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 .
Claim Objections
Claim 20 is objected to because of the following informalities: “wherein-the” in L2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 12-20 are 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.
Regarding claim 12, the phrase "a removable test card, comprising a blood gas detection area and a hemoglobin-and-its-derivatives detection area" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "its-derivatives"), thereby rendering the scope of the claim unascertainable.
Claim 12 is further unclear reciting “the blood gas analyzer host is configured to provide power to the removable reagent pack and control on-off of a pipeline of the removable test card, to complete calibration, sample detection, and emptying” because it is unclear what structural configuration of the blood gas analyzer host is being claimed that provides power to the removable reagent pack and control on-off of a pipeline of the removable test card, to complete calibration, sample detection, and emptying. Dependent claims reciting above elements are similarly unclear.
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 (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.
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(s) 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (Lin et al., US 2013/0140179 A1) in view of ‘295 (Shenzhen Edan Instr Inc., CN 109557295A, see English translated version IDS 06/28/2023) and ‘493 (Sinnowa Medical Science & Tech Co LTD., CN 106290493A, see English translated version IDS 06/28/2023).
Regarding claim 12, Lin teaches:
12. A system, comprising:
an analyzer host (e.g., 10; ¶ 0002);
a removable test card (e.g., 20), comprising detection areas (see i.e., electrochemical sensors which can accurately detect certain biological analytes in blood ¶ 0002); and
a removable reagent pack (e.g., calibration cartridge 30),
wherein the removable reagent pack and the removable test card are connected through respective interfaces (see Figs. 10-11 for example).
wherein no fluid communication is formed between the removable test card and the analyzer host, and no fluid communication is formed between the removable reagent pack and the analyzer host (see i.e., [...] there is no fluid communication from the removable assay cartridge to any surface of the diagnostic device and no fluid communication from the removable calibration fluid cartridge to any surface of the diagnostic device. ¶ 0005);
the removable test card further comprises a first connector (i.e., connector formed by the needle 56, ¶ 0088), and the removable reagent pack further comprises a second connector (e.g., rubber seal 53 which forms a fluid seal at the needle 56 ¶ 0101);
the removable reagent pack and the removable test card are connected through the first connector and the second connector (see Fig. 10A ¶ 0088 and Fig. 10C ¶ 0101 for example); and
the analyzer host is configured to provide power (via power input 19 ¶ 0083, and power control board Fig. 44) to the removable reagent pack and control on-off of a pipeline of the removable test card (see i.e., By controllably powering the vacuum pump 50 on or off, and opening or closing the pinch valves 46-48, the calibration fluid, atmospheric air (or another gas), and fluid sample 39 may enter the assay cartridge 20 in a designated sequence ¶ 0099).
However, Lin does not explicitly teach: a removable test card, comprising a blood gas detection area and a hemoglobin detection area; and a removable reagent pack, comprising a peristaltic pump arranged inside.
‘295 teaches:
a blood gas analyzer host (see Summary and claim 14 for example);
a removable test card (e.g., 3), comprising blood gas detection areas (e.g., 3212, 3213; see i.e., pH, partial pressure of carbon dioxide (PCO2) and partial pressure of oxygen (PO2) in the blood, P1/Background technique); and
a removable reagent pack (e.g., 1, 2; claims 7-8), comprising a peristaltic pump (e.g., 12) arranged inside (see claims 7-8 and Figs. 1, 4 for example).
‘493 teaches:
a blood gas analyzer host (e.g., blood-gas analyzer, see P1/Summary for example); and
a removable test card, comprising a blood gas detection area and a hemoglobin detection area (see i.e., A whole blood sample to be detected is subjected to pH and ion determination and simultaneously, the optical detection method determines oxidized hemoglobin and reduced hemoglobin, P1/Summary; see also P5/advantage 6; and i.e., the electrochemical detection device includes 6 electrodes, which are respectively: a reference electrode 14, a pH electrode 15, a Na electrode 16, a K electrode 17, a Cl electrode 18, and a Ca electrode19; The chemical detection device passes through the electrodes in sequence to detect the pH value and ion concentration of the blood sample to be tested. P7/¶ 6).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Lin with the teachings of ‘295 for the purpose of blood gas detection and to integrate a peristaltic pump to precisely control fluid flow (‘295 Summary); and the teachings of ‘493 for the purpose of blood gas detection and hemoglobin detection (‘493 Summary).
