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 .
Response to Amendment
The Amendment filed on 3/11/2026 has been entered. Claims 1-15 remain pending in the application.
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.
Claim(s) 1-7 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2015/0031039, hereinafter Pipper.
Regarding claim 1, Pipper teaches a point-of-care nucleic acid detection device (figures 1E and 2A), comprising: a rotating body (ring) in which a plurality of test tubes for accommodating a sample are radially coupled around a rotating shaft (intended use MPEP § 2114 (II) and is taught in figure 1E), wherein the sample is mixed with exothermic particles generating heat when light is irradiated thereto (intended use MPEP § 2114 (II) and is taught in paragraph [0072]); a first actuator (paragraph [0084]) for rotating the rotating body so that the test tubes rotate around the rotating shaft (paragraph [0084]); and an irradiation module (Laserdiode, Grating and Mirror) including a plurality of laser light sources (paragraph [0075]) configured to irradiate the light to an irradiation area on a rotation path of the test tubes (figure 2A), wherein the rotation path includes a non-irradiation area to which the light is not irradiated (there are portions along the ring which is not being irradiated, figure 2A), and wherein as the rotating body rotates, the test tubes proceed through the irradiation area and the non-irradiation area on the rotation path (figure 2A and paragraph [0084]).
Regarding claim 2, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Pipper and the apparatus of Pipper is capable of rotating the body by a predetermined angle at a predetermined time interval. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Pipper (see MPEP §2114).
Regarding claim 3, Pipper teaches wherein the plurality of laser light sources are arranged side by side (paragraph [0075]).
Regarding claim 4, Pipper teaches wherein the plurality of laser light sources are disposed to surround the irradiation area (paragraph [0075] and figure 2A).
Regarding claim 5, Pipper teaches wherein the irradiation area is formed so that the light is irradiated to any one of the plurality of test tubes (figure 2A).
Regarding claim 6, Pipper teaches wherein n of the test tubes (n is a natural number of 3 or more) are coupled in the rotating body (figure 2A), and the irradiation area is formed to irradiate the light to m of the n test tubes (m is a natural number of 2 or more and less than n) (figure 2A).
Regarding claim 7, the exothermic particles are not positively claimed and therefore any limitation on the exothermic particles has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Pipper.
Regarding claim 11, Pipper teaches further comprising a detection module, comprising: a detection light irradiating light source for irradiating a detection light to the test tube in a state in which the rotating body is stopper (paragraph [0111]); and a photodiode for detecting the fluorescence intensity of a specific wavelength band in the test tube to which the detection light is irradiated (paragraph [0111]).
Regarding claim 12, Pipper teaches wherein the detection light irradiating light source is disposed to be obliquely inclined at a predetermined angle with respect to the longitudinal direction of the test tube (figure 5A), and the photodiode is disposed to face the upper end of the test tube (figure 5A).
Regarding claim 13, Pipper teaches wherein the detection module further comprises includes: a fluorescence filter disposed between the test tube and the photodiode to pass fluorescence in the specific wavelength band (paragraph [0111] and figure 5A); and a collimation lens disposed between the fluorescence filter and the photodiode to condense collect fluorescence that has passed through the fluorescence filter (paragraph [0111] and figure 5A).
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.
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.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pipper in view of United States Application Publication No. 2011/0287951, hereinafter Emmert.
Regarding claims 8-10, Pipper teaches all limitations of claim 7; however, Pipper fails to teach further comprising a separation module having a magnet which is arranged so as to approach the test tube in a state in which the rotating body is stopped, and attracts the magneto-plasmonic nanoparticles included in the sample to a point inside the test tube, wherein the test tube and the magnet are arranged to correspond one-to-one wherein the separation module further comprises includes: a magnet holder to which the magnet is coupled, wherein the magnet holder is displaced between a first position spaced part from the test tube by a predetermined distance and a second position adjacent to the test tube, and places the magnet adjacent to the bottom of the test tube when in the second position; and a second actuator for transferring the magnet holder to the first position or the second position.
