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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 14 March 2023, 22 June 2023, and 13 September 2023 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16 and 17 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.
Claim 16 recites the limitation “the mounting member comprises a supported portion that is arranged with spaced-apart horizontally from the opening portion.” It is not clear what is intended by “that is arranged with spaced-apart horizontally.” This structural ambiguity amounts to a failure to particularly point out the subject matter, rendering the claim indefinite. For the purposes of examination, the examiner interprets claim 16 to mean “the mounting member comprises a supported portion that is spaced apart from the opening portion horizontally.”
Claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite due to its dependence on claim 16.
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 (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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pudduck (US 20220193679 A1).
With regards to claim 1, Pudduck teaches;
The claimed “a reagent container that stores a reagent that is aspirated by an aspiration tube installed in an analyzer” has been read on the taught ([0006], “The reagent cartridges include at least one pouch assembly configured to hold a reagent… at least one probe having a first position […] and a second position… wherein the at least one probe is configured to move the plug in the aperture in response to the at least one probe being in the second position to open a passageway between the first end and the container.”);
The claimed “a bag-shaped reagent storage that stores the reagent” has been read on the taught ([0029], “The reagent cartridge 106 may include a plurality of pouch assemblies 212 (e.g., reagent pouch assemblies) that are configured to store the calibration reagents.”; The pouch assembly reads on bag-shaped reagent storage.);
The claimed “a frame comprising an opening attached to the bag-shaped reagent storage” has been read on the taught ([0030], “A fitment device 222 may be sealed to the container 220. […] A probe 214A may be received within the fitment device 222 to access the calibration reagent stored in the container 220.”; The fitment device reads on a frame. The fitment device allowing for the probe to be received reads on an opening.);
The claimed “wherein an interior of the bag-shaped reagent storage is sealed by inserting the aspiration tube into the opening from above in conjunction with a predetermined operation to the analyzer” has been read on the taught ([0029], “A plurality of probes 214 may be coupled to the manifold 210 so as to be inserted into the pouch assemblies 212A-212F as the manifold 210 moves in a −Z direction toward the pouch assemblies 212.”; [0041], “…the sealing surface 559 may seal to an exterior surface 214AS of the probe 214A when the probe 214A is located within the aperture 442.”; The probes read on an aspiration tube. The -Z direction reads on “from above.” The sealing surface reads on the interior being sealed when the aspiration tube is in the opening.);
The claim language of “wherein an interior of the bag-shaped reagent storage is sealed by inserting the aspiration tube into the opening from above in conjunction with a predetermined operation to the analyzer” is functional language describing the intended use of the claimed device. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Pudduck teaches all of the structural limitations of the device and is capable of performing the claimed actions, this limitation does not distinguish the instant application over the prior art.
With regards to claim 2, the device of claim 1 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the interior of the bag-shaped reagent storage is sealed by restricting inflow of air into the opening” has been read on the taught ([0041], “The seal between the sealing surface 559 and the exterior surface 214AS of the probe 214A prevents or reduces the exchange of gases between the container interior 2201 of the container 220 (FIG. 3) and the exterior of the container 220 when the probe 214A is located and sealed within the aperture 442.”).
With regards to claim 3, the device of claim 1 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the frame comprises an opening portion that comprises the opening” has been read on the taught ([0033], “The fitment device 222 may include a core 430…”; [0034], “The securing portion 436 may further include a first end of an aperture 442 that extends through the core 430.”; Aperture 442 reads on an opening.);
The claimed “wherein the frame comprises […] a movement control member that controls movement of the opening by contacting a part of the analyzer” has been read on the taught ([0033], “The fitment device 222 may include a core 430…”; [0034], “The core 430 may include a securing portion 436… The securing portion 436 may include a first flange 440A and a second flange 440B... The first flange 440A and the second flange 440B may secure the pouch assembly 212A to the cartridge chassis 224 (FIG. 2A). For example, the space 441 may receive a member of the cartridge chassis 224.”; As shown in Figure 2a, the securing portion contacts cartridge chassis 224 to lock the reagent container in place.).
With regards to claim 4, the device of claim 3 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member controls horizontal movement of the opening by contacting a part of the analyzer in a horizontal direction” has been read on the taught ([0034], “The securing portion 436 may include a first flange 440A and a second flange 440B... The first flange 440A and the second flange 440B may secure the pouch assembly 212A to the cartridge chassis 224 (FIG. 2A).”; As shown in Figure 2a, the securing portion contacts cartridge chassis 224 to lock the reagent container in place, preventing horizontal movement.).
With regards to claim 5, the device of claim 4 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “the movement control member is formed to face an inner surface of a container holder of the analyzer in each of a first direction and a second direction that are mutually orthogonal in a horizontal plane” has been read on the taught ([0034], “The first flange 440A and the second flange 440B may secure the pouch assembly 212A to the cartridge chassis 224…”; Figure 2B, shown below, illustrates the first and second direction that are mutually orthogonal—see blue and red arrow.);
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With regards to claim 6, the device of claim 4 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “the movement control member comprises a horizontal contacting surface comprising one of: […] an inner surface of a notch formed in the movement control member…” has been read on the taught ([0034], “The securing portion 436 may include a first flange 440A and a second flange 440B separated by a distance D41 and thus forming a space 441 there between. […] For example, the space 441 may receive a member of the cartridge chassis 224.”; Space 441 reads on a notch)
The claimed “a side surface of the movement control member” has been read on the taught (See annotated figure 4, below. See also [0042] and Figure 5B, which depicts the member of the cartridge chassis received by the securing member.).
