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
Claims 1-24 and 27-30 are pending. Claims 25-26 are canceled. Claims 29-30 are newly added.
Priority
Acknowledgement is made of Applicant’s claim of priority from PCT Application No. PCT/JP2022/015365 filed March 29, 2022 and Foreign Application No. JP2021-068051, filed April 13, 2021.
Response to Arguments
Applicant’s arguments, see p. 9, filed April 17, 2026, with respect to the 35 USC 112(a) rejections have been fully considered and are persuasive. The rejected claims have been canceled and the rejections have therefore been withdrawn.
Applicant’s arguments, see p. 9-11, filed April 17, 2026, with respect to the 35 USC 101 abstract idea rejections have been fully considered but are not persuasive. Applicant argues that the claims are not directed to an abstract idea, and even if they are, they are integrated into a practical application. Examiner respectfully disagrees. As described in the 35 USC 101 rejection below, a user or person skilled in the art may visually determine if a tip is mounted on the device, expel a specimen into a container using a pipette, determine from an image that something is hindering their ability to determine how much of the specimen was expelled, perform a process to remove the hindrance, and record evidence before and after performing the process. The steps of “acquiring a mounted tip image of a tip mounted on the specimen aspirating/discharging unit” and “acquiring an image of the specimen aspirating/discharging unit after the expelling of the specimen” are merely extra-solution activity of gathering information. Additionally, Examiner asserts that the claims are not integrated into practical application. As stated in MPEP 2106.04(d)(I), “merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea” does not integrate the judicial exception into practical application. Under the broadest reasonable interpretation of the claims, “performing processing so that a determination, of an expelled amount of the specimen, is prevented from being hindered by a phenomenon” is not sufficient to integrate the claims into practical application because merely reciting that a form of “processing” is performed on a computer does not integrate the abstract idea into practical application because the “processing” could still refer to something a person skilled in the art could perform manually. Therefore, the 35 USC 101 abstract idea rejection of the claims is upheld.
Applicant’s arguments, see p. 11-14, filed April 17, 2026, with respect to the 35 USC 103 rejections have been fully considered but are moot because of the new grounds of rejection presented in the sections below. Applicant argues that the Zucchelli and Mitsuru references do not teach the newly amended limitations. However, the Eugeni reference, previously used in the rejection of claims 9-10, 21-22, 25 and 27-28, teaches a camera for the acquisition of images of the tip of the diagnostic device and that at each acquisition the presence of the tip mounted on the pipetting channel of the machine is checked (see Eugeni, Paras. [0031] and [0053]). Therefore, the 35 USC 103 rejection of the claims is upheld, and consequently, THIS ACTION IS FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 1-24 and 27-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system, method, and computer-readable medium for recording execution information of a specimen aspirating/discharging unit. Consider method claim 1:
Step 1:
With regard to Step 1, the instant claim is directed to a method or a process; and therefore, the claim is directed to one of the statutory categories of invention.
Step 2A, Prong One:
With regard to 2A, Prong One, the limitations ‘determining a tip mounting determination result of whether or not the tip is mounted based on the mounted tip image”, “the pre-processing including a step of expelling a specimen in a specimen aspirating/discharging unit to an expelling destination container”, “performing processing so that a determination, of an expelled amount of the specimen, is prevented from being hindered by a phenomenon” and “recording the tip mounting determination result, an evidence obtained by the acquiring of the image of the specimen aspirating/discharging unit after the expelling, and an evidence after the processing in association with one another” as drafted, recite an abstract idea, such as a process that, under its broadest reasonable interpretation, covers performance of the limitations manually and in the mind of a person. That is, a user or person skilled in the art may determine if a tip is mounted on a device, expel a specimen into a container using a pipette, determine from an image that something is hindering their ability to determine how much of the specimen was expelled, perform a process to remove the hindrance, and record evidence before and after performing the process. This is the concept that falls under the grouping of abstract ideas mental processes, i.e., a concept performed in the human mind, evaluation, judgement, and/or opinion of the user.
