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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/21/2025 has been entered.
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.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 14 line 1 recites the limitation "the hinge portion". There is insufficient antecedent basis for this limitation in the claim. For prosecution, the limitation will be interpreted to mean claim 14 is interpreted to depend on claim 13.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 6, 8-10, 12-13, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Saqi et al (US20150289856A1 published 10/15/2015; hereinafter Saqi).
Regarding claim 1, Saqi teaches a medical apparatus comprising:
an elongated body (an elongate tubular body 110 – Fig. 2) having a proximal end (a proximal end 112 with a lid 130 – Fig. 2), a distal end (a distal end 114 with a filter assembly 120 – Fig. 2), and a longitudinal axis (a longitudinal axis along the center of the longitudinal axis – Fig. 2), and defining a loading chamber (a chamber in the elongate tubular body 110 – Fig. 2) between the proximal end and the distal end for storing a liquid therein (the elongate tubular body 110 is capable of storing liquid – Fig. 2), the elongated body defining an outlet at the distal end thereof (an opening at the distal end 114 by the filter assembly 120 – Fig. 2),
a cell block filter assembly (filter assembly 120 – Fig. 2 and paragraph 85) comprising
a cell block body (a removable second filter assembly 220 with a filter membrane 222 – Fig. 6 and paragraph 93) and defining a well portion matingly engageable with the distal end of the elongated body for receiving fluid from the outlet of the elongated body (the filter membrane 222 defining a volume inside of the second filter assembly 220 and engageable with the distal end 114 of the elongated body 110 – Fig. 6 and paragraph 93),
a filter membrane (a filter membrane 122 – Fig. 4);
a cover member positionable over the well portion (a bowl-like filter membrane 622 positionable over the filter membrane 222 – Fig. 13C and paragraph 107);
a base member (a base member 124 – Fig. 4) that secures the cell block at the distal end of the elongated body (the base member 124 is threaded 116 to the elongate tubular body 110 – Fig. 2 and paragraph 83), wherein the base member and the elongated body are configured such that an outer surface of the distal end of the elongated body engages with the base member to secure the cell block at the distal end of the elongated body (threads 116 on the outside of the distal end 114 engages the threads of the base member 124 – Fig. 2 and paragraph 83),
wherein the base member prevents the passage of fluid out of the cell block filter assembly (the base member 124 to securely engage the elongate tubular body 110 – paragraph 83 and Fig. 1), and
wherein the entire cell block filter assembly is sliceable into slices having a thickness suitable for mounting on a laboratory slide (the filter membrane's structural characteristics allow for a blade to slice through the membrane and base member – paragraph 89).
However, Saqi (Fig. 2) does not teach a cell block defining a well opening on a bottom thereof, and a filter disposed across the well opening on the bottom of the well portion.
Saqi (Fig. 20A) teaches a cell block defining a well opening on a bottom thereof (a housing 1124 of a filter assembly 1120 – paragraph 118 and Fig. 20A), and a filter disposed across the well opening on the bottom of the well portion (two filtration surfaces upper surface 1122 and lower surface 1123 disposed across the bottom of the housing 1124 – paragraph 118 and Fig. 20A). Saqi teaches to use the housing 1124 that directs a portion of the flow in a tangential direction to employs cross-flow filtration which increases the filtration surface area and thereby reduces the overall cycle time and minimize clogging (paragraph 118).
It would have been obvious to one of ordinary skill in the art before the effective filing date to replace the second filter assembly 220, as taught by Saqi (Fig. 2), with the housing 1124 and filter assembly 1120, taught by Saqi (Fig. 20A), in order to reduce the overall cycle time required for a desired amount of filtration and minimize clogging. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Saqi teaches different embodiments of the same invention.
Regarding claim 3, Saqi, modified by Saqi, teaches the medical apparatus of claim 1, wherein the base member is secured to the elongate body with a threaded engagement (the base member 124 is threaded 116 to the elongate tubular body 110 – Fig. 2 and paragraph 83).
Regarding claim 6, Saqi, modified by Saqi, teaches the medical apparatus of claim 1, wherein the cover member defines a cover opening (an opening in the shelf 612b of the bowl-like filter membrane 622 – Fig. 13C and paragraph 107), the cover further comprising a cover member filter membrane disposed across the cover opening (the filter membrane shelves 622a of the filter membrane 622 – Fig. 13C and paragraph 107).
Regarding claim 8, Saqi, modified by Saqi, teaches the medical apparatus of claim 1, wherein the distal end portion of the elongate body defines a smaller aperture than the proximal end to define a generally conical portion (the distal end 114 having a smaller aperture than the proximal end 112 of the elongate tubular body 110 and defines a section 118 with a generally conical distal section – Figs. 31A-D).
