DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 02/23/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-20
Withdrawn claims: None
Previously cancelled claims: None
Newly cancelled claims: None
Amended claims: None
New claims: None
Claims currently under consideration: 1-20
Currently rejected claims: 1-20
Allowed claims: None
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over All (“Whole Milk Powder Dairy”, 2015, All American Foods, Inc., https://web.archive.org/web/20150720020837/http://www.aafoods.com:80/whole-milk-powder-dairy/; previously cited) in view of Timmermans (WO 2017/086784; previously cited) and Schuck (Schuck, P., “Spray drying of dairy products: state of the art”, 2002, Lait, vol. 82, pages 375-382; previously cited) as evidenced by BETE (“Spray Dry Manual”, 2020, BETE Fog Nozzle, Inc.; previously cited).
Regarding claims 1, 3, 4, 5, 11, 12, 13, 14, and 15, All teaches a process for the preparation of a powder comprising bioactive molecules wherein the powder comprising bioactive molecules is whole milk powder containing bioactive molecules such as protein. All teaches that the process comprises spray drying pasteurized whole milk (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”; page 3, 2nd paragraph).
All does not specifically teach steps (a)-(e) of the method of present claim 1 or the transportation times recited in present claims 5, 11, 12, 13, 14, and 15.
However, Timmermans teaches a process for pasteurizing milk while preventing heat denaturation of the proteins in the milk to form a semi-finished product (abstract; page 8, lines 24-27; page 15, lines 16-24; page 15, lines 16-17) comprising the steps of: (a) providing milk; (b) pre-heating the milk to a temperature of from 20-70°C such as 40-60°C (page 16, lines 13-16); (c) transporting the pre-heated milk to a direct volumetric heater in the form of a pulsed electric field (PEF) apparatus; and (d) raising the temperature of the pre-heated milk to a temperature of below about 92°C such as below about 70°C (page 15, lines 30-33). This pre-heating temperature of 40-60°C and this heating temperature of about 70°C disclosed by Timmermans fall within the claimed ranges recited in steps (b) and (d) of present claim 1. The PEF apparatus renders the direct electric volumetric heater recited in step (d) of present claim 1 and recited in present claims 3 and 4 obvious. Timmermans also teaches that its process is continuous (page 7, lines 26-33); therefore, transporting the pre-heated milk to the PEF apparatus via a feeding line is rendered obvious.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the present invention to have modified the method of All by producing pasteurized milk using the process of Timmermans. Since All discloses that the milk is pasteurized prior to spray drying and that the milk contains proteins (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”; page 3, 2nd paragraph), but does not disclose a method of pasteurizing the milk, a skilled practitioner would have been motivated to consult an additional reference such as Timmermans in order to determine a suitable method of pasteurizing milk while preserving the proteins in the milk. Therefore, steps (a) and (b) of present claim 1 are rendered obvious.
All discloses that the pasteurized milk is spray dried (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”). The combination of All and Timmermans does not teach that the pre-heated milk is transported to the top of spray drying tower and then transported to a PEF apparatus that is located within the tower feeding line in the vicinity of an atomizer of a spray drying as recited by steps (c) and (d) of present claim 1. The combination of prior art also does not teach step (e) of present claim 1.
