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 .
Claim Objections
Claims 4-6 are objected to because of the following informalities:
Regarding claim 4, line 5 recites “move”. Applicant may correct the subject-verb agreement to read “moves”.
Regarding claim 4, line 7 recites “determine”. Applicant may correct the subject-verb agreement to read “determines”.
Claims 5-6 are objected to based upon dependency of the objected claim 5.
Regarding claim 6, lines 4-5 recite “each of placement surfaces”. Applicant may correct this by adding omitting “of” and singularizing “surfaces” to read “each placement surface”.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0017] reads “a state in a state in which a gripper arm”. Applicant may correct this by deleting “in a state” to ultimately read “a state in which a gripper arm”.
Paragraphs [0030]-[0031], [0034], [0040], [0043], [0063], [0082], [0089]-[0091] state “161,” however, there is no 161 item in the drawings. Applicant may correct this to read “16l”.
Appropriate correction is required.
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.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (Step 2A/1)(an abstract idea through mental processes) without practical application (Step 2A/2) and without significantly more (Step 2B). Although the instant claim 9 encompasses a process (Step 1), it is directed to the following judicial exception of an abstract idea through mental processes (Step 2, Prong 1) (MPEP 2106.04(a)). Claim 1 recites:
“determining the presence or absence of the sample container in the gripping space, based on whether the light from the gripping space is detected”
This determination constitutes a mental process, as it involves evaluating information (i.e. whether a signal is present or absent) to reach a conclusion. A human can use their own fingers to grip a space, shine a light from behind, and make the determination that a container is present based on if the human eye detects the light. Such a determination can practically be performed by a human using observation by the human eye and deciding with the mind if a sample container is present in the gripping space based on the detected intensity (e.g., observing whether light passes through a space)(See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."). Accordingly, claim 9 recites a judicial exception under Step 2A/1.
(Step 2A/2): This judicial exception is not integrated into a practical application because once the presence/absence is determined, there is no further action. The other method steps:
changing a size of a gripping space between the first gripper and the second gripper;
emitting light to the gripping space to detect the light from the gripping space,
are merely extra-solution activities performed to gather data to be used in the abstract idea of determining the presence or absence of the sample container in the gripping space, based on whether the light from the gripping space is detected. These additional steps do not contribute to a technological improvement of controlling a gripper arm and are necessary precursor steps for all uses of the recited judicial exception. Thus the judicial exception is not integrated into a practical application (See MPEP 2106.05(h)).
Lastly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Essentially, if one sees light then the gripping space is empty and if one does not see light then the sample container is present in the gripping space. This appears well-understood, routine and conventional (see MPEP 2106.05(d))(See paras. [0072],[0086]-[0087] of Gross, US 20140036276 A1)(See para. [0059] of Yamasaki, US 20170242046 A1). This would be the same assessment if a controller was used and in this case can be observed mentally by a human and receive the same determination. The other method steps:
changing a size of a gripping space between the first gripper and the second gripper;
emitting light to the gripping space to detect the light from the gripping space,
are also well-understood, routine and conventional in the art as demonstrated in paragraphs of the references above.
Claim 9 fails to include any limitations which would distinguish the method because it does not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception.
Thus, for reasons fully explained above, claim 9 does not satisfy the requirement of 35 U.S.C. 101 and is therefore rejected.
Claim Rejections - 35 USC § 102
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 described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-9 are rejected under AIA 35 U.S.C. 102(a)(1) as being anticipated by Gross (US 20140036276 A1).
