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 of SEQ ID NO:12 as the first guide RNA targeting utrophin, SEQ ID NO:11 as the second guide RNA targeting EEF1a2, and SEQ ID NO:14 as the third guide RNA targeting utrophin, wherein the combination is encoded by SEQ ID NO:55 in the reply filed on May 15, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 1-3, 5-6, 9, 15, 20-23, 32-38, and 43-47 are currently pending in the instant application. Claims 5 and 43-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Accordingly, claims 1-3, 6, 9, 15, 20-23, and 32-38 are under examination on the merits in the instant application.
Specification
1. The disclosure is objected to because the brief description of Figures 1, 2A-2B, 3A-3E, and 4 fails to fully describe all numerical values including “130” and “120”.
2. The disclosure is objected to for containing sequence rule non-compliant subject matter. See page 28, line 21.
Appropriate correction is required as instructed below.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – The amino acid sequence appearing in the specification, see page 28, line 21, is not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/181,059, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. It is found that the ‘059 provisional application fails to adequately describe the structural arrangement as claimed in claim 3 and all dependent claims thereof. Accordingly, claims 3, 5-6, 9, 15, 20-21, and 23 are not entitled to the filing date of the ‘059 application.
Claim Rejections - Improper Markush Grouping
Claims 9, 15, and 22 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination of process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP §706.03(y).
The Markush grouping of sgRNAs complementary to the promoter region of 14 different genes as recited in claim 9 is improper because the alternatives defined by the Markush grouping do not share a significant nucleotide sequence similarity.
The Markush grouping of SEQ ID NOs:10-15 and 42-48 in claim 15 is improper because the alternatives defined by the Markush grouping do not share a significant nucleotide sequence similarity. For instance, SEQ ID NO:10 pertains to a dgFST sequence, whereas SEQ ID NO:11 pertains to a dgEef1a2 sequence.
The Markush grouping of SEQ ID NOs:3-6 and 53-55 in claim 22 is improper because the alternatives defined by the Markush grouping do not share a significant nucleotide sequence similarity. For instance, SEQ ID NO:3 comprises dgFst and dgUtrn sequences, whereas SEQ ID NO:55 elected by applicant comprises dgUtrnT2, dgUtrnNT2, and dgEef1a2 sequences.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternatives within a single claim in fact share a single structural similarity as well as a common use.
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 2-3, 6, 9, 15, 20-21, and 23 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.
The instant claims recite “a first cleavage site”, wherein the term “first” necessarily indicates the presence of a subsequent number (e.g., second, third) of cleavage sites. However, the claims do not recite an additional number of cleavage sites. Hence, it is unclear whether a subsequent cleavage site is inadvertently omitted in the claims or whether the “first” cleavage site should be treated as the only cleavage site include in the claimed nucleic acid.
Claim Rejections - 35 USC § 112
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 1-3, 6, 9, 15, 20-23, and 32-38 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.
The instant claims require “at least two modified MS2-binding loops comprising at least two nucleotide changes”, which “increase the GC content and/or shorten repetitive content of the modified MS2-binding loop sequence”. The broadly claimed “at least two nucleotide changes” in the modified MS2-binding loops read on a myriad of different nucleotide sequences of various lengths, whereas the instant specification at best appears to describe a single modified sequence of 5’-GGCCAGCATGAGGATCACCCATGCCTGCAGGGCC that is used to construct the instantly claimed multiplex system such as SEQ ID NO:55 elected by applicant. This single sequence is not a representative number of species that reflect the structural variants encompassed by the broadly written modified MS2-binding loops comprising “at least two nucleotide changes to the native MS2-binding loop sequence of SEQ ID NO: 16” in view of the art-recognized unpredictability/variability pertaining to the sgRNA activity depending on the actual MS2-binding loop sequence as evidenced by the widely variable, unpredictable target upregulation activity provided by different sgRNAs with differently modified MS2-binding loop sequences as illustrated in Figures 8A-8B of Hatanaka et al. (WO 2019/236081 A1, applicant’s citation), wherein the “MS2dgRNA scaffold was modified by changing the GC ratio, shortening repetitive sequences, or both.” See page 61.
