DETAILED ACTION
Amendments made July 28, 2026, have been entered.
Claims 1-20 are pending.
Claims 12 and 13 have been withdrawn.
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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. All claims have received the benefit in light of the amendments made July 28, 2026.
Specification
The objection to the specification as failing to provide proper antecedent basis for the claimed subject matter has been withdrawn in light of applicant’s amendments made July 28, 2026.
Drawings
The objection to the drawings as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate both “filtration” (see Figures 1-7) which is a specific concentration method and “the concentration process” which encompasses a variety of concentration methods (see the citations throughout the specification, including at paragraphs 17-19, 22, and 48) has been withdrawn in light of applicant’s amendments made July 28, 2026.
Claim Objections
The objection to claims 5 and 8 due to minor informalities has been withdrawn in light of applicant’s amendments made July 28, 2026.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-11 and 14-20 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.
The disclosure as originally filed does not support the amendments made July 28, 2026, which require not pasteurizing or heat treating the liquid milk concentrate prior to adding one or more active dairy cultures. Although the disclosure specifically teaches pasteurization and/or heat treatment before adding the active dairy cultures, there is nothing that shows or suggests that applicant had possession of a process without said steps. It is noted that as the product is not later heat treated, the disclosure appears to actually need the step.
The rejection of claims 1-11 and 20 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 has been withdrawn in light of applicant’s amendments made July 28, 2026.
Claim Rejections - 35 USC § 103
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 previous prior art rejections of claims 1-11 have been withdrawn in light of applicant’s amendments made July 28, 2026. Specifically, Moran et al does not teach not pasteurizing or heat treating the liquid milk concentrate prior to adding one or more active dairy cultures as required by the amendments made July 28, 2026.
Claims 1, 3-6, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Moran et al (US 5,262,183) in view of Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk” https://chriskresser.com/raw-milk-reality-benefits-of-raw-milk/ May 2012, pages 1-8).
Regarding claims 1, 3, and 10, Moran et al (Moran) teaches a method for the production of a food product (title and abstract) comprising:
Subjecting liquid milk to ultrafiltration with diafiltration, i.e. a concentration process, to from a retentate, i.e. a liquid concentrated milk (column 4 lines 8-10, 23-25, and 30-32);
Adding one or more active dairy cultures to the liquid concentrated milk to form an acidified fermented concentrated milk product (column 4 lines 47-52);
Combining the fermented milk concentrate with a clotting enzyme, including rennet (which comprises chymosin), to form a food product (column 5 lines 6-10); and
Removing moisture from the food product through evaporative processing to result in a high cheese solids content, which is taught to be a moisture content of 60% or more (column 3 lines 23-28, column 5 lines 65 through column 6 line 41).
Also see Example VII and claim 1.
Regarding the fermented milk product as containing one or more active dairy cultures and maintaining the food product at or below a temperature of about 120F such that one or more active dairy cultures from the fermented product are retained during the steps of combining the chymosin and evaporative processing as recited in claim 1, preferably at or below 100F as recited in claim 10, although Moran is not explicit to the temperatures for combining the milk and clotting enzyme, i.e. chymosin, as Moran teaches that during evaporation it is desirable that the temperature of the product not exceed 75F for a number of reasons, including that excessive temperatures result in bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity (column 6 lines 13-17), it would have been obvious for the fermented product and the processing thereafter which includes the addition of the chymosin, i.e. a clotting enzyme, and evaporation to be at temperatures not exceeding 75F, in order to prevent bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity.
Moran is silent to the concentrated milk as not pasteurized or heat treated prior to adding the one or more active dairy cultures to the liquid concentrated milk as recited in claim 1.
Kresser teaches that nearly 10 million people in the US alone actively seek out raw milk (milk that has not been pasteurized or heat treated) because it has several positive benefits including nutrition, digestive tolerance, health, flavor, economic benefits of supporting the local community, reduced harm of the environment, and ethics (pages 1-6).
Regarding the concentrated milk as not pasteurized or heat treated prior to adding the one or more active dairy cultures to the liquid concentrated milk as recited in claim 1, it would have been obvious to one of ordinary skill in the art for the milk of Moran to not be pasteurized or heat treated in order to preserve any of the several the benefits of raw milk including nutrition, digestive tolerance, health, flavor, economic benefits of supporting the local community, reduced harm of the environment, and/or ethics in view of Kresser.
Regarding claim 4, Moran teaches retentate is formed from the desired removal of salts, lactose, and water (column 1 lines 16-19 and claim 1), and that the starting milk material is preferably treated with ultrafiltration and diafiltrating to provide a retentate with the desired level of constituents for further treatment (column 4 lines 8-9, 23-25, and 29-32, and Examples).
Regarding claim 5, Moran teaches that the total solids of the concentrated milk is about 30-38% or 17-22% depending on the milk being used (column 4 lines 33-46). As Moran teaches the addition of salt to milk at the fermentation step (column 4 lines column 5 lines 2-5 and column 7 lines 11-26), wherein, as discussed above, concentration was prior to fermentation, and no disclosure of adding salt to the milk prior to concentration was made (all), the teachings of Moran would encompass or alternatively make obvious concentration of unsalted liquid milk. Furthermore, to use the components as disclosed, i.e. milk, without additional treatment steps, such as salting, would have been obvious when practicing the method of the prior art.
