DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/26 has been entered.
Claim Status
Claims 1-3, 5-9, 11-13, 15, and 18 are pending and are examined. Claims 4, 10, 14, 16, and 17 are canceled.
Claim Objections
Claims 4, 10, 14, 16, and 17 are objected to because of the following informalities: Claim X fails to comply with 37 CFR 1.121(c) and is required to have a status identifier of ‘Canceled’ since the claims as originally filed are canceled.
Amendments to a claim must be made by rewriting the entire claim with
all changes (e.g., additions and deletions) as indicated in this subsection, except
when the claim is being canceled. Each amendment document that includes a
change to an existing claim, cancellation of an existing claim or addition of a new
claim, must include a complete listing of all claims ever presented, including the text
of all pending and withdrawn claims, in the application. The claim listing, including
the text of the claims, in the amendment document will serve to replace all prior
versions of the claims, in the application. In the claim listing, the status of every
claim must be indicated after its claim number by using one of the following
identifiers in a parenthetical expression: (Original), (Currently amended),
(Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 11 and 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 11 depends on claim 10 which is currently canceled. For the purpose of example, claim 11 will be interpreted as depending on claim 1.
Claim 12 is dependent on claim 11.
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.
Claims 1, 2, 3, 5, 6, 7, 9, 12, 13, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tian (US Pub 2017/0087548; previously cited), in view of Kim (US Pub 2010/0000304).
Regarding Claim 1, Tian teaches an adaptor configured to fit inside a centrifuge tube for immobilizing and concentrating cells from cell suspensions by centrifugation using a standard centrifuge having a plurality of centrifuge tubes having closing lids ([0113] Fig. 10A shows the tube 10 sitting over a spacer 30 snugly attached to and in a standard 50 mL tube 50 in preparation for centrifugation in a bucket 210 of the centrifuge 200. FIG. 10B illustrates the tube 10 in the tube 50 in a standard swing bucket 210 of the centrifuge 200. FIG. 10C illustrates centrifugation with the tube 10 on its side (and horizontal) rather than angled so that the specimen is collected in a middle 20c (FIG. 1B) of the cell bed 20. The claim language beginning with and following “using a standard centrifuge” is intended use of the device),
the adaptor comprising:
one or more funnel units, configured to receive one or more fluid samples, and wherein each of the funnel units having a wide opening and a narrow neck and a flattened lateral surface that extends from the wide opening to approximately halfway towards the narrow neck ([0112] FIGS. 9A and 9B illustrate another embodiment of a container 10′ where the tube body 10b can releasably attach to an elongate body 150 which may be attached to a second cap 12b. As shown, the elongate body 150 is in fluid communication with the tube fluid cavity 10c. The second tube cap 12b can define a fluid port 153 that allows fluid from the elongate body 150 to be introduced or withdrawn. The tube body 10b with the second cap 12b can be configured to reside in a standard 50 mL tube 50 as shown. In other embodiments, the tube body 10b and second cap 12b can be configured to snugly reside in a centrifuge receptacle (e.g., bucket) without requiring the tube 50. The elongate body 150 can be integral with the tube cap 12b, e.g., a monolithic molded unitary component. In other embodiments, the elongate body can be configured to attach to the lid 12b in other ways including threaded, snap fit and the like, while providing a fluid-tight seal. FIGS. 9C and 9D illustrate a similar configuration of a container 10′ with an alternate top configuration. In some embodiments, the elongate body 150 may be attached at the collection site as the original cap. Fig. 9A, side of the elongate body would be the flattened lateral surface);
a hollow cylinder, having a plurality of external threads on a lateral surface of the cylinder, and attached at the neck and extending therefrom (tubular body 10b);
one or more removable gasket disposed on the narrow side encircling circumference of the narrow side of each of the one or more funnel unit ([0089] In some embodiments, the base 11 is detachable, e.g., releasably attachable to a bottom portion 10l of the tube 10. This releasable attachment can be by any suitable attachment configuration including, for example, threaded attachment, bayonet or frictional fit, snap fit, hooks, VELCRO, adhesive attachment, frangible attachments, any of which may optionally also employ O-rings, compatible sealant, wax or grease or washers to promote a sufficient fluid-tight seal.);
one or more coverslip holding plate, adapted to hold a respective coverslip, deployed proximal to the circumference of the narrow side of the respective one or more funnel unit ([0114] FIG. 11 illustrates the components of a tube 10 according to some embodiments. As noted above, the cell bed 20 can be pre-formed and provided for assembly onsite or may be pre-attached to the base 11 and/or tube body 10b. Typically, the base 11 with the cell bed 20 is attached to the tube body 10b and packaged for use at a collection site.); and
