DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Claims Status
Claims 47-102 are pending and under current examination in this application.
Amendment to the claims and Remarks filed 16 December 2025, are acknowledged and have been considered. Claim 102 is new and is supported by the originally-filed disclosure.
Information Disclosure Statement
The Information Disclosure Statement (IDS), submitted 16 December 2025, has been considered.
Response to Amendment
The Applicant’s Remarks filed 16 December 2025, together with amendments adding new claim 102, have been fully considered. The arguments are not persuasive for the reasons set forth below in the “Response to Arguments” section.
Claims 47–101 remain rejected under 35 U.S.C. §103 for the reasons outlined below and new claim 102 is also rejected under 35 U.S.C. §103 as obvious over Danilovich in view of Wang. The Applicant has not demonstrated unexpected results or criticality sufficient to overcome the prima facie case of obviousness.
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 Applicant regards as his invention.
Claims 58-101 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, regards as the invention.
Claims 58-101 are rejected as being indefinite. Claims 58, 69, 80 and 91 recite, “within 10% of a set value”. The claims do not clearly define how the “set value” is selected, fixed, or controlled, nor whether the ±10% tolerance is temporal, instantaneous, averaged, or cumulative, thus rendering the scope of the claims unclear. The Applicant is advised to revise the claims to provide more objective boundaries. Dependent claims 59-68, 70-79, 81-90 and 92-101 are included in this rejection because they do not cure the defect noted above.
Claims 55, 66, 77, 88, and 99 recite, “aggregate amount of oxygen”. It is unclear whether this refers to dissolved oxygen, total gaseous oxygen content, bioavailable oxygen, or measured under specific temperature and pressure conditions. Because one of ordinary skill in the art would not be able to determine the scope of the claims with reasonable certainty, claims 55, 66, 77, 88, and 99 are indefinite. The Applicant is advised to revise the claims to provide more objective boundaries.
Claim Rejections - 35 USC § 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 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 47, 48, and 51-54, 56-59, 62-65, 67-70, 73-76, 78-81, 84-87, 89-92, 95-98, and 100-102 are rejected under 35 U.S.C. § 103 as being unpatentable over Danilovich et al. (RU2649346C1; publication date 02 April 2018) in view of Wang et al. (The Role of Incubation Conditions on the Regulation of Muscle Development and Meat Quality in Poultry. Front Physiol., 13:883134; publication date 15 Jun 2022) and in further view of Yoshikazu et al. (WO2020138246A1; publication date 02 July 2020) and Greene et al. (Quantum Blue Reduces the Severity of Woody Breast Myopathy via Modulation of Oxygen Homeostasis-Related Genes in Broiler Chickens. Front Physiol., 10:1251; publication date 01 Oct 2019).
Regarding claim 47, Danilovich teaches a method of incubating a fertilized unhatched poultry egg to hatching, comprising incubating the egg (claim 3 and Figure 1 shows diagram of internal device) for an incubation period of 18 to 21 consecutive days in a gaseous atmosphere which is in contact with the egg (Figure 1, egg labeled 3 and gaseous air pump control valve labeled 14), where during that time, an outside source of carbon dioxide (Figure 1, CO2 air pump control valve labeled 15) is fed into the gaseous atmosphere (Figure 1, labeled 3 and 14) so that for at least one period of time of at least 12 hours (relict geological condition time of 9.4 hours (Description, paragraph 13) plus maintaining the condition for 2-3 hours (Description, paragraph 26)) the carbon dioxide concentration in the gaseous atmosphere in contact with the egg (Figure 1, labeled 3 and 15) is 6,000 ppm, as “Relict geological conditions are created in the pressure chamber incubator (increased carbon dioxide content - 0.6% [6000 ppm])” (Description, paragraph 13).
Danilovich does not explicitly teach use of this method to reduce or eliminate the incidence of woody breast in the poultry after hatching or the use of carbon dioxide at a concentration of 7,500-20,000 ppm as specified in instant claim 47.
Wang teaches the use of changes in incubation gas concentrations, including CO2 at different levels up to 40,000 ppm to reduce the incidence of myopathies in poultry and improve the meat quality in poultry specifically in the context of addressing woody breast myopathies (page 2, Introduction; page 3-4, The Effect of Muscle Fiber Development on Meat Quality and page 7, Future Directions and Perspectives) as, "Incubation phase is a critical stage in the life cycle of poultry, which covers the phase from the start of embryogenesis to the beginning of the young bird stage or birth and play an important role in the skeletal muscle growth and final meat quality in poultry. Skeletal muscle is the dominant component of poultry meat. It is well established that poultry muscle fiber number is determined during embryonic development. Evidences have shown that regulation of myofiber development during myogenesis can increase the number and fiber diameter of muscle fiber. Therefore, environmental regulation during the incubation phase may be a novel way out to ameliorate the muscle development and meat quality in poultry." (page 2, Introduction) in addition, "...exposing embryos to a low oxygen (17%) environment at E5-E12 increased 7D broiler body weight, a positive effect that lasted until 28D, and increased breast muscle production. This occurred probably because the low- oxygen environment stimulated the embryonic vasculature to develop in a good direction and to better deliver nutrients to the pectoral muscle, thus promoting posthatch muscle development. Carbon dioxide is an important gas during embryo development and bird egg incubation, and developing embryos require different levels of carbon dioxide at specific developmental stages and is an essential factor affecting embryo development. Placing well-developed embryos in a CO2 incubator at a concentration of 4% [40,000 ppm] at E10-E18 reduced embryo weight, but had no effect on chick weight on the day of fledging or day-old chicks. However, placing fertilized duck eggs in an incubator with 1% CO2 content 10 days before hatching increased T3,T4 and corticosterone levels and body weight in plasma of Pekin ducks at embryonic stage and on the day of hatching, with positive effects on body weight lasting until market age. Thyroid hormones play an important regulatory role in maintaining chicken embryo development and normal development and can promote embryonic development. It was reported that 1% concentration of CO2 [10,000 ppm] may affect embryonic muscle fiber development and posthatch muscle growth by raising blood levels that may stimulate plasma corticosterone and TS, leading to the onset of hatching, thereby increasing Pekin duck embryo and market-day weight. " (page 5-6, Section 2.4.3).
