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 .
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.
Regarding claim 10, “pumping means” is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, “pumping means” is interpreted to be a pump in light of Applicant’s Specification pg. 10 lines 30-31 (Optionally, the system includes a pump for reducing a gas pressure inside the container prior to closing the container).
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “tamper evidence feature” in claim 15. Because this claim limitations is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. However, Applicant’s Specification does not provide enough structure or materials to further define “tamper evidence feature”.
Regarding claim 20, “pumping means” is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, “pumping means” is interpreted to be a pump in light of Applicant’s Specification pg. 10 lines 30-31 (Optionally, the system includes a pump for reducing a gas pressure inside the container prior to closing the container).
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 § 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 2, 5-6, 8 and 15 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.
Regarding claim 2, “the further opening” lacks antecedent basis.
Regarding claim 5, “the first chamber” and “the second chamber” lack antecedent basis. For the purposes of examination, claim 5 is interpreted to depend on claim 4.
Regarding claim 6, “the label” lacks antecedent basis.
Regarding claim 8, “the optional further lid” lacks antecedent basis. For the purposes of examination, claim 8 is interpreted to depend on claim 7.
Regarding claim 15, it is unclear what structure or material is meant by “tamper evidence feature” especially since under 35 U.S.C. 112(f) interpretation, Applicant’s Specification does not provide enough structure or materials to further define this term.
Claim Rejections - 35 USC § 102
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 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 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (US 20080236631 A1).
Regarding claim 11, Lin teaches A reprocessing container for holding a reusable medical instrument, including:
- a tray (Fig. 4B: tray formed by side walls 109) including:
- an inner space (Fig. 4: interior of container 100);
- one or more supports for supporting one or more medical instruments (par. 31: A grid 24 rests slightly above the bottom 14 and supports one or more instrument receiving baskets 26);
- a first opening at a first side for inserting a medical instrument into the inner space through the first opening (Fig. 4C: opening covered by top 102); and
- a first lid for closing the first opening (Fig. 4C: top 102).
Regarding claim 12, Lin teaches the container of claim 11, as set forth above, and teaches further including a second opening at a second side opposite to the first side (Fig. 4C: opening covered by bottom 104), and a second lid for closing the second opening (Fig. 4C: bottom 104).
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 1-4, 7-9, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lin.
Regarding claim 1, Lin teaches a system for reprocessing a reusable medical instrument, (abstract: A method and apparatus provide for automatically cleaning and decontaminating medical instruments; par. 2: After use reusable medical instruments must be both washed and then sterilized before they can be reused) including a decontamination device and a container,
- the container including a tray and a lid, the tray including one or more supports for supporting one or more medical instruments (par. 31: A grid 24 rests slightly above the bottom 14 and supports one or more instrument receiving baskets 26. Both the grid 24 and baskets 26 are preferably formed from a mesh having large enough holes to freely pass cleaning solution and may be formed of stainless steel, aluminum, polyethylene, polypropylene, or styrene, TEFLON polytetrafluoroethylene and other suitable materials)
the tray having an opening for inserting therethrough the one or more medical instruments into an inner space of the tray, and the lid being arranged for closing the opening; (Fig. 4A: container 100 with lids 102 and 104);
- the decontamination device including:
- an entrance for inserting the container into the decontamination device (abstract: inserting the sealed container into a washer/decontaminator and sealing the washer/decontaminator);
- a container handler arranged for holding the container in the decontamination device (Fig. 5: chamber 110, retaining members 112, lifting rods 114; par. 37: Retaining members 112 fit within the flanges 108 to position the container 100 within the chamber 110);
- a decontamination unit arranged for decontaminating the tray, the lid and the medical instrument (par. 33: Line 76 connects to the chamber inlet 58 and also to a vacuum pump 78, a germicide injection system 80; abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; and e) the washer/decontaminator automatically applying a disinfectant to the container); and
- wherein the container handler is arranged for holding the lid positioned away from the opening while decontaminating; and wherein the container handler is arranged for closing the container by closing the lid onto the tray after decontamination (par. 37: Upper lifting rods 114 and lower lifting rods 116 are provided for controlling opening and closing of the top 102 and bottom 104. In all other respects the container 100 and chamber 110 operate as in the previous embodiment with the added advantage of the bottom 104 being able to be removed during the process to enhance access of the cleaning fluid to the instruments during the cleaning procedure; abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; and e) the washer/decontaminator automatically applying a disinfectant to the container to disinfect the instruments whereby to allow safe handling thereof by personnel; par. 7: Preferably, the lid is closed after step e)), but does not teach
- an exit for removing the closed container containing the decontaminated medical instrument from the decontamination device. Lin teaches removing the closed container (par. 36: After the sterilization is completed, the lid 18 and drain 20 are all closed and the container is ready to be removed from the chamber 40) but does not teach an exit separate from the entrance for the embodiment shown in Fig. 4.
