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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/29/2026 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 28 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 28 recites “the outlet wall” and there is insufficient antecedent basis for this limitation in the claim. For prosecution, the limitation will be interpreted as a typo for “outlet well”.
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.
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 1-4, 6-7, 9, 11, 13-15, 18, 20-21, 23-24, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dodgson (US20070264705A1 published 11/15/2007).
Regarding claim 1, Dodgson teaches a device for supporting development of a cellular deposit comprising at least one cell or tissue derived from an ovary (an improved apparatus for handling cellular entities such as cells, oocytes and embryos – Fig. 4e-g and paragraph 5), the device comprising:
an inlet well (an inlet well 68 – Fig. 4f-i and paragraph 53), an outlet well (a second well 54 of a first pair of first and second wells – Fig. 4f), and an enclosed culture chamber disposed between the inlet well and the outlet well (a first well 50 of the first pair of first and second wells and located between the inlet well 68 and the second well 54 – Fig. 4f);
an inlet channel fluidly coupling the inlet well to the culture chamber (an inlet channel 64 – Fig. 4f), wherein a lower wall of the inlet well is in line with a lower wall of the inlet channel (a lower wall of the inlet port 68 is in line with a bottom of the inlet channel 64 – Fig. 4f);
at least one outlet channel fluidly coupling the culture chamber to the outlet well (a channel 52 coupling the first well 50 to the second well 54 – Fig. 4f), wherein a lower wall of the culture chamber is in line with a lower wall of each of the at least one outlet channel (a lower wall of the first well 50 is in line with a lower wall of the channel 52 – Fig.4f);
wherein a height and/or width of the at least one outlet channel is less than a threshold value (the height of the channel 52 is less than a threshold value – Figs. 4f-g), the threshold value being equal to a dimension of a cellular deposit (the threshold value being equal to a dimension of a cellular entity 14 – Figs. 4f-g) (“a dimension of a cellular deposit” is deemed to be a material worked upon by the apparatus and per MPEP 2115 material or article worked upon by a structure being claimed does not impart patentability to the claims) such that the at least one outlet channel is sized to prevent passage of the cellular deposit therethrough (the channel 52 is sized to prevent passage of the cellular deposit – Figs. 4f-g) (The diameter is based on the type of sample, and an ovarian tissue sample can be selected and used with the apparatus to meet these size parameters), wherein the cellular deposit comprises at least one cell or tissue derived from an ovary selected from an oocyte, an ovarian follicle, and ovarian tissue, an embryo at the zygote stage, an embryo at the cleavage stage, and an embryo at the morula stage (an improved apparatus for handling cellular entities such as cells, oocytes and embryos – Fig. 4e-g and paragraph 5) (“a cell or tissue derived from an ovary” is deemed to be a material worked upon by the apparatus and per MPEP 2115 material or article worked upon by a structure being claimed does not impart patentability to the claims), and
wherein a smallest cross-sectional dimension of the inlet channel is above the threshold value (a height of the inlet channel 64 is above the size of the cellular entity 14 – Fig. 4f), the inlet channel being sized to allow passage of a developed material therethrough to allow retrieval of the developed material from the device (the cellular entity 14 is capable of pass a portion of the inlet channel 64 above the first well 50 – Figs. 4f-g), the developed material being an embryo at the cleavage stage, the morula stage, or the blastocyst stage developed from the cellular deposit (an improved apparatus for handling cellular entities such as cells, oocytes and embryos – Fig. 4e-g and paragraph 5) (“the developed material being an embryo at the cleavage stage, the morula stage, or the blastocyst stage” is deemed to be a material worked upon by the apparatus and per MPEP 2115 material or article worked upon by a structure being claimed does not impart patentability to the claims).
Regarding claim 2, Dodgson teaches the device according to claim 1, wherein the inlet channel is configured for flow of fluid by capillary action between the inlet well and the culture chamber (the inlet channel 64 is capable of being used for flow of fluid by capillary action – Figs. 4f-g).
Regarding claim 3, Dodgson teaches the device according to claim 1, wherein each of the at least one outlet channel is configured for flow of fluid by capillary action between the culture chamber and the outlet well (the channel 52 is capable of being used for flow of fluid by capillary action – Figs. 4f-g).
