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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 11/17/2025.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 11/17/2025 of Group I, Claim(s) 38-42, 55-59 is acknowledged.
Applicant has elected in the Reply filed on 11/17/2025 the following species:
A. the reduced dimerization comprises deletion, introduction, and/or relocation of a dimer initiation site/dimer linkage sequence (DIS/DLS) region in the genome sequence (claim 39)
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 38-68 are pending.
Claims 43-54 and 60-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 11/17/2025.
Claims 40-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 11/17/2025.
Claims 38-39, 42 and 55-59 are under examination in this Office Action.
Claim Rejections - 35 USC § 112-1st paragraph (Written Description)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of 35 U.S.C. 112 (pre-AIA ):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38-39, 42 and 55-59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 39, 42 and 55-59 depend directly or indirectly from claim 38.
The specification discloses chemicals, such as the vectors in Table 2 which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 38 is(are) directed to encompass a system comprising payload vectors and packaging vectors, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these payload vectors and packaging vectors meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of payload vectors and packaging vectors. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 102
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.
Claims 38-39, 42 and 55-59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xie et al. (01/29/2018) bioRxiv document 255638 pages 1 to 7 (hereinafter known as "Xie").
With regards to claims 38-39, 42 and 55-59, Xie teaches:
a) as in claims 38-39, 42 and 55-59, a non-naturally occurring engineered lentiviral or retroviral system comprising: a) a plurality of payload vectors, each encoding a lentiviral or retroviral genome comprising at least one genetic perturbation and a barcode sequence that identifies each genetic perturbation, wherein each genome sequence is modified to reduce dimerization of the genomes; and b) one or more packaging vectors encoding lentiviral or retroviral packaging proteins for generating packaging cells or a packaging cell line encoding the lentiviral or retroviral packaging proteins, whereby transfection of the plurality of payload vectors into packaging cells produces a viral expression library comprising viral particles biased to a single genome per virion; wherein the reduced dimerization comprises deletion of a dimer initiation site/dimer linkage sequence (DIS/DLS) region in the genome sequence; wherein the genome sequence is modified to reduce U5:AUG pairing; further comprising an inhibitor of template switching; wherein the genetic perturbation comprises a CRISPR-Cas system; wherein the CRISPR-Cas system is a CRISPR-Cas9 system; wherein the genetic perturbation is one or more guide sequences (see entire document especially Figure 1, Figure 2 and pages 2-3 and 6).
Thus, Xie anticipates the present claims.
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 38-39, 42 and 55-59 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent Number 11535865.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 39 is drawn to a non-naturally occurring engineered lentiviral or retroviral system comprising: a) a plurality of payload vectors, each encoding a lentiviral or retroviral genome comprising at least one genetic perturbation and a barcode sequence that identifies each genetic perturbation, wherein each genome sequence is modified to reduce dimerization of the genomes; and b) one or more packaging vectors encoding lentiviral or retroviral packaging proteins for generating packaging cells or a packaging cell line encoding the lentiviral or retroviral packaging proteins, whereby transfection of the plurality of payload vectors into packaging cells produces a viral expression library comprising viral particles biased to a single genome per virion and claim 1 in U.S. Patent Number 11535865 is drawn to a non-naturally occurring engineered lentiviral or retroviral system comprising a pooled set of payload polynucleotides, each having or encoding at least a genetic perturbation in association with a barcode that identifies the genetic perturbation(s), a multiplicity of carrier polynucleotides that are heterologous to the payload polynucleotides and do not have or encode at least a genetic perturbation in association with a barcode that identifies the genetic perturbation(s), and one or more packaging polynucleotides, wherein the system comprises a 5:1 weight ratio or greater mixture of the carrier polynucleotides to the pooled set of the payload polynucleotides, wherein a multiplicity of packaging cells transfected with the system are capable of producing a viral expression library comprising viral particles, wherein each one of the pooled set of the payload polynucleotides is comprised in at least one of the viral particles, and wherein the packaging cells are sufficiently capable of packaging no more than one payload polynucleotide per viral particle such that target cells transduced with the viral expression library have reduced recombination activity, or template switching activity, or multiple integration activity as compared to counterpart packaging cells transfected with a mixture comprising the pooled set of the payload polynucleotides in the absence of the 5:1 weight ratio or greater of the carrier polynucleotides to the pooled set of the payload polynucleotides.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11535865.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684