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 .
Status of Claims
The preliminary amendment filed on 4/18/2023 is acknowledged. Claims 1-22, 32, 34-35, 39-41, 43, and 49-51 were cancelled. Claims 31, 37-38, 42, and 44 were amended. Claims 23-31, 33, 36-38, 42, and 44-48 will be examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/18/2023 has been considered. Signed copies are enclosed.
The information disclosure statement filed 1/22/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Please provide a translated copy of the Japanese Patent Office’s office action and the Hatta reference for full consideration.
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 23-31, 33, 36-38, 42, and 4are 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.
Claims are broadly drawn to a method decreasing the transmission rate of an infectious disease within a population of individuals comprising providing egg products comprising egg material from eggs to individuals in a population susceptible to or having the infectious disease, wherein the eggs are from female birds inoculated with one or more disease antigens from microbial organisms causing the infectious disease, wherein the egg material comprises one or more avian antibodies that specifically bind and neutralize the microbial organisms in the individuals when consumed by the individuals, including further specification of the female birds, the disease antigens, the formulation of the egg products, the composition of the egg material, and the intended result of the method. Specifically, claim 27 defines the microbial organisms as “bacteria, viruses, fungi, worms, or combinations thereof”. Claim 28 specifies that the microbial organism is a virus and the antibodies prevent viral attachment to host cells. Claim 42 limits the viruses to “Influenza viruses, Coronaviruses, Henipavirus, Ebola virus, Hantaan virus, Lassa fever virus, Marburg virus, Crimean-Congo haemorrhagic fever virus, Monkeypox virus, Rift Valley Fever virus, South American haemorrhagic fever viruses, Central European tick-borne encephalitis virus, Far Eastern tick-borne encephalitis virus, Japanese encephalitis virus, Russian spring and summer encephalitis virus, Kyasanur forest disease virus, Omsk hemorrhagic fever virus, West Nile virus, human respiratory syncytial virus (RSV), human metapneumovirus (hMPV), Picornaviridae, rhinoviruses, enteroviruses, viruses from the family Coronaviridae, or combinations thereof”. Claim 44 specifies that the virus used to inoculate the egg laying female birds is SARS-CoV-2. With the exception of claim 44, the remaining claims are broadly drawn, with independent claim 23 claiming a method of decreasing the transmission rate of any infectious disease.
The specification teaches the inoculation of chickens with the recombinant spike protein of SARS-CoV-2. Figures 1 and 2 show at most a 90% reduction in plaques formed after incubation of SARS-CoV-2 virus with the IgY antibodies from inoculated chickens.
The specification does not teach the many of the claims: the implementation of a method of decreasing transmission rates by providing egg products (claim 23); the egg product formulated for application to the pharyngeal, oropharyngeal, or nasopharyngeal area (claim 37), or into a nasal inhalant, nasal spray, mouth wash, oral spray, oral tablet, mints, chewing gum, or throat lozenges (claim 26); the reduction of symptoms by consumption of the antibodies (claims 31 and 45); the inoculation of chickens to create antibodies to other SARS-CoV-2 antigens (claim 30), or other microbial organisms such as bacteria, fungi, protozoa, or worms (claim 27), or other viruses (claim 28), such as Influenza viruses, Coronaviruses, Henipavirus, Ebola virus, Hantaan virus, Lassa fever virus, Marburg virus, Crimean-Congo haemorrhagic fever virus, Monkeypox virus, Rift Valley Fever virus, South American haemorrhagic fever viruses, Central European tick-borne encephalitis virus, Far Eastern tick-borne encephalitis virus, Japanese encephalitis virus, Russian spring and summer encephalitis virus, Kyasanur forest disease virus, Omsk hemorrhagic fever virus, West Nile virus, human respiratory syncytial virus (RSV), human metapneumovirus (hMPV), Picornaviridae, rhinoviruses, enteroviruses, viruses from the family Coronaviridae, or combinations thereof (claim 42). The specification also does not teach the distribution of the egg product to all individuals in a population, the disruption or decrease of a transmission chain, or the shedding of neutralized organisms, as claimed in instant claims 44-46.
The specification does not reasonably provide adequate written description support of the broad genus of all infectious diseases. Other than the specific organism mentioned above (SARS-CoV-2), there is inadequate written description about the generation of antibodies against attachment molecules via the inoculation of egg laying birds. There is inadequate description of the method of claim 23, as this invention reads on in vivo administration of the antibodies to prevent transmission from an infected individual to an uninfected individual, and the applicant has not shown any in vivo administration of these antibodies or any reduction in transmission among individuals.
