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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/18/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments and remarks, filed on 9/18/2026, have been entered. The claim amendments overcome the previous prior art rejection, and a new prior art rejection is applied.
Claim Status
Claims 1-20 are pending and being examined.
Claim Objections
Claim 13 is objected to because of the following informalities: claim 13 recites “the analyzer, chemical analyzer or clinical analyzer of claim 12” should read “the analyzer of claim 12” in line 4. Appropriate correction is required.
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 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 1-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Peyvan et al (US 20150024384 A1; hereinafter “Peyvan”; already of record on IDS filed 9/17/2025) in view of Quinn et al (US 20130109082 A1; hereinafter “Quinn”).
Regarding claim 1, Peyvan teaches a reagent sleeve system (Peyvan; Abstract) comprising:
a reagent sleeve (Peyvan; Fig. 2A; para [89]; the reagent delivery column 101) comprising: a first end having a first opening (Peyvan; Fig. 2A; Examiner interprets the first end as the top portion of the reagent sleeve which comprises the cap) and a second end (Peyvan Fig. 2A; the Examiner interprets the second end as the bottom portion of the reagent sleeve); a sleeve peripheral wall extending between the first end and the second end (Peyvan; Fig. 2A; para [144]; housing walls), and at least one removable end wall covering the first end or the second end, the at least one removable wall comprising an opening for a passage of a reagent extractor (Peyvan; Fig. 16A; para [154]; the housing 812 can be coupled to a plug member 865 in which opening 862 is formed, configured to secure the breaching element 814); and
a plurality of removable reagent reservoirs located within the reagent sleeve (Peyvan; Fig. 2A, 2B, 4, 5; para [89, 90]; at least one or a plurality of reagent storage elements 104…a housing 112 configured to receive the reagent storage element(s) 104),
wherein each of the plurality of removable reagent reservoirs comprises a respective peripheral wall, and first and second end walls (Peyvan; Fig. 2A, 2B; the peripheral wall is interpreted as the side walls and the first and second end walls are interpreted as the bottom wall and top wall, respectively), whereby each of the plurality of removable reagent reservoirs contains a reagent located therein (Peyvan; Fig. 2B; para [97]; the reagent storage elements 104 can include within their respective volumes the same or distinct reagents, fluids, which may include liquid(s) and/or gas(s), suspensions, or any a combination of fluids and gases), and
the respective first end wall of the plurality of removable reagent reservoirs is pierceable by a reagent extractor (Peyvan; Fig. 2A; para [91]; a breaching element 114, such as a piercing or puncturing structure, for example a needle, configured to pierce, puncture, tear, or otherwise breach the reagent storage elements 104; as notes above the Examiner interprets the bottom wall which is pierceable to be the first end wall), and the reagent sleeve comprises a peripheral wall that encompasses the plurality of removable reagent reservoirs and holds the plurality of reagent reservoirs for sequential use (Peyvan; Fig. 2A; para [91]; two or more reagent storage elements 104 can be stacked or coupled together to form a storage element stack 105, which in turn can be received in the housing 112), wherein the reagent reservoirs are not permanently attached to the reagent sleeves or to each other (Peyvan; para [92]; the reagent storage elements 104 can be permanently or removably coupled to one another), and are freely removable from the reagent sleeve through the at least one removable end wall1 (Peyvan; para [154]; a plug member 865).
1 The limitations are directed to the function and/or the manner of operating the reagent reservoirs, all the structural limitations of the claim has been disclosed by Peyvan and the reagent reservoirs of Peyvan is capable of being “freely removable from the reagent sleeve through the at least one removable end wall”. As such, it is deemed that the claimed reagent reservoirs are not differentiated from the reagent reservoirs of Peyvan (see MPEP §2114). Specifically, if the storage elements are capable of moving/sliding within the housing, then the storage element would be capable of being removed when the plug is removed.
Peyvan does not disclose the second end comprising a second opening.