However, Schuck teaches that tower spray dryers are known in the art and that spray drying involves atomization of liquid (page 379, 1st column, 1st-2nd paragraphs). A composition may enter a spray drying tower through a spray nozzle located at the top or bottom of the spray chamber as evidenced by BETE (page 7, left column, paragraph under “2.9 Vertical dryer”). Therefore, Shuck is considered to teach that the liquid to be spray dried may be transported to the top of a spray drying tower and then transported to the atomizer of the spray dryer since entry to a spray dryer from the top or bottom of the dryer represents a finite number of identified, predictable solutions with a reasonable expectation of success. MPEP §2143.I.E.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the present invention to have modified the method of combined All and Timmermans by using a spray drying tower with an atomizer located at the top of the tower as taught by Schuck. Since All discloses that the pasteurized milk is spray dried (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”); and Timmermans teaches pasteurization of the milk using a PEF apparatus in a continuous method (page 7, lines 26-33; page 15, lines 30-33), but neither reference discloses a method of spray drying the pasteurized milk, a skilled practitioner would have been motivated to consult an additional reference such as Schuck in order to determine a suitable apparatus for spray drying milk. In consulting Schuck, the practitioner would find that the milk may enter the spray dryer through the top of spray drying tower via a tower feeding line and that the PEF apparatus may be located within the tower feeding line in order to maintain a continuous process as disclosed by Timmermans and as recited in steps (c) and (d) of present claim 1. The practitioner would also find that the milk may be transported via the tower feeding line from the PEF apparatus to the atomizer of the spray dryer in order to maintain a continuous process as disclosed by Timmermans and as recited by step (e) of present claim 1.
Furthermore, in regard to the PEF apparatus being located at the top of the spray drying tower in a vicinity of the atomizer of the spray dryer that allows the liquid composition to move from the heater to the atomizer in less than 40 seconds as recited in step (d) of the process, the phrase “top of the spray drying tower” is defined as “a location in the vicinity of the atomizer […] such that the liquid composition can move from the heater to the atomizer within a short time frame” on page 4, lines 25-27 in the present specification. Therefore, the heater does not necessarily need to be located above the spray dryer. Furthermore, the term “allows” in the phrase “allows the liquid composition to move from the heater to the atomizer in less than 40 seconds” means that the composition is not required to actually move from the heater to the atomizer in less than 40 seconds, but have the ability to do so. Therefore, the combination of prior art is considered to render steps (c) and (d) of present claim 1 obvious.
In regard to transporting the milk from the PEF apparatus to the atomizer within less than 40 seconds, 20 seconds, 15 seconds, 10 seconds, 5 seconds, 2 seconds, or 1 second as recited in present claims 1, 5, 11, 12, 13, 14, and 15, respectively, Timmermans teaches that the temperature of the milk and the time at which the milk is exposed to the temperature are kept low so as not to denature the proteins in the milk or cause an unwanted reduction of fresh flavors (page 8, lines 12-16). Timmermans discloses that the pasteurized product is cooled as soon as possible after exposure to PEF heating to prevent the aforementioned detrimental conditions from occurring; and discloses cooling of the product within 3 seconds after the milk is exposed to the PEF (page 16, lines 1-6, 18-21). This disclosure would motivate a skilled practitioner to move the milk from the PEF apparatus to the atomizer within 3 seconds in order to allow the milk to cool within the 3 second time frame. This disclosed time of “within 3 seconds” falls within the timeframes recited by present claims 1, 5, 11, 12, and 13 and encompasses the timeframes recited by present claims 14 and 15.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I. Therefore, the combination of prior art renders step (e) of present claim 1 and the timeframes recited in present claims 5, 11, 12, 13, 14, and 15 obvious.
Regarding claims 2, 9, 10, 18, 19, and 20, All teaches the invention as described above in claim 1, including the liquid composition comprising bioactive molecules is whole milk; and that the powder produced from the liquid composition comprising bioactive molecules is whole milk powder (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”). Therefore, the bioactive molecules are ones naturally occurring in milk as recited by present claim 2; the liquid composition is whole milk as recited in present claims 9 and 18; and the dairy product made from the liquid composition is whole milk powder as recited by present claims 10, 19, and 20.
Regarding claims 6, 7, 8, 16, and 17, All teaches the invention as described above in claim 1, including the liquid composition comprising bioactive molecules is milk (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”). It is known in the art that milk naturally contains glycomacropeptides, α-lactalbumin, β-lactoglobulin, and the immunoglobulin proteins IgA and IgG. Therefore, the prior art renders claims 6, 7, 8, 16, and 17 obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-20 over All, Timmermans, and Schuck as evidenced by BETE: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant argued that the combination of All, Timmermans, Schuck, and BETE fails to render obvious a process for the preparation of a powder wherein the method employs a heater placed within the tower feeding line in a vicinity of an atomizer as presently claimed. Applicant argued that Timmermans teaches cooling a heated liquid product immediately after PEF treatment so that Timmermans’s process is a standalone pasteurization process and not a process step that occurs prior to spray drying (Applicant’s Remarks, page 6, 1st paragraph under section II – page 7, 4th paragraph).
