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
Applicant’s election without traverse of claims 1-16 and 24 in the reply filed on 04/03/2026 is acknowledged.
Claims 17-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 03/13/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2024 is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“temperature regulating device” in claim 1, line 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes claim limitations that uses the word "means". Such claim limitations are:
“sensor means configured to be able to detect the unique identifier present on the reagent tray when the reagent tray is installed into the reagent cartridge” in claim 7, lines 2-4.
In this instant case, the corresponding structure for
the “temperature regulating device” is a thermoelectric heater/cooler (para. 0008) and equivalents thereof.
the “sensor means configured to be able to detect the unique identifier present on the reagent tray” is a barcode scanner or a RFID detector (para. 0124) and equivalents thereof.
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 10-14 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 10 recites the limitation " wherein the reagent cartridge or the reagent tray comprises " in line 1. There is insufficient antecedent basis for “the reagent tray” in the claim. Claim 1 does not comprise a reagent tray.
Claims 11-14 are indefinite because of their dependence on claim 10.
The examiner notes that claims 13 and 14 also recites “the reagent tray”.
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 1-5, 8, 10-11, 13 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onuki (WO 2022049722).
Regarding claim 1, Onuki teaches a reagent handling system configured to maintain reagents within a desired temperature range, the reagent handling system comprising a temperature regulating device (cooling unit 500 and insulated box 101)(Fig. 4 and para. 0017 cooling unit 500 comprises of a thermoelectric element 501, a cooling heat sink 502, a cooling fan 503, a heat dissipation heat sink 504, and a heat dissipation fan 505) and a reagent cartridge (reagents containers 301 and reagent container holders 302 and drawer door 103 and installation part 102)(Figs. 2 and 4) configured to hold a plurality of reagents and configured to be attached to the temperature regulating device (Fig. 4), wherein a temperature-controlled volume (the bottom volume of the insulated box 101 that is beneath the horizontal plane where 302 sits when the drawer is closed as shown in Fig. 4)(see annotated Fig. A) is formed upon attachment of the reagent cartridge to the temperature regulating device (Fig. 4, the drawer door is attached to the insulating box as shown in Fig. 4), and an interior surface of the reagent cartridge (interior wall of 103) and a surface of the temperature regulating device (the bottom wall of 101) form boundaries of the temperature-controlled volume contained within the reagent handling system; and wherein the temperature regulating device is configured to cool or heat a gaseous fluid that is at least partially confined within the temperature-controlled volume (Fig. 4 and para. 0017), and further configured to maintain the gaseous fluid confined in the temperature-controlled volume within the desired temperature range (para. 0017).
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Figure A. Annotated Fig. 4 of Onuki.
Regarding claim 2, Onuki teaches all of the elements of the current invention as stated above with respect to claim 1. Onuki further wherein the reagent cartridge comprises: (i) a reagent tray (the holder 302 with container 301 on the left as shown in Fig. 3) configured to hold a plurality of reagents (interpreted as a functional limitation, containers 301 is capable of holding reagents); and (ii) a carrier (drawer door 103 and the installation part 102), wherein the reagent tray and the carrier form the temperature-controlled volume that confine the gaseous fluid (Fig. 4).
Regarding claim 3, Onuki teaches all of the elements of the current invention as stated above with respect to claim 2. Onuki further teaches wherein the reagent tray is one of a plurality of alternative reagent trays configured to be attached to the carrier to form the temperature-controlled volume (Fig. 3 and Fig. 4, two holders 302 are removably placed/attached to the 102. Further other reagent trays/holder can be placed on 102).
Regarding claim 4, Onuki teaches all of the elements of the current invention as stated above with respect to claim 3. With regards to the limitation “at least two reagent trays of the plurality of alternative reagent trays have different arrangements of reagent receptacles,” only one of the reagent tray is positively recited. Since this limitation requires more than one reagent trays, and thus does not apply. Furthermore, Onuki does teach two reagent holders 302 (Fig. 2 and 4) that are removably placed/attached to the 102, and a holder of the same dimension as holder 302 but with reagent receptable arrangement can be attached to 102).
