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 .
Response to Amendment/Disposition of Claims
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 December 2025 has been entered.
Applicant’s Amendment filed on 18 December 2025 has been received and entered. Claims 1-9, 11, and 13-17 were pending. Claims 1, 3-7, 11, and 15 have been amended. Claims 10 and 12 have been cancelled. No new claims have been added.
Accordingly, Claims 1-9, 11, and 13-17 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2022/0273788 A1, Published 01 September 2022. Applicant’s amended Specification as presented on 17 July 2025 is acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 18 December 2025 regarding the previous Office action dated 18 September 2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Specification
(New Objection) - The disclosure is objected to because of the following informalities: in Paragraph 0011, it is suggested that it say “(such as live attenuated virus and dead virus”) instead of “(such a live attenuated virus and dead virus)”.
In Paragraph 0026, it is suggested that it say “SEQ ID NOs: 1-8 and 17).
in Paragraph 0027, it is suggested that it say “SEQ ID NOs: 9-16).
In Paragraph 0034, it is suggested that it say “24 ASFV genotypes (I-XXIV) have been identified” instead of “24 ASFV genotypes (I-XXIX) have been identified”. “XXIX” is 29 in Roman numerals. “XXIV” is 24.
In Paragraph 0189, it is suggested that it say “…vs intratumoral, etc.)…” instead of “…vs intratumoral, etc)…”. There should be a period after “etc”.
Appropriate correction is required.
Claim Objections
Maintained Objections
(Objection maintained) – The objection to Claims 1, 3-4, 6-7, 11, and 15 for containing minor informalities is maintained as it relates to Claim 4, but is withdrawn as it relates to Claims 1, 3, 6-7, 11, and 15.
Response to Arguments
Applicant's arguments with respect to the objection to the claims have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Claims 3, 4, 7 and 15 have been amended such that they have commas following the claim numbers” (see Page 1 of Remarks, Paragraph 6). This argument is not persuasive as Claim 4 was not actually amended in accordance with Applicant’s statement. As such, the objection to Claims 1, 3-4, 6-7, 11, and 15 for containing minor informalities is maintained as it relates to Claim 4, but is withdrawn as it relates to Claims 1, 3, 6-7, 11, and 15.
New Objections
(New Objection) – Claim 1 is objected to because of the following informalities: it is suggested that “c)” in part (i) be changed to “(c)” so that it is consistent with the rest of the claim language.
Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(a); First Paragraph
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.
(New Rejection) – Claims 1-9, 11, and 13-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an immunogenic composition comprising one or more recombinant polynucleotides which encode polypeptides comprising the claimed sequences (SEQ ID NOs: 1-16) at 100% sequence identity or an immunogenic composition comprising recombinant polypeptides comprising the claimed sequences (SEQ ID NOs: 1-16) at 100% sequence identity for treating African swine fever and a method of treating African swine fever in a subject, does not reasonably provide enablement for an immunogenic composition or a vaccine comprising one or more recombinant polynucleotides which encode polypeptides comprising variants of the claimed sequences (SEQ ID NOs: 1-16) having less than 100% sequence identity or comprising recombinant polypeptides comprising variants of the claimed sequences (SEQ ID NOs: 1-16) having less than 100% sequence identity for preventing African swine fever or a method of preventing African swine fever in a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are drawn to an African swine fever virus (ASFV) subunit vaccine comprising: (i) one or more recombinant polynucleotides which encode polypeptides comprising (a), (b) and (c) wherein: (a) is SEQ ID NO: 1 or a variant with at least 95% sequence identity thereto, (b) is SEQ ID NO: 2 or a variant with at least 95% sequence identity thereto, c) is SEQ ID NO: 3 or a variant with at least 95% sequence identity thereto, and optionally additional ASFV polypeptides; wherein the total number of different ASFV polypeptides encoded by the one or more recombinant polynucleotides is 10 or fewer; or (ii) recombinant polypeptides comprising (a), (b), and (c) wherein: (a) is SEQ ID NO: 1 or a variant with at least 95% sequence identity thereto, (b) is SEQ ID NO: 2 or a variant with at least 95% sequence identity thereto, (c) is SEQ ID NO: 3 or a variant with at least 95% sequence identity thereto; and optionally additional ASFV polypeptides; wherein the vaccine comprises 10 or fewer different ASFV polypeptides, wherein the vaccine comprises: (i) one or more further recombinant polynucleotides encoding one or more ASFV polypeptides selected from SEQ ID NOs: 4-8, or variants with at least 95% sequence identity to one or more of SEQ ID NOs: 4-8; or (ii) one or more further ASFV polypeptides selected from SEQ ID NOs: 4-8, or variants with at least 95% sequence identity to one or more of SEQ ID NOs: 4-8, wherein the vaccine comprises: a) one or more recombinant polynucleotides which encode polypeptides comprising SEQ ID NOs: 1-8 or variants with at least 95% sequence identity to SEQ ID NOs: 