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 .
DETAILED ACTION
Claims 1-32 are currently pending in the instant application, filed November 6, 2023.
Response to Election/Restriction
Applicant's election of Group I without traverse, claims 1-22 directed to nucleic acid amplification method; and Applicant’s election of Species (B) with traverse, as follows:
Species (A): wherein the number of bases in the first base sequence and third base sequence is an integer selected from 4 to 10 (claim 2),
Species (B): wherein the first primer is added at 0.1 to 10 mol% compared to the second primer (claim 5),
Species (C): wherein selection involves selecting double-stranded or single-stranded nucleic acids (claim 12),
Species (D): further comprising a plurality of different samples, a plurality of different first primers and a plurality of different second primers (claim 18), and
Species (E): further comprises the steps of purification, fragmentation, pooling, and preparation (claim 22), in the replies filed September 11, 2026 and September 22, 2026 is acknowledged.
Response to Arguments
Applicant’s arguments filed September 11, 2026 have been fully considered but they are not persuasive. Applicants essentially assert that: (a) regarding Species (B), claims 5-7 recite molar ratios that describe the amount of first primer relative to second primer, not an alternative first-primer structure, wherein neither claim 6 nor claim 7 excludes use of that ratio, and their structural features are not stated to exclude one another (Applicant Remarks, pg. 3, second full paragraph).
Regarding (a), each of claim 5-7 recites a first primer comprising a different characteristic in the method of claim 1 (e.g., wherein the first primer is present at a specific concentration, it contains a substance that inhibits affinity, and it contains a base resistant to nuclease). MPEP 806.04(f) states that:
“where two or more species are claimed, a requirement for restriction to a single species may be proper if the species are mutually exclusive. Claims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species
and not the first”
Each of claims 5, 6 and 7 recite a different species of first primer, where a characteristic of the first primer as recited in claim 5 is not shared in claims 6 and 7, etc., such that each species of first primer is mutually exclusive. Thus, the restriction is proper.
Claims 23-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 3, 6, 7, 11, 13-15, 20 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 11, 2026.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1, 2, 4, 5, 8-10, 12, 16-19 and 22 are under consideration to which the following grounds of rejection are applicable.
Interview Summary
The Examiner contacted Applicant to set up an interview, where such electronic mail interview was conducted between the Examiner and Applicant’s representative Jaeryang Hahn on September 21, 2026. The Examiner noted that the election of species was incomplete in the reply filed September 11, 2026. The Examiner, therefore, requested that Applicant provide an election of species for Species (A) and (C) - (G). Applicant subsequently elected for Species (A), claim 2; Species (C), claim 12; Species (D), claim 18; and Species (E), claim 22.
Priority
The present application filed May 3, 2023 is a 35 U.S.C. 371 national stage filing of International Application PCT/KR2022/008690, filed June 20, 2022, which claims the benefit of Application KR10-2021-0080035, filed June 21, 2021.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of Korea on June 21, 2021; and Applicant’s filing of a certified copy of the Republic of Korea Patent Application No. 10-20210080035 as required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 6, 2023 has been considered. An initialed copy of the IDSs accompany this Office Action.
Claim Objections/Rejections
Claim Objections
Claims 10 and 17 are objected to because of the following informalities: Claims 10 and 17 recite terms such as “biotin dT”, “biotin-TEG”, “PC-biotin”, “NHS ester”, “octadiynyl dU”, “his tag”, “NGS”, “phase M2 DNA”, “Tts”, “PRD1”, “Bst”, etc.” where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 2, 4, 5, 8-10, 12, 16-19 and 22 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1, 8 and 22 are indefinite for the recitation of the terms “the step” or “the steps” such as recited in claim 1, line 1. There is insufficient antecedent basis for the terms “the step” or “the steps” in the claim. The Examiner suggests that Applicant amend the claim to recite, for example, “comprising a step of amplifying nucleic acids” or, “comprising amplifying nucleic acids”.
