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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in provisional Application No. PCT/CA2019/050859, filed on 06/19/2018.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "module" in claim 1, 6, 8, 10, 13, 15, 18, 45.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The term “about” in claim 3, 8, and 47 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examiner is unsure what the limitations are for claim 3, due to the relative term about. "About 30-90%" is indefin.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1-3, 6, 8, 10, 13, 15-18, 45-47, 51-54, 57-59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pebay (US 20180282682 A1), in view of Tanabe (US 20190338237 A1), and further view of Noggle (US 20150166964 A1).
Regarding claims 1 and 45, Pebay discloses An automated system for adaptively passaging a culture of cells in a cell culture medium within a cell culture vessel, the automated system comprising ([0006] The present invention provides an automated system for maintaining, passaging and differentiating cells, particularly stem cells and most particularly induced pluripotent stem cells (iPSCs).):
an imaging module for capturing one or more images of the culture of cells at a first time point and at one or more subsequent time points ([0034] FIG. 2 shows stem cell maintenance using the automated laboratory automation platform. (A-F) Maintenance of cells post-TRA-1-60 selection. Representative images of colonies post-TRA-1-60 sorting, immunostained for OCT-4 (A) or TRA-1-60 (D) with DAPI counterstained (B, E) and merged (C, F). (G-L) Passaging. Representative bright field (G-I) and fluorescent (J-L) images of undifferentiated iPSCs after passage 1 (G), 3 (H) and 4 (I) and immunostained for OCT-4 and TRA-1-60 at passage 4 (J) with DAPI counterstained (K) and merged (L).);
a pipette module having one or more pipettes for drawing a fluid from the cell culture vessel through a pipette tip mateable with an end of the one or more pipettes ([0078] The arm may be a robotic arm that includes at least one pipetting channel to pipette and dispense solutions to and from the culture plate.);
a liquid dispenser module spaced apart from the pipette module, the liquid dispenser module in fluid communication with more than one solution reservoir ([0042] a liquid handling system which interacts with the disposable tip carrier and the receptacle to controllably and sterilely dispense to and remove solution from the culture plate such that the solution is sterilely dispensed without dispersion outside the stem cell culture and removed at a predetermined volume);
a handling module having a pair of opposable arms for gripping and transporting the cell culture vessel or a lid thereof or a daughter cell culture vessel or a lid thereof within the automated system ([0031] fig. 1a: (3) robotic liquid handling arm; (4) manipulator arm; and [0043] a controlling system to automate and program any one of the manipulator arm, the platform and the liquid handling system such that the liquid handling system controllably and sterilely dispenses and removes individual aliquots of medium to and from the culture plate before the manipulator arm optionally returns the culture plate to the housing.), and
at least one processor in communication with the imaging module, the pipette module, the liquid dispenser and the handling module, the processor configured to (fig 1a: ref 14 (computer)):
receive the one or more images from the imaging module ([0034] FIG. 2 shows stem cell maintenance using the automated laboratory automation platform. (A-F) Maintenance of cells post-TRA-1-60 selection. Representative images of colonies post-TRA-1-60 sorting, immunostained for OCT-4 (A) or TRA-1-60 (D) with DAPI counterstained (B, E) and merged (C, F). (G-L) Passaging.);
execute an automated passaging protocol to passage the culture of cells, the protocol including coordinating operation of the pipette module, the liquid dispenser module and the imaging module based on comparing the calculated one or more characteristics of the culture of cells to ([0096] there is provided an automated system for sterile passaging of cells, said system comprising: [0097] a platform for receiving and moving a cell culture plate from a housing; [0098] a manipulator arm for moving the culture plate between the housing and the platform and placing the culture plate on the platform; [0099] a receptacle for containing a sterile solution or a cell releasing solution to be dispensed sterilely to the culture plate; [0100] a disposable tip carrier for providing sterile disposable tips for dispensing the solution or a cell releasing solution from the receptacle to the culture plate; [0101] a liquid handling system which interacts with the disposable tip carrier, and the receptacle to controllably and sterilely dispense to and remove solution and the cell releasing solution from the culture plate such that the solution or the cell releasing solution is sterilely dispensed without dispersion outside the stem cell culture and removed at a predetermined volume):
a) a learned threshold level for the one or more characteristics ([0109] Depending on the size of the culture plate and the volume of cell releasing solution used, the predetermined angle for a predetermined number of times sufficient to spread the cell releasing solution over the cell culture can be determined.). Pebay does not disclose b) an inputted threshold level for the one or more characteristics.
