DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-20 are pending.
Priority
3. Acknowledgement is made of applicants’ claimed domestic priority to U.S. Provisional Application No. 63/052,800, filed on 07/16/2020.
Information Disclosure Statement
4. The IDSs filed on 01/12/2023 and 02/09/2023 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action.
Drawings
5. The Drawings filed on 01/12/2023 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 112(b)
6. 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.
7. Claims 8 and 9 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 term "about" in claims 8 and 9 is a relative term which renders the claim indefinite. The term "about" is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165.
Claim Rejections - 35 USC § 102
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
9. Claim(s) 1-3, 5-12, and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnould et al. (US Patent Application Publication 2006/0153826 A1; cited on IDS filed on 01/12/2023).
10. Claims 1-3 and 5-12 are drawn to a recombinant polynucleotide construct comprising direct repeat sequences flanking a DNA sequence comprising a transgene and at least a first site-specific nuclease recognition site.
Claim 16 is drawn to a host cell comprising the polynucleotide construct of claim 1.
Claim 17 is drawn to a transgenic plant, insect or non-human animal comprising the polynucleotide construct of claim 1, wherein said transgene is capable of being eliminated in progeny of said plant, insect or non-human animal.
Claims 18 is drawn to a method of transforming a host cell comprising introducing the polynucleotide construct of claim 1 into said cell.
Claims 19-20 are drawn to a method of eliminating a transgene sequence from a cell comprising subjecting a cell according to claim 16 to an external stimulus that causes the transgene sequence to be eliminated.
11. With respect to claim 1, Arnould et al. teach a recombinant polynucleotide construct comprising direct repeat sequences flanking a DNA sequence comprising a transgene and at least a first site-specific nuclease recognition site [see Abstract; paragraphs 0066-0067, 0273-0275].
With respect to claim 2, Arnould et al. teach a recombinant polynucleotide construct comprising direct repeat sequences flanking a DNA sequence comprising a transgene and a first site-specific nuclease recognition site and a second site-specific nuclease recognition site [see Abstract; paragraphs 0066-0067, 0273-0275].
With respect to claim 3, Arnould et al. teach a recombinant polynucleotide construct comprising direct repeat sequences flanking a DNA sequence comprising a transgene and a first site-specific nuclease recognition site and a second site-specific nuclease recognition site represented by HIV2 6335 (interpreted as the same) [see Abstract; paragraphs 0066-0067, 0273-0275].
With respect to claim 5, Arnould et al. teach the recombinant polynucleotide construct wherein the site-specific recognition site is recognized by an engineered nuclease [see Abstract; paragraphs 0066-0067, 0273-0275].
With respect to claim 6, Arnould et al. teach the recombinant polynucleotide construct wherein the site-specific nuclease recognition site is recognized by a nuclease native to at least a first eukaryotic species [see paragraphs 0035, 0109, 0148, 0222].
With respect to claim 7, Arnould et al. teach the recombinant polynucleotide construct wherein the DNA sequence comprises a reporter gene [see paragraph 0123].
With respect to claims 8-9, Arnould et al. teach the recombinant polynucleotide construct wherein the direct repeat sequences comprising base pairs that fall within the claimed ranges [see paragraphs 0275-0276, 0306].
With respect to claim 10, Arnould et al. teach the polynucleotide construct comprising a selectable marker [see paragraph 0123].
With respect to claim 11, Arnould et al. teach the polynucleotide construct comprising a nucleic acid sequence encoding a nuclease that recognizes said site-specific nuclease recognition site [see paragraphs 0021-0032, 0066-0067, 0273-0275].
With respect to claim 12, Arnould et al. teach the polynucleotide construct wherein said nucleic acid sequence is operably linked to an inducible promoter or tissue specific promoter [see paragraphs 0108 and 0137].
With respect to claim 16, Arnould et al. teach a host cell comprising the polynucleotide construct [see paragraphs 0036-0037].
With respect to claim 17, Arnould et al. teach a non-human animal comprising the polynucleotide construct wherein said transgene is capable of being eliminated in progeny in said non-human animal [see paragraphs 0036, 0066-0067, 0273-0275].
