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 .
Restriction/Elections
Applicant’s election without traverse of Group 2, claim 13, in the reply filed on 01/08/2026 is acknowledged. Applicant further elected a species directed to a Cumate-CuO regulable system.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/27/2023 and 06/09/2025 have been considered by the examiner.
Status of Claims
Applicant’s addition of dependent claims 14-20 is acknowledged. Claims 13-20 are pending in this application and under consideration. Claims 1-12 are cancelled.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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.
Appropriate action is required so that the sequences disclosed in the specification
comply with the sequence rules as discussed in MPEP 2421, MPEP 2422, and 37 CFR 1.821
through 1.825. Figures 13 and 15 fail to comply with the sequence rules.
The sequence rules embrace all unbranched nucleotide sequences with ten or more
nucleotide bases and all unbranched, non-D amino acid sequences with four or more amino
acids, provided that there are at least 10 "specifically defined" nucleotides or 4 "specifically
defined" or amino acids. The rules apply to all sequences in a given application, whether
claimed or not. All such sequences are relevant for the purposes of building a comprehensive
database and properly assessing prior art. It is therefore essential that all sequences, whether
only disclosed or also claimed, be included in the database. See MPEP 2421.02.
Applicant should carefully review the entire specification to ensure compliance with the
sequence rules. Applicant should provide a corresponding sequence identifier (SEQ ID NO) with
every appearance of a sequence embraced by the sequence rules. If a sequence embraced by
the sequence rules is lacking a corresponding sequence identifier (SEQ ID NO) in the instant
Sequence Listing, Applicant should provide the sequence in a substitute computer readable
form (CRF) copy and a substitute paper copy of the Sequence Listing, as an amendment
specifically directing its entry into the application. Applicant should also provide a statement that
the content of the paper and computer readable copies are the same and, where applicable,
include no new matter, as required by 37 C.F.R.1.821(e) or 1.821(f) or 1.821(g) or 1.825(b) or
1.825(d). Applicant should provide a statement indicating any changes made to the Sequence
Listing. Appropriate action is required in reply to this Office action. See attached PTO-2301.
Claim Objections
Claim 13 is objected to because of the following informalities: The claim recites the abbreviation CuO. The abbreviations should be spelled out in the first appearance in the claims and should be followed by abbreviation in parentheses. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: The claim recites the abbreviation Pol II. The abbreviations should be spelled out in the first appearance in the claims and should be followed by abbreviation in parentheses. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The claim recites the abbreviations snRNA, lncRNA, amiRNA, and circ-RNA. The abbreviations should be spelled out in the first appearance in the claims and should be followed by abbreviation in parentheses. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: The claim recites the abbreviations TK polyA and SV40 polyA V2. The abbreviations should be spelled out in the first appearance in the claims and should be followed by abbreviation in parentheses. Appropriate correction is required.
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 13-20 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.
Claims 13 and 17 recite the limitation "CuO". There is insufficient definition of the term “CuO” in the specification.
Dependent claims 14-16 and 18-20 are included in the basis of the rejection under 35 U.S.C. 112(b) because they do not correct the deficiencies of the claim on which they depend.
Claims 13-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "a gene whose expression needs to be precisely terminated". There is insufficient definition of the term “needs to be precisely terminated” in the specification to recognize the scope of the claim, to recognize a gene that requires precise termination, and to recognize what is considered “precise” termination.
Dependent claims 14-20 are included in the basis of the rejection under 35 U.S.C. 112(b) because they do not correct the deficiencies of the claim on which they depend.
Claim 16 is 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.
Claims 16 recite the limitation "SV40 polyA V2". There is insufficient definition of the term “SV40 polyA V2” in the specification and it is not a term of the art. Therefore, the metes and bounds of the term would be unclear to one of ordinary skill in the art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN107557363A, 2016; hereinafter Wu), and in further view of Mullick et al. (BMC Biotechnology, 2006; hereinafter Mullick).
The reference Wu (CN107557363A) was published in a non-English language, and the following rejection relies upon an English machine translation of the document generated by Google Patents. The citations below refer to the provided English translation. The figures of Wu are provided in the original non-English publication.
