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 .
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Paragraph [0001] of the instant published disclosure, USPgPub 2025/0340597, incorporates provisional U.S. Application No. 63/254,506; paragraph [0033] incorporates WO2022/087031; and paragraphs [0176 and 0177] incorporate WO2018/161049 and WO2017/152146. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 under MPEP § 2414.02 (2):
An amendment to the specification to incorporate by reference the material in the "Sequence Listing XML" by reciting in a separate paragraph of the specification the name of the file, the date of creation, and the size of the file in bytes (37 CFR 1.835(a)(2) and 37 CFR 1.835(c))
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
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.
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c), see paragraph [0011], Table 5 for example, beginning below paragraph [0172] of the instant published application, USPgPub 2025/0340597.
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 sequence identifiers, 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.
Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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 Objections
Claims 1 and 28 are objected to because of the following informalities: Acronyms should be spelled out prior to first use. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-16 and 26-28 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 is drawn to a recombinant HIV-1 envelope (Env) “selected from the
envelope listed in Table 5, Figure 29B”. Claim 16 is drawn to a method of inducing an immune response by administering a prime immunogen from Table 5 and at least one boost immunogen from Tables 3 or Table 4. MPEP § 2173.05(s) states that where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Table 5 appears to list a finite number of HIV Env constructs, but instant paragraph [0075] of the instant published disclosure, USPgPub 2025/034059, states that Figure 29B depicts non-limiting examples of envelope designs and sequences of Table 5 and paragraph [0172] states that the proteins listed in Table 5 are “non-limiting embodiments”. Paragraphs [0073 and 0074] also state that the envelopes described in Tables 3 and 4, respectively, are non-limiting examples. Therefore, it is unclear whether the lists depicted in Tables 3-5 and recited in claims 1 and 16 are exemplative or finite. If the intention of the claims is drawn to a finite list of Env proteins, exceptional circumstances required to define the invention under MPEP § 2173.05(s) by reciting Tables, are not evident. If the lists depicted in Tables 3-5 are exemplative and non-limiting, as described in the specification, it is unclear which recombinant HIV-1 Env is/ are intended by the claims. For these reasons, the instant claims do not particularly point out and distinctly claim the subject matter of the invention, as required under 35 USC 112(b). This rejection affects all dependent claims. In the interest of compact prosecution and broadest reasonable interpretation of the claims consistent with the instant disclosure (MPEP § 2111), the recombinant Env proteins listed in Tables 3-5 are determined exemplative and non-limiting.
Claims 1 and 16 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a "single structural similarity" and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a "single structural similarity" and common use where the alternatives share both a substantial structural feature
and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the Env proteins of claims 1 and 16 found in Figure 29B and Tables 3-5, are not finite as stated in instant paragraphs [0073, 0074, and 0172]. Therefore, the Markush grouping of claims 1 and 16 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use. The claims encompass an exponential number of distinct engineered Env mutants having different mutation combinations, different antibody-envelope encounter residue changes, and different antigenic/antibody binding properties. The specification does not establish that all of the listed alternatives are functionally equivalent for the claimed immunological purpose. The mere fact that the alternatives are all HIV-1 Env-related, does not establish a proper Markush grouping. This rejection affects all dependent claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature, without significantly more. Instant claims 1-3 recite a recombinant envelope “selected from the envelope listed in Table 5, Figure 29B”, where the envelope is a protomer comprised in a stable trimer. Table 5 appears to list a finite number of HIV Env constructs, but instant paragraph [0075] of the instant published disclosure, USPgPub 2025/034059, states that Figure 29B depicts non-limiting examples of envelope designs and sequences of Table 5 and paragraph [0172] states that the proteins listed in Table 5 are “non-limiting embodiments”. Paragraph [0033] states:
In some embodiments, the method further comprises administering an immunogenic composition comprising any HIV-1 envelope sequence from the CH848 infected individual…In some embodiments, the method comprises administering an immunogenic composition comprising any HIV-1 envelope sequence from the CH848 infected individual and variants thereof comprising the modification to the V1 loop described herein as a prime.
Paragraphs [0007, 0008, 0170, 0198] identify HIV-1 Env CH848.d0949.10.17 (also referred to as CH848.d0949.10.17WT), where “WT” is wild-type. Also see Figure 37R, depicting CH848.d0949.10.17 as an immunogen. Therefore, the instant HIV-1 Env encompassed by claims 1-3 is indistinguishable from naturally-occurring HIV-1 Env, CH848.d0949.10.17, isolated from the CH848 infected individual discussed in paragraph [0033] and the viral nucleic acid encoding HIV-1 Env CH848.d0949.10.17 is indistinguishable from the nucleic acid of instant claim 13.
