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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a flow-aligning structure for aligning the flow of the spacing fluid” as in Claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“a series of rows of channels in the direction of flow” as in Fig. 6 and para. [0018] of Applicant’s instant pre-grant publication US 2023/0158502 A1...and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-18 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.
Claim 1 recites the limitation "the direction of flow". There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to amend the claim to recite “a direction of flow”. By this, Claims 2-18 are further rejected for their dependence on Claim 1.
Claim 8 recites “wherein the second inlet comprises a grid across the main channel” wherein, given that a grid is defined as “a network of uniformly spaced lines as for locating points” (Merriam-Webster), it is unclear how the singular second inlet comprises a plurality of spaced apart elements. Applicant may instead intend a plurality of second inlets by reciting “wherein the second inlet comprises a plurality of second inlets arranged as a grid across the main channel”.
Claim 9 recites the limitation "the flow of the spacing fluid". There is insufficient antecedent basis for this limitation in the claim. Applicant may wish to amend the claim to recite “a flow of the spacing fluid”.
Claim 11 recites “wherein the first inlet is configured to introduce droplets into the main channel from outside a plane of the microfluidic structure” wherein it is unclear what is required by “outside a plane” of the device given that the device “a microfluidic structure” as recited by Claim 1 recites the inlet as a positive element of the microfluidic structure, wherein it is thus unclear what is intended by “outside a plane” of the device, interpreted herein as outside the device itself, and thus contradicts the position of the inlet as being a part of the device itself as in claim 1.
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.
Claims 1-8, 10-13, 15, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makarewicz et al. (US 2011/0311978 A1), hereinafter “Makarewicz”.
Regarding Claim 1, Makarewicz teaches a microfluidic structure for spacing out droplets, the structure comprising:
a main channel 838 for guiding droplets 784 in a spacing fluid 846; a first inlet (the connection with the channel attached to sample pump 808) for introducing droplets 784 into the main channel 838; and a second inlet (the connection with dilution pump 810) for introducing a spacing fluid 846 into the main channel 838 (Fig. 17.),
wherein a cross-sectional area of the main channel 838 decreases in the direction of flow starting from the first inlet (See Fig. 17, which shows the main channel 838 as having a reducing cross-sectional area as it approaches the separation region 842. Further note that “direction of flow” is related to a process of flowing not afforded patentable weight in a device claim.), as in Claim 1.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above further comprising a side channel opening into the main channel 838 at the first inlet (See Fig. 17 which shows a side channel connected to the sample pump 808, and to the main channel 838 via the first inlet.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 2 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein at the first inlet, the side channel is angled between 30 degrees and 90 degrees with respect to the main channel (Fig. 17 shows the side channel connected to the main channel 838 at a 90-degree angle.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 2 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein the first inlet is arranged on a first side of the main channel 838 (Fig. 17),
and wherein the main channel 838 comprises a droplet spacing region in which the first side of the main channel is straight and a second side of the main channel 838 opposite the first side converges towards the first side of the main channel 838 (Fig. 17 shows the main channel 838 having the claimed features of a straight region and a converging region toward the inlet side of the channel.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein the second inlet is upstream from the first inlet (As seen through Fig. 17, in terms of the flow of spacing fluid 846, the second inlet is upstream from the first inlet. Further, the device commensurately immerses droplets in spacing fluid prior to active spacing and analysis of the droplets.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above further comprising an outlet channel 844 from the main channel 838, wherein a spacing between droplets in the main channel 838 increases as the droplets flow through the main channel 838 into the outlet channel 844 (Fig. 17 shows that as droplets flow from the main channel 383 to the outlet channel 844, the droplets become spaced apart via flow of the spacer fluid 846.), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above further comprising:
a dilution chamber (The junction between the oil channels as shown in Fig. 23.);
a droplet inlet for introducing droplets into the dilution chamber (Fig. 23 shows droplets entering the dilution chamber via an inlet.);
a carrier fluid inlet for introducing a flow of carrier fluid into the dilution chamber (Fig. 23 shows carrier oil fluid inlets for delivering fluid from the oil channels to the dilution chamber at their junction.);
and a dilution chamber outlet (After passing through the oil stream, the droplets pass through into the main channel, which has a further straight part and tapered part.),
wherein the first inlet is configured to receive droplets from the dilution chamber outlet (Fig. 23 shows the main channel as a separate straight and tapered region, thereby showing the first inlet as at the oil stream junction.),
and wherein the dilution chamber is configured such that droplets flow through the dilution chamber outlet arranged one behind each other (As seen through Fig. 23, the oil streams of the dilution chamber serve to align droplets one after the other, as droplets are compressed by the converging streams. As such, the outlet is arranged to receive droplets flowing one after the other.),
as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, as best understood by the claim, Makarewicz teaches the microfluidic structure discussed above wherein the second inlet comprises a grid across the main channel (As seen through Fig. 17, the second inlet provides a spacing grid for droplets across the main channel.), as in Claim 8.