In a similar field of endeavor of stem cell production, Tanabe teaches b) an inputted threshold level for the one or more characteristics ([0270] Moreover, the density calculating unit 514 may output a timing for transfer to the amplifying culturing, when the cell mass density has reached at least at prescribed threshold value.).
It would have been obvious to one of ordinary skill in the art to combine Pebay’s disclosure with Tanabe’s teaching in order to provide a stem cell production system that allows production of stem cells that has a low cost with good production ([0006], [0007] and [0010]). Pebay and Tanabe do not disclose or teach based on the one or more images received from the imaging module, calculate one or more characteristics of the culture of cells.
In a similar field of endeavor of stem cell production, Noggle teaches based on the one or more images received from the imaging module, calculate one or more characteristics of the culture of cells ([0010] (a) culturing multiple different cell samples, (b) determining, or obtaining information regarding, one or more characteristics or properties of individual samples from among the multiple different cell samples (or of the donor/subject from which such samples were obtained)).
It would have been obvious to one of ordinary skill in the art to combine Pebay and Tanabe’s disclosure with Noggle’s teaching in order to create an automated system for rapidly producing and isolating reproducible iPSC cell lines under standard conditions ([0007]).
Regarding claims 2 and 46, Pebay and Tanabe do not teach or disclose wherein the one or more characteristics includes:
a) a measure of a confluence of the culture of cells;
b) a measure of a morphology of cells or colonies of the culture of cells;
c) a measure of differentiation of cells or colonies of the culture of cells;
d) a measure of colony size distribution of the culture of cells;
e) a measure of the change of a), b), c), or d) from the first time point to the one or more subsequent time points; or
f) a measure of a) relative to b), c) or d), a measure of b) relative to a), c), or d), a measure of c) relative to a), b), or d), or a measure of d) relative a), b), or c).
In a similar field of endeavor of stem cell production, Noggle wherein the one or more characteristics includes:
a) a measure of a confluence of the culture of cells ([0047] Confluence measurements (ii) and Hoechst stained nuclei (iii) are compared against each other to generate a regression model (iv) for calculating count values from unstained samples with confluence measurements);
b) a measure of a morphology of cells or colonies of the culture of cells;
c) a measure of differentiation of cells or colonies of the culture of cells;
d) a measure of colony size distribution of the culture of cells;
e) a measure of the change of a), b), c), or d) from the first time point to the one or more subsequent time points; or
f) a measure of a) relative to b), c) or d), a measure of b) relative to a), c), or d), a measure of c) relative to a), b), or d), or a measure of d) relative a), b), or c).
It would have been obvious to one of ordinary skill in the art to combine Pebay and Tanabe’s disclosure with Noggle’s teaching in order to create an automated system for rapidly producing and isolating reproducible iPSC cell lines under standard conditions ([0007]).
Regarding claims 3 and 47, Pebay and Tanabe do not disclose but Noggle teaches wherein the learned or the inputted threshold level is:
i. for a), between about 30-90% for cell or colony confluence ([0425] Automated methods were used to perform daily feeding and imaging of consolidated iPS cell lines using Freedom medium. Upon reaching 70-90% confluence, the cell were passaged using Accutase (Life Technologies, #A11105-01).);
ii. for b), between about ±30% of a control culture;
iii. for c), between about 0 to 30% of a control culture in a maintenance protocol or between about 50% to 100% of a control culture in a differentiation protocol; or
iv. for d), within about 15% of a mean colony size distribution of a control culture, or a subfraction thereof.
It would have been obvious to one of ordinary skill in the art to combine Pebay and Tanabe’s disclosure with Noggle’s teaching in order to create an automated system for rapidly producing and isolating reproducible iPSC cell lines under standard conditions ([0007]).
