DETAILED ACTION
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.
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/12/24 comply with provisions of 37 CFR 1.97. Accordingly, the examiner considered the information disclosure statements.
Claim Rejections - 35 USC § 112
Claim 13 is 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.
Claim 13 recites the limitation " the upper element" in claim 13, line 1. There is insufficient antecedent basis for this limitation in the claim. The term “the upper element” has not been introduce such having “an upper element.”
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4-11, 17-19, 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zardini (EN112012004786).
Regarding claim 1, Zardini teaches a holding device (¶44, ¶54, ¶71, device 10 receives and mechanically retains holding body 22 of endoscope 12 in seat 32; mechanical connecting means 53 are configured to hold it against the pressure of the circulating liquid) for holding at least a part of an endoscope, the holding device (¶48,the device 10 of the present invention comprises receiving means, in this case a receiving seat 32 of the holding body 222 of the endoscope 12) comprising, a frame for placing the holding device (¶47, ¶49, base body 30, of parallelepiped shape with a rectangular or square base, which carries the seat, the bottom wall and the side walls; the device is in turn placed on the mechanical supports of a rack or trolley inside the washing chamber), at least one receiving element connected to the frame (¶48-¶50, receiving seat 32 formed in and by base body 30, side walls 34 and bottom wall 36 are walls of the base body), the at least one receiving element being configured to at least partly enclose a receiving area for receiving at least the part of the endoscope (¶50, seat 32 is bounded laterally by the two side walls 34 and at the bottom by wall 36, and is open at the front and the top so that holding body 22 can be inserted – i.e., it encloses the receiving area only partly), and a plurality of holding elements connected to the at least one receiving element (¶62, ¶66, ¶70, two retaining pins 63 carried in holes 64 through the side walls 34, plus two conical connectors 44, 46 carried in through-holes 43 in bottom wall 36), wherein the plurality of holding elements are each configured to rest against and to hold at least the part of the endoscope (¶56, ¶64, ¶69, ¶71, pins 63 abut the converging front part 23 of holding body 22; connectors 44, 46 are received in and bear against openings 24, 26 of that same body to achieve a fluid seal) in a fixed and predefined position (¶51, ¶71, ¶86, pins 63 in the projecting position cooperate with holding body 22 to prevent its detachment and withstand -2-3 bar; guide rail 35 makes the seated position repeatable and predefined; mechanical tensioning is expressly achieved on release of the levers).
Regarding claim 2, Zardini teaches the holding device according to claim 1, wherein the plurality of holding elements are each movably supported on the at least one receiving element (¶70, with reference to the mechanical connector means 53, in one embodiment these comprise retaining pins 63 which are positioned along holes 64 (Fig. 1) formed through the lateral walls 34 of the base body 30 and are selectively movable within the holes 54, ¶70-¶72, note: linear travel transverse to the insertion direction; ¶67, connectors 44, 46 are slidably inserted in holes 43 of bottom wall 36 and electrically displaceable through a desired segment).
Regarding claim 4, Zardini teaches the holding device according to claim 1, wherein one or more of a portion of the plurality of holding elements are arranged along a circumference of the receiving area to hold at least the part of the endoscope, and a portion of the plurality of holding elements are arranged along a circle (¶50, ¶62, ¶70, fig. 1-2, Pins 63 are arranged in the two side walls 34 and connectors 44, 46 in the bottom wall 36, i.3., distributed around the boundary of receiving area 32.).
Regarding claim 5, Zardini teaches the holding device according to claim 1, wherein the circle is a vertically arranged circle (¶65, two pins 63 and the two connectors 44, 46 all lie in a common plane transverse to the insertion direction, a vertical plane in the orientation of Fig. 2, so any arrangement of them along a curve lies on a vertically arranged circle. Alternatively, arranging the same elements on a circle of that plane is an obvious rearrangement of parts (MPEP § 2144.04(VI)(C)), the arrangement follows the designer’s chosen port layout (¶65).
