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 Group I in the reply filed on 8/18/2025 is acknowledged.
Claim Rejections - 35 USC § 102 and/or alternatively 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 10 and 12 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kodama et al. (US 2010/0279392).
Regarding claim 1 Kodama discloses a portable RT-PCR device comprising: (See Kodama Abstract and [0248] wherein the device may perform RT-PCR and is portable if one so wished)
a base unit in which amounting space is formed;(See Kodama Fig. 4 wherein a base unit, i.e. frame, in which a mounting space, i.e. space holding all inner elements, is formed.)
a plurality of lower heating units mounted in the mounting space in the base unit; (See Kodama Figs 4-5 wherein a plurality of lower heating units, 10” in units 10a-10,c are mounted in the mounting space)
a lower optical measurement unit mounted in the base unit and arranged in a different position than the plurality of lower heating units and providing measurement light or receiving the measurement light;(See Kodama Figs. 4-5 and 13-14 wherein a lower optical measurement unit 47 is arranged in a different position than , i.e. between, the plurality of lower heating units to receive measurement light from the chambers.)
and a chamber assembly including a plurality of chambers that are seated on the plurality of lower heating units and the lower optical measurement unit, respectively, each chamber being provided in such a manner to be movable from one of the plurality of lower heating units to other one of the plurality of lower heating units or to the lower optical measurement unit. (See Kodama Fig. 6 and 8A-8B and [0178] wherein the chamber assembly includes a plurality of chambers, i.e. individual reaction units, which are seated on and movable between the lower heating units and optical measurement units.)
wherein each of the plurality of chambers comprises: a chamber body for accommodating a chamber unit in which a specimen-unit accommodation space inside which a specimen unit is accommodated is formed; wherein the chamber unit comprises: a chamber unit body in which the specimen-unit accommodation space is formed; (See Kodama Figs. 8A-8B wherein each chamber comprises a chamber body, i.e. space between top 38 and bottom 39 surfaces, for accommodating a chamber unit, i.e. fluidic path in 37, in which a specimen-unit accommodation space, i.e. reaction chamber 12, is formed and holds a specimen. The chamber unit comprises a body 37 in which the specimen-unit accommodation space 12 is formed.)
and a cap unit covering the specimen-unit accommodation space in the chamber unit body from above; (See Kodama Figs. 8B-10 wherein a cap unit, i.e. 40 and/or 38, covers the specimen unit accommodation space in the chamber unit body from above.)
and wherein the specimen unit has an aspect ratio, that is, a height-to-width ratio, which is greater than 0 and smaller than 1.(See Kodama Fig. 8B wherein the specimen unit has a larger width than height.
Furthermore assuming arguendo with respect to the aspect ratio it is noted that such a modification would have required a mere change in dimension, i.e. height of the device, which would have been obvious to one of ordinary skill in the art because such a change is known in order to optimize heat transfer (See Kodama [0067]-[0068]) and because it has been held that a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding claim 2 Kodama discloses all the claim limitations as set forth above as well as the device wherein the chamber assembly further comprises: a chamber movement unit for moving the plurality of chambers, wherein the plurality of chambers are arranged around a rotational center formed in the base unit in such a manner as to be spaced a preset distance apart, and wherein the chamber movement unit rotates the plurality of chambers around the rotational center in one direction at the same time. (See Kodama Figs. 4-6 and [0071] wherein a chamber movement unit, i.e. motor 22, moves the chambers about a rotational center in the base unit and the chambers are spaced and formed a preset distance apart and moved in one direction around the rotational center at the same time.)
Regarding claim 3 Kodama discloses all the claim limitations as set forth above as well as the device, wherein the chamber movement unit comprises: a plurality of connection brackets, first end portions of which are connected to the plurality of chambers, respectively; and a rotation shaft to which second end portions of the plurality of connection brackets are connected and which is provided in a manner that is rotatable about the rotational center, wherein the rotation of the chamber movement unit is stopped for a maintenance time, and the chamber movement unit is rotated for a movement time, and wherein the maintenance time is set to be longer than the movement time. (See Kodama Fig. 4 and [0185] wherein a plurality of connection brackets, i.e. holding block portions 24a, and 24b, includes first send portions 24b connected to the plurality of chambers and second end portions 24a connected to a rotation shaft from motor 22, the rotation of the chambers is provided for moving and maintenance times, i.e. time for rotation and time in contact with a heat source.)
