Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election of the particular species that are: (i) albumin as a particular the skin-forming protein; (ii) perfluorinated as a particular fluorinated anionic surfactant; and (iii) carboxylic acid-terminated perfluoropolyether as a particular anionic surfactant in the reply filed on 04/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 15 is objected to because of the following informalities. The claim recites “The kit of claim 11, the anionic surfactant”, where the phrase “The kit of claim 11, wherein the anionic surfactant” is likely intended.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claims 1-20 are rejected under 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.
Claims 1-20 are unclear over recitation of the limitation “an effective concentration of one or more skin-forming proteins”, as recited in claim 1. It is unclear what the broadly recited “concentration” is required to be “effective” for. While the claim recites “skin-forming proteins”, it is unclear if the concentration of the limitation is intended to be required for “skin-forming”, or there is some other or additional functionality intended for the “effective concentration”.
Claims 1-20 are unclear over recitation of the limitation “wherein heating the emulsion above a threshold temperature creates an interfacial skin between each droplet and the continuous phase, to transform the droplets into capsules”, as recited in claim 1 The limitation introduces a method step (i.e.: heating)into the claims directed a product (i.e.: a kit). A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p).
Claim 6 is unclear over recitation of the limitation “wherein heating the emulsion reduces a solubility of the one or more skin-forming proteins in the aqueous phase” because, as detailed above with regard to claim 1-20, the limitation creates a claim to both an apparatus and the method steps of using the apparatus, which is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p).
Claim 10 is unclear over recitation of the phrase “wherein said albumin is bovine serum albumin” because there is no antecedent basis for any “albumin” in either claim 10 or in claim 1 from which claim 10 depends. The claim may be made more clear in this regard if amended to depend from claim 9.
Claim 15 is unclear over recitation of the limitation “the anionic surfactant is at a concentration of 0.02% to 10% by weight”. It is unclear how the concentration is intended to be measured, where the concentration could be a concentration in the “nonaqueous continuous phase including an oil and at least one ionic surfactant, or the concentration may be the concentration in the total emulsion of the combined aqueous phase and the nonaqueous continuous phase.
Claim Rejections - 35 USC § 103
It is noted that the definiteness of the instant claims has been addressed previously in this Office Action under 35 USC 112. In the interests of customer service and compact prosecution the claims are considered under 35 USC 103 in so far as the limitations of the claims are addressed in the prior art. In comparing the claims with the prior art, it is noted that MPEP 2111.02 provides guidance with regard to the recitation of an intended use in a claim directed to a product. A statement of intended use does distinguish over the prior art with the same structure; a prior art structure which is capable of performing the intended use meets the claim.
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.
Claims 1, 2, 4-17 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Williams et al (2006) (citation 498 on the IDS of 11/27/2023) in view of Visca et al (US Pat 4,990,283; citation 8 on the IDS of 11/27/2023) and Xiao et al (2008).
Relevant to the limitations of the claims, Williams et al teaches a collection of materials (i.e.: reagents and equipment), which is a kit, for the preparation of an emulsion. Relevant to claim 1, Williams includes an aqueous phase including the protein bovine serum albumin (BSA) (e.g.: p.546, step 3) (relevant to claim 9, 10 and 11), nonaqueous continuous phase including an oil and a surfactant (e.g.: p.546, step 1) and a droplet generator (e.g.: p.545 - Magnetic stirrer with speed controller; p.547, step 4).
Relevant to the limitations of 2, 4 and 5, Williams et al teaches nucleic acid amplification reagents in the aqueous phase that include primer pairs, polymerase and dNTPs (e.g.: p.545 – Reagents; p.546, step 3).
Relevant to claim 16, Williams et al teaches a non-aqueous phase that includes multiple surfactants (e.g.: p.546, step 1).
Relevant to claim 20, Williams et al teaches mineral oil, which is a spacing fluid that is miscible with the continuous phase (e.g.: p.545 – Reagents).
Williams et al does not specify a surfactant that is an ionic surfactant, as recited in claim 1. But the use of ionic surfactants in creating microemulsions was known in the prior art and is taught by Visca et al.
