DETAILED ACTION
The present application is a national stage entry of PCT/EP2022/053270, filed 10 February 2022, and claims foreign priority to EP21305183.2, filed 11 February 2021.
The preliminary amendment filed 01 March 2024 is acknowledged. Claims 1, 9-11 and 29-41 are pending in the current application. Claims 9-11 and 36-41 are withdrawn as being drawn to a non-elected invention, see below.
Claims 1 and 29-35 are examined on the merits herein.
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 .
Claim Rejections - 35 USC § 112(b)
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 29 and 34 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 29 recites the broad recitation Bacillus licheniformis, and the claim also recites “preferably wherein said gram-positive thermophilic bacteria is Bacillus licheniformis LP-T14” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The recitation “for preventing or reducing the colonization of the surface by a microbial pathogen” in claim 34, lacks antecedent basis. Claim 34 depends from claim 1, which does not recite any surface or medical device (as recited in claim 35).
Claim Rejections - 35 USC § 102
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.
(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.
Claim(s) 1 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gugliandolo et al. (Microorganisms, 2015, vol. 3, pp. 464-483, cited in IDS submitted 01 March 2024).
Gugliandolo et al. disclose exopolysaccharides (EPSs) can be obtained by thermotolerant bacilli in marine hydrothermal systems, and have promising therapeutic potential (abstract, and p.465, first para). EPSs from Bacillus licheniformis have been obtained, and shown to have a molecular weight of 400-1000 kDa (p. 470, Table 3).
Thus, Gugliandolo et al. disclose an isolated EPS having a Mw that lies within the range recited in the present claims (claim 1; claim 29(i)), which is obtained by fermenting a marine bacteria.
Thus, the disclosure of Gugliandolo et al. anticipates claims 1 and 29 of the present application.
Claim(s) 1, 29, 30, 34 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spano et al. (Curr Microbiol, 2015, vol. 3, pp. 464-483, cited in IDS submitted 01 March 2024).
Spano et al. disclose exopolysaccharides (EPSs) can be obtained by thermotolerant bacilli in marine hydrothermal systems, and have promising therapeutic potential (abstract). EPSs from Bacillus licheniformis have been obtained, and shown to have a molecular weight of 1000 kDa (abstract). Biofilm formation by bacterial pathogens can be involved in various infectious diseases including lung infections of cystic fibrosis, urethritis, otitis, periodontitis and endocarditis (p.1, last para). Spano et al. teach some EPSs from marine bacteria also possess the ability to negatively control biofilm-associated infections (p.2). EPS from Bacillus licheniforms (EPS1-T14) represents a promising biomolecule in pharmaceutical applications, as a natural antiviral agent (p.2). The EPS had anti-biofilm activity against E. coli, K. pneumoniae, P. aeruginosa, and S. aureus (Table 3). Spano et al. teach preparing an aqueous solution comprising EPS1-T14 (p.3, third para).
Thus, Spano et al. disclose an isolated EPS having a Mw that lies within the range recited in the present claims (claim 1; claim 29(i)), which is obtained by fermenting a marine bacteria.
The recitation “for preventing or reducing the colonization of the surface by a microbial pathogen” in claim 34 is an intended use of the product.
Thus, the disclosure of Spano et al. anticipates claims 1, 29, 30, 34 and 35 of the present application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 29-35 are rejected under 35 U.S.C. 103 as being unpatentable over Spano et al. (cited above) in view of Osborne et al. (US Patent Application Publication No. 2016/0317566, cited in PTO-892).
Spano et al. teach as discussed above.
Spano et al. do not expressly disclose the EPS in a nasal delivery system (present claims 31-33).
Osborne et al. teach a method of treating an inflammatory disease comprising administering to a human subject in need thereof, an effective amount of a composition consisting of an exopolysaccharide (claim 4). Osborne et al. teach the composition can be formulated for inhalation, it can be in the form of an aqueous solution, or oil solution for administration as nasal drops, or as a gel to be applied intranasally (para [0059]). Osborne et al. teach treating an inflammatory disease caused by an infectious agent (claims 12 and 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate EPS obtained from marine bacteria having a MW of 1000 kDa as a nasal formulation, because the EPS of Spano et al. (EPS obtained from marine bacteria having a MW of 1000 kDa) has antibacterial properties towards pathogenic bacteria, including against bacterial biofilms involved in lung infections of cystic fibrosis. Spano et al. specifically teach the EPS is active against P. aeruginosa biofilms, the most common bacteria responsible for lung infections in patients with cystic fibrosis. Thus, the ordinary artisan would have been motivated to formulate the EPS of Spano et al. as a nasal formulation for administration to deliver the compound to the airway passage so that it will come in direct contact with the lungs of a patient with cystic fibrosis and at risk of developing a lung infection.
The ordinary artisan would have looked to the teaching of Osborne et al., because they are concerned with various modes of EPS drug delivery, including for EPSs active against inflammation or other conditions caused by infectious agents. Osborne et al. teach nasal drops is a known alternative formulation suitable for EPS drug delivery. And Osborne et al. does not indicate any technical challenges in formulating the EPS as a nasal formulation. Thus, the ordinary artisan would have had a reasonable expectation of success in formulating the EPS of Spano et al. as a nasal formulation.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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