Regarding claim 6, Moran is not specific to a general range of the composition formed by the disclosed method. However, as Moran exemplifies the method as resulting in a product comprising 65.0% solids, 34.1% fat, 26.7% protein, and less than 0.1% lactose (Examples I and II), the method which results in the claimed ranges is considered obvious over the teachings of the prior art. It is noted that the term “about” means near or close to, and thus the claimed ranges are not limited to the exact numerical value recited.
Regarding claim 9, Moran teaches of adding salt at the fermentation step, i.e. to the concentrated milk to limit coagulation, but that excessive salt can affect bacterial growth (column 5 lines 2-5 and column 7 lines 11-25). Moran is not specific for a general range for salt usage. It would have been obvious to one of ordinary skill in the art for the salt added to the concentrated milk to be that which limited coagulation without affecting bacterial growth, including in an amount of 0.4% as exemplified by Moran in example I. Thus, the claimed range is considered obvious over the teachings of the prior art. It is noted that the term “about” means near or close to, and thus the claimed range is not limited to the exact numerical value recited.
Regarding claim 11, although Moran does not generally teach the cheese products as packaged, as Moran exemplifies the product as placed into barrels (Example I-VII), Moran encompasses or alternatively makes obvious packaging the food product as claimed. Alternatively, the examiner takes official notice that packaging was a known means to store and/or distribute food products so that they are have a layer of protection from contaminants. It would have been obvious to package the food product of Moran for a layer of protection during storage and/or distribution. Furthermore, although Moran is not specific for a temperature for packaging, as Moran teaches that during evaporation it is desirable that the temperature of the product not exceed 75F for a number of reasons, including that excessive temperatures result in bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity (column 6 lines 13-17), it would have been obvious for processing after fermentation which includes packaging to be at temperatures not exceeding 75F, in order to prevent bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Moran et al (US 5,262,183) in view of Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8), further in view of Bhaskar et al (WO 2012/060723)
As discussed above, Moran teaches a method for the production of a milk product comprising: concentration of milk, acidification with fermentation, coagulation, and evaporation to produce a cheese product. Moran teaches evaporation will normally occur in a swept surface evaporator, but other types of evaporators may be used (column 6 lines 4-8 and 21-33).
Moran is not specific to the evaporation as in a wiped film evaporator as recited in claim 2.
Bhaskar et al (Bhaskar) teaches treatment of food products including concentration of milk, acidification with fermentation, coagulation, and evaporation, wherein evaporation is in a scraped surface evaporator, and most preferably a wiped surface falling film evaporator (abstract and page 5 lines 7-9).
Regarding the evaporation as in a wiped film evaporator as recited in claim 2, it would have been obvious for the evaporator of Moran to be a wiped film evaporator as Moran teaches other evaporators can be used, and as wiped film was a known and preferred evaporator for processing dairy products that were concentrated and acidified as taught by Bhaskar. Alternatively, it is noted that apparatus limitations may have little weight in process claims. In re Tarczy-Hornoch 158 USPQ 141, 150; Stalego v. Heymes 120 USPQ 473, 478 (CCPA); Ex parte Hart 117 USPQ 193; In re Freeman 44 USPQ 116 (CCPA); In re Sweeney 72 USPQ 501 (CCPA). To be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeiffer, 1962 C.C. 408. The mere inclusion of structure in a method claim does not render it unstatutory or fatally defective. The structural limitation is of no patentable moment unless it affects the process in a manipulative sense. Ex parte Kangas, 125 USPQ 419. In the instant case, as both the prior art and claims use the apparatus for evaporation, the claimed apparatus does not distinguish itself from the method of the prior art.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Moran et al (US 5,262,183) in view of Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8), further in view of Carvalho et al (“Relevant factors for the preparation of freeze-dried lactic acid bacteria” International Dairy Journal, 2004, abstract).
As discussed above, Moran teaches a method for the production of a milk product comprising: concentration of milk, fermentation with a starter culture, and then evaporation. Moran shows in the examples the use of a lactic starter culture (see specifically column 7 line 62).
Moran is silent to the form of the starter culture as freeze dried as recited in claim 7.
Carvalho et al (Carvalho) teaches that industrial application of lactic acid bacteria as a starter depends strongly on the preservation technologies employed which are required to guarantee long-term delivery of stable cultures in terms of viability and activity. Carvalho teaches freeze dried preparations exhibit advantages relative to preparations made with other techniques in terms of long-term preservation, coupled with convenience of handling, storage, marketing, and application. See abstract, paragraph 1.
It would have been obvious for the starter culture taught by Moran to be freeze dried as it was a known form for starter cultures which provided long-term preservation, coupled with convenience of handling, storage, marketing, and application as taught by Carvalho.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Moran et al (US 5,262,183) in view of Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8) and Carvalho et al (“Relevant factors for the preparation of freeze-dried lactic acid bacteria” International Dairy Journal, 2004, abstract), further in view of Aaltonen et al (WO 2012/110706).
As discussed above, Moran teaches a method for the production of a milk product comprising: concentration of milk, fermentation with a starter culture for acidification, and then evaporation, wherein it would have been obvious for the starter culture to be freeze-dried in view of Carvalho.
Moran is not specific to the weight percentage of the starter culture added to the liquid concentrated milk.
