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 Group I, claims 1 – 19 in the reply filed on 02 February 2023 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01 June 2023, 15 December 2023, and 15 April 2026 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 65 (Power supply), T1 (cooling process).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 222.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “a reagent container storage that stores reagent container.” The examiner believes this is a typographical error, and should recite “a reagent container storage that stores a reagent container.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 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 19 does not include a verb, and it is unclear what relation “natural convection generated inside the housing” has to the other limitations of the claim. This ambiguity amounts to a failure to particularly point out and distinctly claim the invention, and renders the claim indefinite. For the purposes of examination, the examiner interprets claim 19 to mean, “natural convention is generated inside the housing…”
Claim 19 recites the limitation "in the order" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets the claim to mean “in an order.”
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 – 11 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niyama et al (US 20180164336 A1).
With regards to claim 1, Niyama et al teaches;
The claimed “a sample measuring apparatus” has been read on the taught ([0001], “The present invention relates to an automated analyzer…”);
The claimed “a reagent container storage that stores a reagent container with a reagent” has been read on the taught ([0019], “…a large number of reagent containers 101 arranged in a reagent container storage apparatus 100…”);
The claimed “a housing that accommodates the reagent container” has been read on the taught ([0026], “The reagent container storage apparatus 100 mainly includes a reagent storage chamber 120 storing the reagent containers 101 and a reagent lid 116.”; A reagent storage chamber 120 and a reagent lid 116 reads on a housing);
The claimed “a cooling section that cools the housing” has been read on the taught ([0026], “The cold water pipe 123 is connected to a cooler 121 as a primary cooling source.”);
The claimed “a measuring unit that measures a sample using the reagent” has been read on the taught ([0025], “A reaction state of the specimen and the reagent is measured by the reaction measurement device 115.”);
The claimed “a ventilation passage is arranged below the reagent container in the housing” and “at least a part of the cooling section is provided in the housing at a higher part of the housing than the ventilation passage” has been read on the taught (See annotated figure 4, which shows the cooling pipe at the top and sides of the chamber, and a ventilation area provided underneath the reagent containers).
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With regards to claim 2, the apparatus of claim 1 is anticipated by Niyama et al.
The claimed “the housing comprises a top part, a bottom part, and a side part” has been read on the taught ([0026], “The reagent container storage apparatus 100 mainly includes a reagent storage chamber 120 storing the reagent containers 101 and a reagent lid 116. A side surface and a bottom surface of the reagent storage chamber 120 is made of metal such as SUS.”; A reagent lid reads on a top part. A side surface and bottom surface read on a side part and a bottom part.);
The claimed “the cooling section is provided on the side part or the top part of the housing” has been read on the taught ([0026], “A cold water pipe 123 for introducing cold water 122 is provided on the side surface or the bottom surface of the reagent storage chamber 120.”).
With regards to claim 3, the apparatus of claim 2 is anticipated by Niyama et al.
The claimed “the side part comprises a first side part; and a second side part that is arranged facing the first side part, and the cooling section is provided on one of the first side part and the second side part in the housing” has been read on the taught (See figure 4, provided on page 5 of this action which shows two side parts arranged facing one another, and the water cooling sections on two sides.).
With regards to claim 4, the apparatus of claim 1 is anticipated by Niyama et al.
The claimed “a pipette that aspirates a reagent stored in the reagent container in the reagent container storage and dispenses the reagent into a reaction container, in which the sample is stored” has been read on the taught ([0022], “Next, a reagent inside the reagent container 101 is dispensed into the reaction container 109 transferred to the reaction container holder 108 by the reagent dispensing mechanism 106.”; Reagent dispensing mechanism 106);
The claimed “a through hole for the pipette to enter and exit that is arranged on a top part of the housing” has been read on the taught (Claim 1, “…the reagent chamber lid and the transfer member include dispensing holes communicating between inside and outside of the reagent container storage apparatus…”).
With regards to claim 5, the apparatus of claim 1 is anticipated by Niyama et al.
