DETAILED ACTION
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 .
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.
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.
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 1-6 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chinese Publication CN 111175525A to Wang Yanshuai (herein Wang) as cited on the 27 June 2023 IDS (see machine translation provided) in view of Chinese Publication CN 108318312A to Zhang Qingdong (herein Zhang) as cited on the 09 January 2025 IDS (see machine translation provided).
Regarding claim 1, Wang discloses an automated blood typing analyzer (i.e., automated molecular diagnostics instrument) comprising a cartridge preprocessing system 40/50 (see [0064]; Figs. 1-11), the cartridge preprocessing system comprising: a sample adding mechanism 40 (i.e., a piercing device) comprising a sample dispensing horizontal and vertical transmission mechanism (i.e., driving assembly) and a movable sample needle 41 (i.e., piercing member), wherein the driving assembly is configured to control the piercing member 41 (see [0077]; Fig. 5) to alternatively move to sampling position 603 (i.e., piercing station) and cleaning cup 53 (i.e., cleaning station), wherein the piercing member 41 is configured to pierce a sealing plug of a test tube 6 (i.e., cartridge) that moves to the piercing station 603 (see [0088]; Figs. 3 and 8-10); and a cleaning mechanism 50 (i.e., cleaning device), configured to clean the piercing member 41 that moves to the cleaning station 53 (see [0089]; Figs. 3 and 8-9). Note that the Merriam-Webster Dictionary defines a cartridge as “a case or container that holds a substance, device, or material which is difficult, troublesome, or awkward to handle and that usually can be easily changed” which under the broadest reasonable interpretation the test tube of Wang reads on a cartridge.
Wang fails to discloses “the piercing member is configured to pierce a barrier film of a cartridge” as recited in the instant claim.
Zhang discloses a fully automated urine formed element staining analyzer comprising a sampling device, wherein the sampling device comprises a needle 479 (i.e., piercing member) configured to pierce an aluminum film (i.e., barrier film) of a cartridge (see [0040]).
Zhang and Wang are analogous in the field automatic molecular diagnostic instruments for biological sample analysis. Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date for the piercing member of Wang to be configured to pierce a barrier film as this is well known in the art as evidenced by Zhang (see MPEP 2144.07 Art Recognized Suitability for an Intended Purpose).
Regarding claim 2, the combination of references above render obvious the invention of claim 1.
Wang discloses the piercing member 41 comprises a cylinder, an upper end of the cylinder is connected with the driving assembly (see Fig. 5).
Wang fails to disclose “a lower end of the cylinder is of a quadrangular pyramid structure” as recited in the instant claims, however, MPEP 2144.04 IV. B. Changes in Shape states that the configuration of a claimed element is a matter of choice one of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration is significant. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to change the shape of the lower end of the cylinder as desired for the type of cartridge being pierced.
Regarding claim 3, the combination of references above render obvious the invention of claim 1.
Wang discloses wherein the driving mechanism comprises a vertical transmission mechanism (i.e., lifting driving part) and a horizontal transmission mechanism, wherein the vertical transmission mechanism is connected to the horizontal transmission mechanism and is configured to control the lifting of the piercing member 41 (see [0077]; Fig. 5), and the horizontal transmission mechanism is connected with the piercing member 41 and configured to control the piercing member 41 to move between the piercing station 603 and the cleaning station 53 (see [0088]; Figs. 3 and 8-10).
Wang fails to disclose “a swinging driving part, wherein the lifting part is connected with the swinging driving part and is configured to control the lifting of the swinging driving part, and the swinging driving part is connected with the piercing member and configured to control the piercing member to swing between the piercing station and the cleaning station” as recited in the instant claim.
Zhang discloses the sampling device comprises a sampling body 47 (i.e., driving assembly), wherein the driving assembly 47 comprises a vertical drive assembly 476 and a vertical support plate 472 (i.e., lifting driving part); and a swinging drive assembly 478 and swinging support plate 474 (i.e., swinging driving part), wherein the lifting driving part is connected to the swinging driving part and is configured to control the lifting of the swinging driving part, and the swinging driving part is connected with a piercing member 479 and configured to control the piercing member to swing (see [0040-0041]; Fig. 4). Zhang discloses the swinging driving part comprises a swing support plate 474 (i.e., swinging fixing seat), a drive assembly 4781 (i.e., swinging motor) and a swinging arm 4785 (see [0041]; Fig. 4). Zhang discloses the swinging fixing seat 474 is fixed to an output end of the lifting driving part and the swinging fixing seat 474 is in sliding fit with the vertical support plate 472 (i.e., lifting guide rail), and the swinging motor 4781 is mounted to the swinging fixing seat 474, a rotating shaft 4783 (i.e., output shaft) of the swinging motor 4781 is connected with the swinging arm 4785 through a swinging transmission assembly 478, and the piercing member 479 is fixed in the swinging arm 4785 (see [0040-0041]; Fig. 4).
Zhang and Wang are analogous in the field automatic molecular diagnostic instruments for biological sample analysis. Therefore, it would have been obvious to one or ordinary skill in the art before the effective filing date to modify the system of Wang to comprise the swinging driving part of Zhang for the benefit of allowing more flexible sampling and sample addition (see [0041] of Zhang).
Regarding claim 4, the combination of references above render obvious the invention of claim 3.
