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 .
Status of the Claims
Claims 1 and 3-16 are pending.
Claims 1 is newly amended.
Claim 16 is newly added.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2024.
Claims 1, 3-13, and 15-16 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claims 1 and 3-5 under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited) are withdrawn in order to address new claim limitations.
The rejection of claims 6-8 and 10 under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited), as applied to claim 1 above, and further in view of Kanke et al. (Stem Cell Reports, 2014, on IDS 08/25/2021, previously cited) are withdrawn in order to address new claim limitations.
The rejection of claim 9 under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021) in view of Ejiri et al. (US20160137962A1, 2016, previously cited), as applied to claim 1 above, and further in view of Egusa et al. (US20140356336, 2014, on IDS 08/25/2021, hereafter “Egusa 2014”, previously cited) is withdrawn in order to address new claim limitations.
The rejection of claims 11-12 and 15 under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited) and Kanke et al. (Stem Cell Reports, 2014, on IDS 08/25/2021, previously cited), as applied to claims 1 and 10 above, and further in view of Kim et al. (Journal of Bioscience and Bioengineering, 2019, available online 09/22/2018, previously cited) as evidenced by Takebe et al. (Cell Reports, 2017, previously cited) are withdrawn in order to address new claim limitations.
The rejection of claim 13 under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited), as applied to claim 1, and further in view of Kim et al. (Journal of Bioscience and Bioengineering, 2019, available online 09/22/2018, previously cited) and Dingwall et al. (Differentiation, 2011, previously cited) is withdrawn in order to address new claim limitations.
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.
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 1, 3-5, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited).
In regards to claims 1, 3, and 16, Egusa teaches methods for producing bone regeneration agents by inducing differentiation of stem cells, which can be induced pluripotent stem (iPS) cells (which are undifferentiated cells) specifically, into mineral-producing cells (Claim 16) (of which osteoblasts are a type). Methodically, Egusa teaches iPSCs are first induced to form embryoid bodies (EBs) in floating (non-adherent) culture (paragraphs [0123-0124]). Following this, Egusa teaches that the iPS cells are differentiated into mesodermal cells (paragraph [0124]).
Egusa teaches that the steps of formation of EBs and differentiation of iPS cells into mesoderm were carried out on low-attachment culture dishes (paragraph [0123]), but is silent as to the properties of the culture dishes (vessels).
However, Ejiri teaches a cell culture chamber with non-adhesive surfaces (claims 1 and 8) for culturing spheroids such as formation of EBs and differentiation of stem cells (paragraphs [0002-0003, 0021-0023, etc.]). As taught by Ejiri this culture chamber comprises a plurality of recesses (wells) that comprises hemispherical bottoms and walls (claim 1; Fig. 1-5). As taught by Ejiri, the wells themselves comprise a plurality of micro-spaces or recesses (depressed portions) (Fig. 1, paragraph [0053]), and are arranged independently (Figs. 1 and 10). Additionally, the circular sidewall can be upright (Fig. 5), and the depressed portions have a circular aperture (Figs 1 and 10).
Ejiri teaches that the equivalent diameter (a circle inscribed in the bottom portion of each recess, see paragraph [0057]) can be between 50 µm to 2mm, and gives preferable embodiments of 500 µm (claim 1; paragraph [0062]), which overlaps with the range of 450 µm to 550 µm.
In regards to overlapping ranges, MPEP 2144.05(I) states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Additionally, the plurality of depressed portions, as taught by Ejiri all appear to have uniform dimensions (Figs 1 and 2), which is greater than a percentage of 90% or more.
It is also noted that the culture vessel as claim 1 appears to be the same as the commercial product, a Corning (Kuraray) Elplasia microspace-shaped low-attachment plate (instant specification, paragraphs [0030-0043], and referring to Figs. 1-14). The culture vessel as taught by Ejiri is this same commercial plate.
A person of ordinary skill in the art would have been motivated to modify the method of Egusa and use an Elplasia plate because Ejiri suggests that the vessel is suitable to control spheroid size (paragraphs [0002-0003, 0012]) and teaches that it is suitable to prepare large numbers of spheroids with uniform size and high efficiency (paragraph [0012, 0033]). They would be further motivated to employ the vessel as taught by Ejiri because Ejiri teaches that it can prevent spheroid necrosis (paragraphs [0062-0063]).
Furthermore, because Ejiri teaches that the vessel is specifically designed for culturing large numbers of spheroids with uniform sizes (paragraphs [0012, 0033]), and indicates that it is suitable for culturing stem cells specifically (paragraphs [0002, 0012]), it could have been done with predictable results and a reasonable expectation of success.
