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 claim set submitted on 20 MARCH 2026 is acknowledged and considered. In the claim set, Claims 1-21 are ‘Canceled’; Claims 22-28, 32, 34-39 are ‘Currently Amended’; Claims 29-31, 33, and 40 are ‘Previously Presented’ ; and Claim 41 is ‘Withdrawn’.
It should be noted that all of Claims 23-41 depend on canceled claims. These claims have been rejected under 112(b).
In addition, Claim 35 has the status as ‘Currently Amended’; however, there are no amendments in the claim. It is interpreted by the Examiner that Claim 35 is ‘Previously Presented’; not ‘Currently Amended’.
Current pending claims are Claims 22-40 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 20 MARCH 2026, with respect to the 112(a) and 112(b) and objection the abstract have been fully considered and are persuasive. The 112(a) and 112(b) and objection the abstract has been withdrawn.
Applicant’s arguments with respect to claims 22-40 have been considered but are moot. In reply to Applicant’s amendment to the claims, Examiner has amended the rejection below to reflect the additional limitation added to the claims. However, the rejection to the claims rely in part on the same prior art.
The rejection below has been amended to reflect the amendment to the claims.
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 23-40 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.
The claims mentioned above, Claims 23-40 depend directly from a canceled claim. Claims 1 and 12 are ‘Canceled’. In the previous claims set that was considered on 04 APRIL 2026, the claims recited proper dependency, but in this most recent claims set, the claim dependency is incorrect.
In the interest of compact prosecution, Examiner will compare the claim set from 04 APRIL 2023 where claims have status identifiers and the claim set submitted on 20 MARCH 2026 and use the dependency from 04 APRIL 2023 to use a guidance in rejection of the claims.
The claims however are still rejected under 112(b) as being indefinite. Appropriate corrections should be made in the next correspondence for proper consideration.
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.
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.
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.
Claims 22-40 are rejected under 35 U.S.C. 103 as being unpatentable over and BOOM, DE 10 2009 021 614 A1, submitted on the Information Disclosure Statement on 04 APRIL 2023, and further in view of ISAAC, US Publication No. 2020/0197941 A1.
An English Machine Translation of the DE document above has been obtained by the Examiner, attached in the previous Office Action has been used as the basis of the rejection below.
Regarding Claim 22, the BOOM reference discloses a apparatus for manipulating one or more microdroplets into an array of microdroplets using EWOD or oEWOD, page 3, “While droplet motions may be achieved…”, page 6 “For droplet movements, a digital microfluidic droplet movement (DMF)…” , the apparatus comprising:
a) a chip for manipulating microdroplets using EWOD or oEWOD forces, Figure 4, Claims, DMF chip, to generate:
i) a plurality of electrowetting pathways leading to the array of microdroplets, Figure 4, paths 22, 22A-C; and
ii) one or more waste electrowetting pathways leading to a waste outlet, Figure 4, page 5, “Further you can, especially in the presorting… individual droplets are now in more or less analyzed, divided and presorted droplet without cells of interest can be sorted out early and the waste…”;
b) a detector for detecting one or more microdroplets with a distinct characteristic, said detector configured to obtain a measured dataset relating to the distinct characteristic of the detected microdroplet, page 4, “In Analysis analyzes can be performed in any way be such. B. by means of photodetectors…or fluorescence (fluorescence correlation spectroscopy, Recognize FCS)…. and “While the sorting process…the system also self-learning can be optimized”;
c) run by a computer/processor which inherently has a storage module for storing data…for self-learning ; and
d) a controller configured to receive the stored dataset one of the waste electrowetting pathway; and wherein the controller is configured to control the motion of the microdroplets along and/or between the electrowetting pathways such that the movement of the microdroplets is synchronized, page 5, “The detection principle is in 3 exemplified…”.
20. The BOOM reference above teaches the claimed invention, but is silent in regards to the ephemeral EWOD or oEWOD pathways.
