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
Applicant’s amendments, filed 11 August 2026, with respect to the drawings, the specification, and the claims have been entered. Therefore, the objections to the drawings have been withdrawn.
Response to Arguments
Applicant’s arguments, filed 11 August 2026, with respect to the claimed capturing, analysis, and transferring of single particles have been fully considered but are not persuasive. Hart discloses capturing of single particles (paragraph 0026, “capture one or more cells”), detection and analysis of single particles (abstract, last sentence, “Raman spectroscopy of single cells”; paragraph 0013, last sentence, “single cell data”; paragraph 0059, “single cell droplet microfluidics, single cell genomics”), and transferring single particles (paragraph 0041, lines 10-11, “control over the direction of a particle or cell”, emphasis added). Hart further discloses separation of cells of a first cell type 150 and cells of a second cell type 155 (paragraph 0041); therefore, the cells of the different types must be identified on an individual basis.
In response to applicant’s arguments, see page 12, regarding the prevention of disturbance of the solution, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991)
Applicant’s arguments with respect to the reservoir in FIG. 6 of Hart have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new interpretation of the previously applied references.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in People’s Republic of China on 06 June 2023. It is noted, however, that applicant has not filed a certified copy of the CN202310666601.5 application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
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.
Claims 1-2 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hart et al. (U.S. Patent Application Publication No. 2021/0121878 A1), hereinafter Hart.
Regarding claim 1, one embodiment of Hart (FIG. 5B, hereinafter “first embodiment”) discloses an analytical system comprising:
a fluid system comprising a reservoir (FIG. 5B, element 130) and a fluid channel (FIG. 5B, channels 510, 520), where solution containing sample particles (paragraph 0041, lines 1-5) is stored in the reservoir (FIG. 5B, solution containing sample particles 150, 155), and a first branch of the fluid channel communicates with the reservoir (FIG. 5B);
an optical detector (FIG. 5B, fiber optics 100, 110) configured to detect optical information of single sample particles (paragraph 0041 discloses separation of cells of a first cell type 150 and cells of a second cell type 155; therefore, the cells of the different types must be identified on an individual basis) in the reservoir (paragraph 0037, lines 8-10); and
a mass spectrometer (paragraph 0059) arranged at a succeeding stage of the fluid system (paragraph 0041, analysis channel 520 to the analysis region), and the single sample particles being moved from the reservoir to the fluid channel (the arrow in FIG. 5B shows a single sample particle being moved from the reservoir 130 to the fluid channel through element 120) and being carried by fluid continuously flowing in the fluid channel toward the mass spectrometer (paragraph 0041, lines 8-12).
The first embodiment of Hart fails to disclose an optical tweezer arranged towards the fluid system and configured to capture single sample particles in the solution in the reservoir; the optical tweezer configured to move relatively between the reservoir and the fluid channel, and the sample particles being moved from the reservoir to the fluid channel by an optical gradient force generated by the optical tweezer.
However, another embodiment of Hart (FIG. 13B, hereinafter “second embodiment”) discloses an optical tweezer (paragraph 0066, lines 7-8 disclose that “optical forces” comprises optical tweezers) arranged towards the fluid system and configured to capture single (paragraph 0049, lines 7-8) sample particles in the solution in the reservoir (paragraph 0049, last sentence; FIG. 13B, reservoir 1310);
the optical tweezer configured to move relatively between the reservoir and the fluid channel, and the sample particles being moved from the reservoir to the fluid channel by an optical gradient force generated by the optical tweezer (paragraph 0049, last sentence).
The disclosure of the second embodiment of Hart demonstrates that the function of optical tweezers is known in the art of fluidic analytical systems. The second embodiment of Hart also shows that substituting optical tweezers for another mechanism of moving sample particles in the fluidic system yields the predictable result of enabling capture and release of sample particles within a fluid reservoir (Hart, paragraphs 0049, 0066). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the first embodiment of Hart to include an optical tweezer arranged towards the fluid system and configured to capture single sample particles in the solution in the reservoir; the optical tweezer configured to move relatively between the reservoir and the fluid channel, and the sample particles being moved from the reservoir to the fluid channel by an optical gradient force generated by the optical tweezer because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Regarding claim 2, Hart as applied to claim 1 discloses the analytical system according to claim 1.
In addition, the first embodiment of Hart discloses that the sample particles are one or a combination of cells (paragraph 0041, lines 20-21), organelles, and single-celled microorganisms.