In addition, Greene teaches that low oxygen levels in the muscle of chickens leads to the development of woody breast which can be alleviated by treatment that increases oxygenation of blood and muscle, as “In the present study, we provide evidence that the circulatory and breast muscle oxygen homeostasis is dysregulated along with the activation of hypoxic signaling pathways in chickens with WB [woody breast] myopathy. We also found that quantum blue (QB), which has been shown to enhance hematological parameters in channel catfish (Peatman and Beck, 2016), improves the expression of oxygen-sensing genes in blood and breast muscle and reduces the severity of WB disorder.” (page 2, Introduction)
Regarding claims 58, 69, 80 and 91, the additional limitations set forth in these claims involve either a change in the incubation CO2 concentration, incubation duration of exposure, the addition of holding time incubations for 3 days after the initial 18-21-day incubation and CO2 concentrations within that time, and/or incremental and interval period incubations.
Danilovich teaches incubation CO2 concentration changes and incremental and interval period incubations as, “When the concentration of carbon dioxide reaches 0.6%, valve 14 opens and fresh air is pumped from the compressor receiver into the container. At the same time, by opening the emergency valve 13, the used air leaves the tank. When the concentration of CO2 decreases to 0.4%, the valve 14 closes, respectively, and the emergency valve 13 stops bleeding air. This cycle is repeated every time the maximum concentration of carbon dioxide is reached. When replacing the air in the tank 1, both temperature and humidity change, which are adjusted by the control device according to the readings of the sensors, according to the cycles described above.” (Description, paragraph 28) and “Now, when CO2 concentration is reduced, it is valve 12 that will be used to bleed air from tank 1, and valve (6.5 atm) 13 will remain purely emergency. The concentration values (maximum and minimum) of CO2 will also decrease stepwise. If you do this in 6 steps of 4 hours each, then these values (max-min.) Can look like this (0.6-0.4; 0.5-0.3; 0.4-0.2; 0, 3-0.1; 0.2-0.05; 0.1-0.05 atm).” (Description, paragraph 33).
Danilovich does not teach the specific limitations of incubation CO2 concentrations, incubation duration of exposures, 3 day holding time incubations after the initial 18-21-day incubation at the CO2 concentration ranges, and/or the incremental and interval period incubations.
However, Wang teaches (page 5-6, 2.4.3 Oxygen and Carbon Dioxide on Muscle Development) that it was known in the art at the time of the invention to modify incubation CO2 concentration within the ranges encompassing the claims and choice of time of exposure to CO2 during the embryonic cycle to hatching as factors influencing hatchability and post-hatch muscle development and weight. Wang also teaches that it was known in the art at the time of the invention as a matter of routine experimentation to incorporate various holding times after 18-21 to optimize muscle fiber growth and development (page 6, 2.5.1 Holding Time of Fertile Egg) under different conditions for different durations, consistent with routine experimentation to arrive at 3 consecutive days immediately following the first 18-day incubation period holding time claimed in the invention. In addition, Wang also teaches that routine experimentation with incremental and interval incubation periods to optimize development and post-hatch weight were known at the time of the invention (page 6, 2.5.2 Short Periods of Incubation).
Danilovich does not explicitly teach the additional limitation of administering water with oxygen nanobubbles to poultry enterally, as specified in instant claim 47, 58, 69, 80 and 91.
Yoshikazu discloses an invention providing poultry drinking water containing ultrafine gas bubbles (claim 1), where the gas is oxygen (claim 3) and the water is administered to poultry enterally (claim 7).
Regarding instant claims 48, 59, 70, 81 and 92, Danilovich teaches use for poultry where poultry is specifically chicken, as “...eggs (gauge 23) of chickens, turkeys, guinea fowl, pheasant and quail...” (Description, paragraph 29). In addition, Yoshikazu discloses use of the invention for poultry eggs that are chicken as, “A method for poultry raising, which comprises obtaining chicken eggs for egg collection from the chicken by giving drinking water containing gas ultrafine bubbles. The poultry raising method according to claim 1, wherein the gas is air. The poultry raising method according to claim 1, wherein the gas is oxygen.” (claim 1).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the teachings in Danilovich to improve poultry broodstock development to include use for improving the condition and quality of meat by reducing the incidence of woody breast in poultry, as known in the art to be problematic, via the teachings of Wang and modifying the CO2 incubation concentration, duration of incubation, add holding time incubations after the initial 18-21 day incubations, and introduce various incubation intervals and increments by routine experimentation, as of all of these factors were known in the art at the time of the invention to be modified to optimize outcomes in hatchability, muscle development, and weight to reduce the incidence of poultry myopathies including woody breast as described by Wang as a parameter optimized within the prior art conditions as a matter of routine experimentation. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Further, Greene discloses that low oxygen levels are a known cause of woody breast, therefore it is reasonable to expect success in reducing woody breast by administering oxygen via a method known at the time of invention for administering oxygen to poultry (i.e., water comprising oxygen nanobubbles), as evidence by Yoshikazu.
One would be motivated to make such changes to manipulating environmental factors during the egg incubation phase and providing supplementary oxygen supply after birth to provide a convenient and low-cost manner of improving poultry welfare, meat production quality and yield, and reduce the economic burden of woody breast to the poultry industry. The proposed invention merely combines the teachings known in the art to provide an alternative means of oxygenating the muscle of poultry.
Regarding claims 51, 62, 73, 84 and 95 which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that at least 5% of all of the water enterally administered to the chickens comprises oxygen nanobubbles, Yoshikazu teaches 100% of the water made available to the chickens contains the ultrafine oxygen gas bubbles (page 27-28, paragraph 0111). The claimed ranges in instant claims 51, 62, 73, 84 and 95 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 52, 63, 74, 85 and 96, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that 50-100 vol. % of all that water that is enterally administered to chickens comprised the oxygen nanobubbles. Yoshikazu teaches 100% of the water made available to the chickens contains the ultrafine oxygen gas bubbles (page 27-28, paragraph 0111). The claimed ranges in instant claims 52, 63, 74, 85 and 96 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 53, 64, 75, 86 and 97, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that the average diameter of said nanobubbles is 10 to 1000 nanometers, Yoshikazu discloses “The ultrafine bubble-containing water of air used as drinking water in the present embodiment is not particularly limited as long as the diameter of ultrafine bubbles of air is 1 nm or more and 1000 nm or less.” (page 11, paragraph 0043). The claimed range in instant claims 53, 64, 75, 86 and 97 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 54, 65, 76, 87 and 98, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that the water comprises at least 100 million of said nanobubbles per milliliter of water, Yoshikazu discloses “The ultrafine bubble-containing water of air used as drinking water of the present embodiment has a concentration of ultrafine bubbles of air of 1x10’ bubbles/mL or more, and the upper limit is not particularly limited, but from the ease of production, it is 10'* bubbles/mL or less.” (page 11, paragraph 0044). Thus, the effective concentration range of ultrafine bubbles disclosed by Yoshikazu is 10 million to 1 trillion, and the claimed range in instant claims 54, 65, 76, 87 and 98 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 56, 67, 78, 89 and 100, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that water administration begins on longer that 2 weeks after the chicken has hatched, Yoshikazu discloses that administration could begin from 0-120 days after the chicken hatches from the egg, describing introduction from hatching to introduction into the chicken house as, “Drinking water containing ultra-fine bubbles of air may be supplied from a point of time until the chicken blows until it is introduced into the hen’s poultry house. By supplying drinking water containing ultra-fine bubbles of air at the time of the winnower, the middle or big winter, the growth of the cheek can be promoted.” (page 11-12, paragraph 0046) which introduction into the chicken house is specified as at 120 days (page 2, paragraph 0003). Thus, the water administration timing disclosed by Yoshikazu and the claimed range in instant claims 56, 67, 78, 89 and 100 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 57, 68, 79, 90 and 101, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that water administration begins on longer that 2 days after the chicken has hatched, Yoshikazu discloses that administration could begin from 0-120 days after the chicken hatches from the egg, describing introduction from hatching to introduction into the chicken house as, “Drinking water containing ultra-fine bubbles of air may be supplied from a point of time until the chicken blows until it is introduced into the hen’s poultry house. By supplying drinking water containing ultra-fine bubbles of air at the time of the winnower, the middle or big winter, the growth of the cheek can be promoted.” (page 11-12, paragraph 0046) which introduction into the chicken house is specified as at 120 days (page 2, paragraph 0003). Thus, the water administration timing disclosed by Yoshikazu and the claimed range in instant claims 57, 68, 79, 90 and 101 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
Regarding instant claim 102, Regarding instant claim 102, Danilovich teaches CO₂ feeding from an external source and air exchange via controlled valves (Fig. 1, valves 13, 14, 15). Danilovich expressly discloses cyclic ventilation with simultaneous CO₂ regulation, including opening valves to introduce fresh air, bleeding used air while controlling CO₂ concentration, and adjusting temperature and humidity during air replacement cycles. Danilovich states, “When the air in the tank 1 is changed, both the temperature and the humidity change, which are corrected by the control device according to the readings of the sensors, according to the cycles described above.” (page 3, paragraph 12). This disclosure teaches air exchange occurring as part of a CO₂-controlled incubation process, not a permanently sealed, non-ventilated system. While Danilovich discloses periods of reduced ventilation, it also discloses continued air exchange during CO₂ management, which falls within the scope of instant claim 102. The instant claim does not exclude intermittent cycling or feedback-controlled ventilation. Accordingly, Danilovich teaches the claimed air exchange limitation.
Moreover, Wang teaches that incubation environments routinely involve controlled ventilation, adjustment of CO₂ concentrations, and independent optimization of gas composition to influence muscle development and hatch outcomes (Abstract). Wang expressly characterizes CO₂ regulation as an environmental incubation parameter, in addition to temperature and oxygen, that is manipulated while maintaining viable incubation conditions (page 5-6, section 2.4.3). A person of ordinary skill in the art would understand this to require continued air exchange, as complete non-ventilation would result in hypoxia, temperature drift, humidity imbalance, and be incompatible with commercial incubation. The claimed feature of maintaining ventilation while regulating CO₂ represents a predictable use of prior art elements according to their established functions (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
It would have been prima facie obvious prior to the instant effective filing date to one of ordinary skill in the art designing an incubator to maintain a specific CO₂ concentration while also controlling humidity and temperature to substitute a continuous exchange with supplementation method for the sealed pulse method taught by Danilovich with a reasonable expectation of success in making the change as both are known control strategies used for the same purpose of achieving stable CO₂ concentration. One of skill in the art would understand that continuous, metered air exchange is one standard method to prevent buildup of other gases (e.g., ethylene) and control humidity, while adding CO₂ to offset its loss.
Claims 47-50, 58-61, 69-72, 80-83, and 91-94 are rejected under 35 U.S.C. 103 as being unpatentable over Danilovich et al. (RU2649346C1; publication date 02 April 2018) in view of Wang et al. (The Role of Incubation Conditions on the Regulation of Muscle Development and Meat Quality in Poultry. Front Physiol., 13:883134; publication date 15 Jun 2022) and in further view of Yoshikazu et al. (WO2020138246A1; publication date 02 July 2020) in view of Greene et al. (Quantum Blue Reduces the Severity of Woody Breast Myopathy via Modulation of Oxygen Homeostasis-Related Genes in Broiler Chickens. Front Physiol.;10:1251; publication date 01 Oct 2019) and in further view of Jeong et al. (KR20140074482A; publication date 18 June 2014).
Danilovich, Wang, Yoshikazu, and Greene teach the limitations of instant claims 47, 48, 58, 59, 69, 70, 80, 81, 91, and 92 (as discussed above), from which instant claims 49, 50, 60, 61, 71, 72, 82, 83, 93 and 94 depend, respectively. However, they do not teach all the specific limitations of instant claims 49, 50, 60, 61, 71, 72, 82, 83, 93 and 94.
