Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This application is a US national phase of PCT/JP2021/023326 filed June 21, 2021, with foreign priority application JP2020-107035, filed June 22, 2020. Applicant’s amendment filed October 22, 2025 is acknowledged. Claims 1-12, 16-18, 22, and 25-28 are canceled, and claims 30-34 are newly added. Claims 13, 19-21, and 24 are amended. Currently claims 13-15, 19-21, 23-24, and 29-34 are pending and under examination.
The previous objection to the specification, 112(a) rejection, 112(b) rejection, and provisional non-statutory double patenting rejection over copending application 16/959781 in the Non-Final office action mailed May 22, 2025 are withdrawn due to Applicant’s amendment to the specification and claims filed October 22, 2025.
Specification
The abstract of the disclosure does not commence on a separate sheet in
accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is
required and must be presented on a separate sheet, apart from any other text.
Claim Objections
Claim 32 is objected to because of the following informalities: new claim 32 recites an incoherent phrase, a drink yogurt. This claim term may be amended to “a drinkable yogurt”.. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14, 19-21, 23-24, 29, and 34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites “the fermented milk” in line 2. The term lacks antecedent basis because the claim from which it depends, claim 13, no longer recites a fermented milk but recites a fermented milk base material.
Claims 19-21 and 34 recite “…wherein the subject has a decreased IL-10 production or a tendency to decrease the production of IL-10”, which are relative terms. It is unclear to one of ordinary skill in the art and neither does the specification provide what standard is used to ascertain the metes and bounds of this limitation in the claims, as ‘decreased IL-10 production’ and ‘a tendency to decrease the production of IL-10’ are ambiguous, and could be interpreted a number of ways, such as decreased in relation to a control population, or based on the individual’s normal IL-10 level range, therefore is indefinite. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 23-24 and 29 are likewise rejected as being dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 23-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 23-24 recite properties/effects of the L. plantarum OLL2712 used in the method, and thus do not further limit the method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13 and 30-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toshimitsu et al. (CN 103314099 A, priority document of previously cited WO 2012/014971 A1, published 12/03/2014, hereinafter “Toshimitsu”), as evidenced by Agriculture.Institute (Printed 12/17/2025, < agriculture.institute/dairy-products-ii/roller-drying-milk-powder-techniques-challenges/>).
Toshimitsu teaches compositions of lactic acid bacterium belonging to Lactobacillus and fermented milk, wherein the compositions are formulated with a starter and raw milk (abstract, pg. 4, para 7-10). The compositions may be mixed and/or homogenized (i.e. ‘stirring step’), sterilizing and cooling the milk or milk product in the starter mixture, through fermentation, cooling to produce raw yoghurt (7⁰C), which anticipates claims 13 and 30-31 [0101].
Toshimitsu teaches the composition can be a functional food in the formulation of a yoghurt drink, which anticipates claim 32 [0100].
Toshimitsu teaches the Lactobacillus bacteria of the invention can be used for medical use or food use, using live bacteria and dead bacteria, such as roller drying [0084], which is a process of drying liquid milk into powder using heated rollers as evidenced by Agriculture.Institute (pg. 2, para 2), thus would inherently result in heat-treated dead bacterial cells recited in claim 33.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19-21, 23-24, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu, as evidenced by Agriculture.Institute.
Toshimitsu teaches an example of skim milk culture supernatants comprising Lactobacillus plantarum OLL2712 (also referred to as strain 23) having anti-inflammatory effects such as markedly inducing IL-10 production in mouse bone marrow-derived BMDC cells, which meets the limitations in claims 19-21 and 34 ([0135], [141-143], Example 2). As evidenced by the Specification, ‘skim milk’ is considered the raw milk material that is fermented with the Lactobacillus to produce the ‘fermented milk’ [0058]. Toshimitsu teaches mice ingested the Lactobacillus and fermented milk composition for efficacy in a diabetes/obesity mice model, which the instant specification defines as a ‘disease caused by inflammation’ thus meeting this limitation in claims 19-21 ([0157], Example 5). Toshimitsu teaches the combination is for improving and/or preventing metabolic syndrome in a subject, for example a human, which meets the limitation in claims 19-21 and 34 [0081, 0156]. Toshimitsu teaches the food composition of the invention is ingested per day and can be properly adjusted corresponding to age, symptoms, body weight, use and the like, which meets this limitation in claims 19-21 and 34 [0109]. Toshimitsu teaches the Lactobacillus bacteria of the invention can be used for medical use or food use, using live bacteria and dead bacteria, such as roller drying[0084], which is a process of drying liquid milk into powder using heated rollers as evidenced by Agriculture.Institute (pg. 2, para 2), thus would inherently result in heat-treated dead bacterial cells recited in claims 19-21 and 34.
