DETAILED ACTION
Status of Application
Claims 13, 17-20, 22, 24, 26-28, 34-36, 38-42 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The following amendments, additions, and cancelations as submitted on 08/04/2026 are acknowledged:
Claims 1-12, 14-16, 21, 23, 25, 29-33, 37 are cancelled.
Claims 13, 17-20, 22, 24, 26-28, 34-35, 39 are amended.
Claims 40-42 are added
Claims 13, 17-20, 22, 24, 26-28, 34-36, 38-42 are being examined.
Claim Objections
The previous objection of claims 13, 26-28 and 37 due to the wording used in the claims are hereby withdrawn by virtue of Applicant’s amendment.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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 13, 17- 22, 24-28, 34-39 were previously 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. In view of the amendment of claims 13, 17-20, 22, 24, 26-28, 34-36, 38-39 and in view of the cancellation of claims 21, 25, 37 this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
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.
Claims 13, 17-20, 24-28, 34-39 were previously rejected under 35 USC § 112(a), for failing to comply with the written description requirement. In view of applicant’s amendment of claims 13, 26-28 and in view of the cancellation of claims 21, 25, and 37, the rejection is hereby withdrawn.
Claims 13, 17-20, 24-28, 34-39 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification did not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. In view of applicant’s amendment of claims 13, 26-28, and in view of the cancellation of claims 21, 25, and 37, the rejection is hereby withdrawn.
Claim 22 was previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. Due to the claim containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. In view of the applicants filing a statement by an attorney of record, stating that the claimed strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 C.F.R. § 1.808, the rejection is hereby withdrawn.
Claim Rejections - 35 USC § 103 (AIA )
Claims 13, 17-20, 21-22, 24, 26-28, 34-35, 38-39 were previously rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu et al. (Journal of dairy science 99.2: 933-946; cited in IDS; published Feb 2016) in view of Frankenhaeuser (Psychopharmacologia 4, 424–432. Published Nov 1963).
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claims 13, 17-20, 21-22, 24, 26-28, 34-35, 38-39 under 35 U.S.C. 103 have been fully considered and are persuasive. Applicant has amended claim 13, 26-28, to recite “wherein the subject is a subject having a fasting blood glucose between 100 and 125 mg/dL, and a blood hemoglobin Alc (HbAlc) level of 5.6 to 6.4, wherein the lactic acid bacteria are Lactobacillus plantarum”, rendering the rejections of 13, 17-20, 21-22, 24, 26-28, 34-35, 38-39 moot. In addition, the Applicant has canceled claims 21, 25, and 37 rendering the rejection of claims 21, 25, and 37 moot. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made.
Claims 25 and 36 were previously rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu et al. (Journal of dairy science 99.2: 933-946. Published Feb 2016) and Frankenhaeuser et al. (Psychopharmacologia 4, 424–432. Published Nov 1963), in further view of Barreto (Nutrition 30.7-8 (2014): 939-942).
Response to Arguments
Applicant’s arguments, with respect to the rejection(s) of claims 25 and 36 under 35 U.S.C. 103 have been fully considered and are persuasive. Applicant has amended claim 13, 26-28, to recite “wherein the subject is a subject having a fasting blood glucose between 100 and 125 mg/dL, and a blood hemoglobin Alc (HbAlc) level of 5.6 to 6.4, wherein the lactic acid bacteria are Lactobacillus plantarum”, rendering the rejections of 36 moot. In addition, the Applicant has canceled claim 25 rendering the rejection of claim 25 moot. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made.
Claims 13, 17-19, 22, 24, 26-28, 34-36, 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu et al. (Journal of dairy science 99.2: 933-946. Published Feb 2016; cited in IDS; hereby "Toshimitsu"), in view of Frankenhaeuser (Psychopharmacologia 4, 424–432. Published Nov 1963; hereby “Frankenhaeuser”), and Toshimitsu et al. (Nutrition 58: 175-180; Epublished 08/23/2018; hereby "Toshimitsu2").
The teachings of Toshimitsu and Frankenhaeuser have been discussed in the 03/28/2025 and 05/04/2026 office actions.
Toshimitsu teaches a method of administering Lactobacillus plantarum OLL2712 to mouse subjects (abstract). Toshimitsu teaches a method of treating metabolic disorders, comprising administering Lactobacillus plantarum OLL2712 to a subject (abstract). Toshimitsu teaches that the benefits of administering Lactobacillus plantarum may be used for the maintenance or improvement of health in individuals suffering from lifestyle-related diseases and metabolic disorders (Toshimitsu, pg. 945, [1]). Toshimitsu teaches that the administration of Lactobacillus plantarum OLL2712 alleviated oxidative stress and adrenaline serum levels in mice (Toshimitsu, abstract). Toshimitsu teaches that Lactobacillus plantarum OLL2712 significantly decreases the serum concentration of IL-6 (Toshimitsu, pg. 944, [1]). Toshimitsu teaches that Lactobacillus plantarum OLL2712 induces production of IL-10 in mouse bone marrow derived dendritic cells and peritoneal macrophages (Toshimitsu, abstract) (pg. 934 [2]). Toshimitsu teaches that the strain of lactic acid bacterium is Lactobacillus plantarum OLL2712 (Toshimitsu, abstract). Toshimitsu teaches that the lactic acid bacterium is a heat-killed Lactobacillus plantarum OLL2712 (Toshimitsu, abstract). Toshimitsu teaches that administering Lactobacillus plantarum OLL2712 induced higher IL-10 production in mouse-derived dendritic cells and peritoneal macrophages (Toshimitsu, abstract).
