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 .
Response to Amendment
Claims 1, 2 and 6-12 are pending, claims 3-5 and 13-19 having been cancelled and claims 6-12 having been withdrawn. Applicant's response filed April 13, 2026 is acknowledged.
Claims 1 and 2 will be examined on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2021/0131962 to Berezhna et al.
As to claim 1, Berezhna discloses a device that can detect a cleanliness of a sample container (see Berezhna Abstract): comprising a light emitter element at a light incident side of the sample container, and configured to emit an emission light wherein the emission light becomes a detection light after traveling through the sample container (see Berezhna paragraphs [0027]-[0030], [0035] and Fig. 1 disclosing light source emitting a light beam, such as an external laser power with a laser path, into and through a flow cell); a detection-light receiver located at a position opposite the light emitter wherein the position is at a light output side of the sample container, and the detection-light receiver is configured to receive the detection light to obtain a detection-light intensity (see Berezhna Fig. 1 disclosing post-flow cell detector; paragraphs [0025]-[0027], [0038]); and a controller coupled to the light emitter and the detection-light receiver and configured to obtain a cleanliness of the sample container according to a variation of the detection light intensity (see Berezhna paragraphs [0011], [0022]-[0025], [0039]-[0040], [0060]).
Regarding the recitation of “obtain a detection-light reference intensity … wherein the detection light-reference intensity is obtained before obtaining the detection-light intensity” and “obtain a ratio of the detection-light intensity to the detection-light reference intensity as a variation of the detection-light intensity after obtaining the detection-light intensity and the detection-light reference intensity,” Berezhna discloses that the light path in which the flow cell cleanliness is assessed ma include and increase or a drop and thus the reference ratios must be calculated and/or calibrated by using the light beam intensities and establishing and adjusting the desired power on a sample prior to performing a cleanliness assessment (see Berezhna paragraphs [0041]-[0044]). It would have been obvious to one of ordinary skill in the art at the time of filing to obtain calibration values and ratios of the sample as suggested by Berezhna and the understanding of one of ordinary skill in the art in order to properly perform a cleanliness assessment on the samples (see Berezhna paragraphs [0041]-[0044]).
As to claim 2, Berezhna discloses that the contamination detection device can further comprise: an emission-light receiver coupled to the controller, located at a light incident side of the sample container and configured to receive the emission light to obtain an emission-light intensity (see Berezhna Fig. 1 disclosing a beam splitter and pre-flow cell detector; paragraphs [0011], [0027]-[0028], [0036]-[0037], [0060]); the controller configured to compensate an error between an emission-light reference intensity and the emission-light intensity to obtain the cleanliness of the sample container according to the emission-light reference intensity or correct the emission-light intensity to approach the emission-light reference intensity to reduce the error before compensating (see Berezhna paragraphs [0011], [0022]-[0027], [0039]-[0044], [0060]).
Response to Arguments
Applicant's arguments filed April 13, 2026 have been fully considered but they are not persuasive.
As discussed in the rejection above, Berezhna discloses that the light path in which the flow cell cleanliness is assessed ma include and increase or a drop and thus the reference ratios must be calculated and/or calibrated by using the light beam intensities and establishing and adjusting the desired power on a sample prior to performing a cleanliness assessment (see Berezhna paragraphs [0041]-[0044]). It would have been obvious to one of ordinary skill in the art at the time of filing to obtain calibration values and ratios of the sample as suggested by Berezhna and the understanding of one of ordinary skill in the art in order to properly perform a cleanliness assessment on the samples (see Berezhna paragraphs [0041]-[0044]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS LEE whose telephone number is (571)270-3296. The examiner can normally be reached M-F 7:30-4:30pm.
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/DOUGLAS LEE/Primary Examiner, Art Unit 1714
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