Regarding claim 6, Zardini teaches the holding device according to claim 1, wherein each of the plurality of holding elements (44, 46, 63) comprise a body (45, 47 (of 44, 46); shank of 63; ¶62, ¶66, ¶77, connectors 44, 46, each is a plug-in conical connector having a rear connecting portion 45, 47 that passes through hole 43 in the bottom wall 36 and protrudes into collection box 38, where it is joined to feed pipes 14, 16 by retaining parts 49, 51. Pins 63, each has an elongate shank with a T-shaped cross-section, carrying flat head 71 at the lever end) and a contact part (conical head of 44, 46; seat-side end of 63), wherein one or more of the body and the contact part is moveable along a moving axis (axis of 44, 46; axis of 63) and relative to the at least one receiving element (32 (34, 36)).
Regarding claim 7, Zardini teaches the holding device according to claim 6, wherein the moving axis (axis of 44, 46 (along F, F’); axis of 63) corresponds to a longitudinal extension (elongate axis of 44, 46 through 43; elongate axis of 63 through 64) of the plurality of holding elements (44, 46, 63 – connectors 44, 46 are displaced linearly along the axis of openings 24, 26, i.e., along their own longitudinal axis, with forward/rearward positioning movement (¶67, arrows F, F’ in fig.4). Pins 63 move linearly along their length, transverse to the insertion direction (¶72).).
Regarding claim 8, Zardini teaches the holding device according to claim 6, wherein one or more of the contact part and the body (conical head and 45, 47 (of 44, 46); seat side end and shank of 63) of each of the plurality of holding elements (44, 46, 63) is biased by a spring element (56 (for 44, 46); 73 acting through 65 (for 63)) towards the receiving area (56 seared in 58, abutting floor of 58 and rear wall 39 of 38, urging 44, 46 through 43 into 32; 73 in 75 coupled to 77 of 65, returning 65 so that 69/71 drive 63 through 64 into 32 – each adjusting means 48 comprises an elastic means 56, e.g. a spring, aligned with the back of each conical connector, which urges the connector towards the seat and lets it yield elastically as it enters the opening (¶67, ¶69). Independently, each lever 65 is coupled to a spring 73 that elastically returns the lever from the rotated position to the rest position, driving the pins 63 into the projecting position inside the seat (¶78, ¶86)).
Regarding claim 9, Zardini teaches the holding device according to claim 8, wherein the spring element (56 (fog 44, 46); 73 (for 63)) is a compression spring (56 captured between the floor of 58 and rear wall 39 of 38; 73 mounted on protruding section 77 within housing seat 75 – spring 56 sits in position seat 58 and bears at one end against the floor of that seat and at the other against rear wall 39 of collection box 38 (¶68), a spring captured between two opposed abutments and loaded in compression as the connector is pushed rearward by opening 24/26 (¶67, ¶69). Likewise spring 73 is mounted on a protruding section 77 of the lever within housing seat 75 (¶79-¶80), the standard arrangement for a compression spring.).
Regarding claim 10, Zardini teaches the holding device according to claim 8, wherein the spring element (56 (for 44, 46); 73 acting through 65 (for 63)) is biased towards at least the part (56 urging 44, 46 through 43 of 36 into 24, 26 (along F, F’); 73 urging 65 so 69/71 drive 63 through 64 of 34 against 23) of the endoscope that is held in the receiving area (22 (of 12), with 23, 24, 26; interior of 32 – spring 56 lets each connector yield and adapt its axial insertion position to the specific opening 24, 26 of the holding body, so that both connectors independently reach their optimum coupling position against the endoscope part (¶67, ¶69). Spring 73 urges pin 63 forward into engagement with the converging part 23 of the held body to ensure mechanical tensioning (¶86)).
Regarding claim 11, Zardini teaches the holding device according to claim 6, wherein the contact part (conical head of 44, 46; seat-side end of 63) has a contact surface for resting against at least the part of the endoscope that is held in the receiving area (interior of 32; tapered surface 44, 46 seated in 24, 26; seat-side end face of 63 against 23; 22(of 12), with 23, 24, 26), and the contact surface of the contact part is smaller than a cross sectional area of the body (cross-section of 45, 47 with 38; cross-section of shank/head 71 of 63) of the holding element (45, 47 (of 44, 46); shank of 63 with head 71 – connectors 44,46 are conical plug-in connectors (¶29. ¶62) sized to fit within openings 24, 26 (¶64). A conical connector tapers towards the endoscope, so the forward contact end that seats in the opening necessarily presents a smaller cross-section/contact area than the body of the connector rearward of it (¶62-¶64, fig. 1). The same is true of pin 63, whose T-shaped cross-section places the enlarged head 71 at the lever end, away from the contact end (¶77)).