Regarding claim 4, Dodgson teaches the device according to claim 1, wherein the inlet channel extends from a lower portion of the inlet well to an upper portion of the culture chamber (the inlet channel 64 extends from a lower portion of the inlet well 68 and to an upper portion of the first well 50 – Figs. 4f-i and paragraph 53).
Regarding claim 6, Dodgson teaches the device according to claim 1, wherein an upper wall of the inlet channel is in line with an upper wall of the culture chamber (an upper wall of the inlet channel 64 is in line with an upper wall of the first well 50 – Figs. 4f-g).
Regarding claim 7, Dodgson teaches the device according to claim 1, wherein each of the at least one outlet channel extends from a lower portion of the culture chamber to a lower portion of the outlet well (the channel 52 extends from a lower portion of the first well 50 – Figs. 4f-g).
Regarding claim 9, Dodgson teaches the device according to claim 1, wherein the lower wall of each of the at least one outlet channel is in line with a lower wall of the outlet well (the lower wall of the channel 52 is in line with a lower wall of the first well 50 – Figs. 4f-g).
Regarding claim 11, Dodgson teaches the device according to claim 1, wherein the height and/or the width of each of the at least one outlet channel is less than or equal to 50% of the diameter of the cellular deposit (The diameter is based on the type of sample, and an ovarian tissue sample can be selected such that the height and/or the width of the channel 52 is less than or equal to 50% of the diameter of the ovarian tissue sample – Figs. 4f-g).
Regarding claim 13, Dodgson teaches the device according to claim 1, wherein the smallest cross-sectional dimension of the inlet channel is at least 1.5 times larger than the diameter of the developed material (The diameter is based on the type of sample, and an ovarian tissue sample can be selected such that the smallest cross-sectional dimension of the inlet channel 64 is at least 1.5 times larger than the diameter of the ovarian tissue sample – Figs. 4f-g).
Regarding claim 14, Dodgson teaches the device according to claim 1, wherein the culture chamber is substantially circular, oval or elliptical in shape and has a constant height (the first well 50 is substantially circular and has a constant height – Figs. 4e-g).
Regarding claim 15, Dodgson teaches the device according to claim 1, wherein a diameter or width of the culture chamber is greater than or equal to a width of the inlet channel (a diameter or width of the first chamber is greater than or equal to a width of the inlet channel 64 – Figs. 4e-g).
Regarding claim 18, Dodgson teaches the device according to claim 1, wherein the inlet well comprises an inclined lower portion (the inlet channel 64 having a inclined lower portion – Figs. 4), wherein the inclined lower portion is inclined towards the opening of the inlet channel at an angle between 0 and 90 degrees (the inclined lower portion is inclined at 0 degrees – Figs. 4f).
Regarding claim 20, Dodgson teaches the device according to claim 1, comprising a plurality of outlet channels (a plurality of channels 52 between each pair of first and second wells – paragraph 52 and Figs. 4e-f).
Regarding claim 21, Dodgson teaches the device according to claim 20, wherein the plurality of outlet channels each extend substantially in parallel between the culture chamber and the outlet well (the plurality of channels 52 are all in parallel between the first well and the second well – paragraph 52 and Fig. 4e).
Regarding claim 23, Dodgson teaches the device according to claim 20, wherein each of the plurality of outlet channels have equal volume (the plurality of channels 52 are the same and therefore have equal volume – paragraph 52 and Figs. 4e-f).
Regarding claim 24, Dodgson teaches the device according to claim 1, further comprising a reservoir (a first well 50 of a second pair of wells connected to the second well 54 via channels 76 – Fig. 4e and paragraph 52) defined between an outer wall of the device and an inner wall spaced apart from the outer wall (the first well 50 of a second pair of wells is defined between an outer wall and inner wall of the apparatus – Fig. 4e), wherein the reservoir extends around the inlet well, outlet well, culture chamber, inlet channel and at least one outlet channel and is configured to retain a volume of fluid therein (the first well 50 of a second pair of wells extends close to the inlet well 68, second well 54, first well 50, inlet channel 64, channel 52 and is capable of retaining a fluid – Fig. 4e).
