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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/183,188, filed on 14 April 2023
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 May 2026 was filed after the mailing date. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites the limitation "the second placement region" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets claim 25 to mean “a second placement region.”
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 – 7, 23, 24, 26, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayama et al (US 20230228780 A1, effectively filed January 14 2022).
With regards to claim 1, Hayama et al teaches;
The claimed “a specimen analyzer” has been read on the taught (Abstract, “Disclosed is a specimen testing system…”);
The claimed “a measurement unit configured to measure the specimen” has been read on the taught ([0054], “The transportation units 12, 31, 51, and 61 transport the rack 100 among the measurement units 32…”; Measurement unit 32 reads on a measurement unit);
The claimed “a transport unit comprising a first placement region which is disposed in front of the measurement unit and in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”);
The claimed “a second placement region which is disposed in a left-right direction relative to the first placement region and in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”; The unit on the left side reads a second placement region);
The claimed “the transport unit configured to transport the specimen racks placed in the first placement region and the second placement region to a start position at which the measurement unit starts measurement” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”; Figure 1 includes arrows describing the movement path, which shows that the first rack may be returned from the left side unit back to the measurement unit 32.).
With regards to claim 3, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport path including the start position, and the transport path extends in the left-right direction between the measurement unit and the first placement region” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”).
With regards to claim 4, the analyzer of claim 3 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport portion configured to transport the specimen racks placed in the first placement region and the second placement region to a predetermined position which is on the transport path and distant from the start position” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”).
With regards to claim 5, the analyzer of claim 4 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport portion transports the specimen racks placed in the first placement region and the second placement region to the predetermined position that is a single position” has been read on the taught ([0060], “The transportation unit 12 transports rearward the rack 100 (first rack) carried in from the transportation unit 31 that is disposed adjacently on the right side, and carries out the rack 100 (first rack) to the specimen rearrangement unit 40 at a rear position.”; The rear position reads on the predetermined position.).
With regards to claim 6, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport path including the start position, the transport path extends in the left-right direction between the measurement unit, and the first placement region and the second placement region, the second placement region is connected to a predetermined position which is on the transport path and distant from the start position” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”; [0060], “The transportation unit 12 transports rearward the rack 100 (first rack) carried in from the transportation unit 31 that is disposed adjacently on the right side, and carries out the rack 100 (first rack) to the specimen rearrangement unit 40 at a rear position.”);
The claimed “the first placement region and the second placement region are connected to each other at a transport start position on the first placement region side and a transport end position on the second placement region side” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”);
The claimed “the transport unit comprises a first transport portion configured to transport the specimen rack in the second placement region to the predetermined position” has been read on the taught ([0060], “The transportation unit 12 transports rearward the rack 100 (first rack) carried in from the transportation unit 31 that is disposed adjacently on the right side, and carries out the rack 100 (first rack) to the specimen rearrangement unit 40 at a rear position.”; Transport unit 12 );
The claimed “a second transport portion configured to transport the specimen rack from the transport start position to the transport end position” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”; Transport unit 31 reads on a second transport portion.).
With regards to claim 7, the analyzer of claim 6 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a third transport portion configured to transport the specimen rack placed in the first placement region, to the transport start position” has been read on the taught ([0058] The supply unit 20 […] carries out the rack 100 (first rack) to the transportation unit 31 disposed adjacently on the left side.”; The location of the supply unit reads on a first placement region. The supply unit which carries the rack to transportation unit 31 reads on a third transport portion).
With regards to claim 23, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the specimen analyzer is a blood cell counter which counts blood cells in a blood specimen” has been read on the taught ([0046], “The specimen testing system 1 includes […] a blood cell counting unit 30 for counting blood cells contained in a specimen…”).
With regards to claim 24, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein a number of the measurement units disposed is two or more” has been read on the taught ([0046], “In the blood cell counting unit 30, one transportation unit 31 and two measurement units 32 form one set, and the blood cell counting unit 30 includes one control unit 33, and two sets each including the one transportation unit 31 and the two measurement units 32.”; four measurement units read on two or more measurement units.).