In regards to wherein the expression of at least one of Collagen 1a1, Bone sialoprotein, and Osteopontin, after 10 days of osteoblastic differentiation induction is higher than those in the method wherein the steps (1) to (3) are performed in the same manner except that a circle-equivalent diameter of the plurality of depressed portions of a bottom surface of a culture vessel is 400 µm or 900 µm in steps (1) and (2), Applicant should note that this is a contingent clause, and describes a property of cells if cultured for this amount of time (after 10 days).
In regards to contingent clauses, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Additionally, according to MPEP 211.04, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.
In the instant case, the claims do not require culturing cells for any amount of time. Therefore, the contingent clause has not been considered limiting because it simply expresses the intended result of a process step positively recited (the steps (1), (2), and (3) that are not limited to timing.
In regards to claim 4, Egusa teaches that the iPS cells can be human or mouse (paragraph [0039]).
In regards to claim 5, Egusa teaches that embryoid bodies were formed over two days (paragraphs 0123-0124]), which overlaps with the range of 0.625 to 3.5 days (see MPEP 2144.05(I) as above).
Therefore, the combined teachings of Egusa and Ejiri renders the invention unpatentable as claimed.
Claims 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited), as applied to claim 1 above, and further in view of Kanke et al. (Stem Cell Reports, 2014, on IDS 08/25/2021, previously cited).
In regards to claims 6-8, Egusa does not explicitly teach that the culture step (2) (inducing differentiation of iPS cells into mesodermal cells) is performed in the presence of at least one kind selected from the groups consisting of a Wnt signal activator and a Hedgehog signal inhibitor.
However, a person of ordinary skill in the art would have been motivated to contact iPS cells with a Wnt signal activator such as CHIR99021 because Kanke teaches that CHIR99021 activates canonical Wnt signaling which cues the differentiation of stem cells into mesodermal cells (Introduction, p751) and promotes the upregulation of mesoderm-related genes (Results and Discussion, p752).
Additionally, a person of ordinary skill in the art would have been motivated to contact iPS cells with a Hedgehog signal inhibitor because Kanke teaches that formation of osteoblasts is a sequential process and that Hedgehog signaling is essential for normal osteoblast development (Introduction, p751, column 2, bottom paragraph) and that the combinational use of Hedgehog signaling inhibitor cyclopamine with CHIR99021 induces the downregulation of Sox1 and leads to increased osteoblast differentiation (p754, column 1, middle paragraph). Furthermore, because Kanke teaches that the combination of CHIR99021 and cyclopamine induced differentiation of pluripotent stem cells to mesoderm (Fig. 1D, p752; p754, column 1, middle paragraph), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 10, in the specific embodiment discussed above, Egusa teaches that iPS cells were maintained on mouse feeder cells (paragraph [0122]). However, Egusa also teaches that while iPS cells are usually co-cultured with feeder cells, they can also be cultured under feeder-free conditions (paragraph [0075]).
Additionally, a person of ordinary skill in the art would have been specifically motived to use feeder-free conditions because Kanke teaches that feeder cells introduce confounding factors (p758, column 1, last paragraph) and a person of ordinary skill in the art would have recognized that feeder-free conditions avoid these confounding factors, as well as xenobiotic contamination. Furthermore, because as above Egusa teaches that iPS cells can be cultured under feeder-free conditions, and Kanke teaches specific methods for differentiating pluripotent stem cells to osteoblasts under feeder-free conditions (Title, Summary, p751), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings if Egusa, Ejiri, and Kanke renders the invention unpatentable as claimed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021) in view of Ejiri et al. (US20160137962A1, 2016, previously cited), as applied to claim 1 above, and further in view of Egusa et al. (US20140356336, 2014, on IDS 08/25/2021, hereafter “Egusa 2014”, previously cited).
In regards to claim 9, Egusa does not explicitly teach that the osteoblast differentiation step was performed in the presence of a statin.
However, a person of ordinary skill in the art would have been motivated to contact cells with a statin because Egusa 2014 teaches that tumorigenesis is suppressed after transplantation when iPS cells are cultured in the presence of a statin and osteoblast differentiation factor, and that this prides a way to efficiently obtain osteoblasts in which tumorigenesis is suppressed without going through complex procedures such as cell sorting to obtain uniformly differentiated cells (paragraph [0048]). Furthermore, because Egusa 2014 teaches that iPS cells can be effectively differentiated to osteoblasts in the presence of a statin (claims 1 and 8), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Egusa, Ejiri, and Egusa 2014, renders the invention unpatentable as claimed.
