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 .
Response to Amendment
The Amendment filed 04/01/2026 has been entered. Claims 10-20 and 22 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 10/02/2025. New grounds of rejections necessitated by amendments are discussed below.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Europe on 03/23/2020. It is noted, however, that applicant has not filed a certified copy of the EP20164950.6 application as required by 37 CFR 1.55.
Claim Objections
Claim 14 is objected to because of the following informalities: In line 10, it is suggested to recite “the pump impeller” as “the impeller” for improved consistency of terminology. Appropriate correction is required.
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 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.
Regarding claim 14, claim 14 recites “a plurality of openings (1314) for receiving a pin” in line 3. It is unclear if the plurality of openings and pin of claim 14 is the same or different from the plurality of openings and pins established in claim 10.
Claim Rejections - 35 USC § 102
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.
Claims 10-11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by McGeehan (US 20120187082 A1; cited in the IDS filed 08/10/2023).
Regarding claim 10, McGeehan teaches a device (Figs. 3-4,6-7) to perform a cell based assay (interpreted as an intended use, see MPEP 2114; Fig. 7 shows a microtiter plate 60 with wells, which are structurally capable of being used to perform a cell based assay) comprising
a plurality of pins (Figs. 6-7, posts 62),
a pin support (Fig. 7, guide plate 54) comprising a plurality of openings (Fig. 7 shows one of a plurality of openings of guide plate 54 where element 62 is inserted through; Figs. 3-4 shows a guide plate with a plurality of openings 28) for receiving said plurality of pins (interpreted as an intended use, Figs. 6-7 shows the openings of guide plate 54 receives pins, i.e. posts 62) and
a base (Fig. 7, microtiter plate 60) comprising a groove channel (Fig. 7, interpreted as a well of the microtiter plate, which is structurally a groove channel of the plate),
wherein each of said plurality of pins (Figs. 6-7, posts 62) comprises a pin body (Figs. 6-7, body of post 62), and wherein said pin body comprises a pin tip (Figs. 6-7, interpreted as an end tip of post 62, such as the tip that includes pad 90).
Regarding claim 11, McGeehan further teaches wherein the pin support (Fig. 7, guide plate 54) and the base (Fig. 7, microtiter plate 60) have a matched shape (Fig. 7) and the openings (Fig. 7 shows one of a plurality of openings of guide plate 54 where element 62 is inserted through; Figs. 3-4 shows a guide plate with a plurality of openings 28) for receiving said plurality of pins (interpreted as an intended use, Fig. 7 shows the openings of guide plate 54 receives pins, i.e. posts 62) are arranged such that they are aligned with the groove channel of the base (Fig. 7).
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.
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.
Claims 10-12, 15-18, and 20 rejected under 35 U.S.C. 103 as being unpatentable over Reis et al. (US 20130029412 A1) in view of Asthana (US 20230002712 A1; effectively filed 11/25/2019).
Regarding claim 10, Reis teaches a device (Figs. 1-3; see below annotated Fig. 3) to perform a cell based assay (interpreted as an intended use, see MPEP 2114; Fig. 3 shows a container with wells, which is capable of being used to perform a cell based assay) comprising
a pin support (Figs. 2-3, interpreted as multiple holders 32) comprising a plurality of openings (Figs. 2-3 and paragraph [0055], interpreted as at least two of the openings 36; see below annotated Fig. 3) for receiving a plurality of pins (interpreted as an intended use, see MPEP 2114; Figs. 2-3, openings 36 are structurally capable of receiving pins at a later time) and a base (Figs. 1-3, carrier 12 comprising wells 14) comprising a groove channel (Fig. 3, interpreted as a channel of at least two wells 14 connected by channels 20 formed in the carrier 12, wherein the wells and channel are grooves or depressions within the carrier; see below annotated Fig. 3).
Reis fails to teach: a plurality of pins; wherein each of said plurality of pins comprises a pin body, and wherein said pin body comprises a pin tip.
Asthana teaches a microwell perfusion plate system including a plate and well on a plate (abstract; Fig. 1). Asthana teaches there is a need for an open, long-term culture system that provides robust control on the fluidic, biophysical and biochemical microenvironment and allows for multiple characterization and functional readouts in order to optimize critical factors that positively affect the differentiation, maturation, and function of organoids (paragraph [0003]). Asthana teaches at least one pump configured to deliver medium to the system and remove medium from the system (paragraph [0017]). Asthana teaches the system is connected to a pump via tubing that is fluidly coupled to the system (paragraph [0127]). Asthana teaches perfusion can improve long term viability and function of a culture sample of a culture platform (paragraph [0144]). Asthana teaches a plurality of pins (Fig. 18 and paragraph [0133] teaches tubes 350, 352, i.e. pins, for each well); wherein each of said plurality of pins comprises a pin body (Fig. 18 and paragraph [0133], body of tubes of each well), and wherein said pin body comprises a pin tip (Fig. 18 and paragraph [0133], bottom end tip of the tubes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Reis to incorporate the teachings of pumps and tubes, i.e. pins, to provide and control medium flow to a culture platform of Asthana (paragraphs [0017],[0127],[0144]) to provide: a plurality of pins; wherein each of said plurality of pins comprises a pin body, and wherein said pin body comprises a pin tip. Doing so would have a reasonable expectation of successfully improving control and optimization of a fluidic environment of the device to improve viability and function of a culture sample as discussed by Asthana (paragraphs [0003],[0144]).