Visca et al teaches reagents that are used for creating microemulsions. Relevant to instantly rejected claim 1, Visca et al teaches that regents for creating microemulsions can include ionic fluorinated surfactants (e.g.: col. 4).
Visca et al teaches a microemulsion of aqueous solution in a fluorinated oil (e.g.: col. 6), relevant to claim 7 and 11, and teaches fluorinated surfactants (e.g.: col. 5; carboxylic acid having perfluoropolyether) (relevant to claims 12-14). Relevant to the rejection of claim 17, Visca et al teaches surfactants that may include fluorinated short-chain alcohols (e.g.: col. 1; col. 2, col. 10).
Further relevant to the claims as they require an ionic surfactant, and an anionic surfactant (claims 8 and 11-14), Xiao et al teaches an analysis of different types of surfactants and the properties of microemulsions, including anionic surfactants (e.g.: p.233 - Ionic surfactant micelle system).
It would have been prima facie obvious to the skilled artisan to have assembled a collection of equipment and reagents (i.e.: a kit) for preparation of a microemulsion, as taught by Williams et al, and to have included additional reagents such as ionic surfactants and fluorinated oil (as exemplified by Visca et al) and anionic surfactants as taught by Xiao et al. The skilled artisan would have been motivated to include such additional reagents based on the expressed teachings of both Vicas et al and Xiao et al that such reagents may be used in the successful creation of a microemulsion. The skilled artisan would thus find motivation to try the reagents taught by Visca et al and Xiao et al in the procedures of Williams et al, and would recognize that providing the reagents in a kit would allow for simple and efficient testing of the reagents in the methods of microemulsion preparation. With regard to the limitations of claim 15, it is noted that these limitations are addressed earlier in this Office Action as indefinite. With regard to the rejection of claim 15 in view of the prior art, where Visca et al and Xiao et al teach various concentrations of surfactants, and Xiao teaches that differing concentrations of surfactant is a results effective variable, the inclusion of any particular amount is obvious as a matter of routine experimentation by the skilled artisan. With regard to the limitations of claims 1 and 6 related to process steps as addressed earlier in this Office Action as indefinite, when considered in view of the prior art the structural limitations of the claimed kit are rendered obvious by the cited prior art, and the intended use of the kits can be performed by the kits suggested by the cited prior art.
Claims 3 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Williams et al (2006) (citation 498 on the IDS of 11/27/2023) in view of Visca et al (US Pat 4,990,283; citation 8 on the IDS of 11/27/2023) and Xiao et al (2008), as applied to claims 1, 2, 4-17 and 20 above, and further in view of Beer et al (2007; citation 440 on the IDS of 11/27/2023).
Williams et al in view of Visca et al and Xiao et al renders obvious a kit comprising an aqueous phase with a skin-forming protein, a nonaquesous phase including an oil and an ionic surfactant, and a droplet generator. Williams et al teaches reaction components that include primer pairs, polymerase and dNTPs.
Williams et al in view of Visca et al and Xiao et al does teach reaction components that include a probe (relevant to claim 3) or a dye (relevant to claim 18). However, such components in the art related to amplification of nucleic acids in an emulsion of droplets were known in the art and are taught by Beer et al.
Beer et al teaches a collection of reagents for the analysis of nucleic acids by amplification in an emulsion of droplets. The reagents of Beer et al includes a probe labeled with an indicator dye (e.g.: p.8473 – PCR Reagents).
It would have been prima facie obvious to someone with ordinary skill in the relevant art to have included the reagents of Beer et al, including a probe labeled with an indicator dye, in the kit rendered obvious by Williams et al in view of Visca et al and Xiao et al. The skilled artisan would have been motivated to include dye labeled probes based on the expressed teachings of Beer et al that such reagents are ideal for detecting single-copy nucleic acids in a complex environment. The skilled artisan would have a reasonable expectation of success because Williams et al teaches the amplification of nucleic acids in droplets.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Williams et al (2006) (citation 498 on the IDS of 11/27/2023) in view of Visca et al (US Pat 4,990,283; citation 8 on the IDS of 11/27/2023) and Xiao et al (2008), as applied to claims 1, 2, 4-17 and 20 above, and further in view of Hwang et al (WO 2005048227 A2) (citation 325 on the IDS of 11/27/2023).
