DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s amendment submitted on 4/8/2026 is acknowledged.
Claims 12-26 and 36 are under examination on the merits.
Formal Matters
Applicant’s interview request is acknowledged, this final rejection should facilitate those discussions. After review of this final rejection, if Applicant is still interested in an interview, please contact Examiner Jeff Sifford at 571-272-7289.
Response to Arguments
Applicant's arguments filed 4/8/2026 regarding the rejections under 35 U.S.C. §102, 35 U.S.C. §103, and for non-statutory double patenting have been fully considered but they are not persuasive. See below.
Applicant’s arguments, see pp. 1-2, filed 4/8/2026, with respect to the rejection under 35 U.S.C. §112(b), and objections to the drawings and claims have been fully considered and are persuasive. The rejection under 35 U.S.C. §112(b) and objections have been withdrawn.
Withdrawn Objections
The following objections are hereby withdrawn due to Applicant’s amendment submitted on 4/8/2026:
Claim objections: objections to claims 12 and 15 for minor informalities.
Drawings: Applicant indicated that it is not necessary for the figures currently executed in color to be in color, and declines to submit a petition requesting color drawings be accepted. The examiner finds that the drawings are not necessary to be in color for the invention to be enabled or have written support. See CFR 1.84(a)(2).
Withdrawn Rejections
The following rejections are hereby withdrawn due to Applicant’s amendment submitted on 4/8/2026:
35 U.S.C. §112(b): claim 25.
Maintained Rejections
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous Rejection Maintained) Claims 12, 14, 22, and 24 are rejected under 35 U.S.C. 102(a) as being anticipated by Khetawat, et al. (Virol J. 2010 Nov 12;7:312. doi: 10.1186/1743-422X-7-312. PMID: 21073718; hereinafter referred to as “Khetawat”).
Applicant traversed the rejection under 35 U.S.C. §102 in the reply filed 4/8/2026, but after careful consideration, the examiner has determined that Applicant’s arguments are unpersuasive.
Applicant presents the following arguments:
Khetawat does not disclose the method as claimed. There is no mention in Khetawat of the specific NiV-F protein recited in the pending claims, an NiV-F protein comprising a cytoplasmic tail lacking amino acid residues 525-546, instead Khetawat describes a series of NiV-F truncation mutations termed ΔCt1-ΔCt7. The NiV-F protein comprising a cytoplasmic tail lacking amino acid residues 525-546 of SEQ ID NO: 1 as claimed is deleted in its cytoplasmic tail such that it ends with the sequence “EKKRNT” at its C-terminus, so the NiV-F mutation recited in the pending claims has a deletion that falls in between two of the NiV-F cytoplasmic tail truncation mutations described in Khetawat, and is thus not represented in any of Khetawat’s constructs.
Applicant’s arguments are not persuasive:
Applicant’s argument is not commensurate in scope with the claims. The claims merely require that the NiV-F cytoplasmic tail lacks amino acid residues 525-546, not that it must lack only those residues. The claims encompass a NiV-F protein with a deletion of 525-546, including FΔCt1-FΔCt3 disclosed by Khetawat (Khetawat, Figure 4).
Therefore, Applicant’s argument is unpersuasive and Khetawat anticipates Claims 12, 14, 22, and 24.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous Rejection Maintained) Claims 12-15, 22, 23-26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Morizono (Nat Med. 2005 Mar;11(3):346-52. doi: 10.1038/nm1192. Epub 2005 Feb 13. PMID: 15711560; hereinafter referred to as “Morizono”) in view of Khetawat (supra).
Applicant traversed the rejection under 35 U.S.C. §103 in the reply filed 4/8/2026, but after careful consideration, the examiner has determined that Applicant’s arguments are unpersuasive.
Applicant presents the following arguments:
Morizono does not disclose a Nipah virus envelope pseudotyped lentiviral vector. Khetawat does not cure this deficiency because it does not teach a lentiviral vector pseudotyped with the specific NiV-F protein recited in the pending claims, which comprises a cytoplasmic tail lacking amino acid residues 525-546. This difference in the range of deleted amino acids provides advantageous properties and supports that the pending claims are non-obvious, especially in view of the combined teachings of the references which emphasize the unpredictability of success of pseudotyping lentiviral particles with NiV-F. Khetawat shows that there are significant differences in relative infectivity of a particle pseudotyped with any of its disclosed constructs. Constructs ΔCt1-ΔCt3 display superior infectivity than ΔCt4-ΔCt7. Specifically, construct ΔCt3 in fact necessitated a change in scale of the Y-axis, construct ΔCt4 was observed to perform worse than a wild-type NiV-F control. The steep decline in efficiency between ΔCt3 and ΔCt4 constructs supports unpredictability. Given the severe reduction in function when comparing the constructs of Khetawat, in which only a few additional amino acid residues retained in the cytoplascmid tail mutant of ΔCt3 different compared to ΔCt4, a skilled artisan would not have had a reasonable expectation of success with any predictability of any particular truncated NiV-F of working, nor that the particular NiV-F deleted in 525-546 of the cytoplasmic tail as claimed would exhibit such improved titer, as evidenced by data in the application discussed below.
