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 .
DETAILED ACTION
Status of Claims
Applicant's preliminary amendment of the instant application, which was originally submitted on 08/02/2023 and later amended on the same day, then 01/29/2024, is acknowledged by the Examiner. Claims 1 – 20 were previously examined and restricted in the Office Action mailed on 12/29/2025.
Election/Restrictions
Applicant’s election without traverse of an attenuated African Swine Fever virus (ASFV), i.e., Group I, in the reply filed on 02/25/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/25/2026. Claims 1 – 19 are pending.
Priority
The instant application is a National Stage Entry of International Patent Application No. PCT/EP2022/052183 filed on 01/31/2022 and claims priority to European Patent Application No. EP21305138.6 filed on 02/02/2021. Priority is granted to the European Patent Application No. EP21305138.6 for claims 1 – 19 of the instant application. Thus, the U.S. effective filing date of the instant application is 02/02/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/02/2023 and 02/23/2024 has been considered by the Examiner. Notably, the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Thus, unless the references have been cited by the Examiner on form PTO-892, they have not been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. Also, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The use of the terms Ion Xpress™ on page 16; Ion Proton™ on page 16; NucleoSpin® on page 19, and possibly others in the specification, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, ℠, or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant is required to properly annotate all trade names and/or marks that are present in the specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 17. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
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.
Drawings
The drawings are objected to under 37 CFR 1.84(u)(1), which states "view numbers must be preceded by the abbreviation "FIG.". In the instant case, the view numbers of Figures 1 – 19 are preceded by the word “Figure” instead of the abbreviation “FIG.”. Additionally, the commas used to represent a decimal place in Figures 4, 6, 7, 9, and 14 – 19 should be replaced with periods to be in agreement with standard United States practice. It is also unclear what the + and – symbols on opposite sides of the dashed line in figure 12 are intended to denote as there is no reference character in the figure legend.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the Examiner, the Applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 – 19 are objected to because of the following informalities:
Claims 1 – 19 have inconsistent terminology, which should be corrected. In claim 1, line 1, the acronym “ASF virus” is defined as being “African Swine Fever virus”. Similar iterations of “ASF virus” occur in claim 2, line 1; claim 3, line 1; claim 4, line 1; claim 5, line 1; claim 6, line 1; claim 7, line 1; claim 8, line 1; claim 9, line 1; claim 10, line 2; claim 11, line 1; claim 12, lines 1 and 3; claim 13, lines 1 and 2; claim 14, line 1; claim 15, lines 1 and 2; and claim 19, lines 1, 2, and 4 – 6. However, in claim 6, line 2, the phrase “ASFV virus” is recited. Not only should an acronym, i.e., “ASFV”, be defined the first time it appears in an independent claim or in the group of claims under an independent claim, but the acronym “ASFV” is inconsistent with “ASF virus”. Moreover, “virus” is part of the acronym, so “ASFV virus” is unnecessary. Similar iterations of “ASFV virus” occur in claim 7, lines 2 and 3; claim 12, lines 2 and 3; and claim 19, line 3. Applicant should pick one acronym to denote African Swine Fever virus throughout the instant application. It is recommended that all abbreviations be amended to “ASFV” to be consistent with the names of the genes;
There is a grammatical error in claim 1, lines 4 and 6; claim 4, lines 2 and 4; and claim 17, lines 2 and 4. It is recommended that “such that” be amended to read “so that”;
In claim 1, line 5, the comma after “translated” should be a semicolon;
In claim 1, line 6 and claim 15, line 5, the acronym “ORF” is recited, but not defined in the claim. An acronym should be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For the purposes of examination, “ORF” is interpreted to mean “open reading frame”, as defined in the specifications;
In claim 1, line 7, the comma after “translated” should be a semicolon;
In claim 1, line 8, the comma after “truncated” should be a semicolon;
There is a translation error in claim 1, line 8; claim 2, line 4; and claim 15, line 7. It is recommended that “et” be amended to “and”. For example, the phrase in claim 1, line 8 should read “genes MGF 505-1R and 505-4R”;
In claim 3, line 2, the comma after “deleted” should be a semicolon;
