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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/23/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 23 June 2025.
Claims 1-7 and 9-18 are pending.
Claim 8 is cancelled.
No claims are withdrawn.
No claims are newly added.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 and 9-18 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 1 recites “the sample containing part is formed in a bottomed cylindrical tubular shape” wherein it is unclear if the sample containing part itself is a cylindrical tubular shape, or if the sample containing part is within a separate cylindrical part given its recitation as formed “in” a cylindrical tubular shape. Applicant may wish to amend the claim to recite on the order of “the sample containing part comprises a bottomed cylindrical tubular shape”.
Further, Claim 1 recites “a bottom of the sample containing part is formed into a hemispherical or conical shape in a liquid reservoir part” wherein the shape limitation is recited as a process not given patentable weight in a device claim. Applicant may wish to amend the claim to recite on the order of “a bottom of the sample containing part is a hemispherical or conical shape”. Further, it is unclear if the required shapes describe a shape of the reservoir part, or if they are within a separate reservoir part given the recitation “comprising a liquid reservoir part”.
Further to the above, Claim 1 recites the sample containing part as a “bottomed cylindrical tubular shape” requiring the sample containing part have the flat bottom of a cylinder, but the claim also recites the bottom of the sample containing part as having a conical or hemispherical shape, thereby rendering indefinite the shape of the sample containing part described as two simultaneous shapes. Applicant may wish to amend the claim to clarify the injection region as comprising a cylindrical shape, and the suction region as having a conical/hemispherical shape if that is Applicant’s intent.
Dependent Claims 2-7 and 9-18 are rejected for their dependence on Claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umetsu et al. (WO 2017/082195 A1), referred to herein as “Umetsu,” as seen through the international search report for PCT/JP20/029378 and the machine-translation available at Google Patents.
Regarding Claim 1, Umetsu teaches a reagent cartridge ([0013]) used for an analysis apparatus that analyzes a result based on a reaction of a sample and a reagent;
the reagent cartridge comprising:
a top surface (Fig. 2 shows the wells 6a/6b extending as a depth from a top surface.); and
a sample containing part 6a/6b that contains the sample (Fig. 2 shows sample wells 6a/6b and Fig. 4 shows the sample wells are filled with sample via a syringe. – Umetsu Claims 1 and 13: “A cartridge used to measure a component to be measured contained in a liquid, wherein a concave well for storing the liquid is formed…wherein the liquid is a specimen or a reagent.),
wherein the sample containing part includes an injection region and a liquid suction region (Fig. 3b shows upper space 8b above the inclined peripheral wall 8a (the injection part) and a space above the flat wall portion 9d (the fluid suction part) in all that is discussed given that [0011] of the instant specification describes the liquid suction part merely as “formed in a lower end of the injection part, and the inclined surface is continuous with the liquid suction part via a side surface of the liquid suction part.” and [0025] states “since the sample containing part includes the injection part and the liquid suction part, the injection and liquid suction of the sample can be performed at separate locations” further implying that the liquid suction part is not creating suction but is rather simply a separate area from the injection part. Further, Fig. 11b shows similar regions in the symmetrical sample containing part separated by a gradient incline portion and a wall surface.), wherein a sample dilution solution is contained in the sample containing part in advance (“In the above-described embodiment, the reagent well 6b [interpreted as a sample well given Umetsu Claims 1 and 13, discussed below] stores a necessary amount of reagent solution that has been injected in advance after the cartridge 2 is molded.” -- Umetsu Claims 1 and 13: “A cartridge used to measure a component to be measured contained in a liquid, wherein a concave well for storing the liquid is formed…wherein the liquid is a specimen or a reagent. – The reagent solution of Umetsu is interpreted herein as a sample dilution solution as claimed given that combining said reagent solution with a sample will inherently result in the dilution of said sample, resulting in a less concentrated sample. The claimed sample dilution solution is broadly recited to encompass such a reagent solution as in Umetsu as constituting this element.),
wherein the sample containing part 6a/6b is formed in a bottomed cylindrical tubular shape extending in the vertical direction from the top surface (Fig. 11 shows the sample-containing part 6b upper space 8b formed as a cylindrical tubular shape extending vertically below the top surface. Note that a cylinder is not required to have circular bases, wherein the elliptical bases of Umetsu form a cylinder shape as defined by Merriam Webster Dictionary: “a geometric shape composed of two parallel faces of identical size and shape (such as circles) and a curved surface that completely connects their borders”. See further the “description of symbols” section labeling the upper part 8a as a “drum cylinder part”.), and
wherein a bottom of the sample containing part is formed into a hemispherical or conical shape in a liquid reservoir part (Fig. 3b shows the bottom part 10b of the sample containing part 6a as having a conical shape tapering toward a vertex. – “As shown in FIGS. 3A to 3C, the sample well 6a has a substantially inverted conical upper barrel portion 8 and a ring-shaped step portion 9 integrally coupled to the lower end of the upper barrel portion 8. And an inverted conical lower barrel portion 10 integrally connected to the step portion 9.”),
as in Claim 1.
