Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 10 November, 2025. Claims 11-20 were canceled without prejudice or disclaimer. Claims 1-10 are pending in the instant application. Applicants’ election of Group I (claims 1-10) without travers for examination on the merits is noted.
37 C.F.R. § 1.98
The information disclosure statement filed 26 June, 2024, has been placed in the application file and the information referred to therein has been considered. Applicants are reminded that the listing of references in the specification (e.g., see pages 52-56) is not a proper information disclosure statement. 37 C.F.R. § 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and M.P.E.P. § 609.04(a), subsection I. states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
37 C.F.R. § 1.84
The drawings filed 26 June, 2024, have been reviewed and are acceptable.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
-claim 1: The phrase “HIV derived TAT-independent and self-inactivating (SIN) lentiviral vector” should read “HIV-derived TAT-independent and self-inactivating (SIN) lentiviral vector”; “FoxP3- CNS3” should read “FoxP3-CNS3”; and “U 5” region should read “U5” region.
-claim 6: The term “PCCL backbone” should read “pCCL backbone”;
35 U.S.C. § 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.
Claim 9 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Claim 9 references an “infectious” lentiviral particle produced by the SIN lentiviral construct of claim 1. SIN lentiviral vectors do not produce infectious virus and are self-inactivating (Miyoshi et al., 1998; Zufferey et al., 1998). SIN lentiviral vectors do not encode any viral proteins but do contain cis-active elements for packaging, reverse transcription and integration. Typically, these vectors contain the following organization: a 5’ LTR (heterologous promoter (or US)/R/U5)-packaging signal (ψ)-polypurine tract (PPT)-heterologous promoter for transgene expression-transgene-woodchuck hepatitis B virus posttranscriptional element (WPRE)-3’ LTR (ΔU3/R/U5). The self-inactivation is caused by the deletion in the U3 region of the long-terminal repeat (LTR). During reverse transcription, this deletion is transferred to the 5’ LTR of the proviral DNA which abolishes the transcriptional activity of the LTR. However, these vectors themselves are incapable of producing an infectious lentiviral particle. The production of lentiviral particles would necessitate the utilization of a plasmid comprising the transfer SIN vector, packaging plasmids encoding Gag/Pol and Rev, and an envelope plasmid typically producing a heterologous envelope (e.g., VSV G). Appropriate correction is required.
35 U.S.C. § 112(d)
The following is a quotation of 35 U.S.C. § 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. § 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim fails to further limit the subject matter from which it depends. Claim 1 references a recombinant lentiviral vector that is Tat-independent and self-inactivating. However, claim 10 also references a recombinant lentiviral vector that is Tat-independent and self-inactivating, which fails to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Nonstatutory 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 obviousness-type 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 U.S.P.Q.2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 U.S.P.Q.2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 U.S.P.Q. 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 U.S.P.Q. 761 (C.C.P.A. 1982); In re Vogel, 422 F.2d 438, 164 U.S.P.Q. 619 (C.C.P.A. 1970); and In re Thorington, 418 F.2d 528, 163 U.S.P.Q. 644 (C.C.P.A. 1969).
A timely filed terminal disclaimer in compliance with 37 C.F.R. § 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 M.P.E.P. § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in M.P.E.P. § 2159. See M.P.E.P. §§ 706.02(l)(1)-706.02(l)(3) 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 C.F.R. § 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,060,566 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the instant application are directed toward a recombinant lentiviral vector (LV) comprising: an expression cassette comprising enhancer elements for driving gene expression of a nucleic acid encoding a peptide, said enhancer elements consisting of a human FoxP3-CNS 1 sequence, a human FoxP3-CNS2 sequence, and a human FoxP3-CNS3 sequence upstream from a human FoxP3 promoter; wherein said LV is an HIV-derived TAT-independent and self-inactivating (SIN) lentiviral vector comprising a U3 region lacking a TATA box, an R region, a U5 region, a packaging signal (ψ), a rev responsive element (RRE), and a central polypurine tract (cPPT) upstream from said enhancer elements, U3 region, R region and U5 region downstream from said nucleotide sequence encoding the protein; and a nucleic acid sequence encoding said peptide sequence operably linked to said enhancer elements and said human FoxP3 promoter. Claim 2 is directed toward a LV having a length of less than 10kb. Claims 3 and 4 further require a FoxP3 3'UTR and an insulator element in the U3 region, respectively. Claim 5 specifies the FoxP3 enhancer elements drive Treg lineage-specific expression in cells transfected with said vector. Claim 6 requires the utilization of a pCCL LV backbone. Claims 7-10 are directed toward lentiviral particles encoded by the TAT-independent SIN LV vector.
The claims of the’ 566 patent are directed toward a recombinant lentiviral vector (LV) comprising: an expression cassette comprising a nucleic acid construct comprising a nucleotide sequence encoding a human FoxP3 protein operably linked to an endogenous human FoxP3 promoter; wherein said expression cassette comprises enhancer elements said enhancer elements consisting of a human FoxP3-CNS1 sequence, a human FoxP3-CNS2 sequence, and a human FoxP3-CNS3 sequence upstream from said promoter; wherein said LV is an HIV-derived TAT-independent and self-inactivating (SIN) lentiviral vector comprising a U3 region lacking a TATA box, an R region, a U5 region, a packaging signal (ψ), a rev response element (RRE), and a central polypurine tract (cPPT) upstream from said enhancer elements, U3 region, R region and U5 region downstream from said nucleotide sequence encoding a human FoxP3 protein; and where said LV has a length of less than 10 kb. Claims 2 and 3 simply reference a human transgene (hFoxP3) and codon-optimized form of this sequence. Claims 4 and 5 further require a FoxP3 3'UTR and an insulator element in the U3 region, respectively. Claim 6 further requires lineage-specific, or physiologic expression of FoxP3 in the appropriate mature lymphocyte. Claims 7 and 12 provide a pCCL backbone and corresponding vector sequence. Claims 8-11 are directed toward lentiviral particles and packaging cells comprising the TAT-independent SIN LV vector.
The only significant difference between the claims is that the instant application simply references a generic transgene, whereas the ‘566 patent references a defined transgene (hFoxP3). Both claim sets encompass the same recombinant LV Tat-independent SIN vector. Therefore, the claims of the ‘566 patent anticipate the claims of the instant application and are not patentably distinct.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 05 January, 2026