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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-7, 9, 11, 16, 19-21 and 23-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vermeiden et al. (US 6,551,554) (Vermeiden).
Regarding claim 1, Vermeiden discloses a biological sample testing device (abstract), comprising:
a slide (2) having a top side (Fig. 1, col. 3, lines 9-12);
a cover slip (3) carried by the top side of the slide (Fig. 1, col. 3. Lines 13-18); and
a spacer layer (7) carried by the top side of the slide and positioned between the top side and the cover slip (Fig. 1, col. 3, lines 42-45), wherein the spacer layer includes a well (1) extending horizontally along a first axis from an inlet (5) at a first side of the biological sample testing device to an outlet (6) at a second side of the biological sample testing device opposite the first side (Fig. 1, col. 3, lines 33-35, 19-20, 51-55), and wherein the set of curved sidewalls define an asymmetric shape about a second axis perpendicular to the first axis (Fig. 1).
Regarding claim 3, Vermeiden discloses wherein the well comprises:
a front section downstream from the inlet (Fig. 1);
a middle section downstream from the front section (Fig. 1); and
a rear section downstream from the middle section, wherein the rear section has a larger aperture than the front section (Fig. 1), because Vermeiden’s Fig. 1 shows the rear/outlet-side portion of the counting compartment having a larger transverse opening/aperture than the narrower inlet/front-side portion.
Regarding claim 5, Vermeiden discloses that wherein:
the well includes a front section downstream from the inlet (5), a middle section downstream from the front section, and a rear section downstream from the middle section (Fig. 1); and
when a biological sample is injected into the inlet:
the front section is shaped to accelerate a first portion of the biological sample moving adjacent to the set of curved sidewalls relative to a second portion of the biological sample moving directly between the inlet and the outlet (open wide shape) (Fig. 1); and
the rear section is shaped to decelerate the first portion of the biological sample relative to the second portion of the biological sample (narrow shape) (Fig. 1).
Regarding claim 6, Vermeiden discloses that wherein the inlet is at least partially defined by a pair of guide surfaces at a non-zero angle with respect to each other Fig. 1), and wherein the non-zero angle is configured to accelerate a biological sample input into the well toward the set of curved sidewalls in the well (open shape) (Fig. 1).
Regarding claim 7, Vermeiden discloses that wherein the pair of guide surfaces is a first pair of guide surfaces, and wherein the outlet is at least partially defined by a second pair of guide surfaces that are at a second non-zero angle with respect to each other, and wherein the second nonzero angle is configured to decelerate the biological sample arriving at the outlet (closed shape) (Fig. 1).
Regarding claim 9, Vermeiden discloses that wherein:
the well includes a front section downstream from the inlet (5), a middle section downstream from the front section, and a rear section downstream from the middle section (Fig. 1); and
the set of curved sidewalls include a first portion between the inlet and the front section and having a first convex profile (Fig. 1), a second portion between the front section and the middle section and having a first concave profile (Fig. 1), a third portion between the middle section and the rear section and having a second concave profile (Fig. 1), and a fourth portion between the rear section and the outlet and having a second convex profile (Fig. 1).
Regarding claim 11, Vermeiden discloses that wherein the first convex profile has a first radius of curvature, and wherein the second convex profile has a second radius of curvature different from the first radius of curvature (Fig. 1).
Regarding claim 16, Vermeiden discloses that the well is a first well, and that the spacer/connecting layer further includes a second well, because Vermeiden expressly discloses that “two counting compartments 1 have been formed on the bottom plate,” with solid connecting mass 17 separating the two counting compartments (Fig. 1, col. 3, line 59-60).
Vermeiden’s Fig. 1 shows each counting compartment extending horizontally/laterally along its own inlet-to-outlet direction. Vermeiden discloses that the inlet 5 is formed by space 4 adjoining boundary strip 15, and that connecting layer 7 extends to the free end 11 of outlet 6. Thus, the second counting compartment extends horizontally along a third axis from a second inlet to a second outlet.