Aaltonen et al (Aaltonen) teaches a method for the product of a milk product comprising: concentration of milk, fermentation with a starter culture for acidification, and then evaporation (abstract and paragraphs 24, 25, 33, 38, and 40). Aaltonen teaches in regards to the acidification of the concentrated milk that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the starter culture as added to the liquid concentrated milk in an amount of about 0.002-0.5% as recited in claim 8, as Moran is not specific to the weight percentage of the starter culture added to the liquid concentrated milk it would have been obvious to one of ordinary skill in the art to use a conventional amount, including 0.5-2% as taught by Aaltonen. To use a known and conventional amount of a disclosed food component would have been obvious and well within the purview of one of ordinary skill in the art.
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Moran et al (US 5,262,183).
Regarding claims 14, 15, and 19, Moran et al (Moran) teaches a method for the production of a food product (title and abstract) comprising:
Subjecting liquid milk to ultrafiltration with diafiltration, i.e. a concentration process, to from a retentate, i.e. a liquid concentrated milk (column 4 lines 8-10, 23-25, and 30-32);
Adding one or more active dairy cultures to the liquid concentrated milk to form an acidified fermented concentrated milk product (column 4 lines 47-52);
Combining the fermented milk concentrate with a clotting enzyme, including rennet (which comprises chymosin), to form a food product (column 5 lines 6-10); and
Removing moisture from the food product through evaporative processing to achieve a high cheese solids content, which is taught to be a moisture content of 60% or more (column 3 lines 23-28, column 5 lines 65 through column 6 line 41).
Also see Example VII and claim 1.
Regarding the fermented milk product as containing one or more active dairy cultures and to maintaining the food product at or below a temperature such that one or more active dairy cultures from the fermented product are retained during the step of combining the chymosin as recited in claim 14, or maintaining the food product at or below a temperature such that one or more active dairy cultures from the fermented product are retained during the step of evaporating as recited in claim 15, although Moran is not explicit to the temperatures for combining the milk and clotting enzyme, i.e. chymosin, as Moran teaches that during evaporation it is desirable that the temperature of the product not exceed 75F for a number of reasons, including that excessive temperatures result in bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity (column 6 lines 13-17), it would have been obvious for the fermented product and the processing thereafter which includes the addition of the chymosin, i.e. a clotting enzyme, and evaporation to be at temperatures not exceeding 75F, in order to prevent bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity.
Regarding claims 16 and 17, as discussed above, Moran teaches chymosin as added to the fermented concentrated product. Moran is not specific to the unit to which the chymosin is added, however, there would be a limited number of options. The chymosin must either be added in the same unit as fermentation, or a different unit, such as the next taught unit in processing, i.e. the evaporation unit. Thus, in practicing the method of the prior art, to use either of the two available options is considered obvious to one of ordinary skill in the art. It is additionally noted that apparatus limitations may have little weight in process claims. In re Tarczy-Hornoch 158 USPQ 141, 150; Stalego v. Heymes 120 USPQ 473, 478 (CCPA); Ex parte Hart 117 USPQ 193; In re Freeman 44 USPQ 116 (CCPA); In re Sweeney 72 USPQ 501 (CCPA). To be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeiffer, 1962 C.C. 408. The mere inclusion of structure in a method claim does not render it unstatutory or fatally defective. The structural limitation is of no patentable moment unless it affects the process in a manipulative sense. Ex parte Kangas, 125 USPQ 419. In the instant case the recitation of a “different unit” for addition, wherein no other processing steps occur is not seen to materially change the claimed method. Regardless of the unit for combining the method would still result in both combining and evaporation. Alternatively, as Moran teaches that the coagulant, i.e. chymosin, is added immediately before evaporation (column 5 lines 65-68), it would have been obvious for the chymosin to be added in the evaporation vessel, i.e. a different apparatus than with fermentation.
Regarding claim 18, although Moran does not generally teach the cheese products as packaged, as Moran exemplifies the product as placed into barrels (Example I-VII), Moran encompasses or alternatively makes obvious packaging the food product as claimed. Alternatively, the examiner takes official notice that packaging was a known means to store and/or distribute food products so that they are have a layer of protection from contaminants. It would have been obvious to package the food product of Moran for a layer of protection during storage and/or distribution. Furthermore, although Moran is not specific for a temperature for packaging, as Moran teaches that during evaporation it is desirable that the temperature of the product not exceed 75F for a number of reasons, including that excessive temperatures result in bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity (column 6 lines 13-17), it would have been obvious for processing after fermentation which includes packaging to be at temperatures not exceeding 75F, in order to prevent bacterial inactivation or die off, reduced bacterial activity, and reduced enzyme activity.
Regarding claim 20, as Moran teaches retentate is formed from the desired removal of salts, lactose, and water (column 1 lines 16-19 and claim 1), and that the starting milk material is preferably treated with ultrafiltration and diafiltrating to provide a retentate with the desired level of constituents for further treatment (column 4 lines 8-9, 23-25, and 29-32, and Examples), the claimed limitation is considered encompassed or alternatively obvious over the teachings of the prior art.
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.
