DETAILED ACTION
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 .
Status of Claims
The claim set submitted on 09 MAY 2024 is acknowledged and considered. In the claim set, Claims 1-20 are presented and are considered on the merits below.
Information Disclosure Statement
The nine (9) information disclosure statement (IDS) submitted on 15 JULY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 11 FEBRUARY 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “306” has been used to designate both pipette controller and reader controller, in [0069] and [0070], respectively. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-4, 7, 8, 10-12 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 18, 19 and 21 of U.S. Patent No. 12,007,403 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant invention further defines “a portion of the carrier shuttle is disposed vertically above a portion of the carousel”.
The ‘403 patent and the instant invention are basically the same as the instant invention simply claims a “a first side; a second side opposite the first side; a loading bay along the first side; a pipetting mechanism adjacent the second side; a rotatable carousel; and a carrier shuttle to transport a carrier between a first position adjacent the first side and a second position adjacent the pipetting mechanism”, while the ‘403 patent teaches the same invention, but with more specificity and limitations. The ‘403 patent does not teach or suggest any specific location or orientation of the carrier shuttle .
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘403 to have “a portion of the carrier shuttle is disposed vertically above a portion of the carousel” create a smaller footprint of the overall device, save space and to have the carrier shuttle access to the carousel with as little movement of the pipetting mechanism, cutting down time for dispensing/aspirating liquid and increase throughput.
The dependent claims in the instant invention, Claims 2-4, 7, 8, 10-12 and 14-20 and the dependent claims in the ‘403 patent , Claims 2-9, 18, 19 and 21, are basically identical in context and verbiage and are indistinguishable from each other.
Claims 1, 6, 9-14 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 7-11 of U.S. Patent No. 11,125,766, submitted on the Information Disclosure Statement on 15 JULY 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant invention and the ‘766 patent are directed towards a diagnostic analyzer with a loading bay, a carrier shuttle and a pipetting mechanism. The instant invention further defines “a portion of the carrier shuttle is disposed vertically above a portion of the carousel”.
The ‘766 patent and the instant invention are basically the same as the instant invention simply claims a “a first side; a second side opposite the first side; a loading bay along the first side; a pipetting mechanism adjacent the second side; a rotatable carousel; and a carrier shuttle to transport a carrier between a first position adjacent the first side and a second position adjacent the pipetting mechanism”, while the ‘766 patent further defines a controller; however, it would be obvious to one having ordinary skill in the art before the effective filing date to modify ‘766 to have “a portion of the carrier shuttle is disposed vertically above a portion of the carousel” create a smaller footprint of the overall device, save space and to have the carrier shuttle access to the carousel with as little movement of the pipetting mechanism, cutting down time for dispensing/aspirating liquid and increase throughput.
Claims 2-6, 11, 2 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-9, 11-15 and 18 of U.S. Patent No. 10,267,818, submitted on the Information Disclosure Statement on 15 JULY 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant invention and the ‘818 patent are directed towards a diagnostic analyzer with a loading bay, first and second carriers, and a pipetting mechanism. While the ‘818 patent is more generically claimed and claims a means for transporting the carriers, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘means for transporting’ to be carrier shuttles as recited in the instant invention to efficiently and effective more than one sample at a time. In addition it would be obvious to one having ordinary skill in the art before the effective filing date to modify ‘818 to have “a portion of the carrier shuttle is disposed vertically above a portion of the carousel” create a smaller footprint of the overall device, save space and to have the carrier shuttle access to the carousel with as little movement of the pipetting mechanism, cutting down time for dispensing/aspirating liquid and increase throughput.
Claims 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,335,338, submitted on the Information Disclosure Statement on 15 JULY 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant invention and the ‘338 patent are directed towards an analyzer with a loading bay, first carrier, and a pipetting mechanism. The ‘338 patent more specifically claims a track, while the instant invention discloses a carrier shuttle. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the ‘338 to have a carrier shuttle so it can be more specific to the carrier and move it in an efficiently and effective way. In addition, it would be obvious to one having ordinary skill in the art before the effective filing date to modify ‘338 to have “a portion of the carrier shuttle is disposed vertically above a portion of the carousel” create a smaller footprint of the overall device, save space and to have the carrier shuttle access to the carousel with as little movement of the pipetting mechanism, cutting down time for dispensing/aspirating liquid and increase throughput.
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.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over LUOMA, US Publication No. 2008/0190735 A1, submitted on the Information Disclosure Statement on 15 JULY 2025.
Regarding Claim 1, the LUOMA reference discloses a diagnostic analyzer , abstract, diagnostic system, Figure 7, comprising: a first side, Figure 7; a second side opposite the first side, Figure 7; a loading bay along the first side, Figure 7, [0069], loading bay 120; a pipetting mechanism adjacent the second side, Figure 7, [0070], pipette 134; a rotatable carousel, Figure 7, carousel 168, or tray 132, [0079]; and a carrier shuttle to transport a carrier between a first position adjacent the first side and a second position adjacent the pipetting mechanism, Figure 7, [0069], robotic transporter 130 with carrier 126 or 128.
The LUOMA reference discloses the claimed invention, but is silent in regards to wherein a portion of the carrier shuttle is disposed vertically above a portion of the carousel.
