DETAILED ACTION
Status of Application
Claims 13, 17-22, 24-28, 34-39 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 .
An amendment of claims 13, 26-28, 37 and cancellation of claims 1-12, 14-16, 23, 29-33 as submitted in a communication filed on 7/28/2025 is acknowledged.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/24/25 has been entered.
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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. 119(a)-(d) to JAPAN 2019-225685 filed on 12/13/2019. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/10/2022, 07/12/2022, 11/03/2023, 03/22/2024, 06/26/2024, 12/23/2024, 04/21/2025, 10/15/2025, and 11/19/2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings submitted on 06/10/2022 have been reviewed and are accepted by
the examiner for examination purposes.
Claim Objections
Claim 13 is objected to due to the recitation of “reducing heart rate of a subject…has normal heart rate or heart rate higher than normal heart rate”. It should be amended to recite “reducing the heart rate of a subject…. has a normal heart rate or a heart rate higher than a normal heart rate”. Appropriate correction is required.
Claims 26-28 are objected to due to the recitation of “wherein the subject is a human that has normal heart rate or heart rate higher than normal heart rate”. The claims should be amended to recite “wherein the subject is a human that has a normal heart rate or a heart rate higher than a normal heart rate”. Appropriate correction is required.
Claim 37 is objected to due to the recitation of “…subject having fasting blood glucose…and blood hemoglobin..”. The claim should be amended to recite “…subject having a fasting blood glucose…and a blood hemoglobin..”. Appropriate correction is required.
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 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 37 was 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 applicant’s amendment of claim 37, the rejection is hereby withdrawn.
Claims 13 and 24 (claims 17-22, 25, 34-37 dependent thereon) are indefinite in the recitation of “wherein the lactic acid bacterium contains a killed bacterial cell of a lactic acid bacterium” for the following reasons. As known in the art, a bacterium is a unicellular organism. Therefore, it is unclear as to how a unicellular organism can comprise a killed bacterial cell. For examination purposes, the statement will be interpreted as “wherein the lactic acid bacterium is a killed lactic acid bacterium”. Correction is required.
Claims 13, 26, 27, 28 (claims 17-22, 24, 34-37, 38-39 dependent thereon) are indefinite in the recitation of an effective amount of lactic acid bacterium” due to the fact that “bacterium”, refers to a single microorganism while “bacteria” is the plural form. For examination purposes, “bacterium” will be interpreted as “bacteria”. Correction is required.
Claim 20 is indefinite in the recitation of the term “90% or more homology with the nucleotide sequence represented by SEQ ID NO: 1”. The term “90% or more homology with the nucleotide sequence represented by SEQ ID NO: 1” is unclear and confusing in the absence of a definition providing the intended meaning of the term or the intended parameters required to determine the required homology value. While one could argue that the term “sequence homology” can be interpreted as “sequence identity”, as known in the art, these terms are not equivalent. The calculation of sequence homology takes into consideration the type of mismatches, i.e. even mismatches contribute to the % homology value, whereas mismatches do not have any weight in the calculation of sequence identity, i.e. only exact matches contribute to the % identity value. Thus, if there is no indication that the term “homology” is intended to mean “identity”, and the specification does not provide the specific parameters intended in the calculation of sequence homology (e.g., PAM matrices), one of skill in the art cannot determine the scope of the term “90% or more homology” because one could have a nucleic acid sequence which is 90% or more sequence homologous to a reference sequence based on a particular matrix/set of parameters, and at the same time, not 90% or more sequence homologous to the same reference sequence if other matrices/parameters are used. No patentable weight will be given to the term “16S rRNA gene having 90% or more homology with the nucleotide sequence represented by SEQ ID NO: 1”. If the intended limitation is “has a 16S rRNA gene having at least 90% sequence identity with the polynucleotide of SEQ ID NO: 1”, the claim should be amended accordingly. For examination purposes claim 20 will be interpreted as a duplicate of claim 13 as interpreted above. Correction is required.
Claim 24 is indefinite in the recitation of “wherein the lactic acid bacterium contains a heat-killed bacterial cell of the lactic acid bacterium” for the following reasons: As known in the art, a bacterium is a unicellular organism. Therefore, it is unclear as to how a unicellular organism can comprise a heat-killed bacterial cell. For examination purposes, the statement will be interpreted as “wherein the lactic acid bacterium is a heat-killed lactic acid bacterium”. Correction is required.
