DETAILED ACTION
The present Office Action is responsive to the Amendment received on June 15, 2026.
Preliminary Remark
Claims 2, 4, 6, and 7 are canceled.
Claims 21 and 22 are new.
The Office notes that Applicants’ recent response does not contain any arguments directed to the obviousness-type double patenting rejection. Such a response is deemed not completely responsive. However, for the purpose of compact prosecution, the Office has accepted the response and the omission an oversight.
Election/Restrictions
Claims remain 9-17 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 26, 2026.
Claim Rejections - 35 USC § 112
The rejection of claim 18 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particularly point out and distinctly claim the subject matter, made in the Office Action mailed on March 18, 2026 is withdrawn in view of the Amendment received on June 15, 2026.
Claim Rejections - 35 USC § 102
The rejection of claim 1-6, 18, and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Makino et al. (US 2016/0333400, published November 17, 2016; IDS ref), made in the Office Action mailed on March 18, 2026 is withdrawn in view of the Amendment received on June 15, 2026. Specifically, Makino et al. do not teach the use of a cover layer made of liquid that having a colored component that absorbs an electromagnetic wave of a wavelength corresponding to an electromagnetic wave to be observed. The covering layer disclosed by Makino et al. is mineral oil and while it may have a hue and naturally existing property of absorb a particular wavelength range, does not have a “colored component”.
Claim Rejections - 35 USC § 103
The rejection of claims 7 and 20 under 35 U.S.C. 103 as being unpatentable over Makino et al. (US 2016/0333400, published November 17, 2016; IDS ref) in view of Blankenstein et al. (JP 2013-528805, published July 11, 2013, using Google-machine translation and references made thereto), made in the Office Action mailed on March 18, 2026 is withdrawn in view of the Amendment received on June 15, 2026 for better rejection format, as Applicants have incorporated the limitation of claim 7 (with additional limitation) into the parent claim 1.
The rationale of the rejection, however, is maintained and Applicants’ arguments are addressed in the “Response to Arguments” section.
Rejection, New – Necessitated by Amendment
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.
Claims 1, 3, 5, 8, 18, 19, 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Makino et al. (US 2016/0333400, published November 17, 2016; IDS ref) in view of Blankenstein et al. (JP 2013-528805, published July 11, 2013, using Google-machine translation and references made thereto).
With regard to claim 1, Makino et al. teach a microfluidic device comprising the below reproduced configuration (from Fig. 8):
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As seen, the artisans teach a microfluidic device comprising:
a substrate having an electromagnetic wave transmission property (see element 24, also “substrate 24 is a plate-like member formed of a material that is substantially transparent … polypstyrene or polypropylene”, section [0170]);
a micropore array layer formed on the substrate and having a plurality of microwells such that the plurality of microwell is configured to receive a target of analysis (see elements 26, see also “all of the plurality of wells 26”, section [0145]); and
a light absorption layer formed over the plurality of microwells of the micropore array layer such that the light absorption layer absorbs an electromagnetic wave (see element 22, also “the oil sealing solution 22 seals the liquid in the plurality of wells …”, section [0149]; also “the oil sealing solution 22, mineral oil1…”, section [0136])
The absorption is asserted to be “in accordance” with the target of analysis, as the device upon construction is employed in a method of detecting a target (“biomolecular analysis method …”, sections [0018] and [0123]).
With regard to claims 3 and 5, the absorption layer is mineral oil and immiscible with aqueous reagents of the assay performed in the microwells (see “a solution which can be fed into the space between the base portion 23 and the cover portion 27 from the inlet portion … oil sealing solution can 22 can be selected from the material which are immiscible with the sample containing the target substance of analysis … oil sealing solution 22, mineral oil … can be used”, section [0135]).
With regard to claim 8, Makino et al. teach a fluorescence observation kit (see sections [0142]-[0143] and [0151], for example) comprising the microfluidic device as discussed above.
With regard to claim 18, the light absorption layer comprises a sealant (i.e., the oil is disclosed as a sealant of the microwells (see above) and the mineral oil is light absorbent.
With regard to claim 19, the micropore array layer is integrally molded with the substrate (“substrate was coated with a positive photoresist, and a pattern was formed thereon by using a photomask … by using O2 plasma, CYTOP was dry-etched … each of the wells … formed of CYTOP had a diameter of 5 mm and had a volume that makes it possible to detect a signal base portion”, section [0172]).
Makino et al. explicitly teach the use of colored agents which are added to the walls forming the microwells for the express purpose of eliminating/subduing interfering the detection signals of the wells:
“micropore array layer 25 formed of a resin … micropore array layer 25 may be colored. If the micropore array layer 25 is colored, in a case where optical measurement such as the measurement of fluorescence, light emission, absorbance, and the like is performed in the wells 26, the influence of light from other wells 26 adjacent to a well 26 that becomes a measurement target can be reduced” (section [0118])
Makino et al., however, do not teach that the cover/sealing layer of oil comprises a colored component that absorbs an electromagnetic wave of a wavelength that correspond to an electromagnetic wave to be detected (claim 1, in-part) and consequently do not teach the grain size of a pigment in relation to the microwells (claim 20), wherein the colored component absorbs light having a wavelength in a range of 350-700 nm (claim 21).
