DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status and Formal Matters
The amendment of 3/28/2025 is technically non-compliant under 37 CFR 1.121. Claim 1 has been amended, but the new language of the claim is not underlined as required. However to promote compact prosecution and customer service the instant response will be examined. Future amendments non-compliant with 37 CFR 1.121 may not be entered or examined.
Priority
The instant application was filed 01/13/2025 and is a continuation of 17086704 , filed 11/02/2020, which claims priority from provisional application 62928647, filed 10/31/2019.
Information Disclosure Statement
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." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 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 independent claim is drawn to A method of treating African Swine Fever in swine in need thereof comprising the steps of administering a combination of: avian-sourced antibodies specific for an African Swine Fever (ASF) Virus isolate, and a carrier matrix comprising of non-hyperimmune colostrum..
Thus the claims encompass any avian sourced antibodies specific by any standard for anything broadly encompassed by an ASF virus isolate by any standard. This is an enormous genus as Villiers (Virology 400 (2010) 128–136) teaches analysis of 11 complete African Swine fever virus genomes (title). Villers teaches the 11 isolates of African Swine fever virus genomes contained between 156 and 167 ORF (table 1). Villers teaches, “The phylogenetic tree analysis derived from the 123 concatenated genes separated the viruses into two major clusters that correlate with their geographical distribution” (page 129m 2nd column).
Barrowclough ( (2016) How Many Kinds of Birds Are There and Why Does It Matter? PLoS ONE 11(11): e0166307. doi:10.1371/journal.pone.0166307) teaches< “Using a sample of 200 species taken from a list of 9159 biological species determined primarily by morphological criteria, we applied a diagnostic, evolutionary species concept to a morphological and distributional data set that resulted in an estimate of 18,043 species of birds worldwide, with a 95% confidence interval of 15,845 to 20,470.” Thus avian sourced antibodies is also a genus.
MPEP 2163. II. 3 states:
For example disclosure of an antigen fully characterized by its structure, formula, chemical name, physical properties, or deposit in a public depository does not, without more, provide an adequate written description of an antibody claimed by its binding affinity to that antigen, even when preparation of such an antibody is routine and conventional. See Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017)(“knowledge of the chemical structure of an antigen [does not give] the required kind of structure-identifying information about the corresponding antibodies”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351-52, 97 USPQ2d 1870, 1877 (Fed. Cir. 2011)(patent disclosed the antigen the claimed antibody was supposed to bind, but did not disclose any antibodies with the specific claimed properties).
Skolnick et al (Trends in Biotechnology Vol. 18, pp 34-39, 2000) teach that the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based on sequence homology is inaccurate, in part because of the multifunctional nature of proteins (e.g., Abstract and Sequence based approaches to function prediction, page 34). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan’s best guess as to function of the structurally related protein (See in particular abstract and box 2).
It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs or hypervariable regions which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of a given antibody. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences, which maintain the required conformation of the CDRs are required in order to produce a protein having antigen-binding function; and further, that proper association of heavy and light chain variable regions is required in order to form functional binding sites.
The fact that not just one CDR is essential for antigen binding or maintaining the conformation of the antigen binding site, is underscored by Casset et al (Biochemical and Biophysical Research Communications Vol. 307, pp 198-205, 2003) which constructed a peptide mimetic of an anti-CD4 monoclonal antibody binding site by rational design and the peptide was designed with 27 residues formed by residues from 5 CDRs (See entire document). Casset et al also states that although CDR H3 is at the center of most if not all antigen interactions, clearly other CDRs play an important role in the recognition process (page 199, left col.).
Vajdos et al (Journal of Molecular Biology Vol. 320, pp 415-428, 2002) state that antigen binding is primarily mediated by the CDRs more highly conserved framework segments which connect the CDRs are mainly involved in supporting the CDR loop conformations and in some cases framework residues also contact antigen (page 416, left column). Wu et al (Journal of Molecular Biology Vol. 294, pp 151-162, 1999) state that it is difficult to predict which framework residues serve a critical role in maintaining affinity and specificity dues in part to large conformational change in antibodies that accompany antigen binding (page 152, left column) but certain residues have been identified as important for maintaining conformation.
Further the claims encompass administering any carrier matrix containing any non-hyperimmune colostrum. This is an enormous genus as the specification does not define non-hyperimmune. Thus it encompasses any colostrum from any species.
Thus while the claims encompass a genus any avian sourced antibodies specific by any standard for any African swine fever virus isolate, the specification provides no specific structure of any antibodies, any avian sourced antibodies, or any specific African swine fever virus isolate by structure.
