Prosecution Insights
Last updated: April 19, 2026
Application No. 18/471,397

ASSAY CARTRIDGE

Non-Final OA §103§112
Filed
Sep 21, 2023
Examiner
EDWARDS, LYDIA E
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Fujifilm Corporation
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
64%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
419 granted / 700 resolved
-5.1% vs TC avg
Minimal +4% lift
Without
With
+4.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
36 currently pending
Career history
736
Total Applications
across all art units

Statute-Specific Performance

§101
0.1%
-39.9% vs TC avg
§103
49.1%
+9.1% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
22.3%
-17.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 700 resolved cases

Office Action

§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. Information Disclosure Statement The information disclosure statement s (IDS) submitted on 12/20/2023 and 10/23/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement s are 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 appl icant regards as his invention. Claim 2 is 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 2 recites the limitation “the projected area of the reagent container” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. 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 1-3 , 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yumbe et al. (hereinafter Yumbe ) EP 3584578 cited in the IDS filed 10/23/2024 . Regarding claim 1 , Yumbe discloses an assay cartridge ( cartridge 15 ) used for immunochromatographic assay, comprising: a carrier ( carrier 30 ) to which a sample and a reagent are supplied ( The carrier 30 is, for example, a nitrocellulose film, and has a test region 31 formed by two test lines A and B and a control line C. On the test line A, a reagent RA that is combined with a test substance DA to be colored is fixed. ) ; a reagent container in which the reagent to be supplied to the carrier is sealed and from which the reagent is discharged to the outside by being crushed ( reducing solution pot 37, and a sensitizing solution pot 38 ) ; a case ( case 15A ) accommodating the carrier and the reagent container and having a pressing operation part ( first pressing unit 56 ) that is operated to apply a pressing force to the reagent container; and a first displacement part ( first arm 60 ) and a second displacement part ( first pressing piece 61 ) that can be displaced in the case, wherein the first displacement part has a first pressing surface for pushing the second displacement part to the reagent container by pressing the second displacement part in a case where the pressing operation part is operated ( first pressing piece 61 is disposed immediately above the reducing solution pot 37 in a case where the cartridge 15 is located at the housing position … the second pressing piece 64 is disposed immediately above the sensitizing solution pot 38 in a case where the cartridge 15 is located at the housing position. ) , and the second displacement part is disposed between the first displacement part and the reagent container as shown in Fig. 3 , and has a second pressing surface that crushes the reagent container in a case where the second displacement part is pressed from the first pressing surface ( In Fig. 3, the first pressing unit 56 has a first arm 60 rotatable around a shaft 60A like a seesaw, a first pressing piece 61 fixed to a lower portion of the distal end of the first arm 60, and a first cam 62 disposed on the lower side of the rear end of the first arm 60. The first cam 62 is connected to a driving shaft 55A rotated by the motor 55 so as to be able to be connected and disconnected through an electromagnetic clutch or the like (not shown), for example. In a case where the first cam 62 rotates, the rear end of the first arm 60 is pushed up, and the first pressing piece 61 at the distal end is lowered. Similarly, the second pressing unit 57 has a second arm 63, a second pressing piece 64, and a second cam 65 (refer to Fig. 2), and the second pressing piece 64 is lowered by the rotation of the second cam 65.) . See [0019-0022 and 0027-0028] ; also see whole document . Yumbe does not expressly state that a projected area of the second pressing surface viewed from a pressing direction where the reagent container is pressed is larger than a projected area of the first pressing surface . However, providing a projected area of the second pressing surface viewed from a pressing direction where the reagent container is pressed is larger than a projected area of the first pressing surface would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. , length or width , would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A). Regarding claim 2 , Yumbe does not expressly state that the projected area of the second pressing surface is larger than the projected area of the reagent container. However, providing a projected area of the second pressing surface that is larger than the projected area of the reagent container would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. , length or width , would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A). Regarding claim 3 , Yumbe does not expressly state that wherein in the pressing direction, a thickness of the second displacement part is smaller than a thickness of the first displacement part. However, providing a in the pressing direction, a thickness of the second displacement part is smaller than a thickness of the first displacement part would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. , thickness , would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A). Regarding claim 1 2 , Yumbe discloses wherein the pressing operation part ( first pressing unit 56 ) and the first displacement part ( first arm 60 ) are integrally formed as shown in Fig. 3 and discussed in [0027-0028] . Regarding claim 14 , Yumbe does not expressly state that the reagent container is formed of a pillow packaging body. However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed reagent container was significant. See MPEP §2144.04 (IV)(B). Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent reagent container shape and since the same expected reagent storage and discharge would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration. Claims 4-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yumbe EP 3584578 as applied to claims 1-3 , 12 and 14 above, and further in view of Ismagilov et al. (hereinafter Ismagilov) US 2016 / 0263577 . Regarding claim 4 , Yumbe does not expressly disclose wherein the reagent container has a sealing portion. Ismagilov discloses a fluidic system comprising A resistant unit (e.g., a blister or a blister pack) can include one or more burstable seals, which can allow for fluid or reagent flow from the resistant unit into a chamber, channel, or other structure [0211] . Therefore, it would have been obvious to one of ordinary skill in the art to modify Yumbe with a sealing portion as taught by Ismagilov in order to enable a controlled release while preventing accidental discharge of the liquid contents. Additionally, i t is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114. Yumbe as modified is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure Yumbe as modified is capable of providing the operating conditions , i.e., opening a sealing portion earlier than other portions in a case where an internal pressure is increased by pressing from