Regarding claim 9, Saqi, modified by Saqi, teaches the medical apparatus of claim 1, wherein the outlet is offset from the longitudinal axis of the elongated body (the housing 1124 of the filter assembly 1120 having a offset outlet – paragraph 118 and Fig. 20A).
Regarding claim 10, Saqi, modified by Saqi, teaches the medical apparatus of claim 1, further comprising a lid disposed on the proximal end of the elongate body (a lid 130 on the proximal end 112 – Figs. 1-2), the lid configured to engage the proximal end of the elongate body to form an airtight seal between the lid and the elongated body (The lid 130 can be configured with thread to engage threads 116 disposed on the proximal end 112 – Figs. 1-2).
Regarding claim 12, Saqi, modified by Saqi, teaches the medical apparatus of claim 10, wherein the outlet is sized to prevent fluid from flowing from the loading chamber when the elongated body is positioned such that the outlet and the fluid are disposed at a bottom portion of the elongated body (the outlet of the distal end 114 can be closed by the base member 124 to prevent fluid from flowing from the elongate tubular body 110 – paragraphs 136 and Figs. 31A-D).
Regarding claim 13, Saqi teaches a medical apparatus comprising:
an elongated body (an elongate tubular body 110 – Fig. 2) having a proximal end (a proximal end 112 – Fig. 2), a distal end (a distal end 114 – Fig. 2), and defining a loading chamber (a chamber in the elongate tubular body 110 between the proximal end and the distal end – Fig. 2) between the proximal end and the distal end for storing a liquid therein (the elongate tubular body 110 is capable of storing liquid – Fig. 2), the elongated body defining an outlet at the distal end thereof (an opening at the distal end 114 by the filter assembly 120 – Fig. 2),
a cell block filter assembly (filter assembly 120 – Fig. 2 and paragraph 85) comprising
a cell block body (a base member 124 – Fig. 4) and defining a well portion engageable with the distal end of the elongated body for receiving fluid from the outlet of the elongated body (the base member 124 defines an internal volume and is threaded 116 to the elongate tubular body 110 – Fig. 2 and paragraph 83),
a filter membrane disposed across the opening on the bottom of the well portion (a filter membrane 122 disposed over the base member – Fig. 4);
a cover member positionable over the well portion (a bowl-like filter membrane 622 positionable over the filter membrane 222 – Fig. 13C and paragraph 107); and
wherein the entire cell block filter assembly is sliceable into slices having a thickness suitable for mounting on a laboratory slide (the filter membrane's structural characteristics allow for a blade to slice through the membrane and base member – paragraph 89).
However, Saqi (Fig. 2) does not teach a cell block body defining an opening on a bottom thereof and a hinge portion for connecting the cover member to the cell block body, the hinge portion being configured such that the cover member is movable from a first position to a second position, wherein when in the second position, the cover member is positioned over the well portion.
Saqi (Figs. 24-25) teaches a cell block body defining an opening on a bottom thereof (a filtration membrane 2340 – Fig. 25-26) and a hinge portion (hinge 2415 – Fig. 24B and paragraph 122) for connecting the cover member to the cell block body (the hinge 2415 connecting the closing mechanism 2414 that secures the filtration membrane 2340 – Fig. 24A and paragraph 122), the hinge portion being configured such that the cover member is movable from a first position to a second position (the hinge 2415 allows the closing mechanism 2414 to be moved from an open position to a closed position – Fig. 24A-B), wherein when in the second position, the cover member is positioned over the well portion (in the closed position, the closing mechanism 2414 is positioned over a well in the filtration membrane 2340 – Fig. 25-26). Saqi teaches to use the filtration membrane 2340 with alternating peaks and valleys around its circumference to increase the surface area and provide greater stability and reliability during both the centrifuge step as well as the subsequent sectioning (i.e. cutting) (paragraph 123).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the base member, as taught by Saqi (Fig. 2), with the filtration membrane 2340, hinge 2415, and closing mechanism 2414, taught by Saqi (Fig. 24-26), to gain a filtration membrane 2340 to increase the surface area and provide greater stability and reliability during both the centrifuge step as well as the subsequent sectioning. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify because Saqi teaches different embodiments of the same invention.
Regarding claim 24, Saqi, modified by Saqi, teaches the medical apparatus of claim 13, wherein the liquid comprises cells therein (a system and method for preparing cells for diagnostic tests and procedures – paragraph 2).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Saqi, modified by Saqi, in view of Kaneko et al (WO2013073558A1 published 05/23/2013; hereinafter Kaneko).
Regarding claim 4, Saqi, modified by Saqi, teaches the medical apparatus of claim 1.
However, Saqi, modified by Saqi, teaches does not teach wherein the cell block body is fabricated substantially from LLDPE.