Rejections over U.S. Patent No. 11,259,535 (‘535)
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 11,259,535 (‘535).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for the production of a food product comprising: subjecting milk to a concentration process; fermenting the liquid concentrated milk thereby forming a fermented concentrated containing one or more active dairy cultures; and combining the fermented milk concentrate with chymosin (claim 10). ‘535 does not explicitly claim that in the combining step the one or more active dairy cultures are retained, however, as ‘535 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claim 1), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including the combining step, so that they were retained in the final food product as desired by claim 1 of ‘535.
Claims 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 11-13 of U.S. Patent No. 11,259,535 (‘535) in view of Aaltonen et al (WO 2012/110706). It is noted that the rejection of claim 14 is an alternative to the one presented above which relies on different claims from ‘535 for the basis of the rejection.
Regarding claims 14 and 15, although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for the production of a food product comprising: subjecting milk to a concentration process; fermenting the liquid concentrated milk thereby forming a fermented concentrated containing one or more active dairy cultures; combining the fermented milk concentrate with other elements; and then removing moisture through evaporative processing, including with a wiped film evaporator; wherein during the combining step and removing moisture the food product is treated at or below 145F, which encompasses at or below 110F, such that the one or more active dairy cultures in the food product are retained (claims 1-3 and 11-13).
‘535 does not claim the combining as including the addition of chymosin as recited in claim 14.
Aaltonen et al (Aaltonen) teaches a method for the production of a milk product comprising: concentration of milk, fermentation with a starter culture for acidification, and then evaporation (abstract and paragraphs 24, 25, 33, 38, and 40). Aaltonen teaches that the acidifier starter and coagulant, like chymosin, are included in the pre-cheese when processing into a final cheese product (paragraph 51). Aaltonen teaches in regards to acidification of the concentrated milk product, that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the combining as including the addition of chymosin as recited in claim 14, it would have been obvious for the combining step claimed by ‘535 to include chymosin so that the food product claimed was coagulated and processed into a final cheese product as taught by Aaltonen. It is further noted that as Aaltonen teaches the acidifier, i.e. starter culture, and coagulant as added, to add the chymosin during or after fermentation would be obvious. As ‘535 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 11), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including the combining step with chymosin, so that they were retained in the final food product as desired by claims 1 and 11 of ‘535.
Regarding claims 19-20, as discussed above ‘535 claims concentration of liquid milk before fermentation. ‘535 does not claim the concentration method as ultrafiltration or microfiltration as recited in claim 19, wherein the concentration process comprises removing at least a portion of lactose or serum proteins from the liquid milk using diafiltration as recited in claim 20.
Aaltonen teaches that the milk may be pretreated with pasteurization to improve the microbiological quality of the raw material (paragraph 26). Aaltonen teaches that the concentration of the milk is advantageously performed through microfiltration and diafiltration to remove lactose and standardize the final lactose content of the cheese product to the range of 0.5-2% (paragraph 33).
Thus, it would have been obvious for the concentration of liquid milk claimed by ‘535 to be with microfiltration and diafiltration to remove lactose and advantageously standardize the final lactose content of the cheese product to the range of 0.5-2% in view of Aaltonen. It would have been further obvious that the milk be pasteurized to improve the microbiological quality of the raw material in view of Aaltonen. Furthermore, as ‘535 does not recite salting of the milk, it would have been encompassed or alternatively obvious for the milk to be unsalted. To perform the claimed method of ‘535 as disclosed would have been obvious to one of ordinary skill in the art.
Regarding claims 16 and 17, as discussed above it would have been obvious for the process claimed by ‘535 to include the combination of chymosin in view of Aaltonen. ‘535 does not claim the unit to which the chymosin is added, however, there would be a limited number of options. The chymosin must either be added in the same unit as fermentation, or a different unit, such as the next taught unit in processing, i.e. the evaporation unit. Thus, in practicing the method claimed by ‘535 in view of the prior art, to use either of the two available options is considered obvious to one of ordinary skill in the art. It is additionally noted that apparatus limitations may have little weight in process claims. In re Tarczy-Hornoch 158 USPQ 141, 150; Stalego v. Heymes 120 USPQ 473, 478 (CCPA); Ex parte Hart 117 USPQ 193; In re Freeman 44 USPQ 116 (CCPA); In re Sweeney 72 USPQ 501 (CCPA). To be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeiffer, 1962 C.C. 408. The mere inclusion of structure in a method claim does not render it unstatutory or fatally defective. The structural limitation is of no patentable moment unless it affects the process in a manipulative sense. Ex parte Kangas, 125 USPQ 419. In the instant case the recitation of a “different unit” for addition, wherein no other processing steps occur is not seen to materially change the claimed method. Regardless of the unit for combining the method would still result in both combining and evaporation.
Regarding claim 18, the examiner takes official notice that packaging was a known means to store and/or distribute food products so that they are have a layer of protection from contaminants. ‘535 does not claim the food product as packaged, however it would have been obvious to package the food product a layer of protection during storage and/or distribution. Furthermore, as ‘535 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 11), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including packaging, so that they were retained in the final food product as desired by claims 1 and 11 of ‘535.
Claims 1-6 and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 11-13 of U.S. Patent No. 11,259,535 (‘535) in view of Aaltonen et al (WO 2012/110706) and Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8).
Regarding claims 1, 2, and 10, although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for the production of a food product comprising: subjecting milk to a concentration process; fermenting the liquid concentrated milk thereby forming a fermented concentrated containing one or more active dairy cultures; combining the fermented milk concentrate with other elements; and then removing moisture through evaporative processing, including with a wiped film evaporator; wherein during the combining step and removing moisture the food product is treated at or below 145F, which encompasses at or below 110F, such that the one or more active dairy cultures in the food product are retained (claims 1-3 and 11-13).
