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
Claims 1-15 and 18-23 are currently pending (claim set as filed on 12/11/2024) and under examination. Claims 16-17 are cancelled.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. BE 2022/5483, filed on 6/20/2022.
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.
Although a certified copy of this application was provided, there was no accompanying English translation of the applicant provided and thus the applicant does not obtain benefit to the earliest effective filing date of 6/20/2022. Thus the earliest effective filing date of this application is 12/11/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2024 was considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The use of the term “Vidas” which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
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 1-15 and 18-23 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.
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. Claim 1 recites “comprising” language preceding the Markush groupings and this is improper as Markush groups must be a closed grouping as indicated by the use of “consisting of” language. See MPEP 2117. The claim is also rendered indefinite as it is unclear based off the language used as to which of the recited components are part of the microorganism and which are part of the composition. Further, it is unclear as to the nature of “performing the sterile and calibrated application of a composition…to a surface to be sampled” and if this indicates if the composition is applied to a surface and if the microorganisms are considered to already be present on said surface.
Claims 2-15 and 18-23 are rejected for depending on claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites the term “calibrated application” which is defined in the specification as “a calibrated application of a controlled volume of said collection composition, preferably a calibrated spraying of a controlled volume of said collection composition” (see specification pg. 7, lines 21-24) which is the same as the claim language of claim 2. The term “calibrated application” is already recited in claim 1, and thus claim 2 fails to further limit the scope of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Although claim 3 does further limit the scope of the independent claim, it is rejected for depending on claim 2.
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.
Claims 1-9, 12-15, 18-19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ripolles-Avila (Ripolles-Avila et al., “New approach for the removal of mature biofilms formed by wild strains of Listeria monocytogenes isolated from food contact surfaces in an Iberian pig processing plant”, 2020 Mar 18, International Journal of Food Microbiology, 323, pgs. 1-9) and further in view of Anand (Anand et al., “Development and Control of Bacterial Biofilms on Dairy Processing Membranes”, 2013 Oct 13, Comprehensive Reviews in Food Science and Safety, 13, pgs. 18-33).
Ripolles-Avila’s general disclosure relates to the use of an enzymatic detergent to remove Listeria biofilms off of food contact surfaces (see abstract).
Regarding claim 1, Ripolles-Avila teaches the application of an enzymatic composition comprising enzymes such as proteases and cellulases (see pg. 2, ¶ 3) and a cleaning product composition comprising an ionic surfactant and sequestering agents (see pg. 3, ¶ 2) to the surface of a stainless steel coupon contained inside a sterile flask (see pg. 3, ¶ 5). Ripolles-Avila discloses the composition remained in contact with the coupon surface for a period of time before biofilm cells were collected from the surface into a separate sterile flask to be quantified (see pg. 3, ¶ 5). Ripolles-Avila also teaches that the cleaning product composition was diluted to just 3% (see pg. 3, ¶ 2), and thus the subcomponents must be 3% or less of the entire concentration of the solution.
However, Ripolles-Avila does not teach that the enzymes and the surfactant(s)/sequestering agent were embodied together in a composition.
Anand’s general disclosure relates to the use of combining enzymes, surfactants, and chelating agents to enhance the enzymes’ ability to penetrate microbial biofilms (see abstract and pg. 26, - “Degradation of biofilm by using enzymes” ¶ 1).
Regarding claim 1, Anand teaches a composition of enzymes, anionic surfactants, and chelating agents to be applied to microbial biofilms to break them down (see Anand abstract and pg. 26, - “Degradation of biofilm by using enzymes” ¶ 1). The instant specification exemplifies a sequestering agent as a chelating agent (see specification pg. 17, ¶ 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to combine the enzymes and surfactant(s)/sequestering agent as taught in Anand to create the composition for applying to a surface as taught in Ripolles-Avila. One would have been motivated to do so because Anand teaches that enzymatic treatment alone is not capable of breaking down biofilms and should be used in conjunction with anionic surfactants to increase its ability to penetrate the biofilm matrix (see Anand pg. 26, - “Degradation of biofilm by using enzymes” ¶ 1). The combination would be advantageous to Ripolles-Avila’s disclosure states that enzymatic treatment is effective at dispersing biofilms but not inactivating the pathogens while the surfactant cleaning treatment is effective at inactivating the pathogens (see Ripolles-Avila pg. 7 – “Conclusions”), and thus combining the two would result in the overall desired effect.
Regarding claim 2, modified-Ripolles-Avila-Anand teaches the composition was applied at a specified volume of 3 ml (see Ripolles-Avila pg. 3, ¶ 4).
