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 Rejections - 35 USC § 112
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 6 and 7 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.
Claim 6 recites the limitation "the copy of the target nucleic acid". There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends from claim 6 and is rejected for the same reason.
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)(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.
Claim(s) 1-7, 11-13, 15-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tsai et al. (WO2016/028887, IDS ref).
Regarding claim 1, Tsai et al. discloses a method of detecting a target nucleic acid (where, for a minority species in a mixture of nucleic acids, the minority species can be specifically captured, isolated from the rest of the nucleic acids in the sample, and subsequently detected, Para. [0105]), the method comprising: obtaining a sample comprising a target nucleic acid (providing a nucleic acid sample comprising a target region, Para. [0007]); binding a protein to the target nucleic acid in a sequence-specific manner (providing two guide RNAs, wherein a first guide RNA comprises a sequence complementary to a first location within the nucleic acid sample that is 3’-adjacent to the target region and a second guide RNA comprises a sequence complementary to a second location within the nucleic acid sample that is 5'-adjacent to the target region; then exposing the guide RNAs to Cas9 endonucleases such that each of the guide RNAs is bound to one of the Cas9 endonucleases to form a sgRNA-Cas9 complex; and then combining the sgRNA-Cas9 complex with the nucleic acid sample under conditions that promote binding of the sgRNA-Cas9 complex to the nucleic acid sample at the first location and the second location, Para. [0007]); digesting non-target nucleic acid in the sample (thereafter subjecting the nucleic acid sample to Cas9 cleavage, wherein the Cas9 endonucleases cleave the nucleic acid sample at the first location and the second location, Para. [0007]; where subsequent enrichment steps use exonuclease digestion, Para. [0072]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to the digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]); and detecting the target nucleic acid (whereby, for a minority species in a mixture of nucleic acids, where it is desired to determine whether a sample comprises a particular minority species, the minority species can be specifically captured, isolated from the rest of the nucleic acids in the sample, and subsequently detected, Para. [0105]).
Regarding claim 2, Tsai et al. discloses the method of claim 1, and further discloses amplifying the target nucleic acid with at least one primer that is resistant to degradation by a nuclease to yield an amplicon that includes a copy of the target nucleic acid and a terminal portion that is resistant to degradation by the nuclease (where enriched nucleic acids can be subjected to amplification to increase the total amount of nucleic acid in any subsequent procedures, where for example primer-binding sites in adapter regions can be used to PCR amplify the portion of the nucleic acid construct that they flank, Para. [0086]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]).
Regarding claim 3, Tsai et al. discloses the method of claim 2, and further discloses wherein digesting the non-target nucleic acid includes exposing amplicons to the nuclease (where enriched nucleic acids can be subjected to amplification to increase the total amount of nucleic acid in any subsequent procedures, where for example primer-binding sites in adapter regions can be used to PCR amplify the portion of the nucleic acid construct that they flank, Para. [0086]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to the digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]).
Regarding claim 4, Tsai et al. discloses the method of claim 3, and further discloses wherein the nuclease digests the non-target nucleic acid while the amplicon that includes the copy of the target nucleic acid is protected by the terminal portions (wherein stem-loop adapters are to be added to the nucleic acids prior to enrichment, such that amplification can be carried out either before or after addition of the adapters, Para. [0082]; where enriched nucleic acids can be subjected to amplification to increase the total amount of nucleic acid in any subsequent procedures, where for example primer-binding sites in adapter regions can be used to PCR amplify the portion of the nucleic acid construct that they flank, Para. [0086]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to the digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]; where all the techniques and apparatus described above can be used in various combinations, e.g., sequentially or simultaneously, Para. [0132]).
Regarding claim 5, Tsai et al. discloses the method of claim 2, and further discloses wherein the at least one primer that is resistant to degradation by a nuclease comprises an oligonucleotide with one or more phosphorothioate linkage (where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to the digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]; where a targeting RNA has modifications at one or both ends that protect the molecule from degradation, and where chemical modifications that can be used include, but are not limited to 2'-0-methyl modifications, and 2'-0-methyl-3'-phosphorothioate modifications, Para. [0075]).
