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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/14/2026 has been entered.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 1/14/2026. Claims 14-15, 17-18, and 26-27 are pending in the application.
Status of Objections and Rejections
All rejections from the previous office action are maintained.
Response to Arguments
Applicant’s arguments, see Page 7, filed 1/14/2026, with respect to the 112(b) rejections have been fully considered and are persuasive. The 112(b) rejections of 10/15/2025 have been withdrawn in light of the amendments made to claim 14.
Applicant's arguments filed 1/14/2026 have been fully considered but they are not persuasive.
On Page 7, the Applicant states that the structural elements of a housing container holder portion, a transport mechanism, a detector configured to obtain a measurement of a sample, and a controller configured to control the operation of the automatic analyzer provide significantly more than just the abstract idea.
In response to this argument, the Examiner respectfully disagrees as the elements of a housing container holder portion, a transport mechanism, a detector configured to obtain a measurement of a sample, and a controller configured to control the operation of the automatic analyzer are known, conventional, and are routine in the art of automatic analyzers. Maetzler, US 2017/0350912, teaches a housing container holder portion (37) with a transport mechanism (47) and an analyzer used to detect an optical measurement of a sample, and a controller to control the overall automatic analyzer (see [0027], [0053], [0063] – [0064], [0080], and [0086]).
On Pages 7-8 of the Remarks, the Applicant further asserts that the newly amended limitation stating that "the controller is configured to perform an analysis of the sample based on a priority order of the first and second consumables" and "the controller controls the transport mechanism to transport the first and second housing containers based on the usage state and the first and second unused states." These features are not insignificant extra-solution activity, but rather are practical applications of the abstract idea that are vital to the operation of the apparatus.
In response to this argument, the Examiner respectfully disagrees as the controller being configured to perform an analysis of the consumable following the determination of the priority order is an instruction to apply the abstract idea using a generic computer does not render the abstract idea eligible, see MPEP 2106.05(f). Using an automatic analyzer to analyze a sample following the obtaining of priority information regarding the consumables does not amount to significantly more than the recited laws of nature, as the additional element of the “analyzer” simply allows a user to observe a sample after the priority states have been assigned to each consumable. Additionally, the claims are drawn to an analyzer where priority states are determined, and action is taken after the abstract idea occurs, therefore the currently amended limitation is considered an insignificant application of the abstract idea.
In response to Applicant’s arguments presented on Page 8, stating that Maetzler does not teach that "the filling state of the consumable is confirmed via a gripping operation of the transport mechanism," the Examiner respectfully disagrees. Maetzler teaches that the gripper is configured to grip a reaction vessel 60 stored in one of the reaction vessel racks 83a , 83b, see [0086]. While the Examiner does agree that the current embodiment of Maetzler et al. does not teach that the filling state of the second consumable is confirmed via a gripping operation, the difference between Maetzler et al. and the claimed invention was a known variation. Specifically, Maetzler et al. teaches that the analyzer can be configured to, for all containers, check a consumable item position in each container from which a last consumable item has been supplied to the analysis process and therefore determine whether a consumable is either used or not used, i.e., filled or not filled (see [0094]- [0096]) and also teaches that the analyzer may check if this position is occupied (i.e., not used, or not filled) after a user has replenished the compartment, see Fig. 6. If the consumable of Maetzler is filled, the consumable is no longer located within the rack, it has been used and has therefore been filled, which is then confirmed with a transport rack movement to determine if the consumable spot is empty, see [0092] – [0096].
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-15, 17-18, and 26-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 14 (and its subsequent dependent claims 15-18, 24, 26-27) recites the abstract ideas of determining the usage state, assigning priorities to the containers, determining that either the first consumable or second consumable is higher priority, determining that a remaining amount is a full amount, and if the remaining amount is a full amount previously then determining the container to be in the second unused state and if the remaining amount is not a full amount then determining the container to be in the first unused state, and the controller controlling the transport mechanism to transport of the first and second housing containers based on the usage state, and the controller performing an analysis of the sample based on the priority order of the first and second consumables. Each of these determination steps are either mental steps or math, as a user can make these determinations through observations or comparisons. Assigning a priority is a determination/mental step as you determine that container A is more important than container B and should be processed first. Although the actions are done by a controller/computer, using a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea, see MPEP 2106.04(a)(2)III.
