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/Restrictions
Applicant’s election without traverse of the species elections of polyethylene glycol (PEG) as the crowding reagent in claim 4, of nonionic surfactant in claim 9, and of polyoxyethylene (23) lauryl ether (Brij-35) in claim 10 in the reply filed on 06/10/2026 is acknowledged. Claims 6, 11, 12, & 120 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A first office action on the merits of claims 1-5, 7-10, & 13-30 is set forth herein and claims 6, 11, 12, & 120 are withdrawn from consideration.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 9, 10, & 13-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le (WO 2017/177025 A1, October 2017), as cited in the IDS dated 09/26/2024.
Regarding claim 1, Le teaches a composition comprising a detergent (surfactant) that is present in the composition at a concentration of about 0.0001% to about 0.50% (w/v) (at least one surfactant, wherein the concentration of the surfactant is at least 0.05% (w/v) or greater), a thermostable DNA polymerase (at least one DNA polymerase), and a crowding agent (at least one crowding reagent) (abstract lines 1-4; paragraph [0008] lines 1-2; paragraph [0061] lines 14-15; paragraph [0064] lines 1-16).
Regarding claim 2, Le teaches the concentration of the detergent (surfactant) in the composition is about 0.001% to about 0.50% (w/v) or about 0.005 % to about 0.1% (w/v) (concentration of the surfactant is at least 0.055% or greater) (paragraph [0064] lines 1-16).
Regarding claim 3, Le teaches the concentration of the detergent (surfactant) in the composition is about 0.001% to about 0.50% (w/v) or about 0.005 % to about 0.1% (w/v) (concentration of the surfactant is between 0.05% and 0.2%) (paragraph [0064] lines 1-16).
Regarding claim 4, Le teaches that the crowding reagent comprises polyethylene glycol (PEG) (paragraph 0061] lines 14-15).
Regarding claim 9, Le teaches the detergent (surfactant) comprises a nonionic detergent (paragraph [0064] lines 3-4).
Regarding claim 10, Le teaches the detergent (surfactant) comprises Brij 35 (polyoxyethylene (23) lauryl ether (Brij-35)) (paragraph [0064] lines 4-6).
Regarding claim 13, Le teaches the composition comprises components that are capable of facilitating or enhancing PCR comprising digital PCR and quantitative PCR (paragraph [0061] lines 3-5; paragraph [0094] lines 6-18).
Regarding claim 14, Le teaches the DNA polymerase is a thermostable polymerase (abstract lines 1-4; paragraph [0008] lines 1-2).
Regarding claim 15, Le teaches the thermostable DNA polymerase is a Taq DNA polymerase (paragraph [0008] lines 1-3).
Regarding claim 16, Le teaches the composition comprises a combination of a dNTP and a dNTP derivative (composition further comprising one or more nucleotides (dNTPs)) (paragraph [0007] lines 3-5).
Regarding claim 17, Le teaches the dNTP nucleotides comprises dTTP, dATP, dCTP, and dGTP (paragraph [0011] lines 1-2).
Regarding claim 18, Le teaches the concentration of the dNTP nucleotides is at a concentration of 0.05 mM to 1.0 mM (concentration of each nucleotides is about 0.5 mM to 5mM) (paragraph [0011] lines 2-3).
Regarding claims 19 & 20, Le teaches the composition further comprises glycerol (composition further comprises a carrier wherein the carrier is glycerol) (paragraph [0061] lines 8-10).
Regarding claim 21, Le teaches the glycerol is present in the composition at a concentration od about 5-50% (paragraph 0062] lines 1-3).
Regarding claims 22-24, Le teaches the composition comprises a passive reference control comprising a ROX dye (composition further comprising a reference control wherein the reference control is a ROX dye) (paragraph [0067] lines 1-7).
Regarding claims 25 & 26, Le teaches the composition can be provided as a concentrated stock solution or mix comprising about 2X, 3X, 4X, or 5X (composition is a concentration stock solution wherein said concentrated stock solution is a 2X to 5X stock solution) (paragraph [0076] lines 1-5).
