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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10 2021 208 185.1, filed on 07/29/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 16-22 and 27-34 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
The instant invention is anticipated by Rawlings et al. (US20160281150A1).
Regarding Claim 16, Rawlings et al. teaches a sample carrier (See the Abstract, the carrier assembly 112 and 400, and Claim(s) 1-20 in [0008]-[0013], [0061]-[0090], [0091]-[0234] in Fig. 1-22) comprising: a sample space that is enclosed by a wall and that is configured to receive a sample (See how the sample 202 includes an optical substrate 204, i.e. a wall, that is represented as a flow cell and includes a first plate or layer 206 and a second plate or layer 208 with an interior volume or channel 210, i.e. a sample space, extending between the first and second layers 206 and 208 in [0061]-[0090] in Fig. 1-3), the wall having at least one transparent region which is transparent to a detection radiation originating from the sample and which acts as a detection window (See how the substrate materials of layers 206 and 208 can be transparent to the optical signals emitted by one or more labels in the sample or to the optical signals that are reflected and or refracted by the sample in [0056] in Fig. 2),
wherein in a direction perpendicular to the transparent region of the wall, the sample space has a clear distance between opposing inner sides of the wall of no more than 50 µm (See in [0137]-[0138], [0180]);
an access opening configured for filling the sample space with the sample (See the first and second ports 454, 456, i.e. access openings, in [0121]-[0130] in Fig. 8-11 and in Claim 2); and
an excitation window configured for radiating an excitation radiation into the sample space (See how the sample 202 may be irradiated by excitation light or radiation 220 along a linear focal region 222 in [0087] in Fig 2; Also, see how the sample region 406 includes a window in [0113]-[0130] in Fig. 8-11; See in [0089]-[0106] in Fig. 5-6).
Regarding Claim(s) 17-22, Rawlings et al. teaches the device limitations of claim 16.
Rawlings et al. further teaches a sample carrier (See the Abstract, the carrier assembly 112 and 400, and Claim(s) 1-20 in [0008]-[0013], [0061]-[0090], [0091]-[0234] in Fig. 1-22), wherein the sample space has a clear distance between opposing inner sides of the wall of no more than 25 µm (See in [0137]-[0138], [0180]);
wherein the sample space has a clear distance between opposing inner sides of the wall of no more than 5 µm (See in [0137]-[0138], [0180]);
wherein the sample space has a clear distance between opposing inner sides of the wall of no more than 1 µm (See in [0137]-[0138], [0180]);
wherein the clear distance is effected between the side walls by virtue of spacers being inserted between opposing side walls or a raised edge being applied to or formed on at least one of the side walls (See the adapter plater 420, i.e. a spacer or edge, in [0052], [0112]-[0130] in Fig. 8-11);
wherein the sample space is embodied in the form of a coverable channel present in a carrier plate (See how the flow cell 450 and the sample region 406, i.e. a sample space, has four flow channels 452 formed within a flow cell body 460 of the flow cell 450 in [0121]-[0130] in Fig. 8-11);
wherein at least one inside reinforcement is present along an inner side of the wall and/or at least one outside reinforcement is present along an outer side of the wall, with the wall being reinforced against deformations as a result of the inside reinforcement and/or as a result of the outside reinforcement (See how the frame body 404 includes apertures 464, 465, 466 in [0123]-[0130] in Fig. 8-11).
Regarding Claim(s) 27-28, Rawlings et al. teaches the device limitations of claim 16.
Rawlings et al. further teaches a sample carrier (See the Abstract, the carrier assembly 112 and 400, and Claim(s) 1-20 in [0008]-[0013], [0061]-[0090], [0091]-[0234] in Fig. 1-22), further comprising an outlet opening configured to allow a previously present medium and/or previously present sample to escape from the sample space when the sample space is filled (See the first and second ports 454, 456, i.e. access openings, in [0121]-[0130], [0182] in Fig. 8-11 and in Claim 2);
further comprising an immersion medium (See in [0049], [0152]).
Regarding Claim 29, Rawlings et al. teaches a method for capturing detection radiation from a sample in sample space of a sample carrier (See the Abstract, the carrier assembly 112 and 400, and Claim(s) 1-20 in [0008]-[0013], [0061]-[0090], [0091]-[0234] in Fig. 1-22), wherein the sample space is enclosed by a wall having at least one transparent region which is transparent to detection radiation originating from the sample and which acts as a detection window (See how the sample 202 may be irradiated by excitation light or radiation 220 along a linear focal region 222 in [0087] in Fig 2; Also, see how the sample region 406 includes a window in [0113]-[0130] in Fig. 8-11; See in [0089]-[0106] in Fig. 5-6 and Claim 10),
wherein in a direction perpendicular to the transparent region of the wall the sample space has a clear distance between opposing inner sides of the wall of no more than 50 µm (See in [0137]-[0138], [0180]),
wherein the sample carrier includes an access opening configured for filling the sample space with the sample (See the first and second ports 454, 456, i.e. access openings, in [0121]-[0130] in Fig. 8-11 and in Claim 2) and
an excitation window configured for radiating an excitation radiation into the sample space (See how the flow channels 452, i.e. a sample space, are linear and the imaging segments 458, i.e. an excitation window, of the flow channels 452 extend parallel to each other. In other embodiments, however, the flow channels 452 may extend along nonlinear paths and/or may extend in nonparallel directions with respect to one another in [0089]-[0106], [0121] in Fig. 5-6 and 10), the method comprising:
introducing the sample into the sample space via the access opening (See the first and second ports 454, 456, i.e. access openings, in [0121]-[0130] in Fig. 8-11 and in Claim 2);
illuminating the sample situated in the sample space with excitation radiation that is radiated into the sample space (See the different optical configurations 281-283 of an optical system 250 that may be used during different imaging sessions in [0091]-[0102], [0165] in Fig. 4-5),
wherein emission of detection radiation is effected by the effect of the excitation radiation on the sample (See in [0089]-[0138] in Fig. 1-22 and Claim(s) 1-15); and
capturing the detection radiation from the sample through the detection window through a detection objective onto a detector (See the detectors 310A-D in [0103] in Fig. 6; Also, see in [0089]-[0138] in Fig. 1-22).
