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 .
Response to Amendment
Applicant's amendment and argument filed 09/17/2025, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-17 and 19-21 are pending of which claims 13-17 and 21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/06/2023.
Claims 1-12 and 19-20 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 10, 12, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita et. al. (US4666725A), Kim et. al. (Corn Particle Size and Nutritional Value of Simple and Complex Diets for Nursery Pigs and Broiler Chicks, Asian-Aust. J. Anim. Sci. 2002. Vol 15, No. 6: 872-877), Oryschak et. al. (Effect of dietary particle size and nutrient supply on energy digestibility and nitrogen excretion in ileal cannulated grower pigs, Can. J. Anim. Sci., received 20 February 2002, accepted a8 June 2002) and Aaron Dodd et. al. (JP5906181B2). This is a new rejection based on the arguments filed on 09/17/2025.
Yamashita’s general disclosure is to processes for producing blood powder (see abstract).
Regarding claims 1-2, Yamashita teaches a process for producing blood powder including the steps of “supplying blood continuously from a blood-collecting vessel to a stirrer, mixing heated live steam with blood in said stirrer to coagulate protein present in the blood as a constituent thereof, transferring partially coagulated blood constituents to a dehydrator, and employing the dehydrator to remove water from the blood constituents to form a solid product having a water content of about 30%-70%, pulverizing the solid product from the dehydrator to produce finely-divided particles having a volume of about 8 mm3, and drying the finely-divided particles within a temperature range of from about 65° C. to 150° C.” (see claim 1). In this context it is the same as providing an aqueous mixture comprising raw blood because mixing live steam in with the blood would essentially create a watered-precipitated, aqueous blood product. Furthermore, the step of dehydration would be the same as increasing the solid content of the mixture because evaporating water would leave behind more solids, thus creating a higher solid content. The dehydrator would essentially be a drying step and remove water content to have a water content of about 30%-70% and inversely would have a solid content of 70%-30% which would meet the instantly claimed criteria.
Regarding claim 3, to wherein the aqueous mixture comprising raw blood has a solid content below 18 wt% and wherein the mixture is increased in solid content to a solid content of about 30 wt% or more by removal of water and/or by adding dry blood meal and/or concentrated blood during, Yamashita teaches reducing the water content and increasing solids to within the claimed range and regarding the solids content being below 18 wt%, the applicant recites that “The amount of solids in raw blood generally is about 5 wt% to 18 wt% and typically between 8 wt% and 12 wt%” (see page 5 of specifications), thus it can be appreciated that the range of solids would be at 18 wt% or lower and would ultimately increase upon dehydration of water.
Yamashita teaches pulverizing the solid product to create finely-divided particles and this would be considered the same as grinding.
Yamashita does not specifically teach that the drying and grinding is done with an air turbulence mill to obtain blood meal having an average particle size (d50) between 20 micrometers and 0.7 millimeters, a d90 of below 1mm as measured with laser diffraction using a dry powder Beckman Coulter particle size analyzer, and an ileal digestibility of about 85% or higher, or wherein the lysine bioavailability is 92% or higher.
Kim’s general disclosure is a report on particle size affecting nutritional value of diets for nursery pigs and broiler chicks (see abstract).
Kim teaches “Overall, pigs fed complex diets had 9% greater ADG (p<0.005) and 5% greater gain/feed (p<0.01) compared to pigs fed simple diets. Also, pigs fed the 500 µm treatments had 3% better overall gain/feed than those fed the 1,000 µm treatments (p<0.007). At d 9, apparent digestibilities of DM, N and GE were greater for complex diets and diets with smaller particle size (p<0.02)” (see abstract). Kim teaches that the complex diets consisted of spray dried blood meal (see p. 873, first para and table 1).
Kim teaches “Usually cereal grains are processed before incorporation into diets for pigs. This processing almost always involves grinding in a hammermill or roller mill to reduce particle size and, thus, improve nutrient digestibility (Kim et al., 2000; Hancock et al., 2000)”
In this regard Kim discusses reducing size of the particles as it teaches grinding particle sizes to be within the instantly claimed ranges and for reasons of increasing digestibility and average daily gains.
Oryschak’s general disclosure is a scientific report on the effect of particle size and nutrient supply on energy digestibility and nitrogen excretion in ileal cannulated grower pigs (see article).
Oryschak teaches that reducing particle size form 900 micrometers to 600 micrometers increased total-tract digestibility of N and energy 3% and increased ileal digestibility of N 9% and energy 11%. Thus, reducing particle size increased energy digestibility (see abstract).
Oryschak teaches wherein “estimates of digestible lysine intake suggested that
all digestible lysine available for protein deposition was retained for both nutrient supplies” (see page 606, left column, 3rd para.).
Dodd’s disclosure is to methods for producing nanoparticle and microparticle powders of a biologically active material which have improved powder handling properties making the powders suitable for commercial use using dry milling processes as well as compositions comprising such materials (see abstract).
Dodd teaches “dry milling techniques are used to reduce particle size and affect drug absorption. However, in conventional dry milling, the fineness limit typically reaches the region of about 100 microns (100,000 nm), at which point the material cakes on the milling chamber and further increases in particle size. Can not be reduced. Alternatively, wet milling can be used to reduce the particle size, but flocculation limits the lower limit of particle size to about 10 microns (10,000 nm). However, since there is a tendency that impurities are mixed in the wet pulverization process, wet pulverization is biased in the pharmaceutical field. Another milling technique, commercial air jet milling, provides particles with an average particle size as small as about 1 micron to about 50 microns (1,000 nm to 50,000 nm)” (see page 8, para. 5).
Dodd teaches “a solid biological activity in a pulverizer comprising a plurality of pulverized bodies for a time sufficient to produce particles of said biologically active material dispersed in at least partially pulverized comminuted material. A method comprising dry milling the material and a millable comminuted matrix. The particle size of the biologically active substance is preferably less than 10,000 nm” (see page 10, para. 5).
Dodd teaches “for example, the dry pulverization can be performed using a jet mill, a rod mill, a roller mill, or a crusher mill” (see page 40, 3rd para.).
Dodd teaches “the use of the method of the invention increases the bioavailability in many situations, so that it is possible to reduce the amount of active substance that needs to be applied” (see page 24, para. 6).
Dodd teaches that the active substance for use in the invention can be blood products (see page 40 2nd to last para.).
Therefore, it would have been obvious to any person having skill in the art before the effective filing date to use the air turbulence mill for drying and grinding the blood meal and creating smaller particle sizes within the instantly claimed range because Dodd teaches using these can increase solubility and bioavailability of active components. Furthermore, Oryschak teaches that reducing particle size specifically from 900 to 600 micrometers increases ileal digestibility. Although the art does not teach using a Beckman Coulter counter for measuring particle size the size of which the particles are being reduced would be below 1mm and between 20 micrometers and 0.7 millimeters as can be recognized by the teachings of Oryschak.
Oryschak teaches wherein the digestible lysine content was retained. Please note, since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Furthermore, the same taught process would be expected to create the same blood meal with an increased bioavailability. The art recognizes using jet mills for increasing the solubility and bioavailability of active ingredients so using the same for creating blood meal products with increased solubility and bioavailability is prima facie obvious.
Dodd teaches the use of air jet mills for creating uniform sized particles with increased solubility and bioavailability of active components.
It would have also been obvious to back-mix blood meal into the mixture into the turbulence mill in order to increase the amount of blood solid contents that the mill is able to process. It would have also been obvious to increase the solid content to 10 % as this is an optimization any person having skill in the art could undertake without any undue experimentation. Furthermore, as discussed in the MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Additionally, it would have been obvious to operate the air turbulence mill with appropriate inlets and outlets for product and streams of gas in which a rotating member is used at speeds of 35-250 m/s, and wherein the air turbulence mill is operated with a gas flow between 5 and 50 m3/hr per kg feed, and with a residence time of less than 10 seconds, because these are all optimizable parameters of an air turbulence mill and any person having skill in the art would optimize these parameters without any undue experimentation. Also, the applicant recognizes that air turbulence mills generally operate at these parameters as can be appreciated by the applicant’s own specifications. The applicant recites “An air turbulence mill generally comprises a chamber (stator) with appropriate inlets and outlets for product and stream(s) of gas in which a rotating member (rotor) is mounted with stacks of impacting devices which rotating member can rotate at high speed” (see page 10 of specs.).
Operating the air turbulence mill with lower oxygen content would also reduce oxidation of the blood meal.
Finally, these parameters do not appear to be critical to the invention and thus would have been obvious parameters to be optimized by any skilled artisan.
There would be a reasonable expectation of success in arriving at the instant invention because these steps are already taught in the prior art.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita et. al. (US4666725A), Kim et. al. (Corn Particle Size and Nutritional Value of Simple and Comlex Diets for Nursery Pigs and Broiler Chicks, Asian-Aust. J. Anim. Sci. 2002. Vol 15, No. 6: 872-877), Oryschak et. al. (Effect of dietary particle size and nutrient supply on energy digestibility and nitrogen excretion in ileal cannulated grower pigs, Can. J. Anim. Sci., received 20 February 2002, accepted a8 June 2002) and Aaron Dodd et. al. (JP5906181B2) as applied to claims 1-5, 10, 12, and 19-21 above, and further in view of Your Doctors Orders (https://yourdoctorsorders.com/2013/06/dont-overcook-healthy-cooking/). This is a new rejection based on the arguments filed on 09/17/2025.