However, Quinn teaches an analogous art of an apparatus for delivering a plurality of liquid volumes (Quinn; Abstract) comprising a reagent sleeve (Quinn; Fig. 3; para [83]; a reagent tube (2) for containing reagent solutions for an immunoassay) further comprising: a first end having a first opening; a second end having a second opening (Quinn; para [42]; two (or more) such openings are provided in the lateral wall of the vessel at a position corresponding to that of a void formed within the vessel). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the reagent sleeve of Peyvan to comprise the second opening as taught by Quinn, because Quinn teaches that it facilitates vacuum filing of liquid into the void (Quinn; para [42]).
Regarding claim 2, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the second end wall of each of the plurality of removable reagent reservoirs is pierceable by a reagent extractor (Peyvan; para [117]; as the centripetal forces continue to act on the reagent storage elements 104, the aforementioned reagent storage element consumption process continues until all reagent storage elements 104 are substantially emptied and slide down in the housing 112 circumscribing the needle 114).
Regarding claim 3, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the plurality of reagent reservoirs is arranged end-to-end (Peyvan; Fig. 2B).
Regarding claim 4, modified Peyvan teaches the reagent sleeve system of claim 2, wherein the plurality of reagent reservoirs is arranged end-to-end and the reagent extractor can pass through a first of the plurality of reagent reservoirs and into a second of the plurality of reagent reservoirs (Peyvan; para [117]; all reagent storage elements 104 are substantially emptied and slide down in the housing 112 circumscribing the needle 114).
Regarding claim 5, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the peripheral wall of each of the plurality of reagent reservoirs is cylindrical (Peyvan; Fig. 9A). The top view of the reagent storage 104.
Regarding claim 6, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the first end wall of each of the plurality of reagent reservoirs comprises a pierceable film (Peyvan; Fig. 5, 6; para [117]; all reagent storage elements 104 are substantially emptied and slide down in the housing 112 circumscribing the needle 114).
Regarding claim 7, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the reagent sleeve comprises a first opening through which each of the plurality of reagent reservoirs can pass (Peyvan; Fig. 2A, 4; para [90]; a housing 112 configured to receive the reagent storage element(s) 104).
Regarding claim 8, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the reagent sleeve comprises a second opening aligned with the pierceable first end wall of a first of the plurality of reagent reservoirs (Peyvan; para [88]; The spacer elements 107 can contribute to promoting better translation of the storage elements 104 in housing 112 and protect the storage elements 104 from prematurely bursting), wherein the reagent extractor passes through the second opening when the reagent extractor pierces the pierceable first end wall of the first reagent reservoir (Peyvan; Fig. 5, 6; para [88]; The spacer elements 107 in some aspects are hollow or include a void or opening toward a central region thereof, to facilitate easy passage over or around the needle 114. Alternatively, the spacer elements 107 can be fabricated of a material that is permeable at least in the area where the needle 114 coincides therewith). The reagent sleeve comprises the second opening covered by the spacer element as seen in Fig. 5 and 6, because Peyvan teaches that the reagent delivery column 101 can include an egress structure, portion, or assembly 102 (Peyvan; para [89]). Thus, the second opening is present at the end with the spacer element if the assembly is removed.
Regarding claim 9, modified Peyvan teaches the reagent sleeve system of claim 8, wherein the second opening is covered with a pierceable cover (Peyvan; Fig. 5, 6; para [88]; the spacer elements 107 can be fabricated of a material that is permeable at least in the area where the needle 114 coincides therewith).
