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 .
DETAILED ACTION
This application has an effective filing date May 7, 2024, with a foreign priority
application DE102023113119.2, filed May 17, 2023. Claims 1-24 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on May 19, 2026 is acknowledged. Claims 11-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 19, 2026. Claims 1-10 are under examination.
Claim Objections
Claim 8 is objected to because of the following informalities: line 8, needs to remove “to the nutrient medium (4)” as this is repeated in line 7, and appears as a typographical error. Appropriate correction is required.
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 1-10 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 recites “the controlled environment is at least one of connected by a fluid line or separable from the cleanroom” but the structural relationship between the controlled environment and the clean room is uncertain, particularly whether the claim requires the controlled environment to be connected by a fluid line, separable from the clean room, both, or either alternative, and the term “separable” lacks objective boundaries, thus is indefinite.
Claim 1 also recites “contacting the fluid flow with a nutrient medium in a controlled environment arranged outside the cleanroom”. Neither the claim nor the specification provides objective boundaries for what constitutes a ‘controlled environment’, merely describing the controlled environment as a space or section in relation to the clean room, and indicates that it may comprise a receptacle for presenting the nutrient medium, but does not identify what environmental conditions are controlled or the degree of control required. Accordingly, one of ordinary skill in the art would not be apprised of the metes and bounds of the claim.
Claim 2 recites “further comprising decontaminating an interface delimiting the controlled environment at least on an inside before the interface is made accessible for the fluid flow to be monitored”. It is unclear what “at least on an inside” is referring to as it lacks objective boundaries regarding which interior surface must be decontaminated. Furthermore, it is unclear when the interface is considered to be ‘made accessible’ and what event constitutes accessibility for the recited fluid flow. The Specification defines the interface as binding the controlled environment, such as through an opening or laterally hinged. Therefore one of ordinary skill in the art would not be able to ascertain the metes and bounds of the claim with reasonable certainty, thus is indefinite.
Claim 5 recites “The method according to claim 1, further comprising at least one of a) the discharging of the fluid flow (17) from the cleanroom (20) being at a process point within the cleanroom (20), at which a cleanroom process is carried out, or b) supplying the fluid flow (17) to the nutrient medium (4) in the fluid line (7) which runs at least partially within the cleanroom (20).”. It is uncertain whether the phrase ‘which runs at least partially within the clean room’ modifies the fluid line or another claim element, and is further unclear whether the nutrient medium is located within the fluid line or whether the fluid flow is conveyed through the fluid line to a nutrient medium located elsewhere. Figures 11 & 12 show device configurations wherein the fluid line runs partially within the cleanroom, however does not indicate the nutrient medium in the device/process, nor where the fluid flow contacts said nutrient medium. Thus, the scope of the claimed method cannot be determined with reasonable certainty, and is indefinite.
Claim 8 recites “…connecting a fluid line (7), which brings the fluid flow (17) to the nutrient medium (4), to the nutrient medium (4) after removing a closure (3) of the nutrient medium (4).”. It is unclear what the fluid line is connected to, and what constitutes the claimed ‘closure of the nutrient medium’, and the relationship between the recited connecting step and the removal of the closure, thus is indefinite. In Figure 16, it appears that a closure (3) is above the nutrient medium (4) that is contained in a nutrient medium carrier (11). However, Figure 1 shows the closure (3) vertically on the side of the apparatus, and the nutrient medium (4) and carrier (11) are located on the bottom of the apparatus, perpendicular to the closure, which does not appear to affect the fluid flow contacting the nutrient medium.
Claim 10 recites “The method according to claim 9, further comprising carrying out a particle detection in the fluid flow (17) or a further fluid flow (17) and presenting the nutrient medium (4) in the fluid flow (17) when the particle detection has detected at least one of a reproducible or living object, by at least one of diverting the fluid flow (17), opening a fluid line (7) conducting the fluid flow (17), or starting the fluid flow (17).”. The phrase “at least one of a reproducible or living objects” is grammatically incorrect and unclear, as ‘reproducible objects’ is not a recognized microbiological category, and whether ‘living’ modifies ‘objects’ independently or in combination with ‘reproducible’, furthermore there is ambiguity as to what class of detected particles satisfies this limitation. It is also unclear what is meant by “presenting the nutrient medium in the fluid flow”, and the phrase “opening a fluid line”, which both fail to identify what structure is actually used and/or opened. Therefore, one of ordinary skill in the art would not be apprised of the metes and bounds of the claim, thus is indefinite.
Claims 3-4, 6-7, and 9 are likewise rejected as being dependent on an indefinite claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Scialo et al. (WO2020102032A1, hereinafter “Scialo”).