With regard to Claim 13, Wu teaches a method for packaging a lentivirus comprising transferring a lentiviral vector into a host cell, wherein the lentiviral vector packaging system comprises a vector for lentiviral packaging. See, for example, claims 5, 7, and 10 of Wu. Wu teaches a structural schematic diagram of the vector, wherein the lentiviral vector has the following elements in sequence from the 5’ end to the 3’ end: a 5’ long terminal repeat (LTR) element, a cPPT element, a first expression cassette which is reversely linked, an optional second expression cassette, a WPRE element, and a second LTR (sinLTR) element. See Figure 2 of Wu. The expression cassette which is reversely linked comprises a promoter, a gene of interest, and a polyA transcription termination signal sequence which are linked in sequence. See, for example, claim 5 of Wu. Wu also teaches that the packaging of the lentiviruses in all examples is the VSVG/ΔR8.91 system with three plasmids (pCMV-VSV-G, pCMVΔR8.91 and vector plasmid), which is a lentiviral packaging system capable of producing HIV vector particles having only primary infectivity and no replication capacity. See General Materials and Methods, page 6, second to last paragraph of Wu.
Wu does not teach that the lentiviral packaging is performed in the presence of a repressor or that the gene expression cassette comprises a repressible operon such as the Cumate-CuO regulable system wherein the gene of interest is a gene whose expression needs to be precisely terminated.
Mullick teaches a Ientiviral vector containing a Cumate-CuO regulatory system, and CuO is placed downstream of a CMV promoter and can control expression of an exogenous gene. See, for example, Figure 7 and Table 1 of Mullick. Mullick also teaches that the ability of inducible systems to regulate both the level and the duration of gene expression of transfected genes allows the study of proteins whose constitutive expression might not be tolerated by the cell. See page 2, left column, lines 1-5 of Mullick. This reads on regulation of a gene of interest whose expression needs to be precisely terminated. Mullick also demonstrates dose-dependent control of the reporter gene by cumate. See Figure 4 of Mullick.
Prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the lentiviral vector packaging system of Wu to further comprise a Cumate-CuO regulable system, in view of Mullick, to regulate both the level and duration of gene expression of transfected genes. One would have been motivated to make such a modification with a reasonable expectation of success to allow for expression of proteins whose constitutive expression would not be tolerated by the cell.
With regard to Claim 14, Wu teaches a method for packaging a lentivirus wherein the gene of interest is used to express a microRNA (miRNA), which is defined by Wu as a class of non-coding single-stranded RNA molecules encoded by endogenous genes with a length of about 20-24 nucleotides, with a promoter such as a CMV promoter, which is a Pol II promoter. See, for example, page 6, third paragraph and Contents of the Invention, page 4, line 2 of Wu.
With regard to Claim 15, as stated above Wu teaches a method for packaging a lentivirus wherein the gene of interest is used to express a microRNA (miRNA), which is defined by Wu as a class of non-coding single-stranded RNA molecules encoded by endogenous genes with a length of about 20-24 nucleotides. Wu further teaches that the most primitive form of miRNA is pri-miRNA which is processed by Drosha to become pre-miRNA, which is the precursor of miRNA, and the length is about 50-90 nucleotides; pre-miRNA is then processed by Dicer enzyme. After digestion, it becomes a mature miRNA with a length of about 20-24 nucleotides. The pre-miRNA of Wu reads on amiRNA of the instant case because the miRNA is produced from an artificial vector. See, for example, page 6, third paragraph of Wu.
With regard to Claim 16, Wu teaches that in a preferred embodiment, the transcription termination signal is herpes simplex virus thymidine kinase (HSV-TK) polyA transcriptional termination signal sequence, preferably HTpA. See Contents of the Invention, page 3, lines 29-30 of Wu.
With regard to Claim 17, Mullick teaches that insertion of CuO at two positions, either between the TATA box and the initiation site or 10 bases downstream of the TATA box, does not affect expression. Mullick cites debate in the literature regarding the role of site of insertion and findings from other work showing that positioning of the operator 10 base pairs downstream of the TATA box results in the repressor sterically blocking the polymerase most effectively. Mullick further teaches that work is in progress to understand DNA-CymR interaction and the sequences both in the repressor and in the DNA that participate in this interaction. See page 11, left column, last paragraph of Mullick. Mullick does not teach insertion of a CuO element of a Cumate-CuO regulable system 40 to 50 nucleotides from a TATA box.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); … Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").” See MPEP § 2144.05.