Step 2A, Prong Two:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional step or a combination of additional steps in the claim to apply, rely on, or use the judicial exception. In the instant case, the additional step of “acquiring a mounted tip image of a tip mounted on the specimen aspirating/discharging unit” and “acquiring an image of the specimen aspirating/discharging unit after the expelling of the specimen” is considered to be extra-solution activity of gathering information. In addition, with respect to the system and computer-readable medium claims of claims 13 and 26, the mere recitation of a generic processor, memory, or storage medium to perform/store programming instructions of the recited/identified abstract idea does not integrate the identified abstract idea into a practical application. Accordingly, the above-mentioned additional elements/limitations do not integrate the abstract idea into a practical application; and therefore, the independent claims recite an abstract idea.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, the additional elements/limitations to perform the recited steps, amount to no more than insignificant extra-solution activity. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. Therefore, independent claims 1 and 13 are not patent eligible. In addition, claims 2-12, 14-24 and 27-30 of the instant application provide limitations that both individually or in combination do not integrate the identified abstract idea into a practical application or provide significantly more than the identified abstract idea.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 5, 7-10, 13, 17, 19-22 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchelli et al. (US 2013/0280143 A1) in view of Mitsuru et al. (JP 2004354100 A, machine translation used herein) further in view of Eugeni et al. (US 2022/0358647 A1).
Regarding claim 1, Zucchelli teaches an execution-information recording method for recording execution information obtained when pre-processing to be performed before a test using a specimen is executed in accordance with a protocol set in advance (Zucchelli, Para. [0075], methods and devices achieving volumetric monitoring and traceability of pipetting operations),
the pre-processing including a step of expelling a specimen in a specimen -aspirating/discharging unit to an expelling destination container (Zucchelli, Para. [0048], a camera allows imaging a pipette tip, a camera allows imaging the biofluid, wherein the relative position of the tip with respect to the various biofluid components is extracted from the image and used in order to control the aspiration and dispensing of a pipette in a certain location. Para. [0077], the reference image constitutes the logical reference after a dispensing operation), the execution-information recording method comprising the steps of:
acquiring an image of the specimen aspirating/discharging unit after the expelling of the specimen (Zucchelli, Para. [0077], the reference image constitutes the logical reference after a dispensing operation, where the presence of droplets or liquid left-overs can also be detected);
Although Zucchelli teaches an image taken after a dispensing operation where the presence of droplets or liquid left-overs can be detected to show that aspiration has not occurred correctly (i.e., a phenomenon hinders determination of an expelled amount of the specimen has occurred in the specimen aspirating/discharging unit), Zucchelli does not explicitly teach “performing processing so that a determination, of an expelled amount of the specimen, is prevented from being hindered by a phenomenon” and “recording the tip mounting determination result, an evidence obtained by the acquiring of the image of the specimen aspirating/discharging unit after the expelling, and an evidence after the processing in association with one another”. However, in an analogous field of endeavor, Mitsuru teaches identifying air bubbles as air bubbles when detecting foreign objects with high sensitivity, and by excluding air bubbles from candidate bubbles, it is possible to detect only foreign objects with high accuracy and high reliability (Mitsuru, Pg. 17). A set of bubble candidates is selected using the static properties of the bubbles and a set of actual bubbles is determined from a set of candidate bubbles. Foreign matter is detected as the residue obtained by subtracting the group of bubbles from the group of differential images of individual floating objects (Mitsuru, Pg. 15). The individual floating matter differential images excluding the floating matter differential images determined to be bubbles are detected as foreign matters and output (Mitsuru, Pg. 16). The multiple images stored in the image memory unit are processed in order by a differential image generation means, an edge pixel extraction means, a floating object differential image extraction means, a bubble candidate determination means, and a bubble judgment means, and finally the foreign object detection means outputs the results of foreign object detection (Mitsuru, Pg. 14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zucchelli with the teachings of Mitsuru by performing processing so that a determination is not hindered by a phenomenon (i.e., excluding bubbles from a foreign object determination) and recording the image before and after the processing in association with each other (i.e., storing multiple images in memory and processing them to obtain output image). One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for detection with high accuracy and reliability, as recognized by Mitsuru. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Although Zucchelli in view of Mitsuru teaches volumetric monitoring and traceability of pipetting operations (Zucchelli, Para. [0075]), they do not explicitly teach “acquiring a mounted tip image of a tip mounted on the specimen aspirating/discharging unit, and determining a tip mounting determination result of whether or not the tip is mounted based on the mounted tip image”. However, in an analogous field of endeavor, Eugeni teaches a camera for the acquisition of images of the tip of the diagnostic device (Eugeni, Para. [0031]), and that at each acquisition the presence of the tip mounted on the pipetting channel of the machine is checked (Eugeni, Para. [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zucchelli in view of Mitsuru with the teachings of Eugeni by including acquiring an image of a tip mounted on the device (i.e., specimen aspirating/discharging unit) and determining whether or not the tip is present (i.e., mounted) based on the image. One having ordinary skill would have been motivated to combine these references because doing so would allow for verifying that a correct volume of liquid has been dispensed, as recognized by Eugeni. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 5, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, wherein the phenomenon that hinders the determination is a film or air bubbles caused in the specimen aspirating/discharging unit (Zucchelli, Para. [0077], a bubble of air has been introduced in the pipette, modifying the actual liquid volume contained in the pipette with respect to the desired volume).
