DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status and Action Summary
This action is in response to the papers filed April 27, 2026.
Currently, claims 39-41, 45-54, and 58-64 are pending. Claims 60-64 were newly added in the amendment filed April 27, 2026.
Claims 39-41, 45-54, and 58-64 are under examination.
Any objections and rejections not reiterated below are hereby withdrawn.
The provisional double patenting rejection over copending application number 18/412,450 was withdrawn in the previous action in view of the approved terminal disclaimer filed in the application 18/412,450 over the present application.
Election/Restrictions
Applicant’s election without traverse of human gene locus EGFR and the corresponding variation COSM6224 (claims 20-32, 35-37, and 39-43) in the reply filed on October 2, 2024 is acknowledged.
Election was made without traverse in the reply filed on October 2, 2024.
Priority/Effective Filing Date
This application is a continuation filing of U.S. Patent Application No. 15/535,768 filed on June 14, 2017, which is a 371 of PCT/AU2015/050797, filed on December 15, 2015, and claims priority to Australian applications 2015903892 (filed September 24, 2015) and 2014905092 (filed on December 16, 2014).
AU2014905092 and AU2015903892 do not provide support for the claimed “reversed sequences”. Therefore, claims 39-41, 45-54, and 58-64 receive the benefit of priority to the December 15, 2015 PCT filing date.
Drawings
The drawings filed March 10, 2025 are acceptable.
Specification
The substitute specification filed March 10, 2025 is acceptable.
Claim Interpretation
The claims and specification use the term “ladder” in the context of mixtures of control oligonucleotides having defined properties relative to an unknown or mixture of unknown polynucleotides. The specification does not provide a special limiting definition for this term. In the molecular biology arts, the term “ladder” or “DNA ladder” typically refers to a standardized mixture of oligonucleotides having known molecular weights (i.e. length in base pairs), and in some instances, relative abundances, typically used in gel electrophoresis protocols and so called because of the well-defined and ideally well-resolved “bands” corresponding to each of the constituent oligonucleotides in the “ladder” mixture resembling “rungs” on a “ladder”.
However, the present application appears to utilize “ladder” broadly as a mixture of nucleic acid standards, and in preferred embodiments, as a mixture of nucleic acid standards having known concentrations in a mixture.
This alternate definition, while not as widespread in the relevant art, appears to be supported at least by Shahbazian et al., US 20150133314 A1 (filed August 15, 2014) which defines “a frequency ladder is composed of many variant [DNA fragments] at different frequencies” (Shahbazian et al., paragraph 0039).
As such, this claim term has been interpreted broadly as encompassing mixtures of polynucleotides wherein the constituent polynucleotides are of known molecular weight and/or known relative and/or absolute abundance.
The claim term “linkers physically linking the copies…” recited by claim 64 is not limited by any special definition in the specification. The only reference to “linker” in the specification appears to be in “Example 60” wherein “a small linker sequences that hosts a I-SceI restriction digestion site between individual DNA standards” (page 92). It is noted that a “linker physically linking the copies” of a particular first polynucleotide sequence and a particular second polynucleotide sequence does not appear to be particularly limited to any specific molecule other than those that are capable of physically linking two nucleic acid molecules. Therefore, the term “linker” is noted to encompass at least any of the following molecules: a polynucleotide sequence of unspecified length and unspecified sequence composition, a single phosphodiester linkage between the 3’ and 5’ termini of the first and second polynucleotides, respectively, or any other molecule suitable for the recited function “physically linking” the copies of the claimed polynucleotides.
Claim Objections
Claim 58 is objected to because of the following informalities: Claim 58 is presently recited on the same line as “55.-57. (Canceled)”. Claim 58 should begin on a new line, separated from preceding claims. 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(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.
Newly added claim 62 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
This is a new grounds of rejection necessitated by the amendments to the claims.
Claim 62 recites: “The composition of claim 62, wherein the first… second… third… and the fourth number of copies…”. It is unclear if claim 62 is meant to be an independent claim or a dependent claim referencing a previous claim.
If claim 62 is an independent claim, antecedent basis is lacking for each of: “the first number… the second number… the third number… and the fourth number” and “the conjoined synthetic polynucleotide”.
Newly added claim 62 is 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.
This is a new grounds of rejection necessitated by the amendments to the claims.