The art of treating diseases with neutralizing antibodies, often referred to as passive immunity, is reviewed in Burton (Burton, D.R. Nat Rev Immunol (2023) 23, 720–734) and Muller et al. (Muller S. et al., Nutrition Journal (2015) 14:109). The art recognizes that passive immunity to specific pathogens can be conferred through the distribution of antibodies to epitopes important to that specific pathogen’s disease progression, like adherence and entry for viruses. The art also acknowledges the potential for avian antibodies, or IgY, to be used for this purpose, as reviewed in Muller et al. Muller shows a few cases where IgY has been successfully used as prophylaxis, including preventing Pseudomonas aeruginosa colonization in cystic fibrosis patients. Muller et al. do not state any cases of prevented transmission of infectious diseases. The remainder of the art is also silent regarding the ability of IgY to control infection in a population of individuals; while protection with IgY has been theorized, there is no support in the art that IgY is capable of preventing transmission across an entire population.
The instant specification provides no support for the claims that the claimed invention can disrupt the transmission chain in a population, and has only provided in vitro data that the antibodies produced by immunized chickens can lessen viral spreading from cell to cell. Burton highlights the differences in in vitro assays and in vivo applications for neutralizing antibodies in viral infections, stating that while prophylactic use of antibodies seems successful, it is highly dependent on antibody concentration, the infected tissue, the particular viral infection, and more. As stated in the MPEP 2164,
“The issue of "correlation" is related to the issue of the presence or absence of working examples. "Correlation" as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a "working example" if that example "correlates" with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute "working examples." In this regard, the issue of "correlation" is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate.”
Burton explains that there is no strict understanding of a correlation between in vitro neutralization and in vivo protection, stating “…there are numerous examples of deviation from a uniform relationship between neutralization and protection and/or therapy” (Banner, pg 730 left column). More specifically, Burton also points out that “…deviation from a uniform relationship between neutralization and protection has been described for [neutralizing antibodies] to influenza virus and for…SARS-CoV-2 (Burton pg 728 left column).” Based on these teachings, a reduction in plaque by neutralizing antibodies, as shown in the instant specification, does not align with a reduction in transmission of the virus. Therefore, there is not sufficient support presented in the specification to prove the applicant has possession of “a method of decreasing transmission rates”, and the claimed invention lacks written description support.
Furthermore, the art regarding the generation of avian antibodies to specific pathogens shows that neutralization of an organism by antibodies very much depends on the epitopes targeted by immunization strategies. Indeed, Lu, Y. et al. (Lu, Y. et al., Journal of Immunology Research (2020) Article 465398) found different epitopes are important for neutralization between SARS-CoV-2 and SARS-CoV, closely related viruses that use the same entry receptor of ACE2. It should be noted the previously mentioned source Burton details the differences between antibody treatment of different viruses, and states that “each antibody–virus combination should probably be considered individually (Burton, pg 730 left column).” These examples are drawn to viruses, specifically, but it is known in the art that antibodies act differently depending on pathogen type, with infections by bacteria, viruses, fungi, protozoa, and worms all mediated by different immune responses, as reviewed in Lu, L. et al, 2018 (Lu, L. et al., Nat Rev Immunol (2018) 18, 46–61). For example, while neutralizing antibodies may commonly work to prevent viral fusion, or block toxin activity, the role of antibodies in bacterial infection is often to mediate complement or induce phagocytosis. As pointed out in the aforementioned source Muller, IgY cannot mediate compliment activation and is not well recognized by phagocytic cells, and therefore may not mediate bacterial infection well. Therefore, the broad claims of using this method on any infectious disease are not supported by the single example of antibodies against SARS-CoV-2.
Claim Rejections - 35 USC § 102
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 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)(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 23-31, 33, 36-38, 42, and 44-48 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Starzl, WO 2021/203034 A2, effective filing date 04/03/2020.
Claim 23 of the instant application is drawn to a method of decreasing the transmission rate of an infectious disease within a population of individuals, this method comprising providing egg products comprising egg material to individuals derived from female birds inoculated with one or more disease antigens from microbial organisms, wherein the egg material comprises one or more avian antibodies that bind and neutralize the organisms when consumed by individuals.
Claim 24 specifies that these female birds of claim 23 are egg laying birds on egg farms. Claim 25 specifies the egg material of claim 23 is formulated into egg powder. Claim 26 discloses that the egg product of claim 23 may be in the form of a nasal inhalant, a nasal spray, mouth wash, oral spray, oral tablet, a mint, chewing gum, a throat lozenge, and combinations thereof.
Claim 27 discloses the microbial organisms of claim 23 are bacteria, viruses, fungi, protozoa, worms or combinations thereof, while Claim 28 specifies that the microbial organism of claim 23 is a virus, and the avian antibodies prevent attachment of the virus to the cells of the individuals. Claim 29 further specifies claim 28, stating that the attachment site is the ACE2 receptor. Claim 30 discloses that the antibodies of claim 23 are directed against an antigen from SARS-CoV-2, wherein the antigen comprises s2 spike protein, s1 spike protein, spike rbd protein, nucleocapsid, envelope or combinations thereof.
