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 .
Application Status
This action is written in response to applicant’s correspondence received 10 November 2025. Claims 86-92, 96-103, 105-108, 110-121 are currently pending. Claims 105-108, 111-116 are withdrawn from prosecution as being drawn to non-elected subject matter. Accordingly, claims 86-92, 96-103, 110, and 117-121 are examined herein. The restriction requirement mailed 27 December 2024 is still deemed proper. Applicant's elected Group I without traverse in the reply filed 26 February 2025.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant's amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow. Because the currently pending double patenting rejections of record and 35 USC 101 rejections were not necessitated by amendment, this rejection is NON-FINAL.
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 96-98 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.
Regarding claim 96, the claim recites that “the at least one of the nucleotide sequences that is operably connected to the promoter is heterologous to the at least one nucleotide sequence”. The scope of the claim is unclear because it is unclear what it means for a nucleic acid sequence to be heterologous to itself.
Regarding claims 97-98, the claims recite that at least one of the nucleotide sequences is operably connected to a constitutive promoter (Claim 97) or an inducible promoter (Claim 98). However, it is unclear if these claims are further limiting the promoter of claim 86 or if the claims are reciting new, second, promoters that are different from the promoter of claim 86.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 86-89 and 96-101 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1: Is the Claim to a Process, Machine, Manufacture, or Composition of Matter? YES.
Regarding claim 86, the claim(s) recite(s) “A CRISPR-Cas system comprising: one or more vectors […] encoding polypeptides of […] an amino acid sequence that is at least 90% identical to SEQ ID NO:2; b) […] an amino acid sequence that is at least 90% identical to SEQ ID NO:4; and c) […] an amino acid sequence that is at least 90% identical to SEQ ID NO:5; and (ii) a crRNA or guide RNA, or a nucleotide sequence encoding the crRNA or guide RNA; wherein the crRNA or guide RNA comprises a spacer that is cognate to a first protospacer in a target sequence”, wherein at least one of the nucleotide sequences is operably connected to a promoter that is […] (ix) a synthetic promoter.”
Therefore, the claim is drawn to a composition of matter.
Step 2A, Prong 1: Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES.
Per MPEP 2106.04(c), the pertinent analysis that will be applied to the claim is the markedly different analysis.
The appropriate counterparts to the currently claimed product of nature are as follows: 1) a naturally occurring [emphasis added] vector encoding polypeptides which comprise amino acid sequences that are at least 90% identical to SEQ ID NO:2 and 4-5; 2) a naturally occurring [emphasis added] crRNA or guide RNA, or a nucleotide sequence encoding the crRNA or guide RNA; wherein the crRNA or guide RNA comprises a spacer that is cognate to a first protospacer in a target sequence; and 3) a naturally occurring [emphasis added] promoter.
The appropriate characteristics identified for analysis are the physical structures of “a vector […] encoding […] a polypeptide which comprises an amino acid sequence that is at least 90% identical to SEQ ID NOs:2 and 4-5”, “a crRNA or guide RNA, or a nucleotide sequence encoding the crRNA or guide RNA; wherein the crRNA or guide RNA comprises a spacer that is cognate to a first protospacer in a target sequence”, and wherein “at least one of the nucleotide sequences is operably connected to a promoter that is […] (ix) a synthetic promoter”.
Regarding the physical structure of “one or more vectors comprising nucleotide sequences encoding polypeptides […]”, as the specification does not explicitly define a vector, the claim term is interpreted as encompassing naturally occurring bacterial chromosomes that possess no markedly different characteristics from naturally occurring bacterial chromosomes.
Regarding the physical structure of “a polypeptide which comprises an amino acid sequence that is at least 90% identical to SEQ ID NO:2 […] SEQ ID NO: 4 […] and SEQ ID NO: 5” and “a crRNA or guide RNA” identified above, particularly in view of the instant specification, the claimed limitations do not possess markedly different structural characteristics from a naturally occurring CRISPR/Cas polypeptide. Given the broadest reasonable interpretation of the claim limitations, the CRISPR-Cas system is interpreted as comprising three different CRISPR-Cas effector proteins, or nucleic acid encoding the CRISPR-Cas effector proteins, wherein the effector proteins comprise the claimed amino acid sequences having at least 90% identity to SEQ ID NOs: 2 and 4-5 alongside a crRNA or guide RNA that comprises a spacer that is cognate to a first protospacer in a target sequence.