Claims 2-3 and dependent claims thereof require “a first cleavage site and a third modified sgRNA”, wherein the “cleavage site” as broadly claimed encompasses any nucleotide sequence species having any cleavage site sequence including an art-recognized endonuclease restriction recognition site hexamer sequence. It appears that the instant specification at best describes a three sgRNA-expression system (e.g., SEQ ID NO:55 elected by applicant) comprises a 77-mer plant-derived Zea mays pre-tRNA sequence as the “first cleavage site” sequence. This single nucleotide sequence species is not a representative number of species that reflect the structural variants encompassed by the broadly written “cleavage site” in view of the art-recognized unpredictability/variability pertaining to the cleavage site-dependent sgRNA processing and subsequent gene editing efficiency. For instance, Xu et al. (Nucleic Acids Research, 2017, 45:e28) report that the plant-derived pre-tRNAGly-linked gRNAs provided “highly efficient” processing of the tRNA-gRNA transcript such that “tRNAGly cleaved both gRNAs very efficiently (close to 90%)”, whereas “only ~33% of the second gRNA” in the self-cleaving ribozyme-linked gRNAs was processed in the mature form. See page 7. In view of the teachings of Xu, the single species of Zea mays pre-tRNA sequence that is actually used to link the third sgRNA to the first or second sgRNA cannot represent the structure-function correlation required by the claimed construct.
Regarding “a sequence having at least 95% sequence identity to” SEQ ID NO:55 elected by applicant, the instant specification is completely silent as to which nucleotide positions of the 1,017-mer sequence can be altered while retaining the intended function of upregulating EEF1a2 and utrophin as there is no identification/disclosure of nucleotide sequence variants having up to about 55 nucleotides that are altered relative to SEQ ID NO:55. Since the function of the instantly claimed subject matter is highly nucleotide sequence-dependent, the single nucleotide sequence species within the genus of sequence variants that are at least 95% identical in sequence to SEQ ID NO:55 cannot satisfy a representative number of species representing the claimed sequence variants.
In view of the foregoing, it is concluded that the instant specification fails to adequately describe the entire genus of the claimed subject matter in the manner that reasonably conveys that the instant co-inventors had possession of the entire genus as of the filing date sought in the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (WO 2019/236081 A1, applicant’s citation) in view of Hunt et al. (US 2021/0079394 A1, applicant’s citation) and Pachuk et al. (US 2009/0298909 A1).
Hatanaka teaches making a construct comprising “MS2 dead sgRNA” (MS2dgRNA), is “modified by changing the GC ratio, shortening repetitive sequences, or both”, wherein the MS2dgRNA includes “14bp-TCAG-MS2dgRNA” (SEQ ID NO:23) comprising 5’-GGCCAGCAUGAGGAUCACCCAUGCCUGCAGGGCC, wherein the underlined two bases are altered from the corresponding bases “A” and “T” respectively in SEQ ID NO:16 of the instant application, thereby increasing the GC content. See page 61; Figure 8A.
Hatanaka demonstrates that SEQ ID NO:23 significantly increased gene regulation compared to unmodified or other modified gRNAs such that “14bp-TCAG-MS2dgLuc provided highest level of reporter activation”. See page 61; Figure 8B.
Hatanaka teaches that “one or more guide nucleic acid molecules can be present in a vector” further comprising a pharmaceutically acceptable carrier and also teaches making “kits that include one or more gRNAs provided herein (which may be part of a vector, such as an AAV vector”, wherein the “kits can further include a nucleic acid encoding a Cas9 protein or dCas9 protein”, wherein the “kits can further include a nucleic acid encoding an MS2-transcriptional activator fusion protein”. See pages 37-39.
Hatanaka teaches that “the TGA system further includes one or more additional gRNAs or dgRNAs, each containing a different targeting sequence than the first gRNA or dgRNA. Multiple additional gRNAs or dgRNAs can be used, each targeting a different gene of interest.” See page 45.