Lin teaches wherein a cleaning area and/or sterilization area has an exit for the transfer of a container between stations, such that the container receives sterilization after cleaning or packaging after sterilization (Fig. 11-12; par. 44: After the washing cycle the partition 188 is opened, the basket 192 is pushed via an actuator 208 into the sterilization section 186 and the partition 188 closed; par. 47: Optionally, the packaging area and sterilization area can be separated with a removable divider. If packaging is not required, then the sterilization process may only occur in the sterilization area. Optionally, the packaging area may be located on the same level as the cleaning area and sterilization area. The packaging area may be located between cleaning area and sterilization area, or after the sterilization area).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber of the Fig. 4 embodiment of Lin to have an exit that allows removal of the container, as taught by Lin, so that after sterilization, the container is transferred into another station for packaging or further cleaning.
Regarding claim 2, Modified Lin teaches the method of claim 1, as set forth above, and teaches wherein the container handler is arranged for maintaining the tray in an upright position with the opening extending in an upright plane, and optionally the further opening extending in a further upright plane, while decontaminating (par. 37: Retaining members 112 fit within the flanges 108 to position the container 100 within the chamber 110; Fig. 5: the position the container is in is interpreted to be an upright position and the opening is interpreted to be in an upright plane).
Regarding claim 3, Modified Lin teaches the method of claim 1, as set forth above, and teaches wherein the container is arranged to be inserted into the decontamination device while the container is in a non-sealed state (NOTE: this is a recitation of intended use; the container of Lin would be capable of being inserted into the chamber in a non-sealed state by manually opening the container and inserting it, at least partially, into the chamber).
Regarding claim 4, Modified Lin teaches the method of claim 1, as set forth above, but does not teach wherein the decontamination device includes a first chamber and a second chamber, wherein the container handler is arranged for transporting the container from the first chamber to the second chamber, wherein the decontamination device is arranged for performing a first decontaminating in the first chamber and a second decontaminating in the second chamber.
Lin teaches wherein a cleaning area and/or sterilization area has an exit for the transfer of a container between stations, such that the container receives sterilization after cleaning (Fig. 11-12; par. 44: After the washing cycle the partition 188 is opened, the basket 192 is pushed via an actuator 208 into the sterilization section 186 and the partition 188 closed).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber of the Fig. 4 embodiment of Modified Lin to consist of two chambers wherein the container can be transferred to the second chamber, via an actuator, for sterilization after a washing cycle in the first chamber as taught by Lin, in order to administer more phases of sterilization for more thorough sterilization.