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Annotated Fig. 3 of Reis.
Regarding claim 11, Reis further teaches wherein the pin support (Figs. 2-3, holder 32) and the base (Figs. 1-3, carrier 12 comprising wells 14) have a matched shape (Fig. 3 teaches holder 32 having a matched shape to the base 12, since the holder matches the shape of the wells 14 and channels 20; see above annotated Fig. 3) and the openings (Figs. 2-3 and paragraph [0055], openings 36) for receiving said plurality of pins (interpreted as an intended use, see MPEP 2114; Figs. 2-3, openings 36 are structurally capable of receiving pins at a later time) are arranged such that they are aligned with the groove channel of the base (Fig. 3 teaches the openings 36 of holder 32 aligning with the wells 14, i.e. groove channel, of the carrier 12; see above annotated Fig. 3).
Regarding claim 12, Reis further teaches wherein the pin support (Figs. 2-3, holder 32) further comprises an opening (see below annotated Fig. 3, interpreted as a different opening 36 of holder 32) for receiving a cell culture insert (interpreted as an intended use, see MPEP 2114; see below annotated Fig. 3; Fig. 2 shows opening 36 receives cell culture inserts 30; note that “cell culture insert” is not positively recited structurally) and the base further comprises a reservoir (see below annotated Fig. 3, interpreted as one of the well 14 of the carrier 12) for receiving a liquid (interpreted as an intended use, MPEP 2114; Fig. 3 shows well 14 is structurally capable of receiving liquid), wherein the reservoir is arranged within the base (see below annotated Fig. 3) such that it is aligned with the opening of the pin support for receiving the cell culture insert (see below annotated Fig. 3 showing one opening of the holder 32 is aligned with one well 14 of the base).
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Annotated Fig. 3 of Reis.
Regarding claim 15, Reis further teaches the device to perform the cell based assay of claim 10 further comprising a reservoir for receiving a liquid (see above annotated Fig. 3, interpreted as one of the well 14 of the carrier 12 which is capable of receiving a liquid; paragraphs [0057]-[0058] teach media supplied to the wells), wherein the groove channel (Fig. 3, interpreted as a channel of at least two wells 14 connected by channels 20 formed in the carrier 12, wherein the wells and channel are grooves or depressions within the carrier; see above annotated Fig. 3) is sized so as to receive the pin tips of said plurality of pins being secured in the openings of the pin support (interpreted as an intended use, see MPEP 2114; Figs. 2-3, openings 36 are sized to be structurally capable of receiving pin tips of pins secured in the openings at a later time), wherein the groove channel is connected to the reservoir (see above annotated Fig. 3, the two wells 14 connected by channels 20 is fluidly connected to the one of well 14).
Regarding claim 16, Reis further teaches wherein the pin support (Figs. 2-3, interpreted as multiple holders 32) and the base (Figs. 1-3, carrier 12 comprising wells 14) are separable parts of the device (Fig. 3; paragraphs [0036]-[0037]).
Regarding claim 17, Reis further teaches wherein the pin support (Figs. 2-3, interpreted as multiple holders 32) and the base (Figs. 1-3, carrier 12 comprising wells 14) are integrated as a single part (Fig. 3 shows the holders 32 being integrated or combined to the carrier 12 as a single part, i.e. a single attached and combined device).
Regarding claim 18, Reis further teaches wherein the base (Figs. 1-3, carrier 12 comprising wells 14) comprises more than one groove channel (Fig. 3 shows a plurality of parallel groups of groove channels).
Regarding claim 20, Reis further teaches wherein the groove channel (Fig. 3, interpreted as a channel of at least two wells 14 connected by channels 20 formed in the carrier 12, wherein the wells and channel are grooves or depressions within the carrier; see above annotated Fig. 3) is in a linear or circular arrangement in the base (see above annotated Fig. 3 shows the two wells 14 and channel 20 are in a linear arrangement in the carrier 12).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Reis in view of Asthana as applied to claim 12 above, and further in view of Greenfield et al. (US 5895762 A).