Mullick provides the general conditions of claim 17, which is a Cumate-CuO regulable system operably linked to the TATA box of a promoter. The distance of the CuO element from the TATA box is a result-effective variable, as shown by the teachings of Mullick regarding the CuO sequence insertion site and resulting effect on repression. One of ordinary skill in the art would have been motivated to optimize through routine experimentation the distance between the TATA box and the CuO insertion site given the teachings of Mullick. Absent a secondary consideration, the insertion site of a CuO element 40 to 50 nucleotides from the TATA box would have been prima facie obvious.
With regard to Claim 18, Wu teaches that the promoter can be a CMV promoter. See Contents of the Invention, page 4, line 2 of Wu.
With regard to Claim 19, Wu teaches that the vector for lentiviral packaging can optionally comprises a terminator operably linked to the coding sequence. See Contents of the Invention, page 3, lines 10-11 of Wu.
With regard to Claim 20, Wu teaches that the lentiviral vector packaging system is the VSVG/ΔR8.91 system which is a three-plasmid packaging system, and the three plasmids (pCMV-VSV-G, pCMVΔR8.91 and vector plasmid) are mixed according to a mass ratio of 1:3:4 and transfected into HEK293T cells. See General Materials and Methods, page 6, second to last paragraph of Wu.
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 13-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/265,820 (reference application) and in further view of Wu et al. (CN107557363A, 2016; hereinafter Wu), and Mullick et al. (BMC Biotechnology, 2006; hereinafter Mullick). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are rendered obvious by the copending claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 13, copending claim 1 recites, “A vector for lentiviral packaging, comprising a first long terminal repeat, a reversely inserted gene expression cassette, and a second long terminal repeat,
wherein the first long terminal repeat is positioned upstream of the reversely inserted gene expression cassette in a direction of viral genome expression,
the second long terminal repeat is positioned downstream of the reversely inserted gene expression cassette in a direction of viral genome expression,
the reversely inserted gene expression cassette comprises a promoter, a repressible operon and an optional gene of interest which are linked in sequence, and
the repressible operon is capable of repressing expression of the gene of interest downstream of the repressible operon in the presence of a repressor.”
Copending claim 13 recites, “A lentiviral vector packaging system, comprising a lentiviral packaging vector of claim 1, wherein the lentiviral vector packaging system is capable of producing HIV vector particles having only primary infectivity and no replication capacity.”
Copending claim 2 recites, “The vector for lentiviral packaging according to claim 1, wherein the repressible operon is selected from a tryptophan operon and/or a Cumate-CuO regulable system.”
The copending claims do not recite that the reversely inserted gene expression cassette comprises a polyadenylation signal which is linked in sequence or that the gene of interest is a gene whose expression needs to be precisely terminated.
As stated above in the rejection under 35 U.S.C. 103, Wu teaches a method for packaging a lentivirus comprising transferring a lentiviral vector into a host cell, wherein the lentiviral vector packaging system comprises a vector for lentiviral packaging. See, for example, claims 5, 7, and 10 of Wu. Wu teaches a structural schematic diagram of the vector, wherein the lentiviral vector has the following elements in sequence from the 5’ end to the 3’ end: a 5’ long terminal repeat (LTR) element, a cPPT element, a first expression cassette which is reversely linked, an optional second expression cassette, a WPRE element, and a second LTR (sinLTR) element. See Figure 2 of Wu. The expression cassette which is reversely linked comprises a promoter, a gene of interest, and a polyA transcription termination signal sequence which are linked in sequence. See, for example, claim 5 of Wu. Prior to the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of the copending claims by including a polyA transcription termination signal sequence as taught by Wu in the expression cassette to allow transcription termination of the gene of interest.
Mullick teaches a Ientiviral vector containing a Cumate-CuO regulatory system, and CuO is placed downstream of a CMV promoter and can control expression of an exogenous gene. See, for example, Figure 7 and Table 1 of Mullick. Mullick also teaches that the ability of inducible systems to regulate both the level and the duration of gene expression of transfected genes allows the study of proteins whose constitutive expression might not be tolerated by the cell. See page 2, left column, lines 1-5 of Mullick. This reads on regulation of a gene of interest whose expression needs to be precisely terminated. Mullick also demonstrates dose-dependent control of the reporter gene by cumate. See Figure 4 of Mullick. Prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of the copending claims to further comprise a Cumate-CuO regulable system, in view of Mullick, to regulate both the level and duration of gene expression of transfected genes. One would have been motivated to make such a modification with a reasonable expectation of success to allow for expression of proteins whose constitutive expression would not be tolerated by the cell.