Applicant’s arguments are not persuasive:
Applicant’s argument is not commensurate in scope with the claims. The claims merely require that the NiV-F cytoplasmic tail lacks amino acid residues 525-546, not that it must lack only those residues. The claims encompass a NiV-F protein with a deletion of 525-546, including FΔCt1-FΔCt3 disclosed by Khetawat (Khetawat, Figure 4).
That the truncations FΔCt1-FΔCt3 perform better is not shocking, because it is in the prior art, as pointed out by Applicant’s reference to Figure 7A of Khetawat.
In fact, a skilled artisan would choose FΔCt1-FΔCt3, which fall within the instant claims’ breadth with regard to NiV-F cytoplasmic tail truncation, because it is the best with regard to function.
Therefore, Applicant’s argument is unpersuasive and Claims 12-15, 22, 23-26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Morizono (Nat Med. 2005 Mar;11(3):346-52. doi: 10.1038/nm1192. Epub 2005 Feb 13. PMID: 15711560) in view of Khetawat (supra).
(Previous Rejection Maintained) Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Morizono and Khetawat (supra), as applied to claims 12-15, 22-26, and 36 above, in further view of Aguilar et al. (J Virol. 2007 May;81(9):4520-32. doi: 10.1128/JVI.02205-06. Epub 2007 Feb 14. PMID: 17301148; hereinafter referred to as “Aguilar”).
(Previous Rejection Maintained) Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Khetawat (supra), as applied to claims 12, 14, 22, and 24 above, in further view of Aguilar et al. (supra).
Applicant traversed the rejection under 35 U.S.C. §103 in the reply filed 4/8/2026, but after careful consideration, the examiner has determined that Applicant’s arguments are unpersuasive.
Applicant presents the following arguments:
Applicant summarizes Aguilar and what they teach. Accordingly, Aguilar teaches that pseudotyping a lentiviral vector with a NiV-F variant is experimentally difficult, and supports that a skilled artisan would not have found the pending claims obvious, and neither Khetawat or Morizono cure these deficiencies. Upon reading the cited references, the skilled person would understand that the truncation in the cytoplasmic tail impacts incorporation during viral formation and therefore subsequent infectivity, such that a skilled person would not have a reasonable expectation of success in carrying out a method to produce a pseudotyped lentivirus particle as claimed.
Applicant’s arguments are not persuasive:
Applicant’s argument is not commensurate in scope. The claims merely require that the NiV-F cytoplasmic tail lacks amino acid residues 525-546, not that it must lack only those residues. The claims encompass a NiV-F protein with a deletion of 525-546, including FΔCt1-FΔCt3 disclosed by Khetawat (Khetawat, Figure 4).
The examiner agrees that testing is needed to show what works, but that was provided by Khetawat for NiV-F proteins with cytoplasmic tail truncations (FΔCt1-FΔCt3), which reads on the claimed NiV-F protein structure.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Therefore, Applicant’s argument is unpersuasive and Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Morizono and Khetawat (supra), as applied to claims 12-15, 22-26, and 36 above, in further view of Aguilar et al. (J Virol. 2007 May;81(9):4520-32. doi: 10.1128/JVI.02205-06. Epub 2007 Feb 14. PMID: 17301148); and Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Khetawat (supra), as applied to claims 12, 14, 22, and 24 above, in further view of Aguilar et al. (supra).
(Previous Rejection Maintained) Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Morizono and Khetawat (supra), as applied to claims 12-15, 22-26, and 36 above, in further view of Xu et al. (Proc Natl Acad Sci U S A. 2008 Jul 22;105(29):9953-8. doi: 10.1073/pnas.0804797105. Epub 2008 Jul 16. PMID: 18632560; hereinafter referred to as “Xu”).
