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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-3, 6, 8-11, 13-15, and 24-26 in the reply filed on 5/14/2026 is acknowledged.
Claims 16-18, 20-21, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/14/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. The following terms use the word “means,” are being interpreted under 112(f), and will be understood to cover their corresponding structure disclosed in the specification (shown italicized and in parentheticals) and all equivalents thereof:
Claim 1, “housing means for containers for biological samples” (understood to be a drilled plate with through holes, page 36, lns. 1-5).
Claim 1, “handling means…which are suitable for conveying the containers for biological samples” (a guide which can allow the supporting frame of housing to be conveyed, page 14, lns. 3-6) .
Claim 1, “means for drying containers for biological samples” (understood to be nozzles for dispensing a gas flow such as compressed gas, page 8, lns. 6-14).
Claim 1, “means for dispensing a biocidal fluid” (understood to be a plurality of atomizer nozzles, page 6, lns. 25-28).
Claim 8, “means for packaging containers for biological samples” (understood to be vacuum gripper with suction cups, page 33, lns. 26-27).
Claim 9, “sterilization means for a secondary container…suitable for sterilizing the surface of said secondary container” (understood to be ultraviolet light lamps, page 10, lns. 18-20).
Claim 14, “means for transferring containers for biological samples” (understood to be a gripper, such as a vacuum gripper, page 16, lns. 13-17).
Claim 15, “scanning means suitable for reading labels or tags” (understood to be optical scanners, page 21, lns. 21-23).
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.
Claim(s) 1-3, 10, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marchau et al. (US 6562281 B1).
Regarding claim 1, Marchau teaches a system for the automated sanitization of containers for biological samples (abstract, Fig. 5, system 1), comprising:
housing means for containers for biological samples (Fig. 5, wheel 6 moves preform containers 3),
a sanitization route having an inlet opening and an outlet opening (Fig. 5, carrying is device 2 connected to an inlet that introduces preformed containers while they are moved along a sanitization route towards an outlet and removed by means 111, col. 6, lns. 6-10),
handling means of said housing means, which are suitable for conveying the containers for biological samples along said sanitization route (Fig. 5, semi-circular guide 61 is part of housing means 6 and helps convey preforms 3 along a sanitization route, col. 3, lns. 53-55).
a sanitization chamber (Fig. 2, busses 41-44 are understood to be a sanitization chamber for providing biocidal fluid, col. 3, lns. 59-65) and
means for drying containers for biological samples (Fig. 5, heating means 100 comprise a furnace that is understood to be means for drying, col. 3, lns. 50-65),
said sanitization chamber comprising means for dispensing a biocidal fluid (col. 3, lns. 59-65, means can be a plurality of sprayers, col. 4, lns. 22-25).
Regarding claim 2, Marchau teaches the system according to claim 1, wherein said means for dispensing a biocidal fluid are placed upstream of said means for drying containers for biological samples along said sanitization route (col. 3, lns. 59-65), said system comprising a drying chamber wherein said means for drying containers for biological samples are placed (Fig. 5, heating means 100 comprise a furnace that is understood to be a chamber for drying, col. 3, lns. 50-65).
Regarding claim 3, Marchau teaches the system according to claim 1, wherein said means for dispensing a biocidal fluid are a plurality of atomizer nozzles (means for dispensing comprises a sprayer 45 which is understood to comprise a plurality of atomizer nozzles, col. 4, lns. 22-25, col. 5, lns. 3-10).
Regarding claim 10, Marchau teaches the system according to claim 1, wherein said housing means for containers for biological samples comprise a drilled plate comprising through holes which are suitable for receiving containers for biological samples, said through holes being dimensioned to receive a single container for biological samples (Fig. 5, wheel 6 has notches 60 configured to receive a single container 3, col. 5, lns. 55-65 = understood to be a drilled plate with through holes).
Regarding claim 13, Marchau teaches the system according to claim 1, wherein said system comprising comprises a loading zone placed close to said inlet opening of said sanitization route, said loading zone being suitable for allowing to temporarily house containers for biological samples before placing them in said housing means (Fig. 5, carrying device 2 is adjacent to inlet opening of sanitization route and temporarily houses preforms 3 before conveying them to housing means 6 = understood to be a loading zone).
Regarding claim 14, Marchau teaches the system according to claim 13, comprising wherein said system comprises means for transferring containers for biological samples, which are suitable for transferring containers for biological samples from said loading zone to said housing means (Fig. 5, carrying device 2 is a conveyor which transfers preforms 3 from loading zone to housing means 6, col. 5, lns. 43-45).
