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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Italy on 1/24/2023. It is noted, however, that applicant has not filed a certified copy of the IT102023000000960 application as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of claims 1-6 and 11 in the reply filed on 4/12/2024 is acknowledged. Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claim 11 is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because of the limitation “separation means” in line 4 of the claim, which is not further modified by sufficient structure, material, or acts for performing the claimed function. As such, “separation means” being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, “separation means” is interpreted as at least two opposing separation walls and the overall dimensions of the treatment machines (pg. 13 lines 18-23: The separation means 205 of each area 201, 202, 203 can be defined by at least two opposing separation walls 206 and by the overall dimensions of the treatment machines 16, 17, 18, 19, 20 associated with the separation walls 206. Specifically, the treatment machines 16, 17, 18, 19, 20 substantially constitute a communication interface between the first area 201 and the second area 202, and between the second area 202 and the third area 203).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
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, 3-4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen (US 20180318458 A1, provided in Applicant’s IDS of 1/23/2024) in view of Hess (AU 2021266596 A1).
Regarding claim 1, Rasmussen teaches
A treatment plant for treating objects comprising a plurality of pre-treatment stations (abstract: pre-processing stations with tables for the pre-washing),
a plurality of pick-up benches for picking up baskets containing pre-treated objects, associated with said pre-treatment stations (abstract: pick-up points at the pre-processing stations for pick-up of the baskets with the pre-washed and/or sorted articles),
a plurality of treatment machines (abstract: a plurality of washers),
and at least one mobile unmanned shuttle (abstract: One or more unmanned vehicles)
provided on board with a first control device for receiving and executing movement information relating to least one path between said pick-up benches and respective inlet apertures of said treatment machines (par. 45: The vehicles 150 are each provided with the aforementioned sensors at least at the front end 152 thereof (see FIG. 3a) and carry an on-board control device OBCD for receiving and executing mission information, i.e. information about a path, normally a two-dimensional path, along which the vehicle 150 should move, such as within a digital map representing a facility floor plan similar to that of FIG. 2a, as well as data representing operation of the basket shifting device described further below; par. 47: From each washer 118 the vehicle 150 receives data, directly or indirectly via a main control unit, preferably by wireless communication and preferably continuously, representing information about the status of the washing cycle carried out by the respective washer 118. Based on this information the on-board control device OBCD directs, or is instructed to direct, the vehicle 150 across the floor towards a washer 180 which is either ready to receive the basket 116, or which first will be ready to receive the basket 116, following which the vehicle 150 moves to the position shown in FIG. 3b in front of that washer 118),
said treatment plant comprising a supervision system (par. 60: As shown in FIG. 2c one or more further unmanned vehicles 150′ are preferably in a similar manner requested to travel on the floor of the clean area C from the outlet opening/extraction doors of the washers 118 upon conclusion of a washing cycle, using third type control devices 105′ (not shown in details) also allowing manual input of requests by the operators 101 and located at the processing stations 115″ in the clean area C)
but does not teach
provided with visual acquisition means connected to a central control unit which is communicating at least with said first control device, said visual acquisition means being configured to frame at least said pick-up benches in order to acquire visual information about a pick-up condition of a basket provided with pre-treated objects which is present on one of said pick-up benches, wherein said central control unit is configured to receive and process both said visual information and also information on the availability status of said treatment machines, to generate said movement information in order to command said movement of said at least one shuttle.
Rasmussen already teaches that the specific contents of the baskets may be sterilized in different washers according to each type of medical instrument (par. 38: The facility 10 comprises seven washers 18, each of which may be arranged for processing a different type of medical instrument. That is, one washer 18 may be arranged for processing respiratory therapy equipment, and another may be arranged for processing instruments used in laparoscopic surgery. Still another of the washers 18 in the facility 10 may be arranged for processing flexible fiber optic scopes). Rasmussen also teaches sorting the instruments (abstract: pre-processing stations with tables for the pre-washing and/or sorting by a human operator). As such there is motivation to improve the device of Rasmussen by adding a convenient means of tailoring the sterilization according to each instrument.
