DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The limitations in claim 1 do not appear to have full support in the earliest filed provisional 62/719085 filed on August 16, 2018. Therefore, it seems that the earliest effective filing date of claim 1 is the later filed provisional 62/855643 filed on May 31, 2019. If applicants believe that the earlier provisional provides support for the instant claims, then the examiner requests that applicants specifically point out the language and locations in which the provisional provides support for each and every limitation of claim 1.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 08, 2025 follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite a “method for user guided initiating of an instrument”, and therefore the answer is “yes”.
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” because said operations could be performed in the mind. The method includes determining whether a number of unused reagent containers, receiving a run plan, and determining whether the number is sufficient, which can be performed in the human mind or basic comparison or counting. Thus, if a claim, under its BRI, covers performance of the limitation in the mind, but for the recitation of generic computer elements, then it falls within the “mental processes” grouping of abstract ideas.
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated are as follows:
(a) the camera and vision module/system are used for generic data collection, and the user interface is used for generic output. The claims do not recite a specific improvement to camera technology, vision processing, or instrument operation such that the recitations amount to no more than instructions to apply the judicial exceptions on said generic computer;
(b) The claims include steps directed to detect the presence of the unused consumable, which is a data gathering step, also recited at a high level of generality. In such case, said detecting is not operatively connected to the application of said judicial exception other than to provide the determination that unused consumables are present;
(c) The claims include steps directed receiving and indicating on a user interface, which are recited at a high level of generality in the claim, wherein the input/output is invoked as a tool to present the information.
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because the camera, vision module/system, and user interface are well-understood, routine, conventional components used in their ordinary capacity, see references applied to the 35 103 rejections below, therefore do not provide an inventive concept.
The claims 2-15 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea. The claims amount to no more than receiving information, and indicating information (displaying data), which is an intangible abstract idea. The instant claims do not include an inventive concept.
Additionally, see MPEP 2106.04(a)(2)(III)(C) states that methods of performing a mental process on a generic computer, performing a mental process in a computer environment, or using a computer as a tool to perform a mental process are all claims that recite a mental process. Specifically, because the claims are directed to receiving and indicating data, which amount to providing information and then displaying information, the steps are directed towards using a computer as a tool to receive and indicate data. Further, because the claims recite the generic use of a computer, the claimed receiving and indicating data is an action that humans could have performed amongst themselves (or in their own mind).
MPEP 2106.04(a) details that the claims must reflect disclosed improvement. Note specifically the MPEP 2106.05(a),4th paragraph- the claims must include the components or steps of the invention that provide the improvement described in the specification. The problem addressed in the specification indicates sequencing and similar automated tests require many reagents and consumables, which makes setup complicated and error-prone, see spec para [0003]-[0004]. Users may place the wrong item, forget an item, leave a lid on, fail to lock a latch, or try to run with a used container. These mistakes can lead to invalid tests, wasted materials, and extra cost para [0004]. The instant claims do not include the components or steps necessary reflect any improvement to solve the stated problem. The user interface displays missing, used, open, or unlatched items so the user can correct setup step-by-step which merely turns preparation into a guided verification workflow similar to a manual checklist.
Thus, the claims are non-statutory. Applicant is encouraged to amend the claims to recite a specific improvement to the vision system or camera technology, or a specific technical solution to the stated problem.
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.
Claims 1, 3, 8, and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites “determining with a vision module including a camera of the instrument a number of unused reagent containers” and subsequently recites “determining with the vision system whether the number of unused reagent containers is sufficient.” The claim first introduces a “vision module including a camera” but later refers to “the vision system.” The term “vision system” lacks antecedent basis. It is unclear whether the “vision system” is the same as or a different element from the “vision module including a camera.”
Claim 3 depends from claim 1 and recites “wherein detecting a number of used reagent containers includes detecting foil piercings.” However, the limitation “detecting a number of used reagent containers” is introduced in claim 2, not claim 1. Claim 1 recites “determining... a number of unused reagent containers” but does not recite “detecting a number of used reagent containers.” Because claim 3 depends from claim 1, not claim 2, the phrase “detecting a number of used reagent containers” lacks antecedent basis in the claim from which it depends. The examiner recommends amending claim 3 to depend on claim 2.