Regarding claim 6, Pebay discloses further comprising a stage module for supporting the cell culture vessel, the stage module movable in a first plane along a first axis or a second axis, or both ([0059] The platform is moveable preferably by tilting, shaking, rotating or any combination thereof. The shaking and rotating movements may be attained by the use of a plate vortex shaker as the platform or an orbital shaker attached to the platform. The role of the platform is to enable suitable movement to ensure that the solutions that are delivered to the culture plates are sufficiently moved around in the culture wells so as to spread the solution over the cells and to tilt the plate so that the solutions pool to enable aspiration of the solutions from the culture plate.).
Regarding claim 8, Pebay discloses wherein the stage module or a subcomponent thereof pivots about an edge thereof along a third axis ([0059] The platform is moveable preferably by tilting, shaking, rotating or any combination thereof. The shaking and rotating movements may be attained by the use of a plate vortex shaker as the platform or an orbital shaker attached to the platform. The role of the platform is to enable suitable movement to ensure that the solutions that are delivered to the culture plates are sufficiently moved around in the culture wells so as to spread the solution over the cells and to tilt the plate so that the solutions pool to enable aspiration of the solutions from the culture plate.).
Regarding claim 10, Pebay discloses wherein the liquid dispensing module includes more than one conduits and each conduit is in fluid communication with a separate one of the more than one solution reservoirs ("[0103] The automated system of the present invention may be used to maintain cell lines by ensuring passage of the confluent cultures. Cell cultures may be removed automatically from the incubator and the cells detached from the cultures and seeded to a new culture plate all via the automated system of the present invention.
[0104] This may be achieved by incorporating an additional dispenser or be incorporated into the liquid handling system to dispense a cell releasing solution from a reservoir such as but not limited to ethylenediaminetetraacetic acid (EDTA), trypsin, ReLeSR™ Trypsin-EDTA, TrypLE™ Express, TrypLE™ Select, Collagenase, Dispase, Phosphate Buffered Saline, Accutase™, Accumax™, Cell dissociation solution (Sigma-Aldrich), Cell dissociation buffer (Thermofisher).").
Regarding claim 13, Pebay discloses further comprising an enclosure to house at least the imaging module, pipette module, liquid dispenser module, stage module, and handling module (fig 1a and [0046] The system may comprise at least a platform, a manipulator arm, housing, a receptacle, a disposable tip carrier, a liquid handling system and a controlling system.).
Regarding claim 15, Pebay does not disclose but Tanabe teaches further comprising a refrigeration module to store one or more of the more than one solution reservoirs and a waste reservoir, wherein the more than one solution reservoirs, the refrigeration module and the waste reservoir are external of the enclosure ([0094] the suspension culture vessel of the initializing culturing apparatus and the suspension culture vessel of the amplifying culturing apparatus inside the case, and a culture medium storing unit that stores culture medium outside the case, may be connected. AND [0095] and a waste liquid storage section that stores waste liquid outside the case, may be connected. AND [0098] the solution exchanger inside the case and a cryopreservation liquid storing device that stores cryopreservation liquid outside the case, may be connected.).
It would have been obvious to one of ordinary skill in the art to combine Pebay’s disclosure with Tanabe’s teaching in order to provide a stem cell production system that allows production of stem cells that has a low cost with good production ([0006], [0007] and [0010]).
Regarding claim 16, Pebay does not disclose but Tanabe teaches wherein the waste reservoir is in fluid communication with a waste trough within the enclosure ([0345] The used culture medium in the initializing culturing vessel 219 is sent to a waste liquid storage section 228 through a waste liquid solution-feeding channel 226 and pump 227. An identifier such as a barcode is attached to the waste liquid storage section 228 for control of the waste liquid information.).
It would have been obvious to one of ordinary skill in the art to combine Pebay’s disclosure with Tanabe’s teaching in order to provide a stem cell production system that allows production of stem cells that has a low cost with good production ([0006], [0007] and [0010]).
Regarding claim 17, Pebay does not disclose but Tanabe teaches wherein the waste trough is coated with a hydrophobic coating ([0215] The inner wall of the preintroduction cell solution-feeding channel 20 may be coated with poly-HEMA (poly 2-hydroxyethyl methacrylate) to render it non-cell-adherent, so that the cells do not adhere.).
