DETAILED ACTION
The present Office Action is responsive to the Amendment received on February 17, 2026.
Preliminary Remark
Claims 2 and 12 are canceled.
Election/Restrictions
Claims 1 and 3-9 are remain from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 29, 2025.
Applicants’ remark regarding rejoinder is noted. Applicants are advised to follow the rejoinder guidelines provided under In re Ochiai (71 F.3d 1565, 37 USPQ2d 1127 (Fed. Cir. 1995), from OG, February 28, 1995).
Claim Interpretation
Claim 10 recites the phrase, “a sample holder disposed in said process chamber for holding at least one sample carrier having at least one cavity for accommodating a DNA containing sample liquid”.
The claimed device does not actively require the at least one sample carrier nor the DNA containing sample liquid as this is an intended purpose.
This is further elucidated by claim 14 directed to a system comprising the device of claim 10 and active requirement of the sample carrier.
Claim Objections
The objection made to claim 11 for the reasons discussed in the Office Action mailed on November 19, 2026 is maintained and reproduced below:
Claim 11 recites the phrase, “said heating device at least one of includes a Peltier element …” It appears that the phrase should recite, “said heating device includes at least one of a Peltier element” for better grammatical form. Appropriate correction is suggested.
Applicants argue that the Office’s suggested change would change the meaning of the claim, contending that the phrase used in the claim is of the “at least one of A or B form accepted by our courts” (page 7, Response).
The Office respectfully request that Applicants’ representative read the below phrase:
“said heating device at least one of includes a Peltier element or is integrated into said sample holder”
While the Office appreciates and agrees that the courts have accepted the concept of “at least one of A or B,” the above phrase is simply grammatically unclear (just what exactly does it mean by “at least one of includes”?)
Correction is required.
Claim Rejections - 35 USC § 112
The rejection of claim 14 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, made in the Office Action mailed on November 19, 2025 is withdrawn in view of the Amendment received on February 17, 2026.
Claim Rejections - 35 USC § 103
The rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 2016/0214112 A1, published July 28, 2016) in view of Hwang (US 2013/0109022 A1, published May 2, 2013), made in the Office Action mailed on November 19, 2025 is withdrawn in view of the Amendment received on February 17, 2026.
Rejection – Maintained
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 rejection of claims 10, 11, 13, and 14 under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 2016/0214112 A1, published July 28, 2016) in view of Hwang (US 2013/0109022 A1, published May 2, 2013), made in the Office Action mailed on November 19, 2025 is maintained for the reasons of record.
Applicants’ arguments presented in the Amendment received on February 17, 2026 have been carefully considered but they have not been found persuasive for the reasons discussed in the, “Response to Arguments” section.
The Rejection:
With regard to claim 10, Saito et al. teach a device for multiplying DNA (“device for performing thermal convection PCR, section [0046]), comprising:
a sample holder for holding at least one sample carrier (“device … includes: a chip mounting section to which a thermal convection generating chip is attachable and detachable”, section [0017]);
a rotational drive configured to rotate the sample holder about a rotation axis during intended operation (see Fig. 2, also “configured to rotate to apply centrifugal force to a liquid in the thermal convection pathway”, section [0017]), said sample holder having a rotational plane (the rotational plane is a horizontal plane) and the at least one cavity having a heat input side lying in said rotation plane (the sample carrier is not required and therefore, the limitation directed to the “cavity” of the sample carrier is not required);
a heating device configured to heat the heat input side to a high temperature value during the intended operation (see Fig. 2, element 32 which is a heater that provided through the chip mounting section (element 20) and located below a PCR chip (or heat input side) that is placed on top, also “[s]tage 20 is provided with four heater mounting holes 21 having an arc shape through which the heat controller 30 is mounted. These heater mounting holes 21 are arranged about the axis AX at 90o angular spacing and in a symmetric manner with respect to the axis AX, section [0060]; “[t]he heat controller 30 includes the first heater 31 having a ring shape, which serves as a low temperature heat controller, and the second heater 32 having a ring shape, which is concentrically disposed at an inner side of the first heater 31 and serves as a high temperature heat controller, section [0062]); and
a controller control-linked to said rotational drive and to said heating device, said controller configured to carry out the method of multiplying (or amplifying DNA; see “[t]he heat controller 30 includes the first heater 31 having a ring shape, which serves as a low temperature heat controller, and the second heater 32 having a ring shape, which is concentrically disposed at an inner side of the first heater 31 and serves as a high temperature heat controller”, section [0062]; “chip 10 rotate in response to a user operating the input section 53 of the controller 50 to start the motor 40”, section [0100], see Fig 2 for reference).