Claim 8 is indefinite for the recitation of the term “the nucleic acid” such as recited in claim 8, line 2. There is insufficient antecedent basis for the term “the nucleic acid” in the claim because claim 1, lines 3-4 recites the term “a target nucleic acid”.
Claim 8 is indefinite for the recitation of the term “amplified with the first primer” such as recited in claim 8, line 3 because claim 8 depends from instant claim 1, wherein claim 1 recites that the amplification reaction comprises a first primer, base sequence, and a second primer, such that the nucleic acid is amplified with all of the recited components and, thus, the metes and bounds of the claim cannot be determined.
Claim 9 is indefinite for the recitation of the term “combined with a capture material” such as recited in claim 9, line 2 because claim 9 depends from instant claims 1 and 8, wherein claims 1 and 8 do not recite the presence of a capture material and, thus, the metes and bounds of the claim cannot be determined.
Claim 10 is indefinite for the recitation of the terms “acrylic” and “acrylic group” such as recited in claim 10, line 4 because the term “acrylic” refers to a family of synthetic plastics, paints, and fibers made from acrylic or methacrylic acid compounds, such that it is unclear which synthetic plastics, paints, and fibers are encompassed by the broad term “acrylic”. Additionally, the term “acrylic group” does not represent or identify a functional group known in organic chemistry (e.g., such as an acrylate group or an acryloyl group) and, thus, the metes and bounds of the claim cannot be determined.
Claim 10 is indefinite for the recitation of the term “the base sequences” such as recited in claim 10, line 7. There is insufficient antecedent basis for the terms “the base sequences” in the claim.
Claim 10 is indefinite for the recitation of the term “the NGS sequencing adapter” such as recited in claim 10, line 7. There is insufficient antecedent basis for the terms “the NGS sequencing adapter” in the claim.
Claim 12 is indefinite for the recitation of the term “double-stranded or single-stranded nucleic acids” such as recited in claim 12, lines 2-3. There is insufficient antecedent basis for the term “double- stranded or single-stranded nucleic acids” in the claim because claim 1, lines 3-4 recites the term “a target nucleic acid”.
Claim 18 is indefinite for the recitation of the term “the samples are plural”, “the target nucleic acids are plural and different from each other”, “the first primers are plural and different from each other” and “the second primers are plural and different from each other” such as recited in claim 16, lines 3-12 because claim 18 depends from instant claim 1, wherein claim 1 does not recite that each of the components is plural (e.g., present as a plurality) and, thus, the metes and bounds of the claim cannot be determined.
Claim 18 is indefinite for the recitation of the term “are fixed” such as recited in claim 18, line 11 because it is completely unclear what the term “are fixed” is referring to, and whether the term is referring to second base sequences that “fixed” such as by formaldehyde, fixed to a substrate or surface, repaired, etc. and, thus, the metes and bounds of the claim cannot be determined.
Claim 19 is indefinite for the recitation of the term “is added at 0.1 to 10 mol %” such as recited in claim 19, line 2 because it is unclear whether the term is referring to a difference in concentration between the primers, a difference in number, a difference in length, or some other difference and, thus, the metes and bounds of the claim cannot be determined.
Claim 22 is indefinite for the recitation of the term “the plurality of the samples” such as recited in claim 22, lines 3-4. There is insufficient antecedent basis for the term “the plurality of the samples” in the claim because claim 1, line 3 recites the term “a sample”.
Claim 22 is indefinite for the recitation of the term “the pooled nucleic acids” such as recited in claim 22, line 8. There is insufficient antecedent basis for the term “the pooled nucleic acids” in the claim because claim 22, line 6 recites the term “pooling of the fragmented nucleic acids”.