Similar to the fact pattern described in Myriad, the genetic information or genetic structure of the instant HIV-1 Env are not created or altered upon isolation from its native environment. Finding or discovering an important structure does not satisfy the §101 inquiry. Isolation by severing chemical bonds naturally linking the HIV-1 Env from the remainder of the naturally-occurring virus does not in itself provide a markedly different characteristic from any HIV-Env and nucleic acid encoding it found in nature since there are no chemical changes resulting from the isolation. Therefore, the instant claims recite a natural phenomenon according to Step 2A in MPEP § 2106.04(II).
A comparison between the HIV-1 Env claimed and naturally-occurring HIV-1 Env, CH848.d0949.10.17, isolated from the CH848 infected individual discussed in paragraph [0033]
indicates no differences in structure, function, or other characteristics. Therefore, the claimed HIV-1 Env and nucleic acid encoding the protein are exception products. See Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two requires eligibility analysis to evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. The instant claims recite no additional element that distinguishes the instantly claimed HIV-1 Env from the naturally-occurring HIV-1 Env, CH848.d0949.10.17, isolated from the CH848 infected individual discussed in paragraph [0033].
Instant claim 14 further requires that the nucleic acid encoding HIV-1 Env is encompassed in a “carrier”. However, recitation of “carrier” fails to meaningfully limit the claim because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. The presence of a possible pharmaceutical carrier, vehicle, and/or excipient does not change the nature or properties of the naturally-occurring HIV-1 Env or the nucleic acids encoding it. Accordingly, recitation of a “carrier” does not integrate the recited judicial exception into a practical application that is patent eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. -U.S.—(June 13, 2013).
Claim Rejections - 35 USC § 112
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 1-16 and 26-28 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. This is a written description rejection.
Claim 1 is drawn to a recombinant HIV-1 envelope (Env) selected from the
envelopes listed in “Table 5, Figure 29B”. Claim 16 is drawn to a method of inducing an immune response by administering a prime immunogen from Table 5 and at least one boost immunogen from Tables 3 or Table 4. Table 5 appears to list a finite number of HIV Env constructs, but instant paragraph [0075] of the instant published disclosure, USPgPub 2025/0340597, states that Figure 29B depicts non-limiting examples of envelope designs and sequences of Table 5 and paragraph [0172] states that the proteins listed in Table 5 are “non-limiting embodiments”. Paragraphs [0073 and 0074] state that the envelopes described in Tables 3 and 4, respectively, are non-limiting examples. Therefore, there is an inadequate description of an HIV-1 Env intended by the claims. The instant claims do not contain a written description of the invention “in such full, clear, concise, and exact terms”, as required under 35 USC 112(a).
The instant HIV-1 Env protein(s) encompassed by the instant claims are defined functionally as inducing cross-reactive, broadly neutralizing antibodies (bnAb) in paragraphs [0003, 0005, and 0006] of the instant published disclosure, USPgPub 2025/0340597. However, the skilled artisan would not recognize a recombinant HIV-1 Env “listed in Table 5, Figure 29B” or an HIV Env with this functional attribute. As discussed above, the instant HIV-1 Env encompassed by the claims is indistinguishable from naturally-occurring HIV-1 Env, CH848.d0949.10.17, isolated from the CH848 infected individual discussed in paragraph [0033].
Bonsignori et al. (Science Translational Medicine. 2017 Mar 15; 9 (381):eaai7514) describe evolution of HIV-1 Env quasi-species in an acutely infected individual (CH848), who developed plasma neutralization against heterologous HIV, years after infection. See the Introduction, “Three N332 V3-glycan-dependent antibody lineages”, “Evolution of the CH848 virus quasi-species”, and Figure 1. Bonsignori et al. propose theories attributing to neutralizing antibody development during natural infection, such as modified Env proteins and “improbable mutations” occurring in multiple B cell lineages expanded during chronic infection, in “Mutations in the DH270 antibody lineage that initiated heterologous neutralization” and the Discussion section.
