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 .
Response to Amendment
The Amendment filed 09/08/2026 has been entered. Claims 1-6, 9, 11, 13, 17, 24, 28, 30, and 37-41 remain pending in the application. Claims 37-38 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities: In the last paragraph, it is suggested to recite instances of “the second baffles” as “the one or more second baffles” for improved consistency of terminology and antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 9, 11, 13, 17, 24, 28, 30, and 39-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 recites the limitation of “to suppress stray light propagation toward the optical detector” in lines 22-23 and “suppresses stray light and cross illumination” in lines 29-30. While the specification discloses the angled pillars to block a portion of light and reducing and preventing specular reflections (page 43, lines 5-8; page 43, lines 26-33; page 44, lines 10-25), reducing and minimizing cross-talk (page 9, lines 20-22; page 20, lines 15-17; page 20, lines 29-31), reducing light pollution (page 20, lines 19-20), reducing unwanted reflections (page 20, lines 32-35), blocking a portion of light incident on or reflected by the test region to reduce an intensity of light received by the optical detector (page 41, lines 23-36), preventing specular reflections (page 41, lines 26-28), the disclosure fails to describe “to suppress stray light propagation toward the optical detector” and “suppresses stray light and cross illumination”. Therefore, the claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-6, 9, 11, 13, 17, 24, 28, 30, and 39-41 are rejected by virtue of their dependency on claim 1. It is suggested to amend the claims to recite the functional limitations as described in the specification.
Regarding claim 40, claim 40 recites a new limitation of “the angled pillars do not contact a test strip of the assay”. While the specification describes the angled pillars (page 43, lines 27-31; page 44, lines 15-25) and the drawings (Figs. 21-22) show angled pillars (3108, 2201), the disclosure fails to describe “the angled pillars do not contact a test strip of the assay”. Note that any negative limitation or exclusionary proviso must have basis in the original disclosure and that the mere absence of a positive recitation is not basis for an exclusion (see MPEP 2173.05(i)). Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 41, claim 41 recites a new limitation of “the angled pillars extend in a direction parallel to a longest dimension of the first opening or of the second opening an amount that is less than the longest dimension.” While the specification describes the angled pillars (page 43, lines 27-31; page 44, lines 15-25) and the drawings (Figs. 21-22) show angled pillars (3108, 2201), the disclosure fails to describe “the angled pillars extend in a direction parallel to a longest dimension of the first opening or of the second opening an amount that is less than the longest dimension”. Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 1-6, 9, 11, 13, 17, 24, 28, 30, and 39-41 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.
Regarding claim 1, claim 1 recites “a multistage optical labyrinth” in line 29. It is unclear of the multistage optical labyrinth is the same or different from the “multistage optical labyrinth” established in line 22. Claims 2-6, 9, 11, 13, 17, 24, 28, 30, and 39-41 are rejected by virtue of their dependency on claim 1. It is suggested to recite “a multistage optical labyrinth” in line 29 as “the multistage optical labyrinth” if referring to the same element.
Regarding claim 39, claim 39 recites “optical module of claim 16”. Claim 16 has been cancelled. Therefore, it is unclear upon which claim that claim 39 depends on. For examination purposes, claim 39 is interpreted as dependent on claim 1. It is suggested to recite “claim 16” as “claim 1”.
Regarding claim 41, claim 41 recites “wherein the angled pillars extend in a direction parallel to a longest dimension of the first opening or of the second opening an amount that is less than the longest dimension.” The phrase “an amount that is less…” is unclear. Is the angled pillars extending in a direction by “an amount” or length? It is suggested to recite the limitations as “wherein the angled pillars extend in a direction parallel to a longest dimension of the first opening or of the second opening by an amount that is less than the longest dimension”.
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 1-2, 11, 13, 28, 30 and 39-40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fang et al. (US 20200225147 A1; effectively filed 01/10/2019).