Claim 25 is indefinite in the recitation of “method according to claim 13 for preventing or treating at least one disease selected from the group…” for the following reasons: The method of claim 13 is a method for reducing the heart rate of a subject. Therefore, it is unclear how the method of claim 25, which depends from claim 13, is method for preventing or treating the recited diseases. It appears that the method of claim 25 is of different scope and is not encompassed by the method of claim 13. Correction is required.
Claim 34 is indefinite in the recitation of “suppress the increase in the amount of …in the blood in the subject” for the following reasons. The term “increase” is a relative term and the claim does not provide the reference standard to determine if an increase is present (i.e., increase compared to what?). For examination purposes, claim 34 will be interpreted as a duplicate of claim 13. Correction is required.
Claim 35 is indefinite in the recitation of “reduce the heart rate in the range of 1 to 10% in the subject” for the following reasons. The term is unclear in the absence of what is the basis for the recited percentages (i.e., X% of what?). For examination purposes, claim 35 will be interpreted as a duplicate of claim 13. Correction is required.
Claim 39 is indefinite in the recitation of “the one to lower the heart rate of the subject” for the following reasons. The term “lower” is a relative term and the claim fails to indicate which is the reference standard to determine if the heart rate has been lowered (i.e., lower compared to what?). For examination purposes, claim 39 will be interpreted as a duplicate of claim 27. Correction is required.
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, 16-28 and 34-39 were rejected under 35 USC § 112(a), for failing to comply with the written description requirement. In view of applicant’s amendment of claim 13, 26-28 the rejection is hereby withdrawn.
Claims 13, 17-20, 24-28, 34-39 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow.
Claims 13, 17-20, 24-28, 34-39 are directed in part to a method that requires a genus of lactic acid bacteria, wherein when ingested the heart rate of the subject is lowered, interleukin-6 (IL-6) is decreased in a subject, interleukin-10 (IL-10) production is promoted in a subject, and can treat cardiovascular disease, coronary disease and hypertension complications. See claim rejections under 35 USC 112(b) for claim interpretation.
As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The claims encompass a large genus of any lactic acid bacteria belonging to Lactobacillus that reduces heart rate, suppresses the production of IL-6, promotes the production of IL-10, or treats cardiovascular disease, coronary disease and hypertension complications in a subject after ingestion. A sufficient written description of a genus of lactic acid bacteria may be achieved by a recitation of a representative number of lactic acid bacteria defined by the recitation of common identifying/functional characteristics reflecting the members of the genus, which features constitute a substantial portion of the genus. However, in the instant case, there is a limited number of lactic acid bacteria disclosed that is capable of reducing heart rate in a subject, suppressing the production of IL-6 in a subject, promoting the production of IL-10 in a subject, or treating cardiovascular disease, coronary disease and hypertension complications in subjects after ingestion. Furthermore, while one could argue that the species disclosed is representative of all the members of the genus of lactic acid bacteria required, it is noted that the art teaches examples of how even different lactic acid bacteria have different inflammatory outcomes. For example, Toshimitsu et al. (Journal of dairy science 99.2 (2016): 933-946.) teach that administration of Lactobacillus plantarum significantly decreased the production of inflammatory cytokines in vivo, while Lactobacillus gasseri did not ameliorate inflammation (Page 993, Abstract). Therefore, since minor differences in bacteria may result in changes affecting cytokine levels, and no representative number of species commensurate in scope with the claimed genus has been provided, one cannot reasonably conclude that the species disclosed are representative of the common identifying/functional characteristics of any lactic acid bacteria required by the claims.
In addition, while the specification discloses a method to reduce heart rate, suppress IL-6 production, and promote IL-10 production in a subject by ingesting Lactobacillus plantarum, the specification is silent with regard to a method to treat cardiovascular disease, coronary disease and hypertension complications in subjects by ingesting any lactic acid bacteria. Furthermore, while one could argue that the method disclosed can be extrapolated to a method to treat cardiovascular disease, coronary disease and hypertension complications, it is noted that the art teaches examples of how reducing the heart rate in subject can worsen cardiovascular diseases like stroke. For example, Kim et al (BMC neurology 16.1 (2016): 113). show that a low heart rate is a potential risk factor of stroke (Page 1, Abstract). Therefore, one cannot reasonably conclude that the method disclosed to reduce heart rate is representative of the method to treat cardiovascular disease, coronary disease and hypertension complications by ingesting any lactic acid bacteria which is required by the claimed process.
