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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/04/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and previously presented claim set filed on 25 June 2025.
Claims 1-2 and 4-20 are pending.
Claims 12-20 are withdrawn.
Claim 3 is cancelled.
No new claims are added.
Claim Interpretation
Regarding Claim 1, the claim recites “A control unit operative in combination with a cassette” in the preamble such that the limitation “operative in combination with a cassette” merely refers to the claimed cassette as an intended use or object worked upon by the control unit. By this, the configuration of the control unit to determine a number of milk analysis units and communicate with the cassette requires the prior art only to be capable of such counting and communication with a cassette.
Further thereto, the control unit functionality recited in claim 1 of obtaining a number, comparing the number, and changing a test modus is also predicated on the cassette, which as mentioned above, is recited as an intended use of the control unit.
If applicant intends the claimed cassette to be part of the claimed invention, it is suggested to specifically claim “a system comprising a control unit and a cassette operable together”. – Note that this issue further pervades into dependent claims of Claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Linder et al. (US 2011/0256551 A1), hereinafter “Linder”, in view of Lizaso (US 2013/0087086 A1), hereinafter “Lizaso”, and Kobashi (US PAT 5,428,993 A), hereinafter “Kobashi”.
Regarding Claim 1, Linder teaches a control unit operative in combination with a cassette of a milk analysis apparatus (Abstract: “Systems and methods for analysis of samples, and in certain embodiments, microfluidic sample analyzers configured to receive a cassette containing a sample therein to perform an analysis of the sample are described.”)
the control unit comprising a first wireless communication device ([0164]: “In some cases, the identification reader may be integrated with a control system via communication pathways. Communication between the identification readers and the control system may occur along a hard-wired network or may be transmitted wirelessly.” – As such, the control system must necessarily comprise a wireless communication device.),
the cassette comprising a memory device ([0158]: “In certain embodiments, an identification system including one or more identifiers is used and associated with one or more components or materials associated with a cassette and/or analyzer. The “identifiers,” as described in greater detail below, may themselves be “encoded with” information (i.e. carry or contain information, such as by use of an information carrying, storing, generating, or conveying device such as a radio frequency identification (RFID) tag or bar code) about the component including the identifier,”),
a predetermined number of milk analysis units 510 (Fig. 22),
wherein the milk analysis units 510 each comprise a dry stick configured to react on presence and/or amount of one or several biomarkers in milk ([0052]: “a first channel may be used to store dry reagents” interpreted as a dry stick of reagent. The measurement zones of Linder are taught as comprising reagents for mixing with the sample, wherein the device performs analysis operations such as and monitoring said mixing ([0149, 0151, 0228] – See also where each measurement zone comprises a reagent storage chamber and connecting channel ([0045]).). – Further, para. [0114] discusses reactions of biomolecules such as DNA, RNA, and carbohydrates with reagents of the device, wherein milk comprises those biomolecules such as DNA, RNA, and carbohydrates.),
and a second wireless communication device ([0217]: “an RFID tag on the cassette”),
the cassette being insertable into the milk analysis apparatus ([0007]: “the cassette is inserted into the sample analyzer”),
each of milk analysis units being one time usage unit ([0053]: “cassette of the invention are disposable after first use”);
the control unit, via first wireless communication device communicating with the second wireless communication device, being configured for communication with the memory device of the cassette ([0163]: “the analyzer 100 includes an RFID module and antenna that are configured to read information from the cassette 20 inserted into the analyzer 100”),
Further regarding Claim 1, Linder does not specifically teach the control unit discussed above wherein the control unit is configured to:
determine a number of consumed milk analysis units during a milk analysis session; and
transmit information related to the consumed number of milk analysis units during the milk analysis session, to the memory device of the cassette, via the first wireless communication device, for storage in the memory device of the cassette,
obtain a number of remaining milk analysis units of the cassette from the memory device of the cassette;
compare the number of remaining milk analysis units with a first trigger level;
and change a test modus of the milk analysis apparatus when fewer milk analysis units than the first trigger level remains, as in Claim 1.