Singh et al. (Journal of Virology. May 2026; 100 (5): e02202-25) review HIV-1 envelope-based vaccine design strategies to induce broadly neutralizing antibodies (bnAbs). See Figure 2. Monovalent immunization of native-resembling-Env trimers induce strong neutralizing antibody responses, but limited heterologous neutralization is achieved. See “Strategies to Design Envelope-Based Immunogens” and “Native-Like Envelope Trimer Design”. In “Priming Immunogens: Germline Targeting Vaccine Design” and “Epitope-Focused Vaccine Design”, Singh et al. explain the development of mutation-engineered-Env proteins to target and expand precursor B cells to induce bnAbs. However, non-neutralizing epitope exposure diminishes bnAb specificities. Under “Lineage-Based Vaccine Design”, Singh et al. review modified Env immunogen, CH848 10.17DT, derived from a B-cell lineage with acquired improbable mutations, found to possess affinity to bnAb precursors of either a CD4 binding site (CH235) or V3-glycan (DH270) from a bnAb lineage. In addition, Env immunogen CH848.d949.10.17 has conferred affinity against V3 and CD4bs bnAb lineages and successfully steers antibody maturation in vivo. However, Singh et al. conclude that few engineered Env immunogens induce a cross-neutralizing response and that an engineered Env inducing a robust and sustained bnAb response has not been achieved.
The working examples provided on pages 30-38 of the instant published disclosure provide discussions of many Env constructs and mutations to defined amino acid residues, glycan sites, and hypervariable loop motifs contained therein. Data is also provided regarding sensitivity or resistance against different B-cell antibody lineages comprising improbable mutations required for antibody maturation, i.e., DH270, depicted in Figures 4, 7, 9, 14-17, 20, 30, 33, 35-39, and 41. However, the instant disclosure fails to identify the exponential quantity of possible HIV-1 Env mutations and HIV-1 Env constructs that induce cross-reactive, broadly neutralizing antibodies (bnAb).
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. A definition by function alone is not sufficient because it is only an indication of what a thing does, rather than what it is. Eli Lily, 119 F.3 at 1568, 43 USPQ2d at 1406.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 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 the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the distinguishing, identifying characteristics of the encompassed genus of HIV-1 Env claimed. The claims do not meet the written description provision of 35 U.S.C. 112, first paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 and 26-28 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Haynes et al. (WO 2018/161049, *due to the file size, importing this reference as an attachment was not possible).
**Note: Instant paragraphs [0073-0075 and 0172] of the instant published disclosure, USPgPub 2025/034059 state that the proteins listed in Tables 3-5, recited in claims 1 and 16, are “non-limiting embodiments” and non-limiting examples”. In the interest of compact prosecution and broadest reasonable interpretation of the claims consistent with the instant disclosure (MPEP § 2111), the recombinant Env proteins listed in Tables 3-5 are determined exemplative and non-limiting.
Haynes et al. claim a recombinant HIV-1 envelope (Env) polypeptide comprising modified amino acids at positions N133 and/or N138 in the CH848.3.D0949.10.17 envelope sequence, anticipating an HIV-1 Env listed in instant Table 5, Figure 29B, see claim 1, as required by instant claim 1. Claim 2 of Haynes et al. anticipates instant claim 2, where the Env protomer forms a trimer. Paragraph [0187], Tables 3, 4, and Figures 58, 61, and 65-68 of Haynes et al. exemplifies stable trimers, anticipating instant claim 3. Paragraph [0032] and claim 4 of Haynes et al. anticipates the Env trimer multimers in a nanoparticle and additionally comprises a carrier, anticipating instant claims 4, 6, and 8. Paragraph [0415] of Hayes anticipates ferritin molecule comprising six Env trimers per particle, as required by instant claim 9. Paragraphs [142 and 0415] describe a self-assembled ferritin nanoparticle, anticipating instant claims 5 and 7. Claims 8-10 and 16 of Haynes et al. anticipates a method of inducing an immune response by administering an HIV-1 Env or a nucleic acid encoding the Env protein in an amount sufficient to induce an immune response, anticipating instant claims 10, 15, and 16, administered as a priming dose, anticipating instant claim 11. Haynes et al. anticipates administration of HIV-1 Env as a boost dose, anticipating instant claim 12. Claim 3 of Haynes et al. anticipates a nucleic acid encoding the recombinant Env and claim 4 anticipates the nucleic acid with a carrier, anticipating instant claims 13 and 14. Claim 14 of Haynes et al. anticipate the prime and/or boost immunogen administered in a nanoparticle, anticipating instant claim 26. Paragraph [0415] describes improving interaction with a B-cell receptor via a self-assembled ferritin particle, anticipating instant claim 27. Paragraph [0203] anticipates administering the immunogens as an mRNA-LNP formulation, anticipating instant claim 28.
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.