Hess teaches a similar system for the automated sterilization of items received from transport containers (abstract: Proposed is a disinfection apparatus for the automatic disinfection of a transport container (2) which is intended for the transport of one or more inspection objects through an inspection system (10); Fig. 2). Hess teaches wherein the transport containers (likened to the baskets of Rasmussen) have identification features that can be visually scanned by a system which then allows for selective disinfection of the contents of the container (pg. 6 lines 23-28: To be able to be individually identified and thus selectively disinfected, the individual transport containers can be equipped with an identification feature that can be detected without contact and thus at a distance, for example an optically recognizable coding (a bar code or QR code marking) or an identification unit that can be read by radio (e.g., an RFID transponder). This allows, for example, the frequency of use of each transport container to be individually recorded and likewise individual disinfection/cleaning to be triggered, for example after a specified number of uses). This reads on a supervision system having a visual acquisition means for determining a pick-up condition.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control system which communicates with the individual unmanned vehicles of Rasmussen to have a visual scanner configured to scan a code on the baskets at pick-up and subsequently determine a disinfection treatment for the contents of the basket, as taught by Hess, in order to tailor the disinfection treatment for different types of medical instruments and thus maximize sterilization effectiveness.
Regarding claim 3, Rasmussen modified by Hess teaches the treatment plant as in claim 1, as set forth above, and teaches wherein, in order to communicate with at least said central control unit, said first control device is provided with a communication interface and said treatment machines each comprise second control devices provided with respective communication interfaces (par. 47: From each washer 118 the vehicle 150 receives data, directly or indirectly via a main control unit, preferably by wireless communication; NOTE: each of the controllers must necessarily have a communication interface to receive data).
Regarding claim 4, Rasmussen modified by Hess teaches the treatment plant as in claim 1, as set forth above, and teaches wherein visual indication means are associated with said pick-up benches and/or with each basket (see Hess modification in claim 1 rejection), to indicate the presence of a basket (NOTE: the code being scanned would by default indicate the presence of a basket), loaded on the respective pick-up bench, in said pick-up condition, and wherein said visual acquisition means are also able to detect the indication of said visual indication means to obtain information usable for said central control unit (see Hess modification in claim 1 rejection).
Regarding claim 6, Rasmussen modified by Hess teaches the treatment plant as in claim 1, as set forth above, and teaches wherein said indication means are coding elements which are associated with respective baskets, and which are readable and/or detectable by said visual acquisition means in order to give an indication of said pick-up condition of a corresponding basket (see Hess modification in claim 1 rejection).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen modified by Hess in view of Zardini (US 20180318458 A1, provided in Applicant’s IDS of 1/23/2024).
Regarding claim 11, Rasmussen modified by Hess teaches A treatment center for carrying out the complete treatment of pre-washing, washing, thermal disinfection and sterilization of objects, which comprises at least a first septic area, wherein said first area is defined by a plant as in claim 1 (see claim 1 rejection), wherein said pre-treatment stations are stations for pre-washing said objects (abstract: pre-processing stations with tables for the pre-washing) and said treatment machines are machines for washing said already pre-washed objects (abstract: a plurality of washers… for washing the pre-washed and/or sortied articles),
But does not teach
and thermally disinfecting
a second clean area, and a third sterile area, which are separated from each other by separation means,
and wherein said second area is defined by another plant as in claim 1, wherein said pre-treatment stations are stations for packaging said washed and thermo-disinfected objects and said treatment machines are machines for sterilizing said objects, in order to prepare them for a subsequent storage in said third area.
