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 .
Applicants’ amendment to the claims filed on 06/16/2023 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-11 are pending and examined on the merits.
Claims 1-11 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/16/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The Drawings filed on 6/16/2023 are acknowledged and accepted by the Examiner.
Priority
Acknowledgement is made of this national stage entry of PCT/FR2021/052374 of Non-provisional Application No. 118/258,199, filed on 12/17/2021, which claims foreign priority under 35 U.S.C. 119(a)-(d) to French Republic Patent Application No. FR2013717, filing date 12/18/2020. The certified copy has been filed in the present application on 6/16/2023.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Objections
Claim 4 is objected to because of the following informalities: the recitation of ‘-.’ Appropriate correction is suggested.
Claim 5 is objected to because the grammar for the last step in claim 5 should state, “step C, purifying and concentrating …”.
Claim 7 is objected to because of the following informalities: the recitation of ‘The use according to claim 1, wherein said material is selected from metals, metal alloys, polymers, glass, ceramic, and food.’ It is recommended that Applicant amend the claim to recite ‘The use according to claim 1, wherein said material is selected from a group consisting of: metals, metal alloys, polymers, glass, ceramic, and food.’
Claims 8, 9-11 are objected to because of the following informalities: there is unnecessary space between pages 4-5 of said claims. Appropriate correction is suggested.
Claim 11 is objected to because of the following informalities: the recitation of ‘the material according to claim 9, selected from a packaging material, in particular food packaging, a water pipe, a heat exchanger, a pipeline, a catheter, a dressing, a cream and a medical device.’ It is recommended that Applicant amend the claim to recite ‘The material according to claim 9, selected from a packaging material a group consisting of: food packaging, a water pipe, a heat exchanger, a pipeline, a catheter, a dressing, a cream and a medical device.’ Appropriate correction is suggested.
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 1-11 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.
Claims 1-7 are rejected as indefinite because they merely recite a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Appropriate correction is suggested
The term “reducing” recited in claims 1 (claims 2-7 dependent thereof), 8, is a relative term which renders the claim indefinite. The term “reducing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term "reducing” is a relative term that renders the claim indefinite because it is unclear whether it is broad or limited. See MPEP § 2173.05(b) III A. Appropriate correction by providing the support for such correction in the specification and specifying the degree upon which the biofilm is reduced in quantitative terms is suggested.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 is indefinite due to the recitation “selected from a probiotic bacterium such as a lactobacillus, a bifidobacterium, an enterococcus, a propionibacterium, a streptococcus and a bacterium of the genus Bacillus, or a yeast such as Saccharomyces cerevisiae and Saccharomyces boulardi or a mixture thereof.” Note that this is an open ended group of parameters. According to MPEP 2173.05(h), claims that set forth a list of alternatives from which a selection is to be made are typically referred to as Markush claims and the listing of specified alternatives within a Markush claim is referred to as a Markush group or Markush grouping. A Markush grouping is a closed group of alternatives and if a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. Applicant may consider amending the phrase “a group comprising” to recite “the group consisting of.”
Regarding claim 4, it is recommended that Applicant amend the claim to separate the bacteria and yeast with (a), (b), etc. as it is not clear to the Examiner from the way the claim is written whether these items are claimed in the alternative or together. Appropriate correction is suggested.
Regarding claims 4, 11, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. It is not clear if the items/phrases followed by this phrase are to be considered as claim limitations. Appropriate correction is suggested. See MPEP § 2173.05(d). Appropriate correction is suggested.
Claim 4 is rejected as Salmonella enterica Enteritidis, Citrobacter freundii, Pseudomonas aeruginosa, Candida albicans recited in claim 4 do not fit within the genus of microorganisms claimed in claim 1. Said microorganisms are not probiotics, as recited in claim 1, upon which claim 4 depends. Appropriate correction is suggested.
Regarding claim 5 (claim 6 dependent thereof), the phrase "the use according to claim 1, wherein the extracellular membrane vesicles are produced by a method" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Said claim contains an improper double preamble. As such, it is unclear if the claim is a ‘use’ or ‘method’ claim. See MPEP § 2173.05(d). Appropriate correction is suggested
Claim 6 is indefinite due to the recitation “comprises at least one step selected from differential centrifugation, density gradient, exclusion chromatography, ultrafiltration, immunocapture and precipitation.” Note that this is an open ended group of parameters. According to MPEP 2173.05(h), claims that set forth a list of alternatives from which a selection is to be made are typically referred to as Markush claims and the listing of specified alternatives within a Markush claim is referred to as a Markush group or Markush grouping. A Markush grouping is a closed group of alternatives and if a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. Applicant may consider amending the phrase “a group comprising” to recite “the group consisting of.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed subject matter does not fall within one of the four one of the four statutory categories of processes, machines, manufactures and compositions of matter because the claimed invention is directed to ‘a use of extracellular membrane vesicles of at least one probiotic for preventing or reducing the formation of a biofilm on the surface of a material.’
Claims are not eligible subject matter under 35 USC 101. It is suggested that Applicant make it clear whether a composition or a method is being claimed in order to overcome this rejection.
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.
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.
Claims 1, 3-5, 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zaborowsk et al (2015, frontiers in Microbiology, Examiner cited) {herein Zaborowska}.
Claims 1, 3-5, 7 are drawn to a use of extracellular membrane vesicles of at least one probiotic for preventing or reducing the formation of a biofilm on the surface of a material.
Claim 8 is drawn to a method for treating a surface of a material for preventing or reducing the formation of a biofilm on said surface, said method comprising a step of contacting extracellular membrane vesicles from at least one probiotic with said surface.
