Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendment filed on December 16, 2026 is acknowledged and has been entered. Claims 1-67 have been canceled. Claim 91 has been added. Claims 68-91 are pending.
Claims 68-91 are discussed in this Office action.
All of the amendments and arguments have been thoroughly reviewed and considered but are not found persuasive for the reasons discussed below. Any rejection not reiterated in this action has been withdrawn as being obviated by the amendment of the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 16, 2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
New Grounds of Rejection
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 68-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. U.S. Patent No. 9428781 (‘781 patent herein) in view of Erill et al. (J of Micromech Microeng, 2004, 14:1558-1568, IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from the ‘781 patent because the claims 1-8, 11-18, 30 and 49 of the ‘781 patent and the pending claims are almost identical in scope and subject matter.
Although the claims at issue are not identical, they are not patentably distinct from the ‘781 patent because the claims of the ‘781 patent and the pending claims are almost identical in scope and subject matter. The subject matter of instant claims 68-74 and the claims of the ‘781 patent are nearly identical. The difference is that the instant claims refer not just to oscillating temperature but also focus on “wherein each temperature cycle is completed in a cycle time of 20 minutes or less”. Further, the broadest claims of the instant method do not include a specific range of temperatures for oscillation and that limitation is not addressed until claim 2 of the instant method.
Claims 68-74 and 81-89 of the instant claims and claims 1-8, 11-18, 30 and 49 of the ‘781 patent recite overlapping dependent limitations while the claims they depend from are not entirely identical, which will be explained in more detail below. In the ‘781 patent, there are multiple methods which incorporate limitations that are present in dependent claims in the instant claims which changes the scope of the claims somewhat but does not render the currently pending claims patentably distinct that correspond to these independent method claims. See, for example, claim 15 of the ‘781 patent:
15. A method for amplifying a template of nucleic acid target sequence contained in a sample comprising: contacting the sample with an amplification reaction mixture comprising: a primer or a primer pair having a length of between 35-70 base pairs and complementary to the template of the nucleic acid target sequence and wherein the melting temperature of each primer of the primer pair is between 70-80° C.; DMSO; monovalent cation; divalent cation; dNTPs; and DNA Polymerase; oscillating a temperature of the reaction between an upper temperature and a lower temperature wherein the change in temperature is no greater than about 20° C. during a plurality of temperature cycles; and amplifying the template of nucleic acid target sequence.
While the scope of the claims is different, claim 15 and the claims that depend from claim 15 are also not patentably distinct for the reasons noted above. Therefore, for at least these reasons, the instant claims are not patent eligible as claimed.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of the ‘781 patent in light of the rapid cycle times and rapid amplification teachings of Erill to arrive at the claimed invention with a reasonable expectation for success. For example, Erill teaches “The main advantage of PCR chips over conventional systems does not arise only from their faster transients (due to reduced volumes), but also from their efficient heat transfer, which ensures that the heat source temperature is distributed almost instantly across the whole PCR chamber” (“3.1 Kinetics and biochemical optimization” heading”). Erill also teaches a method to “minimize redundant hold times at the three PCR temperatures (denaturation, annealing and extension), with a lower limit imposed only by the extension rate of the Taq polymerase [14, 31]. In this work, we tested these hypotheses and optimized PCR kinetics up to the point of reducing denaturation and annealing times to mere spikes (1 and 2 s respectively, see figure 8) and the extension hold to 10 s.” Erill also notes “Active PCR chips present far better speed and power consumption rates, and these may be highly desirable in certain applications, such as portable PCR [40] or rapid pathogen detection [41] systems. In addition, the integration of heating circuitry provides a more scalable technology for the development of multi-chip modules or the integration of additional mechanisms (e.g. sensors or control circuitry).” (p 1567, col 1). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of the ‘781 patent in light of the rapid cycle times and rapid amplification teachings of Erill to include rapid amplification as a focus in addition to the steps of oscillation as included in both the instant claims and the claims of the ‘781 patent. Therefore, the instant claims are not patentably distinct over the claims of the ‘781 patent in view of Erill.