Regarding claim 17, Zardini teaches the holding device according to claim 1, wherein the holding device comprises a lock device (¶70, ¶73, lever 65/retaining pin 63 assembly of mechanical connecting means 53) movable between a locked position, in which at least the part of the endoscope held in the receiving area is locked in the predefined and fixed position (¶71, ¶76, ¶86, with the lever in its rest position parallel to side wall 34, pins 63 project into the seat, abut the converging front part 23 and prevent detachment of holding body 22, withstanding -2-3 bar), and an unlocked position, in which at least the part of the endoscope held in the receiving area is movable about the predefined and fixed position (¶71, ¶76, ¶84, ¶87, rotating end 67 of lever 65 pulls coupling end 71 and retracts pins 63 clear of the seat, allowing the holding body to be inserted and removed without interference).
Regarding claim 18, Zardini teaches the holding device according to claim 17, wherein the lock device (65 with 63 (of 53)) is rotatable (G, G’) about a lock device axis (70, seated in 68, engaging 66 of 65).
Regarding claim 19, Zardini teaches the holding device according to claim 1, wherein the at least part of the endoscope (22 (of 12)) comprises one or more of, an operating part of the endoscope (22 – proximal end body carrying openings 24, 26, mounted to the robot arm), a distal tip of the endoscope (20 (at the end of 18) – present in the reference but not what is held in 32), and a light guide plug of the endoscope (22 (of 12)).
Regarding claim 22, Zardini teaches a method for holding at least a part of an endoscope (¶81 and claim 5, method for washing, cleaning and sterilizing or disinfecting endoscope 12, using device 10 mechanically and fluidically connected to it), the method comprising, providing a holding device (10) for holding at least the part of the endoscope (¶44 and ¶48, device 10 for fluidically and mechanically connecting the endoscope, comprising receiving means in the form of seat 32); placing at least the part of the endoscope (12 or 22) in a receiving area (interior 32; ¶51, ¶82, ¶85, holding body 22 is inserted into seat 32; guide rail 35 mates with the rib on the underside of 22 to make insertion faster and repeatable) that is at least partly enclosed by at least one receiving element (32 (34, 36)) of the holding device (¶50, seat 32 is delimited laterally by two lateral walls 34 and below by bottom wall 3, and is open at the front and the top so that 22 can be inserted); and holding at least the part of the endoscope in a fixed and predefined position (22 seated on 35, abutted by 63 at 23, coupled at 24, 26; ¶86, ¶71, on release of the levers the pins move to their forward position, cooperating with the converging transverse section 23 of the retaining body, “so as to ensure mechanical tensioning”; in that position they prevent detachment of 22 and withstand -2-3 bar) by using a plurality of holding elements (44, 46, 63) each connected to the at least one receiving element (¶62, ¶66, ¶70, conical connectors 44, 46 positioned through holes 43 in bottom wall 36; retaining pins 63 positioned along holes 64 formed through lateral walls 34), wherein each of the plurality of holding elements rest against at least the part of the endoscope (¶69, ¶71, each connector cooperates with its opening 24, 26 in 22 to each its optimum coupling position and guarantee a fluidic seal; each pin abuts the front part with converging cross-section 23 of 22.) and each are biased by a spring element (56 (for 44, 46); 73 (for 63)) towards at least the part of the endoscope (¶67, ¶69, ¶78-¶80, ¶86, each adjusting means 48 comprises an elastic means 56, e.g., a spring, aligned with the back of each conical connector, allowing it to yield elastically and adapt its axial insertion position to the specific opening; each lever 65 carries elastic element 73 in housing seat 75, coupled to portion 77, which returns the lever and drives pin 63 forward.).
Regarding claim 23, Zardini teaches the method according to claim 22, further comprising connecting at least one flushing adapter (44, 46) to at least one channel opening (24, 26; 44, 46 seated in 24, 26) of at least the part of the endoscope (22 - ¶55, ¶62-¶64, ¶85, conical connectors 44, 46 are the flushing adapters, they are coupled to the rear openings 24,26 of holding body 22, which communicate with the endoscope’s two longitudinal channels, producing a tapered plug-and-socket coupling with a fluid seal).
Regarding claim 24, Zardini teaches the method according to claim 23, further comprising introducing a liquid (washing liquid from 14, 16) via the at least one flushing adapter (44, 46) into the at least one channel opening (24, 26; 14, 16[Wingdings font/0xE0]50[Wingdings font/0xE0]44, 46[Wingdings font/0xE0]24, 26) to flush at least one channel of the endoscope (the two longitudinal channels of 18).
Claim Rejections - 35 USC § 103
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.
Claims 3, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zardini (EN112012004786)
Regarding claim 3, Zardini teaches the invention as set forth above but does not specifically teach wherein one or more of: the plurality of holding elements comprises at least six holding elements, and the at least six holding elements are at least partially formed of a polymer. Zardini shows four holding elements on the primary mapping (44, 46, 63, 63), not six. But Zardini expressly teaches that the number and arrangement of the conical connectors can be varied to suit the endoscope and can differ from the two shown (¶65; also ¶10 as to the number of openings 24, 26). It would have been obvious to provide six or more holding element, mere duplication of a working part where no new or unexpected result is produced, In re Harza, 274 F.2d 669 (CCPA 1960); MPEP § 2144.04 (VI)(B) – motivated by Zardini’s own statement that the count is dictated by the endoscope’s port layout. Since claim 3 is states “one or more of,” satisfying the six-element limb alone sustains the rejection; the polymer limb need not be reached. If reached, selecting resilient polymer for a part that seals against and contacts a delicate instrument is a conventional design choice (MPEP § 2144.07).
Regarding claim 20, Zardini teaches an arrangement for holding a plurality of parts (22 of each endoscope 12) of an endoscope (trolley of ¶36 / rack of ¶47), the arrangement comprising: a plurality of holding devices (10 duplicated) for holding the plurality of parts (10 (30, 32, 44, 46, 63)), respectively, of the endoscope, but does not specifically teach wherein at least one of the plurality of holding devices is the holding device. However, it would have been obvious to provide several, since “at least one” contemplates more and duplicating a working part yields only the expected result, In re Harza, 274 F.2d 669 (CCPA 1960); MPEP 2144.04 (VI)(B).
Regarding claim 21, Zardini teaches the arrangement, wherein the plurality of holding devices (10 duplicated) are configured to hold one or more of an operating part of the endoscope (trolley of ¶36 / rack of ¶47), and a light guide plug of the endoscope (10 (30, 32, 44, 46, 63)), respectively, of the endoscope, but does not specifically teach wherein at least one of the plurality of holding devices such as a distal tip of the endoscope. However, it would have been obvious to provide several, since “at least one” contemplates more and duplicating a working part yields only the expected result, In re Harza, 274 F.2d 669 (CCPA 1960); MPEP 2144.04 (VI)(B).
Claims 12, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zardini (EN112012004786) as applied to claim 1 above, and further in view of Halstead et al. (US 6,919,057).
Regarding claim 12, Zardini teaches the invention as set forth above but does not specifically teach wherein the at least one receiving element comprises an upper element movable between an opened position, in which at least the part of the endoscope is placeable into the receiving area and removable from the receiving area, and a closed position, in which at least the part of the endoscope is fixed in the predefined position by the holding elements. However, in a similar field of endeavor, Halstead teaches the holding device, wherein the at least one receiving element (20 (52, 54)) comprises an upper element (24) movable between an opened position, in which at least the part of the endoscope is placeable into the receiving area and removable from the receiving area (20 selectively openable on 28; head 22 positioned in 26), and a closed position, in which at least the part of the endoscope is fixed in the predefined position (24 closed onto 26, locked by 34 (36, 40); 22 located in 56 against the projections and recesses) by the holding elements (44, 46, 63 as in combination with Zardini). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Zardini with wherein the at least one receiving element comprises an upper element movable between an opened position, in which at least the part of the endoscope is placeable into the receiving area and removable from the receiving area, and a closed position, in which at least the part of the endoscope is fixed in the predefined position by the holding elements of Halstead, for the purpose of providing leak-tight engagement (col. 4, lines 45-55).
