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 Status
Claims 1-13 are pending and under examination.
Response to Amendment
The amendments to the claims received on 09/09/2025 are accepted and have overcome the previous drawing objections set forth in the Non-Final Office Action mailed on 06/11/2025. Accordingly, the drawing objections have been withdrawn.
The specification amendments, received on 09/09/2025, are accepted.
Based on the amended claims and remarks received on 09/09/2025, the previous prior art rejection over Lin has been withdrawn and a new prior art rejection set forth (see below).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 5-8 10, & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2013/0142709; already of record – hereinafter “Lin”), and further in view of Witty et al. (US 2004/0228765; already of record – hereinafter “Witty”).
Regarding claim 1, Lin disclose a reagent card (Lin; fig. 7, #20, “assay cartridge”, [0075]), comprising:
a reagent card body (Lin; fig. 7, #36, “cartridge body”, [0086]); and
an installation structure fixed to the reagent card body, (Lin; fig. 7, #34, “receiving port”, [0075]), the installation structure comprising an installation body (Lin; figs. 7-10 & 18, cylindrical body of receiving port 34; ]0109]);
wherein:
the installation body comprises an installation hole configured to sleeve a sample tube (Lin; figs. 7-10 & 18, interior of cylindrical body of receiving port 34 sleeves syringe 25; [0089, 0109]), a hollow needle provided in the installation hole (Lin; figs. 7-10, #38, [0089]), a sealing portion provided in the installation hole (Lin; figs. 7-10, #37, “C-shaped structure 37 is a sleeve for the syringe 25, holding the tip of the syringe 25 within the inlet 34”, [0089]), and an air inlet channel (Lin; fig. 7, channel in the C-shaped structure. “Air flows through the C-shaped structure 37 and into the area between the top of the syringe 25 and the interface 38, replacing the sample 39 that is aspirated into the fluid channel 32”, [0089, 0109]);
one end of the hollow needle is capable of being inserted into the sample tube (Lin; fig. 10, [0089]);
the sealing portion is in sealing fit with an outer wall of the sample tube (Lin; the C-shaped structure 37 is a sleeve for the syringe 25, fig. 10, [0089]);
the air inlet channel comprises an air outlet hole and an air inlet hole (Lin; fig. 7, “Air flows through the C-shaped structure 37 (i.e. an inlet) and into the area between the top of the syringe 25 and the interface 38 (i.e. an outlet), replacing the sample 39 that is aspirated into the fluid channel 32”, [0089, 0109]);
the air outlet hole is configured for communication with the sample tube provided on the installation hole (Lin; fig. 7, “Air flows through the C-shaped structure 37 (i.e. an inlet) and into the area between the top of the syringe 25 and the interface 38 (i.e. an outlet), replacing the sample 39 that is aspirated into the fluid channel 32”, [0089, 0109]).
Lin does not teach the air inlet hole is provided on a surface of the reagent card body and the air inlet channel extends from the installation body into the reagent card body.
However, Witty teach the analogous art of a reagent card body (Whitty; figs. 2 & 4, #20, [0048]), and an installation body (Witty; fig. 2, #22, [0022]), wherein the installation body comprises an installation hole configured to sleeve a sample tube (Witty; opening in dock 22 for inserting sample tube; fig. 2, [0046]), a hollow needle provided in the installation hole (Witty; fig. 4, #44, [0048]), an air inlet channel (Witty; fig. 2, channel defined between #24 and #42; [0048]) comprising an air inlet hole provided on a surface of the reagent card body (Witty; figs. 2 & 4, #24, [0048]), and the air inlet channel extends from the installation body into the reagent card body (Witty; figs. 2 & 4, [0046, 0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reagent card body and air inlet hole of Lin with the air inlet hole provided on a surface of the reagent card body wherein the air inlet channel extends from the installation body into the reagent card body, as taught by Witty, because Witty teaches the air inlet hold provided on a surface of the reagent card body provides low pressure air to force the sample through the other needle into the cartridge. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Lin and Witty both teach transferring a sample from a tube installed in a reagent card body.