It would have been obvious to one of ordinary skill in the art to combine Pebay’s disclosure with Tanabe’s teaching in order to provide a stem cell production system that allows production of stem cells that has a low cost with good production ([0006], [0007] and [0010]).
Regarding claim 18, Pebay does not disclose but Tanabe teaches further comprising one or more sensors, wherein the one or more sensors are configured to i) detect and report on a mass of a load on the imaging module, on the stage module, or in the more than one solution reservoirs ([0104] In the stem cell production system described above, the image processor may calculate the sizes of the extracted cell masses.), trigger an alert when the mass of the load is different than expected ([0266] Consequently, the cell evaluating unit 512 may emit an alert when the individual cell mass sizes are outside of the suitable range).
It would have been obvious to one of ordinary skill in the art to combine Pebay’s disclosure with Tanabe’s teaching in order to provide a stem cell production system that allows production of stem cells that has a low cost with good production ([0006], [0007] and [0010]).
Regarding claim 51, Pebay and Tanabe do not disclose but Noggle teaches further comprising obtaining a suspension of cells from the culture of cells and seeding some or all of the suspension of cells in a daughter cell culture vessel ([0438] The cell counts were auto-exported with the liquid handling software automatically calculating the exact volume of cell suspension required for transfer into daughter wells of a 24 well plate (Corning, #3526).).
It would have been obvious to one of ordinary skill in the art to combine Pebay and Tanabe’s disclosure with Noggle’s teaching in order to create an automated system for rapidly producing and isolating reproducible iPSC cell lines under standard conditions ([0007]).
Regarding claim 52, Pebay and Tanabe do not disclose but Noggle teaches wherein prior to seeding in the daughter cell culture vessel the suspension of cells is passed through a first pipette tip to dissociate the culture of cells into a single cell suspension or a plurality of clumps having an average diameter not exceeding a bore diameter of the first pipette tip ([0341] Cells enzymatically harvested as described above were filtered through a 35 .mu.m cell strainer (BD biosciences) to obtain a single cell suspension prior to resuspension in 100 .mu.l of a sterile iPSC staining buffer [DPBS containing 0.5% bovine serum albumin fraction V (BSA; Invitrogen), 100 U/ml penicillin/streptomycin (Invitrogen), 2 mM EDTA (Invitrogen), and 20 mM glucose (Sigma)].).
It would have been obvious to one of ordinary skill in the art to combine Pebay and Tanabe’s disclosure with Noggle’s teaching in order to create an automated system for rapidly producing and isolating reproducible iPSC cell lines under standard conditions ([0007]).
Regarding claim 53, Pebay discloses wherein obtaining the suspension of cells includes aspirating the cell culture medium from the cell culture vessel and contacting the culture of cells in the cell culture vessel with a detachment solution ([0062] Hence when aspirating, a predetermined volume less than the volume present in the culture well will be removed. This ensures some solution remains to prevent the culture drying.).
Regarding claim 54, Pebay discloses wherein the detachment solution is a fractionation solution, and the fractionation solution selectively detaches either a first population of differentiated cells or a second population of undifferentiated cells from a wall of the cell culture vessel ([0123] a controlling system to automate and program any one of the manipulator arm, the platform, and the liquid handling system such that the liquid handling system controllably and sterilely delivers and optionally removes predetermined aliquots of solution or differentiation factor to and from the culture plate and optionally the manipulator arm returns the culture plate to the housing.).
Regarding claim 57, Pebay discloses wherein the culture of cells are pluripotent stem cells ([0044] Protocols to allow for the automated maintenance of cells have been established by the present invention which enables large-scale sterile culture and passaging of cells such as the human pluripotent stem cells (PSCs) and adapting the automated system to a system such as the Freedom EVO®.).
Regarding claim 58, Pebay discloses wherein the pluripotent stem cells are human pluripotent stem cells ([0044] Protocols to allow for the automated maintenance of cells have been established by the present invention which enables large-scale sterile culture and passaging of cells such as the human pluripotent stem cells (PSCs) and adapting the automated system to a system such as the Freedom EVO®.).
