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 without traverse of claims 4-11 in the reply filed on 2/25/2026 is acknowledged. Claims 1-3 and 12-13 are canceled.
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 4-7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Korogi (US 9895526 B2).
Regarding claim 4, Korogi teaches a retention tool for an autoclave sterilisation facility for bags provided with a flexible container (Fig. 5 or Fig. 19; NOTE: while the prior art does teach a flexible container, the flexible container is not positively recited as part of the claimed retention tool and thus all features of the flexible container are not positively recited either and do not have to be read upon by the prior art) and with a rigid connection portion (NOTE: this feature is not positively recited; Fig. 5, Fig. 18: access portion 208) with a longitudinal axis (NOTE: there would be some axis associated with any structure),
said flexible container being connected to the rigid connection portion (NOTE: the flexible container is not positively recited)
by a weld, said weld being contained in a plane, called a weld plane, substantially normal to the longitudinal axis of the connection portion,
in such a way that the flat face is in or is substantially in the weld plane (NOTE: since the flexible container is not positively recited as part of the claimed retention tool, this is a recitation of intended use, wherein the retention tool could be used with a flexible container that is welded in such a manner),
said facility including an autoclave sterilisation enclosure (NOTE: the facility and all things in the facility are not positively recited; par. 5: the resin container 1 is placed on a sterilization tray 2 and is put into a high pressure steam sterilization apparatus such as an autoclave)
and a support comprising at least one support plate configured to house at least one bag in said enclosure (NOTE: this feature is not positively recited),
the at least one bag adapted to be disposed on the support plate (NOTE: this feature is not positively recited),
the rigid connection portion being oriented opposite the support plate (NOTE: this feature is not positively recited)
and a retention tool adapted to be disposed on the flexible container as close as possible to the connection portion and being fastened to the support plate on either side of the bag in such a way as to limit a displacement of the flexible container with respect to the rigid connection portion (NOTE: the retention tool would be capable of this function depending on the structure of the flexible container, which is not positively recited),
the retention tool including a first portion provided with a flat face adapted to be disposed in a vicinity of the rigid connection portion and in a vicinity of the bag (Fig. 5: top of fluid connector cover 160 would be disposed on the mouth of the container; alternatively, Fig. 19: bottom flat face of 307), and a second portion provided with a curved face (Fig. 5: flexible strap 107/110 Fig. 18-19: flexible member 305 with collar 308)
configured to be oriented by moving away from the support plate (Fig. 5 and Fig. 18 show that the flexible members are capable of changing shape and moving).
Regarding claim 5, Korogi teaches the retention tool according to claim 4, as set forth above, and can be used in such a way to read on wherein a transverse dimension of the first portion is at least equal to a transverse dimension of the flexible container of the bag (NOTE: the device of Korogi can be used with a particular flexible container such that it reads on this limitation, since the flexible container is not positively recited).
Regarding claim 6, Korogi teaches the retention tool according to claim 4, as set forth above, and teaches including at least one hole configured to receive a bolt or at least one clamp configured to engage with a support plate of the facility (Fig. 5; hole in 160 designed to receive the mouth of the container; Fig. 19: collar 308).
Regarding claim 7, Korogi teaches the retention tool according to claim 4, as set forth above, and teaches including a ring configured to at least partially surround the rigid connection portion of the bag (Fig. 5: ring structure disposed on bottom of cover 160, below the threads).
Regarding claim 9, Korogi teaches the retention tool according to claim 4, as set forth above, and teaches including at least two parallel decks or a clamping collar configured to fasten the retention tool to the rigid connection portion in a given relative position (Fig. 19: collar 308) in such a way that the flat face of the first portion is contained in the weld plane (NOTE: this limitation would be read upon depending on the structure of the flexible container that the device of Korogi is disposed on).
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 4-7, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kato (US 20160242453 A1, provided in Applicant’s IDS of 5/5/2023) in view of Ritchey (US 20100274256 A1).
Regarding claim 4, Kato teaches a retention tool for an autoclave sterilisation facility for bags provided with a flexible container (Fig. 4: 1a; NOTE: while the prior art does teach a flexible container, the flexible container is not positively recited as part of the claimed retention tool and thus all features of the flexible container are not positively recited either and do not have to be read upon by the prior art) and with a rigid connection portion (Fig. 1: 1d) with a longitudinal axis (NOTE: there would be some axis associated with any structure),
said flexible container being connected to the rigid connection portion (Fig. 1: portion connecting 1a to 1d))
by a weld, said weld being contained in a plane, called a weld plane, substantially normal to the longitudinal axis of the connection portion,
in such a way that the flat face is in or is substantially in the weld plane (NOTE: since the flexible container is not positively recited as part of the claimed retention tool, this is a recitation of intended use, wherein the retention tool could be used with a flexible container that is welded in such a manner),
said facility including an autoclave sterilisation enclosure (NOTE: the facility and all things in the facility are not positively recited; par. 5: the resin container 1 is placed on a sterilization tray 2 and is put into a high pressure steam sterilization apparatus such as an autoclave)
and a support comprising at least one support plate configured to house at least one bag in said enclosure (Fig. 4: tray 12),
the at least one bag adapted to be disposed on the support plate (Fig. 4: resin container 1),
the rigid connection portion being oriented opposite the support plate (Fig. 4: 1d is positioned relative to the side walls of tray 12, which is interpreted as being oriented opposite the tray)
and a retention tool adapted to be disposed on the flexible container as close as possible to the connection portion and being fastened to the support plate on either side of the bag in such a way as to limit a displacement of the flexible container with respect to the rigid connection portion (Fig. 4: support 12a),
the retention tool including a first portion provided with a flat face adapted to be disposed in a vicinity of the rigid connection portion and in a vicinity of the bag (Fig. 4: the vertical portion of 12a, which occupies the weld plane), and a second portion provided with a curved face (Fig. 4: curved portion of 12a) but does not teach
configured to be oriented by moving away from the support plate.
