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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 29, 2026 has been entered.
Specification
The disclosure is objected to because of the following informalities: several measurements in the specification are recited in English system units that include ounces (weight/mass), pounds, ounces (fluid), and gallons, instead of utilizing metric system units as required (see MPEP 608.01(IV)).
Appropriate correction is required.
Claim Objections
Claims 1, 8, 10, 14, 16, 19, 26-27, and 30 are objected to because of the following informalities: the claims recite measurements in English system units that include ounces (weight/mass) and pounds, instead of utilizing metric system units as required (see MPEP 608.01(IV)).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 6, 8-10, 26-27, 30, and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New Matter
Claim 1 recites a method that has a step of “facilitating daily passive oral ingestion of the nano-silver particles by the animal via the medicated food…increasing in amounts from an initial amount of the medicated food for a remainder of the animal's life, wherein: the initial amount of the medicated food comprises at least 0.388 ounces, the medicated food comprises 0.1 ounces to 1 ounce of the nano-silver particles per pound of the medicated food…”. Claim 26 recites “facilitating daily passive oral ingestion of the second amount of nano-silver particles via the medicated grower food… includes at least 1.764 ounces of the medicated grower food”. Claim 27 recites “the medicated starter food comprises 0.1 ounces to 0.5 ounces of the nano-silver particles per pound of the medicated starter food…facilitating daily passive oral ingestion of the first amount of nano-silver particles via the medicated starter food…of at least 0.338 ounces of the medicated starter food… facilitating daily passive oral ingestion of the second amount of nano-silver particles via the medicated grower food…of at least 3.351 ounces of the grower starter food”. These claim recitations are not supported by the original disclosure.
The instant specification includes the statements:
“The medicated starter food 2800B, in various embodiments, includes an amount of the compound 2802 including silver particles in the range of about 0.1 ounces to about 1 ounce per pound, by weight and/or volume. In certain embodiments, the medicated starter food 2800B includes about 0.5 ounces of the compound 2802 including silver particles per pound, by weight and/or volume” (see paragraph 163). “The medicated grower food 2800B, in various embodiments, includes an amount of the compound 2802 including silver particles in the range of about 0.1 ounces to about 1 ounce per pound, by weight and/or volume. In certain embodiments, the medicated starter food 2800B includes about 0.5 ounces of the compound 2802 including silver particles per pound, by weight and/or volume” (see paragraph 171)
“The compound 2802 including silver particles may include any of the compounds including silver particles discussed above or elsewhere herein” (see paragraph 153).
“As disclosed herein, "silver particles" can include, but are not limited to, "nano-silver particles," "nano-silver," "colloidal silver particles," "colloidal silver," "ionic silver particles," "ionic silver," "solution silver particles," "solution silver," "suspension silver particles," and "suspension silver," among other particles that can include silver that are possible and contemplated herein” (see paragraph 64).
The specification generically recites a compound composed of silver particles, where the silver particles themselves can be an array of compositions that include silver particles or are themselves silver particles. This means that the amount of silver provided by “silver particles” can vary from a 1-to-1 proportion (e.g., 1 gram of particles = 1 gram of silver) to much more dilute concentrations of silver such as in a zeolite carrying silver at a loading of a few percent per gram or even parts per million in a colloid. In addition, the disclosure does not have a general discussion of the quantity of medicated food comprising the silver particles that is administered or a silver dosing level that achieves the claimed outcome of killing Clostridium perfringens in an animal or preventing necrotic enteritis from developing in the animal.