Wang discloses wherein the lifting driving part comprising a lifting motor 47 and a lifting guide rail (see [0078]; Fig. 5) and Wang modified to comprise the swinging driving part of Zhang discloses the remaining features of claim 4 (see claim 3 above).
Regarding claim 5, the combination of references above render obvious the invention of claim 1.
Wang discloses a test tube pushing mechanism 20 (i.e., transmission device), wherein the transmission device comprises a housing and a test tube rack push rod 21 (i.e., pushing part), a transmission passage 601, 602, 603, and 604 is arranged within the housing, the pushing part 21 is configured to push the cartridge 6 to move in the transmission passage, wherein the driving assembly and the cleaning device 50 each is mounted to the housing, and a sampling position 603 (i.e., piercing port) for the piercing member to extent into is arranged at the housing (see [0071];[0087-0089]; Figs. 1-4, and 9).
Regarding claim 6, the combination of references above render obvious the invention of claim 5.
Wang discloses a scanner (i.e., information scanning device) for scanning a barcode at an outer side of cartridge 6, wherein the information scanning device is mounted to the housing, and a code scanning gap (see gap between cartridges 6 in test tube rack 605) for avoiding the information scanning device is arranged in the housing (see [0073]; see Figs. 1 and 4).
Regarding claim 8, the combination of references above render obvious the invention of claim 1.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Regarding claim 9, the combination of references above render obvious the invention of claim 8.
Wang discloses wherein the cleaning hole 533 has an upward opening and is cylindrical, an axis of the cleaning liquid filling port 531 is spaced apart from a center of the cleaning hole 533 by a preset distance (see Figs. 7-8). Wang fails to explicitly disclose “wherein the cleaning liquid forms a vortex in the cleaning hole” as recited in the instant claim, however, as Wang discloses all the structural features of the claim, Wang would be capable of having the cleaning liquid form a vortex in the cleaning hole.
Regarding claim 10, the combination of references above render obvious the invention of claim 9.
Wang discloses the cleaning liquid filling port 531 is distributed on the circumference of the cleaning hole 533 (see Figs. 7-8).
Wang fails to disclose “wherein the number of the cleaning liquid filling port is at least two, and all of the at least two cleaning liquid filling ports are sequentially distributed along a circumferential direction of the cleaning hole” as recited in the instant claim.
MPEP 2144.04 IV. Reversal, Duplication, or Rearrangement of Parts states that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced and the placement of a particular part is an obvious matter of design choice if the placement would not modify the operation of the device. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date for the number of the cleaning liquid filling port to be at least two, and for all of the at least two cleaning liquid filling ports to be sequentially distributed along a circumferential direction of the cleaning hole for the benefit of adding cleaning solution from both sides of the cleaning hole. Furthermore, Zhang discloses a cleaning device 60 comprising cleaning tank 63 (i.e., cleaning hole) (see [0045]) with two cleaning liquid filling ports sequentially distributed along a circumference direction of cleaning hole 63 (see Fig. 6). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date for the number of the cleaning liquid filling port to be at least two, and for all of the at least two cleaning liquid filling ports to be sequentially distributed along a circumferential direction of the cleaning hole as this is a suitable configuration in the art as evidenced by Zhang (see MPEP 2144.07 Art Recognized Suitability for an Intended Purpose).
Regarding claim 11, the combination of references above render obvious the invention of claim 1.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Regarding claim 12, the combination of references above render obvious the invention of claim 3.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Regarding claim 13, the combination of references above render obvious the invention of claim 4.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Regarding claim 14, the combination of references above render obvious the invention of claim 5.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Regarding claim 15, the combination of references above render obvious the invention of claim 6.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chinese Publication CN 111175525A to Wang Yanshuai (herein Wang) as cited on the 27 June 2023 IDS (see machine translation provided) in view of Chinese Publication CN 108318312A to Zhang Qingdong (herein Zhang) as cited on the 09 January 2025 IDS (see machine translation provided); and in further view of United States Patent US 7,186,378 to Dunfee.
Regarding claim 7, the combination of references above render obvious the invention of claim 5.
Wang fails to disclose “wherein the housing is provided with a filling port for adding reagent to the cartridge” as recited in the instant claim.
Dunfee discloses a sampling aliquotter for aspirating aliquot portions of sample fluid from a closed container and for dispensing aliquot portions into a vessel using horizontal and vertical drives to probe into the closed container, to the position the probe above the vessel, and the lower the probe into a cleansing module (see abstract). Dunfee discloses the apparatus comprises a reagent dispensing location (i.e., filling port) for adding reagent to a reaction cuvette (i.e., cartridge) (see Col. 8, lines 45-60).
Dunfee and Wang are analogous in the field of automated molecular diagnostics instruments. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the housing of the system of Wang for further comprise a filling port for adding reagent to the cartridge for the benefit of causing specific reactions with a biological sample for analysis and patient diagnosis (see Col. 1, lines 16-33).
Regarding claim 16, the combination of references above render obvious the invention of claim 7.
Wang discloses the cleaning device 50 comprises inlet chamber 533 (i.e., cleaning hole) for accommodating the piercing member 41, an inlet connector 531 (i.e., a cleaning liquid filling port) for the cleaning liquid to enter the cleaning hole 533, and an outlet connector 532 (i.e., liquid discharge passage) for discharging liquid in the cleaning hole 533 (see [0079-0080 and 0089]: Figs. 7-9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797