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 .
Priority
The instant application claims benefit to PCT/NZ2023/050010 (filed on 02/13/2023) and NZ785100 (filed 02/14/2022) and is acknowledged. The instant claims herein are examined using the effective filing date of 02/14/2022 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 04/14/2025 were properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) were considered.
Specification
The disclosure is objected to because of the following informalities: the specification refers to the drawings as “Figure” instead of “FIG.”.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pg. 28-29. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Drawings
The drawings are objected to because the drawings recite “Figure” instead of “FIG.”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 lists the lactoperoxidase and “at least one other component” in bullet point format and is the only claim that does so. For consistency, it is suggested that the bullet points be removed. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-18 are 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.
Claims 1-16 recite “Use of a combination including: lactoperoxidase; and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk, to modulate a microbiome in a canine animal by selectively inhibiting growth or killing at least one pathogenic microorganism without a comparative inhibition of at least one commensal microorganism, by administering the combination to the oral cavity of the canine animal”. The claims in question recite a use of the lactoperoxidase and at least one other component. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b). Furthermore, Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. Thus, the claims are indefinite (see MPEP 2173.05(q)).
Claim 1, 17, and 18 recite, inter alia, “wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8”. The term “an isoelectric point of or above substantially 6.8” in claims 1, 17, and 18 is a relative term which renders the claim indefinite. The term “above substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Regarding the claim limitation, it is unclear what isoelectric points are covered by the term “above substantially”, as the term is not defined by the claims or the specification. The isoelectric point (pI) range spans from pH 2.77 to 10.76 for standard amino acids, and generally from pH 1.0 to 11.0 for broader proteins. What is considered “above substantially 6.8”? Does the claim cover lactoperoxidases and the “at least one other component” having pIs from 6.9-11? Thus, the claim is indefinite. For the purposes of compact patent prosecution, the examiner is interpreting the claim under broadest reasonable interpretation to encompass any lactoperoxidases or other components having pIs between 6.9-11. Please note that all the dependent claims are also indefinite for dependency on indefinite claim 1.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 112(a)
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.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
While determining whether a specification is enabling, one considered whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would have required undue experimentation to make and use the claimed invention and whether working examples have been provided. There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
All Wands factors listed above have been considered with regard to the instant claims, with the relevant factors discussed below.
Furthermore, the USPTO does not have laboratory facilities to test if an invention with function as claimed when working examples are not disclosed in the specification, therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention, therefore, skepticism raised in the enablement rejection are those raised in the art by artisans of expertise.
Nature of the invention: Claim 18 recites “A method of treating or preventing a condition or disease in a canine animal that has at least a partial causative association with a microbiome in at least one location on or in the canine animal, the method including the step of administering to the oral cavity of the canine animal a combination including lactoperoxidase and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk.”
The breadth of the claims: The claim encompasses “A method of treating or preventing a condition or disease in a canine animal that has at least a partial causative association with a microbiome in at least one location on or in the canine animal, the method including the step of administering to the oral cavity of the canine animal a combination including lactoperoxidase and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk.” The specification defines “treatment” as “cover[ing] any treatment of an infection in a canine animal, and includes: (i) inhibiting the infection; (ii) relieving the infection; or (iii) relieving the conditions caused by the infection, e.g. symptoms of the infection” (see pg. 30). The specification defines “prevention” as “prevention or prophylaxis of an infection in a canine animal and includes preventing the infection from occurring in a canine animal which may be predisposed to the infection but has not yet been diagnosed with the infection.” (see pg. 30). The method has been interpreted under broadest reasonable interpretation to include the treatment or prevention of any and all diseases with any de minimis causative association with a microbiome or infection in a canine (e.g., skin infections, lung infections, ear infections, cavities, acne, gastric ulcers, etc.) by orally administering lactoperoxidase and any other component (e.g., saline, a drug, another enzyme, a vitamin, etc.).
The level of skill in the art: The level of skill is high, including, e.g., a researcher with a PhD degree.
