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
The Notice of Allowance of 4/4/2025 has been withdrawn and this office action is responsive to the Response to Election filed 3/11/2025.
Election/Restrictions
Applicant’s election without traverse of Group III, claim 10 in the reply filed on 3/11/2025 is acknowledged. Claims 1-9 are withdrawn.
Claim Rejections - 35 USC § 112(a), Enablement
The rejection of claim 10 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement is withdrawn in light of applicant’s amendment.
Claim Interpretation
The specification does not provide an explicit definition of “culture thereof” or “an extract thereof” and therefore the BRI is applied. The specification states: The culture may refer to, regardless of the form of a culture, a material including some of or all of materials contained in a medium where the strain is cultured. For example, the culture may refer to a material including a metabolite or a secretion resulting from culturing the strain, or a lysate of the material, and the strain itself may also be contained in the culture. In addition, the culture may refer to inclusion of a fermented product.
The extract may refer to a product obtained by, regardless of an extraction method, an extraction solvent, an extracted component, or an extract type, and is also a broad concept that includes all materials that can be obtained by processing or treating the extract by using different methods such as fractionation, concentration, and the like after extraction.
The term "respiratory disease" as defined herein refers to an inflammation disease of respiratory organs such as external nasal, nasal cavity, pharynx, trachea, bronchial tube, lungs, and the like. In detail, for example, the respiratory disease may include any one of respiratory inflammation diseases such as bronchitis, tuberculosis, chronic pulmonary disease, rhinitis, otitis media, viral respiratory disease, sore throat, tonsilitis, pneumonia, asthma, and chronic obstructive pulmonary disease (COPD). In more detail, the respiratory disease may include any one of respiratory inflammation diseases selected from the group consisting of bronchitis caused by air pollutants or fine dust, tuberculosis, chronic pulmonary disease, rhinitis, otitis media, viral respiratory disease, sore throat, tonsilitis, pneumonia, asthma, and COPD.
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.
Claim 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over KR102098991B1 in view of EP2346517B1 and DE102009050407A1.
KR ‘991 teaches treating or improving an inflammatory disease (allergies, rhinitis) comprising an Lactobacillus plantarum strain (KCCM 12098P) or its culture filtrate having an antioxidant and anti-inflammatory effect. The strain is isolated from kimchi. Note the instant specification states that the strain KC3 may be obtained from kimchi. KR ‘991 teaches the anti-inflammatory effects of the strain and treating inflammatory disease in general . Conditions treated include rhinitis. KR teaches the bacterium produces antibacterial substances including cytoplasm, bacteriocin, organic acid. KR teaches The strain (KCCM 12098P) is taught in an amount of 1 μg / ml to 100 μg / ml to exert an anti-inflammatory effect. KR teaches the strain is added in an amount of 15 parts or less, 10 pats or less based on 10 parts in compositions. KR teaches the amount may be manipulated based on the long term health purpose. See page 4. KR further teaches the treatment dosage depends on patient’s conditions, disease severity, weight, and route of administration. Note examples in which various amounts are used to evaluate the anti-inflammatory effects.
KR’991 does not specifically teach the deposited strain Lactobacillus plantarum KC3 or the addition of Leonurus japonicus.
EP2346517B1 teaches the use of extracts from plants including leonurus japonicus for treating infections such as rhinitis due to its antibacterial effects. See abstract. EP teaches the significant antibacterial effect of the extracts and has the same potency effect of antibiotic control at a ratio of 6:1. The examples utilize 1ml extract. The extraction process is done using water and ethanol. See examples.
DE ‘407 teaches the use of extracts from plants including leonurus japonicus for its anti-inflammatory effects and treating conditions in the bronchial system, allergies, COPD, and asthma in the amount of 0.001 or 0.01 or 0.1 to 1% by weight or up to 5% by weight or up to 10% by weight to 15% by weight. % or to 30.-%, preferably 0.01-10% or preferably 0.1-5.%. Extraction is done with water and ethanol. See examples.
