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 .
Claims status: amended claims: 31, 34, 40, 45, 56-57; canceled claims: 33, 37, 41-43, 46-48, 52-55, 61-122; the rest is unchanged.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive. Applicant argues in pg.6 3rd of the remarks that it would not be obvious to one of ordinary to replace the particle sensor in the first embodiment with a scintillator counter and doing so would have been a hindsight. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Additionally, Ward et al. teach in para. [0187] the “the systems can comprise one or more analytical devices for analyzing particles separated by the systems. Examples of analytical devices include affinity columns, cell counters, particle sorters, e.g., fluorescent activated cell sorters, capillary electrophoresis, microscopes, spectrophotometers, sample storage devices, and sample preparation devices, sequencing machines (e.g., next-generation sequencing machine, e.g., from Illumina), mass spectrometers, HPLC, gas chromatograph, atomic absorption spectrometers, fluorescence detectors, radioactivity counters, scintillation counters, spectrophotometers, cell counters, and coagulometers. In some cases, some devices for separating particles herein can also be used as analytical devices. Furthermore, applicant argues in pg.8 of the remarks that Ward et al. do not teach a scintillator counter for asserting radioactivity of an individual particle. Ward et al. teach a scintillator counter (para. [0187] a scintillator counter, para. [0189] teaches detecting individual particles), for asserting radioactivity of an individual particle (para. [0310] teaches radioactive particles). Regarding claim 35, applicant argues in pg.13 of the remarks that Lowe et al. fail to cure the deficiencies of Ward et al., Lowe et al. do not detect radioactive particles and Lowe et al. do not disclose any location of the detector. Ward et al. is no deficient as shown above. The Lowe et al. reference was used to teach the scintillator counter is positioned within the flow cell. Para. [0447] teaches one or more sensors, para. [0558] a sensor being a scintillator counter and para. [0570] teaches the sensors place within the flow cell. Finally, regarding the combination of Ward et al. and Fowlkes et al., applicant argues in pg.14 of the remarks that Fowlkes et al. do not remedy the deficiency of Ward et al. As shown above the Ward et al. reference is not deficient. The argument about the bodily incorporation and hindsight reasoning regarding the combination of Ward et al. and Fowlkes et al. is not persuasive. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the rejection is maintained and made final.
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.
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.
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.
Claims 31-32, 34, 40, 44-45, 49-50, 56, 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (US 2017/0248508 A1; pub. Aug. 31, 2017).
Regarding claim 31, Ward et al. disclose in a first method: A method of analyzing a particulate sample, the method comprising:
(a) introducing the sample into a flow cytometer comprising: a flow cell for transporting the particulate sample in a flow stream (para. [0201]-[0202]).
In the first embodiment Ward et al. are silent about: (a) a light source for irradiating the particulate sample in the flow stream at an interrogation point; a particle-modulated light detector for detecting light from the interrogation point; and a scintillation counter for assessing particle radioactivity; and
(b) obtaining particle-modulated light intensity data and particle radioactivity data from the particle-modulated light detector and the scintillation counter, respectively for an individual particle among a plurality of particles of the particulate sample.
In a further method Ward et al. disclose: (a) a light source for irradiating the particulate sample in the flow stream at an interrogation point (para. [0187]-[0189]); a particle-modulated light detector for detecting light from the interrogation point; and a scintillation counter for assessing particle radioactivity (para. [0187]); and
(b) obtaining particle-modulated light intensity data and particle radioactivity data from the particle-modulated light detector and the scintillation counter, respectively for an individual particle among a plurality of particles of the particulate sample (para. [0187], [0189]) motivated by the benefits for improved particle analysis accuracy.
In light of the benefits for improved particle analysis accuracy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the two methods of Ward et al.
Regarding claim 32, Ward et al. disclose: preparing a radiolabeled sample for analysis (para. [0201]-[0202]).
Regarding claim 34, Ward et al. disclose: analyzing the sample comprises obtaining aggregate particle radioactivity data from the plurality of particles (para. [0310]).
Regarding claim 40, Ward et al. disclose: the flow cytometer further comprises a particle injection conduit for injecting the particulate sample from the flow cell at a distal end (fig.4A shows the particle stream entering from the top).
Regarding claim 44, Ward et al. disclose: the scintillation counter is operably connected to the particle injection conduit (para. [0187]).
