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, corresponding to claims 1 – 5, 8 – 21, and 27 – 31 in the reply filed on 08/25/2026 is acknowledged. The traversal is on the ground(s) that the prior art does not teach the now included limitation of a single antigenic fusion protein as amended. This is not found persuasive because at the time of the Office Action dated 07/02/2026, the previously cited prior art Borysiewicz and Bian taught the shared technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 and 10 have been amended. Claims 22 and 24 – 26 are withdrawn from further consideration pursuant to 37CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 6 and 7 are cancelled.
Claims 1 – 5, 8 – 21, and 27 – 31 are under consideration.
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application No. PCT/EP2022/081839, filed, on November 14, 2022. This application also claims priority to EP Applications No. EP22306119.3, filed on July 27, 2022, and EP21306581.6, filed on November 15, 2021 and US Provisional Application No. 63/279,945.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 – 5, 9, and 27 – 31 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 “A lentivirus vector, comprising at least four distinct nucleic acid sequences selected from the group consisting of.” However, the recited Markush group contains only four members. It is unclear how “at least four” sequences can be selected from a group consisting of only four members, since selection implies a choice among a larger pool of options. If all four members of the group are required, the “selected from the group consisting of” language is superfluous and creates ambiguity.
Regarding claims 2 – 5 and 9, the use of the transitional phrase “having at least” sequence identity to a SEQ ID NO. It is unclear as to whether open or closed claim language is intended. The amino acid may be defined by the exact SEQ ID NO or may be comprised of the SEQ ID NO. See MPEP 2111.03 (IV). For purposes of compact prosecution and examination, “having” is interpreted as “comprising”. For example, claim 2 is interpreted as “The lentiviral vector according to claim 1, wherein the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV16) E6 protein antigen encodes an amino acid sequence comprising at least 80% sequence identity with the amino acid sequence of SEQ ID NO: 7.”
The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claim Rejections - 35 USC § 112 – Written Description
The following is a quotation of the first paragraph 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 pre-AIA 35 U.S.C. 112:
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 2 – 5, 9, 10, and 27 – 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
The claims are broadly drawn to a genus comprising: an amino acid sequence that is:
In claim 2, at least 80% identical to SEQ ID NO: 7
In claim 3, at least 68% identical to SEQ ID NO: 16
In claim 4, at least 60% identical to SEQ ID NO: 24
In claim 5, at least 83% identical to SEQ ID NO: 33
In claim 9, at least 90% identical to SEQ ID NO: 42
However, the Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genus to establish a structure-function relationship with respect to antigen function. There is not sufficient description of the structural features that must be retained to establish a functional relationship with respect to humoral stimulation.
The broadest reasonable interpretation of the claims encompasses innumerable permeations of nucleic acids and innumerable permeations of proteins. The Specification fails to disclose which regions of a sequence must be retained with respect to function. With respect to the elected species SEQ ID NOs: 7, 16, 24, 33, and 42, the Specification fails to disclose which regions of SEQ ID NOs: 7, 16, 24, 33, or 42 can be mutated, deleted, truncated, etc., or which regions of SEQ ID NOs: 7, 16, 24, 33, or 42 must be retained with respect to function. The claims improperly define the genus based on what they do, in this case, viral antigen trafficking and regulation—not what they are.
SEQ ID NO: 7 encodes an HPV16 E6 protein. SEQ ID NO: 7 is 158 amino acids in length. A variant sharing 80% identity to SEQ ID NO: 7 can have anywhere from 1 to 31 substitutions, deletions or additions in any combination along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (2031 = 2.15 x 1040) comprising trillions upon trillions of sequences.
SEQ ID NO: 16 encodes an HPV16 E7 protein. SEQ ID NO: 16 is 98 amino acids in length. A variant sharing 68% identity to SEQ ID NO: 16 can have anywhere from 1 to 31 substitutions, deletions or additions in any combination along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (2031 = 2.15 x 1040) comprising trillions upon trillions of sequences.
