DETAILED ACTION
Status of the claims
Claims 1, 4-15, 19 and 21-26 are pending.
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.
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: optical means in claim 19.
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 (fluorescence or luminescence) described in the specification paragraph 0033 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.
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.
3. Claims 4, 8-10 and 12 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 8 recites the limitation "the surfactant" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the surfactant" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 4, 9, 10 and 12 contain the trademark/trade name Pluronic F127 and/or Span85. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe surfactant and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4-10 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollack et al. (US 2013/0288254) in view of McEwen et al. (US 2020/0171501).
Claims 1, 4 and 13. Pollack et al. teach a digital microfluidic device comprising a two-dimensional array of planar electrodes (droplet actuator comprising two dimensional planar electrode array; see Fig and [0084]) wherein the device comprises a population of aqueous droplets containing biomolecules (plurality of sample droplets are disposed and comprised of protein or DNA; [0288][0144] and Fig 22) and a first surfactant within a bulk oil phase and wherein the bulk oil phase contains a second surfactant (both the sample droplet and oil phase is comprised of surfactant [0145]).
Pollack et al. do not teach the first surfactant is a pluronic surfactant. However, McEwen et al. teach electrowetting device for actuating droplets across electrodes [0169] wherein the aqueous droplet include surfactant such Pluronics F127 to prevent undesired adhesion or adsorption of cells and biological molecules to surfaces [0301].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of McEwen et al. teaching to add Pluronics F127 as the first surfactant into the sample droplet comprising DNA or protein of Pollack et al. because it would prevent undesired adhesion or adsorption of cells and biological molecules to surfaces.
Claim 5. Pollack et al. teach the oil is mineral oil, silicone oil, an alkyl-based solvent, or a fluorinated oil [0027].
Claim 6. Pollack et al. teach the oil is dodecamethylpentasiloxane, decane or dodecane [0027].
Claims 7-9. Pollack et al. teach the surfactant is a Span85 [0421] which is a sorbitan ester and non-ionic surfactant.
Claim 10. Combined teachings of Pollack et al. and McEwen et al. teach the first surfactant is Pluronic F127 and the second surfactant is Span85 (see rejection of claims 1 and 7-9).
Claim 14. Pollack et al. teach the droplets are moved, split or combined using a subset of the electrodes on the device [0026].
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pollack et al. and McEwen et al. as applied to claim 10 above, and further in view of Chiu et al. (US 2005/0048581).
Claim 11. Pollack et al. in view of McEwen et al. teach oil is silicon oil [0027] but do not teach oil is octamethylcyclotetrasiloxane (CTS), decamethyltetrasiloxane (DMTS) or dodecamethylpentasiloxane. However, Chiu et al. teach silicon oils are low viscosity to high viscosity organosiloxane such as octamethylcyclotetrasiloxane or dodecamethylpentasiloxane used as immiscible phase with a oxane droplets comprising biological component [0078][0074][0079].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Chiu et al. teaching to use dodecamethylpentasiloxane as the choice of silicon oil in the Pollack et al. digital microfluid device because selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07)
Claim 12. Pollack et al. in view of Chiu et al. teach Span85 in dodecamethylpentasiloxane (see rejection of claim 11 and [0421]). McEwen et al. teach 0.1% to 0.5% w/w Pluronic F127 [0301]. Pollack et al. teach concentration of surfactant in filler fluid is selected for performance with reagents used in template preparation protocol [0025]. Pollack et al. in view of McEwen et al. do not explicitly teach 0.05% w/w Pluronic F127 and 0.1% span85. However, discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. (see MPEP § 2144.05, II. B).
Claim(s) 15, 19 and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (RSC Adv., 2020, 10, 26972-26981) in view of Pollack et al. (US 2013/0288254) and McEwen et al. (US 2020/0171501).
Claim 15. Liu et al. teach method for the cell-free expression of peptides or proteins in a digital microfluidic device (method of cell-free protein on a digital microfluidic device comprising two-dimensional array of electrodes; see section 2.3 and Fig. 1) wherein the method comprises one or more droplets containing a nucleic acid template and a cell-free system having components for protein expression in an oil- filled environment, and moving said droplets using electrowetting-on-dielectric (EWoD) (plurality of droplets comprised of nucleic acid template and protein expression components disposed over oil and moving droplets using electrowetting; see sections 2.3 and 2.4 and Fig 1),
Liu et al. do not teach droplets contain a first surfactant such as pluronic surfactant and the oil contains a second surfactant.
However, Pollack et al. teach droplet actuator comprising two dimensional planar electrode array; see Fig and [0084]) comprising plurality of sample droplets disposed comprised of protein or DNA; [0288][0144] and Fig 22 and both the sample droplet and oil phase are comprised of surfactant to prevent contact between sample droplet and hydrophobic surface, thereby preventing contamination [0145][0143].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Pollack et al. teaching to add surfactant to both sample aqueous droplet and oil of Liu et al. to prevent undesired adhesion or adsorption of droplets comprising nucleic acid template and protein expression components to surfaces.
Liu et al. and Pollack et al. do not teach the droplets contain a pluronic surfactant. However, McEwen et al. teach electrowetting device for actuating droplets across electrodes [0169] wherein the aqueous droplet include surfactant such Pluronics F127 to prevent undesired adhesion or adsorption of cells and biological molecules to surfaces [0301].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of McEwen et al. teaching to add Pluronics F127 as the surfactant into the sample droplet comprising DNA or protein of Liu et al. because it would prevent undesired adhesion or adsorption of cells and biological molecules to surfaces.
