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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/23/26 has been entered.
Response to Amendment
As to the amended claims and remarks filed on 12/3/25, the previous 101 rejection is withdrawn as the claims are directed towards a system that would be considered a particular machine and significantly more under steps 2A prong Two and step 2B, respectively.
Based on the claim amendments and remarks, the previous prior art rejection are withdrawn and new rejections are set forth to address the claim amendments.
Claim Status
Claims 1-4, 6-16 are pending with claims 1-4, 6-11 being examined and claims 12-16 deemed withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “a digital vision system comprising at least two cameras…to resister, for reach of the plurality of carriers, a spatial and rotational relationship within the coordinate system…” in lines 11-14. Support for the newly added limitation of the instant claims was not found by the examiner in the original disclosure, as no mention of multiple (each) camera acquiring “rotational” relationships exists in the disclosure. The examiner notes that the instant specification does state that one camera 22 acquires images at rotational positions in [47], but then the specification states in [48] that the other camera images a plan view irrespective of rotation. Therefore, there is not support in the disclosure for at least two cameras that each acquire images to register a rotational relationship, and these limitations are considered new matter. Claims 2-4, 6-11 are rejected based on further claim dependency.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4, 8, 10, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sinz, A (US 20170174448; hereinafter “Sinz”; already of record) in view of Pollack, B (US 20160011224; hereinafter “Pollack”; already of record) and in view of Pollack et al (US 20160025756; hereinafter “Pollack II”).
As to claim 1, Sinz teaches a clinical diagnostics system (Sinz; Fig. 1) comprising: at least one analyzer (Sinz teaches stations 20, 25 which can be analyzers; [30, 32]); a planar track that facilitates motion freely along two horizontal axes, the planar track comprising an upper surface and a plurality of electromagnetic coils that selectively provide electromagnetic actuation along the horizontal axes (Sinz teaches a track; [30, 33, 34], Fig. 1. Sinz teaches electro-magnets; [4, 6, 7, 19-27, 34]); a plurality of carriers, that are selectively moved above the upper surface by the plurality of electromagnetic coils (Sinz teaches carriers moving on the track; [30, 33, 34, 36], Fig. 1); the plurality of carriers each configured to hold one or more patient samples (Sinz teaches carriers moving on the track; [30, 33, 34, 36], Fig. 1); a digital vision system comprising a camera that captures images of the plurality of carriers and samples held by the carrier, and registers a spatial relationship within the coordinate system between the carrier and the one or more patient samples held by the carrier (Sinz teaches adjusting magnetic force to correct position based on feedback from a position detection system such that carriers can be positioned at intended positions, where the detector is a camera connected to a control; Fig. 1, [42]); and an electronic carrier motion control system that monitors a position of each of the plurality of carriers relative to the planar track and thereby tracks the one or more patient samples in the coordinate system, and moves each of the plurality of carriers to align the one or more patient samples with the at least one analyzer (Sinz teaches that the device includes a controller which can determine the position of the carrier and track the carrier and the corresponding sample; [42]. Sinz teaches moving the carriers to an analyzer; [30-34]), wherein the at least one analyzer is arranged above the planar track and the carriers (Sinz teaches plural carriers moving on a horizontal plane, where the carriers are moved to the analyzers and the analyzers are above the horizontal plane and track/carriers such that they can receive the carriers on the track; Fig. 1, [30-34]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Sinz does not specifically teach that the carriers carrying the samples include a rack that holds the samples, or that the vision system includes two cameras, each having a different orientation in the coordinate system, and where the respective positions of the carrier and the racks and samples are monitored. However, Pollack teaches the analogous art of an analyzer system (Pollack; Fig. 16, 25. Pollack teaches an automation system where carriers can move in a two dimensional plane and that tracking positions enables the paths to avoid collisions [193, 197-198], where this provides advantages over track based systems [193-196]) where carriers are used to transport racks that hold samples (Pollack teaches that carriers can hold various payloads, including racks of tubes; [91, 94, 50]), and where there is a vision system that includes two cameras, each having a different orientation in the coordinate system (Pollack teaches tracking positioning with multiple cameras that can be used with the automation system; [223, 224], Fig. 25.), and where the respective positions of the carrier and the racks and samples within the coordinate system are monitored (Pollack teaches the importance of tracking the position of the carriers and their payload in order to improve precision and accuracy during analysis; [123]). It would have been obvious to one of ordinary skill in the art to have modified the carriers carrying samples and the tracking of the positioning of the carriers and samples with a single camera of Sinz to have used carriers carrying a payload of racks holding samples and tracking the positioning of the corresponding carrier payload with two cameras as in Pollack because Pollack teaches that multiple cameras above the system allow real-time tracking (Pollack; [224]) and Pollack also teaches that carriers are known to carry various payloads including racks of samples (Pollack; [91, 94, 50]), because Pollack teaches that multiple cameras to track the positioning are known (Pollack; [223, 224]) and because Pollack teaches that it is important to track the position of the carriers and their payload in order to improve precision and accuracy during analysis (Pollack; [123]).
