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 .
Election/Restrictions
Applicant’s election without traverse of claims 1, 5, 6, 10, 14, 16, 29-31, and 33 (Group I) in the reply filed on 11/05/2025 is acknowledged.
Claims 36, 38, 46, 50, 52, 56, 59, 66, 68, and 84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/05/2025.
Applicant has traversed the election of species requirement, asserting that the species are so linked as to form a single general inventive concept. In response, a search of the prior art has obviated the rationale of the election of species requirement. Accordingly, the election of species requirement within the restriction requirement dated 08/05/2025 is hereby withdrawn.
Accordingly, claims 1, 5, 6, 10, 14, 16, 29-31, and 33 are pending and under consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest effective filing date to which the instant application is entitled is 06/10/2020.
Information Disclosure Statement
Receipt of information disclosure statements on 03/13/2023, 08/19/2024, and 10/29/2025 is acknowledged. The signed and initialed PTO-1449‘s have been mailed with this action.
Drawings
The drawings are objected to because:
Figures 1A-1G are disclosed to provide a schematic of the Type I-C CRISPR-Cas loci architecture of various Clostridium species (page 15, lines 30-34 of the instant specification). However, neither the drawing itself nor the associated brief description in the instant specification clarifies what the diamonds and rectangles indicate. For purposes of clarity, it would be remedial to specify, either in the drawing itself or in the associated brief description in the instant specification, what the depicted diamonds and rectangles indicate.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 6, 10, and 31 are objected to because of the following informalities:
Claims 1, 6, 10, and 31 all recite multiple SEQ ID NOs. In order to comport with standard grammatical conventions, multiple SEQ ID NOs are typically recited as “SEQ ID NOs: 1-4” (bolded and underlined emphasis added), wherein a space separates the first recited SEQ ID NO from the colon preceding it. The instant claims set forth above do not consistently include this space. It would be remedial to amend the instant claims such that a space separates the first recited SEQ ID NO from the colon preceding it for every recitation of SEQ ID NOs.
With specific regard to claim 1, in addition to the inconsistent inclusion of a space separating the first recited SEQ ID NO from the colon preceding it set forth above, there is a space missing in line 12 following the comma after “SEQ ID NOs: 103-105” and preceding the subsequent “or.” It would be remedial to amend the instant claim such that the missing space is properly included.
Furthermore, with specific regard to claim 1, while the instant specification defines a “CRISPR” at page 25, lines 12-24, this is not a term that is commonly used by those of ordinary skill in the art in the field without adding/clarifying what portion(s) of the CRISPR system are being invoked (i.e. a Cas from a CRISPR system, a CRISPR locus, a CRISPR array, etc.). Per page 25, lines 16-18 of the instant specification, a “CRISPR” refers to a nucleic acid molecule that comprises at least one CRISPR repeat sequence and at least one spacer sequence, which is consistent with the instant claim language. Thus, both the disclosure of the instant specification and the limitations of the instant claim read on a CRISPR array. As reviewed in Jiang and Dounda, 2017 (of record; previously cited in the restriction requirement dated 08/05/2025), a typical CRISPR locus comprises an array of repetitive sequences interspaced by short stretches of nonrepetitive spacer sequences. This structure is known as a CRISPR array (Figure 1). In order to ensure that those of ordinary skill in the art are able to easily and clearly interpret the instant claim language, it would be remedial to amend the instant claim language to clarify what CRISPR structure (i.e. a CRISPR array) is being claimed.
With specific regard to claim 10, line 3 recites “…the nucleotide the nucleotide sequence…”, which appears to be a simple typographical error wherein “the nucleotide” was mistakenly duplicated and incorporated into the instant claim set. It would be remedial to delete the duplicate “the nucleotide” from the instant claim language.
Appropriate correction is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 5, 6, 10, 14, 16, and 33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. The claims recite a recombinant nucleic acid construct, said construct comprising a Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) comprising one or more repeat sequences and one or more spacer sequences, as well as a cell comprising the same. The one or more repeat sequences are recited to comprise at least 24 consecutive nucleotides having at least 80% sequence identity to any one of the nucleotide sequences of SEQ ID NOs: 15-19, 34-35, 50-53, 68-71, 86-88, 103-105, or 120-121. The broadest reasonable interpretation of the claimed product is that it reads on a nucleic acid or fragment thereof found in nature. Accordingly, the claims recite natural phenomena.