The instant specification discloses that the claimed SEQ ID NO: 2 is a “Cas-S2.1 amino acid sequence” (pg. 150; see Table 4). The instant specification discloses that the claimed SEQ ID NO: 4 is a “Cas-S4.1 amino acid sequence” (pg. 150; see Table 4). The instant specification discloses that the claimed SEQ ID NO: 5 is a “Cas-S5.1 amino acid sequence” (pg. 150; see Table 4). The instant specification discloses the in-silico identification and in-vivo functional characterization of the previously uncharacterized CRISPR-Cas system, termed a "Type-S CRISPR/Cas system" (pg. 92). The instant specification discloses that the Type-S CRISPR/Cas is a nuclease-deficient system that comprises five Cas proteins, termed Cas-S1 to S5, and a cognate CRISPR array (pg. 97). The instant specification teaches that the cognate CRISPR array may encode a crRNA (pg. 40). The instant speciation teaches that natural target sequences, comprising protospacers, of the cognate CRISPR array were cloned into plasmids and the polypeptide sequences’ targeting efficiencies tested (pg. 93). In the specification, it is noted that the Type-S CRISPR/Cas system comprising Cas-S1 to S5 (i.e., a group comprising SEQ ID NOs: 2 and 4-5) were cloned into a plasmid termed p1793 (pg. 100). It is further noted that the specification identifies p1793 as a plasmid that contains “the wild type Type-S CRISPR/Cas system, Cas-S1 to S5, including the Type-S CRISPR array” (pg. 104).
However, the specification does not teach that SEQ ID NOs: 2 and 4-5 themselves [emphasis added] were modified in any manner as to change the wildtype sequences that were originally identified. Thus, the instant specification teaches a naturally occurring Type-S CRISPR-Cas system comprising the claimed amino acid sequences SEQ ID NOs: 2 and 4-5 alongside a crRNA or guide RNA that comprises a spacer that is cognate to a first protospacer in a target sequence.
Further, Becker (Genome Announcements 3.4 (2015): 10-1128), is the closest prior art and is drawn to a study concerned with the complete genome sequence of a Klebsiella pneumoniae strain (pg. 1). Becker teaches that NCBI accession numbers CP011313-CP011316 were assigned to the complete genome sequence (pg. 1). NCBI accession number CP011314 teaches that the Klebsiella pneumoniae genome encodes a polypeptide having 99.62% identity to the claimed SEQ ID NO: 1, a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 2, a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 3, a polypeptide having 99.57% sequence identity to the claimed SEQ ID NO: 4, and a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 5 (see region 142690-147664 and previously supplemental attachments for sequences).
Regarding the claimed clause “wherein at least one of the nucleotide sequences is operably connected to a promoter that is […] (ix) a synthetic promoter”. It is noted that the instant specification does not provide a special definition for the claimed “synthetic promoter”. Therefore, the broadest reasonable interpretation of a “synthetic promoter” is a promoter that was created synthetically, but comprises the exact same nucleotide sequence as a naturally occurring promoter sequence. Therefore, the broadest reasonable interpretation of the claimed “synthetic promoter” is a promoter that is identical to a naturally occurring promoter and comprises no markedly different characteristics.
Therefore, given the broadest reasonable interpretation of the claim, the claimed CRISPR/Cas effector system does not possess any markedly different characteristics from the naturally occurring CRISPR/Cas effector protein as described in the specification. Rather, the claimed CRISPR/Cas effector protein as currently recited is identical to the naturally occurring CRISPR/Cas effector protein as described in the specification.
Therefore, the CRISPR-associated Cas system as currently recited in claim 86 does not possess any markedly different characteristics when compared to a naturally occurring CRISPR-associated Cas system.
Step 2A, Prong 2: Does the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
This judicial exception is not integrated into a practical application because no additional elements are recited in the claims.
Step 2B: Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim itself does not recite any additional elements.
Thus, claim 86 is rejected under 35 U.S.C. 101 as being drawn to ineligible subject matter as defined in MPEP 2106.
Regarding claims 87-89 and 96-101, as described below, the claims are also rejected under 35 U.S.C. 101 as they are dependent on claim 86 and do not additionally recite either a markedly different characteristic, a practical application, or significantly more.
Regarding claims 87-89, the claims are directed towards additional polypeptide sequences that are at least 90% identical to the claimed SEQ ID NOs: 1 and 3. The claims refer to naturally occurring amino acid sequences as described by the specification (pg. 150; see Table 4).
