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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/25/2022, 06/05/2024, 06/20/2024, 08/25/2025 was filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group 1 claims 1-7, 9-10 12-20 in the reply filed on 11/26/2025 is acknowledged. The traversal is on the ground(s) that “the shared technical feature of a material having ordered structure and artificial metabolism is a special technical feature”.
This is not found persuasive because the preamble recites a intended recitation “for generating a material having an ordered structure and artificial metabolism”. Per MPEP 2111.02 to satisfy an intended use limitation, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. Therefore, the cited arts US2016/0362708; US2010/0260769; and US2004/0002058 are deemed to teach the shared technical feature.
Claims 23-29, 31-44 and 46-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
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.
(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, 9-10, 12-14, 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kong et al (US20070281309A1 published 12/06/2007; hereinafter Kong).
Regarding claim 1, Kong teaches a system for generating a material having an ordered structure and artificial metabolism, comprising
a device (a microfluidic chip – Fig. 2A) and a generation mix (a reaction mix R3 – Fig. 2A and paragraph 37),
wherein the generation mix is a reagent comprising ingredients for forming a polymer (the reaction mix R3 comprises material for gene synthesis of gene segment 1 – paragraph 37), and
wherein the device comprises a main chamber designed to permit a directed flow of a solution comprising the generation mix therethrough (a reaction volume between valves 204 and 206 – paragraph 37 and Fig. 2A), the main chamber comprising obstacles (the walls of the reaction volume – Fig. 2A) to cause vorticity (“to cause vorticity” is an intended use of the main chamber and deemed to read on a chamber capable of being used to cause vorticity) in the directed flow (the walls of the reaction volume are capable of causing vorticity in the direction of flow – Fig. 2A) to initiate and promote assembly of polymers synthesized in the device to form said material (“promote assembly of polymers synthesized” is an intended use of the main chamber and deemed to read on a chamber capable of being used to form a polymer) (the thermocycled reaction mix R3 containing assembled gene segment 1 – paragraph 38).
Regarding claim 2, Kong teaches the system of claim 1, wherein the main chamber comprises at least one inlet port (an inlet 202 – Fig. 2A) and at least one outlet port (an outlet port 226 – Fig. 2A) to permit infusion of the solution comprising the generation mix into the main chamber through the at least one inlet port (the reaction mix R3 is introduced into inlet 202 – paragraph 37) and flow from the at least one inlet port through the main chamber to the at least one outlet port (the reaction mix R3 can then be collected through outlet port 226 – paragraph 38).
Regarding claim 3, Kong teaches the system of claim 1, further comprising a degeneration mix which comprises reagents for depolymerizing the polymer (the reaction mix R3 containing the necessary reagents for oligonucleotide cleavage – paragraph 37).
Regarding claim 4, Kong teaches the system of claim 3, wherein the main chamber comprises at least two inlet ports (an inlet 230 capable of being used to infuse a solution comprising a generation mix – Fig. 2A) for separately infusing a solution comprising a generation mix and a solution of a degeneration mix (an inlet 214 capable of being used to infuse a solution of a degeneration mix – Fig. 2A).
Regarding claim 5, Kong teaches the system of claim 3, wherein the main chamber comprises a middle inlet port (an inlet 230 – Fig. 2A) and two outside inlet ports (inlets 202 and 214 – Fig. 2A), wherein the middle inlet port is for infusing a solution comprising a generation mix (the inlet 230 is capable of being used to infuse a solution comprising a generation mix – Fig. 2A), and wherein the two outside inlet ports are for infusing a solution comprising a degeneration mix (the inlets 202 and 214 and capable of being used to infuse a solution of a degeneration mix – Fig. 2A).
Regarding claim 6, Kong teaches the system of claim 1, wherein the device comprises multiple main chambers (another volume defined by valves 216, 218, 220, 210 – paragraph 37 and Fig. 2A).
Regarding claim 7, Kong teaches the system of claim 1, wherein said material has a static pattern or a mobile pattern (“said material has a static pattern or a mobile pattern” is deemed to be a manner of operating the device, because the patterning is formed by operating the device to form the material; see MPEP 2114II) (the reaction volume between valves 204 and 206 is capable of holding a material with a static pattern or a mobile pattern – paragraph 37 and Fig. 2A).
