DETAILED CORRESPONDENCE
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 .
Response to Amendments
As to applicants amended claims filed on 12/23/25, the previous claim objections and 112b rejections are removed.
As to applicants amended claims and the remarks filed on 12/23/25, some of the previous 101 rejections are removed while some remain.
Regarding applicants amendments to the claims and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Status
Claims 1-9 are pending.
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.
Claim 2 is 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.
As to claim 2, it is unclear what is attempting to be recited. If no module is configured to is configured to analyze an analysis item, then how is the analysis item analyzed. The claim recites that no module in the same group is configured to analyze an analysis item, but the same group includes the only two different analysis items. In other words, if no module (neither first/second analyzer) of the group is configured to analyze the analysis item, then how is the only other analyzer (third analyzer) able to analyze the analysis item when the third analyzer is the same as the second analyzer (evidenced by the fact that priority is given to the second module over the third module in claim 1). Therefore, it is unclear how a third analyzer which accomplishes the same analysis as the second analyzer would be able to analyze a sample if the second analyzer was not configured to analyze that sample.
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 2, 7, 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 2, 7, 8 are rejected under 101 based on the following analysis
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 2 recites the abstract idea of “sets, as a subsequent transport destination”, claim 7 recites “set, as a transport destination”, and claim 8 recites “remove, from the transport target destination candidates” which are mental processes. Each of these concepts of “setting” or “removing” transport destinations is analogous to a determination. A user in their mind could set/decide where to transport samples. MPEP 2106.04(a)(2)III is clear that using a computer to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Once the transport destination is set/removed, then no action is taken. Therefore, there is no particular practical application.
The claim also recites an automatic analyzer with three analysis modules and a transport line, two of the three analysis modules being the same analysis type and the other analysis module analyzing a different analysis type. However, these are recited very broadly and are just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which is not a particular practical application.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of an automatic analyzer with three analysis modules and a transport line, two of the three analysis modules being the same analysis type and the other analysis module analyzing a different analysis type. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Sakazume et al (US 6444171; hereinafter “Sakazume”; already of record). Sakazume teaches an automatic analyzer with a plurality of modules and a transport line, two of the three analysis modules being the same analysis type and the other analysis module analyzing a different analysis type (Sakazume teaches a transport line that runs along analyzer 10 or 100a and analyzers 20/30 or 100b/100c where the second and third analysis modules are the same type and the first is different; Figs. 1, 3, 4, 8, 9, col. 3 line 33-50, col. 10 line 65-col. 11 line 10).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102a1/a2 as being anticipated by Sakazume et al (US 6444171; hereinafter “Sakazume”; already of record).
As to claim 1, Sakazume teaches an automatic analyzer (Sakazume; Figs. 1, 3, 4, 8, 9) comprising: a plurality of analysis modules including at least three or more analysis modules configured to measure a sample; a transport line configured to transport the sample to the plurality of analysis modules; and a control unit configured to control the transport of the sample along the transport line, wherein: the plurality of analysis modules includes two or more analysis modules configured to analyze analysis items corresponding to a first analysis types including one of biochemistry type, immunology type, or electrolyte type; the plurality of analysis modules further includes an analysis module configured to analyze an analysis item corresponding to a second analysis type that is different from the first analysis type, the second analysis type including one of the biochemistry type, immunology type, or electrolyte type; in the plurality of analysis modules, two or more analysis modules configured to analyze the different first and second analysis types form a group; and after a sample dispensing process for the sample is completed in a first analysis module of the group, and when the group with the first analysis module includes a second analysis module that is configured to analyze an unmeasured analysis item of the sample, the control unit is configured to give priority to the second analysis module over a third analysis module that is not in the group, and the control unit is configured to control the transport line to transport the sample to the second analysis module (Sakazume teaches a transport line that runs along analyzer 10 or 100a and analyzers 20/30 or 100b/100c where the second and third analysis modules are the same type and the first is different, whereby the first and second or first and third form a group and either the second or third is out of the grouping; Figs. 1, 3, 4, 8, 9, col. 3 line 33-50, col. 10 line 65-col. 11 line 10. Sakazume teaches that the samples are sequentially processed by the analyzers, whereby the sample would be processed by 20/100b after 10/100a thereby the priority going to the second analysis module over the third analysis module; Fig. 1-9).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Claims 1-4, 7, 8 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Pollack et al (US 20170045545; hereinafter “Pollack”; already of record).