Regarding claim 1, Fang teaches an optical module (abstract; Figs. 1-6) for reading a test region of an assay (abstract and paragraph [0002]), the optical module comprising:
a first light source (Figs. 1, 4 and paragraph [0225], first light-emitting element 101) for illuminating the test region of the assay (interpreted as an intended use of the first light source, MPEP 2114; paragraph [0225] teaches the first light-emitting element illuminates the testing area 403 of the testing element);
an optical detector (Figs. 1, 4 and paragraph [0225], photodetector 201), comprising an optical input for receiving light emitted from the test region of the assay (paragraph [0225] teaches the photodetector receives light from the areas of the testing element, therefore comprises an optical input capable of performing the intended use) and an electrical output (paragraph [0219] teaches the photodetector forms an electrical signal, therefore comprises an electrical output in order for electrical signal to be analyzed from the photodetector);
a substrate (Figs. 4-5 and paragraph [0270] teaches a base board 60) for mounting the first light source and the optical detector (Figs. 4-5 and paragraph [0270] teaches the light emitting elements and photodetector are located on the base board 60, therefore the base board is for mounting the light source and optical detector);
a housing (Figs. 1-5 shows elements of a housing comprising base frame 70, upper casing 80, lower casing 90, cover body 100, and light blocking elements 301, 302, 303) defining a first opening (Figs. 2-3, gap 50 comprising gaps 503,501) for providing a first optical path from the first light source to the test region (Figs. 1-3 and paragraph [0256]) and from the test region to the optical detector (Figs. 1-3 and paragraph [0256]); and
wherein the housing (Figs. 1-5 shows elements of a housing comprising base frame 70, upper casing 80, lower casing 90, cover body 100, and light blocking elements 301, 302, 303) and the substrate (Figs. 4-5 and paragraph [0270] teaches a base board 60) enclose and positionally align the first light source and the optical detector relative to the first opening (Figs. 1, 4-5 and paragraph [0271] teaches the housing supports the components and protects from influence of external environment, therefore the housing and substrate enclose and positionally align the light source and photodetector relative to the first opening to properly function as shown in Figs. 1 and 4);
a second light source (Figs. 1, 4 and paragraph [0225], second light-emitting element 102) for illuminating a control region of the assay (interpreted as an intended use of the first light source, MPEP 2114; paragraph [0225] teaches the second light-emitting element illuminates the control area 405 of the testing element);
wherein the second light source is mounted on the substrate (Figs. 4-5 and paragraph [0270] teaches the light emitting elements are located on the base board 60, therefore the second light source is mounted on the substrate),
wherein the housing comprises a second opening (Figs. 2-3, gap 50 comprising gaps 502,504) for providing a second optical path from the second light source to the control region (Figs. 1-3, paragraph [0256]) and from the control region to the optical detector (Figs. 1-3 and paragraph [0256]), and
wherein the housing and the substrate further enclose and positionally align the second light source relative to the first and second openings, and the optical detector (Figs. 1, 4-5 and paragraph [0271] teaches the housing supports the components and protects from influence of external environment, therefore the housing and substrate enclose and positionally align the second light source relative to the first and second openings and optical detector to properly function as shown in Figs. 1 and 4);
one or more first baffles (Figs. 1-3, light blocking element 301) positioned on the substrate (Fig. 1 shows the assembled system where the light blocking element 301 is positioned on the substrate where the light sources and photodetector are positioned) between the optical detector and the first light source (Fig. 1) to block direct propagation of light from the first light source to the optical detector (Fig. 1 and paragraph [0220] teaches the light blocking element prevents direct propagation of light from the first light source to the photodetector); and
angled pillars (Figs. 2-3 teaches pillar structures 304,305 which have an angle, e.g. 90 degree angle) integrally formed with the housing (Figs. 2-3, 5, 7-8 teaches pillar structures 304,305 are integrally formed with the base frame 70, which is interpreted as part of the housing) and cooperating with the one or more first baffles to form a multistage optical labyrinth (Figs. 2-3 teaches the pillar structures 304,305 cooperates, i.e. works with or is associated with, the light blocking element 301 to form a multistage optical labyrinth that includes various optical pathways, such as elements 503,501) configured to suppress stray light propagation toward the optical detector (Fig. 1 and paragraph [0220] teaches the light blocking elements, i.e. elements 304, 305, 301, prevents direct propagation of light from the first light source to the photodetector; paragraph [0009] teaches the apparatus avoids influence of other stray lights; therefore, the elements 304,305, 301 are capable of suppressing stray light propagation towards photodetector 201),
