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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-13 in the reply filed on 2/27/2026 is acknowledged.
Claim 14-35 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medical product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/27/2026.
Claims 1-13 are pending examination in this response.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Claim limitation “sample tube opening/closing part” in claim 1 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “part” coupled with functional language “opening/closing” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “part” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 1 has/have been interpreted to cover “lower grippers and upper grippers” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., Para [0013] lower grippers 200 and upper grippers 300).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-3 and 6-9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Itoh (US 20080170967 A1).
Regarding claim 1, Itoh teaches “A sample tube opening/closing device comprising:” (Para [0003], automated test tube cap removal apparatus for automatically removing caps from test tubes that contain a specimen);
“a housing that forms an inner space isolated from the outside (Para [0039], Figs. 1 and 2, In the cap remover 11, a storage box 16 is disposed on top of a base 15, and a cap removal mechanism 17 (mentioned later) is located in the box 16. A rack conveying path 18 is provided at the rear part of the box 16.); “and includes a door for carrying in/out a multi-well plate for biological samples” (Para [0039], Figs 1, 2, and 3, The conveying path 18 conveys test tube racks 19 that hold test tubes 20.); “including a plurality of sample tubes in which biological samples are accommodated” (Paras [0040] and [0003], each test tube rack 19 can hold a plurality of test tubes 20. Test tubes that contain a specimen, such as blood.)
“and a sample tube opening/closing part that is installed in the inner space to be spaced apart from the multi-well plate for biological samples” (Paras [0039] and [0055], a cap removal mechanism 17 within the storage box 16. It first removes caps from the first, third, and fifth test tubes 20 (denoted by numbers 20-1, 20-3 and 20-5 in FIG. 11) as viewed in the conveying direction, among the five test tubes 20 supported by the test tube rack 19, as described later. Then, the mechanism 17 removes the remaining second and fourth test tubes 20 (denoted by numbers 20-2 and 20-4).); “and automatically opens” (Para [0055], performs two stages of cap removal in the following manner.); “and closes the sample tubes” (Para [0058], The shutter 97 has an inverted U-shaped cross section. It serves to cover a region around an opening portion including the top opening of each test tube 20 when advanced).
Regarding claim 2, Itoh teaches all of claim 1 in addition to “wherein the sample tube opening/closing part comprises one or more lower grippers for gripping a lower portion of the sample tubes; and one or more upper grippers for gripping an upper portion of the sample tubes.” (Fig. 13, 14 and Paras [0056]-[0058] and [0062], a test tube clamping mechanism 87 that clamps the test tubes 20 supported by the test tube rack 19 when the test tubes are to be uncapped. In the clamping mechanism 87, as shown in FIGS. 13 and 14, a pair of cylinder bases 88 are opposed to each other with the rack conveying path 18 between them. The clamping piece 93 is in the shape of a semicircle along the contour of each test tube 20. A rubber pad 94 is stuck on the inner peripheral surface of each clamping piece 93 so that the pieces 93 can clamp and fixedly hold the trunk of the test tube 20 from both sides. and a shutter 97 is fixed to each piston rod 96. The shutter 97 has an inverted U-shaped cross section. It serves to cover a region around an opening portion including the top opening of each test tube 20 when advanced, thereby preventing foreign matter or the like from getting into the adjacent uncapped test tube 20 through its opening when each test tube 20 is uncapped. Cap removal units 112 are tiltably coupled to the respective lower end portions of the piston rods 109a and 109b of the two-stage cylinders 108a and 108b by knuckle joints 110 and joint shafts 111, individually. One cap removal unit 112 is provided for each moving block 105 that is driven by each of the three twin-rod cylinders 101. Therefore, three units 112 are arranged at regular intervals in the conveying direction of the rack conveying path 18. Each of these intervals is adjusted to a pitch between each two alternately adjacent ones of the five test tubes 20 supported by the test tube rack 19.) Therefore the clamping pieces are the lower grippers and the shutter in addition to the cap removal unit can both be the upper grippers.