21. The ISAAC reference discloses an apparatus for manipulating one or more microdroplets into an array of microdroplets using EWOD or oEWOD, Figure 1, [0036, 0059, 0083], the apparatus comprising:
a) a chip for manipulating droplets using ephemeral EWOD or oEWOD forces to generate, Figure 1, [0083], microfluidic chip manipulate droplets 8b, 9b:
a plurality of ephemeral electrowetting pathways leading to the array of microdroplets, Claim 1, [0007-0024, 0036, 0054, 0056, 0057] ephemeral electrowetting locations, and
one or more ephemeral waste ephemeral electrowetting pathways leading to a waste outlet, [0007-0024, 0036, 0054, 0056, 0057] ephemeral electrowetting locations, Claim 3;
b ) a detector for detecting one or more microdroplets with a distinct characteristic, abstract, detection zone, [0024, 0059, 0060], said detector configured to obtain a measured dataset relating to the distinct characteristic, [0060];
c ) a stored dataset associated with the characteristic measured by the detector, [0060], electrical signal can be processed and analysed in a computer using known algorithms to reveal data characteristic of the sequence of the analyte; and
d ) a controller configured to receive the stored dataset, [0060], computer, and the obtained measured dataset to determine whether the measured dataset is associated with characteristics, [0060-0061];
wherein the controller is configured to select one or more microdroplets having a measured dataset that is associated with a characteristic and control the operation of the microfluidic device, [0007, 0061]; and
wherein the controller is configured to control the motion of the microdroplets along and/or between the ephemeral electrowetting pathways such that movement of the droplets are controlled, [007, 0061].
22. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the EWOD or oEWOD forces of BOOM with the ephemeral EWOD or oEWOD as taught by ISAAC resulting in a composite stack that has the anti-fouling and contact-angle modifying properties from the coated monolayer (or very thin functionalised layer) combined with the performance of a thicker intermediate layer having high-dielectric strength and high-dielectric constant (such as aluminium oxide or hafnia), resulting in the structure being highly suitable for the manipulation of very small volume microdroplets, [0055], and enabling the microdroplets to be precisely steered along the ephemeral electrowetting pathways using closely-controlled electrowetting forces, [0056], and providing highly localized electrowetting fields capable of moving the microdroplets on the surface by induced capillary-type forces to be established anywhere on the dielectric layer, [0036].
23. Additional Disclosures Included by the combination are: Claim 23: wherein the apparatus according to claim 22, wherein the chip further comprises a first region for receiving and manipulating microdroplets and a second region comprising the array, wherein the plurality of ephemeral electrowetting pathways can facilitate the movement of microdroplets between the first and second regions, Figure 4, ISAAC [0007, , 0036, 0054, 0056, 0057, 0060, 0061]. ; Claim 24: wherein the apparatus according to claim 22, wherein the stored dataset Claim 25: wherein the 25. (New) The apparatus according to claim 22, wherein the controller is configured to select one or more undesired microdroplets and cause the one or more selected microdroplets to move from the ephemeral electrowetting pathways into one or the ephemeral waste electrowetting pathway, page 5, “Further you can, especially in the presorting… individual droplets are now in more or less analyzed, divided and presorted droplet without cells of interest can be sorted out early and the waste…” and “While the sorting process…the system also self-learning can be optimized”. ; Claim 26: wherein the apparatus according to claim 22, wherein the controller is configured to select one or more undesired microdroplets and cause the one or more selected microdroplets to move from the first region or the ephemeral electrowetting pathways into one of the ephemeral waste electrowetting pathways before it reaches the second region, page 5, “Further you can, especially in the presorting… individual droplets are now in more or less analyzed, divided and presorted droplet without cells of interest can be sorted out early and the waste…” and “While the sorting process…the system also self-learning can be optimized”, ISAAC [0056, 0057]. ; Claim 27: wherein the apparatus according to claim 22, wherein the controller is configured to select one or more undesired microdroplets and cause the one or more selected microdroplets to move from the first or second region into one of the ephemeral waste electrowetting pathway, page 5, “Further you can, especially in the presorting… individual droplets are now in more or less analyzed, divided and presorted droplet without cells of interest can be sorted out early and the waste…” and “While the sorting process…the system also self-learning can be optimized”, ISAAC [0056, 0057].. ; Claim 28: wherein the apparatus according to claim 22, wherein the controller is configured to select one or more undesired microdroplets and is further configured to: a) move one or more undesired selected microdroplets to a space between ephemeral electrowetting pathways; b) move one or more undesired selected microdroplets across one or more ephemeral electrowetting pathways; and c) move one or more undesired selected microdroplets to a waste outlet via one of the waste ephemeral electrowetting pathway, page 4, “Because of parallelization of sorting operations…” and page 6, “In order to avoid or at least largely…” and “The operation of this exemplary arrangement…”, ISAAC [0056, 0057]. ; Claim 29: wherein the apparatus according to claim 