DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
The claim set submitted on 18 DECEMBER 2025 is acknowledged and considered. In the claim set, Claims 1, 6, 9, 13-15 and 22 are ‘Currently Amended’; Claims 2-5, 9 and 16 are ‘Original’ or ‘Previously Presented’; Claims 23-26 are ‘New’ and Claims 8, 10-12 and 17-2 are ‘Canceled’.
Current pending claims are Claims 1-7, 9, 13-16 and 22-26 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 18 DECEMBER 2025, with respect to the 112(a) rejection and the have been fully considered and are persuasive. The 112(a) rejection has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-7, 9 12-16 and 22 have been considered but are moot. Based on Applicant’s amendments ground of rejection has been modified and relies still on LINK, but now in view of DAVIES, WO 2007/091228 A.
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 1 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.
Claim 1 recites the limitation "the fluidic channel" . There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "different fluidic channels" . The instant claim does not further define the claim from which it depends from. Claim 1 only defines a single ‘fluid(ic) channel’, then in the instant claim, what is claimed are ‘different fluidic channels’, plural.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-7, 9, 13-16 and 22-26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over LINK, US Publication No. 2008/0014589 A1, submitted on the Information Disclosure Statement on 25 JUNE 2024; US Patent Documents Cite No. 087, and further in view of DAVIES, WO 2007/091228 A, submitted on the Information Disclosure Statement on 25 JUNE 2024; Foreign Patent Documents Cite No. 027.
Applicant’s invention is drawn towards a method.
Regarding Claim 1, the LINK reference discloses a method, abstract, Claim 1, comprising:
(a) mixing a fluid comprising the lysing agent and a fluid comprising a biological sample a the carrier fluid to generate the droplets, LINK [0034, 0035, 0037, 0045, 0453], droplets formed includes a sample fluid biological/chemical material/at least one cell with at least one enzyme and can be lysed, lysing of cells, inherently has lysing agent, which includes solvent, [0037, 0158-0162, 0293], surfactants and solvent, Claim 110, Claims 58-59, the carrier fluid which is immiscible with the of the droplets comprise a cell from [[a]] the biological sample, Claim 5 and 6, [0037], a microcarrier, [0037], and [[a]] the lysing agent, [0023, 0035, 0158-0162, 0293];
(b) in the one or more of the droplets, using the lysing agent to lyse the cell to release intracellular components comprising nucleic acid from the cell, [0023, 0035, 0037], Claim 163, lysing the cells within the plurality of droplets … such that the cells release at least one enzyme into the plurality droplet ;
(c) dispensing the droplets comprising released nucleic acid into a vessel, [0179, 0185, 0314, 0415].
LINK reference discloses the claimed invention directed to a method, but is silent in regards to introducing a fluid into a chamber where the chamber comprises a carrier fluid that is immiscible with the fluid.
The DAVIES reference discloses a method comprising:
(a) introducing a fluid into a chamber via a fluid channel, the fluidic channel or the chamber containing carrier fluid that is immiscible with the fluid, thereby generating, in the chamber, droplets wrapped in the carrier fluid, Figure 6, page 11, line 30-page 12 line 31; and
(c) dispensing the droplets in one or more wells of a well plate into a vessel, Figure 5.
It would have been obvious to one having ordinary skill in the art to modify the LINK reference with step (a) of DAVIES in which fluid is introduced into a chamber via a fluid channel, the fluidic channel or the chamber containing carrier fluid that is immiscible with the fluid, thereby generating, in the chamber, droplets wrapped in the carrier fluid to have physical control of the droplets, page 12 line 28-31.
Additional Disclosures Included are: Claim 2: wherein the method of claim 1 further comprising diluting the biological sample prior to (a) such that the droplets on average comprise one cell per droplet, LINK [0120].; Claim 3; wherein the method of claim 2, wherein the biological sample comprises a plurality of homogenous cells, LINK [0444].; Claim 4: wherein the method of claim 2, wherein the biological sample comprises a plurality of heterogenous cells, LINK [0324].; Claim 5: wherein the method of claim 1, wherein the nucleic acid comprises DNA or RNA, LINK [0325, 0332].; Claim 6: wherein the method of claim 1, wherein the one or more the droplets further comprise a microcarrier, and wherein microcarrier is coated with at least one agent, LINK [0160].; Claim 7: wherein the method of claim 6, wherein the at least one agent promotes adherence to the microcarrier, LINK [0160].; Claim 9: wherein the method of claim 8, further comprising rupturing the aqueous droplets in the vessel, LINK [0033], incubating off the substrate.; Claim 13: wherein the method of claim 1, wherein the fluid comprising the lysing agent is different from the fluid comprising the biological sample, LINK [0023, 0035-0037, 0158-0162, 0293-0295, 0453].; Claim 14: wherein the method of claim 13, wherein step (a) further comprises flowing the fluid comprising the lysing agent and the fluid comprising the biological sample through different fluidic channels, LINK [0034-0036, 0159, 0173, 0196, 0294, 0295], step (b) flowing a first sample through first inlet; then method further including lysing cells from step (b) such that cells release at least one enzyme, since the steps occur at different times, it is inherent that the sample and lying agent are in separate flows, and merging the separate flows at a mixing location to generate the Claim 15: wherein the method of claim 14, wherein step (a) further comprises mixing the fluids with the carrier fluid in the chamber at a mixing location to generate the droplets, DAVIES, Figure 6, chamber 34, page 11 line 33, LINK Figure 34, LINK [0034, 0035, 0037, 0045, 0159, 0173, 0196, 0294, 0295, 0303, 0304, 0415, 0453], device includes one or more mixing modules…which comprise features for shaking or otherwise manipulate droplets to mix their contents, includes use of channel geometries, acoustic actuators…. ; and Claim 16: wherein the method of claim 14, further comprising flowing the droplets wrapped in the carrier fluid from the mixing location, LINK Figure 1, DAVIES Figure 6A-G.; Claim 22: wherein the method of claim 1, wherein (a) further comprises adjusting the flow rate of the fluid comprising the lysing agent, or the fluid comprising the biological sample, such that each of a subset of the droplets contains only a single cell, LINK Figure 8, [0056, 0101, 0120, 0139].; Claim 23: wherein the method of claim 1, further comprising subjecting to one or more droplets to an assay, DAVIES page 23 line 12-32. ; Claim 24: wherein the method of claim 23, wherein the vessel comprises individual wells of a well plate, DAVIES Figure 5.; Claim 25: wherein the method of claim 1, further comprising imaging the one or more droplets using a detection device, DAVIES page 23 line 12-32. ; and Claim 26: wherein the method of claim 1, wherein the chamber contains the carrier fluid, DAVIES, Figure 6.
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