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 with traverse of Group I in the reply filed on January 26, 2026 is acknowledged. The traversal is on the ground(s) that the Office has not established that the product can be used in such a way and therefore, fails to support the assertion of other processes or methods. This is argument has been carefully considered but has not found persuasive. Initially, it is pointed out that while Applicants’ contend that the Office has not provided evidence of the claimed device’s capability of being used in a materially distinct process, what is noticeably absent in Applicants’ response is their position of whether the claimed product and the claimed method is obvious over each other in both directions. That is to say, does the product claim render the method of use obvious and visa versa? If such is the case, Applicants are invited to go on record admitting the fact.
Additionally, Applicants’ response simply alleges that the Office failed to provide evidence of an alternative of the claimed device, without reasoning as to why such usage cannot be performed on the claimed device. And by evidence, it is unclear what Applicants are requesting. There is no requirement that the alternative usage as provided by the Office needs to be found in the prior art, so long as the device can be used in a materially different way. To this end, Applicants have failed to provide any substantive argument. Therefore, at least for this reason, the argument cannot be found persuasive. Notwithstanding this, a substrate comprising a microwell can be employed in generating a strand of protein by in vitro system therein (see Stapleton et al. (PLoS One, 210, vol. 5, no. 5, e10554, pages 1-8, in particular page 2, 1st column).
Therefore, applicants’ arguments are not found persuasive as the requirement is still deemed proper and is therefore made FINAL.
Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
The Office advises to follow the guidelines under In re Ochiai for the withdrawn process claims for their rejoinder rights.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS received on April 20, 2023 is proper and is being considered by the Examiner.
Drawings
The drawings received on April 20, 2023 are acceptable.
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 18 is 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 18 recites the limitation, “the liquid of the light absorption layer.” There is an insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 1-6, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makino et al. (US 2016/0333400, published November 17, 2016; IDS ref).
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])
With regard to claim 2, 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 3-6, 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]).
Therefore, Makino et al. anticipate the invention as claimed.
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 7 and 20 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).
The teachings of Makino et al. have already been discussed above.
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 is pigmented/colored (claim 7) and consequently do not teach the grain size of a pigment in relation to the microwells (claim 20).
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).
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.
Therefore, the invention as claimed is deemed prima facie obvious over the cited references.
Double Patenting
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.
Claims 1-8 and 18-20 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). 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
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YOUNG J KIM/Primary Examiner
Art Unit 1637 March 16, 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.