Claim 14 recites the abstract idea of the controller controlling the transport mechanism to transport of the first and second housing containers based on the usage state and the filling state of the consumable being confirmed via a gripping operation of the transport mechanism. The limitation of using the controller to control the transport mechanism following the determination of the usage state is not significant as restricting an analyzer to draw from the area having the least and oldest items is routine in the field of apparatuses having a First-In-First-Out automatic retrieval system. Further, the limitation amounts to mere data gathering and outputting as the data regarding lot information and lot quantity following analysis is relayed to the controller to determine subsequent operations of the analyzer, see MPEP 2106.05(g). The judicial exception is not integrated into a practical application because the judicial exception merely uses the computer/controller to perform the abstract idea of determining and comparing usage states which merely uses a computer as a tool to perform an abstract idea. Once all of the determination steps are complete, then no action is taken. Additionally, confirming the filling state of the consumable is considered mere data gathering as the limitation is drawn to the grabbing of the consumable and performing no further measurements, as claimed. A computer is being used to grab the consumable and no further action is taken.
Claim 14 additionally recites the newly amended limitation of the controller being configured to perform an analysis of the consumable following the determination of the priority order. This limitation is an instruction to apply the abstract idea using a generic computer and does not render the abstract idea eligible, see MPEP 2106.05(f). Using an automatic analyzer to analyze a sample following the obtaining of priority information regarding the consumables does not amount to significantly more than the recited laws of nature, as the additional element of the “analyzer” simply allows a user to observe a sample after the priority states have been assigned to each consumable. Additionally, the claims are drawn to an analyzer where priority states are determined, and action is taken after the abstract idea occurs, therefore the currently amended limitation is considered an insignificant application of the abstract idea.
Additionally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed elements of the elements of a housing container holder portion, a transport mechanism, a detector configured to obtain a measurement of a sample, and a controller configured to control the operation of the automatic analyzer are known, conventional, and are routine in the art of automatic analyzers. Maetzler, US 2017/0350912, teaches a housing container holder portion (37) with a transport mechanism (47) and an analyzer used to detect an optical measurement of a sample, and a controller to control the overall automatic analyzer (see [0027], [0053], [0063] – [0064], [0080], and [0086]). Pang et al. (US Patent 6,060,022) teaches an automatic laboratory analyzer comprising containers for specimen and a track to transport the containers, see Fig. 1 and Col. 13, Lines 55-63. Kondou. (US PG Pub 2010/0115463) teaches a sample analyzer with a controller used to control the movement of reagent tables that contain reagent containers, see Fig. 3 and [0119] – [0125].
Claim 15 further discusses the abstract idea of determining which container is to be used, and while the actions are done by a controller/computer, using a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea. The inclusion of a storage device to store the usage stage is only using a computer memory as a tool to perform an abstract idea.
Claims 17-18 discuss the abstract idea of determining the filling state of a consumable after completing the abstract idea of determining a usage state of the housing container. Each of these determination steps are either mental steps or math, as a user can make these determinations through observations or comparisons and determining whether a consumable is empty and capable of being used. This judicial exception is not integrated into a practical application because the judicial exception merely uses the computer/controller to perform the abstract idea of determining and comparing usage states which merely uses a computer as a tool to perform an abstract idea.
Claim 26 refers to the abstract idea of determining and storing whether an item is in a usage state and determining whether there is an amount of a consumable remaining in a container. Each of these determination steps are either mental steps or math, as a user can make these determinations through observations or comparisons from an original starting point. Additionally, the inclusion of a storage device to store the usage stage is merely using the computer memory as a tool to perform the abstract idea instead of integrating the idea into a practical application.
