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 .
Election/Restrictions
Applicant’s election without traverse of Claim(s) 45-54 and 83-84 in the reply filed on 04/02/2026 is acknowledged. After the claim amendments of 04/02/2026, there is only one independent claim 45 teaching a container for holding a tissue sample. Thus, Claim(s) 45-84 were examined below and the previous election restriction is moot.
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) 45, 47-49, 53, 55-68, and 81-84 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 closest prior art is Levene et al. (US20200348216A1).
Regarding Claim 45, Levene et al. teaches a container for holding a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), the container (See the container 1001 in [0075] in Fig. 1) comprising: a first component made of a rigid material (See how the tissue chambers may be constructed of materials such as metals, plastics, a cyclic olefin polymer, or glass in [0053]) and comprising a cavity having an imaging window on one surface thereof (See how the bottom cover 1015 may form the bottom of the specimen chamber 1005, i.e. a cavity, and may comprise an optically transmissive, transparent, or index-matched material such as a optically transmissive window 1011 in the bottom cover 1015 in [0075] in Fig. 10-11); and
a second component at least in part made of a flexible material and sized and shaped to create an airtight sealed chamber when inserted into the cavity of the first part (See how the fluid ports 1007 may be self-sealing, especially where the cover 1003 is operable form a fluid and air tight seal with the top of the container 1001 to create a sealed environment within the specimen chamber 1005. The self-sealing fluid ports 1007 may include a rubberized or silicone plug or surface that permits introduction of a needle but which seals upon needle removal in [0075] in Fig. 10-11).
Regarding Claim(s) 47-49, Levene et al. teaches the container limitations of claim 45.
Levene et al. further teaches a container for holding a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), wherein the imaging window is refractive-index matched to a refractive index of a fluid to be used in processing a tissue sample to be analyzed (See how the optical window can include a refractive index approximately equal to a refractive index of a fluid in which the tissue sample is immersed prior to imaging in [0022] and in Claim 2);
wherein the imaging window is refractive-index matched to a refractive index of a structure of a tissue sample to be analyzed (See how the sponge support 1013 and/or the bottom cover 1015 may form the bottom of the specimen chamber 1005 and may comprise an index matched material having approximately the same refractive index as the cleared tissue sample to be imaged in [0075]);
wherein the flexible material comprises silicone (See how the container 1001 includes fluid ports 1007 which may include a silicone plug in [0075]).
Regarding Claim 53, Levene et al. teaches the container limitations of claim 45.
Levene et al. further teaches a container for holding a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), wherein one or more of the first component and the second component comprises one or more fluid ports (See how the container 1001 includes fluid ports 1007 which may include a rubberized or silicone plug or surface that permits introduction of a needle but which seals upon needle removal in [0075] in Fig. 10-11 and in Claim 19).
Regarding Claim(s) 55-68, Levene et al. teaches the container limitations of claim 45.
Levene et al. further teaches a container for holding a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), a valved inlet port providing fluidic access to the airtight chamber; and a valved outlet port providing fluidic access to the airtight chamber and located on the container such that, when the container is positioned for filling for tissue processing, the outlet port is at or near a highest point of the airtight chamber and higher than the inlet port (See how the fluid ports 1007 may be self-sealing, especially where the cover 1003 is operable form a fluid and air tight seal with the top of the container 1001 to create a sealed environment within the specimen chamber 1005 in [0075]; Also, see how the self-sealing ports are needle-free connectors, such as those that include a self-closing valve that opens when a tube connector is attached in [0075] in Fig. 10-11);
further comprising a surface comprising a plurality of features configured to contact a tissue sample, reduce surface area contact between the tissue sample and the surface by spacing the tissue sample from the surface, and permit fluid flow between the tissue sample and the surface, the features comprising three-dimensional structures positioned on the surface (See how the sponge support 1013 or other porous compressible material is configured to contact the tissue sample and hold the tissue sample in place after positioning within a tissue chamber for chemical processing, clearing, and/or imaging. In some embodiments the porous compressible material is a plastic sponge. The sponge cell size may be any size that enables adequate tissue support with minimal compression and in a range that helps wet both the tissue and optical surfaces without air bubble trapping in [0076] in Fig. 10);