In claim 4, line 3, the comma after “translated” should be a semicolon;
In claim 5, line 4 and claim 18, line 4, the phrase “open reading phrase” is recited. However, the acronym “ORF” has previously been defined in claims 1 and 15. An acronym should only be defined the first time it appears in an independent claim or in the group of claims under an independent claim. For consistency purposes, Applicant should either stick to using the acronym, i.e., “ORF”, or phrase, i.e., “open reading frame” throughout the claims;
In claim 6, line 3, there is a missing comma after “for example”, wherein the phrase should read “for example, Pig/HLJ/2018”;
In claim 6, line 5, the comma after “ASFV/Kyiv/2016/131” should be a semicolon;
In claim 6, line 6, there is a missing semicolon after “genotype II”, wherein the phrase should read “genotype II; or a”;
In claim 14, line 2, the comma after “wild-boar” should be a semicolon;
In claim 15, line 4, the comma after “translated” should be a semicolon;
In claim 15, line 6, the comma after “translated” should be a semicolon;
In claim 15, line 7, the comma after “truncated” should be a semicolon;
In claim 16, line 2, the comma after “deleted” should be a semicolon;
In claim 17, line 3, the comma after “translated” should be a semicolon;
In claim 19, line 4, there is a missing comma after “genotype II”, wherein the phrase should read “genotype II; or a”;
In claim 19, line 5, the comma after “strain” should be a semicolon;
In claim 6, line 6, there is a missing semicolon after “pigs”, wherein the phrase should read “pigs; and”;
Recommended amendments are underlined. Appropriate correction is required.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 – 19 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.
Claims 1 and 15 are vague and unclear, which renders the claims indefinite. The claims recite various iterations of “genes are not transcribed and/or translation”. It is not clear if transcription and/or translation of the genes themselves is completely nonexistent, or that the genes are transcribed and translated, but the wildtype, i.e., full length, protein is simply not produced, i.e., a truncated protein, is produced. The presence of multiple very different interpretations of the same claim language renders the claim indefinite. This rejection affects all dependent claims, i.e., claims 2 – 19. In the context of this examination, it will be inferred that the genes are still transcribed and/or translated, but the resulting protein is truncated and not the full length, wildtype protein. However, an appropriate amendment is required.
Claims 5 and 18 are vague and unclear, which renders the claims indefinite. Line 2 of both claims recite "the interruption". It is not clear which interruption in claims 1 and 15, upon which claims 5 and 18 depend, correspondingly, is being referenced. Is the interruption referring to the one of the genes, some of the genes, or all of the genes in first bullet point, i.e., genes MGF 360-12L, 360-13L, 360-14L, 505-2R, 505-3R? Could it be the interruption of the second bullet point, i.e., the open reading frame (ORF) of ASFV_G_ACD_00520? What about the interruption of the MGF 505-1R and 505-4R genes defined in the third bullet point? The presence of multiple very different interpretations of the same claim language renders the claim indefinite. In the context of this examination and instant specification, it will be inferred that “the interruption” is the deletion of MGF 360-12L, 360-13L, 360-14L, 505-2R, and 505-3R; ORF of ASFV_G_ACD_00520; AND truncation of MGF 505-1R and 505-4R. However, an appropriate amendment is required.
Regarding claim 6, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The phrase suggests that the limitation is optional or a preferred embodiment, but is unclear from the claim language itself whether that limitation is essential for infringement or an optional feature. The presence of multiple very different interpretations of the same claim language renders the claim indefinite. See MPEP § 2173.05(d).
The term “close” in claims 6, 12, and 19 is a relative term which renders the claim indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not define the degree of variability that is encompassed by “close”. This term is subjective and multiple practitioners could have varying opinions on what constitutes “close” any particular value. Thus, the claims that recite “close” are rendered indefinite. It is suggested that every iteration of the term be removed in its current usage. See MPEP § 2173.05(b).
Claims 11 – 14 recite different iterations of “for use in preventing African Swine Fever” in line 1 of the claims. The claims recite a use without any active steps delineating how the use is actually practiced. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. A claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986) and MPEP § 2173.05(q).