As to claim 1, Pollack teaches an automatic analyzer comprising: a plurality of analysis modules including at least three or more analysis modules configured to measure a sample; a transport line configured to transport the sample to the plurality of analysis modules; and a control unit configured to control the transport of the sample along the transport line, wherein: the plurality of analysis modules includes two or more analysis modules configured to analyze analysis items corresponding to a first analysis types including one of biochemistry type, immunology type, or electrolyte type; the plurality of analysis modules further includes an analysis module configured to analyze an analysis item corresponding to a second analysis type that is different from the first analysis type, the second analysis type including one of the biochemistry type, immunology type, or electrolyte type; in the plurality of analysis modules, two or more analysis modules configured to analyze the different first and second analysis types form a group; and after a sample dispensing process for the sample is completed in a first analysis module of the group, and when the group with the first analysis module includes a second analysis module that is configured to analyze an unmeasured analysis item of the sample, the control unit is configured to give priority to the second analysis module over a third analysis module that is not in the group, and the control unit is configured to control the transport line to transport the sample to the second analysis module (Pollack teaches that there are a plurality of ISE modules 130, where one of the modules 130 is grouped with either immunoassay 110 or chemistry 120; Fig. 1, [62, 63]. The controller of Pollack makes scheduling of the routing of samples, and identifies the routes to send the samples to the next module, which means that after one ISE module 130 evaluated the samples that it would then be sent to the next second module (either 110 or 120), those first and second modules forming one group, prior to sending the sample to the next subsequent module, where the next subsequent module would include the other of 110 or 120, or also another one of the other modules 130; [44, 69, 70, 74, 115, 127]. Pollack also teaches an analyzer with 3-4 modules, where there can be multiple modules that are the same/redundant to enable higher throughput, and the workflow of this example would be similar to that of figure 1 which was previously discussed; Fig. 2a, 3, [41, 42]. Pollack also teaches that the analyzers can be designed such that two modules perform the same assay, in order to help load balance the system; [75, 76]. As best understood, Pollack teaches that some samples are routed to another module for immediate processing; [69]. Similarly, Pollack teaches that samples are transported to the next analyzer that is available such that the sample is not sitting idly by; [70]. Pollack also teaches that STAT samples are processed at the most uncrowded operation cycle; [79]. Pollack teaches that the controller can schedule the next module to help resolve scheduling conflicts; [74]. Pollack teaches that if a sample needs a test shared by two modules, that the sample can be virtually queued/scheduled such that the load is balanced and that the sample can be processed as quickly as possible; [75, 76]. Because the ”groups” have not been specifically isolated or identified, then when two of the same analysis type modules exist, then the module at which the sample moves to would be considered the second module and it would be transferred with priority over the other module that the sample did not move to. The examiner further notes that the “group” of modules are not physically related and can just be any arbitrary analysis modules that are “grouped” in the scheduling/navigation of the samples).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Pollack teaches the automatic analyzer according to claim 1, wherein when no analysis module that is configured to analyze an unmeasured analysis item is present in a same group, the control unit is configured to set, as a subsequent transport destination, an analysis module having a load value indicating a smallest load and configured to analyze the unmeasured analysis item (As best understood, Pollack teaches that some samples are routed to another module for immediate processing; [69]. Similarly, Pollack teaches that samples are transported to the next analyzer that is available such that the sample is not sitting idly by; [70]. Pollack also teaches that STAT samples are processed at the most uncrowded operation cycle; [79]. Pollack teaches that the controller can schedule the next module to help resolve scheduling conflicts; [74]. Pollack teaches that if a sample needs a test shared by two modules, that the sample can be virtually queued/scheduled such that the load is balanced and that the sample can be processed as quickly as possible; [75, 76]).
As to claim 3, Pollack teaches the automatic analyzer according to claim 1, wherein the second analysis module and the third analysis module are analysis modules that analyze equal analysis types (Pollack teaches that there are a plurality of ISE modules 130; Fig. 1, [62, 63]. Pollack also teaches an analyzer with 3-4 modules, where there can be multiple modules that are the same/redundant to enable higher throughput, and the workflow of this example would be similar to that of figure 1 which was previously discussed; Fig. 2a, 3, [41, 42]. Pollack also teaches that the analyzers can be designed such that two modules perform the same assay, in order to help load balance the system; [75, 76]).
As to claim 4, Pollack teaches the automatic analyzer according to claim 3, wherein the second analysis module and the third analysis module are analysis modules that are configured to each measure an electrolyte item (Pollack teaches that there are a plurality of ISE modules 130; Fig. 1, [62, 63]. Pollack also teaches an analyzer with 3-4 modules, where there can be multiple modules that are the same/redundant to enable higher throughput, and the workflow of this example would be similar to that of figure 1 which was previously discussed; Fig. 2a, 3, [41, 42]. Pollack also teaches that the analyzers can be designed such that two modules perform the same assay, in order to help load balance the system; [75, 76]).
