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 .
Status of Claims
The examiner acknowledges the amendments to claims 1-2, 5-7, 11-12, 14, 16, 18, 20-22, 24-25, 32, 34, and 36-37. Claims 1-2, 5-7, 11-12, 14, 16, 18, 20-22, 24-25, 32, 34, and 36-37 remain pending in the application. Claims 3-4, 8-10, 13, 15, 17, 19, 23, 26-31, 33, 35, and 38 are cancelled.
Response to Arguments
Applicant’s amendments, filed 09 April 2026, have overcome the claim objections of record. The claim objections have been withdrawn.
Applicant’s amendments, filed 09 April 2026, have overcome the rejection of claims 1-2, 5-7, 11-12, 14, 16, 18, 20-21, 24-25, 34, and 36-37 under 35 U.S.C. § 112(b). The § 112(b) rejection of claims 1-2, 5-7, 11-12, 14, 16, 18, 20-21, 24-25, 34, and 36-37 has been withdrawn. However, the amendment to claims 22 and 32 have not overcome the rejection under 35 U.S.C. § 112(b) and, thus, remain rejected under 35 U.S.C. § 112(b).
Applicant’s amendments, filed 09 April 2026, have overcome the rejections of claims 1-2, 5-7, 11-12, 14, 16, 18, 20-22, 24-25, 32, 34, and 36-37 under 35 U.S.C. § 103. The § 103 rejections have been withdrawn.
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 22 and 32 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.
Regarding claim 22, line 1 recites the limitation "wherein the system...". There is insufficient antecedent basis for this limitation in the claim. Claim 22 depends on claim 21. Line 1 of claim 21 recites "a screening system", however, line 8 of claim 21 recites "a robotic system". Thus, it is unclear whether "the system" on line 1 of claim 22 referring to the "screening system" or if the limitation is intended to refer to the "robotic system". Therefore, claim 22 is indefinite and is rejected under 35 U.S.C. § 112(b). The examiner assumes line 1 of claim 22 is supposed to instead recite 'wherein the screening system'. If this is applicant's intent, please amend accordingly.
Regarding claim 32, line 5 recites the limitation "wherein the system...". There is insufficient antecedent basis for this limitation in the claim. Claim 32 depends on claim 21. Line 1 of claim 21 recites "a screening system", however, line 8 of claim 21 recites "a robotic system". Thus, it is unclear whether "the system" on line 5 of claim 32 referring to the "screening system" or if the limitation is intended to refer to the "robotic system". Therefore, claim 32 is indefinite and is rejected under 35 U.S.C. § 112(b). The examiner assumes line 5 of claim 32 is supposed to instead recite 'wherein the screening system'. If this is applicant's intent, please amend accordingly.
Allowable Subject Matter
Claims 1-2, 5-7, 11-12, 14, 16, 18, 20-21, 24-25, 34, and 36-37 are allowed in view of the prior art.
Claims 22 and 32 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art of record, taken alone or in combination, neither anticipates nor renders obvious a screening system to identify pathogens or genetic differences, wherein the screening system has a first and second screening mode and comprises: a source of electromagnetic radiation for illuminating a plurality of samples, the source of electromagnetic radiation having a selectable illumination property; and a detector for detecting electromagnetic radiation transmitted through or emitted by the plurality of samples, the detector having a selectable detection property; and an incubator for incubating the samples; a robotic system for loading and unloading of samples; wherein the screening system for screening of pathogens or genetic differences is arranged to identify if and when the screening and/or processing is completed for individual samples or groups of samples, and wherein the robotic system is arranged to: remove the individual samples or groups of samples from the incubator leaving vacant sample holders or groups of sample holders, wherein samples or groups of samples are being removed from locations surrounded by, or adjacent to, samples or groups of samples for which screening and/or processing is not completed; thereafter obtain fresh samples or groups of samples; and thereafter fill the vacant positions in the incubator with the fresh samples; whereby the screening system is suitable for continuous throughput of samples, wherein the screening system is arranged for operation in the first and second screening mode during incubating of the samples in the incubator; wherein the screening system operates in first and second screening modes without adjustment or changing of an optical filter during use of the screening system (emphasis added via bolded words, extra emphasis added via underlined words).