With regard to limitations in claims 12-20 (e.g., blood gas detection [...]hemoglobin-and-its-derivatives detection [...]; [...] to provide power to the removable reagent pack and control on-off of a pipeline of the removable test card, to complete calibration, sample detection, and emptying; a detection [...] is implemented by colorimetric method, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 14-20, modified Lin teaches:
14. The system as claimed in claim 12, wherein the removable reagent pack comprises at least one liquid storage device (e.g., fluid pack 54) comprising an output pipeline (i.e., pipeline of the 52), at least one transport control device (e.g., 47, 48) capable of controlling at least a flow direction in a pipeline inside of the removable reagent pack (see ¶ 0094 for example), and at least one positioning mechanism capable of fixing the removable reagent pack on the analyzer host (see i.e., The calibration cartridge door 14 and the opening behind the door 14 are sized to receive a disposable calibration cartridge 30 [...] Behind the calibration cartridge door 14 is a calibration cartridge port configured to receive the calibration cartridge 30. ¶ 0081; see also ¶ 0093-0094, 0116, 0121 for example).
15. The in-vitro medical diagnosis system as claimed in claim 13, wherein a pipeline between the blood gas detection area and the hemoglobin detection area is capable of being in an open state or in a closed state (see i.e., A pinch valve 46 may be used to open or close the fluid channel 32, allowing the fluid sample 39 to travel into the testing portion 42. ¶ 0098; see also ¶ 0095 for example).
16. The in-vitro medical diagnosis system as claimed in claim 12, wherein the blood gas analyzer host is capable of controlling on-off of the pipeline of the removable test card through a power system (see ¶ 0083, 0127-0129 & Fig. 44 for example).
17. The system as claimed in claim 12, wherein the removable reagent pack at least comprises calibration liquid (see ¶ 0010 for example).
18. The in-vitro medical diagnosis system as claimed in claim 12, wherein a valve is inside of the removable test card, and the valve is capable of controlling an on-off state of the pipeline at a corresponding position of the removable test card (see i.e., the pinch valves 46-48 may be integrated pinch valves, having a thin film that is elastically biased out and can be closed by applying pressure in toward the cartridge 20 or 30. In these embodiments, the pinch valves 46-48 include flexible film areas 76 (shown in FIG. 25). The pinch valves 46-48 may be constructed at least in part with polyethylene terephthalate. ¶ 0100).
19. The system as claimed in claim 12, wherein the removable test card comprises at least three external interfaces; and the at least three external interfaces comprise a first interface (i.e., interface at the T-connector 52 to the needle 56) configured to inject a calibration liquid (see Fig. 10C for example), a second interface (e.g., 38) configured to inject a sample (see Fig. 10A for example), and a third interface (i.e., at the vacuum pump 50 to the fluid channel 32) connected to a waste liquid area of the removable test card (see Fig. 11A for example).
20. The in-vitro medical diagnosis system as claimed in claim 12, wherein the removable test card comprises at least three pipeline control parts (e.g., pinch valve actuators 78 for the pinch valves 46-48, valve control mechanisms); the at least three pipeline control parts are respectively capable of controlling an on-off state of the pipeline between the blood gas detection area and the hemoglobin detection area, connection between a sample inlet of the removable test card and a liquid path inside of the removable test card, and connection between the liquid path inside of the removable test card and a waste liquid area of the removable test card (see ¶ 0100-0101 for example); and an electrical coupling connection is between the blood gas analyzer host and the removable test card are electrically coupling together (see 0104-0106 for example), and the blood gas analyzer host is capable of supplying power to an electrochemical sensor in the removable test card through the electrically coupling (see ¶ 0127-0129 & Fig. 44 for example).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection.
Applicant is encouraged to amend the claims to include additional structural elements of the system.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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