wherein the housing further comprises one or more second baffles (Figs. 1-3, second light blocking element 302) positioned on an inside surface (Figs. 1-3 shows second light blocking element 302 is positioned on at least an inside surface of base frame 70) between the first and second openings (Figs. 1-3), the second baffles being configured to block propagation of light from the first light source to the control region (interpreted as an intended use, see MPEP 2114; Figs. 1-3 and paragraph [0242] teaches the second light blocking element 302 blocks light emitted from the first light-emitting element 101 from illuminating between the testing area and control area; paragraph [0248] teaches the second light blocking element 302 separates the testing area from the control area; therefore is capable of blocking the first light source to the control region; note that “second baffles” is interpreted as the “one or more second baffles” herein) and to block propagation of light from the second light source to the test region (interpreted as an intended use, see MPEP 2114; Figs. 1-3 and paragraph [0248] teaches the second light blocking element 302 separates the testing area from the control area, and therefore is capable of blocking light emitted from the second light-emitting element 102 from illuminating the test area), the second baffles (Figs. 1-3, second light blocking element 302) cooperating with the first baffles (Figs. 1-3, light blocking element 301) and angled pillars (Figs. 2-3 teaches pillar structures 304,305) to form a multistage optical labyrinth (Figs. 1-3 teaches elements 302, 301, and 304,305 structurally cooperate to form a multistage optical labyrinth) that suppresses stray light and cross illumination (interpreted as a functional limitation, see MPEP 2114; Figs. 1-3 and paragraphs [0220],[0254],[0269] teach the light blocking elements, i.e. elements 302, 301, and 304,305, prevents direct propagation of light from the first light source to the photodetector and covers and blocks light from illuminating areas; paragraph [0009] teaches the apparatus avoids influence of other stray lights; therefore, the elements 302, 301, and 304,305 are capable of suppressing stray light and cross illumination).
Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The optical module of Fang is identical to the presently claimed optical module. Fang discloses at least the claimed optical module including the one or more first baffles, angled pillars, and one or more second baffles as claimed and therefore, would have the ability to perform the function or use recited in the claim. See MPEP 2112.01 (I).
Regarding claim 2, Fang further teaches wherein one or more walls of the housing (Figs. 1-5, interpreted as the walls of the housing which comprises base frame 70, upper casing 80, lower casing 90, cover body 100, and light blocking elements 301, 302, 303) comprise a shaped surface configured to receive the substrate in a predetermined position to provide positional alignment (Fig. 5 and paragraphs [0270] and [0281] teaches the base board 60, i.e. substrate, and the base frame 70 are detachably connected, combined or united; therefore, it is implied that the walls of the housing, i.e. the walls at least the base frame 70, comprises at least a shaped surface to allow for detachably connection of the base board).
Regarding claim 11, Fang further teaches the optical module of claim 1 comprising: a blocking portion (Figs. 2-3 and paragraph [0254], interpreted as an upper portion of light blocking element 304, i.e. pillar, which is capable of blocking light) positioned in the first optical path (Fig. 3 and paragraph [0254] teaches the light blocking element 304 is positioned to block light from the first light-emitting element, therefore is in the first optical path) configured to block a portion of light incident on or reflected by the test region to reduce an intensity of the light received by the optical detector (interpreted as a functional limitation of the blocking portion, see MPEP 2114; Fig. 3 and paragraph [0254] teaches the upper portion of the light blocking element 304 blocks the light emitted by the first light-emitting element 101 from illuminating the testing area in front of the testing area of the testing element; therefore, is capable of performing the claimed functional limitation).
Regarding claim 13, Fang further teaches the optical module of claim 11, wherein the blocking portion (Figs. 2-3 and paragraph [0254], interpreted as an upper portion of light blocking element 304, i.e. pillar, which is capable of blocking light) is positioned between an inside surface of the housing and the one or more first baffles (Figs. 2-3 teaches the upper portion of the light blocking element 304 is optically positioned between various inside surfaces of the housing, which includes surfaces of base frame 70, upper casing 80, lower casing 90, cover body 100, and the light blocking element 301, i.e. first baffle) and blocks a central portion of an optical axis of the first optical path (Fig. 3 and paragraph [0254] teaches the upper portion of the light blocking element 304 blocks the light emitted by the first light-emitting element 101 from illuminating the testing area in front of the testing area of the testing element; therefore, the upper portion of the light blocking element 304 blocks a central portion of an optical axis of the first optical path, i.e. the optical path of from first light source 101 to the test region).