In regards to the movement time and maintenance time it is noted that such limitations are directed to intended uses of the claimed device and the device is fully capable of rotating or stopping manually or automatically any amount of time. See MPEP 2114.
Regarding claim 4 Kodama discloses all the claim limitations as set forth above as well as the device wherein a first guide unit for guiding the rotation of each of the plurality of chambers is formed to be positioned between one of the plurality of lower heating units and other one of the plurality of lower heating units or the lower optical measurement unit, wherein the first guide unit is formed in such a manner as to have a curvature corresponding to a curvature radius of an imaginary circle that is formed when the plurality of chambers are rotated, and wherein a guide groove or a guide protrusion that is engaged with the first guide unit is formed in or on a lower portion of each of the plurality of chambers. (See Kodama Fig. 9A-9C wherein a first guide unit, i.e. inner portion of plate 23, is placed in the center of and between the lower heating units and has a curvature corresponding to an imaginary circle formed by rotation of the chambers, and a guide protrusion, i.e. protruding side walls of the chamber, is formed in a lower portion of the chambers.)
Regarding claim 5 Kodama discloses all the claim limitations as set forth above as well as the device wherein a second guide unit that is connected to the first guide unit, has the same curvature radius as the first guide unit, and is selectively engaged with the guide groove in each of the plurality of chambers or the guide protrusion thereon is formed to be positioned on upper surfaces of the lower heating unit and the lower optical measurement unit. (See Kodama Fig. 9A-9C wherein a second guide unit, i.e. outer portion of plate 23, has a groove therein into which the protruding wall of the chambers are placed, and said outer portion the plate shares a same curvature radius as the first guide unit.)
Regarding claim 10 Kodama discloses all the claim limitations as set forth above as well as the device wherein the plurality of lower heating units each are formed in the shape of a plate, wherein lower surfaces of the plurality of chambers are brought into full contact with the plurality of lower heating units, respectively, (See Kodama Fig. 9A-9C wherein the heating units are in the shape of a plate onto which lower surfaces of the chambers are brought into full thermal contact with.)
wherein a chamber-unit insertion space into which the chamber unit is to be inserted is formed in the chamber body of each of the plurality of chambers, and wherein the chamber-unit insertion space is formed in such a manner that a width thereof corresponds to a width of each of the plurality of chamber units. (See Kodama Figs 8B-10 wherein a chamber-unit insertion space, i.e. space between top and bottom 38 and 39 is provided into which the chamber unit 37 us inserted in such a manner that a width of the space matches the width of each chamber unit, i.e. the chamber width is defined by a width of the insertion space.)
Regarding claim 12 Kodama discloses all the claim limitations as set forth above and it is noted that the specimen unit is a material worked on by the device which does not define a structural element which differentiates the claimed invention from the cited prior art as the cited prior art is fully capable of receiving such a specimen unit with a porous membrane structure. See MPEP 2115.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kodama et al. (US 2010/0279392).
Regarding claim 11 Kodama discloses all the claim limitations as set forth above as well as the device wherein a measurement solution is accommodated in the specimen-unit accommodation space in each of the plurality of chamber units,(See Kodama Abstract [0205], and [0246] wherein a measurement solution, i.e. reaction mixture, is accommodated in the specimen-unit accommodation space in each chamber.)
Kodama does not specifically disclose the specimen-unit accommodation space is formed in such a manner that the aspect ratio thereof is greater than 0 and smaller than 1, and wherein the specimen-unit accommodation space is formed in such a manner that a volume thereof is 20 microliters to 100 microliters.
In respect to the aspect ratio and the volume of the specimen unit-accommodation space it is noted that such a modification would have required a mere change in dimension, i.e. width and/or height of the accommodation space, which would have been obvious to one of ordinary skill in the art because such a change is known in order to optimize heat transfer (See [0067]-[0068]) and because it has been held that a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kodama et al. (US 2010/0279392) as applied to claims above, and further in view of Chiou et al. (US 2015/0024474).