However, the concept of monitoring a supply of consumable elements to change a mode of operation of an apparatus consuming said consumable elements and/or alert a user when replenishment of said consumable elements is needed is known in the prior art. For example, Lizaso teaches a bobbin thread monitor which monitors a supply of thread wound about a bobbin of a sewing machine to prevent bobbin thread supply exhaustion ([0009]). Further, once the thread supply reaches a trigger level, the device sends a signal to alert a user to replace the thread supply ([0009]). Herein, the thread unwound from a spool is seen as equivalent to a tape unwound from a spool of a cassette, wherein each of these comprise “units” to be measured by the controller.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the apparatus of Linder with a monitoring system for determining the number of milk analysis units remaining, such as suggested by innovations in the prior art such as Lizaso, so as to be capable of alerting a user when an assay using the cartridge is complete or at a particular level of completeness so as to provide time management to the user, wherein the control unit of Linder is fully capable of providing such monitoring and transmitting steps in as much as is claimed given its commensurate disclosure of a controller comprising a wireless communication device and a cassette comprising a wireless communication device and a memory device; and would have a reasonable expectation of success therein.
Further pursuant to the above, it is noted that MPEP 2143(I)(F) provides that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. Herein, given that the milk analysis zones of Linder are consumable elements consumed by an automated system, the addition of a monitoring system would provide the predictable result of providing a user with status updates for time management, thereby improving productivity.
Further regarding Claim 1, Linder does not specifically teach the analysis device discussed above wherein changing the test modus comprises restricting testing to one or more most-important tests as pre-configured or defined by an operator, as in Claim 1.
However, Kobashi teaches a respective automatic analyzer wherein an operator defines each sample as “ordinary” or “emergency” when inputting the samples into the analyzer, and a controller of the analyzer monitors an amount of a remaining regent supply (analogous to milk analysis units) used to perform analysis on the samples and, when the controller detects that the amount of remaining reagent falls below a threshold, the controller commands the analyzer to only utilize remaining reagent for performing analysis on the emergency samples (col. 6, line 53: “individually calculating the total reagent required quantity De in the emergency specimen group and the total reagent required quantity Du in the ordinary specimen group, when De<Q<Du, only the emergency specimen group is measured, and the ordinary specimen group is not measured. Of course, when De, Du<Q, both groups are measured”). Therein, this arrangement allows for the prioritization of emergency samples such that high-priority analysis results are not time-delayed by ordinary samples taking up time on the analyzer.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the analysis device of Linder wherein changing the test modus comprises restricting testing to one or more most-important tests as pre-configured or defined by an operator, such as suggested by Kobashi, so as to allow for the prioritization of emergency samples such that high-priority analysis results are not time-delayed by ordinary samples taking up time on the analyzer, and would have a reasonable expectation of success therein given that the analyzer of Linder is similarly controlled by a programmable controller.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Linder does not specifically teach the control unit discussed above wherein, the control unit is configured, for a calculation of a remaining number of milk analysis units, to:
obtain a number of remaining milk analysis units of the cassette from the memory device of the cassette before performing a test session;
estimate a remaining number of milk analysis units on the cassette, based on the obtained number of remaining milk analysis units and the number of consumed milk analysis units during the milk analysis session; and the transmitted information concerns the estimated remaining number of milk analysis units, as in Claim 2.
However, as discussed above, the prior art such as Lizaso teaches monitoring a supply of consumable elements to change a mode of operation of an apparatus consuming said consumable elements and/or alert a user when replenishment of said consumable elements is needed. Wherein it is further noted that the controller of Linder is fully capable of performing the above recited operations of Claim 2 given Linder’s commensurate disclosure of a controller comprising a wireless communication device and a cassette comprising a wireless communication device and a memory device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Linder to include the above counting, estimating, and transmitting operations regarding the number of milk analysis units remaining so as to be capable of alerting a user when an assay using the cartridge is complete or at a particular level of completeness so as to provide time management to the user; and would have a reasonable expectation of success therein.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Linder does not specifically teach the control unit discussed above configured to:
obtain a number of remaining milk analysis units of the cassette from the memory device of the cassette before performing a test session;
estimate a remaining number of milk analysis units on the cassette, based on the obtained number of remaining milk analysis units and the number of consumed milk analysis units during the milk analysis session; and the transmitted information concerns the estimated remaining number of milk analysis units, as in Claim 4.
However, as discussed above, the prior art such as Lizaso teaches monitoring a supply of consumable elements to change a mode of operation of an apparatus consuming said consumable elements and/or alert a user when replenishment of said consumable elements is needed; wherein Kajima specifically teaches a second threshold for shutting the battery down and alerting a user for replacement ([0006-0009]). Wherein it is further noted that the controller of Linder is fully capable of performing the above recited operations of Claim 2 given Linder’s commensurate disclosure of a controller comprising a wireless communication device and a cassette comprising a wireless communication device and a memory device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the apparatus of Linder to include the above counting, estimating, and transmitting operations regarding the number of milk analysis units remaining and a second trigger level so as to be capable of alerting a user when the cartridge is exhausted and to alert a user that an assay is over; and would have a reasonable expectation of success therein.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, Linder teaches the control unit discussed above configured to perform the first option of the at least one of: activate the first wireless communication device in association with initiating a test session with the milk analysis units of the cassette ([0172]: “the identification reader 60 reads and identifies information associated with the cassette 20” – As such, the first wireless communication device/the reader must necessarily be activated to identify the identifying information stored in the cassette.), as in Claim 11.
