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 13 OCTOBER 2025 is acknowledged and considered.
In the claim set, Claims 1, 6, 9, 11, 14, 17 and 18 are ‘Currently Amended’ even though Claims 9 and 14 are given status identifiers as ‘Previously Presented’ with amendment notations. Claims 2-5, 7, 8, 10, 12, 13, and 20-24 are ‘Cancelled’; Claims 15, 16 and 19 are ‘Previously Presented’.
Current pending claims are Claims 1, 6, 9, 11 and 14-19 and are considered on the merits below.
Response to Amendment
Applicant’s arguments, see REMARKS, filed 13 OCTOBER 2025, with respect to the 112(b) rejection and the specification objection have been fully considered and are persuasive. The 112(b) rejection and the specification objection have has been withdrawn.
In the REMARKS filed on 13 OCTOBER 2025 Applicant asserts the ISAAC reference does not teach the limitation of the ‘based on the partition co-efficient value of the component, which is defined as P = Co/Cw, where Co is the concentration in oil phase and Cw is the concentration in aqueous phase.
In the ISAAC reference, page 4 line 4-5, the reference discloses step (b), “culturing the population of microdroplets under conditions which cause cell growth and division before or after initial step (a), and in line 15-25, the reference discloses the “oil may optionally further comprise surfactants and other additives to maintain microdroplet stability. The oil also contains low levels of the nutrients and gases required to maintain cell growth during the culturing phase and application of this embodiment causes the nutrient content of the microdroplets to be either periodically or continuously replenished by interfacial diffusion”.
While ISAAC does not specifically use the word a partition coefficient, it does teach and disclose factors that the partition coefficient depends on are in fact monitored and parameters are modified to ‘maintain microdroplet stability…and maintain cell growth…and provide a hypoxic environment to the cells’.
Claim Objections
Claim 9 objected to because of the following informalities: In the last line of the instant claim, ‘a EWOD’ should be ‘an EWOD’. Appropriate correction is required.
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.
Claim 9 is 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.
In the instant claim, the claim defines a ‘plurality of microdroplets’ (plural). This is after in Claim 1 only ‘a microdroplet’ (singular) is claimed.
A dependent claim must further limitation of the subject matter claimed. This ensures the claim properly narrows the scope of the invention. Claim 9 does not further limit as it claims more than one (plural), which is broader than a single microdroplet.
Claims 11 and 17 are also rejected under 112(b) as being dependent upon a claim rejected under 112(b).
Claim 14-16 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.
In Claim 14, the claim language recites “further comprises the step of incubating …”; however , it is unclear as to when this step is occurring. For examination purposes, it can occur at any time. This rejection was mentioned in the previous Office Action.
In Claim 15, the claim language recites “further comprising the step of monitoring …”; however , it is unclear as to when this step is occurring. For examination purposes, it can occur at any time. This rejection was mentioned in the previous Office Action.
In Claim 16, the claim language recites “further comprising the step of performing …”; however , it is unclear as to when this step is occurring. For examination purposes, it can occur at any time. This rejection was mentioned in the previous Office Action.
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 1, 6, 9, 11 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over ISAAC, WO 2020/104769, submitted on the Information Disclosure Statement on 09 FEBRUARY 2023, Foreign Patent Documents Cite No. BA.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference ISAAC discloses a method of maintaining at least one component in an aqueous microdroplet, abstract, page 1 line 1-7, page 3, line 22-24, the method comprising the steps of
supplementing an unconditioned oil with a component to form a conditioned oil, page 3 line 23-25, page 4, line 8-10, line 15-21, oil comprises surfactants and other additives, low level nutrients and gases; and
providing the aqueous microdroplet comprising the component, wherein the microdroplet is dispersed in the conditioned oil to form an emulsion, such that the partitioning of the component from the microdroplet into the conditioned oil is reduced, page 3 line 23-25, page 4, line 8-25,
wherein the maintenance of the component within the microdroplet is based on the partition coefficient value of the component being
The ISAAC reference discloses the claimed invention, but does not specifically use the term ‘partition coefficient’ in the disclosure, however, in the ISAAC reference page 4 line 4-5, the reference discloses step (b), “culturing the population of microdroplets under conditions which cause cell growth and division before or after initial step (a)”, and in line 15-25, the reference discloses the “oil may optionally further comprise surfactants and other additives to maintain microdroplet stability. The oil also contains low levels of the nutrients and gases required to maintain cell growth during the culturing phase and application of this embodiment causes the nutrient content of the microdroplets to be either periodically or continuously replenished by interfacial diffusion”.
While ISAAC does not specifically use the word a partition coefficient, it does teach and disclose factors that the partition coefficient depends on are in fact monitored and parameters are modified to ‘maintain microdroplet stability…and maintain cell growth…and provide a hypoxic environment to the cells’.
Furthermore, the ISAAC reference teaches the weight ratio of the aqueous microdroplets to oil is monitor and determined, page 9 line 4-13. In addition, the creation of droplets can be formed with controlling the environment, which includes the addition of extra materials such as buffer solutions, salts, nutrients, proteins and extracellular matrix materials which change concentration of both the oil and water conventions of the microdroplet, page 6 line 7-27.
While ISAAC does not specifically use the term ‘partition coefficient’, ISAAC implies the many factors which includes both the concentration of where Co is the concentration in oil phase and Cw is the concentration in aqueous phase are determined and can be modified.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the invention of ISAAC to modify the maintenance of the component within the microdroplets based off a partition coefficient to ‘maintain microdroplet stability…and maintain cell growth…and provide a hypoxic environment to the cells’, page 4 line 4-25
Additional Disclosures Included are: Claim 6: wherein the method according to claim 1, wherein the microdroplet further comprises at least one biological cell, page 3 line 24. ; Claim 9: wherein the method according to claim 1, further comprising a plurality of microdroplets and the step of loading the plurality of microdroplets dispersed in the conditioned oil into an EWOD or oEWOD device, page 5 line 1-9, Claim 1, 4, 10, 12, 17. ; Claim 11: wherein the method according to claim 9, further comprises the step of introducing a replacement carrier fluid into the EWOD or oEWOD device, wherein the replacement carrier fluid is conditioned oil, page 8 line 30-34. ; Claim 14: wherein the method according to claim 1, wherein the method further comprises the step of incubating the microdroplet, page 8 line 25-30, Claim 5. ; Claim 15: wherein the method according to claim 1, further comprising the step of monitoring the microdroplet for cell growth, page 7 line 21-31, Claim 17, analysing…., Claim 19 and 24 ; Claim 16: wherein the method according to claim 1, further comprising the step of performing a cell assay, page 5 line 13-30, page 7 line 3-14, Claim 2. ; Claim 17: wherein the method according to claim 9, further comprising one or more of the following steps: merging the microdroplets, splitting the microdroplets and/or dispensing the microdroplets, page 6 line 7-27, page 7 line 19-31, Claim 17, 18 and 21. ; Claim 18: wherein the method according to claim 1, wherein the conditioned oil comprises a mineral oil, a silicone oil or a fluorocarbon oil, page 8 line 33-page 9 line 3, Claim 22 and 23. ; and Claim 19: wherein the method according to claim 1, wherein the component is a biological component, a small molecule or a compound, page 3 line 22-24, Claim 17, contain cells of particular cell type.
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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797