Further, Becker (Genome Announcements 3.4 (2015): 10-1128), is the closest prior art and is drawn to a study concerned with the complete genome sequence of a Klebsiella pneumoniae strain (pg. 1). Becker teaches that NCBI accession numbers CP011313-CP011316 were assigned to the complete genome sequence (pg. 1). NCBI accession number CP011314 teaches that the Klebsiella pneumoniae genome encodes a polypeptide having 99.62% identity to the claimed SEQ ID NO: 1, a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 2, a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 3, a polypeptide having 99.57% sequence identity to the claimed SEQ ID NO: 4, and a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 5 (see region 142690-147664 and supplemental attachments for sequences).
Thus, the claimed SEQ ID NOs: 1 and 3 do not possess any markedly different characteristics when compared to nucleotide sequences encoding naturally occurring polypeptides.
Regarding claim 96, for the purposes of examination the claim is interpreted as limiting the claimed promoter of claim 86, wherein the promoter is structurally different than the at least one nucleotide sequences. Accordingly, the claimed promoter does not possess any markedly different characteristics from a naturally occurring promoter sequence that is linked to a nucleotide sequence of interest because promoter sequences are different than nucleotide sequences encoding amino acid sequences of interest.
Regarding claim 97, the claim is interpreted as limiting the promoter of claim 86. The instant specification teaches that E. coli genomes comprise naturally occurring constitutive promoters, including pBOLA (pg. 111). Thus, the claimed synthetic constitutive promoter is interpreted as encompassing a naturally occurring promoter.
Regarding claim 98, the claim is interpreted as limiting the promoter of claim 86. The instant specification teaches that the inducible promoter may be a pBAD promoter, as described in Guzman (Journal of bacteriology 177.14 (1995): 4121-4130) (pg. 117). Guzman is drawn towards a study concerned with an arabinose pBAD promoter (Abstract). Guzman teaches that the pBAD promoter is a promoter of an arabinose operon present in E. coli cells (pg. 4121).
Thus, the claimed synthetic inducible promoter is interpreted as encompassing a naturally occurring promoter.
Regarding claims 99-100, the claim further limits the vector of claim 86. However, the claim recites that the vector may be “a plasmid vector” or comprise a “bacterial plasmid backbone”. Thus, as the specification does not explicitly define a vector, the claim term is interpreted as encompassing naturally occurring bacterial chromosomes.
Claim 101 is directed towards different PAM sequences in the target sequence. The claim refers to at least one naturally occurring PAM sequences as described by the specification (pg. 103).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 86-89, 96, 99-100, 102-103, 110, and 117-119 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 100-101 of copending Application No. 18/763,680 in view of Ma (Molecular plant 8.8 (2015): 1274-1284).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 86, 96, 110, and 117-119, copending claim 1 claims a transmissible element comprising a nucleic acid modifier comprising a CRISPRi system. Copending claim 100 claims that the nucleic acid modifier is a fusion protein comprising a polypeptide comprising a Cas nuclease fused to a base editor. Copending claim 101 claims that the polypeptide comprises an amino acid sequence that is at least 90% identical to SEQ ID NOs: 1-5 and wherein the nucleic acid modifier further comprises a nucleic acid sequence encoding a guide RNA or crRNA. The copending claimed SEQ ID NOs: 2, 4, and 5 are each independently 100% identical to the instantly claimed SEQ ID NOs: 2, 4, and 5 (see attached sequence alignment).
Copending claims 1 and 100-101 do not claim the use of a vector or at least one promoter (Claim 86).
However, one of ordinary skill in the art would have considered the teachings of Ma as both references are common fields of endeavor pertaining to the use of CRISPR-Cas systems.