Claim 27 further discusses the abstract idea of determining storing whether an item is in a usage state and assigning priorities to the containers by determining that either the first consumable or second consumable is in a different state. Assigning a priority is a determination/mental step as a user would determine that container A is more important than container B and should be processed first. Although the actions are done by a controller/computer, using a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea.
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.
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 is: “a transport mechanism” in claim 14.
Because this claim limitation is 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. The corresponding structure drawn to in the specification is a rack for transportation (see [0014]- [0015] in the Instant Application)
If applicant does not intend to have this limitation 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 14-15, 17-18, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Maetzler et al. (US 2017/0350912 cited on the IDS dated 2/12/2021).
Regarding claim 14, Maetzler et al. teaches an automatic analyzer (automated sample analyzer, see Fig. 3 and [0062]) comprising:
a housing container holder portion that holds a first housing container and a second housing container (repository of consumable items 15 (holder portion) has two storage areas 37a-b (first and second housing containers), see Fig. 3 and [0063]), the first housing container and the second housing container each housing a consumable (storage areas 37a-b contain consumables 39 and 60, see Fig. 3-4, [0063], and [0080]);
a transport mechanism that transports the consumable housed in the first housing container or the second housing container (transfer head rail 47 comprises grippers for grabbing reaction vessel 60 (consumable) from storage area 37, see Fig. 3-4, [0064], and [0086]);
a detector configured to obtain a measurement of a sample (analyzer used to detect an optical property of a sample, see [0027]); and
a controller configured to control all operations of the automatic analyzer (controller of entire analyzer, see [0076]), wherein the first housing container houses a first consumable and a second consumable and the second housing container houses a first consumable and a second consumable (storage areas 37a-b have two different consumables 39 and 60, see Fig. 4 and [0080]),
wherein any one of a reaction container that causes the sample and a reagent to react with each other (reaction vessels 60 located within rack 83, see Fig. 4, [0063] and [0080]) and a dispensing tip that is mounted on a tip of a sample probe of a sample dispensing mechanism (disposable pipetting tip 39 located within tip rack 38, see Fig. 4, [0063], and [0080]) is the first consumable and the other is the second consumable (storage areas 37a-b contain consumables 39 and 60, see Fig. 3-4, [0063], and [0080]);
the controller determines usage states of the first and the second housing containers relating to the first consumable and usage states of the first and the second housing containers relating to the second consumable (controller of analyzer is configured to determine how much of each consumable 39, and 60 is left in the storage areas 37a-b and determines the usability of each consumable in relation to each other, see [0053]),
assigns priorities to the first and the second housing containers based on the usage state of the first housing container and the usage state of the second housing container, determines that the first consumable housed in the first or second housing container having a higher priority is used first based on the usage states of the first and the second housing containers relating to the first consumable, and determines that the second consumable housed in the first or second housing container having a higher priority is used first based on the usage states of the first and the second housing containers relating to the second consumable (the controller is used to determine which storage area 37a-b to withdraw from in regards to the first consumable 39 (housed in tip racks 38a-d) and second consumable 60 (housed in vessel racks 83a-b), see Fig. 4-5 and [0086]- [0088]),
a usage state of the first or second housing container includes a first unused state and a second unused state having a higher priority than the first unused state (the controller is used to determine which storage area 37a-b to withdraw from in regards to which storage area has been prioritized, see Fig. 4-5 and [0100]; the controller is used to reserve a consumable for use, or place the consumable in a first unused state, and switches to withdraw from another storage area which has higher use priority, or a second unused state, as it is not reserved by the automated sample analyzer. A lower priority than the consumable that is used next which would necessarily then have a higher priority, see [0036], [0086], [0100], and [0109]- [0110]), and
