DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/25/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s arguments and amendments set forth in the reply filed 25 August 2025.
Claims 1, 4-7, and 16 are pending.
Claims 2-3 and 8-15 are cancelled.
No claims are withdrawn from consideration.
No claims are newly added.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a first dispensing unit configured to perform” in Claim 1.
“a second dispensing unit configured to perform” in Claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
A movable nozzle and a pump, as in para. [0010] of Applicant’s instant specification, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 1 recites “reagent vessels that store reagents and specimen vessels that store specimens” and is interpreted herein as merely requiring and positively claiming the “vessels” themselves and not as vessels being filled with a specimen or a reagent. Further, the “reagent” and “specimen” designations of the vessels are seen herein as mere nominal designations not particularly defining a structural difference or different contents actually present within the vessels. The terms “reagent” and “specimen” further overlap in scope themselves, as discussed in the 35 USC 112 section below, further supporting their interpretation herein as mere nominal differences.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-7, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “reagent vessels that store reagents and specimen vessels that store specimens” wherein the term “reagent” is broad and may include biological samples or mixtures thereof. Accordingly, a vessel containing a specimen alone or a specimen-reagent mixture would reasonably satisfy bot the “reagent vessel” and the “specimen vessel” limitations depending solely on how its contents are characterized by a user. Thus, because the claim scope depends on such subjective classification rather than objective structural distinctions, one skilled in the art could not determine with reasonable certainty which vessels are covered by each limitation, and whether the claim requires distinct sets of vessels or merely labeling of the same physical set of vessels. The claims are thereby indefinite.
Further regarding Claim 1, the claim recites “a processor configured to: acquire analysis information...”; however, as currently recited, the Claims are drawn to dispensing units accessing a common disc and do not recite any means for performing analysis, such as a light source and/or detector. Thus, it is unclear what structure generates the “analysis information” the controller is configured to obtain and is recited purely as result-oriented not toed to any particular source of the acquired information. Accordingly, the “a processor configured to: acquire analysis information...” is indefinite because the claim does not recite sufficient structure to inform how the controller is to obtain such information.
Claim 19 recites “the first analysis item group indicates an analysis item group related to biochemistry” and “the second analysis item group indicates an analysis item group related to immunity” wherein it is unclear as to how the analysis item group itself “indicates” a group related to biochemistry or immunity given the mere existence of the group is not capable of performing such an “indication”. Does Applicant intend that the first analysis item group itself is related to biochemical testing and that the second analysis item group itself is related to immunological testing?
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, 4-7, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Joji (WO 2017/138285 A1), referred to hereinafter as “Joji”, in view of Suzuki et al. (US 2014/0363896 A1), hereinafter “Suzuki”.
Regarding Claim 1, Joji teaches an automatic analyzer 100 comprising:
a common disk 102 which holds both reagent vessels that store reagents and specimen vessels that store specimens ([0018]: “The sample disk 102 holds a plurality of the sample vessels 101, and rotates in a clockwise or counterclockwise direction to transport a target one of the sample vessels 101 to a position where the sample dispensing mechanism 105 sucks the sample in the sample vessel 101.” – While Joji does not specifically teach the sample disk 102 as holding “both reagent vessels that store reagents and specimen vessels that store specimens” as claimed, the recitation merely requires the disk to hold vessels, given that the specimen and reagents are not positively claimed and are merely inferred as capabilities of the vessels. The claims do not recite any structural feature that distinguishes the reagent vessels from the specimen vessels, but rather merely characterizes the intended contents of the vessels. Herein, the vessels of Joji are structurally capable of containing any liquid used in the analysis, including specimens and reagents.),
a first dispensing unit 105 configured to perform both reagent dispensing from the reagent vessels and specimen dispensing from the specimen vessels to reaction vessels and configured to dispense a specimen related to a first analysis item group having a high possibility of carryover (Fig. 1 and [0017-0019]: “sample dispensing mechanism 105” – Regarding dispensing of both specimen and reagent, the structure of the dispensing unit is not limited by the type of liquid it dispenses. Joji’s dispensing unit is capable of aspirating and dispensing any appropriate liquid contained in the vessels of the common disc. Thus, the limitation that the dispensing unit performs both reagent and specimen dispensing merely depends on what liquid a user chooses to place in the vessels, which is an intended use of the vessels and dispensing unit, not a structural distinction. – While Joji does not specifically teach the sample dispensing mechanism 105 as “for dispensing a specimen related to a first analysis item group having a high possibility of carryover” as claimed, this recitation is merely an intended use of the sample dispensing mechanism, wherein limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the sample dispensing mechanism 105 of Joji is fully capable of dispensing a specimen related to a first analysis item group having a high possibility of carryover – wherein the “possibility” of carryover is not specifically required by the claim.);
