DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of the species “a piezoelectric element or a thermoelectric element” (for the 1st species election requirement) and “using a ligase” (for the 2nd species election requirement) in the reply filed on 6/29/2026 is acknowledged. Since newly added claim 41 suggests that the first printhead, the second printhead, the dispenser, or a combination thereof may comprise both “a plurality of nozzles” and “a piezoelectric element or a thermoelectric element”, the 1st species election requirement is hereby withdrawn. Regarding the 2nd species election requirement, because applicant did not distinctly and specifically point out the supposed error(s) in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Claims 21-41 are currently pending and under examination.
Claim Objections
4. Claim 34 is objected to because of the following informalities:
Claim 34, line 7: “…on the specified site on a substrate using a second printhead” should be changed to “…on the specified site on [[a]] the substrate using a second printhead” for more clarity.
Claim 34, lines 10-11: “dispensing a reaction mixture onto the specified site on the substrate, providing…” should be changed to “dispensing a reaction mixture onto the specified site on the substrate[[,]] and providing…” for more clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claim 31 is rejected 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.
The term “about” in claim 31 (see line 3) is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, would “0 nucleotide” be considered “about 1 nucleotide”? Would “2 nucleotides” be considered “about 1 nucleotide”? How about “3 nucleotides” or “4 nucleotides”?
Claim Rejections - 35 USC § 102
7. 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 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.
8. 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.
9. Claims 21-29, 31-34, 36-39 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peck et al. (US 2008/0085511 A1).
Regarding claims 21-22
Peck et al. teach a system (e.g., a drop dispensing device comprising multiple drop dispensers) for constructing a nucleic acid molecule comprising an identifier, the system comprising: a first printhead (e.g., a first drop dispenser) configured to deposit a first component (e.g., a first nucleotide monomer) of a nucleic acid molecule on a specified site on a substrate, wherein the nucleic acid molecule comprises comprising an identifier; a second printhead (e.g., a second drop dispenser) configured to deposit a second component (e.g., a second nucleotide monomer) of the nucleic acid molecule on the specified site on the substrate; and a dispenser (e.g., the drop dispenser for dispensing activator) configured to deposit a reaction mixture (e.g., the mixture containing activator) onto the specified site on the substrate to link the first component and the second component to construct the nucleic acid molecule, wherein the dispenser comprises a third printhead configured to deposit the reaction mixture on the specified site on the substrate, wherein the nucleic acid molecule represents sequence information (see the whole document, particularly paragraphs [0041]-[0043] for general description of a droplet dispensing device comprising multiple drop dispensers, and paragraph [0075] for a specific example of the droplet dispensing device for synthesizing/constructing a nucleic acid molecule. Paragraph [0042] states that the drop dispenser or dispensing head may be of “a type commonly used in an ink jet type of printer” and certain elements of the dispensing head can be adapted from parts of “a commercially available thermal inkjet print head device”. Note that any sequence segment of a nucleic acid molecule can serve as an identifier.).
Regarding claim 23
The system according to Peck et al., wherein the first printhead, the second printhead, the dispenser, or a combination thereof comprise a plurality of nozzles (see paragraphs [0041]-[0043] and [0075]).
Regarding claim 24
The system of Peck et al. can be used to synthesize/construct any nucleic acid molecule, including a dye-labeled nucleic acid molecule (in which case one of the multiple drop dispensers would be used to deposit a dye-containing monomer). Please note that the nucleic acid molecule is not a structural element of the claimed system.
Regarding claim 25
The system according to Peck et al., wherein the first printhead, the second printhead, or the dispenser comprises a piezoelectric element or a thermoelectric element (see paragraphs [0040]-[0041] and [0106]).
Regarding claim 26
First, the recitation “wherein the reaction mixture comprises a ligase” does not impose any structural limitation on the claimed system which comprises a first printhead, a second printhead and a dispenser but not the recited reaction mixture or nucleic acid molecule. Second, the dispenser (i.e., drop dispenser) in the system of Peck et al. is capable of dispensing any reaction mixture, including a reaction mixture that comprises a ligase.
Regarding claim 27
The system according to Peck et al., wherein the substrate is configured for movement in an x-y plane, a z-direction, or both (see paragraph [0141]).
Regarding claim 28
The system according to Peck et al., further comprising a vision system for aligning the first printhead, the second printhead, the dispenser, or any combination thereof with the substrate (see paragraphs [0069]-[0070] and [0074]-[0078]).
Regarding claim 29
The system according to Peck et al., further comprising a temperature control system, a vacuum device, or both (see paragraphs [0146], [0151] and [0153]).
Regarding claim 31
The system according to Peck et al., wherein the first component, the second component, or both are building blocks (e.g., nucleotide monomer building blocks), and wherein the building blocks comprise 1 nucleotide (see paragraph [0075]).
Regarding claim 32
The system according to Peck et al., wherein the substrate comprises a functionalization pattern (see Figures 1-3 and paragraph [0125]).