Regarding claim 3, modified-Ripolles-Avila-Anand teaches the enzymatic detergent composition was applied at a specified volume of 3 ml (see Ripolles-Avila pg. 3, ¶ 4) to a stainless steel coupon surface which was 1 mm thick and 2 cm in diameter, equaling a surface area of 6.91 cm² (see Ripolles-Avila pg. 2, ¶ 5).
However, modified-Ripolles-Avila-Anand does not specify a surface area of 100 cm².
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to optimize the stainless steel coupon surface to 100 cm² as taught in modified-Ripolles-Avila-Anand. One would have been motivated to do so because modified-Ripolles-Avila-Anand teaches that the bacterial inoculum to produce the biofilm growth was added to the coupon surface at a specific concentration (see Ripolles-Avila pg. 2, ¶ 9). Thus changing the desired amount of bacterial inoculum would require a change in surface area, and it would have only been a matter of routine experimentation for the ordinary artisan to modify the surface area to 100 cm² if changing the surface concentration.
Regarding claim 4, modified-Ripolles-Avila-Anand teaches the composition was applied to the surface for 15 minutes (see Ripolles-Avila pg. 3, ¶ 4), which is at least 10 seconds and no more than 15 minutes.
Regarding claims 5-6, modified-Ripolles-Avila-Anand teaches the cells were harvested from the surface through sterile means such as the composition being washed off the stainless steel coupon surface with sterile distilled water and the stainless steel coupon being placed into a sterile flask (see Ripolles-Avila pg. 3, ¶ 6).
Regarding claim 7, modified-Ripolles-Avila-Anand teaches the storage of a Listeria isolate in a TSA slant at 4[Symbol font/0xB0]C (see Ripolles-Avila pg. 2, ¶ 6-7). TSA slants are considered sterile until inoculated with a microorganism.
Regarding claim 8, modified-Ripolles-Avila-Anand teaches that during the microorganism collection, the stainless steel coupon samples were exposed to a surfactant solution comprising Tween® present at a concentration of 30 g/L, 0.03% by weight (see Ripolles-Avila pg. 3, ¶ 6), which is at least 0.02%.
Regarding claim 9, modified-Ripolles-Avila-Anand teaches the composition comprises at least three enzymes such as proteases, lipases, and cellulases (see Ripolles-Avila pg. 2, ¶ 3).
Regarding claim 12, modified-Ripolles-Avila-Anand teaches the composition was sterile filtered (see Ripolles-Avila pg. 3, ¶ 3).
Regarding claims 13-15, modified-Ripolles-Avila-Anand teaches the collected microorganisms were preserved in a neutralizing solution prior to quantification and wherein the solution contained Tween® which is a polyoxyethylene sorbitan derivative (see Ripolles-Avila pg. 3, ¶ 6). Modified-Ripolles-Avila-Anand teaches the Tween® is present at 30 g per 1000 ml of deionized water (see Ripolles-Avila pg. 3, ¶ 6), which is at least 4 g/L.
Regarding claim 18, modified-Ripolles-Avila-Anand teaches the collected microorganisms were mixed with a medium, transferred to a well plate, and incubated to grow the cells (see Ripolles-Avila pg. 3, ¶ 7) which reads on a cell culturing method.
Regarding claim 19, modified-Ripolles-Avila-Anand teaches that the collected microorganisms were detected using TEMPO Reader Unit quantification system (see Ripolles-Avila pg. 3, ¶ 7).
Regarding claim 23, modified-Ripolles-Avila-Anand teaches the microorganism is a Listeria spp. (see Ripolles-Avila pg. 2 – Table 1). Modified-Ripolles-Avila-Anand also discloses that the method could be carried out with Salmonella spp. biofilms (see Ripolles-Avila pg. 4, ¶ 4).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ripolles-Avila (Ripolles-Avila et al., “New approach for the removal of mature biofilms formed by wild strains of Listeria monocytogenes isolated from food contact surfaces in an Iberian pig processing plant”, 2020 Mar 18, International Journal of Food Microbiology, 323, pgs. 1-9), in view of Anand (Anand et al., “Development and Control of Bacterial Biofilms on Dairy Processing Membranes”, 2013 Oct 13, Comprehensive Reviews in Food Science and Safety, 13, pgs. 18-33), and in further view of Klingman (Pre-Grant Publication No. US 2021/0009922 A1 – date of publication 1/14/2021).
Modified-Ripolles-Avila-Anand’s general disclosure has been set forth above.