Claim 31 discloses that the antibodies of claim 23 reduce the susceptibility or symptoms to the disease upon consumption of the egg product. Claim 33 discloses that the egg product of claim 23 is consumed by the individuals at least once a day. Claim 36 specifies that the egg product of claim 23 comprises egg material that has been separated from the egg shells, and at least part or all of the egg yolk in the egg material comprises non-denatured antibody material upon consumption. Claim 37 discloses that the egg material in claim 23 is formulated into an egg product for consumption by the individuals wherein the formulation comprises the one or more antibodies that specifically bind and neutralize the microbial organisms when consumed by the individuals. Claim 38 discloses that the egg product of claim 23 is formulated for the pharyngeal, nasopharyngeal, or oropharyngeal area.
Claim 42 further specifies that the microbial organisms of claim 27 are viruses, comprising the group “Influenza viruses, Coronaviruses, Henipavirus, Ebola virus, Hantaan virus, Lassa fever virus, Marburg virus, Crimean-Congo haemorrhagic fever virus, Monkeypox virus, Rift Valley Fever virus, South American haemorrhagic fever viruses, Central European tick-borne encephalitis virus, Far Eastern tick-borne encephalitis virus, Japanese encephalitis virus, Russian spring and summer encephalitis virus, Kyasanur forest disease virus, Omsk hemorrhagic fever virus, West Nile virus, human respiratory syncytial virus (RSV), human metapneumovirus (hMPV), Picornaviridae, rhinoviruses, enteroviruses, viruses from the family Coronaviridae, or combinations thereof”. Claim 44 specifies that the method of claim 27 where the virus is SARS-CoV-2, and claim 45 discloses that the method of claim 23 reduces susceptibility to or prevents Covid-19.
Claim 46 specifies that the egg products of claim 23 are provided to all of the individuals in a population with an outbreak of the infectious disease. Claim 47 discloses that the providing of the gg products in claim 23 disrupts and/or decreases the transmission chain of the infectious disease. Claim 48 indicates that the individuals consuming the egg products in claim 23 shed neutralized microbial organisms.
Starzl discloses “anti-SARS-CoV-2 polyclonal IgY antibodies, serum, egg yolk, and/or whole immune egg have been derived from poultry vaccinated with recombinant proteins, nucleic acids, and/or coronavirus vaccines. Compositions comprising the anti-SARS-CoV-2 polyclonal antibodies are useful for decreasing transmission, duration, and/or severity of coronavirus disease 2019 (COVID-19). Oral, parenteral, and inhalable compositions are provided for preventing and treating COVID-19, including Lingual and sublingual alimentary traps” (paragraph [0021]). The invention of Starzl meets the claim limitations of instant claims 23-31, 33, 36-38, 42, and 44-48.
The invention of Starzl discloses a method of decreasing the transmission rate of an infectious disease within a population of individuals (claims 23-27; paragraph [0021]), this method comprising providing egg products comprising egg material to individuals derived from female birds inoculated with one or more disease antigens from microbial organisms (claim 20, paragraph [0021], [0048]), wherein the egg material comprises one or more avian antibodies that bind and neutralize the organisms when consumed by individuals (paragraph [0047: “neutralizing polyclonal IgY antibodies”), and thereby meets the limitations of claim 23.
Starzl teaches the use of chickens, the most common egg-laying farm bird, to produce IgY antibodies (paragraph [00393], example 3), thereby teaching claim 24.
Starzl teaches the antibodies in the form of egg powder (paragraph [0047], [00400]), teaching the limitation of claim 25.
Starzl teaches the composition of antibodies in the form of “a spray, mouth spray, nasal spray, inhalation aerosol, lozenge, troche, gel, mucoadhesive gel, film, liquid, powder, capsule, tablet, caplet, mouth wash, mouth rinse, mouth gargle, inhalable powder, suppository, inhalable fluid, and injectable fluid” (paragraph [0050], see also claim 22, examples 16-19), teaching the limitations of claim 26.
Starzl teaches that the IgY antibodies may be directed towards different viruses and bacteria in paragraphs [00329]-[00333], teaching the limitation of claim 27. These paragraphs also teach the limitations of claims 42 and 44, disclosing many of the viruses in claim 42 and SARS-CoV-2, as stated in claim 44 (see also claims 58-59).
Starzl paragraph [00329] states that the antibodies may be “anti-adherence factor”, and paragraph [00296] discloses the ACE2 receptor as the attachment site for SARS-CoV-2, teaching the limitations of claims 28 and 29 (see also examples 20-21, 23-27).
Starzl [0022] discloses IgY antibodies to SARS-CoV-2 spike proteins, spike RBD protein, and N (nucleocapsid) proteins, meeting the limitation of claim 30 (see also claims 3-5).
