DETAILED ACTION
Claim Objections
Claim 5 objected to because of the following informalities: "to placed" in line 1 should be "to be placed". Appropriate correction is required.
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.
Claim(s) 1-3, 5-6, 8, 10-12, 14, 15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (US 2016/0220992) in view of Markart (USP #6,027,689).
As to claim 1 Lewis teaches a collection card for collecting dried blood spots (Abstract) for diagnostics, comprising: a card body comprising absorbent filter paper (22) configured to receive one or more blood samples ([0043]); a plurality of blood collection targets disposed in a pattern on a top face of the card body (Fig. 18 – 26a-c). It does not specifically teach a plurality of openings disposed in a pattern that provides separation between adjacent blood collection targets, the plurality of opening characterized by a lack of absorbent filter paper. Markart teaches a collection card for evaluating the substance in a body fluid (Abstract) with a plurality of openings disposed in a pattern (Fig. 1 – 30) that provides separation between adjacent collection targets (col. 4 lines 45-64), the plurality of openings characterized by a lack of absorbent filter paper (Fig 2 – openings 30 “cuts through” the cover layer 20). It would have been obvious to modify Lewis with Markart to prevent contamination of collection targets from neighboring ones and increase the accuracy of the device.
As to claim 11, Lewis teaches a system for facilitating capillary blood collection (Abstract), the system comprising: a dried blood spot collection card (10) including: a card body comprising absorbent filter paper configured to receive one or more blood samples (22); a plurality of blood collection targets (26a-c) disposed in a pattern on a top face of the card body (Fig. 18); and a dried blood spot collection device (10.4), including: a body having a first portion (20) and second portion (24) coupled to each other and encapsulating a cavity (area containing 22) configured to hold the dried blood spot collection card (30); a plurality of blood collection apertures (26) configured to direct blood toward the dried blood spot collection card (Fig. 8); and a plurality of observation windows (28a-c) disposed configured to provide a view to the dried blood spot collection card ([0052]).
It does not specifically teach a plurality of openings disposed in a pattern that provides separation between adjacent blood collection targets, the plurality of opening characterized by a lack of absorbent filter paper. Markart teaches a collection card for evaluating the substance in a body fluid (Abstract) with a plurality of openings disposed in a pattern (Fig. 1 – 30) that provides separation between adjacent collection targets (col. 4 lines 45-64), the plurality of openings characterized by a lack of absorbent filter paper (Fig 2 – openings 30 “cuts through” the cover layer 20). It would have been obvious to modify Lewis with Markart to prevent contamination of collection targets from neighboring ones and increase the accuracy of the device.
As to claim 2, while Lewis primarily teaches an embodiment with three blood collection targets, it notes that the device can be sized to accommodate “any number of specimen collection cells” ([0043]). Accordingly it would have been obvious to modify Lewis further to utilize five blood collection targets or any other number as needed, as it would be obvious to try.
As to claims 3 and 14, Lewis teaches the pattern of the plurality of blood collection targets comprises blood collection targets disposed equidistantly in a single line (Fig. 18).
As to claim 5, Lewis teaches a form factor configured to placed inside an objective dried blood spot collection device (Fig. 18 - 10.6).
As to claims 6 and 15, Lewis teaches a desiccant ([0060]).
As to claim 8, Markart teaches the plurality of openings further comprise crescent shapes disposed adjacent to a respective blood collection target (30).
As to claim 10, Lewis teaches the plurality of blood collection targets comprises between two and twelve blood collection targets (Fig. 18 – 26a-c).
As to claim 12, Lewis teaches the plurality of blood collection target spots corresponds to the plurality of blood collection apertures and corresponds to the plurality of observation windows (Fig. 13).
As to claim 17, Lewis teaches the plurality of observation windows comprises a number equivalent to the plurality of blood collection apertures (Fig. 13).
As to claim 18, Lewis teaches the first portion further comprises a plurality of mating pegs disposed on a side of the first portion that is opposite the top face (32a) ;wherein the second portion further comprises a plurality of mating receptacles disposed on a side of the second portion that is opposite the bottom face (32b) ; and wherein respective mating pegs are configured to mate with respective mating receptacles to removably secure the first portion to the second portion ([0045-0046]).
As to claim 19, Lewis teaches a transparent material disposed between the dried blood collection card and the plurality of observation windows ([0044]).
Claim(s) 4, 13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (US 2016/0220992) in view of Markart (USP #6,027,689), and further in view of Whitesides et al. (USP #8,377,710).
As to claims 4, 13, and 16, the above combination does not specifically teach that the pattern of the plurality of blood collection targets/apertures comprises a "W" pattern. Whitesides teaches a collection device with a plurality of collection targets (110), arranged in an offset pattern between multiple lines, equivalent to a W pattern if applied to just five collection targets (Fig. 1A). In addition, Lewis teaches that the device can be sized to accommodate “any number of specimen collection cells” ([0043]). It would have been obvious to modify the above combination with Whitesides to utilize a “W” pattern for the blood collection targets as it would be obvious to try.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (US 2016/0220992) in view of Markart (USP #6,027,689), and further in view of Rosenthal et al. (USP #5,516,487).
As to claim 7, the above combination does not necessarily teach plurality of openings further comprise elongated rectangular shapes disposed equidistantly between adjacent blood collection targets. Rosenthal teaches a sample collection card in which adjacent sample zones are separated by a small area with barrier slits (col. 4 lines 32-46; Fig. 1 - 20) to prevent blood from flowing between the collection targets (col. 4 lines 47-57). It would have been obvious to modify the above combination with Rosenthal to utilize any shape of openings that is known to be usable in preventing blood from flowing from one sample spot to another.
As to claim 9, the above combination does not teach that the plurality of openings further comprise a respective rectangular opening disposed intersecting a respective crescent shape. Markart teaches the plurality of openings further comprise crescent shapes disposed adjacent to a respective blood collection target (30). Rosenthal teaches a sample collection card in which adjacent sample zones are separated by a small area with barrier slits (col. 4 lines 32-46; Fig. 1 - 20) to prevent blood from flowing between the collection targets (col. 4 lines 47-57). Accordingly, it would be a matter of obvious design choice to utilize the specific shape recited for the openings as there is no recited advantage of the specified shape over the various other shapes that are taught by Markart and Rosenthal, and would thus be obvious to modify the above combination further to utilize the recited shape as it would be an obvious substitution yielding similar results.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (US 2016/0220992) in view of Markart (USP #6,027,689), and further in view of Schraga (US 2008/0195132) and Mazzocchhi et al. (US 2002/0022837).
As to claim 20, while Lewis teaches portions made of plastic ([0048]), it does not teach plastic portions having extruded polyurethane with an SPI-A2 rating. Schraga teaches molded plastic having an SPI-A2 finish ([0115]) and Mazzocchhi teaches the use of extruded plastic made of polyurethane for medical devices ([0044]). Accordingly, it would have been obvious to utilize a specific plastic material with the recited rating as it is known to be usable in the making of devices usable for medical purposes.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 11/12/25