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 .
Claim Objections
Claims 28, 48, 50, 52 and 58 are objected to because of the following informalities:
Regarding claim 28, in line 2 before “remote” delete “a” to place the claim in better form.
Before “Bacillus cereus” delete “comprises” and amend to instead recite “comprise”.
In the clause starting with “preheating” delete “deareated” and amend to instead recite “deaerated”.
In the clause starting with “preheating”, delete “; wherein the countercurrent ultra-high temperature sterilization includes:” and amend to instead recite “comprising” to place the claim in better form.
After the first recitation of “130oC and 150oC”, delete “for a duration of 3 seconds to 15 seconds” since the same limitation was already presented in the later recited “holding” clause. The amendment is redundant, does not significantly add to the claim, and thus should be removed.
After “wherein the processed fortified human milk” delete “has” and amend to instead recite “product comprises”.
In the second to final clause, after “(ii) a Bacillus cereus” amend the term “content” to remove italics. In the same clause amend “1000” to instead recite “1,000”.
In the final clause, after “100” delete “g” and amend to instead recite “grams” for consistency.
Regarding claim 48, before “fortified” insert “first volume of the” to place the claim in better form and consistency with the language of claim 28.
Regarding claim 50, delete “protein” and amend to instead recite “composition” for consistency with claim 28.
Regarding claim 52, in line 1 after “suitable for” delete “a” to place the claim in better form.
Before “Bacillus cereus” delete “comprises” and amend to instead recite “comprise”.
Before “standardized human milk sample” insert “a” to place the claim in better form.
In the clause starting with “wherein the countercurrent…” delete “includes” and amend to instead recite “comprises” to place the claim in better form.
Regarding claim 58, amend “1000” to instead recite “1,000” to place the claim in better form.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28, 37, 41 and 44-60 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 28, the limitation “a presterilized human milk sample” renders the claim indefinite since it is unclear what the limitation is referring to. The previous limitation obtains a “clarified human milk sample”, and there is no indication if the “presterilized” sample is intended to be the “clarified” sample, or some other part of the raw human milk. It is further unclear if the term “presterilized” means “prior to sterilization”, or “already sterilized”. In the case that the “fortifying” is performed on the “clarified human milk sample” obtained by the preceding “eliminating” limitation, the rejection can be overcome by amending “a presterilized” to instead recite “the clarified” for consistency of language.
Regarding claim 46, the limitation “a preheating step” renders the claim indefinite since the antecedent basis is ambiguous. It is unclear if the limitation is referring to the “preheating” of claim 28, or a separate preheating step. In the case that the limitation refers to that of claim 28, the rejection can be overcome by deleting “a preheating step” and amending to instead recite “the preheating”.
Regarding claim 52, the claim is rendered indefinite since the preamble recites a method for producing “a processed fortified human milk product”, but it is unclear from the body of the claim at which point said product is actually obtained. It is noted that claim 28 positively recites “cooling…to produce the processed fortified human milk product”. The rejection can be overcome by inserting the limitation “to produce the processed fortified human milk product” after “a cooling medium”.
The limitation “a presterilized human milk sample” renders the claim indefinite for the same reason stated for claim 28. It is unclear if the limitation in question is referring to the “standardized human milk sample” recited in the previous clause, or some other feature. The rejection can be overcome by amending “a presterilized” to instead recite “the standardized”.
Regarding claim 57, the claim is rendered indefinite since it is unclear at which point the claimed C. botulinum content reduction is actually obtained. It is unclear if the 12 log reduction is obtained after e.g., the “eliminating” step, the “engineering step”, the “preheating” and “heating steps, or the “cooling” step. The rejection can be overcome by inserting “of the processed fortified human milk product” after “content”.
Regarding claim 58, the claim is rendered indefinite for the same reason stated for claim 57. The rejection can be overcome by inserting “of the processed fortified human milk product” after “content”.
Regarding claim 60, the limitation “the second volume” lacks antecedent basis and therefore renders the claim indefinite. Claim 28 recites “deaerating a first volume”, but does not recite or otherwise indicate a “second volume”. It is unclear what “the second volume” refers to since there is no prior recitation of said feature in claims 28 and 46.
Claims 37, 41, 44-45, 47-51, 53-56 and 59 are rejected by virtue of their dependence on a rejected base claim.