‘535 does not claim the combining as including the addition of chymosin or to the concentrated milk as not pasteurized or heat treated prior to adding the one or more active dairy cultures to the liquid concentrated milk as recited in claim 1.
Kresser teaches that nearly 10 million people in the US alone actively seek out raw milk (milk that has not been pasteurized or heat treated) because it has several positive benefits including nutrition, digestive tolerance, health, flavor, economic benefits of supporting the local community, reduced harm of the environment, and ethics (pages 1-6).
Aaltonen et al (Aaltonen) teaches a method for the production of a milk product comprising: concentration of milk, fermentation with a starter culture for acidification, and then evaporation (abstract and paragraphs 24, 25, 33, 38, and 40). Aaltonen teaches that the acidifier starter and coagulant, like chymosin, are included in the pre-cheese when processing into a final cheese product (paragraph 51). Aaltonen teaches in regards to acidification of the concentrated milk product, that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the concentrated milk as not pasteurized or heat treated prior to adding the one or more active dairy cultures to the liquid concentrated milk as recited in claim 1, it would have been obvious to one of ordinary skill in the art for the milk claimed by ‘535 to not be pasteurized or heat treated in order to preserve any of the several the benefits of raw milk including nutrition, digestive tolerance, health, flavor, economic benefits of supporting the local community, reduced harm of the environment, and/or ethics in view of Kresser.
Regarding the combining as including the addition of chymosin as recited in claim 1, it would have been obvious for the combining step claimed by ‘535 to include chymosin so that the food product claimed was coagulated and processed into a final cheese product as taught by Aaltonen. It is further noted that as Aaltonen teaches the acidifier, i.e. starter culture, and coagulant as added, to add the chymosin during or after fermentation would be obvious. As ‘535 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 11), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including the combining step with chymosin, so that they were retained in the final food product as desired by claims 1 and 11 of ‘535.
Regarding claims 3-5, as discussed above ‘535 claims concentration of liquid milk before fermentation. ‘535 does not claim the concentration method as ultrafiltration or microfiltration as recited in claims 3, wherein the concentration process comprises removing at least a portion of lactose or serum proteins from the liquid milk using diafiltration as recited in claim 4, or to concentrating an unsalted milk to form a concentrated milk with a total solids content of about 20-55% as recited in claim 5.
Aaltonen teaches that the milk may be pretreated with pasteurization to improve the microbiological quality of the raw material (paragraph 26). Aaltonen teaches that the concentration of the milk is advantageously performed through microfiltration and diafiltration to remove lactose and standardize the final lactose content of the cheese product to the range of 0.5-2% (paragraph 33).
Thus, it would have been obvious for the concentration of liquid milk claimed by ‘535 to be with microfiltration and diafiltration to remove lactose and advantageously standardize the final lactose content of the cheese product to the range of 0.5-2% in view of Aaltonen. It would have been further obvious that the milk be pasteurized to improve the microbiological quality of the raw material in view of Aaltonen. Furthermore, as ‘535 does not recite salting of the milk, it would have been encompassed or alternatively obvious for the milk to be unsalted. To perform the claimed method of ‘535 as disclosed would have been obvious to one of ordinary skill in the art.
Regarding claim 6, as discussed above ‘535 claims forming a fermented dairy product, i.e. a fermented milk product, which is concentrated. ‘535 is silent to the concentrated food product as comprising at least 60% total solids, at least about 15% fat, at least about 15% protein and about 0.5-6% lactose as recited in claim 6. Regarding the total solids, fat, and protein content, Aaltonen teaches that concentration of the fermented and coagulated milk is performed to achieve the desired ratio of calcium and protein, and the moisture content for the final cheese desired, wherein protein contents range from 15% or more, and moisture content of hard cheese is less than 51%, which would provide a total solid of 49% and greater (paragraphs 41-43, 48 and 50). Aaltonen exemplifies the process resulting in a fat content of greater than 15% (Tables 2-5). It would have been obvious for the total solids, fat, and protein content of the food product claimed by ‘535 to be adjusted within known ranges when concentrating, including at least 60% total solids, at least about 15% fat, and at least about 15% protein in order for the concentrating step to result a cheese product with the desired ratios and hardness type. Regarding the lactose content, as discussed above, it would have been obvious for the concentration of liquid milk claimed by ‘535 to be with microfiltration and diafiltration to remove lactose and advantageously standardize the final lactose content of the cheese product to the range of 0.5-2% in view of Aaltonen.
Regarding claim 9,’535 does not claim adding about 0.5-3% salt to the liquid concentrate as recited in claim 9. Aaltonen teaches that salt is added prior to evaporation to prepare ripened cheese (paragraph 52), and that in concentration, after filtration, salt and evaporation can be further used (paragraph 54 and Figure 1). It would have been obvious for the salt to be added to the liquid concentrate claimed by ‘535 for ripening and/or further concentration processing in view of Aaltonen, wherein the specific amount would depend on the desired result.
