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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Response to Amendment
The Amendment filed 02/20/2026 has been entered. Claims 1-3 and 10-17 remain pending in the application and are being examined herein.
Status of Objections and Rejections
The rejections under 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendment.
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 1-3 and 10-17 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 1 recites the limitations “a second plate configured to be bonded …” in line 3 , “a first buffer part configured to be higher than …” in line 19, and “a fluid storage part configured to branch from …” in line 22. The use of “configured to be” renders these limitations unclear in terms of whether the second plate, the fluid storage and the first buffer part are required to be bonded to …., higher than…, branch from …, respectively, or they just need to be structurally be capable being bonded to …., higher than…, branch from …, and what that might look like. Clarification is requested. For the purpose of examination, theses limitations are being interpreted as requirements. It is suggested “configured to be” to be replaced with “is” in the limitations.
Claim 1 recites the limitations “a shape and a height of at least a portion of the microchannel part are determined according to a shape and a thickness of the OCA film” in lines 9-10, “wherein a height of the fluid storage part is determined by a thickness of the OCA film” lines 28-29 and “wherein a shape of the fluid storage part is determined by a shape of the channel forming part“ in lines 30-31. It is unclear how the thickness of a film or a shape of a part determines the shape and height of a channel or a fluid storage part. It appears Applicant intends to recite “is/are defined” instead of “is/are determined.” For the purpose of examination, the limitations are being interpreted as “a shape and a height of at least a portion the microchannel part is defined a shape and a thickness of the OCA film” in lines 9-10, “wherein a height of the fluid storage part is defined by a thickness of the OCA film” lines 28-29, and “wherein a shape of the fluid storage part is defined by a shape of the channel forming part“ in lines 30-31.
Claims 2-3 and 10-17 are indefinite due to their dependence on claim 1.
Claim 3 recites the limitation “a bonding part configured to contact and bond…” in line 2 and “a channel forming part configured to be formed through inside of the bonding part and to determine the shape of at least a portion of the microchannel part.” in lines 3-4. As discussed, in claim 1, the use of “configured to be” renders these limitations unclear in terms of whether the parts are required to contact and bond.., to be formed and to determine…, just need to structurally capable of those things. Furthermore it clear how a channel forming part is configured to determine the shape of a channel part as discussed in claim 1. For the purpose of examination, the limitations being interpreted as “a bonding part that contacts and bonds …” in line 2, and “a channel forming part formed through the inside of the bonding part and defines the shape of at least a portion of the microchannel part.”
It unclear whether a bonding part channel forming part is required to contact and bond, or just needs to be structurally capable of contacting and bonding. For the purpose of examination, it being interpreted required to.
Claim 15 recites “wherein the height of the microchannel part is changed by changing the thickness of the OCA film” in lines 1-2. It is unclear what “changing thickness of the OCA film” means. How is the thickness of the OCA film being changed? Can the thickness be changed after the apparatus is built? Clarification is requested. The limitation is being interpreted as “wherein the height of the microchannel part varies based on the number of stacked OCA films.”
Claim 16 recites the limitation “wherein the height of the microchannel part is changed by changing a number of the OCA films stacked” in lines 1-2. There is insufficient antecedent basis for “the OCA films” in the claim since the invention comprises only 1 OCA film. It is suggested that the Applicant amended to positively recites a number of OCA films, (e.g., wherein the OCA film comprises a number of stacked OCA films …) Furthermore, it is unclear what “changing a number of the OCA stacked” mean. Can this be done after the apparatus is assembled? Clarification is requested. The limitation is being interpreted as “wherein the height of the microchannel part varies based on the number of stacked OCA films.”
Claim 17 recites the limitation “wherein the height of the microchannel part is changed by stacking a combination of the OCA films having the same thickness or different thicknesses” in lines 1-2. It is unclear how the height of the microchannel part can be changed by stacking a single combination of OCA films (for example, if film A has a thickness of “a” and film B has a thickness of “b”, then stacking films A and B will always result in a total thickness of “a” + “b”). Clarification is requested. For the purpose of examination, this limitation is being interpreted as “wherein the height of the microchannel part varies based on a combination of the number of stacked OCA films and the thickness of each OCA film.”
