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 .
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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Figures 2A, 3A and 3B contain sequences without sequence identifiers (SEQ ID NOs).
Required response – Applicant must provide:
Replacement and annotated 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 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.
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.
Claim 4 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.
Claim 4 recites the limitation "the at least one vector" in the second line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination it will be considered that claim 4 depends on claim 3, but appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 12 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The broadest reasonable interpretation of the term "cell" embraces a human having the cell (see paragraphs [0032-0033] of the as-filed specification). It is suggested to amend the claim to recite "An isolated cell" to avoid the claim embracing a human organism.
Claims 1-6, 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The claim(s) recite(s) nucleic acids comprising SEQ ID NOs: 1-3. Such nucleic acids are compositions of matter, therefore satisfying Step 1 of eligibility analysis. Specification defines the nucleic acids as portions of natural DNA (see Figure 2A). Such nucleic acids are not structurally different if they are isolated from human genome. Therefore, the claimed nucleic acids are products of nature, satisfying Step 2A Prong One of eligibility analysis. Association for Molecular Pathologyv. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are "products of nature" which cannot be patented). Accordingly, the claims recite a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two. For analysis in this Step this judicial exception is not integrated into a practical application because claims are drawn to simple products. Because the recited judicial exception is not integrated into practical application, the claims are still directed to judicial exception. Proceeding to Step 2B of eligibility analysis the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because other limitations in the claims require inclusion in the vector of at least one of nucleic acids, meaning that others can still be present as unmodified nucleic acids, natural products.
It is suggested to amend claims to recite vectors comprising the nucleic acids claimed to overcome the rejection.
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.
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.
Claim(s) 1-13, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diakatou et al (International Journal of molecular sciences, 2019, 20, 2542: 1-22, cited from IDS) and in further view of Yang et al (WO 2019/025984, February 2019).
Diakatou suggest treatment of retinitis pigmentosa (see Title, Abstract) using CRISPR/Cas9 system comprising guide RNAs and Cas9 nuclease (see page 7), such system can be delivered by adeno-associated vector (see last paragraph on page 9). Such treatment can be done to correct c.166G>A autosomal dominant mutation in NR2E3 gene, which is an ideal target for gene therapy (see pages 13, 5).
Diakatou do not teach guide RNAs of SEQ ID NOs: 1-3, or administering CRISPR/Cas9 system to iPSC cell, which is further differentiated into retinal progenitor cell.
Yang teach treatment of retinitis pigmentosa (see page 26) by administering genetically modified iPSC cell using CRISPR therapy to the eye of a subject (see page 25). Such iPSC cell can be further differentiated into ocular cell such as retinal progenitor cell (see page 25). CRISPR-associated nuclease and guide RNA can be provided in separate or same vectors such as adeno-associated vector (AAV) and can be a part of pharmaceutical composition (see pages 30, 73). Such CRISPR-based system can be used for treatment of subject in vivo or in vitro through genetic modification of retinal cell and further transplantation of it to the subject (see page 31). Alternatively, iPSC cell can be genetically modified, differentiated and transplanted to the subject (see page 31). Yang teach methods of designing proper guide RNA for CRISPR-based system (see page 71, Figure 12).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to design and use CRISPR-based system to treat retinitis pigmentosa based on teachings of Diakatou and Yang, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so because Diakatou suggests using CRISPR-based system for treatment of retinitis pigmentosa to correct c.166G>A autosomal dominant mutation in NR2E3 gene. Yang provides specific suggestions on designing CRISPR-based system and applying it in vivo and in vitro for treatment of ocular diseases such as retinitis pigmentosa. None of the references teach instant guide RNAs of SEQ ID NOs: 1-3, but Yang teach design of such guide RNAs. Applying such teachings to NR2E3 gene will yield RNAs comprising instant SEQ ID NOs: 1-3. Further it is noted that such guide RNAs of instant invention were designed using publicly available software (see paragraph [0173] of instant specification).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637