Regarding claim 6, Tsai et al. discloses the method of claim 1, and further discloses wherein the protein comprises an RNA-guided protein complexed with a guide RNA, the guide RNA comprising a targeting portion that hybridizes to a complementary portion in the copy of the target nucleic add (comprising exposing said guide RNAs to Cas9 endonucleases such that each of the guide RNAs is bound to one of the Cas9 endonucleases to form a sgRNA-Cas9 complex, Para. [0007]; and then combining the sgRNA-Cas9 complex with the nucleic acid sample under conditions that promote binding of the sgRNA-Cas9 complex to the nucleic acid sample at the first location and the second location, Para. [0007]).
Regarding claim 7, Tsai et al. discloses the method of claim 6, and further discloses wherein the RNA-guided protein comprises a Cas endonuclease or a catalytically deficient homolog thereof (using a site-specific nicking enzyme, e.g., a mutant Cas9 nuclease having an inactivated nuclease domain, to nick a double-stranded fragment at or near a target region and subsequent treatment with T7 endonuclease I, or a derivative thereof, resulting in a double-strand break having an overhang sequence that can be used for specific ligation of an adapter having a complementary overhang, Para. [0064]).
Regarding claim 11, Tsai et al. discloses the method of claim 1, and further discloses wherein the digesting is performed with an exonuclease (wherein the mixture is optionally treated with exonucleases that degrade all the fragments that are not adapter linked, which effectively removes all fragments except those that are adapter linked, Para. [0070]; comprising adding adapters that are not susceptible to exonuclease digestion to both ends, which provides an added benefit where subsequent enrichment steps use exonuclease digestion, since only fragments capped by undigestible adapters will survive the treatment, Para. [0072]; where a double-stranded circular carrier is treated prior to use with one or more exonucleases to ensure there are no 3' or 5’ ends that could interfere with the enrichment procedure, e.g., by linking to adapters intended for the nucleic acids being enriched, which also ensures that the carrier will not be degraded in any exonuclease treatments that may be included in the enrichment process, Para. [0089]; where the mixture was subsequently treated with exonucleases Exolll and Exo VII, to degrade any nucleic acids that were not capped at both ends by a hairpin adapter, and the resulting mixture was purified twice using AMPure PB beads to remove the degraded non-target nucleic acids. The resulting mixture had non-target fragments with symmetric hairpin adapters, both A, and target fragments with asymmetric hairpin adapters, one A and one B, Para. [0120]).
Regarding claim 12, Tsai et al. discloses the method of claim 1, and further discloses wherein the protein comprises a Cas endonuclease complexed with a guide RNA, wherein the guide RNA comprises a targeting portion that hybridizes to a complementary portion in the target nucleic acid (providing two guide RNAs, wherein a first guide RNA comprises a sequence complementary to a first location within the nucleic acid sample that is 3'-adjacent to the target region and a second guide RNA comprises a sequence complementary to a second location within the nucleic add sample that is 5'-adjacent to the target region; then exposing the guide RNAs to Cas9 endonucleases such that each of the guide RNAs is bound to one of the Cas9 endonucleases to form a sgRNA-Cas9 complex; and then combining the sgRNA-Cas9 complex with the nucleic acid sample under conditions that promote binding of the sgRNA-Cas9 complex to the nucleic add sample at the first location and the second location, Para. [0007]).
Regarding claim 13, Tsai et al. discloses the method of claim 1, and further discloses wherein the protein comprises a transcription-activator like effector, TALE (where gene-editing technologies that introduce cuts at specific locations in a nucleic acid sample, and that can also be used in an analogous manner to enrich for a target region, include other RNA-directed endonucleases or other systems for site-specific cleavage such as for example, TAL Effector Nucleases, or TALENs, that can be engineered to create double-strand breaks at specific locations flanking a target region, Para. [0064]).
Regarding claim 15, Tsai et al. discloses the method of claim 1, and further discloses wherein detecting the target nucleic add includes hybridizing the target nucleic acid to a probe or to a primer for a detection amplification step, or labelling the target nucleic acid with a detectable label (where complementary oligonucleotide probes that anneal to a displaced strand typically comprise a moiety to facilitate selection and/or retention of bis-PNA/target/probe complexes such that they can be isolated from non-target nucleic adds in the sample, Para. [0045]; where an oligonucleotide probe can be a primer comprising a 3'-hydroxyl group that serves as a polymerase binding site in a primer extension reaction, Para. [0049]; where a complementary oligonucleotide provides additional functionality whereby for example, a detectable moiety can be linked, such as fluorophores, chromophores, chemiluminescent compounds, quantum dots, and radioisotopes, where said detectable moieties can be used in vitro, in vivo, or in situ to allow one to detect, identify, and/or quantitate the presence of the double-stranded target nucleic acid in a sample of interest, Para. [0049]; where at least one of stem-loop adapters are linked to the target region, comprising a primer binding site complementary to a nucleic add primer, where the nucleic acid primer may be complementary to a binding site entirely within the stem-loop adapter, or may be partially complementary to a portion of the target region immediately adjacent to the primer binding site in the stem-loop adapter, Para. [0007); where an oligonucleotide probe comprises a moiety, for example, a detectable label and/or an affinity tag, for example a biotin moiety, Para. [0006]).