Regarding claims 1 and 7-8, Scialo teaches particle sampling systems and methods for robotic controlled manufacturing barrier systems for automated sampling and/or analysis of controlled environments, and may be used with known particle sampling and analysis techniques and particle detection systems (title, abstract). Scialo teaches methods for reducing risk of biological contamination by monitoring particles in a fluid flow from an environment undergoing monitoring [0006, 0079]. Scialo teaches a cleanroom environment wherein a flow system is located, preferably an isolator, wherein the fluid flow, in particular an air flow, is discharged from the cleanroom [0008, 0014- 0016, 0019-0020, 0022, 0032]. Scialo teaches the fluid flow contacts a nutrient medium in a controlled environment located outside the cleanroom, preferably connected by a fluid line and/or separable from the cleanroom, wherein the nutrient medium is used for monitoring microbiological contamination [0015-0016, 0019-0020, 0022, 0032], therefore anticipates the claims. Scialo teaches the system can be further configured to close the inlet to stop fluid flow into the impactor (containing the nutrient medium) with a protection portion that may be positioned on the dispensing portion so as to occlude one or more openings, and then configured to remove the cover [0105-0106, 0116], which anticipates the limitation of connecting a fluid line to the nutrient medium after removing a closure of the nutrient medium in claim 8.
Regarding claims 2 and 4, Scialo teaches the device for monitoring the clean room comprises an enclosure enclosing the controlled environment or a receptacle presenting the nutrient medium in the controlled environment, which meets the limitation of an interface delimiting the controlled environment (Fig. 5-6, [0105-106]). Scialo teaches the system may comprise a sterilization system for sterilizing all or part of the particle detection device, and may include utilization of vaporized hydrogen peroxide, chlorine dioxide, ethylene oxide, moist heat or dry heat, thus meets the limitation of ‘supplying a decontamination agent to the controlled environment’ [0011].
Regarding claim 6, Scialo teaches an example of an optical particle counter system, wherein fluid flows through a flow system into a flow chamber, and an optical source projects a laser into the flow chamber, which generates an electric signal characteristic of the number and/or size of particles detected [0033]. Scialo teaches the particle sampling or counting device may comprise: A) a collection surface configured to receive the at least a portion of the particles in the fluid; B) a sampling head comprising one or more inlets for sampling at least a portion of the fluid under flow; and C) a base operationally connected to the sampling head to receive at least a portion of the sampled fluid from the sampling head, wherein the base comprises: a collection surface; and a fluid outlet, wherein the sampling head and the base are integrated components that engage to enclose the collection surface; and wherein the flow system is configured to contact at least a portion of the fluid under flow with the collection surface, wherein the collection surface may comprise a growth medium (e.g. agar) for receiving biological particles in the fluid under flow [0052, 0054], which anticipates passing the fluid flow through the particle counter and subsequently passing the same fluid flow to the nutrient medium.
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.
Claims 1, 3, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kiselev et al. (US20250334489A1, filed 4/25/2023, hereinafter “Kiselev”).
Regarding claims 1, 5, and 7-9, Kiselev teaches an in-line airborne microbe sampling adapter remotely sampling air of a zone of interest via a pipe, comprising a main portion comprising a housing and base portion, comprising a sampled air inlet and a first locking mechanism adapted to be switched between an open position during sampling and airtight closed position, wherein the air sampler adapter is detachable from the pipe connecting it to the zone of interest (abstract). Kiselev teaches conventional sampling units generally consist in an air microbial sampler with a nutritive petri dish (a nutrient medium in a controlled environment arranged outside the cleanroom) and are used to detect the presence of airborne microbe containing particles [0003], which is a device that performs monitoring for microbial contamination.
Kiselev teaches the invention comprises an adapter device, preferably an in-line adapter device, which allows the use and transportation of a sampling unit without risking contamination of the sampling unit or the sample source [0009-0010]. In other words, the in-line air sampler adapter 10 is used to prevent contamination of the sample in the air sampling unit 11 when transporting it from its sampling position to an isolator, thus meaning the sampling can be done in any environment, and not necessarily in a cleanroom [0031]. As disclosed in the specification, ‘fluid flow’ is an ‘air flow’ [0002] and can be used for continuous measurement, for example of the cleanroom air [0028]. Kiselev teaches conventional sampling units generally consists an air microbial sampler with a nutritive petri dish, used to detect presence of airborne microbe particles, and discloses the invention can be adapted to any kind of sampling unit including one comprising petri dish [0003, 0035]. As seen in Figure 2 of Kiselev (pg. 2), the airflow flows through the air sample inlet (14) and contacts the air sampling unit (11) within the housing (15) wherein the nutrient medium (petri dish) is located, thus meeting the limitation of contacting the fluid flow with the nutrient medium in claim 1 and claim 8.