Regarding Claim(s) 30-34, Rawlings et al. teaches the method limitations of claim 29.
Rawlings et al. further teaches a method for capturing detection radiation from a sample in sample space of a sample carrier (See the Abstract, the carrier assembly 112 and 400, and Claim(s) 1-20 in [0008]-[0013], [0061]-[0090], [0091]-[0234] in Fig. 1-22), wherein the sample includes microorganisms and/or pathogens present and the detection radiation emanates from the microorganisms and/or pathogens present in the sample (See how a sample may include biological or chemical substances of interests in [0048]-[0049]);
wherein the sample is transported continually or sequentially through the sample space (See how simultaneously or sequentially, a second excitation radiation 236 may be used to irradiate the biological components 214 on the interior surface 218 of the optical substrate 20 in [0089], [0153] in Fig. 3);
further comprising repeatedly exciting the sample with the excitation radiation to emit detection radiation (See the radiation sources 312 and the detectors 310A-C in [0087], [0103], [0144], [0154]-[0230] in Fig. 5-6);
further comprising rotating or tilting the sample carrier while the detection radiation is captured, such that the detection radiation is captured from different regions of the wall (See the alignment mechanism 330 includes a movable arm 332 that is configured to rotate about an axis 333 in [0109]-[0110] in Fig. 7 and Claim(s) 1-15);
further comprising rotating or tilting the sample carrier between two capturing processes for the detection radiation, such that the detection radiation is captured from different regions of the wall during the different capturing processes (See in [0109]-[0110] in Fig. 7 and Claim(s) 1-15).
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.
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) 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rawlings et al. (US20160281150A1) as applied to claim 16 above, and further in view of Colston, Jr. et al. (US9156010B2).
Regarding Claim(s) 23-25, Rawlings et al. teaches the device limitations of claim 16.
Rawlings et al. fails to explicitly teach a sample carrier further comprising a filter element arranged at the access opening, the filter element having a mesh size of no more than 80% of the clear distance.
However, in the analogous art of droplet-based assay systems, Colston, Jr. et al. teaches a sample carrier (See the Abstract, the cartridge 1700 and 1720, and Claim(s) 1-28 in [Col. 58 line 1]-[Col. 63 line 39] in Fig. 42-51), comprising a filter element arranged at the access opening, the filter element having a mesh size of no more than 80% of the clear distance; wherein the filter element has a mesh size of no more than 50% of the clear distance (See how the filters 1706 and 1730 may be a membrane or other similar aperture-type filter with a known characteristic size cutoff in [Col. 58 line 1]-[Col. 63 line 39] in Fig. 42-45);
wherein at least one region of the inner side of the wall facing the sample space, of the detection window, includes a coating for specifically binding constituents of the sample (See in [Col. 58 line 1]-[Col. 63 line 39] in Fig. 42-45).
Thus, it would be obvious to one with ordinary skills in the art to modify the carrier of Rawlings et al. by incorporating a filter element and regional coating (as taught by Colston, Jr. et al.) for the benefit of filtering the size of particles/cells and binding particles/cells in a region within a sample carrier.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rawlings et al. (US20160281150A1) and Colston, Jr. et al. (US9156010B2) as applied to claim 25 above, and further in view of Schulte et al. (US9341515B2).
Regarding Claim 26, The combination of Rawlings et al. and Colston, Jr. et al. teaches the device limitations of claim 25.
The combination of Rawlings et al. and Colston, Jr. et al. fails to explicitly teach a sample carrier, wherein the coating contains poly- L-lysine, poly-D-lysine, and/or collagen.
However, in the analogous art of optical absorbance measurement apparatuses and methods, Schulte et al. teaches a sample carrier (See the Abstract, the apparatus 100, and Claim(s) 1-20 in [Col. 2 line 15]-[Col. 12 line 46], in Fig. 1 and 5), wherein the coating contains poly- L-lysine, poly-D-lysine, and/or collagen (See in [Col. 6 lines 52-65] and [Col. 10 lines 1-15]).
Thus, it would be obvious to one with ordinary skills in the art to modify the combined carrier of Rawlings et al. and Colston, Jr. et al. by incorporating a coating contains poly- L-lysine, poly-D-lysine, and/or collagen (as taught by Schulte et al.) for the benefit of binding particles/cells in a region within a sample carrier.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches similar devices and methods: Chan et al. (US20130120747A1), Goto et al. (US20210387194A1), and Katerkamp (US6274872B1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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