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 .
Claims 1-14 are examined in this office action.
Claim Objections
Claim 7 objected to because of the following informalities:
Claim 7, line 8 "a plan view" should be "a planar view"
Claim 7, line 5 "a functional material" should be "a functional member"
Appropriate correction is required.
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, 7, 8, 9, and 14 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Leong et al. (US Pub No. 20020185384 A1).
Regarding claim 1, Leong discloses a microneedle patch (device 10, Fig. 1) comprising:
a liquid-impermeable base material (housing 18, Fig. 1) that has a through- hole (See annotated Fig. 1);
a liquid-absorbable absorbent material (fluid transfer medium 22, Fig. 1) that fills the through-hole ("… a fluid transfer medium, such as a hydrophilic porous material, by which sampled biological fluid is transferred …" - Abstract);
a needle-shaped portion (microneedles 12, Fig. 1) that is provided on one surface side of the base material (bottom portion 18a, Fig. 1) and has a flow channel formed therein (See annotated Fig. 1); and
a functional member (reaction zone 30, Fig. 1) that is provided on the other surface side of the base material (Fig. 1),
the needle-shaped portion (microneedles 12, Fig. 1) and the absorbent material (fluid transfer medium 22, Fig. 1) being connected to each other (Fig. 1),
the absorbent material (fluid transfer medium 22, Fig. 1) and the functional member (reaction zone 30, Fig. 1) being connected to each other (Fig. 1).
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Regarding claim 7, Leong discloses the microneedle patch (device 10, Fig. 1) as recited above, wherein
the through-hole (See annotated Fig. 1) and the functional material (reaction zone 30, Fig. 1) are provided at positions at which at least a part of the through-hole and at least a part of the functional member overlap each other in a plan view (See annotated Fig. 1).
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Regarding claim 8, Leong discloses the microneedle patch (device 10, Fig. 1) as recited above, wherein
the absorbent material (fluid transfer medium 22, Fig. 1) fills the through-hole (microneedles 12, Fig. 1) so that the absorbent material protrudes from the other surface side of the base material (See annotated Fig. 1) or the other surface of the base material and a surface of the absorbent material are included in a same plane.
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Regarding claim 9, Leong discloses the microneedle patch (device 10, Fig. 1) as recited above, wherein
the absorbent material (fluid transfer medium 22, Fig. 1) is a porous material ("… a fluid transfer medium, such as a hydrophilic porous material, by which sampled biological fluid is transferred …" - Abstract).
Regarding claim 14, Leong discloses a microneedle structure (device 10, Fig. 1) comprising:
a liquid-impermeable base material (housing 18, Fig. 1) that has a through- hole (See annotated Fig. 1);
an absorbent material(fluid transfer medium 22, Fig. 1) that fills the through-hole ("… a fluid transfer medium, such as a hydrophilic porous material, by which sampled biological fluid is transferred …" - Abstract); and
a needle-shaped portion (microneedles 12, Fig. 1) that is provided on one surface side of the base material (bottom portion 18a, Fig. 1) and has a flow channel formed therein (See annotated Fig. 1),
the needle-shaped portion and the absorbent material being connected to each other (Fig. 1).
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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.
Claim(s) 2, 4-6, 10, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US Pub No. 20020185384 A1) in view of Fleming et al. (US Patent No. 6908453 B2).
Regarding claim 2, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
Leong does not expressly disclose that the needle-shaped portion is composed of a porous material.
Fleming teaches the needle-shaped portion (microneedles 30, Fig. 1) is composed of a porous material ("Microneedles in the microneedle arrays of the present invention can be solid or porous." - Col. 12, Lines 33-34).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the microneedle patch of Leong to include that the needle-shaped portion is composed of a porous material as taught by Fleming in order to permit at least fluid passage (Fleming, Col.12, Lines 38-39).
Regarding claim 4, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
Leong does not expressly disclose that a first adhesive layer is provided on the one surface of the base material.