Vermeiden further discloses that each counting compartment is bounded by strip 15, which defines the periphery/sidewalls of the compartment. Vermeiden’s Fig. 1 shows the second compartment having the same general asymmetric inlet-to-outlet shape as the first compartment, such that the sidewalls define an asymmetric shape about an axis perpendicular to the second compartment’s inlet-to-outlet axis.
Regarding claim 19, Vermeiden discloses a biological sample testing slide, comprising:
a well (1) extending horizontally along a first axis from an opening (5) at a first side of the biological sample testing slide to a vent (6) at a second side of the biological sample testing slide opposite the first side (Fig. 1), wherein the well includes a middle section between the opening and the vent (Fig. 7), and wherein the well is defined by a set of sidewalls extending between the opening and the vent, the set of sidewalls comprising:
a first portion in the middle section, the first portion having a first concave curved profile (Fig. 1); and
a second portion in the middle section downstream from the first portion with respect to the opening, the second portion having a second concave curved profile different from the first concave curved profile (Fig. 1).
Regarding claim 20, Vermeiden discloses that wherein the set of sidewalls further comprise:
a third portion between the opening and the middle section, the third portion having a first convex curved profile (Fig. 1); and
a fourth portion between the middle section and the vent, the fourth portion having a second convex curved profile different from the first convex curved profile (Fig. 1).
Regarding claim 21, Vermeiden discloses that wherein the first concave curved profile has a first radius of curvature, and wherein the second concave curved profile has a second radius of curvature smaller than the first radius of curvature (Fig. 1).
Regarding claim 23, Vermeiden discloses a slide for testing biological samples (abstract), the slide comprising:
a slide backing (2) (Fig. 1, col. 3, lines 9-12);
a cover slip (3) carried by the slide backing (Fig. 1, col. 3, lines 39-42); and
a spacer layer (7) carried by the slide backing and positioned between the slide backing and the cover slip, wherein the spacer layer includes a well (1) extending horizontally along a first horizontal axis from an inlet (5) at a first side of the slide to an outlet (6) at a second side of the slide opposite the first side, and wherein the well is asymmetric about a second horizontal axis perpendicular to the first horizontal axis (Fig. 1, col. 3, lines 39-45).
Regarding claim 24, Vermeiden discloses that wherein the well is defined by a set of sidewalls extending between the inlet and the outlet, and wherein the set of sidewalls do not include an angled interface (Fig. 1).
Regarding claim 25, Vermeiden discloses that wherein the set of sidewalls comprise a first portion between the inlet and a middle section of the well and having a first convex profile, a second portion in the middle section and having a first concave profile, a third portion in the middle section and having a second concave profile, and a fourth portion between the middle section and the outlet and having a second convex profile (Fig. 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 2, 7 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermeiden in view of Hamilton et al. (WO 2006/031095) (Hamilton).
Regarding claim 2, Vermeiden does not specifically disclose that wherein the well is symmetric about the first axis. However, Hamilton discloses that the well is symmetric about the first axis (Fig. 1). It would have been obvious to one of ordinary skill in the art to use the well symmetric about the first axis, in order to has a symmetric flow.
Regarding claim 7, Vermeiden’s Fig. 1 shows that the outlet 6 is at least partially defined by a second pair of opposing guide surfaces at a second non-zero angle with respect to each other. Specifically, the outlet-side portion of the counting compartment includes opposing angled boundary surfaces leading toward outlet 6/free end 11. Vermeiden also discloses that the counting compartment has an inlet and outlet and that the connecting layer extends around and up to the free end of the outlet (Fig. 1).
Hamilton teaches the functional purpose of reducing flow at an outlet. Hamilton discloses a capillary loading slide having a chamber with an inlet for introducing a suspension and an outlet for purging air, and teaches that both the inlet and outlet can be provided with respective blockades 16 and 18 (Fig. 1, page 9, par 8). Hamilton also teaches that reducing the flow velocity of air purged out of the chamber reduces the flow velocity of the suspension in the chamber, and that this can be done by providing a partial blockade in the outlet (page 9, par 0).
Therefore, it would have been obvious to one of ordinary skill in the art to configure the outlet-side angled guide surfaces of the modified Vermeiden device to decelerate the biological sample arriving at the outlet, as taught by Hamilton, in order to reduce the flow velocity of the suspension near the outlet. The modification would predictably control the capillary flow through the biological sample chamber while preserving Vermeiden’s inlet-to-outlet counting compartment structure.