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.
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(s) 5, 7, & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (WO 2017/177025 A1, October 2017), as cited in the IDS dated 09/26/2024, in view of Sasaki (Sasaki, Miyoshi, & Suigimoto; Biotechnology Journal, Vol. 1, pages 440-446, January 2006), as cited in the IDS dated 09/26/2024.
The teachings of Le with respect to claims 1 & 4 are discussed above and incorporated herein.
Regarding claims 5, 7, & 8, Le does not teach that the crowding agent PEG has an average molecular weight of about 2,000 to about 14,000 (see claim 5) and is in a concentration of between 1mM and 5mM (see claims 7 & 8).
Sasaki teaches PEG as a crowding reagent in a composition at various concentrations to affect the binding affinity and catalytic activity of a polymerase in the composition wherein the PEG has a molecular weight of 8,000 (crowding agent has an average molecular weight of about 2,000 to about 14,000) and is in the composition at a concentration of 0-20% PEG (4% PEG at molecular weight of 8000g/mol = 5mM concentration of PEG in the composition) (PEG is in a concentration of between 1 mM and 5mM in the composition) (abstract lines 4-10; pg. 440 -441 paragraph bridging pg. 440 & 441 lines 10-15; pg. 441 column 2 1st full paragraph lines 1-4). Sasaki also teaches that this range of concentrations of PEG in a composition comprising PEG and DNA polymerase can enhance the activity of the polymerase thus improving the efficiency of PCR amplification (abstract lines 4-12; pg. 440 -441 paragraph bridging pg. 440 & 441 lines 10-15).
Le and Sasaki are considered to be analogous to the claimed invention because they are all in the same field of compositions comprising DNA polymerase and a crowding agent. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of a DNA polymerase, a crowding agent comprising PEG, and a detergent (surfactant) in Le to incorporate the crowding agent PEG at an average molecular weight of 8,000 and a concentration of 4% (5 mM) as taught in Sasaki because Sasaki teaches that doing so would enhance the activity of the polymerase thus improving the efficiency of PCR amplification.
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (WO 2017/177025 A1, October 2017), as cited in the IDS dated 09/26/2024, in view of Hou (Hou et al.; Soft Matter, Vol. 7, pages 3092-3099, December 2010).
The teachings of Le with respect to claim 1 are discussed above and incorporated herein.
Regarding claims 27-30, Le does not teach that the viscosity of the composition ranges between about 3 cP and about 8 cP.
Hou teaches compositions comprising PEG and glycerol in which the viscosity of this crowded environment composition affects cleavage of DNA wherein the concentration of these components of the composition affect the viscosity of the composition comprising a composition with a viscosity of 10-3 Pa*s (viscosity of 1 cP) to a viscosity of 10-2 Pa*s (viscosity of 10 cP) depending on the concentration of PEG and glycerol in the composition (viscosity of the composition ranges between about 3 cP to about 8 cP) (abstract lines 7-10; pg. 3093 column 2 1st full paragraph lines 1-21; Fig. 2). Hou also teaches that altering the concentration of components in a composition comprising PEG and glycerol is a convenient way to control the DNA cleavage rate in a crowded environment (pg. 3096-3097 paragraph bridging pg. 3096 & 3097 lines 21-24).
Le and Hou are considered to be analogous to the claimed invention because they are all in the same field of compositions comprising a crowding agent PEG and glycerol. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of a DNA polymerase, a crowding agent comprising PEG, and a detergent (surfactant) in Le to incorporate the viscosity of the composition ranging between about 3 cP to about 8 cP as taught in Hou because Hou teaches that doing so would provide a convenient way to control the DNA cleavage rate in a crowded environment through altering the concentration of components comprising PEG and glycerol in a composition.
Conclusion
Claims 1-5, 7-10, & 13-30 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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