Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of claims 1-14 in the reply filed on 7/6/2026 is acknowledged. The traversal is on the ground(s) that the drawings show only one embodiment. This is not found persuasive because while there may be only one embodiment, prior art that reads on the physical structure of the apparatus may not read on the process for the use of the apparatus. For instance, in regards to claim 16, a prior art structure may indeed be deformable by an external force, but the prior art may not also teach steps of deformation by an external force before and after sterilization. Therefore, there is a search burden due to different search strategies needed to search an apparatus compared to a process.
The requirement is still deemed proper and is therefore made FINAL.
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 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 1-5, 11, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulze (WO 2023025809 A1).
Regarding claim 1, Schulze teaches A fixation element for holding a medical instrument during a reprocessing procedure (pg. 4 par. 5: it is proposed according to the invention that the holder arrangement, in particular the instrument holder, has a clamping device which is designed to clamp a surgical instrument in a clamping position and in a release position), wherein the fixation element is configured to undergo a shape change during the reprocessing procedure (pg. 4 last par.: The clamping device, in particular at least one clamping leg of the clamping device, preferably has at least one bimetal which is set up to move the clamping device into the clamping position and/or the release position as a function of the ambient temperature. Such a bimetal preferably ensures that the surgical instruments are safely released when the ambient temperature is high, for example during the sterilization process).
Regarding claim 2, Schulze teaches the fixation element of claim 1, as set forth above, and teaches wherein the fixation element is configured to undergo the shape change in response to a change in temperature (pg. 4 last par.: The clamping device, in particular at least one clamping leg of the clamping device, preferably has at least one bimetal which is set up to move the clamping device into the clamping position and/or the release position as a function of the ambient temperature. Such a bimetal preferably ensures that the surgical instruments are safely released when the ambient temperature is high, for example during the sterilization process).
Regarding claim 3, Schulze teaches the fixation element of claim 2, as set forth above, and teaches wherein the fixation element is configured to change between a first shape and a second shape, the first shape being configured to firmly hold the medical instrument, the second shape being configured to loosely hold the medical instrument (pg. 4 last par.: The clamping device, in particular at least one clamping leg of the clamping device, preferably has at least one bimetal which is set up to move the clamping device into the clamping position and/or the release position as a function of the ambient temperature. Such a bimetal preferably ensures that the surgical instruments are safely released when the ambient temperature is high, for example during the sterilization process; pg. 4 par. 6: If the receiving arrangement is placed on a shelf, the clamping device is deformed by the dead weight of the receiving arrangement and the instruments contained in such a way that the instruments can be removed in the released position without exerting any force; NOTE: since the object can be removed from the released position, the released position is capable of loosely holding the medical instrument).
Regarding claim 4, Schulze teaches the fixation element of claim 3, as set forth above, and teaches wherein the second shape is selected to provide a reduced contact surface between the fixation element and the medical instrument (Fig. 22-23: clamping arms 62, 64; NOTE: the second second shape can satisfy this limitation depending on the geometry of the medical instrument, which in turn is not positively recited).
Regarding claim 5, Schulze teaches the fixation element of claim 3, as set forth above, and teaches wherein the fixation element is configured to automatically change from the first shape to the second shape when the temperature of the fixation element rises above a predetermined transition temperature (pg. 4 last par.: The clamping device, in particular at least one clamping leg of the clamping device, preferably has at least one bimetal which is set up to move the clamping device into the clamping position and/or the release position as a function of the ambient temperature. Such a bimetal preferably ensures that the surgical instruments are safely released when the ambient temperature is high, for example during the sterilization process).
Regarding claim 11, Schulze teaches the fixation element of claim 3, as set forth above, and teaches further comprising a biasing material for biasing the fixation element into one of the first shape or the second shape (Fig. 23: bimetal 72; pg. 7 par. 5: The bimetal 72 is set up to move the clamping device 60 into the clamping position and/or the release position depending on the ambient temperature).
Regarding claim 14, Schulze teaches A reprocessing tray for medical instruments, comprising a tray body (Fig. 5; abstract: The invention relates to a receiving assembly (2) for receiving surgical instruments (10)) and one or more fixation elements according to claim 1 (see claim 1 rejection).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schulze in view of Ramsay (US 4577755 A) and Knieling (US 20180000975 A1).
Regarding claim 6, Schulze teaches the fixation element of claim 5, as set forth above, but does not teach wherein the fixation element is configured to automatically change from the second shape to the first shape when the temperature of the fixation element falls below the predetermined transition temperature.
