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 of Group IV (claims 7 and 4) in the reply filed on October 24, 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)). Non-elected claims 5-6 are withdrawn from further consideration.
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 7 and 4 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.
On line 4 of claim 7, the “known-concentration dye” is indefinite since it is not clear whether this known concentration dye is the same or different from the “single dye” recited on line 3 of claim 7. Is the “known-concentration dye” used “during testing” in the method recited in claim 7 the same or different from the “single-dye” used to generate the reference curve? On line 4 of claim 7, the phrase “(resultant concentration)” is indefinite since it is not clear whether this phrase in parentheses is a part of the claimed invention. On line 6 of claim 7, the phrase “the absorbance” lacks antecedent basis and is indefinite since there is no positive step in the method for measuring an absorbance of the new dye concentration (i.e. the resultant concentration). On lines 6-7 of claim 7, the phrase “the absorbance versus concentration relationship of the earlier generated reference curve” lacks antecedent basis since claim 7 does not positively recite the reference curve as an “absorbance versus concentration relationship”. On lines 7-8 of claim 7, the phrase “the volume of the dye” lacks antecedent basis and is indefinite since it is not clear whether this phrase refers to the dye that has been combined with the diluent in the second step of the method or the dye in the set of known, variable-concentration derivatives of the single dye. On line 8 of claim 7, the phrase “the liquid handling device” lacks antecedent basis since the step of “dispensing” on line 4 of claim 7 is not positively recited as being performed by a liquid handling device. Claim 7 is also indefinite since it is not clear how an undetermined volume of a dye in the sample prepared in the second step of the method by mixing with a volume of diluent is determined from the reference curve which plots absorbance versus concentration, not absorbance versus volume of a dye solution.
On lines 3-4 of claim 4, the phrase “reading absorbance from a calibrated spectrophotometer of a fixed path well volume dispensed into a microtiter plate” is indefinite since it is not clear what is meant by “fixed path well volume dispensed into a microtiter plate”. Does this phrase refer to a volume of each of the fixed-volume, variable-concentration derivatives of the single dye which have been dispensed into a well of a microtiter plate having a fixed pathlength?
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 7 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by each of the YouTube videos entitled “Young Scientist Shows How Easy It is” (URL: Young Scientist Shows How Easy It Is ) and “GoodPipetting LRIG Late Night SLAS 2018 v1” (URL: GoodPipetting LRIG Late Night SLAS 2018 v1 - YouTube) posted on the website for Automation Trainer LLC, and the product entitled “GLH QC Kit” for sale on the Amazon website (URL: GLH QC Kit: Amazon.com: Industrial & Scientific).
Each of the YouTube videos entitled “Young Scientist Shows How Easy It is” (URL: Young Scientist Shows How Easy It Is ) and “GoodPipetting LRIG Late Night SLAS 2018 v1” (URL: GoodPipetting LRIG Late Night SLAS 2018 v1 - YouTube) posted on the website for Automation Trainer LLC, and the product entitled “GLH QC Kit” for sale on the Amazon website (URL: GLH QC Kit: Amazon.com: Industrial & Scientific) teach of a product for verifying the volumes of liquid dispensed by an automated liquid handling device, and a method for using the product. The product is entitled a GLH QC kit, which has been sold on Amazon since December 5, 2018, according to the URL: GLH QC Kit: Amazon.com: Industrial & Scientific. This GLH QC kit is the same type of kit described in the instant specification for performing the method recited in claims 7 and 4. See paragraphs 0025-0027 and 0046-0072 in the instant specification where a GLC QC kit is described for performing the method recited in claims 7 and 4. The kit contains four reference dye pillow packs in combination with four troughs, each reference pack containing a known, variable concentration of a tartrazine-based dye, four test dye pillow packs containing a known concentration of the tartrazine-based dye in combination with five diluent reservoirs, microplates with lids, a manual providing directions for performing a method for verifying the volumes of liquid dispensed by an automated liquid handling device using the kit, and software to perform calculations on the measurements obtained in the method and to determine an unknown volume of the dye dispensed by a pipette in the liquid handling system. See the instruction sheet included in the GLC QC Kit sold on Amazon.
