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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-7, drawn to a droplet microfluidic platform.
Group II, claim(s) 8-20, drawn to a method of making a droplet microfluidic platform.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of the plurality of layers, the droplet generator, a droplet incubation chamber, a valve, a droplet detection mechanism and a sorting mechanism, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2020/0360929 A1 (hereafter ‘929). ‘929 discloses a chip with multiple layers (Fig. 2; layers 203-208; [0036]), droplet generators (generators 132; Fig. 1; [0029]), an incubation chamber (chamber 121; Fig. 1; [0029]), valves (valves 116 & 117; Fig. 1; [0030]), a detector (detector 151; Fig. 1; [0030]) and a sorter (mechanism for sorting 262; Fig. 2; [0041]). Therefore, the claimed inventions do not make a contribution over the prior art.
During a telephone conversation with Applicant’s representative on 04/22/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/11/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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: the droplet mechanism, the sorting mechanism and the functional components in claim 1.
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.
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.
Double Patenting
Claims 1-4 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent Application No. 16/963,324 (the 16/963.324 application has been allowed, but has not proceeded to issue and therefore, does not currently have a Patent Number; will be referred to as ‘324 for this rejection). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘324 discloses the following limitations as discussed in the table below:
18/281,514
16,963,324 (‘324)
(Original) A droplet microfluidic platform, including: a plurality of substrate layers into which various functional components are fabricated into, the functional components including at least one co-flow based droplet generator for continuous generation of cell or reagent- encapsulated droplets; at least one droplet incubation chamber for incubation of the cell or reagent-encapsulated droplets; at least one valve for trapping or releasing the droplets; a droplet detection mechanism; a sorting mechanism for sorting the droplets based on the detection result, and at least one droplet passage to interconnect the functional components; wherein the droplet microfluidic platform is capable of continuous or semi-continuous on-chip operation of droplets in a first-in first-out manner.
7. (Original) The droplet microfluidic platform of claim 1, wherein the droplet microfluidic platform comprises a sandwich multiplexed design, and wherein at least two droplet incubation chambers are in the same horizontal plane.
1. (Previously Presented) A droplet microfluidic platform comprising: a plurality of substrate layers, and a plurality of functional components, wherein the plurality of substrate layers is configured such that, when the plurality of substrate layers are stacked, one or more of the plurality of functional components is collectively formed within two or more of the plurality of substrate layers, the functional components comprising: at least one droplet generator for continuous generation of cell- encapsulated droplets; at least one merging mechanism configured to merge the cell- encapsulated droplets; at least two incubation chambers for on-chip incubation of the cell- encapsulated droplets; at least a first valve for trapping or releasing the cell-encapsulated droplets; a detection mechanism; and a second valve configured to direct the cell-encapsulated droplets from a first of the at least two incubation chambers to a second of the at least two incubation chambers; at least one fluid passage to connect the functional components; wherein the platform is capable of continuous/semi-continuous on- chip operation in a first-in first-out manner, wherein the platform comprises a sandwich design, wherein the at least two incubation chambers are in a same horizontal plane, wherein the at least two incubation chambers are configured such that the cell-encapsulated droplets move out of one of the at least two incubation chambers and travels vertically from a higher substrate layer of the platform to a lower layer of the platform to enter into another incubation chamber of the at least two incubation chambers, wherein the platform is configured such that the cell-encapsulated droplets travel vertically from a lower layer of the platform to a higher layer of the platform.
2. (Original) The droplet microfluidic platform of claim 1, further comprising a functional component for on-chip recovery of sorted droplets.
2. (Currently Amended) The droplet microfluidic platform of claim 1, further comprising a chamber configured to provide for on-chip recovery of the cell- encapsulated droplets.
3. (Original) The droplet microfluidic platform of claim 1, wherein the droplet detection mechanism is configured to detect at least one of optical, dielectric, conductivity, or vibrational spectroscopy signals.
3. (Previously Presented) The droplet microfluidic platform of claim 1, wherein the detection mechanism is configured to detect an optical, dielectric, conductivity, or vibrational spectroscopy signal.
