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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicants submission filed 5/19/2026 has been entered.
Claims 13, 16, 18, 22 and 23 have been amended. Claims 1-12, 14-15, 17, 19, 21 and 25-27 have been cancelled. Claim 13, 16, 18, 20 and 22-24 are pending and under examination.
Information Disclosure Statement
The information disclosure statement filed 05/19/2026 has been considered and an initialed copy is enclosed.
Specification-Objections Withdrawn
The amendment to the specification and sequence listing to comply with the sequence rules (see specific deficiency in the previous Office Action) is acknowledged.
The amendment to the specification to remove the reference to "Supplementary Table S3"at p. 22 line 8 is acknowledged.
The amendment to the specification to remove the embedded hyperlink and/or other form of browser-executable code is acknowledged.
Claim Rejections Withdrawn
The rejection of Claims 21, and 25-27 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the cancellation of these claims.
The rejection of claims 13, 16 and 18-27 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification (scope of enablement) is withdrawn in view of the amendment to the claims.
Claim Rejections Maintained
35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.-The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13, 16, 18, 20 and 22-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 is drawn to a method of raising an immune response in an animal against a CladeV parasitic nematode that inhabits the gastrointestinal tract , said method comprising the step of administering to the animal a vaccine selected from the group consisting of:
a) a vaccine comprising an aluminum-based adjuvant and a Clade V antigenic extracellular worm argonaute protein or an antigenic fragment thereof, and
b) a vaccine comprising a nucleic acid sequence capable of expressing a Clade V antigenic extracellular worm argonaute protein or an antigenic fragment thereof wherein the vaccine is sufficient to induce an immune response to vaccinate the animal against the parasitic nematode, wherein the animal is selected from a group consisting of a human, an ovine, a bovine, an equid, a camelid, and a dog, and wherein the protein has a sequence identity of at least 65% to SEQ ID NO: 1.
Claim 16 is drawn to the method of raising an immune response against a parasitic nematode in an animal as claimed in claim 13, wherein the protein is an orthologue of SEQ ID NO: 1, wherein the orthologue has the same secondary or tertiary structure to the protein of SEQ ID NO: 1.
The claims require a vaccine that is sufficient to induce an immune response to vaccinate the animal against the clade V parasitic nematode, wherein the animal is selected from a group consisting of a human, an ovine, a bovine, an equid, a camelid, and a dog using a genus of antigenic fragments of a protein having a sequence identity of at least 65% to SEQ ID NO: 1. Claim 16 states that the protein having a sequence identity of at least 65% to SEQ ID NO: 1 is an orthologue of SEQ ID NO: 1, wherein the orthologue has the same secondary and tertiary structure to the protein of SEQ ID NO: 1.
The genus of antigenic fragments comprises numerous structural species which are highly variant and the common function of the genus is to vaccinate the animal against the clade V parasitic nematode, wherein the animal is selected from a group consisting of a human, an ovine, a bovine, an equid, a camelid, and a dog.
The specification reduces to practice exWAGO protein from Heligmosomoides bakeri aka Heligmosomoides polygyrus. The exWAGO protein binds small RNAs and may constitute a key mechanism for directing the selective packaging and export of specific parasite siRNAs in EVs for subsequent delivery to host cells. The specification discloses that a protective immune response induced by exWAGO can block the functional activity of exWAGO.
The specification states that exWAGO protein is conserved across a range of parasitic nematodes and appears to function in the same way in a range of parasite nematodes and thus variants, fragments, homologs or orthologs thereof could be utilized against parasitic infections in humans e.g. hookworm Necator amerinanus or livestock e.g. sheep/goat brown worms Teladorsagia circumcinta.
The specification states that it is considered that cattle, equine and Camelid nematode pathogens which would be similar to Clade V exWAGO family (Nematodirus) or Clade III exWAGO family members would also be modulated by an immune response generated by exWAGO and that it may also provide a protective effect in domesticated animals (e.g. dog heart worm Dirofilaria immitis).
The specification reduces to practice administering exWAGO from H. bakeri (SEQ ID NO: 1) in alum and subsequently challenging with H. bakeri. The results show that that worm counts per gut section was reduced by 58% at day 28 post infection. See figure 6-7, p. 22-21 and p. 25.
There is no reduction to practice of any antigenic fragments of exWAGO or antigenic fragments of orthologs that have the same secondary or tertiary structure for reducing clade V parasitic nematode infection.
The specification does not disclose the common structure e.g. protective epitope of the genus of said antigenic fragments that correlates with protection against a parasitic nematode.
The specification does not disclose complete structure, partial structure, physical or chemical properties of members of the genus of antigenic fragments that correlates with vaccinating against clade V parasitic nematodes.
The disclosure of SEQ ID NO: 1 or sequences that are at least 65% identical are not representative of the genus of antigenic fragments of these sequences that is sufficient to vaccinate against the parasitic nematodes.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG V. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). 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 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)
("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "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."
