DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendments to the claims and arguments filed on 09-19-2025 have been received and entered. Claims 24, 88 – 91 have been amended. Claims 2-23, 25-32, 35-48, 50-82, 84-87 have been canceled. Claims 1, 24, 33-34, 49, 83, 88-95 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II claims 24 and 88-95 in the reply filed on 02-14-2025 is acknowledged.
Claims 1, 33-34, 49, 83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02-14-2025.
Claims 24 and 88-95 are under consideration.
Priority
This application claim priority from US provisional application 63/212,063 filed on 06/17/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09-19-2025 are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections- necessitated by amendments
Claim 24 is objected to because of the following informalities:
Claim 24 labels multiple steps in the same claim with the same set of (a), (b), (c), (d). It would be remedial to change to different labeling for different steps with different letter or symbols. Appropriate correction is required.
Maintained in modified form-Claim Rejections - 35 USC § 103- necessitated by amendments
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.
Claims 24, 88, 89, 90, 91, 92, 93, 94, 95 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue et al (Pub. No.: US 2016/0046905 A1, Pub. Date: Feb. 18, 2016) in view of Kemp et al (Pub. No.: US 2016/0257930 A1, Pub. Date: Sep. 8, 2016) and Pebay et al (AU2017202224B2, Publication Date: 2018-10-18) and Hussain et al (Biochemical Engineering Journal 77 (2013) 246–257, Doi: 10.1016/j.bej.2013.05.008) and Tecan HydroControl manual (herein after Tecan HydroControl, Document Part No.: 30064355, 2017-12, Document Revision No.: 2.5) and Tecan Fluent for research laboratories (herein after Tecan Fluent, 400400 V1.1, 2018-09, 30151850, Tecan Trading AG, Switzerland).
Claim interpretation:
The specification teaches that PD0332991 is a cell cycle inhibitor (e.g., [0236] at page 70; [0346] at page 97; etc.). Thus, PD0332991 is interpreted as cell cycle inhibitor.
The specification of the claimed invention teaches that Fluent Automation workstation (Tecan) was used for multiple liquid-handling steps such as cell plating, media changes, experimental treatment, and cell fixation to achieve systematic, reproducible, and precise neuron handling ([0344], page 96). Thus, automation workstation systems and the like such as Fluent Automation workstation (Tecan) are interpreted as automated cell culture system.
Regarding to claim 24, preamble, Inoue et al teach a method of generating a motor neuron from a pluripotent stem cell (Abstract) (For the preamble).
Regarding to claim 24 step a and b, Inoue et al teach a method in which human-derived embryonic stem cells or induced pluripotent stem cells are differentiated into neural progenitor cells, and then, (motor) neuron lineage-specific transcription factors such as Ngn2 is introduced and allowed to express in the neural progenitor cells, so that motor neurons can be obtained 11 days after the introduction. In addition, neuron lineage-specific transcription factors such as Ascl1 can be introduced and allowed to express in human embryonic stem cells, so that neurons can be obtained ([0005], page 1). The nucleic acids express Ngn2 are in a polycistronic manner under the control of an inducible promoter ([0049], page 2) (For step a and b).
Inoue et al do not specifically teach a cell cycle inhibitor, Kemp et al cure the deficiency.
Kemp et al teach neuronal stem cell differentiation (Title). Kemp et al provided a neural cell differentiation medium for the production of neural cells from at least one precursor cell capable of lineage specific differentiation ([0013], page 2) comprising a cell-cycle inhibitor ([0016], page 2). Said cell-cycle inhibitor is an inhibitor of cell cycle progression targeting the G1-S phase checkpoint, such as but not limited to, PD0332991 ([0026], page 2) for at least 1-20 days ([0089], page 4) (For step b).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Inoue et al by using an inhibitor of cell cycle progression such as PD0332991 as taught by Kemp et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Kemp et al provide explicit advantage of the protocol dramatically enhances the spontaneous action potential activity of PSC-derived neurons ([0150], page 6). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Kemp et al were successful in generation of PSC-derived neurons with working examples, data, protocols and instructions.
Regarding to claim 24 step c, Inoue et al teach FIG. 6G shows the measurement of survival of motor neurons that were differentiated (in the presence of astrocytes) from the mouse iPS cells ([0111], page 5). Additionally, Kemp et al teach that the use of astrocyte co-culture or astrocyte-conditioned medium (ACM) has been commonly employed to promote neuronal maturation in vitro ([0176], Page 9) (For step c).
