617Notice 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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. GB2012261.0, filed on 08/06/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group III, claim(s) 26-34 in the reply filed on 03/09/2026 is acknowledged.
Claim Objections
Claim 34 is objected to because of the following informalities: Claim 34 line(s) 1 and 3-4, recites "synthesising ", but it should read as "synthesizing ". Appropriate correction 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.
(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.
Claim(s) 26-30 and 33-34 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The closest prior art is Poehmerer et al. (US20160186166A1).
Regarding Claim 26, Poehmerer et al. teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), comprising: a fluid supply unit (See the first manifold, i.e. a fluid supply unit, in [0636]-[0639] in Fig. 46);
a synthesis unit comprising a microfluidic chip, configured for the synthesis of nucleic acids (See the chip in [0636] in Fig. 46) ;
a valve assembly, comprising at least one multiport valve (See the two rotary valves on the bottom right of configurations 1 and 2 in [0636] in Fig. 46); and
a collection unit configured to collect nucleic acids (See the reaction vessels, i.e. collection units, in [0559]-[0560], [0642]);
wherein the valve assembly is configured to direct fluid between the synthesis unit and the collection unit (See in [0560]-[0561]), the fluid supply unit and the synthesis unit, and the fluid supply unit and the collection unit (See the configuration 2 illustrated in Fig. 46 in [0560], [0636]-[0640]).
Regarding Claim 27, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. further teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the valve assembly is configured to establish two fluid streams between fluid connections of the valve assembly without the two fluid streams coming into contact (See how the two rotary valves on the bottom right of configurations 1 and 2 have two distinct fluid streams in [0636] in Fig. 46).
Regarding Claim 28, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. further teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the system comprises a gas distribution unit (See the second manifold, i.e. a gas distribution unit, in [0636]-[0639] in Fig. 46) and
wherein the gas distribution unit comprises an inlet configured to receive a gas; at least one outlet (See in [0636]-[0639] in Fig. 46); and
at least one valve (See the two rotary valves on the bottom right of configurations 1 and 2 in [0636] in Fig. 46);
wherein the gas distribution unit is configured to supply the gas at the at least one outlet at a predetermined pressure (See in [0636]-[0639] in Fig. 46).
Regarding Claim(s) 29-30, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. further teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the fluid supply unit comprises (See the first manifold, i.e. a fluid supply unit, in [0636]-[0639] in Fig. 46):
a plurality of fluid containers each configured to store a fluid (See in [0559]-[0560]);
a gas supply, configured to provide a gas at a controlled pressure through at least one outlet (See the second manifold, i.e. a gas supply, in [0636]-[0639] in Fig. 46); and
at least one valve manifold comprising a plurality of inlets and an outlet,
wherein each of the at least one valve manifold is configured to selectively fluidly connect at least one inlet to the outlet (See the two rotary valves on the bottom right of configurations 1 and 2 in [0636]-[0639] in Fig. 46);
wherein the gas supply comprises a gas reservoir configured to provide a gas and the gas distribution unit (See in in [0636]-[0639] in Fig. 46).
Regarding Claim 33, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. further teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the collection unit (See the reaction vessels, i.e. collection units, or see the collection device 1905 and collection plate 2220 in [0403]-[0412], [0559]-[0560], [0642] in Fig. 19-21) comprises: an adapter plate, configured to be connected with a plurality of fluid tubes (See the support structure 1930, i.e. an adapter plate, connected with multiple tube in [0403]-[0412] in Fig. 19); and
a well plate, comprising a plurality of wells (See the well plate 1910 in [0403] in Fig. 19);
wherein the collection unit is configured to maintain a connection between the adapter plate and the well plate (See in in [0403]-[0415] in Fig. 19-21); and
wherein the collection unit further comprises a connection mechanism, wherein the connection mechanism is configured to connect the adapter plate and the well plate such that the connection therebetween is maintained (See in in [0403]-[0415] in Fig. 19-21).
Regarding Claim 34, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. teaches a method for synthesising nucleic acids utilizing with a synthesis system(See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 1-8 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the method comprises synthesising nucleic acids on the microfluidic chip (See [0011] and Claim 1);
selectively releasing synthesised nucleic acids from the microfluidic chip; guiding released nucleic acids to the collection unit (See in [0321]-[0334], [0612]-[0617] Claim(s) 2-3); and
collecting released nucleic acids in a well plate comprised by the collection unit (See in [0019]-[0087], [0403]-[0415], [0485], [0579] in Fig. 2A-B and 19-21 and Claim 2-3 in Fig. 15).
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.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Poehmerer et al. (US20160186166A1) as applied to claim 26 above, and further in view of Cucchi et al. (US20190201898A1).
Regarding Claim 31, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. further teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the system further comprises a chip holder (See how the system has a microfluidic chip arranged in a holder in [0636] in Fig. 46), comprising: a body; a cover plate; a chip cover (See the body, the cover plate 204, fluidic lid 2335 in [0089], [0101], [0283]-[0287], [0633] in Fig. 2A-B, 24A-D);
a chip receiving section, configured to accommodate a microfluidic chip (See in [0636] in Fig. 46);
a sealing mechanism configured to maintain a leak-tight connection between the microfluidic chip and the chip cover (See how the fluidic lid 2335 can be affixed firmly onto the chip 2320 to provide a tight seal and provide a flow path for fluids to be delivered to and from the wells in [0635] in Fig. 24A-D; Also, see seal 2445 in [0635] in Fig. 24A-D); and
a connecting mechanism configured to establish an electrical connection between a plurality of electrical contacts comprised by the microfluidic chip and corresponding electrical contacts comprised by the chip holder, and wherein the connecting mechanism is independent of the sealing mechanism (See the various connecting mechanisms between electrical connections and surfaces in [0624]-[0640] in Fig. 23A-24D and 46).