Claim 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Lizaso, as applied to Claims 1-2, 4, and 11 above, and in further view of Anderson et al. (US 2006/0260939 A1), referred to hereinafter as “Anderson”.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Linder/Lizaso does not specifically teach the control unit discussed above, in combination with the cassette wherein the milk analysis units are arranged on a tape of the cassette, as in Claim 5.
However, Anderson teaches a cartridge for milk analysis wherein the milk analysis regions 216 are arranged on a film 222 of a cassette (Fig. 2), wherein this arrangement allows for continuous monitoring of a milk feed ([0046] and Fig. 4), thereby improving productivity.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the controller of Linder/Lizaso in combination with a cassette wherein the milk analysis units are arranged on a tape of the cassette, such as suggested by Anderson, so as to provide for continuous monitoring or a mere alternative method of performing multiple assays within a cartridge via lateral flow assays instead of microfluidic assays, thereby improving productivity; and would have a reasonable expectation of success therein.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, Linder/Lizaso teaches the controller discussed above wherein in combination with the cassette, the control unit configured to:
obtain information concerning a dysfunctional milk analysis unit of the cassette from the memory device of the cassette before performing a test session ([0167]: “Information encoded on or associated with an identifier may also be used, for example, to determine whether the component associated with the identifier (e.g., a cassette) is authentic or counterfeit. In some embodiments, the determination of the presence of a counterfeit component causes system lockout. In one example, the identifier may contain a unique identity code. In this example, the process control software or analyzer would not permit system startup (e.g., the system may be disabled) if a foreign or mismatched identity code (or no identity code) was detected.”);
Further regarding Claim 6, as Linder/Lizaso does not specifically teach analysis units on a tape, Linder/Lizaso does not specifically teach detecting that the subsequent milk analysis units on the tape is dysfunctional; and forwarding the tape in position for milk analysis action on the next non-dysfunctional milk analysis units on the tape, as in Claim 6.
However, the provision of the tape provided for by the obvious combination of Linder/Lizaso and Anderson is fully capable of being advanced by the controller of Linder/Lizaso when a dysfunctional/counterfeit cartridge/unit is detected.
As such, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide a controller capable of monitoring the functionality/authenticity of milk analysis units of Linder/Lizaso/Anderson so as to avoid erroneous measurements; and would have a reasonable expectation of success therein.
Regarding Claim 7, the prior art meets the limitations of Claim 5 as discussed above. Further, Linder/Lizaso teaches the control unit discussed above in combination with the cassette, the control unit configured to:
detect when the cassette is used for the first time; determine a moment in time when the first-time usage of the cassette is detected; and transmit the determined moment in time to the memory device of the cassette, via the first wireless communication device, for storage in the memory device of the cassette ([0166]: “The information from or associated with an identifier can, in some embodiments, be stored, for example in computer memory or on a computer readable medium, for future reference and record-keeping purposes. For example, certain control systems may employ information from or associated with identifiers to identify which components (e.g., cassettes) or type of cassettes were used in a particular analysis, the date, time, and duration of use, the conditions of use, etc.”), as in Claim 7.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Linder in view of Lizaso and Anderson, as applied to Claims 5-7 above, and in further view of Cook et al. (US 2013/0315780 A1), referred to hereinafter as “Cook”.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, Linder/Lizaso/Anderson does not specifically teach the control unit configured to:
determine a current moment in time; check whether the time difference between the stored moment in time of the memory device of the cassette, associated with the first-time usage of the cassette, and the current moment in time exceeds a predetermined time limit; and discontinue usage of the cassette when the predetermined time limit is exceeded, as in Claim 8.