Claims 68-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,316,358 (‘358 patent) in view of Erill et al. (J of Micromech Microeng, 2004, 14:1558-1568, IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the claims are not identical, they are not the same. The claims of the ‘358 patent render the instant claims not patent eligible because the limitations of the instant claims cover the same subject matter when compared to the claims of the ‘358 patent.
For example, claim 1 of the ‘358 patent covers portions of claims 68-70 of the instant claims. The dependent claims of the instant application also include almost identical limitations compared to the ‘358 patent. For example, the limitations of instant claim 69-72 which include features of the upper denaturation temperature and the lower annealing temperature, correspond to claim 6 of the ‘358 patent. Further, the length of the primers (instant claim 79 as compared to claims 21-22 of ‘358 patent), the destabilizing agent (instant claims 85 as compared to claims 23-26 of the ‘358 patent), the single stranded binding protein (instant claim 81 and 87 as compared to claims 36-38 of the ‘358 patent) and the melting temperature of the primers (instant claim 80 as compared to claim 18 of the ‘358 patent). Each of the dependent claims correspond to claims of the ‘358 patent and as the limitations are so similar the instant claims are not patent eligible.
Further, while the difference that the instant claims refer not just to oscillating temperature but also focus on the time needed to complete cycles is rendered obvious by the teachings of Erill. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of the ‘358 patent in light of the rapid cycle times and rapid amplification teachings of Erill arrive at the claimed invention with a reasonable expectation for success. For example, Erill teaches “The main advantage of PCR chips over conventional systems does not arise only from their faster transients (due to reduced volumes), but also from their efficient heat transfer, which ensures that the heat source temperature is distributed almost instantly across the whole PCR chamber” (“3.1 Kinetics and biochemical optimization” heading”). Erill also teaches a method to “minimize redundant hold times at the three PCR temperatures (denaturation, annealing and extension), with a lower limit imposed only by the extension rate of the Taq polymerase [14, 31]. In this work, we tested these hypotheses and optimized PCR kinetics up to the point of reducing denaturation and annealing times to mere spikes (1 and 2 s respectively, see figure 8) and the extension hold to 10 s.” Erill also notes “Active PCR chips present far better speed and power consumption rates, and these may be highly desirable in certain applications, such as portable PCR [40] or rapid pathogen detection [41] systems. In addition, the integration of heating circuitry provides a more scalable technology for the development of multi-chip modules or the integration of additional mechanisms (e.g. sensors or control circuitry).” (p 1567, col 1). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of the ‘358 patent in light of the rapid cycle times and rapid amplification teachings of Erill to include rapid amplification as a focus in addition to the steps of oscillation as included in both the instant claims and the claims of the ‘358 patent. Therefore, the instant claims are not patentably distinct over the claims of the ‘358 patent in view of Erill.
Claims 68-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,293,058 in view of Erill et al. (J of Micromech Microeng, 2004, 14:1558-1568, IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the claims are not identical, the subject matter of instant claims 69-72 and the claims of the ‘058 patent are nearly identical. Further, the broadest claims of the instant method do not include a specific range of temperatures for oscillation and that limitation is not addressed until claim 71-72 of the instant method.
The claims of the ‘058 patent render the instant claims not patent eligible because the limitations of the instant claims are rearranged compared to the claims of the ‘058 patent. For example, claim 1 of the ‘058 patent covers portions of claims 69-72 of the instant claims. The dependent claims of the instant application also include almost identical limitations compared to the ‘058 patent. For example, the length of the primers (instant claims 79 and claim 10-11 of ‘058 patent), and the melting temperature of the primers (claim 80) correspond to claim 9 of the ‘058 patent. Each of the dependent claims correspond to claims of the ‘058 patent and as the limitations are so similar the instant claims are not patent eligible.
