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
Acknowledgement is made that the instant application is a National Stage of International application No. PCT/US2021/051789 (filed 09/23/2021), which claims the benefits of US Provisional Application No. 63/082,253 (filed 09/23/2020).
Election/Restrictions
Applicant’s election without traverse of Group 1 (Claims 1-9), drawn to a replication competent lentiviral vector comprising a nucleic acid sequence encoding at least two proteins selected from hTERT, HPB16 E7, and HPB16 E6 and a promoter suitable for expression in a mammalian cell, in the reply filed on 01/05/2026 is acknowledged. Claims 10-13, 15, and 17-22 are withdrawn from consideration, as being directed to a non-elected invention. Claims 1-9 have been examined on the merits.
Claim Objections
Applicant is advised that should claims 3 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
Claim Rejections - 35 USC § 112(b)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 1-9 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.
Claim 1 recites “the nucleic acid sequence of (i) is transcribed as a single transcript comprising the first protein-cleavable peptide or self-cleaving peptide - second protein”. This statement is unclear because it could be interpreted as requiring a first protein, a cleavable peptide or self-cleaving peptide, and a second protein or as requiring a first protein-cleavable peptide or self-cleaving peptide and a second protein. In the interest of compact prosecution, the claim is being interpreted as requiring a first protein, a cleavable peptide or self-cleaving peptide, and a second protein. Claims 2-9 depend from claim 1 and do not rectify the issue. Thus claims 2-9 inherit the deficiency.
Further regarding claim 4: Claim 4 recites the limitation "the 2A peptide" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to either recite “the self-cleaving peptide is a 2A peptide” or change the dependency of the claim to depend from claim 3.
Further regarding claim 5: Claim 5 recites the limitation "the virus" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “the lentiviral vector”.
Further regarding claim 6: Claim 6 recites the limitation "the recombinant lentivirus" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “the replication competent lentiviral vector”.
Relevant Prior Art
Liu et al (CN107779474A), cited in IDS, disclose pCDH-CMV-E6-Furin-FMDV2A-E7-IRES-GFP-EF1-Puro, a lentiviral vector expressing HPV16 E6 protein, HPV16 E7 protein, and the self-cleavable sequences Furin and foot and mouth disease virus 2A (F2A) (See English translation pg. 2, first two paragraphs and step 4). The Furin and F2A sequences are located between the E6 and E7 proteins (See English translation, pg. 3 (3)).A CMV promoter drives expression of E6 and E7 proteins together with a fluorescent protein (See English translation, pg. 2, third paragraph). Liu et al further disclose transfecting esophageal epithelial cells with pCDH-CMV-E6-Furin-FMDV2A-E7-IRES-GFP-EF1-Puro lentiviral vector (See English translation, pg. 5, Step 8).
Liu et al do not disclose a replication competent lentiviral vector.
Kazi (Charles River, 2023) teaches rare recombination events within plasmic sequences used to generate lentiviral vectors pose a risk of creating a replication competent lentivirus. The presence of a replication competent lentivirus in vector batches increase the risk of insertional mutagenesis due to potential ongoing viral replication and multiple integrations into DNA (See Kazi, fourth paragraph). Due to the potential for pathogenicity, FDA guidelines require testing to exclude the presence of replication competent lentiviruses for use in gene therapy (See FDA, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up, Jan, 2020).
Given that Kazi and FDA guidelines teach replication competent lentiviral vectors are pathogenic and can produce insertional mutations due to ongoing viral replication and multiple integrations into DNA, a person of ordinary skill in the art would not have been motivated to modify the lentiviral vector of Liu et al to produce a replication competent lentivirus.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISOL ANN O'NEILL/ Examiner, Art Unit 1633
/ALLISON M FOX/ Primary Examiner, Art Unit 1633