Regarding claim 13, the phrase "especially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The phrase suggests that the limitation is optional or a preferred embodiment, but is unclear from the claim language itself whether that limitation is essential for infringement or an optional feature. The presence of multiple very different interpretations of the same claim language renders the claim indefinite. See MPEP § 2173.05(d).
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection(s) and art may be applied in a subsequent Office Action.
35 USC § 112(a)
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.
35 USC § 112(a) – Written Description
Claims 1 – 19 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 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"); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005). This requirement is separate and distinct from the enablement requirement. To satisfy the written description requirement for a claimed genus, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. See In re Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345, 54 USPQ2d 1915, 1917 (Fed. Cir. 2000). “Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement.” See In re Enzo Biochem, Inc. v. Gen–Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). See also MPEP § 2163.
The written description requirement 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 applicant was in possession of the claimed genus. See In re University of California v. Eli Lilly & Co., 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997); and Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021).
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, the applicant must describe a sufficient variety of species to reflect the variation within the genus. See In re AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See In re Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." See In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. 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. This is because functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. 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 description needed to satisfy the written description varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. See In re University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); In re AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014); In re Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 94 USPQ2d 1161 (Fed. Cir. 2010); and In re Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.
Claims 1 – 5 and 15 – 18 are drawn to various iterations of the deletion, interruption, or mutation of MGF 360-12L, 360-13L, 360-14L, 505-2R, 505-3R and/or the open reading frame (ORF) of ASFV_G_ACD_00520 and the truncation of MGF 505-1R and 505-4R from attenuated African Swine Fever virus (ASFV) and combinations thereof. While claims 2, 3, 16, and 17 give more specific limitations of the truncation in MGF 505-1R and 505-4R (claims 2 and 16) and the deletion of MGF 360-12L, 360-13L, 360-14L, 505-2R, 505-3R and ORF of ASFV_G_ACD_0052 (claims 3 and 17), they do not concretely provide the exact mutation of the gene that is encompassed by the instant invention, i.e., the specific interruption, truncation, and/or deletion combination of the different MGFs and ORF. As presently written, the claims encompass a substantial number of sequences, wherein there are innumerable combinations of possible interruptions, mutations, truncations, and deletions among the different genes and ORF. Chapman, D. A. G., et. al., (Emerging infectious diseases, 17(4), 599–605; Published 04/2011), hereby Chapman, teaches that the ASFV Georgia 2007/1 genome is 189344 base pairs in length (page 4, sequence of coding regions, last paragraph). As an example, it is taught by Chapman that the MGF 360-12L gene is 1052 base pairs in length, i.e., from nucleotide position 29,382 to 30,434 in the genome (page 4, sequence determination and analysis, first paragraph; see also GenBank® Accession No. FR682468.1). As presently written, the claims encompass any gene with anywhere from 1 to 1052 substitutions, deletions, additions, or any combination thereof, along the length of MGF 360-12L, which corresponds to a massive genus of 41052 = 1.3 x 10633 possible sequence combinations for MGF 360-12L alone. The same logic applies to MGF 360-13L, 360-14L, 505-2R, 505-3R, 505-1R, and 505-4R and ORF of ASFV_G_ACD_0052. Moreover, this logic would further apply to the sequences of the different genes for other virulent ASFV strains selected from the lineage of Georgia 2007/1 as each strain would be subject to sequence variation. At least 8 different example strains are provided, and, likely, many more are encompassed, as presently defined in claims 6, 7, and 19. However, Chapman teaches that the genomes for virulent ASFV isolates range from 182,284 to 193,886 base pairs in length, wherein the variation in length is due to the presence or absence of different numbers of members of the MGFs (page 4, sequence of coding regions, last paragraph; page 5, last paragraph). Furthermore, the attenuated ASFV is employed as a vaccine to prevent African Swine fever in a subject, as defined in instant claims 9 – 14, which means it must elicit neutralizing antibodies in the subject. This would be uncommon with just any random combination of genes in a given ASFV strain. In general, this creates an enormous breadth of potential attenuated ASFVs that becomes innumerable when coupled with the massive genera of possible sequences for the different MGFs and ORF per strain.