Regarding claim 7, Modified Lin teaches the method of claim 1, as set forth above, and teaches wherein the container includes a further lid, the tray having a further opening, preferably opposite the first opening;
- wherein the container handler is further arranged for holding the further lid positioned away from the further opening while decontaminating; and wherein the container handler is further arranged for closing the container by closing the further lid onto the tray after decontamination (Fig. 4A-4C: bottom 104; Fig. 5A-5B: lower lifting rods 116; par. 37: Upper lifting rods 114 and lower lifting rods 116 are provided for controlling opening and closing of the top 102 and bottom 104. In all other respects the container 100 and chamber 110 operate as in the previous embodiment with the added advantage of the bottom 104 being able to be removed during the process to enhance access of the cleaning fluid to the instruments during the cleaning procedure; abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; and e) the washer/decontaminator automatically applying a disinfectant to the container to disinfect the instruments whereby to allow safe handling thereof by personnel; par. 7: Preferably, the lid is closed after step e)).
Regarding claim 8, Modified Lin teaches the method of claim 1, as set forth above, and teaches wherein the entrance is arranged for receiving the container while the lid, and the optional further lid, is closed onto the tray (abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; NOTE the container would have to be closed when it is fully inserted in order to be opened by the device and thus the entrance is arranged to receive the closed container).
Regarding claim 9, Modified Lin teaches the method of claim 8, as set forth above, and teaches wherein the container handler is arranged for removing the lid from the opening, and optionally removing the further lid from the further opening, prior to decontamination (par. 73: Step 3; Opening the lid. Optionally, the bottom can be opened; par. 74: Step 4: Cleaning the load, container and lid; par. 37: Upper lifting rods 114 and lower lifting rods 116 are provided for controlling opening and closing of the top 102 and bottom 104).
Regarding claim 16, Lin teaches a decontamination device for reprocessing a reusable medical instrument, (abstract: A method and apparatus provide for automatically cleaning and decontaminating medical instruments; par. 2: After use reusable medical instruments must be both washed and then sterilized before they can be reused) in a container:
- the container including a tray and a lid, the tray including one or more supports for supporting one or more medical instruments (par. 31: A grid 24 rests slightly above the bottom 14 and supports one or more instrument receiving baskets 26. Both the grid 24 and baskets 26 are preferably formed from a mesh having large enough holes to freely pass cleaning solution and may be formed of stainless steel, aluminum, polyethylene, polypropylene, or styrene, TEFLON polytetrafluoroethylene and other suitable materials)
the tray having an opening for inserting therethrough the one or more medical instruments into an inner space of the tray, and the lid being arranged for closing the opening; (Fig. 4A: container 100 with lids 102 and 104);
- the decontamination device including:
- an entrance for receiving the container into the decontamination device (abstract: inserting the sealed container into a washer/decontaminator and sealing the washer/decontaminator);
- a container handler arranged for holding the container in the decontamination device (Fig. 5: chamber 110, retaining members 112, lifting rods 114; par. 37: Retaining members 112 fit within the flanges 108 to position the container 100 within the chamber 110);
- a decontamination unit arranged for decontaminating the tray, the lid and the medical instrument (par. 33: Line 76 connects to the chamber inlet 58 and also to a vacuum pump 78, a germicide injection system 80; abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; and e) the washer/decontaminator automatically applying a disinfectant to the container); and
- wherein the container handler is arranged for holding the lid positioned away from the opening while decontaminating; and wherein the container handler is arranged for closing the container by closing the lid onto the tray after decontamination (par. 37: Upper lifting rods 114 and lower lifting rods 116 are provided for controlling opening and closing of the top 102 and bottom 104. In all other respects the container 100 and chamber 110 operate as in the previous embodiment with the added advantage of the bottom 104 being able to be removed during the process to enhance access of the cleaning fluid to the instruments during the cleaning procedure; abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; and e) the washer/decontaminator automatically applying a disinfectant to the container to disinfect the instruments whereby to allow safe handling thereof by personnel; par. 7: Preferably, the lid is closed after step e)), but does not teach
- an exit for removing the closed container containing the decontaminated medical instrument from the decontamination device. Lin teaches removing the closed container (par. 36: After the sterilization is completed, the lid 18 and drain 20 are all closed and the container is ready to be removed from the chamber 40) but does not teach an exit separate from the entrance for the embodiment shown in Fig. 4.