The instant specification provides a discussion of one embodiment of administering medicated feed to an animal. It states that figure 29 provides “one embodiment of a feeding schedule for a group of chicks infected with the bacteria Clostridium perfringens to determine the amount of silver particles that is to be added to feed to create a medicated food with an amount of silver particles sufficient to kill the Clostridium perfringens, prevent necrotic enteritis in the chicks, and/or treat necrotic enteritis in the chicks. The amount of food that each chick consumed on a daily basis determined how much of the compound 2802 including silver particles needed to be combined with the feed so that each bird consumed at least 2ppm, by weight and/or volume, of the silver particles daily” (see paragraph 176). In addition, the specification also states, “a daily ingestion rate of 2ppm, by weight and/or volume, of silver particles was the target amount of the feeding schedule shown in the chart 2900” (see paragraph 178). The embodiment added compound 2802 comprising silver particles to feed and the added amount was selected such that a target of 2 ppm silver particles is achieved. The specification mentions an ingestion rate with “ppm” units; however, this unit is a concentration, not a dose. The specification further notes that the chicks consumed, on average, 11 g of medicated feed on day 1 and that the daily consumption rate of food increased to 133 g by day 24, on average, as the chicks grew (see paragraph 177 and figure 29). The claims recite the administration of medicated food with 0.1 ounces to 1 ounce of nano-silver particles per pound of the medicated food. Nano-silver particles (silver nanoparticles) can be elemental metal silver and can also have an oxidized surface that is present as a layer (coating) of silver oxide (see Lok et al. Journal of Biological Inorganic Chemistry 2007 12:527–534, especially abstract, page 527-259 second column first full paragraph). The 0.1 ounces to 1 ounce of nano-silver particles per pound of the medicated food converts to a nano-silver particle concentration of 6250 ppm to 62,500 ppm and the 0.1 ounces to 0.5 ounce of nano-silver particles per pound of the medicated food converts to a nano-silver particle concentration of 6250 ppm to 31,2500 ppm. These ranges of concentrations span from about 3000 to 30,000 times the concentration administered by the instantly disclosed embodiment. There is no suggestion of any particular amount of a medicated feed with the currently claimed concentration of nano-silver particles being administered to an animal. It appears that the instantly claimed 0.338 ounces, 1.764 ounces, and 3.351 ounces of medicated food originates from the conversion of the day 0, day 10, and day 18 feed amounts, respectively, in figure 29. The administered feed quantities for a 2 ppm silver particle loaded feed do not provide written basis for administering the same quantities of a medicated food with a nano-silver particle concentration of 6250 ppm to 62,500 ppm or of 6250 ppm to 31,250 ppm. The outcomes that such a large change in dosing would elicit would not be expected to be the same and were not clearly contemplated in the disclosure. As a result, the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as currently claimed, at the time of filing.
Written Description
Instant claim 1 recites “providing the nano-silver particles and facilitating daily passive oral ingestion of the nano-silver particles by the animal beginning no later than at day 10 of the animal's life and for the remainder of the animal's life is performed to kill Clostridium perfringens bacteria present in the animal or prevent necrotic enteritis from developing in the animal”. Claim 32 similarly also recites “wherein facilitating daily passive oral ingestion of the first amount of nano-silver particles via the medicated starter food prevents necrotic enteritis from developing in the juvenile animal by killing Clostridium perfringens bacteria in the juvenile animal”. The instant specification provides one embodiment of providing silver particles and facilitating daily passive oral ingestion of the silver particles by the animal beginning no later than at day 10 of the animal's life and for the remainder of the animal's life. While the animals were infected with Clostridium perfringens in the disclosed embodiment, the applicant does not discuss assessing for necrotic enteritis in their study, thus it is unclear when or if it occurred. The disclosure is not precise in describing the amount of silver particles added to the medicated food that was administered and does not detail the concentration of silver in the silver particles that were employed. Nevertheless, the instant specification notes a silver particle loading of at least 2 ppm and a target silver particle loading of 2 ppm (see paragraph 176 and 178). The specification further notes that the chicks consumed, on average, 11 g of medicated feed on day 1 and that the daily consumption rate of food increased to 159 g by day 24, on average as the chicks grew (see paragraph 177 and figure 29). At 2 ppm, this yields a varying daily administered quantity of silver particles from 22 mg to 318 mg. Salem et al. (previously cited) detail 30 mg of nano-silver orally administered to chickens as able to kill intestinal Clostridium perfringens over at least a short term period (see abstract, page 6785 first column first full paragraph, page 6786 second column last paragraph, and figure 2). The difference in dosing between killing Clostridium perfringens and preventing necrotic enteritis is not discussed by the instant disclosure and is not clearly extrapolated from the discussion found in the disclosure. As a result a structure-function correlation is missing for the claimed method to prevent necrotic enteritis and it would not have been clear to the artisan of ordinary skill that the applicant was in possession of the scope of invention as currently claimed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14, 27, 31, and 33 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.
Claim 14 recites “a first amount of nano-silver particles via medicated starter food…a second amount of nano-silver particles via a medicated grower food…the medicated starter food comprises the first amount of nano-silver particles in the medicated starter food comprises 0.1 ounces to 0.5 ounces of the nano-silver particles per pound of the medicated starter food, and the second amount of nano-silver particles in the medicated grower food is greater than the first amount of nano-silver particles per pound of the medicated starter food”. An “amount” is a quantity; however, the claim recites the first amount as a concentration in the first starter food. The subsequent recitation of the “amount of nano-silver particles in the second amount” based upon the weight of the medicated starter is confusing. It is unclear which values are to be compared to yield the greater “second amount”. The recitation could be referring to a concentration in the medicated grower food based on the weight of the medicated starter food, and if so, how such a value is determined is unclear. The recitation could alternatively be referring to the quantity of nano-silver particles in the medicated grower food, but how such a value is determined relative to a pound of the medicated starter food is not clear. As a result the requirements of the claim are unclear.
