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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
However, applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date 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 disclosures of the prior-filed application 62935022 filed on 11/13/2019 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. For example, it is noted that the provisional application 62876052 discloses a total of 30 sequences and does not disclose SEQ ID NOs 31-34 . The PCT/US20/60279 filed 11/12/2020 discloses the 46 sequences of instant application. Therefore, the U.S. effective filing dates for all SEQ ID NOs and the claims are set as follow:
SEQ ID NOs 1-30 is set at 11/13/2019.
SEQ ID NOs 31-46, and claims 88, 109-110, and 114 is set at 11/12/2020.
Claim Status
Claim 88 is amended.
Claims 1-2,4,44,48,57,58,78-87 are withdrawn.
Claims 88,109-110, and 114 are under examination.
Withdrawn Objections
Claim Objections
The objection raised against claim 88 is withdrawn in light of claim amendment.
Withdrawn Rejections
Rejections - 35 USC § 112
The rejection of claims 88,109, 110, and 114 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of claim amendment.
Rejections - 35 USC § 103
The rejection of claims 88, 109, 110, and 114 under 35 U.S.C. 103 as being unpatentable over Til et al (Journal of Allergy and Clinical Immunology, 2013), in view of Zarrin et al (Journal of Immunology,1997) is withdrawn in light of claim amendment. Applicants amended claim 88 by deleting the term “ an effective fragment” and adding the word “ having”. Therefore, the rejection is moot.
Allowable Subject Matter
It should be noted that sequence search was extended to include all of the SEQ ID NOs recited in claim 88. Sequence search did not find any prior art with 100% identity to the
claimed SEQ ID NOs: 2,5-12,14-16,18,31,32,and 34.
It should also be noted that upon further consideration that SEQ ID NO: 4 and 17 are also free of art.
Therefore, SEQ ID No: 2,4,5-12,14-17,18,31,32,and 34 are free of art.
Maintained Rejections
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 88 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Saetrom et al (US 2018/0305689 A1).
Regarding claim 88, Saetrom et al et al teach a plurality of oligonucleotides known as saRNAs, which are useful in upregulating the expression of a target gene. Saetrom et al further disclose therapeutic compositions using such oligonucleotides and methods for using them. (See abstract). Saetrom et al teach an saRNA with a SEQ ID NO 915417 that is 100% identical to SEQ ID NO 3 of instant claim. Saetrom et al further teach an saRNA with a SEQ ID NO 915700 that is 100% identical to SEQ ID NO 1 of instant claim. (See alignment below). Saetrom et al teach that an expression vector in a lipid formulation can be used to deliver saRNA to the cells. (See paragraph [0225]).
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Claim 88 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Bonaldo et al (Genome Research,1996).
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Regarding claim 88, Bonaldo et al et al teach a cDNA clone “ "UI-E-EO1-aix-n-04-0-UI" that is 100% identical to SEQ ID NO 13 of instant claim. (See alignment below).
Claim 88 is rejected under 35 U.S.C. 102 (a) (2) as being anticipated by Lee et al (US 11,001,841, with a filing date of 04/13/2018).
Regarding claim 88, Lee et al teach methods and compositions for selectively reactivating or downregulating certain genes. The methods include administering to the cell an inhibitory oligonucleotide that target a sequence within 500 nucleotides of a CTCF binding site on a CTCF-interacting RNA and enhances expression of the X-linked escapee gene. (See abstract). Lee et al teach an oligonucleotide with a SEQ ID NO 8758 that is 100% identical to SEQ ID NO 33 of instant claim. (See alignment below).
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Edited Rejections necessitated by claim amendment
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 88, 109, 110, and 114 are rejected under 35 U.S.C. 103 as being unpatentable over Til et al (Journal of Allergy and Clinical Immunology, 2013), in view of Zarrin et al (Journal of Immunology,1997) and Saetrom et al (US 2018/0305689 A1).