8; or one or more recombinant polypeptides comprising SEQ ID NOs: 1-8 or variants with at least 95% sequence identity to SEQ ID NOs: 1-8; (b) one or more recombinant polynucleotides which encode polypeptides comprising SEQ ID NOs: 1-3 and 6-8 or variants with at least 95% sequence identity to SEQ ID NOs: 1-3 and 6-8; or one or more recombinant polypeptides comprising SEQ ID NOs: 1-3 and 6-8 or variants with at least 95% sequence identity to SEQ ID NOs: 1-3 and 6-8; or (c) one or more recombinant polynucleotides which encode polypeptides comprising SEQ ID NOs: 1-5 or variants with at least 95% sequence identity to SEQ ID NOs: 1- 5; or one or more recombinant polypeptides comprising SEQ ID NOs: 1-5 or variants with at least 95% sequence identity to SEQ ID NOs: 1-5, wherein the one or more recombinant polynucleotides comprise SEQ ID NOs: 9, 10 and 11 or variants thereof with at least 95% sequence identity, and wherein the one or more further polynucleotides comprise one or more of SEQ ID NOs: 12-16 or variants thereof with at least 95% sequence identity. The claims are also drawn to a method for treating and/or preventing African swine fever in a subject which comprises administering a therapeutically effective amount of the vaccine according to claim 1 to the subject.
The instant Specification states that “ASFV is a large, icosahedral, double-stranded DNA virus with a linear genome containing at least 150 genes” (see Paragraph 0033) and that, based “on sequence variation in the C-terminal region of the B646L gene encoding the major capsid protein p72, 24 ASFV genotypes (I-XXIX) have been identified” (see Paragraph 0034). The instant Specification states that although “a variant can be considered in terms of similarity (i.e. amino acids residues having similar chemical properties/functions), in the context of the present invention it is preferred to express a variant in terms of sequence identity” (see Paragraph 0076). The instant Specification also states that the “term ‘variant’ according to the present invention includes any substitution of, variation of, modification of, replacement of, deletion of or addition of one (or more) amino acids from or to the sequence providing the resultant amino acid sequence retains substantially the same activity as the unmodified sequence” (see Paragraph 0085) and that “the variant should be capable of inducing an immune response” (see Paragraph 0087). The instant Specification provides examples of conservative substitutions (see Paragraph 0086). Paragraph 0096 of the instant Specification also defines “variant”, in the context of the claimed polynucleotides, as meaning “a naturally occurring nucleic acid sequence which differs from a subject sequence” and that the “variant” may have at least 70% sequence identity with the subject sequence or up to and including 20 mutations”. Paragraphs 0077-0084 describe ways to determine the percent sequence identity between different sequences. The term “subunit vaccine” is defined as “a vaccine which comprises individual polypeptides or polynucleotides encoding said polypeptides; in contrast to vaccines which comprise whole virus particles (such as live attenuated virus and dead virus)” (see Paragraph 0011). The term “vaccine” is defined as “a preparation which, when administered to a subject, induces or stimulates a protective immune response” (see Paragraph 0173). This paragraph further states that a “vaccine render an organism immune to a particular disease, for example in the present case ASF. The vaccine of the present invention thus induces an immune response in a subject that is protective against subsequence ASFV challenge”. The term “preventing” is defined as “intended to refer to averting, delaying, impeding or hindering the contraction of ASF” (see Paragraph 0184). This paragraph further states that the “vaccine may, for example, prevent or reduce the likelihood of an infectious ASFV entering a cell”. Paragraph 0185 defines the term “treating” as “intended to refer to reducing or alleviating at least one symptom of an existing ASF infection”.
State of the prior art/Predictability of the art. The art teaches that protein chemistry is probably one of the most unpredictable areas of biotechnology. For example, replacement of a single “lysine” residue at position 118 of acidic fibroblast growth factor by “glutamic acid” led to the substantial loss of heparin binding, receptor binding and biological activity of the protein (Burgess et al., J of Cell Bio. 111:2129-2138, 1990). In transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen (Lazar et al. Molecular and Cellular Biology 8:1247-1252, 1988). As these references illustrate, it is unpredictable that a polypeptide variant of a known target protein binder will also bind said target. It is also unpredictable that they would bind said target in the same way, having the same effect on the target (i.e. inhibit or activate). Ju (Proceedings of the National Academy of Sciences, U.S.A., Vol. 88, Pg. 2658-2662, 1991) teaches that the interleukin 1 receptor (IL-1R) antagonist IL-1ra is a naturally occurring protein with no agonist activity in vitro or in vivo (Abstract). However, substitution of a single amino acid lysine145 to aspartic acid changes the property of this peptide to a partial agonist of IL-1R (Abstract). Thus, even a single substitution can change the biological property of a peptide.