Response to Arguments
Applicant’s arguments, see p. 6-11, filed 02/20/2026, with respect to the rejection under 103 have been fully considered and are persuasive due to the argument relating to the Hidetoshi’s reservoir is a collection space and not designed to minimized hydrostatic pressure or to control fluidic velocity by capillary force. Therefore, the rejection of has been withdrawn.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 15-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not disclose nor render obvious all limitations of claim 1 with particular attention to the limitations a fluidic analysis chip comprising …an optically clear adhesive (OCA)… a microchannel part… comprises … a sample injection part …, a first buffer part … and a fluidic storage part branches from the sample injection part and to have a dimension of a height less than a dimension of a height of the first buffer part so as to be filled with the fluid first, wherein the fluid storage part is configured to minimize hydrostatic pressure during fluid injection, thereby enabling stable fluid operation wherein fluid velocity is controlled primarily by capillary force after the hydrostatic pressure is reduced, wherein a height of the fluid storage part is determined by a thickness of the OCA film wherein a shape of the fluid storage part is determined by a shape of the channel forming part, wherein the fluid storage part is configured to branch from the sample injection part in a direction different from a direction toward the channel part, extend a predetermined length, and then extend a predetermined length in a direction in which the channel part extends.
The closest prior art of record is considered to be Park et al. (US 20110243795) in view of Ichimura et al. (JP 2008194568), in view of Hidetoshi et al. (WO 2007136057 A1) and further in view of O’Connor (US 20020112961) as evidenced by Daikin (Product Brochure NEOFLON EFEP, p. 3).
The prior art of record teaches a fluidic analysis chip (Park, Fig. 1) comprising …an OCA (adhesive resin film 3 of Ichimura; Daikin, resin film 3 has transmittance over 90%)… a fluidic storage part (Hidetoshi, channel 234 and reservoir 236) branches from the sample injection part (222 of Hidetoshi/ 110a of Park) and to have a dimension of a height less than a dimension of a height of the first buffer part (Hidetoshi, Fig. 11, channel 234 and reservoir 236 has a height less than that of the blood inlet 222 of Hidetoshi/sample injection port 110a of Park, which has a height less than that of the first buffer part as shown in Fig. 3 of Park. Therefore channel 234 and reservoir 236 has a lower height than that of the first buffer part), wherein a height of the fluid storage part is determined by a thickness of the OCA film wherein a shape of the fluid storage part is determined by a shape of the channel forming part (Ichimura, para. 0033 and 0037)(The fluid storage part is a part of the microchannel part, which is formed by the slit-shaped hole 5 in the adhesive film 3 of Ichimura. Ichimura teaches the thickness of the adhesive resin film 3 after joining the substrates becomes the depth the channel and the slit-shaped hole can have a branched-channel shape as shown in Fig. 4B, para. 0039; and O’Connor teaches in para. 0107, stacking of adhesive film layers to achieve complex microfluidic structures), wherein the fluid storage part (channel 234 and reservoir 236 of Hidetoshi) branches from the sample injection part (222 of Hidetoshi/ 110a of Park) in a direction different from a direction toward the channel part, extend a predetermined length, and then extend a predetermined length in a direction in which the channel part extends (Hidetoshi, Figs. 9).
However, the fluid storage taught by modified Park (Hidetoshi’s channel 234 and reservoir 236) is meant to collect blood cells that has been separated from a whole blood sample injected from the sample injection part, and the collected blood cells remain in reservoir 236 and do not flow to the first buffer part (or the other branch of the sample injection part). Since to achieve minimization of hydrostatic pressure during fluid injection, a fluid needs to completely injected into the fluid storage part first in order to control flow velocity for the fluid then flow to the first buffer part (spec., para. 0084), Hidetoshi’s reservoir, as argued by the Applicant on page 10 in the Remarks of 2/20/2026, is a collection space and not designed to minimized hydrostatic pressure or to control fluidic velocity by capillary force. Therefore, modified Park fails to teach wherein the fluid storage part is configured to minimize hydrostatic pressure during fluid injection, thereby enabling stable fluid operation wherein fluid velocity is controlled primarily by capillary force after the hydrostatic pressure is reduced.
The prior art whether taken individually or in combination would not disclose all of the cumulative limitations of claim 1. Therefore, claim 1 is considered to be patentably distinguished from the prior art of record. Claims 2-3 and 10-17 would be considered to be patentably distinguished from the prior art of record because of their dependence of claim 1.
Conclusion
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/M.L.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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