Prosecution Insights
Last updated: April 19, 2026
Application No. 18/560,126

METHOD FOR OPERATING A LABORATORY AUTOMATION SYSTEM, LABORATORY AUTOMATION SYSTEM, AND LABORATORY IN-VITRO DIAGNOSTIC SYSTEM

Non-Final OA §102§103§112
Filed
Nov 10, 2023
Examiner
BROTHERS, LAURENCE RAPHAEL
Art Unit
3655
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Roche Diagnostics Operations Inc.
OA Round
1 (Non-Final)
83%
Grant Probability
Favorable
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 83% — above average
83%
Career Allow Rate
38 granted / 46 resolved
+30.6% vs TC avg
Strong +24% interview lift
Without
With
+23.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
40 currently pending
Career history
86
Total Applications
across all art units

Statute-Specific Performance

§101
4.8%
-35.2% vs TC avg
§103
48.1%
+8.1% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
23.7%
-16.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 46 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Priority 2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Status 3. Claims 1-15 are pending in this application. All claims were amended by preliminary amendment. Specification 4. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01. Examiner’s Note 5. The examiner would welcome an interview to clarify any of the various rejections seen below in order to expedite prosecution of the instant application. Claim Interpretation 6. Independent claim 1 discloses the following structures, all of which are taken to be distinct, one from another: pluralities of “devices”, “carriers”, and “transfer devices”, at least one “portable device”, and at least one “sample container”. In the absence of formal lexicographic definitions in the instant specification, we apply the following broadest reasonable interpretations based on their usage in the claim: device: when the word “device” is unmodified by any adjective such as “transfer” or “portable”, it is interpreted specifically as a laboratory analysis device capable of configuration for “sample pre-analysis” or capable of analyzing a sample, per claim 1. carrier: any structure capable of carrying a sample container. transfer device: any machine that can transfer a carrier. portable device: any conventional portable computer including a phone, tablet, or laptop. sample container: a container that can contain samples of anything whatsoever. 7. Claims 1 and 5-6 recite “device identification” and “interface identification”. In the context of applicant’s wireless network, we interpret these terms as network addresses such as are universally required for all modern networked devices, including those communicating through Wi-Fi, Bluetooth, or cellular wireless networks. We note that all networked devices necessarily comprise interfaces. 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. 8. Claims 1-15 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. Claims 1 and 14 recite the limitation "the distribution system" in their final limitations. There is insufficient antecedent basis for this limitation in the claims. Claims 2-13 and 15 inherit the indefiniteness of claims 1 and 14. For purposes of examination on the merits in this office action, we interpret “the distribution system” as “the transport system”. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 9. Claims 2 and 4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. It appears that claims 2/1 and 4/3, both of which ultimately depend from claim 1, both in effect repeat the final limitation of claim 1. Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements. 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. 10. Claims 1-6, 9-10 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shibuya, et al., US 2021/0123935 (hereinafter Shibuya). 11. Regarding claim 1, Shibuya discloses: A method for operating a laboratory automation system (100: fig. 1),Also see abstract and [0001]. wherein the laboratory automation system comprises a plurality of devices (analyzer 101: fig.1, 101a-d: fig. 2; analyzer devices 106a-c: fig 1) provided in a laboratory area configured for at least one of sample pre-analytics and sample analysis;Shibuya discloses in figs. 1-2 a plurality of analyzers 101a-d comprising a plurality of analyzer devices 106a-c; either or both of these types of systems could be the “devices” of the claim. a transport system (comprising transfer line 105: fig. 1) having a plurality of carriers (sample rack 103: fig. 1) configured to carry one or more sample containers (sample container 102: fig. 1) and configured to transport the plurality of carriers to the plurality of devices; a plurality of transfer devices (instances of 105: fig. 2) each assigned to at least one of the plurality of devices and configured to transfer at least one of a carrier from the plurality of carriers and a sample container received in the at least one carrier between the transport system and the at least one device;Shibuya discloses in fig. 1 and [0042] an abstract transport line 105 that links analyzer devices 106a-c that are comprised by analyzer 101. Shibuya discloses in fig. 2 analyzers 101a-d that each comprise a distinct transfer line 105 following the pattern of fig. 1, hence a plurality of transfer devices. a portable device (tablet terminal: 114: fig. 1) having one or more data processors and a user interface comprising a display configured to output image data, and an input device configured to receive user input;Tablet computers such as Shibuya’s 114 universally comprise all the claimed substructures and features, namely at least one processor and a touchscreen. and a plurality of data communication modules (113, 209: fig. 4) configured for wireless data communication, wherein each of the plurality of data communication modules is assigned to at least one of a device from the plurality devices, the transport system, a transfer device