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 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 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over “Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments” (NPL 2018, hereinafter referred to as “Guidelines”) in view of Snyder (US 20150023839 A1).
Regarding claim 1, “Guidelines” teaches A method of sterilizing medical items (Title: Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments), the method comprising:
placing one or more unwrapped trays in a sterilization unit having a door;
placing one or more covered trays in the sterilization unit, the one or more covered trays being wrapped, containerized, or sealed within a peel pouch;
sterilizing the one or more unwrapped trays and the one or more covered trays (pg. 7 par. 4: Many surgical trays have instruments from more than one manufacturer; pg. 9 par. 1: Case Medical SteriTite rigid container (which has a door in the form of a latched lid, see NPL “Container Assembly”)… cataract tray; pg. 8 par. 3: Short-cycle sterilization for a contained wrapped or unwrapped load is appropriate for sequential sameday instrument reuse. Unwrapped sterile instruments should be protected from microbial contamination during transfer from the point of sterilization to the point of use. This might be accomplished with an approved covered containment device; NOTE: the loads would necessarily have to be placed in the sterilization unit in order to be sterilized);
and after sterilization:
opening the door to provide access to the one or more unwrapped trays and the one or more covered trays;
removing the medical items in the one or more unwrapped trays for use during a portion of a procedure (pg. 9 par. 2: This simulated prompt use of sterilized instruments that were still wet for a sequential case on the same day; pg. 9 par. 3: Moist or unwrapped instruments sterilized for sequential same-day use should be promptly transported from the sterilizer to the operating room within a covered containment device to prevent microbial recontamination. The covered instrument-containment device should only be opened in the operating room… until retrieved by sterile gloved and gowned staff within the OR for the subsequent case after some short delay).
but does not explicitly teach wherein both the unwrapped and wrapped loads are sterilized at the same time.
“Guidelines” teaches wherein both wrapped and unwrapped loads are sterilized using short-cycle sterilization (pg. 8 par. 3: Short-cycle sterilization for a contained wrapped or unwrapped load is appropriate for sequential sameday instrument reuse). Therefore, if both unwrapped and wrapped instruments are needed, then sterilizing both at the same time would save time over performing the same sterilization cycle twice, especially since short-cycle sterilization is needed for more immediate use anyway.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of “Guidelines” to sterilize both unwrapped and wrapped loads together at the same time using short-cycle sterilization, as taught by “Guidelines”, in order to save the time needed for sterilization of instruments for immediate use.
“Guidelines” still does not teach that the unwrapped instruments are taken out
while the one or more covered trays remain in the sterilization unit; and
removing the medical items in the one or more covered trays after performance of the portion of the procedure.
Snyder teaches a sterilization cabinet for holding multiple trays containing medical instruments (abstract: An improved mobile apparatus for sterilizing surgical trays serves as a self-contained autoclave, allowing sterilization of the interior of the apparatus and its contents. A method of sterilization using the apparatus is presented as well. By means of a dedicated transfer and storage system, the apparatus, integrable with respect to a transfer cart and a lift device, may be moved easily between a location of sterilization, a storage area, and an operating room, and more than one such apparatus may be stacked vertically for storage to enhance storage efficiency).
Snyder teaches wherein surgical procedures may require multiple trays (par. 7: A variety of instruments and supplies are required during modern operations. These are typically stored and sterilized in one or more wrapped trays. For example, an average knee replacement operation requires approximately twelve trays containing the instruments and supplies needed for this operation). Each tray may be removed and used as required, meaning that they do not necessarily have to be removed all at once and immediately, especially since the surgical procedure would involve different tools at different times (par. 155: any surgical tray therein removed and used as required, obviating the necessity of protective wraps and redundant chemical indicators). The wrapped trays don’t have to be used immediately because the wraps can preserve sterility, hence the wraps being protective and having chemical indicators for sterility (par. 10: When required, each tray would be transported to the operating room, inspected and unwrapped as its contents were needed for the procedure being performed. Each tray would bear a chemical indicator that would read the sterilization status of a tray). Therefore, the wrapped trays of “Guidelines” can also be used in the same manner; that is, they can be used later compared to the unwrapped trays during the same procedure in the operating room because their sterility is longer lasting after the sterilization unit is opened.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of “Guidelines” to use chemical indicators on its wrapped loads and to remove its wrapped loads from the sterilization unit later than the unwrapped loads during a procedure in the same operating room, as taught by Snyder, in order to preserve the sterility of the wrapped trays as much as possible until they are needed for certain portions of the procedure.
Regarding claim 2, “Guidelines” modified by Snyder teaches the method of claim 1, as set forth above, but does not teach after removing the medical items in the one or more unwrapped trays, closing the door.