The genus of antigenic fragments of a protein having at least 65% sequence identity SEQ ID NO: 1, and furthermore wherein said protein is a ortholog and has the same secondary or tertiary structure is large and comprises species with differing structure and adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See Noelle v Lederman. 355 F. 3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) and In re Alonso (Fed. Cir. 2008-1079).
To satisfy the written description requirement, a patent 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. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. V. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The specification does not disclose a representative number of members of the genus of antigenic fragments needed to practice the invention as claimed to vaccinate against clade V parasitic nematode and there is also no correlation of the common structure of members of the genus of antigenic fragments that correlates in an immune response that vaccinates the animal against a parasitic nematodes.
Describing members of the genus by function typically will not suffice to sufficiently identify the members of the genus that possess the function. See Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene's function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. V. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)).
It is unpredictable without further testing or screening (e.g. epitope mapping of all the exWAGO conserved proteins and further testing which epitopes can offer vaccine protection) which members of the genus of antigenic fragments will induce an immune response that vaccinates an animal against clade V nematode infection.
The art teaches that subunit vaccines for parasitic nematodes have focused primarily on the idea that the protein antigens targeted by vaccines are important for infection, rather than simply being immunogenic in order to direct the immune system to the pathogen to attack it and immunization with some parasitic nematode antigens triggers IgG responses which blocks antigen function, and if the antigen is essential, protection may be achieved. See Noon et al. (Parasitology (2017), 144, 1845-1870) p. 1850 column 2 2ⁿᵈ paragraph cited previously.
Furthermore, developing vaccines for parasitic nematodes is further complicated because of the limitations with the laboratory challenge infection models. Such limitations include the use of model hosts, parasitic nematode species other than the target species, laboratory strains of the target parasitic nematode species, unnatural infection and other limitations. With the use of model hosts such as golden hamsters, mice, rats, and beagles, and laboratory STH species/strains that are genetically different from natural species/strains, it is unclear if any of the vaccines will translate to humans, and such studies are warranted. Also, the type of adjuvant used plays a role as adjuvants that worked well against one parasitic nematode completely failed against another. See Noon et al. p. 1865 column 2 under "how valid are the laboratory challenge infection models?", p. 1866 under "are pan-anthelmintic vaccines possible?" and p,. 1867 column 1.
The state of the art as summarized above shows that parasitic nematode vaccine development is complex. Thus, the reduction of worm burden by exWAGO (SEQ ID NO: 1 in the presence of alum) is insufficient to fully describe the genus of antigenic fragments of a protein that has at least 65% identity to SQ ID NO: 1 and furthermore wherein the protein is a ortholog with the same secondary or tertiary structure to vaccinate a human, ovine, bovine, equid, camelid and a dog against the parasitic nematode infection.
Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention". "Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement". See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Describing how to obtain possession of members of the claimed genus or how to identify their common structural features is insufficient to show possession of the invention. See University
of Rochester, 358 F.3d at 927, 69USPQ2d at 1895. The written description provision of 35 U.S.C. § 112 are severable from its enablement provision Vas-Cath, Inc. V. Mahurkar, 1115.
Response to Applicants Argument
Applicants argues that the present Application demonstrates raising an immune response against the Clade V parasitic, gastrointestinal nematode H. bakeri using a mixture that includes an aluminum-based adjuvant and a Clade V (H. bakeri) exWAGO protein and that this immune response is achieved by blocking the parasitic immunomodulatory molecules from acting in the gut and that Figure 13 of the present Application shows a high level of conservation between Clade V exWAGO proteins, and the Application further teaches that due to the conservation between argonuates of a nematode lineage , due to the conservation between argonautes of a nematode lineage, it is considered that antibodies to exWAGO proteins generated against a first parasite argonaute protein, for example Heligmosomoides bakeri, may be effective in the treatment of parasitic infections in other animals for example in cattle, sheep, equids, camelids, dogs, humans, in particular against Necator americanus (human hookworm), Teladorsagia circumcinta, Haemonchus contortus and Nematodirus (sheep parasites), Dirofilaria immitis (dog heartworm), and Ostertagia ostertagi (cattle parasite).
Applicants arguments have been carefully considered but is not found persuasive. This is because while there is disclosure of high level of conservation between Clade V exWAGO proteins, Applicants as of the effective filing date were not in possession of antigen fragments of Clade V exWAGO proteins that can be included in a vaccine that is sufficient to induce an immune response to vaccinate the animal against the parasitic nematode for the reasons set forth in the rejection above. The disclosure of SEQ ID NO: 1 and other Clade V exWAGO proteins at least 65% identical to SEQ ID NO: 1, does not provide a description of the antigenic fragment(s) of these exWAGO proteins that is sufficient for inducing an immune response that vaccinates the animal against the clade V parasitic nematode.
Status of Claims
Claims 13, 16, 18, 20 and 22-24 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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