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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 4/28/26. Claims 1, 2, 5-8, 10, 15, 18-21, 26, 28, 29, 31, 32, 36, 38-40, 42-47, and 50-52 are pending. Claims 38-40, 42-47, and 50-52 are withdrawn. Claims 1, 2, 5-8, 10, 15, 18-21, 26, 28, 29, 31, 32, and 36 are considered on the merits.
Election/Restriction Requirement
Applicant’s election without traverse of Group I, claims 1, 2, 5-8, 10, 15, 18-21, 26, 28, 29, 31, 32 and 36, in the reply filed on 4/28/26 is acknowledged.
The Election of Species is withdrawn since the claim amendments recite many of the species as alternative embodiments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 10, 15, and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 is confusing because it requires “nucleic acid sequences required for constituting a virus vector are about 10 kb or greater”. However parent claim 1 is not required to make a complete virus vector, but only have at least one gene required for constituting a virus vector, but not encoding a complete vector. It is unclear if claim 6 is further limiting claim 1 by increasing the number of nucleic acids in the plasmid. It is unclear how complete the virus vector must be and how many genes are required to accomplish this.
Claims 10 appears to include the simple “Ψ” which appears to mean ‘psi’. However this is unclear what gene is implied by this symbol and clarification is required.
Claim 15 contains the phrase:
wherein the plasmid does not comprise a sequence of a gene of at least a part of a whole genome of the virus, and/or wherein the virus is an adenovirus, an adeno-associated virus, a lentivirus, a retrovirus, or a Sendai virus, and/ or wherein the virus is an adeno-associated virus or a lentivirus.
Initially, parent claim 1 does not include a virus, only at least one gene (nucleic acid sequence) required to constitute a virus vector. So it is unclear what part of a whole genome of the virus is excluded. And since claim 1 does not include a virus, it is unclear how those virus listed in the latter part of the phrase further limit claim 1.
Claim 32 is confusing because it contains wherein clauses with product-by-process limitations using a producer cell. It is unclear how these product-by-process limitations are limiting the intended results of the plasmid when placed in a producer cell or alter the structure of the plasmid.
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.
Claim(s) 1, 2, 6-8, 10, 15, 18, 20, 26, 28, 29, 31, and 32, is/are rejected under 35 U.S.C. 103 as being unpatentable over Barber et al. (WO 00/05415, in IDS 5/4/23).
Barber et al. teach a nucleic acid construct as part of a plasmid to produce an AAV vector library (pg. 86 and 90, Example 7) that comprises:
An origin of replication, (pg. 10, lines 10-15 and pg. 25-30);
Promotor and terminator (pg. 25, lines 25-30);
Nucleic acid to be transcribed (e.g. the target nucleic acid or gene of interest) (pg. 10, lines 10-15); and
AAV ITRs (pg. 10, lines 10-15);
They teach suitable cells for replicating this plasmid include E. coli and Bacillus substilis (i.e. hay bacillus) (pg. 29, lines 1-5 and pg. 30, lines 4-10). It would be obvious to one of ordinary skill in the art that if the plasmid is replicated in E. coli or Bacillus substilis, then the origin of replication is adapted to these bacteria.
They teach the plasmid comprises both AAV rep and cap proteins (pg. 50, lines 27). The cap protein encodes the viral capsid protein while the rep protein packages, transcribes and replicates a genome of the virus. The plasmid can be as large as 10 kb (pg. 73, lines 4-8). The plasmid comprises a ribozyme library (e.g. target nucleic acids) which is linked to a promoter (pg. 4, lines 25-30) and terminator that are flanked by the AAV ITR s (pg. 90, lines 10-15). Fig. 5, 7, 9, 10, 11 and 13 shows the expression machinery of the ribozyme library (promoter, target nucleic acids, terminators) are upstream of the between the 5’ ITR and 3’ITR. The ribozyme library comprising can be 4-16 different ribozymes (pg. 18, lines 20-25) which is 4-16 different target genes.
While Barber et al. does not expressly teach all the claim limitations in a single embodiment, it would be obvious for one of ordinary skill in the art to perform the claimed method after reviewing the entire disclosure. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 5, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barber et al. (WO 00/05415, in IDS 5/4/23) as applied to claims 1, 2, 6-8, 10, 15, 18, 20, 26, 28, 29, 31, and 32 above, and further in view of Bowles et al. (US 7892809).
Barber et al. teach a plasmid for producing an AAV vector that comprises a promotor, rep, and cap sandwiched between to AAV ITRs. They do not teach the origin of the ITRs nor that the plasmid comprises a helper gene. However this would be obvious in view of Bowles et al. who teach chimeric vectors that also comprise the rep/cap sequences for producing AAV vectors. Bowles et al. teach plasmids where the rep/cap sequences and helper genes are not flanked by the ITRs so as to produce AAV vectors that do not encapsulate these genes (Bowles, col 22, lines 5-15). Therefore it would be obvious to include rep/cap genes and helper genes outside of the ITRs of the plasmid of Barber et al. so that these genes are not encapsulated in the resulting AAV vector since they are not crucial to the ribozyme library only for the construction of the AAV vector.