Further, while the difference that the instant claims refer not just to oscillating temperature but also length of cycles is not addressed by the claims of the ‘058 patent, the limitation rapid cycle time is rendered obvious by the teachings of Erill. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of the ‘058 patent in light of the rapid cycle times and rapid amplification teachings of Erill arrive at the claimed invention with a reasonable expectation for success. For example, Erill teaches “The main advantage of PCR chips over conventional systems does not arise only from their faster transients (due to reduced volumes), but also from their efficient heat transfer, which ensures that the heat source temperature is distributed almost instantly across the whole PCR chamber” (“3.1 Kinetics and biochemical optimization” heading”). Erill also teaches a method to “minimize redundant hold times at the three PCR temperatures (denaturation, annealing and extension), with a lower limit imposed only by the extension rate of the Taq polymerase [14, 31]. In this work, we tested these hypotheses and optimized PCR kinetics up to the point of reducing denaturation and annealing times to mere spikes (1 and 2 s respectively, see figure 8) and the extension hold to 10 s.” Erill also notes “Active PCR chips present far better speed and power consumption rates, and these may be highly desirable in certain applications, such as portable PCR [40] or rapid pathogen detection [41] systems. In addition, the integration of heating circuitry provides a more scalable technology for the development of multi-chip modules or the integration of additional mechanisms (e.g. sensors or control circuitry).” (p 1567, col 1). Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of the ‘058 patent in light of the rapid cycle times and rapid amplification teachings of Erill to include rapid amplification as a focus in addition to the steps of oscillation as included in both the instant claims and the claims of the ‘058 patent. Therefore, the instant claims are not patentably distinct over the claims of the ‘058 patent in view of Erill.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 68-80 and 90-91 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Erill et al. (J of Micromech Microeng, 2004, 14:1558-1568, IDS reference) in view of Hwang et al. (US PgPub 20040152122; August 2004).
With regard to claim 68, Erill teaches a method for amplifying a target nucleic acid sequence contained in a sample, the method comprising:
contacting the sample with an amplification reaction mixture in a reaction chamber, said amplification reaction mixture comprising a primer complementary to the target nucleic acid sequence (“2.4 PCR protocols” heading, where a pair of primers were used to amplify a template; see Fig 3 as an example of an active PCR chip which includes a reaction chamber);
which comprises 30 or more temperature cycles, wherein the 30 or more temperature cycles are completed within 20 minutes or less, thereby generating an amplification product of the target nucleic acid sequence (Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; the ultra fast PCR completed 45 cycles in 20:19 minutes; see amplification product in Fig 9).
With regard to claim 69, Erill teaches the method of claim 68, wherein a temperature of the amplification reaction is oscillated between an upper temperature and a lower temperature during the temperature cycles (Fig 8 where the temperatures of the PCR cycles are depicted; see also Fig 12, where the same temperatures are depicted).
With regard to claim 70, Erill teaches the method of claim 69, wherein within each temperature cycle, upon reaching the upper temperature or the lower temperature, the temperature is maintained for about 5 seconds to 15 seconds (Fig 8 where the temperatures of the PCR cycles are depicted; see also Fig 12, where the same temperatures are depicted; Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; fast PCR includes 95 for 1 s, 64 for 7 s and 72 for 17 s, which is about 5 seconds to 15 seconds; ultra fast PCR includes 95 for 1 s, 64 for 2 s and 72 for 10 s, which are also about 5 seconds to 15 seconds).
With regard to claim 71, Erill teaches the method of claim 69, wherein the lower temperature is no less than 50°C (Fig 8 where the temperatures of the PCR cycles are depicted; see also Fig 12, where the same temperatures are depicted; Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; fast PCR includes 95 for 1 s, 64 for 7 s and 72 for 17 s; ultra fast PCR includes 95 for 1 s, 64 for 2 s and 72 for 10 s).
With regard to claim 72, Erill teaches the method of claim 69, wherein the upper temperature is no more than 85°C (Fig 8 where the temperatures of the PCR cycles are depicted; see also Fig 12, where the same temperatures are depicted; Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; fast PCR includes 95 for 1 s, 64 for 7 s and 72 for 17 s; ultra fast PCR includes 95 for 1 s, 64 for 2 s and 72 for 10 s).
