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 the Claims
Claims 1-16 are pending in the application.
Claims 15-16 are withdrawn.
Claims 1-14 are the subject of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 7 August 2026 is acknowledged.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7 August 2026.
Priority
The instant application is a 371 National Stage of PCT/EP2021/087016, filed 21 December 2021. The instant application claims benefit of foreign application GB2101978.1, filed in the United Kingdom on 12 February 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 August 2023 and 21 April 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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:
In claim 1: wherein the optical detector is configured to detect one or more tracking features associated with the assay test strip so as to determine when at least a test line on the assay test strip is detectable through the detection aperture
This limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that recited function. That is, the particular physical structure or feature that enable a generic optical detector to use tracking features associated with the assay test strip to determine when at least a test line of the assay test strip is detectable through the detection aperture is not clear within the context of the claim.
In claim 3: the optical detector is further configured to determine when a control line on the assay test strip is detectable through the detection aperture
This limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that recited function. That is, the particular physical structure or feature that enable a generic optical detector to determine when a control line on the assay test strip is detectable through the detection aperture is not clear within the context of the claim.
In claim 4: the test chamber is configured to prevent or minimize ambient light from reaching the detection aperture
This limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that recited function. That is, the particular physical structure or feature that enable a test chamber to prevent or minimize ambient light from reaching the detection aperture is not clear within the context of the claim.
In claim 10: the lateral flow test device of claim 9 configured to use digital image correlation to track a position of the assay test strip within the test chamber
This limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that recited function. That is, the particular physical structure or features that enable the lateral flow test device to use digital image correlation to track a position of the assay test strip within the test chamber is not clear within the context of the claim.
In claim 11: the optical detector is…further configured to determine a speed of insertion of the assay test strip based on a time of detection of each of the two or more tracking features
This limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that recited function. That is, the particular physical structure or features that enable a generic optical detector to determine a speed of insertion of the assay test strip is not clear within the context of the claim.
In claim 12: the lateral flow test device of claim 1, configured to detect one or more of: coronavirus; coronavirus antibodies
This limitation is interpreted under 112(f) because it links a generic placeholder with a recited function, but does not provide sufficient structure to support that recited function. That is, the particular physical structure or features that enable the lateral flow test device as claimed to detect coronavirus or coronavirus antibodies is not clear within the context of the claim.
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(b)
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 1-14 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 the metes and bounds of the claim are unclear. That is, the metes and bounds of what is encompassed by “or another property of the assay test strip” are not defined and are not clear. Additionally, it is not clear if the language “of the assay test strip” is intended to modify every preceding item in the list, or if preceding items in the list stand alone, and the language “of the assay test strip” only modifies the last item presented in the list (i.e. “another property”). Additionally, it is not clear whether or how limitations regarding the assay test strip itself are limiting to the claimed lateral flow test device. That is, the assay test strip itself is not positively recited as a feature of the claimed test device, but rather appears to be a consumable which is intended to be used in conjunction with the claimed lateral flow test device (i.e. such that the strip itself is not a component of the instantly claimed device). If the test strip is a separate product intended to be used with the claimed device rather than a positively recited feature of the device itself, structural features of the assay test strip (i.e. particular properties of the assay test strip) do not serve to distinguish the claimed device itself over the prior art. Clarification is required.
Claim 13 is rejected as indefinite over the limitation “configured as a point of care device”. This is indefinite because whether or not a device is used at point-of-care is largely a matter of intended use which does not structurally or physically distinguish the claimed device. As such, it is not clear what particular structural or physical features are required of a device in order for it to be considered “configured as a point of care device”, and the metes and bounds of the claim are unclear.
The following claim limitations invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
In claim 1: wherein the optical detector is configured to detect one or more tracking features associated with the assay test strip so as to determine when at least a test line on the assay test strip is detectable through the detection aperture
In claim 3: the optical detector is further configured to determine when a control line on the assay test strip is detectable through the detection aperture
In claim 10: the lateral flow test device of claim 9 configured to use digital image correlation to track a position of the assay test strip within the test chamber
In claim 11: the optical detector is…further configured to determine a speed of insertion of the assay test strip based on a time of detection of each of the two or more tracking features
However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The instant specification provides some discussion of physical components which are associated with some of these recited functions (Pg. 8, Ln. 25-35), however the particular structures that enable these functions and how exactly these structures are specifically “configured to” perform the recited functions is not clear, and much of the recited function appears to be a matter of intended use rather than structural limitation, such that the particular physical features or structures required by the recitation of a generic component “configured to” perform the recited function is unclear. That is, the metes and bounds of these limitations are unclear in terms of what structural features or limitations they require of the claimed device, wherein a claimed device is defined by its structural and physical features and not by its intended use.