Regarding claim 11, the examiner takes official notice that packaging was a known means to store and/or distribute food products so that they are have a layer of protection from contaminants. ‘535 does not claim the food product as packaged, however it would have been obvious to package the food product a layer of protection during storage and/or distribution. Furthermore, as ‘535 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 11), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including packaging, so that they were retained in the final food product as desired by claims 1 and 11 of ‘535.
Claims 7 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 11-13 of U.S. Patent No. 11,259,535 (‘535) in view of Aaltonen et al (WO 2012/110706) and Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8), further in view of Carvalho et al (“Relevant factors for the preparation of freeze-dried lactic acid bacteria” International Dairy Journal, 2004, abstract).
As discussed above the claims ‘535 encompass adding a starter active dairy culture to the liquid concentrated milk.
‘535 does not claim the starter culture as freeze dried as recited in claim 7, or as added in an amount of about 0.002-0.5% as recited in claim 8.
Carvalho et al (Carvalho) teaches that industrial application of lactic acid bacteria as a starter depends strongly on the preservation technologies employed which are required to guarantee long-term delivery of stable cultures in terms of viability and activity. Carvalho teaches freeze dried preparations exhibit advantages relative to preparations made with other techniques in terms of long-term preservation, coupled with convenience of handling, storage, marketing, and application. See abstract, paragraph 1.
Aaltonen teaches in regards to acidification of the concentrated milk product, that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the starter culture as added in freeze dried form, it would have been obvious for the starter culture claimed by ‘535 to be freeze dried as it was a known form for starter cultures which provided long-term preservation, coupled with convenience of handling, storage, marketing, and application as taught by Carvalho.
Regarding the starter culture as added to the liquid concentrated milk in an amount of about 0.002-0.5% as recited in claim 8, as ‘535 is not specific in the claims to the weight percentage of the starter culture added to the liquid concentrated milk it would have been obvious to one of ordinary skill in the art to use a conventional amount, including 0.5-2% as taught by Aaltonen. To use a known and conventional amount of a disclosed food component would have been obvious and well within the purview of one of ordinary skill in the art.
Rejections over U.S. Patent No. 12,133,537 (‘537)
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 11,259,535 (‘537).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for the production of a food product comprising: subjecting milk to a concentration process; fermenting the liquid concentrated milk thereby forming a fermented concentrated containing one or more active dairy cultures; and combining the fermented milk concentrate with chymosin (claim 10). ‘537 does not explicitly claim that in the combining step the one or more active dairy cultures are retained, however, as ‘537 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claim 1), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including the combining step, so that they were retained in the final food product as desired by claim 1 of ‘537.
Claims 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9 and 18-19 of U.S. Patent No. 11,259,537 (‘537) in view of Aaltonen et al (WO 2012/110706). It is noted that the rejection of claim 14 is an alternative to the one presented above which relies on different claims from ‘537 for the basis of the rejection.
Regarding claims 14 and 15, although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for the production of a food product comprising: subjecting milk to a concentration process; fermenting the liquid concentrated milk thereby forming a fermented concentrated containing one or more active dairy cultures; combining the fermented milk concentrate with other elements; and then removing moisture through evaporative processing, including with a wiped film evaporator; wherein during the combining step and removing moisture the food product is treated such that the one or more active dairy cultures in the food product are retained (claims 1, 8-9 and 18-19), thus encompassing, below 145F and below 110F as instantly claimed.
‘537 does not claim the combining as including the addition of chymosin as recited in claim 14.
Aaltonen et al (Aaltonen) teaches a method for the production of a milk product comprising: concentration of milk, fermentation with a starter culture for acidification, and then evaporation (abstract and paragraphs 24, 25, 33, 38, and 40). Aaltonen teaches that the acidifier starter and coagulant, like chymosin, are included in the pre-cheese when processing into a final cheese product (paragraph 51). Aaltonen teaches in regards to acidification of the concentrated milk product, that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the combining as including the addition of chymosin as recited in claim 14, it would have been obvious for the combining step claimed by ‘537 to include chymosin so that the food product claimed was coagulated and processed into a final cheese product as taught by Aaltonen. It is further noted that as Aaltonen teaches the acidifier, i.e. starter culture, and coagulant as added, to add the chymosin during or after fermentation would be obvious. As ‘537 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 18), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including the combining step with chymosin, so that they were retained in the final food product as desired by claims 1 and 18 of ‘537.
Regarding claims 19-20, as discussed above ‘537 claims concentration of liquid milk before fermentation. ‘537 does not claim the concentration method as ultrafiltration or microfiltration as recited in claim 19, wherein the concentration process comprises removing at least a portion of lactose or serum proteins from the liquid milk using diafiltration as recited in claim 20.
Aaltonen teaches that the milk may be pretreated with pasteurization to improve the microbiological quality of the raw material (paragraph 26). Aaltonen teaches that the concentration of the milk is advantageously performed through microfiltration and diafiltration to remove lactose and standardize the final lactose content of the cheese product to the range of 0.5-2% (paragraph 33).
Thus, it would have been obvious for the concentration of liquid milk claimed by ‘537 to be with microfiltration and diafiltration to remove lactose and advantageously standardize the final lactose content of the cheese product to the range of 0.5-2% in view of Aaltonen. It would have been further obvious that the milk be pasteurized to improve the microbiological quality of the raw material in view of Aaltonen. Furthermore, as ‘537 does not recite salting of the milk, it would have been encompassed or alternatively obvious for the milk to be unsalted. To perform the claimed method of ‘537 as disclosed would have been obvious to one of ordinary skill in the art.