Regarding claim 28, Fang further teaches the optical module of claim 1, wherein the first light source (Figs. 1, 4 and paragraph [0225], first light-emitting element 101), the optical detector (Figs. 1, 4 and paragraph [0225], photodetector 201) and the second light source (Figs. 1, 4 and paragraph [0225], second light-emitting element 102), and/or an electrical signal processor (the “electrical signal processor” is interpreted as not required due to the “and/or” statement; paragraph [0338] teaches “processor”) are provided adjacent to one another in a first planar arrangement (Fig. 1 shows the light sources and photodetector are provided adjacent to one another in a planar arrangement), wherein the first (Figs. 2-3, gap 50 comprising gaps 503,501) and where present the second openings (Figs. 2-3, gap 50 comprising gaps 502,504) are provided in a second planar arrangement parallel to and facing the first planar arrangement (Figs. 1-3 shows the gaps 50 are in a planar arrangement parallel to the arrangement of the planar arrangement of the light sources and photodetector).
Regarding claim 30, Fang further teaches an assay reader device (Figs. 1-5; abstract, “reading apparatus for reading an assay result on a testing element”) comprising the optical module of claim 1 (see above claim 1; abstract; Figs. 1-6).
Regarding claim 39, Fang further teaches the optical module of claim 1, wherein the first (Figs. 1-3, light blocking element 301) and second baffles (Figs. 1-3, second light blocking element 302) are at least partially directly under the first and second openings, respectively (Figs. 1-3 teaches light blocking element 301 is at least partially directly under gap 50 comprising gaps 503,501, i.e. first opening, and second light blocking element 302 is at least partially directly under gap 50 comprising gaps 502,504, i.e. second opening)
Regarding claim 40, Fang further teaches wherein the angled pillars (Figs. 2-3 teaches pillar structures 304,305 which have an angle, e.g. 90 degree angle) do not contact a test strip of the assay (note that “an assay” is not positively recited structurally and therefore is interpreted as an intended use of the optical module; Figs. 1-2 teaches pillar structures 304,305 are not contacting a test strip of the assay).
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Fang as applied to claim 2 above, and further in view of Patwardham (US 20170087549 A1).
Regarding claim 3, while Fang teaches the base board, i.e. substrate, and the base frame are detachably connected, combined or united (Fig. 5 and paragraphs [0270] and [0281]) and elements can be detachably combined together by a snap to facilitate assembly (paragraph [0346]), Fang fails to explicitly teach: wherein the shaped surface comprises one or more of a step, slot, and/or bevel on one or more surfaces of said one or more walls of the housing.
Patwardham teaches a system for detecting a blood analyte includes a lateral flow test strip and a test strip holder (abstract). Patwardham teaches a lid includes wings and snaps into the base; a lid including ribs for holding a lateral flow test strip in place; or a slot for receiving the lateral flow test strip and the test strip holder combination, where the reading window aligns with a sensor (paragraph [0003]). Patwardham teaches the base (Fig. 3, element 110) comprising a shaped surface comprises a step, slot, and/or bevel (see annotated Fig. 3 below, arrows pointing to a structure comprising a structural step, slot and/or bevel), wherein the lid snaps into the base with beveled wings for ease of manufacturability (paragraph [0020]).
Since Patwardham teaches attachment of elements for an analysis device involving a test strip, similar to Fang, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaped surface of Fang to incorporate the teachings of a base comprising a shaped surface comprises a step, slot, and/or bevel (see annotated Fig. 3 below) to provide: wherein the shaped surface comprises one or more of a step, slot, and/or bevel on one or more surfaces of said one or more walls of the housing. Doing so would have a reasonable expectation of successfully improving and allowing for ease of manufacturability for detachably connecting and aligning desired elements together as taught by Patwardham (paragraphs [0003], [0020]).
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Annotated Fig. 5 of Patwardham: Arrows pointing to two of four structural step, slot and/or bevel.
Regarding claim 4, Fang further teaches wherein the housing (Figs. 1-5, the housing comprises base frame 70, upper casing 80, lower casing 90, cover body 100, and light blocking elements 301, 302, 303) comprises one or more legs extending from a first and/or second outer surface of the housing in a vertical direction (see annotated Fig. 5 below; Fang teaches the base frame 70 comprises at least one leg extending from an outer surface of the base frame in a vertical direction; Fig. 4 additionally shows a close up view of base frame 70 in an upside down position, which shows at least two of the legs).
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Annotated Fig. 5 of Fang: arrows pointing to the one or more legs.