Regarding claim 13, Reis fails to teach wherein the device further comprises a pump comprising an impeller and an impeller shaft, which pump is in fluidic connection to the reservoir, to the groove channel and to the cell culture insert.
Asthana teaches a microwell perfusion plate system including a plate and well on a plate (abstract; Fig. 1). Asthana teaches there is a need for an open, long-term culture system that provides robust control on the fluidic, biophysical and biochemical microenvironment and allows for multiple characterization and functional readouts in order to optimize critical factors that positively affect the differentiation, maturation, and function of organoids (paragraph [0003]). Asthana teaches at least one pump configured to deliver medium to the system and remove medium from the system (paragraph [0017]). Asthana teaches the system is connected to a pump via tubing that is fluidly coupled to the system (paragraph [0127]). Asthana teaches perfusion can improve long term viability and function of a culture sample of a culture platform (paragraph [0144])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Reis to incorporate the teachings of pumps to provide and control medium flow to a culture platform of Asthana (paragraphs [0017],[0127],[0144]) to provide: the device further comprises a pump, which pump is in fluidic connection to the reservoir, to the groove channel and to the cell culture insert. Doing so would have a reasonable expectation of successfully improving control and optimization of a fluidic environment of the device to improve viability and function of a culture sample as discussed by Asthana (paragraphs [0003],[0144]).
Modified Reis fails to teach: the pump comprising an impeller and an impeller shaft.
Asthana teaches a pump can include a peristaltic pump (paragraphs [0127],[0180]).
Greenfield teaches a system for handing fluid samples via tubing and chambers (abstract). Greenfield teaches an internal hydraulic system consists of a reversible, peristaltic pump assembly including an impeller mounted to a shaft (column 4, lines 49-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pump of modified Reis to incorporate the teachings of a fluidic pump including an impeller and impeller shaft of Greenfield (column 4, lines 49-58) to provide: the pump comprising an impeller and an impeller shaft. Doing so would have a reasonable expectation of successfully allowing for controlled fluid handling.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. pump comprising an impeller and an impeller shaft) by known methods with no change in their respective functions (i.e. fluid handling), and the combinations yielded nothing more than predictable results (i.e. providing the pump comprising an impeller and an impeller shaft would yield nothing more than the obvious and predictable result of enabling fluid handling and control). See MPEP 2143(A).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Reis in view of Asthana and Greenfield as applied to claim 13 above, and further in view of Kiyama et al. (US 10087409 B2; cited in the IDS filed 11/06/2023).
Regarding claim 14, Reis further teaches wherein the pin support (Figs. 2-3, interpreted as multiple holders 32) comprises:
a plurality of openings (see above annotated Fig. 3, interpreted as two of the openings 36 of the holder 32) for receiving a pin (interpreted as an intended use, see MPEP 2114; Figs. 2-3, openings 36 are structurally capable of receiving a pin at a later time; note that “pin” is not positively recited structurally),
at least two openings (see above annotated Fig. 3, interpreted as a different two of the openings 36 of the holder 32) to receive at least two cell culture inserts (interpreted as an intended use, see MPEP 2114; Fig. 2 shows two opening 36 receives two cell culture inserts 30; note that “cell culture inserts” is not positively recited structurally),
the base comprises:
at least two reservoirs (see above annotated Fig. 3, interpreted as two of the wells 14 different from the groove channel wells) to receive a cell culture medium (interpreted as an intended use, see MPEP 2114; Fig. 3, wells 14 are structurally capable of receiving a cell culture medium),
an inlet channel (Fig. 3, one of the metering openings 22 which forms a channel) and
an outlet channel (Fig. 3, another one of the metering openings 22 which forms a channel),
wherein the inlet channel and the outlet channel are connected to the reservoir and the groove channel (Fig. 3 shows the channels of the metering openings 22 are fluidly connected to the wells 14 and channels 20).
Reis fails to teach the pin support comprises: at least one opening to receive the impeller shaft of the pump, and the base comprises: at least one opening to receive the pump impeller.