Ma is drawn towards a study concerned with CRISPR/Cas9 editing in monocot and dicot plants (Abstract). Ma teaches that CRISPR systems and their guide RNAs can be expressed from vectors and the CRISPR nuclease was placed under the control of a maize ubiquitin promoter while the guide RNAs are placed under the control of cloned U3 and U6 promoters from rice (i.e., the nucleotide sequences encoding the CRISPR nuclease and guide RNAs are operably connected to a promoter that is heterologous to the at least one nucleotide sequences) (pg. 1275-1276; see Figure 1). Ma teaches that CRISPR guide RNAs comprise spacers that are cognate to a protospacer in a target sequence of interest (pg. 1275). Ma teaches that utilizing the promoters allowed for the expression of the system in a plant cell and the subsequent editing of the plant cell’s genome (pg. 1279; see Figure 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the copending claimed system such that it was encoded on a vector and operably linked to a promoter that is heterologous to one of the nucleic acid sequences, as described by Ma. A person of ordinary skill in the art would have been motivated to do so in order to facilitate CRISPR-mediated genome engineering in pants. A person of ordinary skill in the art would have had a reasonable expectation of success because both the copending claims and Ma teach the use of CRISPR systems and guide RNAs. Further, Ma teaches that CRISPR systems and their guide RNAs can be encoded on vectors and operably linked to heterologous promoters.
Regarding claims 87-89, the copending claimed SEQ ID NOs: 1 and 3 are each independently 100% identical to the claimed SEQ ID NOs: 1 and 3 (see attached sequence alignment).
Regarding claims 99-100, Ma teaches that the backbone of the vector encoding the CRISPR system and the guide nucleic acids is based on the widely used pCAMBIA1300 plasmid vector, which has the capacity of maintaining relatively large inserts in E. coli and A. tumefaciens (i.e., Ma teaches the use of a bacterial plasmid backbone) (pg. 1276, 1280, 1282; see Figure 1).
Regarding claim 102-103, copending claims 100 and 101 claim identical limitations.
Claims 90-92, 101, and 120-121 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 100-101 of copending Application No. 18/763,680 in view of Ma (Molecular plant 8.8 (2015): 1274-1284) as applied to claims 86-89, 96, 99-100, 102-103, 110, and 117-119 above, further in view of Hua (Molecular plant 12.7 (2019): 1003-1014).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 90-92, 101, and 120-121, copending claims 1 and 100-101 in view of Ma render obvious instant claims 86-89, 96, 99-100, 102-103, 110, and 117-119 as described above.
The copending claims in view of Ma do not teach or suggest that the protospacer is not found in E. coli, Pseudomonas, and/or Klebsiella (Claim 90). The copending claims in view of Ma do not teach or suggest that the protospacer is not found in a bacterium which comprises endogenous nucleotide sequences that encode the claimed polypeptides (Claim 91). The copending claims in view of Ma do not teach or suggest that the protospacer is a eukaryotic cell protospacer (Claims 92 and 120). The copending claims in view of Ma do not teach or suggest that the protospacer is immediately adjacent to a PAM selected from 5’-AGG-3’ (Claims 101 and 121).
However, one of ordinary skill in the art would have considered the teachings of Hua as both references are common fields of endeavor pertaining to genome editing in plants via the use of CRISPR systems.
Hua is drawn towards a study concerned with genome engineering in plants using CRISPR variants that recognize NG PAM sequences (Abstract). Hua teaches that CRISPR systems can be engineered to target and edit a broader range of nucleic acid sequences of interest within plant cells via the use of relaxed PAMs (Abstract). Hua teaches the use of guide RNA molecules that can comprise protospacers that are immediately adjacent 5’-AGG-3’ PAM sequences in plants (i.e., Hua teaches that the guide molecules can target utilize protospacers that are not found in bacterium and are immediately adjacent to eukaryotic cell protospacers) (pg. 1007).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system rendered obvious by the copending claims in view of Ma such that the protospacer is not found in a bacterium and is immediately adjacent to a eukaryotic 5’-AGG-3’ PAM, as described by Hua. A person of ordinary skill in the art would have been motivated to do so in order to target nucleic acids present in plant cells with CRISPR systems through the use of a plant specific protospacer and PAM sequence. A person of ordinary skill in the art would have had a reasonable expectation of success because both Hua and the copending claims in view of Ma teach the use of CRISPR systems comprising a guide RNA that can be utilized to target nucleic acids of interest within plant cells.
Claims 97-98 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 100-101 of copending Application No. 18/763,680 in view of Ma (Molecular plant 8.8 (2015): 1274-1284) as applied to claims 86-89, 96, 99-100, 102-103, 110, and 117-119 above, further in view of Kummari (Journal of biosciences 45.1 (2020): 119).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 97-98, copending claims 1 and 100-101 in view of Ma render obvious instant claims 86-89, 96, 99-100, 102-103, 110, and 117-119 as described above.
The copending claims in view of Ma do not teach or suggest the use of a constitutive promoter (Claim 97) or an inducible promoter (Claim 98).