a second dispensing unit 112 configured to perform both reagent dispensing from reagent vessels and specimen dispensing from the specimen vessels to reaction vessels and configured to dispense a specimen related to a second analysis item group having a lower possibility of carryover than the first analysis item group (Fig. 1 and [0017-0018]: “reagent dispensing mechanism 112” – Regarding dispensing of both specimen and reagent, the structure of the dispensing unit is not limited by the type of liquid it dispenses. Joji’s dispensing unit is capable of aspirating and dispensing any appropriate liquid contained in the vessels. Thus, the limitation that the dispensing unit performs both reagent and specimen dispensing merely depends on what liquid a user chooses to place in the vessels, which is an intended use of the vessels and dispensing unit, not a structural distinction. – While Joji does not specifically teach the reagent dispensing mechanism 112 as “for dispensing a specimen related to a second analysis item group having a lower possibility of carryover than the first analysis item group” as claimed, this recitation is merely an intended use of the sample dispensing mechanism, wherein limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the reagent dispensing mechanism 112 of Joji is fully capable of dispensing a specimen related to a second analysis item group having a low possibility of carryover.); and
a processor 116 configured to:
acquire analysis information related to a plurality of analysis items for a plurality of specimens (Fig. 1 and [0024]: “The operating unit 115 is a computer that has an input terminal, such as a keyboard, a mouse, and an operation screen displayed on a display unit, as an input measure.” – Analysis information is sent from the operating unit 115 to the interface 118, and is acquired by the control unit 116. Further, the controller acquires measurement signals: “A measurement signal of the optical intensity A/D-converted in the A/D converter is sent via the interface 118 to the control unit 116 and to the storage unit 117.”),
classify the analysis information into the first analysis item group and the second analysis item group ([0008]: “a control unit for controlling the analysis unit based on the input information, wherein the control unit when information about a plurality of samples is input from the operating unit, compares predicted reaction time lengths of analysis items requested for the plurality of samples, while determining an analysis order so that analyses of the analysis items are performed in descending order of the predicted reaction time length” – As the control unit sorts sample specimens based on predicted reaction time length, and said reaction time lengths constitute item groups (first and second, for example), the control unit thereby classifies the analysis information into groups.); and
determine a dispensing sequence for each specimen for the first analysis item group and determine a dispensing sequence for each analysis item for the second analysis item group ([0028]: “Analysis information, such as the sensed optical intensity which is measurement data, the reaction port number used, the type of sample used, the placement position on the sample disk 102, the type of reagent used, and the placement position on the reagent disk 104, is stored in the storage unit 117.” – [0024]: “The storage unit 117 stores, for example, input information from the operating unit 115, operation information of the sample disk 102 and the like, and information about reagents and samples.” – As the storage unit holds information related to dispensing sequence for respective analysis items, and the storage unit receives sample information from the control unit and returns said information related to dispensing sequence for respective analysis items, and the storage unit is a subordinate system interfaced with the control unit which controls all the operations of the device, the control unit thereby determines a dispensing sequence for each specimen of each of the analysis groups.),
wherein the dispensing sequence for each specimen for the first analysis group is set to a dispensing sequence of specimens and analysis items set forth in the analysis information for the first analysis group (Given that Joji discusses setting sample parameters and dispensing sequence via the operating unit 115: “Test items of samples to be analyzed are input from the keyboard or the operation screen provided in the operating unit 115 and then are input into the control unit 116. The control unit 116 controls the operations of the sample disk 102, the reagent disk 104, the sample dispensing mechanism 105, the reaction vessel transferring mechanism 109, the reaction port 111, the reagent dispensing mechanism 112, and the reagent dispensing mechanism washing mechanism.”, Joji thereby teaches the dispensing sequence for each specimen for the first analysis group being set to a dispensing sequence of specimens and analysis items set forth in the analysis information for the first analysis group.),
and wherein the dispensing sequence for each analysis item for the second analysis item group is set in descending order of reaction times for each analysis item for the second analysis item group (Abstract: “When information about a plurality of samples is entered, the device compares the predicted reaction time length of each requested analysis item for the plurality of samples, determines an analysis sequence to carry out the analysis for each item in order from longest to shortest, and carries out the analysis on the basis of the determined analysis sequence.”),
as in Claim 1.