However, Cook teaches a respective cartridge-based diagnostic system for continuous sample monitoring comprising a disposable test cartridge, wherein the first insertion of the test cartridge to the apparatus records the time of first use and sets a first limit of an expiry time limit predetermined for proper use of the cartridge and discontinues usage of the cartridge after the expiry time limit has elapsed ([0162]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the control unit of Linder/Lizaso/Anderson to determine a current moment in time; check whether the time difference between the stored moment in time of the memory device of the cassette, associated with the first-time usage of the cassette, and the current moment in time exceeds a predetermined time limit; and discontinue usage of the cassette when the predetermined time limit is exceeded, such as suggested by the teaching of an expiry time limit of Cook, so as to prevent use of an expired cassette which would provide inaccurate results or disrupt a production line; and would have a reasonable expectation of success therein.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Linder/Lizaso/Anderson does not specifically teach the control unit configured to:
transmit a blocking sign prohibiting further usage of the cassette, via the first wireless communication device, for storage in the memory device of the cassette, when the predetermined time limit is exceeded, as in Claim 9.
However, Cook teaches a respective cartridge-based diagnostic system for continuous sample monitoring comprising a disposable test cartridge, wherein a controller, upon the first insertion of the test cartridge to the apparatus, records the time of first use and sets a first limit of an expiry time limit predetermined for proper use of the cartridge and discontinues usage of the cartridge after the expiry time limit has elapsed ([0162]).
Cook further teaches the control unit as rejecting cartridges having exceeded the pre-determined expiry time ([0344]: “The software timer can be checked to ensure that the cartridge has been used within a recommended time limit after the first scan.” – See paras. [0338-0343] for further discussion of failsafe mechanism.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the control unit of Linder/Lizaso/Anderson to transmit a blocking sign prohibiting further usage of the cassette, via the first wireless communication device, for storage in the memory device of the cassette, when the predetermined time limit is exceeded, such as suggested by the teaching of an expiry time limit failsafe mechanism of Cook, so as to prevent use of an expired cassette which would provide inaccurate results or disrupt a production line; and would have a reasonable expectation of success therein.
Regarding Claim 10, the prior art meets the limitations of Claim 8 as discussed above. Further, Linder/Lizaso/Anderson does not specifically teach the control unit configured to:
output an alert, encouraging an agricultural manager to change the cassette when the predetermined time limit is exceeded by the time period, via an output device, as in Claim 10.
However, Cook teaches a respective cartridge-based diagnostic system for continuous sample monitoring comprising a disposable test cartridge, wherein a controller, upon the first insertion of the test cartridge to the apparatus, records the time of first use and sets a first limit of an expiry time limit predetermined for proper use of the cartridge and discontinues usage of the cartridge after the expiry time limit has elapsed ([0162]).
Cook further teaches alerting a user when the cartridge has exceeded the predetermined expiry time set by the controller and alert the user to insert a new cartridge ([0155]: “inserting the cartridge into a diagnostic instrument; processing the data from the scanned scannable code to ensure that the correct cartridge was inserted into the diagnostic instrument; and providing feedback to a user on whether the correct cartridge was inserted into the diagnostic instrument.” – [0162]: “providing feedback to user if time limit was breached”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the control unit of Linder/Lizaso/Anderson to output an alert, encouraging an agricultural manager to change the cassette when the predetermined time limit is exceeded by the time period, via an output device, such as suggested by Cook, so as to prevent use of an expired cassette which would provide inaccurate results or disrupt a production line; and would have a reasonable expectation of success therein.
Response to Arguments
I. Summary
Applicant’s arguments are on the grounds that Examiner’s broad interpretation of “milk analysis unit” as any arbitrary unit and “change a test modus” as any change in operational state qualified the combination of the analysis device of Linder with the sewing machine of Lizaso and, in view of Applicant’s amendments narrowing the scope of the “milk analysis unit” as a dry reagent stick and the “change a test modus” as only performing most-important tests, that it would not be obvious to one skilled in the art to make the combination of Linder and Lizaso to arrive at the system of Claim 1.
Applicant’s arguments are not persuasive because one skilled in the art would recognize the concept of Lizaso of monitoring a supply of consumable elements to change a mode of operation of an apparatus consuming said consumable elements and/or alert a user when replenishment of said consumable elements is needed as broadly applicable across different fields where a supply of consumable elements is monitored by a controller which automates alerting an operator and ceasing operation through a change of operational modus. MPEP 2143(I)(F) provides that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. Herein, given that the milk analysis zones of Linder are consumable elements consumed by an automated system, the addition of a monitoring system such as suggested by Lizaso would provide the predictable result of providing a user with status updates for time management, thereby improving productivity.