The closest prior art of record is Kim (WO 2015/030368 A1, of record), Kim teaches a screening system (abstract, Fig. 1-2) to identify pathogens or genetic differences (see lines 33-87), wherein the screening system has a first and second screening mode (abstract, lines 510-513) and comprises: a source of electromagnetic radiation (Fig. 10 source 51-3, source 52-2) for illuminating a plurality of samples (see Fig. 1, 5, and 10; the sources corresponding to absorption measurement terminal 51 and fluorescence measurement terminal 52 illuminate wells 30, wherein the wells are filled with a sample (lines 335-337, 377-380)), the source of electromagnetic radiation having a selectable illumination property (lines 418-423, 446-453, 468-470); and a detector (Fig. 10 PMT 51-1, photodiode 51-5, PMT 52-5) for detecting electromagnetic radiation transmitted through or emitted by the plurality of samples (lines 406-415, 436-453, 597-611), the detector having a selectable detection property (lines 451-453); and an incubator (Fig. 1 incubating lead 32, Fig. 6 heating wire 33, incubating gas injection nozzle 34; see also lines 138-144, 355-374) for incubating the samples (lines 138-144, 355-374); a robotic system (Fig. 2 first tip 40) for loading and unloading of samples (lines 377-380); wherein the screening system operates in first and second screening modes without adjustment or changing of an optical filter during use of the screening system (lines 468-470).
Kim does not teach wherein the screening system is arranged for operation in the first and second screening mode during incubating of the samples in the incubator. Rather, Kim teaches the operation of the screening system in the first and second modes as a distinct step that occurs after the incubation of the sample (lines 586-603). Additionally, during the incubation of the sample in the well plate of Kim, an incubation slide is slid above the well plate to provide a heated and controlled environment to supply incubating gas (lines 591-594). Due to this slide, the screening system of Kim does not have the ability to screen samples during the incubation period. Since the robotic tip that loads samples into the wells is attached to the moveable head that comprises the two screening modes (see Fig. 10), it would not be obvious to modify the screening system of Kim to be arranged for operation in the first and second screening mode during incubating of the samples in the incubator as doing so would render the screening system of Kim inoperable for its intended use.
Furthermore, Kim does not teach the screening system for screening of pathogens or genetic differences is arranged to identify if and when the screening and/or processing is completed for individual samples or groups of samples, and wherein the robotic system is arranged to: remove the individual samples or groups of samples from the incubator leaving vacant sample holders or groups of sample holders, wherein samples or groups of samples are being removed from locations surrounded by, or adjacent to, samples or groups of samples for which screening and/or processing is not completed; thereafter obtain fresh samples or groups of samples; and thereafter fill the vacant positions in the incubator with the fresh samples.
Holmes et al. (WO 2014/127379 A1, of record), hereinafter Holmes relates to screening systems that comprises multiple screening modes, an incubation systems, and a robotic system for loading and unloading samples (see Holmes paragraphs 00266-00268, 00294, 00472-00476, 00507, 00532-00554, 00580-00582, 01708, 02095-02107). However, Holmes does not appear to teach, among other elements, a screening system to identify pathogens or genetic differences, wherein the screening system has a first and second screening mode, wherein the screening system is arranged for operation in the first and second screening mode during incubating of the samples in the incubator, and wherein the screening system operates in first and second screening modes without adjustment or changing of an optical filter during use of the screening system. Rather, Holmes appears to teach that the incubation and the screening are performed separately (see Holmes paragraphs 02095-02107).
Muller et al. (US 2014/0160466 A1, of record), hereinafter Muller, teaches a screening system having first and second modes comprising a light source with a selectable illumination property, detector with a selectable detector property, and a housing that comprises heating means for incubation of samples (see Muller Fig. 1-4, abstract, paragraphs 0079-0082, 0103-0112, 0118-0124, 0131-0140). However, Muller does not teach wherein the screening system is arranged for operation in the first and second screening mode during incubating of the samples in the incubator. Rather, Muller appears to teach the incubation of the samples is performed prior to the screening (see Muller paragraphs 0131-0140). Additionally, Muller does not teach the screening system for screening of pathogens or genetic differences is arranged to identify if and when the screening and/or processing is completed for individual samples or groups of samples, and wherein the robotic system is arranged to: remove the individual samples or groups of samples from the incubator leaving vacant sample holders or groups of sample holders, wherein samples or groups of samples are being removed from locations surrounded by, or adjacent to, samples or groups of samples for which screening and/or processing is not completed; thereafter obtain fresh samples or groups of samples; and thereafter fill the vacant positions in the incubator with the fresh samples, whereby the screening system is suitable for continuous throughput of samples.
Vuong et al. (US 2005/0054083 A1, of record) and Rava et al. (US Patent No. 5,545,531) share similar teachings and deficiencies as Muller.