Further regarding Claim 1, Joji does not specifically teach the automatic analyzer discussed above wherein the second dispensing unit accesses the common disc for retrieving specimen/reagent, as in Claim 1.
However, Suzuki teaches a respective automated analyzer comprising a common disk 108 holding vessels 113, wherein a plurality of dispensing probes 107/109 engage the vessels 113 for handling fluid contents held inside, further pipetting fluid from one vessel 113 to another on the common disk 108 ([0071]). Therein, this plural arrangement of probes reduces the waiting time between analysis operations via multiple processes happening in parallel (dispensing of both sample and reagent to the common disc), thereby improving the throughput ([0035-0041]).
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 automatic analyzer of Joji wherein the first and second probes commonly access a common disk, such as suggested by Suzuki, so as to reduce the waiting time between analysis operations via multiple processes happening in parallel, thereby improving the throughput, and would have a reasonable expectation of success therein given the similar probes and disks of Joji, merely requiring simple rearrangement inspired through Suzuki.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
when the second analysis item group includes a priority item having a higher priority than a general item that requires normal accuracy, arrange the dispensing sequence of the priority item to be positioned first in the second analysis item group and arranges the dispensing sequence of the same specimen as the specimen included in the first analysis item group and including the priority item to be positioned last in the first analysis item group (Figs. 2 and 3, and [col. 6, line 50]: “Monitoring whether or not there is a request of an extra analysis, for example, an analysis of an urgent specimen which has to be analyzed as a top priority is performed in the analyses (step S204). Here, the monitoring refers to regular communication of the automatic analysis device 100 with the operating unit 115. When an analysis of an urgent specimen is requested, the operating unit 115 sends the content of the analysis request to the automatic analysis device 110 in the regular communication. When an extra analysis arises, the test item of the extra analysis is read out (step S205). – See also [col. 8, line 60] and [col. 10, line 8] which discuss routing of sample to a priority port depending on the priority of the sample as set by a user, such as an urgent sample. – See also [col. 9, line 27]: “When the test items requiring 1 minute become absent or when, for example, an analysis for a higher-priority item such as an urgent specimen is allocated, the 6th port as a priority port may be used for another analysis.”), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
when the second analysis item group includes a plurality of the priority items, set a dispensing sequence of the plurality of the priority items to be in descending order of the reaction time, and sets, after the plurality of the priority items, a dispensing sequence of the general items to be in descending order of the reaction time (Figs. 2 and 4, and [col. 6, line 50]: “Next, in step S206, the test item read in step S205 is combined with the test items which are read in step S201 and are sorted in step S202, and the combined test items are re-sorted in descending order of the measurement time length (step S206).” – Given that, as hhown in Figs. 2 and 4, priority items are further subject to the step of sorting by order of reaction time, Joji thereby teaches when the second analysis item group includes a plurality of the priority items, set a dispensing sequence of the plurality of the priority items to be in descending order of the reaction time, and sets, after the plurality of the priority items, a dispensing sequence of the general items to be in descending order of the reaction time as claimed.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
when receiving input of information related to an emergency specimen, determine a dispensing sequence so as to start the analysis of the emergency specimen after the analysis of the specimen currently being analyzed is completed (Figs. 2 and 3, and [col. 6, line 50]: “Monitoring whether or not there is a request of an extra analysis, for example, an analysis of an urgent specimen which has to be analyzed as a top priority is performed in the analyses (step S204). Here, the monitoring refers to regular communication of the automatic analysis device 100 with the operating unit 115. When an analysis of an urgent specimen is requested, the operating unit 115 sends the content of the analysis request to the automatic analysis device 110 in the regular communication. When an extra analysis arises, the test item of the extra analysis is read out (step S205). – See also [col. 8, line 60] and [col. 10, line 8] which discuss routing of sample to a priority port depending on the priority of the sample as set by a user, such as an urgent sample. – Herein, an emergency sample is interpreted as a priority sample. – See also [col. 9, line 27]: “When the test items requiring 1 minute become absent or when, for example, an analysis for a higher-priority item such as an urgent specimen is allocated, the 6th port as a priority port may be used for another analysis.”), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
set a dispensing sequence in the first analysis item group to be in descending order of one specimen analysis time ([col. 2, line 30]: “compares predicted reaction time lengths of analysis items requested for the plurality of samples, while determining an analysis order so that analyses of the analysis items are performed in descending order of the predicted reaction time length”), as in Claim 7.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji does not specifically teach the automatic analyzer discussed above wherein the first analysis item group indicates an analysis item group related to biochemistry, and the second analysis item group indicates an analysis item group related to immunity, as in Claim 16.