Regarding claim 3, Itoh teaches all of claim 2 in addition to “wherein three of the lower grippers and three of the upper grippers are provided corresponding to each other in parallel so that three of the sample tubes are simultaneously opened or closed.” (Figs. 13, 14, Paras [0056-[0058], [0062], the clamping pieces 93 and the shutters 97. The pair of cylinder bases 88 are provided with three pairs of air cylinders 91, which, like the test tube sensors 90, individually face the first, third, and fifth test tubes 20-1, 20-3 and 20-5 as viewed in the conveying direction, among the five test tubes 20 supported by the test tube rack 19. [0062] Cap removal units 112 are tiltably coupled to the respective lower end portions of the piston rods 109a and 109b of the two-stage cylinders 108a and 108b by knuckle joints 110 and joint shafts 111, individually. One cap removal unit 112 is provided for each moving block 105 that is driven by each of the three twin-rod cylinders 101. Therefore, three units 112 are arranged at regular intervals in the conveying direction of the rack conveying path 18. Each of these intervals is adjusted to a pitch between each two alternately adjacent ones of the five test tubes 20 supported by the test tube rack 19.) Therefore the clamping pieces are the lower grippers and the shutter in addition to the cap removal unit can both be the upper grippers.
Regarding claim 6, Itoh teaches all of claim 2 in addition to “wherein, in a state in which the lower grippers grip a lower portion of the sample tubes,” (Figs. 13, 14, Paras [0056-[0058], [0062], clamping pieces are the lower grippers); “the upper grippers grip and lift a sealing member sealing the sample tubes, thereby opening the sample tubes.” (Figs. 13, 14, Paras [0056-[0058], [0062], and Abstract, a cap removal unit disposed in the cap removing position and configured to move upward to remove caps from some of a plurality of test tubes and move upward to remove caps from the remaining test tubes.).
Regarding claim 7, Itoh teaches all of claim 2 in addition to “wherein, in a state in which the upper grippers grip the sealing member sealing the sample tubes and the lower grippers grip a lower portion of the sample tubes, the sample tubes are opened through relative rotation of the upper grippers and the lower grippers.” (Para [0008], The test tube is held by a clamping mechanism, and its cap is supported by engagement with a chuck mechanism as it is rotated and raised in a cap disengaging direction, whereby the cap is removed.)
Regarding claim 8, Itoh teaches all of claim 2 in addition to “wherein the lower grippers comprise: a lower gripping part on which the sample tubes are seated and which grips a lower portion of the sample tubes” (Figs. 13, 14, Paras [0056-[0058], [0062], the clamping pieces 93); “and a lower gripper rotation driving part which rotates the lower gripping part about an axis of an imaginary center line passing through the center of the sample tubes in the vertical direction.” (Para [0049] and [0073], a test tube rotating mechanism 57. The test tube rotating mechanism 57 is provided with a motor bracket 58 that is fixed to the base 15. When the types of the test tube rack 19 and the test tubes 20 are read in the barcode reader section 43, the pair of air cylinders 51 of the rack fixing mechanism 49 are simultaneously actuated to project the piston rods 52, so that the chuck bases 55 move away from each other. )
Regarding claim 9, Itoh teaches all of claim 8 in addition to “wherein the lower grippers comprise an identification code recognition part disposed adjacent to the lower gripping part and identifying the biological samples by recognizing an identification code attached to the sample tubes.” (Paras [0040], Each test tube 20 contains a specimen, such as blood, and a test tube barcode label 22 for test tube identification is stuck on its side face. [0041], [0047], [0073] When the types of the test tube rack 19 and the test tubes 20 are read in the barcode reader section 43, the pair of air cylinders 51 of the rack fixing mechanism 49 are simultaneously actuated to project the piston rods 52, so that the chuck bases 55 move away from each other. Accordingly, the chuck bases 55 leave the side face of the test tube rack 19, thereby releasing the rack 19 from fixation. At the same time, the rotary actuator 46 of the first rack stopper 44 is actuated to rotate the rotating shaft 47, and the stopper piece 48 rocks through about 90 degrees, whereupon the gel tip 48a is retracted from the channel 34, as indicated by solid line in FIG. 7. The second barcode reader 25 simultaneously reads barcodes on the respective test tube barcode labels 22 of the individual test tubes 20. The following is a description of a barcode reader section 43 that includes the first and second barcode readers 24 and 25.)