Claims 5-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Fang in view of Patwardham as applied to claim 4 above, and further in view of David et al. (US 20140179505 A1).
Regarding claim 5, Fang further teaches wherein one or more of the one or more legs comprises a hook portion (see annotated Fig. 4 below; the leg portion comprises a hook shaped element).
While Fang teaches the base board, i.e. substrate, and the base frame are detachably connected, combined or united (Fig. 5 and paragraphs [0270] and [0281]) and elements can be detachably combined together by a snap to facilitate assembly (paragraph [0346]), modified Fang fails to explicitly teach: wherein one or more of the one or more legs comprises a flexible hook portion.
David teaches a centrifuge insert for sample holders (abstract). David teaches: an advantageous embodiment of the clip connection, at least one snap hook is arranged at the carrier which engages a corresponding recess of the body, wherein the snap hook is laterally arranged at the carrier and extends substantially vertically with respect to the base of the centrifuge insert; thus, the clip connection can be build up in a particularly simple constructive manner; and the recess is designed as an opening, whereby the snap hook can be easily pressed out of the recess by the user; wherein this flexibility of the snap hook is a result of its dimensioning (paragraph [0015]). David teaches the connection is a detachable connection (paragraph [0017]).
Since David teaches structures for detachable connection of elements, similar to Fang, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more legs of modified Fang to incorporate the teachings of a flexible snap hook of David (paragraph [0015]) and the teachings of detachably combining elements together by a snap of Fang (paragraph [0346]) to provide: wherein one or more of the one or more legs comprises a flexible hook portion. Doing so would have a reasonable expectation of successfully improving and allowing for ease of connection of the hook portion to a desired element during construction of the optical module via a clip connection or snap connection.
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Annotated Fig. 4 of Fang: Arrow pointing to hook shaped portion of at least one leg.
Regarding claim 6, while Fang teaches the base board, i.e. substrate, and the base frame are detachably connected, combined or united (Fig. 5 and paragraphs [0270] and [0281]) and elements can be detachably combined together by a snap to facilitate assembly (paragraph [0346]), modified Fang fails to teach: wherein the flexible hook portion is configured to secure the housing to the substrate with a snap-fit engagement through one or more respective holes in the substrate preventing relative movement between the substrate and the housing.
David teaches a centrifuge insert for sample holders (abstract). David teaches: an advantageous embodiment of the clip connection, at least one snap hook is arranged at the carrier which engages a corresponding recess of the body, wherein the snap hook is laterally arranged at the carrier and extends substantially vertically with respect to the base of the centrifuge insert; thus, the clip connection can be build up in a particularly simple constructive manner; and the recess is designed as an opening, whereby the snap hook can be easily pressed out of the recess by the user; wherein this flexibility of the snap hook is a result of its dimensioning (paragraph [0015]). David teaches the connection is a detachable connection (paragraph [0017]).
Since David teaches structures for detachable connection of elements, similar to Fang, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more legs of modified Fang to incorporate the teachings of a flexible snap hook that engage with corresponding recesses of a body to provide for a clip connection, i.e. snap-fit engagement, of David (paragraph [0015]) to provide: wherein the flexible hook portion is configured to secure the housing to the substrate with a snap-fit engagement through one or more respective holes in the substrate preventing relative movement between the substrate and the housing. Doing so would have a reasonable expectation of successfully improving and allowing for ease of connection of the hook portion to a desired element during construction of the optical module via a clip connection, i.e. snap-fit engagement.
Regarding claim 9, while Fang teaches the base board, i.e. substrate, and the base frame are detachably connected, combined or united (Fig. 5 and paragraphs [0270] and [0281]) and elements can be detachably combined together by a snap to facilitate assembly (paragraph [0346]), the base board is a circuit board, such as a PCB board (paragraph [0341]), and alignment of components of an assay reader device (Figs. 4-5), modified Fang fails to teach: wherein the one or more legs are configured for mating engagement with one or more respective holes in a printed circuit board of an assay reader device to positionally align the optical module relative to the printed circuit board of the assay reader device.
David teaches a centrifuge insert for sample holders (abstract). David teaches: an advantageous embodiment of the clip connection, at least one snap hook is arranged at the carrier which engages a corresponding recess of the body, wherein the snap hook is laterally arranged at the carrier and extends substantially vertically with respect to the base of the centrifuge insert; thus, the clip connection can be build up in a particularly simple constructive manner; and the recess is designed as an opening, whereby the snap hook can be easily pressed out of the recess by the user; wherein this flexibility of the snap hook is a result of its dimensioning (paragraph [0015]). David teaches the connection is a detachable connection (paragraph [0017]).