Hatanaka discloses that “injection of a combination of AAV-dgUtrn-T2-MPH and AAV-dgUTrn-T16 (dgUTrn-T2+T16)” into “transgenic Cas9/mdx mice” and that the targeted gene activation (TGA) system that increases the expression of utrophin can be used to treat muscular dystrophy. See pages 13, 45-46, and 66; Figures 13A-13B.
Hatanaka does not teach a vector structure comprising two dgRNAs each operably linked to a promoter as claimed in the instant case.
Hunt teaches making a nucleic acid construct comprising separate promoters, each of which is operably linked to a guide RNA sequence. See the following reproduced from Figure 1.
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Pachuk teaches making a construct (“50”) comprising three different short hairpin loop RNA (shRNA) sequences, each of which is operably linked to a separate promoter, wherein the first promoter (“U6 promoter) and the first shRNA sequence (“1907 shRNA”) are in reverse orientation, while the second promoter (“7SK promoter”) and the second shRNA sequence (“1737 shRNA”) are in forward orientation, wherein the three different shRNAs are produced/expressed in cells and reduced target expression as intended by the shRNAs. See Figures 1 and 3. See construct “50” reproduced from Figure 1 below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Hatanaka’s “combination of AAV-dgUtrn-T2-MPH and AAV-dgUTrn-T16 (dgUTrn-T2+T16)” by making and using a single nucleic acid structure comprising the two dgRNAs (dgUTrn-T2 and dgUtrn-T16), each of which is operably linked to a separate promoter in opposing orientation, wherein each dgRNA has the “TCGA-MS2” sequence that has been modified relative to the wild-type MS2 sequence. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make a single TGA construct, instead of two different ones, that can express two effective dgRNAs that upregulate UTRN expression because making a TGA system that includes more than one dgRNA was expressly taught and suggested by Hatanaka, and because one of ordinary skill in the art would have reasonably deemed a single combination construct simultaneously expressing dgUtrn-T2 and dgUTrn-T16 would be more convenient and cost-effective than two separate constructs each expressing the individual dgRNA. When making a single construct for expressing two dgRNAs, one of ordinary skill in the art would have reasonably sought an art-recognized vector expression system comprising two separate promoters each operably linked to one of the two dgRNAs in view of the teachings of Hunt. Since a combination vector construct expressing more than one RNA was known to effectively express multiple RNAs when the first RNA molecule sequence operably linked to a promoter is in reverse orientation compared to the second RNA molecule sequence operably linked to a second promoter as shown in Pachuk’s vector system, one of ordinary skill in the art would have reasonably pursued the art-recognized, art-identified vector construct design of Pachuk when making a single TGA vector encoding dgUtrn-T2 and dgUTrn-T16 such that, for instance, dgUtrn-T2 operably linked to a promoter is in reverse orientation relative to dgUTrn-T16 operably linked to a separate promoter in forward orientation.
Accordingly, claims 1 and 32-38 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 2-3, 6, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hatanaka et al. (WO 2019/236081 A1, applicant’s citation), Hunt et al. (US 2021/0079394 A1, applicant’s citation), and Pachuk et al. (US 2009/0298909 A1) as applied to claim 1 above, and further in view of Liao et al. (Cell, 2017, 171:1495-1507, applicant’s citation) and Xu et al. (Nucleic Acids Research, 2017, 45:e28).
The teachings of each of Hatanaka, Hunt, and Pachuk as well as the prima facie obviousness of claim 1 over the combined teachings of Hatanaka, Hunt, and Pachuk are described hereinabove thus will not be repeated herein.
It is noted that Hatanaka also discloses that “TCAG-MS2gRNA” comprising the modified MS2 sequence of SEQ ID NO:23, which provided the “highest level of reporter activation”, comprises the DNA sequence of SEQ ID NO:1 or the RNA sequence of SEQ ID NO:28 at page 34 as reproduced below.
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None of Hatanaka, Hunt, and Pachuk teaches SEQ ID NO:14 as the Utrn-targeting gRNA sequence.
Liao teaches that “T2” dgUtrn is the most effective dgRNA for upregulating Utrn expression. See Figures 6B and 6D.