This substitution need not be at a position where said residue would contact the target protein. Baker (Immunity, Vol. 13, Pg. 475-484, 2000) teaches that Tax-peptide is an agonist of the of T cell activity (Abstract). However, mutation of proline at position 6 of this peptide to alanine creates a T cell antagonist (Abstract). Importantly, this residue does not contact the T cell receptor (Abstract).
In another case, Huang (The Journal of Biological Chemistry, Vol. 272, No. 43, Pg. 27155-27159, 1997) teaches that conjugation of peptides to other proteins can change their biological properties. They teach that multiple conjugation of the peptide TGFβ1 (residues 41-65) to carrier proteins enhances its antagonist activity but also confers partial agonist activity as well (Abstract). Thus, the chemical context of a biologically active peptide is also important.
Truncation of proteins can also lead to adverse effects on protein structure and thus protein function. Martindale (Nature Genetics, Vol. 18, Pg. 150-154, 1998) teaches that truncation of huntingtin leads to aggregate development which compromises cell viability (Abstract). Nonaka (Human Molecular Genetics, Vol. 18, No. 18, Pg. 3353-3364, 2009) teaches that truncation of TDP-43 to its C-terminal fragments causes abnormally phosphorylated and ubiquitinated inclusions of the protein (Abstract). Taken together, not just any truncation of a protein will yield a soluble, functional, protein fragment.
In summary, these examples teach that the biological function of peptide variants is unpredictable because even a single mutation can abolish activity or give a different function. For example, agonist and antagonist peptides can be interconverted through conjugation or mutagenesis. Importantly, binding can still occur after mutation or conjugation in the literature examples provided above, illustrating that a simple show of binding is not predictive of the nature of a peptide’s biological activity. This point is underlined by Montrose-Rafizadeh (The Journal of Biological Chemistry, Vol. 272, Pg. 21201-21206, 1997) who teaches that receptor binding does not predict agonist or antagonist activity (Pg. 21205, Column 2, Paragraph, first full, Sentence, first).
Reasonable guidance with respect to preventing any viral infection relies on quantitative analysis from defined populations that have been successfully pre-screened and are predisposed to particular types of viruses. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical infection and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent. Further, a preventive administration also must assume that the therapeutic will be safe and tolerable for anyone susceptible to the disease. Therefore, Applicant may provide data showing prevention in vivo.
As stated in Cross v. Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747 (Fed. Cir. 1985): [B]ased upon the relevant evidence as a whole, there is a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence. (Citations omitted.) Therefore, in the absence of the in vivo data above, Applicant may also provide evidence of pharmacological activity that would reasonably correlate with prevention of infection.
In the case of virus vaccines, a reasonable nexus exists between neutralizing antibody generation and prevention of infection. Thus, a showing that an antigen within the recited immunogen scope can produce such antibodies would support enablement for use of said antigen in a vaccine and/or methods of preventing infection therewith of the virus comprising said antigen.
Burton (Nature Reviews Immunology, Vol. 2, Pg. 706-713, 2002) teaches neutralizing antibodies are crucial for vaccine-mediated protection against viral diseases (Abstract). Figure 1 divides antiviral activities of antibodies into two groups: activities against free virus and activities against infected cells. Actual block of infection (prevention of infection) is taught to be the role of neutralizing antibodies (Figure 1). Nonneutralizing antibodies thus cannot prevent infection, only treat an infection.
Adding to the unpredictability is the fact that not just any epitope of a target antigen/virus will lead to antibody generation, let alone that of neutralizing antibodies. Riddell (Journal of Virology, Vol. 74, No. 17, Pg. 8011-8017, 2000) at the abstract teaches patient sera reacts with some but not all B-cell epitopes on ORF7.1 protein. Thus, not just any epitope/antigen/immunogen will contribute to patient immunity against a virus. Sugiyama (Journal of Virology, Vol. 76, No. 4, Pg. 1691-1696, 2002) supports this by teaching in their abstract that even amongst known epitopes that lead to neutralizing antibodies in some species, another subject’s immune reaction will not necessarily generate antibodies against all said epitopes.
Burton (PNAS, Vol. 108, No. 27, Pg. 11181-11186, 2011) teaches three anti-HIV antibodies. Antibodies b12 and b6 bind CD4 binding sites while F240 binds gp41 (Abstract). All were tested for prevention of SHIV transmission to macaques (Abstract). While the two anti-gp120 antibodies have similar binding properties, b12 is strongly neutralizing and b6 is not (Abstract). F240 is nonneutralizing (Abstract). Compared to controls, the protection by b12 achieved statistical significance while no such protection was seen for either b6 or F240 (Abstract). Thus, the work of Burton supports the conclusion that neutralizing antibodies are required for prevention and so a functional vaccine should produce such. It also supports the idea that not just any peptide on protein may generate neutralizing antibodies that protect as evidenced by b12 and b6 performance above. Data are clearly required to calm the concerns of the prior art and make methods of viral infection prevention and vaccine products predictable.