Regarding claims 16 and 17, as discussed above it would have been obvious for the process claimed by ‘537 to include the combination of chymosin in view of Aaltonen. ‘537 does not claim the unit to which the chymosin is added, however, there would be a limited number of options. The chymosin must either be added in the same unit as fermentation, or a different unit, such as the next taught unit in processing, i.e. the evaporation unit. Thus, in practicing the method claimed by ‘535 in view of the prior art, to use either of the two available options is considered obvious to one of ordinary skill in the art. It is additionally noted that apparatus limitations may have little weight in process claims. In re Tarczy-Hornoch 158 USPQ 141, 150; Stalego v. Heymes 120 USPQ 473, 478 (CCPA); Ex parte Hart 117 USPQ 193; In re Freeman 44 USPQ 116 (CCPA); In re Sweeney 72 USPQ 501 (CCPA). To be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. Ex parte Pfeiffer, 1962 C.C. 408. The mere inclusion of structure in a method claim does not render it unstatutory or fatally defective. The structural limitation is of no patentable moment unless it affects the process in a manipulative sense. Ex parte Kangas, 125 USPQ 419. In the instant case the recitation of a “different unit” for addition, wherein no other processing steps occur is not seen to materially change the claimed method. Regardless of the unit for combining the method would still result in both combining and evaporation.
Regarding claim 18, the examiner takes official notice that packaging was a known means to store and/or distribute food products so that they are have a layer of protection from contaminants. ‘537 does not claim the food product as packaged, however it would have been obvious to package the food product a layer of protection during storage and/or distribution. Furthermore, as ‘537 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 18), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including packaging, so that they were retained in the final food product as desired by claims 1 and 18 of ‘537.
Claims 1-6 and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9 and 18-19 of U.S. Patent No. 11,259,537 (‘537) in view of Aaltonen et al (WO 2012/110706) and Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8).
Regarding claims 1, 2, and 10, although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method for the production of a food product comprising: subjecting milk to a concentration process; fermenting the liquid concentrated milk thereby forming a fermented concentrated containing one or more active dairy cultures; combining the fermented milk concentrate with other elements; and then removing moisture through evaporative processing, including with a wiped film evaporator; wherein during the combining step and removing moisture the food product is treated such that the one or more active dairy cultures in the food product are retained (claims 1, 8-9 and 18-19), thus encompassing, below 145F and below 110F as instantly claimed.
‘537 does not claim the combining as including the addition of chymosin or to the concentrated milk as not pasteurized or heat treated prior to adding the one or more active dairy cultures to the liquid concentrated milk as recited in claim 1.
Kresser teaches that nearly 10 million people in the US alone actively seek out raw milk (milk that has not been pasteurized or heat treated) because it has several positive benefits including nutrition, digestive tolerance, health, flavor, economic benefits of supporting the local community, reduced harm of the environment, and ethics (pages 1-6).
Aaltonen et al (Aaltonen) teaches a method for the production of a milk product comprising: concentration of milk, fermentation with a starter culture for acidification, and then evaporation (abstract and paragraphs 24, 25, 33, 38, and 40). Aaltonen teaches that the acidifier starter and coagulant, like chymosin, are included in the pre-cheese when processing into a final cheese product (paragraph 51). Aaltonen teaches in regards to acidification of the concentrated milk product, that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the concentrated milk as not pasteurized or heat treated prior to adding the one or more active dairy cultures to the liquid concentrated milk as recited in claim 1, it would have been obvious to one of ordinary skill in the art for the milk claimed by ‘537 to not be pasteurized or heat treated in order to preserve any of the several the benefits of raw milk including nutrition, digestive tolerance, health, flavor, economic benefits of supporting the local community, reduced harm of the environment, and/or ethics in view of Kresser.
Regarding the combining as including the addition of chymosin as recited in claim 1, it would have been obvious for the combining step claimed by ‘537 to include chymosin so that the food product claimed was coagulated and processed into a final cheese product as taught by Aaltonen. It is further noted that as Aaltonen teaches the acidifier, i.e. starter culture, and coagulant as added, to add the chymosin during or after fermentation would be obvious. As ‘537 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 18), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including the combining step with chymosin, so that they were retained in the final food product as desired by claims 1 and 18 of ‘537.
Regarding claims 3-5, as discussed above ‘537 claims concentration of liquid milk before fermentation. ‘537 does not claim the concentration method as ultrafiltration or microfiltration as recited in claim 3, wherein the concentration process comprises removing at least a portion of lactose or serum proteins from the liquid milk using diafiltration as recited in claim 4, or to concentrating an unsalted milk to form a concentrated milk with a total solids content of about 20-55% as recited in claim 5.
Aaltonen teaches that the milk may be pretreated with pasteurization to improve the microbiological quality of the raw material (paragraph 26). Aaltonen teaches that the concentration of the milk is advantageously performed through microfiltration and diafiltration to remove lactose and standardize the final lactose content of the cheese product to the range of 0.5-2% (paragraph 33).