Regarding claim 2, modified Lin teach the reagent card according to claim 1 above, wherein the sealing portion is provided with a sealing hole in sealing fit with a sample outlet end of the sample tube, one end of the hollow needle is arranged in the sealing hole; and the air outlet hole communicates with the sealing hole (Lin; figs. 7-10 & 18, “Air flows through the C-shaped structure 37 (i.e. an inlet) and into the area between the top of the syringe 25 and the interface 38 (i.e. an outlet), replacing the sample 39 that is aspirated into the fluid channel 32”, [0089, 0109]).
Regarding claim 5, modified Lin teach the reagent card according to claim 1 above, wherein: the reagent card body is fixed to the installation structure (Lin; fig. 7, [0075]), the reagent card body comprises a sample inlet channel communicating with a liquid outlet end of the hollow needle (Lin; fig. 10, #32, [0089]), a detection chamber (Lin; fig. 10, #42, [0090]), and an air receiving end (Lin teach needles 56 on the end of reagent card 20 configured to receive fluid or air; fig. 10, [0088]); and the sample inlet channel and the air receiving end communicate with the detection chamber (Lin; fig. 10, [0099]).
Regarding claim 6, modified Lin teach the reagent card according to claim 5 above, wherein the installation body and the reagent card body are integrally formed (Lin; figs. 7-10, [0075]).
Regarding claim 7, modified Lin teach the reagent card according to claim 5 above, wherein the reagent card body further comprises a calibration liquid channel; and the calibration liquid channel communicates with the detection chamber (Lin teach a pinch valve 47 for controlling the introduction of calibration fluid into the assay cartridge 20 through channel 84 and needle 56; [0088, 0093-0094, 0098-0099, 0116-0119]).
Regarding claim 8, modified Lin teach the reagent card according to claim 7 above, wherein the reagent card body further comprises a waste liquid storage chamber communicating with a liquid outlet end of the detection chamber (Lin; fig. 10, #35, [0090]); and a liquid outlet end of the waste liquid storage chamber communicates with the air receiving end (Lin teach pinch valves 46/47/48 for controlling the flow of liquid and air into the reagent cartridge 20 which communicate with the end of the waste liquid storage chamber; [0099]. The air pushes the calibration fluid into the waste area 35, clearing the testing portion 42 to allow fluid sample to be pumped into the testing portion).
Regarding claim 10, modified Lin teach an in-vitro diagnostic analyzer (Lin; fig. 1, #10, [0075]), comprising the reagent card according to claim 5 (Lin; fig. 1, #20, [0075]), and further comprising: a negative pressure generator (Lin; fig. 10, #50, [0093]); a sample tube (Lin; fig. 10, #25, 0077]); a first retractor (Lin teach a retractor 78 for actuating pinch valves 46-48; fig. 10, #78, [0098, 0100]); a detection device (Lin; fig. 10, #57, [0105]); and a controller; (Lin; fig. 44, main board comprising the processor and memory; [0106]), wherein: the negative pressure generator is in connection with the air receiving end (Lin disclose controlling the negative pressure generator 50 to control the flow of air through the reagent cartridge 20; fig. 10, [0099]); the sample tube is provided with a sample outlet end in clearance fit with the hollow needle (Lin; fig. 10, [0089]); the first retractor is provided with a sealing end configured to seal the air inlet hole (The modification of the reagent card body and air inlet hole of Lin with the air inlet hole provided on a surface of the reagent card body wherein the air inlet channel extends from the installation body into the reagent card body, as taught by Witty, has previously been discussed in claim 1 above. Lin teach the first retractor 78 is configured to cooperate with pinch valve 48 to seal the air inlet hole; figs. 10 & 32-33, [0098, 0100, 0119]); the controller telecommunicates with the negative pressure generator (Lin; fig. 44, [0098-0099]), the first retractor (Lin; fig. 44, [0098-0099]), and the detection device (Lin; fig. 44, [0098-0099]); and a detection end of the detection device is arranged in the detection chamber (Lin; figs. 7-10, #40, #42, [0090]).
Regarding claim 13, modified Lin teach the in-vitro diagnostic analyzer according to claim 10 above, further comprising a calibration liquid channel communicating with the detection chamber (Lin; figs. 10 & 31, #84, [0099, 0116]); and a second calibration liquid bag (Lin; fig. 10, #54, [0116]); wherein the second calibration liquid bag communicates with the calibration liquid channel through an on-off valve (Lin; figs. 10 & 32-34, #47, [0098]).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Witty, and further in view of Takeuchi et al. (US 2018/0321269; already of record – hereinafter “Takeuchi”).