The LUOMA discloses wherein the carrier shuttle overlaps a portion of the carousel. However, LUOMA discloses that the carrier shuttle overlaps underneath the carousel, Figure 7, not wherein the carrier shuttle is disposed vertically above a portion of the carousel.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the reference to have “a portion of the carrier shuttle is disposed vertically above a portion of the carousel” create a smaller footprint of the overall device, save space and to have the carrier shuttle access to the carousel with as little movement of the pipetting mechanism, cutting down time for dispensing/aspirating liquid and increase throughput.
Additional Disclosures Included are: Claim 2: wherein the diagnostic analyzer of claim 1, wherein the carousel is a reagent carousel to support a plurality of containers with reagent liquids for use in the diagnostic analyzer, [0013]. ; Claim 3: wherein the diagnostic analyzer of claim 2, further including a processing carousel to support a plurality of reaction vessels, the pipetting mechanism to aspirate a sample from the carrier and dispense the sample into one of the reaction vessels on the processing carousel, Figure 7, carrier 128 in carousel 168, accessed by pipette 134, [0079].; Claim 4: wherein the LUOMA reference discloses the claimed invention, but is silent in regards to wherein the reaction vessels are reusable cuvettes. It would be obvious to one having ordinary skill in the art before the effective filing date to have the reaction vessels which are reusable cuvettes so that the overall system is ecofriendly cutting down on waste and economically friendly cutting down on costs of parts of the device. ; Claim 5: wherein the diagnostic analyzer of claim 3, wherein the pipetting mechanism is movable along an arcuate path over the reagent carousel and the processing carousel, Figure 7, see arc. ; Claim 6: wherein the diagnostic analyzer of claim 1, wherein the pipetting mechanism is rotatable about an axis outside of a circumference of the carousel, Figure 7. ; Claim 7: wherein the LUOMA reference discloses the claimed invention, but is silent in regards to wherein further including a second carrier shuttle disposed adjacent the first carrier shuttle. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the number of carrier shuttles to increase the throughput of the analyzer and to increase the number of samples to be processed. ; Claim 8: wherein the LUOMA reference discloses the claimed invention, but is silent in regards to wherein a portion of the second carrier shuttle is disposed vertically above a portion of the carousel. The LUOMA discloses wherein the carrier shuttle overlaps a portion of the carousel. However, LUOMA discloses that the carrier shuttle overlaps underneath the carousel, Figure 7, not carrier shuttle is disposed vertically above a portion of the carousel. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the reference to have “a portion of the second carrier shuttle is disposed vertically above a portion of the carousel” create a smaller footprint of the overall device, save space and to have the carrier shuttle access to the carousel with as little movement of the pipetting mechanism, cutting down time for dispensing/aspirating liquid and increase throughput. ; Claim 9: wherein the diagnostic analyzer of claim 7, wherein the second carrier shuttle is independently movable relative to the first carrier shuttle, Figure 7, carousel 168, or tray 132, [0079]. ; Claim 10: wherein the diagnostic analyzer of claim 7, wherein the first and second carrier shuttles are parallel to each other, Figure 7 and 8, transporter 130 and positioning shelf 132.; Claim 11: wherein the diagnostic analyzer of claim 1, further including a positioner to transport the carrier between the loading bay and the carrier shuttle, the positioner moveable along a track, the track disposed along the first side, [0038]. ; Claim 12: wherein the diagnostic analyzer of claim 11, wherein the carrier shuttle is movable in a direction that is perpendicular to the track of the positioner, [0038, 0069]. ; Claim 13: wherein the diagnostic analyzer of claim 11, wherein the positioner includes a reader to detect a label on the carrier, [0077, 0078].; Claim 14: wherein the diagnostic analyzer of claim 1, wherein the carrier shuttle includes a carriage and a lead screw to move the carriage, Figure 5 and 6, screws 82/90, [0050, 0051].; Claim 15: wherein the diagnostic analyzer of claim 1, wherein the carrier shuttle includes a conveyor belt, [0035, 0051]. ; Claim 16: wherein the diagnostic analyzer of claim 15, wherein the carrier shuttle includes a motor to move the conveyor belt and a sensor to detect movement of the conveyor belt, [0035, 0051].; Claim 17: wherein the diagnostic analyzer of claim 16, wherein the motor and the sensor are disposed near opposite ends of the carrier shuttle, Figure 1, motor 58, Figure 6, sensor 102, [0035, 0048, 0049]. ; Claim 18: wherein the diagnostic analyzer of claim 1, wherein the pipetting mechanism includes an arm that is rotatable about an axis of rotation and a pipette at a distal end of the arm, Figure 7, [0070]. ; Claim 19: wherein the diagnostic analyzer of claim 1, wherein the loading bay includes a plurality of slots arranged in a horizontal array along the first side, Figure 4 and 7. ; and Claim 20: wherein the diagnostic analyzer of claim 1, wherein the diagnostic analyzer is to perform an immunoassay or a clinical chemistry assay, [0039, 0056, 0064].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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, LYLE ALEXANDER can be reached at (571) 272-1254. 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.
CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
Prosecution Insights