Thus, it would have been obvious for the concentration of liquid milk claimed by ‘537 to be with microfiltration and diafiltration to remove lactose and advantageously standardize the final lactose content of the cheese product to the range of 0.5-2% in view of Aaltonen. It would have been further obvious that the milk be pasteurized to improve the microbiological quality of the raw material in view of Aaltonen. Furthermore, as ‘537 does not recite salting of the milk, it would have been encompassed or alternatively obvious for the milk to be unsalted. To perform the claimed method of ‘537 as disclosed would have been obvious to one of ordinary skill in the art.
Regarding claim 6, as discussed above ‘537 claims forming a fermented dairy product, i.e. a fermented milk product, which is concentrated. ‘537 is silent to the concentrated food product as comprising at least 60% total solids, at least about 15% fat, at least about 15% protein and about 0.5-6% lactose as recited in claim 6. Regarding the total solids, fat, and protein content, Aaltonen teaches that concentration of the fermented and coagulated milk is performed to achieve the desired ratio of calcium and protein, and the moisture content for the final cheese desired, wherein protein contents range from 15% or more, and moisture content of hard cheese is less than 51%, which would provide a total solid of 49% and greater (paragraphs 41-43, 48 and 50). Aaltonen exemplifies the process resulting in a fat content of greater than 15% (Tables 2-5). It would have been obvious for the total solids, fat, and protein content of the food product claimed by ‘537 to be adjusted within known ranges when concentrating, including at least 60% total solids, at least about 15% fat, and at least about 15% protein in order for the concentrating step to result a cheese product with the desired ratios and hardness type. Regarding the lactose content, as discussed above, it would have been obvious for the concentration of liquid milk claimed by ‘537 to be with microfiltration and diafiltration to remove lactose and advantageously standardize the final lactose content of the cheese product to the range of 0.5-2% in view of Aaltonen.
Regarding claim 9,’537 does not claim adding about 0.5-3% salt to the liquid concentrate as recited in claim 9. Aaltonen teaches that salt is added prior to evaporation to prepare ripened cheese (paragraph 52), and that in concentration, after filtration, salt and evaporation can be further used (paragraph 54 and Figure 1). It would have been obvious for the salt to be added to the liquid concentrate claimed by ‘537 for ripening and/or further concentration processing in view of Aaltonen, wherein the specific amount would depend on the desired result.
Regarding claim 11, the examiner takes official notice that packaging was a known means to store and/or distribute food products so that they are have a layer of protection from contaminants. ‘537 does not claim the food product as packaged, however it would have been obvious to package the food product a layer of protection during storage and/or distribution. Furthermore, as ‘537 does recite preserving the active cultures in the other claimed step after fermentation such that the cultures are retained in the food product (claims 1 and 18), it would have been encompassed, or at least obvious to preserve the active cultures after all steps following fermentation, including packaging, so that they were retained in the final food product as desired by claims 1 and 18 of ‘537.
Claims 7 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9 and 18-19 of U.S. Patent No. 11,259,535 (‘537) in view of Aaltonen et al (WO 2012/110706) and Kresser, Chris (“Raw Milk Reality: Benefits of Raw Milk”, pages 1-8), further in view of Carvalho et al (“Relevant factors for the preparation of freeze-dried lactic acid bacteria” International Dairy Journal, 2004, abstract).
As discussed above the claims ‘537 encompass adding a starter active dairy culture to the liquid concentrated milk.
‘537 does not claim the starter culture as freeze dried as recited in claim 7, or as added in an amount of about 0.002-0.5% as recited in claim 8.
Carvalho et al (Carvalho) teaches that industrial application of lactic acid bacteria as a starter depends strongly on the preservation technologies employed which are required to guarantee long-term delivery of stable cultures in terms of viability and activity. Carvalho teaches freeze dried preparations exhibit advantages relative to preparations made with other techniques in terms of long-term preservation, coupled with convenience of handling, storage, marketing, and application. See abstract, paragraph 1.
Aaltonen teaches in regards to acidification of the concentrated milk product, that the amount of starter is conventionally 0.5-2% (paragraph 38).
Regarding the starter culture as added in freeze dried form, it would have been obvious for the starter culture claimed by ‘537 to be freeze dried as it was a known form for starter cultures which provided long-term preservation, coupled with convenience of handling, storage, marketing, and application as taught by Carvalho.
Regarding the starter culture as added to the liquid concentrated milk in an amount of about 0.002-0.5% as recited in claim 8, as ‘537 is not specific in the claims to the weight percentage of the starter culture added to the liquid concentrated milk it would have been obvious to one of ordinary skill in the art to use a conventional amount, including 0.5-2% as taught by Aaltonen. To use a known and conventional amount of a disclosed food component would have been obvious and well within the purview of one of ordinary skill in the art.
Response to Arguments
Applicant’s arguments filed July 28, 2026 with respect to claim(s) 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are based on the newly added claim limitation for which the previous rejections were withdrawn, and newly cited prior art Kresser was added for a teaching thereof.
Applicant's arguments filed July 28, 2026 with respect to claim(s) 14-20 have been fully considered but they are not persuasive. Applicant argues that the claims are patentable over the prior art because of their dependency upon claim 1. This argument is not convincing as claims 14-20 do not directly or indirectly depend on claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Raw Milk Institute “Testimonials” January 2019 http://www.rawmilkinstitute.org/about-raw-milk/testimonials/, pages 1-3 shows that consumers desired the benefits of raw milk.
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.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/ Primary Patent Examiner, Art Unit 1792