The prior art also teaches that antibody epitopes function as such based in large part on protein primary sequences. Polyak et al. (Blood, Vol. 99, No. 9, Pg. 3256-3262, 2002) teach that mutation of an epitope can have serious consequences on antibody binding. They teach that the sequence AxP at positions 170-172 in human CD20 is critical to the secondary structure of an extracellular loop and its loss causes the loss of binding of three anti-CD20 monoclonal antibodies (Pg. 3261, Column 1, Paragraph, second full). Changes in antigen primary sequences can greatly affect secondary, tertiary, and even quaternary protein structure and in so doing, modify the ability of antibodies to recognize their epitopes. Munodzana et al. (Infection and Immunity, Vol. 66 No. 6, Pg. 2619-2624, 1998) teach that induction of immunity to Anaplasma marginale requires antibodies to conformationally dependent epitopes on the pathogen (Pg. 2622, Column 2, Paragraph, first partial). Epitope mapping on one of the pathogen surface proteins MSP5 revealed antibody dependence on two sets of amino acid sequences 1-91 and 125-161 (Pg. 2622, Column 2, Paragraph, first partial). A dependence on so many amino acids indicates heavy structural requirements for the antibody epitope. Importantly, the N-terminal amino acid sequences include conserved cysteines that participate in intramolecular disulfide bonds (Pg. 2622, Column 2, Paragraph, first partial). Loss of monoclonal antibody ANAF16C1 binding to MSP5 was found after disulfide bond reduction and covalent modification of the reduced sulfhydryl groups (Pg. 2622, Column 2, Paragraph, first partial). By logical extension, the variants encompassed by the instant claims would not therefore predictably yield an antibody with an epitope in a natural virus. Rather, the antibodies would be drawn to the mutated epitopes of the variant instead, yielding unpredictable anti-viral immunity in the clinic.
Since the art teaches that it is unpredictable whether or not peptide variants of immunogenic polypeptides will function as such, and the specification does nothing to ameliorate these concerns, one would be burdened with undue experimentation to use the products of instant claims as broadly as they are currently claimed.
Additionally, taken together, it is clear from the prior art that a PHOSITA cannot predict the preventative power of any immunogen. They must be shown data that supports such a conclusion. Without demonstration of neutralizing antibody production, for example, in the target population with the specific immunogen, no practitioner in this art would see any given immunogen as a functional, predictable prophylactic agent.
Working examples. No working examples of the claimed variants are disclosed in the specification. The only working examples of the immunogenic composition are disclosed in Example 1 of the instant Specification (see Paragraphs 0205-0210; Table 1; Figure 4), presumably with constructs which are 100% identical to the claimed sequences.
Guidance in the specification. The specification provides guidance towards constructs which are presumably 100% identical to the claimed sequences. The instant Specification, however, fails to disclose the critical or essential amino acid residues or nucleotide positions which must be present and also fails to disclose any variants of the claimed sequences. While the instant Specification does define the term “variant” and provide examples of conservative amino acid substitutions, it fails to disclose which regions can tolerate such changes. The instant Specification does not disclose neutralizing antibodies being generated as a result of the administration of the claimed immunogenic composition.
Amount of experimentation necessary. Since the art teaches that it is unpredictable whether or not peptide or nucleotide variants of known sequences will function as intended, and the specification does nothing to ameliorate these concerns, one would be burdened with undue experimentation to carry out and/or use the claimed products and/or methods. Also, additional research is required in order to determine how effective the claimed polypeptides and polynucleotides encoding said polypeptides would be at preventing infection with African swine fever virus and acting as part of a vaccine.