Applicant traversed the rejection under 35 U.S.C. §103 in the reply filed 4/8/2026, but after careful consideration, the examiner has determined that Applicant’s arguments are unpersuasive.
Applicant presents the following arguments:
Xu’s teachings concern the structure of NiV-G and its interaction with its physiological target receptor, ephrin-B3, Xu is wholly silent on pseudotyping lentiviral particles with NiV-G, much less NiV-G along with a particular truncated NiV-F that is deleted to lack residues 525-546 of the cytoplasmic tail as presently claimed. Thus, the teachings of Xu do not cure the deficiencies of Morizono and Khetawat.
Applicant’s arguments are not persuasive:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Khetawat discloses lentiviral particles bearing NiV F and G glycoproteins. The rejection is made under 35 U.S.C. §103, so each individual reference need not teach every limitation of the claims.
Therefore, Applicant’s argument is unpersuasive and Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Morizono and Khetawat (supra), as applied to claims 12-15, 22-26, and 36 above, in further view of Xu et al. (Proc Natl Acad Sci U S A. 2008 Jul 22;105(29):9953-8. doi: 10.1073/pnas.0804797105. Epub 2008 Jul 16. PMID: 18632560).
Applicant’s additional arguments for Non-obviousness are also unpersuasive:
Applicant presents the following arguments:
Applicant has shown in Working Examples (e.g., Example 1) the generation of enveloped pseudotyped lentivirus particles containing the NiV-F mutant lacking amino acid residues 525-546 (designated T234F) with either wild-type NiV-G or a series of stepwise NiV-G truncations containing deletion of amino acids in the cytoplasmic tail of NiV-G. Pseudotyped lentiviral vectors with the T234F cytoplasmic truncation and with either wild-type NiV-G or any of a series of exemplary stepwise truncations exhibit improved titer compared to similar lentiviral vectors which were instead pseudotyped with wild-type NiV-F (see e.g. Example 1, and FIG. 2). Titer as compared to a similar control lentiviral vector pseudotyped with wild-type NiV-F and NiV-G was improved by 2-fold or greater, up to 100-fold. The improved titer was observed across the series of wild-type or stepwise NiV-G truncations.
These results are unexpected in view of each cited reference, which demonstrate a high degree of unpredictability in the art with respect to functional pseudotyping of lentiviral vectors. These secondary indicia supporting nonobviousness are relevant, as the ability to obtain a NiV envelope pseudotyped lentiviral particle with uniquely high titer as demonstrated are relevant to the presently claimed method of using such pseudotyped lentiviral particles for delivering a nucleic acid to a cell.
Under Federal Circuit law, the Examiner must consider this rebuttal evidence of nonobviousness set forth by the patent applicant in assessing patentability.
The results described in the instant application, specifically with respect to the dramatic increases in titer with in vitro studies and infectivity with in vivo studies, extend beyond any achievement in the cited art.
In sum, evidence of the unexpected superior results is provided in the original application as filed, including working Examples, thereby evidencing unexpected advantageous properties in accordance with MPEP §716.02(a)(II). It is evident from the original application that the claimed subject matter possesses unexpected and surprising advantages that were unknown to the skilled artisan, providing strong evidence that the present claims are nonobvious. Thus, even if a prima facie case of obviousness had been established, this has been rebutted, and these rejections under 35 U.S.C. §103 should be withdrawn.
Applicant’s arguments are not persuasive:
Applicant’s results do not demonstrate unexpected advantageous properties. Results commensurate in scope with the claims are already in the prior art, wherein Khetawat’s FΔCt1-FΔCt3 NiV-F protein truncations exhibit enhanced infectivity, so Applicant’s results are not shocking.
“Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
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.
(Previous Rejection Maintained) Claims 12-15, 20, 22, 24-26 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9486539 B2 in view of Khetawat, Morizono, Aguilar, and Xu (supra).
(Previous Rejection Maintained) Claims 12-15, 20, 22, 24-26 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10064958 B2 in view of Khetawat, Morizono, Aguilar, and Xu (supra).
(Previous Rejection Maintained) Claims 12-20, 22, 24-26 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11576982 B2 in view of Khetawat (supra).
Applicant has requested that these provisional rejections are held in abeyance until such time as there is indication of allowability.
The examiner has determined that the nonstatutory double patenting rejections are still proper and are thus maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 JEFFREY MARK SIFFORD whose telephone number is 571-272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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, Michael Allen can be reached at 571-270-3497. 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.
/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights