DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1-4, 6, and 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant specification 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). The “ppm” unit is a concentration while the killing efficacy of a substance is dependent on dose. A single concentration of an antibacterial active can provide an enormous number of different doses and they do not all yield the same level of effectiveness. The figure shows that the chickens ate a different amount of feed each day. At 2 ppm, this yields a varying daily dose 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 dosing threshold between killing Clostridium perfringens and preventing necrotic enteritis is not discussed and is not clearly extrapolated from the disclosure. The applicant does not discuss assessing for necrotic enteritis in their study, thus it is unclear when or if it occurred. As a result as structure-function correlation is missing for the claimed method 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 1-4, 6, 8-10, 30, and 32 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 1 recites “wherein providing nano-silver particle to an animal…facilitating daily passive oral ingestions…wherein providing the nano-silver particles…is performed to prevent necrotic enteritis from developing in the animal by killing Clostridium perfringens bacteria in the animal.” MPEP 2111.04 details that "[a] 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed. Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). The highlighted “wherein” clause of the instant claims appears to function much like a “whereby” clause. However, it is unclear whether the animal to whom the nano-silver particles are provided is required to have Clostridium perfringens bacteria. Further, no dosing is recited in claim 1 or any of its dependent claims, thus the scope of “providing” is not clear as to how much nano-silver is required. Claim 30 recites a concentration of nano-silver particles in the medicated food that carries the nano-silver particles of claim 2, but this does not speak to how much is required to be ingested by the animal to yield the killing of Clostridium perfringens sufficient to prevent the occurrence of necrotic enteritis. Claim 32 presents a similar issue as claim 1 where the ”wherein” recitation appears as part of eh step of ‘facilitating daily passive oral ingestion of the first amount of nano-silver particles”
For the sake of compact prosecution and the application of prior art, the recitation will be interpreted such that Clostridium perfringens are required in the animal, but the outcome of “killing of Clostridium perfringens sufficient to prevent the occurrence of necrotic enteritis” is ‘the intended result of a process step positively recited’ which garners no patentable weight. Clarification is still required.
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 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 the day it is born is not known. In addition, the claim would require facilitating ingestion of two different daily amounts of nano-silver particles on the same day. Thus the metes and bounds of the method embraced by the claim is unknown.
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.
Claims 19-20 are 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. Claim 19 and 20 recite ratios of nano-silver particles to food that do not exist within the range concentrations of nano-silver particles in medicated food that is recited 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 § 102
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 27 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolandi et al. (Italian Journal of Animal Science 2021 20(1):497-504).
Bolandi et al. disclose a method of facilitating daily passive ingestion of a first amount of silver nanoparticles (nano-silver) by a juvenile chicken starting at day 1 via providing medicated starter food in a feeder to which the birds have free access (see page 498 second column last partial paragraph-page 499 first column item 5 and second column last partial paragraph-page 400 first partial paragraph). They change the feed to a medicated grower feed at day 22 (adulthood) until day 42 and facilitate daily passive ingestion of a second amount of silver nanoparticles (nano-silver) via providing medicated starter food in a feeder to which the birds have free access changed (see table 2). A mediated food with 0.75 ppm nano-silver particles is provided (1% zeolite with 75 ppm silver nanoparticles) for both phases and chickens eat a larger quantity of food in the second phase, thereby ingesting a higher second quantity of nano-silver particles (see table 3). The instant specification states that “increase in daily ingestion of the silver particles came as a natural result of each chick growing and needing to consume more calories to sustain growth.” Thus the increased feed consumption in the second 21 day time period of Bolandi et al. is considered daily facilitation of passive oral ingestion of a second amount of nano-silver that is greater than the first amount of nano-silver. Therefore claims 27 and 31 are anticipated by Bolandi et al.
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 14 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ivanovich et al. (previously cited) in view of Kato et al. (previously cited), Salem et al. (previously cited), Khattak et al. (previously cited), and Tsuchibe et al. (previously cited).
Ivanovich et al. teach a feed additive for poultry to protect against gastrointestinal disease composed of silver nanoparticle (nano-silver) containing zeolite (see paragraphs 13-14). Daily administration of the supplemented feed is not explicitly recited.
Kato et al. teach an antibacterial composition that is an animal feed additive (see paragraphs 8 and 102-109). The composition is a mixture of silver nanoparticles (nano-silver) with hydroxyapatite and cysteine (see paragraphs 102-103 and 108). They add the composition to chicken feed and provide it to hens daily to successfully reduce feces odor and “protect” the digestive system from expelling undesirably odorous feces (see paragraph 108).