Although KR’991 does not teach the same deposited strain, the function and properties of the two strains appear similar in that they are used for the same purpose (treating inflammatory conditions such as rhinitis) with a similar function of reducing inflammation. Further both the instant strain and that of the prior art are obtained from kimchi and the instant specification states the claimed strain may be obtained from kimchi. If the two strains are not structurally the same, they are considered obvious variants since both appear to have the same function and properties. Furthermore, assuming arguendo the strain are not the same and there is a slight variation between the strains, the secretions/metabolites produced by the Lactobacillus plantarum reading on “culture thereof” or “an extract thereof” would be the same including lactic acid itself which has bacteriostatic action. Also taught by KR’991, Lactobacillus plantarum generally produces antibacterial agents including cytoplasm, bacteriocin, organic acid.
Furthermore, it would have been further obvious to combine the teachings KR ‘991 and EP ‘517 or DE ‘407 and add Leonurus japonicus extract in the amount claimed. One would have been motivated to do so for its additive effect of treating inflammatory diseases. Regarding the ratio claimed, all references teach the amount of the strain and the extract to treat inflammatory disease. It is within the skill of an artisan to look at the disclosure of the prior art and optimize the amount of each active ingredient achieve the desired effect of treating inflammatory diseases. Further, regarding claim 14 the concentration of the cells is prima facie obvious in light of KR teachings the strain is added in an amount of 15 parts or less, 10 pats or less based on 10 parts in compositions and clearly teaches the amount may be manipulated based patient’s conditions, disease severity, weight, and route of administration.
Regarding claims 11-12, KR teaches the treatment of allergies and DE teaches treatment of COPD and allergies specifically. Further, all the references teach the anti-inflammatory properties of the active components and thus, it is prima facie obvious that strain Lactobacillus plantarum and Leonurus japonicus extract would treat inflammatory conditions including COPD and allergies (respiratory inflammation caused by air pollutants).
Regarding claim 13, the prior art teaches renders the method of treating with the strain Lactobacillus plantarum and Leonurus japonicus extract obvious as discussed above and thus, the inhibition would be inherent since the same composition is administered. The discovery of a new function or property or mechanism of action does not make the claimed invention novel if the art teaches renders the same composition and treatment obvious. See MPEP 2112.
Claim 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al (Park et al , Lactobacillus plantarum DK119 as a Probiotic Confers Protection against Influenza Virus by Modulating Innate Immunity 2013, Vol 8 Issue 10) in view of EP2346517B1 and DE102009050407A1.
Park et al teach Lactobacillus plantarum DK119 (DK119) isolated from the fermented Korean cabbage food (kimchi) for its use as an antiviral to treat influenza (respiratory disease) and as a antiviral probiotic. Note the instant specification states that the strain KC3 may be obtained from kimchi. The bacterium modulated host innate immunity of dendritic and macrophage cells, and cytokine production pattern. The bacterium was observed to increase the levels of IFN-γ, IL-12,and decreasing inflammatory cytokines (IL-4, IL-6, TNF-α). Park teaches the state of the art in which is was found that Lactobacillus stimulated human dendritic cells to secrete Th1/Th17 cytokines including IL-12. Lactobacillus was also shown to induce the production of Th1 polarizing cytokine IL-12 by stimulating murine dendritic cells via Toll-like receptor-2-dependent mechanism. See abstract. Park teaches the oral administration of the strain 200ul of a suspension containing 109; 108; 107 cells.
Park et al does not specifically teach the deposited strain Lactobacillus plantarum KC3 or the addition of Leonurus japonicus.
EP2346517B1 teaches the use of extracts from plants including leonurus japonicus for treating infections such as rhinitis due to its antibacterial effects. See abstract. EP teaches the significant antibacterial effect of the extracts and has the same potency effect of antibiotic control at a ratio of 6:1. The examples utilize 1ml extract. The extraction process is done using water and ethanol. See examples.
DE ‘407 teaches the use of extracts from plants including leonurus japonicus for its anti-inflammatory effects and treating conditions in the bronchial system, allergies, COPD, and asthma in the amount of 0.001 or 0.01 or 0.1 to 1% by weight or up to 5% by weight or up to 10% by weight to 15% by weight. % or to 30.-%, preferably 0.01-10% or preferably 0.1-5.%. Extraction is done with water and ethanol. See examples.