Claim 19. Modified Liu et al. teach merging a plurality of first droplets containing a nucleic acid template with a plurality of second droplets containing a cell-free system having the components for protein expression to form multiple combined droplets capable of cell-free protein synthesis (merging droplets comprising nucleic acid template and protein expression; see Fig 3), wherein the droplets contain a pluronic surfactant (see rejection of claim 15), and detecting the expressed proteins by optical means (fluorescence is used to detect the expressed proteins; see Fig 5).
Claim 21. Liu et al. teach method for cell-free expression of proteins in digital microfluidic device see section 2.3 and Fig. 1) wherein the method comprises : taking plurality of droplets having different nucleic acid template and components for protein expression (see sections 2.3 and 2.4 and Fig 1) and combining droplets and mixing the droplets to enable protein expression and detecting via fluorescence the expression of proteins (see Fig 5)
Liu et al. do not teach droplets contain a first surfactant such as pluronic surfactant and the oil contains a second surfactant.
However, Pollack et al. teach droplet actuator comprising two dimensional planar electrode array; see Fig and [0084]) comprising plurality of sample droplets disposed comprised of protein or DNA; [0288][0144] and Fig 22 and both the sample droplet and oil phase are comprised of surfactant to prevent contact between sample droplet and hydrophobic surface, thereby preventing contamination [0145][0143].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Pollack et al. teaching to add surfactant to both sample aqueous droplet and oil of Liu et al. to prevent undesired adhesion or adsorption of droplets comprising nucleic acid template and protein expression components to surfaces.
Liu et al. and Pollack et al. do not teach the droplets contain a pluronic surfactant. However, McEwen et al. teach electrowetting device for actuating droplets across electrodes [0169] wherein the aqueous droplet include surfactant such Pluronics F127 to prevent undesired adhesion or adsorption of cells and biological molecules to surfaces [0301].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of McEwen et al. teaching to add Pluronics F127 as the surfactant into the sample droplet comprising DNA or protein of Liu et al. because it would prevent undesired adhesion or adsorption of cells and biological molecules to surfaces.
Claim 22. Combined teachings of Liu et al., Pollack et al. and McEwen et al. teach first surfactant is Pluronic F127 (see rejection of claim 21) and the second surfactant is Span85 (see Pollack [0421]).
Claim 23. Liu et al. teach a kit for preparing a plurality of peptide or proteins comprising a digital microfluidic device (see section 2.3); a reagent source to generate a plurality of droplets containing a cell-free system having the components for protein expression (plurality of droplets comprised of nucleic acid template and protein expression; see Fig. 1); and an oil selected from optionally mineral oil, silicone oil, an alkyl-based solvent such as decane or dodecane or a fluorinated oil or a mix thereof (silicon oil; see section 2.4).
Liu et al. do not teach droplets contain a first surfactant such as pluronic surfactant and the oil contains a second surfactant.
However, Pollack et al. teach droplet actuator comprising two dimensional planar electrode array; see Fig and [0084]) comprising plurality of sample droplets disposed comprised of protein or DNA; [0288][0144] and Fig 22 and both the sample droplet and oil phase are comprised of surfactant to prevent contact between sample droplet and hydrophobic surface, thereby preventing contamination [0145][0143].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Pollack et al. teaching to add surfactant to both sample aqueous droplet and oil of Liu et al. to prevent undesired adhesion or adsorption of droplets comprising nucleic acid template and protein expression components to surfaces.
Liu et al. and Pollack et al. do not teach the droplets contain a pluronic surfactant. However, McEwen et al. teach electrowetting device for actuating droplets across electrodes [0169] wherein the aqueous droplet include surfactant such Pluronics F127 to prevent undesired adhesion or adsorption of cells and biological molecules to surfaces [0301].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of McEwen et al. teaching to add Pluronics F127 as the surfactant into the sample droplet comprising DNA or protein of Liu et al. because it would prevent undesired adhesion or adsorption of cells and biological molecules to surfaces.
Claim 24. Liu et al. teach the cell free system includes ribosomes, enzymes, initiation factors, nucleotide monomers, amino acid monomers, metal ions and energy sources (see Fig 5).
Claim 25. Combined teachings of Liu et al., Pollack et al. and McEwen et al. teach first surfactant is Pluronic F127 (see rejection of claim 21) and the second surfactant is Span85 (see Pollack [0421]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al., Pollack et al. and McEwen et al. as applied to claim 25 above, and further in view of Chiu et al. (US 2005/0048581).
Claim 26. Liu et al. teach silicon oil (see section 2.4) but do not teach oil is octamethylcyclotetrasiloxane (CTS), decamethyltetrasiloxane (DMTS) or dodecamethylpentasiloxane. However, Chiu et al. teach silicon oils are low viscosity to high viscosity organosiloxane such as octamethylcyclotetrasiloxane or dodecamethylpentasiloxane used as immiscible phase with a oxane droplets comprising biological component [0078][0074][0079].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Chiu et al. teaching to use dodecamethylpentasiloxane as the choice of silicon oil in the Liu et al. digital microfluid device because selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art (see MPEP § 2144.07).
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
Prosecution Insights