Regarding claim 7, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, wherein the evidence obtained by the acquiring of an image is subjected to processing so that the determination of the expelled amount of the specimen is prevented from being hindered by the phenomenon (Mitsuru, Pg. 14, the multiple images stored in the image memory unit are processed in order by a differential image generation means, an edge pixel extraction means, a floating object differential image extraction means, a bubble candidate determination means, and a bubble judgment means, and finally the foreign object detection means outputs the results of foreign object detection).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 7 and are incorporated herein by reference. Thus, the method recited in Claim 7 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Regarding claim 8, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, wherein the evidence obtained by the acquiring of an image is partially hidden or removed so that the determination of the expelled amount of the specimen is prevented from being hindered by the phenomenon (Mitsuru, Pg. 17, identifying air bubbles as air bubbles when detecting foreign objects with high sensitivity, and by excluding air bubbles from candidate bubbles, it is possible to detect only foreign objects with high accuracy and high reliability).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 8 and are incorporated herein by reference. Thus, the method recited in Claim 8 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Regarding claim 9, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, and further teaches wherein the determination of the expelled amount of the specimen is performed based on the evidence after the processing (Eugeni, Para. [0095], for each pipetting cycle, an image is acquired at the end of aspiration and processed to verify the correctness of the quantity and homogeneity of the aspirated liquid and an image at the end of each dispensing to verify that the correct volume of liquid has been dispensed).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 9 and are incorporated herein by reference. Thus, the method recited in Claim 9 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Regarding claim 10, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 9, further comprising recording an expelled amount determination result obtained by the determination, in association with the evidence obtained by the acquiring of an image and the evidence after the processing (Eugeni, Para. [0099], the frame collected from the image is stored in a system of encrypted folders or an encrypted database; the data relating to the entire session (i.e., evidence after processing) are attached to the log file of the same).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 10 and are incorporated herein by reference. Thus, the method recited in Claim 10 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Regarding claim 29, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, wherein the processing comprises at least one of image correction, image conversion, noise removal, edge enhancement, feature extraction, image recognition, and three- dimensionalization of a two-dimensional image (Mitsuru, Pg. 14, an edge pixel extraction means, a floating object differential image extraction means, a bubble candidate determination means, and a bubble judgment means, and finally the foreign object detection means outputs the results of foreign object detection).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 29 and are incorporated herein by reference. Thus, the method recited in Claim 29 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Claims 13, 17, 19-22 and 30 recite systems with elements corresponding to the steps recited in Claims 1, 5, 7-10 and 29, respectively. Therefore, the recited elements of these claims are mapped to the proposed combination in the same manner as the corresponding steps in their corresponding method claims. Additionally, the rationale and motivation to combine the Zucchelli, Mitsuru and Eugeni references, presented in rejection of Claim 1, apply to these claims. Finally, the combination of the Zucchelli, Mitsuru and Eugeni references discloses image acquiring means (Zucchelli, Para. [0047], a camera allows imaging a pipette tip), processing means (Zucchelli, Para. [0036], software interface allowing to define the liquid handling protocol to be executed), and recording means (Mitsuru, Pg. 12 image storage means).
Regarding claim 27, Zucchelli in view of Mitsuru further in view of Eugeni teaches an execution-information transmitting method for transmitting, to an external device, execution information obtained when pre-processing to be performed before a test using a specimen is executed in accordance with a protocol set in advance,
the execution-information transmitting method comprising transmitting, to the external device via a communication line, one or two or more pieces of execution information selected from among pieces of execution information recorded by the execution-information recording method of any one of claims 1 to 12 (Eugeni, Para. [0006], a transmitter that transmits the image collected by the camera and the collected data to a remote monitoring terminal via the Internet network).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 27 and are incorporated herein by reference. Thus, the method recited in Claim 27 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Regarding claim 28, Zucchelli in view of Mitsuru further in view of Eugeni teaches an execution-information transmitting device for transmitting, to an external device, execution information which is a record obtained when pre-processing to be performed before a test using a specimen is executed in accordance with a protocol set in advance,
the execution-information transmitting device comprising a communicating unit configured to transmit, to the external device via a communication line, one or two or more pieces of execution information selected from among pieces of execution information recorded in recording means by the execution-information recording device of any one of claims 13 to 24 (Eugeni, Para. [0006], a transmitter that transmits the image collected by the camera and the collected data to a remote monitoring terminal via the Internet network).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru and Eugeni references presented in the rejection of Claim 1, apply to Claim 28 and are incorporated herein by reference. Thus, the device recited in Claim 28 is met by Zucchelli in view of Mitsuru further in view of Eugeni.
