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 31, 39, 41, 46, 53-54, 57, 59, and 61-63 are objected to because of the following informalities:
Regarding claim 31, delete “a” and “the” before each recitation of “mass spectrometry” to place the claim in better form.
Regarding claims 39 and 41, after “or greater” insert “than that” for grammar.
Regarding claim 46, after “amino acids are” delete “in form of”, and after “L-isomer” insert “amino acids” for grammar.
Regarding claim 53, delete “a” and “the” before each recitation of “mass spectrometry” to place the claim in better form.
Regarding claim 54, after “or greater” insert “than that”, and after “present in” insert “the” for grammar and consistency.
Regarding claim 57, delete “a” and “the” before each recitation of “mass spectrometry” to place the claim in better form.
Regarding claim 59, delete “retained” and insert “retains” for grammar.
Regarding claims 61-63, after “immunoglobulin A” delete “,”. After “retained at” delete “the human immunoglobulin A” and insert “a” to place the claim in better form.
Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 31, 38-39, 49, 53-55, 57 and 59-66 are rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. (US 8,329,237 B2) in view of Kallioinen et al. (US 2017/0105424 A1), Carrigan et al. (US 2012/0040052 A1), and Hoffmann (US 2014/0348998 A1).
Coyne et al. (US 2014/0141137 A1), Christen (US 2015/0305357 A1), and PDCAAS NPL are relied on as evidence for claim 31.
Regarding claim 31, Maron et al. teaches a sterilized liquid milk product and a process for producing said product (abstract), where the milk source can be human milk (column 3 lines 65-66), necessarily obtained from “raw human milk”, where the milk product is formed by concentrating the milk followed by UHT treatment to sterilize the product, said treatment comprising heating the milk to a temperature of 288oF/~142oC within a short period of time to avoid a “burnt” flavor and maintain structural integrity of the milk (column 5 lines 63-64), then holding said temperature for a period of 4-6 seconds to obtain commercial sterility (column 1 lines 35-39; column 7 lines 30-33). Therefore, the reference teaches a commercially sterilized human milk product. The product would necessarily have an aerobic plate count of less than 10 CFU per gram since it is commercially sterilized. Maron et al. further teaches the sterilized human milk product is packaged using an aseptic filter for extended shelf stability (column 8 lines 27-34), and therefore would have been configured to be safe for remote consumption by an individual. The individual being an infant or premature infant would have been obvious based on the desired application of the product, and nutritional needs of the infant.
Regarding the milk being indirect ultra-high temperature (IN-UHT) sterilized milk, Maron et al. teaches “sterilization may be achieved by any conventional sterilization method…such as conventional indirect plate, coiled tube or scraped surface heat exchangers” (column 6 lines 60-65).
Kallioinen et al. teaches sterilization processes for human milk (paragraph 36) includes indirect treatment and “typically, the indirect UHT treatment is more economical than the direct UHT” (paragraph 22), and therefore understood to be preferable. The reference further acknowledges equivalency between indirect and direct heat treatment (paragraph 54).
Therefore, modification of the process of Maron et al. to be IN-UHT would have been obvious to one of ordinary skill in the art due to the art recognized advantage thereof and/or as a substitution of art recognized equivalents suitable for the same purpose, see MPEP 2144.06 II.
Maron et al. does not teach limitations (ii)-(v) as claimed with respect to the content of C. botulinum, B. cereus, pathogens comprising bacteria, molds, and spores, and their reduction relative to the raw human milk.
It is noted that applicant’s specification discloses the claimed sterilized human milk product is obtained by passing the raw milk through at least one bacterial clarifier, separating into cream and skim fractions, standardizing by combining a portion of the fractions, fortifying, and sterilizing through a countercurrent heat exchange process at a temperature of between 130-150oC and a hold time of 3-15 seconds (paragraphs 7 and 9). The process is disclosed to obtain a milk product that exhibits at least a 12-log reduction in C. botulinum content and greater than 1,000 log reduction of B. cereus (paragraph 7).