Regarding claim 5, Onuki teaches all of the elements of the current invention as stated above with respect to claim 1. Onuki further wherein the temperature regulating device comprises a fan (503) configured to circulate the gaseous fluid within the temperature-controlled volume (Fig. 4 and para. 0017).
Regarding claim 8, Onuki teaches all of the elements of the current invention as stated above with respect to claim 1. Onuki further wherein an upper surface of the reagent cartridge (reagent containers 301 and reagent container holders 302 and drawer door 103 and installation part 102) has a plurality of protrusions (the protrusions form by the containers 301 extending from holders 302) extended downwardly into the temperature-controlled volume and configured to accommodate a plurality of vials or reagents (interpreted as a functional limitation. Containers 301 is structurally capable of accommodating a plurality of vials or reagents).
Regarding claim 10, Onuki teaches all of the elements of the current invention as stated above with respect to claim 1. Onuki further teaches wherein the reagent cartridge
Regarding claim 11, Onuki teaches all of the elements of the current invention as stated above with respect to claim 10. Onuki further teaches wherein each reagent receptacle of the plurality of reagent receptacles (containers 301) extends vertically downwardly into the temperature-controlled volume with an outer surface of the closed end located within the temperature-controlled volume (see annotated Fig. A), thereby allowing for temperature control of a reagent within the reagent receptacle (interpreted as an intended use. The reagent is not positively recited. Moreover, abstract, the Onuki’s invention is for cold storage of reagents).
Regarding claim 13, Onuki teaches all of the elements of the current invention as stated above with respect to claim 10. Onuki further teaches wherein the closed end of any one of the reagent receptacles of the reagent cartridge
Regarding claim 15, Onuki teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation “wherein at least one reagent maintained within the desired temperature range in the system comprises a polypeptide or a protein,” the “at least one reagent is not positively recited. For this reason this limitation does not further limit the structure of the invention.
Regarding claim 16, Onuki teaches all of the elements of the current invention as stated above with respect to claim 1. Onuki further teaches wherein the desired temperature range is different from a temperature outside the reagent cartridge by at least 5 0C (para. 0017).
Claims 1, 6, 10 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Handique et al. (US 20200354715).
Regarding claim 1, Handique teaches a reagent handling system configured to maintain reagents within a desired temperature range, the reagent handling system comprising a temperature regulating device (heating and cooling 150 and the second thermal body 157’) and a reagent cartridge (reagent cartridge 120’ with tubes in the third domain, para. 0056) configured to hold a plurality of reagents and configured to be attached to the temperature regulating device (para. 0105 and Figs 2B, 2C and 3A), wherein a temperature-controlled volume (recesses of second thermal body 157’ and the volume third domain) is formed upon attachment of the reagent cartridge to the temperature regulating device, and an interior surface of the reagent cartridge (the interior surface of third domain) and a surface of the temperature regulating device (the surface of the recesses of second thermal body 157’) form boundaries of the temperature-controlled volume contained within the reagent handling system; and wherein the temperature regulating device is configured to cool or heat a gaseous fluid that is at least partially confined within the temperature-controlled volume, and further configured to maintain the gaseous fluid confined in the temperature-controlled volume within the desired temperature range (Fig. 2B, 2C and 3A and para. 0105, heating and cooling 150 regulate temperature of the air in the recess of thermal body and the recess of third domain 123’).
Regarding claim 6, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. wherein the reagent cartridge (120’ with tubes in the third domain 123’) is configured to hold some of the reagents within the temperature-controlled volume and some of the reagents outside of the temperature-controlled volume (Figs. 2B, 2C and 2D).
Regarding claim 10, Handique teaches all of the elements of the current invention as stated above with respect to claim 1.
Handique further teaches wherein the reagent cartridge
Regarding claim 15, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to the limitation “wherein at least one reagent maintained within the desired temperature range in the system comprises a polypeptide or a protein,” the “at least one reagent is not positively recited. For this reason this limitation does not further limit the structure of the invention. For the purpose of compact prosecution, PCR reagents are stored in in the temperature controlled-volume (para. 0154), and PCR reagent includes DNA polymerase.