With regard to claim 11, the heating device is integrated into the sample holder (the heater is protruded through the holes (21) of the stage (20) to provide heating to the bottom side of the PCR chip (10), see Fig. 2, also “[s]tage 20 is provided with four heater mounting holes 21 having an arc shape through which the heat controller 30 is mounted. These heater mounting holes 21 are arranged about the axis AX at 90o angular spacing and in a symmetric manner with respect to the axis AX”, section [0060]).
With regard to claim 14, the artisans teach the rotation device as discussed above, and the at least one sample carrier having at least one cavity for accommodating a DNA containing sample liquid wherein the at least one cavity having a heat input side lying in said rotation plane1 (see element 10, which is directed to a PCR chip (“thermal convection generating chip 10”, section [0047]; “plurality of thermal convection pathways [or containing sample liquid that circulates therein]”, section [0048]; and the bottom side is where the heat is provided from).
While Saito et al. teach that their device is also configured to detect the amplification signals provided from the convection PCR chip in an exemplary embodiment of Fig. 15, the artisans do not explicitly teach that the rotational device with the chip is disposed in a process chamber.
For the purpose of the present rejection, the word, “chamber’ has been construed to mean that which “houses” or envelopes the device of Saito et al.
Saito et al. do not teach a cooling device configured to cool a heat output side of the cavity (of the chip) to a low temperature value, the heat output side disposed opposite to the heat input side (claim 12), wherein said cooling device includes a fan (claim 13).
Hwang teaches a well-known means of providing a convective thermocycler which comprises rotating means, wherein the device comprises a process chamber housing the rotating thermal cycler (see Figure 47A).
Hwang teaches a convective PCR machine wherein the convection is achieved with heating and cooling means which apply the necessary temperature to a sample holder (see Fig. 39, for example, the sample holder 90 containing the amplification mixture is subject to convective heating/cooling means, elements 160a, 160b, and 160c, see “heating and cooling elements (160a-c)”, section [0073]).
Hwang teaches that thermal convection PCR was faster and more efficient when apparatus included at least one positional or structural asymmetric element of heating or cooling, “helps or enhances generation of the buoyancy force so as to make the amplification process faster and more efficient” (see section [0261]).
Hwang further teaches that the heating/cooling sources can be further equipped with, “one or more cooling elements and/or one or more heating elements … preferred cooling elements are a fan or a Peltier cooler” (section [0478]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Saito et al. with the teachings of Hwang, thereby arriving at the invention as claimed for the following reasons.
The reasons to enclose the rotating device of Saito et al. in a chamber (or housing) is based a combination of factors that rely on common sense, which are: 1) utilizing a housing means to shield the user from the rotating device for safety reasons; 2) providing an enclosed chamber which would prevent the detection signals generated from the device of Saito et al. from interfering ambient light2; 3) providing an isolated chamber which would allow for better temperature maintenance, all of which yielding a predictable outcome expected by an ordinarily skilled artisan in the art of molecular diagnostics.
The Supreme Court has expressed that a combination of elements that yield no more than a predictable outcome is likely to be obvious.
“[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395.
The Supreme Court further stated that there are “[t]hree cases decided after Graham [that] illustrate this doctrine.” Id. at 416, 82 USPQ2d at 1395. (1) “In United States v. Adams, . . . [t]he Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
As discussed above, the enclosure of a rotating device of Saito et al. would have yielded no more than a predictable outcome as discussed above, and therefore, the invention as claimed is deemed prima facie obvious over the cited references.