wherein the plurality of features comprise a material having a refractive index approximately equal to a refractive index of a fluid to be used in processing the tissue sample (See in Claim 2);
wherein the refractive index of the fluid to be used in processing the tissue sample is approximately equal to a refractive index of a structure of the tissue sample to be analyzed (See in [0022] and in Claim 11);
wherein the plurality of features comprise a material having a refractive index of about 1.5 to about 1.7 (See in [0027] and in Claim 4);
wherein the plurality of features comprise a material having a refractive index of between about 1.53 and about 1.60 (See in [0076] and in Claim 5);
wherein the organic solvent is a clearing solution (See in [0027] and in Claim 7);
comprising a porous compressible material configured to contact the tissue sample on a side of the tissue sample opposite the surface (See in [0028], [0076] an in Claim 8);
wherein the porous compressible material has a refractive index that is approximately equal to a refractive index of the tissue sample to be analyzed (See in [0028], [0076] an in Claim 9);
wherein at least a portion of the surface comprises a refractive index approximately equal to a refractive index of a fluid to be used in processing the tissue sample (See in Claim 10);
wherein the refractive index of the fluid to be used in processing the tissue sample is approximately equal to the refractive index of a structure of the tissue sample to be analyzed (See in Claim 11);
wherein the at least a portion of the surface comprises a refractive index of about 1.5 to about 1.7 (See in Claim 12);
wherein the surface at least partially defines a cavity for receiving the tissue sample (See in Claim 18).
Regarding Claim(s) 81-84, Levene et al. teaches the container limitations of claim 45.
Levene et al. further teaches a container for holding a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), further comprising a surface comprising a feature configured to receive and position a tissue sample in a desired position (See how the tissue chamber 101 has a trough 107 for receiving and processing a tissue sample in [0021], [0049] in Fig. 1);
wherein the feature comprises a v-shaped notch and the tissue sample is a core biopsy sample (See the features 403 are shaped in [0057]-[0059] in Fig. 4);
wherein a thickness of the window is between about 100 and about 500 um (See the various dimensions in [0021]-[0028], [0076]);
wherein the imaging window is refractive- index matched to a refractive index of about 1.515 (See how the optical window can comprise a refractive index of about 1.5 to about 1.7 in [0022]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Levene et al. (US20200348216A1) as applied to claim 45 above, and further in view of Levenson et al. (US20170191937A1).
Regarding Claim 46, Levene et al. teaches the container limitations of claim 45.
Levene et al. fails to explicitly teach a container for holding a tissue sample, wherein the rigid material comprises an optical grade plastic.
However, in the analogous art of systems and methods for controlling the depth of imaging in tissues, Levenson et al. teaches a container for holding a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), wherein the rigid material comprises an optical grade plastic (See how the biopsy material is lightly compressed against a transparent window made of fused-silica or quartz, sapphire, or UV-transmissive plastic in [0038]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the container of Levene et al. by incorporating a rigid material comprising an optical grade plastic (as taught by Levenson et al.) for the benefit of observing samples in a container and for using a thin transparent material that is also resistant to shattering.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Levene et al. (US20200348216A1) as applied to claim 45 above, and further in view of Abbott et al. (US20180348097A1).
Regarding Claim 50, Levene et al. teaches the container limitations of claim 45.
Levene et al. fails to explicitly teach a container for holding a tissue sample, wherein the flexible material comprises fluorosilicone.
However, in the analogous art of devices for dissociating a tissue sample, Abbott et al. teaches a container for holding a tissue sample (See the Abstract, the tissue dissociator 100, and the Claim(s) 1 and 4-12 in [0104]-[0116] in Fig. 1-12), wherein the flexible material comprises fluorosilicone (See how the pliable stopper 105 forms a seal with the cutting blade for the tissue sample. The pliable stopper may be formed from any suitable pliable material, including fluorosilicone rubber in [0058-0062] in Fig 1.).
Thus, it would be obvious to one with ordinary skills in the arts to modify the container of Levene et al. by incorporating a rigid material comprising fluorosilicone (as taught by Abbott et al.) for the benefit of selecting a material that would be long lasting and resistant to degradation.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Levene et al. (US20200348216A1) as applied to claim 45 above, and further in view of Tomlin et al. (US20170232753A1).
Regarding Claim 51, Levene et al. teaches the container limitations of claim 45.
Levene et al. fails to explicitly teach a container for holding a tissue sample, wherein the flexible material comprises ethylene propylene diene monomer rubber (EPDM).