Regarding claim 16, Handique teaches all of the elements of the current invention as stated above with respect to claim 1. Handique further teaches wherein the desired temperature range is different from a temperature outside the reagent cartridge by at least 5 0C (para. 0054).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Onuki et al. (WO 2022049722).
Regarding claim 12, Onuki teaches all of the elements of the current invention as stated above with respect to claim 11. Onuki further teaches wherein there is a space filled with the gaseous fluid between the closed end of any one of the reagent receptacles (301) and the surface (the bottom wall of 101, see claim 1) of the temperature regulating device.
Onuki does not explicitly teach the space is 1 millimeter or more.
However, Onuki teaches wherein the space between the closed end of any one of the reagent receptables and the surface is a result-effective variable. Specifically, Onuki teaches a space between the bottom of the reagent container 301 and the inner lower surface of the insulated box 101 is determined based on ensuring a passage for cold air (para. 0018). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to set the space to 1 millimeter or more because it would have been within the ambit of one of ordinary skill in the art to arrive at through routine experimentation.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Onuki et al. (WO 2022049722) in view of Kaneko et al. (US 20100248346).
Regarding claim 9, Onuki teaches all of the elements of the current invention as stated above with respect to claim 8.
Onuki teaches all the containers 301 (protrusions) are of the same type and thus fails to teach wherein the plurality of protrusions comprises at least two different pluralities of cylindrical protrusions, and each plurality of cylindrical protrusions configured to accommodate a different type of vials.
However, Kaneko teaches an biological analyzer comprising a cooler for reagents (abstract). Kaneko further teaches the containers for reagents are of various sizes, and two types of racks are used to accommodate containers of different sizes (0056).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified one of the two holders 302 and the correspond reagent containers 301 to a different holder 302 capable accommodating containers a different size than that of containers 301 as taught by Kaneko because doing so provides a holder and reagent containers of different sizes to hold different reagents to perform analysis with a reasonable expectation of success (Kaneko, para. 0056) (MPEP 2143)(I)(G).
The teachings of Onuki as modified with Kaneko would yield wherein the plurality of protrusions comprises at least two different pluralities of cylindrical protrusions (containers of two different sizes), and each plurality of cylindrical protrusions configured to accommodate a different type of vials (interpreted as a functional limitation. The different containers are structural capable of accommodating different types of vials).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Onuki et al. (WO 2022049722) In view of Yamashita et al. (US 20230219088).
Regarding claim 24, Onuki teaches an apparatus (Fig. 12) for automated treatment of a sample containing macromolecules, the apparatus comprises:
a non-planar reaction chamber (flow cell) with a volume equal to or less than about 20 ml (para. 0002, micro-reaction, flow cell is in the range of sub 1mL, and thus less than 20 mL), wherein the reaction chamber is subjected to temperature control and configured for allowing fluid flow- through (para. 0032, temperature control mechanism 603 for controlling temperature of flow cell, which allows fluid to flow through);
a reagent handling system (100)(Fig. 12, see also Fig. 4) comprising a reagent cartridge (reagents containers 301 and reagent container holders 302 and drawer door 103 and installation part 102)(Figs. 2 and 4) comprising a plurality of reagent receptacles (reagent containers 301) for containing a plurality of reagents, wherein the reagent handling system is configured to maintain the plurality of reagents within a desired temperature range (para. 0017), wherein the reagent handling system further comprises a temperature regulating device (cooling unit 500 and insulated box 101) attached to the reagent cartridge (Fig. 4), wherein a temperature-controlled volume (the bottom volume of the insulated box 101 that is beneath the horizontal plane where 302 sits when the drawer is closed as shown in Fig. 4)( see annotated Fig. A above) is formed upon attachment of the temperature regulating device to the reagent cartridge (annotated Fig. A above), and an interior surface of the reagent cartridge (interior wall of 103) and a surface (the bottom wall of 101) of the temperature regulating device form boundaries of the temperature- controlled volume contained within the reagent handling system; and wherein the temperature regulating device is configured to cool or heat a gaseous fluid that is at least partially confined within the temperature-controlled volume (Fig. 4, para. 0017), and further configured to maintain the gaseous fluid confined in the temperature-controlled volume within the desired temperature range (para. 0017);
a supply line (the common line that connects all the reagent container 301 to 602)(Fig. 12); and
wherein the delivery of the reagents is individually addressable (Fig. 12 and para. 0016, individual suction nozzles 401 allows for delivery of individual reagents), the reagent receptacles are fluidically connected to the reaction chamber via the supply line (Fig. 12).
