Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Status
Claims 1-19 are currently pending. There is no amended, canceled or new claim. Claims 1-19 will be examined on the merits herein.
Priority
Acknowledgment is made of applicant’s priority based on Provisional application PRO 63/568,181 filed on March 21, 2024.
Information Disclosure Statement (IDS)
Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a composition for therapeutic or prophylactic treatment of birds, the composition is a mixture of IgY antibodies derived from one or more eggs laid by one or more avian species, wherein each of the one or more avian species have been vaccinated with one or more of the plurality of antigens and a protective material comprising colostrum.”. This judicial exception is not integrated into a practical application because the claims are directed to a composition which is a product of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations in the claims are either additional statements characterizing the product of nature (claims 1-19) or are recitations of intended use (claims 1, 10). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited.
(MPEP 2106.04(b)(II)):
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
Regarding Step 1 of the analysis, the claims are directed to the statutory category of a product.
Regarding Step 2A, prong one, the claims are directed to and recite the judicial exception of a nature-based product. The claims are directed to “a mixture of IgY antibodies derived from one or more eggs laid by one or more avian species, and a protective material comprising colostrum”. However, the mixture of IgY antibodies derived from one or more eggs laid by avian species, and colostrum collected from ruminants. The specification discloses at page 7 that the after the immunization process, whole shell eggs may be collected from the hens of the avian species. These eggs contain concentrated IgY which bind to the one or more pathogens against which the laying chicken was vaccinated. The yolk of the eggs may be isolated from the egg whites [see paragraph 0029] and the colostrum may be collected from non-hyperimmune ruminants [see paragraph 0034]. The colostrum may be bovine colostrum, The non-hyperimmune ruminants may be non-hyperimmune cattle. In some embodiments, the colostrum may comprise of whole colostrum. The colostrum may be dehydrated and ground to a powder using techniques known in the art. See paragraph [0034]. Therefore, a composition that comprises “a IgY antibodies derived from one or more eggs laid by avian species, and colostrum collected from ruminants are a product of nature. “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). Therefore, the claims encompass a nature-based product/product of nature, which is a judicial exception.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application. The claims do not recite any additional elements.
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps – either in isolation or combination, amount to significantly more than the judicial exception. Here, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more and do not add something “significantly more” so as to render the claims patent-eligible because while claims 1, 10 recite an intended use, this intended use does not further limit the subject matter of the claim. See page 1, abstract and Introduction.
Murai et al. 2001 (Murai A, Murota R, Doi K, Yoshida T, Aoyama H, Kobayashi M, Horio F. Avian IgY is selectively incorporated into the egg yolks of oocytes by discriminating Fc amino acid residues located on the Cυ3/Cυ4 interface. Dev Comp Immunol. 2013 Apr;39(4):378-87. doi: 10.1016/j.dci.2012.12.003) provides evidence that in avian species, maternal IgY is transferred from the maternal blood circulation to the embryonic circulation. The maternal IgY is selectively incorporated into the egg yolks of maturing oocytes. The process of avian maternal IgY transfer appears to be divided into two steps: the first step is the transfer from the maternal circulation to the egg yolks of developing oocytes in the maternal body, and the second step is the transfer from the egg yolks to the embryonic circulation through the yolk sac membrane at the late embryonic stages in the developing eggs.
Playford et al. (Playford RJ, Weiser MJ. Bovine Colostrum: Its Constituents and Uses. Nutrients. 2021 Jan 18;13(1):265. doi: 10.3390/nu13010265) provides evidence that Colostrum is the milk produced during the first few days after birth and contains high levels of immunoglobulins, antimicrobial peptides, and growth factors. Playford also teaches that colostrum is important for supporting the growth, development, and immunologic defense of neonates. Colostrum is naturally packaged in a combination that helps prevent its destruction and maintain bioactivity until it reaches more distal gut regions and enables synergistic responses between protective and reparative agents present within it. Bovine colostrum been used for hundreds of years as a traditional or complementary therapy for a wide variety of ailments and in veterinary practice. See page 1, abstract; and page 3-4, Table 1.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Starzl et al. (US 20120141458 A1; hereafter Starzl; PTO-892).
As claim 1-3, Starzl teaches compositions and methods for passive immunization. Compositions comprising a synergistic combination of specific polyclonal antibodies with a carrier matrix. Methods for the treatment of pathogenic infections in broad-spectrum, undifferentiated, or mixed clinical applications. In one embodiment, compositions and methods for the treatment of diarrhea and enteric infections are provided. See paragraphs [002].
Starzl teaches the at least one specific binding molecule comprises IgY derived from immunized chickens. In other specific aspects, the IgY comprises a pool of IgY specific for at least enterotoxigenic E. coli spp., E. coli K99 pili adherence factor, Clostridium perfringens toxoid, Salmonella typhimurium, rotavirus, and coronavirus. See paragraph [0027].
Starzl teaches the hens are inoculated with antigens or toxins derived from one, two, three, four, five, six, seven, or eight, or a number of pathogenic microorganisms. See paragraph [0131].
Starzl teaches Immunizations of chickens for IgY production. IgY can be generated in a similar fashion in duck, goose, ostrich, quail, or turkey eggs, with use of appropriate amounts of antigen. See paragraph [0123].