(New Rejection) – Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for intramuscular administration, does not reasonably provide enablement for oral, intravenous, subcutaneous, intranasal, or intradermal administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are drawn to an African swine fever virus (ASFV) subunit vaccine comprising: (i) one or more recombinant polynucleotides which encode polypeptides comprising (a), (b) and (c) wherein: (a) is SEQ ID NO: 1 or a variant with at least 95% sequence identity thereto, (b) is SEQ ID NO: 2 or a variant with at least 95% sequence identity thereto, c) is SEQ ID NO: 3 or a variant with at least 95% sequence identity thereto, and optionally additional ASFV polypeptides; wherein the total number of different ASFV polypeptides encoded by the one or more recombinant polynucleotides is 10 or fewer; or (ii) recombinant polypeptides comprising (a), (b), and (c) wherein: (a) is SEQ ID NO: 1 or a variant with at least 95% sequence identity thereto, (b) is SEQ ID NO: 2 or a variant with at least 95% sequence identity thereto, (c) is SEQ ID NO: 3 or a variant with at least 95% sequence identity thereto; and optionally additional ASFV polypeptides; wherein the vaccine comprises 10 or fewer different ASFV polypeptides and a method for treating and/or preventing African swine fever in a subject which comprises administering a therapeutically effective amount of the vaccine according to claim 1 to the subject, wherein the vaccine is administered by oral, intravenous, intramuscular, subcutaneous, intranasal or intradermal administration. The instant Specification states that the “vaccine may be administered in a convenient manner such as by the oral, intravenous, intramuscular, subcutaneous, intranasal, intradermal or suppository routes or implanting (e.g., using slow release molecules)” (see Paragraph 0187) and that those “skilled in the art will appreciate, for example, that route of delivery (e.g., oral vs intravenous vs subcutaneous vs intratumoral, etc.) may impact dose amount and/or required dose amount may impact route of delivery” (see Paragraph 0189).
State of the prior art/Predictability of the art. The art teaches that while intramuscular administration of ASFV vaccines is common, other routes of administration are feasible alternatives to some extent. Sánchez-Cordón et al. (Sánchez-Cordón PJ, Chapman D, Jabbar T, Reis AL, Goatley L, Netherton CL, Taylor G, Montoya M, Dixon L. Different routes and doses influence protection in pigs immunised with the naturally attenuated African swine fever virus isolate OURT88/3. Antiviral Res. 2017 Feb;138:1-8) note that intranasal immunization with strain OURT88/3 induced higher levels of protection than intramuscular immunization, but led to transient clinical reactions or chronic forms of ASFV (see Page 6, Left Column, Last Paragraph and Right Column, First Paragraph). Sánchez-Cordón et al. note “the complexity of standardizing a dose for intranasal immunisation” coupled with the fact that these symptoms were not observed in pigs immunized intramuscularly suggest that intramuscular administration is “the most feasible and safe for immunisations against ASFV” (see Page 7, Left Column, Paragraphs 1-2).
Sang et al. (Sang H, Miller G, Lokhandwala S, Sangewar N, Waghela SD, Bishop RP, Mwangi W. Progress Toward Development of Effective and Safe African Swine Fever Virus Vaccines. Front Vet Sci. 2020 Feb 21;7:84.) note that “simulation of most common natural routes of infection and transmission is critical for evaluation of protective efficacy of vaccine candidates” (see Page 6, Left Column, Paragraph 2) and that “ideal challenge models should closely resemble natural ASFV transmission in swine and the most common transmission route is likely to be via direct contact through mucosal surfaces” (see Page 6, Left Column, Paragraph 4). Sang et al. also teach that oral bait-based vaccines have been used for successful immunization of wild animals against rabies and that “an oral ASFV vaccine candidate, attenuated genotype II ASFV (Lv17/WB/Rie1) was tested in wild boars and shown to confer 92% protection against virulent challenge with ASFV Armo7 isolate” but that “further studies are needed before the vaccine can be approved for deployment” (see Page 5, Right Column, Last Paragraph and Page 6, Left Column, First Paragraph). Sang et al. admit that “the majority of ASFV immunization studies have used intramuscular administration of vaccine and the same route for challenge” and that few studies have aimed “to determine effective intranasal challenge doses of ASFV isolates that differ in virulence” (see Page 6, Right Column, Paragraph 2).
Zhang et al. (Zhang H, Zhao S, Zhang H, Shen Y, Zhang P, Shan H, Cai X. Orally administered recombinant Lactobacillus expressing African swine fever virus antigens that induced immunity responses. Front Microbiol. 2023 Jan 9;13:1103327.) teach the use of an oral ASFV subunit vaccine but using the recombinant Lactobacillus lactis expression system, not a viral vector, which was able to generate humoral and cellular immunity, as well as local mucosal immunity with the use of heat-labile enterotoxin B as an adjuvant, in rabbits (see Abstract).