from the plurality of transfer devices, and the portable device;The two numbered wireless data communication modules 113 and 209 are respectively assigned to a portable device and the overall transport system controlled through the information management PC of fig. 4. Other communication modules are disclosed in fig. 4 for other types of devices such as analyzers, and these can also be considered to be configured for wireless communication inasmuch as portable device 114 can communicate with all these devices at least indirectly via the combination of wireless and possibly wired networks (the generic communication devices of the figure may or may not be wireless). the method comprising: receiving device information for the plurality of devices in the portable device, the device information being indicative of a device identification;Before any wireless device can communicate with another on a computer communications network, it is necessary for the network to receive device identifiers from the devices on the network. This registration step is a universal feature of all modern communication networks such as Wi-Fi, Bluetooth, and cellular networks, and without it the devices could not communicate. receiving a first user input in the portable device, the user input being indicative of a selection of a first device from the plurality of devices;Shibuya discloses the selection of an individual device 101a from the plurality 101a-d by means of the tablet in [0084]-[0086] and [0102]-[0104]. in response to receiving the first user input, pairing the first device with the transport system for data communication in operation of the first device for at least one of sample pre-analytics and sample analysis;Shibuya discloses device pairing via the tablet in [0102]-[104]. When the user taps a device selection button, the device is selected, which selection constitutes pairing as regard subsequent transport of the sample to the analyzer via the transport system. and providing first pairing information in the portable device, the first paring information being indicative of the first device and the distribution system being paired successfully.Shibuya discloses feedback from the system to the tablet after selection of a device to be paired in [0104]. This is indicative of the pairing being accomplished. 12. Regarding claim 2, Shibuya discloses the limitations of claim 1 and also: wherein the pairing comprises pairing a first transfer device assigned to the first device with the transport system for data communication in operation of the first device for at least one of sample pre- analytics and sample analysis.This claim appears to reprise one of the limitations of parent claim 1 and thus the claim is rejected on the same grounds. 13. Regarding claim 3, Shibuya discloses the limitations of claim 1 and also: wherein the pairing comprises pairing the first device with a first transport system interface of the transport system, thereby, assigning the first transport system interface to the first device.All networked devices comprise interfaces. The pairing or assignment of a networked device also represents the pairing or assignment of all a device’s comprised components. As we have already demonstrated the pairing of the transport system and a selected device in the rejection of claim 1 it follows that the transport system interface is also assigned as part of the pairing. 14. Regarding claim 4, Shibuya discloses the limitations of claim 3 and also: wherein the pairing comprises pairing the first transfer device with the first transport system interface for data communication in operation of the first device for at least one of sample pre-analytics and sample analysis.This claim appears to reprise one of the limitations of parent claim 1 and thus the claim is rejected on the same grounds. 15. Regarding claim 5, Shibuya discloses the limitations of claim 1 and also: further comprising assigning a first interface identification to the first transport system interface wherein the first pairing information is indicative of a first device identification assigned to the first device and the first interface identification.Since Shibuya’s devices are networked and since all network devices comprise interfaces, in order to pair or assign an (analyzer) device to the transport system as previously demonstrated in the rejection of claim 1, Shibuya must necessarily pair or assign the interface identifier to the system or else the devices would be unable to communicate. 16. Regarding claim 6, Shibuya discloses the limitations of claim 5 and also: further comprising assigning the first interface identification to the first transport system interface and a first transfer device identification to the first transfer device, wherein the first pairing information is indicative of the first interface identification and the first transfer device identification.Again, for devices to communicate on a network, their identifiers must be shared as part of their registration to the network. A pairing or assignment of two networked devices such as the claimed transfer device and the claimed (analysis) device necessarily indicates a pair of identifiers for the devices. 17. Regarding claim 9, Shibuya discloses the limitations of claim 3 and also: the receiving of the first user input comprises - providing an interface selection menu indicative of one or more transport system interfaces available for pairing with the one or more devices from the device selection menu; outputting the interface selection menu via the display; and in the portable device, receiving a first interface user input indicative of a selection of the first transport system interface from the one or more transport system interfaces provided in the interface selection menu.Regarding these limitations, Shibuya discloses the selection of an analyzer from a device selection screen (i.e. a menu) in [0102]-[0104]. Per Shibuya’s fig. 2 (overall system), and fig. 1 (individual analyzer), each analyzer 101a-d comprises its own transfer line 105. Thus, the selection of an analyzer 101 also constitutes the selection of a transfer device 105. Therefore Shibuya’s device selection screen of [0102] is both an analyzer device selector and a transport device selector. As transport devices comprise transport interfaces, the selection of a device in [0102]-[0104] comprises the selection of a transport device and a transport device interface. Thus the device menu is also a transport interface menu and the user input in this menu is indicative of a transport interface as claimed. 