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.
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.
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) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Marchau et al. (US 6562281 B1) in view of SPRAYING SYSTEMS Co. (spec sheet provided as Non-Patent Literature).
Regarding claim 6, Marchau teaches the system according to claim 3, wherein said atomizer nozzles allow jets of biocidal fluid to be dispensed (col. 5, lns. 3-10), wherein the atomizer nozzles may be the “Autojet” brand sold under reference number 28JJAU by SPRAYING SYSTEMS Co. However, Marchau does not explicitly teach wherein said jets having a jet opening angle between 60° and 90 °.
One having ordinary skill in the art would be concerned with identifying the optimal spray characteristics to apply a biocide said containers, motivating one to turn towards SPRAYING SYSTEMS Co., who teaches the nozzle head under the reference number 28JJAU to be available in a 45° or a 75° configuration (see attached spec sheet). It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to select the 75° spray nozzle as taught by SPRAYING SYSTEMS Co., since it was recognized as a selection from a finite number of potential spray heads compatible with the system of Marchau and would yield a predictable result (directing an atomized stream of biocidal solution towards a container) with a reasonable expectation of success. See MPEP 2143(I)(E).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Marchau et al. (US 6562281 B1) in view of Lejeune et al. (US 20120273694 A1).
Regarding claim 11, Marchau teaches the system according to claim 10, comprising a housing means with a drilled plate with through holes (Fig. 5, wheel 6 has notches 60 configured to receive a single container 3, col. 5, lns. 55-65 = understood to be a drilled plate with through holes) wherein said through holes are longitudinally aligned along the length of said drilled plate (Fig. 5, through holes understood to be longitudinally aligned alongside length of drilled plate) but does not teach wherein said drilled plate has an oblong shape, and said drilled plate comprising two portions which can be separated from each other along a separation line defined by the horizontal symmetry axis of said oblong shape.
One having ordinary skill in the art would be concerned with further supporting the containers as they move through the system, motivating them to turn towards Lejeune. Lejeune teaches a treatment system for containers comprising a rectangular upper plate and lower plate configured to support containers as they move through the system (Fig. 5, rectangular upper plate 104 and lower plate 105 are understood to be two oblong, separable portions that support containers, [0056]).
Lejeune is considered analogous to the claimed invention since both are drawn to container treatment systems. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the drilled plate as taught by Marchau with the separable, oblong, plates as taught by Lejeune to increase support for the containers as they move through the treatment system and this involves the combination of elements (drilled plate of Marchau and the support plates of Lejeune) to yield a predictable result (an oblong upper and lower drilled plate configured to support containers) with a reasonable expectation of success. See MPEP 2143(I)(A).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Marchau et al. (US 6562281 B1) in view of Swart et al. (US 20020159917 A1) (disclosed in Applicant’s IDS filed 10/13/2023).
Regarding claim 15, Marchau teaches the system according to claim 1, including a control system and sensors coupled to a sprayer to detect the arrival of the containers prior to beginning spray operations (col. 5, lns. 30-34, 56-58) but does not teach wherein said system comprises scanning means suitable for reading labels or tags present on said containers for biological samples.
One having ordinary skill in the art would be concerned with further identifying the containers and detailing how many cycles to run, motivating one to turn towards Swart. Swart teaches a system for the disinfection of medical instruments, including a control apparatus coupled to a sprayer, wherein the control apparatus can include a bar code reader that reads a bar code on a rack or object, which details the cycles to run for that rack or object [0064].
Swart is considered analogous to the claimed invention since both are drawn to disinfection apparatuses. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the control system and sensors as taught by Marchau with the control apparatus and bar code reader as taught by Swart because Swart teaches the bar code reader to read a bar code on a rack or object, which details the cycles to run for that rack or object [0064] and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Claim(s) 8-9 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Marchau et al. (US 6562281 B1) in view of Nicoletti (WO 2012007056 A1).
Regarding claim 8, Marchau teaches the system according to claim 1, but does not teach wherein the system comprises a packaging zone comprising means for packaging containers for biological samples, said means for packaging being suitable for packaging containers for biological samples in a secondary container for the transportation of containers for biological samples.