the second pressing surface . Regarding claim 5 , Yumbe as modified does not expressly disclose wherein in a case where in the reagent container, a sealing portion side is defined as a first end portion, a side opposite to the sealing portion is defined as a second end portion, and a direction in which the first end portion and the second end portion are connected is defined as a reference direction, in the reference direction, a width of the second pressing surface is larger than a width of the first pressing surface. However, absent unexpected results, it would have been an obvious matter of design choice to define a sealing portion side as a first end portion, a side opposite to the sealing portion as a second end portion, and a direction in which the first end portion and the second end portion are connected a reference direction, in the reference direction, in addition to providing a width of the second pressing surface that is larger than a width of the first pressing surface, since applicant has not disclosed that defin ing a sealing portion side as a first end portion, a side opposite to the sealing portion as a second end portion, and a direction in which the first end portion and the second end portion are connected a reference direction, in the reference direction solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the assay cartridge of Yumbe as modified. Additionally, s ince providing a width of a second pressing surface that is larger than a width of a first pressing surface would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. , width , would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A). Regarding claim 6 , Yumbe as modified is capable of being arranged such that a second displacement part is provided in such a manner that a second pressing surface crushes a second end portion side of the reagent container earlier than a first end portion side of the reagent container in a case where the second displacement part is pressed from the first displacement part as shown in Fig. 3 of Yumbe reproduced below . Regarding claim 7 , Yumbe as modified does not expressly disclose wherein in the reference direction, a center of the first displacement part is disposed closer to the second end portion than a center of the second displacement part. However, absent unexpected results, it would have been an obvious matter of design choice to provide a center of the first displacement part disposed closer to the second end portion than a center of the second displacement part in the reference direction, since applicant has not disclosed that providing a center of the first displacement part disposed closer to the second end portion than a center of the second displacement part in the reference direction solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the assay cartridge of Yumbe as modified. Regarding claim 8 , Yumbe as modified does not expressly disclose wherein a first end portion side of the second displacement part is a fixed end, and a second end portion side of the second displacement part is a free end, and the second end portion side of the second displacement part comes into contact with the reagent container earlier than the first end portion side of the second displacement part in a case where the second displacement part is pressed from the first displacement part, and thus the second end portion side of the reagent container is crushed earlier than the first end portion side of the reagent container. However, absent unexpected results, it would have been an obvious matter of design choice to provide a first end portion side of the second displacement part as a fixed end, and a second end portion side of the second displacement part as a free end, such that the second end portion side of the second displacement part comes into contact with the reagent container earlier than the first end portion side of the second displacement part in a case where the second displacement part is pressed from the first displacement part, and thus the second end portion side of the reagent container is crushed earlier than the first end portion side of the reagent container, since applicant has not disclosed that providing a first end portion side of the second displacement part as a fixed end, and a second end portion side of the second displacement part as a free end, such that the second end portion side of the second displacement part comes into contact with the reagent container earlier than the first end portion side of the second displacement part in a case where the second displacement part is pressed from the first displacement part, and thus the second end portion side of the reagent container is crushed earlier than the first end portion side of the reagent container solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the assay cartridge of Yumbe as modified. Regarding claim 9 , Yumbe does not expressly state that wherein the second displacement part is formed of a deformable material. Absent unexpected results, it would have been prima facie obvious to provide a second displacement part that is formed of a deformable material , since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. Regarding claim 1 0 , e ven though product-by-process claims are limited by and defined by the process (welding) , determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See MPEP § 2113 . Regarding claim 11 , Yumbe does not expressly disclose wherein in a case where the reagent container includes a plurality of sealing portions, one of the plurality of the sealing portions is a weak sealing portion having a weaker sealing force than the other sealing portions. Ismagilov discloses a fluidic system comprising a resistant unit (e.g., a blister or a blister pack) can include one or more burstable seals, which can allow for fluid or reagent flow from the resistant unit into a chamber, channel, or other structure . Exemplary non-limiting seals include a valve, a weakened heat seal, a pressure seal, and combinations thereof , [0211] . Therefore, it would have been obvious to one of ordinary skill in the art to modify Yumbe with one or more burstable seals sealing portions, one of the plurality of the sealing portions is a weak sealing portion having a weaker sealing force than the other sealing portions as taught by Ismagilov in order to enable a controlled release while preventing accidental discharge of the liquid contents. Regarding claim 13 , Yumbe discloses wherein a regulating part ( first cam 62 or second cam 65 ) that regulates a position of the first displacement part is formed in the second displacement part as shown in Fig. 2 and discussed in [0027] . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LYDIA EDWARDS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3242 . The examiner can normally be reached on FILLIN "Work Schedule?" \* MERGEFORMAT Monday- Wedne sday 08 : 0 0- 18 : 0 0 EST . 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 on FILLIN "SPE Phone?" \* MERGEFORMAT 571- 272- 1234 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LYDIA EDWARDS/ Primary Examiner, Art Unit 1796
Read full office action

Prosecution Timeline

Sep 21, 2023
Application Filed
Mar 28, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
60%
Grant Probability
64%
With Interview (+4.1%)
3y 9m
Median Time to Grant
Low
PTA Risk
Based on 700 resolved cases by this examiner. Grant probability derived from career allow rate.

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