Claim 8 recites “reading a code of the consumable with the vision system and indicating the presence of the consumable via the user interface when the code is correct.” The phrase “when the code is correct” is indefinite because the claim does not specify what standard or comparison is used to determine whether a code is “correct.” The claim does not recite a reference code, a database, or a stored value against which the code is compared.
Claim 16 recites “a user interface in communication with the management module.” However, the claim introduces only “a management system” as an element of the instrument. The term “management module” lacks antecedent basis. It is unclear whether the “management module” is the same as or a different element from the claimed “management system”.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-10, 15, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Glezer et al (US 20180074082; hereinafter “Glezer”- already of record) in view of Chamberlin et al., (US 20110143947; hereinafter “Chamberlin”-already of record) and VanSickler et al. (WO 2017143182; see corresponding US 20200319219 (already of record) for citations below; hereinafter “VanSickler”).
Regarding claim 1, Glezer discloses a method for initiating an instrument 10 having a computer and graphical user interface through which an operator selects a protocol from predetermined protocols.
The protocol defines the assay format, reagent and sample plates, predetermined plate locations, and actions carried out by the robotic and pipetting components. Reagent plates include multiple wells containing reagents. Before operation, the system checks whether the required plates and reservoirs are in their expected locations and whether the correct articles are loaded, see paras [0075]-[0078]; Figs. 1-3. This corresponds to the claimed step of receiving a run plan identifying a test and associated parameters and using reagents stored in a set of reagent containers.
Glezer does not expressly determine with a camera the number of unused reagent containers and compare that number with the requirements of the selected protocol.
Chamberlin records which wells of an assay consumable have been used and which have yet to be used; subsequently reads that information; selects unused wells; determines which wells are available; inventories the consumables present; compares the inventory with the consumable requirements of a selected assay protocol; and prompts the user when a required consumable is absent or in insufficient supply, see paras [0229]-[0230] and [0238]-[0239].
VanSickler teaches the camera based implementation. VanSickler’s pre-analytical deck has a vision system in which a camera acquires an image of racks and containers. The image is evaluated for pierced tubes, capping errors, and mixed container types and is compared with stored rack information; the computing device records the result and the graphical interface notifies the operator, see paras [0236], [0440]-[0442] and Figs. 1-3 and 31.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Glezer's pre-run protocol verification to maintain Chamberlin's used/unused status for the (containers) wells of each reagent plate and to employ VanSickler's camera and image-analysis routine to detect the physical state of the wells. The controller would count wells detected as used, derive the remaining unused count from the known total, and compare that count with the number required by Glezer's selected protocol. These references in combination address the same problem in automated analytical instruments: preventing a run from beginning with incorrect, unavailable, or previously used consumables. The modification uses each controller, camera, identifier, and interface for its disclosed function, leaves the assay-processing principle unchanged, and predictably reduces loading and reuse errors. VanSickler demonstrates that camera inspection of pierced analytical containers and comparison with stored instrument information, thereby establishing a reasonable expectation of success.
Regarding claim 2, Chamberlin records which wells have been used and which remain unused and determines which wells are available, see paras [0229] and [0239]. VanSickler visually identifies containers that are already pierced, see paras [0236] and [0440]. Counting the containers classified as used is the direct counterpart of Chamberlin's determination of the remaining unused wells and could be reasonably performed by the combined controller for the reasons disclosed above.
Regarding claim 3, Chamberlin expressly teaches that a foil seal covers the wells and that an optical sensor may determine whether the foil seal of a well has been pierced, see paras [0099] et seq. VanSickler expressly uses a camera to identify already pierced analytical containers, see paras [0236] and [0440]. It would have been obvious to use VanSickler's camera as Chamberlin's optional optical sensor to classify a foil-covered well as used when a puncture is detected. The combination produces the predictable result disclosed by both references.
Regarding claim 5, Glezer's selected protocol reads on the reagent and sample articles and their expected positions. The Glezer system checks whether the correct articles are loaded, and its computer communicates status to the operator, see paras [0076]-[0078]. Chamberlin inventories protocol required consumables, verifies that they are loaded, and prompts for each absent or insufficient item, see paras [0230] et seq. VanSickler performs the presence/error determination with a vision system and reports the result through GUI 820, see paras [0236] et seq. It would have been obvious for the GUI to display both the required article and an affirmative completion or presence indication when the vision check succeeds, because the complementary success state removes uncertainty after the disclosed missing item check and uses only the already known result of that check.