Regarding Claim 10, the prior art meets the limitations of Claim 8 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein the main channel has a funnel shape (Fig. 17 shows the main channel 838 having a funnel shape as it tapers toward the separation region 842.), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 8 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above further comprising:
a spacing chamber wherein the main channel is inside the spacing chamber, and wherein the first inlet is configured to introduce droplets into the main channel from outside a plane of the microfluidic structure (As best understood by the requirements of the instant claim, Fig. 17 shows droplets 784 as being introduced from a plane outside the microfluidic structure.); and a third inlet configured to introduce a flow of spacing fluid into the spacing chamber (See Fig. 13 which shows a main channel 512 surrounded by a spacing fluid channel/chamber 518 for spacing droplets. Note that the spacing fluid channel/chamber 518 must necessarily comprise a third inlet for supplying said spacing fluid.), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 8 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above further comprising:
an outlet channel from the main channel; and a first funnel structure with a funnel opening, wherein the funnel opening has a first region configured to receive the spacer fluid and a second region configured to receive droplets from the outlet channel, and wherein the funnel structure has a funnel outlet in which, in use, droplets are spaced out further than in the output channel (See Fig. 23 which shows first and second funnel structures used to sequentially space out droplets across a first region and a second region, said droplets being delivered from an outlet channel from the main channel. Note that the outlet channel begins at the junction 1016.), as in Claim 12.
Regarding Claim 13, the prior art meets the limitations of Claim 12 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein the second region is a central region of the funnel opening and the first region lies to either side of the second region (See Fig. 23 which shows the commensurately arranged funnel structures, and thereby demonstrates the claimed regions. Further note that as claimed, these regions do not relate to any specific structure but are rather mere designations of space wherein one skilled in the art could recognize many regions as being such first and second regions as claimed.), as in Claim 13.
Regarding Claim 15, the prior art meets the limitations of Claim 12 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein the funnel outlet comprises side openings configured to introduce additional spacing fluid into the funnel structure (See Fig. 23 which shows oil channels for adding additional spacing oil fluid through side openings of the funnel structure.), as in Claim 15.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as discussed above. Further, Makarewicz teaches the microfluidic structure discussed above wherein the main channel has a curved shape downstream of the first inlet (Fig. 17 shows the main channel 838 as having a curved shape downstream from the first inlet, at the region circled by the fluorescence detector 802 in the figure; and wherein the channel shape itself curves to become narrower downstream of the first inlet.), as in Claim 17.
Regarding Claim 19, Makarewicz teaches a method of spacing out droplets in a microfluidic structure, the method comprising:
providing a main channel 838 for guiding droplets in a spacing fluid (Fig. 17);
providing a first inlet for introducing droplets in the main channel (The connection with the channel attached to sample pump 808.);
providing a second inlet for introducing a spacing fluid into the main channel (Fig. 17: The connection with dilution pump 810.),
wherein a cross-sectional area of the main channel decreases downstream from the first inlet and the second inlet (See Fig. 17, which shows the main channel 838 as having a reducing cross-sectional area as it approaches the separation region 842.);
the method further comprising:
introducing droplets into the main channel from the first inlet; introducing a spacing fluid into the main channel from the second inlet; and guiding the droplets and the spacing fluid through the main channel having a decreasing cross-sectional area to increase spacing between adjacent droplets (See Fig. 17 and paras. [0137-0141]: “The droplets may enter a confluence region or separation region 842 of spacer 839, optionally in single file, as they emerge from inlet channel 838A. The confluence region may be formed at a junction of the inlet channel and at least one dilution channel 844. The dilution channel may supply a stream of dilution fluid 846 driven through confluence region 842, as droplets and carrier fluid/continuous phase 848 enter the confluence region as a stream from inlet channel 838A. The dilution fluid may be miscible with the carrier fluid and serves to locally dilute the emulsion in which the droplets are disposed, thereby increasing the average distance between droplets.”.), as in Claim 19.