Regarding claim 33
The system according to Peck et al., further comprising an alignment unit for aligning the substrate relative to the first printhead, the second printhead, or the dispenser (see paragraphs [0139]-[0141]).
Regarding claim 34
Peck et al. teach a method for constructing a nucleic acid molecule comprising an identifier, the method comprising: depositing a first droplet comprising a first component (e.g., a first nucleotide monomer) of the nucleic acid molecule on a specified site on a substrate using a first printhead (e.g., a first drop dispenser of a drop dispensing device), wherein the nucleic acid molecule comprises an identifier; depositing a second droplet comprising a second component of the nucleic acid molecule on the specified site on the substrate using a second printhead (e.g., a second drop dispenser of the drop dispensing device); and linking the first component and the second component to construct the nucleic acid molecule using a dispenser (e.g., the drop dispenser for dispensing activator), wherein linking is performed by dispensing a reaction mixture (e.g., the mixture containing activator) onto the specified site on the substrate and providing a condition necessary to link the first component and the second component, wherein the nucleic acid molecule represents sequence information (see the whole document, particularly paragraphs [0013]-[0016] for general description of a method for constructing/synthesizing a nucleic acid molecule and paragraphs [0041]-[0043] for general description of a droplet dispensing device comprising multiple drop dispensers used in the method, as well as paragraph [0075] for a specific example for synthesizing/constructing a nucleic acid molecule. Paragraph [0042] states that the drop dispenser or dispensing head may be of “a type commonly used in an ink jet type of printer” and certain elements of the dispensing head can be adapted from parts of “a commercially available thermal inkjet print head device”. Note that any sequence segment of a nucleic acid molecule can serve as an identifier.).
Regarding claim 36
The method according to Peck et al., further comprising incubating the specified site of the substrate (see paragraphs [0075]-[0076]).
Regarding claim 37
The method according to Peck et al., further comprising subjecting the specified site of the substrate to a given temperature, humidity, pressure, or gas content (see paragraph [0153]).
Regarding claim 38
The method according to Peck et al., further comprising capturing the nucleic acid molecule on the substrate (see paragraphs [0016] and [0075]).
Regarding claim 39
The method according to Peck et al., further comprising performing quality control of the nucleic acid molecule (e.g., performing quality control via 1) “control[ling] the movement of the mechanism and the activation of the nozzles of the drop dispensing device in a protocol such that, for at least one of the biopolymer forming reagents and for at least a portion of the method, drops of reagents are dispensed to feature locations from at least two different nozzles for each reagent in at least two different passes of a drop dispensing device” (see paragraphs [0019] and [0138]) and 2) “precisely controlling the position of the drop-dispensing device with respect to a substrate surface” (see paragraph [0140])).
Regarding claim 41
The system according to Peck et al., wherein: the first printhead, the second printhead, the dispenser, or a combination thereof comprise a plurality of nozzles (see paragraphs [0041]-[0043] and [0075]); and the first printhead, the second printhead, or the dispenser comprises a piezoelectric element or a thermoelectric element (see paragraphs [0040]-[0041] and [0106]).
Claim Rejections - 35 USC § 103
10. 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 of this title, 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.
11. 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.
12. Claims 30, 35 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Peck et al. (US 2008/0085511 A1) as applied to claims 21-29, 31-34, 36-39 and 41 above, and further in view of Jacobson et al. (US 2011/0172127 A1).
Peck et al. teach the system/method of claims 21-29, 31-34, 36-39 and 41 as discussed above. Although the system of Peck et al. is configured to be used (or capable of being used) in nucleic acid assembly where nucleic acid amplification via thermal cycling and assembly via ligation would be involved, Peck et al. do not specifically disclose such applications.
However, Jacobson et al. teach that such inkjet-based drop dispensing devices may be used in methods for assembling a polynucleotide (i.e., nucleic acid) having a predefined sequence from a plurality of different oligonucleotides, which involve performing nucleic acid amplification via thermal cycling, linking different oligonucleotides (dispensed by different drop dispensers) via ligation using a ligase, and pooling different nucleic acid molecules for subsequent assembly (see the whole document, e.g., paragraphs [0004]-[0016] and Figures 1-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to use the inkjet-based drop dispensing device of Peck et al. in a method for assembling a polynucleotide (i.e., nucleic acid) having a predefined sequence from a plurality of different oligonucleotides, as taught by Jacobson et al., thus arriving at the instantly claimed invention, because using inkjet-based drop dispensing devices in methods for assembling a polynucleotide (i.e., nucleic acid) having a predefined sequence from a plurality of different oligonucleotides was an art-recognized use for such devices. In addition, combining prior art elements according to known methods to yield predictable results is considered prima facie obvious (see MPEP 2143.I.A). Given the teachings of the prior art and the level of the ordinary skilled artisan at the time of the application’s effective filling date, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Conclusion
13. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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