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 28, 37, 41, 44-45, 47-52 and 54-59 are rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. (US 8,329,237 B2) in view of Carrigan et al. (US 2012/0040052 A1), Hoffmann (US 2014/0348998 A1), Fournell et al. (US 2013/0059050 A1), Graves (US 2,772,979 A), Stovring et al. (US 2014/0345836 A1), and Engineers Edge NPL.
Coyne et al. (US 2014/0141137 A1) and Scientist NPL are relied on as evidence for claim 28, and Heat Transfer NPL is relied on as evidence for claim 45.
Regarding claim 28, Maron et al. teaches a sterilized liquid milk product and a process for producing said product (abstract; column 3 lines 27-34), where the milk source can be human milk (column 3 lines 65-66), necessarily obtained from one or more human donors, where the milk to be treated is “raw” (column 2 lines 66-67), comprising concentrating the milk followed by pre-heating and UHT treatment to obtain a sterilized human milk product, the pre-heating comprising raising the temperature of the milk to 177oF/ 80.6oC in a short period of time (column 7 lines 8-20), the UHT treatment comprising further heating the pre-heated milk to a temperature of 288oF/142.2oC within a short period of time (column 7 lines 24-29), then holding said temperature for a period of 4-6 seconds to obtain sterility while avoiding a “burnt” flavor and maintaining the structural integrity of the milk (column 3 lines 6-12; column 7 lines 30-33), and cooling the milk to produce the sterilized human milk product (column 8 lines 11-18). See also example 1 (column 9 lines 10-20).
Regarding the product being “suitable for a remote consumption by an infant or a premature infant” Maron et al. teaches the sterilized milk product is packaged using an aseptic filter for extended shelf stability (column 8 lines 27-34), and therefore would have “suitable for remote consumption” by an individual at a later time. The individual being an infant or premature infant would have been obvious based on the desired application of the product, nutritional needs of the infant, and the nutritional content of the sterilized milk product.
Maron et al. does not teach removing a fraction of pathogens comprising bacterial, molds, and spores of B. cereus and C. botulinum from the raw human milk by performing one or more clarification processes using one or more centrifugal clarifiers to produce a clarified human milk sample.
Carrigan et al. teaches a process for preparing a mammalian milk product (abstract), the mammal including humans (paragraph 63). The process includes bactofugation to separate microorganisms and heat-resistant spores from the milk, where the process “can make a useful complement to…sterilization” (paragraph 143). The bactofugation is construed to read on the claimed “centrifugal clarifiers” since they are disclosed to perform the same function.
Hoffmann teaches a process for treating milk (abstract), including human milk (paragraph 52), where the milk is treated to reduce pathogens and then aseptically packaged in any suitable container such as a bag such that extended shelf life is achieved (paragraphs 130 and 132-133). The treatment to reduce pathogens includes bactofugation, which separates bacteria and spores from the milk to form a fraction that is “more or less free from bacteria”, where multiple bactofuges in series can be employed for the process (paragraphs 76-77). Physical separation and removal of microorganisms from the milk provide the advantage of significantly reducing biofilm formation in down-stream portions of the processing plant, which in turn facilitates cleaning (paragraph 78). The type of filtration and associated membrane pore size can be adjusted such that they retain “most of the microorganisms of the milk derivative with substantially no alteration of the protein composition of the milk” (paragraph 85). An example of suitable microfiltration solutions for bacteria and spore removal result in more than 99.9% removal of bacteria and spores from the milk (paragraph 87).
While Carrigan et al. and Hoffmann do not explicitly disclose C. botulinum, B. cereus, and their spores, the references still recognize that pathogens and spores are essentially eliminated from the milk by a clarification process such as bactofugation. The claimed bacteria are known to one of ordinary skill in the art to be pathogenic bacteria associated with food spoilage and foodborne disease as evidenced by Coyne et al. (paragraph 64), and therefore understood to be desirable targets to be removed from the milk. Applicant’s specification states that C. botulinum and B. cereus are removed by a similar centrifugal filtration device or a plurality thereof (paragraphs 71-72). Since the prior art teaches multiple bactofugation devices can be used together (Hoffmann), one of ordinary skill in the art would have reasonably expected multiple bactofugation steps to be capable of removing a significant fraction of pathogens within the raw milk.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to remove pathogens including bacteria, mold, and C. botulinum and B. cereus spores from the raw milk using one or more centrifugal clarifiers to produce a clarified human milk sample prior to UHT treatment since the reference already contemplates filtration-type processes (column 6 lines 10-32) prior to sterilization, since the prior art acknowledges using such a process for eliminating pathogens from human milk, and recognizes that bactofugation is complementary to sterilization, since Hoffmann teaches filter pore size can be controlled to provide a desired degree of microorganism exclusion (paragraph 85), in order to reduce biofilm formation in downstream devices, thereby reducing cleaning and other maintenance requirements, and to ensure product quality, safety, and extend shelf life.
