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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-20 are pending.
Claims 1, 3 have been amended.
Claims 16-20 are new.
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.
Claims 1-4, 9, and 11-15 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Jensen et. al. (US 20160300027 A1).
Regarding claim 1, Jensen teaches “A blood gas analyzer for performing a measurement on analyte parameters in a blood sample aspirated into the blood gas analyzer from a blood sample container,” (Paras [0002], [0026], [0029] and [0123], [0103], in the context of blood gas analyzers, infrequent/new operators are more prone to making errors in the pre-analytical phase as well as in the aspiration of the blood sample. Difficulties in choosing sampler types (syringe/capillary). For example, the analyzer may open or close an inlet allowing the operator to insert a sample. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. Capillary sample. )
Further taught “the blood gas analyzer comprising a plurality of user-accessible parts,” (Para [0027], adapting the number of user interface elements). The recitation “each user-accessible part of the plurality of user-accessible parts being configured to be handled by a user of the blood gas analyzer;” is capability of user-accessible parts. Jensen discloses the positively claimed structural elements of the each user-accessible part of the plurality of user-accessible parts as claimed, such each user-accessible part of the plurality of user-accessible parts are said to be fully capable of the recited adaption in as much as recited and required herein.
Further taught “(b) a controller,” (Para [0027], user interface); “and: (c) an aspiration system for aspirating the blood sample from the blood sample container, the aspiration system comprising an inlet structure for connecting to the blood sample container;” (Para [0026], manipulation of movable part of the analyzer such as aspiration) “(d) a monitor for outputting instructions to a the user of the blood gas analyzer for the user's handling of the one or more of the user-accessible parts of the blood gas analyzer” (Para [0027], graphical user interface adapted to display respective user interface elements each associated with one or more steps of an operator-controllable task or workflow performed by the medical analyzer); “and (e ) an electronic memory” (Para [0051], data storage device 209) “comprising at least two pre-stored sets of animated video instructions, each of the pre-stored sets of animated video instructions illustrating the user's correct handling of at least one of the user-accessible parts of the blood gas analyzer;” (Para [0051], [0114-0122] and Table 2, a data storage device 209 for storing program code and data. A training video on ways to avoid clots may be presented during the next logon. a training video on ways to avoid bubbles may be presented during the next logon.)
“wherein the controller is configured to: receive a signal indicative of (A) at least one of a user input;” (Para [0059], [0052], timing parameters determining the relative timing of respective user interface actions. The user interface may be operable to present measurement results to the operator, to request operator inputs or other operator actions, to present selectable options and/or to present instructions to the operator.);” (B) at least one of a presence, a position, or an orientation of the user-accessible parts,” (Abstract, Paras [0057], and [0120], If the analyzer has repeatedly detected that no sample was detected in previous sessions, a training video on ways to aspirate samples may be presented during the next logon. One or more elements of a user interface of at least a first one of the set of medical analyzers when said first medical analyzer is operated by one of the one or more operators. In initial step 310, the operator logs onto the medical analyzer,). Therefore the detection of no sample upon the next logon in which the logon is to the medical analyzer which the user interface (controller) is a part of.
Further taught “and (C) at least one projected handling action of at least one of the user- accessible parts of the blood gas analyzer;” (Paras [0059], [0114-0122], If the analyzer has repeatedly detected that bubbles were present in samples a training video on ways to avoid bubbles may be presented during the next logon.). Therefore the logon is to the medical analyzer which the user interface (controller) is a part of.
Further taught “and in response to the signal, determine if one of the animated video instructions is to be presented to the user, and in the affirmative: (A) select at least one of the at least two pre-stored sets of animated video instructions on a basis of the signal; and (B) output the at least one selected animated video instruction at the monitor.” (Paras [0051], [0059], [0052], [0103], and [0114-0122], and [0141], and [0098], Examples of usage history data, their relation to an operator proficiency level, and the resulting user interface adaptations, such training on the specific analyzer, will be briefly summarized: A training video on ways to avoid clots may be presented during the next logon. a training video on ways to avoid bubbles may be presented during the next logon. Based on the evaluation, the process determines (step S603) whether the operator should be offered to see a short training video. If the process makes the determination that the operator should be offered an instructional video (step S604), completion of the video may be made mandatory. Text and sound may be added to the video for detailing and emphasizing important details. The user interface may include a display such as a touch screen for displaying information, selectable menu items allowing an operator to select operational options, enter parameters, and/or the like. The user interface may be operable to present measurement results to the operator, to request operator inputs or other operator actions, to present selectable options and/or to present instructions to the operator. The guidance may be in the form of one or more screens, with or without one or more animations and/or videos demonstrating clot risk reducing behavior. Videos will only be shown to operators where determined necessary, thus not delaying proficient operators.). Therefore the logon is to the medical analyzer which the user interface (controller) is a part of.
