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 .
The amendment filed 8/29/25 has been entered. Claim 13 has been amended. Claims 1-12, 14-15 and 17 has been cancelled. Claim 13, 16 and 18-27 are pending.
The indicated allowability of claims 20, 22, 23 and 25-26 is withdrawn in view of the amendment to claim 13.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located the specification p. 15 lines 32 thrombase cleavage site amino acid sequence (SGGGG)3.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
The disclosure is objected to because of the following informalities:
The specification on page 21 line 20 refers to “Supplementary Table S3”. There is no Supplementary Table S3 in the application.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Rejections Withdrawn
The rejection of claim(s) 13, 16, 18, 21, 24 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chow et al. Nucleic Acids Research, March 19, 2019, Vol. 47, No. 7, pages 3594-3606 cited in IDS as evidenced by Uniprot Accession No. A0A183G0Y0_HELPZ 9/7/2016 and as evidenced by Behnke et al. Am. J. Trop. Med. Hyg., 80(4), 2009, pp. 684-685 is withdrawn in view of the amendment to the claims.
The rejection of claims 13 and 19 under 35 U.S.C. 103 as being obvious over Chow et al. Nucleic Acids Research, March 19, 2019, Vol. 47, No. 7, pages 3594-3606 cited in IDS as evidenced by Uniprot Accession No. A0A183G0Y0_HELPZ 9/7/2016 and as evidenced by Behnke et al. Am. J. Trop. Med. Hyg., 80(4), 2009, pp. 684-685 in view of Leenaars et al. ILAR Journal, Volume 46, Issue 3, 2005, Pages 269–279 is withdrawn in view of the amendment to the claims.
New Claim Rejections Based on Amendment- 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 and 18-27 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.
The claims are drawn to a method of raising an immune response against a parasitic nematode in an animal,
said method comprising the step of administering to the animal an antigenic extracellular worm argonaute protein or an antigenic fragment thereof or a nucleic acid sequence capable of expressing the protein or the fragment, 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:
a) the protein comprises the sequence of SEQ ID NO: 1;
b) the protein has a sequence identity of at least 60% to SEQ ID NO: 1; or
c) the protein is an orthologue of SEQ ID NO: 1 from a Clade III nematode worm, wherein the orthologue has a sequence identity of at least 30% to SEQ ID NO: 1.
The claims require vaccinating 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 using a genus of proteins comprising members who amino acid sequence varies by up to 40% or up to 70% from SEQ ID NO: 1 and antigenic fragment thereof or genus of nucleic acids capable of expressing said proteins, variants thereof or antigenic fragments thereof.
The genus of proteins comprises numerous structural species which are highly variant and the common function of the genus is 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.
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 other member of the genus of proteins or nucleic acids in reducing parasitic nematode infection.
The specification does not disclose the common structure e.g. protective epitope of the genus of proteins or nucleic acids 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 proteins that correlates with vaccinating against a parasitic nematodes.
The disclosure of SEQ ID NO: 1 is not representative of the genus of proteins that vaccinates 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) (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 variants of SEQ ID NO: 1 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 proteins needed to practice the invention as claimed to vaccinate against a parasitic nematode and there is also no correlation of the common structure of members of the genus of proteins 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 which members of the genus of proteins or nucleic acids will induce an immune response that vaccinates an animal against heterologous or homologous parasitic 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.
The state of the art teaches that there are difference between protein and nucleic acid vaccine as nucleic acid vaccines have to be translated first and can only be presented by Class I MHC and thus the immune response for a nucleic acid vaccine is generally limited to Th1 and particularly to CD8 Tc cells. Noon et al disclose that not a single DNA vaccine has been shown to work in humans. See Noon et al p. 1862 column 2 under “protein or DNA vaccine”. In the case of subunit vaccines, the extracellular nematode antigens are presented on Class II MHC by professional antigen presenting cells (APCs), and along with adjuvant, this can shape intricate Th responses, clearly the majority of successes with recombinant subunit vaccines for parasitic nematodes have been protein-based. See Noon et al p. 1862 column 2 under “protein or DNA vaccine”.
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 proteins and genus of nucleic acids need to vaccinate a human, ovine, bovine, equid, camelid and a dog against 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.
Claims 13, 16 and 18-27 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 a method for inducing an immune response against a Heligmosomoides polygyrus, the method comprising administering a composition comprising alum adjuvant and an antigenic extracellular worm argonaute protein comprising the amino acid sequence of SEQ ID NO: 1 sufficient to induce an immune response that results in reduction in worm burden after H. polygyrus challenge;
does not reasonably provide enablement for a method of raising an immune response against a parasitic nematode to induce an immune response to vaccinate an against a parasitic nematode comprising administering a) the protein comprising the sequence of SEQ ID NO: 1; b) the protein having a sequence identity of at least 60% to SEQ ID NO: 1; c) the protein which is an orthologue of SEQ ID NO: 1 from a Clade III nematode worm, wherein the orthologue has a sequence identity of at least 30% to SEQ ID NO: 1 or a nucleic acid sequence capable of expressing the protein or antigenic fragment thereof
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Enablement is considered in view of the Wands Factors (MPEP 2164.01(A)).
These include: nature of the invention, breadth of the claims, the amount of direction provided by the inventor, the existence of working examples, state of the prior art, the level of predictability in the art and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. All of the Wands Factors have been considered with regard to the instant claims, with the most relevant Factors discussed below.