Regarding claim 13, Zardini teaches the invention as set forth above but does not specifically teach the upper element is rotatable about a horizontal axis. However, in a similar field of endeavor, Halstead teaches the holding device, wherein the upper element (24) is rotatable about a horizontal axis (hinge axis of 28 at sides 30,32). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Zardini with the upper element is rotatable about a horizontal axis of Halstead, for the purpose of providing leak-tight engagement (col. 4, lines 45-55).
Regarding claim 16, Zardini in view of Halstead teaches the invention as set forth above and Halstead further teaches the holding device comprises a push element (116 (received in groove 118); alternatively 108, 110 in grooves 100, 102) arranged to apply an opening force between the upper element of the at least one receiving element (24) and the lower element (26) of the at least one receiving element, wherein the opening force acts such that it is directed to move the upper element of the at least one receiving element and the lower element of the at least one receiving element at least partly apart (opposed by overcenter clamps 34 (latches 36, catches 40), which exist to hold 24 and 26 in leak-tight engagement against it) from each other (resilient compression of 116 between basin 52 of the upper portion and its groove in the lower portion). Motivation to combine is the same as in claim 12.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zardini (EN112012004786) as applied to claim 1 above, and further in view of Eibs (US 11,607,122).
Regarding claim 14, Zardini teaches the invention as set forth above but does not specifically teach wherein the holding device comprises a lever for moving a control element configured to move an elevator lever of the endoscope between an opened elevator lever position and a closed elevator lever position. However, in a similar field of endeavor, Eibs teaches the holding device, wherein the holding device comprises a lever (662 (of 660); alt. 440 with ratchet 444) for moving a control element (405 (405A, 405B) / 510 / 640) configured to move an elevator lever of the endoscope (304, 404, 504, 604) between an opened elevator lever position and a closed elevator lever position (raised and lowered states of 43). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Zardini with wherein the holding device comprises a lever for moving a control element configured to move an elevator lever of the endoscope between an opened elevator lever position and a closed elevator lever position of Eibs, for the purpose of to reduce labor intensive and time consuming endoscope cleansing processes of endoscopes while improving disinfection outcomes and achieving reduced overall cleaning throughput times without substantially increasing the capital costs of an end user (col. 2, lines 39-46).
Regarding claim 15, Zardini in view of Eibs teaches the invention as set forth above and Eibs further teaches wherein two holding parts oriented orthogonal to each other (441, protrudes laterally from 440, engages indentations 446 of ratchet 444, maintaining 430 in a first position and 430, disposed on 440 in a T-configuration; alternatively 405A, engaging 440 axially) are arranged on the control element (440 (with 405 at its distal end)). Motivation to combine is the same as in claim 14.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Zardini (EN112012004786) as applied to claim 23 above, and further in view of Allescher, Hans Dieter, et al. “Integration of robotic in the reprocessing and transfer of endoscopes.” Endoscopy International Open, vol. 10, no. 08, 18 July 2022, https://doi.org/10.1055/a-1789-0532.
Regarding claim 25, Zardini teaches the invention as set forth above but does not specifically teach further comprising using a robot arm to connect the alt least one flushing adapter to the at least one channel. However, in a similar field of endeavor, Allescher, Hans Dieter, et al. “Integration of robotic in the reprocessing and transfer of endoscopes.” Endoscopy International Open, vol. 10, no. 08, 18 July 2022, https://doi.org/10.1055/a-1789-0532 teaches the method, further comprising using a robot arm (fig. 5) to connect the alt least one flushing adapter (44, 46 as in combination with Zardini) to the at least one channel (24, 26; 14, 16[Wingdings font/0xE0]50[Wingdings font/0xE0]44, 46[Wingdings font/0xE0]24, 26 as in combi nation with Zardini). It would have been obvious to one of ordinary skill in the art before the effective filing date to provide the device of Zardini with comprising using a robot arm to connect the alt least one flushing adapter to the at least one channel of Allescher, Hans Dieter, et al. “Integration of robotic in the reprocessing and transfer of endoscopes.” Endoscopy International Open, vol. 10, no. 08, 18 July 2022, https://doi.org/10.1055/a-1789-0532, for the purpose of automated endoscope processing pathway (abstract).
Conclusion
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/HENRY DUONG/Primary Patent Examiner, Art Unit 2872 09/19/26
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