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 .
DETAILED ACTION
Applicant is advised that should claim 1 be found allowable, claim 52 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In this case, claim 52 recites all the method limitations of claim 1. While the features of “commercially sterile” and particular pathogen reduction are not explicitly recited by claim 52, one of ordinary skill would have expected the same process to yield the same features.
Claim Objections
Claims 1, 4, 31-32, 37, 44, 46-47, 49-53 and 55-56 are objected to because of the following informalities:
Regarding claim 1, in the clause starting with “homogenizing”, delete “presterilized” since the term does not significantly add to the meaning of the claim and since “homogenized human milk volume” sufficiently describes the resulting product.
In the clause starting with “preheating the homogenized”, delete “presterilized” for the same reason stated above.
In the same clause, delete the limitation “; wherein the countercurrent ultra-high temperature sterilization step includes:” and amend to instead recite “comprising” in order to simplify the language and place the claim in better form.
After the term “holding”, delete the limitation “a temperature of the preheated heated” and amend to instead recite “the preheated”.
In the clause starting with “cooling”, delete “exchange” and amend to instead recite “exchanger” to place the claim in better form.
In the same clause, insert the term “an” before each of the terms “inlet” and “outlet”, and delete “an opposite direction” and amend to instead recite “opposite directions” to place the claim in better form.
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 last line before “mass spectrometry” delete “a” to place the claim in better grammatical form.
Regarding claim 4, after “0.25” insert “inches” for consistency.
Regarding claim 31, in line 2 delete “a step of a second homogenizing of” and amend to instead recite “homogenizing” to place the claim in better grammatical form.
Regarding claim 32, in line 1 delete “the heating is at”, and in line 2 amend “ranging” to instead recite “ranges”.
Regarding claim 37, delete “is for the duration of” and amend to instead recite “duration is”.
Regarding claim 44, delete “one clarifier” and amend to instead recite “a single clarifier of the one or more centrifugal clarifiers” to place the claim in better grammatical form and for consistency with the language of claim 1.
Regarding claim 46, remove the underlines.
Before “mass spectrometry” delete “the” to place the claim in better form.
Regarding claim 47, in line 2 delete “retained” and amend to “retains”.
After “at least 72.4” delete “% w/w” and amend to “w/w%” for format consistency.
Regarding claim 49, in line 2 delete “% w/w” and amend to “w/w%” for format consistency.
Regarding claim 50, in line 2 after “preheating medium” insert the limitation “used in said preheating”. While it is clear to one of ordinary skill that the “preheating medium” refers to the medium used in the preheating of claim 1, the amendment should be made to place the claim in better form and for consistency with the language used in claim 1.
Regarding claim 51, delete “a fortifier includes” and amend to instead recite “the fortifying comprises adding a fortifier including” for consistency with the language of claim 48 and in order to place the claim in better form.
Regarding claim 52, in the clause starting with “homogenizing”, delete “presterilized” since the term does not significantly add to the meaning of the claim and since “homogenized human milk volume” sufficiently describes the resulting product.
In the clause starting with “preheating the homogenized”, delete “presterilized” for the same reason stated above.
After “countercurrent ultra-high temperature sterilization step” delete “; wherein the countercurrent ultra-high temperature sterilization step includes:” and amend to instead recite “comprising” since the limitation is redundant and to place the claim in better form.
After “holding” delete “a temperature of” since the limitation is redundant and to place the claim in better form.
In the final clause, delete “exchange” and amend to instead recite “exchanger” to place the claim in better form.
In the same clause, insert the term “an” before each of the terms “inlet” and “outlet”, and delete “an opposite direction” and amend to instead recite “opposite directions”.
Regarding claim 53, in the clause starting with “homogenizing”, delete “presterilized” since the term does not significantly add to the meaning of the claim and since “homogenized human milk volume” sufficiently describes the resulting product.
In the clause starting with “preheating the homogenized”, delete “presterilized” for the same reason stated above.
In the clause starting with “preheating”, after “to obtain a” delete “preheat” and amend to instead recite “preheated”.
After “ultra-high temperature sterilization step” delete the limitation “; wherein the countercurrent ultra-high temperature sterilization step includes:” and amend to instead recite “comprising” in order to simplify the language and place the claim in better form.
After “holding” delete “a temperature of” since the limitation is redundant and to place the claim in better form.
Regarding claim 55, in line 2 after “preheating medium” insert the limitation “used in said preheating” as stated for claim 50.