Since David teaches structures for detachable connection of elements, similar to Fang, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more legs of modified Fang to incorporate the teachings of a flexible snap hook that engage with corresponding recesses of a body to provide for a clip connection, i.e. snap-fit engagement, of David (paragraph [0015]) and the teachings of alignment of components of an assay reader device of Fang (Figs. 4-5) to provide: wherein the one or more legs are configured for mating engagement with one or more respective holes in a printed circuit board of an assay reader device to positionally align the optical module relative to the printed circuit board of the assay reader device. Doing so would have a reasonable expectation of successfully improving and allowing for ease of connection and alignment of the one or more legs to a desired element, e.g. printed circuit board, during construction of the optical module via a clip connection, i.e. mating engagement.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fang as applied to claim 1 above, and further in view of Sekimoto et al. (US 20100259747 A1; cited in the IDS filed 01/07/2025).
Regarding claim 17, Fang fails to teach: the optical module of claim 1, wherein the first and second light sources, and/or the optical detector are encased in a moulded polymer compound, and wherein the first and second optical paths are provided through the moulded polymer compound.
Sekimoto teaches a sample detector comprising a light receiving element and light sources (abstract). Sekimoto teaches light sources and a light receiving element are sealed with transparent resin, i.e. moulded polymer compound (paragraph [0038]-[0039]; Fig. 3 shows resins 45, 51), wherein optical paths are provided through the transparent resin (Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first and second light sources, and/or the optical detector of Fang to incorporate the teachings of light sources and an optical detector sealed with a transparent resin of Sekimoto (Fig. 3; paragraphs [0038]-[0039]) to provide: wherein the first and second light sources, and/or the optical detector are encased in a moulded polymer compound, and wherein the first and second optical paths are provided through the moulded polymer compound. Doing so would have a reasonable expectation of successfully improving sealing and thus protection of the optical elements.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Fang as applied to claim 1 above, and further in view of Hardcastle et al. (US 20080171397 A1).
Regarding claim 24, while Fang teaches light blocking elements can include an opaque part that cannot transmit spectra (paragraph [0235]), Fang fails to teach: the optical module of claim 1, wherein a portion of the housing comprises a transparent material having an opaque material on a surface thereof, and wherein the first and/or the second openings comprise gaps in the opaque material.
Hardcastle teaches a multiple analyte detection system comprising a carrier having reagents, and the system including a photodetector (abstract). Hardcastle teaches a carrier composed of a transparent material to facilitate transfer of light (paragraphs [0017],[0038]). Hardcastle teaches a housing portion that defines a transparent window positioned to allow light to pass through the window to illuminate reagents (paragraph [0028]). Hardcastle teaches a baffle to direct light from a light source, wherein the baffle is formed of an opaque material (paragraph [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a portion of the housing of Fang to incorporate the teachings of transparent elements, such as a housing portion that defines a transparent window to allow light to pass, and opaque baffles to direct light of Hardcastle (paragraphs [0017],[0028],[0038],[0041]) and the teachings of light blocking elements comprising an opaque part of Fang (paragraph [0235]) to provide: the optical module of claim 1, wherein a portion of the housing comprises a transparent material having an opaque material on a surface thereof, and wherein the first and/or the second openings comprise gaps in the opaque material. Doing so would have a reasonable expectation of successfully improving control of directing of light while allowing for transmission of light through the housing towards desired locations.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the claimed portion of the housing comprises a transparent material having an opaque material on a surface thereof, and wherein the first and/or the second openings comprise gaps in the opaque material) by known methods with no change in their respective functions (i.e. allowing for transmission of light through the housing while blocking and directing light), and the combinations yielded nothing more than predictable results (i.e. providing the claimed housing and gaps in the opaque material would yield nothing more than the obvious and predictable result of improving control of directing of light while allowing for transmission of light through the housing towards desired locations). See MPEP 2143(A).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Fang as applied to claim 1 above, and further in view of Phelan (US 20050036148 A1; cited in the OA filed 07/17/2025).