Starzl discloses that their invention can reduce susceptibility and symptoms to SARS-CoV-2 and Covid-19 in paragraphs [0035], [00398], and [00489], teaching the limitations of claims 31 and 45.
Starzl paragraph [00489] also teaches the administration of the invention every 2, 4, 6, or 8 waking hours, or twice a day, teaching the limitation of claim 33, “administration at least once a day”.
Starzl discloses the preparation of egg powder comprising separating the egg shell and processing the whole egg, or yolk, including IgY antibodies, to obtain antibodies in paragraph [00375]-[00379] (see also example 15, 17), teaching the limitations of claim 36.
Starzl teaches that the IgY antibodies of the claimed invention can bind and neutralize SARS-CoV-2 virus, thereby teaching the limitations of claim 37, in example 25, as well as examples 21-24 and figure 14-21. Examples 29 and 30 also demonstrate binding/neutralizing antibodies for bacterial pathogens.
Starzl paragraph [00467] discloses the administration of the invention to the subject oropharyngeally, thereby teaching the limitation of claim 38.
Starzl discloses a kit for preventing or decreasing transmission of a SARS-CoV-2 virus comprising the disclosed invention (IgY antibodies) (paragraph [0055]), and paragraph [00456] discloses that the composition of antibodies in the kit will be provided at a concentration several times greater than the “99+% neutralizing titer”, teaching the limitations of claim 46.
Starzl examples 24 and 25 disclose binding and neutralization of SARS-CoV-2 via the disclosed invention, as well as inhibited binding between the virus and the human ACE2 receptor, indicating reduced transmission and infection, thereby meeting claims 47 and 48.
Claims 23, 26-31, 33, 36-38, 42, and 44-48 are anticipated by Starzl as far as applicant has supported the claimed invention in the instant specification.
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 23, 26-28, 31, 36-38, and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 10, 12, and 15 of U.S. Patent No. 9,701,737. Although the claims at issue are not identical, they are not patentably distinct from each other because '737 claims a method of decreasing respiratory illnesses in animals comprising: inhibiting the ability of microbial organisms causing respiratory illnesses to adhere and multiply in the animals' respiratory tract, wherein the inhibition is generated by an egg mixture comprising whole egg contents separated from the egg shells and produced in eggs laid by female birds, the birds inoculated with an organism mixture comprising one or more microbial organisms causing respiratory illnesses, wherein the egg contents comprise adherence inhibiting material and wherein the egg mixture is administered into the respiratory tract of the animal to produce a mist that coats the nasopharynx of the respiratory tract and prevents the microbial organisms causing respiratory illnesses from adhering to the mucous membranes and bronchi and alveolar cells of the animals' respiratory tract (claim 1). ‘737 further teaches the method of claim 1 wherein the respiratory illness causing microbial organisms include bacteria, viruses, fungi and parasites (claim 7); wherein the one or more organisms inoculated into the female birds include one or more viruses (claim 10); wherein the one or more viruses is swine influenza virus (claim 12); and wherein the egg mixture is administered through an oral and nasal delivery (claim 15).
The claimed method of ‘737 uses adherence inhibitory material obtained from the same source performing the same function as the instant application, and thus anticipates instant claims 23, 28, 31, 36, and 37.
Instant claim 23 is drawn to a method of reducing transmission of an infectious disease comprising administering egg material from egg-laying birds that have been inoculated with antigens from the infectious disease, a process patentably indistinct from ‘737 claim 1. Claim 28 is drawn to preventing viral fusion molecules from attaching to the cellular attachment site, thereby reducing the infectious disease, such as the adherence inhibiting material in ‘737 claim 1. Claim 31 is drawn to the reduction of susceptibility or symptoms of the disease upon the administration of the method of claim 23, analogous to ‘decreasing respiratory disease’ in ‘737 claim 1. Claim 36 is drawn to the formulation of the egg material of claim 23, and is the same process stated in ‘737 claim 1. Claim 37 is drawn to the formulation of the egg material so that the avian antibodies contained in the material bind and neutralize the microbial organism responsible for the disease, patentably indistinct from the adherence inhibiting material of ‘737 claim 1.
The claimed microbial organisms of ‘737 include bacteria, viruses, fungi, and parasites (claim 7), as stated in the instant claim 27, as well as viruses (claim 10), as stated in claim 28, and also include swine influenza virus (claim 12), as included in instant claim 42 under ‘Influenza viruses’, and therefore anticipates claims 27, 28, and 42.
Finally, the claimed method of ‘737 is administered through oral or nasal delivery (claim 15), just like the egg products in instant claim 26, and coats the nasopharynx of the target animal (claim 1), indicating the invention is formulated for administration to nasopharynx, as stated by instant claim 38. Thus, ‘737 anticipates instant claims 26 and 38.