Thus the instant claims lack adequate written description.
New Matter
MPEP 2163 IB New or amended claims section II
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04
Claim 2 has been added by amendment and recites, “wherein the non-hyperimmune colostrum is at least part bovine derived.” The response provides no indication where support for the amendment can be found. Review and search of the specification did not reveal antecedent basis for this limitation. While the specification discusses the use of bovine colostrum, the specification does not appear to provide support for, “the non-hyperimmune colostrum is at least part bovine derived,” as the recitation of derived changes the scope of the claim and introduces new matter.
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 1-9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites, “avian-sourced antibodies specific for an African Swine Fever (ASF) Virus isolate.” The recitation of specific is a relative term and suggests there is non-specific antibodies. The specification does not provide a standard to differentiate specific antibodies from non-specific antibodies. This is further confusing as claim 8 recites, “wherein the antibodies are sourced from egg yolks from an avian species immunized with a vaccine comprising at least one antigen which initiates production of antibodies directed against one or more ASF-causing pathogens.” While claim 1 requires, “African Swine Fever (ASF) Virus isolate” claim 8 encompasses anything that can be considered, “one or more ASF-causing pathogens.” The recitation of claim 8 appears to not be limited to “African Swine Fever (ASF) Virus.” Thus the metes and bounds are unclear.
Claim 1 has been amended to recite, “non-hyperimmune colostrum.” The recitation of non-hyperimmune colostrum suggests there is hyperimmune colostrum. Review of the specification did not reveal a definition or standard how to differentiate non-hyperimmune colostrum from hyperimmune colostrum. Thus the metes and bounds are unclear.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubie (Journal of Veterinary Medicine and Animal Health (2015) volume 7, pages 145-158), Afayoa (Bull Anim Hlth Prod Afr (2016) vol 64, pages 7-19), and Giffard et al (US Publication 2005/0079244).
Dubie teaches, “The production of antibodies (Abs) in chickens and the extraction of specific Abs from egg yolk (lgY Abs) are increasingly attracting the interest of the scientific community as demonstrated by the significant growth of the lgY literature.” (p145, bottom). Dubie teaches, “IGY in avian egg has many applications in the medical and research fields, including in the areas such as diagnostics and proteomics. However, the most valuable and promising areas of lgY research is its use for passive immunization to treat and prevent human and animal diseases. Antibodies from eggs may have also many applications against microorganisms in humans and livestock or poultry (Gibbins, 1977).” Dubie teaches, “Incorporating feed grade egg yolk antibodies into animal diets has been examined extensively to attempt to limit pathogenic diarrhea causing Escherichia coli (E.coli) in swine, and limit Salmonella establishment in calves and mice, as well as Campylobacter, Clostridium, and Salmonella in poultry (AI-Adwani et al. , 2013).”(152, 1st column) Dubie teaches, “Yokoyama et al. (1992) studied the passive protective effect of lgY against ETEC infection in neonatal piglets. lgY was administered to the piglets in milk three times a day for 2 days. Control piglets developed severe diarrhea within 12 h and 30% of the pigs died. In contrast, the pigs given lgY exhibited no sign of diarrhea 24 or 48 h after treatment (Marquardt et al., 1999). The passive protective effect of anti- ETEC lgY, in neonatal calves, against fatal enteric colibacillosis, has also been studied (lkemori et al. , 1992). Prevention of ETEC in rabbits through the oral administration of anti-ETEC lgY. Because the oral administration of anti-ETEC lgY has proven to be successful for the treatment of gastrointestinal infections of animals and also the clinical application of passive immunization of lgY against diarrhea is now being examined to prevent and treat ETEC infection in infants (O'Farrelly et al. , 1992).” (page 152, 2nd column, 1st full paragraph)
While Dubie teaches the use of antibodies produced in avian for treatment of disease in animals including picks to treat disease, Dubie does not specifically teach the use of solostrum or African swine fever virus isolates.
However, Afayao teaches there is no vaccine or effective therapy for ASF (page 8, 1st column, bottom). Afayao teaches purified African swine fever virus vp73 was injected healthy local hens (page 10, 2nd column bottom). Afayao teaches the =egg yolk IgY was extracted.