In regards to claims 49, 60, 71, 82 and 93 which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that the water nanobubbles comprises 50-100 vol. % oxygen, in which it has been discussed above for claim 48 that it would have been obvious to one skilled in the art to use high oxygen concentrations since Greene had established hypoxia is a known cause of woody breast and that improving oxygen-sensing genes reduces the severity woody breast. However, Yoshikazu does not explicitly teach that the water nanonbubbles comprises 50-100 vol. % oxygen. Jeong discloses a method for producing drinking water for livestock containing nanobubbles (page 3, paragraph 0032), including preferably poultry (page 4, paragraph 0033), where oxygen is the only gas supplied and no other gas was added (page 4-5, paragraph 0047), therefore at 100%. Thus, the claimed range in instant claims 49, 60, 71, 82 and 93 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 50, 61, 72, 83 and 94, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that the water is maintained at a pressure of up to 25 psig until it is ingested by the chicken. Yoshikazu does not disclose a maintained pressure for the water containing the nanobubbles. Jeong teaches nanonbubble pressure as, “Pressure of step a) according to an embodiment of the present invention may be less than 1 atm [14.6959 psig], more preferably from 0.1 to 1 atm [1.46959 to 14.6959 psig] in terms of bubble generation efficiency, the pressure of step b) may be more than 1 atm [14.6959 psig], In terms of further reducing the size of may be from 1 atm to 2 atm [14.6959 to 29.3919 psig].” (page 4, paragraph 0034) which is maintained as, “In addition, when observed after 6 months using the Nano Particle Tracking Analyzer, a surprising effect of maintaining more than 80% of the nano-bubble population was obtained.” (page 5, paragraph 0049). Thus, the claimed range of up to 25 psig in instant claims 50, 61, 72, 83 and 94 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
Claims 47, 48, 55, 58, 59, 66, 69, 70, 77, 80, 81, 88, 91, 92 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Danilovich et al. (RU2649346C1; publication date 02 April 2018) in view of Wang et al. (The Role of Incubation Conditions on the Regulation of Muscle Development and Meat Quality in Poultry. Front Physiol., 13:883134; publication date 15 Jun 2022) and in further view of Yoshikazu et al. (WO2020138246A1; publication date 02 July 2020) in view of Greene et al. (Quantum Blue Reduces the Severity of Woody Breast Myopathy via Modulation of Oxygen Homeostasis-Related Genes in Broiler Chickens. Front Physiol.;10:1251; publication date 01 Oct 2019) and in further view of Valela et al. (US20020096792A1; publication date 25 July 2002).
Danilovich, Wang, Yoshikazu, and Greene teach the limitations of instant claims 47, 48, 58, 59, 69, 70, 80, 81, 91, and 92 (as discussed above), from which instant claims 55, 66, 77, 88 and 99 depend, respectively. However, they do not teach all the specific limitations of instant claims 55, 66, 77, 88 and 99.
Claims 55, 66, 77, 88 and 99, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, of 20 to 150 milligrams of oxygen per liter of nanobubble water.
Yoshikazu discloses the concentration of the ultra-fine bubbles for use in chickens in terms of bubbles/mL (page 11, paragraph 0044) as discussed above for claims 54, 65, 76, 87 and 98, but does not explicitly state the oxygen concentration in terms of milligrams per liter of water.
Valela discloses the amount of oxygen in the water administered in terms of milligrams per liter of water as, “Moreover the oxygenated [oxygen bubble; abstract] water that exits from the venturi may be collected and bottled for future use. Humans or animals can use this bottled water. Many believe that oxygenated water: 1. bolsters the immune system; 2. treats infections and diseases...” (page 3, paragraph 0046-0048) and where, “Water produced from the method of claim 11 having a oxygen content of up to 48 mg of oxygen per liter of water.” (claim 12).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the prior art teachings, where, as discussed above for claim 48, 59, 70, 81 and 92, Greene had established hypoxia is a known cause of woody breast and that improving oxygen-sensing genes reduces the severity woody breast therefore it would have been obvious to one skilled in the art to use high oxygen concentrations and increase the concentration of oxygen, disclosed by Valela to up to 150 mg as in the instant claims 55, 66, 77, 88 and 99, as matter of optimization of prior art conditions through routine experimentation. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). One would be motivated to make such change to improve poultry broodstock development condition and quality of meat by further reducing hypoxia and associated incidence of woody breast.
Claim Rejections – Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Claims 47-102 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of co-pending US Application No. 17/872,477 in view of Yoshikazu et al. (WO2020138246A1; publication date 02 July 2020) and claims 1-20 of co-pending US Application No. 18/064,376 in view of Danilovich et al. (RU2649346C1; publication date 02 April 2018), Wang et al. (The Role of Incubation Conditions on the Regulation of Muscle Development and Meat Quality in Poultry. Front Physiol., 13:883134; publication date 15 Jun 2022) and Greene et al. (Quantum Blue Reduces the Severity of Woody Breast Myopathy via Modulation of Oxygen Homeostasis-Related Genes in Broiler Chickens. Front Physiol., 10:1251; publication date 01 Oct 2019). Although the claims at issue are not identical, they are not patentably distinct from each other for being obvious variations of the co-pending application claims for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US 17/872,477 claims methods of incubating fertilized poultry eggs comprising incubation for 18–21 days, feeding carbon dioxide from an external source into the incubation atmosphere, and maintaining CO₂ concentrations of 7,500–20,000 ppm for defined time periods and including embodiments involving constant CO₂ setpoints, incrementally increasing CO₂ concentrations, alternating CO₂ exposure and non-exposure periods, and chicken eggs specifically (claims 1-46 of US 17/872,477). Instant claims 47, 58, 69, 80, and 91, and their respective dependent claims, recite substantially identical incubation regimens, including identical incubation durations (18–21 days), identical CO₂ concentration ranges (7,500–20,000 ppm ±10%), identical exposure timing schemes (constant, incremental, alternating), and identical poultry species limitations (chicken eggs).