With regard to claim 73, Erill teaches the method of claim 68, wherein the amplification reaction comprises 40 temperature cycles or less (“2.4 PCR protocols” heading, where a pair of primers were used to amplify a template where the template and primers were optimized for a protocol that includes 40 cycles).
With regard to claim 74, Erill teaches the method of claim 68, wherein each temperature cycle is completed in a cycle time of 40 seconds or less (Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; the ultra fast PCR completed 45 cycles in 20:19 minutes; see amplification product in Fig 9; where the cycle time for the fast PCR protocol is 38 seconds and where the cycle time for the ultra fast PCR protocol is 24.41 seconds).
With regard to claim 75, Erill teaches the method of claim 74, wherein each temperature cycle is completed in a cycle time of 5 seconds or more (Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; the ultra fast PCR completed 45 cycles in 20:19 minutes; see amplification product in Fig 9; where the cycle time for the fast PCR protocol is 38 seconds and where the cycle time for the ultra fast PCR protocol is 24.41 seconds).
With regard to claim 76, Erill teaches the method of claim 68, wherein the 30 or more temperature cycles are completed within 13 minutes or more (Fig 8 legend, where “fast PCR protocol” and “ultra fast PCR protocol” includes 45 cycles; the ultra fast PCR completed 45 cycles in 20:19 minutes; see amplification product in Fig 9; where the cycle time for the fast PCR protocol is 38 seconds and where the cycle time for the ultra fast PCR protocol is 24.41 seconds).
With regard to claim 77, Erill teaches the method of claim 68, wherein the reaction volume is less than or equal to 20 pL (“2.4 PCR protocols” heading, where a pair of primers were used to amplify a template that is 310 bp in length and where the template is 700 bp).
With regard to claim 78, Erill teaches the method of claim 68, wherein the target nucleic acid sequence is a single stranded or double stranded DNA or RNA (Abstract; “2.4 PCR protocols” heading, where a pair of primers were used to amplify a template, where DNA is amplified).
With regard to claim 79, Erill teaches the method of claim 68, wherein the length of the target nucleic acid sequence is less than 1000bp, less than 500bp, less than 250 bp, less than 150 bp or less than 100 bp (“2.4 PCR protocols” heading, where a pair of primers were used to amplify a template that is 310 bp in length and where the template is 700 bp).
With regard to claim 80, Erill teaches the method of claim 68, wherein the primer has (i) a length of between 35-70 base pairs, or between 40-47 base pairs, or (ii) a melting temperature between 10°C and 30°C, or between 65°C and 105C (“2.4 PCR protocols” heading, where a pair of primers were used to amplify a template and where the pair are 19 bp and 20 bp respectively).
With regard to claim 91, Erill teaches the method of claim 77, wherein the reaction volume is greater than or equal to 15 μL (“2.4 PCR protocols” heading, where a pair of primers were used to amplify a template that is 310 bp in length and where the template is 700 bp).
Regarding claim 68, while Erill teaches a method of amplification which includes different degrees of rapid amplification and while the PCR chips of Erill include integrated heating, Erill does not specifically describe applying heat to the reaction chamber to subject the sample to an amplification reaction.
With regard to claim 68, Hwang teaches applying heat to the reaction chamber to subject the sample to an amplification reaction (paragraph 8, 10, 21-24, 59 and Fig 3, where contact between a reaction device or sample with a heating element).