Regarding claims 6-7 Kodama discloses all the claim limitations as set forth above as well as the device wherein the lower heating unit comprises: a first lower heating unit that operates at a first temperature; a second lower heating unit that operates at a second temperature; and a third lower heating unit that operates at a third temperature wherein and wherein the first lower heating unit and the third lower heating unit are on opposite sides of the rotational center and the second lower heating unit and the lower optical measurement unit are on opposite sides of the rotational center.
Kodama does not specifically disclose that the first lower heating unit and the third lower heating unit are symmetrical about the rotational center, and the second lower heating unit and the lower optical measurement unit are symmetrical about the rotational center or the first temperature higher than the third temperature and the third temperature higher than the second.
Chiou et al. discloses a PCR device heating units are arranged about a rotational axis that the first heating unit and the third heating unit are symmetrical about the rotational center, and the second heating unit and a optical measurement unit are symmetrical about the rotational center and the temperatures of all heating units may be configured as desired according to a reaction profile desired. (See Chiou Abstract, Fig. 3, and [0041] wherein first heating unit 201/third heating unit 203 and second heating unit 202/optical unit 501, are respectively symmetrical about a rotational center and may be provided with any desired temperature profile.)
It would have been obvious to one of ordinary skill in the art at the time of invention to provide symmetrical first heating unit and third heating unit as well as symmetrical second heating unit and optical unit and provide them with a desired temperature profile as described by Chiou in the device of Kodama because such adjustments to the heating units and programmable nature thereof allows for greater control over the reaction profile of the biological material as would be desirable in the device of Kodama.
Regarding claim 8 Kodama discloses all the claim limitations as set forth above as well as the device further comprising: a cover unit arranged over the base unit and covering the mounting space; a plurality of upper heating units each of which is arranged between each of the plurality of lower heating units and the cover unit and which are selectively brought into contact with upper surfaces, respectively, of the plurality of chambers; (See Kodama Figs. 4-5 and 9A-9C whereon a cover unit, i.e. upper lid 13, is arranged over the base unit and covers the mounting space. A plurality of upper heating units, 10’, are arranged between the lower heating units and cover unit and are moved to come into contact with upper surfaces of the plurality of chambers.)
and an upper optical measurement unit facing the lower optical measurement unit, receiving the measurement light emitted from the lower optical measurement unit or providing the measurement light toward the lower optical measurement unit.(See Kodama Fig. 13 wherein an upper optical measurement unit 45/49 faces the lower optical measurement unit 47 and provides measurement light toward the lower optical measurement unit.)
Regarding claim 9 Kodama discloses all the claim limitations as set forth above as well as the device wherein the plurality of upper heating units and the plurality of lower heating units are formed in such a manner that a distance between each of the plurality of upper heating units and each of the plurality of lower heating units is variable, wherein, in a case where each of the plurality of chambers is arranged between each of the plurality of upper heating units and each of the plurality of lower heating units and is not moved for a maintenance time, the distance between each of the plurality of upper heating units and each of the plurality of lower heating units corresponds to a height of each of the plurality of chambers, and wherein, in a case where the maintenance time expires and where the plurality of chambers are moved toward other upper heating units, respectively, and toward other lower heating units, respectively, the distance between each of the plurality of upper heating units and each of the plurality of lower heating units is set to be greater than the height of each of the plurality of chambers. (See Kodama Figs. 4,5 and 9A-9C wherein a distance between upper and lower heading units is variable by moving the units relative to the plurality of chambers such that the distance may correspond to the height of the chamber, i.e. Fig. 9C, and wherein the distance between said upper and lower heating units is greater than the height of the plurality of chambers, i.e. Figs 9A and 9B.)
In regards to limitations directed to when the distances are adjusted and for what times it is noted that such limitations are directed to intended uses of the claimed device which do not differentiate the claimed invention form the cited prior art because the cited art is fully capable of such movements at such times by manual or automatic actuation of said heating unit movements. See MPEP 2115.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799