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.
(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.
Claim(s) 1-2, 5-6, 8-10, 12, 14-16, 20-21, 23-24, 27, and 31 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Ray et al., US 6258045 (Roy).
Regarding claim 1, Ray discloses an article configured to separate blood cells from plasma (abstract, fig. 8C, C2/L4-12) comprising:
A first filter (REF 373) configured to retain blood cells (see “separation member”, C5/L1-6, C12/L12-16, C22/L3-9);
A second filter (REF 371, see “member 371 as a second separation member”, C22/L7-8) configured to retain blood cells (see “separation member”, C5/L1-6, C12/L12-16, C22/L3-9), wherein the second filter is disposed beneath the first filter (fig. 8C), and wherein the first and second filters are positioned such that a sample comprising separated blood cells can be recovered therefrom (via component removal, C22/L63-67); and
An absorbent layer (REF 372) comprising a porous absorbent material (see “collection member”, C5/L17-30, C22/L3-9) wherein:
The absorbent layer is disposed beneath the second filter (fig. 8C),
The absorbent layer comprises a sample collection region (i.e. non-overlapping region of REF 372, fig. 8C) fluidically connected with and laterally spaced from the second filter (REF 371), and
The sample collection region is configured to receive plasma from which blood cells have been separated from the second filter (C5/L17-30).
Regarding claim 2, Roy discloses an alternate embodiment of an article (figs. 5A-B) comprising:
A filter (REF 12) configured to retain blood cells (see “separation member”, C5/L1-12); and
An absorbent layer (REF 11) comprising a porous, absorbent material (see “collection member”, C3/L34-41), wherein:
The absorbent layer (REF 11) is disposed beneath the filter (figs. 5A-B);
The absorbent layer comprises a sample collection region (non-overlapping region of REF 11) laterally spaced from the filter;
The absorbent layer comprises a channel (overlapping region of REF 11 and REF 12) fluidically connecting the filter to the sample collection region;
The sample collection region is configured to receive plasma from which blood cells have been separated (C2/L47-50); and
The sample collection region is laterally bounded in a plane of the channel by a boundary (distal end of REF 11) and a terminus of the channel (edge of overlapping region between REF 11, REF 12);
The boundary comprises a section (distal portion of REF 11) having a distance from the terminus of the channel; and
A standard deviation of a distance from the terminus of the channel to the section is less than or equal to 30% of an average distance from a terminus of the channel to the section, and wherein the section makes up greater than 15% of the boundary (figs. 5A-B, where the distance across the collection region is equal between the boundary and terminus).
Regarding claim 5, Roy discloses the first filter (REF 373) configured to separate white blood cells from plasma (C5/L1-11).
Regarding claim 6, Roy discloses the second filter (REF 371) configured to separate red blood cells from plasma (C5/L1-11, C22/L7-8).
Regarding claim 8, Roy discloses the first filter (REF 373) having a mode pore size greater than or equal to 1 micron and less than or equal to 30 microns (C5/L1-11).
Regarding claim 9, Roy discloses the second filter having a mode pore size that is greater than or equal to 0.1 micron and less than or equal to 5 microns (C5/L1-11, C22/L7-8).
Regarding claim 10, Roy discloses the second filter where at least 20% of the pores have a pore size of less than or equal to 20 microns (C5/L1-11, C22/L7-8).
Regarding claim 12, Roy discloses the absorbent layer configured to transport fluid via capillary action (see “collection member”, C2/L13-29, C13/L10-28).
Regarding claim 14, Roy discloses the sample collection region (i.e. non-overlapping region of REF 372, fig. 8C) in the shape of a sector of a circle.
Regarding claim 15, Roy discloses the absorbent layer comprising a channel (overlapping region between REF 371/372) fluidically connecting the second filter to the sample collection region (non-overlapping region of REF 372), wherein the sample collection region is laterally bounded in a plane of the channel by a boundary (distal end of REF 372) and a terminus of the channel (edge of overlapping region between REF 371, 372), wherein at least a section of the boundary is a gap in the absorbent layer (i.e. arcuate edge portions between REF 371, 372).
Regarding claim 16, Roy discloses the absorbent layer (REF 372) comprises a channel (region between REF 371, 372) fluidically connecting the second filter (REF 371) to the sample collection region (REF 372), wherein the sample collection region is laterally bounded in a plane of the channel by a boundary (edge of REF 372 beneath REF 371) and a terminus of the channel (edge of overlapping region between REF 371, 372), wherein at least a section of the boundary is an external boundary of the absorbent layer (edge of REF 372 underneath REF 371).
Regarding claim 20, Roy discloses the sample collection region (REF 372) configured to be removed via tweezers (fig. 8C).
Regarding claim 21, Roy discloses the first filter comprising polyester (C5/L1-5).
Regarding claim 23, Roy discloses the first (REF 373) and/or second (REF 371) filter as removable from the article (fig. 8C).
Regarding claim 24, Roy discloses the first filter (REF 373) separates blood cells based on size exclusion and electrostatic interactions (C5/L1-16).
Regarding claim 27, Roy discloses the article comprising a reagent comprising a surfactant (see “polyoxyethylene sorbitan”, C5/L1-12).
Regarding claim 31, Roy discloses a method of using the article described above comprising:
Passing a blood sample to an absorbent layer through a first filter and a second filter to separate at least a portion of the blood cells from the plasma; and
Transporting the plasma laterally within the absorbent layer to a sample collection region that is laterally spaced from the first and second filters (C6/L45-56, C23/L8-17).
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.
Claim(s) 7 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roy.
Regarding claim 7, Roy does not disclose the absorbent layer having the recited absorbency range. However, Roy recognizes the absorbency of the absorbent layer as variable dependent upon desired minimum/maximum volume of material (C19/L24-60).
Therefore, at the time of invention, it would have been obvious to one having ordinary skill in the art to modify the absorbency of the absorbent layer to be within the claimed ranged, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art absent a showing of criticality or unexpected results (MPEP 2144.05, Section II, Part A).
Regarding claim 22, while Roy recognizes the second filter can be made from a variety of well-known materials (C12/L12-45), Roy does not disclose the second filter material comprising asymmetric polysulfone. However, it would have been obvious to one having ordinary skill in the art to use asymmetric polysulfone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (MPEP 2144.07).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roy in view of Dick et al., US 2016/0290901 (Dick).
Regarding claim 19, Roy discloses the absorbent layer (REF 372) comprises a channel (overlapping region between REF 371, 372) fluidically connecting the second filter (REF 372) to the sample collection region (REF 371), wherein the sample collection region is laterally bounded in a plane of the channel by a boundary (distal end of REF 372) and a terminus (edge of REF 372 beneath REF 371) of the channel.
Roy does not disclose at least a section of the boundary of the sample collection region is perforated. However, Dick discloses multi-layer plasma separation devices (abstract, fig. 6) where an absorbent layer (REF 10) has removable absorptive members (REF 11), the absorptive members having a perforated border between the absorbent layer and said absorptive members (fig. 6, ¶ 0013).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the article of Roy to include the perforated border section described in Dick in order to facilitate removal of an absorptive layer from the sample separation device for later analysis (Dick, ¶ 0013).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIRK R BASS whose telephone number is (571)270-7370. The examiner can normally be reached 8-4:30 EST Monday-Friday.
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DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/Primary Examiner, Art Unit 1779
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