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 Arguments
Applicant's arguments filed 3/12/2026 with respect to the U.S.C. 102 rejection over McDougall et al. have been fully considered but they are not persuasive.
On Pages 10-12 of the Remarks, the Applicant asserts that the prior art reference of McDougall does not teach a “resonant cavity” as there is no wall forming a trap where cells can be maintained without the influence of the flow.
However, the Examiner notes that the channel 24 contains particle traps 34 where particles are bound and are deemed to no longer be under the influence of additional flow and are instead controlled by acoustic or optical forces based on the particle size, see Page 39, P. 3. The channel walls, indicated by inside surfaces 30, see Fig. 5a and 5b, are shown to be outside of inlet 44 and outlet 46 and is therefore a trap where cells are maintained outside of the influence of flow 48, see Fig. 5a.
On Pages 12-14, the Applicant asserts that within the instant invention, some cells are sensitive to the illumination wavelength due to optical absorption properties of the cells. The cells that are not sensitive remain clustered together when the optical signal is applied. This differs from the invention of McDougall et al. as “the optical beam is directed only to cells that must change the trajectory.”
The Examiner respectfully disagrees as McDougall et al. states that the optical beam is used to illuminate all cells of a cluster and move the non-photosensitive particles to a different layer within the channel, see Page 37, P. 3-4, which is analogous to the resonant cavity of the instant invention.
On Pages 14-15 of the Remarks, the Applicant states McDougall discloses the particles moving between traps, however the instant invention is related to cells being impacted by the optical illumination to be displaced from the center of the aggregate towards the outside of the aggregate, but always on the same layer, the same acoustic node.
In response to this argument, the Examiner respectfully disagrees as McDougall teaches that the particles are displaced near to, and not outside of the node, based on the size characteristics of the particle, where the particles are separated by optical forces and are not under the influence of the flow rate, see Pages 39-40. Further, it is unclear how changing trajectory while maintaining the same distance between particles differs from the claimed limitation of the claimed optical emitter being used to “radially exclude only said sensitive cells from a center of the aggregate but always on the said at least one layer…” as the particles are only being slightly shifted from each other, see Page 37, P.4.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDougall et al. (WO2017/006093, cited on the IDS filed 12/6/2021).
Regarding claim 25, McDougall et al. teaches a method for manipulating cells in acoustic levitation in a microfluidic chip (method of manipulating particles using acoustic forces on in a microfluidic channel, see Page 9) including:
- a block made from biocompatible material (microscope slide 40 that supports biological material and is therefore biocompatible, see Page 16, p. 2, and Page 29, p. 3);
- a passage channel made in the block for the passage of cells bathed in a liquid (inlet 44 and outlet 46 for the flow of a fluid medium 22, see Page 29, p. 3 – Page 30, p. 2);
- a resonant cavity made in the block, connected to the passage channel but out of the passage channel, and comprising walls for containing the cells originating from the passage channel, in such a way that the cells are no longer under the influence of a flow in the passage channel (capillary 24 mounted on slide 40 connected to - but outside of - inlet 44 and outlet 46, see Fig. 5a and Page 29, p. 3 – Page 30, p. 2, where the capillary comprises nodes 18 where particle movement stops, see Page 29 p. 2);
- an acoustic wave generator (acoustic transducer 12, see Fig. 5a-6a and Page. 30, p. 2); and
- at least one optical emitter (optical beam 54, see Fig. 7a and Page 35, p. 2);
Said method comprising the following steps:
- injecting cells (particles 10) into the resonant cavity via an inlet of the passage channel (particles 10 move into acoustic node (cavity) of capillary 24 (channel) via inlet 44, see Pages 29-30);;
- generating acoustic waves using the acoustic wave generator for acoustically levitating the injected cells inside the resonant cavity so as to form an aggregate of cells in at least one layer; and (the transducer 12 generates waves to form groups of particles 34 at nodes 18, see Fig. 5a-6b and Pages 30-31); and
- at least one phase of illuminating simultaneously all cells of the aggregate of cells while simultaneously maintaining the acoustic waves (optical beam 54 illuminates particle trap 34 and exerts optical force to separate sensitive particles while other particles remain suspended by the acoustic field, see Fig. 7a-7d and Page 36-37), the aggregate comprising at least two types of cells, one type being sensitive to the illumination wavelength depending on the optical absorption properties, the other type being not sensitive to the illumination wavelength (the particle trap 34 contains two cells, larger-diameter cells 10 and smaller-diameter particles 11, where the larger particles are sensitive to a specific wavelength and are sorted out, see Page 31);
the illuminating phase comprising:
- illuminating the cells of aggregate in a same optical axis as an axis of the acoustic waves (optical beam 54 illuminates particle trap 34 and exerts optical force to separate sensitive particles while other particles remain suspended by the acoustic field in the same direction of the standing wave pattern made by the anti-nodes of the acoustic transducer, see Page 26)
- using at said at least one optical emitter having a wavelength for which a portion of cells are sensitive, so as to radially exclude only said sensitive cells from a center of the aggregate but always on the said at least one layer according to the optical exclusion principle (optical beam 54 illuminates particle trap 34 to separate photosensitive 10 cells from non-photosensitive cells where the non-sensitive cells 10 form an aggregation and photosensitive cells are deflected, or excluded, see Fig. 7a-d, Page 26, Page 37, and Page 38, P. 1-2, and are maintained in a radial direction when in a no-flow environment, see Page 2, P. 1 and Page 30, P. 2).