However, in the analogous art of containers for storing and dispensing a liquid, Tomlin et al. teaches a container for holding a tissue sample (See the Abstract, the replaceable cartridge 2, and the Claim(s) 1-13 and 15-21 in [0036]-[0060] in Fig. 1-7), wherein the flexible material comprises ethylene propylene diene monomer rubber (EPDM) (See how the valve body may be formed of an ethylene propylene diene monomer rubber material in [0008] in Fig. 1-4).
Thus, it would be obvious to one with ordinary skills in the arts to modify the container of Levene et al. by incorporating a flexible material comprising ethylene propylene diene monomer rubber (EPDM) (as taught by Tomlin et al.) for the benefit of making the port from a durable material that is capable of forming a seal within the chamber.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Levene et al. (US20200348216A1) as applied to claim 45 above, and further in view of Fan et al. (US20210163864A1).
Regarding Claim 52, Levene et al. teaches the container limitations of claim 45.
Levene et al. fails to explicitly teach a container for holding a tissue sample, wherein the second component comprises a cavity for receiving a tissue sample.
However, in the analogous art of containers for stabilizing and aligning a sample for analysis, Fan et al. teaches a container for holding a tissue sample (See the Abstract, the sample container 100, and the Claim(s) 1-47 in [0036]-[0065] in Fig. 1-13), wherein the second component comprises a cavity for receiving a tissue sample (See how the apparatus can include a sealing member coupled to the sample bag and configured to maintain the sample bag in an airtight condition. In some embodiments, the sealing member can be coupled to a circumference of the opening of the sample bag in [0021] Fig. 1-4).
Thus, it would be obvious to one with ordinary skills in the arts to modify the container of Levene et al. by incorporating a second component comprising a cavity for receiving a tissue sample (as taught by Fan et al.) for the benefit of simplifying the design by consolidating the fluid ports with the main opening of the chamber.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Levene et al. (US20200348216A1) as applied to claim 45 above, and further in view of Eastman et al. (US20150277094A1).
Regarding Claim 54, Levene et al. teaches the container limitations of claim 45.
Levene et al. fails to explicitly teach a container for holding a tissue sample, wherein the second component comprises a deformable portion operable to compress a tissue sample within the airtight sealed chamber against the imaging window upon application of a negative pressure differential to the airtight sealed chamber.
However, in the analogous art of cassettes for optical sectioning of a retained sample, Eastman et al. teaches a container for holding a tissue sample (See the Abstract, the cassette 10, and the Claim(s) 42-61 in [0048]-[0055] in Fig. 1-14), wherein the second component comprises a deformable portion operable to compress a tissue sample within the airtight sealed chamber against the imaging window upon application of a negative pressure differential to the airtight sealed chamber (See how when the cassette is closed, i.e., the tissue specimen is sealed in the cavity between the pliable plastic membrane and window, the membrane is held tightly by the upper member against the base member over the tissue specimen. The pressure of the membrane may compress the tissue specimen toward the window of the base member in [0019]-0022]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the container of Levene et al. by incorporating a second component comprising a deformable portion operable to compress a tissue sample within the airtight sealed chamber against the imaging window upon application of a negative pressure differential to the airtight sealed chamber (as taught by Eastman et al.) for the benefit of pressing the specimen to the window so that it could be more easily focused under a microscope for observation.
Claim(s) 69-80 are rejected under 35 U.S.C. 103 as being unpatentable over Levene et al. (US20200348216A1) as applied to claim 55 above, and further in view of Levene et al. (U20190360901A1) herein referred to as Torres et al.
Regarding Claim(s) 69-80, Levene et al. teaches the container limitations of claim 55.
Levene et al. further teaches a method for analyzing a tissue sample (See the Abstract, the tissue chamber 101, and the Claim(s) 1-20 in [0048]-[0060] in Fig. 1-11), the method comprising: orienting a tissue sample in the tissue container of claim 55 in a desired position; positioning the tissue chamber in a processing orientation such that the valved outlet port is positioned higher than the valved inlet port and at or near a highest point of the tissue chamber relative to ground; exposing the tissue sample to a first solution for chemical processing in the desired position in the tissue chamber in the processing orientation by introducing the first solution through the valved inlet port and allowing air to escape the tissue chamber through the valved outlet port; immersing the chemically processed tissue sample in a fluid in the desired position in the tissue chamber in the processing orientation by introducing the fluid through the valved inlet port; and imaging the immersed tissue sample in the desired position in the tissue chamber without repositioning the tissue sample after orienting (See in [0009], [0021], [0033], [0048], [0055], [0076]-[0079] in Fig. 10-11).