Regarding Claim 20, the prior art meets the limitations of Claim 19 as discussed above. Further, Makarewicz teaches the method discussed above comprising:
providing a side channel opening into the main channel at the first inlet (See Fig. 17 which shows a side channel connected to the sample pump 808, and to the main channel 838 via the first inlet.); and
the method further comprising:
guiding a spacing fluid through the main channel of the microfluidic structure from the second inlet; and introducing droplets into the main channel from the side channel opening (See Fig. 17 and paras. [0137-0141] as discussed above.), as in Claim 20.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Makarewicz in view of Solomon et al. (WO 2019/094775 A1), hereinafter “Solomon”. Makarewicz has been discussed above.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Makarewicz does not specifically teach the microfluidic structure discussed above further comprising a flow-aligning structure for aligning the flow of the spacing fluid into the second inlet, wherein the flow- aligning structure is located upstream of the second inlet, as in Claim 9.
Note the Claim Interpretation section above which defines Applicant’s “flow-aligning structure for aligning” as “a series of rows of channels in the direction of flow” as in Fig. 6 and para. [0018] of Applicant’s instant pre-grant publication US 2023/0158502 A1...and equivalents thereof.
However, Solomon teaches a respective microfluidic device for droplet manipulation comprising a series of channels 41 and 43 which converge into a convergent inlet funnel chamber 42 so as to allow for droplet merging (Fig. 1 and Summary of the Disclosure) wherein this arrangement allows for assays to be performed by merging sample and reagent droplets, thereby reducing the amount of reagent needed by conventional reagent-stream systems, as well as enabling numerous reagent-based assays. Further note that the flow aligning structure 41/42/43 is located upstream of the inlet end 62.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Makarewicz so as to include a flow-aligning structure for aligning the flow of the spacing fluid into the second inlet, wherein the flow-aligning structure is located upstream of the second inlet, such as suggested by Solomon, so as to allow for assays to be performed by merging sample and reagent droplets, thereby reducing the amount of reagent needed by conventional reagent-stream systems, as well as enabling numerous reagent-based assays; and would have a reasonable expectation of success therein.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Makarewicz. Makarewicz has been discussed above.
Regarding Claim 14, the prior art meets the limitations of Claim 12 as discussed above. Further, Makarewicz does not specifically teach the microfluidic structure discussed above further comprising a funnel channel, wherein the funnel structure is inside the funnel channel, and wherein a cross- sectional area of the funnel channel decreases downstream from the funnel opening, as in Claim 14.
However, given that Makarewicz teaches a sheath fluid channel for surrounding droplets deposited therein within a sheath of carrier fluid (Fig. 13), and that the funnel structure of Fig. 23 is merely a differently shaped nozzle to that of the input channel 512 of Fig. 13, one skilled in the art would find it obvious to substitute the funnel structure as being within the sheath fluid channel 518 of Fig. 13 so as to achieve both the benefits of sorting and spacing of the funnel structure, as well as the benefits of a sheath fluid of the sheath channel structure; and would have a reasonable expectation of success therein.
Regarding Claim 16, the prior art meets the limitations of Claim 12 as discussed above. Further, Makarewicz does not specifically teach the microfluidic structure discussed above further comprising a second funnel structure wherein a second region of the second funnel structure is configured to receive droplets from the funnel outlet of the first funnel structure, as in Claim 16.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, one of ordinary skill in the art would find it obvious to provide an additional funnel structure so as to further achieve a desired spacing of droplets and to further align the droplets as one after another along a single axis.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Makarewicz in view of Smith et al. (US 2016/0252446 A1), hereinafter “Smith”. Makarewicz has been discussed above.
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, Makarewicz does not specifically teach the microfluidic structure discussed above wherein the spacing fluid and/or a carrier fluid containing the droplets is an oil comprising a fluorosurfactant, as in Claim 18.
However, Smith teaches a respective droplet handling apparatus wherein droplets are suspended in an oil phase, wherein the oil phase comprises a fluorosurfactant, thereby minimizing the refractive index of the carrier oil, thereby improving the accuracy and precision of beams of light entering and exiting the carrier oil, reducing error due to refraction causing unwanted light dynamics ([0037]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Makarewicz wherein the spacing fluid and/or a carrier fluid containing the droplets is an oil comprising a fluorosurfactant, such as suggested by Smith, so as to minimize the refractive index of the carrier oil, thereby improving the accuracy and precision of beams of light entering and exiting the carrier oil, reducing error due to refraction causing unwanted light dynamics; and would have a reasonable expectation of success therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JOSEPH KASS whose telephone number is (703) 756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (571) 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798