Regarding to claim 24 step d, Inoue et al and Kemp et al do not specifically teach an automated cell culture system. Pebay et al cure the deficiency.
Pebay et al teach automated system for maintenance and differentiation of pluripotent stem cells (title). Also, The laboratory automation platform Freedom EVO (Tecan Switzerland AG) has been adapted to maintain mouse embryonic stem cells and differentiate them towards a neuronal lineage (Page 2, lines 4-6) (For step d).
Additionally, Inoue et al teach neurons obtained from pluripotent stem cells over approximately 2 months ([0388], page 24). Further, Kemp et al teaches that in contrast to existing techniques, which can often take several months, it has been found that the disclosed method and media results in maturation of stem cell-derived neural progenitors to produce a high yield of functional, spontaneously electrically excitable neurons within 2-3 weeks ([0011], page 2). Thus, Since the art recognizes that the maturation of stem cell-derived neural progenitors to produce neurons can occur between 2-3 weeks to two or several months, a person of ordinary skill in the art would be able to differentiate and mature the PSC-derived neurons for at least about 60 to about 90 days out of the course of routine optimization (For step d).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Inoue et al and Kemp et al by using automated system for maintenance and differentiation of pluripotent stem cells such as the laboratory automation platform Freedom EVO from Tecan as taught by Pebay et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Pebay et al teach that the laboratory automation platform Freedom EVO (Tecan Switzerland AG) has been adapted to maintain mouse embryonic stem cells and differentiate them towards a neuronal lineage (Page 2, lines 4-6). The automated system is advantageously adaptable as a modular system integrating other components such as an incubator and a hotel for storage and incubation of culture plates during processing of culture plates through the automated system (Page 17, lines 17-20). The automated system may be housed in a biosafety cabinet to improve sterility during the processing of culture plates (Page 17, lines 26-27). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Pebay et al were successfully in applying the automated system for maintenance pluripotent stem cells and differentiate them towards a neuronal lineage with instruction and data.
The teachings of Inoue et al, Kemp et al and Pebay et al above do not teach one or more rounds of automated culture media replacements. Hussain et al cure the deficiency.
Regarding to claim 24 step d and claim 88, Hussain et al teach reproducible culture and differentiation of mouse embryonic stem cells using an automated microwell platform (Title) to direct differentiation of murine Oct-4-GiP ESC line into neural precursors (Abstract). Automation platform used in this study was a Tecan Freedom Evo 100 equipped with one four channel liquid handling arm and one gripper, RoMa arm (Page 249, left column, 2nd para.). The plates were inoculated overnight and subsequently serum containing medium was removed and replaced with NDIFF–RHBA medium. Throughout the course of the differentiation, a complete medium exchange was automatically carried out every 48 h (Page 249, right column, 2nd para.). Additionally, as described above Inoue et al teach neurons can be obtained from pluripotent stem cells over approximately 2 months ([0388], page 24). Thus, a person of ordinary skill in the art would be able to differentiate and mature the PSC-derived neurons for at least about 60 out of the course of routine optimization.
Regarding to claim 24 step d and claim 89, Hussain et al teach the SOP devised for automated, hands-free ESC expansion is shown in Fig. 2(a), and the cell suspension mixed, by repeated aspiration and dispensing, to ensure efficient recovery of cells (Page 249, left column, 3rd para). Hussain et al also teach tissue culture plates in a schematic of the automated platform deck in figure 1.
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Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Inoue et al, Kemp et al and Pebay et al by using automated cell culture system of Tecan Freedom Evo 100 as taught by Hussain et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Hussain et al provide explicit advantage of reproducible culture and differentiation of mouse embryonic stem cells using an automated microwell platform (title) with a 3-fold improvement in the consistency of cell growth kinetics with automated passaging (Abstract). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Hussain et al were successful in adopting automated bioprocess routes to produce cells for therapy and for use in basic discovery research (Abstract).
The teachings of Inoue et al, Kemp et al, Pebay et al and Hussain et al do not specifically teach specification of settings of automated cell culture system as cited in claim 24-step d and claims 90-91.