Regarding claim 1, Gross teaches an analysis system (system 1100; [0039]; Fig. 2) including a pretreatment apparatus (Cartesian or gantry robot 1000; [036; Fig. 1) for pretreating a sample (the system 1100 is functionally capable of pretreating the sample since “the laboratory automation system 1104 may include an input module, a distribution area, a centrifuge, a decapper, a serum indices measurement device, an aliquotter and an output/sorter” which overlaps in the treatment types of the instant publication (US 20140036276 A1) at paragraph [0003]; [0039]; Fig. 2), comprising:
a gripper arm (a specimen gripper 1004; [0037]; Fig. 1) configured to convey a sample container (As the specimen gripper 1004 is transported by the robot arm 1002, the specimen gripper 1004 may transport a specimen container 1006 held by the specimen gripper 1004; [0037]); Fig.1) and
a controller (PLC 1108(a); [0044]) configured to control the gripper arm (the gripper unit 1114 may also include or interface with other units to enable the gripper unit [to] perform the intended function; [0046]; See bidirectional line between the gripper unit 1114 and the processing unit 1106 in Fig. 2),
wherein the gripper arm includes
a first gripper and a second gripper for gripping the sample container (The specimen gripper 1004 may have two or more moveable gripper fingers 1008, 1010 coupled to a body 1012 to grip the specimen container 1006; [0038]; Fig. 2) by pinching the sample container ( the gripper fingers 1008, 1010 may move inwardly toward the specimen container 1006 until the specimen container 1006 is held in a fixed position between the gripper fingers 1008 and 1010; [0038; Fig. 1),
a drive mechanism (a worm drive assembly; [0086]) configured to change a size of a gripping space between the first gripper and the second gripper (paragraphs [0086] and [0087] and Figs. 9A-C explain that the worm driver assembly closes and opens the gripper fingers 1802), and
a photoelectric sensor (an optical sensor system; [0071]; Fig. 4) configured to emit light to the gripping space and detect the light from the gripping space (When a specimen container is located between the gripper fingers 1208 and 1210, the light emitted from the fiber optic source 1306 is not received by the fiber optic receiver 1308 because the specimen container blocks some or all of the emitted light from the fiber optic source 1306; [0072]; Fig. 4), and
wherein the controller determines the presence or absence of the sample container in the gripping space based on the presence or absence of a detection signal of the photoelectric sensor (a signal is received by the PLC 1108(a) from the fiber optic receiver 1308 indicating the absence of a specimen container…a signal is received by the PLC 1108(a) from the fiber optic receiver 1308 indicating the presence of a specimen container; [0072]; Fig. 4).
Regarding claim 2, Gross teaches the analysis system as recited in claim 1, wherein the controller determines the presence or absence of the sample container in the gripping space in a conveyance step for the gripper arm to convey the sample container (gathering various data related to a specimen container, such as detection of the presence of a specimen container within the gripper…Some or all of this information can be gathered during a specimen container transport or manipulation process; [0031])(The recited “conveyance step” merely specifies the operational context in which the gripper arm is transporting the sample container, during which the controller determines the presence or absence of the container, and does not define a separate method step).
Regarding claim 3, Gross teaches the analysis system as recited in claim 1, wherein the controller determines the presence or absence of the sample container in the gripping space when a power source of the pretreatment apparatus is turned on (Paragraphs [0065]-[0066] and Fig. 4 disclose that, when the system is powered, a voltage corresponding to the gripper finger position is generated by the linear potentiometer and received by the PLC via an ADC, and that calibrated voltage ranges correspond to gripper states including open, closed, and illegal conditions; therefore, in order to determine whether a specimen container is present or absent in the gripping space, the power must be turned on).
Regarding claim 8, Gross teaches the analysis system as recited in claim 1, wherein the photoelectric sensor (See item 1300 of Fig. 4; See also the fiber optic system 1500 of Fig. 6; [0077]) includes
a light-projecting unit (light emitted from the fiber optic source 1306; [0072; Fig. 4) for projecting the light to the gripping space (See path of item 1306 aimed toward the gripping space occupied by container 1212 in Fig. 4)(Paragraph [0072] explains that the light emitted is blocked by a sample container which is in the gripping space); and
a light-receiving unit (the fiber optic receiver 1308; [0072; Fig. 4) for receiving the light (light emitted from the fiber optic source 1306 is received by the fiber optic receiver 1308; [0072; Fig. 4),
wherein the gripper arm includes a first arm (mounting structure 1204 ; [0055]; Fig. 3) including the first gripper (gripper finger 1208; [0055]; Fig. 3)(The mounting structures 1204…may be part of a body 1230 of the gripper unit 1200…the mounting structure 1204 is coupled to the gripper finger 1208; [0055]; Fig. 3), the first arm being configured to attach the light-projecting unit (The fiber optic source 1306… may be attached to elongated structures forming at least part of the gripper fingers 1208; [0071]; Figs. 3-4), and
a second arm (mounting structure 1206; [0055]; Fig. 3) including the second gripper (gripper finger 1210; [0055; Fig. 3)(The mounting structures…1206 may be part of a body 1230 of the gripper unit 1200…the mounting structure 1206 is coupled to the gripper finger 1210; [0055]; Fig. 3), the second arm being configured to attach the light-receiving unit (the fiber optic receiver 1308 may be attached to elongated structures forming at least part of the gripper fingers…1210; [0071]; Figs. 3-4),
wherein the first gripper and the second gripper each have a contact surface that comes into contact with the sample container (the specimen container 1212 is gripped by replaceable jaws 1214 and 1216 coupled to the gripper fingers 1208 and 1210, respectively; [0052]; Fig. 2).