With regards to claim 26, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “a smear preparation device” has been read on the taught ([0046] The specimen testing system 1 includes […] a smear sample preparation unit 52…”).
With regards to claim 27, the analyzer of claim 26 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the smear preparation device comprises a smear preparation unit configured to prepare a smear of a specimen in the specimen container” has been read on the taught ([0236], “…a smear sample is prepared from a specimen in each container 110 held in the rack 100.”);
The claimed “a transport unit configured to transport the specimen rack transported from the specimen analyzer to a start position at which the smear preparation unit starts preparing the smear” and “the transport unit of the smear preparation device comprises a third collection region which is disposed in front of the smear preparation unit and in which a plurality of the specimen racks can be collected” has been read on the taught ([0236], “…the containers 110 […] is transported to the front of the smear sample preparation unit 52 by the specimen rearrangement unit 40 and the transportation unit 51…”; Transportation unit 51 reads on the transport unit. The front of the smear sample preparation unit reads on a third collection region.);
The claimed “a fourth collection region which is disposed in the left-right direction relative to the third collection region and in which a plurality of the specimen racks can be collected” has been read on the taught ([0236], “When the preparation of the smear sample has ended, the rack 100 is transported to the specimen storage unit 70 by the transportation units 51, 61.”; Specimen storage unit 70 reads on a fourth collection region. Figure 1 shows the storage unit arranged in a left-right direction.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 8 – 10, 12 – 19, 21, 22, 25, 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hayama et al (US 20230228780 A1).
With regards to claim 2, Hayama et al teaches;
The claimed “a specimen analyzer” has been read on the taught (Abstract, “Disclosed is a specimen testing system…”);
The claimed “a measurement unit configured to measure the specimen” has been read on the taught ([0054], “The transportation units 12, 31, 51, and 61 transport the rack 100 among the measurement units 32…”; Measurement unit 32 reads on a measurement unit);
The claimed “a transport unit comprising a first placement region which is disposed in front of the measurement unit and in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”);
The claimed “a second placement region […] in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”; The unit on the left side reads a second placement region);
The claimed “the transport unit configured to transport the specimen racks placed in the first placement region and the second placement region to a start position at which the measurement unit starts measurement” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”; Figure 1 includes arrows describing the movement path, which shows that the first rack may be returned from the left side unit back to the measurement unit 32.).
While Hayama et al does not explicitly disclose the limitation “a second placement region which is disposed in an up-down direction relative to the first placement,” this is held to be a mere rearrangement of parts. Hayama et al teaches that components may be placed in an up-down direction, as seen in [0064] or [0068]. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The location of the second placement region would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with a second placement region located in an up-down direction, for the predictable benefit of creating a specimen analyzer with a smaller lateral footprint.
With regards to claim 8, the analyzer of claim 7 is anticipated by Hayama et al.
Hayama et al does not explicitly disclose “wherein the first transport portion and the third transport portion transport the specimen racks in opposite directions, respectively.” Rather, the transport portions taught by Hayama et al operate in orthogonal directions.
However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The movement direction of the transport parts would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the transport portions moving in opposite directions, for the predictable benefit of creating a specimen analyzer with a desired lateral footprint.
With regards to claim 9, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a second transport path configured to transport the specimen rack placed in the first placement region, to the second placement region” has been read on the taught ([0059], “The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”; Figure 1 shows an arrow describing the movement path, which transfers from the first placement region to the second placement region.);
Regarding the limitation, “the transport unit transports the specimen rack placed in the first placement region to the start position through the second transport path and the second placement region, and transports the specimen rack placed in the second placement region to the start position without causing the specimen rack to pass through the second transport path and the first placement region,” this is held to be an obvious rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The transportation unit being capable of transporting the specimen rack to the measurement unit start position without crossing the first placement region would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the transportation unit capable of transporting the specimen rack placed in the second placement region to the start position without causing the specimen rack to pass through the second transport path and first placement region, for the predictable benefit of allowing the device to hold a specimen rack in the second placement region without causing a collision.
