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 . This is a first action on the merits of the application. Claims 1-3, 5-7, 10-18 and 20-24 are pending.
Election/Restrictions
Applicant's election without traverse of invention I, claims 1-3, 5-7, 10-15 and 20-22 in the reply filed on December 08, 2025 is acknowledged. Claims 16-18, 23 and 24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claims 1, 2, 6, 7, 11 and 12 are objected to because of the following informalities:
Claim 1 recites “a sample injection part communicating the detection pool,” in line 5. It is respectfully suggested to amend the limitation to “a sample injection part communicating with the detection pool,” for formal recitation of claim limitation.
Claim 2 recites “sample injection port communicating the detection pool” in line 3. It is respectfully suggested to amend the limitation to “sample injection port communicating with the detection pool” for formal recitation of claim limitation.
Claim 6 recites “an axis of the sample injection channel forms a 20-60° angle with the first board” in lines 1-2. It is respectfully suggested to amend the limitation to “a horizontal axis of the sample injection channel forms a 20-60° angle with a horizontal axis of the first board” for clarification purposes.
Claim 7 recites “the detection pool is between the first board and the second board” in line 3. It is respectfully suggested to amend the limitation to “the detection pool is located between the first board and the second board” for clarification purposes.
Claim 11 recites “the height of the sample injection port” in line 2 which lacks an antecedent basis. It is respectfully suggested to amend the limitation to “a height of the sample injection port” or define “a height of the sample injection port” earlier in the claim.
Claim 12 recites “the length of the sample injection channel” in line 2 which lacks an antecedent basis. It is respectfully suggested to amend the limitation to “a length of the sample injection channel” or define “a length of the sample injection channel” earlier in the claim.
Appropriate corrections are required.
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.
Claims 1, 2, 3, 5, 7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Columbus et al. (EP 0 318 255 A2, herein referred as “Columbus”).
In regard to claim 1, Columbus discloses a cuvette (30, Fig. 4 which meets “a particle detection device”) (Fig. 4; col. 6, line 45 thru col. 9, line 7), including a substrate (a substrate including a first board 36, Fig. 4 and a second board 34, Fig. 4) and at least one detection unit (30, Fig. 4) arranged on the substrate, wherein the at least one detection unit (30, Fig. 4) comprises:
(i) a detection pool (an internal space defined by a chamber 32, Fig. 4 to accommodate liquid), configured to accommodate a sample liquid;
(ii) a sample injection part (a combination of a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) communicating the detection pool, the sample injection part being sealable with a liquid driving device (a pipette P as shown in Figs. 10, 12 or 15 that shows various embodiments of applying pipette P into the sample injection part of Fig. 4 and sealing mechanisms), wherein the liquid driving device (a pipette P) and the sample injection part cooperate to enable the sample liquid to get in and out of the detection pool (32, Fig. 4) (see the description in col. 6, line 45 thru col. 9, line 7).
In regard to claim 2, Columbus discloses the sample injection part (80, Fig. 4) (a combination of a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) includes a sample injection channel and a sample injection port, the sample injection port communicating the detection pool through the sample injection channel (Fig. 4).
In regard to claim 3, Columbus discloses an inner diameter of the sample injection channel gradually decreases along a direction from the sample injection port to the detection pool (col. 8, lines 10-16, “a liquid access aperture 60 is formed in wall 36 adjacent end 42. The aperture has an upper portion 62 and a lower portion 64 that connects the upper portion with chamber 32. Preferably at least portion 62 is conical in shape, the slope of which allows a large number of different conical pipette designs P, Figure 2, to mate therewith”).
In regard to claim 5, Columbus discloses:
the substrate includes a first board (36, Fig. 4) and a second board (34, Fig. 4);
the detection pool (an internal space defined by a chamber 32, Fig. 4 to accommodate liquid) is configured on the second board (34, Fig. 4) ;
the sample injection port (a combination of a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) is configured on the first board (36, Fig. 4); and
the sample injection channel is configured on the first board (36, Fig. 4) and the second board (34, Fig. 4).
In regard to claim 7, Columbus discloses:
the first board (36, Fig. 4) and the second board (34, Fig. 4) are sealed using adhesives (col. 8, lines 52-57),
the detection pool (an internal space defined by a chamber 32, Fig. 4 to accommodate liquid) is between the first board (36, Fig. 4) and the second board (34, Fig. 4),
the sample injection channel communicates with the detection pool and the sample injection port (the sample injection part (80, Fig. 4) (a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) includes a sample injection channel and a sample injection port, the sample injection port communicating the detection pool through the sample injection channel (Fig. 4)).
In regard to claim 10, Columbus discloses the sample injection part (80, Fig. 4) (a combination of a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) includes a sample injection channel and a sample injection port, the sample injection port communicating the detection pool through the sample injection channel (Fig. 4). Columbus discloses the sample injection port protrudes from a surface where the sample injection port is disposed (Fig. 4).
Columbus discloses every limitation recited in claims 1, 2, 3, 5, 7 and 10.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 6, 11-15 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Columbus et al. (EP 0 318 255 A2, herein referred as “Columbus”).
