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The Notice of Allowance of 4/4/2025 has been withdrawn and this office action is responsive to the Response to Election filed 3/11/2025.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 Claims 1-9 are withdrawn.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
Claim 10 is rejected under 35 U.S.C. 112(a) 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.
Claim 10 is 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 treating respiratory disease, does not reasonably provide enablement for preventing all respiratory diseases. 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.
In re Wands (858 F2d, 721, 727, 8 USPQ 2d 1400, 1404 (Fed Cir. 1988)), the issue of enablement in molecular biology was considered. It was held that the following factors should be considered to determine whether the claimed invention would require the skilled artisan undue experimentation:
Amount of experimentation necessary;
Amount of direction or guidance presented;
Presence or absence of working examples;
Nature of the invention;
State of the prior art;
Relative skill of those in the art;
Predictability or unpredictability of the art; and
Breadth of the claims.
Nature of the invention: The invention is directed towards a method of treating or preventing respiratory diseases comprising administering a composition to a subject in need thereof, the composition comprising, as active ingredients, 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 Leonurus japonicus extract. Respiratory disease encompasses any condition that affects the lungs and respiratory system.
Breadth of the claims: The term “respiratory disease” is defined on page 10 “to an inflammation disease of respiratory organs such as external nasal, nasal cavity, pharynx, trachea, bronchial tube, lungs, and the like”. Thus, the breadth of the claim includes a method of preventing any respiratory diseases including genetic respiratory diseases including cystic fibrosis, chronic obstructive pulmonary disease, lymphangioleiomyomatosis, lung cancer, to name a few. Preventing a respiratory disease including genetic respiratory diseases would require identification of the disease prior to treatment.
State of the prior art: The state of art teaches:
Lymphangioleiomyomatosis (LAM) is a rare lung disease occurring predominantly in women. LAM can occur sporadically or in conjunction with tuberous sclerosis complex (TSC), an inherited autosomal dominant disorder. (Steagall et al, The Lymphangioleiomyomatosis Lung Cell and Its Human Cell Models, American Journal of Respiratory Cell and Molecular Biology, Volume 58, Issue 6, June 2018, Pages 678-683, https://doi.org/10.1165/rcmb.2017-0403TR )
Cystic fibrosis is caused by an abnormal gene inherited from parents. (Savant et al, Cystic Fibrosis. 2001 Mar 26 Available from: https://www.ncbi.nlm.nih.gov/sites/books/NBK1250/)
COPD have several factors including genetics and identification of genetic variation contributing to disease progression is important for a number of reasons including identification of risk alleles, understanding underlying disease mechanisms and development of novel therapies. (Hall et al, Genetic risk factors for the development of pulmonary disease identified by genome-wide association. Respirology. 2019; 24: 204–214. https://doi.org/10.1111/resp.13436)
Amount of direction or guidance presented: As discussed above, the term respiratory disease on page 10 of the instant specification includes any inflammation of the respiratory organs including the lung. The term “prevention” is defined on page 10 of the instant specification as” as used herein refers to all actions that can inhibit or delay a respiratory disease by administering the composition including the extract above.” The instant specification discusses the mechanism of action of the instant strain and extract in treating, i.e. the instant strain and extract, reduce the inflammatory response by reducing neutrophils …inhibiting expression of one or more selected from the group consisting of bronchial inflammation factor cytokines IL-17A, TNF-a, and CXCL-1, and also reducing an amount of symmetricdimethylarginine (SDMA) in the blood of a patient having COPD. reducing the inflammatory response.” However, the specification does not discuss the preventing diseases of respiratory diseases particularly genetic respiratory diseases. The instant specification does not provide any guidance on how to identify a patient that may be predisposed to a genetic respiratory disease and preventing the disease.
Presence or absence of working examples: The instant Specification provides examples for assessing the efficacy the instant bacteria on mouse models having respiratory damage and assessing the antibacterial and anti-inflammatory activity. However, all of the examples are limited to the mouse model having respiratory diseases. The examples do not administer the claimed bacteria to a pre-disposed individual to prevent the disease.
Relative skill of those in the art: Based on the state of the prior art, the relative skill of those in the art pertaining to prevention of certain genetic respiratory diseases such as LAM, COPD, and CF are low.
Based on the Applicant’s disclosure, the instant invention is not enabled for the prevention of respiratory disease since the neither the specification nor the examples provide guidance on preventing a respiratory disease.
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 is rejected under 35 U.S.C. 103 as being unpatentable over US20110052553A1 in view of EP2346517B1.
US’553 teaches Lactobacillus plantarum LP2 and its metabolic products for allergic disorders including allergic rhinitis, bronchial asthma. [4]. The bacteria is isolated from fermented substances. [28] The bacteria is taught to promote the secretion of Th1 cytokine, IFN-.gamma., and negatively controls the production of Th2 cytokine, IL-4; therefore reduces the hypersensitivity reaction in human. See [10]
US ‘553 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.
Although US ‘553 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) by functioning to reducing inflammatory cytokine production. Further both strains are obtained from fermented sources. 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 strains 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 of US ‘553 and EP ‘651 and add Leonurus japonicus extract. One would have been motivated to do so for for its additive effect of treating rhinitis as taught by EP ‘651.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over KR102098991B1 in view of EP2346517B1.
KR ‘991 teaches treating or improving an inflammatory disease 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. Conditions treated include rhinitis. KR teaches the bacterium produces antibacterial substances including cytoplasm, bacteriocin, organic acid.
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.
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 and add Leonurus japonicus extract. One would have been motivated to do so for its additive effect of treating rhinitis as taught by EP ‘517.
Claim 10 is 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.
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). 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 et al does not specifically teach the deposited strain Lactobacillus plantarum KC3 or the addition of Leonurus japonicus.
EP ‘651 teaches the use of extracts from plants including leonurus japonicus for treating infections such as rhinitis due to its antibacterial effects. See abstract.
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 et al and EP ‘651 and add Leonurus japonicus extract. One would have been motivated to do so for its additive effect of treating rhinitis as taught by EP ‘651.
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
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653