Lai et al. disclose the use of a subunit vaccine, specifically a lipid nanoparticle-encapsulated DNA vaccine encoding ASFV p54 antigen, which was administered intramuscularly to the pigs used in the experiment (see Abstract; Page 3, Left Column, Last Paragraph and Right Column, First Paragraph), which aligns with the observations of Sánchez-Cordón and Sang et al. The teachings of Lokhandwala et al. (Lokhandwala S, Waghela SD, Bray J, Martin CL, Sangewar N, Charendoff C, Shetti R, Ashley C, Chen CH, Berghman LR, Mwangi D, Dominowski PJ, Foss DL, Rai S, Vora S, Gabbert L, Burrage TG, Brake D, Neilan J, Mwangi W. Induction of Robust Immune Responses in Swine by Using a Cocktail of Adenovirus-Vectored African Swine Fever Virus Antigens. Clin Vaccine Immunol. 2016 Nov 4;23(11):888-900.), Lopera-Madrid et al. (Lopera-Madrid J, Osorio JE, He Y, Xiang Z, Adams LG, Laughlin RC, Mwangi W, Subramanya S, Neilan J, Brake D, Burrage TG, Brown WC, Clavijo A, Bounpheng MA. Safety and immunogenicity of mammalian cell derived and Modified Vaccinia Ankara vectored African swine fever subunit antigens in swine. Vet Immunol Immunopathol. 2017 Mar;185:20-33.), and Zajac et al. (Zajac MD, Sangewar N, Lokhandwala S, Bray J, Sang H, McCall J, Bishop RP, Waghela SD, Kumar R, Kim T, Mwangi W. Adenovirus-Vectored African Swine Fever Virus pp220 Induces Robust Antibody, IFN-γ, and CTL Responses in Pigs. Front Vet Sci. 2022 May 31;9:921481.) all support the observations of Sánchez-Cordón and Sang et al, as these references all disclose viral-vectored ASFV subunit vaccines, specifically using either Adenovirus or modified vaccinia Ankara vectors, being administered intramuscularly (see Page 889, Right Column, Paragraph 4 of Lokhandwala et al.; Page 22, Right Column, Paragraph 5 of Lopera-Madrid et al.; Page 3, Right Column, Paragraph 2 of Zajac et al.).
Working examples. The only working example disclosed in the specification states that swine subjects were administered the prime-boost regimen of the immunogenic composition via the intramuscular route. This was also the same route used for challenging the pigs with ASFV.
Guidance in the specification. The specification only provides guidance towards intramuscular administration of the compositions comprising the separate adenovirus vectors and the modified vaccinia Ankara vectors. No other routes of administration are used in the data provided.
Amount of experimentation necessary. In light of the teachings of the art, additional research is required in order to determine how effective the instant subunit vaccine would be delivered via administration routes other than the intramuscular route, and the instant Specification does nothing to ameliorate the concerns regarding the unpredictability of delivering said subunit vaccine via other administration routes.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to make and/or use the claimed products and/or methods.
(New Rejection) – Claims 1-9, 11, and 13-17 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 instant application attempts to tie function to sequence identity in the context of an African swine fever virus (ASFV) subunit vaccine comprising: (i) one or more recombinant polynucleotides which encode polypeptides comprising (a), (b) and (c) wherein: (a) is SEQ ID NO: 1 or a variant with at least 95% sequence identity thereto, (b) is SEQ ID NO: 2 or a variant with at least 95% sequence identity thereto, c) is SEQ ID NO: 3 or a variant with at least 95% sequence identity thereto, and optionally additional ASFV polypeptides; wherein the total number of different ASFV polypeptides encoded by the one or more recombinant polynucleotides is 10 or fewer; or (ii) recombinant polypeptides comprising (a), (b), and (c) wherein: (a) is SEQ ID NO: 1 or a variant with at least 95% sequence identity thereto, (b) is SEQ ID NO: 2 or a variant with at least 95% sequence identity thereto, (c) is SEQ ID NO: 3 or a variant with at least 95% sequence identity thereto; and optionally additional ASFV polypeptides; wherein the vaccine comprises 10 or fewer different ASFV polypeptides, wherein the vaccine comprises: (i) one or more further recombinant polynucleotides encoding one or more ASFV polypeptides selected from SEQ ID NOs: 4-8, or variants with at least 95% sequence identity to one or more of SEQ ID NOs: 4-8; or (ii) one or more further ASFV polypeptides selected from SEQ ID NOs: 4-8, or variants with at least 95% sequence identity to one or more of SEQ ID NOs: 4-8, wherein the vaccine comprises: a) one or more recombinant polynucleotides which encode polypeptides comprising SEQ ID NOs: 1-8 or variants with at least 95% sequence identity to SEQ ID NOs: 8; or one or more recombinant polypeptides comprising SEQ ID NOs: 1-8 or variants with at least 95% sequence identity to SEQ ID NOs: 1-8; (b) one or more recombinant polynucleotides which encode polypeptides comprising SEQ ID NOs: 1-3 and 6-8 or variants with at least 95% sequence identity to SEQ ID NOs: 1-3 and 6-8; or one or more recombinant polypeptides comprising SEQ ID NOs: 1-3 and 6-8 or variants with at least 95% sequence identity to SEQ ID NOs: 1-3 and 6-8; or (c) one or more recombinant polynucleotides which encode polypeptides comprising SEQ ID NOs: 1-5 or variants with at least 95% sequence identity to SEQ ID NOs: 1- 5; or one or more recombinant polypeptides comprising SEQ ID NOs: 1-5 or variants with at least 95% sequence identity to SEQ ID NOs: 1-5, wherein the one or more recombinant polynucleotides comprise SEQ ID NOs: 9, 10 and 11 or variants thereof with at least 95% sequence identity, and wherein the one or more further polynucleotides comprise one or more of SEQ ID NOs: 12-16 or variants thereof with at least 95% sequence identity.