Toshimitsu teaches Lactobacillus plantarum OLL2712 (strain 23) is applied in the method of evaluating anti-obesity activity. Toshimitsu teaches in figures 4a-4b, strain 23 is a BMDC cell to which a dead cell of strain 23 is added, which shows increasing concentrations of dead strain 23 inhibits IL-12 production at 10 µg/ml compared to the lowest concentration meeting the limitation in claim 23, and also increasing the ratio of IL-10 to IL-12 by each increasing concentration of the bacteria (e.g. for 10µg/ml the ratio is ~7.7, whereas for 0.5 µg/ml the ratio is ~0.5), thus meeting the limitation in claim 24 (pg. 7, para 1; Figures 4a & 4b).
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ method they exemplify. As such, the claimed methods taught by Toshimitsu are within the scope of the instant claims, and thus Toshimitsu’s methods render the invention prima facie obvious. The rationale to support this conclusion of obviousness is that Toshimitsu provides a teaching, suggestion, and motivation to utilize the composition in the claimed methods as disclosed within the reference.
Claims 14-15 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu as applied to claims 13, 19-21, 23-24, and 30-34 and further in view of Brandao et al. (BR PI0300179 B1, cited in PTO-892 mailed 5/22/2025, hereinafter “Brandao”).
Toshimitsu teaches the composition used in the method comprises Lactobacillus and yogurt/fermented milk, but does not explicitly teach the average particle size recited in claims 14 and 29, nor the specific stirring speed recited in claim 15.
However, Brandao teaches methods of manufacturing creamy fat-free curd by comprising skimmed whole milk, inoculating a starter culture to obtain fermented skim milk, and stirring, wherein the starter culture can comprise Lactobacillus delbrueckii ssp Bulgaricus (abstract, claims 1 & 3). Brandao teaches the concentrated fermented skim milk is mixed by slow stirring and stirring at 400 rpm, which meets the limitation of claim 15 (claims 9 & 57). Brandao teaches a method of manufacturing fat-free creamy curd comprising obtaining a source of concentrated skimmed milk, inoculating a culture to obtain a skim milk mass, adding water to said skim milk mass, transferring to a mixer, and adding microcrystalline cellulose to the skim milk, wherein the microcrystalline cellulose have a size between 2-25 µm (claims 48 & 52). Brandao doesn’t explicitly disclose the fermented milk is within the recited range of claims 14 and 29. However, Brandao does explicitly teach the microcrystalline cellulose particles are within the recited range and are added to the milk which inherently adjusts the fermented milk within the range of 0.5 to 100 µm, thus meeting the limitation in claims 14 and 29.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of producing a composition that promotes IL-10 production comprising Lactobacillus plantarum OLL2712 and fermented milk to a subject as taught by Toshimitsu, and adjust the stirring speed to 400 rpm, as well as adjust the particle size of the fermented milk to between 2-25 µm as taught by Brandao with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to formulate the fermented milk with microcrystalline cellulose in this size range as a body agent in the manufacturing of a health-food, IL-10 promoting, creamy fat-free milk as taught by Brandao (pg. 5, para 3; pg. 7, para 2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19-21, 23-24, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-27 and 38 of copending Application No. 17/784312 in view of Toshimitsu
Regarding claims 19-21 and 34, claim 26 and 27 of ‘312 recites a method of promoting production of IL-10 and suppressing IL-6 in a subject, wherein the subject ingests an effective amount of Lactobacillus, wherein the subject is a human that has normal heart rate. ‘312 does not explicitly recite the Lactobacillus is administered in combination with fermented milk, nor that the Lactobacillus is L. plantarum OLL2712 that are essentially heat-killed dead bacterial cells, nor that the method is for treating inflammation or a disease caused by inflammation and produced by the method according to claim 13.
However, Toshimitsu teaches an example of skim milk culture supernatants comprising Lactobacillus plantarum OLL2712 (also referred to as strain 23) having anti-inflammatory effects such as markedly inducing IL-10 production in mouse bone marrow-derived BMDC cells, which meets the limitations in claims 19-21 and 34 ([0135], [141-143], Example 2). As evidenced by the Specification, ‘skim milk’ is considered the raw milk material that is fermented with the Lactobacillus to produce the ‘fermented milk’ [0058]. Toshimitsu teaches mice ingested the Lactobacillus and fermented milk composition for efficacy in a diabetes/obesity mice model, which the instant specification defines as a ‘disease caused by inflammation’ thus meeting this limitation in claims 19-21 ([0157], Example 5). Toshimitsu teaches the combination is for improving and/or preventing metabolic syndrome in a subject, for example a human, which meets the limitation in claims 19-21 and 34 [0081, 0156]. Toshimitsu teaches the food composition of the invention is ingested per day and can be properly adjusted corresponding to age, symptoms, body weight, use and the like, which meets this limitation in claims 19-21 and 34 [0109]. Toshimitsu teaches the Lactobacillus bacteria of the invention can be used for medical use or food use, using live bacteria and dead bacteria, such as roller drying[0084], which is a process of drying liquid milk into powder using heated rollers as evidenced by Agriculture.Institute (pg. 2, para 2), thus would inherently result in heat-treated dead bacterial cells recited in claims 19-21 and 34.