Starzl teaches The term "carrier matrix", or protective/reactive matrix, refers to any substrate, compound, formulation, or supplemental admixture (whether natural or synthetic) containing elements, co-factors, or other components in appropriate ratios and concentrations so as to supply elements required to propagate, promote, support, or enhance an in situ immune-type response, cascade, or reaction. These elements may variously promote cleavage and maturation reactions, the formation of assemblies and complexes, depletion and adsorption functions, supply essential elements, biologics, or compounds, and provide protective functions for active elements or components. A carrier matrix may or may not contain endogenous antibodies (immune factors), which may or may not be specific to targeted antigens.
Starzl teaches the compositions allow are used as a delivery medium for, e.g., oral administration of the antibody formulation. This approach may provide an effective way of reliably scaling antibody production for formulation in this manner, so as to control titer, consistency, and continuous availability, for commercial use. In one embodiment antibodies are harvested from the eggs of an inoculated animal, and may be purified or treated or retained in the egg material, and added to bovine colostrums. See paragraph [0172].
As claim 4, Starzl teaches whole bovine colostrum is used as the carrier matrix. See paragraph [0172].
As claim 5, Starzl teaches that after processing, one dried whole immune egg contains about 80 to 110 mg total IgY and about 6 to 10 mg of total mixed antigen-specific IgY, e.g., from a chicken immunized with, for example a mixed antigen preparation. See paragraph [0106]. One gram each of the dried anti-E. coli antibody preparation and the dried anti-scours antibody preparation were added with 3 grams or 4 grams of commercial dried full-fat bovine colostrum in a single dose packet. See paragraph [0211].
Starzl teaches the composition comprises an equivalent weight amount of dried immune egg product from each of three flocks inoculated with different antigens or different mixed antigen preparations is co-packaged with a specific weight amount of commercial dried non-hyperimmune bovine colostrum. In one aspect, 0.5 to 3 g. 0.7 to 2.0 g, 1.0 g, 1.3 g, or 1.5 g of dried immune egg product from each flock is added to a single dose packet. Preferably either 1.0 g or 1.3 g each immune egg product is added to a one dose packet. In another aspect, 1 to 5 g, 2 g to 4 g, 1.5 g, 2.0 g, 2.5 g, 3.0 g, 3.5 g, 4.0 g, 4.5 g or 5 g dried colostrum is added to the same packet. See paragraph [0196].
As claim 6-19, Starzl teaches the composition includes a pharmaceutically acceptable carrier. In other embodiments, the composition includes a food grade carrier. In embodiments, the compositions can be administered via oral delivery, nasal delivery, ocular delivery or combinations thereof. See paragraph [0016].
Starzl teaches the formulation comprising the specific binding molecule is a dry solid (egg powder) formulation. The powdered formulation is sealed in airtight packets, optionally layered with an inert gas. The formulation can be stored for extended periods of time at room temperature, under refrigeration, or frozen temperatures. In other embodiments, the dried composition is formulated into capsules or tablets for oral administration. See paragraph [0179].
Starzl teaches the pharmaceutical acceptable diluents for formulating the composition, wherein said pharmaceutical acceptable diluents are selected from the group consisting of a lactose, mannitol, sorbitol, microcrystalline cellulose, sucrose, sodium citrate, dicalcium phosphate, or any other ingredient of the similar nature alone or in a suitable combination thereof; binder selected from the group consisting of gum tragacanth, gum acacia, methyl cellulose, gelatin, polyvinyl pyrrolidone, starch or any other ingredient of the similar nature alone or in a suitable combination thereof; excipients selected from the group consisting of agar-agar, calcium carbonate, sodium carbonate, silicates, alginic acid, corn starch, potato tapioca starch, primogel or any other ingredient of the similar nature alone or in a suitable combination thereof; lubricants selected from the group consisting of a magnesium stearate, calcium stearate or steorotes, talc, solid polyethylene glycols, sodium lauryl sulfate or any other ingredient of the similar nature alone; glidants selected from the group consisting of colloidal silicon dioxide or any other ingredient of the similar nature alone or in a suitable combination thereof; a sweetening agent selected from the group consisting of such as sucrose, saccharin or any other ingredient of the similar nature alone or in a suitable combination thereof; a flavoring agent selected from the group consisting of peppermint, methyl salicylate, orange flavor, vanilla flavor, or any other pharmaceutically acceptable flavor alone or in a suitable combination thereof; wetting agents selected from the group consisting of acetyl alcohol, glyceryl monostearate or any other pharmaceutically acceptable wetting agent alone or in a suitable combination thereof; absorbents selected from the group consisting of kaolin, bentonite clay or any other pharmaceutically acceptable absorbents alone or in a suitable combination thereof; retarding agents selected from the group consisting of wax, paraffin, or any other pharmaceutically acceptable retarding agent alone or in a suitable combination thereof. See paragraph [0180].
Starzl teaches teaches the formulations for oral use may also be prepared as troches, chewable tablets, or as hard gelatin capsules wherein the active ingredient is mixed with an inert solid diluent (e.g., potato starch, lactose, microcrystalline cellulose, calcium carbonate, calcium phosphate or kaolin), or as soft gelatin capsules wherein the active ingredient is mixed with water or an oil medium, for example, peanut oil, liquid paraffin, or olive oil. Powders and granulates may be prepared using the ingredients mentioned above under tablets and capsules in a conventional manner using, e.g., a mixer, a fluid bed apparatus or a spray drying equipment. See paragraph [0185].
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571) 272-2784. The examiner can normally be reached 6:15AM-3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PRICILA NMN HAUK TEODORO/ Examiner, Art Unit 1645
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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