With regards to claim 10, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport path extending in the left-right direction between the measurement unit, and the first placement region and the second placement region, the transport path including the start position” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”);
The claimed “a first transport portion configured to transport forward or rearward the specimen rack in the first placement region” has been read on the taught [0060], “The transportation unit 12 transports rearward the rack 100 (first rack) carried in from the transportation unit 31 that is disposed adjacently on the right side, and carries out the rack 100 (first rack) to the specimen rearrangement unit 40 at a rear position.”);
The claimed “a second transport portion which is disposed at front ends of the first placement region and the second placement region, the second transport portion configured to transport the specimen rack between the first placement region and the second placement region” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”);
Hayama et al does not explicitly disclose “a third transport portion configured to transport the specimen rack in the second placement region in a direction opposite to a direction in which the first transport portion transports the specimen rack.” However, the examiner believes this to be a mere duplication of parts and rearrangement of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). A third transport configured to transport the specimen rack in the second placement region in a direction opposite to a direction in which the first transport portion transports the specimen rack would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer as obvious over Hayama et al with a third transport portion, which is capable of returning the specimen rack to an earlier position.
With regards to claim 12, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al further teaches;
The claimed “wherein the transport unit further comprises a first collection region […] in which a plurality of the specimen racks can be collected” has been read on the taught ([0055], “When all of the necessary tests have ended, the rack 100 is collected by the collection unit 13.”).
Hayama et al does not explicitly disclose wherein the collection unit 13 is “disposed in front of the measurement unit.” However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The movement direction of the transport parts would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the transport portions moving in opposite directions, for the predictable benefit of creating a specimen analyzer with a desired lateral footprint.
Hayama et al does not explicitly disclose “a second collection region which is disposed in the left-right direction relative to the first collection region and in which a plurality of the specimen racks can be collected.” However, the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer as obvious over Hayama et al with a second collection region, as mere duplication of parts which allows a greater number of specimen racks to be retrieved.
With regards to claim 13, the analyzer of claim 12 is obvious over Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport path including the start position, and the transport path extends in the left-right direction between the measurement unit and the first collection region” has been read on the taught ([0052], “With reference to FIG. 1, in the specimen testing system 1, the feeding unit 11, the supply unit 20, the two transportation units 31, the transportation unit 12, the specimen rearrangement unit 40, the transportation unit 51, the transportation unit 61, the specimen storage unit 70, and the collection unit 13 are aligned in line toward the left direction in order, respectively, so as to be adjacent to each other. The rack 100 is transported mutually between the two adjacent units.”; Figure 1 shows the transport path comprising transport units.).
With regards to claim 14, the analyzer of claim 12 is obvious over Hayama et al.
Hayama et al does not explicitly disclose wherein a number of the specimen racks which can be placed in a placement region of the transport unit and a number of the specimen racks which can be collected in a collection region of the transport unit are equal to each other.
However, the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). A change in the number of specimen racks which could be placed or collected would not modify the operation of the device.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer as obvious over Hayama et al with the placement region and collection region having an equal capacity for specimen racks, for the predictable benefit of allowing all placed specimen racks to be collected when testing is completed.
With regards to claim 15, the analyzer of claim 12 is obvious over Hayama et al.
Hayama et al does not explicitly disclose wherein a number of the specimen racks which can be collected in a collection region of the transport unit is larger than a number of the specimen racks which can be placed in a placement region of the transport unit.
However, the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). A change in the number of specimen racks which could be placed or collected would not modify the operation of the device.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer as obvious over Hayama et al with the collection region having a larger capacity for specimen racks than the placement region, for the predictable benefit of allowing all placed specimen racks to be collected when testing is completed, and allowing multiple operations to be completed before the collection region must be emptied.
With regards to claim 16, the analyzer of claim 13 is obvious over Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport portion configured to transport the specimen rack positioned at a predetermined position which is on the transport path and distant from the start position to the first collection region and the second collection region” has been read on the taught ([0064], “The specimen storage unit 70 carries out the empty rack 100 (first and second racks) to the transportation unit 61 disposed adjacently on the right side or the collection unit 13 disposed adjacently on the left side.”; Transportation unit 61 reads on the claimed transport portion.).
With regards to claim 17, the analyzer of claim 12 is obvious over Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit comprises a transport path including the start position and the transport path extends in the left-right direction between the measurement unit, and the first collection region and the second collection region” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32… The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”).
