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 08 NOVEMBER 2024 is acknowledged and considered. In the claim set, Claims 1-19 are presented and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08 MAY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities: In claim 6, in the preamble, it recites ‘any of claim 1’; which should be changed to ‘of claim 1’. 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.
Claims 2, 8, 9 and 11 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.
Regarding claim 8, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
12. Regarding claim 8, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 11, the phrase "preferably", "more preferably" and "particularly" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Dependent claims follow the same reasoning.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by STREY, US Publication No. 2011/059556 A1, submitted on the Information Disclosure Statement, US Patent Applications Publications Cite No. 1.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference STREY discloses a microfluidic device, abstract, microfluidic device, Claim 1, [0006], comprising:
- an inlet channel having an inlet configured to be operatively connected with a droplet source wherein the inlet channel has a width w, and height h, Figure 6, [0024, 0026, 0027]; and - an outlet channel with at least one outlet channel branch operatively connected with the inlet channel at a passage point, Figure 6 and 9, [0024, 0027], said outlet channel having a width wo, wherein the width wo of the at least one outlet channel branch and the height hi and the width wi, of the inlet channel satisfy a geometrical condition of
z
=
2
w
o
/
(
2
h
i
+
2
w
i
)
, [0027].
Additional Disclosures Included are: Claim 2: wherein the microfluidic device of claim 1, wherein an aspect ratio is defined as
λ
=
h
o
/
w
o
said aspect ratio is
λ
>1, wherein particularly said aspect ratio is 1<
λ
<10, particularly 2<
λ
<5, and/or wherein a width ratio is defined as
φ
=
w
i
/
w
o
, said width ratio is
φ
>1, wherein particularly said width ratio is 1<
φ
<10, particularly 2<
φ
<5, Figure 9, [0027].; Claim 3: wherein the microfluidic device of claim 1, wherein two outlet channel branches are provided which extend perpendicularly with respect to said inlet channel , abstract, T junctions, [0074].; Claim 4: wherein the microfluidic device of claim 3, wherein the passage point corresponds to an intersection which acts as a droplet-splitting junction for droplets passing the passage point and which is located in the center of the outlet channel, thereby separating the outlet channel into two equal outlet channel branches, abstract, T junctions, [0056, 0074].; Claim 6: wherein the microfluidic device of Claim 18: wherein the microfluidic device of any of the claim 2, wherein one outlet channel branch is provided, wherein the outlet channel branch is running coaxially to the inlet channel, Figure 6.
Applicant’s invention is directed towards a microfluidic system.
Regarding Claim 7, the reference STREY discloses microfluidic system (1) comprising the microfluidic device of claim 1, [0024], “chip” (a microfluidic device”), and also see rejection of Claim 1 above.