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20080170967 A1) as applied to claim 3 and in further view of Silbert et. al. (US 2013/065797 A1).
Regarding claim 4, Itoh teaches all of claim 3 in addition to movement in a forward and backward direction within Para [0058] but does not teach explicitly teach “wherein the upper grippers are each independently linearly movable in an X direction, a Y direction, or a Z direction.”
Silbert teaches an automated sample handling instrument and system in addition to “wherein the upper grippers are each independently linearly movable in an X direction, a Y direction, or a Z direction.” (Fig. 1 and Para [0078], Most frequently, the pipettor and tube gripper are incorporated on the same robotic arm (405), but each has an independently operable Z-axis. This system frequently has common XY axes and 2 independent Z axes to service the pipettor and tube gripper. This system also frequently comprises a cartesian system with belt driven X, Y and gear driven Z axes.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Itoh to incorporate the teachings of Silbert wherein the upper grippers are each independently linearly movable in an X direction, a Y direction, or a Z direction. Doing so would allow more flexibility in tube selection and manipulation of different tube sizes. It will allow the device to grasp different tubes and remove different size caps.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20080170967 A1) and Silbert et. al. (US 2013/065797 A1) as applied to claim 4 and in further view of Lauscher et. al. (DE 102011008975 A1).
Regarding claim 5, Itoh teaches all of claim 4 in addition to “wherein the upper grippers comprise: an upper gripping part for gripping an upper portion of the sample tubes” (Figs. 16-20 and Paras [0013] and [0062] Cap removal units 112 are tiltably coupled to the respective lower end portions of the piston rods 109a and 109b of the two-stage cylinders 108a and 108b by knuckle joints 110 and joint shafts 111, individually. One cap removal unit 112 is provided for each moving block 105 that is driven by each of the three twin-rod cylinders 101. Therefore, three units 112 are arranged at regular intervals in the conveying direction of the rack conveying path 18. Each of these intervals is adjusted to a pitch between each two alternately adjacent ones of the five test tubes 20 supported by the test tube rack 19. A cap removal unit disposed in the cap removing position and configured to move upward to remove caps from some of a plurality of test tubes); “an upper gripper forward/backward driving part for moving the upper gripping part in the forward/backward direction, which is a process processing direction;” (Para [0013], The cap removal unit includes a pair of engaging members which are capable of advance and retreat with respect to the caps and laterally clamp each cap when advanced). In addition to teaching “and an upper gripper upward/downward driving part for moving the upper gripping part in the upward/downward direction.” (Para [0013], a lift mechanism which raises the pair of engaging members while alternately moving the engaging members upward, thereby removing the cap from each test tube).
Itoh does teach the cap guide member which is part of the cap removal unit that guides the cap for dropping which could be in a left/right direction but does not explicitly teach “an upper gripper left/right driving part for moving the upper gripping part in the left/right direction with respect to the process processing direction”.
Lauscher teaches an opener for opening screw-type cap container within the title in addition to “an upper gripper left/right driving part for moving the upper gripping part in the left/right direction with respect to the process processing direction”. (Page 9, Open rotary gripper right direction. When the drive shaft drive gear rotary gripper 47 and the attached drive gear rotary gripper 50 considered by a drive means from the top in a rightward directed rotational movement, move necessarily the outer gears rotary gripper 52 in left-directed rotational movement. Because of the screw cap gripper 53 the firmly attached to the outer gears rotary gripper 52 are fixed, the rotational movement and thus the path of the gears have to join, initially increases the distance of all installed Schraubverschlussgreifer 53 evenly and continuously to all sides, from the center of the drive gear, the Z1 axis of the device 100 , outwardly.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Itoh to incorporate the teachings of Lauscher wherein the upper grippers have a left/right driving part moving in the left/right direction. Doing so would allow more flexibility in tube selection and allow the grippers to move to the exact location of each tube and its size.
Claim 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20080170967 A1) as applied to claim 1 and in further view of Blanchard (US 20180087020A1).
Regarding claim 10, Itoh teaches all of claim 1 as above but does not teach “wherein the housing comprises a UV lamp part provided on at least one of the lower surface of the inner space and an upper portion of the door."
