Prosecution Insights
Last updated: October 27, 2026
Application No. 18/591,102

FLOW CHANNEL STRUCTURE AND METHOD FOR PRODUCING LIPID PARTICLE

Non-Final OA §102§103§112
Filed
Feb 29, 2024
Priority
Sep 15, 2022 — JP 2022-147321 +1 more
Examiner
YOH, JULIUS FRANCIS
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kabushiki Kaisha Toshiba
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allowance Rate
3 granted / 4 resolved
+15.0% vs TC avg
Strong +33% interview lift
Without
With
+33.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
30 currently pending
Career history
31
Total Applications
across all art units

Statute-Specific Performance

§103
40.7%
+0.7% vs TC avg
§102
22.1%
-17.9% vs TC avg
§112
36.1%
-3.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 4 resolved cases

Office Action

§102 §103 §112
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 . Election/Restrictions Applicant’s election of Group I, Claims 1-11 in the reply filed on 08/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Priority Receipt is acknowledged of certified copies of papers (JP2022-147321) required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) filed on 02/29/2024, 01/26/2026, and 08/12/2026 have been certified and made of record. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “Mixing unit” in claim 4 – the specification teaches a mixing unit as including a first diverging and merging flow channel and a second diverging and merging flow channel Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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 2, 9, and 10 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. Claims 2 and 9 recite the limitation "first shallow portion" in line 20 of p. 1 and line 19 of p.3, respectively. There is insufficient antecedent basis for this limitation in the claim. Furthermore, claim 10 depends on rejected claim 9 and therefore is included in the rejection. For examination purposes, a “first shallow portion” will be treated as the shallow portion prior the second shallow portion along the flow channel structure. Claim Rejections - 35 USC § 102 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. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bharadwaj et al. (US 20190134633 A1) (referenced in IDS). Regarding claim 1, Bharadwaj et al. teaches a flow channel structure (microfluidic channel structure – See annotated FIG. 2A/2B below) comprising: PNG media_image1.png 547 689 media_image1.png Greyscale a first flow channel (side channel segment 208a), a second flow channel (side channel segment 208b), a third flow channel (See annotated FIG. 2A); a first merging portion (intersection – element 204) that connects one end of the first flow channel, one end of the second flow channel, and one end of the third flow channel to one another (Annotated FIG. 2A – first merging portion).; a fourth flow channel (Annotated FIG. 2A, 210a), a fifth flow channel (210b – side channel segments); a second merging portion that connects another end of the third flow channel, one end of the fourth flow channel; and one end of the fifth flow channel to one another; and a second shallow portion that is located at the one end of the fourth flow channel and is shallower than a depth of the second merging portion (See Annotated FIG. 2A and 2B). Regarding claim 2, Bharadwaj et al. teaches a flow channel structure according to claim 1. Furthermore, Bharadwaj et al. teaches a depth of the first shallow portion is less than ½ of the depth of the first merging portion and/or a depth of the second shallow portion is less than ½ of the depth of the second merging portion (“ The step structures described herein may exist at one or both of the upper and/or lower channel walls, and may result in an increase in the depth dimension of the channel, e.g., the dimension perpendicular to the main plane of a device, of at least about 1%, at least about 5%, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, and in some cases by at least about 100% or more” para. [0082]). Regarding claim 3, Bharadwaj et al. teaches a flow channel structure according to claim 1. Furthermore, the depth of channel structure for the fourth flow channel is larger than depths of the first, second, and third flow channels. Therefore, the cross-sectional areas of the fourth flow channel would be larger than the other three flow channels, and is therefore anticipated by Bharadwaj et al. Claim Rejections - 35 USC § 103 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 4-6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj et al. (referenced in IDS) in view of Miyamoto et al. (EP 1997553 A2) (referenced in 892 and attached). Regarding claim 4, Bharadwaj et al. teaches the flow channel structure of claim 1. Bharadwaj et al. further teaches shallow portions in flow channel structures (See FIG. 2B), but fails to teach: a mixing unit, the mixing unit including a first diverging and merging flow channel and a second diverging and merging flow channel