Claims 2, 4, 5, 16 and 17 are indefinite insofar as they ultimately depend from instant claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8, 9, 12 and 18 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites (in part): “which further comprises the step of selecting the nucleic acid amplified with the first primer” such as recited in claim 8, lines 1-3 because claim 8 depends from instant claim 1, wherein claim 1 recites amplifying nucleic acids by adding a first primer, base sequence, and a second primer, such that the nucleic acid is amplified with all of the recited components. Claim 1 does not recite that a nucleic acid is amplified with the first primer. Thus, claim 8 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites (in part): “wherein the first primer is combined with a capture material” such as recited in claim 9, lines 1-2 because claim 9 depends from instant claims 1 and 8, wherein claims 1 and 8 do not recite the presence of a capture material. Thus, claim 9 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites (in part): “at least 10 base sequences among the base sequences that make up the NGS sequencing adapter” such as recited in claim 10, lines 1-3 because claim 10 depends from instant claims 1, 8 and 9, wherein claims 1, 8 and 9 do not recite the presence of an NGS sequencing adapter. Thus, claim 10 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites (in part): “wherein the selection involves selecting double-stranded or single-stranded nucleic acids” such as recited in claim 12, lines 2-3 because claim 12 depends from instant claims 1 and 8, wherein claims 1 and 8 do not recite double-stranded or single-stranded nucleic acids. Thus, claim 12 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 18 recites (in part): “wherein the samples are plural and different from each other…and different from each other”” such as recited in claim 18, lines 2-12 because claim 18 depends from instant claim 1, wherein claim 1 does not recite that each of the components is plural (e.g., present as a plurality). Thus, claim 18 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 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.
Claims 1, 2, 4, 5, 8-10, 12, 16-18 and 22 are rejected under 35 U.S.C. 102(a1)/102(a2) as being anticipated by May et al. (hereinafter “May”) (US Patent Application Publication 20200102594, published April 2, 2020) as evidenced by Unger et al. (hereinafter “Unger”) (US Patent No. 7118910, issued October 10, 2006).
Regarding claim 1, May teaches a method for amplifying, tagging, and barcoding a plurality of target nucleic acids in a plurality of samples including preparing an amplification mixture for each target nucleic acid (interpreted as amplifying target nucleic acids in a sample, claim 1) (paragraph [0011]). May teaches in Figures 15A and 15B, an example of a multi-primer reaction set-up using 4 outer primers with different combinations of primer binding site and nucleotide tags (Example 5) (A), wherein two forward barcoded primers (454B-BC-Tag8, 454ABC- Tag8 and two reverse barcode primers (454A BC-Tag5, 454B-BC-Tag8) are combined with one inner primer pair (Tag8-TSF and Tag5-TSR) (B), wherein amplification comprises at least one cycle of the sequential procedures of: annealing at least one primer with complementary or substantially complementary sequences in at least one target nucleic acid; synthesizing at least one strand of nucleotides in a template dependent manner using a polymerase (interpreted as amplifying a target nucleic acid; a first target-specific primer and a second target-specific primer, each comprising a third base sequence (barcode) that hybridizes to the target; and a polymerase, claim 1) (paragraphs [0060]; [0096]; and Figure 15A & 15B).
Regarding claims 2 and 4, May teaches that primers have a length from at least 7 nucleotides to 50 nucleotides long, wherein the term “primer length” refers to the portion of an oligonucleotide or nucleic acid that hybridizes to the complementary “target’ sequence (interpreted as the first base sequence and third base sequence is from 4 to 10 bases; and a second base sequence is 4-35 bases, claim 2) (paragraph [0083], lines 7-15). May teaches that the term “oligonucleotide” refers to a nucleic acid that is relatively short including shorter than 50 nucleotides (interpreted as encompassing 4 to 10 nucleotides, claim 2) (paragraph [0082]).
Regarding claims 8 and 12, May teaches that where the target nucleotide sequences are to be sequenced by automated DNA sequencing, the first and second additional primer binding sites are capable of being bound by DNA sequencing primers (interpreted as selecting amplified nucleic acids for sequencing, claim 8) (paragraph [0031], lines 10-13). May teaches that after amplification, the PCR products were harvested from the Access Array Integrated Fluidic Circuit (Access Array IFC) using the Post-PCR IFC Loader AX (interpreted as selecting nucleic acids amplified with a first primer; and interpreting PCR products to be single-stranded or double-stranded, claims 8 and 12) (paragraph [0272]).
