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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim limitation “spinner device” in claim 16 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “device” coupled with functional language “spin(ning)” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “device” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 16 has/have been interpreted to cover “a spin motor” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., para [0041]).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the sample” in line 12. There is insufficient antecedent basis for this limitation in the claim. Note, in line 4 of claim 1 applicant recites that the sample reservoir is “configured” to receive a sample; however, the sample is not recited as an element of the device of claim 1. Accordingly there is no antecedent basis for “the sample” in line 12.
Claims 2-12 depend on claim 1.
Claim 10 recites “the separation” in line 2. There is insufficient antecedent basis for this limitation in the claim since claim 1 previously recites “at least one flow path comprising at least one separation into a main channel and a side channel” The limitation in claim 10 will be interpreted as “the at least one separation of the at least one flow path” for consistency and clarity.
Claim 12 recites the structural relationship between the side channel and the main channel in dependence on the rotational direction of the rotatable substrate. As such claim 12 fails to clearly recite the structural configuration of the side channel and main channel.
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.
1. Claims 1-4 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20100282611; hereafter “Kim ‘611”) in view of Kim (US 20140341788, cited by applicant; hereafter “Kim ‘788”).
Regarding claim 1, Kim ‘611 teaches a device for sorting cells, comprising:
a rotation disk 130 (rotatable substrate) configured to rotate about a rotation axis to generate a centrifugal force (para 0029; see e.g., Figs. 1-3), the rotatable substrate comprising:
a storage portion 131 (135) (sample reservoir) configured to receive a sample (para 0020-0021);
at least one flow path coupled to the storage portion 131(135) (sample reservoir) and extending away from the storage portions 131(135) (sample reservoir), the at least one flow path comprising a path 137 (main channel) and a path 133 (side channel) (para 0020-0021; see e.g., Figs. 1-3; and
an upper cover 170 (cover layer) attached to the rotation disk 130 (rotatable substrate) and comprising a storage hole 173 (first opening) in fluid communication with the path 137 (channel) and a hole 171 (second opening) in fluid communication with the path 133 (channel) (para 0027; see e.g., Figs. 1-3); wherein
the device is configured to divert sample cells to the path 133 (side channel) by an electric field via electrodes 151, 153 as the disk 130 (rotatable substrate) continues to rotate (para 0025, 0031).
As mentioned above, Kim ‘611 teaches providing a cover plate (cover layer) with holes 171, 173 (openings) in communication with paths 133, 137 (channels).
Kim ‘611 does not explicitly teach each flow path comprises a separation into two separate channels.
However, Kim ‘788 teaches at least one flow path comprising at least one separation into chambers 110, 200 (channels), for the benefit of discarding portions of the sample prior to separation (para 0043; see e.g., Fig. 2). Thus, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the flow paths of Kim ‘611 separate into two channels, as taught by Kim ‘788, for the benefit of discarding portions of the sample prior to separation.
The recitation “comprising target cells and non-target cells” does not further structurally limit the apparatus as claimed since the manner or method in which such machine is to be utilized is not germane to the issue of patentability of the machine itself (see MPEP 2115). The apparatus of Kim would be capable of receiving various sample cells, including the claimed target and non-target cells, since Kim teaches every mechanical and structural feature necessary to carry out the recited function (see MPEP 2114(I)).
I.) Regarding applicant’s claim 1, as noted above Kim ‘611 in view of Kim ‘788 teaches all the limitations of claim 1.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 1 obvious.
II.) Regarding claim 2, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that first opening is further in fluid communication with a collection region, and the second opening is further in fluid communication a waste region.
Kim ‘611 in view of Kim ‘788 does not teach that that first opening is further in fluid communication with a collection region, and the second opening is further in fluid communication a waste region.
As noted above, Kim ‘611 teaches a storage portion 131 (collection region), but does not teach a waste region.
Kim ‘788 teaches a waste region 110.
It would have been obvious to modify Kim ‘611 to include a waste region as taught by Kim ‘788 and provide fluid communication to direct cells to the collection and waste region for purposes of collecting and discarding cells.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 2 obvious.
III.) Regarding claim 3, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that a location of the at least one separation in relation to the center of the rotatable substrate is a function of a rotation speed of the rotatable substrate.
In Kim ‘611 in view of Kim ‘788 the location of the separation at any given time would be dependent on the rotation speed of the rotatable substrate.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 3 obvious.
IV.) Regarding claim 4, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the main channel is an extension of the at least one flow path along a same direction toward to a periphery of the rotatable substrate.
In Kim ‘611 the channels 137 and 133 are extensions with one another and with the unlabeled channel between 173 and 131.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 4 obvious.
V.) Regarding claim 6, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the sample reservoir is disposed at the center of the rotatable substrate.
In Kim ‘611 in view of Kim ‘788 sample reservoir 173 is at the center of the rotatable substrate.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 6 obvious.
VI.) Regarding claim 7, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that a waste reservoir disposed at a distal end of the main channel and in fluid communication with the main channel through the first opening, and a collection reservoir disposed at a distal end of the side channel and in fluid communication with the side channel through the second opening.
Kim ‘611 in view of Kim ‘788 does not teach that a waste reservoir disposed at a distal end of the main channel and in fluid communication with the main channel through the first opening, and a collection reservoir disposed at a distal end of the side channel and in fluid communication with the side channel through the second opening.
As noted above, Kim ‘611 teaches a storage portion 131 (collection region), but does not teach a waste region.
Kim ‘788 teaches a waste region 110.
It would have been obvious to modify Kim ‘611 to include a waste region as taught by Kim ‘788 and provide fluid communication, including main channel to direct cells to the collection and a side channel to directed cells to the waste region for purposes of collecting and discarding cells.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 7 obvious.