Regarding claim 59, Pebay and Tanabe do not disclose but Noggle teaches wherein the pluripotent stem cells are passaged as clumps ([0345] Embryoid bodies (EB) were formed by placing clumps of iPSCs in 96-well non-tissue culture treated V-bottom plates (Evergreen 222-8031-01V) containing HUESM.).
It would have been obvious to one of ordinary skill in the art to combine Pebay and Tanabe’s disclosure with Noggle’s teaching in order to create an automated system for rapidly producing and isolating reproducible iPSC cell lines under standard conditions ([0007]).
Claim(s) 4 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pebay (US 20180282682 A1), in view of Tanabe (US 20190338237 A1), view of Noggle (US 20150166964 A1), in view of Bhatia (US 9365821 B2) and in further view of Stice (US 20140363467 A1).
Regarding claims 4 and 48, Pebay, Tanabe and Noggle do not teach or disclose wherein the one or more characteristics calculated in respect of the culture of cells in the cell culture vessel and a second culture of cells in a second cell culture vessel is different at the first time point or at the one or more subsequent time points and the one or more characteristics become more consistent during a subsequent passage.
In a similar field of endeavor of transformed human stem cells, Bhatia teaches wherein the one or more characteristics calculated in respect of the culture of cells in the cell culture vessel and a second culture of cells in a second cell culture vessel is different at the first time point or at the one or more subsequent time points (col 34, lines 48-55: Referring to FIG. 13, phase contrast images of morphological data illustrates the differential characteristics between normal induced pluripotent stem cells (iPSCs) (FIG. 13a-b) and transformed induced pluripotent stem cells (tiPSCs) (FIG. 13c-f).).
It would have been obvious to one of ordinary skill in the art to combine Pebay, Tanabe and Noggle’s disclosure with Bhatia’s teaching in order to provide methods of culturing cells for use in a cell-based screening assay comprising placing one or more transformed human pluripotent stem cells into a receptacle and culturing said stem cells in the receptacle to form a monolayer of stem cells without cell overlap (Abstract).
In a similar field of endeavor of transformed human stem cells, Stice teaches the one or more characteristics become more consistent during a subsequent passage ([0361] After passaging, ciPSC displayed morphological characteristics consistent with iPSCs including a colonial growth pattern with colonies forming highly refractive colonies with well defined boarders (FIG. 17B).).
It would have been obvious to one of ordinary skill in the art to combine Pebay, Tanabe, Noggle and Bhatia’s disclosure with Stice’s teaching in order to have a production of avian induced pluripotent stem cells from non-pluripotent somatic cells, including embryonic fibroblasts and adult somatic cells (abstract).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim1-4, 6, 8, 10, 15-18, 45-48, 51-54 and 57-59 rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-5, 7, 11-12, 14, 19, 21-24, 33, 35-36, 39 of U.S. Patent No. 20220315877. Although the claims at issue are not identical, they are not patentably distinct from each other because The instant application mentions an automatic cell passage system while the prior art mentions an adaptive cell passage system. Both applications have the same scope.
Although the conflicting claims are not identical, they are not patentably distinct from each other as will be described in reference to the table below. Emphasis has been added in bold to the elements which are identical; and elements which are similar but not identical have been italicized.
Instant application: 19032526
Reference application: 17253838 (US patented application 12385001)
Claims 1 and 45: An automated system for adaptively passaging a culture of cells in a cell culture medium within a cell culture vessel, the automated system comprising:
an imaging module for capturing one or more images of the culture of cells at a first time point and at one or more subsequent time points;
a pipette module having one or more pipettes for drawing a fluid from the cell culture vessel through a pipette tip mateable with an end of the one or more pipettes;
a liquid dispenser module spaced apart from the pipette module, the liquid dispenser module in fluid communication with more than one solution reservoir;
a handling module having a pair of opposable arms for gripping and transporting the cell culture vessel or a lid thereof or a daughter cell culture vessel or a lid thereof within the automated system, and
at least one processor in communication with the imaging module, the pipette module, the liquid dispenser and the handling module, the processor configured to:
receive the one or more images from the imaging module;
based on the one or more images received from the imaging module, calculate one or more characteristics of the culture of cells; and
execute an automated passaging protocol to passage the culture of cells, the protocol including coordinating operation of the pipette module, the liquid dispenser module and the imaging module based on comparing the calculated one or more characteristics of the culture of cells to:
a) a learned threshold level for the one or more characteristics; or
b) an inputted threshold level for the one or more characteristics.