Regarding claim 2, Jensen teaches all of claim 1 as above in addition to “wherein the user-accessible parts of the blood gas analyzer comprises at least one of: a solution pack, an inlet probe of the inlet structure, an inlet connector gasket, and an inlet gasket with a holder therefor” (Para [0145], solution pack); “an inlet module,” (Para [0026], the analyzer may open or close an inlet); “a sensor cassette,” (Para [0026], sensor unit).
Regarding claim 3, Jensen teaches all of claim 2 as above in addition to “wherein said signal is indicative of a need or a user desire to conduct at least one of: a manual flush for removing clots in a conduit of the blood gas analyzer, replacement or installation of the solution pack, replacement or installation of the sensor cassette, replacement of the inlet probe, replacement of the inlet connector gasket, replacement of the inlet gasket with holder, and replacement of the inlet module.” (Para [0144-0145], The system has detected that a certain operator has a poor history of solution pack replacement.).
Regarding claim 4, Jensen teaches all of claim 1 as above in addition to “wherein each of the animated video instructions illustrates a sequence of steps of the user's correct handling of the at least one user-accessible part.” (Para [0114], training videos).
Regarding claim 9, Jensen teaches all of claim 1 as above. The recitation “the recitation “wherein the signal indicative of the projected handling is derived on the basis of a sensor signal, a measurement, a message from an external source, a maintenance or upgrade schedule, and/or a detected need for training.” Jensen teaches a signal processor and a sensor unit within (Paras [0026], and [0148], Examples of such a physical manipulation may comprise an operator-operated or operator-initiated movement of a movable part of the analyzer, insertion, placement, removal, or replacement of specimen, analytes, liquids, replacement parts such as a sensor unit or parts thereof. A suitably programmed microprocessor, one or more digital signal processor, or the like.).
Regarding claim 11, Jensen teaches all of claim 1 as above in addition to “wherein the controller is configured to not allow the user to bypass the output of the at least one selected animated video “ (Para [0143], Once the guidance is completed successfully, the normal measuring workflow is initiated as usual.).
Regarding claim 12, Jensen teaches all of claim 1 as above in addition to “further comprising a sensor system for detecting the completion of steps to which the at least one selected animated video instruction relates,” (Para [0025], [0026], and [0072], sensor unit, the determination of preferences and/or performance indicators may be performed every time an operator has completed a task. The rule engine has completed the processing of all rules, the rule engine sends a response); “and wherein the controller is configured to progress outputting of the least one animated video instruction on the basis of the detected completion of completed steps.” (Para [0029], [0098], [0114]-[0122], and [0027], user interface, After an operator logs on to the analyzer, the operator history may be evaluated; based on the evaluation, appropriate training is activated if deemed necessary. The training may be in the form of a video, animation, instructions, etc. that is displayed directly on the medical analyzer.).
Regarding claim 13, Jensen teaches all of claim 1 as above in addition to “further comprising a communication interface for communicating with an external device or network.” (Para [0049], Any number of medical analyzers, each being connectable to the computer network via a suitable communications interface).
Regarding claim 14, Jensen teaches all of claim 1 as above in addition to “A system for performing a measurement on analyte parameters in a blood sample comprising a blood gas analyzer according to claim 1 and a blood sample container.” (Paras [0001], [0017], [0029], and [0125],Embodiments of the methods, product means, systems and analyzers disclosed herein relate to the field of medical analyzers for analyzing specimens, in particular multi-operator analyzers for use in a clinical, point-of-care (POC) or laboratory environment. One or more quality parameters indicative of a result of the analysis of a specimen including a blood sample. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. Sampler types (syringe/capillary)).