Claims 11-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited) and Kanke et al. (Stem Cell Reports, 2014, on IDS 08/25/2021, previously cited), as applied to claims 1 and 10 above, and further in view of Kim et al. (Journal of Bioscience and Bioengineering, 2019, available online 09/22/2018, previously cited) as evidenced by Takebe et al. (Cell Reports, 2017, previously cited).
In regards to claim 11, Egusa is silent as to the number of iPC cells seeded.
In an (Elplasia) micro-space culture chamber, Ejiri teaches that the lower limit of the total number of cells is equal to or greater than the number of recesses present in the culture chamber (paragraph [0087]), while the upper limit is equal to or less than a number obtained by multiplying the number of recesses by a value obtained by dividing the volume of each of the recesses of the culture chamber by the volume of cells to be seeded (paragraph [0088]). Thus, Ejiri indicates that the number of seeded cells can vary and is dependent on the number of recesses in the culture chamber.
In regards to specific seeding densities per mL, Kim teaches that using an Elplasia plate, iPS cells were seeded with 2mL of cell suspension at a concentration of 2.5 x 105 cells/mL/well which overlaps with the range of 1.5 x 105 cells/mL to 3.5 x 105 as in claim 11 (see MPEP 2144.05(I) as above). A person of ordinary skill in the art would have been motivated to use a cell suspension at a concentration of 2.5 x 105 cells/mL/well because Kim indicates that this seeding density is sufficient to induce uniform iPS cell aggregation in Elplasia dishes (Static suspension culture, p373). Furthermore, because Kim indicates that a concentration of 2.5 x 105 cells/mL/well which overlaps with the range of 1.5 x 105 cells/mL to 3.5 x 105 as in claim 11 is sufficient to induce aggregate formation of iPS cells on Elplasia plates, specifically, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 12, Egusa teaches at least a 6-well plate (paragraph [0122]). Ejiri also teaches at least a 6-well Elplasia plate (paragraph [0052]) as well. In regard to steps (2) and (3), Egusa teaches different vessels (i.e., 6-well Elplasia plates) and culture liquid media changes for steps (2) and (3).
In regards to claim 15, as above, Egusa teaches iPSCs are first induced to form embryoid bodies (EBs) in floating (non-adherent, and thus, suspension) culture (paragraphs [0123-0124]).
In regards to the depressed portions of an Elplasia dish, as above, Ejiri teaches that the number of cells is equal to or less than a number obtained by multiplying the number of recesses by a value obtained by dividing the volume of each of the recesses of the culture chamber by the volume of cells to be seeded (paragraph [0088]).
As evidenced by Takebe (co-creators of the dish), there are about 320 microwell (depressions) per cm2 of plate (Supplementary information, p9). Therefore, there are about 600 microwells per well in a 24-well plate format, about 3,000 microwells per well in a 6-well plate format, and about 20,000 microwells per plate in an omniplate format (Supplementary information, p9). This noted by the instant specification which also says that for a 24-well Elplasia plate there are 554 to 580 depressions/well (paragraph [0120]).
As discussed above, Kim teaches that using an Elplasia plate, iPS cells were seeded with 2mL of cell suspension at a concentration of 2.5 x 105 cells/mL/well. For 24-well plates and 6-well plates, this corresponds to approximately 833 cells per microwell and 167 cells per microwell, respectively, which overlaps with the range of 100 cells to 3,000 cells (see MPEP 2144.05(I) as above).
Therefore, the combined teachings of Egusa, Ejiri, Kanke, and Kim renders the invention unpatentable as claimed.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Egusa (US20160287753, 2016, on IDS 08/25/2021, previously cited) in view of Ejiri et al. (US20160137962A1, 2016, previously cited), as applied to claim 1, and further in view of Kim et al. (Journal of Bioscience and Bioengineering, 2019, available online 09/22/2018, previously cited) and Dingwall et al. (Differentiation, 2011, previously cited).
In regards to claim 13, Egusa does not explicitly teach that during step (1) (inducing formation of an embryoid body from undifferentiated iPS cells) the step is performed in the presence of a ROCK inhibitor. However, a person of ordinary skill in the art would have been motivated to include a ROCK inhibitor because Kim teaches that the addition of a ROCK inhibitor to prevent apoptosis after single-cell dissociation (Fig. 1, p374). Furthermore, because Kim teaches that a ROCK inhibitor can be added to iPS cell lines for aggregation in Elplasia plates (Fig. 1, p374), it could have been done with predictable results and a reasonable expectation of success. Furthermore, in regard to the use of retinoic acid in steps (2) and (3), Egusa teaches the use of retinoic acid in step (2) (paragraph [0124]).