However, the above recitation of Claim 16 is merely drawn to an intended use, wherein limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). -- "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). As discussed above, the cited prior art of Joji provides to commensurately disclose the positively claimed structural elements of first and second dispensing units, an input unit, a classification unit, and a determination unit of Claim 1, which are fully capable of use with a first group of analysis items related to biochemistry and a second group of analysis items related to immunity.
Additionally as in Claim 4, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the controller of an automatic patient sample analyzer, such as that of Joji, such that when the second analysis item group includes a priority item having a higher priority than a general item that requires normal accuracy, arrange the dispensing sequence of the priority item to be positioned first in the second analysis item group and arranges the dispensing sequence of the same specimen as the specimen included in the first analysis item group and including the priority item to be positioned last in the first analysis item group so as to reduce the processing time of priority samples, thereby allowing for more rapid initiation of treatment in priority/urgent patient conditions, and to arrange such same samples among the at least two groups to be measured one after the other to further improve measurement accuracy and reduce the time required to obtain a measurement result; and would have a reasonable expectation of success therein.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law – see MPEP 2144(I).
Herein, it is well-known in medicine that urgent patient conditions require rapid identification/analysis and treatment to provide the best patient outcomes so as to reduce organ and tissue damage related to such time-sensitive conditions (Such as measuring troponin in a patient suspected of experiencing a cardiac event.).
Additionally as in Claim 6, 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 of an automatic patient sample analyzer, such as that of Joji, such that when receiving input of information related to an emergency specimen, determine a dispensing sequence so as to start the analysis of the emergency specimen after the analysis of the specimen currently being analyzed is completed, thereby allowing for more rapid initiation of treatment in priority/urgent patient conditions; and would have a reasonable expectation of success therein.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law – see MPEP 2144(I).
Herein, it is well-known in medicine that urgent patient conditions require rapid identification/analysis and treatment to provide the best patient outcomes so as to reduce organ and tissue damage related to such time-sensitive conditions (Such as measuring troponin in a patient suspected of experiencing a cardiac event.).
Response to Arguments
35 USC 102 and 103
Applicant’s arguments are on the grounds that Joji allegedly does not teach a common disk storing both reagent and specimen vessels, nor the first and second dispensing units configured to dispense both reagent and specimen, as in Applicant’s amendments to Claim 1, so as to shorten analysis time.
Applicant’s arguments are not persuasive because the current recitation of “reagent vessels that store reagents and specimen vessels that store specimens” does not structurally differentiate the reagent and specimen vessels, but rather merely recites the intended contents of the vessels through the use of the phrasing of “that store”. Accordingly, the storing of reagents and specimens is interpreted herein as functionality of the vessels, wherein the apparatus of Joji comprises a disc for storing vessels fully capable of holding either specimen or reagent therein, and dispensing units fully capable of dispensing both reagent and specimen from the vessels. – Further, as discussed above in the Claim Interpretation section, the claims are interpreted as merely providing vessels capable of being filled with reagent or specimen, wherein no structural distinction between the vessels is provided and the reagent/specimens merely serve as intended workpieces. And, as discussed above in the 35 USC 112 section, the distinction between reagent and specimen is indefinitely defined, the disc of Joji thereby remaining applicable over Claim 1.
Further, while Joji does not specifically teach both sampling probes accessing a common disc, this deficiency is cured by obvious modification with the common probe/disc arrangement of Suzuki, as discussed above in the body of the rejection, wherein one skilled in the art would find it obvious to modify the probe/diss arrangement of Joji by merely rearranging the probes to commonly access a common disk, as in Suzuki, thereby improving throughput.
Applicant further argues that Joji does not teach the particular configurations of the processor as recited in Claim 1. However, Applicant does not appear to substantiate this argument with an explanation, and the recitations do not appear to particularly depend on the common disc and dispensing units used with both reagent and specimen vessels which, as discussed above, are anticipated by Joji.
Thus, Examiner respectfully sets forth the rejection of Claims 1, 4-7, and 16 under 35 USC 103 as anticipated by Joji in view of Suzuki, and Claims 4 and 6 under 35 USC 103 as additionally unpatentable over Joji in view of Suzuki, as discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JOSEPH KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (703)756-5501. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798