Lin teaches wherein a cleaning area and/or sterilization area has an exit for the transfer of a container between stations, such that the container receives sterilization after cleaning or packaging after sterilization (Fig. 11-12; par. 44: After the washing cycle the partition 188 is opened, the basket 192 is pushed via an actuator 208 into the sterilization section 186 and the partition 188 closed; par. 47: Optionally, the packaging area and sterilization area can be separated with a removable divider. If packaging is not required, then the sterilization process may only occur in the sterilization area. Optionally, the packaging area may be located on the same level as the cleaning area and sterilization area. The packaging area may be located between cleaning area and sterilization area, or after the sterilization area).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber of the Fig. 4 embodiment of Lin to have an exit that allows removal of the container, as taught by Lin, so that after sterilization, the container is transferred into another station for packaging or further cleaning.
Regarding claim 17, Modified Lin teaches the method of claim 16, as set forth above, and teaches wherein decontamination device is arranged to receive the container while the container is in a non-sealed state (NOTE: this is a recitation of intended use; the container of Lin would be capable of being inserted into the chamber in a non-sealed state by manually opening the container and inserting it, at least partially, into the chamber).
Regarding claim 19, Modified Lin teaches the method of claim 16, as set forth above, and teaches wherein the entrance is arranged for receiving the container while the lid is closed onto the tray (abstract: the washer/decontaminator automatically opening the container and applying a washing fluid thereto to wash the instruments within the container; NOTE the container would have to be closed when it is fully inserted in order to be opened by the device and thus the entrance is arranged to receive the closed container).
Regarding claim 20, Modified Lin teaches the method of claim 16, as set forth above, and teaches further including pumping means for reducing a gas pressure inside the container prior to closing the container (par. 36: Preferably, the sterilization process comprises admitting heated air through inlet 58 to dry the chamber 40 and its contents followed by sealing the chamber and lowering the pressure via the vacuum pump 78 to below 1 torr whereupon a 59% hydrogen peroxide solution is vaporized into the chamber 40 and left in contact with for a sufficient period of time to effect sterilization of the container 10 and the instruments 12 therein. After the sterilization is completed, the lid 18 and drain 20 are all closed and the container is ready to be removed from the chamber 40)
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 20080236631 A1) in view of Henniges (WO 2014159696 A1) and Srnka (US 20120086958 A1).
Regarding claim 6, Modified Lin teaches the method of claim 1, as set forth above, but does not teach wherein in the non-sealed state a perforation of the lid and/or tray provides an open connection from an inner space of the container to ambient air, and wherein the system further comprises a labelling unit arranged for closing the perforation with the label.
Henniges teaches a method of sterilizing medical instruments by placing them in a container which is then placed in a decontamination chamber (par. 25: The container of instruments is placed within a sterilization chamber, the chamber door is closed and a sterilization cycle performed). Henniges teaches holes on the lid of the sterilization container for letting in sterilant during sterilization (par. 136: Two arrays of holes 459 are defined in and extend through panel 452. Holes 459 are located toward each of the ends of panel 452. Holes 459 allow sterilant to enter and leave container 402 during sterilization processing). Lin already teaches opening the lid during sterilization in order to let in sterilant, and therefore, having holes on the lid would be an additional means of achieving the same function, which increases the amount of sterilant that can be transferred to the interior of the container.
Henniges teaches filters covering the holes on the cover in order to block the passage of any microbial substances while allowing the passage of sterilant (par. 139: Filter 440 is formed from a microbial barrier material that is permeable to sterilant. Filter 440 allows sterilant to pass from the outside of cover 450, through holes 459, through filter 440, through apertures 445 and into interior cavity 420 where the sterilant contacts surgical instruments. Filter 440 also forms a microbial barrier preventing microorganisms from entering into container 100). Lin already teaches semipermeable filters in other embodiments as optional additions (par. 45: Optionally, semi-permeable filters 210 can be provided on the container 190 to allow a vapor phase sterilization process to be carried out with the cover 196 sealed to the bottom 194).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Lin to utilize a sterilization container with an array of holes on the lid, which are in turn covered by a filter, as taught by Henniges, as an additional means of allowing sterilant into the container during sterilization, which increases the amount of sterilant transferred to the interior of the container and thus the amount of sterilant that contacts the sterilization targets, and/or allows sterilization even if the lids are closed. The pores of the filter would provide an open connection between the interior and exterior spaces of the container and thus read on perforations.
