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 .
Status of Claims
Claims 1-2, 4-6, 8-19 and 23-32 are pending and under examination in this application. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-6, 8-19 and 23-32 are rejected under 35 U.S.C. 103 as being unpatentable over Makino et al. US 20160206733 in view of Kido et al. WO 2018034279.
Please note the rejection below for Kido is based off of paragraph numbers added to the PE2E English translation supplied with the rejection.
Regarding claims 1-2, 5-6, and 26-27 Makino teaches a method of orally administering (oral ingestion [0038], [0087]) a fermented milk [0095] to a person (a subject; [0038], [0049], [0089]), as required by claims 1, 5-6 and 26-27. Makino does not state that the person (subject) suffers from sleep disturbance [0038], [0089]. Therefore, the person is considered a person not suffering from sleep disturbance, as required by claims 1 and 16.
Makino teaches orally administering (ingesting) for at least 8 weeks and where the upper limit for the ingestion period is not particularly limited [0116-0117]. This encompasses the claimed range of orally administering for 16 weeks or more, as required by claims 1, 5-6 and 26-27. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Makino teaches the fermented milk contains (i) at least one lactic acid bacterium of genus Lactobacillus selected from the group consisting of Lactobacillus delbrueckii subsp. bulgaricus (Abstract, [0027], [0091], [0095]), as required by claims 1, 5-6 and 26-27.
Regarding the fermented milk containing (ii) a metabolite, Makino teaches a fermented milk [0095] that has lactic acid bacterium Lactobacillus delbrueckii subsp. bulgaricus (Abstract, [0027], [0091], [0095]). In the instant specification it states in [0006], “the term ‘metabolite’ as used herein means a substance or the like produced as a result of fermentation of milk by lactic acid bacterium.” The claim also states, “a metabolite produced as a result of fermentation of milk by the at least one lactic acid bacterium.” Therefore, since the composition of Makino is a fermented milk that is fermented with lactic acid bacteria and is identical to the claimed fermented milk composition used in the claimed method, the fermented milk composition of Makino is considered to have a lactic acid bacterium metabolite, specifically an extracellular polysaccharide of the lactic acid bacterium, as required by claim 2. Thus, Makino has the claimed metabolite produced as a result of fermentation of milk by the at least one lactic acid bacterium, as required by claims 1, 5-6 and 26-27. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Makino teaches the fermented milk has a metabolite, as discussed in the rejection above, but is silent as to the amount of metabolite. Kido teaches a method of ingesting a fermented milk daily [0027] wherein the fermented milk contains a lactic acid bacteria from the genus Lactobacillus (Abstract, [0030]). Kido teaches the fermented milk has exopolysaccharide as a metabolite produced by Bulgaricus R-1 strain [0014-0015], where the Bulgaricus R-1 strain is Lactobacillus delbrueckii subspecies bulgaricus OLL 1073R-1 [0010]. Kido discloses that the composition, which contains the metabolite, suppresses decrease in acquired immune function [0011], [0031]. Kido teaches the metabolite in the composition is in the range of 500 μg or more for daily intake, where the upper limit is not specifically limited [0015]. This overlaps the claimed range of 100 μg to 200 mg per day, as required by claims 1, 5-6 and 26-27.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Makino to incorporate the teachings of Kido by having the metabolite be within the claimed range per day since the composition suppresses decrease in acquired immune function, as recognized by Kido [0011], [0031].
Makino teaches the method of orally administering a fermented milk to a person, is a method for improving overall health of a person (promotion of health; [0053]), as required by claim 5.
Makino in view of Kido teaches a substantially identical method of administering with a substantially identical composition that is being administered in the claimed method, as shown by the above rejection. Since modified Makino teaches the method of administering is substantially identical and the composition being administered in the method is substantially identical to the claims, the method of modified Makino is considered to have the same effects within the preamble and body of the claims. Specifically, Makino is considered to decrease total scores on the Pittsburg Sleep Questionnaire of a person not suffering from sleep disturbance, as required by claim 1, to improve vitality of a person, as required by claim 6, to suppress deterioration of quality of sleep of a person not suffering from sleep disturbance, as required by claim 26 and to prevent sleep disturbance of a person, as required by claim 27. Thus, the method of modified Makino is considered to have the effects as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claims 4, 8, 9 and 10 Makino teaches the lactic acid bacterium of the genus Lactobacillus is Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 (FERM BP-10741) (Abstract, [0027], [0070]), as required by claims 4, 8, 9 and 10.
Regarding claims 11, 12 and 13 Makino teaches the lactic acid bacterium of the genus Lactobacillus is Lactobacillus delbrueckii subsp. bulgaricus (Abstract, [0027]), as required by claims 11, 12 and 13.