Regarding claim 28, Dodgson teaches the device according to claim 1, wherein the device comprises a plurality of outlet channels (a plurality of channels 52 between each pair of first and second wells – paragraph 52 and Figs. 4e-f), wherein each outlet channel of the plurality of outlet channels couples the culture chamber to the outlet wall (each of the plurality of channels 52 is connected to the second well 54 of the first pair of first and second wells in series - Figs. 4e-f).
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 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dodgson in view of Qin et al (US20180071736A1 published 03/15/2018; hereinafter Qin).
Regarding claim 16, Dodgson teaches the device according to claim 1.
However, Dodgson does not teach wherein the culture chamber has a volume from about 3nL to about 100µL .
Qin teaches a microfluidic aliquot chip for isolating cells wherein the culture chamber has a volume from about 3nL to about 100µL (inlet well has a volume of 3-5 μL – paragraph 120). Qin teaches to use the inlet well to enable a user to load a cell suspension through the top of the chip (paragraph 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the volume of the first well, as taught by Dodgson, with the volume of 3-5 μL, taught by Qin, to enable a user to load a cell suspension through the top of the chip. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dodgson and Qin teach microfluidic devices for manipulating cells.
Regarding claim 17, Dodgson teaches the device according to claim 1.
However, Dodgson does not teach wherein the inlet well and the outlet well each have a volume from about 2 µL to about 20 µL.
Qin teaches a microfluidic aliquot chip for isolating cells wherein the inlet well and the outlet well each have a volume from about 2µL to about 20µL (inlet well having a diameter of 2-4 mm and a volume of 3-5 μL – paragraph 28) (A plurality of side outlet wells have a diameter of 1.5-2 mm and a volume of 1-3 μL). Qin teaches that the chip is designed to increase the space between two neighboring channels around the center inlet well while maintaining uniform liquid distribution from the center inlet well to the outlet wells (paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the volume of the inlet well 68 and second well 54, as taught by Dodgson, with the dimensions and volumes, taught by Qin, to increase the space between two neighboring channels around the center inlet well while maintaining uniform liquid distribution. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dodgson and Qin teach microfluidic devices for manipulating cells.
Regarding claim 19, Dodgson teaches the device according to claim 1
However, Dodgson does not teach wherein the inlet channel has a volume substantially equal to a total volume of the at least one outlet channel.
Qin teaches a microfluidic aliquot chip for isolating cells wherein the inlet channel has a volume substantially equal to a total volume of the at least one outlet channel (A plurality of branched channels have a width of 50-100 μm – paragraph 28). Qin teaches that the chip is designed to increase the space between two neighboring channels around the center inlet well while maintaining uniform liquid distribution from the center inlet well to the outlet wells (paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the volume of the inlet channel 64 and the channel 52, as taught by Dodgson, with the dimensions and volumes, taught by Qin, to increase the space between two neighboring channels around the center inlet well while maintaining uniform liquid distribution. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dodgson and Qin teach microfluidic devices for manipulating cells.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Dodgson in view of Van Noort et al (US20110269226A1 published 11/03/2011; hereinafter Van Noort).
Regarding claim 22, Dodgson teaches the device according to claim 20.
However, Dodgson does not teach wherein at least one of the plurality of outlet channels has a different volume compared to another one of the plurality of outlet channels.
Van teaches a microfluidic continuous flow device for culturing biological material (Fig. 1-2) wherein at least one of the plurality of outlet channels (one of the outlet channels 33 – Fig. 2) has a different volume compared to another one of the plurality of outlet channels (one of the outlet channels 23 connected to a cultivation chamber 18 – Van Fig. 1) (the outlet channel 33 having a different volume compared to the outlet channel 23 because the outlet channel 33 is longer – Fig. 2 and paragraph 35). Van also teaches that the multiple inlet and outlet arrayment of the cultivation chamber serves to distribute the medium in the cultivation chamber more evenly (paragraph 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the channel 52, as taught by Dodgson, with the multiple inlet and outlet arrayment, taught by Van, to distribute the medium in the cultivation chamber more evenly. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success Dodgson and Van teach microfluidic devices for culturing biological material.
Response to Arguments
Applicant’s addition arguments with respect to the 102/103 rejections of the claims have been considered, and a new prior art rejection has been made in order to address the amended claim language.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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