Modified Lin modified by Henniges still does not teach wherein the system further comprises a labelling unit arranged for closing the perforation with the label.
Srnka teaches a labeling device for producing labels for items in medical contexts so that sterilized items can be identified (abstract: Provided is a method and apparatus for generating a label for use in a medical application. Label content specified by a user that is to be applied to a surface of the label is received. The label content, which includes a machine-generated character, is printed on demand onto the surface of the label. The label bearing the label content is dispensed in a condition suitable for use in the sterile environment; par. 5: Other objects such as medical equipment can also be contaminated with infectious organisms and such organisms into sterile environments. Bedding, medical devices, and virtually all other objects brought into a sterile environment must undergo sterilization procedures to minimize the risk of infection to patients. Labels for identifying medications, personal possessions, tissue samples, or any other object within a sterile environment are among the other objects that also undergo a sterilization procedure).
Lin already teaches sterilizing medical items (abstract: A method and apparatus provide for automatically cleaning and decontaminating medical instruments).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Modified Lin modified by Henniges to also include a labeling unit, as taught by Srnka, in order to identify sterilized medical objects. Since the label is manually applied to the medical object, the user can choose to close the perforation (the individual pores of the filter can read on perforations) with the label printed from the labeling device, and thus the labeling device would read on for closing the perforation with the label.
Regarding claim 18, Modified Lin teaches the method of claim 16, as set forth above, but does not teach including a labelling unit arranged for closing a perforation of the container with a label, in the non-sealed state the perforation of the container providing an open connection from an inner space of the container to ambient air.
Henniges teaches a method of sterilizing medical instruments by placing them in a container which is then placed in a decontamination chamber (par. 25: The container of instruments is placed within a sterilization chamber, the chamber door is closed and a sterilization cycle performed). Henniges teaches holes on the lid of the sterilization container for letting in sterilant during sterilization (par. 136: Two arrays of holes 459 are defined in and extend through panel 452. Holes 459 are located toward each of the ends of panel 452. Holes 459 allow sterilant to enter and leave container 402 during sterilization processing). Lin already teaches opening the lid during sterilization in order to let in sterilant, and therefore, having holes on the lid would be an additional means of achieving the same function, which increases the amount of sterilant that can be transferred to the interior of the container.
Henniges teaches filters covering the holes on the cover in order to block the passage of any microbial substances while allowing the passage of sterilant (par. 139: Filter 440 is formed from a microbial barrier material that is permeable to sterilant. Filter 440 allows sterilant to pass from the outside of cover 450, through holes 459, through filter 440, through apertures 445 and into interior cavity 420 where the sterilant contacts surgical instruments. Filter 440 also forms a microbial barrier preventing microorganisms from entering into container 100). Lin already teaches semipermeable filters in other embodiments as optional additions (par. 45: Optionally, semi-permeable filters 210 can be provided on the container 190 to allow a vapor phase sterilization process to be carried out with the cover 196 sealed to the bottom 194).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Lin to utilize a sterilization container with an array of holes on the lid, which are in turn covered by a filter, as taught by Henniges, as an additional means of allowing sterilant into the container during sterilization, which increases the amount of sterilant transferred to the interior of the container and thus the amount of sterilant that contacts the sterilization targets, and/or allows sterilization even if the lids are closed. The pores of the filter would provide an open connection between the interior and exterior spaces of the container and thus read on perforations.
Modified Lin modified by Henniges still does not teach wherein the system further comprises a labelling unit arranged for closing the perforation with the label.