Regarding claim 15, Jensen teaches all of claim 1 as above in addition to “A method of performing point of care (POC) measurement” (Para [0001], [0001] Embodiments of the methods, product means, systems and analyzers disclosed herein relate to the field of medical analyzers for analyzing specimens, in particular multi-operator analyzers for use in a clinical, point-of-care (POC) or laboratory environment.);”on analyte parameters” (Para [0017], One or more quality parameters indicative of a result of the analysis of a specimen; ); “in a blood sample,” ( Para [0029], blood sample); the method comprising: obtaining the blood sample from a patient; (Para [0002], These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. ) aspirating blood from the blood sample into the blood gas analyzer of claim1; (Para [0098], how the operator can properly and securely aspirate the sample. ); and measuring analyte parameters in said blood. (Paras [0001] and [0017] as above).
Claim Rejections - 35 USC § 103
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 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, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et. al. (US 20160300027 A1).
Regarding claim 5, modified Jensen teaches all of claim 4. The recitation “wherein: the signal indicative of the projected handling action includes an indication if one or more of said steps have been completed;” Jensen teaches all of the positively claimed features of the device and therefore is capable of performing the claimed method steps. In addition to teaching (Para [0025], Alternatively, the determination of preferences and/or performance indicators may be performed every time an operator has completed a task).
Jensen does not explicitly teach “and the controller is configured to carry out the selection of the animated video instructions in such a manner that those one or more of the animated video instructions or those one or more parts thereof associated with the completed steps are omitted from outputting at the monitor.” However Jensen does teach host system may be omitted, the training videos will only be shown to users needing them and if needed they will be mandatory. In addition, to teaching the monitor within (Paras [0027], [0049], [0098], and [0141], It will be appreciated that, in embodiments where all analyzers include the functionality of the host system, a network interconnecting the analyzers with each other or a separate host system may be omitted. The graphical user interface adapted to display respective user interface elements each associated with one or more steps of an operator-controllable task or workflow performed by the medical analyzer. The guidance may be in the form of one or more screens, with or without one or more animations and/or videos demonstrating clot risk reducing behavior. Videos will only be shown to operators where determined necessary, thus not delaying proficient operators. If the process makes the determination that the operator should be offered an instructional video (step S604), completion of the video may be made mandatory). Therefore it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Jensen by having the controller configured to so that the videos of the completed steps are omitted from the outputting monitor since Jensen teaches that videos will not be shown if they are not needed. If the task requiring the video is completed it would be classified as a task that is completed and therefore it would not need the video as it would be a step that is completed. In addition, not showing videos for steps that are already completed would streamline the analysis process and speed up the time required to complete the analysis.
Regarding claim 6, Jensen teaches all of claim 1 as above. However does not explicitly teach “wherein each of the pre-stored sets of animated video instructions comprises a simulation of a haptic feedback during the user's handling of the at least one of the user-accessible parts.” reads as a method step and not modifying the device. Therefore this recitation is interpreted capability of the device. Jensen teaches all of the positively claimed features of the device and therefore is capable of performing the claimed method steps. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Jensen by having the set of animated video instructions comprise a simulation of haptic feedback during the user’s handling of at least one of the user-accessible parts, since Jensen teaches a user interface and allows the operator to interact with the medical analyzer within Para [0052] in addition to training videos as above. Therefore, it would be a matter of an obvious engineering choice, to have the user interface to allow a haptic feedback to the user during the training videos. The haptic feedback allows increased interaction with user and device which increases users skills and muscle memory during operation.
Regarding claim 10, Jensen teaches all of claim 1 as above. But does not explicitly teach “wherein the controller is configured to prompt the user for confirmation of outputting of the at least one selected animated video instruction, and wherein the outputting of the at least one selected animated video instruction is subject to user confirmation.”. However Jensen does teach individual steps have to have confirmation within (Para [0145], For each individual step a confirmation is required). It would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Jensen by having arranged the controller configured to prompt the user to confirm the outputting of at least one animated video and it’s also subject to user confirmation, since Jensen teaches confirmation is required and also teaches a user interface. The user would to make this confirmation and having the controller configured as suck would have been a matter of an obvious engineering choice within a device which has a user interface and requires confirmation of steps.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et. al. (US 2016300027 A1) as applied to claim 1 and in further view of Ahlfors (WO 2017221155 A1).