Regarding claim 3, modified Lin teach the reagent card according to claim 1 above.
Modified Lin does not teach wherein an outer edge of the air inlet hole is provided with a sealing layer.
However, Takeuchi teach the analogous art of a structure comprising a channel (Takeuchi; figs. 2A-C, #10, #44, [0022-0023]) wherein the channel comprises an air inlet hole (Takeuchi; fig. 2C, #61, [0039]) wherein an outer edge of the air inlet hole is provided with a sealing layer (Takeuchi; fig. 2C, #60, #80, [0039, 0049]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the air inlet hole of modified Lin to comprise a sealing layer, as in Takeuchi, because Takeuchi teaches the sealing layer 60/80 fluid to sweep through the channel; [0023]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Lin and Takeuchi both teach channels comprising holes for air to exchange.
Regarding claim 4, modified Lin teaches the reagent card according to claim 3 above, wherein the sealing layer comprises an elastic layer and an adhesive layer arranged on the elastic layer, and the elastic layer is arranged facing outward (The modification of the air inlet hole of modified Lin to comprise a sealing layer, as in Takeuchi, has previously been discussed in claim 3 above. Takeuchi further teaches the sealing layer comprise an elastic layer and an adhesive layer; [0039, 0049]).
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Witty, and further in view of Lauks et al. (US 2004/0222091; already of record – hereinafter “Lauks”).
Regarding claim 9, modified Lin teach the reagent card according to claim 7 above.
Modified Lin does not teach wherein: the reagent card body further comprises a first calibration liquid bag and a valve core; the first calibration liquid bag is fixed on the reagent card body; the first calibration liquid bag is provided with a matching portion in connection with the calibration liquid channel; the valve core is arranged in the calibration liquid channel or in the first calibration liquid bag; and the valve core is provided with a spiked portion configured to pierce the matching portion.
However, Lauks teaches the analogous art of a reagent card (Lauks; figs. 2A-B, [0041]) comprising a reagent card body (Lauks; fig. 2A, #200, [0041]) wherein the reagent card body further comprises a first calibration liquid bag (Lauks; fig. 2A, #220, [0040]) and a valve core (Lauks; figs. 2C-2E, #282, [0045]); the first calibration liquid bag is fixed on the reagent card body (Lauks; fig. 2A, #220, [0040]); the first calibration liquid bag is provided with a matching portion in connection with the calibration liquid channel (Lauks; fig. 2C-2E, [0043]); the valve core is arranged in the calibration liquid channel or in the first calibration liquid bag (Lauks; figs. 2C-2E, [0045]); and the valve core is provided with a spiked portion configured to pierce the matching portion (Lauks; figs. 2C-2E, corner spike of valve core 282 causes foil 286 to break and release fluid from the calibration liquid bag 220; [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reagent card of modified Lin to further comprise a first calibration liquid bag, valve core, and matching portion, as in Lauks, because Lauks teaches the first calibration liquid bag, valve core, and matching portion allows calibration of sensors in the reagent card (Lauks; [0045]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Lin and Lauks both teach calibrating a reagent card with calibration fluid.
Regarding claim 12, modified Lin teach the in-vitro diagnostic analyzer according to claim 10 above, wherein: the reagent card body further comprises a calibration liquid channel communicating with the detection chamber (Lin; figs. 10 & 31, #84, [0099, 0116]); and the in-vitro diagnostic analyzer further comprises a second retractor that telecommunicates with the controller; a telescopic end of the second retractor is capable of pressing the calibration liquid channel or the calibration liquid bag in a preset direction (Lin teaches retractors 78 for actuating pinch valves 46-48; figs. 10 & 32-34, #78, [0098, 0100]).
Modified Lin does not teach a first calibration liquid bag; and a valve core; the first calibration liquid bag is fixed on the reagent card body; the first calibration liquid bag is provided with the matching portion in connection with the calibration liquid channel; the valve core is arranged in the calibration liquid channel or in the first calibration liquid bag; the valve core is provided with a spiked portion configured to pierce the matching portion; such that the spiked portion pierces the matching portion.