Regarding claims 10-11, modified-Ripolles-Avila-Anand teaches the collection composition (see Ripolles-Avila pg. 2, ¶ 3 and pg. 3, ¶ 2).
However, modified-Ripolles-Avila-Anand does not teach a stabilizing agent chosen from polyols and propylene glycol at a relative weight of at least 15% of the composition; or that the sequestering agent is selected from a carboxymethyl inulin, a phosphonate, sodium glycolate, and mixtures thereof at a relative weight of at least 0.1% of the composition.
Klingman’s general disclosure relates to a biofilm reduction composition comprising enzymes coupled with surfactants, sequestering agents, and stabilizing agents (see abstract and [0193] and [0197]) and wherein the sequestering and stabilizing agents serve to stabilize the enzymes in the composition (see [0068]).
Regarding claim 10, Klingman teaches the composition contains a stabilizing agent, referred to as a dispersion medium when the composition is formulated as a gel, comprising propylene glycol and polyols such as glycol (see [0193]). Klingman teaches that the stabilizing agents were present in the composition at 75% w/v (see [0193]), which is at least 15%.
Regarding claim 11, Klingman teaches the composition contains chelant sequestering agents comprising amino phosphonates that are present up to 5% w/w (see [0197]), which is at least 0.1%.
Regarding claims 10-11, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date add the stabilizing agent and sequestering agent as taught in Klingman to the composition in the microorganism collection method as taught in modified-Ripolles-Avila-Anand. One would be motivated to do so because Klingman teaches that the stabilizers such as propylene glycol and chelant sequestering agents in the composition serve to stabilize the enzymes and provide a suitable pH (see [0068]). These additions would be advantageous to modified-Ripolles-Avila-Anand’s disclosure which balances the enzymatic solution at a specific pH (see Ripolles-Avila 3, ¶ 2) and thus the ordinary artisan could improve upon their method by providing additional compounds to keep the pH, and subsequently the enzymes, of the composition stable.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ripolles-Avila (Ripolles-Avila et al., “New approach for the removal of mature biofilms formed by wild strains of Listeria monocytogenes isolated from food contact surfaces in an Iberian pig processing plant”, 2020 Mar 18, International Journal of Food Microbiology, 323, pgs. 1-9), in view of Anand (Anand et al., “Development and Control of Bacterial Biofilms on Dairy Processing Membranes”, 2013 Oct 13, Comprehensive Reviews in Food Science and Safety, 13, pgs. 18-33), and in further view of Kirmusaoglu (Kirmusaoglu, “The Methods for Detection of Biofilm and Screening Antibiofilm Activity of Agents”, Antimicrobials, Antibiotic Resistance, Antibiofilm Strategies and Activity Methods, 2019 Feb 11, IntechOpen, pgs. 1-17).
Modified-Ripolles-Avila-Anand’s general disclosure has been set forth above.
Regarding claims 20-22, modified-Ripolles-Avila-Anand teaches the collected microorganisms were detected using a quantification system (see Ripolles-Avila pg. 3, ¶ 7).
However, modified-Ripolles-Avila-Anand does not teach wherein the detection method is carried out by immunology or that it further comprises genetic analysis and a biochemical enzymatic test.
Kirmusaoglu’s general disclosure relates to different methods to detect microorganisms within biofilms such as PCR and micro enzyme-linked immunosorbent assays (microELISA) (see abstract and pgs. 2-3 – Table 1).
Regarding claims 20 and 22, Kirmusaoglu teaches the detection of collected microorganisms from a biofilm using immunology methods such as micro enzyme-linked immunosorbent assays (microELISA), which is a biochemical enzymatic test (see pgs. 2-3 – Table 1).
Regarding claim 21, Kirmusaoglu teaches the detection of collected microorganisms from a biofilm using genetic analysis methods such as polymerase chain reaction (PCR) (see pgs. 2-3 – Table 1).
Regarding claims 20-22, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the immunology-based biochemical enzymatic test and genetic analysis detection methods as taught in Kirmusaoglu to the microorganism collection method as taught in modified-Ripolles-Avila-Anand. One would have been motivated to do so because Kirmusaoglu teaches that these detection methods are adept at identifying the presence of microorganisms within a sample (see Kirmusaoglu pg. 8, ¶ 3 and pg. 10, ¶ 2). Thus, the addition would be an advantage to the disclosure of modified-Ripolles-Avila-Anand which states a great need within the food industry for a way to detect biofilm presence on food contact surfaces when creating disinfection procedures (see Ripolles-Avila pg. 2, ¶ 3).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/EMMALEE R WILLIAMS/Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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