when the controller determines that a remaining amount of the consumable in the first or second housing container is a full amount ('not used'), if the remaining amount of the first or second consumable in the first or second housing container is further determined to be a full amount in a previous determination of the usage state of the first or second housing container, the control unit determines that the first or second housing container is in the second unused state, and if the remaining amount of the first or second consumable in the first or second housing container is determined not to be a full amount in the previous determination of the usage state of the first or second housing container (‘partially used’), the control unit determines that the first or second housing container is in the first unused state (the controller of the analyzer, see [0076], determines if the storage area (housing container) is 'not used' (second unused state), and also determines if the storage area is 'partially used' (first unused state), see [0092]- [0095])
the controller controls the transport mechanism to transport of the first and second housing containers based on the usage state and the first and second unused states (the controller controls withdrawal of consumable from each drawer 37a-b based on the ‘used’ state determination, see [0091] – [0095] and [0107] – [0112]),
the controller causes a storage device to store a housing state of the first or second consumable in the first or second housing container at an end of analysis measurement (the controller houses use state of consumable following withdrawal, see [0111] – [0112]),
in a case where the controller determines a usage state of the first or second housing container after the analysis measurement, the controller determines the usage state of the first or second housing container by comparing a filling state of the first or second consumable in the first or second housing container to the housing state of the consumable in the first and second housing container that is stored in the storage device, and determines whether or not the first or second consumable housed in the first or second housing container is usable based on the usage state of the first or second housing container (the controller is able to obtain a logging status after withdrawal and compare current consumable inventory to stored inventory, see [0107] – [0111] and [0121]), and
the filling state of the first or second consumable is confirmed via a gripping operation of the transport mechanism (the gripper is configured to grip a reaction vessel 60 stored in one of the reaction vessel racks 83a , 83b, see [0086]), and
the controller is configured to perform an analysis of the sample based on a priority order of the first and second consumables (the controller uses the determined sample priority order to analyze the supplied vessels, see [0031] – [0032]).
The current embodiment of Maetzler et al. does not teach that the filling state of the second consumable is confirmed via a gripping operation.
However, the difference between Maetzler et al. and the claimed invention was a known variation. Specifically, Maetzler et al. teaches that the analyzer can be configured to, for all containers, check a consumable item position in each container from which a last consumable item has been supplied to the analysis process and therefore determine whether a consumable is either used or not used, i.e., filled or not filled (see [0094]- [0096]) and also teaches that the analyzer may check if this position is occupied (i.e., not used, or not filled) after a user has replenished the compartment, see Fig. 6. If the consumable of Maetzler is filled, the consumable is no longer located within the rack, it has been used and has therefore been filled, which is then confirmed with a transport rack movement to determine if the consumable spot is empty, see [0092] – [0096].
Further, there were design incentives for implementing the claimed variation of gripping the second consumable of the rack. Specifically, Maetzler states that the implementation would have allowed the analyzer to assume that the user properly replenished rack 38b, and as a consequence, a filling status indicator for rack 38b can be switched to ‘full.’ Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the analyzer and its associated controller to implement the gripping transport mechanism for the second consumable as exemplified for the benefit of checking a filling status of a consumable within an automatic analyzer for appropriate operations, see [0092] – [0096].
Regarding claim 15, Maetzler et al. teaches the automatic analyzer according to claim 14, wherein the first consumable and the second consumable are used in pairs (consumables are used in sets, or in pairs, see [0017]), the automatic analyzer further includes a storage device that stores a usage state of the first housing container and a usage state of the second housing container relating to the first consumable and a usage state of the first housing container and a usage state of the second housing container relating to the second consumable (the analyzer comprises a filling status indicator (storage device) that stores the use data of each storage area in relation to both consumables, see Fig. 4-5 and [0092]), the controller determines which pair is to be used among a pair of the first consumable housed in the first housing container and the second consumable housed in the first housing container, a pair of the first consumable housed in the first housing container and the second consumable housed in the second housing container, a pair of the first consumable housed in the second housing container and the second consumable housed in the first housing container, and a pair of the first consumable housed in the second housing container and the second consumable housed in the second housing container (the controller is used to determine which set (pair) of consumables will be withdrawn from each storage area, see [0017], [0062], [0088], and [0100]).