SEQ ID NO: 24 encodes an HPV18 E6 protein. SEQ ID NO: 24 is 158 amino acids in length. A variant sharing 60% identity to SEQ ID NO: 24 can have anywhere from 1 to 63 substitutions, deletions or additions in any combination along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (2063 = 9.22 x 1081) comprising trillions upon trillions of sequences.
SEQ ID NO: 33 encodes an HPV18 E7 protein. SEQ ID NO: 33 is 105 amino acids in length. A variant sharing 83% identity to SEQ ID NO: 33 can have anywhere from 1 to 17 substitutions, deletions or additions in any combination along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (2017 = 1.31 x 1022) comprising trillions upon trillions of sequences.
SEQ ID NO: 42 encodes an HPV16/17 E6 and E7 fusion protein. SEQ ID NO: 42 is 395 amino acids in length. A variant sharing 90% identity to SEQ ID NO: 42 can have anywhere from 1 to 39 substitutions, deletions or additions in any combination along any length of the sequence. Thus, just for substitutions with canonical amino acids alone, the instant claims encompass an enormous genus (2039 = 5.5 x 1050) comprising trillions upon trillions of sequences.
While the claims are drawn to a nebulous genus of ill-defined variants, the Specification and Drawings have only adequately described and successfully reduced to practice four HPV16/18 E6 and E7 fusion proteins (Figure 1, Figure 8).
At best, the Specification contemplates the use of BLAST to identify functional homologs based on sequence homology (¶0149). However, this is not sufficient to describe members of the claimed genus because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genus does not sufficiently meet the written description requirement.
Moreover, Putra et al (medRxiv, 2025, 10.1101/2025.11.03.25339381, hereinafter, “Putra”) teaches that when designing vaccines and treatments, the E6/E7 sequence of HPV must be taken into consideration (Abstract). Putra teaches the immunogenicity profiles across amino acid positions of E6 and E7, teaching that amino acid position affects T-cell response rate (Supplemental Figure 1). Putra also teaches that HPV epitopes across HPV genomes affect cross-type coverage as well as activation (Figure 4, Figure 5).
Similarly, Riemer et al (JBC, 2010, 10.1074/jbc.M110.126722, hereinafter, “Riemer”) teaches that epitope sequence of HPV 16 E7 affect T-cell activity (Abstract). Reimer teaches epitope sequence determines binding strength of HLA-A*0201 T2 based peptides (Figure 2). Reimer also teaches that epitope sequence can affect presentation and identify a previously used epitope used in vaccines were not detected by certain CTL (Abstract). Thus, when taken with the teachings of Putra and Reimer, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples, the Specification must at least
describe the structural features that are required for the claimed function, in this case, with regards to SEQ ID NO: 7, 16, 24, 33, or 42 viral antigen function and regulation.
However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to function, let alone the various improved properties required throughout the instant claims. Applicant merely offers a cursory statement that any amino acid sequence with 80%, 68%,60%, 83%, or 90% identity to SEQ ID NOs: 7, 16, 24, 33, or 42, respectively, will work.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 112 – Scope of Enablement
The following is a quotation of the first paragraph 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 pre-AIA 35 U.S.C. 112:
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.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ specific viral vectors, i.e., I-5759 and I-5762. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted on pages 18 and 19 of the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Claim Rejections - 35 USC § 112 – Dependence
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 27 – 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Claim 27 depends from claim 2, which recites inter alia “wherein the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV 16) protein E6 antigen encodes an amino acid sequence having at least 80% sequence identity with the amino acid sequence set forth as SEQ ID NO: 7.” SEQ ID NO: 2 shares 75.9% sequence identity with SEQ ID NO: 7 (reproduced below). Claim 27, does not further limit any aspect of claim 2 since it appears to encompass additional sequences beyond those of claim 2.
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Claim 28, depends from claim 3, which, recites inter alia “wherein the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV16) protein E7 antigen encodes an amino acid sequence having at least 68% sequence identity with the amino acid sequence set forth as SEQ ID NO: 16. SEQ ID NO: 15 shares 61.9% sequence identity with SEQ ID NO: 16 (reproduced below). Claim 28 does not further limit any aspect of claim 3 since it appears to encompass additional sequences beyond those of claim 3.