Snyder teaches wherein if one of the wrapped trays were found to be non-sterile, then the sterilization unit and the trays in it would have to be re-sterilized in an autoclave, a step which would necessitate the closing of the sterilization unit’s door and transporting the unit into an autoclave afterwards (par. 12: If a wrap were found to have been torn or breached, the contents of the tray to which that wrap had been applied would have to be considered non-sterile. In this event, the autoclaving procedure would have to be repeated (which takes about one hour and 45 minutes), or in the alternative, an emergency "flash autoclave" would have to be performed).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of “Guidelines” to close the lid/door of its sterilization unit and insert it into a sterilizer again if one of the wrapped trays is breached, as taught by Snyder, in order to ensure the sterility of all medical instruments used in a procedure.
Regarding claim 3, “Guidelines” modified by Snyder teaches the method of claim 1, as set forth above, and teaches further comprising, after closing the door, transporting the sterilization unit and the one or more covered trays (see Snyder modification in claim 2 rejection).
Regarding claim 5, “Guidelines” modified by Snyder teaches the method of claim 1, as set forth above, and teaches wherein the medical items removed from the one or more covered trays are for use during a second portion of the procedure (see Snyder modification in claim 1 rejection).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over “Guidelines” modified by Snyder in view of Hui (JP 2003070884 A).
Regarding claim 6, “Guidelines” modified by Snyder teaches the method of claim 1, as set forth above, but does not teach further comprising wrapping the one or more covered trays with a wrap.
Previously, the wrap of “Guidelines” was interpreted to be the covering for the tray. For this claim, the wrap is instead interpreted to be the wrap of the instant claim, which necessitates a structure to read on a covering for the tray.
Hui teaches a method for sterilizing instruments (abstract: The method for sterilizing tools in a sterilizer contains a step of arranging the tools in the sterilizer, a step of introducing a specified amount of hydrogen peroxide in the form of a gas or steam into the sterilizer and a step of sterilizing the tools in the sterilizer). Hui teaches wherein the load can comprise a tray with a lid in addition to another layer of covering to prevent contamination (pg. 2 par. 3: Typically, the sterilization load includes any medical device placed in a package and / or pouch, such as a container, tray, barrier wrap, etc… Therefore, the tray requires a packaging barrier that is gas and vapor permeable and impermeable to microorganisms on the outside of the tray. In other words, this packaging barrier prevents the entry of microorganisms into the tray by allowing the sterilant to spread inside and outside the packaged tray, and keeps the instruments inside the packaged tray in a sterile state even after sterilization. To do. The tray may have a lid, which does not act as a microbial barrier). The lid suggested by Hui would be useful for keeping items from falling out of the tray during handling.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the load of “Guidelines” modified by Snyder to comprise a tray with a lid, underneath the wraps, as taught by Hui, in order to prevent items from falling out of the trays.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over “Guidelines” modified by Snyder in view of Kowanko (US 20010000227 A1).
Regarding claim 7, “Guidelines” modified by Snyder teaches the method of claim 1, as set forth above, but does not teach further comprising sealing each of the one or more covered trays in a peel pouch.
Kowanko teaches a sterilization method for lumened devices (abstract: A method of and system for sterilizing the internal surfaces of one or more elongate relatively narrow passages of interest contained in a device of interest). Kowanko teaches wherein packaging for a load can be replaced by a peel pouch (par. 55: Thus, cassette 10 or package 62 may be replaced by peel pouch package for containing an endoscope, medical catheter or the like). The peel pouch can provide additional sterility protection or provide an easier way to contain and access the load compared to wrapping the load.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wraps of “Guidelines” modified by Snyder to be replaced by or supplemented by a peel pouch, as an alternative or additional means of providing sterility protection for medical instruments and/or provide an easier way to contain/access the load.
Regarding claim 8, “Guidelines” modified by Snyder and Kowanko teaches the method of claim 1, as set forth above, and teaches further comprising sealing all of the one or more covered trays in a single peel pouch (see Kowanko modification in claim 7 rejection; NOTE: each load is contained in one peel pouch, which reads on a single peel pouch, or alternatively, a peel pouch would require at least one peel, which reads on a single peel pouch).
Regarding claim 9, “Guidelines” modified by Snyder and Kowanko teaches the method of claim 1, as set forth above, and teaches wherein each of the one or more covered trays is containerized (see Kowanko modification in claim 7 rejection; Kowanko interprets the pouch as a container; Kowanko claim 14: wherein said storage container is a peel pouch).
Allowable Subject Matter
Claim 4 is 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 4, “Guidelines” modified by Snyder and Kowanko teaches the method of claim 3, as set forth above, but does not teach wherein after transporting the sterilization unit and the one or more covered trays, removing the medical items in the one or more covered trays for use in a second procedure.
Furthermore, it would not be obvious to modify “Guidelines” to read on this limitation because opening the sterilization unit and then transporting the sterilization unit after the initial transfer to the operating room would increase the risk of contamination to the contents within the unit.
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