Giffard teach that colostrum components include IgA, IgG1, IgG2, IgM, IGF-1, IGF-11, TGF, EGF, lactoferrin, lysozyme, lactoperoxidase, growth hormone and insulin. (See paragraph 0009). Giffard et al further teach that it was routine in the art to administer compositions comprising colostrum, probiotics and prebiotics. (See claim 1 and 19).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have taken the avian antibody to African swine fever virus as taught by Afayoa and to combine the antibody with colostrum, prebiotics and probiotics to create a composition for the treatment of African swine fever. One would have been motivated to produce such a composition in view of Giffard et al teaching that colostrum comprises numerous antibodies effective for treatment, and that when combined with probiotics and prebiotics forms a safe and effective composition. The artisan would be further motivated as Dubie suggests the use of avian antibodies to treat disease in swine including through consumption of milk. The artisan would have a reasonable expectation of success as the artisan is merely using known method to produce antibodies and treat swine.
With regards to claim 2, Giffard teaches, “[0026] The colostrum to be used according to the present invention is not limiting. It is preferably a highly specified colostrum and is preferably derived from bovine animals. “
With regards to claim 3-4, Giffard teaches, “[0007] Accordingly, the present invention provides, according to a first aspect, a foodstuff which comprises colostrums, a probiotic and a prebiotic.”
With regards to claim 5, Giffard teaches the use of salts (electrolytes (0025, 0043,
With regards to claim 6, Giffard teaches the use of growth factors (0009-0011)
With regards to claim 7, Giffar teaches, “ In addition, the nutrients and growth factors can help ensure proper gut development, nutritional uptake and growth.” (0011)
With regards to claim 8, Afayao teaches purified African swine fever virus vp73 was injected healthy local hens and eggs were collect(page 10, 2nd column bottom).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dubie (Journal of Veterinary Medicine and Animal Health (2015) volume 7, pages 145-158), Afayoa (Bull Anim Hlth Prod Afr (2016) vol 64, pages 7-19), and Giffard et al (US Publication 2005/0079244) as applied to claims 1-8 above, and further in view of : Diraviyam T( (2014) Effect of Chicken Egg Yolk Antibodies (IgY) against Diarrhea in Domesticated Animals: A Systematic Review and Meta-Analysis. PLoS ONE 9(5): e97716. )
It is noted the specification provides no evidence of an unexpected result dependent on the percentage of antibodies to colostrum.
The teachings of Dubie, Afayoa, and Giffard are set forth above.
While, Dubie, Afayoa, and Giffard suggest the use of avian derived ASF virus antibodies in colostrum for treatment of swine. They do not specifically teach the relative amount of colostrum to avian antibody material.
However, Diraviyam teaches a meta analysis about the use of avian IgY antibodies including use of colostrum as a carrier. Diraviyam teaches, “In conclusion, the present SR and meta-analysis demonstrated the beneficial effect of IgY in controlling and preventing the diarrhea in domesticated animals. This supports the opinion that IgY is useful for prophylaxis and treatment of gastrointestinal infection by oral passive immunization as an alternative strategy to antibiotics. However, the further investigations are indispensable for the robustness of IgY application are indispensable to optimize the effective IgY dose with suitable formulation in order to withstand in the gastric environment; to determine the combinatorial effect of IgY with other alternative therapeutic strategies including probiotics and plant extracts for the improved performance.” (Pages 11-13)
MPEP 2144.05 II A States:
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to optimize the concentration of antibodies from avian sources to colostrum, including 50% of each. The artisan would be motivated to use different ratios to determine what ratio of avian IgY antibodies to colostrum and other carrier matrix provide the most protection from African swine fever virus. The artisan would have a reasonable expectation of success as the artisan is merely using known methods assay different ratios of colostrum to antibodies.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12194096 Although the claims at issue are not identical, they are not patentably distinct from each other because are coextensive in scope.
Independent claim is drawn to a method of treating African Swine Fever in swine in need thereof comprising the steps of administering a combination of:avian-sourced antibodies specific for an African Swine Fever (ASF) Virus isolate, anda carrier matrix comprising of non-hyperimmune colostrum.
The claims of 096 are drawn to a composition for treatment of African Swine Fever in swine, the composition comprising avian-sourced polyclonal antibodies specific for an African Swine Fever Virus isolate, wherein said polyclonal antibodies are produced by avian animals immunized against the African Swine Fever Virus isolate; and a protective/reactive matrix obtained from, isolated from, or derived from, non-hyperimmune colostrum, wherein the composition is administered to an animal to prevent or treat an occurrence of African Swine Fever in the animal.
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to treat swine with the composition of claims of 096. The artisan would be motivated as the claim recites, “wherein the composition is administered to an animal to prevent or treat an occurrence of African Swine Fever in the animal.” The artisan would have a reasonable expectation of success as treating swine with a known composition is predictable.
Dependent claims are obvious over the prior claims as they are coextensive in scope.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683