Regarding claim 9, Kong teaches the system of claim 7, wherein the pattern is a mobile pattern (“a mobile pattern” is deemed to be a manner of operating the device, because the pattern is formed by operating the device to form the material; see MPEP 2114II) and the mobile pattern is a locomotive behavior, or a racing behavior between two locomotive bodies (the reaction volume between valves 204 and 206 is capable of holding a material with a mobile pattern and a locomotive behavior – paragraph 37 and Fig. 2A).
Regarding claim 10, Kong teaches the system of claim 1, wherein the polymer is DNA or RNA (the thermocycled reaction mix R3 containing assembled gene segment 1 – paragraph 38).
Regarding claim 12, Kong teaches the system of claim 10, wherein the polymer is DNA (the thermocycled reaction mix R3 containing assembled gene segment 1 – paragraph 38) and wherein the generation mix comprises dNTPs, a template nucleic acid, a primer, and a DNA polymerase (dNTPs, gene segment 1, polymerase, primers, a specially designed DNA construct such as a bacterial artificial chromosome (BAC) – paragraphs 37 and 49) .
Regarding claim 13, Kong teaches the system of claim 12, wherein the primer and the template nucleic acid are annealed prior to being supplied to the main chamber (“annealed prior to being supplied to the main chamber” is a product by process limitation and per MPEP 2113 the patentability of a product does not depend on its method of production. The limitation is deemed to read an annealed the primer and the template nucleic acid) (the reaction mixture R3 is thermocycle in order to achieve synthesis of gene segment 1 and reads on annealing because the oligonucleotides and primer must bind in order to synthesis gene segment 1– paragraph 38).
Regarding claim 14, Kong teaches the system of claim 12, wherein the template nucleic acid is a circular DNA (a specially designed DNA construct, for example, but not limited to, a bacterial artificial chromosome (BAC), where BACs are plasmids and circular DNA – paragraph 49).
Regarding claim 16, Kong teaches the system of claim 3, wherein the degeneration mix comprises one or more nucleases (Examples of such enzymatic cleavage include DNA Endonuclease – paragraph 34).
Regarding claim 17, Kong teaches the system of claim 1, wherein the generation mix comprises a reagent that produces a detectable signal (the reaction mix R3 comprises material for gene synthesis of gene segment 1 is capable of producing a detectable signal – paragraph 37).
Regarding claim 18, Kong teaches the system of claim 1, wherein the polymer is DNA (the thermocycled reaction mix R3 containing assembled gene segment 1 – paragraph 38), and the generation mix comprises (i) dNTPs, a template nucleic acid, and a DNA polymerase, (ii) dNTPs, a primer, and a DNA polymerase (polymerase, dNTPs, primers – paragraph 38), or (iii) dNTPs, a template DNA, a primer, a DNA polymerase, and a ligase.
Regarding claim 19, Kong teaches the system of claim 1, wherein the main chamber has at least a substantially planar shape (the reaction volume is planar – Fig. 2A).
Regarding claim 20, Kong teaches the system of claim 1, wherein the main chamber has a dimension, along the direction of directed flow, in micron to millimeter scale (Microfluidic chip means a device for manipulating nanoliter to microliter volumes of liquid and is in the micron to millimeter scale – paragraph 27).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kong in view of Blanco et al (US Pat No. 5,198,543A published 03/30/1993; hereinafter Blanco).
Regarding claim 15, Kong teaches the system of claim 12.
However, Kong does not teach wherein the DNA polymerase is a Phi29 DNA polymerase.
Blanco teaches DNA sequencing wherein the DNA polymerase is a Phi29 DNA polymerase (The improvement is provision of a DNA polymerase which is a .phi.29-type DNA polymerase – column 2 line 1). Blanco also teaches that polymerases have a highly active 3'-5' exonuclease activity, but no 5'-3' exonuclease activity and are useful for DNA sequencing (column 2 lines 15-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the DNA polymerase, taught by Kong, with the .phi.29-type DNA polymerase, taught by Blanco, to gain a highly active 3'-5' exonuclease activity. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Kong and Blanco teach techniques for DNA amplification.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796