With regard to claim 90, Hwang teaches the method of claim 68, wherein applying heat to the reaction chamber comprises applying heat to one surface of the reaction chamber (paragraph 8, 10, 21-24, 59 and Fig 3, where contact between a reaction device or sample with a heating element).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of Erill to include contact with a heater as guided and emphasized by Hwang to arrive at the claimed invention with a reasonable expectation for success. Erill teaches a comparison between passive PCR chips which are heated using an external heat source. Erill is focused primarily on active PCR chips which include chips with integrated heating and sensing circuitry. Hwang teaches “In the most widely used method, a reaction vessel containing the sample is made in contact with a solid metal block having a high thermal conductivity, and the temperature of the solid metal block is changed by combining it with heating and cooling devices to achieve the desired temperature cycling of the sample”. Hwang also teaches “In this type of methods, a fluid heated to a suitable temperature is circulated around the reaction vessel in a manner that an efficient thermal contact can be provided between the fluid heat source and the reaction vessel containing the sample. Other types of methods have also been developed to achieve rapid temperature cycling. Additional examples include a method of contacting the reaction vessel containing the sample or the sample itself sequentially with multiple heat sources each at a specific temperature, a method of heating
the sample directly with infrared radiation, etc” (paragraph 8). Finally, Hwang teaches “embodiments as shown in FIG. 2, it is contemplated that three specific regions of the reaction
vessel are in thermal contact with a plurality of heat sources. FIG. 2a shows a schematic diagram illustrating one embodiment” (paragraph Therefore, one of ordinary skill in the art at the time the invention was made would have adjusted the teachings of Erill to include contact with a heater as guided and emphasized by Hwang to arrive at the claimed invention with a reasonable expectation for success.
Claim 81-89 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Erill et al. (J of Micromech Microeng, 2004, 14:1558-1568, IDS reference) in view of Hwang as applied over claims 68-80 and 90-91 above and further in view of Ralser et al. (Biochem Biophys Res Comm, 2006, vol. 347, p. 747-751).
Regarding claims 81-89, while Erill and Hwang teaches the limitations of claims 68-80 and 90, Erill does not teach the inclusion of a destabilizing agent like DMSO or betaine or single stranded binding protein.
With regard to claim 81, Ralser teaches the method of claim 68, wherein the amplification reaction mixture comprises a cation, a nucleic acid destabilizing agent, a single stranded binding protein, or a combination thereof (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 82, Ralser teaches the method of claim 81, wherein the cation comprises a monovalent cation, a divalent cation, or combinations thereof (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 83, Ralser teaches the method of claim 82, wherein the divalent cation is a salt comprising magnesium, manganese, copper, zinc, or any combination thereof (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 84, Ralser teaches the method of claim 83, wherein the monovalent cation is a salt comprising one or more of sodium, potassium, lithium, rubidium, cesium, ammonium, or any combination thereof (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 85, Ralser teaches the method of claim 81, wherein the nucleic acid destabilizing agent comprises dimethylsulfoxide (DMSO), formamide, glycerol, or a mixture thereof.
With regard to claim 86, Ralser teaches the method of claim 85, wherein the nucleic acid destabilizing agent is at a concentration between 8 and 15 volume percent (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 87, Ralser teaches the method of claim 81, wherein the single stranded binding protein is a thermal stable single stranded binding protein or non-thermal stable single stranded binding protein (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 88, Ralser teaches the method of claim 68, wherein the amplification reaction is conducted in the presence of alcohol or salt (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
With regard to claim 89, Ralser teaches the method of claim 88, wherein the sample comprises alcohol at a concentration of about 10% (v/v) (Abstract; Figure 1, where DMSO is added to PCR reactions, p. 748, col. 2, where various “PCR enhancing additives” were evaluated).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have adjusted the teachings of Erill to include the PCR destabilizing additives of DMSO or formamide as taught by Ralser to arrive at the claimed invention with a reasonable expectation for success. As taught by Ralser, “Here we designed and tested a novel effective and low-cost PCR enhancer, a concentration-dependent combination of betaine, dithiothreitol, and dimethyl sulfoxide that broadly enhanced the quantitative and/or qualitative output of PCRs. Additionally, we showed that the performances of this enhancer mix are comparable to those of commercially available PCR additives and highly effective with different DNA polymerases”. Therefore, one of ordinary skill in the art at the time the invention was made would have been motivated to have adjusted the teachings of Erill to include the PCR destabilizing additives of DMSO or formamide as taught by Ralser to arrive at the claimed invention with a reasonable expectation for success.
Response to Arguments
Applicant’s arguments with respect to claim(s) 68-91 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed. All claims stand rejected.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on December 16, 2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681
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