Examiner further notes that both items are provided as named parts to “a sample containing part,” “an injection part,” “a liquid suction part,” and “a liquid reservoir part” wherein these nominal parts are not recited with any functionality(ies) thereto and are interpreted merely as regions within the open space of the cartridge.
Examiner further notes that mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B).
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Umetsu teaches the cartridge discussed above, wherein the injection region and the liquid suction region mutually extend in a vertical direction of the sample containing part (The vertical axis of Umetsu is interpreted as the axis X2 shown in Fig. 3B wherein the vertical direction extends perpendicular from the flat bottom surface 10c towards the top opening 12. Fig. 3b shows that the two regions of the upper space 8b discussed above regarding Claim 1 mutually extend in the vertical direction X2 such as to form a container cavity for holding liquid.)
Further regarding Claim 2, the sample containing part has an inclined surface that is inclined toward the liquid suction region and formed at a lower end of the injection region (Fig. 3b shows that right side wall 11d is inclined toward the suction part.),
and the inclined surface is continuous with a liquid reservoir part at a lower end of the liquid suction part via a surface of the sample containing part at a side surface of the liquid suction region (Fig. 3b shows that the right side wall 11d of the injection part is continuous with the peripheral wall 10a of the suction part.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Umetsu teaches the cartridge discussed above, wherein a guide surface that is inclined with respect to the vertical direction of the sample containing part is formed in the injection region (Fig. 3b shows that left side wall 11a is inclined toward the suction part.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Umetsu teaches the cartridge discussed above, wherein the guide surface is formed in a side wall of the sample containing part opposing the liquid suction region (Fig. 3b shows an inclined surface for guiding injection liquid into the suction part, formed by the left side wall 11a opposing the liquid suction part.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 3 as discussed above. Further, in all that is discussed by the claim, Umetsu teaches the cartridge discussed above, wherein a holding part is positioned at a predetermined interval from the guide surface, wherein Fig. 3b shows an upper portion 2b against which a pipette tip can be leaned upon and held immobile for stabilization and more accurate pipetting.), as in Claim 5.
Further note that the recitation to ”a holding part” is a nominal part not recited with any functionality(ies) thereto.
Regarding Claim 6, the prior art meets the limitations of Claim 2 as discussed above. Further, Umetsu teaches the cartridge discussed above, wherein the inclined surface is inclined at 30 degrees to 60 degrees with respect to the vertical direction of the sample containing part (Note that the term “vertical direction” is indefinite as discussed above. Further, Umetsu [0072] states “The upper peripheral wall 8a is formed so that its inner wall surface forms an inclination angle of 0.5 to 70° with a plumb line X1 to the opening 12.” and Umetsu is commensurate in structural arrangement in as much as claimed herein.) as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 2 as discussed above. Further, Umetsu teaches the cartridge discussed above, wherein the inclined surface is continuously formed with the liquid reservoir part so as to form a part of the liquid reservoir part (Fig. 3b shows that the inclined surface right side wall 11d is continuously formed with the liquid reservoir 10b and as such forms a part of the liquid reservoir part.), as in Claim 7.