Regarding claim 6, Glezer and Chamberlin verify multiple reagent, sample, and assay consumables required by a protocol, see citations above. Repeating the same indication, vision detection, and success reporting for another required consumable would have been the ordinary operation of the multi-item inventory and would yield the same predictable verification result.
Regarding claim 7, Chamberlin compares the installed inventory with the selected protocol and prompts the user when a required consumable is absent or present in insufficient supply; processing does not begin without an available matched set wherein the insufficiency results from used wells identified by the camera, see para [0230] et seq. Directing the user to replace that partially or fully used consumable is the immediate corrective instruction that restores the required supply. VanSickler likewise advises removal of a rack found by vision to have a pierced container error, see [0236] et seq. The replacement indication to the operator through an interface therefore would have been an obvious and predictable response to the insufficiency determination.
Regarding claim 8, Chamberlin associates consumable with identifiers including barcodes or RFID identifiers, and verifies that loaded components match the assay requirements, see para [0235] et seq. Using code matching as the condition for confirmation via the operator interface would have been an obvious way to prevent a physically present but incorrect consumable using Chamberlin’s inventory check.
Regarding claim 9, VanSickler teaches that each consumable rack may carry an RFID tag that is scanned upon entry into system 10 to identify the types of containers present, see para [0113] et seq. Chamberlin teaches RFID as a consumable identifier and uses consumable identifiers to inventory and verify protocol-required articles, see paras [0092] and [0230]-[0239]. Employing the disclosed RFID detection for a second consumable and displaying the
resulting presence state through Glezer's interface would have been a predictable alternative where line of sight vision is not possible or convenient.
Regarding claim 10, Glezer expressly checks whether the required plates or reservoirs have lids and notifies the operator when a lid is missing, see paras [0077] et seq. VanSickler's vision system detects capping errors from a camera image and reports the error through the interface 820, see paras [0236] et seq. It would have been obvious to perform Glezer's lid check with VanSickler's disclosed vision technique and to display the affirmative lid -present state upon successful detection for the same reason given for claim 5.
Claim 15 broadly recites “the instrument is a nucleic acid sequencing instrument”. The examiner has interpreted the claimed “nucleic acid sequencing instrument” as very broad, not necessarily indefinite. Applicant’s specification as filed is devoid of technical details to the particular structure(s) (or sequencing operations) corresponding to a “nucleic acid sequencing instrument”. Since the claim does not require specific limitations there is no difference between the claimed nucleic acid sequencing instrument and the Glezer instrument. In fact, Glezer discloses the instrument 10 can be used for nucleic acid sequencing, see para [0182] et seq.
Regarding claim 16, Glezer discloses an automated instrument having a computer that manages a selected assay protocol, communicates with the automated components, and provides a graphical user interface. The protocol identifies the required reagent, sample, and assay plates and their expected positions; the system checks whether the correct consumables are loaded and reports loading or lid errors, see paras [0066]-[0068] and [0076]-[0078]; Figs. 1-3. VanSickler discloses a vision system and camera on an automated analytical deck, a computing device that evaluates the images against stored rack information, and GUI 820 through which the operator is notified of detected consumable errors, see para [0236],[0440]-[0442]; Figs. 1-3, 31. Combining VanSickler's camera and image analysis module with Glezer's management computer and user interface yields the recited management system, vision module, set of cameras, and communicating interface for the same advantages delineated above.
It would have been obvious to display successive status screens or prompts for the several protocol-required consumables because Glezer checks multiple articles and VanSickler reports the result of each image-based check. A series of interfaces is a conventional presentation of those already determined states and does not change the detection process. The combination predictably guides the operator through loading while retaining the operating principle of each automated instrument (see reasoning applied to claim 1 above).
Regarding claim 17, VanSickler further teaches RFID tagged racks scanned on entry to identify the container types present. VanSickler, see paras [0113] et seq. Providing the associated RFID reader/module and antenna in communication with Glezer's management computer for a second set of consumables would have been an ordinary implementation of that express teaching, particularly for consumables outside the camera's view or requiring stored identity data. The RFID components perform their known detection function and supply the result to the same management interface.