Maron et al. does not teach fortifying “a part of a presterilized human milk sample” with supplemental nutrients comprising one or more of colostrum, vitamins, minerals, and a free amino acid high net nitrogen utilization (NNU) composition, to achieve one of a target characteristic of the fortified sample or a target concentration of a component in the sample. In view of the rejection under 35 USC 112(b) above, the limitation “a part of the presterilized human milk sample” is interpreted to be the “clarified human milk sample” obtained in the preceding “eliminating” step. The claim recites alternatives. For the sake of examination, the alternatives “vitamins” and “minerals” are chosen. The alternatives of “colostrum” and “NNU composition” are therefore construed to be not required by the claimed method.
Fournell et al. teaches a method for treating raw human milk to produce a treated human milk having undetectable levels of bacteria (abstract), where the reference acknowledges that “variability of human milk vitamin and mineral concentrations and the increased needs of the preterm infant requires minimal fortification to [ensure] that a developing infant is receiving adequate amounts of vitamins and minerals” (paragraph 58). The appropriate level of vitamins and minerals required for the infants is construed to be a “target characteristic” or a “target concentration” of said substances.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Maron et al. to fortify a part the clarified human milk sample with vitamins and/or minerals to achieve a target characteristic since the reference suggests addition of further ingredients prior to sterilization (column 6 lines 57-59), since the prior art recognizes that vitamin and mineral variability exists within human milk, since there is no evidence of record indicating that the required and components yield unexpected results, and therefore to ensure the product has sufficient amounts of said components as needed by the consumer. It is noted that Maron et al. is directed to a continuous process (column 5 lines 29-32). Thus, fortifying “a part” of the clarified sample would have been obvious based on known features such as capacity of downstream units/processes, and to allow subsequent portions of the sample to be fortified differently as needed for different applications and intended users.
Maron et al. does not teach deaerating a first volume of the fortified clarified human milk sample.
Carrigan et al. further teaches subjecting human milk to vacuum deaeration to remove bulk air (paragraph 124).
Graves teaches a method for processing milk products (column 1 lines 15-16), where the method includes deaeration such that the process “excludes oxidation …for its greater stability and capacity to remain unchanged during storage” (column 20 lines 42-44 and 55-58). The deaeration occurs before heat treatment (column 18 lines 67-68).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to deaerate the fortified clarified milk to remove gasses since the process is recognized to remove unwanted air and oxygen from the milk, thereby minimizing oxidation and facilitating preservation thereof.
Maron et al. does not teach sterilization comprises countercurrent heating in a tube at the sterilization temperature while flowing the milk through the tube in a first direction, the tube heated by flowing heating fluid in a second direction counter to the first direction, wherein the heating fluid is in contact with an exterior surface of the tube.
However, the reference states that sterilization can be achieved by any conventional sterilization method such as passing the milk over one or more conventional heat exchangers (column 6 lines 60-65).
Stovring teaches a heat exchanger for heating liquid products using heat transfer media (abstract), including liquid foods (paragraph 25), where the heat exchanger comprises a tube 30 which transports the liquid product from an inlet 33 to an outlet 34 and then to further processing equipment (figure 1; paragraph 49), and a vessel 20 for transporting heat transfer media from inlet 21 to outlet 22 (paragraph 43). Since the inlet 21 of the heat transfer media is on the opposite end of the exchanger from inlet 33 of the food product, and visa-versa for the respective outlets, heat transfer media flows in a counter direction to that of the liquid product (figure 1). The heat transfer media flows in contact with the exterior surface of tube 30 (paragraph 50). The tube 30 forms a plurality of loops dependent on the desired amount of heat transfer (paragraph 51).
