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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/2022, 08/12/2025 were filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2-16 are objected to because of the following informalities:
Claims 2-16 recite “Claim” and should be amended to lower case “claim”
Claim 12 lines 3-6 recite “at least one supply unit”, “at least two microscope slide scanners”, “at least one intermediate storage rack”, “at least one final storage rack” and should be amended to “the at least one supply unit”, “the at least two microscope slide scanners”, “the at least one intermediate storage rack”, “the at least one final storage rack”
Appropriate correction is required.
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.
Claim 1-16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 1 line 4 recites “which in each case” and is unclear whether the limitation “each case” refers to the loading of each microscope slide or to each physical microscope slide. For prosecution, the limitation “each case” will be interpreted to mean each slide. Claims 2-16 dependent on claim 1 are also rejected for said dependency.
Claim 10 line 3 recites “and/or the steps e') and e''')” and there is insufficient antecedent basis for this limitation in the claim. For prosecution, the limitation and/or will be interpreted to mean “or”.
Claim 14 line 3 recites “and/or the steps e') and e''')” and there is insufficient antecedent basis for this limitation in the claim. For prosecution, the limitation and/or will be interpreted to mean “or”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lefebvre (US20160245833A1 published 08/25/2016).
Regarding claim 1, Lefebvre teaches a method for scanning microscope slides using at least two microscope slide scanners (imagers 308, 310, 312 – Fig. 4 and paragraph 75), comprising:
a) loading a supply unit for microscope slides with a multiplicity of microscope slides (obtaining at a material handling system a biological sample that has been mounted on a slide – paragraph 21 and Fig. 1) (a group of 10 slides placed in a basket – paragraphs 56, 86), which in each case belong to one of a plurality of sample series (a “sample series” is interpreted as a set of two or more related slides) (the group of slides are deemed to be related because the slides are subjected to the sample staining protocol (paragraph 54) and comprises more than two sets of related slides),
b) transferring one microscope slide in each case from the supply unit to each microscope slide scanner not loaded with a microscope slide (Once the imager is available, the slide is transported to the imager (block 114) for imaging – paragraph 25) (any other type of robot device suitable for transferring a slide between processing stations may be used such as a robotic arm – paragraph 82),
c) carrying out a scanning process for each loaded microscope slide scanner (Individual slides or the basket of slides may be assigned to one of imagers 308, 310, 312 based on the imagers availability – paragraph 56),
d) transferring each scanned microscope slide from the respective microscope slide scanner to an intermediate storage rack (a group of slides are transported within a basket, and a robot arm may be used to retrieve and deposit individual slides within the basket – paragraph 82),
e) providing a data record for each scanning process for examination (the specimen(s) may be examined and the data may be made available to a diagnostician and/or an optional interpretation module which automatically interprets the data – paragraph 25 and Fig. 1), and
f) transferring all microscope slides of a sample series from the intermediate storage rack to a final storage rack (a tray or basket holding 10 slides may be stored within one of slide stations 602 of a storage module 314 – Fig. 4, 8-9 and paragraph 86) (the basket is deemed to hold “all microscope slides of a sample series” ) (Following the iterations of additional tests and procedures, the pathologist repeats the examination process, and may then request still further tests in an iterative fashion until an ultimate finding is reached – paragraph 9).
Regarding claim 2, Lefebvre teaches the method according to Claim 1, wherein each microscope slide of the supply unit is transferred to a microscope slide scanner (the slide is transferred to the transport module using a robotic transferring device – paragraph 22), scanned there and subsequently transferred to the intermediate storage rack (a group of slides are transported within a basket, slides must be removed individually from the basket for imaging and a robot may be used to retrieve and deposit individual slides within the basket – paragraph 82), according to the steps b), c) and d).
Regarding claim 3, Lefebvre teaches the method according to Claim 1, wherein step f) is carried out for all sample series to which the microscope slides (a tray or basket holding 10 slides may be stored within one of slide stations 602 – paragraph 86), with which the supply unit (6) was loaded according to step a), belong (a group of slides are transported within a basket, slides must be removed individually from the basket for imaging – paragraph 82).
Regarding claim 4, Lefebvre teaches the method according to Claim 1, wherein the intermediate storage rack has a multiplicity of identifiable storage positions (storage module 314 may have a plurality of slide stations 602. Each of slide stations 602 may be dimensioned to receive and store a slide – paragraph 86) and the storage position of each microscope slide in the intermediate storage rack is stored in a database (Slides stored within stations 602 may be located and retrieved from storage 314 using an indexing system retrievable by a system – paragraph 87) (The slide location information may be stored by the system – paragraph 96).
Regarding claim 5, Lefebvre teaches the method according to Claim 1 wherein in step d), the microscope slides are placed in the intermediate storage rack in an unordered manner according to sample series (For example, a tray or basket holding 10 slides may be stored within one of slide stations 602 – paragraph 86) (storing the basket of 10 slides is deemed to read on unordered manner according to sample series because the basket is interpreted to hold more than two sets of related slides).
