DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1683) whose telephone number is (571) 272-1113.
Preliminary Amendment
3. The preliminary amendment filed 2 February 2023, in which the Abstract and claims 10, 12, and 14 were amended and new claim 15 was added is acknowledged and entered.
Election/Restrictions
4. Applicant’s election of Group I in the reply filed on 14 October 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 14 October 2025.
Claims 1-11 are under prosecution.
Drawings and Specification
5. The disclosure is objected to because of the following informalities:
The descriptions of the Figures are inconsistent with what is presented therein. Specifically, The descripts are as follows:
Paragraph 34 of the instant specification state that Figure 1 depicts a mixing reaction chamber. However, the components presented in the Figure (e.g., flow guide tube 27, test kit upper and lower housings 21 and 22, etc., as discussed in paragraphs 51 ff of the instant specification, describe the test portion, not the mixing reaction chamber.
Paragraph 37 of the instant specification state that Figure 4 depicts a test portion. However, Figure 4 shows an inverted mixing reaction chamber (i.e.,. b comparison to Figure 2).
6. Appropriate correction is required.
7. Applicant is strongly cautioned against the introduction of new matter in response to this objection.
Claim Interpretation
8. The claims are subject to the following interpretation:
A. The claims recite “test kit.” A review of the specification (e.g., Figure 1) shows that components 21 and 22 are part of the “kit.” Thus the claimed “kit” is interpreted as a set of articles or equipment (i.e., as opposed to a collection of reagents).
B. It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in the claims (e.g., performing amplifications, inversely placing the mixing reaction chamber, accommodating solutions,) fail to define additional structural elements of the claimed device and fail to further limit the structure of the device.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-11 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.
A. The term “rapid” in each of claims 1-11 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
B. Claim 3 (upon which claims 4 and 6-8 depend) is indefinite in the recitation “the upper housing,” which lacks antecedent basis because claim 1 does not recite an upper housing.
It is noted that the upper housing is also recite in each of claims 6 and 7.
C. The term “close to” in claim 7 (upon which claim 8 depends) is a relative term which renders the claim indefinite. The term “close to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Conclusion
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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, Anne Gussow can be reached at 571-272-6047. 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.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683