The judicial exception is not integrated into a practical application.
With regard to claim 1, which recites “a recombinant nucleic acid construct comprising a Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) comprising one or more repeat sequences and one or more spacer sequence(s), wherein each of the one or more spacer sequences is linked at its 5’-end to a repeat sequence or potion thereof, and the spacer sequence is complementary to a target sequence (protospacer) in a nucleic acid of a target organism, wherein the target sequence is located immediately adjacent (3’) to a protospacer adjacent motif (PAM), wherein the one or more repeat sequences comprise at least 24 consecutive nucleotides having at least 80% sequence identity to any one of the nucleotide sequences of SEQ ID NOs: 15-19, [34-35, 50-53, 68-71, 86-88, 103-105, or 120-121]…”, it is well-known by those of ordinary skill in the art in the field that CRISPR systems naturally occur in prokaryotes as an evolved defense mechanism (reviewed in Hille and Charpentier, 2016). These CRISPR systems comprise CRISPR arrays, which themselves comprise repeat sequences that are interspersed by spacer sequences, said spacer sequences being derived from invading phages for purposes of mounting a defense response wherein the targeted phage sequence is degraded (see Figure 1 of Hille and Charpentier, 2016). The selection of the phage target sequence that is integrated into the CRISPR array is not random, but rather this selection is informed by the protospacer adjacent motif (PAM), which is crucial for acquisition and interference and is located directly next to the protospacer (Hille and Charpentier, 2016: page 3, column 1, paragraph 2). Thus, the architecture of the claimed recombinant nucleic acid construct reads on the natural structure of a CRISPR array occurring in prokaryotic species. Furthermore, regarding the specifically defined repeat sequences, the claimed SEQ ID NOs are all derived from naturally-occurring bacterial species, as set forth at Table 1 of the instant specification and supported by BLAST searching of said SEQ ID NOs. Therefore, claim 1 reads on a nucleic acid or fragment thereof found in nature and is directed to the judicial exception without significantly more.
With regard to claim 5, which additionally recites that “the PAM comprises a nucleotide sequence of 5’-TTC-3’, 5’-CTC-3’, or 5’-TTT-3’ that is immediately adjacent to and 5’ of the target sequence (protospacer),” as set forth above, the requirement of a PAM sequence for spacer acquisition is a known natural phenomenon (reviewed in Hille and Charpentier, 2016). Additionally, the instant specification explicitly discloses that the PAM sequences of the instant invention were derived from analysis of CRISPR spacer sequences extracted from the naturally-occurring CRISPR arrays of each of the strains described therein (Example 2). Therefore, claim 5 is also directed to the judicial exception without significantly more.
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With regard to claims 6 and 10, which respectively additionally recite that the claimed CRISPR construct further comprises a promoter or a terminator sequence that is operably linked to the CRISPR construct, wherein the promoter and terminator sequences are optionally limited to SEQ ID NOs: 122-133 and 134-142 (respectively), it is known that naturally-occurring CRISPR systems comprise promoters that drive expression of the same (Hille and Charpentier, 2016: page 3, column 2, paragraph 1) and that the palindromic nature of CRISPR repeat sequences serve as transcriptional terminator sequences (Martynov et al., 2017: page 4, paragraph 1). Furthermore, SEQ ID NO: 122 and SEQ ID NO: 134 are both natural sequences found in C. scindens and C. bolteae, as shown below.
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Both of these species are disclosed at Table 1 of the instant specification as species from which the CRISPR constructs of the instant invention were derived. The Examiner notes that some Clostridium clades have been reclassified as Enterocloster species, resulting in the divergent nomenclature shown in the BLAST results above (see Haas and Blanchard, 2020). Therefore, given that CRISPR systems are known to naturally comprise promoters and terminator sequences and that at least SEQ ID NOs: 122 and 134 are known to be natural sequences found in bacterial species from which the instantly claimed CRISPR constructs were derived, claims 6 and 10 read on a nucleic acid or fragment thereof found in nature and are also directed to the judicial exception without significantly more.