10. wherein the liquid dispensing module includes more than one conduits and each conduit is in fluid communication with a separate one of the more than one solution reservoirs.
4 and 48. wherein the one or more characteristics calculated in respect of the culture of cells in the cell culture vessel and a second culture of cells in a second cell culture vessel is different at the first time point or at the one or more subsequent time points and the one or more characteristics become more consistent during a subsequent passage.
Claims 1 and 45: An automated system for adaptively passaging a culture of cells in a cell culture medium within a cell culture vessel, the automated system comprising:
an imaging station comprising a camera for capturing one or more images of the culture of cells at a first time point and at one or more subsequent time points;
a pipette module having one or more pipettes for drawing a fluid from the cell culture vessel through a pipette tip mateable with an end of the one or more pipettes;
a liquid dispenser station spaced apart from the pipette module and in fluid communication with more than one solution reservoir, the liquid dispenser station comprising more than one conduit respectively in fluid communication with a separate one of the more than one solution reservoirs, wherein a solution is dispensed from the liquid dispenser station in bulk into the cell culture vessel;
a handling module having a pair of opposable arms for gripping and transporting the cell culture vessel or a lid thereof or a daughter cell culture vessel or a lid thereof within the automated system; and
at least one processor in communication with the imaging station, the pipette module, the liquid dispenser station, and the handling module, the processor configured to:
receive the one or more images from the imaging station;
based on the one or more images received from the imaging station, calculate one or more characteristics of the culture of cells; and
execute an automated passaging protocol to passage the culture of cells, the protocol including coordinating operation of the pipette module, the liquid dispenser station and the imaging station based on comparing the calculated one or more characteristics of the culture of cells to:
a) a learned threshold level for the one or more characteristics; or
b) an inputted threshold level for the one or more characteristics;
wherein:
the one or more characteristics calculated in respect of the culture of cells in the cell culture vessel and a second culture of cells in a second cell culture vessel is different at the first time point or at the one or more subsequent time points and the different one or more characteristics become more consistent between the culture of cells in the cell culture vessel and the second culture of cells in the second cell culture vessel during a subsequent passage; and
wherein the culture of cells and the second culture of cells are the same type of cells.
Claims 1 and 45, of the instant application are rejected because they are similar and broader to claims 1 and 45 of the patented application.
Claims 2 and 46 of the instant application is rejected because it is identical than claim 2 and 46 of the patented application.
Claim 3 and 47 of the instant application is rejected because it is identical to claim 3 (and 47) of the patented application.
Claim 4 (and 48) of the instant application is rejected because it is similar but more broad to the last limitation to claims 1 and 45 of the patented application.
Claim 6 of the instant application is rejected because it is identical to claim 6 of the patented application.
Claim 8 of the instant application is rejected because it is identical to claim 8 of the patented application.
Claim 10 of the instant application is rejected because it is identical to a limitation of claim 1 of the patented application.
Claim 13 of the instant application is rejected because it is similar to claim 15 of the patented application.
The combination of claims 15 of the instant application are rejected because they are similar but more broad than claim 15 of the patented application.
Claim 16 of the instant application is rejected because it is identical to claim 16 of the patented application.
Claim 17 of the instant application is rejected because it is identical to claim 17 of the patented application.
Claim 18 of the instant application is rejected because it is identical to claim 18 of the patented application.
Claim 51 of the instant application is rejected because it is identical to claim 51 of the patented application.
Claim 52 of the instant application is rejected because it is identical to claim 52 of the patented application.
Claim 53 of the instant application is rejected because it is identical to claim 53 of the patented application.
Claim 54 of the instant application is rejected because it is identical to claim 54 of the patented application.
Claim 57 of the instant application is rejected because it is identical to claim 57 of the patented application.
Claim 58 of the instant application is rejected because it is identical to claim 58 of the patented application.
Claim 59 of the instant application is rejected because it is identical to claim 59 of the patented application.
Conclusion
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/AHMED A NASHER/Examiner, Art Unit 2675
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
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