Engineers Edge NPL shows that counter-flow is a common method of heat exchange (page 1 second paragraph), and that counter-flow heat exchange provides advantages over parallel heat exchange, including more uniform temperature difference between the fluids to minimize thermal stresses, the outlet temperature of the cold fluid can approach the highest temperature of the hot fluid (in parallel flow the cold fluid never exceeds the lowest temperature of the hot fluid as stated in page 1), and more uniform rate of heat transfer throughout the exchanger (page 2 “figure 10” and second paragraph).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to heat the fortified milk in a tube and to flow heating fluid counter to the flow of milk as claimed since the reference does not particularly limit the sterilization method and teaches that known heat exchangers/methods can be used, since counter-flow heat exchange is a commonly used method, since there is no evidence of criticality or unexpected results associated with the claimed features, to minimize thermal stresses on the milk, and to provide more uniform rate of heat transfer.
Further, adjusting the sterilization temperature and holding duration in view of the modification above would have been within the capability of one of ordinary skill based on the stated findings, especially since Maron et al. does not particularly limit the sterilization heating parameters (column 6 lines 66-67), since there is no evidence of criticality or unexpected results associated with the claimed feature, and such the values would have been used during routine experimentation and optimization procedures due to factors such as pathogen inactivation, aroma, flavor, and texture/mouthfeel (column 10 lines 30-31).
Maron et al. does not teach the commercially sterilized human milk product has a C. botulinum content of at least 12 log reduction and a B. cereus content of at least 1,000 log reduction than that in the raw milk.
However, the combination of Maron et al. with Hoffmann above includes one or more bactofugation steps followed by commercial sterilization, which one of ordinary skill would have expected to result in a sterilized human milk product that is essentially free of pathogens, including the claimed bacteria and their spores.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to obtain the claimed reduction values since the prior art recognizes the advantages associated with removing pathogens and the devices/methods for such removal, since Applicant has not persuasively shown unexpected results associated with the claimed features, and since the values would have been used during the course of routine experimentation and optimization procedures due to factors such as reduction of downstream biofilm formation, shelf life, intended consumer e.g., immunocompromised individuals, and consumer safety.
Maron et al. does not teach a protein content measured according to AOAC 992.23 with factor 6.38 in a range of 6 to 9 grams per 100 grams of the processed fortified human milk product. It is noted that Applicant’s specification recites the protein content can be obtained by fortification (paragraph 147).
Fournell et al. further teaches protein content can be adjusted by adding protein from known sources (paragraph 50), where the fortifier itself contains about 20-70 mg/ml protein (paragraph 59).
Scientist NPL is relied on as evidence to show that AOAC method 992.23 is a known method of protein determination by combustion, where the factor can be changed in accordance with the food type (page 2).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Maron et al. to fortify the milk to include the claimed range of protein content for the same reasons stated in the above stated fortification modification, thereby ensuring optimal nutritional content for an intended user. The claimed measurement method does not appear to be critical, and therefore would have also been obvious as a preferred method of determining protein content based on known methods and standards.
Regarding claim 37, Maron et al. teaches the milk to be treated can be fortified with a stabilizer such as carrageenan or phosphate salts (column 5 lines 6-7), where carrageenan is both a carbohydrate and an oligosaccharide, and phosphate salts are ionic salts.
Regarding claim 41, Maron et al. teaches the sterilized milk is subsequently sent to an aseptic filler, and therefore packaged through an aseptic process (column 8 lines 24-32).
Regarding claim 44, Maron et al. teaches cooling the sterilized milk by transferring to a flash chamber down leg, followed by further cooling (column 7 lines 61-67; column 8 lines 11-18). The cooling “may be achieved by any conventional means”, where a preferred method is accomplished through a heat exchanger”. The cited cooling steps do not require vacuum to remove steam.
Regarding claim 45, Maron et al. teaches maintaining a desired temperature for a predetermined time for sterility as stated for claim 28 above, but does not teach the length of the tube and flow rate of the milk are chosen for holding the milk at the temperature and duration as claimed.
Stovring teaches the tube 30 carrying the liquid product forms a plurality of loops dependent on the desired amount of heat transfer (paragraph 51). Increasing or decreasing the number of loops would naturally also increase or decrease the length of the tube.