As to claim 7, Pollack teaches the automatic analyzer according to claim 1, wherein when load values are equal in the analysis modules that are transport target destination candidates, the control unit is configured to set, as a transport destination, a group that is configured to perform a remaining analysis item of requested analysis items and that is closest to a current position of the sample (As best understood, Pollack teaches that the samples are transferred to subsequent modules, where the next module would be considered the most analyzable. Pollack teaches that some samples are routed to another module for immediate processing; [69]. Similarly, Pollack teaches that samples are transported to the next analyzer that is available such that the sample is not sitting idly by; [70]. Pollack also teaches that STAT samples are processed at the most uncrowded operation cycle; [79]. Pollack teaches that the controller can schedule the next module to help resolve scheduling conflicts; [74]. Pollack teaches that if a sample needs a test shared by two modules, that the sample can be virtually queued/scheduled such that the load is balanced and that the sample is can be processed as quickly as possible; [75, 76]).
As to claim 8, Pollack teaches the automatic analyzer according to claim 1, wherein, when a specific analysis type is an electrolyte item, the control unit is configured to remove, from transport target destination candidates, an analysis module configured to analyze a different electrolyte item (As best understood, any analyzer would not analyze an item that was not requested. In this case, Pollack teaches analyzing specific analysis items with specific analyzers, and if an electrolyte item was requested then Pollack would not transfer to (or have as an available destination) an analyzer that did not analyze the specific electrolyte item. In other words, Pollack teaches scheduling tests at various modules and Pollack would remove, and not send samples to be tested at modules that were not able to analyze/test those specific samples).
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.
Claims 5-6, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Pollack et al (US 20170045545; hereinafter “Pollack”; already of record) in view of Tatsutani et al (US 20170285052; hereinafter “Tatsutani”; already of record).
As to claim 5, Pollack teaches the automatic analyzer according to claim 1, wherein the transport line includes: a shared transport line configured to transport the sample in a shared manner in the three or more analysis modules (Pollack teaches the transport line to transport to the analyzers; Fig. 1, 2a, 3).
Pollack does not specifically teach a grouping of two different types of analyzers having an exclusive transport line to transport the sample between analysis modules of the same group, and in transporting the sample from the first analysis module to the second analysis module, the control unit is configured to cause the sample to be transported through the exclusive transport line, and not through the shared transport line. However, Tatsutani teaches the analogous art of an automatic analyzer (Tatsutani; abstract) where there is a shared transport line to move the samples to all of the analyzers and where a grouping of two different types of analyzers having an exclusive transport line to transport the sample between analysis modules of the same group, and in transporting the sample from the first analysis module to the second analysis module, the control unit is configured to cause the sample to be transported through the exclusive transport line, and not through the shared transport line (Tatsutani teaches one group including measurement modules 10 and 20, where 10 and 20 can either measure the same or different analysis items; [39, 40, 41], Fig. 1. See also Tatsutani [155, 156]. Tatsutani teaches shared line 31, and exclusive line 32 which transfers from the first module 10 to the second module 20; Fig. 1, 4). It would have been obvious to one of ordinary skill in the art to have modified the one grouping of the first and second analyzer module that include a shared transport line of Pollack to have included an exclusive transport line to move the samples to the first grouping as in Tatsutani because Tatsutani teaches that it is known to include an exclusive transport line off of a shared line (Tatsutani; Fig. 1, 4) and also because Tatsutani teaches that the exclusive line helps improve measurement efficiency (Tatsutani; [60]). Further, without some statement of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art at the time the invention was made to rearrange one grouping of the first and second analyzer module that include a shared transport line of Pollack to be together with an exclusive transport line to move the samples to the first grouping as in Tatsutani to prevent the main shared line from clogging with samples thereby keeping the line open if emergency samples needed to be processed or to help samples move downstream for analysis without waiting in queue, thereby improving throughput and decreasing sample wait time, since it has been generally recognized that to shift location of parts when the operation of the device is not otherwise changed is within the level of ordinary skill in the art, In re Japikse, 86 USPQ 70; In re Gazda, 104 USPQ 400.'
As to claim 6, Pollack teaches the automatic analyzer according to claim 5, wherein the exclusive transport line is placed between analysis modules in the same group (The modification of the one grouping of the first and second analyzer module that include a shared transport line of Pollack to have included an exclusive transport line to move the samples to the first grouping as in Tatsutani; see claim 5 above. Tatsutani teaches that the transport line 32 is connected between the one group modules 10 and 20 such that the sample is transferred from the first module 10 to the second module 20; Fig. 1, 4).
As to claim 9, Pollack teaches the automatic analyzer according to claim 5 (see above).