Due to the fact that the specification only discloses a limited number of lactic acid bacteria that are required by the claimed method, and the lack of description of treating the recited conditions, one of skill in the art would not recognize from the disclosure that the applicant was in possession of the claimed invention.
Claims 13, 17-120, 24-28, 34-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reducing heart rate, suppressing the production of IL-6, and promoting the production of IL-10 in a subject by making a subject in need thereof ingest an effective amount of Lactobacillus plantarum, does not reasonably provide enablement for a method for reducing heart rate, suppressing the production of IL-6, promoting the production of IL-10, or treating cardiovascular disease, coronary disease and hypertension complications by making the subject ingest an effective amount of any lactic acid bacteria. The specification does 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.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2nd 1400 (Fed. Cir. 1988)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breadth of the claims. The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
The breadth of the claims. Claims 13, 17-19, 24-28, 34-39 broadly encompass a method for reducing the heart rate in a subject, suppressing the production of Interleukin-6 in a subject, promoting the production of Interleukin-10 in a subject, or treating cardiovascular disease, coronary disease and hypertension complications, comprising making a subject in need thereof ingest an effective amount of any lactic acid bacteria. See Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA ) for claim interpretation. The enablement provided is not commensurate in scope with the claims due to the lack of knowledge regarding the common identifying/functional characteristics of any lactic acid bacteria that can be effectively ingested to reduce the heart rate in a subject, suppress the production of IL-6 in a subject, promote the production of IL-10 in a subject, or treat cardiovascular disease, coronary disease and hypertension complications in a subject. In the instant case, the specification enables a method of ingesting Lactobacillus plantarum, OLL2712, to reduce the heart rate of a subject, suppress the production of IL-6 in a subject, and promote the production of IL-10 in a subject.
The amount of direction or guidance presented and the existence of working examples. The specification discloses a method of ingesting Lactobacillus plantarum to reduce the heart rate of a subject, suppress the production of IL-6 in a subject, and promote the production of IL-10 in a subject.
However, the specification fails to provide any clue as to the common identifying/functional characteristics required in any lactic acid bacteria that can be effectively ingested to reduce a subject’s heart rate, suppress IL-6, promote IL-10, or treat the recited diseases. The specification does not teach those common identifying/functional characteristics that should be present in any lactic acid bacteria that can be effectively ingested to reduce a subject’s heart rate or treat the recited diseases. Therefore, one skilled in the art has limited guidance as to which lactic acid bacteria can be effectively ingested to reduce a subject’s heart rate, suppress IL-6 production, promote IL-10 production, or treat the recited diseases.
The state of prior art, the relative skill of those in the art, and the predictability or unpredictability of the art. The type of lactic acid bacteria ingested determines its health benefits and cytokine level outcomes in a subject. While the art discloses a limited number of lactic acid bacterium, neither the specification nor the art provides an adequate amount of common identifying/functional characteristics such that one of skill in the art can envision any lactic acid bacterium that can be used in the claimed method. The art clearly teaches that selecting any lactic acid bacteria with the expectation of yielding similar health benefits, is highly unpredictable. For example, Qi et al. (Frontiers in immunology 14 (2023): 1125239) teach that Lactobacillus crispatus is associated with a balanced vaginal microbiome (Page 01, Abstract). Remes-Troche et al. (Therapeutic Advances in Gastroenterology 13 (2020): 1756284820971201) teach that Lactobacillus acidophilus is associated with aiding in digestion (Page 1, Abstract). In addition, the art clearly teaches that selecting any lactic acid bacterium to effect cytokine levels similarly after ingestion, is highly unpredictable. For example, Toshimitsu et al. (Journal of dairy science 99.2 (2016): 933-946) teach that administration of Lactobacillus plantarum significantly decreased the production of inflammatory cytokines in vivo, while Lactobacillus gasseri did not ameliorate inflammation (Page 993, Abstract). Therefore, choosing from a selection of any lactic acid bacterium to reduce heart rate, suppress IL-6 production, promote IL-10 production, or treat the recited diseases is highly unpredictable.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification. While methods selecting bacterium for treating conditions are known in the art at the time of the invention, it was not routine in the art to screen by a trial and error process for an essentially infinite number of lactic acid bacteria to find the lactic acid bacteria that can be used as claimed. In the absence of (i) a rational and predictable scheme for selecting a lactic acid bacterium most likely to have the desired outcomes after ingestion, and/or (ii) a correlation between cellular characteristics of lactic acid bacteria and the ability of lactic acid bacteria to effectively reduce heart rate, suppress IL-6 production, promote IL-10 production, or treat the recited diseases, one of skill in the art would have to test an essentially infinite number of lactic acid bacteria to determine which ones have the desired characteristics.
Therefore, taking into consideration the extremely broad scope of the claim, the lack of guidance, the amount of information provided, the lack of knowledge about the common identifying/functional characteristics and the desired health/cytokine outcomes, and the high degree of unpredictability of the prior art in regard to lactic acid bacteria selection, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. Thus, Applicant has not provided sufficient guidance to enable one of ordinary skill in the art to make and use the invention in a manner reasonably correlated with the scope of the claims.
Claim 22 is 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. The claim(s) contains 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.
The invention appears to employ a novel strain (i.e., L. plantarum OLL2712 deposited under accession No. FERM-BP-11262). Since the strain is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. There is no indication that this strain is readily available to the public. The enablement requirements of 35 U.S.C. §112 may be satisfied by a deposit of the strain. The specification does not disclose a repeatable process to obtain the strain. Accordingly, it is deemed that a deposit of this strain should have been made in accordance with 37 CFR 1.801-1.809.
It is noted that Applicant has deposited the strain as stated in the specification but there is no indication in the specification as to public availability. If the deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be available to the public under the conditions specified in 37 CFR 1.808, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
a. during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
b. upon granting of the patent the strain will be available to the public under the conditions specified in 37 CFR 1.808;
c. the deposit will be maintained in a public repository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer; and
d. the deposit will be replaced if it should ever become non-viable.
Claim Rejections - 35 USC § 102
Claims 26-28 and 38-39 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toshimitsu (Previously cited in the Final Rejection filed 03/28/2025). Applicant argues that claims 26-28 has been amended, and that the reference of Toshimitsu no longer anticipates each and every limitation of claims 26-28, and dependent claims 38-39. Applicant’s arguments are found persuasive, and the rejection is withdrawn.
Claims 13, 20-21 and 36 were previously rejected under 35 U.S.C. 102(a)(1) as being anticipated by Possemiers (Previously cited in Non-Final Rejection filed 03/28/2025). Applicant argues that claim 13 has been amended, and that the reference of Possemiers no longer anticipates each and every limitation of claims 13, and dependent claims 20-21 and 36. Applicant’s arguments are found persuasive, and the rejection is withdrawn.
Claim Rejections - 35 USC § 103 (AIA )
Claims 13, 17-20, 21-22, 24, 26-28, 34-35, 38-39 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) in view of Frankenhaeuser (Psychopharmacologia 4, 424–432. Published Nov 1963)
Applicant argues that the motivation found in the previous office action is no longer obvious in view of amended claims. The amended claims emphasize that the subject is a human that has a normal heart rate or heart rate higher than normal. The teachings of Toshimitsu and Frankenhaeuer have been discussed previously in the 03/28/2025 office action. In addition, 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]). Therefore, the teachings of Toshimitsu and Frankenhaeuer suggest administering Lactobacillus plantarum to individuals with a high heart rate or normal heart rate to lower the heart rate is obvious to try. The argument is not considered to be persuasive.
Claims 20, 27, 28, 38, 39 are rejected under 35 U.S.C. 103 as being unpatentable over Toshimitsu, in view of Frankenhaeuer.