The claimed “the housing comprises a heat transfer housing part that has thermal conductivity” and “wherein the heat transfer housing part comprises a first side wall; a second side wall that is arranged facing the first side wall across the reagent container and a top surface connection part that connects the first side wall and second side wall” have been read on the taught ([0026], “The reagent container storage apparatus 100 mainly includes a reagent storage chamber 120 storing the reagent containers 101 and a reagent lid 116. A side surface and a bottom surface of the reagent storage chamber 120 is made of metal such as SUS. As the side surface and the bottom surface are made of metal, thermal conductivity is higher than a resin material, therefore, the reagent container storage apparatus 100 can be efficiently cooled.”; Reagent lid 116 reads on the top surface connection part);
The claimed “the cooling section is provided in the first side wall, the second side wall, or the top surface connection part” has been read on the taught ([0026], “A cold water pipe 123 for introducing cold water 122 is provided on the side surface or the bottom surface of the reagent storage chamber 120.”).
With regards to claim 6, the apparatus of claim 5 is anticipated by Niyama et al.
The claimed “the cooling section is provided on the first side wall or the second side wall” has been read on the taught ([0026], “A cold water pipe 123 for introducing cold water 122 is provided on the side surface or the bottom surface of the reagent storage chamber 120.”).
With regards to claim 7, the apparatus of claim 5 is anticipated by Niyama et al.
The claimed “the bottom part of the housing comprises a material that has a lower thermal conductivity than the heat transfer housing part” has been read on the taught ([0026], “A side surface and a bottom surface of the reagent storage chamber 120 is made of metal such as SUS. As the side surface and the bottom surface are made of metal, thermal conductivity is higher than a resin material, therefore, the reagent container storage apparatus 100 can be efficiently cooled.”).
With regards to claim 8, the apparatus of claim 5 is anticipated by Niyama et al.
The claimed “the top surface connection part of the heat transfer housing part is provided in a location where the top surface connection part does not overlap a reagent container accommodated in the housing in a plan view” has been read on the taught ([0028], “Therefore, the inside, particularly in an upper space of the reagent container storage apparatus 100 is warmed due to effects of outside air flowing from dispensing holes 117 of the reagent container storage apparatus 100…”; The dispensing holes 117 read on a portion of the top surface connection part that does not overlap a reagent container.).
With regards to claim 9, the apparatus of claim 5 is anticipated by Niyama et al.
The claimed “the housing accommodates a plurality of reagent containers side by side along a direction perpendicular to a direction from the first side wall to the second side wall” has been read on the taught ([0019], “…a large number of reagent containers 101 arranged in a reagent container storage apparatus 100 are set on a circumference on a reagent disk 102 as a conveying device (a reagent lid is not shown).”).
With regards to claim 10, the apparatus of claim 5 is anticipated by Niyama et al.
The claimed “wherein the reagent container is accommodated in the housing while being stored in a reagent container rack, wherein the reagent container rack has a shape that extends in a longitudinal direction, in which a plurality of reagent containers are accommodated side by side, and the housing accommodates the reagent container rack with the longitudinal direction of the reagent container rack oriented in a direction perpendicular to a direction from the first side wall to the second side wall” has been read on the taught ([0027], “The reagent disk 102 for storing the reagent containers 101 is provided inside the reagent container storage apparatus 100, and a large number of reagent containers 101 can be stored there inside. The reagent disk 102 is fixed to a central axis of the reagent container storage apparatus 100, which can be rotated by a drive source such as a motor…”).
With regards to claim 11, the apparatus of claim 5 is anticipated by Niyama et al.
The claimed “wherein the housing comprises an insulation housing part that covers the heat transfer housing part” has been read on the taught ([0031], “In this case, a portion between the inner wall 124 and the reagent lid 116 is a heat insulating member 126 with a low thermal conductivity…”).
With regards to claim 19, the apparatus of claim 3 is anticipated by Niyama et al.
Niyama et al teaches circulation and heat exchange within the device, as described in Figure 4 and [0034].
The claim language of “wherein natural convection is generated inside the housing by cooling of the cooling section circulates between the first side part of the housing and the reagent container, the ventilation passage, between the second side part facing the first side part of the housing and the reagent container, and between the top part of the housing and the reagent container in an order” describes the intended function of the device, and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Niyama et al teaches all of the structural limitations of the apparatus as defined in claim 19, this additional limitation does not define the instant application over the prior art.
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 12, 13, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Niyama et al (US 20180164336 A1) in view of Miyazaki et al (US 20190383844 A1).