When there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The claims are drawn to a massive genus, i.e., different combinations of mutated ASFV genes and ORF for numerous virulent ASFV strains, which are each comprised of innumerable sequences, yet, the specification has only adequately described, and successfully reduced to practice an attenuated ASFV for two strains, i.e., Georgia 2007/1 and ASFV-989, wherein nucleotide positions 29,439 to 36,898 are deleted, amounting to a deletion of 7,458 nucleotides in each strain (page 20, lines 15 – 23; figures 1 and 3). To be more specific, MGF 360-12L, MGF 360-13L, MGF 360-14L, MGF 505-2R, MGF 505-3R, and ASFV G ACD 00520 are completely deleted; MGF 505-1R has its start codon maintained, but a deletion starting at nucleotide position 29,439 that includes its stop codon, and MGF 505-4R has its stop codon maintained, but a deletion early in the gene at nucleotide position 36,898 that includes the start codon (page 20, lines 15 – 23; figures 1 and 3; see also GenBank™ Accession No. FR682468). This is not representative of the extremely large genus of sequences and expression systems claimed. One of ordinary skill in the art cannot conclude that Applicant was in possession of the trillions of sequences encompassed by the disclosed genera. Absent the disclosed attenuated ASFVs with the deletion of 7,458 nucleotides between nucleotide positions 29,439 and 36,898, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, each individual sequence utilized. Thus, it is clear that the breadth of the recited genera in the claims far overreaches the Applicant’s contribution.
In the absence of a representative number of examples, the specification must at least describe the structural features that are required for the claim function. In the instant case, the specification should explain how the deletion of the genes, and, thus, the attenuated ASFV elicits an effective immune response in a patient. However, the specification fails to describe any substantive structural limitations as to establish a structure–function relationship with respect to an immune response against ASFV. At best, the specification contemplates the use of BLAST to identify functional homologs based on sequence homology. 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. Therefore, one having ordinary 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.
The art teaches that protein chemistry is an extremely unpredictable area of biotechnology, wherein even a single substitution can change the biological property of a peptide, wherein some combinations of ASFV antigen genes result in unfavorable immune responses. For example, Burgess, W. H., et. al., (The Journal of cell biology, 111(5 Pt 1), 2129–2138; Published 11/1990), hereby Burgess, teaches that replacement of a single lysine residue by a glutamic acid residue can lead to substantial loss of receptor binding and biological activity of a protein (page 2129; abstract). Moreover, Friedberg, I., (Briefings in bioinformatics, 7(3), 225–242; Published 01/25/2006), hereby Friedberg, teaches that homology–based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub–regions is critical to functional annotation, and that often addition, deletion, or re–shuffling of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that as databased and, thus, diversity of sequences, get larger, sequence–based tools are not sensitive enough to identify functional protein similarity (page 228, first full paragraph). Thornton, J., (Trends in biochemical sciences, 26(2), 88–89; Published 02/01/2001), hereby Thornton, teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thornton further describes examples of little correlation between specific binding function and overall protein structure (page 992, right column, lines 2 – 10). Furthermore, Goatley, L. C., et. al., (Vaccines, 8(2), 234; Published 05/18/2020), hereby Goatley, teaches that a previous screening of 40 ASFV genes for immunogenicity led to an immunization regime that did not protect animals after challenge (page 1, abstract). It is further taught by Goatley that certain antigens, or combinations of antigens, can induce enhanced disease in swine (page 2, second paragraph). Thus, when taken with the teachings of Burgess, Friedberg, Thornton, and Goatley one having ordinary 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 and that different combinations of antigen genes would be a result effective parameter requiring optimization wherein even a single substitution within the antigen gene could change the effectiveness of the vaccine.
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 and that any combination of the ASFV genes will not inherently provide protect immunization responses. In other words, a single mutation in the ASFV protein, as encoded by the gene, could result in hindered function, wherein some combinations are known to cause vaccine-induced enhanced disease (Goatley; page 2, second paragraph). Thus, while Applicant has described a species within the genus recited, and the art may provide more, each genus is very large and would encompass peptide structures that cannot be visualized from the prior art or instant disclosure. One having ordinary skill in the art cannot determine the structures encompassed by the claimed genera. Thus, the described species cannot be considered representative of the entire recited genus.