Regarding to claim 24 step d and claims 90-91, Tecan HydroControl teaches that the aspirating needle is positioned at a user-defined distance (Page 30, 1st para), and the pipet tip is at an angle of about 90° to the bottom surface of the well for aspirating step (page 29) and Z-position for dispense step (Page 30):
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Tecan HydroControl also teaches the Head speed for aspirate/ Dispense step can be 1 - 20 mm/s (Page 27)
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Regarding to claim 24 step d, the claimed: automated culture media aspiration and replenishment at specific pipetting speeds and pipette distance from the bottom surface of the well, it is noted that the Tecan HydroControl teaches that the aspirating needle is positioned at a user-defined distance (Page 30, 1st para), and the Head speed for aspirate/ Dispense step can be 1 - 20 mm/s (Page 27). Further, Pebay et al teach the automated system allows for substantial customization of both equipment and cell handling parameters (Page 32, lines 5-6), and Hussain et al teach an SOP for automated monolayer neuronal differentiation was established in a similar manner to that for cell passaging (Fig. 2(a)). Many of the optimized factor settings used in the cell expansion SOP, such as definition of the plate tilt angle and aspiration location for maximum removal of spent culture medium from a well, could be directly translated to the SOP for monolayer differentiation (Fig. 2(b)). Further optimization was needed in certain areas however. For example, it was necessary to separately determine maximum aspiration (150 mL s-1) and dispensing (300 mL s-1) flow rates for cell suspensions containing cells with significant neurite outgrowth. This being a consequence of their greater sensitivity to the hydrodynamic and shear forces experienced during pipetting (Page 254, bridging last paragraph in left column to right column). Thus, adjusting/optimizing pipetting settings/configuration for the automated cell culture system for neuron differentiation was recognized in the prior art to be a result-effective variable. A person of ordinary skill in the art would have been motivated to perform the adjusting setting/configurations for pipetting in the automated cell culture system a plurality of times out of the course of routine optimization.
Also, the specification of the claimed invention teaches that Fluent Automation workstation (Tecan) was used ([0344], page 96), and Pebay et al teach the use of the laboratory automation platform Freedom EVO (Tecan Switzerland AG) (Page 2, lines 4-6), and Hussain et al teach the automated pipetting station used in this study was a Tecan Freedom Evo 100 (Tecan, Reading, UK) equipped with one four channel liquid handling arm and one gripper, RoMa, arm. (Page 249, left column, 2nd para.). Thus, the automation workstation cell culture system manufactured by the Tecan company were commercially available and used for neuron differentiation by Pebay et al and Hussain et al before the effective filing date of the rejected claims so that a person of ordinary skill in the art would be able to run the automation workstation cell culture system according to user-defined preferences.
The teachings of Inoue et al, Kemp et al, Pebay et al and Hussain et al do not specifically teach one or more batches of 384-well plates.
Regarding to claims 92, 93, Tecan Fluent teaches of 384-pipet tips for media aspiration (Page 05) with one or more batches of 384-well plates with up to four stacks of 50 microplates (Page 08). Thus, it is obvious for a person of ordinary skill in the art to arrange the plates in 5 columns and 5 rows.
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Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Inoue et al, Kemp et al, Pebay et al, and Hussain et al to specify settings of automated cell culture system as taught by Tecan HydroControl for cell culture system comprising batch of 384-well plates as taught by Tecan Fluent as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Tecan HydroControl and Tecan Fluent provide explicit advantage of enhancing productivity while maintaining precision and accuracy, enabling laboratories to get more done in less time- and less space. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Tecan Fluent automated cell culture system is commercialized available and have been tested in the art.
Regarding to claim 94-95, Kemp et al teach cell culture was continued in SCM2 differentiation medium, exchanging 80:20 of the SCM2 medium every 2-3 days, for up to 30 days ([0164], page 7). Thus, a person of ordinary skill in the art would be motivated to set up the program of Tecan Fluent automated cell culture system to change medium for multiple rounds of culture media replacements.
Response to Arguments
Applicant's arguments filed 09-19-2025 have been fully considered but they are not persuasive. The 35 USC 103 rejections necessitated by amendments are as described above. Relevant arguments are addressed below.
1. Applicants argue that Pebay teaches an automated instrument to achieve automated maintenance and differentiation of reprogrammed somatic cells into pluripotent stem cells (PSCs). Pebay does not teach or suggest a method of generating homogenous and terminally differentiated neurons from pluripotent stem cells comprising automated culture media aspiration and replenishment at specific pipetting speeds and pipette distance from the bottom surface of the well. The Examiner has failed to provide a sufficient rationale for why one of ordinary skill in the art would have looked to Pebay for methods of culturing PSC-derived neural stem cells, much less why one would have had a reasonable expectation of success for such a method given the challenges associated with culturing such cells (Remarks, page 9).
