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 .
Status of Claims
Claims 1 and 11 have been amended. Claims 1-11 and 13-21 have been examined.
Examiner Note: In an effort for compact prosecution, Examiner contacted Attorney Xu on 02/17/2026 to come to an agreement on allowable subject matter (for example, language from claim 3, language from specification page 15, lines 9-14 or language regarding the structural configurations and relationship between components such as the controller, driver and conveyor and the fluid channel) for an Examiner’s Amendment to put the case in condition for allowance. However, Attorney Xu could not be reached.
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.
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 is indefinite because it recites at lines 4-5 that the conveyor controls the reagent to flow but it is unclear where the reagent is intended to be flowed. For example, claim 1 has recited that the reagent is driven in the liquid storage chamber to enter the detection chip, is this the flow the conveyor is controlling? Additionally, claim 1 has also incorporated a fluid channel in communication with inlet and outlet of the chip, is the conveyor controlling the reagent to flow in the fluid channel as well? As such, there is a link missing between the conveyor and what specific flow communication it is intending to control between components of the device.
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)(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, 4-6 and 14 are rejected under 35 U.S.C. 102(1) as being anticipated by Wada et al. (US 2018/0292398, hereinafter “Wada”).
Regarding claim 1, Wada teaches throughout the publication an immunoassay device (abstract and see Figure 2) wherein the immunoassay device comprises: a housing (paragraph 0011, housing case), a driving assembly (paragraph 0035, upstream end of inspection strip 1; as the claimed driving assembly contains no structure, the capillary action of the strip is interpreted as the driving assembly), a detection chip (inspection strip 1) and a liquid storage chamber (container 47);
the detection chip is provided with a fluid channel (insoluble carrier 2), and a liquid inlet and a liquid outlet in communication with the fluid channel (inherent inlet and outlets are present within the carrier for fluid to enter and exit), wherein the fluid channel comprises a first reaction zone and a second reaction zone in communication with each other (see zones L1-L3);
the housing has a first accommodating part (carrier accommodation portion 21) and a second accommodating part (pot accommodation portion 24), and the detection chip is disposed in the first accommodating part (see Figure 2), and the liquid storage chamber is disposed in the second accommodating part (see Figure 2), and the liquid storage chamber is configured at least to store reagent (paragraph 0046, second amplification liquid); and
the driving assembly is configured to communicate a liquid outlet of the liquid storage chamber with a liquid inlet of the detection chip, and drive the reagent in the liquid storage chamber to enter the detection chip (see paragraphs 0059, 0096, 0131 describing the capillary force driving the liquid throughout the claimed components).
Regarding claim 4, Wada teaches the device (see Figure 1) wherein the housing comprises: a top wall (lower case 20) and a bottom wall (upper case 10) disposed opposite to each other, and a side wall connected between the top wall and the bottom wall (see Figure 2), wherein the first accommodating part is disposed on a side of the top wall away from the bottom wall and the second accommodating part is formed on the side wall (see Figure 2, portion 22 disposed in the lower case, interpreted as the top wall; portion 24 juts out from side wall of case 20) and the driving assembly is disposed in a space enclosed by the top wall, the bottom wall and the side wall (see Figure 2, enclosed within the top, bottom and sides of casing).
Regarding claims 5-6, Wada teaches the device wherein the first accommodating part is a first groove formed on the top wall (see 22 formed on the lower case, interpreted as the top wall), and the immunoassay device further comprises a cover plate configured to define a darkroom with the first groove and hinged to the top wall so as to open or close the darkroom (Figure 2, see member 35 that covers the groove of the accommodation part 22).
Regarding claim 14, Wada teaches the device further comprising a chip clamp disposed in the first accommodating part and configured to clamp the detection chip (Figure 2, member 35 holds the carrier in the accommodating part).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 7 and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wada et al. (US 2018/0292398, hereinafter “Wada”), as applied to claim 1 above.
Regarding claim 7, Wada teaches the device further comprising a display disposed on the casing and configured to display parameters of the driving assembly, a hollowed-out portion disposed on the casing and exposing a display area of the display (Figure 2, see window 18; paragraphs 0039 and 0099, flow confirmation confirmed through window). Although Wada does not specifically teach that the display is disposed on a side of the top wall close to the bottom wall and the hollowed-out portion is disposed on the top wall, such limitations are drawn to a matter of design choice. Matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art (see MPEP 2144.04).
Regarding claim 20, Wada teaches production and dimensions of the immunoassay device (paragraph 0112). While Wada does not specifically teach the device wherein the housing has a length between 25cm and 40cm, a width between 20cm and 30cm, and a height between 15cm and 25 cm; and a dimension of the detection chip is between 70mm and 80mm in length, between 20cm and 30cm in width and between 1.0mm and 2.0mm in thickness, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 20 are for any particular purpose or solve any stated problem, and the prior art teaches that device component dimensions may be varied based on desired detection parameters, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the immunoassay analyzer art.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wada et al. (US 2018/0292398, hereinafter “Wada”), as applied to claim 1 above, and further in view of Clark et al. (US 6190617, hereinafter “Clark”).
Regarding claim 21, Wada teaches the device as described above that can use reagents such as antigen/antibody assay reagents and a label substance for detection (see paragraphs 0072, 0101)) and further teaches utilizing the driving assembly to drive the liquid outlet of the liquid storage chamber to communicate with the liquid inlet of the detection chip, and drive the reagent in the liquid storage chamber to enter the detection chip (see paragraphs 0059, 0096, 0131 describing the capillary force driving the liquid throughout the claimed components).
While Wada fails to teach the specific immunoassay reaction conducted within the device, Clark teaches throughout the publication an analytical instrument (abstract). More specifically, Clark teaches that a sandwich immunoassay can be conducted with a sample solution containing an antigen to combine at least a part of the antigen in the sample solution with a fluorescent antibody preset in the detection chip, and a complex formed after combination is captured by a capture object preset in the detection chip (column 12, line 51 – column 13, line 9, column 14, lines 19-36 and column 14, line 56 – column 15, line 6).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the device and methods of Wada to include a sandwich assay with antigen/fluorescent antibody binding for subsequent binding and capture as taught by Clark because Wada is generic regarding the types of labels that can be incorporated within reactions in the device (paragraph 0072) and one skilled in the art would have been motivated to choose the appropriate assay format based on the desired analytes to be detected.
Allowable Subject Matter
Claims 3, 8-13 and 15-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments filed 11/06/2025 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims. Wada teaches the device as presently claimed and thus the claims remain unpatentable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gould (US2006/0275922) teaches an assay device comprising a housing holding a detection chip and liquid storage chamber in separate accommodating parts (see for example, Figure 13). Similarly, Mori (US 2012/0058465) teaches an assay device comprising a housing holding a detection chip and liquid storage chamber in separate accommodating parts (see Figure 1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677