Regarding claim 10, modified Peyvan teaches the reagent sleeve system of claim 1, wherein the reagent sleeve is sized and configured to interface with an analyzer, chemical analyzer or clinical analyzer and the reagent extractor to pierce the first end wall of one of the plurality of reagent reservoirs (Peyvan; Fig. 1; para [30]; The eluent will contain the RNA and is ready for downstream applications). The limitation is directed to the function and/or the manner of operating the reagent sleeve, all the structural limitations of the claim has been disclosed by Peyvan and the reagent sleeve of Peyvan is capable of being “configured to interface with an analyzer, chemical analyzer or clinical analyzer and the reagent extractor to pierce the first end wall of one of the plurality of reagent reservoirs”. As such, it is deemed that the claimed reagent sleeve is not differentiated from the reagent sleeve of Peyvan (see MPEP §2114).
Regarding claim 11, modified Peyvan teaches the reagent sleeve system of claim 1, wherein each of the plurality of reagent reservoirs comprises a set of analysis reagents (Peyvan; para [49]; a plurality of reagent storage elements having a reagent stored therein), with each of the set of analysis reagents having an expiration date set, and each of the plurality of reagent reservoirs has the same set of analysis reagents with the same expiration date sets (Peyvan; para [131]; The reagent storage elements 104 may respectively store the same or different reagents. They can store the same reagents where it is desired for the same reagent to be delivered at intervals in the same or different quantities). The “expiration date set” would be inherent to the analysis reagents as there are factors that degrade effectiveness over time.
Regarding claim 20, modified Peyvan teaches the reagent sleeve system of claim 1, further comprising an access opening located on a side of the sleeve peripheral wall or the at least one removable end wall (Peyvan; para [154]; a plug member 865 in which opening 862 is formed), and wherein the reagent sleeve system is configured to enable tracking and management of expiration dates for each reagent reservoir, wherein expired reagent reservoirs of the plurality of reagent reservoirs is individually removable and replaceable to minimize reagent waste. The limitations are directed to the function and/or the manner of operating the reagent reservoirs, all the structural limitations of the claim has been disclosed by Peyvan and the reagent reservoirs of Peyvan is capable of being “configured to enable tracking and management of expiration dates for each reagent reservoir, wherein expired reagent reservoirs of the plurality of reagent reservoirs is individually removable and replaceable to minimize reagent waste.”. As such, it is deemed that the claimed reagent reservoirs are not differentiated from the reagent reservoirs of Peyvan (see MPEP §2114). Specifically, the Applicants do not provide any positively recited structure to distinguish the expired reagent reservoirs from the plurality of reagent reservoirs.
Claims 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20200173909 A1; hereinafter “Lee”; priority filed on 2/11/2016; already of record) in view of Peyvan in view of Quinn.
Regarding claim 12, Lee teaches an analyzer (Lee; Abstract) comprising: a reagent sleeve system port configured to receive a reagent sleeve system (Lee; Fig. 2; para [36]; measurement cartridge 100 is mounted on a mounting portion 210); the reagent sleeve system removably connected to the reagent sleeve port (Lee; Fig. 2; para [36]; The measurement cartridge 100 is mounted on the mounting portion 210); the reagent extractor configured to deliver reagent from one of the plurality of reagent reservoirs for use in the analyzer (Lee; para [36]; In a state in which the measurement cartridge 100 is mounted on the meter 200, the sample and the dry reagent are introduced into the liquid reagent so that a measurement process is performed).
Lee does not teach the reagent sleeve system of claim 1.