Onuki teaches the analytical apparatus is a nucleic acid analyzer (para. 0032). Onuki teaches the reagent containers 301 are each individually connected to the flow cell 602 through suction nozzle 401 which are connected to the supply line (Fig. 12 and para. 0033), but Onuki fails to explicitly teach a plurality of valves connected to the supply line. Furthermore, Onuki teaches the reagents in the reagent containers 301 are individually delivered, but Onuki fail to explicitly teach a control unit to control delivery of reagents of the plurality of reagents to the reaction chamber wherein:
the delivery of the reagents is individually addressable,
the reagent receptacles are fluidically connected to the reaction chamber via the supply line, and
temperature control of the reaction chamber, temperature control of the temperature- controlled volume, positioning of valves of the plurality of valves, and/or delivery of the reagents to the reaction chamber is automated and controlled by the control unit.
However, Yamashita teaches a nucleic acid analyzer (Fig. 5) with a plurality of reagent containers (505-507). Yamashita further teaches the reagent containers (505-507) are each individually connected to substrate 107 (flow cell) through a suction line with a valve (502-504) which are connected to a supply line (501)(Fig. 5, para. 0035-0036). Yamashita teaches the valves are allows for desired reagent to be selectively introduced into the substrate 107 (para. 0036) for nucleic acid analysis (para. 0002). Yamashita further teaches the a arithmetic device executing software (i.e. a computer) controls units 113 and 114 which control reagents delivery (Fig. 5, paras. 0022 and 0049).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Onuki to include a valve for each suction nozzle 401 (a plurality of valves) as taught by Yamashita because doing do so allow for selective reagent aspiration for performing nucleic acid analysis (Yamashita, paras. 0002, 0035) with a reasonable expectation of success (MPEP 2143)(I)(G). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus taught by Onuki to include a computer and control units to control delivery of reagents as taught by Yamashita because doing so provide an automated means to control reagent delivery for nucleic analysis with a reasonable expectation of success (Yamashita, paras. 0022, 0049) (MPEP 2143)(I)(G). Moreover, providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. (2144.04 (III).
The teachings of Onuki as modified by Yamashita would yield the apparatus comprising a plurality of valves (Yamashita, Fig. 5) connected to the supply line; and a control unit (an arithmetic device executing software, i.e. computer) to control delivery of reagents of the plurality of reagents to the reaction chamber (Yamashita, para. 0022 and 0049), wherein:
the delivery of the reagents is individually addressable (Yamashita, para. 0039 and Onuki’s suction nozzles for each individual 301),
the reagent receptacles are fluidically connected to the reaction chamber via the supply line (Onuki, Fig. 12), and
.
Claims 2-4 and 7 rejected under 35 U.S.C. 103 as being unpatentable over Handique et al. (US 20200354715) in view of Brown (US 20080287585).
Regarding claim 2, Handique teaches all of the elements of the current invention as stated above with respect to claim 1.
Handique further teaches wherein the reagent cartridge (reagent cartridge 120’ with tubes in the third domain 123’) comprises a carrier (cartridge 120’).
Handique further teaches the third domain 123’ of cartridge 120’ is for storing tubes with PCR reagents and is in a array format (para. 0056 and Fig. 3A). Handique does not teach the tubes are in an individual format or in a strip/multi-array tray format and thus fails to teach the reagent cartridge comprise a reagent tray configured to hold a plurality of reagents, and consequently fails wherein the reagent tray and the carrier form the temperature-controlled volume that confine the gaseous fluid.