Claims 9-11 are drawn to a material comprising at its surface extracellular membrane vesicles of at least one probiotic, or wherein extracellular membrane vesicles of at least one probiotic are incorporated.
With respect to claims 1, 3, 4, 5, 7, 8, 9, 11 Zaborowska teaches the use of extracellular membrane vesicles from biofilm derived gentamycin resistant Streptococcus epidermidis for the decreased attachment of clinical Streptococcus epidermidis (not gentamycin resistant) onto glass (abstract). It is the Examiner’s position that said use would inherently involve contacting gentamycin resistant Streptococcus epidermidis onto glass in order for it to exhibit its molecular effects. Furthermore, absent evidence otherwise, it is the Examiner’s position that a decrease in attachment, taught by Zaborowska, to be the same as ‘reducing the formation of a biofilm’ as recited in claim 8 of the instant application since both result in a disruption in the biofilm. Zaborowska further teaches said use involves the method of culturing biofilm derived gentamycin resistant S. epidermidis under conditions to produce extracellular vesicles (page 2, column 2, para 4). Subsequently, the extracellular membrane vesicles and cells were purified by sequential filtration (page 2, column 2, para 4). The total concentration of extracellular membrane vesicles were determined by quantitation utilizing a Pierce BCA Assay kit (page 3, column 2, para 2). In addition, Zaborowska teaches the extracellular membrane vesicles of the invention were isolated from a patient with implant related osteomyelitis (page 2, column 2, para 3). Examiner is interpreting the implant related osteomyelitis taught by Zaborowska to be a medical device (as it is utilized in a medical application), of which Applicant defines as a surface within the instant application claims 8-9 and 11.
With respect to claim 10, Zaborowska teaches the thickness of the vesicles range from 84.5nm to 134.7nm (page 5, column 1, para 2).
For the reasons stated herein, the teachings of Zaborowska anticipate claims 1, 3-5, 7-11.
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.
Claims 2, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Zaborowsk et al (2015, frontiers in Microbiology, Examiner cited) {herein Zaborowska} as applied to claims 1, 3-5, 7-11 in view of Liu et al (2017, BMC Microbiology, Examiner cited) {herein Liu}.
Claim 2 is drawn to the use according to claim 1, wherein the at least one probiotic is selected from a probiotic bacterium such as a lactobacillus, a bifidobacterium, an enterococcus, a propionibacterium, a streptococcus and a bacterium of the genus Bacillus, or a yeast such as Saccharomyces cerevisiae and Saccharomyces boulardi or a mixture thereof.
Claim 6 is drawn to the use according to claim 5, wherein said purification and concentration step comprises at least one step selected from differential centrifugation, density gradient, exclusion chromatography, ultrafiltration, immunocapture and precipitation.
With respect to claims 2, 6, Liu teaches the utilization of extracellular membrane vesicles produced by Lactobacillus plantarum to treat patients infected with pathogenic bacteria (abstract), which have an impact on biofilm formation (page 3, column 2, para 2). Liu further teaches said extracellular membrane vesicles were purified by precipitation (page 6, column 1, para 2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Zaborowska of the use of extracellular membrane vesicles from biofilm derived gentamycin resistant Streptococcus epidermidis for the decreased attachment of clinical Streptococcus epidermidis (not gentamycin resistant) onto glass (abstract) or combine the teachings of Liu because Liu teaches the utilization of extracellular membrane vesicles produced by Lactobacillus plantarum to treat patients infected with pathogenic bacteria (abstract), which have an impact on biofilm formation (page 3, column 2, para 2).
One of ordinary skill in the art would be motivated to either use the teachings of Zaborowska by itself or combine the teachings of Liu because Liu provides the motivation for Zaborowska to combine the extracellular membrane vesicles produced by Streptococcus epidermidis (taught by Zaborowska) with the extracellular membrane vesicles produced by Lactobacillus plantarum (taught by Liu) because the extracellular membrane vesicles produced from L. plantarum up-regulate the expression of host defense genes and provide protective effects on hosts (Liu: abstract) which can result in lasting immunity to infection, inhibit cytokine-induced apoptosis and decrease the pathogenicity of various other pathogens, such as E. coli and vancomycin resistant bacteria (Liu: page 1, column 1, para 1). One of ordinary skill in the art knowing the benefit of extracellular membrane vesicles based on the teachings of Zebrowski and Liu would have a reasonable expectation of success to combine both gentamycin resistant Streptococcus epidermidis extracellular membrane vesicles and Lactobacillus plantarum extracellular membrane vesicles because one of ordinary skill in the art would expect the administration of extracellular membrane vesicles from both strains to result in a more efficient and effective disruption of a biofilm as Zebrowski and Liu teaches the disruption of biofilms due to the administration of extracellular membrane vesicles from gentamycin resistant Streptococcus epidermidis and Lactobacillus plantarum (Zebrowski: abstract; Liu: abstract, respectively) separately. Furthermore, MPEP 2144.06.I states “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, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).” Additionally, utilizing extracellular membrane vesicles from both strains is cost effective as it will not require the purchasing and storage of costly antibiotics for the prevention and/or reduction in the development of biofilms on surfaces and medical devices. Furthermore, utilizing extracellular membrane vesicles will reduce the prevalence of antibiotic resistant bacteria.
One of skill in the art would have a reasonable expectation of success to make and use the claimed extracellular vesicles membranes from gentamycin resistant Streptococcus epidermidis and Lactobacillus plantarum and its uses and methods of making it. Reference of Liu provides the teachings for making and using extracellular membrane vesicles produced by Lactobacillus plantarum to treat patients infected with pathogenic bacteria (abstract), which have an impact on biofilm formation (page 3, column 2, para 2). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of Claims:
Claims 1-11 are pending
Claims 1-11 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656