Makino et al. also do not explicitly teach that the colored component further absorbs an electromagnetic wave of a wavelength corresponding to an electromagnetic wave to be irradiated onto the microfluidic device (claim 22).
Blankenstein et al. teach the use of a pigment/dye in an oil in a well of reaction chamber, for the express purpose of reducing interfering signals during a detection even therein:
“In particular, the undesired interference signal may be, for example, light emitted into or through the liquid 12 through the base or lower component 17 or by another wall part of the detection chamber 17, etc., after being appropriately excited, in particular by the illumination light L1” (page 11)
“liquid 12 in the detection chamber 10 is preferably optically activated or optically active as a result of the addition of dyes and/or pigments or particles 25 to achieve the desired optical properties …” (page 11)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, thereby arriving at the invention as claimed for the following reasons.
As discussed above, Makino et al. were aware of interference signals which could arise from the surfaces surrounding the microwell in which the target analytes were detected, expressly suggesting the use of colored material between the wall elements of the microwells.
While the artisans did not explicitly teach that the cover layer liquid (or sealing layer) of oil should also be pigmented (or colored), it would have been obvious to combine the teachings of Blankenstein et al. who also teach the potential of interfering signal which could be produced from a chamber in which the target analytes are being detected.
In particular, Blakenstein et al. teach that the excitation source that illuminates the signal inducing elements of the target analytes can also produce interfering signals from surrounding regions of the chamber, such as the substrate walls and surfaces (i.e., bottom/top, see above).
Blankenstein et al. teach the use of a pigment/dye dissolved into the aqueous layer in which the reaction is performed to prevent the incident ray of the excitation source reaching the substrate surfaces, producing interference signals therefrom.
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The configuration by which Blankenstein et al. achieve this outcome is represented in Fig. 2 (see below):
“interference signal may be an emitted light which is emitted by the wall material of the base or lower part 17, or by another wall part of the detection chamber 17, etc., after being appropriately excited, in particular by the illumination light L1” (page 11, Blankenstein).
As seen, the incident light from the emitted light comprising a detection wavelength penetrates the oil (thus absorbed) and is detected by the detector (24).
However, in the detection means of Makino et al., the detection excitation light would have been produced from the bottom of the substrate and therefore, the potential interfering signals produced from the top surface of the microfluidic device of Makino et al. would have been prevented by introducing the pigmented/color into the intervening oil layer that is used as a sealant layer in Makino et al.’s device, yielding no more than a predictable outcome of providing a device that shields the reaction chamber from sources of interfering signals thereby, “achiev[ing] an improvement of more than 5 times with respect to the S/N ratio.” (page 11).
As for the grain size of the pigment dissolved into the oil layer of Makino et al., doing so would have been an optimization of the reaction condition, which is deemed routine as pigment’s characteristic would have been directly correlated with the outcome of reducing the S/N ratio of detection (i.e., result effective variable).
In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.
As to the wavelength of the colored component absorbing light having a wavelength in a range of 350 to 700 nm, such a wavelength is a commonly employed excitation ranges for fluorescent dyes that are typically employed in a diagnostic assay and therefore would have been an obvious wavelength range to absorb (also evidenced by Blankenstein et al., “sensor 24 is preferably in the visible range … 500-650 nm”, page 10, 7th paragraph).
With regard to claim 22, the colored component absorbs the irradiated electromagnetic wave that is irradiated onto the microfluidic device (i.e., the wavelength range that covers the dye excitation).
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Response to Arguments:
Applicants traverse the rejection.
Applicants state that Blankenstein teaches the use of pigmented/dye in a well and not as a cover layer or in an oil or other on-aqueous liquid (page 7, Response).
This argument has been carefully considered but has not been found persuasive in view of the fact that Makino et al. already teaches a cover layer comprising oil through which a light source travels and one of ordinary skill in the art would have recognized the benefit of having the oil pigmented (or colored) so as to prevent any interfering excitation light reaching back to the detector (as explicitly taught by Blankenstein et al.), as well as when coupling with Blankenstein’s suggestion that suggests, that “any other liquid can be used” (page 5, 2nd para).
Next, Applicants contend that Blankenstein et al. specifically teaches that any dye or pigment makes the optically active liquid 12 such that the incident light L1 can penetrate into the liquid 12 as little as possible or not at all,” citing page 11 of the translated document (see page 7, bottom paragraph to page 8, 1st paragraph, Response).
Continuing, Applicants contend that the optically active liquid is used as an optically neutral background for detection of emitted or emitted light L2, especially for fluorescence measurement whereas in the instant invention, the optically active liquid absorbs the light to be detected (emitted light L2).
Applicants conclude that if the optically active liquid L2 absorbed light L2, a disadvantageous decrease in the intensity of the emitted light would be observed (page 8, Response).