With respect to claim 18, Arnould et al. teach a method of transforming a host cell comprising introducing the polynucleotide construct into said cell [see Abstract; paragraphs 0036-0037, 0066-0067, 0273-0275].
With respect to claim 19, Arnould et al. teach a method of eliminating a transgene sequence from a cell comprising subjecting a cell to an external stimulus that causes the transgene sequence to be eliminated [see Abstract; paragraphs 0036-0037, 0066-0067, 0273-0275].
With respect to claim 20, Arnould et al. teach the method wherein the external stimulus is a chemical stimulus (the teaching of an inducible promoter for expression is interpreted as an external stimulus as the compound to induce the expression of the meganuclease can reasonably be interpreted as a chemical stimulus) [see Abstract; paragraphs 0036-0037, 0066-0067, 0107, 0137, 0273-0275].
Claim Rejections - 35 USC § 103
12. 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.
13. Claim(s) 4 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnould et al. (US Patent Application Publication 2006/0153826 A1; cited on IDS filed on 01/12/2023).
14. The relevant teachings of Arnould et al. as applied to claims 1-3, 5-12, and 16-20 are set forth above.
With respect to claim 4, Arnould et al. teach the recombinant polynucleotide construct comprising direct repeat sequences flanking a DNA sequence comprising a transgene and a first site-specific nuclease recognition site and a second site-specific nuclease recognition site [see Abstract; paragraphs 0066-0067, 0273-0275].
With respect to claim 14, Arnould et al. teach the polynucleotide construct the polynucleotide construct comprising a nucleic acid sequence encoding a nuclease that recognizes said site-specific nuclease recognition site [see paragraphs 0021-0032, 0066-0067, 0273-0275].
With respect to claim 15, Arnould et al. teach the polynucleotide construct wherein said nucleic acid sequence is operably linked to an inducible and/or constitutive promoter [see paragraphs 0108 and 0137].
Although Arnould et al. does not explicitly teach wherein the first and second site specific nuclease recognition site are different of claim 4; a second nuclease that recognizes a second site-specific nuclease recognition site in said DNA sequence of claim 14 and different promoters that drive different levels of expression of claim 15, these modifications would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention because Arnould et al. acknowledges the use of these site specific nucleases for gene therapy and diseases that contain mutations affecting multiple genes. Accordingly, one of ordinary skill in the art would desire to use multiple nucleases having different recognition sites and different promoters in order to target different genes involved in the disease phenotype in order to facilitate effective treatment of said disease. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
15. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Arnould et al. (US Patent Application Publication 2006/0153826 A1; cited on IDS filed on 01/12/2023) in view of Alphey et al. (US Patent Application Publication 2018/0312870 A1; cited on IDS filed on 01/12/2023).
16. The relevant teachings of Arnould et al. as applied to claims 1-3, 5-12, and 16-20 are set forth above.
With respect to claim 13, Arnould et al. teach the polynucleotide construct wherein said nucleic acid sequence is operably linked to an inducible promoter or tissue specific promoter [see paragraphs 0108 and 0137]. Arnould et al. also teach the use of nuclease specific modification of polynucleotides in specific tissues in gene therapy applications [see paragraphs 0108, 0137 and claims].
However, Arnould et al. does not teach the polynucleotide construct of claim 13, wherein said tissue-specific promoter is a germline-specific promoter.
Alphey et al. teach a expression systems for expressing in eukaryotic cells comprising at least one coding sequence to be expressed in an organism and at least one promoter operably linked thereto wherein said promoter is a tissue specific promoter such as a germline-specific promoter [see Abstract; paragraphs 0008, 0031, 0053, 0156, 0423].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Arnould et al. and Alphey et al. according to the teachings of Alphey et al. to use a germline specific promoter in the constructs of Arnould et al. because Arnould et al. teach polynucleotide constructs comprising tissue specific promoters for targeted gene therapy. Alphey et al. teach that germline specific promoters for genetic modification in an organism. One of ordinary skill in the art would have had a reasonable expectation of success and a reasonable level of predictability to combine Arnould et al. and Alphey et al. because Alphey et al. acknowledges that germline specific promoters can be used for genetic modification for gene expression in an organism. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
17. Status of the claims:
Claims 1-20 are pending.
Claims 1-20 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL J HOLLAND/Primary Examiner, Art Unit 1656