Additionally, the recitation to “…is continuously formed…” in Claim 7 is drawn to a process-type recitation not afforded patentable weight in a device claim.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. The claim’s statement that “a liquid surface of the sample dilution solution is located between an upper end and a lower end of the inclined surface” merely recites an intended use as it describes how the inclined surface is expected to function rather than affirmatively limiting the structure of the inclined surface. Further, the physical presence of liquid within the cartridge is not positively claimed, wherein such liquid surface/sample dilution solution is drawn to an intended workpiece, thus this liquid/its surface within the cartridge is not explicitly required. Umetsu provides a cartridge of commensurate structure and arrangement as claimed and is fully capable of holding a sample dilution solution wherein the liquid surface of the sample dilution solution is located between an upper end and a lower end of the inclined surface as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Umetsu teaches the cartridge discussed above, comprising: at least one of a reagent containing part (Fig. 2 shows a plurality of reagent containing wells 6b.),
that contains the reagent (Umetsu states, “…after injecting a necessary amount of reagent into the reagent well 6b, each cartridge 2 is thermocompression-bonded to the surface of the well forming portion 2b with an aluminum seal…” The injection of a reagent solution into the reagent well 6b must necessarily provide a reagent solution contained in the reagent containing part as gravity will pull the reagent solution downward and into the closed cavity of the reagent well 6b.), as in Claim 10.
Further regarding Claim 10, Umetsu does not teach an antibody containing part that contains an antibody, as in Claim 10.
However, the claim is written as an alternative-type recitation wherein only one of the “reagent containing part that contains the reagent” and/or the “antibody containing part that contains an antibody” is positively required. Thus, Umetsu remains anticipatory over Claim 10 as Umetsu teaches the “reagent containing part that contains the reagent” as discussed above.
Regarding Claim 11, the prior art meets the limitations of Claim 10 as discussed above. The claim’s statement that “…at least either one of the liquid reservoir part, and the reagent containing part and the antibody containing part is substantially arranged on an operation line of the analysis apparatus…” merely describes an intended use of how the wells are to interact with an analysis apparatus (intended workpiece), rather than positively claiming an analysis apparatus itself or imposing a structural limitation to the cartridge. Since an analysis apparatus is not affirmatively claimed as part of the invention, it cannot serve to limit the scope of the claim.
Further regarding Claim 11, Umetsu commensurately discloses the claimed structural arrangement of the cartridge and is thereby fully capable of being arranged on such an operation line of an analysis apparatus in as much as claimed and required herein.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, Umetsu teaches the cartridge discussed above wherein the injection region and the liquid suction region together serve as an injection and liquid suction region (Fig. 3B shows the liquid injection region 8b and the liquid suction region as forming a continuous volume. Thus, they together form a liquid injection and liquid suction region.), as in Claim 16.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as discussed above. Further, the claim’s recitation to the reagent liquid surface being such that a droplet of sample reaches the reagent surface before being separated from a tip of a pipette is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight.
As discussed above, the cited prior art of Umetsu provides to commensurately disclose the positively claimed structural arrangement/functionality of the cartridge device as claimed and is thus fully capable of being utilized with a pipette tip wherein the sample discharged from the pipette tip reaches the reagent dilution solution before separating from the pipette tip in as much as presently recited and required herein.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, Umetsu teaches the cartridge discussed above wherein the injection region and the liquid suction region together serve as an injection and liquid suction region (Fig. 3B shows the liquid injection region 8b and the liquid suction region as forming a continuous volume. Thus, they together form a liquid injection and liquid suction region.), as in Claim 17.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Umetsu, as applied to Claims 1-11 above, in light of Shimamoto et al. (US20090170714A1), referred to herein as “Shimamoto”.
Regarding Claim 12, as best understood herein, the prior art meets the limitations of Claim 10 as discussed above. Further, Umetsu does not teach the cartridge discussed above further comprising a closing part including a first closing part that closes the at least one of the reagent containing part and the antibody containing part, and in which an air vent hole is formed at a position corresponding to at least one of the reagent containing part and the antibody containing part, and a second closing part that closes the air vent hole are laminated. (Note that the recitation “…and a second closing part that close the air vent hole are laminated” is drawn to a process recitation not afforded patentable weight in a device claim.)
However, Shimamoto teaches an analogous microwell incubation apparatus, wherein the microwell lower tray 13 is covered by a first closing part upper tray 11 comprising holes 5 corresponding to each of the wells (reagent containing parts), and a second closing part comprising LEDs 15 which compliment and plug/seal the holes 5. Shimamoto teaches the benefit of this assembly as allowing for photometric observation of the liquid contained by each of the wells ([0076]). (Note that gasket 14 is interpreted as ‘laminated’ sealing of the holes across the first and second covering parts 11/15, in as much as claimed and understood herein).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the cartridge taught by Umetsu with the first and second coverings taught by Shimamoto to allow for photometric observation of the liquid contained by each of the wells while blocking outside interfering elements.