Also Bowles et al. teach their method works on any AAV known including AAV wild type, AAV2 to AAV11 (Bowles, col 12, lines 45-65). It would be obvious to use an ITR from any of these AAV serotypes since Bowles et al. teach these AAVs are interchangeable. One of ordinary skill would recognize this as simply using a known technique to produce a plasmid for making recombinant AAV vectors (MPEP 2141 V (C)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barber et al. (WO 00/05415, in IDS 5/4/23) and Bowles et al. (US 7892809) as applied to claims 1, 2, 5-8, 10, 15, 18, 19, 20, 26, 28, 29, 31, and 32 above, and further in view of Weber et al. (US 2006/0286545).
Barber et al. and Bowles et al. rendering obvious making a plasmid for recombinant AAV vectors with helper genes, but do not identify those genes in claim 21. However this would be obvious in view of Weber et al. who also teach making AAV vectors from plasmids but identifies the helper genes as E1A, E1B, E2A, and E4 (Weber, 0055). It would be obvious for one of ordinary skill to integrate E1A, E1B, E2A, and E4 into the plasmid of Bowles et al. and Barber et al. since these are known helper genes and are required to produce recombinant AAV vectors. One of ordinary skill would recognize this as simply using a known technique to produce a plasmid for making recombinant AAV vectors (MPEP 2141 V (C)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barber et al. (WO 00/05415, in IDS 5/4/23) as applied to claims above, and further in view of Wahle et al. (EP 0987327).
Barber et al. teach a plasmid for producing an AAV vector that comprises a promotor, rep, and cap sandwiched between to AAV ITRs. Barber et al. is clear their plasmids are closed circular DNA (Barber, Example 9). However they do not teach the purity of their circular DNA plasmids. However this would be obvious in view of Wahle et al. who teach a method of purifying closed-circular DNA including plasmids (Wahle, 0002 and Example 2). They teach their method produces 99% supercoiled DNA with less than 1% genomic DNA (Wahle, 0036).
It would be obvious for one of ordinary skill in the art to purify the plasmid of Barber et al. with the technique of Wahle et al. since that will provide them with high quality starting material for cell transfection and downstream experiments. One of ordinary skill would recognize this as simply using a known technique to produce a highly pure plasmids for making recombinant AAV vectors (MPEP 2141 V (C)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
It is noted that 19/042240 was re-opened on 6/18/26.
Claims 1, 2, 5-8, 10, 15, 18-21, 26, 28, 29, 31, 32, 36 and 38-40, 42-47, and 50-52 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19-22, 24-26, and 30 of copending Application No. 19/042240. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to a plasmid which promotes replication in hay bacillus comprising:
cap, a nucleic acid sequence encoding a capsid protein of the virus;
rep, a nucleic acid sequence encoding a protein which packages, transcribes, and replicates a genome of the virus;
two ITRs, which are two terminal repeat sequences of the virus;
E1A, E1B, E2A, E4, VA, which are nucleic acid sequences encoding helper genes;
A promoter and a terminator and
A 10-100 genes of interest.
This plasmid can be introduced into a producer cell, including E. coli or Hay bacillus (i.e. Bacillus subtilis), to make recombinant virus vectors. The plasmid has a CCC purity of 80% or greater.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5-8, 10, 15, 18-21, 26, 28, 29, 31, 32, 36 and 38-40, 42-47, and 50-52 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 30, 32-34, 37-39, 41-47 of copending Application No. 18/251737. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to a plasmid which promotes replication in hay bacillus comprising:
cap, a nucleic acid sequence encoding a capsid protein of the virus;
rep, a nucleic acid sequence encoding a protein which packages, transcribes, and replicates a genome of the virus;
two ITRs, which are two terminal repeat sequences of the virus;
E1A, E1B, E2A, E4, VA, which are nucleic acid sequences encoding helper genes;
A promoter and a terminator and
A 10-100 genes of interest.
This plasmid can be introduced into a producer cell, including E. coli or Hay bacillus (i.e. Bacillus subtilis), to make recombinant AVV vectors. The plasmid has a CCC purity of 80% or greater.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5-8, 10, 15, 18-21, 26, 28, 29, 31, 32, 36 and 38-40, 42-47, and 50-52 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 11, 12, 14, 15, 17, 19-21, 23-30 of copending Application No. 19/042220. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to a plasmid which promotes replication in hay bacillus comprising:
cap, a nucleic acid sequence encoding a capsid protein of the virus;
rep, a nucleic acid sequence encoding a protein which packages, transcribes, and replicates a genome of the virus;
two ITRs, which are two terminal repeat sequences of the virus;
E1A, E1B, E2A, E4, VA, which are nucleic acid sequences encoding helper genes;
A promoter and a terminator and
A 10-100 genes of interest.
This plasmid can be introduced into a producer cell, including E. coli or Hay bacillus (i.e. Bacillus subtilis), to make recombinant AVV vectors. The plasmid has a CCC purity of 80% or greater.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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