Toshimitsu does not teach that the method is for reducing the heart rate of a human subject. However, Frankenhaeuser teaches that heart rate increases as adrenaline levels increase in humans (pg. 431, summary; pg. 428, table; pg. 429, fig. 1).
Toshimitsu does not teach the subject having a fasting blood glucose between 100 and 125 mg/dL, and a blood hemoglobin Alc (HbAlc) level of 5.6 to 6.4. However, Toshimitsu2 teaches that the administration of heat-killed OLL2712 cells suppressed chronic inflammation and improved hyperglycemia in a mouse model of obesity and diabetes (Abstract). Toshimitsu2 teaches that the ingestion of a OLL2712 beverage significantly improved fasting plasma glucose levels, serum glycoalbumin levels, and insulin resistance indexes compared with baseline levels in humans and the intervention also suppressed interleukin-6 levels (abstract). Toshimitsu2 discloses the average fasting glucose of the subjects before treatment was 116 ± 1 and the average HbA1c was 16.2 ± 0.4 (Table 2).
Regarding claim 36, Toshimitsu does not teach the effective amount of cells is 5 x109 cells or more. However, Toshimitsu2 discloses a study wherein 30 individuals consumed a dairy beverage containing 1x1010 heat-killed OLL2712 cells for 12 weeks (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the lactic acid bacteria of Toshimitsu to a human subject with a normal or high heart rate to reduce their heart rate. A person of ordinary skill in the art is motivated to modify the teachings of Toshimitsu to use Lactobacillus plantarum to get the result of lowering the heart rate in a human subject, because of the Lactobacillus plantarum decreases adrenaline, as taught by Toshimitsu, and humans with high adrenaline levels have an increased heart rate, as suggested by Frankenhaeuser. Accordingly, one of ordinary skill would use the Lactobacillus plantarum of Toshimitsu to decrease adrenaline levels in a human subject and consequently reduce the heart rate of a subject. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Toshimitsu2 in the motivation above, to administer an effective amount of heat-killed Lactobacillus plantarum to human subjects having the claimed fasting blood glucose and HbA1C levels. A person of ordinary skill in the art is motivated to use the subject criteria and the effective amount of Lactobacillus plantarum used in Toshimitsu2 because the subjects that had the recited initial fasting blood glucose and HbA1c levels had positive health outcomes and reduced IL-6 levels after ingesting 1x1010 heat-killed OLL2712. Thus, one of ordinary skill would implement the known beneficial methods of Toshimitsu2 in the combined teachings of Toshimitsu and Frankenhaeuser to obtain the improved metabolic and anti-inflammatory outcomes.
Regarding claim 28, Toshimitsu teaches that the administration of Lactobacillus plantarum OLL2712 resulted in decreased serum adrenaline levels in the subject (Toshimitsu, pg. 944, [3]). Toshimitsu teaches that serum adrenaline concentrations positively correlate to the sympathetic nerve activity (Toshimitsu, pg. 944, [3]). Toshimitsu additionally speculates that the administration of Lactobacillus plantarum OLL2712 stimulates the parasympathetic nervous system by normalizing adrenaline levels (Toshimitsu, pg. 944, [3]). Presently, claim 28 recites “a method for activating the parasympathetic nervous system in a subject… wherein the parasympathetic nervous system of the subject is activated”. However, the specifications filed 06/10/2022 do not define “activating the parasympathetic nervous system” or what an activated parasympathetic nervous system may be. Given the broadest reasonable interpretation of claim 28, decreasing serum levels of adrenaline in the subject would meet the limitation of “activating the parasympathetic nervous system in a subject” and “wherein the parasympathetic nervous system of the subject is activated”. Thus, the combined teachings of Toshimitsu, Toshimitsu2, Frankenhaeuser teach the method of claim 28
Regarding claim 35, Toshimitsu teaches the method of claim 13 (shown above). Claim 35 recites “the method according to claim 13, wherein the effective amount is the one to reduce the heart rate in the range of 1 to 10%, compared to the heart rate in the subject before being made to ingest the lactic acid bacteria”. MPEP section 2111.04 states “a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited". Claim 35 merely recites an intended result of a process step in claim 13. As shown above, the teachings of Toshimitsu, Toshimitsu2 and Frankenhaeuser render claim 13 obvious, and therefore, also render claim 35 obvious.