Regarding claim 7, Jensen teaches all of claim 1 as above but does not teach “wherein the aspiration system comprises an aspiration point for establishing a fluid flow communication with the blood sample container,”.
Ahlfors teaches systems and methods for automated cell processing of biological samples including blood sample in addition to having a gas within the system. Ahlfors also teaches “wherein the aspiration system comprises an aspiration point for establishing a fluid flow communication with the blood sample container,” (Paras [0050], and [00234], [00234], As can be seen in Fig. 15, the robotic aspirator/gripper 812 can be used with an aspirator tip 870 so as to function as a robotic aspirator to aspirate liquid from a container, such as a cell processing container 314. In operation, when aspiration is desired). Therefore, having the aspirator which aspirates liquid from a container creates a fluid flow from the aspirator to the sample container.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jensen to incorporate the teachings of Ahlfors wherein the aspiration system comprises an aspiration point for establishing a fluid flow communication with the blood sample container. Doing so allows the device to aspirate and have transfer of fluid with the container without the need for a user to perform this task.
Jensen further teaches “and wherein the blood gas analyzer further comprises a detection structure for detecting a presence of the blood sample container at the aspiration point.” (Paras [0119] and [0120], The process has detected that during previous operator sessions, aspiration was frequently aborted due to errors in the aspiration process: [0120] If the analyzer has repeatedly detected that no sample was detected in previous sessions, a training video on ways to aspirate samples may be presented during the next logon.).
Regarding claim 8, modified Jensen teaches all of claim 7 as above in addition to “wherein the controller is configured to: deny the performance of analyte parameter measurements if it is determined that one or more of the at least one projected handling actions or one more steps thereof is due;” (Para [0005] US 2013/0024247 disclose an analyzing system comprising an analyzer and a host system. The analyzer requests confirmation as to whether the operator operating the analyzer has completed training. If the operator has not completed the training, the analyzer prevents measurement of a sample.); “or prompt for a user confirmation of the performance of analyte parameter measurements if it is determined that one or more of the at least one projected handling action is due.” (Para [0142] The guidance may include one or more requests for confirmation of performance of the desired behavior.).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et. al. (US 2016300027 A1) in view of Ahlfors (WO 2017221155 A1).
Regarding claim 16, Jensen teaches “A blood gas analyzer for performing a measurement on analyte parameters in a blood sample aspirated into the blood gas analyzer from a blood sample container,” (Paras [0002], [0026], [0029] and [0123], [0103], in the context of blood gas analyzers, infrequent/new operators are more prone to making errors in the pre-analytical phase as well as in the aspiration of the blood sample. Difficulties in choosing sampler types (syringe/capillary). For example, the analyzer may open or close an inlet allowing the operator to insert a sample. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. Capillary sample. ); “the blood gas analyzer comprising: (a) a plurality of user-accessible parts;” (Para [0027], adapting the number of user interface elements); “(b) a controller;” (Para [0027], user interface); “(c) an aspiration system for aspirating the blood sample from the blood sample container, the aspiration system comprising an inlet structure for connecting to the blood sample container;” (Para [0026], manipulation of movable part of the analyzer such as aspiration); “(d) a monitor for outputting instructions to a user of the blood gas analyzer for the user's handling of one or more of user-accessible parts of the blood gas analyzer; ” (Para [0027], graphical user interface adapted to display respective user interface elements each associated with one or more steps of an operator-controllable task or workflow performed by the medical analyzer); “and (e) an electronic memory” (Para [0051], data storage device 209); “comprising at least two pre-stored sets of animated video instructions, each of the pre-stored sets of animated video instructions illustrating the user's correct handling of at least one of the user-accessible parts of the blood gas analyzer,” (Para [0051], [0114-0122] and Table 2, a data storage device 209 for storing program code and data. A training video on ways to avoid clots may be presented during the next logon. a training video on ways to avoid bubbles may be presented during the next logon.)
Jensen does not teach “wherein the user-accessible part comprises a gasket;”.
