DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statements submitted on 22 December 2022 and 20 July 2023 were filed before the mailing of an Office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 2-4 and 6 are objected to because of the following informalities: Claims 2 and 6 were amended in a preliminary amendment and deleted the percent symbol after wt.; Claim 3, line 3, sylviarum is misspelled as sylviarumi; and Claim 4 recites “an effected surface” but should state “an affected surface”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3 and 5-20 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.
Instant claim 1 recites “using the composition for the treatment…” It is unclear what active step is being performed by “using the composition”. Claims 2-3 and 5-20 depend from claim 1 and do not clarify what active step is being performed. It is noted that instant claim 4 states, “said composition is applied… to the affected surface”. Therefore, it clarifies that the active step is applying the composition to a surface.
Claim 9 recites the limitation “the surfactant” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 1 which does not recite a surfactant. It is possible that Applicant intended to have claim 9 depend from claim 8, which states that the additive is one or more of surfactants, oils and polymers.
Claim 10 recites the limitation “the oil” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 depends from claim 1 which does not recite an oil. It is possible that Applicant intended to have claim 10 depend from claim 8, which states that the additive is one or more of surfactants, oils and polymers.
Claim 11 recites the limitation “the polymer” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 depends from claim 1 which does not recite a polymer. It is possible that Applicant intended to have claim 11 depend from claim 8, which states that the additive is one or more of surfactants, oils and polymers.
Instant claims 12-13 and 19-20 recite “further including” or “further comprising”, which indicates steps that are in addition to the steps recited in claim 1. Therefore, it is unclear whether the step of applying the composition recited in claim 12 is separate from the step of “using the composition” in claim 1. It is unclear whether claim 12 requires the steps 1) obtaining a composition, 2) using the composition, and 3) applying the composition at least 2 times to a surface.
Similarly, it is unclear whether claim 13 requires all the steps of claim 12, 1) obtaining a composition, 2) using the composition, and 3) applying the composition at least 2 times to a surface, followed by the steps, a), b), c) and d). The same rationale applies to claims 19-20.
Instant claims 13 and 19-20 each recite “applying a composition according to the invention”. It is unclear what embodiments are being referred to with “the invention”. The examiner recommends Applicant amend the claims to recite “applying the composition to a surface”, which would refer back to the composition of claim 1 being applied to a surface.
Instant claims 15 and 19-20 recite “per application and per 1000 chickens”. It is unclear how the number of chickens is relevant to the methods since the claims do not recite applying the composition to a chicken. It is also unclear how and where the composition is applied in the instant claims. It appears, based on the recitation of “per application and per 1000 chickens” that the method is for treating hematophagous ectoparasites either on chickens or in their habitats, but the claims do not state whether the composition is applied to the chickens or to their habitats.
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 1-8, 10 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (WO 2020/069148 A1) in view of Yang et al. (Practical Food Safety: Contemporary Issues and Future Directions, 2014).
Regarding instant claims 1-3, Farmer et al. teach a method for controlling a pathogen in an enclosure, such as a coop for poultry, waterfowl or other birds, comprising contacting said pathogen with a composition comprising a beneficial microorganism and/or a growth by-product thereof and a carrier (Claims 15-19). The growth by-product is a biosurfactant, such as a sophorolipid, and the carrier is water (pg. 3, ln. 28-32; pg. 10, ln. 28-32; Claims 23 and 35). Farmer et al. teach pathogens according the subject invention can be any infectious agent including, for example, bacteria, viruses, fungi, molds, protozoa, prions, parasites, helminths, and algae, including lice and mites (pg. 22, ln. 21-33). Farmer et al. teach that in certain embodiments, the concentration of the one or more biosurfactants in the disinfectant composition is about 0.001 to 90 by weight % (wt %), about 0.01 to 50 wt %, or about 0.1 to 20 wt % (pg. 10, ln. 33-35).
Farmer et al. do not explicitly disclose that the mites are the instantly claimed ectoparasites.
