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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-14, 18, 24-27 in the reply filed on 05/11/2026 is acknowledged. The traversal is on the ground(s) that cited references do not teach lentiviral-packaging system claimed. This is not found persuasive because references presented below in obviousness rejection make such system obvious.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-17, 19-23, 28-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/11/2026.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 18 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).
A lentivirus-like particle of claim 18 produced by the method of claim 15, such method requires transfecting cells with lentiviral packaging system of claim 1 and culturing them, will be identical to lentiviral packaging system of claim 1, because such method simply amplifies amount of lentiviral packaging system of claim 1.
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.
Claims 24-27 are rejected under 35 U.S.C. 101 because 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.
Claims 24-27 are 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 (for example, see instant specification paragraph [0011]). It is suggested to amend the claim to recite "An isolated cell" to avoid the claim embracing a human organism.
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) 1-14, 18, 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al (WO 2019/213257, 7 November 2019, cited from IDS) and in further view of Gaudelli et al (Nature, 2017, vol. 551: 464-474).
Lu teach lentiviral packaging systems for delivery of CRISPR-associated endonuclease mRNAs, with reduced off-target effects comprising packaging plasmid comprising a eukaryotic promoter operably linked to a Gag nucleotide sequence, wherein the Gag nucleotide sequence comprises a nucleocapsid (NC) coding sequence and a matrix protein (MA) coding sequence, wherein one or both of the NC coding sequence or the MA coding sequence comprises at least one non-viral aptamer-binding protein (ABP) nucleotide sequence, and wherein the packaging plasmid does not encode a functional integrase protein (see paragraphs [0004-0005, 0061]) and further comprising a mammalian expression plasmid comprising an eukaryotic promoter operably linked to a non-viral nucleic acid sequence, such non-viral nucleic acid comprises guide RNA coding sequence and at least one aptamer coding sequence (see paragraph [0007]). Such aptamer coding sequence can be MS2 coat protein aptamer sequence or COM protein aptamer sequence, such aptamer sequence binds ABP nucleotide sequence (see paragraph [0083]). Further gRNA coding sequence can comprise aptamer inserted into ST2 loop of such gRNA coding sequence (see paragraph [0200]). Lu teach that such system can further comprise an envelope plasmid comprising an envelope glycoprotein coding sequence (see paragraph [0008]). Further, packaging plasmid can comprise Rev and Tat nucleotide sequences or Rev nucleotide sequence can be in a second packaging plasmid (see paragraph [0068]). ABP nucleotide sequence can encode MS2 coat protein (see paragraph [0083]). Lu teach lentivirus-like particle comprising: a) a fusion protein comprising a nucleocapsid (NC) protein or a matrix (MA) protein , wherein the NC protein or MA protein comprises at least one non-viral aptamer binding protein (ABP); and b) a ribonucleotide protein (RNP) complex comprising a CRISPR-associated endonuclease and a guide RNA; wherein the lentivirus-like particle does not comprise a functional integrase protein (see paragraphs [0010-0012]). Such CRISPR-associated endonuclease can be Cas9 protein (see paragraph [0059]). Further Lu teach cells comprising the lentiviral packaging systems and particles (see paragraph [0139]) and cells modified by transduction of plurality of lentivirus-like particles (see paragraph [0015]).
Lu do not teach a nucleic acid sequence encoding adenine base pair editor (ABE), wherein the ABE is a fusion protein comprising an adenosine deaminase and a catalytically impaired CRISPR-associated endonuclease such as Cas9 D10A as part of a mammalian expression plasmid, wherein ABE is ABE7.10.
Gaudelli teach adenine base editors (ABE), which comprise adenosine deaminase fused to a catalytically impaired CRISPR-associated endonuclease Cas9. Such ABEs have less off-target effects in human cells than just Cas9 and can be used for disease treatments (see Abstract). One of such ABE is ABE7.10, which provides substantially improved editing efficiency (see first column on page 469). Cas9 endonuclease of such ABE is Cas9 D10A (see second column on page 465).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to include ABEs taught by Gaudelli into lentiviral packaging system taught by Lu, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Gaudelli teach ABEs comprising Cas9 with improved activity and Lu teach delivery system to deliver nucleic acids encoding such endonucleases with reduced off-target effects, therefore delivering such ABEs using such delivery system will provide more efficient system for gene editing, which can be used for human disease treatment.
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.
Claims 1-14, 18, 24-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,398,182 in view of Gaudelli, above. Claims from ‘182 recite lentiviral packaging system same as in instant claims except that such system does not comprise ABEs as instantly claimed. Teachings of Gaudelli are discussed above. It would have been obvious to include ABEs taught by Gaudelli into lentiviral packaging system from ‘182 to create more efficient gene editing system, arriving at instant invention.
Claims 1-14, 18, 24-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 102-108, 114-116, 120-123, 133, 149, 156, 168, 175-179, 183 of copending Application No. 19/270,184 in view of Gaudelli, above. Claims from ‘184 recite lentivirus-like particles same as in instant claims except that such particles do not comprise ABEs as instantly claimed. Teachings of Gaudelli are discussed above. It would have been obvious to include ABEs taught by Gaudelli into lentivirus-like particles from ‘184 to create more efficient gene editing system, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
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.
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.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
Prosecution Insights