Claim 4 is rejected under 35 U.S.C. § 103 as unpatentable over Glezer in view of Chamberlin and VanSickler, as applied to claim 3 above, and further in view of Dickopf (US 20150111236), already of record.
Regarding claim 4, the Glezer/Chamberlin/VanSickler combination as applied to claim 3 above, detects a foil puncture from a camera image but does not expressly require a pixel-by-pixel comparison. Dickopf teaches acquiring digital images of an analytical test article, comparing every pixel of a current image with the corresponding pixel of a reference image, generating a matrix of pixel differences or ratios, and classifying pixels by applying thresholds to the differences, see paras [0050]-[0051] and [0070]-[0071].
It would have been obvious to implement VanSickler's current image comparison with Chamberlin's foil covered wells using Dickopf's corresponding pixel difference and threshold technique. A puncture is a localized visual discontinuity; corresponding pixel comparison supplies a known way to locate and classify such a discontinuity relative to an unpierced reference. The modification is a software substitution operating on the same camera images and does not change the mechanical or assay operation of any of the applied references. Dickopf is reasonably pertinent because it addresses precise optical detection of localized changes on diagnostic test articles. Dickopf’s implementation of the algorithm provides a reasonable expectation that the method would distinguish punctured from intact regions. The references do not teach away from digital comparison, and the rejection does not require incorporation of Dickopf's analyte chemistry into the automated instrument.
Claims 11-14 are rejected under 35 U,S.C. § 103 as unpatentable over Glezer Chamberlin and VanSickler, and further in view of Yuyama et al. (US 20150335531; hereinafter “Yuyama”- already of record).
Regarding claim 11, Glezer teaches a latching member 405 that engages and fixedly holds an assay consumable in a storage unit, see paras [0129]-[0130]; and Figs.13(a-d). Yuyama teaches chuck 140 having movable upper locking member 142 and lower member 141. The locking member fixes the neck of a medical-fluid container, and its angle and locked relationship are optically evaluated, see paras [0090] et seq.; Figs. 6 and 7. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to apply Yuyama's optical locked-position verification to Glezer's consumable latch so that the existing controller confirms that the reagent-containing consumable is fixed before robotic processing. Both mechanisms secure analytical or medical consumables, and the added optical verification does not alter the latch's holding function.
Regarding claim 12, Yuyama's locking member 142 has marks 142c on its upper surface. Camera 121 images the marks, and controller 500 recognizes them to evaluate the lock, see paras [0090] et seq. Those marks are the claimed set of indicators, and using them on Glezer's latch provides a direct noncontact indication of latch position.
Regarding claim 13, Yuyama expressly states that pivoting upper member 142 engages the ratchet and locks the container neck. The controller analyzes the image of marks 142c and determines when locking has not been made properly, see paras [0090] et seq. Determining the complementary successful state when the expected marks and container relationship are present is an express or at least inevitable result of the disclosed lock-verification routine.
Regarding claim 14, Yuyama discloses a plurality of three marks 142c and explains that an improperly positioned container neck can hide the marks so that they cannot be detected, see para [0090] et seq. Thus, the number of detected marks changes according to whether the locking relationship exposes or obscures the marks. Configuring the controller to compare the detected number with the expected number is the direct quantitative implementation of Yuyama’s express missing mark test and predictably distinguishes locked from improperly locked states.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,131,399 (hereinafter ‘399). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons delineated below.
Note: the judicially created doctrine of obviousness-type double patenting prevents extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in an earlier patent. The present application is a continuation of the application that issued as the '399 patent. The parent prosecution record includes a restriction requirement entered June 27, 2023. That restriction requirement does not preclude this rejection. The safe harbor of 35 U.S.C. § 121 is limited to a divisional application filed as a result of a restriction requirement and maintaining consonance with that requirement. The present application identifies itself as a continuation, not a divisional application. Accordingly, the present record does not establish entitlement to the§ 121 safe harbor. See MPEP §§ 804.01 and 821. Consonance is relevant to the availability of the safe harbor; it is not relied upon as the affirmative ground for this rejection. The rejection instead rests on the claim-to-claim lack of patentable distinctness set forth below.