The working examples and guidance provided: The specification fails to provide any working examples in which any composition having the claimed lactoperoxidase and any other component was administered orally to canines to treat or prevent any diseases with at least a de minimis causative association with a microbiome. The specification only provides working examples where cationic fractions of lactoperoxidase, quiescin, jacalin-like protein, chitinase-like protein, angiogenin, and lactoferrin isolated from bovine milk was used for inhibition trials on pathogens and commensal microbes, aerobic testing on microtiter plates against C. albicans, S. aureus, S. epidermidis, S. mitis. S. mutans, S. salivarius, B. bifidum, B. breve, C. difficile, C. perfringens, P. acnes, and 4 strains of bacteria isolated from dog saliva (see Examples 2-7).
The state and unpredictable nature of the prior art: The state of the prior art for treating or preventing any and all diseases with at least a de minimis causative association with a microbiome was unpredictable before the effective filing date of the claimed invention.
Yadav et al (Biotechnology Advances 33 (2015) 756–774) evidences “Lactoperoxidase (LP) is a natural enzyme of the mammals' host defense system. The molecular mass of lactoperoxidase is 78 kDa. This enzyme is a single polypeptide chain of 612 amino acid residues. It contains 15 cysteines, one heme group and about 10% w/w of carbohydrate moieties. The enzymatic activity is influenced by temperature and time, i.e. enzymatic activity is lost at 62.5 °C after 30 min, 70 °C after 15 min or 85 °C after 15 s. The main use of lactoperoxidase is as a protective factor against infectious microbes. Mice infected by the influenza virus can be attenuated by oral administration of lactoperoxidase” (see pg. 764). Yadav evidences the ability of lactoperoxidase to be a natural enzyme as part of the host defense system in mammals and that oral administration attenuates influenza virus. However, the art does not recognize lactoperoxidase as a treatment/preventative measure for any and all diseases with any de minimis causative association with a microbiome or infection in a canine.
Native Pet (“IBS in Dogs”; available online Oct 29, 2021; retrieved online from https://nativepet.com/blogs/health/ibs-in-dogs?srsltid=AfmBOooAHwDtt3gvPfSpxkLcsBGv7uycaVeE-HNmChXon5LmmoVjt8nu) evidences IBS in dogs, which causes chronic diarrhea, vomiting, abdominal pain, mucus in the feces, bloating, strained elimination, constipation, loss of appetite, flatulence, and lethargy symptoms (see pg.2-3). Native Pet evidences that the precise cause of the disease is not well understood and can be brought on by a variety of factors such as stress, anxiety, allergies, dietary indiscretion, and improper antibiotic use, which upsets the balance of the good and bad bacteria in a dog’s intestinal tract (see pg. 3-5). Native Pet evidences various treatments including antispasmodic medications, anti-diarrheal drugs, and anti-inflammatory drugs, reduction of stress and anxiety, dietary changes, and supplementation of the dog’s diet (see pg. 7). Native Pet is silent to the use of lactoperoxidase to treat or prevent IBS in canines.
Sanguansermsri et al. (Comparative proteomic study of dog and human saliva. PLoS One. 2018 Dec 4;13(12):e0208317) evidences that certain dog salivary proteins were found to have potential roles in tumorigenesis, anti-inflammation and antimicrobial processes (see abstract). “Saliva is an important fluid that maintains homeostasis in the oral cavity. It contains many kinds of proteins and peptides including immunoglobulins, enzymes and cytokines. . . proteins with antimicrobial properties found in dog saliva include cystatin S, SA, and SN, histatin, interferon alpha-1/2-like, lactoperoxidase and prolactin-inducible protein (see pg. 7). While Sanguansermsri evidences lactoperoxidase, and other enzymes found in dog saliva to exhibit antimicrobial properties, the reference is silent to the use of lactoperoxidase as a treatment or preventative measure for any and all diseases encompassed by the instant claim.