Heat Transfer NPL is relied on as evidence to teach that heat transfer rate in a heat exchanger is a function of the flow rate of the heating fluid, modeled by the equation Q = mH * CpH (THin – THout) = mC * CpC (TCout – TCin), where mH is the mass flow rate of the hot fluid and mC is the mass flow rate of the cold fluid (page 4).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to choose the length of tube and flow rate of milk to hold the milk within the temperature range for the duration since adjusting tube length and material flow rate to achieve a desired heat transfer is known, to ensure sterility of the milk is achieved, thereby ensuring product safety and shelf life, to apply a known technique (adjusting tube length and flow rate of a heat exchanger) to a similar and known product/process (heat exchanger in a milk sterilization process) ready for improvement to yield predictable results in similar adjustments to the amount and rate of heat transfer between the heating medium and milk, see MPEP 2143.I.C-D, and since the claimed parameters would have been subjected to routine experimentation and optimization procedures due to said factors of degree of heat transfer, sterility, and shelf life.
Regarding claim 47, Hoffmann as applied to claim 28 teaches that bactofugation separates bacteria and spores from the milk to form a fraction that is “more or less free from bacteria”, where the process can be performed with a single bactofuge (paragraphs 76-77).
While the reference does not explicitly teach a single bactofuge removing up to 90% of pathogens in the raw milk, the claimed feature would have been obvious based on the characteristics of the particular bactofuge, the parameters of the separation process, and optimization thereof, particularly since there is no evidence of record showing Applicant’s bactofuge is any different from that of the prior art.
Regarding claim 48, the combination applied to claim 28 teaches deaerating the fortified milk in order to remove air and oxygen. While the cited prior art does not explicitly recite the process removes bubbles from the sample, one of ordinary skill in the art would have reasonably expected that a process of removing gas from milk using vacuum would similarly minimize the tendency for gas bubbles to form therein. Furthermore, the prior art recognizes that deaeration can be used to remove gas from milk, and Applicant has not provided evidence to show that the claimed deaeration process is any different from that recognized by the prior art, nor that the process yields unexpected results.
Regarding claim 49, Maron et al. does not teach an amino acid score between 1.1 and 1.4 as measured according to NRC 10th Ed 1898.
Fournell et al. teaches supplementing protein by adding free amino acids (paragraph 50), where protein content can be varied as stated for claim 28.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to fortify the milk to obtain an amino acid score between 1.1 and 1.4 since amino acids are known nutritional components, since there is no evidence of criticality or unexpected results associated with the claimed range, and for the same reasons stated for the fortification modification applied to claim 28. Likewise, the claimed measurement method does not appear to be critical, and therefore would have been obvious as a preferred method of determining amino acid score based on known methods and standards.
Regarding claim 50, claim 28 recites alternatives, where the NNU composition is not required as explained for said claim. Since claim 50 does not positively require the NNU composition to be present in the fortification, the limitation of claim 50 is similarly construed to be not required.
Regarding claim 51, Maron et al. teaches a commercially sterilized human milk product. The product would therefore necessarily have an aerobic plate count of less than 10 CFU per gram to obtain said sterility.
Regarding claim 52, the combination applied to claim 28 teaches a method of producing a processed fortified human milk product as stated for said claim. The same combination is applied to claim 52 and would have been obvious for the same reasons.
Claim 52 further recites engineering a volume of the clarified human milk sample to produce a standardized human milk sample and cooling via a cooling medium. In view of the rejection under 35 USC 112(b) above, the limitation “a part of the presterilized human milk sample” is interpreted to be the “standardized human milk sample” obtained in the preceding “engineering” step. The limitation “engineering…standardized human milk sample” is interpreted in view of the specification to encompass adjusting the composition of the human milk using known methods (paragraphs 63 and 68).
Maron et al. teaches separation of the raw whole milk into skim and cream portions (figure 1; column 4 lines 11-14), concentrating the skim portion to remove water and form an intermediate liquid concentrated milk product (generated retentate) having desired non-fat solids content and butterfat concentration (column 4 lines 17-22), and mixing the separated cream with the intermediate milk concentrate to form a liquid blend having a predetermined range of fat content i.e., engineering a standardized human milk volume (column 4 lines 44-47).