Toshimitsu teaches Lactobacillus plantarum OLL2712 (strain 23) is applied in the method of evaluating anti-obesity activity. Toshimitsu teaches in figures 4a-4b, strain 23 is a BMDC cell to which a dead cell of strain 23 is added, which shows increasing concentrations of dead strain 23 inhibits IL-12 production at 10µg/ml compared to the lowest concentration meeting the limitation in claim 23, and also increasing the ratio of IL-10 to IL-12 by each increasing concentration of the bacteria (e.g. for 10µg/ml the ratio is ~7.7, whereas for 0.5µg/ml the ratio is ~0.5) thus meeting the limitation in claim 24 (pg. 7, para 1; Figures 4a & 4b).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of promoting IL-10 production thereby suppressing IL-6 in a subject by administering Lactobacillus as recited in ‘312 and also administer fermented milk in combination with the L. plantarum OLL2712 for treating inflammation and diseases caused by inflammation as taught by Toshimitsu with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to combine the L. plantarum OLL2712 strain with the fermented milk in the methods for promoting IL-10 production to formulate a food composition that can be more suitably ingested as taught by Toshimitsu.
Regarding instant claims 23-24, ‘312 does not explicitly recite the effective amount of Lactobacillus inhibits IL-12 production, nor that the ratio of IL-10/IL-12 is increased.
However, Toshimitsu teaches Lactobacillus plantarum OLL2712 (strain 23) is applied in the method of evaluating anti-obesity activity which meets the limitation in claims 25 and 28. Toshimitsu teaches in figures 4a-4b, strain 23 is a BMDC cell to which a dead cell of strain 23 is added (meeting the limitation in claim 26), which shows increasing concentrations of dead strain 23 inhibits IL-12 production at 10µg/ml compared to the lowest concentration meeting the limitation in claim 23, and also increasing the ratio of IL-10 to IL-12 by each increasing concentration of the bacteria (e.g. for 10µg/ml the ratio is ~7.7, whereas for 0.5µg/ml the ratio is ~0.5) thus meeting the limitation in claim 24 (pg. 7, para 1; Figures 4a & 4b).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of promoting IL-10 production and suppressing IL-6 by administering Lactobacillus recited in ‘312 in combination with the fermented milk, wherein the Lactobacillus is L. plantarum OLL2712, as taught by Toshimitsu with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to promote IL-10 production with OLL2712 thereby inhibiting the proinflammatory cytokine IL-12, which reduces inflammation in the subject as taught by Toshimitsu.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed October 22, 2025 have been fully considered but they are not persuasive.
Regarding Remarks directed to the 102 rejection, Applicant argues the stirring step in the method disclosed in Toshimitsu is conducted before adding the lactic acid bacterium so as to improve the viability of the lactic acid bacteria during storage period (paragraph [0015] in Toshimitsu). This suggests that it is important to keep the viability of the lactic acid bacterium in Toshimitsu. In amended claim 13, stirring step is conducted after adding the lactic acid bacterium in, which means that viability is not important in the present invention. Furthermore, the lactic acid bacterium is specified to contain essentially heat-treated dead bacterial cells of the lactic acid bacterium, which means that the method in amended claim 13 comprises dead bacteria, which is different from that of Toshimitsu that comprising live bacteria.
In response to Applicant’s arguments about the stirring step conducted before adding the LAB to improve viability, the Examiner points to para [0101] of the priority Toshimitsi document (CN103314099A1) which states the Lactobacillus strains can be used for yoghurt through the fermenting milk carried out according to conventional methods, such as homogenizing, but does not mention the viability of the LAB. In response to Applicant’s argument that Toshimitsu doesn’t teach heat-treated deal cells, para [0084] teaches roller drying which is a form of heat treating, and Toshimitsi also explicitly teaches the dead cells of L. plantarum OLL2712 are applied to mammalian cells, thus teaching this limitation.
Regarding remarks directed to the 103 rejection, Applicant argues in the specification, the production of IL-10 is further increased in the obtained composition by cooling in the stirring step (Examples of the specification), which is an advantageous effect that could not be predicted by a skilled person in view of Brandao and Toshimitsu, and thus teach away to adopt the stirring step after adding lactic acid bacterium in Brandao in view of Toshimitsu. Thus, the methods of amended claim 13 and the dependent claims thereon are not obvious over Brandao in view of Toshimitsu. Applicant argues Toshimitsu and Brandao neither describe nor suggest the subject having "a decreased IL- 10 production or a tendency to decrease the production of IL-10". Thus, amended claims 19, 20, and 21 as well as the dependent claims thereon are not obvious over Toshimitsu and Brandao.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., IL-10 production increased by cooling in stirring step) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, Applicant’s argument that Toshimitsu doesn’t teach a stirring step while cooling, Toshimitsu explicitly teaches the fermented milk can be homogenized and cooled, which the claim 13 recites that LAB containing composition can be the Lactobacillus added to fermented milk base material. The limitations regarding a subject with decreased IL-10 production is indefinite, thus is not applicable to the arguments.
Regarding the non-statutory double patenting rejections, Applicant argues in view of the amended claims and for the reasons noted above, are not anticipated or rendered obvious over Toshimitsu.
However, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the copending application 17/784912 and references.
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 JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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