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 “clarifier” disclosed by applicant since they are disclosed to perform the same function. The process includes thermal treatment using known processes and parameters, such as “at least about 125oC for at least about 2 seconds or at least about 135oC for at least 2 seconds” in order to “destroy harmful pathogenic bacteria, viruses, protozoa, molds and yeasts” (paragraph 142).
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. Applicant’s specification states that C. botulinum and B. cereus are removed by a similar centrifugal filtration device or a plurality thereof (paragraphs 72-73). Since the prior art teaches multiple bactofugation devices can be used together (Hoffmann), since C. botulinum and B. cereus 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 desirable to be removed from the milk, one of ordinary skill in the art would have reasonably expected multiple bactofugation steps to similarly remove all of the claimed pathogens from the milk.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process disclosed by Maron et al. to employ multiple bactofugation steps followed by UHT at the temperature of between 130-150oC and a hold time of 3-15 seconds as disclosed by applicant since the reference already contemplates filtration-type processes (column 6 lines 10-32) and UHT 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, to ensure product quality, safety, and extend shelf life, and since the UHT conditions would have been used during the course of routine experimentation and optimization procedures due to factors such as sterilization degree and damage to desirable substances in the milk.
While the prior art does not explicitly recite the content, concentration, and reduction values in the sterilized human milk product as claimed, the modification of Maron et al. with the teachings of Kallioinen, Carrigan et al. and Hoffmann to include multiple bactofugation steps prior to IN-UHT sterilization would have resulted in, with a reasonable expectation of success, 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. (and therefore the product) to obtain the claimed values since the prior art recognizes the advantages associated with removing pathogens and spores 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 milk product comprises human lactoferrin and human immunoglobulin A (IgA) in the respective concentrations relative to the raw milk, as measured by mass spectrometry.
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.
Christen is relied on as evidence to show a human milk product (abstract) comprising human lactoferrin and human IgA, where human lactoferrin and IgA present in the milk provide desirable biological functions such as bacteriostatic property, boosting immune defense and antioxidant activity (paragraphs 16, 66, and 72).
Since Maron et al. teaches sterilization of raw human milk, since the process of Maron et al. as modified above renders obvious the process by which Applicant obtains the claimed product, including IN-UHT, and since human lactoferrin and IgA are known to be present in human milk and desirable, one of ordinary skill in the art would have reasonably expected similar levels of lactoferrin and IgA retention in the sterilized product formed by the process of the prior art combination.
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.
PDCAAS NPL teaches the score represents the protein in a product that has been adjusted for its ability to provide sufficient amino acids (page 1 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 1 third paragraph to page 2 first paragraph). 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 2 last 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 the process Applicant uses to obtain the claimed product, one of ordinary skill in the art would have reasonably expected a similar range of retained PDCAAS.
Regarding claim 38, Maron et al. teaches the milk product is commercially sterile as stated for claim 31, and therefore would have essentially no CFU of yeast and mold.
Furthermore, the combination applied to claim 31 teaches a sterilized human milk product, where the product is made by a process that is taught by the cited prior art and rendered obvious. The process appears to be the same as that of the process that applicant discloses to yield the claimed product. Absent persuasive evidence to the contrary, one of ordinary skill in the art would have reasonably expected the process of the prior art combination to yield a product having the claimed feature.
Regarding claim 39, Maron et al. does not teach the sterilized human milk product comprises human IgG at the claimed concentration.
However, the combination applied to claim 31 teaches a sterilized human milk made the same process disclosed by applicant as stated above. Absent persuasive evidence to the contrary, one of ordinary skill in the art would have reasonably expected the product of the prior art combination to have similar IgG concentration.
Regarding claim 49, Maron et al. teaches the sterilized human milk product is packaged using an aseptic filter for extended shelf stability (column 8 lines 27-34), but does not specify the type of package.
Hoffmann further teaches the milk is treated to reduce pathogens and then aseptically packaged in any suitable container such as a bag i.e., a pouch, such that extended shelf life is achieved (paragraphs 132-133).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Maron et al. such that the sterilized milk is aseptically packaged in a pouch for extended shelf-life since aseptic packaging methods are known in the art as taught by Hoffman (paragraph 10), since the prior art acknowledges aseptic packaging methods facilitate extended shelf-life, and thus to similarly ensure the product of Maron et al. is not reintroduced to contamination after sterilization, thereby similarly extending shelf-life and minimizing risk to consumers.
