DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-15 and Species ATCC 14917, in the reply filed on 5/5/26 is acknowledged. The traversal is on the ground(s) that it would not place an undue burden on the Examiner to examine the entirety of the claims.
This has been fully and carefully considered, but is not found persuasive because this application is a 371 national stage application and the Restriction Requirement was made under 35 U.S.C. 121 and 372. As stated in the Restriction Requirement, this application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. As stated in the Restriction Requirement the inventions of Groups I-III are found to have no special technical feature that defines over the prior art of:
Parul et al (J. Functional Foods. Vol 70. April 30, 2020, pages 1756-4646; provided by Applicants) relates to the effects of probiotics formulations on oral health (abstract); in particular, a composition comprising plantaricin for use in inhibiting the formation of C. albicans biofilms (page 7, left-hand column, paragraph 2).
Wasfi et al (J. Cellular and Molec. Med. 22(3): 1972-1983; provided by Applicants) discloses oral care compositions for use in inhibiting the formation of S. mutans biofilms, wherein said compositions comprise L. plantarum ATCC14917 and/or L. salivarius ATCC 11741 (abstract; page 1973, left-hand column, paragraph 5; figure 2). Further applications such as prevention of tooth decay is also taught in Wasfi (page 1981, right-hand column, paragraph 3).
CN 113 577 218 provided by Applicants discloses compositions for oral care (paragraphs [0003], [0023]; claim 1), wherein said compositions comprise L. plantarum ATCC 8014 and L. salivarius ATCC 11741. Said compositions are for use in inhibiting the growth i.e. biofilm formation of S. mutans (example 1).
CN 110 507 672 provided by Applicants discloses compositions comprising L. salivarius ATCC 11741 and L. plantarum ATCC 8014, wherein said compositions are for use in oral care, including the prevention of bacteria-based biofilm formation.
CN 112 852 686 discloses an oral care composition for use in the prevention of S. mutans biofilm formation (paragraphs [0069] - [0078]; example 4), wherein said composition comprises L. plantarum LP220 i.e. L. plantarum ATCC 14917 (paragraphs [0013], [0034]; claim 1).
KR 2021 0154341 provided by Applicants discloses oral care compositions comprising L. plantarum ATCC 14917 and L. plantarum ATCC 8014 (paragraph [0123]; claim 1) for use in the prevention of S. mutans biofilm formation (paragraphs [0026], [0034], [0048], [0089], [0112]).
The scope of the instant claims includes pharmaceutical composition to include just one or more of the recited strains of Lactobacillus and the plantaricin in the method claim is optional “and/or.” Therefore, Applicant’s invention does not contribute a special technical feature when viewed over the prior art. Accordingly, the inventions of groups I-III do not have a single inventive concept and so lack unity of invention, and therefore the restriction for examination purpose as indicated is proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 and 9-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wasfi et al (J. Cellular and Molec. Med. 22(3): 1972-1983; provided by Applicants).
The scope of the instant claims includes methods of administering to a subject an effective amount of just one or more of the recited strains of Lactobacillus. The plantaricin in the method claim is optional, e.g., “and/or.”
Wasfi et al discloses oral care compositions for use in inhibiting the formation of S. mutans biofilms, wherein said compositions comprise L. plantarum ATCC 14917 and/or L. salivarius ATCC 11741 (abstract; page 1973, left-hand column, paragraph 5; figure 2). Further applications such as prevention of tooth decay is also taught in Wasfi (page 1981, right-hand column, paragraph 3). Wasfi teaches that Streptococcus mutans contributes significantly to dental caries, which arises from homoeostasic imbalance between host and microbiota. They hypothesized that Lactobacillus sp. inhibits growth, biofilm formation and gene expression of Streptococcus mutans. Antibacterial (agar diffusion method) and antibiofilm (crystal violet assay) characteristics of probiotic Lactobacillus sp. against Streptococcus mutans (ATCC 25175) were evaluated. We investigated whether Lactobacillus casei (ATCC 393), Lactobacillus reuteri (ATCC 23272), Lactobacillus plantarum (ATCC 14917) or Lactobacillus salivarius (ATCC 11741) inhibit expression of Streptococcus mutans genes involved in biofilm formation, quorum sensing or stress survival using quantitative real-time polymerase chain reaction (qPCR). Susceptibility testing indicated antibacterial (pH-dependent) and antibiofilm activities of Lactobacillus sp. against Streptococcus mutans. Scanning electron microscopy revealed reduction in microcolony formation and exopolysaccharide structural changes. Of the oral normal flora, L. salivarius exhibited the highest antibiofilm and peroxide-dependent antimicrobial activities. All biofilm-forming cells treated with Lactobacillus sp. supernatants showed reduced expression of genes involved in exopolysaccharide production, acid tolerance and quorum sensing. Thus, Lactobacillus sp. can inhibit tooth decay by limiting growth and virulence properties of Streptococcus mutans. Wasfi’s study showed that Lactobacillus sp. can inhibit tooth decay and control dental caries. See abstract and “Discussion.”
Claim(s) 1-5 and 9-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Min et al (KR 2021 0154341, 6/12, 2020; provided by Applicants).
The scope of the instant claims includes methods of administering to a subject an effective amount of just one or more of the recited strains of Lactobacillus. The plantaricin in the method claim is optional, e.g., “and/or.”
Min discloses oral care compositions comprising L. plantarum ATCC 14917 and L. plantarum ATCC 8014 (paragraph [0123]; claim 1) for use in the prevention of S. mutans biofilm formation (paragraphs [0026], [0034], [0048], [0089], [0112]).
Claim(s) 1-5 and 9-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xiaoping et al (CN 112 852 686; 5/28/21; provided by Applicants).
The scope of the instant claims includes methods of administering to a subject an effective amount of just one or more of the recited strains of Lactobacillus. The plantaricin in the method claim is optional, e.g., “and/or.”
Xiaoping et al discloses an oral care composition for use in the prevention of S. mutans biofilm formation (paragraphs [0069] - [0078]; example 4), wherein said composition comprises L. plantarum LP220 i.e. L. plantarum ATCC 14917 (paragraphs [0013], [0034]; claim 1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6-8, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over any one of Wasfi et al (J. Cellular and Molec. Med. Jan. 8, 2018, 22(3): 1972-1983; provided by Applicants), Min et al (KR 2021 0154341, 6/12/2020; provided by Applicants), or Xiaoping et al (CN 112 852 686; 5/28/21; provided by Applicants) in view of Chugh et al (J. Functional Foods. Vol 70. April 30, 2020, pages 1756-4646; provided by Applicants) and Bosy et al (US 20180230519 A1).
The teachings of Wasfi et al, Min et al and Xiaoping et are set forth above. However, they do not specifically recite the use of additional agents that inhibit biofilm formation which may include antifungal agents in their compositions, and more specifically nystatin or plantaricin.
Chugh et al relates to the effects of probiotics formulations on oral health and in prevention and treatment of oral infections, including dental caries and other periodontal disease (abstract); in particular, a composition comprising plantaricin for use in inhibiting the formation of C. albicans biofilms (page 7, left-hand column, paragraph 2). The reference teaches that probiotics play a vital role in the prevention and treatment of oral diseases such as dental caries, periodontitis, halitosis, candida infections and gingivitis; when consumed regularly. Chugh teaches more than 700 species of microorganisms inhabit the oral cavity. These include mostly prokaryotes which are further divided into two groups namely Gram positive (Streptococcus, Enterococcus, Micrococcus, Peptococcus, Peptosteptococcus, Lactobacillus, Corynebacterium, Actinomyces, Arachnia, Rothia, Eubacterium, Propioni bacterium, Bifidobacterium, Bacillus and Clostridium) and Gram negative (Nisseria, Veillonela, Campylobacter, Eikenella, Actinobacillus, Capnocytophaga, Heamophilus, Simonsiella, Bactertoides, Fusobacterium, Porphyromonas, Provotella, Laptotrichia and Wolinella) and some eukaryotes (protozoa, yeasts, mycoplasma, candida, spirochetes).Section 2.1 recites that Candida spp. is present on the surface of different body parts including oral cavity of humans. About 75% of adults have candida present in their oral cavity. Usually, it is a harmless fungus but under specific conditions, it can become pathogenic and lead to infections. Among all the candida species, C. albicans is majorly responsible for causing fungal infection known as “Oral Candidiasis” in the oral cavity. Chugh cites a study that shows fungicidal activity present in spent culture filtrate of L. plantarum LR14 on C. albicans. The reference recites that the artificially synthesized plantaricin peptides PlnE, F and J displayed fungicidal activity against Candida albicans (page 7, left-hand column, paragraph 2).