Claims 2-3, 6, 14-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchelli et al. (US 2013/0280143 A1) in view of Mitsuru et al. (JP 2004354100 A, machine translation used herein) further in view of Eugeni et al. (US 2022/0358647 A1), as applied to claims 1, 5, 7-10, 13, 17, 19-22 and 27-30 above, and further in view of Hansen et al. (US 2004/0029260 A1).
Regarding claim 2, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, as described above.
Although Zucchelli in view of Mitsuru further in view of Eugeni teaches a method of volumetric monitoring and traceability of pipetting operations (Zucchelli, Para. [0075]), they do not explicitly teach “wherein the test using a specimen is a test of analyzing a base sequence of a nucleic acid or an amino acid sequence”. However, in an analogous field of endeavor, Hansen teaches a method for the isolation, amplification and detection of targeted nucleic acid sequences (Hansen, Para. [0051]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zucchelli in view of Mitsuru further in view of Eugeni with the teachings of Hansen by including testing the specimen by analyzing the nucleic acid sequence. One having ordinary skill in the art before the effective filing date would have been motivated to combine these references because doing so would allow for detecting target nucleic acids for diagnosing diseases, as recognized by Hansen. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 3, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according claim 1, as described above.
Although Zucchelli in view of Mitsuru further in view of Eugeni teaches a method of volumetric monitoring and traceability of pipetting operations (Zucchelli, Para. [0075]), they do not explicitly teach “wherein the test using a specimen is a test using a specimen liquid obtained by adding a buffer solution to a specimen”. However, in an analogous field of endeavor, Hansen teaches elution buffer is aspirated into pipette tips and is then dispensed into, and mixed with, the magnetic particles, thereby releasing the total nucleic acid from the magnetic particles (Hansen, Para. [0069]).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru, Eugeni and Hansen references presented in the rejection of Claim 2, apply to Claim 3 and are incorporated herein by reference. Thus, the method recited in Claim 3 is met by Zucchelli in view of Mitsuru further in view of Eugeni and Hansen.
Regarding claim 6, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, as described above.
Although Zucchelli in view of Mitsuru further in view of Eugeni teaches air bubbles are introduced into the pipette that modify the actual volume contained in the pipette (Zucchelli, Para. [0077], they do not explicitly teach “wherein the phenomenon that hinders the determination is caused due to characteristics of a buffer solution”. However, in an analogous field of endeavor, Hansen teaches elution buffer is aspirated into pipette tips and is then dispensed into, and mixed with, the magnetic particles, thereby releasing the total nucleic acid from the magnetic particles (Hansen, Para. [0069]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the method of Zucchelli in view of Mitsuru further in view of Eugeni with the teachings of Hansen by including aspirating buffer into pipette tips which causes the phenomenon that hinders as taught by Zucchelli. One having ordinary skill in the art because doing so would allow for detecting target nucleic acids for diagnosing diseases, as recognized by Hansen. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claims 14-15 and 18 recite systems with elements corresponding to the steps recited in Claims 2-3 and 6. Therefore, the recited elements of these claims are mapped to the proposed combination in the same manner as the corresponding steps in their corresponding method claims. Additionally, the rationale and motivation to combine the Zucchelli, Mitsuru, Eugeni and Hansen references, presented in rejection of Claim 2, apply to these claims. Finally, the combination of the Zucchelli, Mitsuru, Eugeni and Hansen references discloses image acquiring means (Zucchelli, Para. [0047], a camera allows imaging a pipette tip), processing means (Zucchelli, Para. [0036], software interface allowing to define the liquid handling protocol to be executed), and recording means (Mitsuru, Pg. 12 image storage means).
Claims 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchelli et al. (US 2013/0280143 A1) in view of Mitsuru et al. (JP 2004354100 A, machine translation used herein) further in view of Eugeni et al. (US 2022/0358647 A1), as applied to claims 1, 5, 7-10, 13, 17, 19-22 and 27-30 above, and further in view of Cui et al. (US 2022/0016633 A1).
Regarding claim 4, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, as described above.