Regarding claim 53, the combination applied to claim 31 teaches a commercially sterilized human milk product and a method for making said product. The same combination is applied to claim 53 and would have been obvious for the same reasons. The product of the prior art combination is therefore construed to teach the claimed features of human lactoferrin, human IgA, and pathogenic content in a commercially sterilized human milk product.
Regarding claim 54, the modification applied to claim 39 renders obvious the claimed IgG concentration. The same modification is applied to claim 54 and would have been obvious for the same reasons.
Regarding claim 55, Maron et al. teaches the milk product is commercially sterile as stated for claim 31 (and claim 53), and therefore would have essentially no CFU of yeast and mold.
Furthermore, the combination applied to claim 31 teaches a sterilized human milk product, where the product is made by a process that is taught by the cited prior art and rendered obvious. The process appears to be the same as that of the process that applicant discloses to yield the claimed product. Absent persuasive evidence to the contrary, one of ordinary skill in the art would have reasonably expected the process of the prior art combination to yield a product having the claimed feature.
Regarding claim 57, the combination applied to claim 31 teaches a commercially sterilized human milk product and a method for making said product. The same combination is applied to claim 57 and would have been obvious for the same reasons. The product of the prior art combination is therefore construed to teach the claimed features of human lactoferrin, human IgA, and pathogenic content.
The difference between claims 31 and 57 is that the latter recites the sterilized human milk product “consists of a thermally sterilized human milk product”. The limitation is interpreted to mean that the final product is thermally sterilized.
Maron et al. teaches the human milk product is thermally sterilized by UHT as stated for claim 31, and further teaches the milk is sterilized, cooled, and then aseptically packaged (column 8 lines 24-28).
Regarding claim 59, one of ordinary skill in the art would have expected the product of modified Maron et al. to retain a PDCAAS of 72.4% as recited for claim 31. The value of 72.4 wt% would have been obvious for the same reasons, and since there is no evidence of criticality or unexpected results associated with the claimed features and the claimed value would have been used during the course of routine experimentation and optimization procedures due to factors such as time and temperature of the UHT sterilization, as well as degree of pathogen reduction/elimination desired.
Regarding claim 60, the sterilized human milk product is an indirect ultra-high temperature sterilized human milk product as stated for claim 31 (and by extension claim 57).
Regarding claims 61-63, the combination applied to claims 31, 35, and 57 renders obvious the method for making the claimed product. One of ordinary skill in the art would have reasonably expected similar values of IgA retention for the same reasons stated for claim 31. Further, it would have been obvious to one of ordinary skill in the art to modify the product to have the claimed values of retained IgA since there is no evidence of criticality or unexpected results associated with the claimed feature, and since the claimed value would have been used during the course of routine experimentation and optimization procedures due to factors such as time and temperature of the UHT sterilization, as well as degree of pathogen reduction/elimination desired.
Regarding claims 64-66, Maron et al. teaches a sterilized human milk product having extended shelf-life (column 8 lines 27-34).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Kallioinen, Carrigan et al., and Hoffmann as applied to claims 31 and 39 above, and further in view of Buck et al. (US 8,802,650 B2).
Regarding claim 40, Maron et al. does not teach the sterilized product further comprises the claimed 2’fucosyllactose concentration.