Regarding claim 41, Fang fails to explicitly teach wherein the angled pillars (Figs. 2-3 teaches pillar structures 304,305 which have an angle, e.g. 90 degree angle) extend in a direction parallel to a longest dimension of the first opening (Figs. 2-3, gap 50 comprising gaps 503,501) or of the second opening (Figs. 2-3, gap 50 comprising gaps 502,504) an amount that is less than the longest dimension.
Phelan teaches an assay result reading device comprising a light source or light sources and a photodetector (abstract). Phelan teaches a baffle between an LED and photodetector (Fig. 5). Phalen teaches an angled pillar (Fig. 5, element 70 comprising an angled pillar towards element 30) that extends in a direction parallel to a longest dimension of a first opening by an amount that is less than the longest dimension (Fig. 5 teaches element 70 has a portion that extends horizontally from line 64 towards element 30, the horizontal direction is parallel to the longest dimension D1 of an opening under element 30, by an amount that is less than the longest dimension D1). Phelan teaches the arrangement also provides an optimal or near optimal path length between the light source and photodetector thus establishing a strong signal (paragraph [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angled pillars of Fang to incorporate Phelan’s teachings of dimensions of an angle pillar relative to an opening (Fig. 5) to provide: wherein the angled pillars extend in a direction parallel to a longest dimension of the first opening or of the second opening an amount that is less than the longest dimension. Doing so would have a reasonable expectation of successfully optimizing optical path lengths and improving desired blocking of light. Additionally, doing so would have been an obvious change in size or proportion of the angle pillars in relation to the first or second opening (MPEP 2144.04(IV)(A)).
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 09/08/2026, with respect to the rejections under 35 U.S.C. 112(a) regarding the limitation of “angled pillars…cooperating with the one or more baffles to form a multistage optical labyrinth” have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(a) of 07/02/2026 regarding “angled pillars…cooperating with the one or more baffles to form a multistage optical labyrinth” have been withdrawn.
Applicant's arguments, see pages 8-9, filed 09/08/2026, with respect to the rejections under 35 U.S.C. 112(a) regarding the limitation of “configured to suppress stray light propagation toward the optical detector”, have been fully considered but they are not persuasive.
In response to applicant’s arguments that the disclosure provides support for “configured to suppress stray light propagation toward the optical detector” (Remarks, pages 8-9), the examiner disagrees. Applicant discussed support for blocking light, blocking specular reflections, reducing noise, cross-talk, and unwanted reflections (Remarks, page 8). However, the disclosure fails to recite “configured to suppress stray light propagation toward the optical detector”. While the specification discloses the angled pillars to block a portion of light and reducing and preventing specular reflections (page 43, lines 5-8; page 43, lines 26-33; page 44, lines 10-25), reducing and minimizing cross-talk (page 9, lines 20-22; page 20, lines 15-17; page 20, lines 29-31), reducing light pollution (page 20, lines 19-20), reducing unwanted reflections (page 20, lines 32-35), blocking a portion of light incident on or reflected by the test region to reduce an intensity of light received by the optical detector (page 41, lines 23-36), preventing specular reflections (page 41, lines 26-28), the disclosure fails to describe “to suppress stray light propagation toward the optical detector”. Therefore, the claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. It is suggested to amend the claims to recite the functional limitations as described in the specification.
Applicant's arguments, pages 9-11, filed 09/08/2026, with respect to the rejections under 35 U.S.C. 102(a)(2) and 103, specifically regarding claim 1, have been fully considered but they are not persuasive.
In response to applicant’s argument that Fang fails to teach the claimed “multistage optical labyrinth” (Remarks, pages 9-10), the examiner disagrees.