With regards to claim 7, the device of claim 6 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a shape extending along a first direction in a horizontal plane, and the horizontal contacting surface comprises a first surface comprising the side surface of the movement control member” has been read on the taught (See annotated figure 4, below. See also [0042] and Figure 5B, which depicts the member of the cartridge chassis received by the securing member.).
With regards to claim 8, the device of claim 6 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a shape extending along a first direction in a horizontal plane, and the horizontal contacting surface comprises a second surface comprising the side surface extending along the first direction of the movement control member” has been read on the taught (See annotated figure 4, below. See also [0042] and Figure 5B, which depicts the member of the cartridge chassis received by the securing member.).
With regards to claim 9, the device of claim 6 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a notch formed in the side surface, and the horizontal contacting surface comprises a third surface comprising an inner surface of the notch and contacting a part of the analyzer entering into the notch” has been read on the taught (See annotated figure 4, below. See also [0042] and Figure 5B, which depicts the member of the cartridge chassis received by the securing member.).
With regards to claim 10, the device of claim 6 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a hole formed in a top surface” has been read on the taught ([0034], “The securing portion 436 may further include a first end of an aperture 442 that extends through the core 430.”);
The claimed “the horizontal contacting surface comprises a fourth surface comprising an inner surface of the hole and contacting a part of the analyzer entering into an interior of the hole” has been read on the taught ([0039], “The conical portion 552 may guide the probe 214A into the aperture 442 as the probe 214A transitions from the first position spaced away from the aperture 442 to the second position where the probe 214A is located within the aperture 442 as shown in FIGS. 5B and 5C.”; Conical portion 552 reads on the horizontal contacting surface. The probe reads on a part of the analyzer entering into an interior of the hole.).
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With regards to claim 11, the device of claim 3 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member controls vertical movement of the opening by contacting a part of the analyzer in a vertical direction” has been read on the taught ([0025], “A moveable plug may be located in the aperture and may seal the aperture so as to prevent the flow of gases through the aperture, such as when is storage. In use, a probe, that can be part of a reagent cartridge, may be receivable in the aperture and may push the plug from the aperture to enable the gas analyzer to access the calibration reagent.”; The plug reads on a part of the movement control member which controls vertical movement of the opening. The probe reads on a part of the analyzer.).
With regards to claim 12, the device of claim 11 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member is formed to face an inner surface of a container holder of the analyzer in each of an upward direction and a downward direction” has been read on the taught ([0042], “The cartridge chassis 224 may include members extending from a lower surface that coupled to and support the fitment device 222… The first member 560A includes a first extension 562A and the second member 560B includes a second extension 562B that may be received in the space 441.”; The cartridge chassis 224 reads on a container holder. The members which couple to the fitment device, extending from a lower surface of the chassis read on an inner surface of a container holder of the analyzer. The extensions being received in space 441 reads on the movement control member facing an inner surface in each of an upward direction and a downward direction, as further illustrated in Figure 5A.).
With regards to claim 13, the device of claim 11 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a top surface and a bottom surface vertically in contact with a part of the analyzer” has been read on the taught ([0042], “The cartridge chassis 224 may include members extending from a lower surface that coupled to and support the fitment device 222 and thus the pouch assembly 212A. In the embodiment depicted in FIGS. 5A-5C, the cartridge chassis 224 includes a first member 560A and a second member 560B that extend from the cartridge chassis 224. The first member 560A includes a first extension 562A and the second member 560B includes a second extension 562B that may be received in the space 441.”; Figure 5A shows extensions 562A and 562B being “sandwiched” in the space 441. The space 441 reads on a top surface and a bottom surface vertically in contact with a part of the analyzer.).
With regards to claim 14, the device of claim 3 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member is fixed to the opening portion so as to project horizontally from the opening portion” has been read on the taught ([0034], “The core 430 may include a securing portion 436… The securing portion 436 may include a first flange 440A…”; The first flange reads on the movement control member being fixed to the opening portion so as to project horizontally from the opening portion.).
With regards to claim 15, the device of claim 14 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a fixing portion that is fixed to the opening portion and a supporting portion that supports an upper part of the bag-shaped reagent storage at a position away from the opening portion” has been read on the taught ([0034], “The core 430 may include a securing portion 436 and a container portion 438, which may be located at respective ends of the core 430.”; The securing portion 436 reads on a fixing portion. The container portion 438 reads on a supporting portion. The securing and container portions being located at respective ends of the core reads on the supporting portion supporting an upper part of the reagent storage at a position away from the opening portion.).
