to determine whether the enclosure is present, to detect presence of sample enclosure/container ([0031]).
Claim 28 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable by Joris and Skold, and further in view of Rigby – US 20220160581.
As to claim 28, modified Joris does not explicitly teach at least one of a key or a keyway associated with at least one of the base or the lid, the at least one of the key or the keyway being operable to facilitate proper alignment of the enclosure with the at least one of the base or the lid.
Rigby teaches a concept of: when cap 70-6 is securely closed, the arrows on each of the cap 70-6 and vial 70-1, indicated by a pair of single * asterisks, will align together ([0058] and figs.7-9).
It would thus have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify base and the sample enclosure of the biological sample processing system of modified Joris with teachings of Rigby to include at least one of a key or a keyway associated with at least one of the base or the lid, the at least one of the key or the keyway being operable to facilitate proper alignment of the enclosure with the at least one of the base or the lid, for aligning together aspect ([0058]).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRUONG D PHAN whose telephone number is (571)272-8883. The examiner can normally be reached Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John Breene can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRUONG D PHAN/ Examiner, Art Unit 2855
/JOHN E BREENE/Supervisory Patent Examiner, Art Unit 2855
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