Claims 23-27, 31, 33, 36-38, and 46-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8, 11-13, 15, 19-24 of U.S. Patent No. 9,655,962. Although the claims at issue are not identical, they are not patentably distinct from each other because '962 claims a method of reducing or eliminating pathogenic infections in an animal, the method comprising: treating lymphatic tissue in the oropharynx and the nasopharynx of the animal with a tonsillar composition to reduce or eliminate one or more disease causing entities from the lymphatic tissue, wherein the tonsillar composition comprises avian antibodies from eggs of hens inoculated with one or more of the disease causing entities and wherein the avian antibodies bind and/or neutralize the one or more disease causing entities (claim 1); a method of reducing or eliminating one or more disease causing entities in the oral cavity of an animal, the method comprising: treating the oral cavity of the animal with a composition comprising avian antibodies from eggs of hens inoculated with one or more of the disease causing entities, wherein the treatment comprises contacting the oral cavity with the composition to reduce or eliminate disease causing entities from the oral cavity of the animal; and a method of operating a farm comprising farm animals, the method comprising: providing the farm animals with a composition to reduce or eliminate disease causing entities from the lymphatic tissue of the orpharynx and/or nasopharynx, the composition comprising avian antibodies from eggs of hens inoculated with one or more of the disease causing entities, wherein the providing comprises inclusion of the composition in the drinking water of the farm animals (claim 21). The claims of ‘962 also include further limitation of these methods, including the method of claim 1 wherein the one or more disease causing entities are derived from bacteria, viruses, yeast, fungi or combinations thereof (Claim 11); wherein the composition reduces complications associated with infection from the disease causing entities (claim 8); wherein the treatment comprises administering the composition for at least 10 days (claim 3); wherein the avian antibodies are spray dried egg contents, purified avian antibody, partially purified avian antibody, egg yolks or combination thereof (claim 12); the method of claim 13 wherein the treatment comprises providing the composition in a liquid with…spray dried egg powder (claim 13) and wherein the liquid is mouthwash (claim 20); and the method of claim 21, wherein the providing is commenced before or at the first evidence of pathogenic infection on the farm (claims 23 and 24).
These claims anticipate the instant application claims 23-27, 31, 33, 36-38, and 46-48, as they teach a method of decreasing transmission rates of an infectious disease within a population, directed against the microbial organisms defined in the instant claim 27, for the same purpose as the instant application.
Instant claim 23 is drawn to a method of decreasing transmission of an infectious disease comprising administering egg material from egg-laying birds that have been inoculated with antigens from the infectious disease, a process patentably indistinct from ‘962 claim 1 and claim 21, as the methods use the same material from the same source and the application of this same material in the same formulation with the same outcome. Instant claim 24 further specifies that the female birds of claim 23 are egg laying birds on egg farms, and ‘962 claim 21 is drawn to the use of hens, or female chickens, the most common egg laying birds on farms. Claim 25 is drawn to the formulation of the egg material into egg powder, as in ‘962 claims 12 and 13 specify egg powder. Claim 27 of the instant applications states that the microbial organisms are bacteria, viruses, fungi, protozoa, worms, or combinations thereof, as listed in ‘962 claim 11. Claim 31 is drawn to the reduction of susceptibility to or symptoms of a disease upon administration of the method of claim 23, patentably indistinct from ‘962 claim 8, which states the method of ‘962 claim 1 will reduce complications associated with infection. Claim 33 specifies the method of claim 23 should be administered once a day, as met by ‘962 claim 3 and 21, where the compound is administered for at least 10 days and in the drinking water of the farm animals. Claim 36 specifies the egg material formulation comprises antibody material, stated in ‘962 claims 1 and 21, and claim 37 specifies the egg material formulated for consumption, where the antibodies bind and neutralize the microbial organisms, as stated in ‘962 claim 1. Claim 38 specifies the egg material is formulated for administration to the nasopharynx or oropharynx, as stated in ‘962 claim 21. Claim 46 specifies that the egg products are provided to all individuals in a population, while claim 47 is drawn to the reduction of transmission upon administration of the egg products in a population, and both these claims would be accomplished by administering the method of claim 21-24 in ‘962, by providing the composition of ‘962 in the drinking water of the farm animals for the purpose of reducing infectious disease. Finally, claim 48 is drawn to the shedding of neutralized organisms, an inherent consequence of bound and neutralized microbial organisms, as stated in ‘962 claim 1 and 21.
Therefore, ‘962 claims 1, 3, 8, 11-13, 15, 19-24 anticipate instant application claims 23-27, 31, 33, 36-38, and 46-48 as presented.