However, Peyvan teaches a reagent sleeve system (Peyvan; Abstract) comprising: a reagent sleeve (Peyvan; Fig. 2A; para [89]; the reagent delivery column 101) comprising: a first end having a first opening (Peyvan; Fig. 2A; Examiner interprets the first end as the top portion of the reagent sleeve which comprises the cap) and a second end (Peyvan Fig. 2A; the Examiner interprets the second end as the bottom portion of the reagent sleeve); a sleeve peripheral wall extending between the first end and the second end (Peyvan; Fig. 2A; para [144]; housing walls), and at least one removable end wall covering the first end or the second end, the at least one removable wall comprising an opening for a passage of a reagent extractor (Peyvan; Fig. 16A; para [154]; the housing 812 can be coupled to a plug member 865 in which opening 862 is formed, configured to secure the breaching element 814); and a plurality of removable reagent reservoirs located within the reagent sleeve (Peyvan; Fig. 2A, 2B, 4, 5; para [89, 90]; at least one or a plurality of reagent storage elements 104…a housing 112 configured to receive the reagent storage element(s) 104), wherein each of the plurality of removable reagent reservoirs comprises a respective peripheral wall, and first and second end walls (Peyvan; Fig. 2A, 2B; the peripheral wall is interpreted as the side walls and the first and second end walls are interpreted as the bottom wall and top wall, respectively), whereby each of the plurality of removable reagent reservoirs contains a reagent located therein (Peyvan; Fig. 2B; para [97]; the reagent storage elements 104 can include within their respective volumes the same or distinct reagents, fluids, which may include liquid(s) and/or gas(s), suspensions, or any a combination of fluids and gases), and the respective first end wall of the plurality of removable reagent reservoirs is pierceable by a reagent extractor (Peyvan; Fig. 2A; para [91]; a breaching element 114, such as a piercing or puncturing structure, for example a needle, configured to pierce, puncture, tear, or otherwise breach the reagent storage elements 104; as notes above the Examiner interprets the bottom wall which is pierceable to be the first end wall), and the reagent sleeve comprises a peripheral wall that encompasses the plurality of removable reagent reservoirs and holds the plurality of reagent reservoirs for sequential use (Peyvan; Fig. 2A; para [91]; two or more reagent storage elements 104 can be stacked or coupled together to form a storage element stack 105, which in turn can be received in the housing 112), wherein the reagent reservoirs are not permanently attached to the reagent sleeves or to each other (Peyvan; para [92]; the reagent storage elements 104 can be permanently or removably coupled to one another), and are freely removable from the reagent sleeve through the at least one removable end wall1 (Peyvan; para [154]; a plug member 865).
Modified Lee does not disclose the second end comprising a second opening.
However, Quinn teaches an analogous art of an apparatus for delivering a plurality of liquid volumes (Quinn; Abstract) comprising a reagent sleeve (Quinn; Fig. 3; para [83]; a reagent tube (2) for containing reagent solutions for an immunoassay) further comprising: a first end having a first opening; a second end having a second opening (Quinn; para [42]; two (or more) such openings are provided in the lateral wall of the vessel at a position corresponding to that of a void formed within the vessel). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the reagent sleeve of modified Lee to comprise the second opening as taught by Quinn, because Quinn teaches that it facilitates vacuum filing of liquid into the void (Quinn; para [42]).
Regarding claim 13, modified Lee teaches a method of using the analyzer of claim 12, the method comprising: piercing the first end wall of one of the plurality of reagent reservoirs with the reagent extractor of the analyzer, chemical analyzer or clinical analyzer of claim 12 (Peyvan; Fig. 5, 6; para [91]; the egress structure 102 includes a breaching element 114, such as a piercing or puncturing structure, for example a needle, configured to pierce, puncture, tear, or otherwise breach the reagent storage elements 104) to fluidly connect the one of the plurality of reagent reservoirs with the analyzer, chemical analyzer or clinical analyzer through the reagent extractor (Peyvan; para [106]; the target chamber 116 can include any suitable target receiving area based on user preference and intended application. For example, FIG. 3A illustrates an example target chamber 116 a); and withdrawing reagent from the one of the plurality of reagent reservoirs through the reagent extractor (Peyvan; para [112]; The first reagent 122 then flows through the hollow needle and is thereby communicated to the matrix 119 and the target chamber 116).