However, Yang et al. teach that the most common ectoparasite for laying hens is the poultry red mite (Dermanyssus gallinae), the vector for transmitting S. Enteritidis. The mite transmits Salmonella as it feeds from one chicken to another, including transmitting Salmonella to chicks (pg. 540, col. 1). The northern fowl mite, Ornithonyssus sylviarum, is widely distributed and the most common ectoparasite. In tropical areas, the most common species may be the tropical fowl mite, O. bursa (pg. 541-542, Section 26.3.2).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant invention to control pathogens, such as mites, on poultry, water fowl and other birds by applying sophorolipids according to Farmer et al. It would have been obvious to treat Dermanyssus gallinae, Ornithonyssus bursa and/or Ornithonyssus sylviarum since they are common ectoparasites that infect poultry and other birds, as reasonably taught by Yang et al.
Regarding instant claims 5, 8 and 10, Farmer et al. teach that the disinfectant composition can also be prepared in combination with other ingredients such as organic solvents, salts, essential oils, fragrances, chelants, enzymes, acids (e.g., acetic acid), carbonates or bicarbonates, phosphates, wetting agents, dispersing agents, hydrotropes, rheology control agents, foam suppressants, corrosion inhibitors, pH adjusters, natural phenolic compounds (e.g., thymol or carcavrol), sequestering agents, fog promoting agents (e.g., monopropyleneglycol (MPG)), and other ingredients that serve a particular desired function (pg. 4, ln. 11-16). In one embodiment, the composition comprises one or more essential oils having one or more beneficial properties, including anti-pathogenicity and/or pest deterrence. Essential oils can be selected from, for example, oregano, lavender, tea tree, frankincense, peppermint, lemon or other citrus, rosemary, thyme, cinnamon, eucalyptus, clove, lemongrass, citronella, cedarwood, nutmeg, neem, and others. Preferably, the essential oil comprises from 0.5% to 10% (v/v), or 1% to 5% of the final composition (pg. 12, ln. 3-8).
It would have been prima facie obvious for a person of ordinary skill in the art to include other ingredients in an amount of 0.5% to 10% (v/v), or 1% to 5% of the final composition, as reasonably suggested by Farmer et al.
Regarding instant claims 6-7, Farmer et al. teach that in one embodiment, the disinfectant composition can further comprise a carrier, such as water, a ketone, an oil (e.g., mineral oil or vegetable oil), an oil/water emulsion, an aldehyde and/or an alcohol (e.g., ethanol or isopropyl alcohol). The carrier can comprise about 1% to about 99%, about 5% to 95%, about 10% to 90%, or preferably about 50% to 80% of the final composition (pg. 11, ln. 26-30).
Regarding instant claim 15, Farmer et al. teach that in one embodiment, a treatment dosage for an enclosure will be determined based on the cubic volume of the enclosure. In one exemplary embodiment, approximately 5 to 25L, or about 10 to 20L of a 1 to 15% or 5 to 10% biosurfactant solution, or less, can be used to treat about 750 to 1,500 m³ or about 1,000 m³ of enclosed space (pg. 21, ln. 30-33).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to determine through routine experimentation the optimum quantity of formulation to apply per application and per 1000 chickens.
Regarding instant claims 16-18, Farmer et al. teach in certain embodiments, the concentration of the one or more biosurfactants in the disinfectant composition is about 0.001 to 90 by weight % (wt %), about 0.01 to 50 wt %, or about 0.1 to 20 wt %. In certain embodiments, the biosurfactants are present at about 0.01 g/L to about 500 g/L, about 0.5 g/L to about 50.0 g/L, about 1.0 to about 10.0 g/L, or about 2.0 to about 5.0 g/L (pg. 10, ln. 33 to pg. 11, ln. 2).
It would have been prima facie obvious for a person of ordinary skill in the art to determine the optimum quantity of sophorolipid in the disinfectant composition according to Farmer et al. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
The examiner respectfully points out the following from MPEP 2144.05: “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Regarding instant claims 4, 12-14 and 19-20, Farmer et al. teach that in one embodiment, methods are provided for controlling a disease-causing pathogen in an enclosure, the method comprising contacting a disinfectant composition of the subject invention with the pathogen. Preferably, the enclosure is a building or enclosure used for housing, feeding, and/or transporting livestock. Even more preferably, the enclosure is an AFO, such as a coop or barn used for producing poultry, waterfowl, or other avian species (pg. 4, ln. 22-26).