Schulze teaches switching to the clamping position depending on the ambient temperature (pg. 4 last par.: The clamping device, in particular at least one clamping leg of the clamping device, preferably has at least one bimetal which is set up to move the clamping device into the clamping position and/or the release position as a function of the ambient temperature) but does not teach wherein the release position is achieved after the temperature drops below the same threshold temperature that triggered the transition into the release position.
Ramsay teaches a medical instrument tray (abstract: A surgical instrument tray has a base with a raised portion to support lever members of ring-handled surgical instruments). Ramsay teaches wherein it is advantageous to hold the instruments firmly in place on the tray to prevent disruption of the instruments during transport or handling (C4L49-52: simultaneously hold the surgical instrument snugly in place and to avoid disruption in the event the ring handles 28 or lever members 26 are bumped or touched during movement or handling of the tray 10), which reduces wear and tear on the instruments. Thus, it may be advantageous to return to the clamping position after sterilization in order to keep instruments from falling out or suffering from wear during transportation of the sterilized instruments.
Knieling teaches a device for cleaning a valve (abstract: The present invention relates to a device and a method for cleaning and sterilizing a filling valve of a beverage filling system for filling a container with a filling product). Knieling teaches wherein the valve is operated by a shape memory member that opens the valve above a preset temperature and closes the valve below that preset temperature (abstract: the valve includes a shape-memory material for switching the valve between an open and closed position at a predetermined temperature; par. 19: Because the cleaning of the filling valve normally takes place at lower temperatures than the sterilization of the filling valve, it is advantageous to design the device such that the positioning element closes the valve in the region of a predetermined lower temperature, and in the region of a predetermined higher temperature, it enables an open position of the valve). The closing of the valve is likened to the closing of the clamps in the clamping position of Schulze.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamping device of Schulze to return to the clamping position when the temperature is below the preset threshold for which triggers the releasing position, as taught by Ramsay and Knieling, in order to implement Schulze’s teaching of switching to the clamping position as a function of temperature and also to keep instruments in place during transportation to prevent them from falling out or suffering from wear.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schulze in view of AC (US 20210102473 A1).
Regarding claim 7, Schulze teaches the fixation element of claim 5, as set forth above, but does not teach wherein the fixation element is configured to maintain the second shape when the temperature of the fixation element falls below the predetermined temperature.
Schulze teaches, by way of example, reducing the clamping force during cooling at room temperature (pg. 4 last par.: for example… and that the clamping force applied to the surgical instruments is reduced again when they cool down at room temperature, so that the instruments can be easily removed) but it is unclear if a second release position is attained at a different threshold temperature than the one for triggering the release position, and if so, what occurs in the range between those two temperature thresholds. It is also unclear whether or not the clamping position is reverted to again after sterilization and whether or not the reduction in clamping force occurs as a result of temperature rather than gravity (pg. 4 par. 6: If the receiving arrangement is placed on a shelf, the clamping device is deformed by the dead weight of the receiving arrangement and the instruments contained in such a way that the instruments can be removed in the released position without exerting any force). However, this at least provides motivation to have the instruments held in the release position so that they are easier to release right after sterilization.
AC teaches a variable inlet guide vane featuring a shape memory alloy for changing its shape (abstract: A variable inlet guide vane assembly (200) and methods of operating the variable inlet guide vane assembly (200) are disclosed. The variable inlet guide vane assembly (200) includes an inlet guide vane (210) and an actuator (220). The actuator (220) is at least partially embedded in the inlet guide vane (210) and is configured to change an angle of the inlet guide vane (210) relative to a gas flow. The actuator (220) includes a shape memory alloy). AC teaches wherein a one way shape memory allow may be used wherein the second shape is retained even after the temperature falls below the threshold (par. 34: The shape-memory alloys used herein may have one-way or two-way shape characteristics. In some embodiments, a one-way shape memory alloy actuator 220 is in a first shape at a first temperature below the transition temperature of the shape memory alloy and transitions to a second shape (an operative shape) at a second temperature that is at or above its transition temperature. The shape memory alloy actuator remains in that operative shape even after cooling of the shape memory below the transition temperature to the first temperature).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamping device of Schulze so that the release position is maintained even after the temperature falls below the threshold temperature, as taught by AC, in order to allow the instruments to be easily accessed after sterilization.
Regarding claim 8, Schulze modified by AC teaches the fixation element of claim 7, as set forth above, and teaches wherein the fixation element is configured to be deformed from the second shape to the first shape by applying an external force while the temperature is below the predetermined transition temperature (pg. 4 par. 6: If the receiving arrangement is placed on a shelf, the clamping device is deformed by the dead weight of the receiving arrangement and the instruments contained in such a way that the instruments can be removed in the released position without exerting any force; pg. 4 last par.: preferably has at least one bimetal; NOTE: if the clamping device can be deformed by the weight of gravity before reverting to a clamping position at some point, then it would be capable of being deformed by an external force back into the clamping position, especially since it comprises a bimetal, which is deformable).