Regarding claim 1 and claim 1 of the '399 patent, both receives a run plan through an instrument user interface, uses a camera-containing vision system to determine the number of unused reagent containers in a set, and determines whether that number is sufficient for the run plan. Present claim 1 removes limitations from that patented combination but adds no feature that produces a patentably distinct result. The claimed subcombination is an obvious variation of patented claim 1.
Regarding claim 2 and patented claim 1 determines the number of unused reagent containers by determining the number of used reagent containers. Present claim 2 isolates the same determination.
Regarding claim 3 and patented claim 1 detects foil piercings of used reagent containers with the vision system. Present claim 3 isolates the same detection.
Regarding claim 4 and patented claim 1 both detects foil piercings based on comparison of pixel values of a camera image with expected values. Conducting that disclosed image comparison on a corresponding-pixel basis is a direct and predictable implementation of the patented comparison and does not yield a patentably distinct result.
Regarding claim 5 and patented claim 1 both indicate run-plan consumables on a user interface, detects a consumable with the vision system, and indicates the presence of the consumable through the interface. Present claim 5 recites the same functions.
Regarding claim 6 and patented claim 2, in combination with patented claim 1, indicates another consumable, detects its presence, and indicates that presence. Present claim 6 recites the same subject matter.
Regarding claim 7 and patented claim 4, in combination with patented claim 1, indicates that a used consumable is to be replaced when the number of unused reagent containers is insufficient for the run plan. Present claim 7 recites the same subject matter.
Regarding claim 8 and patented claim 6, in combination with patented claim 1, reads a code of a consumable with the vision system and indicates presence when the code is correct. Present claim 8 recites the same subject matter.
Regarding claim 9 and patented claim 7, in combination with patented claim 1, determines the presence of a second consumable with an RFID system and indicates that presence through the user interface. Present claim 9 recites the same subject matter.
Regarding claim 10, patented claim 8, in combination with patented claim 1, detects with the vision system a lid disposed on a consumable and indicates the lid through the user interface. Present claim 10 recites the same subject matter.
Regarding claim 11, patented claim 1 detects with the vision system the position of a latch that holds an associated reagent container in place when locked. Present claim 11 recites the same subject matter.
Regarding claim 12, patented claim 1 detects visual indicators on the latch to determine latch position. Present claim 12 recites that same indicator detection at a broader level.
Regarding claim 13 and patented claim 1 both detects the locked position of the latch with the vision system. Present claim 13 recites the same subject matter.
Regarding claim 14 and patented claim 5, in combination with patented claim 1, detects the locked position from a change in how many visual indicators are detected. Present claim 14 recites the same subject matter.
Regarding claim 15 and patented claim 3, in combination with patented claim 1, identifies the instrument as a nucleic acid sequencing instrument. Present claim 15 recites the same subject matter.
Regarding claim 16, patented claims 1 and 2 require receipt of a run plan, an instrument user interface, a camera containing vision system, vision detection of run-plan consumables and interface indications for multiple consumables. Providing those patented functions in the recited management-system, vision-module, camera, and user-interface architecture is an obvious apparatus implementation in which each component performs its ordinary function.
Regarding claim 17 and patented claim 7 adds RFID detection of a second consumable and interface reporting of that detection. Providing an RFID module and antenna in the instrument of instant claim 16 to perform the patented RFID detection is an obvious apparatus implementation of patented claim 7.
A timely filed terminal disclaimer in compliance with 37 C.F.R. § 11321 may be used to overcome this rejection if the statutory and common-ownership requirements are satisfied.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Pertinent Prior Art
The following prior art is hereby made of record. Although the prior art is relied upon, the examiner considers the listed prior art relevant to the applicant’s invention and may be relied upon in a future prior art rejection or as general background information related to applicant’s field of endeavor.
Benedetti et al., (US 20170177913) teach a method for storing temporary data in a memory of a RFID tag associated with a consumable of a laboratory instrument for processing a reagent or biological sample is disclosed. The method comprises providing the RFID tag associated with the consumable. The RFID tag comprises a memory. The memory comprises a user memory configured to store user data and a system memory configured to store system data. The laboratory instrument writes the temporary data into the system memory. The temporary data are associated with a process to be carried out by the laboratory instrument. Further, a system comprising a laboratory instrument for processing a reagent or biological sample, a consumable and a RFID tag associated with the consumable is disclosed. The laboratory instrument is configured to carry out the method.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per 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.
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.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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