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Claim 29, depends from claim , which,recites inter alia “wherein the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV18) protein E6 antigen encodes an amino acid sequence having at least 60% sequence identity with the amino acid sequence set forth as SEQ ID NO: 24.” SEQ ID NO: 20 shares 59.4% sequence identity with SEQ ID NO: 24 (reproduced below). Claim 29, does not further limit any aspect of claim 4 since it appears to encompass additional sequences beyond those of claim 4.
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Claim 30, depends from claim 5, which,recites inter alia “wherein the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV18) protein E7 antigen encodes an amino acid sequence having at least 83% sequence identity with the amino acid sequence set forth as SEQ ID NO: 33.” SEQ ID NO: 30 shares 78.8% sequence identity with SEQ ID NO: 33 (reproduced below). Claim 30, does not further limit any aspect of claim 5 since it appears to encompass additional sequences beyond those of claim 5.
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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.
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.
Claim(s) 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Orlinger et al (US20180179257A1, hereinafter, “Orlinger”) in view of Bian et al (US20160324952A1, hereinafter, “Bian”) and Zhao et al (Virol J, 2011, 10.1186/1743-422X-8-302, hereinafter, “Zhao”).
Orlinger teaches modified arenaviruses that are suitable as vaccines against HPV associated neoplastic diseases or cancers (Abstract). Orlinger teaches the arenavirus viral vectors are engineered to contain a genome comprising HPV16 and 18 E proteins, including E6 and E7 antigens (Claim 76, ¶0083, ¶0747). Orlinger teaches that the HPV16/18 E6 and E7 proteins can be fused together and can swapped in different orders including a HPV16 E7/6 and HPV18 E7/6 order (¶0745 – 0747).
Regarding claims 1 and 8, Orlinger teaches an arenavirus viral vector encoding HPV16 E7/6 and HPV18 E7/6 (¶0745 – 0747). Olringer teaches that the HPV16 and HPV18 fusion proteins can be fused together either directly or via a peptide linker or self-cleaving peptide (¶0746). Orlinger teaches an HPV16 E7/6 to HPV18 E7/6 order (¶0747).
Orlinker does not teach a lentivirus viral vector.
However, Bian teaches viral vectors encoding HPV16 and 18 E6 and E7 multivalent fusion proteins (Abstract). Bian teaches that the nucleic acid can be placed in a multitude of viral vectors including lentiviruses (¶0016). Bian also teaches the use of the viral vector encoding HPV16 and 18 E6 and E7 multivalent fusion protein antigen to treat HPV associated infections, cervical cancer, and lesions (¶0001).
Both Orlinker and Bian do not explicitly teach the HPV E antigens are non-oncogenic.
However, Zhao teaches a recombinant vaccinia virus co-expressing the HPV16/18 E7/E6 fusion proteins for use as a therapeutic vaccine for the treatment of HPV16+ and HPV18+ cancers (Abstract). Zhao teaches that the bivalent construct expresses both HPV16/18 E7/E6 fusion proteins at high levels (Figure 1). Zhao teaches the engineered virus can generate significant immune responses and immunity in both mice and rhesus monkeys (Abstract).
Regarding claim 1, Zhao teaches E7 and E6 proteins were modified to inactivate their oncogenic activity (2.3.1 Mutagenesis of E7 and E6 for HPV16 and HPV18).
Orlinger, Bian, and Zhao are considered to be analogous to the claim invention because they teach HPV fusion proteins. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, into a lentivirus backbone, as taught by Bian, because doing so would allow the integration of the lentiviral payload into the host cell genome allowing for long-term expression of the fusion protein. One of ordinary skill in the art would have had a reasonable expectation of success in encoding a HPV16 E7/E6-HPV18 E7/E6 fusion protein into a lentivirus backbone given that inserting HPV E proteins into a lentiviral backbone is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 2 and 4 are rejected under 35 U.S.C. 103 over Orlinger, Bian, and Zhao as applied to claims 1 and 8 above, and further view of Sette et al (US20070053922A1, hereinafter, “Sette”).