Regarding claims 88, 109, 110, and 114, Til et al disclose a lentiviral vector comprising a polynucleotide that encodes for the RAG1 protein. Til et al also teach a construct comprising a polynucleotide that is operably linked to the endogenous native human RAG1 promoter (referred to as the CP promoter). (See Supplementary methods, section “ Lentiviral vector construction”). Til et al teach that the endogenous RAG 1 promoter (i.e. the CP promoter ) were made by PCR amplification of human genomic DNA. It is noted that Til et al do not teach a promoter comprising the identical nucleotide sequence of SEQ ID NO: 2. Til et al, on the other hand, disclose sequencing primers that define a genomic locus within chromosomes 11 that contains the endogenous RAG 1 promoter. ( See Supplementary table E1). It should also be noted that Til et al cite Zarrin et al as a source reference for the cloning and characterizing the human RAG1 promoter region. Zarrin et al disclose a method for mapping and characterizing the RAG1 promoter within the human genome. (See Material and Methods, page 105). Zarrin et al demonstrate a promoter region that is 94.8% identical to SEQ ID NO 2. (See alignment below ). Zarrin et al disclose that the human RAG1 promoter is active in both lymphoid and non-lymphoid cell lines, and suggest that other regulatory elements are probably involved in the tissue-specific transcriptional regulation of RAG1 gene.( See Zarrin et al , abstract-page 103).
Neither Til nor Zarrin teach a nucleic sequence that is 100% identical to SEQ ID NO 2.
The teachings of Saetrom et al are set forth above. Saetrom et al teach a “ SEQ ID NO 915417 ” that is 100% identical to SEQ ID NO 3 of instant claim. Taken together, one of ordinary skill in the art could have combined these prior art elements to generate the recombinant nucleic acid of instant claim 88. Because Til et al teach a recombinant nucleic acid comprising a polynucleotide encoding for RAG 1 protein that is operably linked to the endogenous native human RAG1 promoter. Zarrin et al teach that the human RAG1 promoter is active in both lymphoid and non-lymphoid cell lines, and clearly suggest that other regulatory elements are probably involved in the tissue-specific transcriptional regulation of RAG1 gene. Saetrom et al teach plurality of oligonucleotides known as saRNAs, which are useful in upregulating the expression of a target gene.. Therefore, an ordinary skill in the art would be motivated to build a recombinant nucleic acid, as taught by Til and Zarrin, and then add the oligonucleotide of Saetrom et al to fine-tune the transcriptional output. In other words, the combination of these elements according to known methods should yield the predictable result of generating a recombinant nucleic acid of claim 88 containing at least the SEQ ID NO 915417 which reads on the claimed sequence of SEQ ID 3.
Response to Arguments
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive.
Applicants argue the rejections raised against SEQ ID NOs 1,3,13, and 33 as none of the disclosed prior arts taught the same nucleic acid sequences as of the aforementioned SEQ ID. For example, Applicants argue that SEQ ID NO 915417 of Saetrom is a sequence of 450nucleotides , but the claimed SEQ ID NO 3 is a sequence of 150 nucleotides. Applicant argue that Saetrom et al do not anticipate instant claim 88 because their sequence is not the same length as SEQ ID NO 3.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive. This is because the claim is directed to a nucleic acid comprising one or more of the SEQ ID recited in instant claim 88. In other words, Applicants claim a nucleic acid using the transitional term comprising, which is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. As per the MPEP, ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). In Gillette Co. v.Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005). Therefore, even if Saetrom et al claim a recombinant nucleic acid that comprise a sequence of 450 nucleotides, which is not the same length of SEQ ID 3, the SEQ ID of Saetrom contains the 150 nucleotides of SEQ ID 3. The same response can be applied to the Applicants argument in regard to other SEQ ID NOs 1,13, and 33.
Applicant also argue that the combination of Til et al and Zarrin et al does not teach or suggest a recombinant nucleic acid comprising a promoter having the sequence of SEQ ID NO:2 . This is because Zarrin et al teach a sequence of 253 nucleotide, whereas SEQ ID NO 2 is a 267 nucleotides.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive. While the office agrees with Applicants that the sequence of Zarrin et al does not read on SEQ ID NO: 2, it should be noted that Applicants amended claim 88 by deleting the term “ an effective fragment of the” and adding the word “ having”. For this reason, a new ground of rejection is made over Til et al in view of Zarrin et al and Saetrom et al, that covers all the limitation of instant claims. See the rejection above.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMAH KHALAF MATALKAH whose telephone number is (703)756-5652. The examiner can normally be reached Monday-Friday,7:30 am-4:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638