Yoshikazu discloses an invention providing poultry drinking water containing ultrafine gas bubbles (claim 1), where the gas is oxygen (claim 3) and the water is administered to poultry enterally (claim 7). Regarding claims 51, 62, 73, 84 and 95 which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that at least 5% of all of the water enterally administered to the chickens comprises oxygen nanobubbles, Yoshikazu teaches 100% of the water made available to the chickens contains the ultrafine oxygen gas bubbles (page 27-28, paragraph 0111). The claimed ranges in instant claims 51, 62, 73, 84 and 95 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 52, 63, 74, 85 and 96, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that 50-100 vol. % of all that water that is enterally administered to chickens comprised the oxygen nanobubbles. Yoshikazu teaches 100% of the water made available to the chickens contains the ultrafine oxygen gas bubbles (page 27-28, paragraph 0111). The claimed ranges in instant claims 52, 63, 74, 85 and 96 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 53, 64, 75, 86 and 97, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that the average diameter of said nanobubbles is 10 to 1000 nanometers, Yoshikazu discloses “The ultrafine bubble-containing water of air used as drinking water in the present embodiment is not particularly limited as long as the diameter of ultrafine bubbles of air is 1 nm or more and 1000 nm or less.” (page 11, paragraph 0043). The claimed range in instant claims 53, 64, 75, 86 and 97 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 54, 65, 76, 87 and 98, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that the water comprises at least 100 million of said nanobubbles per milliliter of water, Yoshikazu discloses “The ultrafine bubble-containing water of air used as drinking water of the present embodiment has a concentration of ultrafine bubbles of air of 1x10’ bubbles/mL or more, and the upper limit is not particularly limited, but from the ease of production, it is 10'* bubbles/mL or less.” (page 11, paragraph 0044). Thus, the effective concentration range of ultrafine bubbles disclosed by Yoshikazu is 10 million to 1 trillion, and the claimed range in instant claims 54, 65, 76, 87 and 98 "overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 56, 67, 78, 89 and 100, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that water administration begins on longer that 2 weeks after the chicken has hatched, Yoshikazu discloses that administration could begin from 0-120 days after the chicken hatches from the egg, describing introduction from hatching to introduction into the chicken house as, “Drinking water containing ultra-fine bubbles of air may be supplied from a point of time until the chicken blows until it is introduced into the hen’s poultry house. By supplying drinking water containing ultra-fine bubbles of air at the time of the winnower, the middle or big winter, the growth of the cheek can be promoted.” (page 11-12, paragraph 0046) which introduction into the chicken house is specified as at 120 days (page 2, paragraph 0003). Thus, the water administration timing disclosed by Yoshikazu and the claimed range in instant claims 56, 67, 78, 89 and 100 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
In regards to claims 57, 68, 79, 90 and 101, which adds the limitation to claims 48, 59, 70, 81 and 92, respectively, that water administration begins on longer that 2 days after the chicken has hatched, Yoshikazu discloses that administration could begin from 0-120 days after the chicken hatches from the egg, describing introduction from hatching to introduction into the chicken house as, “Drinking water containing ultra-fine bubbles of air may be supplied from a point of time until the chicken blows until it is introduced into the hen’s poultry house. By supplying drinking water containing ultra-fine bubbles of air at the time of the winnower, the middle or big winter, the growth of the cheek can be promoted.” (page 11-12, paragraph 0046) which introduction into the chicken house is specified as at 120 days (page 2, paragraph 0003). Thus, the water administration timing disclosed by Yoshikazu and the claimed range in instant claims 57, 68, 79, 90 and 101 “overlap or lie inside ranges disclosed by the prior art", and therefore a prima facie case of obviousness exists (MPEP 2144.05 A).
Claim 102, which further recites air exchange during CO₂ feeding, does not overcome the rejection. US 17/872,477 inherently contemplates controlled gas exchange during incubation, as maintaining CO₂ concentrations necessarily requires air exchange with an external source. The additional recitation of air exchange is therefore an obvious and inherent process feature, insufficient to confer patentable distinctness.
The incubation steps recited in the instant claims are not patentably distinct from the incubation steps claimed in US 17/872,477 in view of Yoshikazu. The differences in phrasing or organization of exposure periods do not impart a patentable distinction, as they merely restate or trivially modify claimed embodiments already covered by US 17/872,477.
US 18/064,376 claims methods of reducing or eliminating woody breast in poultry comprising enteral administration of water containing oxygen nanobubbles, specific limitations regarding oxygen volume percentage (50–100 vol.%), nanobubble size (10–1000 nm), nanobubble concentration (≥100 million/mL), oxygen content (20–150 mg/L), pressure maintenance up to 25 psig, and administration timing relative to hatching (≤2 weeks or ≤2 days) (claims 1-20 of US 18/064,376). Instant claims 47 and 48–57, 59–68, 70–79, 81–90, and 92–101 recite identical enteral nanobubble water administration limitations, including the same oxygen nanobubble compositions, the same quantitative ranges, the same administration timing relative to hatching, and the same poultry species (chicken).
Danilovich teaches a method of incubating a fertilized unhatched poultry egg to hatching, comprising incubating the egg (claim 3 and Figure 1 shows diagram of internal device) for an incubation period of 18 to 21 consecutive days in a gaseous atmosphere which is in contact with the egg (Figure 1, egg labeled 3 and gaseous air pump control valve labeled 14), where during that time, an outside source of carbon dioxide (Figure 1, CO2 air pump control valve labeled 15) is fed into the gaseous atmosphere (Figure 1, labeled 3 and 14) so that for at least one period of time of at least 12 hours (relict geological condition time of 9.4 hours (Description, paragraph 13) plus maintaining the condition for 2-3 hours (Description, paragraph 26)) the carbon dioxide concentration in the gaseous atmosphere in contact with the egg (Figure 1, labeled 3 and 15) is 6,000 ppm, as “Relict geological conditions are created in the pressure chamber incubator (increased carbon dioxide content - 0.6% [6000 ppm])” (Description, paragraph 13).
Danilovich does not explicitly teach use of this method to reduce or eliminate the incidence of woody breast in the poultry after hatching or the use of carbon dioxide at a concentration of 7,500-20,000 ppm as specified in instant claim 47.