With regards to claim 12, the apparatus of claim 2 is anticipated by Niyama et al.
However, Niyama et al does not explicitly disclose wherein the reagent container is accommodated in the housing while being stored in a reagent container rack, wherein the reagent container storage comprises a rack support that supports the reagent container rack in the housing, and wherein the rack support is freely pulled out from the housing.
In the analogous art of reagent container storage, Miyazaki et al teaches;
“A reagent container storage with a housing and reagent containers” has been read on the taught ([0028], “…an apparatus 1 includes a temperature control space 4 inside a housing 2.”; [0029], “A sample plate 10 holding a sample is placed on the bottom of the temperature control space 4 […] sample plate 10 may hold a plurality of vials containing a sample…”);
The claimed “wherein the reagent container is accommodated in the housing while being stored in a reagent container rack” and “wherein the reagent container storage comprises a rack support that supports the reagent container rack in the housing” have been read on the taught ([0029], “A sample plate 10 holding a sample is placed on the bottom of the temperature control space 4 in a state of being mounted on the sample rack 12.”; Sample plate 10 reads on a reagent container rack. Temperature control space 4 reads on the housing. Sample rack 12 reads on a rack support.);
The claimed “wherein the rack support is freely pulled out from the housing” has been read on the taught (Abstract, “The air temperature control part is configured to reduce an amount of air flowing near the rack insertion opening while the sample rack is pulled out from the temperature control space.”).
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 sample measuring apparatus of Niyama et al with the pull-out rack support as taught by Miyazaki et al, for the predictable benefit of allowing easy insertion of a new sample as taught by Miyazaki et al ([0005], “Accordingly, installation work of a sample in the temperature control space is easy.”).
With regards to claim 13, the apparatus of claim 12 is obvious over Niyama et al in view of Miyazaki et al.
Niyama et al does not explicitly disclose wherein the ventilation passage is provided between the reagent container rack and the rack support.
Miyazaki et al further teaches;
The claimed “wherein the ventilation passage is provided between the reagent container rack and the rack support” has been read on the taught ([0031], “Further, the sample rack 12 is disposed in the temperature control space 4 with a gap 32 between the sample rack 12 and a floor surface of the temperature control space 4.”) 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 sample measuring apparatus of Niyama et al with the ventilation passage taught by Miyazaki et al, for thee predictable benefit of providing a circulation path which cools the bottom of the sample rack, as taught by Miyazaki et al ([0035], “…air taken in from the air intake portion 22 and cooled by the Peltier element 18 takes a circulation path, in which the air flows through the gap 32 between the lower surface of the sample rack 12 and the floor surface of the temperature control space 4…”).
With regards to claim 14, the apparatus of claim 12 is obvious over Niyama et al in view of Miyazaki et al.
The claimed “wherein the ventilation passage is provided in the rack support” has been read on the taught ([0039], “In the variations shown in FIGS. 3 and 4, a cover 12d is attached above the sample plate 10 of the sample rack 12, and space 40 in which air flows is formed between the bottom plate of the sample rack 12 and the cover 12d.”; Space 40 reads on a ventilation passage in the rack support.).
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 of Niyama et al with the ventilation passage as taught by Miyazaki et al, for the predictable benefit of allowing cooling ventilation across the sample as taught by Miyazaki et al ([0038], “FIGS. 3 and 4 show variations of the configuration for allowing cooled air to flow along the sample rack 12.”).
With regards to claim 16, the apparatus of claim 12 is obvious over Niyama et al in view of Miyazaki et al.
The claimed “the ventilation passage is provided in the reagent container rack” has been read on the taught ([0039], “In the variations shown in FIGS. 3 and 4, a cover 12d is attached above the sample plate 10 of the sample rack 12, and space 40 in which air flows is formed between the bottom plate of the sample rack 12 and the cover 12d.”; Space 40 reads on a ventilation passage in the rack support.).
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 of Niyama et al with the ventilation passage as taught by Miyazaki et al, for the predictable benefit of allowing cooling ventilation across the sample as taught by Miyazaki et al ([0038], “FIGS. 3 and 4 show variations of the configuration for allowing cooled air to flow along the sample rack 12.”).
With regards to claim 17, the apparatus of claim 2 is anticipated by Niyama et al.