One having ordinary skill in the art would be concerned with preparing the containers for transport while maintaining their sterility, motivating one to turn towards Nicoletti. Nicoletti teaches a system for the packaging and sterilization of primary containers contained within secondary containers, wherein the primary containers are glass containers for pharmaceutical use (page 9, para 1). Nicoletti teaches the primary containers to be washed then transferred to a sterile environment (understood to be a packaging zone) where they are placed into a secondary container (Fig. 3, tray 9 understood to be packaging means) where they are nested (page 9, para 2) and sealed within the secondary container (page 10, para 1-3). The secondary container is then subsequently sterilized before transport to another site (page 11, para 1-2).
Marchau and Nicoletti are considered analogous to the claimed invention since both are drawn to the sterilization of pharmaceutical containers. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the automated sanitization system as taught by Marchau with the packaging zone and means downstream of the container outlet as taught by Nicoletti because Nicoletti teaches the packaging means to organize pre-washed packages in a secondary container (page 9, para 2), seal them against contamination (page 10, para 1-3), and prepare them for sterile transport to another site (page 10, para 1-3) for further operations and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Regarding claim 9, Modified Marchau teaches the system according to claim 8, comprising a sterilization chamber for a secondary container for the transportation of containers for biological samples, said sterilization chamber comprising sterilization means for a secondary container for the transportation of containers for biological samples suitable for sterilizing the surface of said secondary container for the transportation of containers for biological samples (Nicoletti, secondary containers are understood to be housed in a sterilization chamber suitable for sterilizing the external surface of the secondary container, page 11, para 1-2).
Regarding claim 24, Modified Marchau teaches the system according to claim 8, wherein said means for packaging are suitable for air-tight sealing said secondary container for the transportation of containers for biological samples (Nicoletti, page 10, para 1-3).
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Marchau et al. (US 6562281 B1) in view of Nicoletti (WO 2012007056 A1), as applied to claim 8 above, further in view of Graff (US 20130284309 A1).
Regarding claim 25, Modified Marchau teaches the system according to claim 8, but does not teach wherein said system comprises a separation element, placed downstream of said sanitization chamber and upstream of said packaging zone along said sanitization route, said separation element acting as a barrier for said biocidal fluid.
One having ordinary skill in the art would be concerned with excess biocidal fluid from being emitted from the spraying elements and coating other parts of the system, motivating one to turn towards Graff. Graff teaches a filling machine for filling bottles with a liquid filling material [0016] comprising empty containers (Fig. 3, 2) conveyed by a conveyor (Fig. 3, 8) and filled via a spray nozzle assembly (Fig. 5, 13). Graff teaches wherein vertical separating panels can be positioned between the filling positions and shield each container from being sprayed when it is not positioned to do so [0023].
Graff is considered analogous to the claimed invention since both are drawn to the container filling and conveying arts. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system as taught by Modified Marchau with the separating walls as taught by Graff to be positioned between the sanitization chamber and packaging zone because Graff teaches the wall to prevent the undesired spraying of containers on a conveying belt [0023] and this involves the combination of elements to yield a predictable result with a reasonable expectation of success. See MPEP 2143(I)(A) and 2143(I)(G).
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Marchau et al. (US 6562281 B1) in view of Nicoletti (WO 2012007056 A1), as applied to claim 9 above, further in view of Clark et. al (US 20030155531 A1).
Regarding claim 26, Modified Marchau teaches the system according to claim 9, including a sterilization means for sterilizing a secondary container (Nicoletti, secondary containers are understood to be housed in a sterilization chamber suitable for sterilizing the external surface of the secondary container, page 11, para 1-2) but does not teach wherein said sterilization means for a secondary container for the transportation of containers for biological samples are ultraviolet light lamps.
One having ordinary skill in the art would be concerned with how to sterilize the contents of the secondary packaging, motivating one to turn towards Clark. Clark teaches a system for sterilizing the exterior surface of a package [0065], comprising a conveying line (Fig. 3, rollers 15) configured to move a package through a forming, filling, and sealing apparatus before being sterilized with a plurality of UV lights within a sterilization chamber (Fig. 3, 18. [0065-0068], [0096-0097]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the sterilization means as taught by Modified Marchau with the sterilization chamber and UV lights as taught by Clark because Clark teaches the chamber and lights to effectively sterilize the exterior of a package [0065]. See MPEP 2143(I)(G).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nebyate Seged whose telephone number is (703)756-4611. The examiner can normally be reached M-F 8-5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.S.S./Examiner, Art Unit 1758
/SEAN E CONLEY/Primary Examiner, Art Unit 1799
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