Fleming teaches a first adhesive layer (adhesive 462, Fig. 9) is provided on the one surface of the base material ("… the backing 460 faces the opposing major surface of the substrate 420. The backing may preferably include an adhesive 462 …" - Cols. 7-8, Lines 67 and 1-2).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the microneedle patch of Leong to include that a first adhesive layer is provided on the one surface of the base material as taught by Fleming so that the backing can be adhered to the substrate (Fleming, Col. 8, Lines 2-3).
Regarding claim 5, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
Leong does not expressly disclose the first adhesive layer is a pressure sensitive adhesive layer.
Fleming teaches the first adhesive layer (adhesive 462, Fig. 9) is a pressure sensitive adhesive layer ("The adhesive 462 may preferably be a pressure sensitive adhesive." - Col. 8, Line 4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the microneedle patch of Leong to include the first adhesive layer is a pressure sensitive adhesive layer as taught by Fleming so that the backing can be adhered to the substrate (Fleming, Col. 8, Lines 2-3).
Regarding claim 6, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
Leong does not expressly disclose a second adhesive layer is provided on the other surface of the base material.
Fleming teaches a second adhesive layer (adhesive 648, Fig. 13) is provided on the other surface of the base material (substrate 620, Fig. 13).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the microneedle patch of Leong to include a second adhesive layer is provided on the other surface of the base material as taught by Fleming so that the backing can be adhered to the substrate (Fleming, Col. 8, Lines 2-3).
Regarding claim 10, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, further comprising
a sheet (Leong, cover 18b, Fig. 1) that covers at least the functional member (Leong, Fig. 1),
Leong does not expressly disclose that the sheet has an adhesive layer on a surface on the functional member side.
Fleming teaches that the sheet (backing 460, Fig. 9) has an adhesive layer (adhesive 462, Fig. 9) on a surface on the functional member (sensor element 470, Fig. 9) side ("… the backing 460 faces the opposing major surface of the substrate 420. The backing may preferably include an adhesive 462 …" - Cols. 7-8, Lines 67 and 1-2).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the microneedle patch of Leong to include the sheet has an adhesive layer on a surface on the functional member side as taught by Fleming so that the backing can be adhered to the substrate (Fleming, Col. 8, Lines 2-3).
Regarding claim 11, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
the sheet (Leong, cover 18b, Fig. 1) includes a ventilation means (Leong, "… one or more tiny air holes within housing cover 18b." - Para [0057]) that exhausts air accumulated between the sheet and the base material (Leong, "… purging or displacing air within the cell …" - Para [0057]).
Regarding claim 13, Leong in view of Fleming disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
the functional member (Leong, sensor element 470, Fig. 9) comprises a plurality of functional members (Leong, "… devices according to the present invention may include more than one sensor element." - Col. 8, Lines 47-48), the functional members include at least a first functional member and a second functional member (Leong, sensor element 470, Fig. 9)( Leong, "… devices according to the present invention may include more than one sensor element." - Col. 8, Lines 47-48), and the first functional member and the second functional member are each the detection member that detects a different component (Leong, "Further, the sensor elements may be the same or different." - Col. 8, Lines 39-40).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leong et al. (US Pub No. 20020185384 A1) in view of Kim et al. (US Pub No. 20200405235 A1).
Regarding claim 3, Leong in view of Kim disclose the microneedle patch (Leong, device 10, Fig. 1) as recited above, wherein
Leong does not expressly disclose that the needle-shaped portion has a hole portion formed therein, and the hole portion also opens on a side surface of the needle- shaped portion.
Kim teaches that the needle-shaped portion (microneedle 20, Fig. 4) has a hole portion (holes 21a, Fig. 4) formed therein, and the hole portion also opens on a side surface of the needle- shaped portion (See annotated Fig. 4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the microneedle patch of Leong to include that the needle-shaped portion has a hole portion formed therein, and the hole portion also opens on a side surface of the needle- shaped portion as taught by Kim for the liquid to be collected (Kim, Para [0041]).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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