However, Brown teaches PCR reagent tubes in an individual format or in a strip/multi-array tray format (reagent tray) (para. 0017).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tubes that are in the third domain 123’ taught by Handique with a tubes in strip/multi-array tray format as taught by Brown (Brown, para. 0017) because one of ordinary skill in the art would accordingly have recognized tubes whether in an individual format or in a strip/multi-array tray format would result in the predictable result of providing tubes for containing PCR reagent.
The teachings of Handique as modified by Brown would yield wherein the reagent cartridge comprises: (i) a reagent tray (tubes in a strip/multi-array tray format) configured to hold a plurality of reagents, wherein the reagent tray and the carrier form the temperature-controlled volume that confine the gaseous fluid.
Regarding claim 3, modified Handique further teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Handique further wherein the reagent tray is one of a plurality of alternative reagent trays configured to be attached to the carrier to form the temperature-controlled volume (the tubes in a strip/multi-array tray format can be removably placed/attached into the third domain 123’ of cartridge 120’, and another set of tubes in a strip/multi-array tray format can be alternately be placed in the third domain 123’).
Regarding claim 4, modified Handique teaches all of the elements of the current invention as stated above with respect to claim 3. With respect to the limitation “at least two reagent trays of the plurality of alternative reagent trays have different arrangements of reagent receptacles,” only one of the reagent tray is positively recited. Since this limitation requires more than one reagent trays, and thus does not apply. Furthermore, tubes can be in a strip or a multi-array format).
Regarding claim 7, modified Handique teaches all of the elements of the current invention as stated above with respect to claim 2.
Handique further teaches wherein the reagent handling system further comprises a sensor means (camera that read tags such as barcodes) configured to be able to detect the unique identifier (tags, e.g., barcodes) associated with various disposables including the reagent cartridge (para. 0153, 0158).
Modified Handique does not explicitly teaches wherein the reagent tray (of the reagent cartridge) comprises a unique identifier and consequently also fails to reach the sensor means is configured to detect the unique identifier present on the reagent tray when the reagent tray is installed into the reagent cartridge.
However, Handique teaches the system uses the camera to read tags (e.g. barcodes) on disposables for inventory management (para. 0153).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reagent tray taught by modified Handique to include a unique identified as taught by Handique because doing so enables inventory management with a reasonable expectation of success (Handique, para. 0153) (MPEP 2143)(I)(G).
The teachings of modified Handique would yield wherein the reagent tray comprises a unique identifier, and wherein the sensor means configured to be able to detect the unique identifier present on the reagent tray when the reagent tray is installed into the reagent cartridge (para. 0153).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Onuki et al. (WO 2022049722) in view of Kaneko et al. (US 20100248346) and further in view of Spoto (US 3744665).
Regarding claim 14, Onuki teaches all of the elements of the current invention as stated above with respect to claim 10.
Onuki teaches the reagent containers 301 (reagent receptables) are removable installed in the holder 302. Onuki further teaches only one type of reagent container, and thus Onuki fails to teaches wherein closed ends of at least two different reagent receptacles (containers 301) of the reagent cartridge
However, Kaneko teaches an biological analyzer comprising a cooler for reagents (abstract). Kaneko further teaches the containers for the reagents are of various sizes, and two types of racks are used to accommodate containers of different sizes (0056). In addition Spoto further reagent container of different sizes can be of different diameter and height (Fig. 2).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified one of the two holders 302 and the correspond reagent containers 301 to a different holder capable of accommodating containers of a different size that is of a different height and diameter than that of containers 301 as taught by Kaneko and Spoto because doing so provides a holder and reagent containers of different reagents for an analysis with a reasonable expectation of success (Kaneko, para. 0056) (MPEP 2143)(I)(G).
The teachings of Onuki as modified with Kaneko would yield wherein wherein closed ends of at least two different reagent receptacles (containers 301 and containers of a different size/height) of the reagent cartridge are located at different distances from the surface of the temperature regulating device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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