Although Park does not teach the same deposited strain, the function and properties of the two strains appear similar in that they are used for the same purpose (treating respiratory disease) with a similar function of reducing inflammatory cytokine production. Further both the instant strain and that of the prior art are obtained from kimchi and the instant specification states the claimed strain may be obtained from kimchi. If the two strains are not structurally the same, they are considered obvious variants since both appear to have the same function and properties. As taught by Park et, the state of the art indicates Lactobacillus bacterium is used to modulate the inflammatory pathway. Moreover, the prior art stain and the instant strain are taught to have the same cytokine modulation. Furthermore, assuming arguendo the strain are not the same and there is a slight variation between the strains, the secretions/metabolites produced by the Lactobacillus plantarum reading on “culture thereof” or “an extract thereof” would be the same including lactic acid itself which has bacteriostatic action.
Furthermore, it would have been further obvious to combine the teachings Park and EP ‘517 or DE ‘407 and add Leonurus japonicus extract in the amount claimed. One would have been motivated to do so for its additive effect of treating inflammatory diseases such as respiratory diseases. Regarding the ratio claimed , all references teach the amount of the strain and the extract to treat inflammatory disease. It is within the skill of an artisan to look at the disclosure of the prior art and optimize the amount of each active ingredient achieve the desired effect of treating inflammatory diseases
Regarding claims 11-12, Park teaches the antiviral properties and immunomodulating effects of Lactobacillus plantarum and DE teaches the anti-inflammation properties of Leonurus japonicus extract and treatment of COPD and allergies specifically. Thus, it is prima facie obvious that strain Lactobacillus plantarum and Leonurus japonicus extract would treat inflammatory conditions including COPD and allergies (respiratory inflammation caused by air pollutants).
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended to recite a specific weight ratio which yields an unpredictable and synergistic effect. Applicant argues Example 5 describes the preparation of the mixture at a 1:1 weight ratio based on dry weight, which falls directly within the claimed 1:0.1 to 1:10 range. Applicant points to Table 9 wherein the KC3 Strain and Leonurus extract showed unexpected rather than additive effect.
These arguments are not persuasive. Table 9 and the examples have been considered. Table 9 relies on specific ratio of 1:1 using specifically the strain cells and the extract.
The instant claims are directed to:
A method of preventing or treating a respiratory disease, the method comprising administering a composition to a subject in need thereof, the composition comprising, as active ingredients, (a)one or more selected from the group consisting of a Lactobacillus plantarum KC3 strain (Accession No: KCTC13375BP), a culture thereof, a fermentation solution thereof, a lysis solution thereof, an extract thereof, and a concentrate of the culture; and (b) Leonurus japonicus extract, wherein the composition comprises the active ingredients (a) and (b) at a weight ratio of 1:0.1 to 1:10 (w/w)based on dry weight.
The claims are not commensurate in scope. Applicant has shown specifically the strain cells and the extract in a 1:1 ratio provides a purportedly synergistic result. However, the broadest embodiment claimed is a composition that does not require the cells per se. The claims recites a culture thereof, a fermentation solution thereof, a lysis solution thereof, an extract thereof, and a concentrate of the culture, all of which do not require the cells per se . Thus, Applicant has not shown that all embodiments (for instance an extract) would have the same “synergistic” effect. Note the claim interpretation of an extract or culture thereof discussed in the office action. Moreover, applicant broadly claims a ratio of 1:0.1 to 1:10 but only one ratio that has “synergistic” effect. Since the art teaches the components for the same purpose one would expect at least an additive effect and applicant has not shown the entire range claimed would have a synergistic rather than additive effect as expected. See MPEP 2144.06- "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven.
Thus the claims are not commensurate in scope. See MPEP 716.02(d) and the rejections are maintained.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. KR-10-2011883 is cited for it teachings of Lactobacillus plantarum KC3 strain (Accession No: KCTC13375BP).
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.
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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