one or more removable caps having a plurality of internal or external threads, adapted to enclose the respective one or more coverslip holding and configured to fasten over the respective one or more hollow cylinder ([0108] The lid 12 can also be threadably attached to an upper portion of the tube body 10 via threads 12t, 138. The base 11 and cap 12 can have a ledge 39, 139 with a diameter that defines a tight fit with a receptacle of a standard centrifuge or with a standard tube, sleeve or other adapter allowing the tube 10 to be placed in a centrifuge for processing.);
wherein the one or more removable gasket is adapted to restrict leaking of the one or more fluid samples inside the one or more funnel units and the coverslip is placed in a horizontal position inside the one or more funnel units ([0089] In some embodiments, the base 11 is detachable, e.g., releasably attachable to a bottom portion 10l of the tube 10. This releasable attachment can be by any suitable attachment configuration including, for example, threaded attachment, bayonet or frictional fit, snap fit, hooks, VELCRO, adhesive attachment, frangible attachments, any of which may optionally also employ O-rings, compatible sealant, wax or grease or washers to promote a sufficient fluid-tight seal. The o-ring would restrict leakage. The examiner notes that the limitation “the coverslip is placed in a horizontal position inside the one or more funnel units” is directed to intended use since the coverslip is not required for the claimed “adaptor”).
Tian is silent to a flattened lateral surface that extends from the wide opening to approximately halfway towards the narrow neck.
Kim teaches processing a biological and/or chemical sample. [0041] As an illustrative example the apparatus may contain a (vertically) straight lateral wall. This circumferential/lateral wall may for instance be a cylindrical wall surrounding the processing compartment. As a further example of a straight circumferential wall the apparatus may contain one lateral wall of horseshoe shape and one flat lateral wall, connected with each other via edges. As yet a further example the apparatus may contain 3, 4, 5, or more flat or rounded circumferential walls connected via edges.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a flattened lateral surface located on the broad side of each of the one or more funnel units that extends to approximately halfway towards the narrow neck, as taught by Kim, to the device of Tian, to allow for an alternative geometrical configuration for the wall, as taught by Kim, in [0041].
Regarding Claim 2, Tian teaches the adaptor as claimed in claim 1, wherein each of the one or more funnel units along with the one or more hollow cylinder, the one or more removable gasket, the one or more coverslip holding plate, the respective coverslips and the one or more removable caps are placed inside each of the respective centrifuge tubes of the standard centrifuge with the lids closed (Figs. 1-7E, 9A-10B, [0083]-[0113], the examiner notes this limitation is written as a process claim because of terms “placed inside” and the terms “centrifuge” and “lid” are not part of the claimed device. ).
Regarding Claim 3, Tian teaches the adaptor as claimed in claim 1, wherein the standard centrifuge is configured to immobilizing cells or concentrate cells inside the one or more funnel unit using centrifugal force by pushing the cells in the fluid sample toward the coverslip ([0113] Fig. 10A centrifuge, centrifuge would be capable of immobilizing cells or concentrate cells in a funnel unit).
Regarding Claim 5, Tian teaches the adaptor as claimed in claim 1, wherein the narrow side of the one or more funnel units having a first set of rabbets adapted to hold the one or more removable gasket ([0089], [0101] presence of rabbets to hold gasket is inherent).
Regarding Claim 6, Tian teaches the adaptor as claimed in claim 1, wherein the one or more coverslip holding plate having a second set of rabbets adapted to hold the respective one or more coverslips holding plate inside the one or more removable caps (the presence of rabbet to hold coverslip support 10b is inherent from Fig. 7A).
Regarding Claim 7, Tian teaches the adaptor as claimed in claim 1, wherein the one or more coverslips holding plate further having a third set of rabbets adapted to hold the coverslip (the presence of rabbet to hold a coverslip/cell bed 2- inside a support 10b is inherent in Fig. 7E).
Regarding Claim 9, Tian teaches the adaptor as claimed in claim 3, wherein the immobilized cells are collected on the coverslip or other receptacle ([0112]-[0113] cells are collected on the cell bed. The examiner notes that “immobilized cells are collected” would be a process limitation.).
Regarding Claim 12, Tian teaches the adaptor as claimed in claim 1, further including a filter, disposed between the broad side of the one or more funnel unit and the respective coverslip, configured to allow the capture of cells on the filter during the centrifugation process, with the non-filtered cells immobilized on the coverslip ([0078]).