Wang teaches the use of changes in incubation gas concentrations, including CO2 at different levels up to 40,000 ppm to reduce the incidence of myopathies in poultry and improve the meat quality in poultry specifically in the context of addressing woody breast myopathies (page 2, Introduction; page 3-4, The Effect of Muscle Fiber Development on Meat Quality and page 7, Future Directions and Perspectives) as, "Incubation phase is a critical stage in the life cycle of poultry, which covers the phase from the start of embryogenesis to the beginning of the young bird stage or birth and play an important role in the skeletal muscle growth and final meat quality in poultry. Skeletal muscle is the dominant component of poultry meat. It is well established that poultry muscle fiber number is determined during embryonic development. Evidences have shown that regulation of myofiber development during myogenesis can increase the number and fiber diameter of muscle fiber. Therefore, environmental regulation during the incubation phase may be a novel way out to ameliorate the muscle development and meat quality in poultry." (page 2, Introduction) in addition, "...exposing embryos to a low oxygen (17%) environment at E5-E12 increased 7D broiler body weight, a positive effect that lasted until 28D, and increased breast muscle production. This occurred probably because the low- oxygen environment stimulated the embryonic vasculature to develop in a good direction and to better deliver nutrients to the pectoral muscle, thus promoting posthatch muscle development. Carbon dioxide is an important gas during embryo development and bird egg incubation, and developing embryos require different levels of carbon dioxide at specific developmental stages and is an essential factor affecting embryo development. Placing well-developed embryos in a CO2 incubator at a concentration of 4% [40,000 ppm] at E10-E18 reduced embryo weight, but had no effect on chick weight on the day of fledging or day-old chicks. However, placing fertilized duck eggs in an incubator with 1% CO2 content 10 days before hatching increased T3,T4 and corticosterone levels and body weight in plasma of Pekin ducks at embryonic stage and on the day of hatching, with positive effects on body weight lasting until market age. Thyroid hormones play an important regulatory role in maintaining chicken embryo development and normal development and can promote embryonic development. It was reported that 1% concentration of CO2 [10,000 ppm] may affect embryonic muscle fiber development and posthatch muscle growth by raising blood levels that may stimulate plasma corticosterone and TS, leading to the onset of hatching, thereby increasing Pekin duck embryo and market-day weight. " (page 5-6, Section 2.4.3).
In addition, Greene teaches that low oxygen levels in the muscle of chickens leads to the development of woody breast which can be alleviated by treatment that increases oxygenation of blood and muscle, as “In the present study, we provide evidence that the circulatory and breast muscle oxygen homeostasis is dysregulated along with the activation of hypoxic signaling pathways in chickens with WB [woody breast] myopathy. We also found that quantum blue (QB), which has been shown to enhance hematological parameters in channel catfish (Peatman and Beck, 2016), improves the expression of oxygen-sensing genes in blood and breast muscle and reduces the severity of WB disorder.” (page 2, Introduction)
Regarding claims 58, 69, 80 and 91, the additional limitations set forth in these claims involve either a change in the incubation CO2 concentration, incubation duration of exposure, the addition of holding time incubations for 3 days after the initial 18-21-day incubation and CO2 concentrations within that time, and/or incremental and interval period incubations.
Danilovich teaches incubation CO2 concentration changes and incremental and interval period incubations as, “When the concentration of carbon dioxide reaches 0.6%, valve 14 opens and fresh air is pumped from the compressor receiver into the container. At the same time, by opening the emergency valve 13, the used air leaves the tank. When the concentration of CO2 decreases to 0.4%, the valve 14 closes, respectively, and the emergency valve 13 stops bleeding air. This cycle is repeated every time the maximum concentration of carbon dioxide is reached. When replacing the air in the tank 1, both temperature and humidity change, which are adjusted by the control device according to the readings of the sensors, according to the cycles described above.” (Description, paragraph 28) and “Now, when CO2 concentration is reduced, it is valve 12 that will be used to bleed air from tank 1, and valve (6.5 atm) 13 will remain purely emergency. The concentration values (maximum and minimum) of CO2 will also decrease stepwise. If you do this in 6 steps of 4 hours each, then these values (max-min.) Can look like this (0.6-0.4; 0.5-0.3; 0.4-0.2; 0, 3-0.1; 0.2-0.05; 0.1-0.05 atm).” (Description, paragraph 33).
Wang teaches (page 5-6, 2.4.3 Oxygen and Carbon Dioxide on Muscle Development) that it was known in the art at the time of the invention to modify incubation CO2 concentration within the ranges encompassing the claims and choice of time of exposure to CO2 during the embryonic cycle to hatching as factors influencing hatchability and post-hatch muscle development and weight. Wang also teaches that it was known in the art at the time of the invention as a matter of routine experimentation to incorporate various holding times after 18-21 to optimize muscle fiber growth and development (page 6, 2.5.1 Holding Time of Fertile Egg) under different conditions for different durations, consistent with routine experimentation to arrive at 3 consecutive days immediately following the first 18-day incubation period holding time claimed in the invention. In addition, Wang also teaches that routine experimentation with incremental and interval incubation periods to optimize development and post-hatch weight were known at the time of the invention (page 6, 2.5.2 Short Periods of Incubation).
Claim 102, which further recites air exchange during CO₂ feeding, does not overcome the rejection as controlled gas exchange during incubation, as maintaining CO₂ concentrations necessarily requires air exchange with an external source. The additional recitation of air exchange is therefore an obvious and inherent process feature.
The nanobubble water administration steps of the instant claims are fully encompassed by, and obvious over, the claims of US 18/064,376 in view of the teachings of Danilovich, Wang and Greene.
Further, the combination of these two independent methods is a mere aggregation of two known processes directed to the same ultimate goal of reducing woody breast in poultry. There is no disclosed or claimed synergistic interaction or unexpected result arising from their combination. A person of ordinary skill in the art, aware of an incubation method to improve poultry health from the US 17/872,477 application and a post-hatch hydration/nutrition method to reduce woody breast from the US 18/064,376 application, would find it obvious to apply both treatments to the same poultry to address the same condition.
The instant claims are obvious over the claims of the US 17/872,477 application in view of the US 18/064,376 application. One would have been motivated to add the known, beneficial post-hatch nanobubble treatment of the US 18/064,376 application to the incubation process of the US 17/872,477 application to further promote poultry health and reduce woody breast.