Kiyama teaches a cell culturing vessel for holding and culturing cells (abstract; Fig. 1B). Kiyama teaches the vessel (Fig. 1B, element 1) comprises a pin support (lid member 15) and a base (pressing member 6 and main vessel 2), wherein the pin support comprises openings configured to receive a pump (Fig. 1B shows elements 17-20 are inserted through openings of lid member 15) and the base comprises openings configured to receive the pump (Fig. 1B shows elements 19-20 are inserted through openings of element 6), and the channels or tubing of elements 17-20 are fluidly connected to the vessel (Fig. 1B). Kiyama teaches the cell culturing vessel are connected to ports 17-19 for supplying and discharging culture medium (column 6, lines 54-63). Kiyama teaches a controller comprising programming to automatically control the device, such as a pump to control liquid delivery and discharge to the vessel (column 11, lines 61-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pin support and the base to incorporate the teachings of a cell culturing vessel comprising various openings for coupling the vessel to a pump for controlling liquid delivery to the vessel of Kiyama (Fig. 1B; column 6, lines 54-63; column 11, lines 61-67) to provide: the pin support comprises: at least one opening to receive the impeller shaft of the pump, and the base comprises: at least one opening to receive the pump impeller. Doing so would have a reasonable expectation of successfully improving the ability of the device to be coupled with a pump, therefore improving delivery and discharge of desired fluids to the device for optimized cell culturing.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Reis in view of Asthana as applied to claim 15 above, and further in view of Li (US 20050101010 A1).
Regarding claim 19, Reis fails to teach wherein the groove channel has a stepwise shape comprising an upper part, a step and a lower part, wherein the upper part has a bigger dimension than the lower part.
Li teaches a cell co-culture tool comprising a base with groove channels (abstract; Figs. 2-5,10). Li teaches a need for cell culture systems to achieve cell co-culturing (paragraph [0006]). Li teaches an embodiment (Fig. 10) comprising a cell culture insert (1130) aligned with a groove channel (Fig. 10, interpreted as the well comprising element 1150 of cell culture tool 1000) and the groove channel has a stepwise shape comprising an upper part (1135), a step (1110) and a lower part (1120), wherein the upper part (1135) has a bigger dimension than the lower part (Fig. 10 shows the lower part 1120 has a smaller width than the upper part 1135). Li teaches other embodiments of a base with a groove channel having a stepwise shape (Figs. 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the groove channel of Reis to incorporate the teachings of a cell culture tool with a base having a groove channel with a stepwise shape of Li (Figs. 2-5 and 10) to provide: wherein the groove channel has a stepwise shape comprising an upper part, a step and a lower part, wherein the upper part has a bigger dimension than the lower part. Doing so would have a reasonable expectation of successfully improving culturing of cells in the device, such as achieving cell co-culturing as discussed by Li (paragraph [0006]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Reis in view of Asthana as applied to claim 10 above, and further in view of Murphy et al. (US 7842499 B2).
Regarding claim 22, Reis further teaches wherein the pin support and the base are made of plastic (paragraph [0043] teaches the container, i.e. base, and holder, i.e. pin support, are made of plastic).
Modified Reis fails to teach the said plurality of pins are made of plastic.
Murphy teaches devices for detecting and quantifying cells (column 1,lines 15-27). Murphy teaches composition of a reservoir and a delivery tube can be made of various materials including glass, polypropylene, polystyrene, and silicone (column 72, lines 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pins of modified Reis to incorporate the teachings of known materials such as plastic for a reservoir and tube of Murphy (column 72, lines 2-5)to provide: the said plurality of pins are made of plastic. Doing so would have a reasonable expectation of successfully allowing for delivery of fluids.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 04/01/2026, with respect to the claim objections and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112(b) of 10/02/2025 have been withdrawn.
Applicant's arguments, see page 7, filed 04/01/2026, with respect to the rejections under 35 U.S.C. 102(a)(1) and 102(a)(2) over McGeehan, have been fully considered but they are not persuasive.
In response to applicant’s arguments that McGeehan does not disclose a cell seeding system comprising a groove channel since McGeehan’s well does not read on the common definition of a groove of a “long narrow channel or depression” (Remarks, page 7), the examiner disagrees. McGeehan’s base (Fig. 7, microtiter plate 60) comprising a groove channel (Fig. 7, interpreted as a well 100 of the microtiter plate, which is structurally a groove channel of the plate). The well 100 shown in Fig. 7 is interpreted as a relatively long narrow channel or depression, and therefore reads on the claimed “groove channel”. Note that claim 10 does not further define the structural features of the groove channel. It is suggested to incorporate further limitations to the structures of the device, such as more structural detail to the groove channel to differentiate the claims from the prior art.
Applicant’s arguments, see pages 7-10, filed 04/01/2026, with respect to the rejection(s) of claims 10-12, 15-18, and 20-22 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Reis and the rejections of the dependent claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Reis et al. (US 20130029412 A1) in view of Asthana (US 20230002712 A1; effectively filed 11/25/2019).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Malin et al. (EP 1405919 A1) teaches a device (Fig. 4) to perform a cell based assay (abstract) comprising a pin support (Fig. 4, elements 22,12) comprising a plurality of openings (26) for receiving a pin (38) and a base (14) comprising a groove channel (interpreted as the well 16 of element 14, which is a depression or groove of the structure 14).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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