DETAILED ACTION
Applicant’s amendments to the claims filed January 30, 2026 were received. Claims 1 and 4-11 were amended. Claims 2 and 3 were cancelled.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office 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
Claims 1 and 8 are objected to because of the claims recite “pin-assy”. The expression should read as “pin-assembly” rather than the abbreviation. Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claims 1-6 and 11 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Andrevski et. al. (US 20030203491 A1).
Regarding claim 1, “A cartridge” (Figs. 7 and 8, Paras [0126] and [0128] multi-chamber reaction station 700, multi-chamber elution station 800) “for sandwich ELISA,” is capability of the cartridge; “comprising: a body” (Figs. 7 and 8, Paras [0126] and [0128], reaction chamber holding means 720, elution heating block 820); “ comprising a plurality of wells” (Figs. 7 and 8, Para [0126] and [0128], Reaction chambers 710, Elution chamber 810); “arranged in rows and columns in a width direction and a length direction, respectively, the wells” (Fig. 7); “having reagents” (Fig. 8, Para [0128], comprising elution reagent 811); “accommodated therein, and formed on a top surface thereof, a pin-assy” (Fig. 2a, Para [0104], rod assembly 200); “that includes a plurality of pins” (Fig. 2a, Para [0104] and [0128],handle means 220, handle means 850); “extending in one direction and having a capture antibody coated on some areas” (Fig. 2a, Paras [0087], [0104], [0127] and [0128], shape of substrate 240, substrate 730, receive substrate 830. The substrate may be of any type known to be useful by the skill artisan,); “of one end thereof and a single bar extending in the width direction and coupled to the other end of the pins so that the pins are" (Fig. 2a, Para [0104 and [0128], carrying means 210, carrying rod 855); “arranged to correspond to positions of the plurality of wells included in the row of wells; and a provider that extends in the width direction to support the pin-assy” (Para [0127] and [0128], transfer apparatus 760 places substrate 730 into chamber 710 , Cover 860); “and is movably formed in the length direction from the top surface of the body to provide the row comprised of the pins with the row comprised of the wells.” is capability of the provider. Andrevski discloses the positively claimed structural elements of the provider as claimed. Such provider is fully capable of the recited adaption in as much as recited and required herein. In addition, Andrevski teaches the movement within (Paras [0141] and [0142] Substrate 1230 is connected onto hanger bracket 1000. Hanger bracket 1000 is connected to bracket mount 1170 which, in turn, is connected to agitation mechanism 1105 by hanger bracket connection element 1165. Agitation mechanism 1105 is attached to track element 1115 by virtue of holder element 1110. Track element 1115 is adapted to move agitation mechanism 1105 and hanger bracket 1000 in a horizontal direction in order to position substrates 1130 above top openings 1197 of reaction chambers 1140. Track element 1115 is attached onto reaction chamber holding element 1125 by connection element 1120.); wherein the bar is rotatably coupled to the provider, and the one end of the pin is configured to be immersed in or taken out from the plurality of wells by the rotation of the bar; (Para [0104] and material already taught above, Carrying means 210 is made of any suitable material known in the art, such as, for example, metals, such as aluminum, polymers or copolymers, such as plastic, polypropylene and is freely rotable about axis 212.); “the bar being further configured to be rotated by the movement of the provider in the length direction, (Para [0118], [0118] Further, transfer apparatus 410, reaction chamber holder 450 and platform 460 may move in the x-y-z direction. Movement in the x-y-z direction provides for sealing valve 471 of plunger element 470 to align with aperture 443);
wherein the pins protrude in an opposite direction to a traveling direction of the provider to be supported on the top surface of the body, (Para, [0114], transfer apparatus 370 rotates 90 degrees downward to configure substrate 340 into a substantially vertical position for run-off of excess biological sample 320. In a preferred embodiment, only enough sample 320 is dispensed to be fully absorbed by the substrate.); when the provider is arranged at a position where the wells do not exist on the top surface of the body, and wherein the one end of the pins is immersed in the wells by the rotation of the bar, when the provider is arranged at a position where the wells exist on the top surface of the body.” (Para [0104] and [0114], and material already taught above, Carrying means 210 is made of any suitable material known in the art, such as, for example, metals, such as aluminum, polymers or copolymers, such as plastic, polypropylene and is freely routable about axis 212. Transfer apparatus 370 rotates 90 degrees downward to configure substrate 340 into a substantially vertical position for run-off of excess biological sample 320. In a preferred embodiment, only enough sample 320 is dispensed to be fully absorbed by the substrate.).
