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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS received on December 17, 2024 and September 22, 2025 are proper and are being considered by the Examiner.
Drawings
The drawings received on September 24, 2026 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.
Claims 1-6 are 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 1 is indefinite because the claim is directed to a product, but contains limitations that appears to be an intended usage, or in the alternative, what can be construed as a method of usage.
For example, claim 1 recites the phrase, “[a] test container, into which a sample is to be put … sample solution to be fed from the inlet is stored … fed from the first chamber is stored … the sample solution being transferred from the first chamber to the second chamber in order by a centrifugal force”.
This appears to be an intended usage of the test container, but also could be construed as combining a product claim with a method of its usage.
The Federal Circuit decided an issue of first impression in that Court - whether a patent claim that covers both an apparatus and method of use of that apparatus passes muster under 35 USC §112, para. 2 (indefiniteness). Defending its "1-click system," Amazon won a summary judgment ruling of invalidity, IPXL Holdings, LLC v. Amazon.com, Inc., 333 F. Supp. 2d 513 (E.D. Va. 2004), which the Federal Circuit affirmed in part, 2005 U.S. App. LEXIS 25120.
After upholding the district court's claim constructions and affirming the finding that all but one of the asserted claims were anticipated, the Federal Circuit next affirmed the summary judgment of invalidity (for indefiniteness) for the remaining asserted claim, which read:
25. The system of claim 2 [including an input means] wherein the predicted transaction information comprises both a transaction type and transaction parameters associated with that transaction type, and the user uses the input means to either change the predicted transaction information or accept the displayed transaction type and transaction parameters.
Claim 25 on its face is directed to a "system." However, it also recites use steps ("the user uses the input means to ...change the predicted transaction information ... ") This claim was found indefinite by the district court.
Thus, for the above reasons, instant claim 1 is indefinite.
Applicants must address all such phrases which appear throughout claim 1.
Claim 1 is also indefinite for reciting the phrase, “the test container being attached to a centrifuge”. Claim 1, however, is directed to a test container. Therefore, the claimed limitation has been construed to be an intended usage.
Claim 1 is also indefinite for reciting the phrase, “the sample solution to be fed from the first chamber is stored”. It is unclear just exactly what is “stored.” This is because the claim recites that the test container includes an inlet, but the introduction of the sample is an intended usage. Therefore, the claimed cartridge has nothing that is “stored.” For the purpose of prosecution, the phrase has been construed to mean that the test container comprises a first chamber. This claim interpretation has been adopted for subsequent similar phrases.
Claim 2 is indefinite because the claim appears to be a “conditional” configuration, “wherein a case where volume of the liquid reservoir portion is denoted by V1 … a relationship V1>V2>V3>V3 is satisfied”, rendering the claimed product vague and indefinite. The claim has been construed to actively comprise the requisite volume relationship. In other words, the phrase has been construed as “wherein the volume of the liquid reservoir portion is denoted by V1 … establishing the relationship: V1>V2>V3>V4.”
Claim 3 is indefinite for being vague in whether the claim is an intended usage of containing the sample solution, in which the case, result in no distinction in the structure of parent claim 1; or combining a method of using the product as discussed above (for claim 1). For the purpose of prosecution, the claim has been construed to be an intended usage.
Claims 4 and 5 are indefinite due to their dependency on claim 3.
Claims 2-6 are indefinite by way of their dependency back to claim 1.
Conclusion
No claims are allowed.
Claims are free of prior art.
Park et al. (US 2013/0065280) teach a microfluidic apparatus that operates based on centrifugation for moving fluid and reagents (see Fig. 1). Park et al., however, do not teach or suggest a valve that operates based on rotation (i.e., rotary valve) that has three different states that allow passage of fluid between from one chamber to another chamber.
Shandy et al. (US 2010/0158646 A1) teach a rotary valve that allow passage magnetically bound particles from one chamber to another chamber (see Fig. 1A-1D). However, the device does not teach or suggest the device with the valve expressly lack a vent flow channel through which gas is released.
Wang et al. (US 2019/0143324; IDS ref) teach a microfluidic device that operates based on centrifugation with a valve that is rotary based (see Fig. 1 and 6). However, the device expressly requires the presence of a vent (see section [0010], [0022], also Fig. 1, element 14 and 15), which is expressly not required in the presently claimed test container.
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 30, 2026
/YJK/