The extremely broad scope of the claims and lack of guidance in the specification exacerbates a highly unpredictable art. While the results presented in the art do not necessarily preclude Applicant’s hypotheses regarding treating a canine having diseases characterized by a de minimis causative association with a microbiome, they certainly fail to support it in its totality that the claimed pharmaceutical is capable of the functions as instantly claimed. Applicants do not provide the details of how one of ordinary skill would reasonably administer the compositions as instantly claimed to a canine and assess the effect of the administered compound on being capable of producing at least some de minimis ability to treat or prevent the massive genus of diseases, nor is there a reduction to practice of the instant method.
Consequently, the state of the art, when combined with the lack of any disclosed direct experimental test of Applicant’s hypothesis, shows that one of ordinary skill would have no basis to reasonably predict or conclude that administration of lactoperoxidase and any other component would result in tangible effects (treating or preventing diseases with a de minimis causative association with a microbiome) as instantly claimed. Though not controlling, the lack of working examples is, nevertheless, a factor to be considered in a case involving both physiological activity and an underdeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, they run the risk that unless one of ordinary skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them. Ex parte Sudilosky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971).
In essence, the specification merely presents an idea of, and leaves it entirely up to the practitioner to determine how to carry out the claimed methods. It has been established by legal decision that a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. Tossing out the germ of an idea does not constitute an enabling disclosure. While every aspect of a generic claim need not have been carried out by an inventor or exemplified in the specification, reasonable detail must be provided in order to enable one of ordinary skill to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph. Absent specific guidance, one skilled in the art before the effective filing date of the claimed invention would not know how to practice the claimed invention and would require undue experimentation to practice over the full scope of the invention claimed.
The amount of experimentation necessary: The specification merely contains a speculative embodiments of the potential of the lactoperoxidase, lactoferrin, angiogenin, jacalin-like protein, etc. in combination to treat infectious disorders in canines and leaves it entirely up to one of ordinary skill to determine which population or subpopulations of canines would be able to be treated for, e.g., skin infections, cavities, lung infections, etc., when orally administered, effective dosages of each composition in the disease populations, etc. One of ordinary skill in the art could not reasonably take these mere speculative embodiments and immediately apply it in the claimed methods. The specification offers no working examples or direction for treatment of any disorder with partial causative association with a microbiome (at any and all stages of the disease) in virtually any canine suffering from the disease(s) (through administration of the claimed composition at any time. Nothing in the specification remotely demonstrates or suggests that the claimed lactoperoxidase combined with any additional component would have any efficacy against all of these exemplified disease states, because the specification does not have any data suggesting that the compositions were ever administered to a subject or subjects encompassed by the instant claims.
The essential elements toward validation of a therapeutic is the ability to test the drug and link those results with subsequent histological confirmation of the presence, decrease, or absence of symptomology. This irrefutable link between antecedent drug and subsequent knowledge of treatment or prevention of the reaction is the essence of a valid treatment agent. All of this underscores the criticality of providing workable examples which are not disclosed in the specification for, e.g., treatment of the disorders as instantly claimed.
For the reasons set forth above, one skilled in the art before the effective filing date of the claimed invention would not be able to make and/or use the invention as claimed. This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of the art.
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.
Non-Statutory Subject-Matter
Claims 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 129 USPQ227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. 101"). In this case, claim 1-16 recite “Use of a combination including: lactoperoxidase; and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk, to modulate a microbiome in a canine animal by selectively inhibiting growth or killing at least one pathogenic microorganism without a comparative inhibition of at least one commensal microorganism, by administering the combination to the oral cavity of the canine animal”, however, said claims fail to recite at least one of the four categories of patent eligible subject matter.
Claim Rejections - 35 USC § 102/103
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 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.
(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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-18 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bragger et al (WO2017183996A1; cited in 04/14/2025).
Bragger teaches use of a combination including: lactoperoxidase; and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk, to selectively inhibit growth or kill at least one pathogenic micro-organism without a comparative inhibition of at least one commensal micro-organism by administering the lactoperoxidase and at least one other component to an animal (see claim 1). Bragger teaches the composition can be delivered internally or externally to the animal (see claims 4-5, 21-23).