Kaneko teaches a filter and container for sample cells wherein the cell block body is fabricated substantially from LLDPE (the container made of a thermoplastic resin such as linear low density polyethylene LLDPE – page 6 last paragraph). Kaneko teaches that the container is preferably made of LLDPE for chemical resistance and moldability and not accompanied by odor (page 6 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Saqi as modified by Saqi, with LLDPE construction, as Kaneko, to gain chemical resistance and moldability and not accompanied by odor. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success of because Saqi and Kaneko teach containers for cell samples.
Regarding claim 5, Saqi, modified by Saqi, teaches the medical apparatus of claim 1.
However, Saqi, modified by Saqi, does not teach wherein the cover is fabricated substantially from LLDPE.
Kaneko teaches a filter and container for sample cells wherein the cover member is fabricated substantially from LLDPE (the container made of a thermoplastic resin such as linear low density polyethylene LLDPE – page 6 last paragraph). Kaneko teaches that the container is preferably made of LLDPE for chemical resistance and moldability and not accompanied by odor (page 6 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cap, as taught by Saqi as modified by Saqi, with LLDPE construction, as Kaneko, to gain chemical resistance and moldability and not accompanied by odor. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success of because Saqi and Kaneko teach containers for cell samples.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Saqi, modified by Saqi, in view of Shu et al (CN203079956U published 07/24/2013; hereinafter Shu).
Regarding claim 7, Saqi, modified by Saqi, teaches the medical apparatus of claim 1.
However, Saqi, modified by Saqi, does not teach wherein the filter membrane is fabricated substantially from ePTFE.
Shu teaches a tissue culture vessel wherein the filter membrane is fabricated substantially from ePTFE (PTFE bacterial filter membrane made from expanding and stretching low molecular weight PTFE resin – paragraph 8). Shu teaches that the PTFE bacterial filter membrane has a temperature resistance of 300˚C.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filter membrane, as taught by Saqi as modified by Saqi, with ePTFE filter membrane, taught by Shu, to gain the temperature resistance of 300˚C. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Saqi and Shu teach devices for cell processing.
Claims 11, 14-16, 19, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Saqi, modified by Saqi, in view of Clark et al (US20160228870A1 published 08/11/2016; hereinafter Clark).
Regarding claim 11, Saqi teaches the medical apparatus of claim 10.
However, Saqi does not teach where the lid is threadedly engaged with the elongated body with threads formed on the outer surface of the lid and threads formed on the inner surface of the proximal end of the elongated body.
Clark teaches a cell processing device wherein the lid is threadedly engaged with the elongated body with threads formed on an outer surface of the lid and threads formed on an inner surface of the proximal end of the elongated body (base cap 16 with outside threads and a body 12 with internal threads 6 – Fig. 1B). Clark further teaches that the base cap 16 is used with an O-ring 22 to positive tactile feedback to the user that the base cap 16 is fully engaged (paragraph 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cap and elongate body, as taught by Saqi (Fig. 2) as modified by Saqi (Fig. 20A), with the threads and O-ring, taught by Clark, to gain positive tactile feedback to the user that the cap is fully engaged. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Saqi and Clark teach devices for cell processing.
Regarding claim 14, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11.
However, Saqi, as modified by Saqi modified by Clark, does not teach wherein the hinge portion for connecting the cover member to the cell block body is a "living hinge".
Saqi teaches another embodiment wherein the hinge portion for connecting the cover member to the cell block body is a "living hinge" hinge portion (hinge 2415 – Fig. 24B and paragraph 122) for connecting the cover member to the cell block body (the hinge 2415 connecting the closing mechanism 2414 that secures the filtration membrane 2340 – Fig. 24A and paragraph 122). Saqi teaches to use the living hinge with a locking mechanism 2416 on the distal end of the elongate tubular body 2320 in order to secure the closing mechanism 2414 in the closed position and retain the filter membrane 2340 (paragraph 122).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the second filter assembly 220, as taught by Saqi (Fig. 2) as modified by Saqi (Fig. 20A) modified by Clark, with the living hinge and locking mechanism, taught by Saqi (Figs. 24-25), to secure the post filtration cap in the closed position and retain the filter membrane/assembly. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Saqi teaches different embodiments of the same invention.
Regarding claim 15, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11, further comprising a base member (a base member 124 – Fig. 4) for securing the cell block filter assembly at the distal end of the elongate body (the base member 124 is threaded 116 to the elongate tubular body 110 – Fig. 2 and paragraph 83), and wherein the outer surface of the distal end of the elongate body is configured to engage with the base member (threads 116 on the outside of the distal end 114 engages the threads of the base member 124 – Fig. 2 and paragraph 83).