Conversely, the instant claims are obvious over the claims of the US 18/064,376 application in view of the US 17/872,477 application. One would have been motivated to pretreat the poultry (via the claimed incubation method) before applying the known post-hatch nanobubble treatment to provide a more comprehensive approach.
Allowing claims 47-102 would permit the applicant to extend the exclusive right to practice the separately claimable inventions of the US 17/872,477 and US 18/064,376 applications by combining them in a single, later-expiring patent. This is the precise scenario the nonstatutory double patenting doctrine is designed to prevent.
This rejection may be overcome by filing a terminal disclaimer in compliance with 37 CFR § 1.321(c), disclaiming any patent term extending beyond the expiration of the referenced application(s) and agreeing to common ownership for the life of the patent or amending the claims to establish a patentably distinct invention over the claims of the referenced applications. Any amendment to the claims must comply with 35 U.S.C. § 112 and 35 U.S.C. § 132.
Response to Arguments
With respect to the Applicant Arguments/Remarks, filed 16 December 2025, claim 102 depends from claim 47 and recites, “…during incubation, air exchange is carried out in which air from a source outside the gaseous atmosphere is exchanged with the gaseous atmosphere, and while feeding carbon dioxide from a source outside the egg into the gaseous atmosphere, air exchange continues.” The claim does not require a particular air exchange rate, continuous ventilation without interruption, independence of CO₂ control from temperature or humidity control, or simultaneous adjustment of all three parameters. The claim merely requires continued air exchange concurrent with CO₂ feeding.
The Applicant argues that Danilovich “teaches stopping air exchange while pumping CO₂” and therefore fails to teach claim 102. This argument is not persuasive. Danilovich expressly discloses cyclic ventilation with simultaneous CO₂ regulation, including opening valves to introduce fresh air, bleeding used air while controlling CO₂ concentration, and adjusting temperature and humidity during air replacement cycles.
Danilovich states, “When replacing the air in the tank, both temperature and humidity change, which are adjusted by the control device according to the readings of the sensors…” (paragraph 28). This disclosure teaches air exchange occurring as part of a CO₂-controlled incubation process, not a permanently sealed, non-ventilated system. While Danilovich discloses periods of reduced ventilation, it also discloses continued air exchange during CO₂ management, which falls within the scope of claim 102. The claim does not exclude intermittent cycling or feedback-controlled ventilation. Accordingly, Danilovich alone teaches the claimed air exchange limitation.
Furthermore, Danilovich's system uses valves to control gas ingress and egress (Fig. 1, valves 13, 14, 15). A person of ordinary skill designing an incubator to maintain a specific CO₂ concentration while also controlling humidity and temperature, as Danilovich does, would understand that continuous, metered air exchange is one standard method to prevent buildup of other gases (e.g., ethylene) and control humidity, while adding CO₂ to offset its loss. Choosing between a "sealed pulse" method similar to that of Danilovich and a "continuous exchange with supplementation" method of instant claim 102 is a matter of obvious substitution of a known alternative control strategy to achieve a known goal of stable CO₂ concentration. The specification admits non-ventilation is an "available method" but claims superiority for continuous exchange.
Wang further teaches simultaneous gas exchange during CO₂ incubation. Wang teaches that incubation environments routinely involve controlled ventilation, adjustment of CO₂ concentrations, and independent optimization of gas composition to influence muscle development and hatch outcomes. Wang expressly characterizes CO₂ regulation as an environmental incubation parameter, analogous to temperature and oxygen, that is manipulated while maintaining viable incubation conditions. A person of ordinary skill in the art would understand this to require continued air exchange, as complete non-ventilation would be incompatible with commercial incubation.
The Applicant argues that Everaert and El-Hanoun teach “closed” or “non-ventilated” incubators and therefore teach away from claim 102. This argument is unpersuasive for several reasons: neither reference states that all air exchange ceases entirely during CO₂ administration, “closed incubator” in experimental literature denotes controlled atmosphere, not hermetic isolation, teaching one mode of operation does not “teach away” from alternative known modes (see In re Gurley, 27 F.3d 551 (Fed. Cir. 1994)). Moreover, Wang cites these studies as evidence that CO₂ levels may be manipulated during incubation, not as a repudiation of ventilation.
Danilovich teaches incubating poultry eggs, including chicken eggs, in a controlled gaseous atmosphere, actively feeding CO₂ from an external source to maintain a concentration of 0.6% (6000 ppm) for at least 12 hours, with the express purpose of accelerating growth and protein synthesis (see above). This is a direct and explicit teaching of the claimed method step of "incubating the egg... feeding carbon dioxide from a source outside the egg into the gaseous atmosphere as necessary so that for at least one period of time of at least 12 hours the carbon dioxide concentration... is within 10% of 7,500 ppm to within 10% of 20,000 ppm." While Danilovich's lower bound is 6000 ppm (just outside the claimed 7500 ppm lower bound), the upper bound and the method of administration are directly taught. However, the Applicant correctly notes Danilovich's focus is on growth acceleration, not woody breast.
Instant claim 47 recites a method of reducing woody breast, but the steps recited are incubation and post-hatch administration steps. The prior art need not recognize the same benefit to render the method obvious (In re Huai-Hung Kao, 639 F.3d 1057 (Fed. Cir. 2011); i.e., intended use does not confer patentability). In addition, Wang expressly teaches that incubation environment modulates muscle development, including myopathies.
Wang supplies motivation and reasonable expectation for treating woody breast with CO₂ incubations. Wang, however, is a comprehensive review article that directly addresses the relationship between incubation conditions and poultry meat quality defects, including woody breast. Wang states, "Incubation phase... play an important role in the skeletal muscle growth and final meat quality in poultry... environmental regulation during the incubation phase may be a novel way out to ameliorate the muscle development and meat quality in poultry." (page 2, left column, paragraph 3). Moreover, Wang reviews studies showing that CO₂ incubation (specifically at 1% or 10,000 ppm and 4% or 40,000 ppm) modulates muscle fiber development and post-hatch weight (page 6, left column, paragraph 2). A person of ordinary skill in the art, aware of the problem of woody breast (as documented by Wang and Greene) and knowing that Danilovich's method accelerates growth through gaseous modulation, would have been motivated to consult Wang to see if such modulation could be directed to improving meat quality.