Hayama et al does not explicitly disclose wherein the second collection region is connected to a predetermined position which is on the transport path and distant from the start position, with the transport unit comprising a first transport portion configured to transport the specimen rack positioned at the predetermined position to the second collection region. However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Additionally, the first collection region is on the transport path and distant from the start position (see Figure 1), and one of ordinary skill in the art would arrange a second collection region similarly. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with a second collection region connected to a predetermined portion which is on the transport path and distant from the start position, for the predictable benefit of allowing the specimen racks to be collected at a second collection region.
Hayama et al does not explicitly disclose a second transport portion configured to transport the specimen rack in the second collection region toward the first collection region. However, the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Additionally, all components of the device as taught by Hayama et al are connected by transport portions; see Figure 1, and [0053].
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with a second transport portion configured to transport the specimen rack in the second collection region toward the first collection region, for the predictable benefit of allowing movement between the collection units.
With regards to claim 18, the analyzer of claim 17 is obvious over Hayama et al.
Hayama et al does not explicitly disclose wherein the transport unit comprises a third transport portion configured to transport the specimen rack transported toward the first collection region by the second transport portion into the first collection region.
However, the examiner believes this to be a mere duplication of parts and rearrangement of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). A third transport portion configured to transport the specimen rack transported toward the first collection region by the second transport portion into the first collection region would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer as obvious over Hayama et al with a third transport portion, which is configured to transport the specimen rack toward the first collection region by the second transport portion, for the predictable benefit of allowing the collection of specimen racks by various transport paths.
With regards to claim 19, the analyzer of claim 18 is obvious over Hayama et al.
Hayama et al does not explicitly disclose wherein the second transport portion collectively transports a plurality of the specimen racks in the second collection region toward the first collection region and the third transport portion collectively transports, into the first collection region, the plurality of the specimen racks which are collectively transported by the second transport portion.
However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Additionally, Hayama et al teaches that the units are all connected with one another; please see [0053].
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the action of the second and third transport portions, for the predictable benefit of allowing the specimen racks to be collected at the collection regions.
With regards to claim 21, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al does not explicitly disclose wherein at least a part of the first placement region is disposed in front of the measurement unit in a range of a left-right width of a bottom surface of the measurement unit.
However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The distance of the first placement region from the measurement unit would not modify the operation of the device. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with at least a part of the first placement region is disposed in front of the measurement unit in a range of a left-right width of a bottom surface of the measurement unit.
With regards to claim 22, the analyzer of claim 12 is obvious over Hayama et al.
Hayama et al does not explicitly disclose wherein at least a part of the first collection region is disposed in front of the measurement unit in a range of a left-right width of a bottom surface of the measurement unit.
However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The distance of the first placement region from the measurement unit would not modify the operation of the device. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with at least a part of the first placement region is disposed in front of the measurement unit in a range of a left-right width of a bottom surface of the measurement unit.
With regards to claim 25, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al does not explicitly disclose wherein a number of the specimen containers that can be placed in the first placement region and the second placement region at one time is 160 or more and 800 or less and a number of the specimens that can be analyzed per one hour by the specimen analyzer is 130 or more and 400 or less.
Regarding the limitation “wherein a number of the specimen containers that can be placed in the first placement region and the second placement region at one time is 160 or more and 800 or less,” the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the analyzer as obvious over Hayama et al with a defined number of specimen containers which can be placed, as mere duplication of parts which determines the number of specimen containers which can be processed.
Regarding the limitation “a number of the specimens that can be analyzed per one hour by the specimen analyzer is 130 or more and 400 or less,” this limitation discusses an optimum workable range of a device, and does not disclose additional structural limitations. The specification of the instant invention does not disclose that the hourly processing rate of the invention is critical. Accordingly, the examiner believes the processing rate of the instrument to be subject to routine optimization, per MPEP 2144.05(II)(A), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, this limitation does not distinguish the claimed invention from the prior art of Hayama et al.