Ahlfors teaches “wherein the user-accessible part comprises a gasket;”. (Para [00131], A gasket (not shown) is installed around the enclosure access port 240 for forming a sealed connection between the isolator 120 and the enclosure 110.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Jensen to incorporate the teachings of Ahlfors wherein the user-accessible part comprises a gasket. Doing so allows the device to have a seal in which the user can access in order to maintain its cleanliness and ease of replacement if needed. This increases the life of the analyzer and the gasket itself.
Jensen further teaches “wherein the controller is configured to:(i) receive a signal indicative of:(A) at least one of a user input,” (Para [0059], [0052], timing parameters determining the relative timing of respective user interface actions. The user interface may be operable to present measurement results to the operator, to request operator inputs or other operator actions, to present selectable options and/or to present instructions to the operator.); (B) at least one of a presence, a position, and/or an orientation of the user-accessible parts, (Abstract, Paras [0057], and [0120], If the analyzer has repeatedly detected that no sample was detected in previous sessions, a training video on ways to aspirate samples may be presented during the next logon. One or more elements of a user interface of at least a first one of the set of medical analyzers when said first medical analyzer is operated by one of the one or more operators. In initial step 310, the operator logs onto the medical analyzer,). Therefore the detection of no sample upon the next logon in which the logon is to the medical analyzer which the user interface (controller) is a part of.
Jensen further teaches “or (C) at least one projected handling action of at least one of the user- accessible parts of the blood gas analyzer;” (Paras [0059], [0114-0122], If the analyzer has repeatedly detected that bubbles were present in samples a training video on ways to avoid bubbles may be presented during the next logon.). Therefore the logon is to the medical analyzer which the user interface (controller) is a part of.
Jense further teaches “and(ii) in response to the signal, determine if one of the animated video instructions is to be presented to the user, and in the affirmative: (A) select at least one of the at least two pre-stored sets of animated video instructions on a basis of the signal, and(B) output the at least one selected animated video instruction at the monitor.” (Paras [0051], [0059], [0052], [0103], and [0114-0122], and [0141], and [0098], Examples of usage history data, their relation to an operator proficiency level, and the resulting user interface adaptations, such training on the specific analyzer, will be briefly summarized: A training video on ways to avoid clots may be presented during the next logon. A training video on ways to avoid bubbles may be presented during the next logon. Based on the evaluation, the process determines (step S603) whether the operator should be offered to see a short training video. If the process makes the determination that the operator should be offered an instructional video (step S604), completion of the video may be made mandatory. Text and sound may be added to the video for detailing and emphasizing important details. The user interface may include a display such as a touch screen for displaying information, selectable menu items allowing an operator to select operational options, enter parameters, and/or the like. The user interface may be operable to present measurement results to the operator, to request operator inputs or other operator actions, to present selectable options and/or to present instructions to the operator. The guidance may be in the form of one or more screens, with or without one or more animations and/or videos demonstrating clot risk reducing behavior. Videos will only be shown to operators where determined necessary, thus not delaying proficient operators.).
Regarding claim 17, modified Jensen teaches all of claim 16 in addition to teaching “wherein the user-accessible parts of the blood gas analyzer further comprises at least one of: a solution pack, an inlet module, a sensor cassette, an inlet probe of the inlet structure, and an inlet connector gasket. ” (Paras [0026], [0145], solution pack, sensor unit, The analyzer may open or close an inlet. )
Regarding claim 18, modified Jensen teaches all of claim 17 in addition to teaching “wherein said signal is indicative of a need or a user desire to conduct at least one of: a manual flush for removing clots in a conduit of the blood gas analyzer, replacement or installation of the solution pack, replacement or installation of the sensor cassette, replacement of the inlet probe, replacement of the inlet connector gasket, replacement of the inlet gasket with holder, and replacement of the inlet module.” (Para [0144-0145], The system has detected that a certain operator has a poor history of solution pack replacement.).
Regarding claim 19, modified Jensen teaches all of claim 16 in addition to teaching “wherein each of the animated video instructions illustrates a sequence of steps of the user's correct handling of the at least one user-accessible part.” (Para [0114], training videos).