VII.) Regarding claim 8, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the cover layer comprises a plate having a smooth surface configured to receive a plurality of electrode pins.
The cover layer in Kim ‘611 in view of Kim ‘788 comprises a plate having a smooth surface.
The recitation that the cover layer is “configured” to receive a plurality of electrode pins does not incorporate a structural limitation into claim 8.
Therefore, Kim ‘611 in view of Kim 788 renders claim 8 obvious.
VIII.) Regarding claim 9, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the at least one flow path comprises a plurality of flow paths circumferentially arranged around the sample reservoir and substantially parallel to force lines of the centrifugal force.
Kim ‘611 in view of Kim ‘788 does not teach that the at least one flow path comprises a plurality of flow paths circumferentially arranged around the sample reservoir and substantially parallel to force lines of the centrifugal force.
As noted above, it would have been obvious to modify the flow paths of Kim ‘611 separate into two channels, as taught by Kim ‘788, for the benefit of discarding portions of the sample prior to separation.
Kim ‘788 teaches a plurality of flow paths circumferentially arranged around the sample reservoir and substantially parallel to force lines of the centrifugal force.
It would have been obvious to modify Kim ‘611 to include flow paths as taught by Kim ‘788, including a plurality of flow paths circumferentially arranged around the sample reservoir and substantially parallel to force lines of the centrifugal force.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 9 obvious
IX.) Regarding claim 10, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 10 depends.
Claim 10 recites that the cover layer is in physical contact with an electrode pin array disposed in a vicinity of a circular traveling path of the separation and external to the rotatable substrate.
Kim ‘611 in view of Kim ‘788 does not teach that the cover layer is in physical contact with an electrode pin array disposed in a vicinity of a circular traveling path of the separation and external to the rotatable substrate.
As noted above, Kim ‘611 teaches electrodes 151, 153 that comprise microelectrodes which are in physical contact with the cover layer.
In Kim ‘611 as modified in view of Kim ‘788 it would have been obvious to provide the microelectrodes with pin for providing electro connection to the microelectrodes.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 10 obvious.
X.) Regarding claim 11, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 11 depends.
Claim 11 recites that the rotatable substrate comprises a low auto-fluorescent material.
Kim ‘611 in view of Kim ‘788 does not teach that rotatable substrate comprises a low auto-fluorescent material.
Kim ‘611 teaches that the lower plate can be made of glass. [0018]
Kim ‘788 teaches that the valves can be made from cyclic olefin copolymer. [0045]
It would have been obvious to make the rotatable substrate of Kim ‘611 in view of Kim ‘788 form the rotatable substrate from a low auto-fluorescent material such as glass or a cyclic olefin copolymer as these materials are taught to be useful by Kim ‘611 and Kim ‘788.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 11 obvious.
XI.) Regarding claim 12, as noted above Kim ‘611 in view of Kim ‘788 renders claim 1 obvious from which claim 12 depends.
Claim 12 recites that a position of the side channel in relation to the main channel depends on a rotation direction of the rotatable substrate.
In Kim ‘611 in view of Kim ‘788 it would have been obvious to orient the position of each channel in relation to the main channel dependent on a selected rotation direction of the rotatable substrate.
Therefore, Kim ‘611 in view of Kim ‘788 renders claim 12 obvious.
Allowable Subject Matter
Claims 13-24 are allowed.
The prior art does not teach or suggest an apparatus for sorting cells that includes a rotatable substrate having a sample reservoir and a flow path including a main channel and a side channel and a stationary substrate having a power supply and at least one height adjustable pin in a vicinity of the junction of the main and side channels and in physical contact with the rotatable substrate when the rotatable substrate and the stationary substrate are brought together as recited in claim 13.
The prior art does not teach or suggest a method of sorting cells, including target cells that are fluorophore-labeled and provided in a sample reservoir of a rotatable substrate having a flow path coupled to the sample reservoir, wherein the flow path comprises an area branching into a main channel and a side channel and the method includes: rotating the rotatable substrate to generate a centrifugal force to drive a portion of the sample from the sample reservoir into the flow path; detecting an optical signal from a target cell by an optical sensor; and generating an electric field for immobilizing the target cell in response to the detected optical signal as recited in claim 19.
The prior art does not teach or suggest a sorting system that includes a rotatable substrate comprising at least one fluidic channel extending towards a periphery of the rotatable substrate and at least one branch fluidic channel extending off of the fluidic channel from a branch point; a detector configured to detect target units in a fluid in the fluidic channel at or upstream of the branch point; an electric field source configured to generate an electric field at or proximate a circular traveling path of the branch point in response to the detector detecting a target unit, wherein the system is configured to: rotate the rotatable substrate to cause the fluid to flow through the fluidic channel towards the periphery of the rotatable substrate, and activate the electric field source in response to the detector detecting a target unit in the fluid such that the generated electric field facilitates diversion of the detected target into the branch fluidic channel as recited in claim 22.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Korean Patent Application Publication No. KR20080089835A to Cho et al. discloses a centrifugal force-based microfluidic device is provided to separate a fluid from particles by using centrifugal force that uses valves to control flow through various channels.
U.S. Patent Application Publication No. 2004/0229349 to Daridon teaches centrifugal particle sorting and that electric fields and be used to position particles. [0054], [0180].
U.S. Patent No. 5,032,381 to Bronstein et al. illustrates how electrical fields can be used to pull or push particles in Fig. 1.
U.S. Patent No. 6,540,895 to Spence et al. teaches that cells are directed into one or another of a pair of outlet channels by electrodes that apply an electric field across the branch point, which effectively directs a particular cell into a predetermined outlet or branch channel (column 3, lines 53-57).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798