Response to Arguments:
The rejections are as described above. Additionally, In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, it is noted that the Tecan HydroControl teaches that the aspirating needle is positioned at a user-defined distance (Page 30, 1st para), and the Head speed for aspirate/ Dispense step can be 1 - 20 mm/s (Page 27). Further, Pebay et al teach the automated system allows for substantial customization of both equipment and cell handling parameters (Page 32, lines 5-6), and Hussain et al teach an SOP for automated monolayer neuronal differentiation was established in a similar manner to that for cell passaging (Fig. 2(a)). Many of the optimized factor settings used in the cell expansion SOP, such as definition of the plate tilt angle and aspiration location for maximum removal of spent culture medium from a well, could be directly translated to the SOP for monolayer differentiation (Fig. 2(b)). Further optimization was needed in certain areas however. For example, it was necessary to separately determine maximum aspiration (150 mL s-1) and dispensing (300 mL s-1) flow rates for cell suspensions containing cells with significant neurite outgrowth. This being a consequence of their greater sensitivity to the hydrodynamic and shear forces experienced during pipetting (Page 254, bridging last paragraph in left column to right column). Thus, adjusting/optimizing pipetting settings/configuration for the automated cell culture system for neuron differentiation was recognized in the prior art to be a result-effective variable. A person of ordinary skill in the art would have been motivated to perform the adjusting setting/configurations for pipetting in the automated cell culture system a plurality of times out of the course of routine optimization.
Also, the specification of the claimed invention teaches that Fluent Automation workstation (Tecan) was used ([0344], page 96), and Pebay et al teach the use of the laboratory automation platform Freedom EVO (Tecan Switzerland AG) (Page 2, lines 4-6), and Hussain et al teach the automated pipetting station used in this study was a Tecan Freedom Evo 100 (Tecan, Reading, UK) equipped with one four channel liquid handling arm and one gripper, RoMa, arm. (Page 249, left column, 2nd para.). Thus, the automation workstation cell culture system manufactured by the Tecan company were commercially available and used for neuron differentiation by Pebay et al and Hussain et al before the effective filing date of the rejected claims so that a person of ordinary skill in the art would be able to run the automation workstation cell culture system according to user-defined preferences.
2. Applicants argue that Applicant unexpectedly found an automated culturing platform that generated homogenous and terminally differentiated neurons for the long-term. Automating differentiation and culturing of induced pluripotent stem cell- (PSC-) derived neural stem cells (NSCs) is challenging. As stated in paragraph [0003] of the as-filed specification, "iPSC differentiation and culturing protocols are long and variable, posing challenges to maintaining consistency." Not only are human PSC-derived neurons sensitive and require extended culturing time to develop mature neuron characteristics, but traditional manual techniques used for long-term neuronal maintenance is challenging (see, e.g., lines 4-9 in the first column and first paragraph of page 2 of Bassil et al., Nat Commun., 2021, submitted as Exhibit A). Applicant unexpectedly found that the claimed method maintained consistent and healthy neurons for up to 6 months (see, e.g., paragraph [0350] of the as-filed specification). When two different human PSC-derived NSC lines were differentiated using the claimed method, the resulting neurons from both PSC-derived NSC lines were homogenous upper-layer cortical neurons (over 95% of the neurons expressed CUX2, a marker of upper-layer cortical neurons) that had extensive synaptic connections (including pre- and post-synaptic markers PSD95, SHANK, PanSHANK, GluRl, GluR2, vGLUT2, Synapsin 1/2, PanSAPAP, and NRl) (see, e.g., Example 1, FIGs. lK-lR and 19A-19H of the as-filed specification). The homogenous and longterm maintenance of terminally differentiated neurons generated by the claimed method is strong evidence of the non-obviousness of the amended claims (Remarks, page 10)
Response to Arguments:
Applicants cited Bassil et al reference (Nat Commun 12, 5220 (2021). Doi: 10.1038/s41467-021-25344-6) that teach “Fluent automation workstation (Tecan)” (see page 2, right column, 2nd para) and “The Fluent automation workstation was used to maintain longterm iPSC neuronal cultures in 384-well plates. Convenience features of the automated workstation allowed walk-away implementation to maintain consistent and healthy neurons for up to 6 months (Fig. 1d–j)” (see page 2, right column, last para). Thus, as evidenced by applicant own work, using Fluent automation workstation manufactured by Tecan company can maintain consistent and healthy neurons for up to 6 months. Since the cited prior art teach the same Tecan Fluent Automation Workstation (see above for Tecan Fluent reference) which is commercially available before the effective filing date of the rejected claims, it is expected that the same Tecan Fluent Automation Workstation would maintain consistent and healthy neurons for up to 6 months as same as the claimed invention. Buying commercially available product to use it to improve cell culture is not inventive concept or unexpected results.