Poehmerer et al. fails to explicitly teach a system comprising: a chip holder, comprising: a body ;a cover plate; a chip cover; a chip receiving section, configured to accommodate a microfluidic chip; a sealing mechanism configured to maintain a leak-tight connection between the microfluidic chip and the chip cover; and a connecting mechanism configured to establish an electrical connection between a plurality of electrical contacts comprised by the microfluidic chip and corresponding electrical contacts comprised by the chip holder, and wherein the connecting mechanism is independent of the sealing mechanism
However, in the analogous art of cartridges and systems for sample preparation and molecule analysis, Cucchi et al. teaches a system (See the Abstract, the system 1, and the Claim(s) 1-27 in [0023]-[0053], [0086]-[0107], [0112]- in Fig. 1-4), further comprising: a chip holder (See the cartridge 2 in [0023], [0104] in Fig. 4A), comprising:
a body (See the casing 5, i.e. a body, in [0023], [0104] in Fig. 4);
a cover plate (See the first closing wall 81, i.e. a cover plate, in [0106] in Fig 4);
a chip cover (See the body 80, i.e. a chip cover, or the second closing wall 82in [0106] in Fig 4);
a chip receiving section, configured to accommodate a microfluidic chip (See how the analysis recess 84A, i.e. a chip receiving section, accommodates the chip 48 in [0112] in Fig. 4);
a sealing mechanism, configured to maintain a leak-tight connection between the microfluidic chip and the chip cover (See in [0106]-[0107], [0112] in Fig. 4); and
a connecting mechanism configured to establish an electrical connection between a plurality of electrical contacts comprised by the microfluidic chip and corresponding electrical contacts comprised by the chip holder, and wherein the connecting mechanism is independent of the sealing mechanism (See how the chip 48 has on the back electrical contacts 49 designed to be electrically coupled with the electrical-connection element 47 on the control machine 3, thus connecting the chip 48 to the control unit 35 in [0112], [0124] in Fig. 4).
Thus, it would be obvious to one with ordinary skills in the arts to modify the system of Poehmerer et al. by incorporating a chip holder comprising a connecting mechanism that is independent of a sealing mechanism (as taught by Cucchi et al.) for the benefit of synthesizing nucleic acids 0n a microfluidic chip.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Poehmerer et al. (US20160186166A1) as applied to claim 26 above, and further in view of Schroeder et al. (US20070039866A1).
Regarding Claim 32, Poehmerer et al. teaches the system limitations of claim 26.
Poehmerer et al. further teaches a system (See the Abstract, the oligonucleotide synthesis system, and the Claim(s) 9-15 and 19-23 in [0359], [0553]-[0561], [0579], [0612], [0617], [0636]-[0640] in Fig. 12, 33, and 46), wherein the at least one multiport valve comprises a rotary valve (See the two rotary valves on the bottom right of configurations 1 and 2 in [0636] in Fig. 46), the rotary valve comprising: a plurality of channels and tubes (See the tubes 206 in [0291], [0636] in Fig. 2B, 46).
Poehmerer et al. fails to explicitly teach a system, wherein the rotary valve comprising: a stator comprising a plurality of channels; and a rotor comprising at least one groove; a plurality of tubes, wherein each tube extends into a channel, respectively; wherein the rotary valve is configured such that the at least one groove can fluidly connect the channels.
However, in the analogous art of systems for depositing processed fluid volumes, Schroeder et al. teaches a system (See the Abstract, the fluid processing system 10, and the Claim(s) 1-28, 64-71, 74, 83-87, and 93-94 in [0169]-[0188], [0216], [0230] in Fig. 1A-B and 23-28) a rotary valve (See the rotary valves 71, 73, 75, 77, and 79 in [0184] in Fig1A) comprising:
a stator comprising a plurality of channels (See the stator 2302 and channels in [0340]-[0348] in Fig. 23-28); and
a rotor comprising at least one groove (See the rotor 2304 in [0340]-[0348] in Fig. 23-28);
a plurality of tubes, wherein each tube extends into a channel, respectively; wherein the rotary valve is configured such that the at least one groove can fluidly connect the channels (See in [0340]-[0348] in Fig. 23-28).
Thus, it would be obvious to one with ordinary skills in the arts to modify the system of Poehmerer et al. by incorporating a rotary valve comprising: a stator comprising a plurality of channels; a rotor comprising at least one groove; a plurality of tubes, wherein each tube extends into a channel; wherein the rotary valve is configured such that the at least one groove can fluidly connect the channels (as taught by Schroeder et al. ) for the benefit of synthesizing nucleic acids on a microfluidic chip.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches similar devices and methods: McCaffrey et al. (US20190309361A1); Labmaster OY (WO2018096206A1); and Jovanovich et al. (US20070248958A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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