Regarding claim 56, delete “exchange” and amend to instead recite “exchanger” to place the claim in better form. In the same clause, insert the term “an” before each of the terms “inlet” and “outlet”, and delete “an opposite direction” and amend to instead recite “opposite directions”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, 3-5, 10, 12, 31-32, 37, 44 and 46-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, in the final clause of the claim the limitation “retained at a human immunoglobulin A concentration of 88 w/v% or greater” is not supported by the specification. Paragraph 17 recites a percent retention of immunoglobulin A (IgA) is “above 88%,” but does not specify or otherwise indicate that the percentage is directed to units of weight per volume. Paragraphs 179-182 describe figures 6C-D, which show the “retention %” as a ratio between the measured IgA concentration before and after sterilization. While the measured concentrations are expressed as g/L, it appears from Applicant’s disclosure that “retention %” itself is dimensionless. Therefore, the specification does not support the “retained” IgA at a “concentration of 88 w/v% or greater.”
Regarding claim 46, the limitation “retained at a human lactoferrin concentration of 81 w/v% or greater” is not supported by the specification for the same reasons stated for claim 1 above. Paragraph 17 recites “retains above 81% of lactoferrin” but does not indicate the “w/v” units as claimed.
Regarding claim 47, the limitation “retained a protein digestibility corrected amino acid score (PDCAAS) of at least 72.4% w/w” is not supported by the specification since the limitation “at least” encompasses all values above 72.4 and up to 100, but the specification provides support for only 72.4% and 73.3% “retained” PDCAAS (figure 8A; paragraphs 178 and 194). While a PDCAAS of 100% can be achieved, doing so requires fortification (figure 9A; paragraph 200). Thus, there is no indication that the retained PDCAAS percentages extend beyond 73.3% as claimed.
Claims 3-5, 10, 12, 31-32, 37, 44 and 48-51 are rejected by virtue of their dependence on a rejected base claim.
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.
Claim 1, 3-5, 10, 12, 31-32, 37, 44, 46-51 and 53-56 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 1, the limitation “retained at a human immunoglobulin A concentration of 88 w/v% or greater” renders the claim indefinite since it is unclear exactly what is being claimed. The percent retention of IgA concentration is acknowledged to be “88% or greater” (paragraphs 17 and 163; figures 6C-D), but the percentage is dimensionless as explained in the section above. Therefore, it is unclear if the retained percentage is actually based on units of w/v as recited. The rejection can be overcome by amending the limitation in question to instead recite “(iii) a human immunoglobulin A concentration that is retained at 88% or greater than that of the human immunoglobulin A present in the raw human milk”, which better reflects the language recited in the specification.
Regarding claim 46, the limitation “retained at a human lactoferrin concentration of 81 w/v% or greater” renders the claim indefinite for the same reasons stated for claim 1 above. The rejection can be overcome by amending the limitation in question to instead recite “a human lactoferrin concentration that is retained at 81% or greater than that of the human lactoferrin concentration present in the raw human milk”.
Regarding claim 49, the claim is rendered indefinite since it is unclear if “a fortified sterilized human milk product” is referring to any generic product, or a product that is obtained from the method of claim 48. In the case of the latter, the rejection can be overcome by amending “a” to instead recite “the”, thereby establishing appropriate antecedent basis to “sterilized human milk product” in claim 1 and “fortifying” in claim 48.
Regarding claim 50, the limitation “the heating fluid in the tube” renders the claim indefinite since the limitation contradicts claim 1 which recites “the heating fluid is in contact with an exterior surface of the tube” i.e., the heating fluid is not “in the tube” as required by claim 50. The rejection can be overcome by deleting “in the tube” to remove said contradiction, particularly since the antecedent basis of simply “the heating fluid” is already sufficient and clear.
Regarding claim 53, in the clause starting with “generating a retentate”, the limitation “wherein the cream sample and the skim sample are from raw human milk passed through at least one bacterial clarifier” renders the claim indefinite since it is unclear if the limitation is the same as, or different from the previous limitation “removing a fraction of pathogens…from the raw human milk using one or more centrifugal clarifiers”. According to the specification, the bacterial clarifier is the centrifugal clarifier (paragraphs 69 and 73), and therefore it is unclear the limitation in question is a repeat of the “centrifugal clarifier” limitation, or a separate limitation. In the case that the limitation was erroneously added, the rejection can be overcome by deleting “, wherein the cream sample and the skim sample are from raw human milk passed through at least one bacterial clarifier”.