Further, as discussed below, Linder teaches the specific reagent stick and the newly added reference of Kobashi, as necessitated by Applicant’s amendments, teaches changing a test modus so as to only perform most-important tests, thereby curing the alleged deficiencies in Linder/Lizaso. Thus, Examiner respectfully sets forth the rejection of Claims 1-2, 4, and 11 under 35 USC 103 over Linder in view of Lizaso and the newly added reference of Kobashi, as necessitated by Applicant’s amendments to Claim 1.
II. 35 USC 103 Linder in view of Lizaso
Applicant’s arguments are on the grounds that Linder/Lizaso does not teach the milk analysis unit as a dry stick test article that reacts to milk biomarkers. Applicant notes that the “measurement zones” of Linder are merely zones and comprise no dry stick of reagent.
Applicant’s arguments are not persuasive because the measurement zones of Linder are taught as comprising reagents for mixing with the sample, wherein the device performs analysis operations such as and monitoring said mixing ([0149, 0151, 0228] – See also where each measurement zone comprises a reagent storage chamber and connecting channel ([0045]).). The dry reagents thereby forming an elongated “stick” through the channel capillary as seen through Fig. 22 given the broadest reasonable Merriam-Webster Dictionary definition of “stick” as “something that is long and thin”. Further, as discussed above in the body of the rejection, Linder specifies that the reagents are for binding to DNA, RNA, and/or carbohydrates, which are all biomarkers present in milk.
Applicant’s arguments are further on the grounds that Linder/Lizaso does not teach the change in test modus as restricting testing to one or more most-important tests as defined by an operator, as in Applicant’s amendment to Claim 1. However, Applicant’s arguments are moot as Linder and Lizaso are not relied upon for teaching the specific change in test modus to most-important tests, but rather the newly added reference of Kobashi (included herein as necessitated by Applicant’s amendments) is provided herein for curing the alleged deficiency of Linder/Lizaso regarding the specific change in test modus to performing only most-important tests.
Thus, Examiner respectfully sets forth the rejection of Claims 1-2, 4, and 11 under 35 USC 103 over Linder in view of Lizaso and the newly added reference of Kobashi, as necessitated by Applicant’s amendments to Claim 1.
III. 35 USC 103 Linder in view of Lizaso and Anderson
Applicant’s arguments are on the grounds that Anderson does not cure the alleged deficiencies of Linder/Lizaso teaching Claim 1 regarding the milk analysis units and change in test modus. However, Applicant’s arguments are moot as no such deficiency exists in Linder regarding the milk analysis units as dry sticks, given Linder’s teaching of dry reagent regions in the capillary channels of the cassette and further teaching of such reagents as present in or directly connected to each of the respective measurement zones, and given that the alleged deficiency in the change of test modus is cured by obvious combination of Linder/Lizaso and Kobashi for providing change in device operation to only test most-important items. Thus, Anderson is not relied on for curing any of the alleged deficiencies.
IV. 35 USC 103 Linder in view of Lizaso and Cook
Similarly as above, Applicant’s arguments are on the grounds that Cook does not cure the alleged deficiencies of Linder/Lizaso teaching Claim 1 regarding the milk analysis units and change in test modus. However, Applicant’s arguments are moot as no such deficiency exists in Linder regarding the milk analysis units as dry sticks, given Linder’s teaching of dry reagent regions in the capillary channels of the cassette and further teaching of such reagents as present in or directly connected to each of the respective measurement zones, and given that the alleged deficiency in the change of test modus is cured by obvious combination of Linder/Lizaso and Kobashi for providing change in device operation to only test most-important items. Thus, Cook is not relied on for curing any of the alleged deficiencies.
V. Rejoinder of Claims 12-20
Applicant’s arguments are on the grounds that amended Claims 12-20 now recite all the core elements of Claims 1-11 and are thereby eligible for rejoinder.
As now amended, Claims 12-20 may recite certain core features in common with elected claim group 1–11; however, the features common to these groups remain those which are already disclosed in the prior art and thus cannot serve as the required special technical feature linking the inventions. Claims 12–20 therefore do not share a common special technical feature with the elected claims, and they are not drawn merely to a process of using or making the elected cassette/system that includes all of the patentable limitations of an allowable elected claim. Accordingly, the claims of former nonelected group(s) continue to be directed to a different invention than that elected and examined.
For these reasons, Claims 12–20 are not eligible for rejoinder and remain withdrawn from consideration pursuant to the earlier restriction / lack-of-unity requirement. If further amendment results in claims that clearly include all limitations of an allowable elected claim and introduce no additional special technical feature, unity and possible rejoinder will be reconsidered at that time.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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