Regarding claim 16, Tsai et al. discloses the method of claim 1, and further discloses binding the protein to the target nucleic add, digesting away non-target, dissociating the bound protein, and amplifying the target nucleic acid by a rolling circle amplification (where said guide RNAs are bound to one of the Cas9 endonucleases to form a sgRNA-Cas9 complex; combining the sgRNA-Cas9 complex with the nucleic add sample under conditions that promote binding of the sgRNA-Cas9 complex to the nucleic acid sample at the first location and the second location, Para. [0007]; where subsequent enrichment steps use exonuclease digestion, Para. [0072]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to the digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081] where the value of the sequencing data [subsequently) generated is substantially increased where a majority of the complex sample is removed prior to sequencing, Para. [0023]; where enriched nucleic acids can be subjected to amplification to increase the total amount of nucleic acid in any subsequent procedures, where for example primer-binding sites in adapter regions can be used to PCR amplify the portion of the nucleic acid construct that they flank, Para. [0086]; following the enrichment procedure, the pool of fragments enriched for the target region can be subjected to further manipulations, such as rolling-circle amplification, Para. [0090]; where a preferred polymerase for rolling-circle amplification is Phi29, Para. [0082]).
Regarding claim 17. Tsai et al. discloses the method of claim 1, and farther discloses wherein the sample comprises a liquid biopsy sample (where genomic nucleic acids can be collected from various sources including, but not limited to, whole blood, and biopsies, Para. (0026]).
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 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. in view of Stefano (US 6,297,010, IDS ref).
Regarding claim 8, Tsai et al. discloses the method of claim 1, and further discloses wherein the target nucleic acid includes a mutation (where enriched templates are native DNA that can be used for mutation detection, Para. [0096]).
Tsai et al. fails to explicitly disclose wherein the sample further includes homologous non-mutated nucleic acid, and the digesting step includes digesting the homologous non-mutated nucleic acid, amplified copies thereof, or both.
Stefano is in the field of molecular biology and medicine, as relates to methods of detecting and identifying mutations in nucleic acid sequences (Col. 1, Ln. 5-7), and teaches wherein a target nucleic acid includes a mutation (where a method for identification of one or more mutations in a plurality of sample polynucleotides comprises wherein polynucleotide duplexes are contacted by an agent which recognizes base pair mismatches under conditions which allow the agent to bind to the duplex at the mismatch to form a duplex:agent complex, where the mixture is then digested with a 3'—>5' exonuclease, and where a single-stranded adapter oligonucleotide is then ligated to the duplex termini and the sample polynucleotides are then amplified using primers, Col. 3, Ln. 66 - Col. 4, Ln. 12; where the primers used to generate and analyze DNA are terminated with a blocking group such as a cordecypin 3’ deoxyadenosine phosphate, propyl group or the like. Col. 14, Ln. 15-18), and wherein a sample further includes homologous non-mutated nucleic acid (where the sample polynucleotides may have identical or non-identical sequences. Col. 4, Ln. 1-2). Stefano furthermore teaches wherein a digesting step includes digesting homologous non-mutated nucleic acid, amplified copies thereof, or both (where the complex is then contacted with an agent that removes unprotected base pairs such as a 5'-3’ exonuclease to form a single-stranded region terminating at the position of the agent where the exonuclease is then removed or inactivated, and where a pair of “adapter” oligonucleotides of predetermined sequence, both having a short tract of degenerate sequence at their 3' ends are then ligated onto the digested sample strand 5’ termini, whereafter the undigested single-stranded 3’ overhangs left by the exonuclease and the unligated adapters are then degraded using a single-strand specific 3’-5‘ exonuclease, Col. 5, Ln. 15-25).
It would have been obvious to one of ordinary skill in the art, at the time of the claimed invention, to modify the method of Tsai et al. to further comprise the mutated target nucleic acid of Stefano. The motivation would have been to modify said method for the purpose of mutation identification/scanning, within a known genomic region (Col. 18, Ln. 62-65).