Claims 23, 26-28, 31, and 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 9,849,175. Although the claims at issue are not identical, they are not patentably distinct from each other because '175 claims a method of preventing or reducing the incidence of respiratory illness caused by viruses in an animal, the method comprising: dispersing an intranasal composition comprising whole egg material, wherein the whole egg material comprises egg yolk, albumin and antibody produced in eggs laid by female birds, wherein the birds are chickens inoculated with one or more viruses or virus antigens causing the respiratory illness, wherein the composition is formulated for dispersion into the respiratory tract and is effective to prevent or reduce the adherence of the virus causing the respiratory illness to the mucosal membranes of the respiratory tract, wherein a dose comprises about 4 percent by volume of a whole chicken egg (claim 14); wherein the composition is further formulated as an oral spray and the dispersing comprises spraying the contents of the oral spray into the mouth of the animal (claim 15); wherein the composition is formulated for oral regimens and placed onto an oral strip and the dispersing comprises placing the oral strip into the mouth of the animal (claim 16); and wherein a mouth rinse comprises the composition further formulated for oral regimens and the dispersing is by gargling with the mouth rinse (claim 17).
These claims anticipate instant claims 23-24, 26-28, 31, and 36-38, as they teach a method of decreasing transmission rates of an infectious disease within a population comprising the same material from the same source and the application of this same material in the same formulation as the instant claims, directed against the microbial organisms defined in the instant claim 28, for the same purpose as the instant application.
Claim 23 is drawn to a method of decreasing transmission of an infectious disease comprising administering egg material from egg-laying birds that have been inoculated with antigens from the infectious disease, a process patentably indistinct from claim 14 of ‘175. The method of claim 14 of ‘175 comprises intranasally administering the claimed composition, meeting the limitations of instant claims 26 and 38, when the composition is derived from whole egg material and contains antibodies to the infectious disease, meeting the limitations of instant claims 36 and 37, when the eggs are laid by chickens, the most common egg laying bird on egg farms, meeting the limitation of instant claim 24, when said chickens were inoculated with viruses or viral antigens, meeting the limitations of claims 27 and 28. ‘175 claim 14 also states that the composition will reduce the adherence of the virus to the respiratory tract, which would reduce the susceptibility of the animal to the disease, meeting the limitations of claim 31. The subsequent claims 15-17 in ‘175 further specify that the composition can be formulated and administered as a oral spray, oral strip, or mouthwash, meeting the limitations of instant claim 26 and 38, as these compositions would be formulated for the oropharyngeal area.
Claims 23, 25-31, 36-38, and 42 and 44-48 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-15, 17, and 19-21 of copending Application No. 17/313,738 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because '738 claims a method of delivering avian antibodies to an individual comprising administering a formulation comprising egg material, wherein the egg material comprises one or more avian antibodies specific for one or more target viruses, the egg material formulated to coat all or a portion of mucosal surfaces in the individual's pharyngeal area, wherein the one or more avian antibodies in the formulation binds and/or neutralizes the one or more target viruses wherein the one or more target viruses comprise SARS-CoV-2 (claim 9) and a method of reducing the transmission of a respiratory disease comprising administering a formulation comprising egg material, wherein the egg material comprises one or more avian antibodies to coat all or a portion of mucosal surfaces in the individual's pharyngeal area, wherein the avian antibodies in the formulation binds and neutralizes one or more viruses causing the respiratory disease, wherein administering the formulation prevents Covid-19 (claim 19). ‘738 also claims the method of claim 9, wherein the formulation comprises an oral formulation, wherein the oral formulation comprises an oral spray, a tablet, a candy, a gummy and/or a throat lozenge (claim 10); wherein the formulation comprises a powdered nasal inhalant or a liquid nasal spray (claim 11); wherein the avian antibody formulation prevents a viral fusion molecule in the one or more viruses from attaching to the cellular attachment site of cells in the pharyngeal area of an individual (claim 12); wherein the avian antibodies are directed against an antigen from SARS-CoV-2, wherein the antigen comprises s2 spike protein, s1 spike protein, spike rbd protein, nucleocapsid, envelope or combinations thereof (claim 13); wherein the avian antibody formulation reduces the transmission of disease by binding and/or neutralizing the one or more viruses in the pharyngeal area of the individual, wherein the individual is infected and the neutralizing prevents the one or more viruses from infecting a second individual, wherein the second individual is an uninfected individual (claim 14); wherein the formulation is administered to the nasopharyngeal and/or the oropharyngeal area (claim 15); wherein administering the formulation prevents Covid- 19 (claim 17); and the method of claim 19, wherein the method reduces disease transmission from an infected individual to an uninfected individual, wherein the uninfected individual is administered the avian antibody formulation (claim 20) and wherein the method reduces disease transmission from an infected individual to an uninfected individual, wherein the infected individual is administered the avian antibody formulation (claim 21).
These claims anticipate instant claims 23, 25-31, 36-38, and 42 and 44-48, as they are drawn to a method of decreasing transmission rates of an infectious disease within a population comprising the same material from the same source and the application of this same material in the same formulation as the instant claims, and concern the same virus (SARS-CoV-2) and disease (Covid-19) as the instant claims.