As discussed above, claims 1 and 8 were rendered prima facie obvious in view of Orlinger, Bian, and Zhao.
The references do not teach the nucleic acid sequence encoding the non-oncogenic HPV 16 protein E6 antigen encodes an amino acid sequence having at least 80% sequence identity with the amino acid sequence set forth as SEQ ID NO: 7 nor do the references teach nucleic acid sequence encoding the non-oncogenic HPV18 protein E6 antigen encodes an amino acid sequence having at least 60% sequence identity with the amino acid sequence set forth as SEQ ID NO: 24.
However, Sette teaches epitope-based vaccines directed towards HPV (Abstract). Sette teaches the epitope can be bound to an HLA heavy chain, β2-microglobulin, and strepavidin complex to form a tetramer (Claim 11). Sette teaches that the HPV epitope can be delivered using a retroviral vector (¶0172).
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Regarding claim 2, Sette teaches an HPV 16 E6 antigen that has 100% sequence identity to SEQ ID NO: 7 (reproduced below, Qy is SEQ ID NO: 7, Db is Sette).
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Regarding claim 4, Sette teaches an HPV 18 E6 antigen that has 100% sequence identity to SEQ ID NO: 24 (reproduced below, Qy is SEQ ID NO: 24, Db is Sette).
Orlinger, Bian, Zhao, and Sette are considered to be analogous to the claim invention because they teach the use of HPV antigens to treat HPV associated conditions. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, using the exact sequence taught by Sette into a lentivirus backbone, as taught by Bian, because the HPV antigen taught by Sette is known to elicit strong immune responses. One of ordinary skill in the art would have had a reasonable expectation of success in encoding the exact sequences of SEQ ID NO: 7 and/or SEQ ID NO: 24 into the HPV16 E7/E6-HPV18 E7/E6 fusion protein given that HPV E antigen sequences is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 3 is rejected under 35 U.S.C. 103 over Orlinger, Bian, and Zhao as applied to claims 1 and 8 above, and further view of Frazer et al (US20110287039A1, hereinafter, “Frazer”).
As discussed above, claims 1 and 8 were rendered prima facie obvious in view of Orlinger, Bian, and Zhao.
The references do not teach the nucleic acid sequence encoding the non-oncogenic HPV16 protein E7 antigen encodes an amino acid sequence having at least 68% sequence identity with the amino acid sequence set forth as SEQ ID NO: 16.
However, Frazer teaches expressing antigens that are modified to modulate the quality of an immune response in a mammal (Abstract). Frazer teaches the antigen can be HPV16 E7 (Table 8). Frazer teaches that the antigen can be delivered using a lentivirus viral vector (¶0156-0158).
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Regarding claim 3, Frazer teaches an HPV 16 E7 antigen that has 100% sequence identity to SEQ ID NO: 16 (reproduced below, Qy is SEQ ID NO: 16, Db is Frazer).
Orlinger, Bian, Zhao, and Frazer are considered to be analogous to the claim invention because they teach the use of HPV antigens to treat HPV associated conditions. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, using the exact sequence taught by Frazer into a lentivirus backbone, as taught by Bian, because the HPV antigen taught by Frazer is known to elicit strong immune responses. One of ordinary skill in the art would have had a reasonable expectation of success in encoding the exact sequence of SEQ ID NO: 16 into the HPV16 E7/E6-HPV18 E7/E6 fusion protein given that HPV E antigen sequence is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 5 is rejected under 35 U.S.C. 103 over Orlinger, Bian, and Zhao as applied to claims 1 and 8 above, and further view of Baker et al (US20070014810A1, hereinafter, “Baker”).
As discussed above, claims 1 and 8 were rendered prima facie obvious in view of Orlinger, Bian, and Zhao.
The references do not teach the nucleic acid sequence encoding the non-oncogenic HPV18 protein E7 antigen encodes an amino acid sequence having at least 83% sequence identity with the amino acid sequence set forth as SEQ ID NO: 33.