Regarding claim 55, the limitation “the heating fluid in the tube” renders the claim indefinite since the limitation contradicts claim 53 for the reasons explained for claim 50 above. The rejection can be overcome by deleting “in the tube”.
Claims 3-5, 10, 12, 31-32, 37, 44, 47-48, 51, 54 and 56 are rejected by virtue of their dependence on a rejected base claim.
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 1, 3-4, 10, 12, 31-32, 37, 44, 46-48, 50, and 52-56 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), Ellertson et al. (US 2,822,277 A), Stovring et al. (US 2014/0345836 A1), Engineers Edge NPL and Medo et al. (US 9,149,052 B2).
Coyne et al. (US 2014/0141137 A1) is relied on as evidence for claim 1, Heat Transfer NPL for claims 3-4, Christen (US 2015/0305357 A1) for claim 46, Merieux NPL (made of record 12/30/2020) for claim 47, and Palm (US 3,451,471) for claim 50.
Regarding claim 1, Maron et al. teaches an extended shelf-life sterilized liquid milk product and a process for producing said product (abstract; column 3 lines 27-34), where the milk source includes human milk (column 3 lines 65-66), 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 commercial sterility while avoiding a “burnt” flavor and maintaining the structural integrity of the milk (column 7 lines 30-33), homogenizing, and cooling the milk to produce the commercially sterilized human milk product (column 7 lines 61-66; column 8 lines 11-18). See also example 1 (column 9 lines 10-20).
Regarding the “engineering a volume of…to produce a standardized human milk volume”, the limitation is interpreted in view of the specification to encompass adjusting the composition of the human milk using known methods (paragraph 74).
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).
Maron et al. does not teach removing a fraction of pathogens comprising bacterial, mold and spores comprising B. cereus and C. botulinum spores from the raw human milk using one or more centrifugal clarifiers to produce a clarified human milk volume.
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 uses a specially designed centrifuge that 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). The bactofuge is construed to read on the claimed “centrifugal clarifier” since the device is disclosed to perform the same function of removing pathogens via centrifuge.
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).
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 removed 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 majority 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 volume 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, 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 of the product.
Maron et al. does not teach homogenizing a part of the standardized human milk volume prior to preheating.
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, 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).
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 a portion of the standardized human milk volume since the prior art recognizes doing so for producing sterilized milk products, since there is no evidence of criticality or unexpected results associated with the claimed feature, and to provide the movement force as taught by Ellertson et al. It is noted that both Maron et al. and Ellertson et al. are directed to continuous processes. Since a volume of standardized milk flowing into the homogenizer would have necessarily comprised a first portion that contacts, and is treated by the homogenizer, prior to subsequent portions thereof, the continuous process of Maron et al. as modified above is construed to read on “a port of the standardized human milk volume”.
Maron et al. does not teach the UHT sterilization is countercurrent sterilization comprising heating the preheated human milk volume 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 direction the milk flow, 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 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). This suggests to one of ordinary skill in the art at that the sterilization process of Maron et al. is not limited to direct steam injection, see also MPEP 2123.
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 arrows). 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 treat the preheated human milk volume by a counter current ultra-high temperature sterilization step (IN-UHT) comprising the claimed features 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 with known advantages, since there is no evidence of criticality or unexpected results associated with the claimed features, to minimize thermal stresses on the milk, to provide more uniform rate of heat transfer, and as a substitution of art recognized equivalents suitable for the same purpose of sterilizing milk, see MPEP 2144.06 II. It is noted that adjusting the sterilization holding duration in view of the IN-UHT modification above would have been within the capability of one of ordinary skill based on the findings above.
Maron et al. teaches cooling is “achieved by any conventional means”, where a “preferred way of cooling the sterilized product is accomplished through the use of a heat exchanger” (column 8 lines 13-17), but does not teach cooling the heated human milk volume via a countercurrent heat exchanger comprising a milk inlet and cooling medium outlet that are in opposite directions to each other.
Stovring and Engineers Edge NPL as cited above teaches a countercurrent heat exchanger and associated advantages. The same modification is applied to the cooling heat exchanger of Maron et al. and would have been obvious for the same reasons.