Regarding claim 9, modified Tsai et al. discloses the method of claim 8. Tsai et al. further discloses wherein the sample is from a patient, and method includes providing a report describing the mutation as present in the patient (where said method can be used to enrich target fragments comprising regions having diagnostic utility in patient management, Para. [0100]).
Regarding claim 10, modified Tsai et al. discloses the method of claim 9. Tsai et al. further discloses identifying a treatment based on the presence of the mutation in the patient and including the identified treatment option in the report (where said method can be used to enrich target fragments comprising regions having diagnostic utility in patient management, Para. [0100]; in order to better diagnose an individual to determine their risk of developing such a disorder, and potentially informing on an appropriate treatment for the individual, Para. [0100]).
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. in view of Gourguechon et al. (WO2017/031360, IDS ref).
Regarding claim 14, Tsai et al. discloses the method of claim 1, and further discloses amplifying the target nucleic acid with at least one primer that includes a phosphorothioate linkage to yield an amplicon that includes a copy of the target nucleic acid and the phosphorothioate linkage (where enriched nucleic acids can be subjected to amplification to increase the total amount of nucleic acid in any subsequent procedures, where for example primer-binding sites in adapter regions can be used to PCR amplify the portion of the nucleic acid construct that they flank, Para. [0086]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]; where a targeting RNA has modifications at one or both ends that protect the molecule from degradation, and where chemical modifications that can be used include, but are not limited to 2'-0-methyl modifications, and 2'-0-methyl-3'-phosphorothioate modifications, Para. [0075]), wherein the protein comprises a Cas endonuclease complexed with a guide RNA, wherein the guide RNA comprises a targeting portion that hybridizes to a complementary portion In the copy of the target nucleic acid (comprising exposing said guide RNAs to Cas9 endonucleases such that each of the guide RNAs is bound to one of the Cas9 endonucleases to form a sgRNA-Cas9 complex, Para. [0007]; and then combining the sgRNA-Cas9 complex with the nucleic acid sample under conditions that promote binding of the sgRNA-Cas9 complex to the nucleic acid sample at the first location and the second location, Para. [0007)), wherein digesting the non-target nucleic acid includes exposing the sample to an exonuclease (wherein the mixture is optionally treated with exonucleases that degrade ail the fragments that are not adapter linked, which effectively removes all fragments except those that are adapter linked, Para. [0070]; comprising adding adapters that are not susceptible to exonuclease digestion to both ends, which provides an added benefit where subsequent enrichment steps use exonuclease digestion, since only fragments capped by undigestible adapters will survive the treatment, Para. [0072]; where a double-stranded circular carrier is treated prior to use with one or more exonucleases to ensure there are no 3’ or 5' ends that could interfere with the enrichment procedure, e.g., by linking to adapters intended for the nucleic acids being enriched, which also ensures that the carrier will not be degraded in any exonuclease treatments that may be included in the enrichment process, Para. [0089]; where the mixture was subsequently treated with exonucleases Exolll and Exo VII, to degrade any nucleic acids that were not capped at both ends by a hairpin adapter, and the resulting mixture was purified twice using AMPure PB beads to remove the degraded non-target nucleic acids. The resulting mixture had non-target fragments with symmetric hairpin adapters, both A, and target fragments with asymmetric hairpin adapters, one A and one B, Para. [0120]), wherein the exonuclease digests the non-target nucleic acid while the amplicon that include the copy of the target nucleic acid is protected from digestion by the exonuclease by the phosphorothioate linkage (wherein stem-loop adapters are to be added to the nucleic acids prior to enrichment, such that amplification can be carried out either before or after addition of the adapters, Para. [0082]; where primers that are to be annealed prior to a nuclease degradation step are preferably resistant to the digestion, e.g. due to having a blocking group on any susceptible termini, Para. [0081]; where a targeting RNA has modifications at one or both ends that protect the molecule from degradation, and where chemical modifications that can be used include, but are not limited to 2-O-methyl modifications, and 2’-0-methyl-3'-phosphorothioate modifications, Para. [0075]).
Tsai et al. fails to explicitly disclose wherein said protection from digestion by an exonuclease further comprises protection by a bound Cas endonuclease.