Overall, the claims as currently written are not adequately described and one of ordinary skill in that art would readily appreciate that Applicant was not in possession of the claimed genera at the time of filing. At present, it is recommended that the claims remove all recitations of “vaccine” and amend it to “immunogenic composition” or “therapeutic composition” or provide evidence of a neutralizing antibody response. Additionally, it is recommended that the claims be amended to read on the genes and ORFs that are deleted in the two virulent ASFV strains Applicant had in their possession. For example, the claims should be amended to read that genes MGF 360-12L, MGF 360-13L, MGF 360-14L, MGF 505-2R, and MGF 505-3R are deleted; ORF of ASFV_G_ACD_00520 is deleted; MGF 505-1R is truncated at nucleotide position 29439, wherein the start codon is maintained at the beginning of the gene; and MGF 505-4R is truncated up to nucleotide position 36898, wherein the stop codon is maintained at the end of the gene in ASFV Georgia 1007/1 and ASFV-989 strains.
35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. — Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
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 11 – 14 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 11 requires “[A]n attenuated ASF virus according to claim 1” and its intended use in preventing African Swine Fever. Claim 1, which claim 11 is dependent upon, recites “[A]n attenuated (African Swine Fever (ASF) virus”. Given that the intended use of claim 11 does not carry patentable weight, as discussed in paragraph 18 above, there are no additional limitations in claim 11 that are not recited in claim 1. Thus, claim 11 fails to further limit the subject matter of claim 1. This rejection affects all claims that are dependent upon claim 11, i.e., claims 12 – 14.
Claims 12 – 14 recite “[A]n attenuated ASF virus or a vaccine for use according to claim 11”. Claim 11 requires “[A]n attenuated ASF virus according to claim 1” and its intended use in preventing African Swine Fever. Due to the “or” in the preamble, claims 12 – 14 can be interpreted to only need the use of claim 11 and not the structure. In this regard, the limitation of an attenuated ASFV in claim 11 is not recited in claims 12 – 14. Thus, claims 12 – 14 fails to include all the limitations of the claim upon which it depends, i.e., claim 11.
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 § 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 – 7 and 9 – 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abrams, C., et. al., (US 20170136114 A1; Published 05/18/2017; NOTE: this US publication is from the National Stage Entry application of WO 2015193685, which was cited in Applicant’s IDS on 08/02/2023 as Foreign Patent Document Cite No. 2), hereby Abrams; and as evidenced by GenBank® Accession No. FR682468.1 (Published 11/24/2019), hereby GenBank.
Abrams teaches an attenuated African Swine Fever Virus (ASFV) and a method of attenuating said ASFV, wherein the following genes, among others, may be partially or completely interrupted or deleted from a wildtype ASFV isolate: MGF 360-12L, 360-13L, 360-14L, 505-1R, 505-2R, 505-3R, and 505-4R (abstract; page 3, paragraphs 0047 and 0051 – 0056; page 4, paragraphs 0072 – 0079; page 8, paragraphs 0124 and 0125; page 9, paragraphs 0136 – 0142; page 10, paragraphs 0177 – 0185), as required in instant claims 1, 3, 15, and 16. The interruption or deletion may cause the gene to not be transcribed and/or translated or otherwise made non-functional (page 8, paragraphs 0124 and 0125; page 9, paragraph 0155), as defined in instant claims 1, 4, 15, and 17. It is further taught that the interruption or deletion may comprise one or more nucleotide change(s) that ablate expression of the gene, i.e., a frame shift; introduction or one more stop codons in the open reading frame of the gene; deletion or other modification of the start codon; or a modification of a translational start site (page 9, paragraphs 0146 – 0151, 0153, and 0154; page 10, paragraph 0189), as disclosed in instant claims 2, 5, and 18. Abrams goes on to teach that the remainder of the genome is the same as the wildtype ASFV strain, wherein the ASFV isolate strain may be from Georgia 2007/1 (page 3, paragraph 0064; page 8, paragraphs 0127, 0130, and 0131; claims 8 and 9), as recited in instant claims 6 and 7. A vaccine composition comprising the attenuated ASFV is also taught, which may be comprised of a plurality of attenuated ASFVs of different genotypes or isolates (page 3, paragraphs 0068 and 0069; page 9, paragraph 0134; claim 13), as required in instant claims 9 and 10.