Regarding the particular direction/orientation of the claimed inlet and outlet, Stovring teaches the heat exchanger comprises product inlet 33 and heat transfer medium outlet 22 (figure 1; paragraphs 49 and 59), where the liquid product travels in an opposite direction to the transfer medium. While the reference does not explicitly teach opposite directions of the inlet and outlet per se, there is no evidence of record indicating to one of ordinary skill that the claimed structure is critical and/or yields unexpected results. Rather, one of ordinary skill would have reasonably expected the structure to have minimal effect since the majority of heat transfer is known to occur in the area of the exchanger denoted by baffles 35 (paragraph 50).
Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the respective inlet and outlet structures to be in opposite directions to each other based on the structure of connecting pipes and/or requirement due to the layout of the processing plant, the specifications of the heat exchanger manufacturer, and as a matter of preferred configuration having minimal to no expected impact on overall heat transfer, see MPEP 2144.04 IV.B.
Regarding the sterilized human milk product “having 90% or more of the pathogens physically removed from the raw human milk” the combination of Maron et al. with Hoffmann teaches one or more centrifugal clarifiers that separates the milk into “a fraction that is more or less free from bacteria, and a concentrate (bactofugate), which contains both spores and bacteria in general” (paragraph 76). While the cited prior art does not explicitly recite “90% or more” removal, one of ordinary skill in the art would have reasonably expected the one or more clarifiers of the prior art combination to achieve a pathogen removal with in the claimed range, and modification to achieve the claimed removal percentage would have been obvious for the same reasons stated for the respective combination above.
Regarding “the IN-UHT sterilized human milk product having reduced pathogens is 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 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 values since the prior art recognizes the advantages associated with removing pathogens and the devices/methods for such removal as stated above, 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 the sterilized human milk product retains a human immunoglobulin A (IgA) concentration of 88 w/v% or greater compared to IgA concentration of the raw human milk, measured by mass spectrometry. In view of the rejection under 35 USC 112(b) above, the limitation is interpreted to recite “88% or greater”.
It is noted that determination of a component concentration in a composition using mass spectrometry is a process well-known in the art, and use of said means would have been prima facie obvious as a matter of preference between known measurement methods.
Medo et al. teaches a process for sterilization of human milk (abstract; figure 1) where IgA is recognized to be a desired component present in said milk, and therefore heat processing should be performed to “preserve adequate quantities of those essential components which are potentially heat labile”, while ensuring safety of the milk product (column 8 lines 55-59). This suggests to one of ordinary skill in the art that it would have been similarly desirable to perform the sterilization process of Maron et al. to retain as much activity of the IgA present in the raw human milk as possible.
While the prior art does not explicitly teach the retained concentration of IgA being 88% or greater, the combination of cited references teaches the same clarifying, standardizing, homogenizing, preheating, heating, holding, and cooling steps as Applicant’s claimed process, at temperatures and durations within or overlapping the claimed ranges. Maron et al. further teaches that exposing the milk to lower levels of heating yields a product that has “suffered no structural damage”, “retains the natural milk flavor and taste”, and “whose structural integrity is maintained” (column 3 lines 15-20; column 7 lines 19-20). Additionally, removal of pathogens via bactofuge as applied above would have reasonably allowed for a “gentler” heat treatment to obtain the same degree of overall sterilization.
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. such that human IgA concentration is retained in the claimed values relative to those present in the raw milk since the reference already recognizes the need to control heating parameters such that the “structure” of the milk is retained, since the prior art recognizes that the claimed protein is desirable and provides advantageous biological functions, where it is well-understood that proteins are susceptible to heat denaturization, and therefore to ensure the protein is not denatured during treatment, since there is no evidence of record convincingly showing that Applicant’s claimed process and values are critical or yield unexpected results, and therefore since the claimed values would have been obtained through routine experimentation and optimization procedures by adjusting known result-effective parameters such as heating temperature and duration.
Regarding claim 3, Maron et al. teaches maintaining a desired temperature for a predetermined time for sterility as stated for claim 1 above, but does not specifically teach the length of the tube and flow rate of the milk are chosen for holding the milk at the temperature 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, modelled 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 choose the length of tube and flow rate of milk to hold the temperature of 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 process (heat exchanger in a milk sterilization process) ready for improvement to yield predictable results in similar adjustments to the amount 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 such as rate/degree of heat transfer, sterility, and shelf life.
Regarding claim 4, Maron et al. does not teach a tube diameter between 0.25 and 10 inches.
Stovring further teaches the tube can have a diameter of 48 mm, i.e. ~1.9 in (paragraph 57).