Regarding claim 6, Lefebvre teaches the method according to Claim 1, wherein, in step f), the stored storage position in the intermediate storage rack is read for all microscope slides of the respective sample series (A reader (e.g., an RFID or bar code reader) may be positioned at the entrance to storage module to read an identifier associated with the slide, and a controller 400 uses the information to identify an open slide station within storage module 314 – paragraph 96) and the microscope slides are ordered in the final storage rack according to sample series (storage module 314 is configured to group slides according to user-defined criteria. For example, slides pertaining to a patient case could be placed in the same area – paragraph 60).
Regarding claim 7, Lefebvre teaches the method according to Claim 1, wherein, after step e) and before step f) (Following the iterations of additional tests and procedures, the pathologist repeats the examination process, and may then request still further tests in an iterative fashion until an ultimate finding is reached – paragraph 9), the method additionally comprises
e’) transferring a microscope slide from the intermediate storage rack (16) to an unloaded microscope slide scanner (when the pathologist repeats the examination process a group of slides are transported within a basket and the slides are individually from the basket to the imagers 308, 310, 312 for imaging – paragraph 82),
e’’) carrying out a re-scanning process of the microscope slide (the pathologist repeats the examination process, and may then request still further tests in an iterative fashion until an ultimate finding is reached – paragraph 9), and
e’’’) transferring the re-scanned microscope slide to the intermediate storage rack (when the pathologist repeats the examination process a robot arm may be used to retrieve and deposit individual slides within the basket – paragraph 82).
Regarding claim 8, Lefebvre teaches the method according to Claim 7, comprising after step e) for each data record, determining whether the associated microscope slide is to be re-scanned according to the steps e') to e''') (In a further aspect of the invention, the diagnostician may order or conduct further iterative processing, testing or examination – paragraph 27).
Regarding claim 9, Lefebvre teaches the method according to Claim 7, wherein, after step e), the scanning parameters for the scanning process according to step e'') are determined (Examination, imaging and interpretation of the sample may be continued until the system or diagnostician deems it to be complete – paragraph 27).
Regarding claim 10, Lefebvre teaches the method according to Claim 1, wherein one, a plurality or all transfers of the microscope slides according to the steps b), d) and f), and/or the steps e') and e''') are executed by at least one industrial robot (a Gantry or Cartesian coordinate type robot, a selective compliant assembly robot arm (SCARA) type robot, an articulated arm type robot, or a combination thereof – paragraph 82).
Regarding claim 11, Lefebvre teaches the method according to Claim 10, wherein the at least one industrial robot is an articulated robotic arm (an articulated arm type robot – paragraph 82).
Regarding claim 12, Lefebvre teaches a device (automated system 300 – Figs. 3-4) for scanning microscope slides according to the method according to Claim 1, comprising:
at least one supply unit for microscope slides (group of slides placed in a basket may be loaded into staining module 304 – paragraph 54),
at least two microscope slide scanners (imagers 308, 310, 312 – Fig. 4 and paragraph 96),
at least one intermediate storage rack for microscope slides (a basket holding slides – paragraph 82), and
at least one final storage rack for microscope slides (the storage module 314 may have a plurality of slide stations 602 – paragraph 86).
Regarding claim 13, Lefebvre teaches the device according to Claim 12, comprising at least one industrial robot designed to execute one, a plurality or all of the steps b), d) and f) (“designed to execute” is interpreted as intended use and is deemed to read on a robot capable of executing one, a plurality or all of the steps b), d) and f)) (the robotic arm is capable of executing all of the steps b), d) and f) – paragraph 82).
Regarding claim 14, Lefebvre teaches the method according to Claim 1, wherein one, a plurality or all transfers of the microscope slides according to the steps b), d) and f), and/or the steps e') and e''') are executed by exactly one industrial robot (an articulated arm type robot – paragraph 82).
Regarding claim 15, Lefebvre teaches the method according to Claim 10, wherein the at least one industrial robot is a 6-axis, 7-axis or 8-axis articulated robotic arm (a SCARA type robot has an articulated robotic arm, and a SCARA type robot coupled in a Gantry type robot has at least 6-axis – paragraph 82), which has a gripper for gripping the microscope slides (a robotic arm capable of grasping slide 424 and transferring slides between imagers 308, 310, 312 – paragraph 82).
Regarding claim 16, Lefebvre teaches the device according to Claim 12, comprising exactly one industrial robot (an articulated arm type robot – paragraph 82), which is designed to execute one, a plurality or all of the steps b), d) and f) (“designed to execute” is interpreted as intended use and is deemed to read on a robot capable of executing one, a plurality or all of the steps b), d) and f)) (the articulated arm type robot is capable of executing all of the steps b), d) and f) – paragraph 82).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 5712727129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796