DETAILED ACTION
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 of the Claims
Acknowledgement is made of the response filed on July 7, 2025. In that response, claims 1, 3, 4, 6, 9, 10, 12, 14, and 18 were amended and claim 19 was cancelled. Claims 1-7, 9, 10, 12, and 14-18 are treated on the merits in this action. The claim objections and the rejections under 35 U.S.C. 101 and 112 are withdrawn in view of the Applicant’s arguments and claim amendments. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-7, 9, 10, 12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Berkes (US 2017/0020139) in view of Biffi (US 2021/0236566) as evidenced by Salas-Jara (Salas-Jara, M.J., et al., Biofilm Forming Lactobacillus: New Challenges for the Development of Probiotics, Microorganisms 2016, 4, 35).
Berkes teaches a “method of inhibiting microbial growth on a surface, wherein the method comprises applying to the surface a microbial growth-inhibiting amount of a composition comprising a bioactive L. fermentum bacterial strain grown as biofilm,…”, including in some embodiments Lactobacillus fermentum Qi6, referred to as Lf Qi6 (claim 1; para.0021, para.0092 (“in specific embodiments, compositions comprising biofilm, …, of Lf Qi6 have the advantage of promoting the growth of commensal bacteria in the human skin microbiome”); see title; abstract; paras.0019, 0052, 0057, 0065, 0075, 0093, 0111-12).
Berkes teaches the “pharmaceutical compositions provided herein may suitably be provided as a patch, adhesive plaster, bandage, dressing, or the like which is impregnated with, or coated with, the microbial biofilm and/or one or more extracts thereof and, optionally, one or more other pharmaceutically-acceptable ingredients …” (para.0093 (emphasis added); see paras.0087, 0094, 0128). Other suitable substates include “implants and prosthesis (including stents, valves, eyes, hearing aids, gastric bands, dentures, artificial joint replacements etc.), surgical instruments or other medical devices prior to administration to, or treatment of, or use with, a subject” (para.0094). In other words Berkes teaches a device such as a patch or stent which is coated with a microbial biofilm. As evidenced by Salas-Jara it is prior art knowledge that a biofilm is formed by attachment of microbes to a surface, followed by development of biofilm architecture (p.4, 3.1. fourth para.). Therefore formation of a biofilm coating inherently involves applying to the surface of the medical device a coating layer comprising bacteria.
Regarding the “non-living commensal bacteria” in claim 1 limitation (b) and claim 14, Berkes expressly teaches not only live bacterial biofilm, but also non-living forms such as “bioactive extracts thereof, in a lyophilized, freeze dried, and/or lysate form.” (para.0050: “The Subject invention also provides compositions comprising L. fermentum bacterium, and/or bioactive extracts thereof, in a lyophilized, freeze dried, and/or lysate form”; see also paras.0015, 0024, 0052, 0065; claim 9). Salas-Jara evidences prior art knowledge that lyophilization or freeze-drying is lethal to microorganisms in a biofilm (p.9 first para.; see p.2 first para., p.9 5.Conclusion). Berkes further states as follows.
The extract can also include cell mass obtained through centrifugation. The cells may be intact or not intact, viable or not viable. The extract may comprise cell membrane components and/or intracellular components. (Para.0058 (emphases added)).
Berkes’s claim 9 is drawn to a method of inhibiting microbial growth on a surface, comprising applying to the surface a microbial growth-inhibiting amount of a composition comprising a bioactive extract of L. fermentum that had been grown as a biofilm (see claims 1, 9).
Berkes does not expressly teach an embodiment wherein the coating layer or the biofilm has been dried in order to kill the microorganisms or bacteria in the biofilm, or bacteria in the genus of Streptococcus as in claims 1, 6, 14, and 16-18.
Biffi is drawn to treating “disorders affecting the skin, in particular inflammatory disorders, in particular autoinflammatory disorders of dermatological interest such as atopic dermatitis” (abstract) by administering probiotics, specifically strains of Lactobacillus paracasei in combination with others specifically including Streptococcus oralis (claims 1, 4, 6). The microorganisms are “dead or tyndallized” (para.0060). Claim 7 states as follows.
The composition …, wherein said microorganisms are live or dead or tyndallized, or in the form of a lysate and/or extract, or in the form of bacterial products or in the form of a supernatant or in a derivative form preferably selected from: metabolites, metabolic bioproducts, post-biotic, cell wall and components thereof, exopolysaccharides, and compounds containing immunogenic components preferably selected from: ribosomes and glycoproteins, immunostimulant derivatives, such as glucans and other polysaccharides, lipopolysaccharides and any component of the supernatant. (Claim 7.)
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Berkes and Biffi and dry the biofilm coating of Berkes to kill the microbes therein as recited in the instant claims and to include a Stereptococcal bacterial strain in the biofilm as recited here. The skilled person would have been motivated to do so because both are drawn to application of microbial bioproducts comprising, and Biffi teaches that (i) dead or tyndallized bacteria (recently termed postbiotics) are useful for treatment as are alive probiotics, and (ii) Streptococcus oralis is another beneficial strain for “prevention and/or treatment of disorders and/or pathologies, preferably of an inflammatory type, affecting the skin…” (claim 1). Therefore the skilled person would have been motivated to prepare and implant or apply the “dead or tyndallized” bacteria in the biofilm coating that comprises dried or lysated cells that Berkes teaches.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7, 9, 10, 12, and 14-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614