The specification appears to indicate that the only physical components required for these recited functions are an optical detector comprising an optical sensor and electronic circuit (Spec pg. 8, Ln. 31-34). The rest of the support for the recited function appears to be related to particular intended methods of using these physical structures, wherein an intended method of use does not distinguish a claimed device over the prior art (see, e.g. Spec Pg. 12, Ln. 15-Pg. 13, Ln. 2; Pg. 5, Ln. 7-18; Pg. 6, Ln. 6-13), since a claim to a device is defined by what the device is and not how or why it is used. As such, if a device of the prior art teaches the required structural features or functional equivalents, it may be understood to be capable of performing the recited intended use/function and is therefore understood to meet the instant claim, regardless of whether it explicitly teaches the same intended use/function.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Dependent claims 2-14 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Busa et al (US 10,823746 B1; IDS entered).
Regarding claim 1, Busa teaches a lateral flow test device (Abstract) comprising:
A test chamber having a detection aperture (Col. 8, Ln. 1-16, Col. 9, Ln. 62-Col. 10, Ln. 9; Col. 11, Ln. 24-27; Figs. 3, 10); and
An optical detector configured to receive light from an assay test strip though the detection aperture, when the assay test strip is provided in the test chamber (Col. 8, Ln. 1-16, Col. 9, Ln. 62-Col. 10, Ln. 9; Col. 11, Ln. 24-27; Col. 11, Ln. 45-57 Figs. 3-4, 10);
Wherein the test chamber is configured for manual feed of at least a portion of the assay test strip passed the detection aperture (Col. 12, Ln. 5-8, Ln. 53-58); and
Wherein the optical detector is configured to detect one or more tracking features associated with the assay test strip so as to determine when at least a test line on the assay test strip is detectable through the detection aperture (Col. 11, Ln. 6-27; Col. 12, Ln. 5-8, Ln. 53-58; Fig. 5; Col. 14, Ln. 4-Col. 15, Ln. 5).
Regarding claim 2, Busa further teaches the device wherein the tracking features comprise one or more of: a mark, a symbol, a shape, a protuberance, an indentation, a cutout, a color, a material, a roughness, a thickness, a transparency, or another property of the assay test strip (Col. 11, Ln. 6-27; Col. 12, Ln. 5-8, Ln. 53-58; Fig. 5; Col. 14, Ln. 4-Col. 15, Ln. 5).
Regarding claim 3, Busa further teaches the device wherein the optical detector is further configured to determine when a control line on the assay test strip is detectable through the detection aperture (Col. 11, Ln. 6-27; Col. 12, Ln. 5-8, Ln. 53-58).
Regarding claim 4, Busa further teaches the device wherein the test chamber is configured to prevent or minimize ambient light from reaching the detection aperture (Fig. 3, 10; Col. 10, Ln. 20-29).
Regarding claim 5, Busa further teaches the device wherein the test chamber comprises an entrance aperture for entrance of the assay test strip into the device and an entrance obscurer for preventing or minimizing ambient light from entering the entrance aperture (Fig. 3, 10; Fig. 3, 10; Col. 10, Ln. 20-29; tray 32 and light shield door 1030).
Regarding claim 6, Busa further teaches the device wherein the entrance obscurer comprises one or more of: a curtain, a screen, and a brush (Fig. 3, 10; Col. 10, Ln. 20-29).
Regarding claim 9, Busa further teaches the device comprising a single optical emitter configured to emit light onto the assay test strip when provided in the test chamber (Fig. 4; Col. 11, Ln. 45-67).
Regarding claim 10, Busa does not explicitly teach the device configured to use digital image correlation to track a position of the assay test strip within the test chamber. However, as discussed in the Claim interpretation and 112(b) sections above, the specification appears to indicate that the structural feature associated with this function is an optical detector comprising an optical sensor and electronic circuit, while the particular use of digital image correlation to track a position of the assay test strip within the test chamber constitutes an intended method of using those structural features. As such, since Busa teaches the required structural features, it is understood to be capable of performing the intended use and is understood to meet the instant claim, regardless of whether it explicitly teaches the same intended use (see, e.g. Busa, Col. 10, Ln. 10-19).
Regarding claim 11, Busa further teaches the device wherein the optical detector is configured to detect two or more tracking features associated with the assay test strip and the device is further configured to determine a speed of insertion of the assay test strip based on a time of detection of each of the two or more tracking features (Col. 14, Ln. 4-Col. 15, Ln. 5).