Yamashita, Kim and Oryschak’s combined art teach the method for producing blood meal however are silent on the sterilization/pasteurization step.
Your Doctor’s Orders teaches that “Within the U.S. Department of Agriculture (USDA), the entity responsible for this is the Food Safety and Inspection Service (FSIS). As with most government bodies, it has a scientific advisory panel that makes recommendations. The advisory panel found that the FSIS figures for poultry were way too high. The FSIS recommends temperature and time enough to kill 99.99999 percent of the bacteria but the panel recommended enough to kill 99.995 percent of the bacteria. At 122°F there are no bacteria that are pathogenic (cause illness) to humans that survive.” (see 3rd para.). Additionally, it is taught that at 150 degrees F. for 67 seconds this is enough time to have a 6.5 log lethality of bacteria (see chart).
Therefore, it would have been obvious to any person having skill in the art before the effective filing date to sterilize/pasteurize the blood meal for the instantly claimed temperatures and times because one would want to guarantee that the product was free of microorganisms and as Your Doctor’s Orders teaches, the temperature needed to kill any pathogenic bacteria would be 122 F and increasing the time and temperature would increase the lethality of any pathogens. It would have also been obvious to dry and grind the material at temperatures of about 90 degrees Celsius or below because at this temperature guarantees the killing of pathogenic microbes. Additionally, this parameter is an optimizable one in which any person having skill could perform without any undue experimentation. Also, as stated in the MPEP, section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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).”
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yamashita et. al. (US4666725A), Kim et. al. (Corn Particle Size and Nutritional Value of Simple and Comlex Diets for Nursery Pigs and Broiler Chicks, Asian-Aust. J. Anim. Sci. 2002. Vol 15, No. 6: 872-877), Oryschak et. al. (Effect of dietary particle size and nutrient supply on energy digestibility and nitrogen excretion in ileal cannulated grower pigs, Can. J. Anim. Sci., received 20 February 2002, accepted a8 June 2002) and Aaron Dodd et. al. (JP5906181B2) as applied to claims 1-5, 10, 12, and 19-21 above, and further in view of Lykken et. al. (US2963230A). This is a new rejection based on the arguments filed on 09/17/2025.
Yamashita, Kim and Oryschak’s combined art teach the method for producing blood meal however are silent on the mill having a classifying device allowing recirculation of coarse material into the mill.
Lykken’s general disclosure is to a dry material pulverizer with an integral classifier (see patent).
Lykken teaches of classifiers which can be coupled to vertical pulverizers and to dryer systems (see claims).
Lykken teaches “It is the principal object of this invention to provide classifier means integral with a vertical axis pulverizer providing for controlled air flow and scavenging effect in the grinding zone for continuous selective withdrawal of the finished material from the grinding zone into the classifier zone and the return of the oversize to the grinding zone” (see 2nd para.).
Therefore, it would have been obvious to any person having skill in the art before the effective filing date to use a classifier system which can recirculate coarse material back into the mill for further grinding into smaller particle sizes as Lykken teaches that this is what classifiers are intended for. Furthermore, if one were to want products with uniform particle size this step would assist in creating such a desired product.
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive. The applicant argues that Yamashita is not concerned with increasing lysine content bioavailability. Oryschak teaches wherein the digestible lysine content was retained in a process wherein particle size is reduced and teaches digestibility to be increased. Dodd teaches the use of jet mills increase solubility and bioavailability of active components and each art teaches using mills for creating blood products. One could easily rely on the art available to create the instant process for creating blood meal compositions.
The applicant argues that Yamashita is silent on the use of an ultra-flash dryer however this component is not claimed. The applicant argues that Yamashita doesn’t teach concurrently drying and grinding however Dodd teaches using a jet mill (air turbulence mill) and this mill would do the same as claimed.
The applicant argues that Kim’s teachings only pertain to corn, field peas and barely which are low in protein and although teaches including blood meal in complex pig diets does not discuss controlling the size of the blood meal. Dodd is also relied upon to show, additionally how to control for particle sizes using air mills and teaches wherein blood products are components useful in such process for increasing solubility and bioavailability of active components. Thus incorporating one of these air turbulence mills to concurrently dry and grind the blood meal to increase bioavailability would have been prima facie obvious.
Please note, since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Furthermore, the same taught process would be expected to create the same blood meal with an increased bioavailability. The art recognizes using jet mills for increasing the solubility and bioavailability of active ingredients so using the same for creating blood meal products with increased solubility and bioavailability is prima facie obvious.
Conclusion
No claims are 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.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/TERRY A MCKELVEY/ Supervisory Patent Examiner, Art Unit 1655