Regarding claim 14, modified Lee teaches the method of claim 13, further comprising: removing the one of the plurality of reagent reservoirs from the reagent sleeve prior to piercing the first end wall of the one of the plurality of reagent reservoirs with the reagent extractor (Peyvan; para [129, 132]; In applications where exceedingly long durations between reagent delivery are desired, an embodiment may use a centrifugal device adapted or configured to utilize a computer readable protocol to cease and restart centrifugal device operation or set the rotation speed of the centrifugal device 110 to separate the reagent storage element movement toward the needle 114 at the desired pace... In some embodiments, the centripetal force can be selectively and/or automatically adjustable to control the pace at which reagents are delivered to the desired destination). Peyvan teaches that the centrifuge can be programmed to move the storage element away from the needle and back to apply the second reagent.
Regarding claim 15, modified Lee teaches the method of claim 13, wherein the one of the plurality of reagent reservoirs is located at least partially within the reagent sleeve when the reagent is withdrawn from the one of the plurality of reagent reservoirs through the reagent extractor (Peyvan; Fig. 5, 6; para [117]; the centripetal forces continue to act on the reagent storage elements 104, the aforementioned reagent storage element consumption process continues until all reagent storage elements 104 are substantially emptied and slide down in the housing 112 circumscribing the needle 114).
Regarding claim 16, modified Lee teaches the method of claim 13, further comprising: withdrawing the reagent extractor from the one of the plurality of reagent reservoirs; then moving a second of the plurality of reagent reservoirs to a position where the first end wall of the second of the plurality of reagent reservoirs is pierceable by the reagent extractor; then piercing the first end wall of the second of the plurality of reagent reservoirs with the reagent extractor to fluidly connect the second of the plurality of reagent reservoirs with the analyzer, chemical analyzer or clinical analyzer through the reagent extractor; and withdrawing reagent from the second of the plurality of reagent reservoirs through the reagent extractor (Peyvan; Fig. 5, 6; para [98, 112, 117]). The examiner notes that the reagent storage element is moved further/withdrawn into the needle as seen in Fig. 6 as centripetal force moves the first reagent reservoir after the first reagent is withdrawn. Thus, the second of the plurality of reagent reservoirs is introduced and pierced until all reagent storage elements are emptied.
Regarding claim 17, modified Lee teaches the method of claim 13, further comprising: moving the reagent extractor through the second end wall of the one of the plurality of removable reagent reservoirs; piercing the first end wall of the second of the plurality of reagent reservoirs with the reagent extractor; fluidly connecting the second of the plurality of reagent reservoirs with the analyzer, chemical analyzer or clinical analyzer through the reagent extractor; and withdrawing reagent from the second of the plurality of reagent reservoirs through the reagent extractor, wherein the second end wall the one of the plurality of removable reagent reservoirs is pierceable by a reagent extractor (Peyvan; Fig. 5, 6; para [98, 112, 117]; the centripetal forces continue to act on the reagent storage elements 104, the aforementioned reagent storage element consumption process continues until all reagent storage elements 104 are substantially emptied and slide down in the housing 112 circumscribing the needle 114).
Regarding claim 18, modified Lee teaches the analyzer claim 12 (the reagent sleeve of Peyvan is modified to be comprised by the analyzer, chemical analyzer, or clinical analyzer as taught by Lee), wherein the analyzer is a chemical analyzer (Lee; para [55]; the dry reagent accommodating portion may include a coloring dye, a fluorescent substance, and a luminescence substance for measuring a substance produced or consumed by a reaction between an analyte in a sample and an enzyme).
Regarding claim 19, modified Lee teaches the analyzer of claim 12 (the reagent sleeve of Peyvan is modified to be comprised by the analyzer, chemical analyzer, or clinical analyzer as taught by Lee), wherein the analyzer is a clinical analyzer (Lee; para [69]; When an albumine creatinine ratio (ACR) is measured by measuring microalbumine and creatinine existing in urine in a single reagent container 110 using the measurement cartridge 100). Examiner notes the broadest reasonable interpretation for the clinical analyzer would relate to care or observation in a medical setting, and Lee teaches testing urine.
Response to Arguments
Applicant’s arguments filed, 9/18/2026, have been considered and the arguments are found to be persuasive. However, those arguments are directed towards the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
