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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/19/2026 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 3/19/2026, has been entered. The claim amendments overcome the previous 112(b) rejection of claim 1.
The amendments and remarks, filed on 3/19/2026, has been entered. The claim amendments do not overcome the previous prior art rejection, and Applicants' arguments are addressed below.
Claim Status
Claims 1-20 are pending and being examined.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyvan et al (US 20150024384 A1; hereinafter “Peyvan”; already of record on IDS filed 9/17/2025).
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 sleeve peripheral wall (Peyvan; Fig. 2A; para [144]; housing walls) and at least one removable end wall or an access opening (Peyvan; para [158]; the apparatus 600 can include an external threaded member 664, such as a cap; examiner notes that the various embodiments can be combined as described in para [209]); 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 removable end wall or the access opening1 (Peyvan; para [158]; the cap can be threadedly coupled to an outer wall of the housing 603 via a plurality of threads 666).
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 “removable from the reagent sleeve”. 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.
Regarding claim 2, 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, 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, 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 from 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, Peyvan teaches the reagent sleeve system of claim 1, wherein the peripheral wall each of the plurality of reagent reservoirs is cylindrical (Peyvan; Fig. 9A). The top view of the reagent storage 104.
Regarding claim 6, 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, 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, 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, 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, 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, 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, Peyvan teaches the reagent sleeve of claim 1, wherein the access opening is located on a side of the sleeve peripheral wall or the end wall (Peyvan; Fig. 14), 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.
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 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.
Regarding claim 12, Lee teaches an analyzer, chemical analyzer or clinical 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, chemical analyzer or clinical 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); 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 first end wall 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), 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). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the reagent sleeve system of Lee to be the same as the one taught by Peyvan, because Peyvan teaches that reagent sleeve system makes the multiple and sequential suspension, solution, reagent, and/or other fluid delivery is made more efficient, expedient, and sanitary, and less labor intensive (Peyvan; para [123]).
Regarding claim 13, modified Lee teaches a method of using the analyzer, chemical analyzer or clinical 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, chemical analyzer or clinical 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, chemical analyzer or clinical 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, chemical analyzer or clinical 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, chemical analyzer or clinical 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 have been fully considered, and the arguments are not found to be persuasive. The non-persuasive arguments are addressed below.
In the Applicants’ arguments, 6-8, the Applicant argues that Peyvan fails to teach the claim amendments. The Examiner respectfully disagrees. Peyvan teaches a reagent sleeve (Peyvan; Fig. 2A; para [89]; the reagent delivery column 101) comprising a sleeve peripheral wall (Peyvan; Fig. 2A; para [144]; housing walls) and at least one removable end wall or an access opening (Peyvan; para [158]; the apparatus 600 can include an external threaded member 664, such as a cap; examiner notes that the various embodiments can be combined as described in para [209]) and 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 removable end wall or the access opening1 (Peyvan; para [158]; the cap can be threadedly coupled to an outer wall of the housing 603 via a plurality of threads 666). 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 “removable from the reagent sleeve”. 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.
In the Applicants’ arguments, on page 8, the Applicant argues that claim 20 is believed to be allowable by virtue of dependency on claim 1 and the features it recites individually. The Examiner respectfully disagrees. 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.
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 Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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