The two linked YouTube videos provided on the website for Automation Trainer LLC teach that a method for using the GLC QC kit sold on Amazon was described in the video GoodPipetting LRIG Late Night SLAS 2018 v1 - YouTube and demonstrated in the video Young Scientist Shows How Easy It Is at a SLAS (Society for Laboratory Automation and Screening) conference in 2018. The method described and demonstrated in the videos comprises the steps of pouring each of the known, variable concentration tartrazine single dye reference solutions (i.e. reference dye alpha, reference dye beta, reference dye gamma, and reference dye omega) held within the reference dye pillow packs into the four troughs, pipetting a fixed volume of the known, variable concentration tartrazine single dye reference solutions from each of the troughs into a well on a microtiter plate having a fixed pathlength, reading an absorbance of each of the known, variable concentration tartrazine single dye reference solutions having a fixed volume with a calibrated photometer, generating a reference curve that relates measured optical density or absorbance of each of the reference dye solutions to a concentration and volume of the reference dye solutions held within the fixed pathlength microtiter wells (claims 7 and 4), dispensing an underdetermined volume of the known concentration tartrazine-based dye from each of four test dye pillow packs into one of the diluent reservoirs along with a diluent using an automated liquid handling device (i.e. robot) which results in a new resultant dye concentration (claim 7), mixing the diluted test dye solutions in the diluent reservoirs, measuring an absorbance of each of the test dye solutions of unknown volume in the diluent reservoirs with a calibrated photometer, and comparing the measured absorbances of the test dye solutions to the reference curve using the software provided in the kit to determine the unknown volume of each of the test dye solutions dispensed into each of the diluent reservoirs using the automated liquid handling device (claim 7).
Since the GLH QC kit used to perform the method recited in instant claims 7 and 4 has been sold on Amazon since December 5, 2018, and the since the YouTube videos entitled “Young Scientist Shows How Easy It is” (URL: Young Scientist Shows How Easy It Is ) and “GoodPipetting LRIG Late Night SLAS 2018 v1” (URL: GoodPipetting LRIG Late Night SLAS 2018 v1 - YouTube) posted on the website for Automation Trainer LLC, which describe and demonstrate the method recited in instant claims 7 and 4, were made publicly available at a SLAS (Society for Laboratory Automation and Screening) conference in 2018, each of these prior art sources qualify as prior art under 35 USC 102(a)(1) against claims 7 and 14 because these prior art sources were publicly available more than one year prior to the effective filing date of the instant application (i.e. January 30, 2021).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Bullington et al (US 10,194,853) who teach of devices and methods for verifying a sample volume; Lung et al (US 5,061,639) who teach of a liquid dispenser accuracy verification method; Freeman et al (US 5,258,308) who teach of a method for verifying calibration of vertical photometers; Rhode et al (US 2006/0063272) who teach of a method for characterizing a liquid handling technique using microplates; Curtis et al (US 2009/0250664) who teach of a method for determining liquid volume of a sample; Curtis (US 7,187,455) who teach of a photometric calibration of liquid volumes; Hattori (US 2015/0112629) who teach of a method for validating the accuracy of actual volumes dispensed by a pipette in an automated analyzer; the poster entitled “Controlling a modified tartrazine-based single-dye method from Automation Trainer on qualification of automated liquid handlers for use in industry applications (SLAS 2020 conference); Dong et al (article from JALA, April 2006, pages 60-64) who teach of a dual dye photometric calibration method in an automated liquid handling system; and Albert et al (article from JALA, June 2007, pages 172-180) who teach of volume verification methods for liquid handlers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 November 19, 2025