In the alternative, it would have been prima facie obvious to one of ordinary skill to use the combination as taught by Bragger to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill would have been motivated to use the combination because Bragger teaches that the combination has a significant advantage over previous methods of treatment such as broad spectrum antibiotics which do not have a high degree of specificity, may be developed easily using known techniques and includes proteins derived from milk that have a wide consumer acceptance and safety profile.
Regarding claim 2, Bragger teaches the combination is a composition (see claim 2).
Regarding claim 3, Bragger teaches the lactoperoxidase and at least one other component are in intimate admixture in the milk and remain in intimate admixture in the formation of the composition (see claim 3).
Regarding claim 4, Bragger teaches one other component are independent selected from: lactoferrin; angiogenin; and lysozyme-like protein (see claim 6).
Regarding claim 5, Bragger teaches the combination includes lactoperoxidase, lactoferrin, angiogenin, and lysozyme-like protein (see claim 7).
Regarding claim 6, Bragger teaches the combination includes lactoperoxidase, lactoferrin, angiogenin, lysozyme-like protein, quiescin, and jacalin-like protein (see claim 8).
Regarding claim 7, Bragger teaches the combination includes cathelicidin-1 and serum amyloid A (see claim 15).
Regarding claim 8, Bragger teaches the combination includes substantially all proteins isolated from milk which have an isoelectric point of or above substantially 6.8 (see claim 9).
Regarding claim 9-10, Bragger teaches the pathogenic microorganism is Propionibacterium acnes, Trichophyton mentagrophytes, Trichophyton rubrum, Escherichia coli, Streptococcus pyogenes, Malassezia furfur, Candida albicans, Staphylococcus aureus and Streptococcus mutans and the commensal microorganism is Staphylococcus epidermidis, Streptococcus pneumonia, Staphylococcus hominis, Lactobacillus bulgaricus, Lactobacillus casei, Porphyromonas gingivalis, Streptococcus mitis and Streptococcus salivarius (see claims 10-11).
Regarding claim 11, Bragger teaches the combination further includes one or more components selected from substrates; adjuvants; prebiotics; and/or probiotics (see claim 12).
Regarding claim 12, Bragger teaches the combination further includes one or more components selected from a peroxidase substrate; hydrogen peroxide or a source of hydrogen peroxide; and a cell-lysing substance capable of fully, or partially lysing cell walls (see claim 13).
Regarding claim 13, Bragger teaches the combination further includes one or more components selected from thiocyanate, ascorbate, glucose oxidase, glucose, and monolauryl glycerol (see claim 14).
Regarding claim 14, Bragger teaches the combination further includes one or more components selected from: cathelicidin 1; N-acetyl glucosaminidase; serum amyloid A; β Defensin; Peptidoglycan recognition protein; Xanthine dehydrogenase; immunoglobulin(s) and/or growth factors (see claim 15).
Regarding claim 15, Bragger teaches the combination selectively inhibits growth of at least one pathogenic micro-organism by a multiple of at least 1.1 compared with the degree of inhibition of at least one commensal micro-organism (see claim 16).
Regarding claim 16, Bragger teaches the combination selectively inhibits growth of at least one pathogenic micro-organism by a multiple of at least 2 compared with the degree of inhibition of at least one commensal micro-organism. (see claim 17).
Regarding claim 17, Bragger teaches a method of modulating a microbiome by selectively inhibiting growth or killing at least one pathogenic micro-organism without a comparative inhibition of at least one commensal micro-organism, the method including the step of administering to an animal a combination including lactoperoxidase and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk by administering the component internally to the animal (see claim 18-20).
Regarding claim 18, Bragger teaches a method of treating or preventing a condition or disease in an animal that has at least a partial causative association with a microbiome in at least one location on or in the animal, the method including the step of administering a combination including lactoperoxidase and at least one other component, wherein the lactoperoxidase and at least one other component have an isoelectric point of or above substantially 6.8 and which are extracted from milk by administering the component internally to the animal (see claim 21-23).
Accordingly, the claimed invention was anticipated, or in the alternative, rendered prima facie obvious by the teachings of Bragger.
Conclusion
NO CLAIMS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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