**Note: Instant paragraphs [0073-0075 and 0172] of the instant published disclosure, USPgPub 2025/034059 state that the proteins listed in Tables 3-5, recited in claims 1 and 16, are “non-limiting embodiments” and non-limiting examples”. In the interest of compact prosecution and broadest reasonable interpretation of the claims consistent with the instant disclosure (MPEP § 2111), the recombinant Env proteins listed in Tables 3-5 are determined exemplative and non-limiting.
Claims 1, 2, 4, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, and 10 of U.S. Patent No. 10,968,255. Although the claims at issue are not identical, they are not patentably distinct from each other because the recombinant HIV-1 envelope polypeptide of ‘197, claim 1, is a species anticipating the genus of HIV-1 recombinant Env recited in instant claim 1. Claims 2 and 3 of ‘255 anticipate a carrier and the Env as a trimer, recited in instant claim 2. Claim 9 of ‘255 further requires the trimer comprised in a nanoparticle, recited in claims 4. Claim 10 of ‘255 anticipates a method of inducing an immune response in a subject by administering the recombinant Env, recited in instant claim 10.
Claims 1, 4, 10-16, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 8, 11, 13, and 17 of U.S. Patent No. 11,246,920. Although the claims at issue are not identical, they are not patentably distinct from each other because the recombinant HIV-1 envelope polypeptide of ‘920, claim 1, comprising amino acids 25-648 of CH848.3.D0949.10.17CHIM.6R.SOSIP.664V4.1 (SEQ ID NO: 483), or wherein the polypeptide comprises amino acids 25-648 of CH848.3.D0949.10.17chim.6R.DS.SOSIP.664 (SEQ ID NO: 491), are species anticipating the genus of HIV-1 recombinant Env recited in instant claim 1. Claims 8 and 11 of ‘920 anticipate the HIV-1 Env in a nanoparticle and further comprising a carrier, anticipating instant claim 4. Claims 4 and 5 of ‘920 anticipate a nucleic acid encoding the HIV-1 Env and further comprising a carrier, as recited in claims 13 and 14. Claim 13 of ‘920 is drawn to a method of inducing an immune response by administering one or more recombinant HIV-1 Env or one or more nucleic acid encoding Env as a combination (c), anticipating the prime-boost administration of instant claims 10-12, 15, and 16. Claim 17 of ‘920 anticipates the administration of the Env in a nanoparticle, anticipating instant claim 26.
Claims 1, 4, 10-16, 26, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 10, 17, 22, 28, and 30 of U.S. Patent No. 11,318,197. Although the claims at issue are not identical, they are not patentably distinct from each other because the recombinant HIV-1 envelope polypeptide of ‘197, claim 1, is a species anticipating the genus of HIV-1 recombinant Env recited in instant claim 1. Claims 4 and 22 of ‘197 anticipate the HIV-1 Env in a nanoparticle and further comprising a carrier, anticipating instant claim 4. Claims 3 and 5 of ‘197 anticipate a nucleic acid encoding the HIV-1 Env and further comprising a carrier, as recited in claims 13 and 14. Claims 8 and 28 of ‘197 is drawn to a method of inducing an immune response by administering one or more recombinant HIV-1 Env or one or more nucleic acid encoding Env, anticipating instant claim 10, 15, and 16. The instant prime-boost regimen of instant claims 11 and 12 is anticipated by the prime administration required by claim 10 of ‘197 and administrations of the Env protein multiple times, recited in claim 30 of ‘197. Claim 17 of ‘197 anticipates the immunogen in the prime dose in a nanoparticle, anticipating instant claims 26 and 27.
Claims 1, 2 and 4-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-14, and 16 of copending Application No. 18/274,943 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the HIV-1 Env of ‘943 recited in claim 1 is a species anticipating the HIV-1 Env genus recited in instant claim 1. Claims 2 and 4-14 of ‘943 and instant claims 2 and 4-14 are indistinguishable. Claim 16 of ‘943, drawn to a method of inducing an immune response by administering of a nucleic acid encoding the Env protein anticipates the corresponding method recited in claim 15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Henderson et al. (Nature Communications. 2024 Nov 3; 15 (1): 9503) describe identifying HIV-Env mutations predicted to induce specific antibody mutations in B-cell lineages and designing Env recombinants based on the specific antibody mutations to induce bnAb in vivo. See the abstract and Figure 2.
Swanson et al. (Science Translational Medicine. 2025 Jan 8; 17 (780): eadr2218) describe HIV vaccine immunogen engaging the expansion of B-cell lineages consequently containing improbable mutations, resulting production of broadly neutralizing HIV antibodies. See the abstract and Figures 2-4.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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