Instant claim 23 is drawn to a method of decreasing transmission of an infectious disease comprising administering egg material from egg-laying birds that have been inoculated with antigens from the infectious disease, a process patentably indistinct the methods in ‘738 claim 9 and 19. The method of ‘738 claim 9 also states that the egg material contains antibodies, meeting the limitations of instant claim 36, and that the antibodies bind and/or neutralize virus, meeting the limitations of claim 37. ‘738 claim 9 also states that the target of the antibodies is the virus SARS-CoV-2, meeting the limitations of instant claims 27 (directed to the type of microbial organism targeted), 28 (directed to a virus as a target), 42 (directed to a variety of viruses as a target, including coronaviruses), and 44 (directed to the target of SARS-CoV-2).
Claims 25 and 26 are drawn to the egg product’s form, and are met by ‘738 claims 10 and 11, which indicate the claimed invention is in the same form as the instant invention (claim 26) and that the claimed invention, when in the form of a powdered nasal inhalant, comprises egg powder. Furthermore, ‘738 claims 10 and 11 show the claimed invention is formulated for the nasopharynx and oropharynx, meeting the limitations of instant claim 38.
‘738 claim 12 is drawn to the antibodies of the presented invention preventing viral attachment, meeting the limitations of claim 28 in full, and as ‘738 claim 9 states the antibodies are directed against SARS-CoV-2, the attachment site must be the ACE2 receptor, meeting the limitations of claim 29. ‘738 claim 13 defines the antigens from SARS-CoV-2 the antibodies are directed against and is patentably indistinct from instant claim 30.
‘738 claim 14 states that the antibodies of claim 9 reduce transmission of disease by binding/neutralizing virus, preventing the spread of the disease from an infected individual to an uninfected individuals, which meets the limitations of instant claims 23, 31, 37, 47, and 48, as claim 23 speaks to a method of providing antibodies in egg products to reduce transmission rates, claim 31 is directed to the antibodies reducing susceptibility to a disease, claim 37 states that the consumed antibodies bind and neutralize the target microbial organism, claim 47 states that providing the egg products of claim 23 decreases transmission, and claim 48 states that individuals consuming the product will shed neutralized microbial organisms.
Instant claim 38 states that the egg product is formulated for use in the pharyngeal, nasopharyngeal, or oropharyngeal area, a limitation met by ‘738 claim 15. Claim 45 states that the administration of the method of 23 reduces susceptibility to Covid-19, a limitation patentably indistinct from ‘738 claim 17.
The method of ‘738 claim 19 is a method of reducing the transmission of a respiratory disease, patentably indistinct from instant claim 23, and states that the egg material contains antibodies, meeting the limitations of instant claim 36, that the antibodies bind and/or neutralize virus, meeting the limitations of claim 37, and that the method prevents Covid-19, meeting the limitations of claim 44. Additionally, claim 20 states that the method of 19 is administered to uninfected individuals, thereby reducing their susceptibility to the virus, which meets the limitations of instant claim 31, stating that the method of claim 23 reduces susceptibility to an infectious disease. The stipulations of claims 20 and 21, that the antibodies are administered to both infected and uninfected individuals, indicates that an entire population can receive the antibodies, thereby meeting the limitations of instant claim 46 (providing egg products to all individuals in a population).
Therefore, ‘738 claims 9-15, 17, and 19-21 anticipate instant claims 23, 25-31, 36-38, 42, and 44-48.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 23-31, 36-38, 42, and 44-48 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-17 and 19-21 of copending Application No. 19/364,838 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘838 claims a method of delivering avian antibodies to an individual comprising administering a formulation comprising egg material, wherein the egg material comprises one or more avian antibodies specific for one or more target viruses, the egg material formulated to coat all or a portion of mucosal surfaces in the individual's pharyngeal area, wherein the one or more avian antibodies in the formulation binds and/or neutralizes the one or more target viruses (claim 9) and a method of reducing the transmission of a respiratory disease comprising administering a formulation comprising egg material, wherein the egg material comprises one or more avian antibodies to coat all or a portion of mucosal surfaces in the individual's pharyngeal area, wherein the avian antibodies in the formulation binds and neutralizes one or more viruses causing the respiratory disease (claim 19). ‘738 also claim the method of claim 9, wherein the formulation comprises an oral formulation, wherein the oral formulation comprises an oral spray, a tablet, a candy, a gummy and/or a throat lozenge (claim 10); wherein the formulation comprises a powdered nasal inhalant or a liquid nasal spray (claim 11); wherein the avian antibody formulation prevents a viral fusion molecule in the one or more viruses from attaching to the cellular attachment site of cells in the pharyngeal area of an individual (claim 12); wherein the avian antibodies are directed against an antigen from SARS-CoV-2, wherein the antigen comprises s2 spike protein, s1 spike protein, spike rbd protein, nucleocapsid, envelope or combinations thereof (claim 13); wherein the avian antibody formulation reduces the transmission of disease by binding and/or neutralizing the one or more viruses in the pharyngeal area of the individual, wherein the individual is infected and the neutralizing prevents the one or more viruses from infecting a second individual, wherein the second individual is an uninfected individual (claim 14); wherein the formulation is administered to the nasopharyngeal and/or the oropharyngeal area (claim 15); wherein the virus comprises SARS-CoV-2 (claim 16); wherein administering the formulation prevents Covid- 19 (claim 17); and the method of claim 19, wherein the method reduces disease transmission from an infected individual to an uninfected individual, wherein the uninfected individual is administered the avian antibody formulation (claim 20) and wherein the method reduces disease transmission from an infected individual to an uninfected individual, wherein the infected individual is administered the avian antibody formulation (claim 21).