Regarding claims 14, 15 and 16 Makino teaches a fermented milk [0095] but is silent as to the amount of non-fat milk solids. Kido teaches the fermented milk has 4% to 12% non-fat milk solid content [0018], and the composition suppresses decrease in acquired immune function [0011], [0031]. This encompasses the claimed range of 8% to 11% non-fat milk solids in the fermented milk, as required by claims 14, 15 and 16. See MPEP 2144.05(I).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Makino to incorporate the teachings of Kido by having the non-fat milk solids within the claimed range since the composition suppresses decrease in acquired immune function, as recognized by Kido [0011], [0031].
Regarding claims 17, 18 and 19 Makino teaches wherein the fermented milk is orally administered to the person in a range of preferably 100 to 200 ml per day [0098]. This is within the claimed range of 50 ml to 200 ml per day required by claims 17-19.
Regarding claims 23, 24 and 25 Makino teaches the lactic acid bacterium of the genus Lactobacillus has a range of 9x107 to 1012 cfu per package, or 9x107 to 1012 cfu per day since the amount in one package is 10-1000 ml per package and this amount contained in one package is taken per day [0035-0036], [0039]. This is within the claimed range of 106 cfu to 1012 cfu per day, as required by claims 23, 24 and 25.
Regarding claims 28, 29, 30, 31 and 32 Makino teaches the fermented milk [0095] is orally administered once per day [0098] for at least 8 weeks and where the upper limit for the ingestion period is not particularly limited [0116-0117]. This encompasses the claimed range of orally administering once per day for 16 weeks or more, as required by claims 28, 29, 30, 31 and 32. See MPEP 2144.05(I).
Response to Arguments
Applicant's arguments filed December 4, 2025 have been fully considered but they are not persuasive.
Applicant states, on pgs. 10-12 of their remarks, that claims 1, 5-6 and 26-27 now incorporate the subject matter from cancelled claims 20-22 and require the metabolite. Applicant argues that Makino does not disclose or suggest the administration to a person of the metabolite in the range of 100 µg to 200 mg per day. Applicant contends Makino does not disclose the administration of the metabolite since Makino does not ever mention the production of a metabolite. Applicant states that the Office Action dated August 4, 2025 contends the metabolite is inherently present in the fermented milk of Makino. Applicant argues the rejection does not meet the stringent standard to rely on inherency. Applicant contends the rejection presumes the specifically claimed oral administration dosage is achieved simply by some undefined amount of metabolite being present in the fermented milk of Makino. Applicant argues that Makino provides no teaching or suggestion that would lead the skilled artisan to produce and administer the metabolite in the claimed range. The Office disagrees for the following reasons.
The Office applies the rejection of the now cancelled claim 20-22 of Makino in view of Kido from the non-final rejection dated 08/04/2025, to the above rejection of claims 1, 5-6 and 26-27. While it is maintained that the fermented milk of Makino does inherently produce the metabolite during fermentation, the rejection recognizes that the dosage of the metabolite is not disclosed by Makino.
As shown in the above rejection, Makino teaches a fermented milk [0095] that has lactic acid bacterium Lactobacillus delbrueckii subsp. bulgaricus (Abstract, [0027], [0091], [0095]). In the instant specification it states in [0006], “the term ‘metabolite’ as used herein means a substance or the like produced as a result of fermentation of milk by lactic acid bacterium.” The claim also states, “a metabolite produced as a result of fermentation of milk by the at least one lactic acid bacterium.” Therefore, since the composition of Makino is a fermented milk that is fermented with lactic acid bacteria and is identical to the claimed fermented milk composition used in the claimed method, the fermented milk composition of Makino is considered to have a lactic acid bacterium metabolite, specifically an extracellular polysaccharide of the lactic acid bacterium. Thus, Makino necessarily possesses the claimed metabolite produced as a result of fermentation of milk by the at least one lactic acid bacterium, as required by claims 1, 5-6 and 26-27. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)). Additionally, the rejection is viewed as meeting the stringent standard of providing a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art.
As stated in the above rejection, Makino is silent as to the amount of metabolite. However, Kido teaches the metabolite is in the composition at an amount of 500 μg or more for daily intake, where the upper limit is not specifically limited [0015]. This overlaps the claimed range of 100 μg to 200 mg per day, as required by claims 1, 5-6 and 26-27. Kido also provides motivation to a person of ordinary skill to modify Makino to have the dosage amount of metabolite within the claimed range. Specifically, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Makino to incorporate the teachings of Kido by having the metabolite be within the claimed range per day since the composition suppresses decrease in acquired immune function, as recognized by Kido [0011], [0031].