Abrams does not explicitly teach that the ORF of ASFV_G_ACFD 00520 may be interrupted or deleted with MGF 360-12L, 360-13L, 360-14L, 505-1R, 505-2R, 505-3R, and 505-4R. However, Abrams teaches the deletion of 10,551 nucleotides, i.e., from nucleotide position 19,482 to nucleotide position 30,033, in the genome of ASFV isolate Benin 97/1, which results in the deletion of eight MGF genes, i.e., MGF 360-10L, 360-11L, 360-12L, 360-13L, 360-14L and MGF 505-1R, 505-2R, 505-3R; truncation of MGF-9L at its 3’ end, i.e., maintaining the start codon; and truncation of MGF 505-4R at its 5’ end, i.e., maintaining its stop codon (page 13, paragraph 0219; see also figures 1 and 3). The corresponding deletion in ASFV isolate Georgia 2007/1 would be from nucleotide position 25,210 to 35,803 (page 5, paragraph 0116; table 1). Therefore, this deletion would inherently include the ORF of ASFV_G_ACFD 00520, which is evidenced by GenBank to be located in between MGF 505-3R and 505-4R from nucleotide position 35,706 to nucleotide position 35,828 in ASFV isolate Georgia 2007/1, as defined in instant claims 1, 3, 4, and 15 – 17. Note, that while normally, only one reference should be used in making a rejection under 35 USC § 102. However, a 35 USC § 102 rejection over multiple references has been held to be proper when the extra references are cited to show that a characteristic not disclosed in the reference is inherent. "To serve as an anticipation when the reference is silent about the asserted inherent characteristic, such gap in the reference may be filled with recourse to extrinsic evidence. Such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill." See MPEP § 2131.01(III).
Claims 11 – 14 are drawn to the attenuated ASFV of claim 1 and/or its intended use of preventing African Swine Fever in a subject. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81; and MPEP § 2111.02.
The preamble purpose of preventing African Swine Fever in a subject is not supported by any distinct definition of the attenuated ASFV and merely states the intended use of the invention of claim 1. Therefore, a prior art reference that teaches the embodiments of claim 1 anticipates claims 11 – 14, i.e., Abrams. To expedite prosecution, it should be noted that Abrams teaches a vaccine comprising the attenuated ASFV for use in treating and/or preventing African Swine Fever (page 4, paragraph 0070; abstract), as recited in instant claim 11. The vaccine composition with the attenuated ASFV may induce an immune response when administered to a subject, wherein this response is protective against subsequent challenge with virulent ASFV strains (page 3, paragraph 0066), as defined in instant claim 12. The vaccine may be administered via intramuscular, intranasal, oral, subcutaneous, transdermal, or vaginal routes (abstract; page 4, paragraphs 0094 – 0096; page 10, paragraph 0173), as required in instant claim 13. The subject that the vaccine is administer to may be a domestic pig, warthog, or bush pig and administered following a prime-boost regime (page 4, paragraphs 0083 and 0084; page 10, paragraphs 0171, 0171, and 0176; page 11, paragraph 0201), as disclosed in instant claim 14.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Abrams, C., et. al., (US 20170136114 A1; Published 05/18/2017) hereby Abrams, as applied to claims 1 – 7 and 9 – 18 above, and in further view of Vink, T., et. al., (Methods, 65(1), 5–10; Published 07/17/2013), hereby Vink.
Abrams does not an attenuated ASFV that does not contain a reporter gene, as required in instant claim 8. All embodiments of Abrams teach a reporter gene with the ASFV deletions.
However, Vink teaches an optimized mammalian expression system capable of producing antibodies, wherein plasmids encoding human p21 and p27 were cloned into pcDNA3.3, and then the resulting plasmid was expressed in FreeStyle™ 293F (HEK-293F) cells in FreeStyle™ 293 Expression Medium (abstract; page 6, sections 2.1 – 2.3). The plasmid has no reporter gene, yet, expression volumes were stable and consistent with relatively high numbers of product (see whole document). Thus, expression of the two p21 and p27 does not require a reporter gene, as defined in instant claim 8.