Niyama et al does not explicitly disclose a heat exhaust section that exhausts heat generated by the cooling section.
In the analogous art of reagent container storage, Miyazaki et al teaches;
The claimed “a heat exhaust section that exhausts heat generated by the cooling section” has been read on the taught ([0033], “The Peltier element 18 is provided in such a way that a heat absorption side is disposed inside the temperature control space 4 and a heat radiation side is disposed outside of the temperature control space 4.”; A heat radiation side reads on a heat exhaust section.).
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 of Niyama et al with the heat exhaust section as taught by Miyazaki et al, for the predictable benefit of supplying cool air, as taught by Miyazaki et al ([0032], “The air temperature control part 16 includes a Peltier element 18 which is a cooling element, a fan 20, an air intake portion 22, the hood 24, a rising guide 26, a heat radiation fin 28, and a heat absorbing fin 30. The air temperature control part 16 sucks air in the temperature control space 4 from the air intake portion 22, cools the air with the Peltier element 18, and supplies the cooled air toward the sample plate 10 in the temperature control space 4.”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Niyama et al (US 20180164336 A1) in view of Miyazaki et al (US 20190383844 A1) and further in view of Gwynn et al (US 20130132006 A1).
With regards to claim 15, the apparatus of claim 12 is obvious over Niyama et al in view of Miyazaki et al.
Niyama et al does not explicitly disclose wherein the bottom part of the housing comprises a rail that slides the rack support, and the ventilation passage is provided in the rail.
Miyazaki et al further teaches that the ventilation passage can be provided underneath the sliding sample rack, and that any configuration providing ventilation may be used, as read on the taught ([0037], “Note that in the embodiment shown in FIGS. 1 and 2, while the sample rack 12 is accommodated in the temperature control space 4, the air blown by the fan 20 flows through the gap 32 between the lower surface of the sample rack 12 and the floor surface of the temperature control space 4. However, the present invention is not limited to such a configuration, and any configuration may be employed as long as the configuration allows cooled air to flow along the sample rack 12.”).
However, Niyama et al in view of Miyazaki does not explicitly disclose wherein the bottom part of the housing comprises a rail that slides the rack support, and the ventilation passage is provided in the rail.
In the analogous art of sample measuring apparatuses, Gwynn et al teaches;
The claimed “wherein the bottom part of the housing comprises a rail that slides the rack support” has been read on the taught ([0220], “In operation, sample holders 616 can rest on the support rails, and may be free to slide along the support rails with sample holders 616 loaded earlier in the process pushed along the support rails by adjacent sample holders 616 loaded later.”).
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 sliding sample rack with a ventilation passage provided therein as taught by Niyama et al in view of Miyazaki et al with the sliding rails as taught by Gwynn 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 Niyama et al in view of Miyazaki et al teaches a “base” device with a sliding sample holder, upon which the claimed invention can be seen as an ”improvement.” The prior art of Gwynn et al teaches a comparable device that has been improved in the same way, with a sliding rail. One of ordinary skill in the art could have applied the known improvement technique of sliding rails in the same way to the base device, for the predictable improvement of a stable, sliding sample platform which can accommodate a ventilation passage underneath.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Niyama et al (US 20180164336 A1) in view of Gwynn et al (US 20130132006 A1).
With regards to claim 18, the apparatus of claim 1 is anticipated by Niyama et al.
However, Niyama et al does not explicitly disclose an apparatus housing that accommodates the measuring unit and the reagent container storage inside.
In the analogous art of sample measuring apparatuses, Gwynn et al teaches;
The claimed “an apparatus housing that accommodates the measuring unit and the reagent container storage inside” has been read on the taught ([0180], “one embodiment of the instrument of the invention includes a generally rectangular housing 102 with sides defining the front, back, left and right sides, top and bottom as illustrated.”).
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 sample apparatus as taught by Niyama et al with the housing as taught by Gwynn 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 Niyama et al teaches a “base” device with a measuring unit and reagent container storage, upon which the claimed invention can be seen as an ”improvement.” The prior art of Gwynn et al teaches a comparable device that has been improved in the same way, with an overall device housing. One of ordinary skill in the art could have applied the known improvement technique of a device housing in the same way to the base device, for the predictable improvement of an apparatus where individual components are protected in a housing.
Conclusion
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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