Modified Sinz does not specifically teach that the rotational relationship of the carrier and rack held by the carrier are determined. However, Pollack II teaches the analogous art of an analyzer system (Pollack II; [56]) with multiple cameras that determine various characteristics including the rotational relationship of the carrier and rack (Pollack II teaches that there can be multiple cameras; [15, 67, 93, 96, 118, 205]. Pollack II teaches that various characteristics of the carrier and rack can be determined [205-233], where these characteristics include the rotational offset of the carrier and rack/tube [13, 95, 208]). It would have been obvious to one of ordinary skill in the art to have modified the system using multiple cameras to capture images and use imaged characteristics to register the location and track and move the carriers and racks of modified Sinz to have also evaluated the rotational offset as in Pollack II because Pollack II teaches that rotational offset is a known characteristic that is used to help identify the location and orientation of the sample rack/vessel (Pollack II; [13, 95, 208]) and also because Pollack II teaches that the various characterization information helps to ensure that the sample rack/vessel is is processed correctly (Pollack II; [66]).
As to claim 2, modified Sinz teaches the clinical diagnostics system of claim 1, wherein the track and the plurality of carriers are configured for real-time positioning of each carrier relative to the clinical diagnostics system (Sinz teaches adjusting magnetic force to correct position based on feedback from a position detection system such that carriers can be positioned at intended positions; Fig. 1, [42]).
As to claim 3, modified Sinz teaches the clinical diagnostics system of claim 1, wherein the spatial relationship registered by the digital vision system comprises position and orientation of the one or more patient samples relative to each of the plurality of carriers (Sinz teaches that the device includes a controller which can determine the position of the carrier and track the carrier and the corresponding sample; [42]. Further, the modification of Sinz with Pollack has already been discussed above, and Pollack teaches the importance of tracking the position of the carriers and their payload in order to improve precision and accuracy during analysis; [123]).
As to claim 4, modified Sinz teaches the clinical diagnostic system of claim 1, wherein the electronic carrier motion control system comprises a processor and a plurality of magnetic sensors (Sinz teaches adjusting magnetic force to correct position based on feedback from a position detection system such that carriers can be positioned at intended positions, where the detector is a camera connected to a control; Fig. 1, [42]. Sinz teaches magnetic hall sensors; [35]).
As to claim 8, modified Sinz teaches the clinical diagnostics system of claim 1, wherein the track and the plurality of carriers are configured to effect magnetic levitation and motion of the carriers in a horizontal plane above an upper surface of the track by using permanent magnets (As best understood, Sinz teaches electromagnetic transport in a horizontal plane along the track, which would involve magnetic levitation and motion; [4, 6, 7, 19-27, 34]. Sinz teaches the use of permanent magnets; [15, 36]. The instant specification (see page 7 of instant specification) relies on electromagnetic transport, thereby providing the same configuration).
As to claim 10, modified Sinz teaches the clinical diagnostics system of claim 1, wherein the at least one analyzer comprises a robotic pipettor configured for linear pipette motion in a direction substantially parallel to a vertical axis (Sinz teaches that the stations may include an aliquot station or a pipetting station, which would require a pipette to move vertically in order to access the tube contents; [32]).