Regarding claim 9, Schulze modified by AC teaches the fixation element of claim 8, as set forth above, and teaches wherein the fixation element comprises one or more of a bimetal element (pg. 4 last par.: preferably has at least one bimetal), a shape memory alloy (SMA) element, and a shape memory polymer (SMP) element.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schulze modified by AC in view of Bettenhausen (US 7341148 B2).
Regarding claim 10, Schulze modified by AC teaches the fixation element of claim 9, as set forth above, but does not teach further comprising an elastic material covering the at least one of the bimetal element, the SMA element, and the SMP element.
Bettenhausen teaches a sterilization container for surgical instruments (abstract: A container system for organizing, protecting, sterilizing, storing and delivery of surgical instruments, implants and related devices). Bettenhausen teaches wherein the structures holding the instruments are covered by an elastic material in order to prevent damage to the instruments from contact with metal (C5L47-51: Further, the silicone brackets completely encase posts 108 preventing damage to the devices held by the brackets by preventing the devices from contacting the posts as compared to conventional brackets and metal posts not encased in silicone or other protective coatings). This would be advantageous for Schulze, which also teaches a sterilization container for surgical instruments using metal supports.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the clamping arms of Schulze to have a silicone material covering them, as taught by Bettenhausen, in order to prevent damage to surgical instruments from contact with metal.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schulze.
Regarding claim 12, Schulze teaches the fixation element of claim 3, as set forth above, but does not explicitly teach wherein the fixation element comprises a first contact surface for contacting the medical instrument when the fixation element is in the first shape, and a second contact surface for contacting the medical instrument when the fixation element is in the second shape. This is because it is unclear what surfaces the clamping device has from Fig. 22-23, which only present a side view of curved clamping arms. If the arms are fully curved, then there are no two discreet surfaces.
However, in the absence of any teaching to the contrary, the shape of the clamping arms of Schulze does not affect operation in any unexpected way since they would still be capable of clamping and holding a medical instrument so long as they have points of contact, and different medical instruments meet those points of contact in different ways. Absent a showing of significance or unexpected results, the shape of X is prima facie obviousness and do not modify the operation of the invention and further, does not add patentable significance. MPEP 2144.04.B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). In this case, changes to the shape of the clamping arms can be made to improve their grip on medical instruments of different shapes, which is an expected effect. Accordingly, the claimed dimensions and shapes are considered to be not patentably distinct from the disclosed device of Schulze. 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 clamping arms of Schulze to have a first contact surface for contacting the medical instrument when the fixation element is in the first shape, and a second contact surface for contacting the medical instrument when the fixation element is in the second shape, with a reasonable expectation that the clamping arms would be well suited to clamping or holding medical instruments of different shapes or a particular shape.
Regarding claim 13, Schulze teaches the fixation element of claim 12, as set forth above, but does not explicitly teach wherein the first contact surface is larger than the second contact surface.
However, in the absence of any teaching to the contrary, the shape of the clamping arms of Schulze does not affect operation in any unexpected way since they would still be capable of clamping and holding a medical instrument so long as they have points of contact, and different medical instruments meet those points of contact in different ways. Absent a showing of significance or unexpected results, the shape of X is prima facie obviousness and do not modify the operation of the invention and further, does not add patentable significance. MPEP 2144.04.B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant). In this case, changes to the shape of the clamping arms can be made to improve their grip on medical instruments of different shapes, and/or to decrease the area covered by the clamping arms so that more surface area of the instrument can be sterilized. In fact, Schulze teaches the latter motivation (pg. 2 3rd last par.: In this way, on the one hand, the accessibility of the surgical instrument by the assistant staff or operator is increased and at the same time it is ensured that the surgical instrument can be sterilized in the receiving arrangement in such a way that only the smallest possible area of the surgical instrument is covered by the receiving arrangement), so this is an expected effect. Having a smaller contact area in the released position would increase the surface area being sterilized. Accordingly, the claimed dimensions and shapes are not considered to be patentably distinct from the disclosed device of Schulze. 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 clamping arms of Schulze to so that the first area is greater than the second area, with a reasonable expectation that the clamping arms would be well suited to clamping or holding medical instruments of different shapes or a particular shape, and that the released position would expose more surface area of the medical instrument to sterilization.
Conclusion
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/C.C./Examiner, Art Unit 1796
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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