Regarding Claim 13, Tian teaches the adaptor as claimed in claim 1, wherein the one or more fluid sample is selected from a group comprising urine, sputum, spinal fluid, pleural fluid, pericardial fluid, and ascitic (e.g., urine, blood plasma or serum versus FNA).
Regarding Claim 18, Tian teaches an adaptor configured to fit inside a centrifuge tube for immobilizing and concentrating cells from cell suspensions by centrifugation using a standard centrifuge having a plurality of centrifuge tubes having closing lids ([0113] Fig. 10A shows the tube 10 sitting over a spacer 30 snugly attached to and in a standard 50 mL tube 50 in preparation for centrifugation in a bucket 210 of the centrifuge 200. FIG. 10B illustrates the tube 10 in the tube 50 in a standard swing bucket 210 of the centrifuge 200. FIG. 10C illustrates centrifugation with the tube 10 on its side (and horizontal) rather than angled so that the specimen is collected in a middle 20c (FIG. 1B) of the cell bed 20. The claim language beginning with and following “using a standard centrifuge” is intended use of the device), the adaptor comprising:
one or more funnel units, configured to receive one or more fluid samples, and wherein each of the funnel units having a wide opening and a narrow neck, ([0112] FIGS. 9A and 9B illustrate another embodiment of a container 10′ where the tube body 10b can releasably attach to an elongate body 150 which may be attached to a second cap 12b. As shown, the elongate body 150 is in fluid communication with the tube fluid cavity 10c. The second tube cap 12b can define a fluid port 153 that allows fluid from the elongate body 150 to be introduced or withdrawn. The tube body 10b with the second cap 12b can be configured to reside in a standard 50 mL tube 50 as shown. In other embodiments, the tube body 10b and second cap 12b can be configured to snugly reside in a centrifuge receptacle (e.g., bucket) without requiring the tube 50. The elongate body 150 can be integral with the tube cap 12b, e.g., a monolithic molded unitary component. In other embodiments, the elongate body can be configured to attach to the lid 12b in other ways including threaded, snap fit and the like, while providing a fluid-tight seal. FIGS. 9C and 9D illustrate a similar configuration of a container 10′ with an alternate top configuration. In some embodiments, the elongate body 150 may be attached at the collection site as the original cap.);
a hollow cylinder, having a plurality of external threads on a lateral surface of the cylinder; and attached at the neck and extending therefrom (tubular body 10b);
one or more removable gasket disposed on the narrow side encircling circumference of the narrow side of each of the one or more funnel unit ([0089] In some embodiments, the base 11 is detachable, e.g., releasably attachable to a bottom portion 10l of the tube 10. This releasable attachment can be by any suitable attachment configuration including, for example, threaded attachment, bayonet or frictional fit, snap fit, hooks, VELCRO, adhesive attachment, frangible attachments, any of which may optionally also employ O-rings, compatible sealant, wax or grease or washers to promote a sufficient fluid-tight seal.);
one or more coverslip holding plate; adapted to hold a respective coverslip, deployed proximal to the circumference of the narrow side of the respective one or more funnel unit and each of the coverslips being separately placed in a horizontal position inside the one or more funnel units ([0089] In some embodiments, the base 11 is detachable, e.g., releasably attachable to a bottom portion 10l of the tube 10. This releasable attachment can be by any suitable attachment configuration including, for example, threaded attachment, bayonet or frictional fit, snap fit, hooks, VELCRO, adhesive attachment, frangible attachments, any of which may optionally also employ O-rings, compatible sealant, wax or grease or washers to promote a sufficient fluid-tight seal. The term “coverslips” and its arrangement is not part of the claimed adaptor because it is not positively recited.); and
one or more removable caps having a plurality of internal or external threads, adapted to enclose the respective one or more coverslip holding plates, and configured to fasten over the respective one or more hollow cylinder; wherein the one or more removable gasket is adapted to restrict leaking of the one or more fluid samples inside the one or more funnel units ([0089] In some embodiments, the base 11 is detachable, e.g., releasably attachable to a bottom portion 10l of the tube 10. This releasable attachment can be by any suitable attachment configuration including, for example, threaded attachment, bayonet or frictional fit, snap fit, hooks, VELCRO, adhesive attachment, frangible attachments, any of which may optionally also employ O-rings, compatible sealant, wax or grease or washers to promote a sufficient fluid-tight seal. The o-ring would restrict leakage).
Tian is silent to a flattened lateral surface located on the broad side of each of the one or more funnel units that extends to approximately halfway towards the narrow neck.