Khattak et al. teach administering feed to broiler chickens that has been supplemented with an additive to fight against the impact and presence of a bacteria in the animals (see abstract). They provide the supplemented feed ad libitum which means that the chickens were facilitated to freely eat the feed (passive oral ingestion) (see page 1393 second column first partial paragraph; instant claims 14 and 21-23).
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 with silver nanoparticles (nano-silver) (see page 6783-6784 first column and table 1).
Tsuchibe et al. teach a feed composition and antimicrobial silver zeolite supplement for the feed composition to improve/protect the digestive system of animals, such as chickens, from bacteria and accelerate their growth (see abstract and paragraphs 5-7 and 22). 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; instant claim 27). They further detail feeding the supplemented feed to animals during various stages of life where the concentration of silver from birth through the starter phase (juvenile) as compared to the subsequent grower phase and finisher phase in adulthood is different (see paragraphs 15-18 and diagram following paragraph 18; instant claim 14). They teach the starter phase concentration to exceed the grower phase concentration and further envision the concentration of the finisher phase to potentially be greater than that of the starter phase (see paragraphs 51-52 and 54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to practice the invention of Ivanovich et al. with their supplemented feed composition provided to poultry generically and to also treat necrotic enteritis due to Clostridium perfringens infection in chickens as detailed by Salem et al. because the method also administers silver nanoparticles to a similar patient population susceptible to the same condition. Daily facilitation of passive oral ingestion would have been obvious in light of Khattak et al. who also detail administering a supplemented feed to ameliorate the impacts of bacterial infection in chickens via this administration regime and Kato et al. who ensure daily intake of supplemented feed to also address bacterial infection in chickens. Introduction of the medicated food to the chickens during the starter stage (day 0 to day 22 or about day 14 ≈ day 10) of their life would have been obvious in light of Tsuchibe et al. who detail this initiation time frame as well as varied dosing levels of silver supplemented feed over the course of life so as to protect the digestive system of the animals (see instant claims 26-27). It would then follow to also apply their altered dosing level at the various life stages (see instant claims 14 and 24-25). Therefore claim 14 and 24-27 are obvious over Ivanovich et al. in view of Kato et al., Salem et al., Khattak et al., and Tsuchibe et al.
Claims 1-2, 27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Dosoky et al. (Scientific Reports 2022 11(4166):1-15) in view of Van Immerseel et al. (Avian Pathology 2004 33(6):537-549).
Dosoky et al. teach silver nanoparticle doped silica nanoparticles as a dietary supplement for chickens as a replacement for antibiotics (see abstract and page 13 third full paragraph). They provide 288 chickens with a starter diet from day 1 to 28 and grower diet from day 29 to 35 supplemented with various concentrations of the silver nanoparticle doped silica nanoparticles, where several amongst each treatment group were slaughters and analyzed (see page 3 first-last full paragraphs; instant claims 1-2 and 27). The supplemented feed was provided and the chickens were permitted to freely eat (passively ingest) throughout the test period (see page 3 third full paragraph). Additionally the feed consumption increased to a higher level in the growth period (see table 2). Dosoky et al. details that concentrations of 4 mg/kg or lower were non-toxic to the chickens and recommend their use for feed supplementation (see page 13 third full paragraph).
Van Immerseel et al. teach that Clostridium perfringens is an anaerobic bacteria
frequently found in broiler chicken intestines with an occurrence across about 75 to 95%
of the population (see page 538 first column first full paragraph and second column last
partial paragraph; instant claims 1 and 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide feed supplemented with nano-silver via the nanoparticles of Dosoky et al. at a concentration of 4 mg/kg or less to broiler chickens in place of antibiotics. Given the prevalence of Clostridium perfringens in this chicken population taught by Van Immerseel et al. some fraction of those treated by Dosoky et al. would have had been infected by the bacteria or would be infected by the bacteria upon application of the process to other broiler chickens. Therefore claims 1-2, 27, and 32 are obvious over Dosoky et al in view of Van Immerseel et al.
Claims 1-3, 8, 27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Dosoky et al in view of Van Immerseel et al. applied to claims 1-2, 27, and 32 above, and further in view of Tsuchibe et al.
Dosoky et al in view of Van Immerseel et al. render obvious the limitations of instant claims 1-2, 27, and 32. A start day for feed supplementation aft day 1 is not explicitly detailed.