18. Regarding claim 10, Shibuya discloses the limitations of claim 1 and also: wherein receiving of the device information comprises receiving device signals indicative of device information and broadcasted by the plurality of devices while the portable device is moving through the laboratory area.All the devices on a local-area wireless communications network broadcast device signals with their network addresses (i.e. indicative of device information) and all these signals are received by a tablet such as Shibuya’s 114 which is plainly part of Shibuya’s laboratory system and thus is in the laboratory area. These signals are received regardless of whether the device is moving or not. 19. Regarding claim 13, Shibuya discloses the limitations of claim 1 and also: further comprising - providing protocol information in the portable device, the protocol information being indicative of the one or more paired devices;All network communication comprises protocol information, for example Internet Protocol (IP), among many other network protocols. Whenever devices are “paired” (which state comprises networked communication) they necessarily provide protocol information as part of their networked communication. An indication of pairing occurs whenever one paired networked device communicates directly to another paired networked device because the network addresses of both devices are part of the protocol used in the communication. and - transmitting the protocol information to a central backend device (112: fig. 4) in response to user confirmation input received in the portable device.Shibuya discloses in fig. 4 several central back end devices including an information management PC 112. Shibuya discloses communication between tablet 114 and this device in great detail over [0098]-[0116], but considering for example [0105], the user has selected a device on their tablet 114, and the terminal display unit 208 of the tablet confirms the user input. Subsequently, after various other tablet activities in the intervening paragraphs, in [0112] the information management communication unit 231 of the information management pc receives communication from the tablet. This communication, like all network communication, necessarily comprises the claimed protocol information. 20. Regarding claim 14, Shibuya discloses: A laboratory automation system (100: fig. 1) comprising a plurality of devices (analyzer 101: fig.1, 101a-d: fig. 2; analyzer devices 106a-c: fig 1) provided in a laboratory area configured for at least one of sample pre-analytics and sample analysis; a transport system (comprising transfer line 105: fig. 1) having a plurality of carriers (sample rack 103: fig. 1) configured to carry one or more sample containers (sample container 102: fig. 1) and configured to transport the plurality of carriers to the plurality of devices; a plurality of transfer devices (instances of 105: fig. 2) each assigned to at least one of the plurality of devices and configured to transfer at least one of a carrier from the plurality of carriers and a sample container received in the at least one carrier between the transport system and the at least one device; a portable device (tablet terminal: 114: fig. 1) having one or more data processors and a user interface comprising a display configured to output image data, and an input device configured to receive user input; and a plurality of data communication modules (113, 209: fig. 4) configured for wireless data communication, wherein each of the plurality of data communication modules is assigned to at least one of a device from the plurality devices, the transport system, a transfer device from the plurality of transfer devices, and the portable device; wherein the laboratory automation system is configured to: receive device information for the plurality of devices in the portable device, the device information being indicative of a device identification;Before any wireless device can communicate with another on a computer communications network, it is necessary for the network to receive device identifiers from the devices on the network. This registration step is a universal feature of such communication networks and without it the devices could not communicate. receive a first user input in the portable device, the user input being indicative of a selection of a first device from the plurality of devices;Shibuya discloses the selection of an individual device 101a from the plurality 101a-d by means of the tablet in [0084]-[0086] and [0102]-[0104]. in response to receiving the first user input, pair the first device with the transport system for data communication in operation of the first device for at least one of sample pre-analytics and sample analysis; Shibuya discloses device pairing via the tablet in [0102]-[104]. When the user taps a device selection button, the device is selected, which selection constitutes pairing as regard subsequent transport of the sample to the analyzer via the transport system. and provide first pairing information in the portable device, the first paring information being indicative of the first device and the distribution system being paired successfully.Shibuya discloses feedback from the system to the tablet after selection of a device to be paired in [0104]. 