As discussed in the rejection of claim 1 under 35 U.S.C. 103 Fang teaches:
angled pillars (Figs. 2-3 teaches pillar structures 304,305 which have an angle, e.g. 90 degree angle) integrally formed with the housing (Figs. 2-3, 5, 7-8 teaches pillar structures 304,305 are integrally formed with the base frame 70, which is interpreted as part of the housing) and cooperating with the one or more first baffles to form a multistage optical labyrinth (Figs. 2-3 teaches the pillar structures 304,305 cooperates, i.e. works with or is associated with, the light blocking element 301 to form a multistage optical labyrinth that includes various optical pathways, such as elements 503,501) configured to suppress stray light propagation toward the optical detector (Fig. 1 and paragraph [0220] teaches the light blocking elements, i.e. elements 304, 305, 301, prevents direct propagation of light from the first light source to the photodetector; paragraph [0009] teaches the apparatus avoids influence of other stray lights; therefore, the elements 304,305, 301 are capable of suppressing stray light propagation towards photodetector 201),
wherein the housing further comprises one or more second baffles (Figs. 1-3, second light blocking element 302) positioned on an inside surface (Figs. 1-3 shows second light blocking element 302 is positioned on at least an inside surface of base frame 70) between the first and second openings (Figs. 1-3), the second baffles being configured to block propagation of light from the first light source to the control region (interpreted as an intended use, see MPEP 2114; Figs. 1-3 and paragraph [0242] teaches the second light blocking element 302 blocks light emitted from the first light-emitting element 101 from illuminating between the testing area and control area; paragraph [0248] teaches the second light blocking element 302 separates the testing area from the control area; therefore is capable of blocking the first light source to the control region; note that “second baffles” is interpreted as the “one or more second baffles” herein) and to block propagation of light from the second light source to the test region (interpreted as an intended use, see MPEP 2114; Figs. 1-3 and paragraph [0248] teaches the second light blocking element 302 separates the testing area from the control area, and therefore is capable of blocking light emitted from the second light-emitting element 102 from illuminating the test area), the second baffles (Figs. 1-3, second light blocking element 302) cooperating with the first baffles (Figs. 1-3, light blocking element 301) and angled pillars (Figs. 2-3 teaches pillar structures 304,305) to form a multistage optical labyrinth (Figs. 1-3 teaches elements 302, 301, and 304,305 form a multistage optical labyrinth) that suppresses stray light and cross illumination (interpreted as a functional limitation, see MPEP 2114; Figs. 1-3 and paragraphs [0220],[0254],[0269] teach the light blocking elements, i.e. elements 302, 301, and 304,305, prevents direct propagation of light from the first light source to the photodetector and covers and blocks light from illuminating areas; paragraph [0009] teaches the apparatus avoids influence of other stray lights; therefore, the elements 302, 301, and 304,305 are capable of suppressing stray light and cross illumination).
Therefore, Fang teaches the housing and one or more second baffles as claimed.
Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. See MPEP 2114. The optical module of Fang is identical to the presently claimed optical module. Fang discloses at least the claimed optical module including the one or more first baffles, angled pillars, and one or more second baffles as claimed and therefore, would have the ability to perform the function or use recited in the claim. See MPEP 2112.01 (I).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Remarks, page 10, second paragraph, “second baffles are not merely additional barriers, but rather part of a coordinated optical system that specifically redirects reflection paths. The second baffle plane is optically coupled and does not act independently”; Remarks, page 10, third paragraph, “bidirectional optical labyrinth…bidirectional light blocking between test and control regions through geometric cooperation of first and second baffles…multistage filtering that suppresses stray light by structural design…synergistic interaction between optical and mechanical features is achieved…housing geometry (see paragraphs [0049]-[0052]) enables integration of the second baffles described in [0037] to [0038]…geometrically defined, bidirectional labyrinth”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is suggested to incorporate additional structural details to the angled pillars to further differentiate the claims from the prior art (e.g. Figs. 21a-21b; the instant specification, page 44, lines 15-25 and Figs. 23a-23b discusses the angled pillars widens as it extends away from the baffles to the inside, upper surface of the housing, where the angled pillars are connected to the baffles and upper surface of the housing).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ino et al. (US 20180292776 A1) teaches an optical sensor (abstract; Figs. 5A-5B) including light receiving elements (34,35), an LED (33), angled light shielding walls (38, 39), separation component (59), and openings (60, 61,63) formed by inner walls of a housing (37). Ino teaches surface of the separation component 59 can be formed to have an angle that prevents the light emitted from the LED 33 from being reflected toward the light receiving elements 34 and 35 ([0103]). Ino teaches (Fig. 10; [0110]) surface of the projection 39b can be formed to have an angle that prevents the light beams 80 to 82 emitted from the LED 33 and reflected by the boundary surfaces 49a and 49b from being reflected toward the light receiving elements 34 and 35; this can decrease the possibility that the reflection light beams 80 to 82 become stray light beams received by the light receiving elements 34 and 35 (Fig. 10; [0110]). Ino teaches angles of the boundary surfaces 49a and 49b may be set so that the reflection light beams generated by the boundary surfaces 49a and 49b do not travel toward the light receiving elements 34 and 35 ([0112]).
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 HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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