However, Baker teaches epitope-based vaccines directed towards HPV (Abstract). Baker teaches the vaccine can comprise of a polynucleotide encoding of multiple HPV E antigens (Claim 1).
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Regarding claim 5, Baker teaches an HPV 18 E7 antigen that has 100% sequence identity to SEQ ID NO: 16 (reproduced below, Qy is SEQ ID NO: 33, Db is Baker).
Orlinger, Bian, Zhao, and Baker are considered to be analogous to the claim invention because they teach the use of HPV antigens to treat HPV associated conditions. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, using the exact sequence taught by Baker into a lentivirus backbone, as taught by Bian, because the HPV antigen taught by Baker is known to elicit strong immune responses. One of ordinary skill in the art would have had a reasonable expectation of success in encoding the exact sequence of SEQ ID NO: 33 into the HPV16 E7/E6-HPV18 E7/E6 fusion protein given that HPV E antigen sequence is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 11 – 18, 20, and 21 are rejected under 35 U.S.C. 103 over Orlinger, Bian, and Zhao as applied to claims 1 and 8 above, and further view of Bauche et al (US20140120132A1, hereinafter, “Bauche”).
As discussed above, claims 1 and 8 were rendered prima facie obvious in view of Orlinger, Bian, and Zhao.
The references do not teach a lentiviral vector comprising a MHC Class I promoter, a cPPT/CTS sequence, or WPR The references also fail to teach a lentivirus comprising VSV-G.
However, Bauche teaches lentivirus vectors containing an MHC Class I promoter (Title). Bauche teaches that the MHC class I promoter directs transcription of a transgene within mammalian cells and that the transgene can be an immunogenic polypeptide (Abstract). Bauche teaches these cells can include APC dendritic cells (Abstract).
Regarding claim 11, Bauche teaches a lentivirus vector comprising an MHC Class I promoter driving a transgene sequence encoding a immunogenic polypeptide (Claim 1).
Regarding claim 12, Bauche teaches a lentivirus vector comprising a cPPT/CTS sequence (Claim 3).
Regarding claims 13 and 14, Bauche teaches a lentivirus vector wherein the lentiviral vector comprises a 3’ long terminal repeat (LTR) which is devoid of its U3 promoter sequence and enhancer sequence (¶0020, 0041).
Regarding claim 15, Bauche teaches a lentivirus vector comprising a Woodchuck Post Transcriptional Regulatory Element (WPRE) (¶0076-0077).
Regarding claims 16, 20, and 21, Bauche teaches a lentiviral vector particle comprising at least one lentiviral vector within an isolated cell (¶0124 – 0126, Claim 14).
Regarding claim 17, Bauche teaches a lentivirus vector comprising a functional lentiviral integrase protein (¶0014).
Regarding claim 18, Bauche teaches a lentivirus vector pseudotyped with VSV-G (¶0124).
Orlinger, Bian, Zhao, and Bauche are considered to be analogous to the claim invention because they deal with immunogenic proteins. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, into a lentivirus backbone, as taught by Bian, in the specific lentiviral backbones taught by Bauche because the lentiviral vector is known to effectively deliver immunogenic proteins. One of ordinary skill in the art would have had a reasonable expectation of success in encoding the HPV16 E7/E6-HPV18 E7/E6 fusion protein given that HPV E antigen sequence into the lentiviral backbones taught by Bauche given that the fusion protein and viral vector are well known, have been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 19 is rejected under 35 U.S.C. 103 over Orlinger, Bian, Zhao, and Bauche as applied to claim 1, 8, 11 – 18, 20, and 21, above, and further view of Tran et al (US20140234908A1, hereinafter, “Tran”).
Regarding claims 1, 8, 11 – 18, 20, and 21, as discussed above, Orlinger teaches a viral vector encoding a HPV16 E7/E6-HPV18 E7/E6 fusion protein, Bian teaches HPV16/18 fusion proteins can be encoded in a lentivirus viral vector, Zhao teaches the HPV proteins can be modified to be non-oncogenic, while Bauche teaches lentiviral vectors capable of transgene expression of immunogenic proteins within host cells.