Additional Disclosures Included are: Claim 8: wherein the microfluidic system according to claim 7, operatively connected with a droplet source, wherein the droplet source provides parent droplets of a sample fluid floating in a carrier fluid, wherein the sample fluid and the carrier fluid are non-mixable, wherein particularly the sample fluid is a watery solution and the carrier fluid an oil or wherein the sample fluid is an oil and the carrier fluid is a watery solution, wherein particularly the droplet source comprises a droplet generating unit operatively connected with a reservoir , e.g. comprising deformable samples such as biological cells, micro-organisms, microparticles, pollens, and deformable beads. and with the inlet of the inlet channel, Figure 10, [0014-0015, 0028, 0041-0044]. ; Claim 9: wherein the system of claim 7, further comprising:- an operatively connected pressure source configured to apply a pressure inside the microfluidic device to move a parent droplet from the droplet source towards the microfluidic device, and/or - merging channels connected with the outlets of the outlet channel branches to merge the droplet flow through the outlets of the outlet channel branches into a merging point, wherein the merged droplet flow is particularly fed to a sorting module for sorting the droplets by size to filter out smaller sample droplets generated by the microfluidic device from larger child droplets, [0063-0065].; Claim 10: wherein the system of claim 7, comprising a separation module, where the separation module comprises:- a receiving inlet being in direct communication with an outlet opening of the at least one outlet channel branch to receive sample droplets being droplets including a deformable sample and sampleless droplets which are empty droplets, with a constant velocity or flow rate; - a separation chamber directly connected to the receiving inlet and having an asymmetric shape of a cross-section between two walls being in direct communication with the receiving inlet with respect to the axial direction of the at least one outlet channel branch; - a separation element configured to separate sample droplets and sampleless droplets travelling on different trajectories, [0054-0056].; Claim 11: wherein the system of claim 10, wherein a first one of the two walls of the separation chamber extends with a first angle of between 0° and 60°, particularly between 0° and 450, more preferably between 0° and 30°, with respect to an axial direction of the at least on outlet channel branch at the outlet opening and an opposing second one of the two walls extends with a second angle with respect to an axial direction of the at least on outlet channel branch at the outlet opening wherein the second angle is larger than the first angle, particularly between 60° and 180°,more preferably between 70° and 120°, [0008, 0056].; Claim 12: wherein the system of claim 10, wherein the separation element is formed as a separation structure with separation walls located between the trajectories of the sample droplets and the child, Figure 6, 8-10, [0008, 0056]. ; Claim 15: wherein the method of claim 11, wherein the parent droplet (P) contains a deformable sample which has a cross-section that corresponds to a critical dimension of the outlet channel or has a cross-section of between 90 % and 200% of the critical dimension of the outlet channel, wherein the sample is compressible under exertion of an external force to a cross-section across the critical dimension of the outlet channel which has a size of 40 to 95% of the cross-section of the non- compressed sample, [0026, 0027, 0044, 0052, 0063-0065].; and Claim 19: wherein the method for using the system of claim 7, wherein - for the production of sample droplets (S) as droplets containing a deformable sample included in a parent droplet (P) and deriving from the breakup of a parent droplet (P) into at least one child droplet (C) in at least one outlet channel branch downstream the passage point, or for the production of droplets from a parent droplet (P) and deriving from the breakup of the parent droplet (P) into at least one child droplet (C) in at least one outlet channel branch downstream the passage point, Figure 6.
Applicant’s invention is directed towards a method .
Regarding Claim 13, the STREY reference disclose a method for using the microfluidic device of claim 1, Claim 1 and 19, Figure 6-10, [0024-0028], wherein
- for the production of sample droplets (S) as droplets containing a deformable sample included in a parent droplet (P) and deriving from the breakup of a parent droplet (P) into at least one child droplet (C) in at least one outlet channel branch downstream the passage point, Figure 6, [0024, 0091], production in step 4, lower channel, containing components in step 2- cell lysis and deriving from break up of droplet produced in step 2 and washing buffer in step-3 washing step in outlet channel branch in step 4, separate into lower and upper channels, or
- for the production of droplets from a parent droplet (P) and deriving from the breakup of the parent droplet (P) into at least one child droplet (C) in at least one outlet channel branch downstream the passage point , Figure 6, production of droplet in step 4 lower branch from a parent droplet cell produced at end of step 1 or beginning of step 2 and deriving from breakup of parent into at least one child, beginning to step 4 .
Applicant’s invention is directed towards a method.
Regarding Claim 14, the reference STREY discloses a method for operating the microfluidic device, Figure 6-10, [0024-0028, 0041-0044], according to claim 1, see rejection to Claim 1 above, for producing sample droplets, comprising the step of:
- flowing a parent droplet (P) of a sample fluid in a carrier fluid through the inlet channel to the intersection, Figure 6, [0024, 0091-0094], wherein flow rate, parent droplet length (L), and capillary number (Ca) are selected to promote a central breakup of the droplet thread at the intersection, [0033]; wherein flow rate, parent droplet length (L), and capillary number (Ca) are further selected so that when a deformable sample is included in the parent droplet (P) the central breakup of the droplet thread is delayed so that a breakup occurs in at least one of the outlet channel branches downstream the intersection thereby forming a small sample droplet (S) and at least one larger child droplet (C), [0034, 0044, 0063, 0069, 0070].