Claim 62 appears to be a dependent claim: “The composition of claim 62, wherein…” but references itself rather than a claim previously set forth.
In the interest of compact prosecution, the prior art has been applied to claim 62 under an interpretation wherein claim 62 depends from claim 61 because claim 61 is the only previous claim that recites antecedent basis for “a first… a second… a third… and a fourth number of copies” of “a first… a second… a third… and a fourth synthetic polynucleotide”, required by claim 62.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 39-41, 45-49, 52-54, and 58-64 are rejected under 35 U.S.C. 103 as being unpatentable over Shahbazian et al., US 2015/0133314 A1 (filed August 15, 2014) in view of WalkerPeach et al., US 6,395,470 B2 (issued May 28, 2002).
This is a new grounds of rejection necessitated by the amendments to the claims, now requiring “conjoined synthetic polynucleotide(s)”. It is noted that all of the references applied in this new grounds of rejection are already of record in previous rejections.
Regarding claims 39, 45-46, and 61 Shahbazian et al. teach synthetic nucleic acid molecules comprising multiple variants of a particular reference sequence, wherein the variants may be present in the synthetic nucleic acid molecules at a high- or low- frequency (Shahbazian et al., paragraphs 0003-0005), wherein the synthetic nucleic acid comprising multiple variants comprises a plurality of variants at different frequencies to provide a “frequency ladder” (Shahbazian et al., paragraph 0012) for quantitative “next-generation sequencing” assays (Shahbazian et al., paragraph 0026). Shahbazian et al. provide a generic example figure depicting a synthetic nucleic acid molecule comprising multiple variants of a particular reference sequence “Seq1-Seq10” (wherein the variants have equal copy numbers) and each constituent sequence is separated from the other constituent sequences by a polynucleotide (i.e. a linker) comprising a restriction enzyme site (“RE” in the figure below) (Shahbazian et al., figure 3, see below).
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Shahbazian et al. further teach the synthetic nucleic acids spaced by RE sites can be organized into “cassettes” (i.e. a repeating, modular arrangement exemplified in figure 3 above), wherein a typical cassette may vary between 50-20,000 base pairs in length (Shahbazian et al., paragraph 0029).
Shahbazian et al. further teaches exemplary arrangements wherein variants (i.e. control sequences) are included in the synthetic nucleic acid molecule at “different frequencies to provide a “frequency ladder”” (Shahbazian et al., paragraph 0012) (i.e. the number of copies of a first sequence is different from the number of copies of a second sequence… a third sequence… a fourth sequence… an Nth sequence… in a predetermined frequency (i.e. ratio/concentration in the composition, wherein the frequency (number of copies) of each are different)).
Shahbazian et al. further teach compositions wherein the synthetic polynucleotide frequency ladder functions as internal controls in sequencing reactions comprising target polynucleotides (Shahbazian et al., paragraph 0042) (i.e. an amount of a target polynucleotide…), and may explicitly comprise multiple components comprising control sequences that may be used together as a panel (i.e. different conjoined polynucleotides; the sequences of the different synthetic polynucleotides are different) (Shahbazian et al., paragraph 0032) (e.g. a first, a second, a third, a fourth… an Nth synthetic polynucleotide having a first, a second, a third, a fourth … an Nth number of copies).
Shahbazian et al. further teach the composition is a sequencing reaction and comprises a restriction enzyme “RE” (i.e. a fragmentation reagent of a NGS polynucleotide sample preparation kit) that separates the component synthetic polynucleotides (Shahbazian et al., paragraph 0042-0056).
Shahbazian does not teach that the first polynucleotide comprises an artificial portion of at least 100 contiguous nucleotides that has a same relative order as in a 5’ to 3’ portion of a target polynucleotide and are connected in the 3’ to 5’ direction wherein the 5’ to 3’ sequence of the control is distinguishable from the 5’ to 3’ sequence of the target polynucleotide (i.e. not a so-called “mirror repeat”).
However, WalkerPeach et al. teach internal control cassettes (i.e. synthetic polynucleotides) comprising a portion of a gene sequence wherein the 5’ to 3’ connectivity of the nucleic acid sequence is reversed (i.e. 3’ to 5’ direction) (WalkerPeach et al., figure 1 and column 4, lines 35-50). For example, WalkerPeach et al. teach such a cassette comprising a 148 base pair segment of the HSV gB gene, with the central 39 base pairs in the “reverse” orientation.