Srnka teaches a labeling device for producing labels for items in medical contexts so that sterilized items can be identified (abstract: Provided is a method and apparatus for generating a label for use in a medical application. Label content specified by a user that is to be applied to a surface of the label is received. The label content, which includes a machine-generated character, is printed on demand onto the surface of the label. The label bearing the label content is dispensed in a condition suitable for use in the sterile environment; par. 5: Other objects such as medical equipment can also be contaminated with infectious organisms and such organisms into sterile environments. Bedding, medical devices, and virtually all other objects brought into a sterile environment must undergo sterilization procedures to minimize the risk of infection to patients. Labels for identifying medications, personal possessions, tissue samples, or any other object within a sterile environment are among the other objects that also undergo a sterilization procedure).
Lin already teaches sterilizing medical items (abstract: A method and apparatus provide for automatically cleaning and decontaminating medical instruments).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Modified Lin modified by Henniges to also include a labeling unit, as taught by Srnka, in order to identify sterilized medical objects. Since the label is manually applied to the medical object, the user can choose to close the perforation (the individual pores of the filter can read on perforations) with the label printed from the labeling device, and thus the labeling device would read on for closing a perforation with a label.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Busted (US 20080166263 A1) and Kemp (WO 2016039647 A2).
Regarding claim 10, Modified Lin teaches the method of claim 1, as set forth above, and teaches further including pumping means for reducing a gas pressure inside the container prior to closing the container (par. 36: Preferably, the sterilization process comprises admitting heated air through inlet 58 to dry the chamber 40 and its contents followed by sealing the chamber and lowering the pressure via the vacuum pump 78 to below 1 torr whereupon a 59% hydrogen peroxide solution is vaporized into the chamber 40 and left in contact with for a sufficient period of time to effect sterilization of the container 10 and the instruments 12 therein. After the sterilization is completed, the lid 18 and drain 20 are all closed and the container is ready to be removed from the chamber 40), but does not teach and wherein the container is arranged for maintaining said reduced gas pressure inside the container after removing the closed container from the decontamination device.
Busted teaches an ozone sterilization chamber for reusable medical equipment (abstract: The present invention concerns an apparatus and a method for sterilization of at least one item with ozone gas. The method includes the steps of providing a housing having a sterilization chamber in which at least one item is placed; par. 2: The method and apparatus is in particular suited for sterilization of members such as reusable medical equipment, in particular heat-sensitive equipment such as endoscopes or ultrasound transducers). Busted teaches wherein it is advantageous to tailor the sterilization parameters according to different sterilization targets (par. 4: However, the autoclave process destroys heat sensitive instruments, such as arthroscopes, endoscopes, and ultrasound transducers, which are adversely affected by the heat due to the different materials being used, these materials having different coefficients of thermal expansion, destroying sensitive parts such as lenses, delicate electrical connections and circuits, and ceramic sound emitters. Further, due to the low pressure of the process, air bubbles may be formed in existing thin water and air ducts, if both ends of the capillary ducts are subjected to under pressure simultaneously, which air bubbles increases the risk of bacteria formation). Busted teaches wherein sterilization parameters like pressure can be controlled by the user (par. 40: The front side of said cabinet 70 is provided with a control panel 72, from which an operator is able to control start and end of the sterilization process, or set parameters such as selection of preset sterilization programs, control and monitor temperature, pressure, flow of exhaust gas, ozone gas amount, and/or other functions to control and preferably electronically record the sterilization process within the sterilization chamber inside the housing 1).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Lin to allow a user to control sterilization process parameters, including pressure, as taught by Busted, in order to optimize and tailor the sterilization process for different sterilization targets.
Modified Lin modified by Busted would be capable of and wherein the container is arranged for maintaining said reduced gas pressure inside the container after removing the closed container from the decontamination device since a user can simply set the pressure to vacuum levels for the duration of the entire process, before, while, and after the lid is closed. However, Lin modified by Busted does not explicitly teach wherein the container is capable of maintaining a vacuum.