Williams et al in view of Visca et al and Xiao et al renders obvious a kit comprising an aqueous phase with a skin-forming protein, a nonaqueous phase including an oil and an ionic surfactant, and a droplet generator. Visca et al teaches teach emulsions forming reagents including a fluorinated oil, a fluorinated alcohol, and a fluorinated surfactant.
Williams et al in view of Visca et al and Xiao et al does teach reaction components that include perfluorodecanol. However such a component in the art related to reagents for forming an emulsion of droplets were known in the art and are taught by Hwang et al.
Hwang et al the reagent fluorinated alcohol perfluorodecanol (e.g.: page 29 line 10 provides 1 H, 1 H, 2H, 2H-perfluorodecanol [CF3CF2)7CH2CH2OH]). Hwang et al teaches the reagent in preparing emulsions to achieve a specific (e.g.: page 8 lines 5-14).
It would have been prima facie obvious to someone with ordinary skill in the relevant art to have included the perfluorodecanol reagent of Hwang et al in the kit rendered obvious by Williams et al in view of Visca et al and Xiao et al. The skilled artisan would have been motivated to include perfluorodecanol based on the expressed teachings of Hwang et al that such a reagent may facilitate the emulsification process by reducing viscosity.
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 1, 2, 6-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 8,399,198 in view of Ahern (1995).
The conflicting claims are directed to assay methods that include making an emulsion of droplets from an aqueous phase including skin-forming proteins and a nonaqueous continuous oil phase. The conflicting claims include the use of the same reagents as set forth in the rejected claims, such as a negatively-charged, fluorinated surfactant, and fluorinated oil.
The conflicting claims are not directed to a kit of reagents.
However, the inclusion of reagents used for related purposes in kits was well known in the art at the time the invention was made and is taught by Ahern.
Ahern teaches aspects of kits of reagents. Ahern teaches that a kit supplies all of the necessary reagents for a particular application and provides detailed instructions to follow (p.20 - The kit concept, Saving time and money).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have packaged reagents recited in the methods of the conflicting claims in a kit as taught by Ahern. One would have been motivated to do so based on the assertion of Ahern that kits of reagents are convenient and save time (p.20 - The kit concept), and the skilled artisan would recognize that such a kit comprising the reagents of the conflicting claims would be convenient in performing the analyses of the conflicting claims.
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 8,399,198 in view of Ahern (1995), as applied to claims 1 and 6-18 and 20 above, and further in view of Beer et al (2007; citation 440 on the IDS of 11/27/2023).
The conflicting claims in view of Ahern provide a kit of regents for forming an emulsion of droplets encapsulated by a skin-forming protein. The conflicting claims are further directed to amplification of a target nucleic acid.
The conflicting claims do not include specifically recited primers, probes, polymerases, nucleotides, or dyes. However, such components in the art related to amplification of nucleic acids in an emulsion of droplets were known in the art and are taught by Beer et al.
Beer et al teaches a collection of reagents for the analysis of nucleic acids by amplification in an emulsion of droplets. The reagents of Beer et al includes primers, probes, polymerase, a probe labeled with an indicator dye, and nucleotides which are used to amplify a target nucleic acid (e.g.: p.8473 – PCR Reagents).
It would have been prima facie obvious to someone with ordinary skill in the relevant art to have included the reagents of Beer et al, in the kit rendered obvious by the conflicting claims in view of Ahern. The skilled artisan would have been motivated to include dye labeled probes based on the expressed teachings of Beer et al that such reagents are ideal for detecting single-copy nucleic acids in a complex environment. The skilled artisan would have a reasonable expectation of success because the conflicting claims include the amplification of nucleic acids in droplets.