However, one of ordinary skill in the art would have considered the teachings of Kummari as both references are common fields of endeavor pertaining to the use of promoters within plant cells.
Kummari is drawn towards a review study concerned with the use of different promoters in plants (Abstract). Kummari teaches that promoters can be selected to develop transgenic plants via the expression of programmable DNA-binding proteins such as CRIPR proteins (pg. 119). Kummari teaches that inducible promoters can be utilized in plant cells to increased gene expression in a tissue of interest or at specific developmental stages and provide more predictable gene expression, with minimal or no penalties on final yield (pg. 118). Kummari teaches that constitutive promoters are promoters that express a gene of interest throughout a plant’s lifecycle, irrespective of the external factors, which can be beneficial for developing plants with insect resistance (pg. 118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the promoter of the copending claims in view of Ma for an inducible or constitutive promoter, as described by Kummari. A person of ordinary skill in the art would have been motivated to do so in order to express the CRISPR system at a specific developmental stage of the plant or to provide expression of the CRISPR system during the entirety of the plant’s lifecycle in order to provide the plant with insect resistance. A person of ordinary skill in the art would have had a reasonable expectation of success because both the copending claims in view of Ma and Kummari teach the use of promoters that can express CRISPR systems in plants.
Closest Prior Art
The closest prior art is Becker (Genome Announcements 3.4 (2015): 10-1128), is the closest prior art and is drawn to a study concerned with the complete genome sequence of a Klebsiella pneumoniae strain (pg. 1). Becker teaches that NCBI accession numbers CP0O11313- CP011316 were assigned to the complete genome sequence (pg. 1). NCBI accession number CP011314 teaches that the Klebsiella pneumoniae genome encodes a polypeptide having 99.62% identity to the claimed SEQ ID NO: 1, a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 2, a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 3, a polypeptide having 99.57% sequence identity to the claimed SEQ ID NO: 4, and a polypeptide having 100% sequence identity to the claimed SEQ ID NO: 5 (see region 142690- 147664 and previously attached sequence alignments).
However, Becker nor the prior art teaches or suggests that the claimed SEQ ID NOs: 1-5were known in the art to be part of a CRISPR-Cas system nor that the claimed SEQ ID NOs: 1-5 could function alongside crRNAs or guide RNAs (Claims 86 and 91). Becker nor the prior art teaches or suggests the use of a vector comprising nucleotide sequences encoding the claimed SEQ ID NOs (Claim 86). Becker does not teach or suggest the use of a protospacer that is not found in a bacterium which comprises endogenous nucleotide sequences which encode the polypeptides of claim 91 (Claim 91). Becker does not teach or suggest that the claimed SEQ ID NOs: 1-5 could be fused to a heterologous polypeptide in order to form a fusion protein (Claim 102).
Therefore, one of ordinary skill in the art would not have had a reasonable expectation of success in modifying the polypeptide sequences of Becker such that the claimed SEQ ID NOs could be utilized alongside, and complex with, a crRNA or a guide RNA that comprises a spacer that is cognate to a protospacer in a target sequence. Because the prior art does not characterize the claimed SEQ ID NOs, one of ordinary skill in the art would not have had a reasonable expectation of success in utilizing a crRNA or guide RNA alongside the claimed SEQ ID NOs in a system or fusing the claimed SEQ ID NOs: 1-5 to a heterologous polypeptide. Further, the prior art does not teach or suggest the surprising effect of utilizing the system to target nucleic acids without inducing cleave, as shown by Applicant (see Example 1.3.4 and FIG. 8 in instant specification).
Therefore, if all outstanding 35 USC 101, 112(b), and double patenting rejections of record are overcome, the claims would be placed in condition for allowance.
Response to Arguments
With regard to the previously pending rejections under 35 USC 101 and 112(b), Applicant’s arguments pertaining to the eligibility of the claims due to the incorporation of previously dependent claims is not found persuasive, as discussed above in the newly pending rejections of claims 86-89 and 96-101 under 35 USC 101 and 112(b) above.
With regard to the previously pending double patenting rejections of record, Applicant's amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance because the copending claims in view of Ma, Hua, and Kummari render the instant claims obvious, as described above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE T REGA whose telephone number is (571)272-2073. The examiner can normally be reached M-R 8:30-4:30, every other F 8:30-4:30 (EDT/EST).
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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636