Regrading claim 4, Andrevski teaches all of claim 1 as above in addition to, “wherein the top surface of the body is covered with a membrane to prevent the reagents accommodated in the wells from being separated,” (Para [0051], 2) an inlet for dispensing at least one elution reagent; wherein said elution station comprises sealing means and a cover removably engaged to said sealing means.) “and the one end of the pins is immersed in the wells while crushing the membrane, when the bar is rotated by the movement of the provider in the length direction.” (Paras [0104], [0127], and [0128], and material already taught above, Carrying means 210 is made of any suitable material known in the art, such as, for example, metals, such as aluminum, polymers or copolymers, such as plastic, polypropylene and is freely routable about axis 212. Transfer apparatus 760 places substrate 730 into chamber 710 , Cover 860).
Regarding claim 5 Andrevski teaches all of claim 4 as above in addition to, “wherein at least some of the plurality of pin includes a tearer whose one end surface is inclined so that a tip thereof is sharply formed.” (Paras [0125] and [0094] and Fig. 6, Elution chamber 610 comprises a top opening 625 to receive substrate 630, wherein substrate 630 is allowed to be compressed against elution chamber 610. Top end 121 of handle means 120 is engaged to connection means 111 of carrying rod 110. Bottom end 122 is engaged to frame 130. Frame 130 is made of any suitable material known in the art, including metals such as aluminum or polymers or copolymers and may be in any form known in the art, such as, for example, rectangular, circular or elliptical. Preferably, frame 130 approximates the shape of substrate 140.) Therefore, the substrate in the shape which comes to a point is the tearer.
Regarding claim 6, Andrevski teaches all of claim 5 as above in addition to “wherein the at least some of the plurality of pin includes sample-stations recessed in a dish form that are formed in some areas on which the capture antibody is coated.” (Paras [0087] and [0095] Frame 130 functions to fixedly or detachably affix substrate 140. The substrate may be of any type known to be useful by the skill artisan, such as antibody-coated beads. Therefore, the frame teaches to the dish and the antibody-coated beads are the capture antibody which is coated on the substate.
Regarding claim 11, Andrevski teaches all of claim 1 as above in addition to “A sandwich ELISA device” within what is already taught above.
Claim Rejections - 35 USC § 103
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Andrevski et. al. (US 20030203491 A1) as applied to claim 6 and in further view of Kraemer (WO 2006005483 A1), machine translation.
Regarding claim 7, Andrevski teaches all of claim 6 as above but does not teach, “wherein the sample-station are formed on an opposite side where the tearer is formed.”
Kraemer teaches a test element cartridge and to a system for the analysis of liquid samples with the aid of at least one test element. In addition to “wherein the sample-station are formed on an opposite side where the tearer is formed.” (Page 5, This allows a simplified construction of an integrated measuring system, since the receiving location of the liquid sample and the puncturing device can be arranged on opposite sides of the test element and the puncture device of the sample holder thus does not stand in the way.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Andrevski to incorporate the teachings of Kraemer wherein the sample-station is formed on an opposite side where the tearer is formed. Doing so reduces the changes of contamination and pre mixing and reactions to happen within the material within the wells and the sample.
Allowable Subject Matter
Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not teach, or fairly suggest the cartridge, as claimed, including two holes at either end of the provider and the bar is accommodated in the groove.
The prior art does not teach, or fairly suggest, the cartridge as claimed including a pair of rails extending along a length at both ends of the body and sliders to engage with the rails to move the provider along the length of the cartridge.
Response to Amendments
Claim Amendments
In view of the claim amendments, the examiner has added further clarification in the 102 rejection above.
Objections
Examiner has withdrawn the previous claim objections in regards to the missing parentheses since the claims were amended.
112b Rejections
Applicant’s arguments are found persuasive. The rejections under 35 USC 112(b) are withdrawn.
Response to Arguments
Applicant's arguments filed 1/30/2026 have been fully considered.
Applicant argues that not all features of the claims are taught by Andrevski.
Examiner maintains the rejection and highlights the applicant has not pointed out which claim features are not taught within the 102 rejection.
Applicant argues that Kraemer contains no configuration corresponding to the well, etc.
Examiner points out that the rejection is not stating that Kraemer teaches the well. However Kraemer does not have to teach every element within the prior claims to be used for a 103 rejection. Examiner maintains the 103 rejection using Kraemer.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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