Furthermore, WalkerPeach et al. teach several advantages of inverted polynucleotide sequences as internal controls. Namely, WalkerPeach et al. teach the control sequence generated by inverting a target sequences shares many of the same biochemical characteristics of the target sequences (e.g. reaction kinetics, melting temperature, and nucleotide composition) (WalkerPeach et al., Column 5, line 18-27). In addition, and of particular import, WalkerPeach et al. teach:
“Another important feature of the present invention is the length and composition of the control sequence. The length and composition of the sequence amplified may affect the signal obtained from the assay. During polymerization, the action of the synthesizing enzyme may decrease as the length of the target sequences increases. So, the longer the target sequence, the more likely that it is that the PCR enzyme will fall off of the template before completing the synthesis of the replicated strand. Premature termination of polymerization results in a product that differs in length from the target sequence and that difference could be misread as a negative result. The positive control of the present invention eliminates this problem. Since the amplified region of the positive control plasmid is the same length as the target sequence, the rate of premature termination should be the same for both sequences. As a result, if there are apparent qualities of the target sequence which cause the PCR enzyme to fall off, those same characteristics should be present in the inverted control sequence and the PCR enzyme should fall off that sequence as well.” (WalkerPeach et al., column 6, line 24-45).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the positive control polynucleotide cassettes taught by Shahbazian et al. (see, for example, figure 3) to comprise a “reversed” sequence of the target polynucleotide or (a) variant(s) thereof, as taught by WalkerPeach et al. The ordinary artisan would have been motivated to modify the quantitative internal control polynucleotides of Shahbazian et al. with the “sequence reversing” taught by WalkerPeach et al. by the detailed scientific teachings of WalkerPeach et al. that reversing the molecular polarity of a naturally occurring polynucleotide sequence (i.e. 5’ to 3’ to 3’ to 5’) wherein the inverted control polynucleotide is the same length as the target polynucleotide. Furthermore, the ordinary artisan would have reasonably expected such a control polynucleotide to possess the most comparable biochemical properties possible for any given target polynucleotide sequence.
As such, the ordinary artisan would have had a reasonable expectation that the sequence reversing techniques of WalkerPeach would have produced an ideal control nucleic acid, especially for processes requiring replication of target and control nucleic acids (e.g. PCR, sequencing by synthesis, etc.) wherein the length and sequence composition of the control nucleic acid were known as particular results effective variables in the art that affect the processivity (i.e. the rate of “falling off”) of various enzymes on nucleic acid substrates (e.g. DNA polymerases). Shahbazian et al. in particular teach examples of control cassettes wherein the control polynucleotide sequence ranges in length from 50 to 20,000 base pairs (i.e. encompassing control polynucleotides having “at least 1000 nucleotides” and encompassing control polynucleotides having “no more than 10,000 contiguous nucleotides”).
Regarding claims 40-41 and 60, Shahbazian et al. teach that each of a large number of variants in the conjoined synthetic polynucleotide(s) are present at a high or a low frequency and may be present at a frequency of 1%, 10%, … or 0.1% (Shahbazian et al., paragraph 0061) (i.e. 0.1-10% of polynucleotides in the composition… compris[e] the artificial portion).
Shahbazian et al. further teach an advantage of the disclosed control materials is that the “truth” of a sample is known… the absolute frequency of a given variant or combination of variants present (Shahbazian et al., paragraph 0062-0063).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have optimized the frequency of any particular variant polynucleotide within the conjoined synthetic polynucleotide for any particular “true” ratio of variants/standards necessary in any particular known assay including those specifically listed in paragraph 0061 including 0.1% (i.e. less than 0.5%), 1%, and 10% (i.e. 1/1000, 1/100, and 1/10; the ratio between the first and the second is 1/10 and the ratio between the first and the third is 1/100). The ordinary artisan would have been motivated to select this particular combination of frequencies as a set of standards for any particular sequencing assay because, as described above, such a “ten-fold” series is routine in the art for calibrating measurements of frequency (i.e. concentration) of a particular variant in a population of nucleic acids.
Regarding claims 47 and 48, Shahbazian et al. teach the control reagent (i.e. the conjoined synthetic polynucleotide comprises DNA or RNA (Shahbazian et al., paragraph 0028).