With regards to claim 28, Hayama et al teaches;
The claimed “a specimen analyzer” has been read on the taught (Abstract, “Disclosed is a specimen testing system…”);
The claimed “a measurement unit configured to measure the specimen” has been read on the taught ([0054], “The transportation units 12, 31, 51, and 61 transport the rack 100 among the measurement units 32…”; Measurement unit 32 reads on a measurement unit);
The claimed “a transport unit comprising a placement region in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”);
The claimed “the transport unit configured to transport the specimen racks placed in the placement region to a start position at which the measurement unit starts measurement” ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”; Figure 1 includes arrows describing the movement path, which shows that the first rack may be returned from the left side unit back to the measurement unit 32.).
Hayama et al does not explicitly disclose wherein a number of the specimen containers that can be placed in the first placement region and the second placement region at one time is 160 or more and 800 or less and a number of the specimens that can be analyzed per one hour by the specimen analyzer is 130 or more and 400 or less.
Regarding the limitation “wherein a number of the specimen containers that can be placed in the first placement region and the second placement region at one time is 160 or more and 800 or less,” the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Accordingly, it would have been obvious to one of ordinary skill in the art to modify the analyzer as obvious over Hayama et al with a defined number of specimen containers which can be placed, as mere duplication of parts which determines the number of specimen containers which can be processed.
Regarding the limitation “a number of the specimens that can be analyzed per one hour by the specimen analyzer is 130 or more and 400 or less,” this limitation discusses an optimum workable range of a device, and does not disclose additional structural limitations. The specification of the instant invention does not disclose that the hourly processing rate of the invention is critical. Accordingly, the examiner believes the processing rate of the instrument to be subject to routine optimization, per MPEP 2144.05(II)(A), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). As such, this limitation does not distinguish the claimed invention from the prior art of Hayama et al.
With regards to claim 29, the analyzer of claim 28 is obvious over Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the placement region includes a first placement region which is disposed in front of the measurement unit and in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”);
The claimed “a second placement region which is disposed in a left-right direction relative to the first placement region and in which a plurality of the specimen racks can be placed” has been read on the taught ([0059], “The transportation unit 31 carries out the rack 100 (first rack) to the unit disposed adjacently on the left side.”; The unit on the left side reads a second placement region).
With regards to claim 30, the analyzer of claim 29 is obvious over Hayama et al.
Hayama et al additionally teaches;
The claimed “wherein the transport unit further comprises a first collection region […] in which a plurality of the specimen racks can be collected” has been read on the taught ([0055], “When all of the necessary tests have ended, the rack 100 is collected by the collection unit 13.”).
Hayama et al does not explicitly disclose wherein the collection unit 13 is “disposed in front of the measurement unit.” However, the examiner believes this to be a mere rearrangement of parts. Per MPEP 2144.04(IV)(C), rearrangement of parts may be prima facie obvious provided that the rearrangement does not modify the operation of the device; see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The movement direction of the transport parts would not modify the operation of the device, and would amount only to a different transportation path configured using mechanisms known in the art.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the transport portions moving in opposite directions, for the predictable benefit of creating a specimen analyzer with a desired lateral footprint.
Hayama et al does not explicitly disclose “a second collection region which is disposed in the left-right direction relative to the first collection region and in which a plurality of the specimen racks can be collected.” However, the examiner believes this to be a mere duplication of parts. Per MPEP 2144.04(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. Please see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analyzer as obvious over Hayama et al with a second collection region, as mere duplication of parts which allows a greater number of specimen racks to be retrieved.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hayama et al (US 20230228780 A1, effectively filed January 14 2022) as applied to claim 1 above, and further in view of VanSickler et al (US 20250012824 A1, effectively filed 17 October 2016).
With regards to claim 11, the analyzer of claim 1 is anticipated by Hayama et al.
Hayama et al additionally teaches;
The claimed “a first transport portion configured to transport the specimen rack placed in the first placement region” has been read on the taught ([0059], “The transportation unit 31 transports the rack 100 (first rack) carried in from the unit that is disposed adjacently on the right side, to the front of the measurement unit 32.”);
The claimed “a second transport portion configured to transport the specimen rack placed in the second placement region” has been read on the taught ([0060], “The transportation unit 12 transports rearward the rack 100 (first rack) carried in from the transportation unit 31 that is disposed adjacently on the right side, and carries out the rack 100 (first rack) to the specimen rearrangement unit 40 at a rear position.”);
Hayama et al additionally teaches the use of detectors configured to detect specimen racks, as read on ([0070], “The sensor 302 is a transmission-type photoelectric sensor, and detects the rack 100 positioned at a carrying-in position P11 on the carrying-in path 301.”).