Applicant argues, on pgs. 12-13, that Makino in view of Kido does not reasonably teach or suggest the requirements of the claimed methods. Applicant contends it would not have been obvious to modify Makino in view of Kido by having the metabolite be within the claimed range per day. Kido discloses a method of suppressing deterioration of the acquired immune function due to the use of an anti-influenza drug. Applicant asserts that Kido teaches 500 μg or more of metabolite per day can suppress the deterioration of acquired immune function due to the use of anti-influenza drug, which differs from Makino’s disclosure of an antibody titer-increasing agent. Applicant argues that just because two references can be combined does not necessarily mean that one skilled in the art would have had a motivation to combine them. Applicant asserts the rejection suggests that it would be obvious to modify the primary reference with the secondary reference to achieve the objective of the secondary reference; and then states, the object of the secondary reference is the result of anti-influenza drugs, which are not even utilized in the primary reference. Applicant concludes there is no rational reason to modify Makino in view of Kido to achieve the claimed amount of metabolite administered per day. The Office disagrees for the following reasons.
The Abstract for Kido explains that the objective of administering the composition is to control acquired immune function suppression. While Kido does explain the acquired immune function in terms of anti-influenza drugs, there is no reason to suppose that this benefit in immune function can’t be seen in other areas. As stated in Kido, “the present invention is not limited to this” or not limited to only being used with an anti-influenza drug [0004]. The objective of Kido is to prevent any decrease in acquired immune function (Abstract). Thus, there is a rational reason to modify Makino in view of Kido to achieve the claimed amount of metabolite administered per day, specifically modifying Makino to incorporate the teachings of Kido because administering the claimed amount of metabolite per day suppresses decrease in acquired immune function, as recognized by Kido [0011], [0031].
Furthermore, in response to applicant's argument that anti-influenza drugs are not used in the Makino reference, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues, on pg. 14, that the present claims require the administration of the fermented milk for 16 weeks or more in addition to the metabolite being orally administered to the person in a range of 100 μg to 200 mg per day. Applicant continues stating Kido provides no characterization of the amount or type of metabolites formed. Applicant contends that Kido provides no reasonable suggestion for the skilled artisan to provide an administration for 16 weeks or more in addition to the metabolite being administered to the person in the claimed range. Applicant asserts Kido and Makino differ in their application and purpose, with Makino focusing on an antibody titer-increasing agent that is administered for at least 8 weeks and Kido focusing on a administering a metabolite at a lower limit of 500 μg per day to combat the deterioration of an acquired immune function. Applicant argues there cannot be a reasonable basis to combine these different dosages. The Office disagrees for the following reasons.
Regarding Applicant’s argument that Kido provides no characterization of the amount or type of metabolites formed; Kido teaches the Bulgaricus R-1 strain produces exopolysaccharide as a metabolite and the composition that is ingested daily contains the exopolysaccharide produced from Bulgaricus R-1 strain [0015]. Kido also teaches the amount of metabolite in the composition that is ingested daily is at a lower limit of 500 μg [0015]. Thus, Kido does state the type of metabolite formed and the lower limit of the amount of metabolite within the fermented milk composition that is administered.
It is noted that Kido is not relied on for the teaching of administering the fermented milk composition for 16 weeks or more. This is taught in the Makino reference, as shown by the rejection above. Moreover, Kido doesn’t limit the amount of time that their composition may be taken but just suggest taking the composition “daily” [0015], [0027], which would be for more than one day or multiple days. Thus, it would be reasonable to take the composition of Kido for any amount of time, as long as it is taken daily, including for 16 weeks or more.
Makino and Kido are considered combinable because they are concerned with the same field of endeavor. Makino teaches a method of orally administering (oral ingestion [0038], [0087]) a fermented milk [0095] to a person (a subject; [0038], [0049], [0089]) to improve health (promotion of health; [0053]). Kido teaches a method of orally administering a fermented milk to a person to improve health (ingesting a fermented milk daily for controlling acquired immune function suppression; [0011], [0027], [0031], Abstract). Makino teaches the lactic acid bacterium of the genus Lactobacillus is Lactobacillus delbrueckii subsp. bulgaricus OLL1073R-1 (FERM BP-10741) (Abstract, [0027], [0070]), and Kido teaches the same bacteria in the fermented milk product, Lactobacillus delbrueckii subspecies bulgaricus OLL1073R-1 [0010]. A person of ordinary skill in the art would find it reasonable to combine the dosage of the fermented milk product of Makino of administering for at least 8 weeks, with the daily metabolite dosage of the fermented milk product of Kido. Thus, it is reasonable to combine the dosages of Makino and Kido, which are both concerned with the same field of endeavor of improving health by administering a fermented milk product produced by the same strain of bacteria.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759