With regards to claim 16, the device of claim 15 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the opening portion is formed in a mounting member arranged on an upper part of the bag-shaped reagent storage” has been read on the taught ([0034], “An extension 437 may join the securing portion 436 and the container portion 438... The aperture 442 may extend through the core 430 to the second end at the container portion 438.”; Extension 437 reads on a mounting member. Aperture 442 reads on the opening portion.);
The claimed “wherein the mounting member comprises a supported portion that is spaced apart from the opening portion horizontally” has been read on the taught ([0034], “An extension 437 may join the securing portion 436 and the container portion 438…”; Figure 5A shows extension 437 having a wall that extends around the aperture 442 and including internal, funnel-shaped features (see [0040]), which reads on the supported portion being spaced apart from the opening portion horizontally. );
The claimed “the fixing portion is fixed to the opening portion” has been read on the taught ([0034], “The core 430 may include a securing portion 436 and a container portion 438… The securing portion 436 may further include a first end of an aperture 442 that extends through the core 430.”; Securing portion 436 reads on the fixing portion. The securing portion including a first end of an aperture reads on the fixing portion being fixed to the opening portion.);
The claimed wherein “the supporting portion is fixed to the supported portion” has been read on the taught ([0034], “An extension 437 may join the securing portion 436 and the container portion 438…”; Container portion 438 reads on the supporting portion. Extension 437 reads on the supported portion.).
With regards to claim 17, the device of claim 16 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the mounting member comprises a resin material formed separately from the bag-shaped reagent storage” has been read on the taught ([0047], “The container 220 (FIG. 3) may be adhered to the container portion 438 of the fitment device 222.”; Claim 3, “The fitment device of claim 1, wherein the core comprises nylon.”; Nylon reads on a resin material. The container being adhered to the fitment device reads on the mounting member being formed separately from the bag-shaped reagent storage.);
The claimed “an outer circumference part of the mounting member is welded to an inner circumference part of the bag-shaped reagent storage” has been read on the taught ([0047], “The container 220 (FIG. 3) may be adhered to the container portion 438 of the fitment device 222. For example, the first container material 324A may be adhered to the first surface 443A of the fitment device 222 and the second container material 324B may be adhered to the second surface 443B.”; The container material being adhered to the container portion reads on the outer circumference part of the mounting member being welded to an inner circumference part of the bag-shaped reagent storage.).
With regards to claim 18, the device of claim 14 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a fixing portion that is fixed to the opening portion” has been read on the taught ([0034], “The core 430 may include a securing portion 436 and a container portion 438… The securing portion 436 may further include a first end of an aperture 442 that extends through the core 430.”; Securing portion 436 reads on the fixing portion. The securing portion including a first end of an aperture reads on the fixing portion that is fixed to the opening portion.);
The claimed wherein the movement control member comprises “a bottom supporting member that supports a bottom part of the bag-shaped reagent storage” has been read on the taught ([0029], “The reagent cartridge 106 may include a plurality of pouch assemblies 212 (e.g., reagent pouch assemblies) that are configured to store the calibration reagents.”; [0030], “The fitment device 222 may secure the pouch assembly 212A to a cartridge chassis 224 within the reagent cartridge 106…”; Figure 1B shows cartridge 1B including a bottom, which would support a bottom part of the internal pouch assemblies 212.).
With regards to claim 19, the device of claim 3 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member comprises a guiding portion that extends along a first direction in a horizontal plane and guides the movement of the opening in a state in which the opening is positioned below the aspiration tube of the analyzer” has been read on the taught ([0034], “The core 430 may include a securing portion 436… The securing portion 436 may include a first flange 440A and a second flange 440B… The first flange 440A and the second flange 440B may secure the pouch assembly 212A to the cartridge chassis 224 (FIG. 2A).”; The first flange and second flange read on a guiding portion that extend along a first direction in a horizontal plane and guides the movement of the opening.).
With regards to claim 20, the device of claim 19 is anticipated by Pudduck.
Pudduck additionally teaches;
The claimed “wherein the movement control member is fixed to the opening portion between one end and a center of the movement control member in the first direction” has been read on the taught ([0034], “The securing portion 436 may further include a first end of an aperture 442 that extends through the core 430. “; [0040], “The aperture 442 may further include a lip 554… the lip 554 may be annular and may extend around the circumference of the aperture 442…”; Lip 554 extending around the aperture, and the securing portion including the aperture reads on the movement control member being fixed to the opening portion between one end and a center of the movement control member in the first direction. See also figure 4, which shows the aperture 442 located at the center of the movement control member.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tanaka et al (US 20210199681 A1) teaches a bag-shaped reagent container with an opening for use with an aspiration tube.
Funazaki et al (JP 2017181033 A, cited on the IDS provided 06/22/2023) teaches a bag-shaped reagent container with includes a mounting bracket and a bottom support section.
Tominaga et al (JP 2004226314 A, cited on the IDS provided 03/14/2023) teaches a bag-shaped reagent container with a holding bracket, notch, and a bottom supporting section.
Sasaki et al (US 6193933 B1) teaches a reagent storage bag including movable valves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797