The references do not teach a lentiviral vector particle comprising a HIV-1 subtype D Gag protein.
However, regarding claim 19, Tran teaches lentiviral vectors comprising a subtype D gag-pol sequence (Abstract). Tran teaches that the use of the subtype D Gag protein are useful in the preparation of therapeutic “compositions or vaccines which are capable of inducing or contributing to the occurrence or improvement of an immunogical reaction against epitopes, more particularly those encoded by the transgene present in the vectors” (¶0102). Tran also teaches that lentivirus containing the subtype D Gag protein have increased viral titers (Figure 3).
Orlinger, Bian, Zhao, Bauche, and Tran are considered to be analogous to the claim invention because they deal with immunogenic proteins. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, in a lentiviral vector comprising the subtype D Gag, as taught by Tran, because doing so would increase viral titers. One of ordinary skill in the art would have had a reasonable expectation of success in encoding the HPV16 E7/E6-HPV18 E7/E6 fusion protein given that HPV E antigen sequence into the lentivirus vector particle comprising a subtype D Gag given that the use of a lentivirus vector particle comprising a subtype D Gag to increase viral titer is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 29 is rejected under 35 U.S.C. 103 over Orlinger, Bian, Zhao, and Sette as applied to claims 1, 2, 4, and 8 above, and further view of Burny et al (US20200123571A1, hereinafter, “Burny”).
As discussed above, claims 1, 2, 4, and 8 were rendered prima facie obvious in view of Orlinger, Bian, Zhao, and Sette.
Orlinger teaches a viral vector encoding a HPV16 E7/E6-HPV18 E7/E6 fusion protein, Bian teaches HPV16/18 fusion proteins can be encoded in a lentivirus viral vector, while Zhao teaches the HPV proteins can be modified to be non-oncogenic. Sette teaches an HPV 16 E6 antigen that has 100% sequence identity to SEQ ID NO: 24 (reproduced above).
The references do not that the nucleic acid sequence encoding the non-oncogenic HPV 18 protein E6 antigen is selected from the group consisting of SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, and SEQ ID NO: 23.
However, Burny teaches compositions containing one or more E proteins of HPV18 (Abstract). Burny teaches that these compositions can be used to treat conditions associated with HPV infections (Abstract). Burny teaches the nucleic acid comprising a HPV18 E6 protein can be packaged in a viral vector (¶0391).
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Regarding claim 27, Burny teaches an amino acid sequence for HPV 18 E6 antigen that has 100% sequence identity to the nucleic acid SEQ ID NO: 21 (reproduced below, Qy is SEQ ID NO: 21, Db is Burny).
Orlinger, Bian, Zhao, Sette, and Burny are considered to be analogous to the claim invention because they teach the use of HPV antigens to treat HPV associated conditions. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to encode a non-oncogenic HPV16 E7/E6-HPV18 E7/E6 fusion protein, as taught by Orlinger and Zhao, using the exact sequence taught by Rooke into a lentivirus backbone, as taught by Bian, because the HPV antigen taught by Burny is known to elicit strong immune responses. One of ordinary skill in the art would have had a reasonable expectation of success in encoding a sequence of SEQ ID NO: 21 into the HPV16 E7/E6-HPV18 E7/E6 fusion protein given that HPV E antigen sequence is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
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 – 5, 8 – 21, and 27 – 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 – 21 of copending Application No. 18/997,335 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to lentiviral vector particle comprising four HPV antigens for the treatment or prevention of an HPV.
Claim 1 of the conflicting application discloses a non-integrative lentiviral vector particle for use in the treatment or prevention of an HPV induced cancer comprising at least four distinct nucleic acid sequences selected from the group consisting of:
- at least one nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPVl6) protein E6 antigen,
- at least one nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E7 antigen, -
at least one nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E6 antigen, and
- at least one nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV 18) protein E7 antigen,
wherein the lentiviral vector particle comprising at least one of the lentiviral vector.
Claim 3 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1 further comprises the nucleic acid sequence encoding the non- oncogenic Human papillomavirus (HPV16) protein E6 antigen encodes an amino acid sequence having at least 80% sequence identity with the amino acid sequence set forth as SEQ ID NO: 7, the nucleic acid sequence being in particular selected from the group consisting of SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5 and SEQ ID NO: 6.