Although Zucchelli in view of Mitsuru further in view of Eugeni teaches volumetric monitoring and traceability of pipetting operations (Zucchelli, Para. [0075]), they do not explicitly teach “wherein the test using a specimen is a test using a sequencer”. However, in an analogous field of endeavor, Cui teaches a sample is loaded into a portable sample loading device using a pipette and the portable sample loading device is put on a sequencing biochip platform of a sequencer for 10 minutes (Cui, Para. [0110]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zucchelli in view of Mitsuru further in view of Eugeni with the teachings of Cui by including the test performed on the specimen is a test in a sequencer. One having ordinary skill in the art before the effective filing date would have been motivated to combine these references because doing so would allow for simple and effective sample loading in a sequencer, as recognized by Cui. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claim 16 recites a system with elements corresponding to the steps recited in Claim 4. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Zucchelli, Mitsuru, Eugeni and Cui references, presented in rejection of Claim 4, apply to this claim. Finally, the combination of the Zucchelli, Mitsuru, Eugeni and Cui references discloses image acquiring means (Zucchelli, Para. [0047], a camera allows imaging a pipette tip), processing means (Zucchelli, Para. [0036], software interface allowing to define the liquid handling protocol to be executed), and recording means (Mitsuru, Pg. 12 image storage means).
Claims 11-12 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Zucchelli et al. (US 2013/0280143 A1) in view of Mitsuru et al. (JP 2004354100 A, machine translation used herein) further in view of Eugeni et al. (US 2022/0358647 A1), as applied to claims 1, 5, 7-10, 13, 17, 19-22 and 27-30 above, and further in view of Michael Rein (US 2020/0384655 A1).
Regarding claim 11, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, as described above.
Although Zucchelli in view of Mitsuru further in view of Eugeni teaches images stored in the memory for performing processing on (Mitsuru, Pg. 14), they do not explicitly teach “wherein the pre-processing includes a step of closing a cap of a specimen container after drawing of the specimen” and “wherein the execution-information recording method further comprises the steps of: determining whether or not the specimen container after the drawing of the specimen is capped; and recording a capping determination result obtained by the determination in association with specimen identification information for identifying the specimen”. However, in an analogous field of endeavor, Rein teaches the sample containers can be closed by caps of a given cap type (Rein, Para. [0012]). The control device can be configured to determine if the sample container is closed by a cap or not closed by a cap based on the sampled longitudinal profile (Rein, Para. [0015]). Further, the control device can determine the cap type based on the sampled longitudinal profile (Rein, Para. [0035]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zucchelli in view of Mitsuru further in view of Eugeni with the teachings of Rein by including a step of closing the cap of a sample container and recording a determination of if the sample container is closed by a cap or not closed by a cap and determining the cap type (i.e., specimen identification information). One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for performing capping determinations using a control device, as recognized by Rein. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 12, Zucchelli in view of Mitsuru further in view of Eugeni teaches the execution-information recording method according to claim 1, as described above.
Although Zucchelli in view of Mitsuru further in view of Eugeni teaches images stored in the memory for performing processing on (Mitsuru, Pg. 14), they do not explicitly teach “wherein the evidence obtained by the acquiring of an image and the evidence after the processing are recorded in association with specimen identification information for identifying the specimen or/and expelling destination identifying information for identifying an expelling destination of the specimen”. However, in an analogous field of endeavor, Rein teaches a color sensor coupled to the control device and configured to sense a color of the cap and may determine a cap type and/or sample container type (i.e., expelling destination identifying information) based on the color of the cap (Rein, Para. [0035]).
The proposed combination as well as the motivation for combining the Zucchelli, Mitsuru, Eugeni and Rein references presented in the rejection of Claim 11, apply to Claim 12 and are incorporated herein by reference. Thus, the method recited in Claim 12 is met by Zucchelli in view of Mitsuru further in view of Eugeni and Rein.
Claims 23-24 recite systems with elements corresponding to the steps recited in Claims 11-12. Therefore, the recited elements of these claims are mapped to the proposed combination in the same manner as the corresponding steps in their corresponding method claims. Additionally, the rationale and motivation to combine the Zucchelli, Mitsuru, Eugeni and Rein references, presented in rejection of Claim 11, apply to these claims. Finally, the combination of the Zucchelli, Mitsuru, Eugeni and Rein references discloses image acquiring means (Zucchelli, Para. [0047], a camera allows imaging a pipette tip), processing means (Zucchelli, Para. [0036], software interface allowing to define the liquid handling protocol to be executed), and recording means (Mitsuru, Pg. 12 image storage means).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Emma Rose Goebel/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
