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 (claims 1-2) in the reply filed on 12/29/2025 is acknowledged.
Claims 3-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Claim Objections
Claim 1 is objected to because of the following informalities:
-Claim 1, Line 8: “of” should be inserted between “cut-off” and “dialysis”.
Appropriate correction is required.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 5,525,475 (Ladouceur).
Ladouceur teaches a substance separating device (10)(see Figs. 1A-1B, 6A-7C; col. 5, lines 1-40; col. 9, line 62 – col. 11, line 18) comprising:
a reaction vessel (1) (transparent container) provided with an interior that is partitioned into a first chamber (3) and a second chamber (5) by a dialysis membrane (13) (semipermeable membrane), a solution being stored in the reaction vessel, wherein
a specimen (bacteria or fungal organisms 29) is stored in the first chamber (3),
an enzyme labeled molecule (see Figs. 6A-6D: an antibody 25 labeled with an enzyme 27) that has a binding ability for specifically binding to a substance (bacteria or fungal organisms 29) to be measured is stored in at least one of the first chamber and the second chamber, the substance (bacteria or fungal organisms 29) to be measured being included in the specimen and having a molecular weight that is greater than a molecular weight cut-off (mwco) of the dialysis membrane (see Figs. 6A-6C; col. 10, lines 28-35: the semipermeable membrane has mwco of 300,000 and the complex of the microorganism and the labeled antibody does not pass through), and
the enzyme labeled molecule has a molecular weight that is less than the molecular weight cut-off of the dialysis membrane (see Fig. 7B-7C; col. 11, lines 3-11: the semipermeable membrane has mwco of 300,000 and the antibody-enzyme conjugate has a molecular weight of 218,000 and can migrate through the membrane).
Ladouceur teaches an enzyme labeled molecule or an enzyme modified antibody.
Claim 1 differs from Ladouceur in reciting a dye-modified molecule.
Ladoucer teaches that a dye-modified antibody e.g., fluorescently labeled antibody is used to detect the presence of substance to be measured (see Figs. 5A-5F; col. 8, line 1 – col. 9, line 62) and further teaches that a variety of enzymes may be used to label the antigens in place of the chromophores or fluorophores i.e. dye (see col. 6, lines 63-65).
It would have been obvious to a person of ordinary skill in the art to substitute the enzyme labeled molecule for the dye-modified molecule in the device of Ladoucer for detecting the presence of substance to be measured. See In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958). MPEP 2144.06 II.
Regarding claim 2, Ladoucer teaches the reaction vessel (20) includes a first reaction vessel (3, 5) and a second reaction vessel (3’, 5’), an interior of each of the first reaction vessel and the second reaction vessel being partitioned into a first chamber (3, 3’) and a second chamber (5, 5’),
specimens of mutually different types (control sample, test sample) are stored and, also a dye-modified molecule of an identical type is stored in the first reaction vessel and the second reaction vessel, or
specimens of identical types and, also, dye-modified molecules of mutually different types (chromogen, fluorescein) are stored in the first reaction vessel and the second reaction vessel (see Fig. 2; col. 5, lines 51-63; col. 7, lines 53-67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, IN SUK BULLOCK can be reached at 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/John Kim/Primary Examiner, Art Unit 1777
JK
3/2/26