Heat Transfer NPL further teaches that basic heat exchanger design can be modelled by the equation Q = U A ΔTlm, where A is the heat transfer surface area (page 2). Changing the diameter of the tube would have necessarily changed the respective surface area.
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 use the claimed tube diameter since adjusting tube diameter to achieve a desired heat transfer is known, for the same reasons stated for claim 3 above, and since the claimed values would have been subjected to normal experimentation and optimization procedures due to said factors of rate/degree of heat transfer, sterility, and shelf life.
Regarding claim 10, Maron et al. teaches separation of the raw whole milk into skim and cream samples (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 generated retentate to form a standardized human milk volume having a predetermined range of fat content (column 4 lines 44-47).
Regarding claim 12, Maron et al. teaches the sterilized milk is subsequently sent to an aseptic filler, and therefore packaged through an aseptic process (column 6 lines 24-32).
Regarding claim 31, Maron et al. teaches homogenizing the sterilized milk product after a cooling step (column 7 lines 61-64; column 8 lines 1-5).
Regarding claims 32, Maron et al. teaches the heating temperature is about 142.2oC as stated for claim 1.
Regarding claim 37, Maron et al. teaches the holding duration of 4-6 seconds (column 7 lines 57-60) as stated for claim 1.
Regarding claim 44, Hoffmann et al. as applied to claim 1 teaches that bactofugation 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).
The same combination is applied to claim 44 and would have been obvious for the same reasons. Since the process is disclosed to provide a product from which essentially all bacteria and spores have been separated, the prior art combination is construed to read on the claim.
Regarding claim 46, Maron et al. does not teach human lactoferrin retained at 81% or greater.
Christen is relied on as evidence to show a human milk product (abstract) comprising human lactoferrin, where lactoferrin present in human milk provides desirable biological functions such as bacteriostatic property, boosting immune defense and antioxidant activity (paragraphs 16, 66, and 72).
The combination applied to claim 1 renders obvious the claimed method, where it is desirable to minimize damage to useful components (e.g., IgA) of the milk as stated for said claim. Absent persuasive evidence to the contrary, one of ordinary skill would have reasonably expected a similar retention percentage of human lactoferrin using the process of the prior art combination, particularly since the benefits of human lactoferrin are recognized in the art.
Regarding claim 47, Maron et al. does not teach a retained protein digestibility corrected amino acid score (PDCAAS) of at least 72.4 wt% compared to the raw milk.
Merieux NPL is relied on as evidence to show the 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).
The teachings above indicate to one of ordinary skill that raw human milk, known to comprise casein and whey proteins, would generally have high PDCAAS. Maron et al. is directed to sterilizing the product without substantial damage to the components thereof (column 3 lines 16-20) and teaches denaturation of milk proteins is undesirable (column 2 lines 6-10). Since the modified process of Maron et al. appears to be the same as Applicant’s claimed process, one of ordinary skill in the art would have reasonably expected a similar range of retained PDCAAS.
Regarding claim 48, Maron et al. does not teach fortifying the standardized human milk volume before the sterilization step.
Medo et al. further teaches the milk is separated into cream and skim portions, combined into a standardized composition, fortified with minerals, then pasteurized (column 15 lines 26-40, 45-47 and 61-62). The composition can also be supplemented with vitamins, where supplementation ensures the infant receives a sufficient amount of said vitamins and minerals for development (Column 11 lines 6-10).
It would have been obvious to one of ordinary skill in the art at time of the invention to modify the process of Maron et al. to fortify the milk prior to sterilization since the prior art recognizes for human milk products, since there is no evidence of criticality or unexpected results associated with the order of processing steps, and in order to ensure the milk provides sufficient nutritional content based on the needs of the intended recipient.
Regarding claim 50, the limitation “a second pressure of a preheating medium” is construed to refer to that of the “preheating” step in claim 1 as explained in the “objections” section above.
The combination applied to claim 1 teaches preheating followed by indirect countercurrent heat exchange in an exchanger such as that of Stovring et al.
Maron et al. teaches the milk is preheated in a heat exchanger (column 7 lines 34-36). The milk is heated to a temperature below boiling during said preheating, and a temperature above boiling during the actual sterilization step as stated for claim 1.
Palm is relied on as evidence to show that indirect heating devices for liquid foods are known, where the devices can use water that is liquid, steam, or both as the heating medium (column 1 lines 49-53).