Regarding claim 16, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 15, wherein the base member is secured to the elongate body with threaded engagement (the base member 124 is threaded 116 to the elongate tubular body 110 – Fig. 2 and paragraph 83), friction fit, or a ratchet engagement.
Regarding claim 19, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11, wherein the cover member defines a cover opening (an opening in the shelf 612b of the bowl-like filter membrane 622 – Fig. 13C and paragraph 107), the cover further comprising a cover member filter membrane disposed across the cover opening (the filter membrane shelves 622a of the filter membrane 622 – Fig. 13C and paragraph 107).
Regarding claim 21, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11, wherein the distal end portion of the elongate body defines a smaller aperture than the proximal end to define a generally conical portion (the distal end 114 having a smaller aperture than the proximal end 112 of the elongate tubular body 110 and defines a section 118 with a generally conical distal section – Figs. 31A-D).
Regarding claim 22, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11, wherein the outlet is offset from the longitudinal axis of the elongated body (the housing 1124 of the filter assembly 1120 having a offset outlet – paragraph 118 and Fig. 20A).
Regarding claim 23, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11, wherein the outlet is sized to prevent fluid from flowing from the loading chamber when the elongated body is positioned such that the outlet and the fluid are disposed at a bottom portion of the elongated body (the outlet of the distal end 114 can be closed by the base member 124 to prevent fluid from flowing from the elongate tubular body 110 – paragraphs 136 and Figs. 31A-D).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Saqi, as modified by Saqi modified by Clark, in view of Kaneko.
Regarding claim 17, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11.
However, Saqi, as modified by Saqi modified by Clark, does not teach wherein the cell block body is fabricated substantially from LLDPE.
Kaneko teaches a filter and container for sample cells wherein the cell block body is fabricated substantially from LLDPE (the container made of a thermoplastic resin such as linear low density polyethylene LLDPE – page 6 last paragraph). Kaneko teaches that the container is preferably made of LLDPE for chemical resistance and moldability and not accompanied by odor (page 6 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Saqi as muddied by Saqi modified by Clark, with LLDPE construction, as Kaneko, to gain chemical resistance and moldability and not accompanied by odor. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success of because Saqi and Kaneko teach containers for cell samples.
Regarding claim 18, Saqi, as modified by Saqi modified by Clark, the medical apparatus of claim 11.
However, Saqi, as modified by Saqi modified by Clark, does not teach wherein the cover member is fabricated substantially from LLDPE.
Kaneko teaches a filter and container for sample cells wherein the cover member is fabricated substantially from LLDPE (the container made of a thermoplastic resin such as linear low density polyethylene LLDPE – page 6 last paragraph). Kaneko teaches that the container is preferably made of LLDPE for chemical resistance and moldability and not accompanied by odor (page 6 last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cap, as taught by Saqi as modified by Saqi modified by Clark, with LLDPE construction, as Kaneko, to gain chemical resistance and moldability and not accompanied by odor. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success of because Saqi and Kaneko teach containers for cell samples.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Saqi, as modified by Saqi modified by Clark, in view of Shu.
Regarding claim 20, Saqi, as modified by Saqi modified by Clark, teaches the medical apparatus of claim 11.
However, Saqi, as modified by Saqi modified by Clark, does not teach wherein the filter membrane is fabricated substantially from ePTFE.
Shu teaches a tissue culture vessel wherein the filter membrane is fabricated substantially from ePTFE (PTFE bacterial filter membrane made from expanding and stretching low molecular weight PTFE resin – paragraph 8). Shu teaches that the PTFE bacterial filter membrane has a temperature resistance of 300˚C.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filter membrane, as taught by Saqi as modified by Sai modified by Clark, with ePTFE filter membrane, taught by Shu, to gain the temperature resistance of 300˚C. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Saqi, Clark, and Shu teach devices for cell processing.
Response to Arguments
Applicant’s addition arguments with respect to the 102/103 rejections of the claims have been considered, and the prior art rejection has been modified in order to address the amended claim language.
Point 1: The applicant’s argument that the office does not identify in the cited art disclosure of "a base member that secures the cell block at the distal end of the elongated body, wherein the base member and the elongated body are configured such that an outer surface of the distal end of the elongated body engages with the base member to secure the cell block at the distal end of the elongated body" is not persuasive.
The examiner points out that Saqi (Fig.2) teaches a base member (a base member 124 – Fig. 4) that secures the cell block at the distal end of the elongated body (the base member 124 is threaded 116 to the elongate tubular body 110 – Fig. 2 and paragraph 83), wherein the base member and the elongated body are configured such that an outer surface of the distal end of the elongated body engages with the base member to secure the cell block at the distal end of the elongated body (threads 116 on the outside of the distal end 114 engages the threads of the base member 124 – Fig. 2 and paragraph 83).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796