Regarding claim 9, Hart as applied to claim 1 discloses the analytical system according to claim 1.
In addition, Hart discloses that the optical detector is one or a combination of a Raman spectrometer, an infrared spectrometer, a fluorescence analyzer, or an optical microscope (paragraph 0059).
Regarding claim 10, Hart as applied to claim 1 discloses the analytical system according to claim 1.
In addition, Hart discloses an image recognition system configured to recognize the sample particles from the solution (paragraph 0041, fiber optics direct cells based on property or type).
Regarding claim 11, the first embodiment of Hart discloses an analytical method comprising:
a fluid system comprising a reservoir (FIG. 5B, element 130) and a fluid channel (FIG. 5B, channels 510, 520), and the solution flows from the reservoir through the fluid channel (the arrow in FIG. 5B shows solution flowing from the reservoir 130 to the fluid channel through element 120);
an optical analysis step for detecting optical information of the sample particles (FIG. 5B, fiber optics 100, 110; paragraph 0037, lines 8-10); and
a mass spectrometry detection step (paragraph 0059) for driving the captured sample particles towards a mass spectrometer (paragraph 0041, analysis channel 520 to the analysis region) and detecting mass spectrum information of the sample particles with the mass spectrometer (paragraph 0059).
The first embodiment of Hart fails to disclose a capturing step for capturing sample particles in a solution of a fluid system by an optical tweezer; and driving the captured sample particles with the optical tweezer.
However, the second embodiment of Hart discloses a capturing step for capturing sample particles in a solution of a fluid system (paragraph 0049, last sentence; FIG. 13B, reservoir 1310) by an optical tweezer (paragraph 0066, lines 7-8 disclose that “optical forces” comprises optical tweezers); and
driving the captured sample particles with the optical tweezer (paragraph 0049, last sentence).
The disclosure of the second embodiment of Hart demonstrates that the function of optical tweezers is known in the art of fluidic analytical systems. The second embodiment of Hart also shows that substituting optical tweezers for another mechanism of moving sample particles in the fluidic system yields the predictable result of enabling capture and release of sample particles within a fluid reservoir (Hart, paragraphs 0049, 0066). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the first embodiment of Hart to include a capturing step for capturing sample particles in a solution of a fluid system by an optical tweezer; and driving the captured sample particles with the optical tweezer because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Regarding claim 12, Hart as applied to claim 11 discloses the analytical method according to claim 11.
In addition, Hart discloses that the optical analysis step is performed simultaneously with the capturing step (paragraph 0057, last sentence).
Claims 4-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hart as applied to claim 1 above, in view of Chen et al. (“Single-Cell Analysis Using Drop-on-Demand Inkjet Printing and Probe Electrospray Ionization Mass Spectrometry”, 2016), hereinafter Chen.
Regarding claim 4, Hart as applied to claim 1 discloses the analytical system according to claim 1.
In addition, Hart discloses that the solution in the fluid channel flows toward an outlet end (FIG. 5B, leftmost ends of fluid channels 510, 520).
Hart fails to disclose that an ionization device is arranged at the outlet end of the fluid channel, and an ion inlet of the mass spectrometer is arranged opposite to the ionization device.
However, Chen discloses that an ionization device (FIG. 1, tungsten tip) is arranged at the outlet end of the fluid channel (FIG. 1, lower end of channel labeled ‘Piezo ceramic’), and an ion inlet of the mass spectrometer is arranged opposite to the ionization device (FIG. 1, inlet of mass spectrometer ‘MS’).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hart to include that an ionization device is arranged at the outlet end of the fluid channel, and an ion inlet of the mass spectrometer is arranged opposite to the ionization device, based on the teachings of Chen that this arrangement provides optimal ionizing performance (Chen, page 4356, column 2, paragraph 1).
Regarding claim 5, Hart in view of Chen as applied to claim 4 discloses the analytical system according to claim 4.
In addition, Chen discloses that the fluid system further comprises:
a nozzle opening formed at the fluid channel (FIG. 1, Piezo ceramic and page 4356, column 2, last 3 lines) and located downstream of the reservoir (FIG. 1, microtube);
an inkjet actuator arranged in correspondence with the nozzle opening (page 4356, column 2, last 3 lines), droplets containing the sample particles expelled one by one through the nozzle opening (page 4355, column 1, last paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hart in view of Chen to include that the fluid system further comprises: a nozzle opening formed at the fluid channel and located downstream of the reservoir; an inkjet actuator arranged in correspondence with the nozzle opening, droplets containing the sample particles expelled one by one through the nozzle opening, based on the additional teachings of Chen that this arrangement provides optimal ionizing performance (Chen, page 4356, column 2, paragraph 1).
