FINAL 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 .
Amendments and Status of the Claims
2. This action is in response to papers filed 18 February 2026 in which claims 1, 2, 7-8, 10, and 29 were amended, claim 15-16, 18, 21-22, 25, and 30-32 were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
Any previous rejections not reiterated below are withdrawn in view of the amendments.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments.
3. Claims 1-2, 4, 7-10, 13-14, and 29 are under prosecution.
4. This Office Action includes new rejections necessitated by the amendments.
Information Disclosure Statement
5. The Information Disclosure Statement filed 18 February 2026 is acknowledged and has been considered.
Claim Rejections - 35 USC § 112 and Claim Interpretation
6. 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.
7. Claims 2, 4, 7, 10, and 13-14 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. Regarding claim 2 (upon which claims 4 and 7 depend):
I. Claim 2 is indefinite in the recitation “thereby providing the subsequent reaction mixture” in step (d). Claim 1 already states that the subsequent reaction mixture was provided by step ii), and clearly implies that the “subsequent reaction mixture” is the mixture of the amplified reaction mixture and the unamplified sample. Thus, it is unclear how step (d) of claim 2 can provide the subsequent reaction mixture when it was already provided by step ii) of claim 1.
II. Further, step iii) of claim 1 states that the subsequent reaction mixture
is “in said reaction chamber.” Thus, claim 2 is further indefinite because claim 2 clearly implies “the subsequent reaction mixture” is in a waste reservoir, while claim 1 clearly states “the subsequent reaction mixture” is in the reaction chamber.
III. In addition, step (c) of claim 2 requires “conditions amplifying a target polynucleotide” be applied to “the first reaction mixture,” and step (d) of claim 2
which is already required by step i) of claim 1. Thus, it is unclear if step (c) is part of step i) or an additional amplification step.
IV. Further, step iv) of claim 2 repeats the cycle of steps ii) and iii); thus it is unclear if additional subsequent reaction mixtures are created.
B. Claim 7 is indefinite in the recitation “the first or subsequent reaction mixture present in the reaction chamber.” As noted above, claim 1 clearly states “the subsequent reaction mixture” is in the reaction chamber. Claim 2, (upon which claim 7 depends) clearly implies “the subsequent reaction mixture” is in a waste reservoir. Thus, it is unclear how claim 7 can have “the subsequent reaction mixture” in the reaction chamber when claim 2 implies “the subsequent reaction mixture” is in the waste chamber.
C. Regarding claim 10 (upon which claim 13-14 depend):
I. Similar to claim 2 above, step (c) of claim 10 requires “conditions for amplifying a target polynucleotide” be applied to “the first reaction mixture,” which is already required by step i) of claim 1. Thus, it is unclear if step (c) is part of step i) or an additional amplification step.
II. Further similar to claim 2 above, claim 10 is indefinite in the recitation “thereby providing the subsequent reaction mixture” in step (d). Claim 1 already states that the subsequent reaction mixture was provided by step ii), and clearly implies that the “subsequent reaction mixture” is the mixture of the amplified reaction mixture and the unamplified sample. Thus, it is unclear how step (d) of claim 10 can provide the subsequent reaction mixture when it was already provided by step ii) of claim 1.
III. Similar to claim 7 above, claim 10 is indefinite in the recitation “the first or subsequent reaction mixture present in the reaction chamber.” As noted above, claim 1 clearly states “the subsequent reaction mixture” is in the reaction chamber, while instant claim 10 clearly implies “the subsequent reaction mixture” is in a waste reservoir. Thus, it is unclear how claim 10 can have “the subsequent reaction mixture” in the reaction chamber when claim 1 clearly states “the subsequent reaction mixture” is in the reaction chamber.
Claim Interpretation
8. With respect to claim 29, step ii) of the claim states that “the amplified reaction mixture in said reaction chamber” is replaced with a further unamplified aliquot and amplification reagents,
“wherein said amplified reaction mixture is moved to a store reservoir, thereby providing a subsequent reaction mixture; (and)
iii) subjecting the subsequent reaction mixture comprising said unamplified
aliquot in said reaction chamber to conditions amplifying a target polynucleotide….”
Thus, “the amplified reaction mixture” (i.e., all of the amplified reaction mixture) must be in the store reservoir, and “the subsequent reaction mixture… in said reaction chamber” of step iii) must be the “further unamplified aliquot of said sample and with further reagents necessary for nucleic acid amplification” of step ii).
Allowable Subject Matter
9. Claims 1, 8-9, and 29 are drawn to replacing a portion of an amplified reaction mixture in a reaction chamber with a further unamplified aliquot of the sample, which is free and clear of the prior art of record.
Conclusion
10. Claims 1, 8-9, and 29 are allowed. Claims 2, 4, 7, 10, and 13-14 are rejected.
11. 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.
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.
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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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683