However, the Examiner points out that Timmermans teaches that its pasteurization process may be used on a semi-finished product (page 11, lines 10-16; page 15, lines 12-17). Since “semi-finished” means that the product is not yet finished after applying the pasteurization process of Timmermans, Timmermans at least suggests that the food product undergoes at least one further processing step in order to become a finished product. Therefore, Applicant’s assertion that the pasteurization process of Timmermans is a standalone process and not a process that occurs prior to the spray drying step of All is not supported.
Applicant then argued that Schuck and BETE fail to disclose or suggest that a heater is positioned within the tower feeding line in the vicinity of an atomizer so that the liquid composition can move from the heater to the atomizer within less than 40 seconds. Applicant argued that Schuck and BETE do not disclose any tower feeding line configuration or integration of a heater within the tower feeding line. Applicant argued that the Office’s conclusion that a skilled practitioner would place the PEF apparatus of Timmermans within the tower feeding line in the vicinity of the atomizer does not follow from any teaching or suggestion in the cited references and thus appears to be based on improper hindsight. Applicant argued that the specific placement of the heater in the vicinity of the atomizer so as to permit the transportation of the liquid composition from the heater to the atomizer within less than 40 seconds is a key feature of the claims. (Applicant’s Remarks, page 7, 5th paragraph – page 8, 2nd paragraph; page 9, 4th paragraph – page 10, 1st paragraph).
However, as described above in the rejection of present claim 1, since All discloses that the pasteurized milk is spray dried (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”); and Timmermans teaches pasteurization of the milk using a PEF apparatus in a continuous method (page 7, lines 26-33; page 15, lines 30-33), but neither reference discloses a method of spray drying the pasteurized milk, a skilled practitioner would have been motivated to consult an additional reference such as Schuck in order to determine a suitable apparatus for spray drying milk. Schuck teaches that spray drying involves atomization of liquid (page 379, 1st column, 1st-2nd paragraphs); and a composition may enter a spray drying tower through a spray nozzle located at the top or bottom of the spray chamber as evidenced by BETE (page 7, left column, paragraph under “2.9 Vertical dryer”). Therefore, Shuck is considered to teach that the liquid to be spray dried may be transported to the top of a spray drying tower and then transported to the atomizer of the spray dryer since entry to a spray dryer from the top or bottom of the dryer represents a finite number of identified, predictable solutions with a reasonable expectation of success. MPEP §2143.I.E.
In consulting Schuck, the practitioner would find that the milk may enter the spray dryer through the top of spray drying tower via a tower feeding line and that the PEF apparatus may be located within the tower feeding line in order to maintain a continuous process as disclosed by Timmermans. The practitioner would also find that the milk may be transported via the tower feeding line from the PEF apparatus to the atomizer of the spray dryer in order to maintain a continuous process as disclosed by Timmermans. Therefore, the combination of All, Timmermans, and Schuck as evidenced by BETE at least suggests that a heater is positioned within the tower feeding line in the vicinity of an atomizer as presently claimed, thereby disclosing a tower feeding line configuration and integration of a heater within the tower feeding line.