Emmert teaches a PCR device in which a separation module (Emmert, paragraph [0479]) having a magnet which is arranged so as to approach the test tube in a state in which the rotating body is stopped (Emmert, paragraph [0479]), and attracts the magneto-plasmonic nanoparticles included in the sample to a point inside the test tube (Emmert, paragraph [0479]), wherein the test tube and the magnet are arranged to correspond one-to-one (Emmert, paragraph [0479]) wherein the separation module further comprises includes: a magnet holder (Emmert, paragraph [0479]) to which the magnet is coupled, wherein the magnet holder is displaced between a first position spaced apart from the test tube by a predetermined distance and a second position adjacent to the test tube (Emmert, paragraph [0479]), and places the magnet adjacent to the bottom of the test tube when in the second position (Emmert, paragraph [0479]); and a second actuator for transferring the magnet holder to the first position or the second position (Emmert, paragraph [0479]) so that magnetic beads can be removed that are incompatible with later procedures (Emmert, paragraph [0479]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the separation module of Emmert to the device of Pipper because it would allow for the magnetic beads to be removed that are incompatible with later procedures (Emmert, paragraph [0479]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pipper in view of United States Application Publication No. 2022/0048026, hereinafter Choy.
Regarding claim 14, Pipper teaches all limitations of claim 1; however, Pipper fails to teach a pretreatment kit comprising: a plurality of chambers provided side by side at predetermined intervals so that the samples or reagents can be accommodated therein: a plurality of discharge passages formed to correspond to the plurality of chambers one-to-one; a plurality of plungers respectively disposed in the plurality of chambers and configured to flow the reagent accommodated in each chamber to the discharge passage when proceeding in one direction; an outlet formed so that the plurality of discharge passages converge to one and communicate with the outside; and a filter coupled to the outlet to purify the nucleic acid discharged through the outlet.
Choy teaches a pretreatment kit (Choy, figure 3) comprising: a plurality of chambers (Choy, items 52, 54 and 56) provided side by side at predetermined intervals so that the samples or reagents can be accommodated therein (Choy, figure 3): a plurality of discharge passages (Choy, the outlets of each of items 52, 54 and 56) formed to correspond to the plurality of chambers one-to-one (Choy, figure 3); a plurality of plungers respectively disposed in the plurality of chambers and configured to flow the reagent accommodated in each chamber to the discharge passage when proceeding in one direction (Choy, paragraphs [0037] and [0126]); an outlet (Choy, the outlet that enters item 58) formed so that the plurality of discharge passages converge to one and communicate with the outside (Choy, figure 3); and a filter (Choy, item 72 and paragraph [0052]) coupled to the outlet to purify the nucleic acid discharged through the outlet (Choy, figure 3) so that all of the reagents and sample can be passed to the reaction chamber in a particular timing sequence (Choy, abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the pretreatement kit of Choy to the device of Pipper because it would allow for all of the reagents and sample to be passed to the reaction chamber in a particular timing sequence (Choy, abstract).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pipper and Choy as applied to claim 14 above, and further in view of United States Application Publication No. 2012/0070823, hereinafter Rothmann.
Regarding claim 15, Pipper and Choy are silent with regards to specific material for the filter, therefore, it would have been necessary and thus obvious to look to the prior art for conventional types of filters. Rothmann provides this conventional teaching showing that it is known in the art to use silica gel as a filter (Rothmann, paragraph [0020]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the filter from silica gel motivated by the expectation of successfully practicing the invention of Rothmann.
Response to Arguments
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive.
Regarding applicant’s arguments that Pipper’s beamlets are not configured to irradiate the light to an irradiation area like the claim requires is not found persuasive. Pipper does indeed discuss the beamlets are directed to three distinct points along the circumference of the ring with non-irradiation areas between the adjacent beamlets. However, the claim does not specify any further detail about the irradiation areas or the number of irradiation areas. Therefore, it is interpreted that only one of the locations where the beamlets are directed to is considered to be the “irradiation area.” Additionally, the claim does not specify that the three irradiation areas are acted on by a plurality of beamlets, the claim only states that the plurality of laser light sources are configured to irradiate the light to an irradiation area. Based upon paragraph [0075] which discusses the use of a plurality of laser light sources, Pipper discloses all of the limitations of the claim.
Additionally, all of the three distinct points along the circumference of the ring Pipper can also be considered to be the “irradiation area.” The claim does not specify that the irradiation area is contiguous and therefore, each of the three distinct points can together be considered the irradiation area. As the claim does not specify that the irradiation area is contiguous, applicant’s argument that the irradiation area would be the entire circumference of the ring is also not persuasive as just the three points are considered to be the irradiation area. As such the rotation path would include non-irradiation areas where the light is not irradiated, thereby reading on the instant claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796