As seen in Fig. 1 of the instant, the discharging of the fluid flow through the fluid line (7) is the same as Kiselev’s sample inlet (14), and contacting the air flow with the nutrient medium in the air sampling unit (11) is the same as contacting the fluid flow with the instant nutrient medium carrier (11). Thus, Kiselev’s device in working operation necessarily performs the clamed method steps. Similarly, Kiselev’s portable air sampling adapter device would inherently perform the limitation of ‘contacting the fluid flow with a nutrient medium in a controlled environment arranged outside the cleanroom, wherein the controlled environment is separable from the cleanroom’ in claim 1, and ‘discharging the fluid flow from the cleanroom being at a process point within the cleanroom’ in claim 5.
Kiselev teaches the in-line airborne microbe sampling adapter can be attached to a pipe comprising an air inlet from the cleanroom, and a first locking mechanism adapted to be switched between an open position during sampling, the locking mechanism comprising an upper and lower part mounted to each other via a threading mechanism, such that twisting the two parts slightly will lock/unlock them, which meets the limitation of a horizontal pivoting movement in claim 9, wherein each part comprises a bore which will allow air passage when aligned when the two parts are mounted together, and the bore closing module has the form of a sliding tongue with an opening, which can be misaligned to close the air passage (Fig 4, [0042-0044]). As shown in Figure 3, the locking mechanism (12) is attached to the sampling air inlet (14) that allows the sampling air to be transferred into the main portion of the adapter (15), wherein the air sampling unit (11) is contained, that may comprise a nutritive petri dish for microbiological detection (Fig 2-3, [0035]), thus meeting the limitation of ‘connecting a fluid line that bring the fluid flow to the nutrient medium after removing a closure of the nutrient medium’ in the configuration recited in claim 8. Furthermore, the nutritive petri dish inherently is ‘introduced into the controlled environment from the outside and positioned at a receptacle’ as recited in claim 7.
Regarding claim 3, Kiselev teaches the upper and lower parts (121, 122) are mounted together so as to provide a gap (19) between the two bore closing modules (1212, 1222) which acts as a security zone, indeed when a user wants to stop the collection and detach the adapter both bore closing module (1212, 1222) are closed and create a non-contaminated air buffer volume further protecting the inside of the housing, effectively ‘diverting’ the air flow from the air inlet/fluid line, which meets the limitation of a diverter on the fluid line (Figure 4, [0045]).
In view of the foregoing, all the claimed method limitations are obvious process steps of the normal operational use of the air sampling adapter device taught by Kiselev, and the disclosed device components implicitly disclose the process limitations as set forth in the claimed method. Therefore the claimed method is prima facie obvious over Kiselev, especially in view of Kiselev’s explicit suggestion of the air sampling unit as used to detect the presence of airborne microbe containing particles [0003].
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kiselev as applied to claims 1, 3, 5, and 7-9 above, and further in view of Scialo.
As discussed above, claims 1, 3, 5 and 7-9 are obvious over Kiselev’s air sampling adapter device. Kiselev does not teach the device further comprises a particle counter that presents the nutrient medium to the fluid flow when the particle detection has detected at least one of a reproducible or living object.
However, Scialo teaches an example of an optical particle counter system, wherein fluid flows through a flow system into a flow chamber, and an optical source projects a laser into the flow chamber, which generates an electric signal characteristic of the number and/or size of particles detected, flowing at least a portion of the fluid through the flow chamber of the optical particle counter, determining the number and/or size of particles based on the electric signal, wherein at least one of the providing step or the flowing step is performed by a system configured for robotic control [0033]. Scialo teaches the particle sampling or counting device may comprise: A) a collection surface configured to receive the at least a portion of the particles in the fluid; B) a sampling head comprising one or more inlets for sampling at least a portion of the fluid under flow; and C) a base operationally connected to the sampling head to receive at least a portion of the sampled fluid from the sampling head, wherein the base comprises: a collection surface; and a fluid outlet, wherein the sampling head and the base are integrated components that engage to enclose the collection surface; and wherein the flow system is configured to contact at least a portion of the fluid under flow with the collection surface, wherein the collection surface may comprise a growth medium (e.g. agar) for receiving biological particles in the fluid under flow [0052, 0054], which meets the limitation of passing the fluid flow through the particle counter and subsequently passing the same fluid flow to the nutrient medium.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus for monitoring microbiological contamination with an in-line airborne microbe sampling adapter taught by Kiselev, by integrating a particle counter to detect particles in the fluid flow, and robotically controlling the flowing step when particles are detected as taught by Scialo. One of ordinary skill in the art would have been motivated to integrate the particle detection system taught by Scialo into the air sampling adapter device taught by Kiselev, as the incorporation of detecting airborne particles in the air sampling device would provide useful data in evaluating contamination. Further it would have been obvious to incorporate a flow controlling step based on particle detection by opening the fluid line of the air sampling adapter for presentation to the nutrient medium contained in the sampling unit for microbiological contamination monitoring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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