Buck et al. teaches a human milk fortifier including human milk oligosaccharides (HMO) intended for preterm infants, term infants, toddlers, and children for improving airway defense mechanisms (column 1 lines 16-23), the fortifier being suitable for mixing with breast milk (column 5 lines 61-65), where 2’-fucosyllactose (2’FL) is an HMO used to improve airway defense mechanisms (column 2 lines 24-31), the concentration ranging from 1-10 g/L (column 11 lines 66-67; column 12 line 6). Buck et al. further teaches that HMOs act as pathogen receptor analogs, but activate immune factors by infant intestinal epithelial cells and/or associated immune cell populations, and function as antioxidants and immune modulators to assist in regulation of inflammatory responses to infection or other injury (column 1 lines 48-55).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the milk product of Maron et al. to include the claimed amount of 2’FL since the prior art acknowledges the claimed amount is used to fortify human milk, and therefore to achieve the same benefits taught by Buck et al., and since the claimed values would have been used during the course of normal experimentation and optimization procedures due to factors such as desired immunological and/or regulation of inflammatory response, type of product, intended user’s specific needs, and those taught by Buck et al.
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Kallioinen, Carrigan et al., Hoffmann, and Buck et al. as applied to claims 31 and 3-40 above, and further in view of Lund et al. “The role of osteopontin in inflammatory processes”. Bos et al. (US 2009/0226533 A1) is relied on as evidence.
Regarding claim 41, Maron et al. does not teach osteopontin concentration as claimed.
Lund et al. teaches that osteopontin (OPN) is a protein that mediates cell migration, adhesion, and survival, functions as a Th1 cytokine, promotes cell-mediated immune responses, plays a role in chronic inflammatory and autoimmune diseases, regulates biomineralization and inhibits vascular calcification (abstract). OPN is found in human milk (page 312 right column “post-transitional modifications” lines 4-5).
Bos et al. is relied on as evidence to show that osteopontin can be purified from human milk (paragraph 21).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the product of Maron et al. to include the claimed amount of OPN since purified human osteopontin was available to fortify the product, in order to provide the same benefits taught by Lund et al., and since the claimed values would have been used during the course of normal experimentation and optimization procedures due to factors such as desired immunological and/or regulation of inflammatory response, type of product, intended user’s specific needs, and those taught by Lund et al.
Regarding claim 42, Maron et al. does not teach IgM concentration as claimed.
However, the combination applied to claim 31 teaches a product made from the same process as applicants disclosed process, and therefore one of ordinary skill in the art would have reasonably expected similar IgM concentration.
Claims 44 and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Kallioinen, Carrigan et al., and Hoffmann as applied to claim 31 above, and further in view of Lamb et al. (US 2014/0227422 A1).
Regarding claim 44, Maron et al. does not teach the product has a nitrogen utilization (NNU) protein concentration, interpreted in view of the specification to be a composition comprising free amino acids (paragraph 141), at least 95% of a weight of amino acids in the NNU composition being free amino acids.
Lamb et al. teaches sterilized protein supplements including extensively hydrolyzed casein for use with human milk (abstract), the composition including predominately (e.g., at least 75%) free amino acids, di-peptides and tri-peptides (paragraph 19). The extensively hydrolyzed proteins provide an improved source of protein and can be hypoallergenic (paragraphs 18 and 49). The protein can also be entirely replaced by free amino acids (paragraph 55).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the product of Maron et al. to have the NNU with free amino acids as claimed since free amino acids are known for use in nutritional products as taught by Lamb et al. (paragraph 55), and therefore in order to similarly provide high quality, hypoallergenic protein, and since the claimed values would have been used during the course of normal experimentation and optimization procedures due to factors such as type of product, intended user, and nutritional profile.
Regarding claims 46-47, Lamb et al. as applied to claim 44 teaches the free amino acids which are known to be used in nutritional products include the L-isomer of those recited in claim 47 (paragraph 55).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the product to include said L-isomer amino acids since the prior art acknowledges the L-isomer can be used for nutritional supplements, and for the same reasons stated for claim 44.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Maron et al. in view of Kallioinen, Carrigan et al., and Hoffmann as applied to claim 31 above, and further in view of Bisgaard-Frantzen (US 2011/0200591 A1).
Regarding claim 51, Maron et al. teaches human milk, but does not specify the milk comprises colostrum.