Toshimitsu and Frankenhaeuer have been discussed previously in the 03/28/2025 office action. Regarding claims 20, 27, 28, 38, 39, Toshimitsu teaches a method of treating metabolic disorders, comprising administering Lactobacillus plantarum OLL2712 to a subject. Toshimitsu teaches that the administration of Lactobacillus plantarum OLL2712 alleviated oxidative stress and adrenaline serum levels in mice (Toshimitsu, abstract). Regarding claims 27 Toshimitsu teaches that Lactobacillus plantarum OLL2712 significantly decreases the serum concentration of IL-6 (Toshimitsu, pg. 944, [1]). Regarding claim 28, Toshimitsu teaches that the administration of Lactobacillus plantarum OLL2712 stimulates the parasympathetic nervous system by normalizing adrenaline levels (Toshimitsu, pg. 944, [3]). Regarding claim 38 Toshimitsu teaches that Lactobacillus plantarum OLL2712 induces production of IL-10 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer lactic acid bacterium to suppress the production of IL-6, induce the production of IL-10, and activate the parasymatheic nervous system in a human subject with a normal or high heart rate. A person of ordinary skill in the art is motivated to modify the teachings of Toshimitsu to use Lactobacillus plantarum to suppress the production of IL-6, induce the production of IL-10, and activate the parasympathetic nervous system to get the result of lowering the heart rate in a human subject, as suggested by Frankenaeuser. One of ordinary skill in the art has a reasonable expectation of success at arriving to suppressing the production of IL-6, inducing the production of IL-10, activating the parasympathetic nervous system, and reducing heart rate in a human subject with a normal or high heart rate because all that is required is administering Lactobacillus plantarum to a human subject.
Regarding claim 20, claim 20 is interpreted as a duplicate of claim 13. Accordingly, claim 20 is rejected. See 112 (b) for claim interpretation. 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”. 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, Toshimitsu teaches the method of claim 27, and, therefore, also teaches the method of claim 39. Accordingly, claim 39 is rejected.
Claims 25 and 36 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) and Frankenhaeuser et al. (Psychopharmacologia 4, 424–432. Published Nov 1963). In further view of Barreto (Nutrition 30.7-8 (2014): 939-942).
Applicant argues that the motivation found in the previous office action is no longer obvious in view of amended claims. The applicant also argues that none of the cited references, individually or combined, suggest that the human subject has a "normal heart rate or heart rate higher than normal heart rate", and "wherein the heart rate of the subject is lowered". The amended claims emphasize that the subject is human that has a normal heart rate or heart rate higher than normal heart rate. The teachings of Toshimitsu, Frankenhaeuer, and Barreto have been discussed previously in the 03/28/2025 office action. As stated previously, Barreto teaches a method of administering Lactobacillus plantarum, which reduced cardiovascular disease risk factors in human subjects (Barreto, abstract). Barreto also teaches that the human subjects were administered per day 80 mL of fermented milk containing 1.25 x 10^7 UFC/g Lactobacillus plantarum for 90 days (Barreto, pg. 940, methods). In addition, 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]). The MPEP 2145 states “An "obvious to try" rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. " [A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007)”. In this case, the combination of teachings suggest administering an effective amount Lactobacillus plantarum, as taught by Barreto, to individuals with a cardiovascular disease, a high heart rate, or a normal heart rate, as suggested by Toshimitsu and Frankenhaeuer, is obvious to try. The argument is not considered to be persuasive.
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.
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Although the claims at issue are not identical, they are not patentably distinct from each other. Applicant argues that the non-patentably distinct claims identified in the previous office action are now patentably distinct in view of amended claims. The amended claims recites that the subject is human that has a normal heart rate or heart rate higher than normal heart rate. This amendment makes the claim not identical. Therefore, the argument is not considered to be persuasive. The claims remain not patentably distinct from one another due to the explanations below.
Claims 13 are 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).
Claim 13 of the instant claims and 1 of ‘152 are directed in part a method comprising administering an effective amount of lactic acid bacterium to a subject. Claim 13 is directed to the same inventive concept, but differs in scope.
Toshimitsu and Frankenhaeuer have been discussed previously in the 03/28/2025 office action and also above. 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). Frankenhaeuser teaches that heart rate increases as adrenaline levels increase in humans (pg. 431, summary; pg. 428, table; pg. 429, fig. 1).