Claim 14, the parent claim 27, recites “the first amount of nano-silver particles in the medicated starter food…and…the second amount of nano-silver in the medicated grower food…” Claim 27 then recites “the grower starter food”. There is insufficient antecedent basis for this limitation in the claim and it appears that it may be an amalgam of two components separately recited in the parent. Thus the scope of the recitation in claim 27 is unclear.
The animal required to practice the method claim 33 is unknown. Claim 33 recites that “ingestion of the second amount of nano-silver particles…begins on day 1 of the juvenile animal’s life. However the parent claim recites “in response to the juvenile animal maturing into an adult animal, facilitating passive oral ingestion of a second amount of the nano-silver particles”. The identity of an animal that matures to adulthood on day 1 of its juvenile life is not known. Thus the metes and bounds of the method embraced by the claim is unknown.
Claims that are rejected but are not elaborated upon are indefinite because they depend from an indefinite claim and do not add clarity.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The range of 1:10 to 1:50 for nano-silver particles to feed in the claim corresponds to 1.96% to 9.1%, while the parent claim recites a range of 0.1 ounces to 1 ounce nano-silver particles per pound of medicated food which corresponds to 0.625% to 6.25%. The upper bound of the range in the dependent claim exceeds the upper bound for the range in the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 16, 19, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Yangwon-dong (KR200412842 – English translation referenced for citations) in view of Holladay et al. (previously cited).
Yangwon-dong teach nano-silver particle coated grains such as rice, barley, soybeans, red beans, corn, and sesame seeds to inhibit decay, treat the body upon ingestion, and visually stimulate appetite (see abstract and page 6 third paragraph; instant claim 16). These grains can all be considered food. They detail the coating applied via various methods that include plasma, lamination, thin film, deposition, plating, and spraying (see page 17 fourth paragraph). The nano-silver particles range in size from 0.01 to 500 nm and are applied at 0.001 to 10 wt%, based on the final product (see page 8 fifth full paragraph page 17 fourth paragraph; instant claims 16 and 19). Nano-silver with an oxide coating is not explicitly detailed.
Holladay et al. detail nano-silver with a silver oxide coating for use in a living subject via oral administration (see abstract and paragraph 166). They are also applied as coating onto the surface of beef via spraying of a colloidal suspension of the nano-silver (see paragraphs 32-36 and 149-150). Holladay et al. detail the nano-silver particles as antimicrobial (see paragraph 63). The oxide coating permits stability without added surfactants (see paragraph 59). They more specifically describe the oxide coating as AgO and Ag4O4 (see paragraphs 28-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a nano-silver of Yangwon-dong via spray coating of particles of Holladay et al. This modification would have been obvious because Yangwon-dong detail spray coating as an envisioned route to generating their coated grains and the particles of Holladay facilitate such a deposition process with the benefit of a stabilized deposition dispersion without surfactant additives. The modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome and as the application of the same technique to a similar product in order to yield k the same improvement. The range of nano-silver loading coated on the grains embraces the 0.625 to 6.25 wt% (0.1 to 1 oz/lb) instantly claimed, thereby render the claimed range obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). The instantly claimed loading of 3.125 wt% is also obvious due to the teaching of Yangwon-dong because it lies with their disclosed range and there is no evidence of the criticality of the range (see MPEP 2144.05(I)). Therefore claims 16, 19, and 28-29 are obvious over Yangwon-dong in view of Holladay et al.
Relevant Prior Art and Non-obvious Embodiments
The daily quantity of nano silver particles administered in the method of instant claim 1 via its at least 0.388 ounces of food with 0.1 ounces of nano-silver per pound (0.625 wt%; 6250 ppm) of medicated food is at least 69 mg. The upper end of the claimed nano-silver concentration is 1 ounce per pound of medicated food and yields 692 mg. Instant figure 10 reports an average day 0 chick weight of 0.4 kg for Cobb 500 broiler (as calculated by the examiner). If the medicated feed quantity minimum and concentrations are applied to this initial weight, it corresponds to a silver particle dosing of about 172 mg/kg body mass to 1732 mg/kg body mass (as calculated by the examiner).This quantity is administered to an animal by passive oral ingestion to kill Clostridium perfringens in the animal.