In regard to the combination of prior art disclosing transporting the milk from the PEF apparatus to the atomizer within less than 40 seconds, Timmermans teaches that the temperature of the milk and the time at which the milk is exposed to the temperature are kept low so as not to denature the proteins in the milk or cause an unwanted reduction of fresh flavors (page 8, lines 12-16). Timmermans discloses that the pasteurized semi-finished product is cooled as soon as possible after exposure to PEF heating to prevent the aforementioned detrimental conditions from occurring; and discloses cooling of the product within 3 seconds after the milk is exposed to the PEF (page 11, lines 10-16; page 16, lines 1-6, 18-21). This disclosure would motivate a skilled practitioner to move the semi-finished pasteurized milk from the PEF apparatus to the atomizer within 3 seconds in order to allow the milk to cool within the 3 second time frame so as to form the finished spray dried pasteurized milk disclosed in All (page 2, 1st paragraph under “Manufacturer of Whole Milk Powder Dairy Replacers”; page 3, 2nd paragraph). This disclosed time of “within 3 seconds” falls within the claimed 40 second timeframe.
Applicant then argued that the Office has not identified a legally sufficient rationale for modifying the references to result in the claimed method, but instead bases conclusions on improper hindsight (Applicant’s Remarks, page 8, 3rd paragraph – page 9, 2nd paragraph).
However, the Examiner states the sufficient legal rationale for combining each of the references in the claim rejections above and reiterates some of the rationales in Examiner’s responses to Applicant’s arguments above.
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant then argued that the Office’s contention that a skilled practitioner would place the PEF apparatus within the tower feeding line in order to maintain a continuous process is unsupported by the cited prior art because the continuity described in Timmermans refers to the flow of liquid through the PEF apparatus itself, not continuity of downstream spray drying equipment (Applicant’s Remarks, page 9, 3rd paragraph).
However, the Examiner points out that Timmermans teaches that the upstream process(es) bringing the liquid composition to the PEF apparatus is/are continuous (corresponding to “continuously supplying the liquid product to the inlet of the apparatus”); and teaches that the flow of the liquid product through the PEF apparatus is continuous (corresponding to “continuously […] flowing the liquid product through the apparatus”) (page 7, lines 32-33). Since the upstream process(es) is/are continuous and the heating process is continuous, it would be obvious for the downstream process(es) (i.e., spray drying) to also be continuous, especially wherein making a process continuous is obvious. MPEP §2144.04.V.E. For at least these reasons, the Office’s contention that a skilled practitioner would place the PEF apparatus within the tower feeding line in order to maintain a continuous process is sufficiently supported by the cited prior art.
Applicant then argued that Timmermans teaches away from the claimed configuration as Timmermans teaches active cooling of the heated liquid composition immediately after flowing through the PEF apparatus, preferably within 3 seconds of leaving the PEF apparatus. Applicant argued that atomization in a hot spray drying chamber is not a cooling step so that Timmermans’ discussion of rapid cooling of the liquid product within three seconds provides no guidance to a skilled practitioner regarding placement of a heater within the vicinity of the spray dryer atomizer. Applicant argued that the process of Timmermans is incompatible with subsequent and immediate spray drying and that a skilled practitioner would recognize that Timmermans is directed to producing liquid, cooled end products (Applicant’s Remarks, page 10, 2nd paragraph – page 11, 1st paragraph).
However, as described in Examiner’s responses above, Timmermans teaches that its pasteurization process may be used on a semi-finished product (page 11, lines 10-16; page 15, lines 12-17). Since “semi-finished” means that the product is not yet finished after applying the pasteurization process of Timmermans, Timmermans at least suggests that the food product undergoes at least one further processing step in order to become a finished product. Therefore, Timmermans is not solely directed to producing liquid, cooled end products as is asserted by the Applicant. Furthermore, a skilled practitioner would be motivated to complete any subsequent processing steps which involved temperatures above ambient temperature within the preferable 3 second timeframe disclosed by Timmermans.
In response to Applicant’s assertion that Timmermans teaches active cooling of the heated liquid composition immediately after flowing through the PEF apparatus, preferably within 3 seconds of leaving the PEF apparatus, Timmermans discloses an option for active cooling (page 16, lines 21-27), but does not require active cooling. Although atomization during spray drying is not a cooling step, spray dried particles are typically cooled after the atomization, especially wherein a reference for a method comprising the spray drying, such as the Timmermans reference, teaches cooling after pasteurization of the liquid used to form the spray dried particles.