21. Regarding claim 15, Shibuya discloses the limitations of claim 14 and also: A laboratory in-vitro diagnostic system, comprising the laboratory automation system of claim 14.Shibuya discloses the analysis of blood and urine samples (i.e. in vitro diagnostic) in [0002]. 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. 22. Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Lippman, et al., US 2013/0232425 (hereinafter Lippman). 23. Regarding claim 7, Shibuya discloses the limitations of claim 1 but not: wherein the receiving of the device information comprises receiving device information being indicative of a device location in the laboratory area.Shibuya does not disclose location information. Lippman, an invention in the field of laboratory automation, teaches: wherein the receiving of the device information comprises receiving device information being indicative of a device location in the laboratory area.Lippman teaches the mapping of both “devices” (analyzers) and user devices (data entry terminals) in [0040] and [0050]. Lippman’s data entry terminals may be fixed or mobile per [0016] (i.e. may be like Shibuya’s tablets). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the system of Shibuya, wherein the receiving of the device information comprises receiving device information being indicative of a device location in the laboratory area, as taught by Lippman, because in a large laboratory with many analyzers and many operators, some operators may be assigned to particular groups of analyzers and transport devices, and so for efficiency the device information they receive should ideally be limited to the devices for which they are responsible. 24. Regarding claim 8, Shibuya in view of Lippman teaches the limitations of claim 7 and also: the receiving of the first user input comprises - determining a local position of the portable device within the laboratory area;Lippman teaches the mapping of user devices (data entry terminals) in [0040] and [0050]. Lippman’s data entry terminals may be fixed or portable per [0016] (i.e. may be like Shibuya’s tablets). - providing a device selection menu indicative of one or more devices from the plurality of devices), the one or more devices being located in the vicinity of the local position of the portable device; - outputting the device selection menu via the display;Shibuya teaches the display of device selection buttons (i.e. a menu) in [0102]. As modified by Lippman, this selection would only be of devices in the vicinity of the portable device. and - in the portable device, receiving a first user input indicative of a selection of the first device from the one or more devices provided in the device selection menu.Shibuya teaches this interaction in [0102]-[0104]. 25. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shibuya in view of Taga, et al., JP 2012027628 (hereinafter Taga). 26. Regarding claim 11, Shibuya discloses the limitations of claim 1 but not: further comprising outputting a laboratory layout via the display, the laboratory layout being indicative of the arrangement of the plurality of devices and the transport system in the laboratory area.While Shibuya discloses displaying a list of laboratory devices, it does not disclose the layout. Taga, an invention in the field of laboratory automation, teaches: further comprising outputting a laboratory layout via the display, the laboratory layout being indicative of the arrangement of the plurality of devices and the transport system in the laboratory area.Taga teaches a map display of laboratory devices in [0052] and fig. 19. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the system of Shibuya, wherein the receiving of the device information comprises receiving device information being indicative of a device location in the laboratory area, as taught by Taga, because in a large laboratory with many analyzers, where an operator has to manually perform some task associated with an analyzer it is important for the operator to be able to determine a device’s location easily. 27. Regarding claim 12, Shibuya in view of Taga teaches the limitations of claim 11 and also: wherein the outputting comprise outputting the laboratory layout with first marking information being indicative of one or more paired devices from the plurality of devices being successfully paired with the transport system.As Shibuya discloses user feedback from their selection of a device for pairing in its [0102]-[0104] and Taga teaches the display of a layout of devices including status information in its [0052], the combination of Shibuya and Taga would teach an indication of pairing (a form of status information) on the displayed layout of devices. Conclusion 28. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0106821 and US 2019/0154717 exemplify laboratory automation systems similar in many respects to applicant’s. Applicant’s own prior art US 2020/0116745 has some features in common with the instant application. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURENCE RAPHAEL BROTHERS whose telephone number is (703)756-1828. The examiner can normally be reached M-F 0830-1700. 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, Ernesto Suarez can be reached at (571) 270-5565. 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. /ERNESTO A SUAREZ/Supervisory Patent Examiner, Art Unit 3655 LAURENCE RAPHAEL BROTHERS Examiner Art Unit 3655A /L.R.B./Examiner, Art Unit 3655
Read full office action

Prosecution Timeline

Nov 10, 2023
Application Filed
Feb 27, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
83%
Grant Probability
99%
With Interview (+23.5%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 46 resolved cases by this examiner. Grant probability derived from career allow rate.

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