Tsuchibe et al. teach a feed composition and antimicrobial silver zeolite supplement for the feed composition to improve/protect the digestive system of animals, such as chickens, from bacteria and accelerate their growth (see abstract and paragraphs 5-7 and 22). Other carriers for the silver are envisioned to include silica (see paragraph 30). 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to start broiler chickens with the supplement of Dosoky et al in view of Van Immerseel et al. at a later time up to about 14 days. This choice would have been obvious in light of Tsuchibe et al. whose teach a later initiation point for a similar silver particle for a similar purpose. There is no data indicating the criticality of the start day, therefore any day within this range would have been obvious. MPEP 2144.05 states that “[a] prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In addition it also states that “[a] range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004)”. The combined teachings of Dosoky et al. and Tsuchibe et al. yield such a range and it that embraces the claimed start day. Therefore claims 1-3, 8, 27, and 32 are obvious over Dosoky et al in view of Van Immerseel et al. and Tsuchibe et al.
Claims 1-2, 8, 27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Dosoky et al in view of Van Immerseel et al. applied to claims 1-2, 27, and 32 above, and further in view of Jacob et al. (previously cited).
Dosoky et al in view of Van Immerseel et al. render obvious the limitations of instant claims 1-2, 27, and 32. The supplemented composition is provided for broilers daily via the modified method; however the quantity of feed provided is not explicitly detailed.
Jacob et al. teach that broiler chickens typically consume about a quarter of a pound of feed daily (see table 1, average of cumulative average; instant claim 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide broiler chickens four ounces (quarter pound) of the supplemented feed of Dosoky et al. in view of Van Immerseel et al. daily as detailed by Jacob et al. because it was a quantity commonly known to be suitable. Therefore claims 1-2, 8, 27, and 32 are obvious over Dosoky et al in view of Van Immerseel et al. and Jacob et al.
Claims 1-2, 8-10, 27, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Dosoky et al in view of Van Immerseel et al. and Jacob et al. as applied to claims 1-2, 8, 27, and 32 above, and further in view of Aziz et al. (previously cited).
Dosoky et al in view of Van Immerseel et al. and Jacob et al. render obvious the limitations of instant claims 1-2, 8, 27, and 32. The supplemented composition is fed to broiler chickens daily via the modified method; however the frequency of feed administered is not explicitly detailed.
Aziz et al. teach that a twice daily feeding regimen of equal quantities can improve the health and weight gain of broiler chickens as compared to single or triple feedings as well as in comparison to differential twice daily feedings (see abstract, tables 1-2 and page 81 first full column second full paragraph; instant claims 9 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to feed the broiler chickens the four ounces of the supplemented feed of Dosoky et al in view of Van Immerseel et al. and Jacob et al. in two equal allotments in light of Aziz et al. This modification would have been obvious as the application of the same technique to a similar method in order to yield the same improvement. Therefore claims 1-2, 8-10, 27, and 32 are obvious over Dosoky et al in view of Van Immerseel et al., Jacob et al., and Aziz et al.
Claims 16 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Lohakare et al. (Sustainability 2022 14(13715):1-12) in view of Holladay et al. (US PGPub No. 2005/0061678).
Lohakare et al. teach a nano-silver supplemented feed for broilers that improved the performance in several attributes (see abstract and page 10 third full paragraph). A concentration of 4 ppm nano-silver was employed (see page 2 first full paragraph). 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). 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 silver supplemented feed as suggested by Lohakare et al. to improve broiler performance where the nano-silver of Holladay et al. is employed. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The 4ppm concentration is adjacent to the claimed range. MPEP 2144.05discussess that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Here there is no evidence of the criticality of the instantly claimed range, thus it is rendered obvious by that of Lohakare et al. Therefore claims 16 and 28-29 are obvious over Lohakare et al. in view of Holladay et al.
Response to Arguments
Applicant's arguments filed September 29, 2025 have been fully considered. In light of the amendment to the claims, the previous grounds of rejection are withdrawn except hat over claims 14 and 26-27. New grounds of rejection are detailed to address the new claim limitations. The arguments against the remaining claim are not persuasive.
The applicant argues against the Tsuchibe teaching facilitating a greater amount of silver ingestion in adulthood than in a juvenile stage. Tsuchibe et al. teach that the C phase concentration may be the same as or greater than the A phase concentration. The phase C bird is an adult while the phase A bird is a juvenile, making a greater amount of nano-silver being ingested in phase C than in phase A as a dosing regimen within the scope of their options detailed. The applicant’s own specification states that “increase in daily ingestion of the silver particles came as a natural result of each chick growing and needing to consume more calories to sustain growth”; thus the phase C bird consumes more feed than a phase A bird (see instant specification paragraph 177). There is no clear distinction between grower phase food and finisher phase food. Since there is no evidence of an unexpectedly superior outcome due to the ingestion of a greater quantity of nano-silver in later/adult life phase as compared to a juvenile phase, the claim remains obvious over the cited prior art.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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