Regarding claim 39, Toshimitsu teaches the method of claim 27 (shown above). Claim 39 recites “The method according to claim 27, wherein the effective amount is the one to lower the heart rate of the subject, compared to the heart rate in the subject before being made to ingest the lactic acid bacteria”. MPEP section 2111.04 states “a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited". Claim 39 merely states an intended result of claim 27 and does not include additional process steps. As shown, the combined teachings of Toshimitsu, Toshimitsu2, Frankenhaeuser teach the method of claim 27, and, therefore, also teaches the method of claim 39.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu et al. (Journal of dairy science 99.2: 933-946. Published Feb 2016; cited in IDS; hereby "Toshimitsu") in view of Frankenhaeuser (Psychopharmacologia 4, 424–432. Published Nov 1963; hereby “Frankenhaeuser”), and Toshimitsu et al.(Nutrition 58: 175-180; published 08/23/2018; hereby "Toshimitsu2"), as applied to 13, 17-19, 22, 24, 26-28, 34-36, 38-42, in further view of GENEBANK: MH473436 (06/18/2018)
The combined teachings of Toshimitsu, Frankenhaeuser, and Toshimitsu2 are discussed above.
The combined teachings of Toshimitsu, Frankenhaeuser, and Toshimitsu2 do not teach that the lactic acid bacteria have 16S rRNA gene having 99% identity or more with the nucleotide sequence represented by SEQ ID NO: 1.
GENEBANK: MH473436 teaches Lactobacillus plantarum, strain that is a 16S ribosomal RNA gene. It is noted that MH473436 has 100% identity to SEQ ID NO: 1 (See alignment below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a lactic acid bacteria having an 16S rRNA gene having 99% identity or more with the nucleotide sequence represented by SEQ ID NO: 1. A person of ordinary skill in the art is motivated to administer Lactobacillus plantarum having the sequence of MH473436 because Lactobacillus plantarum naturally possess the 16S ribosomal RNA gene. Accordingly, one of ordinally skill in the art would administer Lactobacillus plantarum having a 16S rRNA gene having 99% identity or more with the nucleotide sequence represented by SEQ ID NO: 1. One of ordinary skill would have reasonable expectation of success at arriving to administering Lactobacillus plantarum having a 16S rRNA gene having 99% identity or more with the nucleotide sequence represented by SEQ ID NO: 1 because all the is required is administering Lactobacillus plantarum containing a well-known Lactobacillus plantarum gene. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
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Double Patenting
Claim 13 was previously rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12083152 B2 (referred to as 1 of ‘152), in view of Toshimitsu (Journal of dairy science 99.2: 933-946. Published Feb 2016) and Frankenhaeuer (Psychopharmacologia 4, 424–432. Published Nov 1963).
Response to Arguments
Applicant’s argument, with respect to the rejection(s) of claim 13, under nonstatutory double patenting have been fully considered and is persuasive. Applicant has amended claim 13 to recite “wherein the subject is a subject having a fasting blood glucose between 100 and 125 mg/dL, and a blood hemoglobin Alc (HbAlc) level of 5.6 to 6.4, wherein the lactic acid bacteria are Lactobacillus plantarum”, rendering the rejection of claim 13 moot. Therefore, the rejection has been withdrawn.
Claims 13, 17, and 20-22, 24-28 were provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/267,687 (hereby referred to as ‘687) in view of Toshimitsu (Journal of dairy science 99.2: 933-946. Published Feb 2016) and Frankenhaeuer (Psychopharmacologia 4, 424–432. Published Nov 1963).
Response to Arguments
Applicant’s argument, with respect to the rejection(s) of claim 13, 17, and 20-22, 24-28 under nonstatutory double patenting have been fully considered and is persuasive. Applicant has amended claims 13, 26-28 to recite “wherein the subject is a subject having a fasting blood glucose between 100 and 125 mg/dL, and a blood hemoglobin Alc (HbAlc) level of 5.6 to 6.4, wherein the lactic acid bacteria are Lactobacillus plantarum”, rendering the rejection of claims 13, 17, and 20-22, 24-28 moot. In addition, the Applicant has canceled claim 25 rendering the rejection of claim 25 moot. Therefore, the rejection has been withdrawn.
Claims 13, and 25-28 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 and 22 of copending Application No. 18/012,112 (hereby referred to as ‘112) in view of Toshimitsu (Journal of dairy science 99.2: 933-946. Published Feb 2016) and Frankenhaeuer (Psychopharmacologia 4, 424–432. Published Nov 1963).
Response to Arguments
Applicant’s argument, with respect to the rejection(s) of claim 13, and 25-28 under nonstatutory double patenting have been fully considered and is persuasive. Applicant has amended claims 13 and 26-28 to recite “wherein the subject is a subject having a fasting blood glucose between 100 and 125 mg/dL, and a blood hemoglobin Alc (HbAlc) level of 5.6 to 6.4, wherein the lactic acid bacteria are Lactobacillus plantarum”, rendering the rejection of claims 13 and 26-28 moot. In addition, the Applicant has canceled claim 25 rendering the rejection of claim 25 moot. Therefore, the rejection has been withdrawn.
Conclusion
No claim is in condition for allowance.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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