that are two flow channels diverging from the third flow channel and merging into the third flow channel again between the one end and said another end of the third flow channel, and the first diverging and merging flow channel and the second diverging and merging flow channel each include: a diverging portion that diverges from the third flow channel; and merging portion that merges into the third flow channel; and intermediate portion that connects the diverging portion and the merging portion and bends a connection part Miyamoto et al. teaches a channel structure (FIG. 6) that performing fluid mixing (abstract), comprising a first and second diverging/merging flow channels (FIG. 6 – elements 111 and 112), wherein each flow channel contains a diverging portion, merging portion, and intermediate portion (FIG. 6). Miyamoto specifically teaches “these bifurcation and convergence are repeated to increase the degree of mixing the fluids without increasing the number of stages serially.” (p. 2). It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Miyamoto et al.’s bifurcation design (converging and diverging) in Bharadwaj et al.’s flow channel structure because the repeated bifurcation and convergence structure increases the degree of mixing the fluids without increasing the number of stages serially. Furthermore, the combination of references would encompass a structure of a third shallow portion that is located at an end of the first diverging and merging flow channel on the merging portion side and is shallower than a depth of the third flow channel and a fourth shallow portion that is located at the intermediate portion of the second diverging and merging flow channel and is shallower than depths of the merging portion of the second diverging and merging flow channel. This method of improving Bharadwaj et al.’s flow structure was within the ability of one of ordinary skill in the art based on the teachings of Miyamoto et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Miyamoto et al. and Bharadwaj et al. to obtain the invention specified in claim 4. Regarding claim 5, modified Bharadwaj et al. teaches the flow channel structure according to claim 4. Furthermore, the combination of references of claim 4 would encompass a structure of a merging portion of each of the first diverging and merging flow channel and the second diverging and merging flow channel into the third flow channel is connected to the third flow channel at an angle symmetrical to each other with respect to a long axis of the third flow channel (FIG. 4 - Miyamoto et al.). Therefore, the claim is prima facie obvious. Regarding claim 6, modified Bharadwaj et al. teaches the flow channel structure according to claim 4. Furthermore, the combination of references of claim 4 would encompass a structure of a plurality of mixing units, wherein the mixing units are connected to each other in parallel (FIG. 4 - Miyamoto et al.). Therefore, the claim is prima facie obvious. Regarding claim 11, Bharadwaj et al. teaches the flow channel structure according to claim 1, but fails to teach the claim limitation: “the flow channels A having a shallow portion on another end side of the fifth flow channel; and a flow channels B each of which is connected to each of the flow channels A, wherein when each of the flow channels A is represented as a (2n+4)-th flow channel (hereinafter, n is an integer of 1 to m), and each of the flow channels B (total number is m) is represented as a (2n+5)-th flow channel, another end of a (2n+3)-th flow channel, one end of the (2n+4)-th flow channel, and one end of the (2n+5)-th flow channel are connected to one another in a (n+2)-th merging portion, and the one end of the (2n+4)-th flow channel includes a (n+2)-th shallow portion that is shallower than a depth of the (n+2)-th merging portion.” Miyamoto et al. teaches a fluid mixer wherein “which a first fluid is introduced; second-fluid introduction paths (12) which are arranged alternately with the first-fluid introduction paths, and into which a second fluid is introduced; first bifurcation paths (13) formed of ends of the first-fluid introduction paths and ends of the second-fluid introduction paths, the ends bifurcating in two directions; first confluence paths (14) formed by combining ends of the first bifurcation paths with adjacent ends of different first bifurcation paths; n bifurcation paths (19) formed of ends of n-1 confluence paths (18), the ends bifurcating in two directions; n confluence paths (20) formed by combining ends of the n bifurcation paths with adjacent ends of different n bifurcation paths; and mixed-fluid discharging paths (21) formed of the n confluence paths extended to the end, the mixed-fluid discharging path for discharging a mixed fluid.” (abstract). Miyamoto specifically teaches “these bifurcation and convergence are repeated to increase the degree of mixing the fluids without increasing the number of stages serially.” (p. 2). It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Miyamoto et al.’s bifurcation design in Bharadwaj et al.’s flow channel structure because the repeated bifurcation and convergence structure increases the degree of mixing the fluids without increasing the number of stages serially. This method of improving Bharadwaj et al.’s flow structure was within the ability of one of ordinary skill in the art based on the teachings of Miyamoto et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Miyamoto et al. and Bharadwaj et al. to obtain the invention specified in claim 11. Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj et al. (referenced in IDS) in view of Cypes et al. (US 20080275653 A1) (referenced in 892). Bharadwaj et al. teaches the flow channel structure of claim 1, but fails to teach that the third flow channel further includes a flow channel that takes longer time for a solution to pass through than the first flow channel, second flow channel, fourth flow channel and fifth flow channel. Cypes et al. teaches a microfluidic separation device with fluid flow channels (abstract), as Cypes et al. teaches that microscale flow channel may be between 5 and 200 cm in length, with longer flow channels being desirable to provide for longer residence times (para. [0044]). It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Cypes et al.’s teaching of longer flow channels in Bharadwaj et al.’s flow channel structure because longer flow channels would enable longer residence times in the channel. This method of improving Bharadwaj et al.’s flow structure was within the ability of one of ordinary skill in the art based on the teachings of Cypes et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Cypes et al. and Bharadwaj et al. to obtain the invention specified in claim 7. Regarding claim 8, Bharadwaj et al. teaches the flow channel structure according to claim 7. Furthermore, the combination of references of claim 7 would encompass a structure wherein the flow channel that takes a longer time for a solution to pass through has a longer flow channel length (Cypes et al., para. [0044]). Therefore, the claim is prima facie obvious. Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bharadwaj et al. (referenced in IDS) in view of Glieberman et al. (US 20210197196 A1) (referenced in 892). Regarding claim 9, Bharadwaj et al. teaches the flow channel structure according to claim 1, but fails to teach a trap structure configured to trap a foreign substance in the flow channel on a side closer to another end than the first shallow portion, wherein a depth of the trap structure is shallower than a depth of the first flow channel on a side closer to said another end than the first shallow portion. Glieberman et al. teaches a plurality of trapping channels in parallel with each other for trapping a plurality of objects (para. [0005]). Specifically, Glieberman et al. teaches that trapping channels are used to trap an object having a diameter in a specified sub-millimeter range (para. [0005]), as said traps (through protrusions extending from the sidewall) accomplish this goal (para. [0016]). It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Glieberman et al.’s trap structures in Bharadwaj et al.’s flow channel structure because the trap structures (protrusions in channels) trap an object having a diameter in a specified sub-millimeter range. This method of improving Bharadwaj et al.’s flow structure was within the ability of one of ordinary skill in the art based on the teachings of Glieberman et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bharadwaj et al. and Glieberman et al. to obtain the invention specified in claim 9. Regarding claim 10, modified Bharadwaj et al. teaches the structure of claim 9. Furthermore, the combination of references of claim 9 would encompass a structure of trap structure in the fourth flow channel on a side closer to another end than the second shallow portion and/or the second flow channel on a side closer to said another end than the first merging portion. Therefore, the claim is prima facie obvious. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM. 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, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JULIUS FRANCIS YOH/Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799
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Prosecution Timeline

Feb 29, 2024
Application Filed
Sep 30, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12767918
MICROFLUIDIC ELECTROPORATION DEVICE
3y 2m to grant Granted Oct 20, 2026
Patent 12668764
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3y 1m to grant Granted Jun 30, 2026
Study what changed to get past this examiner. Based on 2 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
75%
Grant Probability
99%
With Interview (+33.3%)
3y 1m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 4 resolved cases by this examiner. Grant probability derived from career allowance rate.

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