Yang et al. teach that many pests on poultry farms can be controlled with proper measures. It is critical to use clean broiler houses to prevent pest invasion and bird contamination. Floors should be cleaned after every flock passes through and properly monitored for the presence of pests (). Evaluation is the last part of any good integrated pest management (IPM) program. The outcome of the pest control program should be constantly evaluated. This can be performed in several ways by counting pests before and after treatment, rating comparative damage, comparing costs of pest control periodically, recording pesticide usage, and evaluating its effectiveness. Once pests are under control, it is just a matter of maintaining that level and continuing the monitoring program. Remember that pest problems never can be totally eradicated; they must however be controlled at a manageable level (pg. 547-548).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to monitor the effectiveness of the sophorolipid compositions according to Farmer et al., and apply additional doses of disinfectant at necessary intervals to achieve the suitable control of mites in the coop and on the poultry. Through routine experimentation, a person of ordinary skill in the art would be able to determine the most effective treatment regimen for the control of mites according to Farmer et al.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (WO 2020/069148 A1) in view of Yang et al. (Practical Food Safety: Contemporary Issues and Future Directions, 2014) as applied to claims 1-8, 10 and 12-20 above, further in view of Awada et al. (US 8,680,060).
The teachings of Farmer et al. and Yang et al. are discussed above.
Regarding instant claim 9, Farmer et al. teach that the disinfectant composition can also be prepared in combination with other ingredients such as organic solvents, salts, essential oils, fragrances, chelants, enzymes, acids (e.g., acetic acid), carbonates or bicarbonates, phosphates, wetting agents, dispersing agents, hydrotropes, rheology control agents, foam suppressants, corrosion inhibitors, pH adjusters, natural phenolic compounds (e.g., thymol or carcavrol), sequestering agents, fog promoting agents (e.g., monopropyleneglycol (MPG)), and other ingredients that serve a particular desired function (pg. 4, ln. 11-16).
Farmer et al. do not explicitly disclose formulations comprising a surfactant selected from the group consisting of lecithin, sodium stearoyl lactylate, polysorbate 20, polysorbate 40, polysorbate 60 and polysorbate 80, wherein the surfactant is present at 0.1-2 wt.%.
Awada et al. teach biosurfactants produced by microbes (e.g., sophorolipids) used to control pests, such as mites (col. 1, ln. 51-56; col. 3, ln. 25; Claims 1, 12). The natural biosurfactants' active components may be used according to the invention either alone or combined with other acceptable active or inactive (inert) components that may be used as adjuvants or may have pesticidal activity. It is preferable to use adjuvants or pesticidal components of natural source to complement the natural aspects of the biosurfactants. These components can be either an oil component such as cinnamon oil, clove oil, cottonseed oil, garlic oil, or rosemary oil; another natural surfactant such as Yucca or Quillaja saponins; or the component may be an aldehyde such as cinnamic aldehyde. Other oils that may be used as a pesticidal component or adjuvants include: almond oil, camphor oil, castor oil, cedar oil, citronella oil, citrus oil, coconut oil, corn oil, eucalyptus oil, fish oil, geranium oil, lecithin, etc. (col. 6, ln. 5-23).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Farmer et al. and include adjuvants, such as lecithin, in an amount that complements the biosurfactant, as reasonably taught by Awada et al.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al. (WO 2020/069148 A1) in view of Yang et al. (Practical Food Safety: Contemporary Issues and Future Directions, 2014) as applied to claims 1-8, 10 and 12-20 above, further in view of Murphy et al. (US 8,298,559).
The teachings of Farmer et al. and Yang et al. are discussed above.
Regarding instant claim 11, Farmer et al. do not explicitly disclose formulations comprising amylopectin and/or amylose, present at 0.1-0.5 wt.%.
Murphy et al. teach a pesticide for delivering a physical mode of action kill, comprising a polymer active ingredient being present in a concentration of from about 0.10 wt. % to about 1.0 wt. % based on the total weight of said pesticide, about 20 wt. % to about 40 wt. % of a mammalian safe, low-toxicity surfactant, solvent, etc. (Abstract; col. 2, ln. 20-30; col. 4, ln. 46-53; Claim 1). The polymer active ingredient includes corn starches comprising 100% amylopectin, or a mixture of amylopectin and amylose (such as 50% amylopectin and 50% amylose or 30% amylopectin and 70% amylose) (col. 5, ln. 1-11; Claim 1). Murphy et al. teach that the compositions are suitable for control of mites (col. 7, ln. 1-7).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare formulations according to Farmer et al., further including amylopectin or amylose as a physical mode of action kill for the mites, as reasonably suggested by Murphy et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616