4. (Original) The droplet microfluidic platform of claim 1, wherein the substrate layers comprises 5 to 20 layers.
4. (Original) The droplet microfluidic platform of claim 1, wherein the substrate layers comprises about 9 to about 20 polydimethylsiloxane layers.
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 5 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.
It is unclear, in light of the specification, how the platform can be made with a plurality of substrate layers and be made as a single injection molded piece. This seems to be two different processes that are not normally combined in a single process and the specification does not provide an example as to how this could work. For purposes of examination, this will be interpreted as each layer is a single injection molded piece.
Clarification and appropriate corrective action is required.
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 1-7 are rejected under 35 U.S.C. 102a1 as being anticipated by Guzman et al. (WO 2019/148013 A2 – hereafter ‘013).
It should be noted that while the ‘013 reference has a inventor in common with the instant application, the applied as art under 35 U.S.C. 102a1 and has a publication date more than a year before the earliest effective filing date of the instant application.
‘013 discloses a integrated on-chip ultra-high-throughput droplet microfluidic screening platform (Abstract) that includes the following limitations for claim 1:
“A droplet microfluidic platform”: ‘013 discloses a microfluidic platform (platform 100; Fig. 1) that processes droplets ([0028]; [0029]).
“a plurality of substrate layers into which various functional components are fabricated into”: ‘013 discloses that the platform has a plurality of substrate layers (201-208; Fig. 2; [0036]) where the chambers and functional components of the chip are fabricated.
“the functional components including”: ‘929 discloses the following functional components.
“at least one co-flow based droplet generator for continuous generation of cell or reagent-encapsulated droplets”: ‘013 discloses droplet generators (generators 132 and 134; Fig. 1; [0029]) that are used for the continuous generation of cell-encapsulated droplets.
“at least one droplet incubation chamber for incubation of the cell or reagent-encapsulated droplets”: ‘013 discloses a cell incubation chamber (chamber 121) for the incubation of the cell-encapsulated droplets ([0029]).
“at least one valve for trapping or releasing the droplets”: ‘013 discloses two valves (valves 116 and 117; Fig. 1; [0030]) that are used for trapping and releasing the droplets.
“a droplet detection mechanism”: ‘013 discloses a detection mechanism (mechanism 151; Fig. 1; [0030])).
“a sorting mechanism for sorting the droplets based on the detection result”: ‘013 discloses a sorting mechanism (mechanism 262; Fig. 2; [0041]) that sorts the droplets based on the detection result.
“at least one droplet passage to interconnect the functional components”: ‘013 discloses connection channels (Fig. 1; Fig. 2; [0036]) that connects the various components within the chip.
“wherein the droplet microfluidic platform is capable of continuous or semi-continuous on-chip operation of droplets in a first-in first-out manner.”: The platform of ‘013 is fully capable of continuous or semi-continuous operation ([0006]).
For claim 2, ‘013 discloses a recovery chamber ([0041]) that is being interpreted as the recovery component of the instant application.
For claim 3, ‘013 discloses that the detection mechanism (mechanism 271; Fig. 2) can detect optical, dielectric, conductivity or vibrational spectroscopy ([0040]).
For claim 4, ‘013 discloses that there can be 8 layers (Fig. 2; [0036]) and further discloses about 9 to 20 layers for the chip ([0007]).
For claim 5, ‘013 discloses that the chip can be manufactured through injection molding ([0027]).
For claim 6, ‘013 discloses that platform includes multiple injection molded pieces, stacked up on each other ([0036]; Fig. 2; [0007]; [0008]; [0027]).
For claim 7, ‘013 discloses that the components can be multiplexed ([0022]; [0035]; [0050]) where two chambers are in the same horizontal plane (Fig. 2; claim 7).
Therefore, ‘013 meets the limitations of claim 1-7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Strey et al. (US 2011/0059556 A1) discloses a device to concentrate and extract analytes using functionalized particles in a droplet microfluidic device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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