Regarding instant claim 14, the copending claims do not recite that the gene of interest is used to express non-coding RNA promoted by Pol II promoter.
Wu teaches a method for packaging a lentivirus wherein the gene of interest is used to express a microRNA (miRNA), which is defined by Wu as a class of non-coding single-stranded RNA molecules encoded by endogenous genes with a length of about 20-24 nucleotides, with a promoter such as a CMV promoter, which is a Pol II promoter. See, for example, page 6, third paragraph and Contents of the Invention, page 4, line 2 of Wu. Prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of the copending claims to further comprise a gene of interest used to express non-coding RNA promoted by Pol II promoter to regulate gene expression of transfected genes. One would have been motivated to make such a modification with a reasonable expectation of success to allow for expression of proteins whose constitutive expression would not be tolerated by the cell.
Regarding instant claim 15, the copending claims do not recite that the non-coding RNA is selected from snRNA, lncRNA, amiRNA, or circ-RNA.
Wu teaches a method for packaging a lentivirus wherein the gene of interest is used to express a microRNA (miRNA), which is defined by Wu as a class of non-coding single-stranded RNA molecules encoded by endogenous genes with a length of about 20-24 nucleotides. Wu further teaches that the most primitive form of miRNA is pri-miRNA which is processed by Drosha to become pre-miRNA, which is the precursor of miRNA, and the length is about 50-90 nucleotides; pre-miRNA is then processed by Dicer enzyme. After digestion, it becomes a mature miRNA with a length of about 20-24 nucleotides. The pre-miRNA of Wu reads on amiRNA of the instant case because the miRNA is produced from an artificial vector. See, for example, page 6, third paragraph of Wu. Prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of the copending claims to further comprise that the non-coding RNA is selected from snRNA, lncRNA, amiRNA, or circ-RNA to regulate gene expression of transfected genes. One would have been motivated to make such a modification with a reasonable expectation of success to allow for expression of proteins whose constitutive expression would not be tolerated by the cell.
Regarding instant claim 16, copending claims do not recite that the polyadenylation signal is TK polyA or SV40 polyA V2.
Wu teaches that in a preferred embodiment, the transcription termination signal is herpes simplex virus thymidine kinase (HSV-TK) polyA transcriptional termination signal sequence, preferably HTpA. See Contents of the Invention, page 3, lines 29-30 of Wu. Prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the invention of the copending claims to further comprise that the polyadenylation signal is TK polyA or SV40 polyA V2 to regulate gene expression of transfected genes. One would have been motivated to make such a modification with a reasonable expectation of success to allow for expression of proteins whose constitutive expression would not be tolerated by the cell.
Regarding instant claim 17, copending claim 4 recites, “The vector for lentiviral packaging according to claim 2, wherein a distance between a site where a CuO element of the Cumate-CuO regulable system is inserted into the gene expression cassette and a TATA BOX of the promoter is 40 to 50 nucleotides.”
Regarding instant claim 18, copending claim 5 recites, “The vector for lentiviral packaging according to claim 1, wherein the promoter is CMV, EF1a, SFH, CAG, CBh, UBC, SFFV, SV40, RSV, mCMV, GAPDH, PGK, CASI, SMVP, GUSB or UCOE promoters.”
Regarding instant claim 19, copending claim 12 recites, “The vector for lentiviral packaging according to claim 1, wherein the vector for lentiviral packaging further comprises at least one of a reporter gene, an enhancer, an internal ribosome entry site, or a terminator.”
Regarding instant claim 20, copending claim 14 recites, “The lentiviral vector packaging system according to claim 13, wherein the lentiviral vector packaging system is a two-plasmid packaging system, a three-plasmid packaging system, or a four-plasmid packaging system.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH PHILIPOSE whose telephone number is (571)272-9562. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/H.P./Examiner, Art Unit 1631
/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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