Regarding claim 12, Busa further teaches the lateral flow test device wherein a single optical detector is provided to detect the one or more tracking features and to receive light from at least the test line of the assay test strip (Col. 11, Ln. 6-27; Col. 12, Ln. 5-8, Ln. 53-58; Fig. 5).
Regarding claim 13, Busa further teaches the device configured as a POC device (Col. 20, Ln. 42-61).
Regarding claim 14, Busa further teaches the device configured to detect one or more of: coronavirus, coronavirus antibodies (Abstract: one use of the reader is for detection of SARS-CoV-2 infection; Col. 2, Ln. 42-54; Col. 3, Ln. 34-38).
Claims 1-6 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bachur et al (US 7,444,005 B2; IDS entered).
Regarding claim 1, Bachur teaches a lateral flow test device (Abstract) comprising:
A test chamber having a detection aperture (Fig. 1, test chamber formed inside reader 20; Fig. 4: aperture 48 of PCB 42); and
An optical detector configured to receive light from an assay test strip though the detection aperture, when the assay test strip is provided in the test chamber (Fig. 2, array 50);
Wherein the test chamber is configured for manual feed of at least a portion of the assay test strip passed the detection aperture (Col. 6, Ln. 37-42); and
Wherein the optical detector is configured to detect one or more tracking features associated with the assay test strip so as to determine when at least a test line on the assay test strip is detectable through the detection aperture (Col. 6, Ln. 37-42, 54-66; Col. 8, Ln. 33-55).
Regarding claim 2, Bachur further teaches the device wherein the tracking features comprise one or more of: a mark, a symbol, a shape, a protuberance, an indentation, a cutout, a color, a material, a roughness, a thickness, a transparency, or another property of the assay test strip (Col. 6, Ln. 37-42, 54-66; Col. 8, Ln. 33-55).
Regarding claim 3, Bachur further teaches the device wherein the optical detector is further configured to determine when a control line on the assay test strip is detectable through the detection aperture (Col. 6, Ln.63-66).
Regarding claim 4, Bachur further teaches the device wherein the test chamber is configured to prevent or minimize ambient light from reaching the detection aperture (Figs. 1-2).
Regarding claim 5, Bachur further teaches the device wherein the test chamber comprises an entrance aperture for entrance of the assay test strip into the device and an entrance obscurer for preventing or minimizing ambient light from entering the entrance aperture (Figs. 1-2 the test strip 22 fits tightly into the entrance aperture 24. The test strip is therefore an entrance obscurer and thus forms a screen between the inner test chamber and the outside of the reader).
Regarding claim 6, Bachur further teaches the device wherein the entrance obscurer comprises one or more of: a curtain, a screen, and a brush (Figs. 1-2 the test strip 22 fits tightly into the entrance aperture 24. The test strip is therefore an entrance obscurer and thus forms a screen between the inner test chamber and the outside of the reader).
Regarding claim 9, Bachur further teaches the device comprising a single optical emitter configured to emit light onto the assay test strip when provided in the test chamber (Fig. 2, LED 46).
Regarding claim 10, Bachur further teaches the device configured to use digital image correlation to track a position of the assay test strip within the test chamber (Col. 6, Ln. 37-67).
Regarding claim 11, Bachur further teaches the device wherein the optical detector is configured to detect two or more tracking features associated with the assay test strip and the device is further configured to determine a speed of insertion of the assay test strip based on a time of detection of each of the two or more tracking features (Col. 6, Ln. 37-67; Col. 8, Ln. 37-55).
Regarding claim 12, Bachur further teaches the lateral flow test device wherein a single optical detector is provided to detect the one or more tracking features and to receive light from at least the test line of the assay test strip (Col. 8, Ln. 33-55 describe the use of two Agilent chips, each comprising an optical detector 50, however the disclosure indicate that two chips are only required if a problem is encountered when reading the surface of the lateral flow strip. The standard configuration uses one optical detector 50 for detecting tracking features and receiving light from at least the test line of the assay test strip as shown in the figures).
Regarding claim 13, Bachur further teaches the device configured as a POC device (Fig. 1-2; Col. 5, Ln. 5-8).
Subject Matter Free of Prior Art
Claims 7-8 are rejected as described above, but appear to be free of the prior art.
Busa et al (US 10,823746 B1; IDS entered) and Bachur et al (US 7,444,005 B2; IDS entered)are the closest prior art, as discussed in the 102 rejection above, however, neither reference teaches the lateral flow test device comprising an exit port, and does not contain teaching which would make it obvious to one of ordinary skill in the art to modify the device such that it would comprise an exit aperture as claimed. As such, these references do not meet the requirements of instant claims 7-8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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 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.
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.
/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
Prosecution Insights