Regarding Claim 13, the prior art meets the limitations of Claim 12 as discussed above. Further, modifying the cartridge taught by Umetsu with the first covering taught by Shimamoto results in the covering of at least one of the liquid suction region and/or the injection region, given that the first covering taught by Shimamoto cover the entirety of the wells of the bottom microtiter plate (Shimamoto Fig. 7.), and that Shimamoto Claim 4 states “…each of the holes in the lid and in the well-housing vessel has a diameter smaller than that of the wells…”, as in Claim 13.
Further regarding Claim 13, note that the process of closing at least one of the liquid suction part or the injection part is not required by the claim as the claims are drawn to a device, and the claim provides for a functionality of the first closing part to have this capability (which is met by Umetsu in view of Shimamoto as discussed above).
Thus, it would have been obvious to one of ordinary skill in the art to modify Umetsu to provide a first closing part for closing at least one of the liquid suction part and injection part such as taught by Shimamoto above in order to allow for securely sealing the suction part or injection part from external interfering elements.
Regarding Claim 14, the prior art meets the limitations of Claim 13 as discussed above. Further, Claim 12 (on which Claim 14 depends) already specifies “an air vent hole” and the dependent Claim 14 introduces an additional air vent hole without clearly distinguishing it from the air vent hole of Claim 12. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B).
Further regarding Claim 14, the device having the claimed relative arrangement of air vent holes “formed at a position corresponding to the liquid suction region in the first closing part” would not perform differently than the prior art device taught by Umetsu/Shimamoto, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said air vent holes – see MPEP 2144.04 (VI)(C). Umetsu/Shimamoto has the capability of providing multiple vent holes, as in Claim 14.
Regarding Claim 15, the prior art meets the limitations of Claim 13 as discussed above. Further, Claim 12 (on which Claim 14 depends) already specifies “an air vent hole” and the dependent Claim 15 introduces an additional air vent hole without clearly distinguishing it from the air vent hole of Claim 12. Mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B).
Further, the device having the claimed relative arrangement of air vent holes “formed at a position corresponding to the injection region in the first closing part” would not perform differently than the prior art device taught by Umetsu/Shimamoto, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of said air vent holes – see MPEP 2144.04 (VI)(C). Umetsu/Shimamoto has the capability of providing multiple vent holes as in Claim 15.
Response to Arguments
35 USC 102 and 103
Applicant’s arguments allege the cited references fail to teach the additional amended features of Claim 1 requiring the sample containing part having a cylindrical tubular shape, wherein its bottom is formed into a hemispherical or conical shape, as in the amendments to Claim 1 submitted 06/23/2025.
Regarding the cylindrical tubular shape, Applicant’s arguments are not persuasive because, as discussed above in the body of the action regarding the rejection of Claim 1, Umetsu teaches the sample containing part having a cylindrical tubular shape given that a cylinder is defined by Merriam Webster Dictionary as “a geometric shape composed of two parallel faces of identical size and shape (such as circles) and a curved surface that completely connects their borders” – see the annotated Fig. 11b below. Further, Umetsu refers to the upper part as a “drum cylinder part” (Fig. 11c).
Regarding the bottom conical shape, Applicant’s arguments are not persuasive because, as discussed above in the body of the action regarding the rejection of Claim 1, Umetsu teaches the bottom of the sample containing part formed into a conical shape (“an inverted conical lower barrel portion 10 integrally connected to the step portion 9”). While Applicant points out that the bottom surface of the wells are represented by the figures as being flat, the “bottom” of the sample containing part is interpreted in Umetsu as the bottom portion 10, which is formed into a conical shape as shown in the annotated Fig. 11b below. Further, having a “conical shape” merely describes objects shaped like a cone, such as a traffic cone. As shown in the annotated Fig. 11b below, the bottom of Umetsu has a conical shape where the side walls taper towards a single vertex. While the vertex itself exists outside the space of the well, the claim does not specifically require the well itself forming the vertex.
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Further to the above, Examiner notes that the cylindrical tubular shape and conical shape are recited by way of process recitations not afforded patentable weight in a device claim. Therein, Umetsu is fully capable of performing the recited process recitations of being formed into various shapes given its moldable plastic material.
Thus, examiner respectfully maintains the rejection of Claim 1 under 35 USC 102 as anticipated by Umetsu.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JOSEPH KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (703)756-5501. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.J.K./
Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798