Regarding claim 17, Maetzler et al. teaches the automatic analyzer according to claim 16, wherein the controller causes the storage device to store a remaining amount of the first or second consumable filled in the first or second housing container and a housing position of the first or second housing container that is finally accessed by the transport mechanism as the housing state of the first or second consumable in the first or second housing container at the end of analysis measurement (the controller causes the filling status indicator (storage device) to monitor the consumption (remaining amount) and the position (housing state) of the first or second consumable in the storage area (housing container) following analysis, see [0092]- [0096]), and
in the case where the controller determines the usage state of the first or second housing container after the analysis measurement, the controller determines the usage state of the first or second housing container by comparing the filling state of the first or second consumable in the first or second housing container to the remaining amount of the first or second consumable filled in the first or second housing container and the housing position of the first or second housing container that is finally accessed by the transport mechanism, the remaining amount and the housing position being stored in the storage device (the controller is used to determine the filling status (usage state) by comparing the filling status indicator (filling state within storage device) of each storage area 37 (housing container) and a consumable item position (housing position), see [0092]- [0096], where the filling state includes a "partially filled" indication for areas that have been accessed by the translation system (transport mechanism), see [0084]).
Regarding claim 18, Maetzler et al. teaches the automatic analyzer according to claim 16, wherein in a case where the controller detects that the housing container holder portion is taken out, the controller determines a usage state of the first or second housing container by comparing a filling state of the first or second consumable in the first or second housing container to the housing state of the first or second consumable in the first or second housing container that is stored in the storage device, and updates a priority of the first or second housing container based on the usage state of the first or second housing container (the controller monitors when the repository (holder) is taken out and new consumables are inserted, see [0090], where the controller determines filling status of each storage area (housing container) and updates where first or second consumables are withdrawn based on the filling status (usage state), see [0087], [0090], and [0100]).
Regarding claim 26, Maetzler et al. teaches the automatic analyzer according to claim 14, wherein the usage state of the first or second housing container further includes a being-used state, an unclear history state, and an empty state (the filing status (usage state) of the storage area (housing container) includes a 'used' state (being-used), a warning state (unclear history), and a 'completely used' state (empty), see [0092]- [0096]), and
the controller causes a storage device to store a housing state of the first or second consumable in the first or second housing container at the end of analysis measurement and determines that the usage state of the first or second housing container is the being-used state if the remaining amount of the first or second consumable in the first or second housing container is not a full amount and the filling state of the first or second consumable in the first or second housing container is consistent with the housing state of the first or second consumable in the first or second housing container that is stored in the storage device, determines that the usage state of the first or second housing container is the unclear history state if the filling state of the first or second consumable in the first or second housing container is not consistent with the housing state of the first or second consumable in the first or second housing container that is stored in the storage device, and determines that the usage state of the first or second housing container is the empty state if the remaining amount of the first or second consumable in the first or second housing container is 0 (the controller of the analyzer, see [0076], determines storage area (housing container) is in 'used' (being-used) state if some first or second consumable has been used, area generates warning/error (unclear) if improperly placed, and 'completely used' (empty) when completely depleted, see [0092]- [0096]).
Regarding claim 27, Maetzler et al. teaches the automatic analyzer according to claim 26, wherein in a case where the usage state of the first or second housing container is the unclear history state or the empty state, the controller does not use the first or second housing container, and in a case where the usage state of the first or second housing container is the first unused state, the second unused state, or the being-used state, the controller sets the priority for the being-used state, the second unused state, and the first unused state in descending order thereof (when analyzer detects error (unclear) or 'completely used' (empty) indication, controller prompts analyzer to draw from 'used' (being-used) area, then 'not used' (second unused state) area, then finally the 'partially used' (first unused state) area, see [0084]-0088] and [0092]- [0096]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pang et al. (US Patent 6,060,022) teaches an automatic laboratory analyzer comprising containers for specimen and a track to transport the containers, where the containers are supplied using a “first in, first out” processing system.
Kondou (US 2010/0115463) teaches a sample analyzer where reagents are used based on the order in which they are entered into the system (see [0089]).
Fritchie et al. (US 20100324722) also teaches a system of managing the priorities of reagents where the partially used reagents are used first, then the oldest, then the newest (see Fig. 4B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.N.M./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758