Gourguechon et al. is in the field of methods for the efficient capture of nucleic acid regions of interest (Para. [0002]), and teaches protection from digestion by a nuclease, comprising protection by a bound Cas endonuclease (where, to enrich for certain regions from a human genomic DNA library, such as SNPs, guide RNAs targeting said regions were made and incubated with catalytically dead nucleic acid-guided nuclease, dCas9, Para. [0214]; whereby said catalytically dead nucleic acid-guided nuclease remains bound at the target locations and protects the regions of interests such as SNPs from being cleaved, whereby the DNA of interest remains intact, while all other DNA will be cleaved and eliminated, Para. [0214]; where, for proof of concept testing, mitochondrial DNA was enriched from a total human genomic DNA library, whereupon mitochondrial specific guide RNAs added to dCas9 were then added to the library, Para. [0215]; whereafter random guide RNAs complexed with Cas9 degraded any sequence, except for those inaccessible because already protected by bound dCas9, thereby allowing enrichment of the mitochondrial DNA, Para. [0215]).
It would have been obvious to one of ordinary skill in the art, at the time of the claimed invention, to modify the protection of Tsai et al. to further comprise protection from exonuclease digestion by the bound Cas endonuclease of Gourguechon. The motivation would have been to modify said method, for the purpose of capturing target nucleic acid sequences of interest (Para. [0073], Protocol 4, Fig. 10).
Claims 18 and 19 lack an inventive step under PCT Article 33(3) as being obvious over Tsai et al. in view of Diehl et al. (WO2010/014920, IDS ref)
Regarding claim 18. Tsai et al. discloses the method of claim 17, but fails to explicitly disclose wherein the target nucleic acid includes a mutation specific to a tumor.
Diehl et al. is in the field of cancer diagnosis, prognosis, therapeutics, and monitoring (Para. [0002]), and teaches wherein a target nucleic acid includes a mutation specific to a tumor (where tumor samples are used to identify a somatically mutated gene in the tumor that can be used as a marker of tumor in other locations in the body, for example, where a particular somatic mutation in a tumor can be identified by any standard means known in the art, including typical means such as direct sequencing of tumor DNA, using allele-specific probes, allele-specific amplification, Para. [0038]; where a sequence that is identified as somatically mutated in the tumor DNA of the patient is specifically determined in an ectopic body sample, Para. [0041]).
It would have been obvious to one of ordinary skill in the art, at the time of the claimed invention, to modify the target nucleic acid according to the method of Tsai et al. to further comprise the tumor mutation-specific target nucleic acid of Diehl et al. The motivation would have been to conduct said method for the purpose of detecting specific tumor mutations in nucleic acid (mutant DNA molecules offer unique advantages over cancer-associated biomarkers because they are so specific, Para. [0040]).
Regarding claim 19, modified Tsai et al. discloses the method of claim 18. Tsai et al. fails to explicitly disclose wherein the tumor mutation is present at no more than about 0.01% among matched normal, non-tumor nucleic acid.
Diehl et al. is in the field of cancer diagnosis, prognosis, therapeutics, and monitoring (Para. [0002]), and teaches wherein a tumor mutation is present at no more than about 0.01% among matched normal, non-tumor nucleic acid (where tumor samples are used to identity a somatically mutated gene in the tumor that can be used as a marker of tumor in other locations in the body, for example, where a particular somatic mutation in a tumor can be identified by any standard means known in the art, including typical means such as direct sequencing of tumor DNA, using allele-specific probes, allele-specific amplification, Para. [0038]; where a sequence that is identified as somatically mutated in the tumor DNA of the patient is specifically determined in an ectopic body sample, Para. [0041]; where circulating mutant DNA represents only a tiny fraction of the total circulating DNA, sometimes less than 0.01%, Para. [0004]).
It would have been obvious to one of ordinary skill in the art, at the time of the claimed invention, to modify the target nucleic acid according to the method of Tsai et al. to further comprise the tumor mutation-specific target nucleic acid of Diehl et al., present at no more than about 0.01% among matched normal, non-tumor nucleic acid. The motivation would have been to conduct said method for the purpose of detecting specific tumor mutations in nucleic acid (mutant DNA molecules offer unique advantages over cancer-associated biomarkers because they are so specific, Para. [0040]).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-19 of copending Application No. 18/514,333 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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, 6, 7, 11, 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,081,829. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘829 claim 1 is a species which anticipates the more generic instant claims.
Claims 1, 6, 7, 11, 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,370,700. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘700 claim 1 is a species which anticipates the more generic instant claims.
Conclusion
No claims are allowed.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681