In the following rejections of claims for issues related to double patenting in view of the conflicting claims of US Pats: 9,598,725; 10,378,048; 11,060,136; and 11,866,771 the requirements of 35 USC 121 and the prohibition against nonstatutory double patenting rejections are noted (see MPEP 804.01). To prevent a rejection on the ground of nonstatutory double patenting over a conflicting patent, 35 USC 121 requires that the divisional application is filed before the issuance of the patent. In the instant case the instant application was filed after each of: 9,598,725; 10,378,048; and 11,060,136. Additionally, the 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction; the prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. The instant application is filed as a division from parent application 17/345,834 (issued as US Pat 11,866,771), but there was no requirement for restriction made in application 17/345,834.
Claims 1, 2, 6-15, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,598,725 in view of Ahern (1995).
The conflicting claims are directed to assay methods that include making an emulsion of droplets from an aqueous phase including skin-forming proteins and a nonaqueous continuous oil phase. The conflicting claims include the use of the same reagents as set forth in the rejected claims, such as a negatively-charged, fluorinated surfactant, and fluorinated oil.
The conflicting claims are not directed to a kit of reagents.
However, the inclusion of reagents used for related purposes in kits was well known in the art at the time the invention was made and is taught by Ahern.
Ahern teaches aspects of kits of reagents. Ahern teaches that a kit supplies all of the necessary reagents for a particular application and provides detailed instructions to follow (p.20 - The kit concept, Saving time and money).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have packaged reagents recited in the methods of the conflicting claims in a kit as taught by Ahern. One would have been motivated to do so based on the assertion of Ahern that kits of reagents are convenient and save time (p.20 - The kit concept), and the skilled artisan would recognize that such a kit comprising the reagents of the conflicting claims would be convenient in performing the analyses of the conflicting claims.
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of U.S. Patent No. 9,598,725 in view of Ahern (1995), as applied to claims 1, 2, 6-15, and 20 above, and further in view of Beer et al (2007; citation 440 on the IDS of 11/27/2023).
The conflicting claims in view of Ahern provide a kit of regents for forming an emulsion of droplets encapsulated by a skin-forming protein. The conflicting claims are further directed to amplification of a target nucleic acid.
The conflicting claims do not include specifically recited primers, probes, polymerases, nucleotides, or dyes. However, such components in the art related to amplification of nucleic acids in an emulsion of droplets were known in the art and are taught by Beer et al.
Beer et al teaches a collection of reagents for the analysis of nucleic acids by amplification in an emulsion of droplets. The reagents of Beer et al includes primers, probes, polymerase, a probe labeled with an indicator dye, and nucleotides which are used to amplify a target nucleic acid (e.g.: p.8473 – PCR Reagents).
It would have been prima facie obvious to someone with ordinary skill in the relevant art to have included the reagents of Beer et al, in the kit rendered obvious by the conflicting claims in view of Ahern. The skilled artisan would have been motivated to include dye labeled probes based on the expressed teachings of Beer et al that such reagents are ideal for detecting single-copy nucleic acids in a complex environment. The skilled artisan would have a reasonable expectation of success because the conflicting claims include the amplification of nucleic acids in droplets.
Claims 1, 2, 6-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,060,136 in view of Ahern (1995).
The conflicting claims are directed to an emulsion of droplets of an aqueous phase including skin-forming proteins and a nonaqueous continuous oil phase. The conflicting claims include the use of the same reagents as set forth in the rejected claims, such as a negatively-charged, fluorinated surfactant, and fluorinated oil.
The conflicting claims are not directed to a kit of reagents.
However, the inclusion of reagents used for related purposes in kits was well known in the art at the time the invention was made and is taught by Ahern.
Ahern teaches aspects of kits of reagents. Ahern teaches that a kit supplies all of the necessary reagents for a particular application and provides detailed instructions to follow (p.20 - The kit concept, Saving time and money).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have packaged reagents components of the emulsion set forth in the conflicting claims in a kit as taught by Ahern. One would have been motivated to do so based on the assertion of Ahern that kits of reagents are convenient and save time (p.20 - The kit concept), and the skilled artisan would recognize that such a kit comprising the reagents of the conflicting claims would be convenient in performing the analyses of the conflicting claims.