As to the addition of a cooling means to the device of Saito et al., doing so would have resulted in enhancing buoyancy of the reaction mixture which is relied upon in a convective amplification reaction of Saito et al. as motivated by Hwang, and therefore, one of ordinary skill in the art would have been motivated to modify the device of Saito et al. with a cooling means at either side of the heating means so as to improve the buoyancy during the convective PCR procedure, the cooling means provided by a fan as explicitly taught by Hwang.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Response to Arguments:
Applicants traverse the rejection.
Applicants contend that none of the teachings provide the element where the cooling device is configured to cool a heat output side of the cavity to a low temperature value, the heat output side disposed opposite to the heat input side (page 10, Response).
Applicants’ position is that the device provided by Saito, although utilizes convection, appears to provide the heating and cooling from the same side and only at different locations (page 10, Response).
This argument has been carefully considered but has not been found persuasive.
The Office notes that the rotation device as claimed presently does not actively require the presence of the “at least one carrier having at least one cavity.” Rather, the device is simply recited as comprising a processing chamber and a sample holder disposed in the process chamber for holding at least one sample carrier.
And at least one sample carrier is what comprises the “heat output side” that is disposed opposite side of a “heat input side.”
Because the system does not comprise the at least one sample carrier, there is no requirement by the claimed device to have a heat input, let along heat output side, so long as the device of the prior art teach a process chamber and sample holder which is capable of holding a “sample carrier” thereon, to which Saito et al. clearly teach.
In addition, the location of the cooling device or the generically recited “heat output side” are also not deemed to distinguish the claimed device over that of the device produced by the combination of Saito et al. and Hwang because the so-called “heat output side” on the device can be construed under BRI (broadest reasonable interpretation) to include any region of the device from which heat can dissipate. Because the cooling device as taught by the combination of artisan is cooled wherein heat can dissipate from any region of the device, such a location can be anywhere of the device through which heat can dissipate, including side opposite of the region where heat input is made.
Therefore, Applicants’ arguments are not deemed persuasive and the rejection is maintained.
Conclusion
No claims are allowed.
Allowable Subject matter
The Office reiterates that the inventive concept directed to the at least one sample carrier being actively placed on the claimed rotation device, oriented in a horizontal direction, wherein said sample carrier comprises a “flow resistance” and oriented in such a way that the sample liquid in the regions between the heat input side and the heat output side is counteracted by at least doubled current (or flow) resistance (see section [0023], and exemplary Figure 3).
This flow resistance allows for the duration the sample remains in the annealing and denaturation regions within the convective flow during the amplification reaction which a feature not taught or suggested in the art.
“[a]s a result of this control, it is thus advantageously possible to specify the residence time of the liquid particles in the respective region, i.e., preferably the extension time” (section [0023])
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Young J. Kim whose telephone number is (571) 272-0785. The Examiner can best be reached from 7:30 a.m. to 4:00 p.m (M-F). The Examiner can also be reached via e-mail to Young.Kim@uspto.gov. However, the office cannot guarantee security through the e-mail system nor should official papers be transmitted through this route.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Gary Benzion, can be reached at (571) 272-0782.
Papers related to this application may be submitted to Art Unit 1681 by facsimile transmission. The faxing of such papers must conform with the notice published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 CFR 1.6(d)). NOTE: If applicant does submit a paper by FAX, the original copy should be retained by applicant or applicant’s representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED, so as to avoid the processing of duplicate papers in the Office. All official documents must be sent to the Official Tech Center Fax number: (571) 273-8300. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 April 30, 2026
/YJK/
1 Because claim 14 actively requires the sample carrier of claim 10 (by reference), the limitation is discussed herein.
2 Saito et al. teaches that their device is configured to provide excitation light and detection of the emitted light, see Fig. 13, also “thermal convection generating device may include … excitation light source … a fluorescence detector configured to detect fluorescence emitted by the fluorochrome …”, section [0022]
Prosecution Insights