Regarding cooling via a cooling medium, Maron et al. teaches cooling the product can be achieved by “any conventional means”, where a preferred method of cooling is by heat exchanger using a cooling medium such as water (column 8 lines 11-18).
Regarding claim 54, Maron et al. teaches a commercially sterilized human milk product. The product would therefore necessarily have an aerobic plate or yeast count of less than 10 CFU per gram to obtain said sterility.
Regarding claim 55, claim 52 recites alternatives, where the NNU composition is not required as explained for said claim. Since claim 55 does not positively require the NNU composition to be present in the fortification, the limitation of claim 55 is similarly construed to be not required.
Regarding claim 56, Maron et al. does not teach an amino acid score between 1.1 and 1.4 as measured according to NRC 10th Ed 1898. However, modification would have been obvious for the same reasons stated for claim 49 above.
Regarding claims 57-58, Maron et al. does not teach the commercially sterilized human milk product has a C. botulinum content of at least 12 log reduction and a B. cereus content of at least 1,000 log reduction than that in the raw milk.
However, the combination of Maron et al. with Hoffmann applied to claim 28 (and 52) teaches one or more bactofugation steps followed by commercial sterilization, which one of ordinary skill would have expected to result in a sterilized human milk product that is essentially free of pathogens, including the claimed bacteria and their spores.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to obtain the claimed reduction values for the same reasons stated for claim 28.
Regarding claim 59, Maron et al. as applied to claim 52 above teaches cooling by heat exchanger using a cooling medium such as water (column 8 lines 11-18). The cooling “may be achieved by any conventional means”, where a preferred method is accomplished through a heat exchanger”. The cited cooling does not require vacuum to remove steam.
Claims 46 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Carrigan et al., Hoffmann, Fournell et al., Graves, Stovring et al., and Engineers Edge NPL as applied to claim 28 above, and further in view of Ellertson et al. (US 2,822,277 A).
Regarding claim 46, Maron et al. does not teach homogenizing the fortified sample before a preheating step. In view of the rejection under 35 USC 112(b) above, “a preheating step” is construed to refer to the “preheating” limitation of claim 28.
Ellertson et al. teaches a method of making an evaporated milk product, where the method includes homogenizing the milk before or after sterilization (column 3 lines 4-10; column 4 lines 26-27). The homogenization process prevents fat separation or settling out of the butter fat by reducing the average diameter of the fat globules such that the globules are stabilized with a protective layer of protein (column 4 lines 3-9). While homogenization after sterilization was found to be preferred since fat globules tend to cluster and form aggregates with protein during heating, homogenization prior to sterilization was found to obtain sufficiently similar results (column 4 lines 30-37). Further, homogenization prior to sterilization is disclosed to provide the force necessary to move the milk through the heating tube and minimize the risk of contamination after sterilization (column 5 lines 30-37). The process includes homogenizer valve 20, independent from homogenizer 16, in order to further break up fat globules after heating and cooling (column 5 lines 38-45).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to homogenize the fortified human milk volume before sterilization (and optionally after) since the reference already contemplates homogenization (column 8 lines 1-4), since there is no evidence of criticality or unexpected results associated with the claimed feature, for the advantages taught by Ellertson et al., and in order to ensure a desired final fat globule size is obtained after processing and prior to packaging.
Regarding claim 60, it is noted that the antecedent basis for “the second volume” is ambiguous as stated in the rejection under 35 USC 112(b) above, and said basis cannot be determined from the response and disclosure. Applicant’s response on 8/20/2025 states “claim 60 is supported by previous claim 28”, but no such support is found. The specification does not provide any further guidance. Thus, “the second volume” is interpreted to be a volume of the fortified milk sample that is deaerated after “the first volume”.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use equal volumes between each volume of milk to be deaerated in order to ensure each volume is treated equally for oxygen removal, thereby ensuring consistency of product quality and shelf-life.
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Carrigan et al., Hoffmann, Fournell et al., Graves, Stovring et al., and Engineers Edge NPL as applied to claim 52 above, and further in view of Bradley et al. (US 2014/0212565 A1). Merieux NPL is relied on as evidence.
Regarding claim 53, combination applied to claim 52 above teaches fortification, but does not teach the fortified product has a PDCAAS of about 100% w/w.