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,060,136 in view of Ahern (1995), as applied to claims 1, 2, 6-18, and 20 above, and further in view of Beer et al (2007; citation 440 on the IDS of 11/27/2023).
The conflicting claims in view of Ahern provide a kit of regents for forming an emulsion of droplets encapsulated by a skin-forming protein. The conflicting claims are further directed to amplification of a target nucleic acid.
The conflicting claims do not include specifically recited primers, probes, polymerases, nucleotides, or dyes. However, such components in the art related to amplification of nucleic acids in an emulsion of droplets were known in the art and are taught by Beer et al.
Beer et al teaches a collection of reagents for the analysis of nucleic acids by amplification in an emulsion of droplets. The reagents of Beer et al includes primers, probes, polymerase, a probe labeled with an indicator dye, and nucleotides which are used to amplify a target nucleic acid (e.g.: p.8473 – PCR Reagents).
It would have been prima facie obvious to someone with ordinary skill in the relevant art to have included the reagents of Beer et al, in the kit rendered obvious by the conflicting claims in view of Ahern. The skilled artisan would have been motivated to include dye labeled probes based on the expressed teachings of Beer et al that such reagents are ideal for detecting single-copy nucleic acids in a complex environment. The skilled artisan would have a reasonable expectation of success because the conflicting claims include the amplification of nucleic acids in droplets.
Claims 1, 2, 6-18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,866,771 in view of Ahern (1995).
The conflicting claims are directed to methods that include making an emulsion of droplets from an aqueous phase including skin-forming proteins and a nonaqueous continuous oil phase. The conflicting claims include the use of the same reagents as set forth in the rejected claims, such as a negatively-charged, fluorinated surfactant, and fluorinated oil.
The conflicting claims are not directed to a kit of reagents.
However, the inclusion of reagents used for related purposes in kits was well known in the art at the time the invention was made and is taught by Ahern.
Ahern teaches aspects of kits of reagents. Ahern teaches that a kit supplies all of the necessary reagents for a particular application and provides detailed instructions to follow (p.20 - The kit concept, Saving time and money).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have packaged reagents recited in the methods of the conflicting claims in a kit as taught by Ahern. One would have been motivated to do so based on the assertion of Ahern that kits of reagents are convenient and save time (p.20 - The kit concept), and the skilled artisan would recognize that such a kit comprising the reagents of the conflicting claims would be convenient in performing the analyses of the conflicting claims.
Claims 3-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,866,771 in view of Ahern (1995), as applied to claims 1, 2, 6-18, and 20 above, and further in view of Beer et al (2007; citation 440 on the IDS of 11/27/2023).
The conflicting claims in view of Ahern provide a kit of regents for forming an emulsion of droplets encapsulated by a skin-forming protein. The conflicting claims are further directed to amplification of a target nucleic acid.
The conflicting claims do not include specifically recited primers, probes, polymerases, nucleotides, or dyes. However, such components in the art related to amplification of nucleic acids in an emulsion of droplets were known in the art and are taught by Beer et al.
Beer et al teaches a collection of reagents for the analysis of nucleic acids by amplification in an emulsion of droplets. The reagents of Beer et al includes primers, probes, polymerase, a probe labeled with an indicator dye, and nucleotides which are used to amplify a target nucleic acid (e.g.: p.8473 – PCR Reagents).
It would have been prima facie obvious to someone with ordinary skill in the relevant art to have included the reagents of Beer et al, in the kit rendered obvious by the conflicting claims in view of Ahern. The skilled artisan would have been motivated to include dye labeled probes based on the expressed teachings of Beer et al that such reagents are ideal for detecting single-copy nucleic acids in a complex environment. The skilled artisan would have a reasonable expectation of success because the conflicting claims include the amplification of nucleic acids in droplets.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rampon, et al (2001) teaches the stabilization of emulsion droplets with serum albumin (BSA).
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/ Primary Examiner, Art Unit 1683
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