Regarding claim 8, Hart in view of Chen as applied to claim 4 discloses the analytical system according to claim 4.
In addition, Chen discloses that the ionization device is an electrospray ionization source (page 4355, column 1, last paragraph), an atmospheric pressure chemical ionization source, an inductively coupled plasma ionization source, or a matrix-assisted laser desorption/ionization source.
The disclosure of Chen demonstrates that the function of an electrospray ionization source is known in the art of analytical systems comprising mass spectrometers. Chen also shows that substituting an electrospray ionization source for another ionization source yields the predictable result of improving analytical capacity for complex samples and reducing the need for pretreatment of the samples (Chen, page 4355, column 1, paragraph beginning “[s]ince its discovery…”). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hart in view of Chen to include that the ionization device is an electrospray ionization source because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hart in view of Chen as applied to claim 5 above, and further in view of Amirav (U.S. Patent Application Publication No. 2003/0003595 A1), hereinafter Amirav.
Regarding claim 6, Hart in view of Chen as applied to claim 5 discloses the analytical system according to claim 5.
In addition, Hart discloses that the fluid channel comprises a first fluid channel (FIG. 5B, element 520) and a second fluid channel (FIG. 5B, element 510), and an outlet of the reservoir is connected to the first fluid channel (FIG. 5B: the outlet of the reservoir 130 at element 120 is connected to first fluid channel 520).
In addition, Chen discloses that the nozzle opening and the inkjet actuator are connected to the first fluid channel (page 4356, column 2, paragraph 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hart in view of Chen to include that the nozzle opening and the inkjet actuator are connected to the first fluid channel, based on the additional teachings of Chen that this arrangement provides optimal ionizing performance (Chen, page 4356, column 2, paragraph 1).
Hart in view of Chen fails to disclose that the ionization device is connected to the second fluid channel, and the second fluid channel has a channel opening arranged in correspondence with the nozzle opening, for receiving the droplets expelled through the nozzle opening.
However, Amirav discloses that the ionization device (FIG. 1, element 20) is connected to the second fluid channel (FIG. 1, channel through elements 16, 18, 20), and the second fluid channel has a channel opening (FIG. 1, element 16) arranged in correspondence with the nozzle opening (FIG. 1, element 12), for receiving the droplets expelled through the nozzle opening (paragraphs 0053-0054).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hart in view of Chen to include that the ionization device is connected to the second fluid channel, and the second fluid channel has a channel opening arranged in correspondence with the nozzle opening, for receiving the droplets expelled through the nozzle opening, based on the teachings of Amirav that this arrangement improves analysis sensitivity (Amirav, paragraph 0033).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hart in view of Chen as applied to claim 5 above, and further in view of Jones et al. (U.S. Patent Application Publication No. 2004/0036868 A1), hereinafter Jones.
Regarding claim 7, Hart in view of Chen as applied to claim 5 discloses the analytical system according to claim 5.
Hart in view of Chen fails to disclose that the fluid system further comprises a target plate arranged below the nozzle opening.
However, Jones discloses that the fluid system further comprises a target plate (FIG. 1a, element 10) arranged below the nozzle opening (FIG. 1a, element 20).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Hart in view of Chen to include that the fluid system further comprises a target plate arranged below the nozzle opening, based on the teachings of Jones that this arrangement provides a cheap yet highly accurate deposition process (Jones, paragraph 0018).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Murtazin et al. (U.S. Patent Application Publication No. 2015/0255262 A1), hereinafter Murtazin, teaches manipulation and analysis of single sample particles.
Imai et al. (U.S. Patent Application Publication No. 2017/0306383 A1), hereinafter Imai, teaches an optical detector comprising a fluorescence analyzer.
Parchen et al. (U.S. Patent Application Publication No. 2020/0176239 A1), hereinafter Parchen, teaches a matrix-assisted laser desorption/ionization source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALINA R KALISZEWSKI whose telephone number is (703)756-5581. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/A.K./Examiner, Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881
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