Zardini teaches an automated washing system with pre-wash stations and wash stations wherein the wash stations also use heat disinfection (abstract: Washing plant to perform a washing cycle of objects providing at least a pre-wash operation and a washing and heat disinfecting the objects operation. The plant includes a first battery of pre-wash units, in series one after the other along a first alignment axis and a second battery of washer and heat disinfection machines along a second alignment axis). Adding heat disinfection improves sterilization effectiveness.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the washers of Rasmussen modified by Hess to utilize heat disinfection, as taught by Zardini, in order to further improve sterilization effectiveness.
Rasmussen modified by Hess and Zardini does not teach a second clean area, which are separated from each other by separation means,
and wherein said second area is defined by another plant as in claim 1, wherein said pre-treatment stations are stations for packaging said washed and thermo-disinfected objects and said treatment machines are machines for sterilizing said objects
However, having a second area is a mere duplication of parts for multiplied sterilization productivity.
However, absent a showing of significant or unexpected results, the duplication of the entire treatment facility of Rasmussen modified by Hess and Zardini is prima facie obviousness and does not further modify the operation of the invention, and further does not add patentable significance. The Manual of Patent Examining Procedures discloses that in In re Harza, 274, F.2d 669, 124 USPQ 378 (CCPA 1960), a mere duplication of parts for a multiplied effect has no patentable significance unless a new and unexpected result is produced. As such, the duplication of the treatment facility does not create a patentable distinction over the reference of Rasmussen modified by Hess and Zardini. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Rasmussen modified by Hess and Zardini to have another treatment facility juxtaposed alongside the first one, with a reasonable expectation that more dirty items can be processed at the same time. The walls of the treatment facility and the bodies of the washers adjacent to the walls (Fig. 1b, 1c) would serve as the separation means.
Rasmussen modified by Hess and Zardini does not teach a third sterile area for storage.
Zardini teaches an area downstream of the sterilization area for storing or returning sterilized items to the operating room (par. 12: The objects thus sterilized pass to the subsequent third sterile sector where they are stored or returned to the operating room for use), which is relevant since Rasmussen is also directed towards sterilizing medical instruments from operating rooms for reuse (par. 3: n the dirty area, trays with dirty medical devices are received in containers or the like from the operating rooms).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment facility of Rasmussen modified by Hess and Zardini to have a sterile sector, as taught by Zardini, in order to store sterilized items prior to reuse in operating rooms.
Allowable Subject Matter
Claims 2 and 5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 2, Rasmussen modified by Hess teaches the treatment plant as in claim 1, as set forth above, but does not teach wherein said visual acquisition means, comprising at least one video camera, are configured to also frame said treatment machines in order to acquire information on the availability status thereof usable for said central control unit.
The secondary reference, Hess, does not teach a video camera, and furthermore, it would not be obvious to modify Rasmussen to use a video camera to determine the availability status of the washers. This is because Rasmussen teaches an automated system for determining the availability of the washers based on an internal indication of the status of the washing cycle (par. 41: When the washer 18 has finished a washing programme and is ready to receive a new batch for washing, a mechanical transferring device may automatically transfer the basket 16 on the associated platform 20 into the washer 18; claim 6: receiving data representing information about the status of the washing cycle carried out by the respective washers, shifting a basket containing articles to be washed to said loading platform structure of said vehicle arrived at said pick-up point (WP-x), and directing said vehicle towards the washer which is either ready to receive a basket for washing, or which first will be ready to receive a basket, based on said received information).
Regarding claim 5, Rasmussen modified by Hess teaches the treatment plant as in claim 4, as set forth above, but does not teach wherein said indication means are status light elements associated with said pick-up benches and configured to selectively emit a light radiation able to indicate said pick-up condition of a corresponding basket.
Furthermore, the secondary reference, Hess, does not teach wherein the indication means are status light elements configured to emit a light radiation able to indicate a pick-up condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGRU CHEN whose telephone number is (571)272-1201. The examiner can normally be reached Monday-Friday 7:30-5:30.
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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