Salem et al. teach of the effectiveness of orally administered silver nanoparticles (nano-silver) against infection of broiler chickens with necrotic enteritis induced from Clostridium perfringens, where bacterial counts were significantly reduced due to treatment (see abstract, page 6785 first column first full paragraph, page 6786 second column last paragraph, and figure 2; instant claims 1 and 12). They detail the bacteria as the cause of necrotic enteritis which results in death and is a large problem in broiler production (see page 6783-6784 first column). The pathology yields considerable damage to the tissues of the digestive system (see page 6784 first column). Salem et al. detail the reduced mortality rate of the Clostridium perfringens infected chickens when treated daily with 30 mg of oral silver nanoparticles (nano-silver) (see page 6783-6784 first column and table 1). This dose amount is 2300 times less than that instantly claimed.
Tsuchibe et al. (previously cited) teach a feed composition and antimicrobial silver zeolite supplement for the feed composition to improve/protect the digestive system of animals, such as chickens, swine, and cattle, from bacteria and accelerate their growth (see abstract and paragraphs 5-7 and 22, and 83). The broiler chicken is detailed as having a starter phase from birth to day 21, a grower phase from day 22 to day 35, and a finisher phase from the end of the grower phase up to the shipping date (see paragraph 57). Tsuchibe et al. also discuss initiating provision of the supplemented feed at about day 14 of a broiler chicken’s life (see paragraph 50). The silver is present in the feed at various levels during life such as 0.01 to 2000 ppm (generally, 200 to 1000 ppm (0.02 to 0.1 wt%) in the starter phase and 1 to 500 ppm (0.0001 to 0.05 wt%) during the grower phase (see paragraphs 49 and 52). While they detail phased feeding in which different stages of life have different concentrations of silver feed supplementation, the maximum silver concentration envisioned is less than half the minimum instantly claimed.
Kim et al. detail a toxicity study examining daily oral administration of various concentrations of nano-silver to rats (see Particle and Fibre Toxicology 2010 7(20):1-11). Dosing of 30 mg/kg, 125 mg/kg, and 500 mg/kg were tested. Male rats had a significant reduction in weight gain starting at four weeks of the 500 mg/kg dose (see figure 2). Across the collection of adverse events they noted, they determined the lowest dosing where adverse events were observable to be 125 mg/kg (see page 11 first column). This concentration is lower than what would be administered to fowl in the instant claims.
Al-Sultan et al. also explore toxicity of passive oral nano-silver which they study in reference to supplemented chicken feed (see Italian Journal of Animal Science 2022 21(1):967-978). They tested feed supplemented from day 7 to day 42 at 2.5 to 20 mg/kg feed (2.5 to 20 ppm) (see page 969 first column. They note the occurrence of necrosis and lesions in various organs at higher concentrations that were tested (see table 7). At the end of the study, Al-Sultan et al. recommend feed supplement concentration below about 2.5 ppm for safe administration (see page 976 first column last partial paragraph-second column first partial paragraph). This concentration is multiple orders of magnitude below the concentration instantly claimed.
Thus facilitating daily oral ingestion by an animal of at least 0.388 ounces of medicated food comprising 0.1 ounces to 1 ounce per pound of medicated food, starting no later than day 10 of life, appears to be non-obvious, given the expected toxicity in various animals and large difference between the claimed nano-silver particle loading and that administered by the prior art.
Response to Arguments
Applicant's arguments filed April 29, 2026 have been fully considered. In light of the amendment to the claims, the rejections under 35 USC 102 and 35 USC 103 are hereby withdrawn. The rejections under 35 USC 112(d) and under 35 USC 112(b), except for that against claim 33, are also withdrawn. The remaining rejections under 35 USC 112 are maintained or modified in light of the amendment to the claims. New grounds of rejection are detailed to address new claim limitations. The applicant’s arguments against maintained rejections are not persuasive.
Regarding rejections under 35 USC 112(a):
The applicant argues that the amendment to claim 1 overcomes this rejection. The amendment to claim 1 does not satisfy the written description requirement in a manner that demonstrates that the applicant had possession of the method that prevents necrotic enteritis. Instead, it adds new configurations of embodiments that differ considerably from the singular embodiment that discussed details of dose timing and amount.
Regarding rejections under 35 USC 112(b):
The applicant argues that the amendment to claim 33 provides clarity. To the contrary, the claim still recites an animal that does not clearly exist.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARALYNNE E HELM/ Examiner, Art Unit 1615