It would have been obvious to one of ordinary skill in the art to modify the teachings of application ‘152, with the teachings of Toshimitsu and Frankenhaeuer to lower the heart rate of a subject. One would have been motivated to combine the above references because application ‘152 teaches that administering lactic acid bacterium to the subject would improve a variety of health conditions in humans (page 5; left column; line 65). This would motivate one of ordinary skill to administer lactic acid bacterium to subjects and try to improve the health of individuals as taught by Toshimitsu and Frankenhaeuer.
One of ordinary skill would have a reasonable expectation of success in combining the above elements because all the is required is administering an effective amount of lactic acid bacterium. Therefore, it would have been obvious to one of ordinary skill in the art to combine the above elements of application ‘152, with Toshimitsu and Frankenhaeuer.
Claims 13, 17, and 20-22, 24-28 are provisionally rejected on the ground 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).
Claims 13, 17, and 20-22, 24-28 of the instant claims and 25, 27, 29, 31,37-42 of ‘687 are directed in part a method comprising administering an effective amount of lactic acid plantarum to a human subject wherein the bacterium is a heat treated dead cell to reduce inflammation. Claims 13, 17, and 20-22, 24-28 are directed to the same inventive concept, but differs in scope.
Toshimitsu and Frankenhaeuer have been discussed previously in the 03/28/2025 office action and also above. Toshimitsu teaches a method of treating metabolic disorders, comprising administering Lactobacillus plantarum OLL2712 to a subject. 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 the administration of Lactobacillus plantarum OLL2712 stimulates the parasympathetic nervous system by normalizing adrenaline levels (Toshimitsu, pg. 944, [3]). Toshimitsu teaches that Lactobacillus plantarum OLL2712 induces production of IL-10 in mouse derived dendritic cells and peritoneal macrophages (Toshimitsu, abstract). Frankenhaeuser teaches that heart rate increases as adrenaline levels increase in humans (pg. 431, summary; pg. 428, table; pg. 429, fig. 1).
It would have been obvious to one of ordinary skill in the art to modify the teachings of application ‘687, with the teachings of Toshimitsu and Frankenhaeuer to lower the heart rate of a subject, reduce IL-6 in a subject, produceIL-10 in a subject, and activate the parasympathetic nervous system in a subject. One would have been motivated to combine the above references because application ‘687 teaches that administering lactic plantarum to the subject would improve a variety of brain conditions in humans (Page 2; [0046][37]) and reduce inflammatory cytokines (Page 2; [0042][27]). This would motivate one of ordinary skill to administer the lactic acid bacterium taght in ‘687 to human subjects and try to improve the health of individuals, lower heart rate, reduce IL-6, produce IL-10, and stimulate the parasympathetic system, as taught by Toshimitsu and Frankenhaeuer.
One of ordinary skill would have a reasonable expectation of success in combining the above elements because all the is required is administering an effective amount of lactic acid bacterium to a human subject. Therefore, it would have been obvious to one of ordinary skill in the art to combine the above elements of application ‘687, with Toshimitsu and Frankenhaeuer.
Claims 13, and 25-28 are 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).
Claims 13, and 25-28 of the instant claims and 19 and 22 of ‘112 are directed in part a method of promoting the production of interleukin-10 in a human subject, comprising allowing the subject to ingest an effective amount of a lactic acid bacterium. Claims 13, and 25-28 are directed to the same inventive concept, but differs in scope.
Toshimitsu and Frankenhaeuer have been discussed previously in the 03/28/2025 office action and also above. One would have been motivated to combine the above references because application ‘112 teaches that administering lactic acid bacterium would improve a variety of disease caused by inflammation in humans (Page 4; [0069]). This would motivate one of ordinary skill to administer the lactic acid bacterium taught in ‘112 to human subjects and try to improve the health of individuals, lower heart rate, reduce IL-6, produce IL-10, and stimulate the parasympathetic system, as taught by Toshimitsu and Frankenhaeuer.
One of ordinary skill would have a reasonable expectation of success in combining the above elements because all the is required is administering an effective amount of lactic acid bacterium to a human subject. Therefore, it would have been obvious to one of ordinary skill in the art to combine the above elements of application ‘112, with Toshimitsu and Frankenhaeuer.
Conclusion
No claims are allowed.
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/S.L.S./Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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