further comprising embedding the tissue sample in the desired position in the tissue chamber in the processing orientation by introducing embedding fluid through the valved inlet port; wherein the desired position is a desired position for sectioning of the embedded tissue sample (See in [0005]-[0014], [0033]-[0034], [0048]-[0052]);
wherein the fluid comprises a clearing agent; wherein the clearing agent is BABB (See how the clearing solutions may comprise benzyl alcohol and benzyl benzoate (BABB) and, accordingly, features 403 may comprise materials known to dissolve in BABB in [0027]-[0034], [0059], [0076]-[0079]).
wherein the first solution comprises a dehydrant; wherein the first solution comprises a fixative; wherein the fixative is a dehydrant; wherein the first solution comprises a dye; wherein the first solution comprises a dye (See in (See in [0034], [0048]-[0057], [0077]-[0079]);
wherein the desired position is a desired position for imaging of the tissue sample (See in [0076]-[0079]);
wherein the tissue chamber comprises a plurality of features disposed on an interior surface of the tissue chamber and configured to contact the tissue sample and permit fluid flow between the tissue sample and the interior surface (See in Claim 1).
Levene et al. fails to explicitly teach a method for analyzing a tissue sample comprising: positioning the tissue chamber in a processing orientation such that the valved outlet port is positioned higher than the valved inlet port and at or near a highest point of the tissue chamber relative to ground; exposing the tissue sample to a first solution for chemical processing in the desired position in the tissue chamber in the processing orientation by introducing the first solution through the valved inlet port and allowing air to escape the tissue chamber through the valved outlet port; immersing the chemically processed tissue sample in a fluid in the desired position in the tissue chamber in the processing orientation by introducing the fluid through the valved inlet port; and imaging the immersed tissue sample in the desired position in the tissue chamber without repositioning the tissue sample after orienting; further comprising embedding the tissue sample in the desired position in the tissue chamber in the processing orientation by introducing embedding fluid through the valved inlet port; wherein the desired position is a desired position for sectioning of the embedded tissue sample; wherein the fluid comprises a clearing agent; wherein the clearing agent is BABB; wherein the first solution comprises a dehydrant; wherein the first solution comprises a fixative; wherein the fixative is a dehydrant; wherein the first solution comprises a dye; wherein the first solution comprises a dye; wherein the desired position is a desired position for imaging of the tissue sample.
However, in the analogous art of tissue chambers, Torres et al. teaches a method for analyzing a tissue sample (See the Abstract, the container 101, and the Claim(s) 1-13 in [0048]-[0063] in Fig. 1-11), comprising: positioning the tissue chamber in a processing orientation such that the valved outlet port is positioned higher than the valved inlet port and at or near a highest point of the tissue chamber relative to ground; exposing the tissue sample to a first solution for chemical processing in the desired position in the tissue chamber in the processing orientation by introducing the first solution through the valved inlet port and allowing air to escape the tissue chamber through the valved outlet port; immersing the chemically processed tissue sample in a fluid in the desired position in the tissue chamber in the processing orientation by introducing the fluid through the valved inlet port; and imaging the immersed tissue sample in the desired position in the tissue chamber without repositioning the tissue sample after orienting (See Claim 1);
further comprising embedding the tissue sample in the desired position in the tissue chamber in the processing orientation by introducing embedding fluid through the valved inlet port; wherein the desired position is a desired position for sectioning of the embedded tissue sample (See Claim(s) 2 and 11);
wherein the fluid comprises a clearing agent (See Claim 4) ; wherein the clearing agent is BABB (See Claim 5);
wherein the first solution comprises a dehydrant (See Claim 6); wherein the first solution comprises a fixative (See Claim 7); wherein the fixative is a dehydrant (See Claim 8); wherein the first solution comprises a dye; wherein the first solution comprises a dye; wherein the desired position is a desired position for imaging of the tissue sample(See Claim 12).
Thus, it would be obvious to one with ordinary skills in the arts to modify the container of Levene et al. by incorporating a method for analyzing a tissue sample (as taught by Torres et al.) for the benefit of imaging a tissue in the container.
Conclusion
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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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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