While a percent identity threshold is provided in the claims, the instant Specification fails to disclose the critical or essential amino acid residues or nucleotide positions which must be present and also fails to disclose any variants of the claimed sequences. It states that although “a variant can be considered in terms of similarity (i.e. amino acids residues having similar chemical properties/functions), in the context of the present invention it is preferred to express a variant in terms of sequence identity” (see Paragraph 0076). The instant Specification also states that the “term ‘variant’ according to the present invention includes any substitution of, variation of, modification of, replacement of, deletion of or addition of one (or more) amino acids from or to the sequence providing the resultant amino acid sequence retains substantially the same activity as the unmodified sequence” (see Paragraph 0085) and that “the variant should be capable of inducing an immune response” (see Paragraph 0087). The instant Specification provides examples of conservative substitutions (see Paragraph 0086). Paragraph 0096 of the instant Specification also defines “variant”, in the context of the claimed polynucleotides, as meaning “a naturally occurring nucleic acid sequence which differs from a subject sequence” and that the “variant” may have at least 70% sequence identity with the subject sequence or up to and including 20 mutations”. Paragraphs 0077-0084 describe ways to determine the percent sequence identity between different sequences. While the instant Specification does define the term “variant” and provide examples of conservative amino acid substitutions, it fails to disclose which regions can tolerate such changes. As such, it would be unclear to a person having ordinary skill in the art to know what to change and what not to change.
Furthermore, while it is not explicitly stated, it is assumed that the constructs used in the instant Specification have sequences which are 100% identical to the claimed sequences. Even if that is not the case, the data shown do not explicitly include any claimed variants having as little as 95% sequence identity, or even 96-99% sequence identity, raising questions about how effective these claimed variants would be in the data provided. Thus, it is not clear what was tested, it does not appear that any claimed variants were tested, and the essential characteristics of the genus being claimed by Applicant have not been identified or disclosed.
“[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 contributions to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle and Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient details that one skilled in the art can reasonably conclude that the invention had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
MPEP § 2163 states that 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, 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 applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, as here in which the peptide or nucleotide variants can have any sequences which vary from instant SEQ ID NOs: 1-16 by as much as 5%, one must describe a sufficient variety of species to reflect the variation within the genus. However, one of skill in this art cannot envision the structure of any peptide or nucleotide variants with the required sequence identity other than the few species provided by Applicant and the prior art. Therefore, since only a few species are provided to represent the genera, the claims encompassing the same clearly fail the written description requirement.
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014).
Overall, at the time the invention was made, the level of skill for preparing peptide and nucleotide variants and then selecting those peptides and nucleic acids which meet the desired percent identity cutoff was high. However, even if a selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identity peptide and nucleotide variants with the recited percent identity cutoff, the written description provision of 35 U.S.C. 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010). Absent the conserved structure provided by a core peptide or nucleotide sequence, the skilled artisan would not be able to visualize or otherwise predict, a priori, what any peptide or nucleotide which meets the recited percent identity cutoff would look like structurally.
While applicant has described a few species within the genera recited, and the art may provide more, each genus is very large and would encompass peptide and nucleotide structures that cannot be visualized from the prior art or instant disclosure. One of skill in this art cannot determine the peptide or nucleotide structures encompassed by the claimed/recited genera only defined by sequence identity. Any future peptide and nucleotide variants may or may not be encompassed, as if they are, they would not have been represented in Applicant’s disclosed species. Thus, the described species cannot be considered representative of the entire recited genera of peptide and nucleotide variants. E.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Therefore, the claims are rejected here.
As such, it does not appear Applicant was in possession of the full scope of the claimed invention at the time of filing and thus Claims 1-9, 11, and 13-17 do not meet the written description requirement.
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.
(Rejection maintained) – The rejection of Claims 1-9, 11, and 13-17 under 35 U.S.C. 103 as being unpatentable over Nikolin et al. (US 2020/0306360 A1, earliest Priority Date 27 March 2019), Chapman et al. (Chapman, D. A. G., Tcherepanov, V., Upton, C., & Dixon, L. K. (2008). Comparison of the genome sequences of non-pathogenic and pathogenic African swine fever virus isolates. The Journal of general virology, 89(Pt 2), 397–408.), Rodriguez and Salas (US 2015/0165018 A1, Published 18 June 2015), and Finger et al. (US 2022/0105170 A1, earliest Priority Date 28 June 2019) is maintained.
