DETAILED ACTION
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.
Claims 1 and 4-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hess et al. (US PGPub 2010/0261159, hereinafter Hess).
Regarding claim 1, Hess discloses an analysis plate (platen containing cells, see paragraph [0119]) configured to allow characterization of microorganisms (e.g. bacteria, see paragraph [0332]) by mass spectrometry (mass spectrometry, see paragraph [0070]), the analysis plate comprising at least one analysis zone (platen has at least one of 500,000 through holes, see paragraph [0336]) configured for a biological sample (e.g. biological compositions, see paragraph [0119]) containing a population of at least one microorganism (e.g. a dilute culture enterococcus faecium bacteria is applied to the platen, see paragraph [0336]), wherein part or the whole of the analysis zone is made of a porous material (membrane comprises pores that are no more than half the through hole diameter, see paragraph [0047], porous material inside the through-holes ([0011])), the analysis zone comprising at least one antimicrobial agent (antibiotic activity, see paragraph [0027]; bacteria applied to platen is observed for reduction in growth, see paragraphs [0336-0337]).
Regarding claim 4, Hess discloses the plate comprises a plurality of analysis zones (platen includes 500,000 through holes for, see paragraph [0336]), each analysis zone bearing at least one antimicrobial agent (bacteria applied to platen is observed for reduction in growth, see paragraphs [0336-0337]).
Regarding claim 5, Hess discloses at least one first analysis zone from the plurality bears a first antimicrobial agent (one of 500,000 member combinatorial peptide library on the platen), and a second analysis zone from the plurality bears a second antimicrobial agent (another one of 500,000 member combinatorial peptide library on the platen) different than the first antimicrobial agent (screening for antibiotics by determining reduction in growth, see paragraphs [0336-0337]).
Regarding claim 6, Hess discloses a system comprising an analysis plate (platen having a plurality of through holes, see paragraph [0022]) on which a population of at least one microorganism (e.g. bacterial cells, see paragraph [0073]) and a culture medium (cell culture, see paragraph [0022]) are deposited on at least one analysis zone (through holes in the platen, see paragraph [0022]) and an incubation element configured to maintaining the humidity of the at least one analysis zone (array is incubated in an enclosed humidity chamber, see paragraph [0204]), the incubation element being positioned under the analysis plate (e.g. platen is incubated in an enclosed humidity chamber, see paragraph [0204]).
Regarding claim 7, Hess discloses a method for characterizing a population of at least one microorganism (e.g. bacteria, see paragraph [0332]), the characterization comprising at least determination of the possible resistance (antibiotic activity, see paragraph [0027]; screening for antibiotics by reduction in growth, see paragraphs [0336-0337]) of a population of a microorganism to at least one antimicrobial agent (antibiotics, see paragraph [0027]), wherein the method comprises:
a step of supplying an analysis plate as claimed in claim 1 (see claim 1 above), for characterization of the population of at least one microorganism (e.g. bacteria, see paragraph [0336]),
a step of depositing the population of the at least one microorganism (e.g. Enterococcus faecium bacteria, see paragraph [0336]) in liquid form (dilute culture, see paragraph [0336]) on the at least one analysis zone (platen includes 500,000 through holes, see paragraph [0336]) in contact with the antimicrobial agent (screening for antibiotics by reduction of growth, see paragraphs [0336-0337]; 500,000 member combinatorial peptide dissolved in a sterile cell culture medium in the through holes, see paragraph [0336]) previously deposited on the analysis zone,
an incubation step, consisting of storing the analysis plate in conditions (e.g. incubation at 30 degrees Celsius for 5 hours, see paragraph [0336]) and for a sufficient period (e.g. 5 hours) to allow interaction of the at least one antimicrobial agent and of the at least one microorganism present (screening for antibiotics by reduction of growth, see paragraph [0337]),
a step of removing the liquid containing the population of the at least one microorganism by aspiration through the pores of the analysis zone (controlling evaporation and facilitating the aspirating of individual samples from an array of through holes, see paragraph [0288]),
a step of analysis, by mass spectrometry using a MALDI ionization technique (matrix added to the samples for analysis by MALDI, see paragraph [0290]), of a population of the at least one microorganism deposited on the analysis zone, making it possible to conclude whether a population of a microorganism resistant to the antimicrobial agent is present in the analysis zone (screening for antibiotics by reduction of growth, see paragraph [0337]).