Kato teaches wherein a plate is laid on the bottom of the tray (par. 75: The sterilization tray 100 illustrated in FIG. 4 is different from the sterilization tray 10 illustrated in FIG. 1 in that a perforated plate 15 is 1aid on the bottom (perforated plate 13) of the sterilization tray 10). That is, if the plate 15 moves, then the second portion is capable of moving away from the support plate/tray.
Kato teaches wherein the support/retention member is fixed to the tray (par. 7: Meanwhile, a stopper part 1d of the resin container 1 is supported by a support 2a fixed to the bottom of the sterilization tray 2) which means that the plate 15 would also have to be fixed to the support 12a (as shown in Fig. 4, but does not teach a means of doing so.
Furthermore, it is unclear whether or not the plate is permanently fixed to the bottom of the tray. Kato provides motivation to keep the components modular/detachable since it teaches that plate 15 can be substituted by another material (par. 93: Meanwhile, instead of the perforated plate 15 1aid on the bottom of the sterilization tray 100, it is acceptable to 1ay a wire gauze, a porous member or the like so that no sterilization traces are left).
Ritchey teaches “A field generator for use in a surgical targeting system is disclosed” (abstract). Ritchey teaches wherein a part is fixed to another part via a hole and a bolt in a detachable/adjustable way (par. 157: A fastener (not shown) may be placed through the fastener hole 1814 to attach the adjustable stop to the insertion handle 1700). Ritchey teaches wherein the fastener is a bolt (par. 183: As described above, the adjustable stop 1801 can be attached to the insertion handle 2210 by a bolt 1807; par. 171: The stop 1801 includes a thumb wheel 1806 that is used to turn a threaded bolt 1807 for attaching the stop 1801 to an insertion handle while the stop 1803 includes a knob clamp 1804 that is also connected to a threaded bolt 2531). Thus, this fulfills the need of Kato, and a threaded bolt would allow two parts to be detached and thus oriented away from each other.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support 12a, plate 15, and tray 12 of Kato each have holes configured to receive a threaded bolt/fastener, as taught by Ritchey, as a means of connecting the support 12a to the plate 15 and the tray 12.
Regarding claim 5, Kato teaches the retention tool according to claim 5, as set forth above, and teaches wherein a transverse dimension of the first portion is at least equal to a transverse dimension of the flexible container of the bag (NOTE: the transverse direction is interpreted to be a vertical direction; Fig. 4: the height of the first portion would be equal to a height of the container 1a at some point along its length).
Regarding claim 6, Kato teaches the retention tool according to claim 5, as set forth above, but and teaches including at least one hole configured to receive a bolt or at least one clamp configured to engage with a support plate of the facility (see Ritchey modification in claim 1 rejection).
Regarding claim 7, Kato teaches the retention tool according to claim 5, as set forth above, and teaches including a ring configured to at least partially surround the rigid connection portion of the bag (Fig. 10: rings around 1d contacting support 22a).
Regarding claim 10, Kato teaches an assembly of a support plate of a support for the autoclave sterilisation facility and of the retention tool according to claim 4 (Fig. 4: plate 15).
Regarding claim 11, Kato modified by Ritchey teaches An assembly of a support plate of a support for the autoclave sterilisation facility and of the retention tool according to claim 6 (Fig. 4: plate 15), wherein the support plate includes at least one hole or at least one edge configured to engage with the at least one hole or the at least one clamp, respectively, of the retention tool (see Ritchey modification in claim 6 rejection).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Korogi as applied to claims 1-7 and 9 above.
Regarding claim 8, Korogi teaches the retention tool according to claim 4, as set forth above, and teaches wherein the second portion provided with the curved face includes an upper plate and reinforcements ensuring its rigidity (Fig. 19: gripping means 306 on collar 308 is interpreted to be an upper plate, with the ribbed protrusions acting as reinforcements)
but does not teach wherein the first portion includes a polygonal section tube, the flat face being formed at least by a face of said tube.
However, Korogi not only teaches various different embodiments having different shapes, but also explicitly teaches that various geometries are possible (C13L52-59: The cover member may comprise portions constructed of elastomeric, plastic, absorbent e.g. sponge or foam or any combination thereof and may comprise any geometry determined to be advantageous for effectively disinfecting its corresponding access site of a connector housing. This may be, but is not limited to geometries that exactly or closely replicate the geometry of the access site geometries of the connector housing).
Furthermore, in the absence of any teaching to the contrary, the shape of the fluid cover does not affect operation since they would still be capable of covering the mouth of the container so long as the geometry is close enough to that of the mouth of the contaienr. 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). Accordingly, the claimed dimensions and shapes are considered to be not patentably distinct from the disclosed device of Korogi. 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 ring portion of the fluid cover in Fig. 5 of Korogi, to have its inner and/or outer circumference be shaped as a polygonal tube as opposed to a circular tube, with a reasonable expectation that the fluid cover would be capable of covering a container with a polygonal shaped mouth and/or neck portion, and/or would still be close enough in geometry to a circular neck.
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