Response to Arguments
Applicant's arguments with respect to the rejection of Claims 1-9, 11, and 13-17 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Nikolin merely discloses an ASFV subunit vaccine which may comprise SEQ ID NO: 74, which is 87.4% identical to SEQ IDNO: 1” and “SEQ ID NO: 126 which is 100% identical to SEQ ID NO: 2” (see Page 3 of Remarks, Paragraph 4). Applicant also argues that the “person skill in the art developing a subunit vaccine to induce immune protection to ASFV reading Nikolin would be pointed to one of the preferred combination polypeptides therein, for example the 13 polypeptides of claim 25” and that “Nikolin does not disclose SEQ ID NO: 126 (E183L) as part of a preferred combination of polypeptides” (see Page 3, Paragraph 4). Applicant then argues that the “combination of cited art would not have motivated one of ordinary skill to arrive at a vaccine comprising the minimal combination of SEQ ID NO: 1, 2, and 3 or variants with at least 95% sequence identity thereto to be sufficient to induce a protective immune response to ASFV challenge” (see Page 4, Paragraph 1). Applicant additionally argues that “it would not have been reasonably predictable which ASFV polypeptides could induce protection to ASFV challenge based merely on a proteome generated from a full-length genomic sequence as in Chapman” and that “the skilled person would have had no expectation that the combination of any three proteins therein would be sufficient to form a minimal combination which can induce immune protection to ASFV, let alone specifically the three proteins of the instant invention” (see Page 4, Paragraph 3), which “the present inventors have surprisingly found that the minimal combination of three ASFV polypeptides are capable of inducing repeatable protection against ASFV”, those three polypeptides being “B602L (SEQ ID NO: 1), E183L (SEQ ID NO: 2), and EP153R (SEQ ID NO: 3)” (see Page 5, Paragraph 1).
While Examiner agrees that none of the cited prior art individually teaches all limitations of the instant claims, Examiner disagrees with the assertion and conclusion that the instant invention is not rendered obvious by the combination of the cited prior art. Applicant’s claim that the optimal embodiment disclosed by Nikolin et al. does not provide any motivation or guidance to look for alternative combinations ignores the fact that the prior art serves as a reference for all that it teaches, not just its preferred or most preferred embodiment(s). See MPEP 2123. Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). MPEP 2123. The immunogenic peptide prediction method disclosed by Finger et al. could be used to generate immunogenic proteins from the genomes disclosed by both Chapman et al. and Rodriguez and Salas, as the genomes disclosed must be used as the starting point for generating the proteomes which would then be used by Finger et al. to generate said immunogenic proteins for use in the subunit vaccine disclosed by Nikolin et al. Nikolin et al. also teach a method for identifying immunogenic epitopes in the ASFV proteome and demonstrate repeated protective immunity using some of the identified epitopes (see Paragraphs 1172-1182). While these do not include the instantly claimed proteins in the most preferred embodiment, Nikolin et al. nonetheless contemplates the instantly claimed proteins as part of its immunogenic composition, and thus the prior art teachings encompass the limitations of the instant claims, much the same way Finger et al. teach a method of administering one viral vector and then administering a second viral vector (see Paragraphs 0224, 0318), wherein the viral vectors can include Adenovirus and modified vaccinia Ankara virus, and thus teach a prime-boost method encompassing the claimed instant method wherein the priming composition comprises an Adenovirus vector and the boosting composition comprises a modified vaccinia Ankara vector.
Applicant states in their arguments Nikolin discloses an ASFV vaccine with instant SEQ ID NO. 2 and so the technical effect of protective immunity is not surprising. A PHOSITA reading Nikolin would expect such a result from the one immunogen alone or with additional immunogens. Also, additivity is expected and so such results are equally not surprising and cannot obviate the rejection. Furthermore, all the instantly claimed polypeptides were found in the prior art and are taught as immunogens for an ASFV vaccine. As such, it would be obvious to combine them together, as they have all been taught for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
In response to Applicant's Arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
With respect to protection, no claim is drawn solely to prevention. See the use of the vaccine in claim 11, for example, for treatment. Thus, even if such were unexpected, the claims are not commensurate in scope with preventative effects.
As such, the rejection of Claims 1-9, 11, and 13-17 under 35 U.S.C. 103 as being unpatentable over the prior art is maintained.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Mwangi et al. (US 2019/0307879 A1, Published 10 October 2019)
Mwangi et al. teach an Adenovirus-vectored multivalent immunogenic composition comprising multiple ASFV antigens. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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