These arguments have been carefully considered but they have not been found persuasive.
In particular, regarding Applicants’ statement that if the optically active liquid absorbed the emitted light, then the intensity of the emitted light being decreased and thus becomes disadvantageous, it is unclear how this statement does not equally apply to Applicants’ own invention. In other words, if the cover layer simply absorbs the wavelength of the detection (or emission) light, then why does this not affect Applicants’ own device? Claim 1 recites that the cover layer absorbs the electromagnetic wave of a wavelength that correspond to the electromagnetic wave to be observed (or detected). If the emitted light wavelength is simply absorbed by the cover layer, then Applicants’ own device will be equally affected.
Absent such a clarification, the Office construes the absorbance of the electromagnetic wavelength to be observed to mean that the pigmented cover layer comprise colored component that “allows” the wavelength which correspond to a detectable emission (i.e., filter through). To this end, the liquid disclosed by Blankenstein et al. explicitly teach that the incident excitation light containing the detectable (emission) wavelength (L1) filters through the liquid layer and exits back to the detector (24) in the form of L2.
For these reasons, Applicants’ arguments are not deemed persuasive and the rejection is maintained.
Double Patenting
Claims 2, 4, 6, and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,662,313 (herein, “the ‘313 patent), made in the Office Action mailed on March 18, 2026 is withdrawn in view of the Amendment received on June 15, 2026, canceling the rejected claims.
Maintained, New – Necessitated by Amendment
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The rejection of claims 1, 3, 5, 8 and 18-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,662,313 (herein, “the ‘313 patent) made in the Office Action mailed on March 18, 2026 is maintained for the reasons of record.
In addition, claims 21 and 22 are rejected herein as being necessitated by Amendment (i.e., their addition).
Applicants have not presented any arguments directed to the instant rejection, for which Office has construed as an oversight. Therefore, the rejection is maintained for reasons already of record.
In addition, claims 21 and 22 are deemed obvious over the ‘313 patent because the absorbance of the light having a range of 350-700 nm would have been obvious due to the wavelength covering a typical detectable emission wavelength as discussed above.
The Rejection (maintained):
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With regard to instant claim 1, claims of the ‘313 patent claims a microfluidic device comprising:
a substrate having an electromagnetic wave transmission property (“a substrate having an electromagnetic wave transmission property”, see claim 1);
a micropore array layer formed on the substrate and having a plurality of microwells such that the plurality of microwells is configured to receive a target of analysis (“micropore array layer formed on the substrate and having a plurality of microwells such that the plurality of microwells”, see claim 1; also “aqueous liquid including the target of analysis into the flow channel such that the aqueous liquid is introduced into the microwells …”, see claim 9); and
a light absorption layer formed over the plurality of microwells of the micropore array layer such that the light absorption layer absorbs an electromagnetic wave (“a light absorption layer comprising a liquid and filling the flow channel between the micropore array layer and the lid member such that the light absorption layer is configured to absorb an electromagnetic wave”, see claim 1).
With regard to instant claim 2, the light absorption layer includes a light absorption material that absorbs light of a wavelength in accordance with the target of analysis (“light absorption layer is configured to absorb an electromagnetic wave corresponding to an observation light of the target of analysis”, see claim 1).
With regard to instant claims 3 and 4, the light absorption layer is liquid (see above).
With regard to instant claims 5 and 6, the liquid is not readily miscible with an aqueous liquid (“the liquid of the light absorption layer is an oil-based sealant”, see claim 4).
With regard to instant claim 7, the light absorption layer includes a colored component (“the light absorption layer includes a colored component dispersed in the liquid”, see claim 7).
With regard to instant claim 8, the microfluidic device is in a kit (see claim 8).
With regard to instant claim 18, the device comprises a sealant (“the liquid of the light absorption layer is an oil-based sealant”, see claim 5).
With regard to instant claim 19, “microwells is formed in a microarray area of the micropore array layer”, wherein the micropore array layer is formed on the substrate (see claim 1).
While the claims of the ‘313 patent do not explicitly claim a pigment grain size of a colored component that renders the layer (i.e., instant claim 20), “light absorbent,”, one of ordinary skill in the art would have been capable of utilizing the requisite pigment grain and the size so as to render the light absorbent layer work to reduce the S/N ratio that result from autofluorescence of elements outside of the desired target substance being assayed. Doing so would have been prima facie obvious because the claims of the ‘313 patent explicitly claims that the light absorbing layer is liquid (claim 5) that comprises colored component dispersed in the liquid (see claim 1 and 7).
Therefore, the invention as claimed is deemed prima facie obvious over the claims of the ‘313 patent.
Conclusion
No claims are allowed.
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.
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.
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/YOUNG J KIM/Primary Examiner
Art Unit 1637 September 4, 2026
/YJK/
1 Mineral oil is known to absorb a wavelength of light of between UV range (200-450 nm), see Jensen, Martin on-line publication attached herein.
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