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 .
Status of Claims
There are two (2) sets of claims submitted on 14 FEBUARY 2024.
The claim set considered is the claim set with status identifiers.
In the claim set, Claims 1-20 are presented and considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 is objected to. It is dependent upon itself. For examination purposes, the Examiner interprets Claim 3 to be dependent upon Claim 1.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 1, character 998; Figure 2, character 903, 904; Figure 3, character 978; Figure 13, character 991, 935, 9119; Figure 14, character 770; Figure 17, character 871, 875, 874; Figure 18, character 875; Figure 22, character 44, 45, 50, 36, 37. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because the characters in Figures 24-27 are extremely blurry.. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
A “testing element being configured to detect one or more analytes in the liquid sample” in claim 1 and 18.
An “element” does not connote any particular structure. The specification describes the “testing element” to be a lateral flow test strip that can detect a variety of analytes, [0064, 0065], or claim 16.
A “testing unit is configured to be inserted into a test result reading device” in claim 1and 18.
A “unit” does not connote any particular structure. The specification describes the “testing unit” to be described in [0056, 0059, 0073-0075], or claim 8 and 9.
A “locking element is configured to make the testing unit fixed…” in claim 4.
An “element” does not connote any particular structure. The specification describes the “locking element” to be a hook, [0062], or seen in Figure 19 as protrusions 706, 707, 708, or described in claim 5.
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 § 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KIM, EP 3 296 718 B1.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference KIM discloses a device for detecting analytes in a liquid sample, Figure 7A, 7B, comprising :
a main body, Figure 7A, 7B, [0083], holder 411, wherein the main body comprises a plurality of testing units, Figure 7A, 7B, 21A, 21B, one or more cuvette, [0083], each testing unit comprising a testing element therein, and the testing element being configured to detect one or more analytes in the liquid sample, [0049, 0141];
the testing units are capable of being detachably combined with the main body, [0069];
when testing needs to be performed, each testing unit is separable from the main body; and the testing unit is configured to be inserted into a test result reading device for automatic reading of test results, Figure 6, [0048].
The claim language that recites “when testing needs to be performed…” is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Additional Disclosures Included are: Claim 2: wherein the device according to claim 1, wherein after the testing unit is separated from the main body, the testing unit is capable of being combined with the main body again after the reading of the test result is completed, Figure 21A, 21B, [0065, 0069]. ; Claim 3: wherein the device according to claim 3, wherein when the testing unit is combined with the main body again, the testing unit is locked with and inseparable from the main body, [0065, 0145]. ; Claim 4: wherein the device according to claim 4, wherein the main body comprises a locking element, and the locking element is configured to make the testing unit fixed in the main body without separation after the testing unit leaves the main body, completes testing and returns into the main body, Figure 7B-E, 411b and 411c, [0083].; Claim 5: wherein the test device according to claim 4, wherein the main body comprises an insertion chamber, Figure 7B, 7C, walls, [0083], the locking element is elastic and is provided with a barb and located in the insertion chamber, Figure 7B, 7E, [0085], the testing element comprises an insertion end, and the insertion end comprises an insertion hole, Figure 13, 16, 21A, wherein after the testing unit completes the reading of the test results, when the insertion end is inserted into the insertion chamber, the locking element is inserted into the insertion hole on the insertion end such that the testing unit is locked to the main body and connected with the main body into an integrated structure. The claim language that recites “wherein after the testing unit completes the reading of the test results, when the …” is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).; Claim 6: wherein the device according to claim 5, wherein when the testing unit is in an initial state before leaving the main body, the testing unit is not locked, but is located on the locking element, kept in the insertion chamber by means of friction between an insertion slot of the insertion chamber and the testing unit and detachably combined with the main body. The claim language of the instant claim is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The claim has been given a relative amount of patentable weight. ; Claim 7: wherein the device according to claim 4, wherein the main body has connecting columns, and the testing units also comprise connecting columns; and the connecting columns on the main body are connected to the connecting columns on the testing units in an easily breakable manner. The claim language in the instant claim is directed towards a manner in which the claimed apparatus is intended to be employed, [0068].; Claim 8: wherein the device according to claim 7, wherein the main body comprises an insertion chamber, Figure 7B, 7C, walls, [0083], each testing unit comprises an insertion end, the insertion end has an opening, , Figure 13, 16, 