Regarding claim 26, McDougall et al. teaches the method according to claim 25, in which method the injected cells have different natures (the particles are larger 10 or smaller 11 and therefore have different natures, see Fig. 7c and Page 37), the steps of generating acoustic waves and of illuminating being carried out as follows:
- generating acoustic waves for acoustically levitating the injected cells (cells are acoustically focused into particle traps 34, see Fig. 6a-b and Page 34) and at the same time applying a light beam at a wavelength making the principle of exclusion of a portion of the cells possible, so that only the cells not sensitive to this optical wavelength form an aggregate in one layer (light is applied to the particle trap 34 where the sensitive particles migrate and the insensitive particles remain aggregated, see Fig. 7b-d and Page 37); and
- maintaining the acoustic waves and stopping the light beam so that the cells sensitive to the wavelength of the light beam now form aggregates on the periphery of the aggregate already formed, to thus obtain a radially structured aggregate (the light is modulated such that the particles under the influence of light group particles within an acoustic trap 34 outside of the adjacent acoustic traps 52, see Fig. 9b and Pages 39-40).
Regarding claim 27, McDougall et al. teaches the method according to claim 25 for producing a three- dimensional structure (see Fig. 6b and 9b) formed of several layers of aggregates:
- the step of injecting comprising the injection of cells into the resonant cavity via one or more inlets (particles 10 move into acoustic node (cavity) of capillary 24 (channel) via inlet 44, see Pages 29-30); and
- the step of generating acoustic waves moreover comprising the generation of acoustic waves for acoustically levitating several aggregates of cells injected on several levels (transducer 12 generates waves for acoustically trapping particles into different traps 34 and 52, see Figs. 6b and 9b, and Pages 31-32, the levels being acoustic pressure nodes the number of which is a function of the wavelength of the acoustic waves and the height of the resonant cavity (the particle traps are located at acoustic nodes which correspond to the wavelength produced by the transducer and the height of the channel 24, see Pages 26-27).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over McDougall et al. (WO2017/006093, cited on the IDS filed 12/6/2021) as applied to claim 25 above, and further in view of Kennedy, III et al. (US PG Pub 20160369236 A1, hereinafter Kennedy).
Regarding claim 28, McDougall et al. teaches the method according to claim 25, characterized in that it moreover comprises a step of carrying out a cell culturing (method is applied to cell culture, see Page 2-3), but does not teach that the method includes holding the aggregate or the aggregates obtained immobile in acoustic levitation for the duration of the culturing.
However, in the analogous art of devices for acoustic manipulation of cellular samples, Kennedy teaches a step of carrying out a cell culturing while holding the aggregate or the aggregates obtained immobile in acoustic levitation for the duration of the culturing (nutrient fluid flows over cells while the cells are trapped by an acoustic standing wave within a cavity, see Fig. 4, [0004]- [0005], [0023], and [0054]- [0055]).
Modifying a chamber comprising an acoustic transducer and acoustic reflector to allow for acoustic manipulation of a sample to keep a target molecule immobilized to execute cell culturing was known in the art before the effective filing date of the instant application (see [0006] in Kennedy and Page 2-3 in McDougall). Therefore, a person possessing ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the method of McDougall et al. to include the step of introducing a nutrient broth to perform cell culturing on a target cell or other particle within the resonant cavity for harvesting, see [0006] in Kennedy. Modifying the method of McDougall to include the step of introducing a nutrient fluid through an inlet of a channel to flow over the acoustically trapped particles of the resonant cavity as exemplified by Kennedy would have yielded the reasonable expectation of successfully facilitating the separation and subsequent collection of target molecules within a sample.
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.
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/A.N.M./
Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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