Bisgaard-Frantzen teaches a colostrum from human origin (paragraph 73), where the colostrum is sterilized (paragraphs 443 and 445-446), and further teaches colostrum contains elevated concentration of immunoglobulins compared to normal milk, where the survival of a newborn mammal is critically dependent on ingestion and successful absorption of immunoglobulins during the first 24 hours (paragraph 2). The colostrum can be used as a supplement (paragraph 1).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the product of Maron et al. to include colostrum since the prior art recognizes sterilized colostrum as a supplement, where the substance is known to provide critical nutrition and immunity benefits for newborn health, and therefore to provide the same benefits in the sterilized human milk product.
Response to Amendment
The Declaration of Glenn Snow under 37 CFR 1.132 filed 6/13/2025 is insufficient to overcome the rejection of claims 31, 38-39, 49, 53-55 and 57 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 the amendments necessitated new grounds of rejection. Kallioinen is now relied on to show that IN-UHT is desirable for commercially sterilizing milk, including human milk, as stated for claim 31. Further, the reference also establishes equivalency between indirect and direct UHT sterilization as stated above. One of ordinary skill in the art would have modified the process of Maron et al. to be IN-UHT sterilization, particularly since the reference already suggests other methods of sterilization can be used, where the product obtained by the modified process would have reasonably been expected to have similar if not the same composition as that of the claimed product. Therefore, the prior art renders the claimed IH-UHT feature, with respect to known milk components desired to be retained and pathogen content, obvious and predictable.
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 argued feature is not specified in the claims, and 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). In view of the modifications made in the prior art rejection above, cooling the IN-UHT sterilized product in a similarly indirect way would have been obvious for the same reasons stated for claim 1.
Response to Arguments
Applicant’s arguments filed 6/13/2025 have been fully considered, but the amendments to claims 31, 53, and 57 necessitated new grounds of rejection.
Kallioinen is relied on to provide motivation for one of ordinary skill in the art to use IN-UHT sterilization for raw human milk, and further to establish equivalency between indirect and direct sterilization of human milk. Since the evidence of record has not established criticality or unexpected results associated with the claimed features, one of ordinary skill in the art would have reasonably expected the IN-UHT sterilization of the prior art combination to yield a sterilized human milk product having the same characteristics as the claimed product.
Applicant’s arguments (reason 1) against fortification of the sterilized milk with the claimed compounds has been fully considered, but the new grounds of rejection no longer rely upon fortification. One of ordinary skill in the art would have expected retention of the claimed substances in the claimed amounts for the same reasons stated in the prior art rejection above.
Applicant’s argument (reason 2) that the PDCAAS in the product is not adjusted is not persuasive since the PDCAAS NPL reference is not relied on to teach “adjusting” as argued. The “adjusting” stated in the reference refers to the score of a product having accounted for the relative digestibility of the proteins therein (page 1 third paragraph). The reference is relied on to show that milk proteins such as casein and whey are generally understood to be “good quality proteins” with scores of 1.00 i.e., “100%”. Therefore, one of ordinary skill in the art would have expected the sterilized product formed by the prior art combination to retain a similar PDCAAS percentage of the raw human milk prior to sterilization.
Applicant argues (reason 3) that Maron et al. teaches direct steam injection UHT sterilization, which yields a different product from that of IN-UHT. Applicant cites Hoffman to show that one would be discouraged to make an IN-UHT sterilized human milk product that is safe for consumption by an infant or premature babies, and cites Lee et al. for support.
This is not persuasive since the reference does not limit the sterilization process to direct steam injection, and discloses that indirect methods can be used (column 6 lines 60-65). The prior art teaches IN-UHT is advantages over direct steam injection, and modification would have been obvious as stated for claim 31. Thus, the product of the prior art combination would have been expected to exhibit similar protein and overall composition characteristics. See also response to the Snow Declaration above.
Further, Hoffman is not relied on to teach the sterilization process/conditions, and instead to show that bactofugation is known and advantages for milk sterilization processes in general. Likewise, Lee et al. is not relied on to teach the sterilization, nor is the reference incorporated into the combination applied to claim 1. Rather, Maron et al. as modified by Kallioinen et al. motivates one to use IN-UHT sterilization for the advantages disclosed by the latter.
New claims 59-66 have been addressed in the instant Office Action. Arguments against the dependent claims 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 mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571)-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.K/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792