These claims anticipate instant claims 23-31, 36-38, and 42 and 44-48, as they are drawn to a method of decreasing transmission rates of an infectious disease within a population comprising the same material from the same source and the application of this same material in the same formulation as the instant claims, and the claims encompass the same virus (SARS-CoV-2) and disease (Covid-19) as the instant claims.
Instant claim 23 is drawn to a method of decreasing transmission of an infectious disease comprising administering egg material from egg-laying birds that have been inoculated with antigens from the infectious disease, a process patentably indistinct the methods in ‘838 claim 9 and 19. The method of ‘838 claim 9 also states that the egg material contains antibodies, meeting the limitations of instant claim 36, that the antibodies bind and/or neutralize virus, meeting the limitations of claim 37, and that the antibodies are directed against a virus, meeting the limitations of claims 27, which specifies the microbial organisms of claim 23, and 28, which specifies a virus.
Claims 25 and 26 are drawn to the egg product’s form, and are met by ‘838 claims 10 and 11, which indicate the claimed invention is in the same form as the instant invention (claim 26) and that the claimed invention, when in the form of a powdered nasal inhalant, comprises egg powder. Furthermore, ‘838 claims 10 and 11 show the claimed invention is formulated for the nasopharynx and oropharynx, meeting the limitations of instant claim 38.
‘838 claim 12 is drawn to the antibodies of the presented invention preventing viral attachment, meeting the limitations of claim 28 in full. ‘838 claim 16 states that the virus is SARS-CoV-2, matching the limitation of instant claim 44. As ‘838 claim 16 specifies that the antibodies are directed against SARS-CoV-2, the attachment site must be the ACE2 receptor, meeting the limitations of claim 29. ‘838 claim 13 defines the antigens from SARS-CoV-2 the antibodies are directed against and is patentably indistinct from instant claim 30.
‘838 claim 14 states that the antibodies of claim 9 reduce transmission of disease by binding/neutralizing virus, preventing the spread of the disease from an infected individual to an uninfected individuals, which meets the limitations of instant claims 23, 31, 37, 47, and 48, as claim 23 speaks to a method of providing antibodies in egg products to reduce transmission rates, claim 31 is directed to the antibodies reducing susceptibility to a disease, claim 37 states that the consumed antibodies bind and neutralize the target microbial organism, claim 47 states that providing the egg products of claim 23 decreases transmission, and claim 48 states that individuals consuming the product will shed neutralized microbial organisms.
Instant claim 38 states that the egg product is formulated for use in the pharyngeal, nasopharyngeal, or oropharyngeal area, a limitation met by ‘838 claim 15. Claim 45 states that the administration of the method of 23 reduces susceptibility to Covid-19, a limitation patentably indistinct from ‘838 claim 17.
The method of ‘838 claim 19 is a method of reducing the transmission of a respiratory disease, patentably indistinct from instant claim 23, and states that the egg material contains antibodies, meeting the limitations of instant claim 36, and that the antibodies bind and/or neutralize virus, meeting the limitations of claim 37 and 48. Additionally, claim 20 states that the method of 19 is administered to uninfected individuals, thereby reducing their susceptibility to the virus, which meets the limitations of instant claim 31, stating that the method of claim 23 reduces susceptibility to an infectious disease. ‘838 claim 21 states that the method of claim 19 is administered to infected individuals, indicating that the transmission chain from infected to uninfected individuals will be reduced, meeting the limitations of instant claim 47, which states that providing egg products will disrupt the transmission chain from infected individuals to uninfected individuals. The stipulations of claims 20 and 21, that the antibodies are administered to both infected and uninfected individuals, indicates that an entire population can receive the antibodies, thereby meeting the limitations of instant claim 46 (providing egg products to all individuals in a population).
Finally, claim 1 of ‘838 speaks to a formulation of egg material from chickens, the most common bird on egg laying farms, meeting the limitations of claim 24, which states that the egg material comes from female birds that are egg laying birds on egg farms.
Therefore, ‘838 claims 1, 9-17 and 19-21 anticipate instant claims 23-31, 36-38, 42, and 44-48.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674