In regard to claim 6, Columbus discloses an inner diameter of the sample injection channel gradually decreases along a direction from the sample injection port to the detection pool (col. 8, lines 10-16, “a liquid access aperture 60 is formed in wall 36 adjacent end 42. The aperture has an upper portion 62 and a lower portion 64 that connects the upper portion with chamber 32. Preferably at least portion 62 is conical in shape, the slope of which allows a large number of different conical pipette designs P, Figure 2, to mate therewith”). In light of teachings from Columbus, the claimed recitation “an axis of the sample injection channel forms a 20-60° angle with the first board” would have been obvious to one of ordinary skill in the art through routine experimentation in an effort to optimize sample injection channel activity and utility taking into consideration the operational parameters of the sample injection operation, the geometry of the substrate bodies, the physical and chemical make-up of the liquid being handled.
In regard to claims 11 and 12, Columbus discloses the sample injection part (80, Fig. 4) (a combination of a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) includes a sample injection channel and a sample injection port, the sample injection port communicating the detection pool through the sample injection channel (Fig. 4). Columbus discloses the sample injection port protrudes from a surface where the sample injection port is disposed (Fig. 4). In light of teachings from Columbus, the claimed recitation “the height of the sample injection port protruding from surface where the sample injection port is disposed is 0.5mm-3mm” or “the length of the sample injection channel is greater than 1 mm” would have been obvious to one of ordinary skill in the art through routine experimentation in an effort to optimize sample injection channel activity and utility taking into consideration the operational parameters of the sample injection operation, the geometry of the substrate bodies, the physical and chemical make-up of the liquid being handled.
In regard to claim 13, in an embodiment shown Fig. 15, Columbus discloses the sample injection part (a combination of a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) further includes an elastomer sealing part, wherein the elastomer sealing part is provided with a through hole, and the elastomer sealing part is installed on the sample injection channel and/or the sample injection port (col. 12, lines 27-41, “A spring 150 biases portion 120d so that, normally, it is raised to misalign paths 130d and 132d with respect to chamber 32d and vent passageway 72d, respectively, thus sealing off chamber 32d from the outside environment. To access the chamber, the user need only press down on portion 120d, such as by engaging access aperture 60d with a pipette P, and push against spring 150”).
In regard to claim 14, Columbus discloses the depth of the detection pool is 0.5 to 2.5 mm (col. 7, lines 1-7) which overlaps the recited distance of less than 2mm. This renders the recited. Since the claimed distance range of less than 2mm overlaps the depth of the detection pool 0.5 to 2.5 mm taught by Columbus, the range recited in claim 14 is considered prima facie obvious. See MPEP 2144.05.
In regard to claim 15, Columbus discloses one or more reagent (i.e., a pre-embedded marker) layers (50, Fig. 4) can be applied to the interior surface of wall 36, Figure 4, in a form that will allow the one or more layers to enter into a reaction with liquid sample inserted into chamber 32. Thus "a reagent" is a substance that will interact physically or chemically with the liquid sample. Such reagent layer can be applied in conventional ways, such as by spraying and drying. Such reagents can include a polymerase enzyme, salts, buffers and stabilizers. A more effective dissolution occurs for those reagents when liquid is introduced (col. 7, line 46 thru col. 8, line 9). This renders the recitation of claim 15 prima facie obvious.
In regard to claim 20, Columbus discloses:
the substrate includes a first board (36, Fig. 4) and a second board (34, Fig. 4);
the detection pool (an internal space defined by a chamber 32, Fig. 4 to accommodate liquid) is configured on the second board (34, Fig. 4) ;
the sample injection port (a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) is configured on the first board (36, Fig. 4); and
the sample injection channel is configured on the first board (36, Fig. 4) and the second board (34, Fig. 4).
But Columbus does not explicitly disclose the sample injection port is configured on the second board.
However, Columbus discloses various embodiments of sample injection port as shown in Figs. 8, 9. 12, 14 and 15. In light of teachings from Columbus, the claimed recitation “the sample injection port is configured on the second board” would have been obvious to one of ordinary skill in the art through routine experimentation in an effort to optimize sample injection channel activity and utility taking into consideration the operational parameters of the sample injection operation, the geometry of the substrate bodies, the physical and chemical make-up of the liquid being handled.
In regard to claim 21, Columbus discloses a use of pipette in Fig. 12 and Fig. 15 which meets the recited “liquid driving device”. Since the pipette is used in conjunction with the cuvette (30, Fig. 4 that is a particle detection device) (Fig. 4; col. 6, line 45 thru col. 9, line 7) (i.e., a particle detection device” this meets the limitation “the liquid driving device is a portion of the particle detection device” as recited.
In regard to claim 22, Columbus discloses a movable valve is disposed to selectively open and close access to the chamber within the cuvette (col. 11, line 42 thru col. 12, line 1). Columbus discloses that: in Fig. 12, a valve is provided, comprising a rotatable portion 120 mounted within a mating conically shaped aperture 122, Figure 12. Rotatable portion 120 has an exterior, conically shaped surface 123. The valve has an axis of rotation 124, preferably concentrically disposed within aperture 60c. A handle 126 permits manual or automated rotation of the valve. Both the access aperture 60c, as well as air vent opening 74c, are located in the movable valve portion 120, Figures 11 and 13 (col. 11, line 42 thru col. 12, line 1). Upon introduction of a valve in the cuvette in the sample injection part (a cylindrical boss 80, Fig. 4 and a channel in fluid communication with the detection pool 32, Fig. 4) as taught by Columbus, one skilled in the art would have reasonably expected that “a separation valve disposed in the cavity separates the cavity into a first cavity and a second cavity” as recited.
Conclusion
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/YOUNGSUL JEONG/Primary Examiner, Art Unit 1772
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