Hayama et al additionally teaches a controller which controls transport portions, as read on the taught ([0066], “The transportation control unit 80 determines a destination to which the rack 100 (first and second racks) is to be transported, and controls each unit that transports the rack 100 (first and second racks) so as to transport the rack 100 (first and second racks) to the determined destination.”).
However, Hayama et al does not explicitly disclose a first detector configured to detect the specimen rack placed in the first placement region, a second detector configured to detect the specimen rack placed in the second placement region, and a controller programmed to control the first and the second transport portions so as to cause the first transport portion to transport the specimen rack when the first detector detects the specimen rack, and cause the second transport portion to transport the specimen rack when the second detector detects the specimen rack.
In the analogous art of automated analyzers, VanSickler et al teaches;
The claimed “a first detector configured to detect the specimen rack placed in the first placement region; a second detector configured to detect the specimen rack placed in the second placement region; and a controller programmed to control the first and the second transport portions so as to cause the first transport portion to transport the specimen rack when the first detector detects the specimen rack, and cause the second transport portion to transport the specimen rack when the second detector detects the specimen rack” have been read on the taught ([0179], “…shuttle 280 is placed on first track 310a activating a sensor 305 located at one end thereof. This notifies system 10 of the shuttle's presence on first track 310a where instructions for further operation are determined/provided.”; Activating sensors 305 reads on a first and second detector. System 10 reads on a controller.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the position detectors and controllers as taught by VanSickler et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Hayama et al teaches a “base” device with placement region and transportation units, upon which the claimed invention can be seen as an improvement. The prior art of VanSickler et al teaches a “comparable” device of an analyzer with specimen rack transport, which has been improved in the same way with detectors which determine the specimen racks location and a controller which begins transport when it detects a specimen rack. One of ordinary skill in the art could have applied the sensing technique in the same way to the device of Hayama et al, for the predictable result of an analyzer which can automatically sense and move full specimen racks.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hayama et al (US 20230228780 A1, effectively filed January 14 2022) as applied to claim 19 above, and further in view of Tatsutani et al (US 20110244583 A1).
With regards to claim 20, the analyzer of claim 19 is obvious over Hayama et al.
However, Hayama et al does not explicitly disclose wherein the transport unit comprises a shutter configured to set whether or not the specimen rack is to be transported between the first collection region and the second collection region.
In the analogous art of sample transport systems, Tatsutani et al teaches;
The claimed “wherein the transport unit comprises a shutter configured to set whether or not the specimen rack is to be transported between the first collection region and the second collection region” has been read on the taught ([0015], “…when a user operates a switch which is provided in another transport apparatus different from the one transport apparatus, transmitting a signal to a control apparatus from the another transport apparatus; and responsive to the signal transmitted from the another transport apparatus, restarting, by the control apparatus, the transport of the sample rack by the plurality of transport apparatuses.”; The switch reads on a shuttle configured to set the transportation of the specimen rack.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device as taught by Hayama et al with the switch as taught by Tatsutani et al. According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the prior art of Hayama et al teaches a “base” device with transport units, upon which the claimed invention can be seen as an improvement. The prior art of Tatsutani et al teaches a “comparable” device of an analyzer with specimen rack transport, which has been improved in the same way with a switch that can direct the transport of sample racks. One of ordinary skill in the art could have applied the sensing technique in the same way to the device of Hayama et al, for the predictable result of an analyzer which can use a first or second track.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bryant et al (US 20210132097 A1) teaches an automated system analyzer with sample tube transport sections.
Itoh (US 20080053790 A1) teaches a specimen transport system including specimen racks.
Nagai et al (US 20100330609 A1) teaches a specimen analyzer with multiple measurement unit and transports.
Kitagawa et al (US 20110065193 A1) teaches a sample processing apparatus with a controller for directing container transport.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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