21A, and the locking element is located in the insertion chamber and provided with a barb, Figure 7B, 7E, [0085]; and after the testing unit completes the reading of the test results, when the insertion end of the testing unit is inserted into the insertion chamber, the barb passes through the opening such that the testing unit is locked with the main body without separation. . The claim language that recites “after the testing unit completes the reading of the test results, when the …” is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).; Claim 9: wherein the device according to claim 8, wherein the testing unit comprises a casing, Figure 21A, 21B, [0069], and the connecting columns are provided with labels indicating a test item or type or a specific analyte, the labels being automatically identifiable by the reading device, [0035, 0074]. ; Claim 10: wherein the device according to claim 9, wherein the casing comprises first and second connecting columns, Figure 21A, 21B, see protrusions left of character 210, the first connecting column comprising a label indicating a type of the analyte tested, and the second connecting column comprising a label indicating a name of the specific analyte. ; Claim 11: wherein the device according to claim 10, wherein the labels are in a form of patterns, numbers, grooves with different widths, threads with different widths, or different colors, [0074]. ; Claim 12: wherein the device according to claim 11, wherein the device has a sensor or an optical sensor for sensing the labels so as to identify the labels, such that a signal generated after identifying the label is transmitted to a control center and the control center allows a computing center to retrieve the corresponding type of the analyte or the name of the analyte from a storage device of the device, [0010, 0074-0077], Claim 11, Figure 12. ; Claim 13: wherein the device according to claim 12, wherein the sensor in the device is a sensor capable of sensing different colors, [0076].; Claim 14: wherein the device according to claim 12, wherein the device comprises a memory, and the memory stores data of the labels, and types of analytes or names of specific analytes, [0150], Figure 22. ; Claim 15: wherein the device according to claim 13, wherein the types of the analytes comprise drugs, infectious diseases and tumor markers, [0002]. Instant claim is directed to the device’s intended use of what type of analyte is to be detected. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). There is no claim language in particular that is directed towards the critically of what is to be detected. In addition, what is to be detected on the device does not structurally differentiate the device from the prior art. ; Claim 16: wherein the device according to claim 14, wherein the testing element comprises labels with color granules, and when a color line appears on a test line, it indicates a positive result, or when no color line appears on the test line, it indicates a positive result. The claim language that recites “and when a color line appears on a test line , it indicates …” is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).; and Claim 17: wherein the device according to claim 15, wherein the testing element is a lateral flow testing element, and the test line is located on a nitrocellulose (NC) membrane, [0072].
Applicant’s invention is directed towards a system.
Regarding Claim 18, the reference KIM discloses a system for detecting analytes in a liquid sample, Figure 1-6, comprising
a test device and a device for reading test results of a testing area on the test device, wherein the test device comprises a main body, and the main body comprises a plurality of testing units, Figure 7A-E, cuvette 200, [0064-0066], each testing unit comprising a testing element, and the testing element being configured to detect one or more analytes in the liquid sample, [0049, 0141]; the testing elements are capable of being detachably combined with the main body, [0069]; when testing needs to be performed, each testing unit is separable from the main body, Figure 6, [0048]; the testing unit comprises the testing area, Figure 7A, [0083]; the testing unit is configured to be inserted into the test result reading device for automatic reading of the test results on the testing area, Figure 1, [0065]; and the testing unit comprises a color label of a name of a specific analyte, [0074]; and the device comprises a sensor for sensing colors, [0074-0077].
The claim language that recites “when testing needs to be performed…” is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Additional Disclosures Included are: Claim 19: wherein the system according to claim 18, wherein after sensing the color, the sensor generates an electrical signal and transmits the electrical signal to a control center, the control center retrieves the name of the specific analyte from data of names of analytes corresponding to colors and transmits the name of the specific analyte to a computing center, and in the computing center, output signal data is generated based on the name of the specific analyte and the test result and thus transmitted to an output device to be output, [0154-155], Figure 24 and 25. The claim language that recites “when after sensing the color, the sensor generates and electrical signal….” is directed towards a manner in which the claimed apparatus is intended to be employed. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).; and Claim 20: wherein the system according to claim 19, wherein the output device is a display, Figure 22, 26, [0150].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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