For at least these reasons, the cited prior art provides guidance to a skilled practitioner regarding placement of a heater within the vicinity of the spray dryer atomizer so as to transport a liquid composition from a heater to the atomizer within 40 seconds. As such, Timmermans is not incompatible with subsequent and immediate spray drying; and Timmermans does not teach away from the claimed method.
Applicant then argued that positioning the heater within the tower feeding line in the vicinity of the atomizer such that the liquid composition can move from the heat to the atomizer within less than 40 seconds as presently claimed unexpected and advantageously permitting pasteurization of the liquid composition without causing denaturation of bioactive molecules. Applicant stated that in order to produce powders of dairy products, the products are typically subjected to: pasteurization at least 72°C for at least 15 seconds; transportation via a tower feed line to the top of a spray-drying tower; and then atomization in the spray dryer. Applicant stated that the product remains around 72°C as the product is transported from the heater to the atomizer so that the product remains at a temperature of at least 72°C for at least a minute due to pasteurization and transportation. Applicant stated that denaturation of most bioactive proteins begins at temperatures above 65°C so that the product may experience significant denaturation during the at least one minute spent at a temperature of at least 72°C. Applicant stated that the extent of denaturation of bioactive molecules depends on the temperature and the time which the product is held at this temperature. Applicant stated that by positioning the heater in the vicinity of the atomizer so that transportation between the heater and the atomizer occurs in less than 40 seconds, the inventors found that the extent of denaturation may be decreased. Applicant pointed to the results of Processes 1-3 in Table 2 of the present specification to demonstrate retention of bioactive molecules by the claimed process and comparative processes. Applicant stated that these vast improvements in bioactive preservation are directly attributable to the placement of the heater within the tower feeding line in the vicinity of the atomizer, which is not taught or suggested by the cited prior art references (Applicant’s Remarks, page 11, 2nd paragraph – page 13, 3rd paragraph).
However, the Examiner points out that the Applicant discloses that the claimed process is known in the art, with the exception being that the liquid composition in the typical process is transported from the heater to the atomizer within about 45 seconds (i.e., the about one minute minus the at least 15 seconds for pasteurization) (Applicant’s Remarks, page 11, 3rd-4th paragraphs). It is unclear as to how Applicant arrived at this timeframe of about 45 seconds as the transportation time between the heater and atomizer is based upon distance between the two locations and the flow rate. Flow rate is known to be a variable which is easily manipulated by an operator and there is no flow rate nor distance between a heater and atomizer that is required in the art (e.g., the distance between the two locations may be 2 meters and the flow rate may be 1 meter per second, thereby providing a transportation time of 2 seconds; or the distance between the two locations may be 1 meter and the flow rate may be 0.5 meters per second, thereby also providing a transportation time of 2 seconds).
Furthermore, the extent of denaturation of bioactive molecules being determined by temperatures above 65°C and time spent at that temperature is known in the art as disclosed by Timmermans (page 8, lines 12-18, 20-28; page 17, 5-13). Reducing the temperature and/or reducing the time of exposure of the bioactive molecules to denaturation temperatures as a method of preventing denaturation is also known in the art and disclosed in the cited prior art (Timmermans, page 8, lines 24-27; page 17, 9-13). Such knowledge in the field of the art and teachings from the cited prior art would motivate a skilled practitioner to keep the exposure of the bioactive molecules to denaturation temperatures as short as possible, which includes timeframes of less than 40 seconds such as the exemplified 3 seconds disclosed by Timmermans (page 16, lines 20-21). For at least these reasons, Applicant’s assertion that the results of the claimed method are unexpected and not disclosed by the cited prior art are not supported.
Since the prior art has been shown to render the present claims obvious and Applicants arguments have been shown to be unpersuasive, the rejections of the claims are maintained as written herein.
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.
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/KELLY P KERSHAW/Examiner, Art Unit 1791
Prosecution Insights