,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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 14, the phrase "wherein the channel is disposed at an acute angle relative to the collection region" and thus the positioning of the channel is not clear. It is not clear what orientation said channel has relative to the rotational center of the device and the first and second reservoir and collection region and constricted region. Further, it is not clear to what surface or wall of said collection region the channel is disposed at an acute angle of.
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 1-13 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al., J. Micromech. Microeng. 20 (2010) 105024, pages 1-10 (hereinafter referred to as “Li”).
Regarding claim 1, Li discloses a device for separating blood plasma from whole blood comprising a first reservoir (top triangle + valve in fig. 5a) and a second reservoir (bottom triangle in fig. 5a), the second reservoir fluidically connected to the first reservoir, the first reservoir comprising a collection region and a channel (see Fig. 5a on top of top reservoir) fluidly connected to the collection region, the collection region comprising a first fraction of whole blood the first fraction comprising blood plasma from which substantially all red blood cells have been removed, the channel comprising the first fraction, the second reservoir comprises a second fraction of the whole blood the second fraction comprising blood plasma and the red blood cells that have been removed from the first fraction (see fig. 5b) (see Fig. 1, 3(b), 5; abstract; sections 3.3, 4.2, 4.3)..
Recitations of “a first fraction of whole blood” and “a second fraction of whole blood” are material worked upon by a structure. “Inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 2, Li teaches that the channel is configured to substantially fill with the first fraction via capillary action responsive to termination of a centrifugal force (see fig. 5a).
Regarding claim 3, Li teaches an optically transparent cover (see Fig. 4b).
Regarding claim 4, Li teaches that the channel comprises an outlet fluidly connected to the collection region by a channel (see Fig. 5a on top of top reservoir).
Regarding claim 5, Li teaches a constricted region configured to inhibit the second fraction from entering the collection region (see Fig. 1, 3(b), 5; abstract; sections 3.3, 4.2, 4.3).
Regarding claim 6, Li teaches that the second reservoir (bottom triangle in fig. 5a) is fluidly connected to the first reservoir (top triangle + valve in fig. 5a) by a constriction region (see Fig. 1, 3(b), 5; abstract; sections 3.3, 4.2, 4.3).
Regarding claim 7, Li teaches a device for separating blood plasma from whole blood comprising a first reservoir (top triangle + valve in fig. 5a) and a second reservoir (bottom triangle in fig. 5a), the second reservoir fluidically connected to the first reservoir, the first reservoir comprising a collection region and a channel (see Fig. 5a on top of top reservoir) fluidly connected to the collection region, the collection region comprising whole blood at a first time point, the channel and second reservoir are empty at the first time point, the collection region comprising a first fraction of the whole blood the first fraction comprising blood plasma and less than 25% red blood cells at a second time point, the channel comprising the first fraction at the second time point.
Recitation of “whole blood at a first time point, the channel and second reservoir are empty at the first time point, the collection region comprising a first fraction of the whole blood the first fraction comprising blood plasma and less than 25% red blood cells at a second time point, the channel comprising the first fraction at the second time point” is an intended use of the apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Recitations of “whole blood” and “a first fraction of whole blood” are material worked upon by a structure. “Inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 8, Li teaches that centrifugal force is applied (see fig. 1). Application of a centrifugal force is not a method step and not a structural claim and not given patentable weight.
Regarding claim 9, recitation of “at a third time point the first reservoir is empty” is an intended use of the apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 10, Li teaches a device for separating blood plasma from whole blood comprising a first reservoir (top triangle + valve in fig. 5a) and a second reservoir (bottom triangle in fig. 5a), the second reservoir fluidically connected to the first reservoir, the first reservoir comprising a collection region and a channel (see Fig. 5a on top of top reservoir) fluidly connected to the collection region, the collection region comprising whole blood at a first time point, the channel and second reservoir are empty at the first time point, the collection region comprising at a second time point a first fraction of the whole blood the first fraction comprising blood plasma and less than 25% red blood cells, the channel comprising the first fraction at the second time point, the second reservoir comprises at a second time point a second fraction of the whole blood the second fraction comprising blood plasma and red blood cells.
Recitation of “whole blood at a first time point, the channel and second reservoir are empty at the first time point, the collection region comprising at a second time point a first fraction of the whole blood the first fraction comprising blood plasma and less than 25% red blood cells, the channel comprising the first fraction at the second time point, the second reservoir comprises at a second time point a second fraction of the whole blood the second fraction comprising blood plasma and red blood cells” is an intended use of the apparatus.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Recitations of “whole blood”, “a first fraction of the whole blood” and “a second fraction of the whole blood” are material worked upon by a structure. “Inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Regarding claim 11, recitation of “at a third time point the first reservoir is empty” is an intended use of the apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 12, the recitation of “the red blood cells are in a pellet” is material worked upon by a structure. “Inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Li teaches red blood cells in the second reservoir (see bottom triangle in fig.5b).
Regarding claim 13, recitation of “at a third time point the first fraction is removed from the first reservoir via an outlet in the channel” is an intended use of the apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 15, the recitation of “the first fraction substantially fills the first reservoir” is an intended use of the device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 16, the recitation of “the device sits radially on a disk” is an intended use of the device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Li teaches that the device is a disk (see fig. 4b).
Regarding claim 17, the recitation of “a meniscus of the blood plasma is within the first reservoir” is an intended use of the device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Regarding claim 18, Li teaches that the second reservoir i.e. sedimentation reservoir has ~4.7 microliter which is 50% of the volume of the first reservoir i.e. supernatant reservoir of ~9.4 microliter (see section 3.2).
Regarding claim 19, the recitation of “at least 99% of the red blood cells in the sample of whole blood are removed from the first fraction” is an intended use of the device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Li teaches that the plasma purity can reach up to 99.9% which means 99.9% of red blood cells are removed (see Figure 5).
Regarding claim 20, the recitation of “the channel is substantially filled with the first faction” is an intended use of the device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). Li teaches that the channel is configured to substantially fill with the first fraction (see fig. 5a).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 10 above, and further in view of US 2014/0341788 A1 to Kim et al. (hereinafter “Kim”).
Li teaches a device for separating blood plasma from whole blood as described above.
Claim 14 differs from Li in reciting that the channel is disposed at an acute angle relative to the collection region.
Kim teaches a microfluidic apparatus for separation of biological samples comprising a channel (20) is disposed at an acute angle relative to the collection region (300)(see figures 2, 5-6) wherein the inclined portion (401) serves to effectively guide target material which is introduced into the collection region (300) through the recovery channel (20) toward the bottom (301)(see fig. 5-6; paragraph [0047]).
It would have been obvious to a person of ordinary skill in the art to modify the channel of Li to be disposed at an acute angle relative to the collection region to effectively guide target material such as red blood cells to the second reservoir as suggested by Kim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
1/21/26