Regarding claim 17, As discussed for claim 1, Vermeiden discloses a biological sample counting compartment formed between a microscope slide and cover slip, with an inlet and outlet. Vermeiden also discloses that two counting compartments are formed on the bottom plate and that the compartments are bounded by the connecting layer/strip structure (Fig. 1, col. 3, line 59-60).
Hamilton teaches a capillary-loading slide for microscopic research of biological samples, where a connecting layer and plates form a boundary surrounding a chamber having an inlet and outlet (page 9, par 8). Hamilton’s Fig. 1 shows the chamber having a rounded, apple-shaped perimeter.
It would have been obvious to one of ordinary skill in the art to configure the curved sidewalls of the modified Vermeiden well to define an apple-shaped perimeter, as taught by Hamilton, because Hamilton is in the same field of capillary-loading biological sample slides and teaches a known chamber perimeter shape for receiving and transporting a biological suspension from an inlet to an outlet. The modification would have predictably provided an alternative rounded chamber shape suitable for capillary loading and microscopic biological sample analysis.
Regarding claim 18, Hamilton teaches a rounded/apple-shaped capillary chamber perimeter (Fig. 1). A tear-shaped perimeter would have been an obvious design variation of Hamilton’s rounded asymmetric chamber perimeter because both shapes provide curved sidewalls and an asymmetric inlet-to-outlet well shape for capillary sample loading. The modification would have predictably maintained the same function of defining a biological sample chamber from inlet to outlet, and the claimed tear shape has not been shown to produce a different or unexpected result relative to the rounded/apple-shaped perimeter.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermeiden as evidenced by Li et al. (Microsyst Technol, 2017) (Li).
Regarding claim 6, Vermeiden’s Fig. 1 shows that inlet 5 is at least partially defined by a pair of guide surfaces at a non-zero angle with respect to each other, the guide surfaces opening/diverging from inlet 5 toward the sidewalls of the counting compartment. Vermeiden further discloses that “the inlet 5 of the compartment is formed by a space 4” adjoining boundary strip 15. (col. 3, lines 19-20).
Li teaches that “edge effect, which means that the traversal rate for the mobile phase near the channel sidewall is far faster than through the body of the channel, are frequently observed (Huang et al. 2013; Weislogel and Lichter 1998; Ahmadlouydarab et al. 2015). The edge effect is mainly induced by corner flow along the corner between sidewall and top/bottom surface.” (page 4733, par 3).
It would have been obvious that the non-zero angle of Vermeiden’s inlet guide surfaces, in the modified device, would accelerate or direct the biological sample toward the curved sidewalls because capillary liquid near a microfluidic sidewall/corner advances faster than liquid through the center/body of the channel, as evidenced by Li. Therefore, the angled inlet guide surfaces are configured to accelerate the biological sample input into the well toward the curved sidewalls.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermeiden et al. (US 6,551,554) (Vermeiden) in view of Chou et al. (US 2018/020903) (Chou).
Regarding claim 12, Vermeiden does not specifically disclose that wherein the spacer layer comprises a hydrophobic oil paint. However, Chou discloses that wherein the spacer layer comprises a hydrophobic oil paint (par [1528]). Chou teaches that “the surface wetting properties can be, as expected, significantly altered by surface treatment to become more hydrophilic or more hydrophobic.” (par [1528]). It would have been obvious to one of ordinary skill in the art to apply a hydrophobic oil paint on the spacer layer, in order to alter the wetting property.
Claim(s) 10, 13-15 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermeiden et al. (US 6,551,554) (Vermeiden)
Regarding claim 10, 13-15 and 22, it would have been obvious to one of ordinary skill in eth art to optimize the angles and radius of the sidewall by routine experimentation.
Allowable Subject Matter
Claim 4 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose that the well is shaped to control a speed of a biological sample moving from the inlet to the outlet along the sidewall so that a first portion of the biological sample moving along the first travel path arrives at the outlet generally simultaneously with a second portion of the biological sample moving along the second travel path.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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