Blanchard teaches a transfer device may include one or more robotic arms capable of gripping, lifting, pushing, grabbing, sliding, rotating, translating, releasing, raising, lowering, and/or tilting in addition to “wherein the housing comprises a UV lamp part provided on at least one of the lower surface of the inner space and an upper portion of the door." (Paras [0010], [0031], and [0033], An incubator can include one or more light sources (e.g., an incandescent bulb, LED, UV, or other light source). These can be placed within the incubator to illuminate regions within the cabinet. In some embodiments, the culture system operation is monitored using a camera or other light sensitive device that can be placed within or outside the incubator. In some embodiments, the light source is a sterilizing light source. For example, a UV lamp may be located within the transfer chamber and/or the interior chamber of the incubator provided herein.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Itoh to incorporate the teachings of Blanchard wherein the housing has a UV lamp on at least one of the lower surface of the inner space and an upper portion of the door. Doing so would sterilize the device and decrease cross-contamination.
Regarding claim 11, modified Itoh teaches all of claim 10 as above but does not teach “wherein the housing comprises an ozone sensor installed in the inner space to detect ozone generated by the UV lamp part.”.
Blanchard teaches “wherein the housing comprises an ozone sensor installed in the inner space to detect ozone generated by the UV lamp part.” (Paras [0044], and [0043], One or more valves, flow meters, ozone sensors, pumps, or other devices may control the amount of ozone introduced to one or more portions of the incubator cabinet and/or be used to remove excess ozone from the incubator cabinet. One or more valves, flow meters, ozone sensors, pumps, or other mechanisms may control the amount of ozone introduced to one or more portions of the incubator cabinet and/or be used to remove excess ozone from the incubator cabinet or portion thereof. In some embodiments, one or more ozone sensors may provide information to an interlock system to prevent the inner door from being opened if ozone is present at a detectable level (or above a threshold level that can be specified) in the transfer chamber. This can be useful to prevent ozone from entering the internal chamber.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Itoh to incorporate the teachings of Blanchard by having an ozone sensor installed in the inner space to detect ozone generated by the UV lamp part. Doing so would allows for the device to have needed safety safeguards to monitor and detect harmful ozone.
Claim 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20080170967 A1) as applied to claim 1 and in further view of Park et. al. (EP 2844564B1).
Regarding claim 12, Itoh teaches all of claim 1 as above but does not teach “wherein the housing comprises a negative pressure forming part for performing exhaust in one direction from the inner space to an outer space so that the inner space is maintained in a negative pressure state.”.
Park teaches a cover removal system for use in controlled environment enclosures in addition to “wherein the housing comprises a negative pressure forming part for performing exhaust in one direction from the inner space to an outer space so that the inner space is maintained in a negative pressure state.”. (Para [0026] In another embodiment the controlled environment enclosure 120 can be fully sealed and be operated at a positive or negative pressure differential relative to the surroundings.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Itoh to incorporate the teachings of Park where the housing comprises a negative pressure forming part for exhaust. Doing so provides a device which removes harmful vapors out of the device within the exhaust direction ensures the environment around the device and within the device is safer.
Regarding claim 13, Itoh teaches all of claim 12 as above but does not teach “wherein the negative pressure forming part comprises: a discharge fan provided on one side surface of the housing to discharge air from the inner space; and an ozone filter provided in front of the discharge fan to filter ozone present in the inner space.”.
Park teaches “wherein the negative pressure forming part comprises: a discharge fan provided on one side surface of the housing to discharge air from the inner space; and an ozone filter provided in front of the discharge fan to filter ozone present in the inner space” (Para [0026] Those skilled in the art will understand that several other filter and blower arrangements can be used to establish a controlled environment inside controlled environment enclosure 120. A suitable controlled environment can be obtained, for example without limitation, by means of any one or more of turbulent airflow, horizontal unidirectional airflow and vertical unidirectional airflow.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Itoh to incorporate the teachings of Park wherein the negative pressure part has a discharge fan and a ozone filter. Doing so makes the device safe for the operator and decreases the chances of contamination of the samples by removing harmful vapors by use fo the fam and ozone filter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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