Regarding claims 9 and 10, May teaches that the forward primer additionally includes a first nucleotide tag, and if desired, the reverse primer can additionally include a second nucleotide tag (interpreted as the first primer being combined with a capture material, claim 9) (paragraph [0016]). May teaches that one or more of the forward primer, reverse primer, and barcode primer includes at least one additional primer binding site upstream of the barcode nucleotide sequence, wherein the additional primer binding sites are capable of being bound by DNA sequencing primers (interpreted as a capture material; and a polynucleotide at least 10 base sequences, claims 9 and 10) (paragraph [0128], lines 1-10 and 26-27). May teaches that for selective immobilization of the desired nucleic acids, the desired nucleic acids can be immobilized on a solid support, wherein an affinity moiety, such as biotin (e.g., photo-biotin), is attached to desired nucleic acid, and the resulting biotin-labeled nucleic acids immobilized on a solid support comprising an affinity moiety-binder such as streptavidin (interpreted as combining the first primer with a capture material (biotin and streptavidin); and biotin, photo-biotin, and biotin-labeled nucleic acids, claims 9 and 10) (paragraph [0248], lines 1-8).
Regarding claim 16, May teaches nucleotide polymerization in the presence of DNA or RNA polymerase or a reverse transcriptase (interpreted as DNA or RNA polymerase, claim 16) (paragraph [0083], lines 5-7).
Regarding claim 17, May teaches PCR and the use of Taq polymerase (paragraph [0103], lines 3-5). May teaches that PCR (polymerase chain reaction) is used to amplify and/or quantify target nucleic acid, wherein other amplification systems or detection systems can be used to detect amplification products, including, e.g., systems described in Unger et al., U.S. Pat. No. 7,118,910, which is incorporated herein by reference in its entirety (interpreted as encompassing T5 and T7 polymerases (paragraph [0227]), wherein polymerases for amplification include T7 RNA polymerase, AmpliTaq Gold polymerase, DyNAzyme polymerase, rTH polymerase XL, and Tgo DNA polymerase as evidenced by Unger (interpreted as T7 polymerases, etc., claim 17) (col 24, lines 29-31; and col 25, lines 6-18). May teaches enzymes, protocols, and kits for long-range PCR that are suitable for use in the methods described here are commercially available including: SequalPrep Long PCR Kit, PfuU!tra II Fusion HS DNA polymerase, Phusion DNA polymerases, Phusion Flash High-Fidelity PCR Master Mix (Finnzymes) (paragraph [0120]).
Regarding claim 18, May teaches a method for amplifying, tagging, and barcoding a plurality of target nucleic acids in a plurality of samples including preparing an amplification mixture for each target nucleic acid (interpreted as a plurality of target nucleic acids, claim 1) (paragraph [0011]). May teaches that the method entrails amplifying a plurality of target nucleic acids in a plurality of samples, wherein the same set of target nucleic acids can be amplified in each of two or more different samples (interpreted as a plurality of samples, claim 18) (paragraphs [0022]; and [0111], lines 6-8). May teaches one or more of the forward primer, reverse primer and barcode primer (interpreted as a plurality of first primers, and a plurality of second primers, claim 18) (paragraph [0031], lines 1-3). May teaches that each well or chamber in the device is prepared such that it contains a suitable tagged target-specific primers and a unique combination of forward and reverse barcode primers (interpreted as a plurality of unique first primers, and a plurality of unique second primers, claim 18) (paragraph [0137], lines 5-7). May teaches that emulsion PCR (emPCR) isolates individual DNA molecules along with primer-coated beads in aqueous droplets within an oil phase, wherein PCR produces copies of the DNA molecule, which bind to primers on the bead, followed by immobilization for later sequencing (interpreted as first primers that are fixed to a bead, claim 18) (paragraph [0134], lines 7-11).