Bradley et al. teaches a nutritional beverage comprising protein (abstract), where the proteins have a PDCAAS at or near 1.00, where the beverage can also contain one or more amino acids that are added to increase the PDCAAS value (paragraph 41).
Merieux NPL is relied on as evidence to show a PDCAAS score represents the protein in a product that has been adjusted for its ability to provide sufficient amino acids (page 2 first paragraph), where the score is an evaluation of a food’s protein quality by comparing its amino acid composition to what our bodies can use, where digestibility values for many common ingredients have been established and made available for reference, calculated by means of weight average (page 2 third and fourth paragraphs). The highest score any protein can achieve is 1.0, and generally casein and whey are considered good quality proteins having scores of 1.0 (page 3 third paragraph).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Maron et al. to fortify the composition with amino acids to increase the PDCAAS to about 100% since the prior art recognizes fortifying beverages for the same reason, since scores closer to 100% are understood to be desirable as evidenced by Merieux NPL, and therefore to optimize the nutritional profile and digestibility of the protein in the product.
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).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 28, 37, 41, and 44-60 (particularly claim 28) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 10, 12, 31-32, 37, 44, and 46-56 (particularly claims 1, 48 and 51) of copending Application No. 15/723,936 in view of Graves as cited in the Office Action above.
The ‘936 application recites a method of sterilizing a raw human milk comprising the features of claim 28, particularly fortifying with colostrum and/or a NNU composition, removing B. cereus and C. botulinum spores using one or more centrifugal clarifiers, preheating to 80-100oC, heating in a tube at a temperature of 130-150oC while flowing heating fluid counter-current to the milk, the heating fluid in contact with an exterior surface of the tube, holding the temperature for 3-15 seconds, cooling, and the pathogenic spore reduction values.
The ‘936 application does not teach fortifying to achieve a target concentration of a component in the clarified human milk sample and deaerating.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of the ‘936 application to fortify to achieve the claimed feature in order to ensure each serving contains a desired nutritional profile, and further to ensure consistency between batches.
Graves teaches a method for processing milk products (column 1 lines 15-16), where the method includes deaeration such that the process “excludes oxidation from the time the milk is drawn from the cow…for its greater stability and capacity to remain unchanged during storage” (column 20 lines 42-44 and 55-58). The deaeration occurs before heat treatment (column 18 lines 67-68).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of the ‘936 application to deaerate the fortified clarified milk to remove gasses since the process is recognized to remove unwanted air and oxygen from the milk, thereby minimizing oxidation and facilitating preservation thereof as taught by the prior art.
This is a provisional nonstatutory double patenting rejection.
Response to Amendment
The Declaration under 37 CFR 1.132 filed 8/20/2025 is insufficient to overcome the rejection of claims 28, 37, 41 and 44-48 based upon 35 USC 103 as set forth in the last Office action because:
Applicant argues the now amended indirect UHT (IN-UHT) process yields a composition of proteins and other substances that is different from that obtained by direct steam injection UHT.
The statements have been considered, but are not persuasive since the prior art recognizes direct steam injection and indirect heat exchange as equivalents suitable for sterilization of human milk.
Kallioinen et al. (US 2017/0105424 A1) teaches processing human milk (paragraph 36), where the processing includes UHT and “heat treatment can be either direct (steam to milk, milk to steam) or indirect (tube heat exchanger, plate heat exchanger, scraped-surface heat exchanger)” (paragraph 54), thus establishing equivalency with respect to sterilization of milk. It is noted the reference further states “typically, the indirect UHT treatment is more economical than the direct UHT” (paragraph 22), suggesting a preference for indirect heating.
Further, Maron et al. as applied to claim 28 teaches sterilization can be achieved by any conventional sterilization method, such as passing the milk over one or more conventional heat exchangers including coiled tube exchangers (column 6 lines 60-65), where the details of direct steam injection as cited above are directed to “an embodiment” of the invention (column 7 lines 1-3), see also MPEP 2123. The prior art therefore provides suggestion and motivation to modify the method of Maron et al. to use indirect sterilization, where one of ordinary skill would have expected the product of said indirect sterilization to be substantially similar in composition to that obtained from Applicant’s claimed process.