Pollack does not specifically teach a buffer module, wherein when a reexamination request is issued to a sample present in a buffer module in the analysis modules that constitute one group, the control unit is configured to cause the sample to be transported to an analysis module to be connected to the buffer module. However, Tatsutani teaches the analogous art of an automatic analyzer (Tatsutani; abstract), with a buffer module, wherein when a reexamination request is issued to a sample present in a buffer module in the analysis modules that constitute one group, the control unit is configured to cause the sample to be transported to an analysis module to be connected to the buffer module (Tatsutani teaches the buffer module as region of space 341, where when a retest is ordered that the sample is transferred to the next module for a retest; Fig. 1, 4, [66, 67, 155, 156]). It would have been obvious to one of ordinary skill in the art to have modified the analyzer modules and transportation lines of Pollack to have included a buffer module as in Tatsutani because Tatsutani teaches that this buffer space enables the samples to be held after analysis if a retest is required (Tatsutani; Fig. 1, 4, [66, 67, 155, 156]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Ha et al (WO 2019111790 where US 20200271683 is used as the corresponding document; hereinafter “Ha”; already of record) teaches an ISE electrolyte module and then two of the same modules AU1/AU2; Fig. 4.
Sakazume et al (US 6444171; hereinafter “Sakazume”; already of record) teaches a transport line that runs along analyzer 10 or 100a and analyzers 20/30 or 100b/100c; Figs. 1, 3, 4, 8, 9, col. 3 line 33-50, col. 10 line 65-col. 11 line 10.
Tokieda et al (US 200090162247; hereinafter “Tokieda”; already of record) teaches multiple analyzers with buffer units, and load balancing and transferring to the lightest load [16, 119, 122], Figs. 1, 2, 18, 19.
Response to Arguments
Applicant's arguments filed 12/23/25 have been fully considered.
Applicants argue on page 16 of their remarks that the dependent claims are patent eligible due to their claim dependency. The examiner respectfully disagrees. Independent claim 1 was amended to no longer recite an abstract idea, while the dependent claims were amended to recite abstract ideas. Therefore, some of the dependent claims are rejected under 35 USC 101 (see above).
Applicant’s arguments with respect to the prior art rejection have been considered, but are moot because the arguments are towards the amended claims and not the current ground of rejection.
However, because the examiner has applied the same reference in the rejection, then the examiner will address applicants arguments. Applicants argue that Pollack does not specifically teach claim 1 limitation of “after a sample dispensing process for the sample is completed in a first analysis module of the group, and when the group with the first analysis module includes a second analysis module that is configured to analyze an unmeasured analysis item of the sample, the control unit is configured to give priority to the second analysis module over a third analysis module that is not in the group, and the control unit is configured to control the transport line to transport the sample to the second analysis module. However, the examiner respectfully disagrees. Pollack teaches that there are a plurality of ISE modules 130, where one of the modules 130 is grouped with either immunoassay 110 or chemistry 120; Fig. 1, [62, 63]. The controller of Pollack makes scheduling of the routing of samples, and identifies the routes to send the samples to the next module, which means that after one ISE module 130 evaluated the samples that it would then be sent to the next second module (either 110 or 120), those first and second modules forming one group, prior to sending the sample to the next subsequent module, where the next subsequent module would include the other of 110 or 120, or also another one of the other modules 130; [44, 69, 70, 74, 115, 127]. Pollack also teaches an analyzer with 3-4 modules, where there can be multiple modules that are the same/redundant to enable higher throughput, and the workflow of this example would be similar to that of figure 1 which was previously discussed; Fig. 2a, 3, [41, 42]. Pollack also teaches that the analyzers can be designed such that two modules perform the same assay, in order to help load balance the system; [75, 76]. As best understood, Pollack teaches that some samples are routed to another module for immediate processing; [69]. Similarly, Pollack teaches that samples are transported to the next analyzer that is available such that the sample is not sitting idly by; [70]. Pollack also teaches that STAT samples are processed at the most uncrowded operation cycle; [79]. Pollack teaches that the controller can schedule the next module to help resolve scheduling conflicts; [74]. Pollack teaches that if a sample needs a test shared by two modules, that the sample can be virtually queued/scheduled such that the load is balanced and that the sample can be processed as quickly as possible; [75, 76]. Because the ”groups” have not been specifically isolated or identified, then when two of the same analysis type modules exist, then the module at which the sample moves to would be considered the second module and it would be transferred with priority over the other module that the sample did not move to. The examiner further notes that the “group” of modules are not physically related and can just be any arbitrary analysis modules that are “grouped” in the scheduling/navigation of the samples.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798