Kemp teaches a sterilization container for containing items to be sterilized inside a sterilization chamber (abstract: A steam steriliser, a single use/disposable container for use in the steriliser and a sterilisation method. The container is a rigid or semi-rigid container having a sealable elongate conduit through which steam sterilant may be introduced into the container and steam sterilant and condensate may be removed from the container. Once one or more items to be sterilised are placed in the container a cover is sealed over the mouth of the container. The steam steriliser has a sterilisation chamber adapted to receive the container and provide sterilant within and around the container). Similar to Lin, Kemp teaches drawing a vacuum prior to sterilization (In the next stage the vacuum 27 is deactivated and steam source 28 supplies steam to port 26 and via conduit 8 to container 1 so that the entire contents of container 1 are exposed to steam sterilant). In addition, Kemp teaches maintaining a vacuum in the container after sterilization, in order to provide an indication that the sterility inside the container is maintained (P10L28-P11L2: Subjecting the package to a vacuum state whence sealed after load sterility is achieved enables immediate visible indication of package vacuum loss due to either a fault of seal integrity loss, package integrity breach or package opening under normal controlled aseptic opening of terminally sterilised package. In the event that the package has lost its vacuum as a result of a failure the package may be immediately be deemed contaminated and no longer sterile; P16L4-7: At the completion of steam sterilisation, steam source 28 is closed and vacuum source 27 connected to port 26 to extract fluid from container 1 and its surrounds). The cover of Kemp must necessarily be hermetically sealed to the container opening in order for a vacuum to be maintained. Furthermore, Kemp teaches wherein the cover is capable of maintaining a vacuum (P13L4-6: The cover may be formed of a stretch or non-stretch material that provides the required microbial, oxygen and vapour barriers and can withstand sterilisation conditions. Certain vacuum skin packaging materials will be suitable) and wherein the cover is put on the container opening within the sterilization chamber (P15L27-28: The cover 15 may be secured to the rim 7 of container 1 either prior to entering sterilisation chamber 20 or within sterilisation chamber 20).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Modified Lin modified by Busted to be capable of maintaining a vacuum as taught by Kemp, in order to provide a convenient visual indication of whether or not the vacuum, and thus the sterility, of the container interior has been maintained following sterilization and removal of the container from the sterilization chamber.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Gabele (DE 19851239 B4).
Regarding claim 13, Lin teaches the container of claim 11, as set forth above, but does not teach wherein the first lid, the second lid and/or the tray includes a perforation providing an open connection from an inner space of the container to ambient air, the container including a label closing the perforation.
Lin already teaches semipermeable filters in other embodiments as optional additions (par. 45: Optionally, semi-permeable filters 210 can be provided on the container 190 to allow a vapor phase sterilization process to be carried out with the cover 196 sealed to the bottom 194). These filters are interpreted to comprise perforations. If the filter then has a marking that indicates information, then the filter itself can be interpreted as a label.
Gabele teaches a filter for a sterilization container (abstract: use a flat Filter layer of PTFE, which consists of compact, fused together and constructed between pore-forming PTFE particles, for covering a perforated area of a sterilization container). Gabele teaches wherein filters allow steam to get into the interior of the container to sterilize the objects inside the container (pg. 2 par. 3: Sterilization containers usually have a broken open area, through the hot steam into the interior penetrate and air can escape from the interior into the environment, so that by the high temperature entering water vapor Bacteria and other germs inside the sterilization container are killed. Known filter layers are used, for example, as paper filters trained, which are replaced after each sterilization process have to). In addition, Gabele teaches putting colored markings on its filters to indicate the expiration date of the filters (pg. 3 par. 1: The commonly produced PTFE surfaces have these colors, the completely clean Schäloberfläche, however, assumes these colors, especially when these dyes are particulate in a solution and can therefore store in the pores of the filter layer, and thus allows a label of the filter layer, for example to indicate a date of expiry or replacement). Because the filter has colored markings on it, the entire filter is interpreted to be a single label. Furthermore, this filter/label is covering numerous perforations in the lid of a container (Fig. 1: circular openings 5; pg. 3 par. 7: At the bottom of the lid 2 becomes the entire area 4 from a flat, thin filter layer 6 , ( 2 ) covered by a suitable, not shown in the drawing holding frame sealing against the underside of the lid 2 is created and thus all breakthroughs 5 of the area 4 covered). Lin teaches filters but does not teach the exact structure of the filters, which Gabele provides.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Figure 4 of Lin to have a filter with a colored markings, constituting a label, wherein the filter is attached to a container and/or lid wall that has perforations and covers those perforations, as taught by Gabele, in order to sterilize the items within the container even if the lids are closed, if necessary, and to provide convenient information to a user about when to replace the filter.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Kemp.