Regarding claims 49 and 52-54, Shahbazian et al. teach the synthetic polynucleotides comprise target-associated regions comprising a reference sequence of a reference genome and/or one or more variants of the reference sequence (Shahbazian et al., paragraph 0027-0028), and in particular, that a control reagent may be designed from “a genome reference source (e.g. Genome Reference Consortium Human Reference 37 (GRCh37))” (Shahbazian et al., paragraph 0045) (i.e. a human reference genome; “hg19”).
Regarding claims 58 and 59, Shahbazian et al. teach synthesizing control sequences for “particular gene(s) of interest and/or variants thereof (e.g., those targeted by commercially-available NGS tests such as the AMPLISEQ Cancer Hotspot Panel v2)…” (Shahbazian, 0046) Shahbazian further teaches control polynucleotides comprising a portion of the EGFR gene locus (Shahbazian 0034) and multiple variants thereof including COSM6224 (Shahbazian, Tables 1 and 5) (i.e. the elected species, EGFR AND COSM6224).
Regarding claim 62, interpreted herein as depending from claim 61, Shahbazian et al. teach examples wherein a frequency ladder comprises ten different synthetic polynucleotide sequences (i.e. a first… a fourth), each having a different number of copies such that variants are present in a frequency ladder at 10 percent frequency increments form 0-100% (i.e. 10%, 20%, 40%, 80%; a copy number ratio of 1:2:4:8) (Shahbazian et al., paragraph 0042).
Regarding claim 63, Shahbazian et al. teach that the control reagents may be supplied as multiple plasmids (i.e. an additional conjoined synthetic polynucleotide standard), derived form a common vector (i.e. comprising a shared “first synthetic polynucleotide”), each control reagent having a particular “frequency” (i.e. copy number) for use in a “frequency ladder” (Shahbazian et al., paragraph 0042 and 0045-0056).
Regarding claim 64, Shahbazian et al. teach the conjoined synthetic polynucleotide comprises linkers linking the copies of the first synthetic polynucleotide and the copies of the second… such that a linker of the linkers is located between each of the copies… (Shahbazian et al., figure 3 (see above) and paragraph 0045-0056).
Claims 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Shahbazian et al., US 2015/0133314 A1 (filed August 15, 2014) and WalkerPeach et al., US 6,395,470 B2 (issued May 28, 2002) as applied to claims 39-41, 45-49, 52-54, and 58-64 above, and further in view of Zook et al., “Integrating human sequence data sets provides a resource of benchmark SNP and indel genotype calls.” Nat Biotechnol 32, 246–251 (2014).
Regarding claims 50-51, Shahbazian et al. teach the synthetic polynucleotides of the conjoined synthetic polynucleotide comprise target-associated regions comprising a reference sequence of a reference genome and/or one or more variants of the reference sequence (Shahbazian et al., paragraph 0027-0028), and in particular, that a control reagent may be designed from “a genome reference source (e.g. Genome Reference Consortium Human Reference 37 (GRCh37))” (Shahbazian et al., paragraph 0045) (i.e. a human reference genome; “hg19”).
Shahbazian et al. in view of WalkerPeach et al. does not teach sequence-reversed control polynucleotides are derived from a specific human reference genome, namely NA12878.
However, Zook teaches NA12878 as a “genome in a bottle”, “a whole-genome reference material… for sequencing and assessing variant-call accuracy and understanding biases.” (Zook, page 246, line 3-7).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to modify the conjoined synthetic polynucleotide taught by Shahbazian et al. in view of WalkerPeach et al. by selecting an extremely well characterized benchmark genome (i.e. a reference genome; from a specific human) as a source material for derived control polynucleotides as taught by Zook.
The ordinary artisan would have been motivated to use the NA12878 reference genome as taught by Zook as a source material for spike-in control polynucleotides for modification of the polynucleotides that are sequence-reversed taught by Shahbazian et al. in view of WalkerPeach et al. because Zook teaches that “high-confidence genotype calls from a well-characterized whole genome are useful for assessing biases and rates of accurate and inaccurate genotype calls in any combination of sequencing and bioinformatics methods. High-confidence genotype calls for publicly available genomes will be particularly useful for performance assessment of rapidly evolving sequencing and bioinformatics methods.” (Zook, page 251, column 1, paragraph 3)
Therefore, the ordinary artisan would have had a reasonable expectation that sequence-reversed polynucleotides derived from NA12878 would have been successful as spike-in controls for quantitation of the corresponding 5’ to 3’ sequences in an experimental sample.