However, Lauks teaches the analogous art of a reagent card (Lauks; figs. 2A-B, [0041]) comprising a reagent card body (Lauks; fig. 2A, #200, [0041]) wherein the reagent card body further comprises a first calibration liquid bag (Lauks; fig. 2A, #220, [0040]) and a valve core (Lauks; figs. 2C-2E, #282, [0045]), the first calibration liquid bag is fixed on the reagent card body (Lauks; fig. 2A, #220, [0040]), the first calibration liquid bag is provided with a matching portion in connection with the calibration liquid channel (Lauks; fig. 2C-2E, [0043]), the valve core is arranged in the calibration liquid channel or in the first calibration liquid bag (Lauks; figs. 2C-2E, [0045]), and the valve core is provided with a spiked portion configured to pierce the matching portion, such that the spiked portion pierces the matching portion (Lauks; figs. 2C-2E, corner spike of valve core 282 causes foil 286 to break and release fluid from the calibration liquid bag 220; [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the reagent card and retractor of modified Lin to further comprise a first calibration liquid bag, valve core, and matching portion, as in Lauks, because Lauks teaches the first calibration liquid bag, valve core, and matching portion allows calibration of sensors in the reagent card (Lauks; [0045]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Lin and Lauks both teach calibrating a reagent card with calibration fluid.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Witty, and further in view of Gutsell et al. (US 2015/0346105; already of record – hereinafter “Gutsell”).
Regarding claim 11, modified Lin teach the in-vitro diagnostic analyzer according to claim 10 above, comprising the sealing end.
Modified Lin does not teach wherein: the sealing end is provided with a protruding sealing ring; and the sealing ring can be hermetically arranged at an outer edge of the air inlet hole.
However, Gutsell teaches the analogous art of a sealing end (Gutsell; fig. 3B, #27, [0192]) wherein the sealing end is provided with a protruding sealing ring (Gutsell; fig. 3B, #29, [0192]), and the sealing ring can be hermetically arranged at an outer edge of a hole (Gutsell; fig. 3B, [0192]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sealing end of modified Lin with the sealing end comprising a protruding sealing ring hermetically arranged at an outer edge of a hole, as in Gutsell, because Gutsell teaches the sealing end comprising the protruding sealing ring forms a sealing contact with the hole (Gutsell; [0192]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Lin and Gutsell both teach retractor devices configured to seal a hole.
Response to Arguments
Applicant’s arguments, filed 09/09/2025, have been considered but are moot because the arguments are towards the amended claims and do not apply to the current grounds of rejection. However, because the examiner is using the same prior art in the rejection, then the examiner will address applicant’s remarks in order to promote compact prosecution.
Applicant argues on pages 9-11 of their remarks that neither Lin nor Lai teach or suggest the amended claim limitation “the air inlet hole is provided on a surface of the reagent card body”. The examiner agrees and notes the arguments are toward the amended claim language and do not apply to the current ground(s) of rejection. Further, the examiner has withdrawn the previous prior art rejection and set forth a new prior art rejection over Lin and further in view of Witty which teach the amended limitations of claim 1.
Applicant further argues on pages 11-12 that the prior art does not disclose the sealing portion is in sealing fit with an outer wall of the sample tube. Applicant further argues that the C-shape structure comprises a gap which is permanently open and thus rendering Lin incapable of providing a sealing fit. The examiner respectfully disagrees. Lin disclose the C-shaped structure 37 is a sleeve for the syringe 25, figs. 10 & 18, [0089, 0109]. In other words, the portion of the outer wall of syringe 25 that is in contact with the C-shaped structure 37 is sealed, which reads on the argued limitation. If applicant is intending to claim that the entire outer perimeter of the sample tube is sealed by the sealing portion, then the examiner suggests applicant amend the claims to further define the limitation. For example, the examiner suggests applicant amend the argued limitation to recite “the sealing portion is in sealing fit with a circumference of an outer wall of the sample tube”.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CURTIS A THOMPSON whose telephone number is (571)272-0648. The examiner can normally be reached on M-F: 7:00 a.m. - 5:00 p.m..
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798