Wang provides a clear link by teaching that modifying incubation gases like CO₂ can alter muscle development pathways. The combination is not based on an "increase weight therefore increase woody breast " syllogism, but on the more sophisticated understanding from Wang that hormonal and metabolic pathways influenced by CO₂ can be tuned to ameliorate myopathies and are nuanced by temporal differences in CO2 interventions, such as the production of markedly different physiological outcomes based on the introduction and levels used during specific developmental stage time points. The combination of the prior art does not teach indiscriminately applying Danilovich for maximum weight gain, rather it teaches applying Danilovich's method of controlled CO₂ incubation with the knowledge from Wang that such methods can influence muscle quality. Moreover, Wang discusses that CO₂ incubation can increase weight in ducks, yet presents this in the context of exploring factors that affect muscle development. A skilled artisan would understand that the outcome of weight gain vs. woody breast reduction depends on the specific parameters such as timing, concentration, duration- which are the subject of routine optimization.
Therefore, modifying Danilovich's known CO₂ incubation method, using the concentrations and principles discussed in Wang to target muscle quality. The references provide an obvious expectation that optimizing CO2 incubation conditions would affect muscle pathology development, with a reasonable expectation of affecting woody breast incidence even if not explicitly disclosed for woody breast. The prior art provides the motivation treat woody breast via incubation conditions and CO₂ incubations as a tool to do so. Discovering the specific parameters within the disclosed ranges (e.g., 7500-20,000 ppm) that yield a net reduction in woody breast is the predictable result of routine experimentation (see In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
The Applicant relies on Petracci, Bowker, and Kang to argue that increased weight correlates with woody breast. However, these references do not evaluate the specific incubation protocols claimed and are not commensurate in scope to that of the instant claims. Bowker and Kang address post-hatch oxygen administration, whereas the claimed method involves in ovo oxygen administration during critical embryonic development periods (e.g., embryonic gas exposure would impact developmental programming mechanisms, whereas post-hatch exposure affects already-formed tissue). The references do not address the developmental programming effects central to the combined teaching of Danilovich and Wang. Wang teaches that CO₂ can reduce or alter muscle fiber development depending on timing and concentration. The claims encompass broad CO₂ ranges and timeframes, many of which overlap Wang’s teachings.
The Applicant argues that oxygenated water does not affect systemic oxygenation. This argument is not persuasive. The Applicant contends that Yoshikazu teaches a drinking water administration method for improving egg production, not for reducing woody breast myopathy. The Applicant argues this represents a fundamentally different field focused on reproductive performance rather than muscle quality and that Greene suggests a relationship between oxygen homeostasis and woody breast mitigation without providing evidence that oxygenated drinking water would achieve this effect. Further, Applicant maintains the Piantadosi citation to argue that it is not obvious to expect oxygenated water administration to significantly affect hypoxia levels.
Yoshikazu establishes that oxygenated water administration systemically improves oxygen delivery to tissues and improves oxygen homeostasis in poultry. Greene establishes the scientific foundation that oxygen homeostasis disruption contributes significantly to woody breast pathogenesis. Greene explicitly identifies hypoxia (low oxygen) as a key factor in the pathogenesis of woody breast and shows that modulating oxygen homeostasis reduces woody breast severity.
This provides the motivation to implement interventions that improve oxygen delivery, such as the oxygenated water administration taught by Yoshikazu. This combination of an identified problem by Greene with a solution provided by Yoshikazu represents a classic obviousness combination under 35 U.S.C. § 103 of adapting the same principal solution in a different production context. A person of ordinary skill, confronted with the problem of woody breast and knowing hypoxia contributes to it as taught by Greene, would have been motivated to supply supplemental oxygen. Yoshikazu provides a known, effective method for delivering oxygen to poultry via enteral administration. The combination provides a known oxygen-delivery method (Yoshikazu) to address a known oxygen-deficiency pathology (Greene). Whether the mechanism is fully understood is irrelevant, as a reasonable expectation of success, not certainty, is required. The Examiner is not required to prove physiological equivalence, only that one of ordinary skill would have been motivated to combine the teachings.
The Applicant's new evidence (i.e., Charton, Konjar, Shepard) does not negate that Greene establishes the need for oxygen and Yoshikazu offers a plausible route of administration used in poultry. A skilled artisan would have had sufficient motivation to try this combination with a reasonable expectation that it might help alleviate a hypoxia-related condition. The fact that the underlying transport mechanics are complex does not render the combination non-obvious. The Applicant’s new references used to argue that ingested oxygenated water does not reliably increase systemic oxygenation do not outweigh the explicit teaching of Yoshikazu that administering such water does have a physiological effect on poultry. More importantly, they do not undermine the prima facie obviousness of the combination. The legal test is whether there is a "reasonable expectation of success," not a guarantee (see In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)).
The Piantadosi reference is not considered relevant because the study uses adult human subjects with a distinct developmental stage difference and physiology to that of poultry and different administration protocols than those claimed, wherein protocol variations could produce different outcomes. The Applicant’s human and porcine studies do not “teach away” from avian physiology and are not dispositive.
Regarding instant claims 58, 69, 80, and 91 with holding periods and alternating CO₂ feeding, the Applicant argues that the teachings of Wang relate only to pre-incubation storage. This argument is not persuasive. As previously stated, Danilovich teaches varying CO₂ concentrations in cycles. Wang teaches holding periods, short incubation intervals, and incremental environmental changes as routine tools during incubation that are parameters known to be adjusted to influence development for optimizing embryonic development (pages 5-6). Applying such techniques during later incubation stages is a predictable variation within the skill of the art. The claimed three-day period and alternating CO₂/no-CO₂ intervals (e.g., maintaining CO₂ for 18 days, then 3 days with or without supplementation; alternating periods of feeding CO₂) are obvious variations of the cyclic or sustained administration taught by Danilovich and represent optimization of known variables for effects on muscle development as suggested by the teachings of Wang, which is prima facie obvious (In re Aller, 220 F.2d 454, 105 USPQ. 233 (CCPA 1955)).
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615