Additional Disclosure Included is: Claim 16: wherein the method according to claim 14, wherein the flows of child droplets (C) and of sample droplets (S) from the outlet channel branches are merged and the merged droplets are sorted in size to filter out the sample droplets, [0008, 0044, 0052].
Applicant’s invention is directed towards a method.
Regarding Claim 17, the STREY reference discloses a method for setting up operation of a microfluidic device Figure 6-10, [0024-0028, 0041-0044], according to claim 1, see rejection to Claim 1 above, wherein parent droplets (P) of a sample fluid in a carrier fluid are flown through the inlet channel to the passage point, Figure 6, [0024, 0091-0094], wherein flowrate, parent droplet length, and capillary number (Ca) are selected to promote a breakup of the droplet thread at the passage point, [0033], wherein at least the parent droplet length and capillary number (Ca) are selected by the steps of:
- While flowing parent droplets (P) through the inlet channel , varying both the parent droplet length (L) and the capillary number (Ca) to observe different potential breakup regimes for each combination of droplet length (L) and capillary number (Ca), [0033];
- associating breakup regimes for the combinations of droplet lengths (L) and capillary numbers (Ca) in a mapping thereby forming a transition range separating the combinations of droplet lengths (L) and capillary numbers (Ca) with different breakup regimes, [0033, 0044];
- selecting a parent droplet length (L) and a capillary number (Ca) which is above the transition range by about 10 to 30% of the droplet length (L) associated with the selected capillary number (Ca), [0033, 0044].
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over STREY, US Publication No. 2011/059556 A1, submitted on the Information Disclosure Statement, US Patent Applications Publications Cite No. 1, and further in view of BLAUCH, US Publication No. 2019/0368979 A1, submitted on the Information Disclosure Statement, US Patent Applications Publications Cite No. 2.
Regarding Claim 5, the STREY reference discloses the claimed invention, but is silent in regards to wherein the outlet of each outlet channel branch connects to a widening channel portion with a widening cross-section with an inclination angle of at least one channel wall of between 1 to 30, or wherein the outlet of each outlet channel branch is connected with a channel portion with a step-like widened cross-section which has at least a cross-section of more than 200% of the cross-section of the respective outlet channel branch.
BLAUCH discloses a microfluidic device, abstract, microfluidic device, Figure 1A, [0025], comprising:
- an inlet channel having an inlet configured to be operatively connected with a droplet source wherein the inlet channel has a width w, and height h, Figure 1A, inlet 102, and droplet dispenser, [0025, 0031]; and - an outlet channel with at least one outlet channel branch operatively connected with the inlet channel at a passage point, Figure 1A, inlet 102 connected to outlets 104/106 at point 108, [0025], said outlet channel having a width wo, wherein the width wo of the at least one outlet channel branch and the height hi and the width wi, Figure 1A, 1E, wherein the outlet of each outlet channel branch connects to a widening channel portion with a widening cross-section with an inclination angle of at least one channel wall of between 1 to 30, or wherein the outlet of each outlet channel branch is connected with a channel portion with a step-like widened cross-section which has at least a cross-section of more than 200% of the cross-section of the respective outlet channel branch, Figure 1E, [0036].
36. It would be obvious to one having ordinary skill in the art before the effective filing date to modify STREY with the outlet channel as taught by BLAUCH such that an outlet of each outlet channel branch is connected with a channel portion with a step-like widened cross-section which has at least a cross-section of more than 200% of the cross-section of the respective outlet channel branch so that the flow rate in the channel will be different and controlled, [0036].
Conclusion
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
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