Piette et al. (US 2024/0003810 A1), hereinafter Piette, teaches a multi-modal screening system comprising an light source with a selectable illumination property, detector with a selectable detection property, and an incubator for incubating the samples, wherein operation in the various screening modes is performed during the incubating of the samples with the incubator (see Piette abstract, Fig. 6-7 and 17, paragraphs 0085-0089, 0095-0102, 0118, 0191, 0195-0199). However, Piette teaches that the screening system operates in the first and second screening modes by adjusting/changing a confocal cube that is used for illumination, the confocal cube being a beam splitter with differing excitation and emission filters on it (Piette paragraphs 0102, 0118-0122, 0147). Thus, Piette does not teach wherein the screening system operates in first and second screening modes without adjustment or changing of an optical filter during use of the screening system. Additionally, Piette does not teach the screening system for screening of pathogens or genetic differences is arranged to identify if and when the screening and/or processing is completed for individual samples or groups of samples, and wherein the robotic system is arranged to: remove the individual samples or groups of samples from the incubator leaving vacant sample holders or groups of sample holders, wherein samples or groups of samples are being removed from locations surrounded by, or adjacent to, samples or groups of samples for which screening and/or processing is not completed; thereafter obtain fresh samples or groups of samples; and thereafter fill the vacant positions in the incubator with the fresh samples, whereby the screening system is suitable for continuous throughput of samples.
Zimenkov et al. (US 2012/0300194 A1, of record), Heffelfinger et al. (US Patent No. 5,784,152, of record), and Chu et al. (US 2016/0228876 A1, of record) share similar teachings and deficiencies as Piette.
King (US 2004/0178357 A1) and Sezerman et al. (US 2021/0349025 A1) both relate to fluorescent screening system having a plurality of individual light sources with selectable illumination properties and detectors with selectable detection properties. However, neither of these references teach, among other elements, a screening system to identify pathogens or genetic differences, wherein the screening system has a first and second screening mode.
Ozcan et al. (WO 2021/021906 A1, of record), hereinafter Ozcan, teaches a multimodal screening system comprising a light source with a selectable illumination property, a detector, and an incubator (see Ozcan abstract, Fig. 1A-B). However, Ozcan does not teach, among other elements, that the detector has a selectable detection property, and wherein the screening system for screening of pathogens or genetic differences is arranged to identify if and when the screening and/or processing is completed for individual samples or groups of samples, and wherein the robotic system is arranged to: remove the individual samples or groups of samples from the incubator leaving vacant sample holders or groups of sample holders, wherein samples or groups of samples are being removed from locations surrounded by, or adjacent to, samples or groups of samples for which screening and/or processing is not completed; thereafter obtain fresh samples or groups of samples; and thereafter fill the vacant positions in the incubator with the fresh samples; whereby the screening system is suitable for continuous throughput of samples.
Additionally, the remaining references cited on applicant’s information disclosure statement and previously made of record by the examiner, that are not specifically mentioned above, have been reconsidered by the examiner. None of these references teach the bolded and/or underlined limitations outlined above, in combination with the remaining limitations from the claim.
Therefore, for the reasons outlined above, claim 1 is indicated as having allowable subject matter. Claims 2, 5-7, 11-12, 14, 16, 18, and 20 depend on claim 1 and are therefore also indicated as having allowable subject matter.
Regarding claim 21, the prior art of record, taken alone or in combination, neither anticipates nor renders obvious a screening system to identify pathogens or genetic differences, wherein the screening system has a first and second screening mode and comprises: a source of electromagnetic radiation for illuminating a plurality of samples, the source of electromagnetic radiation having a selectable illumination property; and a detector for detecting electromagnetic radiation transmitted through or emitted by the plurality of samples, the detector having a selectable detection property; and an incubator for incubating the samples; a robotic system for loading and unloading of samples, wherein the screening system for screening pathogens or genetic differences is arranged to identify if and when the screening and/or processing is completed for individual samples or groups of samples, and wherein the robotic system is arranged to: remove the individual samples or groups of samples from the incubator leaving vacant sample holders or groups of sample holders, wherein samples or groups of samples are being removed from locations surrounded by, or adjacent to, samples or groups of samples for which screening and/or processing is not completed; thereafter obtain fresh samples or groups of samples; and thereafter fill the vacant positions in the incubator with the fresh samples; whereby the screening system is suitable for continuous throughput of samples, wherein the screening system is arranged for transferring between the first screening mode and the second screening mode by selecting at least one of the detection property of the detector and the illumination property of the source of electromagnetic radiation during incubation of the samples in the incubator; wherein the screening system operates in first and second screening modes without adjustment or changing of an optical filter during use of the screening system (emphasis added via bolded words, extra emphasis added via underlined words).
Claim 21 has similar limitations to the limitations of claim 1 that were indicated as being allowable subject matter. Therefore, for the same reasons outlined above, claim 21 is indicated as having allowable subject matter. Claims 24-25, 34, and 36-37 depend on claim 21 and are therefore also indicated as having allowable subject matter. Claims 22 and 32, which also depend on claim 21, would be allowable if rewritten to overcome the rejections under 35 U.S.C. § 112(b) outlined above.
Conclusion
THIS ACTION IS MADE FINAL. 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 NOAH J HANEY whose telephone number is (571)270-1282. The examiner can normally be reached Monday-Friday 9am-6pm eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached at (571) 270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOAH J. HANEY/ Examiner, Art Unit 2877
/Michael A Lyons/ Primary Examiner, Art Unit 2877
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