wherein the light-projecting unit and the light-receiving unit are attached to positions that differ from the contact surface (the fiber optic source 1306 and the fiber optic receiver 1308 may be attached to elongated structures forming at least part of the gripper fingers 1208, 1210; [0071] See Fig. 4).
Regarding claim 9, Gross teaches a method of controlling a gripper arm for conveying a sample container (The laboratory automation system 1104 may utilize the robot arm 1002 to grip a specimen container (e.g., sample tube) using the gripper unit 1114; [0046]; Figs. 1-2), the gripper arm including a first gripper and a second gripper (The gripper unit 1114 may include…gripper fingers 1118; [0046]; Fig. 2) for holding the sample container by pinching the sample container (gripper fingers 1208 and 1210 slide inward to grip the specimen container 1212 until the specimen container 1006 is held in a fixed position between the gripper fingers 1008 and 1010; [0065]; Fig. 3), the method comprising the steps of:
changing a size of a gripping space between the first gripper and the second gripper (paragraphs [0066]-[0067] teach this limitation by disclosing that the gripper fingers have calibrated positions including fully open, fully closed, and intermediate positions, each corresponding to different finger separations and container diameters. To place the gripper at fully open for the presence sensor, the system must move the gripper fingers, which therefore changes the size of the gripping space. Thus the act of setting the gripper to the fully open position requires changing the gripping space)(Figs. 3,4,6 show these gripper arms would need to be open to an extent in order to position a container of a certain diameter);
emitting light to the gripping space to detect the light from the gripping space (light emitted from the fiber optic source 1306 is received by the fiber optic receiver 1308,” or “the light emitted from the fiber optic source 1306 is not received by the fiber optic receiver 1308”; [0072]; Fig. 6; See path of item 1306 aimed toward the gripping space occupied by container 1212 in Fig. 4)(“Paragraph [0072] explains that when light is emitted it can be blocked by a sample container that is in between gripper fingers as shown in Fig. 2 and therefore emits light to the gripping space) and
determining the presence or absence of the sample container in the gripping space, based on whether the light from the gripping space is detected (The presence or absence of the specimen container 1212 between the gripper fingers 1208 and 1210 can be determined based on a signal received by the PLC 1108(a) from the fiber optic receiver 1308; [0072]).
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.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20140036276 A1), in view of Ali et al. (“Grasping and Placing Operation for Labware Transportation in Life Science Laboratories using Mobile Robots”; 2017).
Regarding claim 4, Gross teaches the analysis system as recited in claim 1, wherein determining the presence or absence of the sample container in the gripping space is based on the presence or absence of the detection signal.
Gross fails to teach that the pretreatment apparatus is provided with a first placement portion for placing the sample container, and
wherein the controller move[sic] the first gripper and the second gripper to the first placement portion before conveying the sample container to the first placement portion by the gripper arm.
Gross does, however, teach a controller that controls a robotic gripper system that relies on sensor feedback to determine container presence ([0037]), which implies a need for reliable verification prior to subsequent transport or analysis steps.