22, wherein the detector is a bright-field imaging detector configured to detect microdroplets and to obtain the measured dataset, page 4, “In Analysis analyzes can be performed in any way be such. B. by means of photodetectors…or fluorescence (fluorescence correlation spectroscopy, Recognize FCS)…. , ISAAC [0059, 0060]. ; Claim 30: wherein the apparatus according to claim 22, wherein the distinct characteristic measured by the detector is one or more of the following: the number of objects contained therein; microdroplet diameter; fluorescence or transmittance of light through the microdroplet, page 4, “In Analysis analyzes can be performed in any way be such. B. by means of photodetectors…or fluorescence (fluorescence correlation spectroscopy, Recognize FCS)…, ISAAC [0059, 0060]. ; Claim 31: wherein the apparatus according to claim 22, wherein the detector is configured to detect the fluorescence of one or more desired microdroplets, page 5, “For Special applications can be added to the system…”, page 7, “The detection principle is in 3 exemplified…”, ISAAC [0059, 0060]. ; Claim 32: wherein the apparatus according to claim 22, wherein the ephemeral electrowetting pathways and/or waste ephemeral electrowetting pathways are created by a series of moving sprite patterns, Figure 4, see exploded views on side. ; Claim 33: wherein apparatus according to claim 32, wherein each individual sprite controls a single droplet, Figure 4, right zoomed in figures. ; Claim 34: wherein the apparatus according to claim 22, wherein centre to centre spacing between the ephemeral electrowetting pathways is at least the average droplet diameter, Figure 4, see spacing of pathway, motion paths example 22A, and see droplet within the path with particles, figures on side of Figure 4. ; Claim 36: wherein the apparatus according to claim 22, wherein the number of ephemeral electrowetting pathways is 2 to 250, Figure 2 and 4, see number of pathways in Figures, ISAAC [0054, 0056, 0057, 0058]. ; Claim 37: wherein the apparatus according to claim 22, wherein two or more ephemeral electrowetting pathways propagate from the first region at differing angles, page 3, ‘While droplet motions may be achieved to some extent…In electrowetting forces are generated by non-symmetric contact angles…”, ISAAC [0054, 0056-0058]. ;Claim 38: wherein the apparatus according to claim 22, wherein two or more ephemeral electrowetting pathways propagate from the first region at substantially the same angle, Figure 2 and 4, ISAAC [0054, 0056-0058]. ; Claim 39: wherein the apparatus according to claim 22, wherein one or more ephemeral electrowetting pathways is configured to split to form two or more ephemeral electrowetting pathways, Figure 2, ISAAC [0054, 0056-0058]. ; and Claim 40: wherein the apparatus according to claim 22, wherein one or more of the microdroplets comprises a biological or chemical material which is one or more of the following: a biological cell, cell media, a chemical compound or composition, a drug, an enzyme, a bead or a microsphere optionally bound to a surface and/or to a second material, page 4, ‘Under “biological Objects…”, ISAAC [0001, 0025].
24. Regarding Claim 35, the BOOM and ISAAC references disclose the claimed invention, but is silent in regards to the average spherical microdroplet diameter is 20 to 200 mm.
25. The BOOM discloses the size of the particles can be determined, page 4, “In Analysis analyzes can be performed …Particle size determination, according to Coulter principle…”.
26. The ISAAC reference discloses the microdroplet to have a diameter less than 10 μm, [0055]. However, ISAAC also discloses that the size of the microdroplets have an intrinsic diameter which is more than 10% greater suitably more than 20% greater, than the depth of the microdroplet space based on the first and second dielectric layers and therefore the first and second walls define a microfluidic space, [0050].
27. While BOOM disclose the particle size can be determined, the size of the microdroplets do not have patentable weight as it is the material worked upon the device and does not define the device structurally. In addition, ISAAC teaches the size of the microdroplets can be modified based on the walls of the layers, [0050]. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
26. The size of the droplet diameter does not have any patentable weight of the device itself.
27. The device of BOOM is directed to a microfluidic device for treating droplets and particles suspended in the droplet, abstract, page 3, “The The Invention relates to…” and well as in ISAAC, abstract, [0007-0024]. BOOM also teaches it is beneficial to measure the droplet size, the number of biological objects per droplet and analysis settings to define in a presorting stage to have optimal droplet size values and the cell number / droplets given in for the system. For example, a parameter can be of high cell count / droplets at low percentages of cells of interest and a simultaneously large total population and low Cell count / droplets at high concentration of interest cells, page 5 “Farther it may be beneficial…”.
28. Since the device of BOOM teaches a device to treat droplets and particles on a microfluidic device, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention such that the material worked upon, the microdroplets, have an average spherical microdroplet diameter is 20 to 200 mm as the device is a digital microfluidic circuit, so it is possible based on the percentage distribution of those present in the total population cells of interest have optimal droplet size values and the cell number / droplets given in for the system, page 5 “Father it may be beneficial to measure the droplet size…”.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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