Regarding claim 8, Hess discloses the system comprises an incubation support, made of porous material (porous membrane on platen, see paragraph [0043]; platen incubated in a controlled environment, see paragraph [0336]).
Regarding claim 9, Hess discloses the incubation support is moistened by a culture medium (dilute culture for incubation with a dissolved peptide, see paragraph [0336]) or by the incubation element (platen is incubated in an enclosed humidity chamber, see paragraph [0204]).
Regarding claim 10, Hess discloses the incubation step is carried out by an incubation chamber (platen is incubated in an enclosed humidity chamber, see paragraph [0204]).
Regarding claim 11, Hess discloses the incubation step is carried out for at least 2 hours (e.g. 5 hours of incubation time, see paragraph [0336]).
Regarding claim 12, Hess discloses a step of determining the resistance of the microorganism to the antimicrobial agent is observing the presence of proteins of the microorganism in quantity (e.g. holes showing a greater than 99% reduction in growth are identified, see paragraph [0337]) such that it can be concluded that there is growth of the microorganism despite the presence of the antimicrobial agent during the incubation step (e.g. analysis where growth was not reduced, see paragraph [0337]).
Regarding claim 13, Hess discloses a population of a single microorganism to be characterized is deposited (average 1 to 2 bacteria per through hole, see paragraph [0332]).
Regarding claim 14, Hess discloses the population of microorganisms is obtained after a step of concentration (e.g. dilute culture added to platen, see paragraph [0336]), enrichment (e.g. incubation) corresponds to a colony or to a fraction of a colony obtained after growth (through holes showing a greater than 99% reduction in growth are identified, see paragraph [0337]) on a suitable medium (platen with 500,000 through holes, see paragraph [0336]).
Regarding claim 15, Hess discloses the characterization comprises, in addition, identification of the genus, or of the species of a population of a microorganism (e.g. Enterococcus faecium bacteria, see paragraph [0336]) deposited on the analysis zone (platen with 500,000 through holes, see paragraph [0336]).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hess as evidenced by Dahal (“Enterococcus faecalis: A Comprehensive Guide”, www.microbenotes.com/enterococcus-faecalis-overview/#, hereinafter Dahal).
Regarding claim 2, Hess discloses the pore size of the analysis zone is less than the size of the at least one microorganism to be characterized (membrane comprises pores ranging from 0.2 μm to 1 μm, see paragraph [0047]; microorganism to be characterized is Enterococcus faecium bacteria, see paragraph [0336]).
As evidenced by Dalah, the Enterococcus faecalis bacteria typically has cells in the range of 0.5 to 2 μm in diameter and elongate up to 0.6 to 2.5 μm (see Morphology of Enterococcus faecalis, first bullet point), and would therefore be larger than the disclosed pore size of Hess.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hess in view of Ramjeet et al. (US PGPub 2017/0211123, hereinafter Ramjeet).
Regarding claim 3, Hess fails to teach the plate is made at least partially of polymer covered with a layer of stainless steel.
Ramjeet teaches a MALDI analysis plate being formed by a polymer (e.g. polypropylene) coated with a layer of stainless steel (see paragraph [0067]) as a conductive surface.
Ramjeet modifies Hess by suggesting the analysis plate be made of a polymer and coated with stainless steel.
Since both inventions are drawn to MALDI analysis plates, it would have been obvious to the ordinary artisan before the effective filing date to modify Hess by using the analysis plate of Ramjeet as a simple substitution to achieve predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANWAY CHANG whose telephone number is (571)270-5766. The examiner can normally be reached Monday - Friday 7:30 AM - 4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Hanway Chang
/HC/ Examiner, Art Unit 2881
/MICHAEL J LOGIE/ Primary Examiner, Art Unit 2881