Ali teaches a pretreatment apparatus (See H20 mobile robot and different labware and tube racks in Figs. 1-2) with a first placement portion for placing the sample container (holder…occupied by a labware; p. 1233, col. 2, para. 2, ll. 3-4), and
wherein the controller (See control systems of Fig. 19) move[sic] the first gripper and the second gripper to the first placement portion (“According to the holder number (1-8), the robot moves to the required position (1 or 2) for performing the task,” wherein “The H20 mobile robot has dual 6-DOF arms with 2-DOF grippers”; p. 1232, col. 2, ll. 22-24; p. 1229, col. 1, ll. 1-2) before conveying the sample container to the first placement portion by the gripper arm (it is very necessary for the robot to check whether the holder is already occupied by a labware or not before performing the placing task; p. 1233, col. 2, para. 2, ll. 2-4).
Ali is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated sample handling and analysis systems involving container placement, detection, and transport using robotic grippers. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analysis system taught by Gross by incorporating both Ali’s first placement portion and Ali’s controller instructions to precheck for the presence of labware before loading a sample at the first placement portion. Ali demonstrates that verifying whether a placement location is empty before conveyance improves placement reliability and avoids collisions. Gross already teaches a specimen gripper coupled to “a Cartesian or gantry robot 1000 with three independently moveable directions x-, y-, and z-“ ([0033],[0036]). The apparatus is to be used in a medical laboratory system for processing patient samples such as blood, serum, gel, and plasma ([0032]) by transporting specimen containers across various areas of a laboratory system, including input, distribution, centrifuge, decapper, aliquotter, output, sorting, recapping, and secondary tube lift areas ([0033]). Gross further discloses that the specimen gripper is equipped with one or more means for detecting information about specimen containers that it grips ([0033]) and that the gripper unit can “provide information about a rack of specimen tubes (e.g., sample tubes), such as filled and unfilled rack positions” ([0061]). This disclosure establishes that Gross’s system naturally involves repeated placement and transport of containers to multiple processing locations, each of which must be available to receive a container. Ali teaches a robotic arm with a first placement portion (e.g. rack position, Fig. 16) and checking whether the placement portion is empty prior to placing labware so as to prevent misplacement and handling errors. One of ordinary skill in the art would have been motivated to incorporate Ali’s first placement portion and pre-placement presence checking into the gripper-based system of Gross to ensure that each processing location to which the gripper transports a specimen container is available before conveyance, thereby improving reliability and preventing collisions or misrouting of patient samples. This combination is supported under MPEP 2143(I)(A and C) as the addition of known labware (container position in a rack) and application of a known technique (checking placement location occupancy before placement) to a known device (Gross’s gripper-based handling system) to achieve the predictable result of improved placement reliability without changing the basic operation of the gripper system of Gross.
Regarding claim 6, Modified Gross teaches the analysis system as recited in claim 5, wherein the controller is provided with a memory (the PLC 1108(a) may include one or more of a microcontroller…memory; Gross; [0044]) for storing position information on each of the first placement portion and the second placement portion, and wherein the controller moves the first gripper and the second gripper to each of placement surfaces of the first placement portion and the second placement portion, based on the position information (Yamasaki teaches that the controller sequentially sends the holder to specific storage positions and then to a next storage position if a sample container is not detected ([0005]). This disclosure naturally requires that the controller store positional information for each storage position and move the holder based on that stored positional information in order to determine which position to visit next (e.g., positions 81-82 of Fig. 8)).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20140036276 A1), in view of Ali et al. (“Grasping and Placing Operation for Labware Transportation in Life Science Laboratories using Mobile Robots”; 2017), as applied to claim 4 above, in further view of Yamasaki et al. (US 20170242046 A1).
Regarding claim 5, Modified Gross teaches the analysis system as recited in claim 4.
Modified Gross fails to teach that the pretreatment apparatus is further provided with a second placement portion for placing the sample container, wherein the controller sequentially moves the first gripper and the second gripper to each of the first placement portion and the second placement portion before conveying the sample container to the first placement portion by the gripper arm, and determines the presence or absence of the sample container in the gripping space at each of the first placement portion and the second placement portion.