Regarding claim 19 (in part), May teaches in Example 8 that PCR conditions were identical to those in Example 4 with the exception that primer concentrations were varied (interpreted as first primer and second primer at different concentrations, claim 19) (paragraph [0292]).
Regarding claim 22, May teaches that DNA sequencing techniques rely on “sequencing by synthesis”, which entrail library creation, massively parallel PCR amplification of library molecules, and sequencing, wherein library creation starts with conversion of sample nucleic acids to appropriately sized fragments, ligation of adaptor sequences onto the ends of the fragments, and selection for molecules properly appended with adaptors (interpreted as fragmentation, pooling, and preparation for NGS, claim 22) (paragraph [0124]). May teaches that PCR products for each sample were pooled based on concentrations calculated from the Agilent Bioanalyzer traces, wherein the product pool was purified using AMPure beads according to the manufacturer's instructions (interpreted as pooling and purifying amplification products, claim 22) (paragraph [0274]). May teaches that undesired components can be removed by purification (interpreted as purifying amplification products, claim 22) (paragraph [0247], lines 3-4).
May does not specifically exemplify a first primer added at 0.1 to 10 mol % compared to the second primer (claim 19, in part).
May meets all the limitations of the claims and, therefore, anticipates the claimed invention.
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 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.
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.
Claims 1, 2, 4, 5, 8-10, 12, 16-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over May et al. (hereinafter “May”) (US Patent Application Publication 20200102594, published April 2, 2020) in view of Cherkasov et. al. (hereinafter “Cherkasov”) (US Patent No. 10612082, issued April 7, 2020) as evidenced by Unger et al. (hereinafter “Unger”) (US Patent No. 7118910, issued October 10, 2006).
The teachings of Hacohen as applied to claims 1, 2, 4, 5, 8-10, 12, 16-18 and 22 are described supra.
May does not specifically exemplify a first primer added at 0.1 to 10 mol % compared to the second primer (claim 19, in part).
Regarding claim 19 (in part), Cherkasov teaches that the concentrations of primer 1, primer 2 and activator oligonucleotide used are for example in ranges between 0.01 μmol/l and 100 μmol/1, wherein the high concentration of components can increase the rate of the amplification, wherein the respective concentrations of individual components can independently be varied in order to achieve the desired reaction result (interpreted as a concentration of a first primer added at 0.1 to 10 mol % compared to the second primer, claim 19) (col 10, lines 25-32). Cherkasov teaches that toward the end of an amplification reaction the main product of the reaction (the nucleic acid to be amplified) can mainly be single-stranded or mainly form a complementary double strand, such that this can be determined by the relative concentrations of both primers and the appropriate reaction conditions (col 18, lines 9-14). Cherkasov teaches that the concentration of the first primer oligonucleotide comprises ranges of 0.01 μmol/l to 50 μmol/l, preferably of 0.1 μmol/l to 10 μmol (interpreted as first primer added at 0.1 to 10 mol% as compared to second primer, claim 19) (col 43, lines 46-49). Per MPEP 2144.05(II)(A), it is noted that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).”
It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of achieving a desired reaction result as exemplified by Cherkasov, it would have been prima facie obvious for one of ordinary skill in the art at the time the invention was made to modify the method of amplifying, tagging, and barcoding a plurality of nucleic acids in a plurality of samples as disclosed by May, to include varying the concentration of components in the amplification mixture including varying the concentration of the first primer relative to the concentration of the second primer as taught by Cherkasov with a reasonable expectation of success in achieving a desired reaction result such as preparing DNA sequencing libraries having good coverage; and/or in producing amplicons suitable for automated DNA sequencing.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly
rejected under 35 USC §103(a) as obvious over the art.
Conclusion
Claims 1, 2, 4, 5, 8-10, 12, 16-19 and 22 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/AMY M BUNKER/
Primary Examiner, Art Unit 1684
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