Liao discloses the 14-mer gRNA sequence “dgUtrn-T2” in Table S1 as reproduced below.
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It is noted that SEQ ID NO:14 claimed in the instant case is a combination of the 14-mer sequence “dgUtrn-T2” consecutively linked to SEQ ID NO:1 of Hatanaka.
Xu teaches that two guide RNAs can be operably linked to a single promoter via an insertion of a self-cleaving ribozyme sequence or a self-cleaving tRNA sequence between the two guide RNAs, thereby enabling simultaneous editing of two or more gene sites via two or more gRNAs, wherein “[T]his strategy not only saves labor associated with constructing the plasmids, but also reduces the amount of CRISPR/Cas9 components, thus reducing the cost associated with manufacturing the reagents and the potential adverse side effects.” See Figures 1A and 6A; page 7.
Xu also teaches that the “usage of multiple promoters” “may not be a clinically viable option as it can increase the risk of adverse side effects occurring through off target effects and immunological complications.” See page 7.
Xu reports that a single expression cassette comprising a single promoter linked to four different gRNAs via three self-cleaving RNA sequences provided reduced gRNA processing thus reduced gene editing efficiency compared to an expression cassette comprising a single promoter linked to two gRNAs via a self-cleaving RNA sequence thus “there is a reduction in gRNA processing efficiency with an increased number of gRNAs.” See Figures 4C-D; page 5.
It would have been obvious to one of ordinary skill in the art before the effective filing date to further include a third dgRNA into the combination TGA vector construct rendered obvious in the above rejection, wherein the third dgRNA is operably linked to the first or second dgRNA via Xu’s self-cleaving RNA sequence. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to cost-effectively and labor-efficiently make a clinically viable expression system that simultaneously edits three gene sites while using a fewer number of promoters or a fewer number expression cassettes comprising separate promoters because use of multiple promoters was suggested as not being a clinically viable option due to the increased adverse side effects as evidenced by the teachings of Xu, who also taught that use of a self-cleaving RNA sequence linking two gRNA sequences under the same promoter can reduce labor and cost associated with manufacturing multiple promoters each linked to a single gRNA. As such, when adding a third dgRNA into the above TGA vector construct comprising two dgRNAs each linked to its own promoter, the first dgRNA-promoter being in the reverse orientation within the vector and the second promtoer-dgRNA being in the forward orientation within the vector, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to utilize the art-recognized, functional self-cleaving RNA sequence of Xu as a linker sequence and link the third dgRNA at the free, promoter-unliked terminus of the first gRNA or the second gRNA. When making a combination TGA vector system comprising Hatanaka’s dgUTrn-T2+T16 and a third dgRNA, it would have been obvious to one of ordinary skill in the art to readily envision that SEQ ID NO:14 claimed in the instant case is prima facie obvious as the nucleotide sequence is the combination of the 14-mer sequence “dgUtrn-T2” (5’-TTGAATAAAGGGCA) consecutively linked to SEQ ID NO:1 of Hatanaka.
Accordingly, claims 2-3, 6, 9, and 15 taken as a whole would have been prima facie obvious before the effective filing date.
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 1-3, 6, 9, 15, and 32-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 21-22, and 25-30 of copending Application No. 17/104,372 in view of Hatanaka et al. (WO 2019/236081 A1, applicant’s citation), Hunt et al. (US 2021/0079394 A1, applicant’s citation), Pachuk et al. (US 2009/0298909 A1), Liao et al. (Cell, 2017, 171:1495-1507, applicant’s citation), and Xu et al. (Nucleic Acids Research, 2017, 45:e28).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘372 claims, which are drawn to a vector encoding a dgRNA whose MS2-binding loop is modified such that “at least two nucleotide changes increase the GC content”. It would have been obvious to make a combination product as claimed in the instant case as making a system that simultaneously express multiple dgRNAs was an art-recognized goal as evidenced by Hatanaka and Xu, and because the structural limitations of the instant claims were prima facie obvious in view of the teachings provided by the combination of Hatanaka, Hunt, Pachuk, Liao, and Xu as explained in the §103 rejections above, which are fully incorporated by reference herein thus will not be repeated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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