Regarding claim 45, Ward et al. disclose: the flow cytometer further comprises a particle ejection conduit for ejecting particles from the flow cell at a distal end (para. [0200], fig.4E item 405.1).
Regarding claim 49, Ward et al. disclose: the scintillation counter is operably connected to the particle ejection conduit (para. [0187]).
Regarding claim 50, Ward et al. disclose: the scintillation counter comprises: a scintillator; and a scintillated light detector operably attached to the scintillator (para. [0187]).
Regarding claim 56, Ward et al. disclose: associating the obtained particle-modulated light intensity data and particle radioactivity data with the individual particle via a processor operably coupled to the particle-modulated light detector and the scintillation counter (para. [0187]).
Regarding claim 58, Ward et al. disclose: adjusting the rate with which particles are transported through the flow cell such that the elapsed time is altered (para. [0369]).
Regarding claim 59, Ward et al. disclose: the particle- modulated light detector comprises a fluorescent light detector (para. [0187]).
Regarding claim 60, Ward et al. disclose: the particle- modulated light detector comprises a forward-scattered light detector (para. [0010]).
Regarding claim 61, Ward et al. disclose: the particle- modulated light detector comprises a side-scattered light detector (para. [0010]).
Claims 35-36, 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (US 2017/0248508 A1; pub. Aug. 31, 2017) in view of Lowe et al. (US 2011/0053289 A1; pub. Mar. 3, 2011).
Regarding claim 35, Ward et al. are silent about: the scintillation counter is positioned within the flow cell.
In a similar field of endeavor Lowe et al. disclose: the scintillation counter is positioned within the flow cell (para. [0155] teaches a sensor can be placed adjacent the liquid-liquid interface, para. [0447] teaches one or more sensors, para. [0558] teaches the sensor is scintillator counter) motivated by the benefits for a compact device.
In light of the benefits for a compact device, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ward et al. with the teachings of Lowe et al.
Regarding claim 36, Ward et al. disclose; the scintillation counter is separated from the interrogation point (para. [0187]).
Regarding claim 38, Lowe et al. disclose: the scintillation counter is positioned within the flow cell at a downstream location relative to the interrogation point (para. [0155] teaches a sensor can be placed adjacent the liquid-liquid interface, para. [0447] teaches one or more sensors, para. [0558] teaches the sensor is scintillator counter) motivated by the benefits for a compact device.
Regarding claim 39, Lowe et al. disclose: the scintillation counter is positioned within the flow cell at an upstream location relative to the interrogation point (para. [0155] teaches a sensor can be placed adjacent the liquid-liquid interface, para. [0447] teaches one or more sensors, para. [0558] teaches the sensor is scintillator counter) motivated by the benefits for a compact device.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (US 2017/0248508 A1; pub. Aug. 31, 2017) in view of Stein (US 2017/0059722 A1; pub. Mar. 2, 2017).
Regarding claim 51, Ward et al. are silent about: the scintillation counter further comprises a photocathode positioned between the scintillator and the scintillated light detector.
In a similar field of endeavor Stein discloses: the scintillation counter further comprises a photocathode (fig.1 item 20) positioned between the scintillator (fig.1 item 10) and the scintillated light detector (fig.1 item 50) motivated by the benefits for improved imaging accuracy.
In light of the benefits for improved imaging accuracy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ward et al. with the teachings of Stein.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (US 2017/0248508 A1; pub. Aug. 31, 2017) in view of Fowlkes et al. (US 2004/0043420 A1; pub. Mar. 4, 2004).
Regarding claim 57, Ward et al. are silent about: the processor is configured to associate the received particle-modulated light intensity data and particle radioactivity data with the individual particle based on the amount of elapsed time between the time point at which particle-modulated light is detected and the time point at which the radioactivity of the particle is assessed.
In a similar field of endeavor Fowlkes et al. disclose: the processor is configured to associate the received particle-modulated light intensity data and particle radioactivity data with the individual particle based on the amount of elapsed time between the time point at which particle-modulated light is detected and the time point at which the radioactivity of the particle is assessed (para. [0058], [0494], [0647]) motivated by the benefits for improved detection accuracy.
In light of the benefits for improved detection accuracy, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ward et al. with the teachings of Fowlkes et al.
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 MAMADOU FAYE whose telephone number is (571)270-0371. The examiner can normally be reached Mon – Fri 9AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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