Claim 4 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1 further comprises the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV16) protein E7 antigen encodes an amino acid sequence having at least 68% sequence identity with the amino acid sequence set forth as SEQ ID NO: 16, the nucleic acid sequence being in particular selected from the group consisting of SEQ ID NO: 14 and SEQ ID NO: 15.
Claim 5 of the conflicting application discloses the lentiviral vector or lentiviral vector particle further comprises the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV18) protein E6 antigen encodes an amino acid sequence having at least 60% sequence identity with the amino acid sequence set forth as SEQ ID NO: 24, the nucleic acid sequence being in particular selected from the group consisting of SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22 and SEQ ID NO: 23.
Claim 6 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1 further comprises the nucleic acid sequence encoding the non-oncogenic Human papillomavirus (HPV18) protein E7 antigen encodes an amino acid sequence having at least 83% sequence identity with the amino acid sequence set forth as SEQ ID NO: 33, the nucleic acid sequence being in particular selected from the group consisting of SEQ ID NO: 30, SEQ ID NO: 31 and SEQ ID NO: 32.
Claim 7 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1 further comprises the at least four distinct nucleic acid sequences encoding antigens are fused together, forming a single antigenic nucleic acid sequence encoding a single antigenic fusion protein under the control of a single promoter sequence.
Claim 8 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1, wherein the order of the at least four distinct nucleic acid sequences, from 5' end to 3' end, is selected from the group consisting of:
(a) nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV 16) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPVl6) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E6 antigen;
(b) nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV 18) protein E7 antigen;
(c) nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E7 antigen; and
(d) nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E6 antigen.
Claim 9 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1, wherein the order of the at least four distinct nucleic acid sequences, from 5' end to 3' end, is (a) nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV16) protein E6 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E7 antigen - nucleic acid sequence encoding a non-oncogenic Human papillomavirus (HPV18) protein E6 antigen.
Claim 10 of the conflicting application discloses the lentiviral vector or lentiviral vector particle of claim 1, comprising a nucleic acid sequence which encodes an amino acid sequence having at least 90% sequence identity with the amino acid sequence set forth as SEQ ID NO: 42, the nucleic acid sequence being in particular the nucleic acid sequence SEQ ID NO: 41.
Claim 11 of the conflicting application discloses the lentiviral vectoror lentiviral vector particle for use according to claim 1, being selected from the group consisting of the non-integrative lentiviral vectors filed at the CNCM under accession numbers I-5759, I-5760,I-5761 and I-5762, and is in particular the non- integrative lentiviral vector filed at the CNCM under accession number 1-5759.
Claim 12 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector comprises a MHC Class I promoter
Claim 13 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector comprises a cPPT/CTS sequence.
Claim 14 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector comprises a 3' long terminal repeat (LTR) which is devoid of its U3 promoter sequence.
Claim 15 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector does not comprise a constitutive enhancer sequence.
Claim 16 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector comprises a mutant form of the woodchuck hepatitis B virus (WHV) post- transcriptional regulatory element (WPRE).
Claim 17 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector particle comprises a functional lentiviral integrase protein.
Claim 18 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector particle comprises a vesicular stomatitis virus glycoprotein (VSVG).
Claim 19 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector particle comprises HIV-1 subtype D Gag and Pol proteins.
Claim 20 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector or the lentiviral vector particle is comprised in an isolated cell.
Claim 21 of the conflicting application discloses the lentiviral vector or lentiviral vector particle for use according to claim 1, wherein the lentiviral vector or the lentiviral vector particle is comprised in a vaccine composition.
The scope of the conflicting application and the instant application significantly overlaps. These claims make claim 1 – 5, 8 – 21, and 27 – 31 of the instant application obvious. Although claim 1 of ‘335 does not recite the specific HPV antigen sequence required by claim 1 of the instant application, its broader definition reasonably encompasses that sequence as one species within its genus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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