Since the temperature required by the preheater is below boiling and the temperature required by the sterilizing heater is above boiling, where using water in liquid and/or steam form for heat exchange is known, one of ordinary skill in the art would have reasonably expected the pressure of the heating fluid used in sterilization to be higher than that of the preheating medium.
Regarding claim 52, the limitations recited by the claim are encompassed by that of claim 1. The same combination is applied to claim 52 and would have been obvious for the same reasons.
Regarding claim 53, in view of the rejection under 35 USC 112(b) above, the limitation “wherein the cream sample and the skim sample are from raw human milk passed through at least one bacterial clarifier” is construed to be the same as the “removing” limitation in the first clause.
The limitations recited by the claim are encompassed by that of claim 1. The same combination is applied to claim 53 and would have been obvious for the same reasons.
The difference between the claims is that claim 53 recites the features of “separating the clarified human milk…a skim sample” and “generating a retentate…second portion of the retentate”.
Maron et al. teaches separation of the raw whole milk into skim and cream samples (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 generated retentate to form a standardized human milk volume having a predetermined range of fat content (column 4 lines 44-47).
Regarding claim 54, Maron et al. does not teach fortifying the standardized human milk volume before the sterilization step.
However, the combination applied to claim 48 renders obvious the claimed feature. The same combination is applied to claim 54 and would have been obvious for the same reasons.
Regarding claim 55, the limitation “a second pressure of a preheating medium” is construed to refer to that of the “preheating” step in claim 53 as explained in the “objections” section above.
The combination applied to claim 53 renders obvious the claimed feature as explained for claim 50 above. The same reasoning is applied to claim 55.
Regarding claim 56, the combination of Maron et al., Stovring et al., and Engineers Edge NPL applied to claim 53 renders obvious the claimed feature (explained in claim 1). The same combination is applied to claim 56 and would have been obvious for the same reasons.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Carrigan et al., Hoffmann, Ellertson et al., Stovring et al., Engineers Edge NPL, and Medo et al. as applied to claims 1 and 3 above, and further in view of MacGregor et al. (US 2011/0318463 A1). Heat Transfer NPL is relied on as evidence.
Regarding claim 5, Maron et al. does not specifically teach the flow rate of the milk sample through the sterilizer is between 0.25 and 25 gallons per minute.
MacGregor et al. teaches a method for pasteurizing milk by heating (abstract; paragraph 71) comprising flowing milk through the heating system at rates ranging from 1-5 gpm (paragraph 116), where the flow rate is selected based on features such as minimizing mechanical abuse of the milk (paragraph 68) and desired pump size and/or size of the fluid pathways (paragraph 70). While MacGregor et al. teaches a pasteurization process, the reference is analogous since it is directed to the same field of invention of heat-treating milk flowing through the treatment system to reduce pathogens (paragraph 5).
Heat Transfer NPL teaches that heat transfer rate in a heat exchanger depends on the flow rate of the heating fluid (page 4) as stated for claim 3 above.
It would have been obvious to one of ordinary skill in the art at time of the invention to modify the process of Maron et al. to flow the milk through the tube of the sterilizer at the claimed flow rate range since the rate is known for milk heat treatment processes, since flow rate is known to affect the amount of heat transfer in a heat exchanger as evidenced by Heat Transfer NPL, and therefore in order to ensure a residence time and degree of heat transfer from the heating medium to achieve sufficient sterility based on given processing parameters (e.g. temperatures, times, etc.). Furthermore, flow rate is an art recognized result-effective variable, the result being residence time within a given length of tube and degree of heat transfer. Therefore, the claimed flow rate values would have been used during the course of normal experimentation and optimization procedures due to such factors.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Carrigan et al., Hoffmann, Ellertson et al., Stovring et al., Engineers Edge NPL and Medo et al. as applied to claims 1 and 48 above, and further in view of Bradley et al. (US 2014/0212565 A1). Merieux NPL is relied on as evidence.
Regarding claim 49, in view of the rejection under 35 USC 112(b) above, the limitation “a fortified sterilized human milk product” is interpreted to refer to a product obtained from the method of claim 48.
The combination applied to claim 48 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).
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 explained in claim 47, and therefore to optimize the nutritional profile and digestibility of the protein in the product.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Carrigan et al., Hoffmann, Ellertson et al., Stovring et al., Engineers Edge NPL and Medo et al. as applied to claims 1 and 48 above, and further in view of Bisgaard-Frantzen (US 2011/0200591 A1).
Regarding claim 51, the claim recites alternatives. For the sake of examination, the alternative “colost