With regard to claim 14, which additionally recites “the spacer sequence is about 80% complementary to the target sequence,” as set forth above regarding instant claim 1, naturally-occurring CRISPR systems comprise CRISPR arrays, which themselves comprise repeat sequences that are interspersed by spacer sequences, said spacer sequences being derived from invading phages for purposes of mounting a defense response wherein the targeted phage sequence is degraded (see Figure 1 of Hille and Charpentier, 2016). Given that these spacer sequences are derived directly from the invading phages for future targeting, it is considered that the spacer sequences must naturally have greater than 80% complementarity to the target sequence. Therefore, claim 14 also reads on a nucleic acid or fragment thereof found in nature and is also directed to the judicial exception without significantly more.
With regard to claim 16, which recites “at least two of the…spacer sequence(s) comprise nucleotide sequences that are complementary to different target seuqences,” as set forth above regarding instant claim 1, naturally-occurring CRISPR systems comprise CRISPR arrays, which themselves comprise repeat sequences that are interspersed by spacer sequences, said spacer sequences being derived from invading phages for purposes of mounting a defense response wherein the targeted phage sequence is degraded (see Figure 1 of Hille and Charpentier, 2016). Thus, it is considered that naturally-occurring CRISPR systems are known to derive spacer sequences from multiple invading phages for purposes of mounting a defense response to the invading phages. Therefore, claim 16 also reads on a nucleic acid or fragment thereof found in nature and is also directed to the judicial exception without significantly more.
With regard to claim 33, which additionally recites “a cell comprising the recombinant nucleic acid of claim 1,” as set forth above, instant claim 1 encompasses subject matter that reads on a nucleic acid or fragment thereof found in nature. Given that cells are known to comprise genomic material (i.e. nucleic acid sequences), the additionally recitation of a cell comprising said nucleic acid sequence does not alter the broadest reasonable interpretation of the claimed product reading on a nucleic acid or fragment thereof found in nature. Therefore, claim 33 is also directed to the judicial exception without significantly more.
Viewed as a whole, the additional claim elements do not provide meaningful limitation(s) to transform the judicial exception such that the claims amount to significantly more than the judicial exception itself.
Claim 33 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
With regard to claim 33, which recites “a cell comprising the recombinant nucleic acid of claim 1,” the broadest reasonable interpretation of the term “cell” embraces a human having the cell. Neither the instant claim language nor the disclosure of the instant specification precludes this interpretation. It would be remedial to amend the instant claim to recite “an isolated cell” to avoid the claim embracing a human organism.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 6, 10, 14, 16, 29-31, and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a recombinant nucleic acid construct comprising one or more CRISPR repeat sequences and one or more spacer sequence(s). Claims 5, 6, 10, 14, and 16 directly depend from claim 1, while claims 23-31 and 33 all require the recombinant nucleic acid construct of claim 1. The rejected claims thus comprise a recombinant nucleic acid construct comprising up to an unlimited number of CRISPR repeat sequences and spacer sequences.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification describes experimentation with CRISPR arrays, such as those disclosed at Example 7 of the instant specification that comprise two repeats flanking a targeting spacer. No description is provided of a recombinant nucleic acid construct comprising up to an unlimited number of CRISPR repeat sequences and spacer sequences.
It is known that CRISPR arrays comprising CRISPR repeat sequences interspaced by spacer sequences (see Figure 1 of Jiang and Doudna, 2017 (of record; as cited in the restriction requirement dated 08/05/2025)) may have a wide range of numbers of repeat sequences and spacer sequences, wherein the CRISPR arrays of some CRISPR-Cas systems comprise only one or a few spacers, while others have dozens or even hundreds of spacers (Martynov et al., 2017: page 2, paragraph 1 of “Introduction”). However, the prior art is silent as to any CRISPR array comprising up to an unlimited number of CRISPR repeat sequences and spacer sequences, as is encompassed by the instant claim language.
In view of the disclosed examples and the accepted principles in the field reflected in the prior art and set forth above, the skilled artisan would have reasonably concluded that applicants were not in possession of the claimed invention for claims 1, 5, 6, 10, 14, 16, 29-31, and 33.