Regarding claim 20, Jensen teaches “A blood gas analyzer for performing a measurement on analyte parameters in a blood sample aspirated into the blood gas analyzer from a blood sample container,” (Paras [0002], [0026], [0029] and [0123], [0103], in the context of blood gas analyzers, infrequent/new operators are more prone to making errors in the pre-analytical phase as well as in the aspiration of the blood sample. Difficulties in choosing sampler types (syringe/capillary). For example, the analyzer may open or close an inlet allowing the operator to insert a sample. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. These analyses includes in vitro measurements on individual samples of e.g. whole blood, serum, plasma and urine, tissue samples or other types of samples obtained from a patient. Capillary sample. ); “the blood gas analyzer comprising: (a) a plurality of user-accessible parts;” (Para [0027], adapting the number of user interface elements); “(b) a controller;” (Para [0027], user interface); “(c) an aspiration system for aspirating the blood sample from the blood sample container, the aspiration system comprising an inlet structure for connecting to the blood sample container;” (Para [0026], manipulation of movable part of the analyzer such as aspiration); “(d) a monitor for outputting instructions to a user of the blood gas analyzer for the user's handling of one or more of user-accessible parts of the blood gas analyzer;” (Para [0027], graphical user interface adapted to display respective user interface elements each associated with one or more steps of an operator-controllable task or workflow performed by the medical analyzer); “and (e) an electronic memory” (Para [0051], data storage device 209); “comprising at least two pre-stored sets of animated video instructions, each of the pre-stored sets of animated video instructions illustrating the user's correct handling of at least one of the user-accessible parts of the blood gas analyzer;” (Para [0051], [0114-0122] and Table 2, a data storage device 209 for storing program code and data. A training video on ways to avoid clots may be presented during the next logon. a training video on ways to avoid bubbles may be presented during the next logon.); “wherein the controller is configured to:(i) receive a signal indicative of an orientation of the user-accessible parts,” (Paras [0059], [0114-0122], If the analyzer has repeatedly detected that bubbles were present in samples a training video on ways to avoid bubbles may be presented during the next logon.); “and (ii) in response to the signal, determine if one of the animated video instructions is to be presented to the user, and in the affirmative:(A) select at least one of the at least two pre-stored sets of animated video instructions on a basis of the signal, and (B) output the at least one selected animated video instruction at the monitor.” (Paras [0051], [0059], [0052], [0103], and [0114-0122], and [0141], and [0098], Examples of usage history data, their relation to an operator proficiency level, and the resulting user interface adaptations, such training on the specific analyzer, will be briefly summarized: A training video on ways to avoid clots may be presented during the next logon. a training video on ways to avoid bubbles may be presented during the next logon. Based on the evaluation, the process determines (step S603) whether the operator should be offered to see a short training video. If the process makes the determination that the operator should be offered an instructional video (step S604), completion of the video may be made mandatory. Text and sound may be added to the video for detailing and emphasizing important details. The user interface may include a display such as a touch screen for displaying information, selectable menu items allowing an operator to select operational options, enter parameters, and/or the like. The user interface may be operable to present measurement results to the operator, to request operator inputs or other operator actions, to present selectable options and/or to present instructions to the operator. The guidance may be in the form of one or more screens, with or without one or more animations and/or videos demonstrating clot risk reducing behavior. Videos will only be shown to operators where determined necessary, thus not delaying proficient operators.).
Response to Amendments
Claim Amendments
Applicant’s amendments to independent claim 1 have overcome the double patenting rejection based on the present claims require that the controller is configured to receive a signal from a user input which US patent application 18/004,462 does not require.
Response to Arguments
The applicant stated the claims were amended as discussed in the interview and all claims are in condition for allowance.
In response, the examiner conducted a further review for the gasket and has identified teachings in the prior art. Therefore, rejections are applied to the new claims (e.g., claim 16) requiring the gasket.
The attorney stated that the cited prior art in the previous Office action did not teach all of the limitations (A), (B), and (C) as recited in claim 1.
In response, it was noted during the interview held on November 24, 2025 that the cited prior art would be “double checked” when the proposed amendments were formally filed. Upon further review of the cited prior art, the examiner identified claimed components (A), (B), and (C) (see Action above).
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 VELVET E HERON whose telephone number is 571-272-1557. The examiner can normally be reached M-F 8:30am – 4:30 pm.
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 http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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 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 would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798