Abrams and Vink are considered to be analogous to the claimed invention because both are drawn to expression using FreeStyle™ systems. Based on the prior art teachings, it would have been obvious to a person having ordinary skill in the art to have substituted the expression system of plasmids without a reporter gene in HEK293F cells taught by Vink into the attenuated ASFV as taught by Abrams. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Abrams and Vink before the effective filing date of the claimed invention with a reasonable expectation of success to develop an attenuated ASFV, which lacks a functional version of 360-12L, 360-13L, 360-14L, 505-1R, 505-2R, 505-3R, and 505-4R, as an alternative ASFV vaccine candidate with improved efficacy and safety profiles (Abrams; abstract; page 1, paragraph 0014). All the claimed elements were known in the prior art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. The substitution would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143B and 2143.02.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Abrams, C., et. al., (US 20170136114 A1; Published 05/18/2017) hereby Abrams, as applied to claims 1 – 7 and 9 – 18 above, and further in view of Turner, C., and Williams, S. M., (Journal of applied microbiology, 87(1), 148–157; Published 04/08/1999), hereby Turner, and Chen, W., et. al., (Science China. Life sciences, 63(5), 623–634; Published 03/01/2020), hereby Chen.
Abrams does not teach that the attenuated ASFV has a step of thermal-attenuation or is amplified by inoculation of Specific-Pathogen-Free (SPF) pigs, as required in instant claim 19. However, Turner teaches that ASFV is relatively stable at lower temperatures, i.e., 4 °C, 22 °C, and 40 °C, but was sensitive to 50 °C and 60 °C, where the viral titers were below detectable levels after 24 hours and 15 min, respectively, in media (page 151, right column).
Abrams and Turner do not teach the inoculation of SPF pigs. However, Chen teaches the virulence, immunogenicity, safety, and protective efficacy of different gene-deleted ASFVs strain HLJ/18, including one with the genes MGF 505-1R, MGF 505-2R, MGF 505-3R, MGF 360-12L, MGF 360-13L, and MGF 360-14L deleted, by inoculating SPF pigs with different doses of the virus (abstract; page 624, left column, last paragraph; page 632, right column, last three paragraphs), as defined in instant claim 19.
Abrams, Turner, and Chen are considered to be analogous to the claimed invention because both are drawn to ASFV. Based on the prior art teachings, it would have been obvious to a person having ordinary skill in the art to have combined the heat inactivation of ASFV taught by Turner and the inoculation of SPF pigs taught by Chen with the attenuated ASFV strain Georgia 2007/1 taught by Abrams. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the teachings of Abrams, Turner, and Vick before the effective filing date of the claimed invention with a reasonable expectation of success to develop an attenuated ASFV, which lacks a functional version of 360-12L, 360-13L, 360-14L, 505-1R, 505-2R, 505-3R, and 505-4R, as an alternative ASFV vaccine candidate with improved efficacy and safety profiles (Abrams; abstract; page 1, paragraph 0014). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
Conclusion
Claims 1 – 19 are rejected. No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Borca, M. V., et. al., (US 20160130562 A1; Published 05/12/2016; Cited in Applicant’s IDS on 08/02/2023 as US Patent Application Publications Cite No. 1), hereby Borca, teaches a recombinant mutant ASFV, and in vitro methods to produce the mutant ASFV, wherein 7,559 nucleotides are deleted, i.e., nucleotide position 27,928 through nucleotide position 35,487, in comparison to the wildtype ASFV genome of Georgia 2007 isolate, including a deletion of MGF 360-12L, 360-13L, 360-14L, and 505-2R; truncation of 505-1R with the start codon maintained; and truncation of 505-3R with the stop codon maintained. Borca also teaches that a vaccine composition with the mutant ASFV provides an effective vaccine that is administered by intramuscular, subcutaneous, or intranasal route to pigs and protects them against clinical presentation of the disease when challenged with the parental ASFV isolate Georgia 2007/1
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Hallie N. Pennington, Ph.D. whose telephone number is (571)272-6781. The Examiner can normally be reached M-Th 7:30-5:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Michael Allen can be reached at (571)270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HALLIE N. PENNINGTON, PH.D./Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights