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
In applicant’s reply on 11/19/2024, the claims were amended. Based on these amendments, drawing objection and rejection under 35 U.S.C. 112 have been withdrawn. Revised rejections under 35 U.S.C. 103 can be found below.
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 18, 21-25, 27-30, 32, 34-35, and 37, 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Rajhoria (“Ghee”, in IDS filed 08/26/2021) in view of Mackereth (US 2013/0078356 A1, in IDS filed 01/09/2023), as evidenced by Anne (“What’s Really Happening When You Churn Butter?”).
Regarding Claim 18, Rajhoria teaches a method for producing ghee (method of ghee manufacture Pg. 1 Col. 2 Par. under “Method of Manufacture”; “Methods of AMF Production” Pg. 6 Col. 1; AMF can be used to make ghee Pg. 6 Col 2. Par. under “Uses of AMF”)
the method comprising: providing cream (cream separator Pg. 2 Col. 1 Par. Under “Creamery Butter Method”)
churning the cream to form butter (butter churn separator Pg. 2 Col. 1 Par. Under “Creamery Butter Method”)
melting the butter and heating the melted butter to a temperature of between 45 and 90°C (raise temperature to 90°C Pg. 2 Col. 2 Par. 2)
concentrating by centrifugal separation into an oil fraction as an intermediate product and a serum fraction (desludging by centrifugation to remove most of the aqueous phase Pg. 6 Col. 2 Par. 1)
boiling the oil faction (returned to heat exchanger for temperature adjustment; layer of fat is heated, usually to 110°C Pg. 2 Col. 2 Par. 2 under “Prestratification Method”). This temperature, 110°C, falls within the range applicant teaches for the boiling temperature of the oil, 100°C-130°C, in claim 23 below and the top of Pg. 6 of the specification filed 08/26/2021.
supplying at least one milk product to the oil faction (addition of skim milk or dahi powder Pg. 6 Col. 2 Par. under “Conversion of AMF to Ghee”)
and clarifying the boiled oil faction with the at least one milk product to produce ghee having a fat content of at least 99.0 wt.% (final clarification Pg. 2 Col. 2 Par. 2; fat content of AMF 99.3-99.8%, ghee 99.6% Table 2)
wherein immediately before or during the boiling of the oil faction, an amount of 0.5-10 wt.% of the at least one milk product is supplied to set a defined solids-non-fat content (addition of 5% dahi powder and heating the mixture to 120°C Pg. 6 Col. 2 Par. under “Conversion of AMF into Ghee”)
wherein the at least one milk product is previously separated skim milk, alpha serum, serum fraction, buttermilk, or of one or more further milk products (dahi powder Pg. 6 Col. 2 Par. under “Conversion of AMF into Ghee”)
wherein the method is a continuous method for producing ghee (continuous gheemaking first section of Pg. 3)
Regarding churning the cream to form butter and buttermilk, Rhajoria discloses using a churn to produce butter, but is silent regarding buttermilk. As evidenced by Anne, the process of churning butter produces buttermilk as a byproduct (cream separates into butter and buttermilk Par. 6 of reply), therefore the churning process of Rhajoria would additionally produce buttermilk.
Rhajoria does not teach performing phase inversion of the melted butter by shearing to form a serum-containing oil or an oil fraction as an intermediate product having a milk fat content less than 99.0 wt.%
Mackereth, in the same field of endeavor, teaches performing phase inversion by shearing to form a serum-containing oil (subjecting to shear forces to convert into a water-in-oil emulsion Par. 0007). Though Mackereth teaches phase inversion of cream rather than the phase inversion of butter of the invention, as Rhajoria teaches churning cream into butter, it would have been obvious to one having ordinary skill in the art to apply the phase inversion to the butter of Rhajoria.
and an oil fraction as an intermediate product having a milk fat content less than 99.0 wt.% (removing water resulting in a water-in-oil emulsion with 85-99.5% lipid Par. 0007).
It would have been obvious to one having ordinary skill in the art to modify the invention of Rhajoria with that of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping (Mackereth Par. 0006).
Regarding Claim 21, Rhajoria further discloses the melting of the butter takes place in a heat exchanger (melting by heat exchanger Pg. 6 Col. 1 “Semidirect process” Par. under “Methods of AMF Production”) but is silent regarding the type of heat exchanger.