Furthermore, the repeat sequences of the nucleic acid construct of claim 1 are recited to comprise at least 24 consecutive nucleotides having at least 80% sequence identity to any one of the nucleotide sequences of SEQ ID NOs: 15-19, 34-35, 50-53, 68-71, 86-88, 103-105, or 120-121. As set forth above, claims 5, 6, 10, 14, and 16 directly depend from claim 1, while claims 23-31 and 33 all require the recombinant nucleic acid construct of claim 1. The rejected claims thus comprise a set of nucleic acids with a large number of variable residues, all variations of which must encode functional CRISPR array repeat sequences
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification describes the CRISPR repeat nucleotide sequences of SEQ ID NOs: 15-19, 34-35, 50-53, 68-71, 86-88, 103-105, or 120-121 (such as at page 41, line 4-page 42, line 13). Table 1 of the instant specification discloses that these CRISPR repeat nucleotide sequences correspond to different Clostridium species. No description is provided of CRISPR repeat nucleotide sequences having at least 80% identity to the instantly claimed sequences.
As set forth above, Table 1 of the instant specification discloses that different CRISPR repeat nucleotide sequences correspond to different species. As is known to those of ordinary skill in the art, CRISPR repeat sequences are known to display high sequence conservation, even across species, thereby facilitating horizontal acquisition of “pre-immunized CRISPR arrays” wherein the spacers acquired by one system may then be used by another system (reviewed in Yair and Gophna, 2019). However, these CRISPR repeat sequences have known sequence and structural features that make them well-suited for this purpose. Namely, CRISPR repeat sequences are nearly (but not necessarily completely) palindromic, which leads to relative stable RNA secondary structures transcribed from the repeats (reviewed in He and Deem, 2010). The instant claim language does not limit the claimed variants of the recited SEQ ID NOs such that this palindromic structure must be maintained. Furthermore, the instant specification is silent as to the essentiality of this palindromic structure, although it does disclose that the 3’ hairpin of mature C. scindens crRNA carries the palindrome within the CRISPR (page 85, lines 23-26).
Even if one accepts that the examples described in the specification meet the claim limitations of the rejected claims with regard to structure and function, the examples are only representative of the instantly claimed sequences (SEQ ID NOs: 15-19, 34-35, 50-53, 68-71, 86-88, 103-105, and 120-121). The results are not necessarily predictive of any nucleic acid construct comprising at least 24 consecutive nucleotides having at least 80% sequence identity to said sequences, as the claimed level of variation necessarily embraces sequences that do not have a palindromic structure (and thus would not function as a CRISPR repeat sequence) and sequences with a high number of variable residues that may or may not function as a CRISPR repeat sequence. Thus, it is impossible for one to extrapolate from the few examples described herein those nucleic acid constructs that would necessarily meet the structural/functional characteristics of the rejected claims.
The prior art does not appear to offset the deficiencies of the instant specification in that it does not describe a set of CRISPR repeat sequences with at least 80% sequence identity to SEQ ID NOs: 15-19, 34-35, 50-53, 68-71, 86-88, 103-105, and 120-121.
Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claims 1, 5, 6, 10, 14, 16, 29-31, and 33.
Furthermore, with specific regard to claim 30, which recites “the vector of claim 29 further compris[es] a recombinant nucleic acid encoding a Type I-C Cascade complex comprising a Cas3 polypeptide, a Cas5b polypeptide, a Cas8 polypeptide, and a Cas9 polypeptide,” the Examiner notes that the instant specification is entirely silent as to the instantly claimed Cas5b polypeptide. While the instant specification discloses Cas5 polypeptides (i.e. at Table 1), there is no support in the instant specification for the instantly claimed Cas5b species. Cas5b species are known to exist in nature, for example Gene ID: 13350762 (see attached NCBI Gene ID 13350762), the instant specification is entirely silent as to the claimed Cas5b polypeptide.
Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claim 30.