Nature of the invention and Breadth of the Claims
The nature of the invention is drawn to a method of raising an immune response against a parasitic nematode in an animal,
said method comprising the step of administering to the animal an antigenic extracellular worm argonaute protein or an antigenic fragment thereof or a nucleic acid sequence capable of expressing the protein or the fragment, 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:
a) the protein comprises the sequence of SEQ ID NO: 1;
b) the protein has a sequence identity of at least 60% to SEQ ID NO: 1; or
c) the protein is an orthologue of SEQ ID NO: 1 from a Clade III nematode worm, wherein the orthologue has a sequence identity of at least 30% to SEQ ID NO: 1.
SEQ ID NO: 1 or antigenic fragment thereof or variants of SEQ ID NO: 1 or nucleic acid capable of expressing the protein are being used to vaccinate against any parasitic nematode i.e. a universal vaccine against parasitic nematodes.
Furthermore, the breadth of the claims also encompasses administering nucleic acid sequence capable of expressing the proteins.
Guidance in the specification and the existence of working examples
The specification reduces to practice exWAGO protein (SEQID NO: 1) 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.
State of the prior art and the level of predictability in the art and Amount of Direction Provided by the Inventor
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.
The state of the art teaches that there are difference between protein and nucleic acid vaccines as nucleic acid vaccines have to be translated first and can only be presented by Class I MHC and thus the immune response for a nucleic acid vaccine is generally limited to Th1 and particularly to CD8 Tc cells. Noon et al disclose that not a single DNA vaccine has been shown to work in humans. See Noon et al p. 1862 column 2 under “protein or DNA vaccine”. In the case of subunit vaccines, the extracellular nematode antigens are presented on Class II MHC by professional antigen presenting cells (APCs), and along with adjuvant, this can shape intricate Th responses, clearly the majority of successes with recombinant subunit vaccines for parasitic nematodes have been protein-based. See Noon et al p. 1862 column 2 under “protein or DNA vaccine”.
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.
A thesis (Kyriaki Neophytou. Molecular and functional characterization of an extracellular Argonaute protein secreted by a gastrointestinal nematode. 2022. Retrieved from https://era.ed.ac.uk/bitstream/handle/1842/39280/NeophytouK_2022.pdf?sequence=1&isAllowed=y on 11/18/2025) published after the effective filing date of the instant invention shows that vaccination with exWAGO of H. polygyrus (aka H. bakeri) in alum adjuvant confers partial protection (reduction in worm burden) to H. bakeri larval challenge and vaccination did not affect the worm lifecycle and development of larvae to adult worms, since the presence of adult worms in the gut lumen of vaccinated mice indicates that the larvae were able to penetrate the gut wall, development to adult worms and then emerge in the gut lumen. Vaccination with said exWAGO and QuilA adjuvant did not reduce the number of worms or the number of eggs compared to mice vaccinated with PBS in QuilA, thus in this scenario exWAGO did not confer protection against H. bakeri infection. See under section 6.2 starting on p. 187. In the thesis, the exWAGO was tested against infection with a single, unnaturally large dose of larvae which does not stimulate field condition where humans, livestock and wild animals are chronically and repeatedly infected with gastrointestinal nematodes.
As of the effective filing date of the instant invention and even after the effective filing date as evidenced by the thesis, it is not clear whether exWAGO from H. polygyrus (aka H. bakeri) can be used to generate protection against other parasitic nematodes including the Clade III and Clade V nematodes. The thesis teaches that if exWAGO can successfully generate protection against other Clade V parasitic nematodes that infect humans and ruminants, it would be important to understand if the vaccine establishes long-term immunity or if frequent vaccine boosts would be required. See thesis at p. 197 last paragraph to p. 198 first paragraph.
As set forth above, vaccinating against parasitic nematodes is a complex art. Thus, more guidance is needed on how to use the argonaute protein SEQ ID NO: 1, proteins that have a sequence identity of at least 30% or 60% to SEQ ID NO: 1; and the antigenic fragments thereof or nucleic acids expressing the protein or antigenic fragment thereof to induce an immune response to vaccinate humans, ovine, bovine, equid, camelid and a dog against the full breadth of parasitic nematodes.
There is no correlation between any immune response generated by antigenic fragments of SEQ ID NO: 1 or the variants of SEQ ID NO: 1 or antigenic fragments thereof in a subject with protection (vaccinating) from a parasitic nematode infection.
There is no correlation between any immune response generated by nucleic acid expressing antigenic fragments of SEQ ID NO: 1 or variants of SEQ ID NO: 1 or SEQ ID NO: 1 in a subject with protection (vaccinating) from a parasitic nematode infection.
There is no correlation established between the immune response generated by the exWAGO protein or the nucleic acid expressing said protein from H. bakeri with protection from infection by any other parasitic nematode.
As evidenced by the complexity of the art, protection from parasitic nematodes in unpredictable due to the numerous factors discussed above that can affect vaccinating efficacy.
It is noted that in the case of protection from H. polygyrus the presence of alum adjuvant was key in achieving 58% reduction in adult worm counts. See figure 15.
The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a specific and useful teaching.’
The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a lull enabling disclosure of the claimed technology.” (Citations omitted)).< The “predictability or lack thereof’ in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. See MPEP 2164.03.
More direction and/or working example is needed correlating immunogenicity of SEQ ID NO: 1, the variants thereof, the antigenic fragment thereof, nucleic acid capable of expressing the protein or antigen fragment with vaccinating against parasitic nematodes in humans, ovine, bovine, equid, camelid and a dog.
Status of Claims
Claims 13, 16 and 18-27 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645