Regarding the citations to Cattaneo et al. and Liang et al. showing that fortifier proteins are susceptible to heat damage, the references have been considered but the prior art renders obvious an indirect, countercurrent heating sterilization method as explained above. Maron et al. teaches preheating and heating to the claimed temperature ranges and the claimed holding duration, where one of ordinary skill would have applied similar conditions to obtain sterility in an indirect heating method. Further, selection of optimal heating conditions to retain desired biological components would have been obvious as stated in the rejection above, particularly in the absence of persuasive evidence indicating criticality or unexpected results. Thus, one of ordinary skill would have reasonably expected the process of the prior art combination to result in similarly minimized damage to desirable proteins.
Applicant argues the claimed IN-UHT does not require a vacuum cooling step to avoid unwanted flavor profile changes.
This is not persuasive since the prior art recognizes multiple methods of cooling milk as needed. Maron et al. teaches “cooling of the product may be achieved by any conventional means…through the use of a heat exchanger where the temperature difference between the cooling media…and the product is kept high” (column 8 lines 11- 19). Therefore, cooling the sterilized product via countercurrent heat exchanger, without vacuum cooling, would have been obvious for the reasons stated in the prior art rejection.
Response to Arguments
Applicant's arguments filed 8/20/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 9-10 that Maron’s disclosure centers on cow’s milk, where “human” milk appears only as one option among many, and Examiner has failed to provide evidence or rationale to explain how a disclosure focused on cow’s milk using direct UHT would motivation one to apply the method to human milk via indirect UHT.
This is not persuasive since Maron explicitly recites the process can be applied to human milk (column 3 lines 63-66), where one of ordinary skill would have readily understood that human milk must be sourced from human donors. While Maron’s disclosure provides examples using cow’s milk, the teaching above still suggests to one of ordinary skill in the art that human milk can be used instead. See also MPEP 2123 II. “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Further, the prior art combination applied to claim 28 teaches and renders obvious an indirect, countercurrent heat exchange method for sterilization.
Applicant argues on page 11 that a person skilled in the art would be discouraged to use UHT sterilization to make sterilized human milk product that is safe for consumption by an infant, citing Celsis in Vitro and Hofffman in support.
This is not persuasive since Hoffmann is not relied on to teach the sterilization process/conditions, and instead to show that bactofugation is known and advantageous for milk sterilization processes. Maron already teaches and renders obvious the conditions as explained above, and the combination applied to claim 1 teaches IN-UHT using a countercurrent heat exchanger.
Applicant argues on pages 12-13 that one of ordinary skill would be discouraged from using indirect UHT sterilization, citing Maron’s disclosure of a characteristic burnt taste and Lee et al., 2017 to show a preference for direct heat treatment.
While the disclosure of Lee et al. has been considered, the reference is not relied upon in the prior art rejection. Additionally, it is unclear what time and temperature conditions were employed in the process.
Regarding the burnt taste disclosed by Maron, the argument is not persuasive since the reference does not recite or otherwise indicate that indirect heat treatment leads to the burnt taste. Rather, the reference teaches using non-heating processes for the concentration of the raw milk coupled with “careful selection of the heat-treatment temperature and time of exposure” allows for inhibiting microbiological activity while producing a product that is “free from the characteristic ‘burnt’ flavor” (column 2 lines 30-37). Selection of indirect heat treatment via countercurrent heat exchange would have been obvious for the reasons stated above.
Additionally, the prior art combination applied to claim 1 teaches a sterilized human milk product that is “suitable for remote consumption by an infant or a premature infant” as explained in the rejection above.
Applicant argues on page 13 that the Declaration explains unexpected results associated with fortifiers being susceptible to heat damage, the protein content, and the pathogen reduction.
This is not persuasive for the same reasons stated in the “Response to amendment” section above. The prior art combination appears to teach the same process as that of Applicant’s claimed process, and the prior art acknowledges adding protein as fortifier to milk products. Since the combination applies bactofugation to remove pathogens followed by indirect sterilization at the same temperature and duration claimed by Applicant, followed by cooling using indirect heat exchange, one of ordinary skill in the art would have reasonably expected similar results in the product obtained by the prior art combination process.
Applicant’s arguments against the dependent claims and the double patenting rejection are not persuasive for the same reasons stated above.
Conclusion
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 m