Further, regarding to applicant argument about “resulting neurons from both PSC-derived NSC lines were homogenous”, it is noted that Inoue et al teach “According to the present invention, since homogenous motor neurons or neurons can be efficiently induced from pluripotent stem cells, an excellent cell model for neurodegenerative disease or nerve injury, which is useful for searching for a therapeutic agent for the disease, can be provided.” ([0420], page 27). Additionally, Kemp et al teach “this protocol also results in the generation of a homogenous population of mature neurons.” ([0183], page 10). Thus, both Inoue et al and Kemp et al teach homogenous population of mature neurons so that it is expected to obtain homogenous population of mature neurons as taught by the prior arts. Also, the prior arts were successful in generation of PSC-derived neurons, so it is expected that PSC-derived neurons as taught by prior arts have all neuron markers.
According to MPEP 716.02 allegations of unexpected results, Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, there is no evidence in records that using commercially available automated workstation and adjusting the settings would result in unexpected results.
3. Applicants argue that Inoue, Kemp, and Pebay, alone or in combination, do not teach or suggest the claimed method of generating homogenous and terminally differentiated neurons from pluripotent stem cells comprising automated culture media aspiration and replenishment at specific pipetting speeds and pipette distance from the bottom surface of the well. Hussain, Tecan HydroControl, and Tecan Fluent do not remedy the deficiencies of Inoue, Kemp, and Pebay. Hussain teaches using an automated microwell platform to maintain murine Oct-4-GiP embryonic stem cells (ESCs) and to differentiate the murine Oct- 4-GiP ESCs into neural precursors. Hussain does not teach a method of generating homogenous and terminally differentiated neurons from pluripotent stem cells. Tecan HydroControl provides instructions and example values for customizing programs. Tecan Fluent teaches an automated liquid handler. Tecan HydroControl and Tecan Fluent do not teach a method of generating homogenous and terminally differentiated neurons from pluripotent stem cells, let alone a method comprising automated culture media aspiration and replenishment at specific pipetting speeds and pipette distance from the bottom surface of the well (Remarks, page 11).
Response to Arguments:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, the teachings of prior arts are as described above. The Hussain et al reference was added to teach one or more rounds of automated culture media replacements, and Hussain et al also teach reproducible culture and differentiation of mouse embryonic stem cells using an automated microwell platform (Title) and using automated cell culture system of Tecan Freedom Evo 100 (Page 249, left column, 2nd para). One of ordinary skill in the art would have been motivated to combine the references because Hussain et al provide explicit advantage of reproducible culture and differentiation of mouse embryonic stem cells using an automated microwell platform (title) with a 3-fold improvement in the consistency of cell growth kinetics with automated passaging (Abstract). Tecan HydroControl was cited to specify settings of automated cell culture system for cell culture system and Tecan Fluent was added to teach batch of 384-well plates in the automated cell culture system. One of ordinary skill in the art would have been motivated to combine the prior arts because Tecan HydroControl and Tecan Fluent provide explicit advantage of enhancing productivity while maintaining precision and accuracy, enabling laboratories to get more done in less time- and less space.
The cited prior arts teach the same Tecan Fluent Automation Workstation (see above for Tecan Fluent reference) which is commercially available before the effective filing date of the rejected claims. As explained above, adjusting/optimizing pipetting settings/configuration for the automated cell culture system for neuron differentiation was recognized in the prior art to be a result-effective variable. A person of ordinary skill in the art would have been motivated to perform the adjusting setting/configurations for pipetting in the automated cell culture system a plurality of times out of the course of routine optimization.
Conclusion
No claim is allowed.
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.
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632