Modified Gross instead teaches only that the controller moves the grippers to a first placement portion in order to verify the absence of a sample container. The grippers then directly proceed to convey a sample container to the first placement portion (See p. 1233, col. 2, para. 2, ll. 2-4 of Ali).
Yamasaki teaches a pretreatment apparatus (A sample measurement apparatus; Abstract) provided with a second placement portion (a second storage position; [0005]) for placing the sample container (sample container at the second storage position; [0005]), wherein the controller sequentially moves the first gripper and the second gripper to each of the first placement portion and the second placement portion, and determines the presence or absence of the sample container in the gripping space at each of the first placement portion and the second placement portion (causing a holder for holding a sample container to move to a point above a first storage position on a rack capable of storing the sample containers…detects that there is no sample container at the first storage position, directly sending the holder from the point above the first storage position to a point above a second storage position…causing the detection unit to detect whether or not there is the sample container at the second storage position”; [0005])(Paragraphs [0058]-[0059] describe the process of determining the presence or absence of the sample container in the gripping space using two gripper claws).
Yamasaki is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated sample handling and analysis systems involving container placement, detection, and transport using robotic grippers. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller instructions taught by Gross in view of Ali by incorporating sequential presence/absence checks at different locations as taught by Yamasaki. Doing so would allow Ali’s gripper-based placement system to verify availability at multiple placement portions prior to placement. Ali already teaches a gripper-based placement system in which a controller moves first and second grippers to a placement portion and determines presence or absence of a sample container prior to placement in order to avoid improper placement. Yamasaki likewise teaches a controller-directed gripping mechanism that is moved to multiple candidate positions, with a presence or absence determination performed at each position before further transfer or placement occurs. Thus, Yamasaki shares with Ali the same fundamental architectural elements, including a movable gripping mechanism, controller-based positions, and position-specific presence/absence determination used to control subsequent handling operations. Combining these steps merely applies a known control technique to a known gripper-based system to achieve the predictable result of improved placement reliability by ensuring that more than one available placement portion is identified prior to placement (See MPEP 2143(I)(C)).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20140036276 A1), in view of Sawada et al. (WO-2019176297-A1, see attached English translation).
Regarding claim 7, Gross teaches the analysis system as recited in claim 1.
Gross is silent to teaching a notification device configured to notify a determination result of the presence or absence of the sample container by the controller.
Gross does, however, teach that “The presence or absence of the specimen container 1212 between the gripper fingers 1208 and 1210 can be determined based on a signal received by the PLC 1108(a) from the fiber optic receiver 1308” ([0072]). Consequently, Gross states that “An alert could be generated based on the dangling tube condition by the PLC 1108(a) that may be provided to the operator 1102” ([0067]). This demonstrates a need for handling error conditions (e.g., missing container) during automated operation.
Sawada teaches a notification device (alarm on the display unit 116 (step 708); p. 6, para. 2, l. 3; Figs. 1,7) configured to notify a determination result of the presence or absence of the sample container (The presence or absence of the container is confirmed, and if there is no reaction container, the user is warned by an alarm; p. 4, para. 4, ll. 3-5) by the controller (wherein the controller confirms the presence or absence of a reaction container by determining whether or not the reaction container is gripped by a reaction container transport mechanism; p. 7, Claims, ll. 11-13).
Sawada is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated sample handling and analysis systems involving container placement, detection, and transport. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analysis system taught by Gross with the addition of a notification device configured to notify a determination result of the presence or absence of the sample container by the controller in order to inform an operator or supervisory system of the status of the system. Gross already discloses that “an alert could be generated based on the dangling tube condition by the PLC 1108(a) that may be provided to the operator 1102,” as well as a means for conveying this alert (monitor 22; [0096]; Fig. 12). Supplementing Gross’s analysis system with Sawada’s notification device, that includes the functionality to alert a user to of the presence or absence of the sample container, applies a known device (display unit) using a known technique (system notification) to a known analysis system to achieve the predictable result of an improved system usability, monitoring, and error handling (See MPEP 2143(I)(A)).
Conclusion
No claims are allowed.
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/V.S./Examiner, Art Unit 1758
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758