Response to arguments:
The response traverses the 103 rejections of record of claims 39 and 45-48 over Jian, WalkerPeach, Tan, and Satinsky. The response asserts:
“the amended claims are non-obvious because none of the cited references, either alone or in combination, provide at least… “a conjoined synthetic polynucleotide comprising a first number of copies of a first synthetic polynucleotide; and a second number of copies of a second synthetic polynucleotide, different from the first number of copies…”, as claimed.”
These assertions of patentability are not persuasive, because it depends upon features which were not claimed in the previously rejected claims.
The amended and newly added claims have been addressed in the rejections above using references which were already of record, that were cited in the previous rejection to address features of the previously pending dependent claims.
The response further asserts “since each of the dependent claims depends from a base claim that is believed to be in condition for allowance, for the sake of brevity, applicant believes that it is unnecessary at this time to argue the further distinguishing features of the dependent claims… and reserves the right to specifically address the further patentability of the dependent claims in the future.”
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Furthermore:
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
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.
Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23, 32, and 38 of copending Application No. 19/663,889 (herein referred to as ‘889).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter in ‘889 is coextensive in scope with the present independent claim 39.
Claim 23 of ‘889 recites “a conjoined synthetic polynucleotide… comprising: a first number of copies of a first synthetic polynucleotide; a second number of copies of a second synthetic polynucleotide, different from the first number of copies, wherein the first number of copies and the second number of copies define a predetermined ratio of number of copies of the first and second synthetic polynucleotides… and one or more linkers physically linking the copies of the first synthetic polynucleotide and the second polynucleotide… wherein the first and second polynucleotide have different nucleotide sequences”. Claim 32 of ‘889, which depends from claim 23, further requires that “the first polynucleotide comprises an artificial portion of at least 100 contiguous nucleotides that… has a same relative order as in a 5’ to 3’ portion of a target polynucleotide… are connected in the 3’ to 5’ direction… wherein the 5’ to 3’ sequence of the artificial portion is distinguishable from the 5’ to 3’ sequence of the target polynucleotide. Claim 38 of ‘889, which also depends from claim 23, recites a composition comprising the conjoined synthetic polynucleotide of claim 23, a target polynucleotide, and a polynucleotide fragmentation reagent of a next-generation sequencing sample preparation kit.
Therefore, the present claim 39 differs from the cited claims of ‘889 only in that present claim 39 is a nearly verbatim combination of elements recited by claims 32 and 38 of ‘889, which each depend from independent claim 23 of ‘889. As such, the combination of elements as recited in present claim 39 would have been obvious over the claims of ‘889 at least because ‘889 claims 32 and 38 are each preferred embodiments of the claims of ‘889.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20, 23-24, and 31 of copending Application No. 19/664,002 (herein referred to as ‘002).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter in ‘002 is coextensive in scope with the present independent claim 39.
Claims 20 and 23-24 of ‘002 recite:
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Claim 31 of ‘002, further requires:
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Therefore, the present claim 39 differs from the cited claims of ‘002 only in that ‘002 recites “primer binding sites” and requires that the first and second polynucleotide are present in a 1:1 ratio in the conjoined synthetic polynucleotide.
As such, the composition recited by the present claim 39 would have been obvious over the combination of elements recited in the claims of ‘002, modified only by the ratio of numbers of copies of the first and second conjoined synthetic polynucleotides because they are each preferred embodiments of the claims of ‘002 and the modification of the ratio of the number of copies of the first polynucleotide to the second polynucleotide is an obvious variant of the claim elements as recited by ‘002.
Claim 39 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 19/631,308 (herein referred to as ‘308).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter in ‘308 is coextensive in scope with the present independent claim 39.
Claims 1-2 of ‘308 recite:
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Therefore, the present claim 39 reciting a conjoined synthetic polynucleotide comprising a first and second synthetic polynucleotide having a first and second number of copies in the conjoined synthetic polynucleotide… comprising an artificial portion… having a same relative order as in a 5’ to 3’ portion of the target polynucleotide and are connected in the 3’ to 5’ direction, wherein the 5’ to 3’ sequence… is distinguishable from the 5’ to 3’ sequence of the target polynucleotide anticipates the claims of ‘308.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/Z.M.T./Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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