Regarding claim 14, Lin teaches the container of claim 11, as set forth above, but does not teach wherein the container is arranged to maintain a reduced gas pressure inside when closed.
Kemp teaches maintaining a vacuum in the container after sterilization, in order to provide an indication that the sterility inside the container is maintained (P10L28-P11L2: Subjecting the package to a vacuum state whence sealed after load sterility is achieved enables immediate visible indication of package vacuum loss due to either a fault of seal integrity loss, package integrity breach or package opening under normal controlled aseptic opening of terminally sterilised package. In the event that the package has lost its vacuum as a result of a failure the package may be immediately be deemed contaminated and no longer sterile; P16L4-7: At the completion of steam sterilisation, steam source 28 is closed and vacuum source 27 connected to port 26 to extract fluid from container 1 and its surrounds). The cover of Kemp must necessarily be hermetically sealed to the container opening in order for a vacuum to be maintained. Furthermore, Kemp teaches wherein the cover is capable of maintaining a vacuum (P13L4-6: The cover may be formed of a stretch or non-stretch material that provides the required microbial, oxygen and vapour barriers and can withstand sterilisation conditions. Certain vacuum skin packaging materials will be suitable) and wherein the cover is put on the container opening within the sterilization chamber (P15L27-28: The cover 15 may be secured to the rim 7 of container 1 either prior to entering sterilisation chamber 20 or within sterilisation chamber 20).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Lin to be capable of maintaining a vacuum as taught by Kemp, in order to provide a convenient visual indication of whether or not the vacuum, and thus the sterility, of the container interior has been maintained following sterilization and removal of the container from the sterilization chamber.
Regarding claim 15, Lin modified by Kemp teaches the container of claim 14, as set forth above, but does not teach including a tamper evidence feature arranged for being in a first state when the reduced gas pressure is present inside the container, and in a second state when ambient pressure is present inside the container.
Kemp uses a rigid, lightweight, disposable plastic form to visually indicate whether or not the vacuum is still sealed (pg. 16 line 29-pg. 17 line 2: By providing a rigid container in a lightweight disposable plastic form with the contents sealed in a partial vacuum the barrier integrity status can be immediately determined by visual and tactile confirmation of vacuum remaining therein). This ould be useful for determining whether or not the sterility of the interior of the container has been compromised.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Lin modified by Kemp to comprise a rigid, lightweight, disposable plastic form, as taught by Kemp, in order for the container to be capable of visually indicating whether or not the vacuum, and thus the sterility, of its interior has been compromised.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim and rejected under 35 U.S.C 112(b), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten to overcome the 35 U.S.C. 112(b) rejection.
Regarding claim 5, Lin teaches the method of claim 1, as set forth above, but does not teach wherein the system is arranged for closing the container while moving it from the first chamber to the second chamber.
Furthermore, it would not be obvious to modify Lin to read on this limitation because the device Lin already needs to be modified to read on having a first and second chamber for the embodiment of Fig. 4-5, and it would not then be obvious to configure the device of Lin to try to close the container while moving it because then the lifting rod would also have to move with the container, and they are not capable of doing so without further modification.
Conclusion
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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