Mackereth discloses a plate heat exchanger (steam heated plate heat exchanger Par. 0121). It would have been obvious to further modify the invention of Rhajoria and Mackereth with the plate heat exchanger of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping (Mackereth Par. 0006).
Regarding Claim 22, modified Rhajoria further discloses the butter is fed to the shearing via a container with agitator as intermediate buffer (pumped to agitated holding vats Pg. 6 Col. 2 “Indirect Process” Par. under “Methods of AMF Production”)
Regarding Claim 23, modified Rhajoria further discloses the boiling is performed in a tube or a boiling kettle at a temperature between 100-130°C (butter is pumped into ghee boiler Pg. 2 Col. 2 Par. 2; steam jacketed ghee kettle Pg. 2 Col. 1 Par. under “Creamery Butter Method”; layer of fat is heated, usually to 110°C Pg. 2 Col. 2 Par. 2 under “Prestratification Method”).
Regarding Claim 25, modified Rhajoria further discloses after concentrating or boiling, sediment is drained from a boiling kettle (ghee is pumped via an oil filter or clarifier into settling tanks Pg. 2 Col. 2 Par. 2). As the ghee is drained to the settling tanks, the sediment is caught in a filter, therefore the sediment is additionally drained from the ghee kettle.
Regarding Claim 27, Rhajoria does not disclose supplying the at least one milk product involves feeding serum fraction, buttermilk, skim milk, or alpha serum, which is previously separated by the steps of the method.
Mackereth discloses supplying the at least one milk product involves feeding serum fraction, buttermilk, skim milk, or alpha serum, which is previously separated by the steps of the method (cohesive mixture of concentrated milk fat and one or more milk powders Par. 0106; whole milk separated into skim milk and cream Par. 0118; skim milk may be dried to produce skim milk powder Par. 0116; Milk powder may be skim milk powder Par. 0055).
It would have been obvious to further modify the invention of Rhajoria and Mackereth with the milk product of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping (Mackereth Par. 0006).
Regarding Claim 28, Rhajoria further discloses the clarification is performed by a centrifuge (fed to a centrifuge to remove last traces of solids and reduce moisture (Pg. 6 Col. 2 Par. 1).
Regarding Claim 29, modified Rhajoria further discloses the steps a-g or a-h are performed successively (see rejection of claim 18)
wherein execution of the steps is performed in a plant having a plurality of machine elements (cream separator, butter churn, butter melting outfits, steam jacketed stainless steel ghee kettle with agitator and process controls, etc. Pg. 2 Col. 1 Par. under “Creamery Butter Method”)
wherein the plurality of machine elements are connected to one another to form a production line, such that the method steps a-g or a-h are carried out in the production line (pumps and pipelines interconnecting these facilities Pg. 2 Col. 1 final Par. – Col. 2 Par. 1).
Regarding Claim 30, Rhajoria discloses a method for producing ghee (method of ghee manufacture Pg. 1 Col. 2 Par. under “Method of Manufacture”; “Methods of AMF Production” Pg. 6 Col. 1; AMF can be used to make ghee Pg. 6 Col 2. Par. under “Uses of AMF”)
the method comprising: providing cream (cream separator Pg. 2 Col. 1 Par. Under “Creamery Butter Method”)
concentrating by centrifugal separation into an oil fraction as an intermediate product and a serum fraction (desludging by centrifugation to remove most of the aqueous phase Pg. 6 Col. 2 Par. 1)
boiling the oil faction (returned to heat exchanger for temperature adjustment; layer of fat is heated, usually to 110°C Pg. 2 Col. 2 Par. 2 under “Prestratification Method”)
supplying at least one milk product to the oil faction (addition of skim milk or dahi powder Pg. 6 Col. 2 Par. under “Conversion of AMF to Ghee”)
and clarifying the boiled oil with the at least one milk product to produce ghee having a fat content of at least 99.0 wt.% (final clarification Pg. 2 Col. 2 Par. 2; fat content of AMF 99.3-99.8%, ghee 99.6% Table 2)
wherein immediately before or during the boiling of the oil faction, an amount of 0.5-10 wt.% of the at least one milk product is supplied to set a defined solids-non-fat content (addition of 5% dahi powder and heating the mixture to 120°C Pg. 6 Col. 2 Par. under “Conversion of AMF into Ghee”)
wherein the at least one milk product is previously separated skim milk, alpha serum, serum fraction, buttermilk, or of one or more further milk products (dahi powder Pg. 6 Col. 2 Par. under “Conversion of AMF into Ghee”)
wherein the method is a continuous method for producing ghee (continuous gheemaking first section of Pg. 3).
Rhajoria does not disclose concentrating the cream to form a concentrated cream having a fat content of 65-85 wt.%, performing phase inversion of concentrated cream by shearing to form a serum-containing oil, or an oil fraction as an intermediate product having a milk fat content less than 99.0 wt.%
Mackereth, in the same field of endeavor, teaches concentrating the cream to form a concentrated cream having a fat content of 65-85 wt.% (high fat cream prepared from whole milk and low fat cream by known concentration methods Par. 0091; 70-85% lipid Par. 0026)
performing phase inversion by shearing to form a serum-containing oil (subjecting to shear forces to convert into a water-in-oil emulsion Par. 0007). Though Mackereth teaches phase inversion of cream rather than the phase inversion of butter of the invention, as Rhajoria teaches churning cream into butter, it would have been obvious to one having ordinary skill in the art to apply the phase inversion to the butter of Rhajoria.
and an oil fraction as an intermediate product having a milk fat content less than 99.0 wt.% (removing water resulting in a water-in-oil emulsion with 85-99.5% lipid Par. 0007).
It would have been obvious to one having ordinary skill in the art to modify the invention of Rhajoria with that of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping (Mackereth Par. 0006).
Regarding Claim 32, Rhajoria further discloses the boiling in step is performed in a tube or a boiling kettle at a temperature between 100-130°C (butter is pumped into ghee boiler Pg. 2 Col. 2 Par. 2; steam jacketed ghee kettle Pg. 2 Col. 1 Par. under “Creamery Butter Method”; layer of fat is heated, usually to 110°C Pg. 2 Col. 2 Par. 2 under “Prestratification Method”).
Regarding Claim 34, Rhajoria further discloses after concentrating or boiling, sediment is drained from a boiling kettle (ghee is pumped via an oil filter or clarifier into settling tanks Pg. 2 Col. 2 Par. 2). As the ghee is drained to the settling tanks, the sediment is caught in a filter, therefore the sediment is additionally drained from the ghee kettle.
Regarding Claim 35, Rhajoria does not disclose the concentration of the cream is performed at a temperature of 45-95°C.
Mackareth discloses the concentration of the cream is performed at a temperature of 45-95°C (centrifuged to separate into skim milk and cream Par. 0137; separated at 65°C Par. 0128). Though Mackareth is silent regarding the temperature while centrifuging to separate the skim milk and cream, one having ordinary skill in the art would reasonably use the temperature Mackareth provides for a similar separation. It would have been obvious to further modify the invention of Rhajoria and Mackereth with the separation process of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping Mackereth Par. 0006).
Regarding Claim 37, Rhajoria does not disclose the shearing is performed by a homogenizer or a shear pump.
Mackareth discloses the shearing is performed by a homogenizer or a shear pump (shearing in second step, second step using homogenizer Par. 0009). It would have been obvious to further modify the invention of Rhajoria and Mackereth with the homogenizer of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping Mackereth Par. 0006).
Regarding Claim 39, Rhajoria does not disclose supplying the at least one milk product involves feeding serum fraction, buttermilk, skim milk, or alpha serum, which is previously separated by the steps of the method.
Mackereth discloses supplying the at least one milk product involves feeding serum fraction, buttermilk, skim milk, or alpha serum, which is previously separated by the steps of the method (cohesive mixture of concentrated milk fat and one or more milk powders Par. 0106; whole milk separated into skim milk and cream Par. 0118; skim milk may be dried to produce skim milk powder Par. 0116; Milk powder may be skim milk powder Par. 0055).
It would have been obvious to further modify the invention of Rhajoria and Mackereth with the milk product of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping (Mackereth Par. 0006).
Regarding Claim 40, Rhajoria further discloses the clarification is performed by a centrifuge (fed to a centrifuge to remove last traces of solids and reduce moisture (Pg. 6 Col. 2 Par. 1).
Regarding Claim 41, modified Rhajoria further discloses the steps a-g or a-h are performed successively (see rejection of claim 30)
wherein execution of the steps is performed in a plant having a plurality of machine elements (cream separator, butter churn, butter melting outfits, steam jacketed stainless steel ghee kettle with agitator and process controls, etc. Pg. 2 Col. 1 Par. under “Creamery Butter Method”)
wherein the plurality of machine elements are connected to one another to form a production line, such that the method steps a-g or a-h are carried out in the production line (pumps and pipelines interconnecting these facilities Pg. 2 Col. 1 final Par. – Col. 2 Par. 1).
Claim 19, 31, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Rhajoria in view of Mackareth, further in view of Bell (“Is Whole Milk Better Than Low-Fat and Skim Milk?”)
Regarding Claim 19, Rhajoria discloses the cream has 25-45 wt.% fat (cream 35% fat Pg. 6 Col. 1 “Direct Process” Par. below “Methods of AMF Production”).
Rhajoria does not disclose the provision of cream involves providing whole or raw milk having 2-10 wt.% fat to cream and separating the whole or raw milk at a temperature of 4-65°C to form the cream
Mackareth discloses the provision of cream involves providing whole or raw milk to cream (high fat cream prepared from whole milk and low fat cream by known methods Par. 0091)
and separating the whole or raw milk at a temperature of 4-65°C to form the cream (centrifuged to separate into skim milk and cream Par. 0137; separated at 65°C Par. 0128). Though Mackareth is silent regarding the temperature while centrifuging to separate the skim milk and cream, one having ordinary skill in the art would reasonably use the temperature Mackareth provides for a similar separation. It would have been obvious to further modify the invention of Rhajoria and Mackereth with the separation process of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping Mackereth Par. 0006).
Mackareth is silent regarding the fat content of the whole milk.
Bell, in the same field of endeavor, discloses whole milk having 2-10% milkfat (3.25 % milkfat Pg. 2 Par. 4). It would have been obvious to modify the invention of Rhajoria and Mackereth with the milk fat content of Bell. One having ordinary skill in the art would have been motivated to make this modification to have a milk with higher omega-3 content (Bell Pg. 2 Table 1).
Regarding Claim 31, Rhajoria discloses the cream has 25-45 wt.% fat (cream 35% fat Pg. 6 Col. 1 “Direct Process” Par. below “Methods of AMF Production”).
Rhajoria does not disclose the provision of cream involves providing whole or raw milk having 2-10 wt.% fat to cream and separating the whole or raw milk at a temperature of 4-65°C to form the cream
Mackareth discloses the provision of cream involves providing whole or raw milk to cream (high fat cream prepared from whole milk and low fat cream by known methods Par. 0091)
and separating the whole or raw milk at a temperature of 4-65°C to form the cream (centrifuged to separate into skim milk and cream Par. 0137; separated at 65°C Par. 0128). Though Mackareth is silent regarding the temperature while centrifuging to separate the skim milk and cream, one having ordinary skill in the art would reasonably use the temperature Mackareth provides for a similar separation. It would have been obvious to further modify the invention of Rhajoria and Mackereth with the separation process of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping Mackereth Par. 0006).
Mackareth is silent regarding the fat content of the whole milk.
Bell, in the same field of endeavor, discloses whole milk having 2-10% milkfat (3.25 % milkfat Pg. 2 Par. 4). It would have been obvious to modify the invention of Rhajoria and Mackereth with the milk fat content of Bell. One having ordinary skill in the art would have been motivated to make this modification to have a milk with higher omega-3 content (Bell Pg. 2 Table 1).
Regarding Claim 36, Rhajoria does not disclose the concentration of the cream is performed starting from milk with a fat content of 2-10 wt.% to cream having a fat content of 65-85 wt.%.
Mackareth discloses the concentration of cream is performed starting from milk (high fat cream prepared from whole milk and low fat cream by known methods Par. 0091)
to cream having a fat content of 65-85 wt.% (high fat cream 70-85% lipid Par. 0026)
It would have been obvious to further modify the invention of Rhajoria and Mackereth with the separation process of Mackereth. One having ordinary skill in the art would have been motivated to make this modification to produce an improved alternative lipid product suitable for shipping Mackereth Par. 0006).
Mackareth is silent regarding the fat content of the whole milk.
Bell, in the same field of endeavor, discloses whole milk having 2-10% milkfat (3.25 % milkfat Pg. 2 Par. 4). It would have been obvious to modify the invention of Rhajoria and Mackereth with the milk fat content of Bell. One having ordinary skill in the art would have been motivated to make this modification to have a milk with higher omega-3 content (Bell Pg. 2 Table 1).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Rhajoria in view of Mackareth, further in view of Frey (“How to Make Butter”).
Regarding Claim 20, Rhajoria discloses the churning is performed by a churning machine (butter churn Pg. 2 Col. 1 Par. under “Creamery butter Method”).
Rhajoria does not disclose the temperature during churning.
Frey, in the same field of endeavor discloses churning at a temperature of 8-20°C (60-65°F (15.5-18.3°C) first Par. under “What You Need” after ingredients). It would have been obvious to modify the invention of Rhajoria and Mackereth with the churning temperature of Frey. One having ordinary skill in the art would have been motivated to make this modification to pick a temperature which is not cold to make it difficult to form globules, but also not too warm to make the butter too soft to manipulate (Frey first Par. under “What You Need” after ingredients).
Response to Arguments
Applicant's arguments filed 11/19/2024 have been fully considered but they are not persuasive.
Applicant argues there is no evidence in the record to conclude that one having ordinary skill in the art would have combined steps from the different methods described in Rajorhia. Though Rajoria discloses that the methods vary based on materials, intermediate steps, and scales of production, it is well within the skill of one having ordinary skill in the art to combine aspects of the different methods with reasonable expectation of success. As they are all taught within the same reference as valid methods to form ghee, one would have been motivated to try a combination of them.
Applicant further argues that it would not have been obvious to one having ordinary skill in the art to combine the ghee methods with the AMF methods of adding skim milk dahi or dahi powder and desludging. As with the above argument, the mere fact that the various methods are discosed in the same piece of art would have motivated one having ordinary skill in the art to try to combine method steps. Additionally, Rajorhia teaches addition of skim milk dahi or dahi powder to enhance the flavor (Pg. 6 “Conversion of AMF into Ghee section), which would be a desirable outcome regardless of SNF content. Rajorhia teaches desludging to remove solids (Pg. 5 Col. 2 Par. 1), which is also a step in the Creamery butter method of gheemaking performed with a ladle (Pg. 2 Col. 2 Par. 2). This similarity would have motivated one having ordinary skill to try the centrifuge of AMF rather than the ladle of ghee.
Applicant argues one would not have found it obvious to modify Rajorhia with the phase inversion of Mackereth because Mackereth discloses phase inversion of cream rather than butter. Rhajoria discloses raising the temperature of the butter as long as the moisture is driven off (Rhajoria Pg. 2 Col. 2 Par. 2). One having ordinary skill in the art would have recognized that the phase inversion of Mackereth as a precursor to the water removal and be motivated to try it on the butter of Rhajoria as it is a product of cream.
Applicant further argues the motivation for combining Mackereth and Rhajoria is flawed because the final products are not the same. The aspect of Mackereth to produce an improved alternative lipid product suitable for shipping would have motivated one having ordinary skill in the art to try to combine Mackereth and Rhajoria to attempt to achieve this same property in the ghee of Rhajoria.
Applicant argues Rajorhia’s disclosure of a continuos gheemaking process does not specifically involve the steps claimed and is therefore not obvious to apply. The examiner asserts that Rajoha’s inclusion of a continuous gheemaking section would have motivated one having ordinary skill in the art to apply it to the other method sections disclosed in order to overcome the problems of batch methods such as limitations on scale (Pg. 3 First Par. under “Continuous Gheemaking).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIEL M RODGERS whose telephone number is (571)272-7857. The examiner can normally be reached Monday - Friday 9:00 am - 6:00 pm.
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/A.M.R./Examiner, Art Unit 1792
/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758