As to claim 11, modified Sinz teaches the clinical diagnostics system of claim 1, further comprising an automation control system configured for workflow optimization and sample prioritization (Sinz teaches a control device, where the system controls the movement of the sample carriers, and therefore the samples are processed in a controlled order and are therefore prioritized; [6]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sinz, A (US 20170174448; hereinafter “Sinz”; already of record) in view of Pollack, B (US 20160011224; hereinafter “Pollack”; already of record) in view of Pollack et al (US 20160025756; hereinafter “Pollack II”) in view of Stein et al (WO2018017771 where US 20190277869 is used as the corresponding document; hereinafter “Stein”; already of record).
As to claims 6-7, Sinz teaches the clinical diagnostics system of claim 1, with analyzer stations above the track where the analyzer station includes a loader, and where the analyzer stations would need some type of reagent in order to provide sample analysis (Sinz teaches loader; [14, 19]. Sinz also teaches various stations for analysis that require reagents; [30, 32]).
Although Sinz teaches the respective stations above the track, Sinz does not specifically teach that the stations include one or more loaders; and one or more supply stations for biochemical reagents. However, Stein teaches the analogous art of an analyzer (Stein; Figs. 1-2, 4-6) with various carriers on a track, and a loader and reagent supply (Stein teaches loader 20; [75, 83]. Stein teaches a reagent supply 354 that also connects to a handling robot; [254-257]. Stein teaches the reagent carrier 64 as a reagent supply; [3, 82, 100, 101]). It would have been obvious to one of ordinary skill in the art to have modified the stations of Sinz to include the loader and reagent supply as in Stein because Stein teaches that in order to provide an automated analysis device that samples and reagents need to be provided to the device (Stein; [75, 83, 100-101, 254-257]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sinz, A (US 20170174448; hereinafter “Sinz”; already of record) in view of Pollack, B (US 20160011224; hereinafter “Pollack”; already of record) and in view of Pollack et al (US 20160025756; hereinafter “Pollack II”) in view of Wissmann et al (WO2019027769 where US 20200256884 is used as the corresponding document; hereinafter “Wissmann”; already of record).
As to claim 9, modified Sinz teaches the clinical diagnostics system of claim 3, wherein the digital vision system comprises one or more digital cameras (Sinz; [42]).
Modified Sinz does not specifically teach the digital vision system comprises one or more digital cameras equipped with a telecentric objective. However, Wissmann teaches the analogous art of an analyzer (Wissmann; Fig. 1) where the imaging device can include a variety of detectors including a telecentric camera (Wissmann; Fig. 3-4, [53]). It would have been obvious to one of ordinary skill in the art to have modified the position detecting camera of modified Sinz to be a telecentric camera as in Wissmann because Wissmann teaches that telecentric cameras are well-known imaging devices commonly used to provide imaging in automated analysis devices (Wissmann; [53]).
Claim 8 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Sinz, A (US 20170174448; hereinafter “Sinz”; already of record) in view of Pollack, B (US 20160011224; hereinafter “Pollack”; already of record) in view of Pollack et al (US 20160025756; hereinafter “Pollack II”) in view of Komori, M (US 20080029368; hereinafter “Komori”; already of record).
As to claim 8, Sinz teaches the clinical diagnostics system of claim 1, wherein the track and the carriers are configured to effect magnetic levitation and motion of the carriers in a horizontal plane above an upper surface of the track (As best understood, Sinz teaches electromagnetic transport in a horizontal plane along the track, which would involve magnetic levitation and motion; [4, 6, 7, 19-27, 34]. Sinz teaches the use of permanent magnets; [15, 36]. The instant specification (see page 7 of instant specification) relies on electromagnetic transport, thereby providing the same configuration). However, if it is deemed that Sinz does not disclose magnetic levitation, then Komori teaches the analogous art of a transfer device for a carrier which relies on magnetic levitation to move the carrier (Komori teaches carrier 12 which moves to transport an object via magnetic levitation; [35]. Komori also teaches the transfer of samples; [50]). It would have been obvious to one of ordinary skill in the art to have modified the track and carriers which relied on magnetic movement of Sinz to provide magnetic levitation as in Komori because Komori teaches that magnetic levitation is a well-known method to transfer the carrier (Komori; [35]) and that magnetic levitation is effective to provide non-contact transport of samples (Komori; [50]).
Response to Arguments
Applicant’s arguments, filed on 12/3/25, have been considered but are moot because the arguments are towards the amended claims and not the current ground of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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