Finally, with specific regard to claim 31, claim 31 recites that the Cas polypeptides claimed therein (Cas3, Cas5, Cas8, and Cas7) each comprise a sequence having at least 80% sequence identity to any one of the amino acid sequences of SEQ ID NOs: 1, 20, 36, 54, 72, 89, or 106; SEQ ID NOs: 2, 21, 37, 55, 73, 90, or 107; SEQ ID NOs: 3, 22, 38, 56, 74, 91, or 108; and SEQ ID NOs: 4, 23, 39, 57, 75, 92, or 109, respectively. The rejected claim thus comprises a set of nucleic acids with a large number of variable residues, all variations of which must encode functional Cas polypeptides.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof. The specification describes SEQ ID NOs: 1, 20, 36, 54, 72, 89, or 106; SEQ ID NOs: 2, 21, 37, 55, 73, 90, or 107; SEQ ID NOs: 3, 22, 38, 56, 74, 91, or 108; and SEQ ID NOs: 4, 23, 39, 57, 75, 92, or 109 (corresponding to Cas3, Cas5, Cas8, and Cas7) at Table 1. No description is provided of Cas sequences having at least 80% identity to the instantly claimed sequences.
As is known to those of ordinary skill in the art, Cas polypeptides are enzymes (reviewed in Jiang and Doudna, 2017 (of record; previously cited in the restriction requirement dated 08/05/2025)). As is also known to those of ordinary skill in the art, the three-dimensional structure of any enzyme is crucial to its function, as its configuration can either facilitate or inactivate function (see Figure 3 of Jiang and Doudna, 2017 (of record; previously cited in the restriction requirement dated 08/05/2025)). The amino acid sequence of a polypeptide is known to determine the structure and function of said polypeptide, thereby affecting its function, as set forth above. While the instant specification does disclose the SEQ ID NOs set forth above corresponding to various Cas species, these examples are only representative of the instantly claimed sequences, and they are not necessarily predictive of the ability of any amino acid sequence with at least 80% identity thereto to form a polypeptide that is capable of functioning as a Cas enzyme. The instant specification is silent as to the essentiality of any particular residues or motifs, such as those that determine Cas configuration, including its active site.
Even if one accepts that the examples described in the specification meet the claim limitations of the rejected claim with regard to structure and function, the examples are only representative of polypeptides comprising 100% sequence identity to the SEQ ID NOs set forth above. The results are not necessarily predictive of any amino acid sequence with at least 80% identity to said SEQ ID NOs. Thus, it is impossible for one to extrapolate from the few examples described herein those amino acid sequences that would necessarily meet the structural/functional characteristics of the rejected claims.
The prior art does not appear to offset the deficiencies of the instant specification in that it does not describe a set of amino acids with at least 80% identity to SEQ ID NOs: 1, 20, 36, 54, 72, 89, or 106; SEQ ID NOs: 2, 21, 37, 55, 73, 90, or 107; SEQ ID NOs: 3, 22, 38, 56, 74, 91, or 108; and SEQ ID NOs: 4, 23, 39, 57, 75, 92, or 109 that correspond to Cas3, Cas5, Cas8, or Cas7.
Therefore, the skilled artisan would have reasonably concluded applicants were not in possession of the claimed invention for claim 31.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16 and 31 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 16, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “one or more spacer sequence(s)”, and the claim also recites “at least two of the…spacer sequence(s)”, which is a narrower statement of the range/limitation of one or more spacer sequence(s). The recitation of “one or more spacer sequence(s)” (also recited at instant claim 1) necessarily embraces embodiments with one spacer sequence. However, the full recitation of “at least two of the one or more spacer sequence(s)” cannot embrace embodiments with one spacer sequence, as at least two spacer sequences are required by the instant claim language. The claim is thus considered indefinite because it is unclear whether the bounds of protection sought include CRISPR constructs comprising one (or more) spacer sequences or comprising at least two spacer sequences. It would be remedial to amend the instant claim language such that one of ordinary skill in the art would be reasonably apprised of the bounds of protection sought regarding the spacer sequences of the claimed CRISPR constructs.
Claim 31 recites the limitation "the Cas5 polypeptide" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 30, from which claim 31 depends, recites “a Cas5b polypeptide” but not a Cas5 polypeptide, as in claim 31. It would be remedial to amend the instant claim language such that there is appropriate antecedent basis for all claim terms.
Conclusion
No claims are allowed.
Claims 1, 6, 10, and 31 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah E Allen whose telephone number is (571)272-0408. The examiner can normally be reached M-Th 8-5, F 8-12.
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/SARAH E ALLEN/ Examiner, Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637