Bosy describes methods and kits for selecting treatments for, and treating, an oral infection in a patient. Oral samples are collected from multiple locations of the patient's oral cavity and include saliva, tongue biofilm, and interproximal biofilm. The samples are analyzed to determine a pathogen profile of the oral cavity, using nucleic-acid based analysis. Based on the pathogen profile, an antibiotic rinse is selected as the treatment of the oral infection. 0082] In some embodiments, antibiotic rinses may include an antifungal agent to control opportunist yeasts. When an antifungal agent is included in an antibiotic rinse, it can prevent oral thrush resulting from systemic antibiotic use. Exemplary antifungal agents include nystatin, which can be an essential ingredient of the rinse formulations when Candida is detected as a component of oral biofilms. Recent studies have found that Candida may exacerbate the amount of acid production when combined with Streptococci. [0083] The combination of metronidazole and nystatin can be used to control most of the microorganisms including Candida. Nystatin, sold under the brand name Mycostatin among others, is a very well-known antifungal medication. Oral nystatin has been widely used as a preventive treatment in people who are at risk for fungal infections and as a mouthwash to treat oral thrush.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to use an additional agent or agents that inhibit biofilm formation in the primary references because reference teaches that probiotics play a vital role in the prevention and treatment of oral diseases such as dental caries, periodontitis, halitosis, candida infections and gingivitis; when consumed regularly. Chugh teaches more than 700 species of microorganisms inhabit the oral cavity. Chugh teaches that about 75% of adults have candida present in their oral cavity. Usually, it is a harmless fungus but under specific conditions, it can become pathogenic and lead to infections. Among all the candida species, C. albicans is majorly responsible for causing fungal infection known as “Oral Candidiasis” in the oral cavity. Chugh cites a study that shows fungicidal activity present in spent culture filtrate of L. plantarum LR14 on C. albicans. The reference recites that the artificially synthesized plantaricin peptides PlnE, F and J displayed fungicidal activity against Candida albicans (page 7, left-hand column, paragraph 2). Bosy also discusses the presence of Candida and other fungi in biofilm formations negatively effecting oral health. Bosy specifically that exemplary antifungal agents which include nystatin, can be an essential ingredient of the rinse formulations when Candida is detected as a component of oral biofilms. The use of these additional agents would have a reasonable expectation of increasing the decolonization or inhibition formation of harmful oral biofilms in a subject.
Claim Rejections - 35 USC § 112-Deposit Information
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 1-15 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 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 specification lacks complete deposit information for the deposit of strain L. plantarum ATCC 14917. Because it is not clear that the properties of the strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the plasmids, a suitable deposit for patent purposes is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1)The name and address of the depository;
2)The name and address of the depositor;
3)The date of deposit;
4)The identity of the deposit and the accession number given by the depository;
5)The date of the viability test;
6)The procedures used to obtain a sample if the test is not done by the depository; and
7)A statement that the deposit is capable of reproduction.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and address of the depository is required.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Prior art not presently relied upon:
Biyari et al (Shiraz E Medical Journal, (June 2018) Vol. 19, No. 6):
The inhibitory effect of probiotic bacteria against drug - resistant candida species isolated from the oral cavity of the elderly. The study on dairies showed that most isolated strains belonged to Lactobacilli. It was also revealed that the probiotic bacteria were able to prevent the growth of Candida species. The highest inhibitory effect was seen in Lactobacillus plantarum. Moreover, desirable antifungal effects were observed in preventing the growth of C. albicans as well as non-albicans species, particularly C. glabrata. Conclusions: Concerning the high resistance of Candida isolates to antifungal agents and the inhibitory effects of lactic bacteria, especially Lactobacillus plantarum, it is recommended to se its metabolites directly in the diet of the elderly or to use them in the form of supplements in order to control oral candidiasis. The broth microdilution method was used to determine the minimum inhibitory concentration (MIC) of nystatin and itraconazole based on the CLSI document
Journal of dental biomaterials, (2017 Mar) Vol. 4, No. 1, pp. 347-352):
In this study, antibacterial and antifungal effects of nano-CuO were studied against some oral bacteria and yeast fungi. MATERIALS AND METHODS: The minimum inhibitory concentrations (MICs) of copper oxide nanoparticles (CuO NPs) for oral bacterial and fungal test strains were determined in 96-well microtiter plate technique. The agar diffusion test (ADT) was employed to assess the antifungal properties of nystatin.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 6/22/6
Prosecution Insights