Kim teaches processing a biological and/or chemical sample. [0041] As an illustrative example the apparatus may contain a (vertically) straight lateral wall. This circumferential/lateral wall may for instance be a cylindrical wall surrounding the processing compartment. As a further example of a straight circumferential wall the apparatus may contain one lateral wall of horseshoe shape and one flat lateral wall, connected with each other via edges. As yet a further example the apparatus may contain 3, 4, 5, or more flat or rounded circumferential walls connected via edges.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a flattened lateral surface located on the broad side of each of the one or more funnel units that extends to approximately halfway towards the narrow neck, as taught by Kim, to the device of Tian, to allow for an alternative geometrical configuration for the wall, as taught by Kim, in [0041].
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tian (US Pub 2017/0087548; previously cited), in view of Kim (US Pub 2010/0000304), and further in view of Tian (US Pub 2015/0338321; previously cited).
Regarding Claim 8, modified Tian teaches the device as claimed in claim 7.
Modified Tian is silent to the one or more coverslips holding plate further be coated in a hydrophobic layer to allow the user to directly perform immunocytochemistry on the plate.
Tian teaches cell tubes used for pathology collection. [0087] The internal base surface 11i can include a non-stick material and/or coating that reduces sliding friction and/or otherwise facilitates the removal of the cell bed 20 from the base 11 with the cell block 100 (FIG. 4C) for conventional cell evaluation after processing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have coated a hydrophobic layer (non-stick, as taught by Tian ‘321, to the one or more coverslips holding plate in the device of modified Tian ‘548, to allow for reduce sliding friction, as taught by Tian ‘321, in [0087].
Regarding Claim 15, Tian teaches the device as claimed in claim 1.
Tian is silent to further coated with a non-stick material.
Tian teaches cell tubes used for pathology collection. [0087] The internal base surface 11i can include a non-stick material and/or coating that reduces sliding friction and/or otherwise facilitates the removal of the cell bed 20 from the base 11 with the cell block 100 (FIG. 4C) for conventional cell evaluation after processing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have coating a hydrophobic layer (non-stick, as taught by Tian ‘321, the device of Tian ‘548, to allow for reduce sliding friction, as taught by Tian ‘321, in [0087].
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tian (US Pub 2017/0087548; previously cited), in view of Kim (US Pub 2010/0000304).
Regarding Claim 10, modified Tian teaches the device as claimed in claim 1.
Modified Tian is silent to the flattened lateral surface extends approximately halfway along each of the one or more funnel units from the broad side towards the narrow side.
In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). See MPEP 2144.04 VI.C.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have re-arranged the flattened lateral surface extends approximately halfway along each of the one or more funnel units from the broad side towards the narrow side in the device of modified Tian so that the sample does not get stuck in a non-flat region.
Regarding Claim 11, modified Tian teaches the device as claimed in claim 11, wherein the flattened lateral surface further having grooves adapted to fix inside each of the respective centrifuge tubes to rigidify each of the one or more funnel units inside each of the respective centrifuge tubes while the centrifugation ([0109] The cap and base ledges 39, 139 can be configured to have the same outer diameter size. The outer perimeter of the ledge can include a pattern of circumferentially spaced apart recesses or grooves 39g, 139g. The ledges 39, 139 can provide a resilient fit to provide for snug engagements using an overcoat, outerlayer or substrate of resilient material or just based on the groove configurations.).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tian (US Pub 2017/0087548; previously cited), in view of Kim (US Pub 2010/0000304), and further in view of Gibbons (US Pub 2016/0006928; previously cited).
Regarding Claim 15, modified Tian teaches the device as claimed in claim 1.
Modified Tian is silent to including a quality control mechanism configured to alert a user of possible loss of the one or more fluid sample.
Gibbons teaches in the related art of the methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. See Abstract. [0028] providing an alert if an undesirable quality is detected for performing the one or more assays on the blood sample; or performing the one or more assays in the instrument if an undesirable quality is not detected.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a quality control mechanism (alert), as taught by Gibbons, in the device of modified Tian, to allow for informing that assay quality or condition quality is undesirable, as taught by Gibbons in [0028].
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues on page 7 paragraphs 3 and 4 that the combination of centrifugation and sample volume weight results in high-stress forces exerted on the glass substrate. The horizontal orientation of the coverslip is not a random geometric detail, but explicitly contributes to solving the problem.
In response, the examiner notes that the Applicant’s argument is directed to intended use of the device because centrifugation, sample volume weight, and the horizontal orientation of the coverslip refer to the use of the claimed adaptor and not the structure of the claimed adaptor. Further, a coverslip is not positively recited and not part of the claimed adaptor. Therefore, it is maintained that Tian meets the limitation recited in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798