Additionally, while Egusa teaches that iPS cells were treated with retinoic acid (RA) for the step of forming mesoderm (claim 1 step (2)) (paragraph [0124]), Egusa does not explicitly teach that mesodermal cells were cultured with RA for the step of differentiating mesodermal cells into osteoblasts (claim 1 step (3)).
However, a person of ordinary skill in the art would have been motivated to culture mesoderm-EBs in the presence of retinoic acid because Dingwall teaches that treatment of pluripotent precursor cells with retinoic acid inhibits adipogenesis and enhances osteoblastogenesis and that retinoic acid treatment stimulates the expression of Runx2 (Abstract, p57). Furthermore, because Dingwall teaches that cells can be cultured in differentiation media comprising retinoic acid (Experimental procedures, Cell Culture and differentiation, p58), and because Egusa and Dingwall are in the same technical field of inducing differentiation of pluripotent cells into osteoblasts, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Egusa, Ejiri, Kim, and Dingwall renders the invention unpatentable as claimed.
Response to Arguments
In regards to Applicant’s allegations of unexpected results, Applicant argues that according to MPEP 2141.02(V), “Obviousness cannot be predicated on what is not known at the relevant time, even if the inherency of a certain feature is later established” (Remarks, p6).
Continuing, Applicant argues that claim 1 as amended requires wherein the expression of at least one of Collagen 1a1, Bone sialoprotein, and Osteopontin, after 10 days of osteoblastic differentiation induction is higher than those in the method wherein the steps (1) to (3) are performed in the same manner except that a circle-equivalent diameter of the plurality of depressed portions of a bottom surface of a culture vessel is 400 µm or 900 µm in steps (1) and (2) (Remarks, p6-7).
Applicant argues that as demonstrated in Fig, 5, these three markers show significantly higher expression in the ELP 500 plate (Remarks, p7).
Applicant’s arguments filed 01/09/2026 have been fully considered but are not found persuasive.
In regards to allegations of unexpected results, according to MPEP 716.02(d), whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
In the instant case, claim 1 does not require a ELP500 plate. Rather, it more broadly claims dimensions that are between a ELP400 and an ELP500 plate (450 to 550 µm), and as demonstrated in Fig. 5, ELP400 plates are unable to produce the claimed results.
Furthermore, as discussed above, the “wherein clause” is a contingent clause, and describes a property of cells if cultured for this amount of time (after 10 days)
In regards to contingent clauses, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Additionally, according to MPEP 211.04, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.
In the instant case, the claims do not require culturing cells for any amount of time. Therefore, the contingent clause has not been considered limiting because it simply expresses the intended result of a process step positively recited (the steps (1), (2), and (3) that are not limited to timing.
As a result, the results are also not commensurate in scope because also require timings which are not recited in the claims.
Applicant argues that while it is not disputed that a person of ordinary skill in the art may have been motivated to modify the method of the primary reference, Egusa, and use an Elplasia plate, as such plates are suitable to control spheroid size and to prepare large numbers of spheroids with uniform size and high efficiency, prior to the invention of the claimed method, if one skilled in the art would have considered modifying Egusa's method, that skilled artisan would have had multiple options for plates, including any one of ELP 400, ELP 500, and ELP 900 (Remarks, p7). Applicant argues that the ELP 500 was just one of many options available to the person of ordinary skill in the art prior to the instant invention (Remarks, p7).
Continuing, Applicant argues that based on the level of skill in the art, as evidenced by Moon et al., the skilled artisan would have chosen a smaller diameter of depressed portions as Moon et al. suggests that the smaller the diameter of depressed portions, the more easily growth factors such as mesoderm inducers can diffuse into the interior of larger cell aggregates, and that concave microwells with such depressed portions are therefore more suitable for differentiation induction (Remarks, p7).
Applicant’s arguments filed 01/09/2026 have been fully considered but are not found persuasive.
In regards to the size of the specific plate, as discussed above, Ejiri, and gives a preferable embodiment of 500 µm (claim 1; paragraph [0062]), which overlaps with the claimed range of 450 µm to 550 µm as in claim 1, and the specific dimension of 500 µm as in claim 16. Thus, a person of ordinary skill in the art would have been specifically motived to choose this dimension because it is preferred by Ejiri for culturing spheroids derived from stem cells. As above, specifically, a person of ordinary skill in the art would have been motivated to modify the method of Egusa and use an Elplasia plate because Ejiri suggests that the vessel is suitable to control spheroid size (paragraphs [0002-0003, 0012]) and teaches that it is suitable to prepare large numbers of spheroids with uniform size and high efficiency (paragraph [0012, 0033]). They would be further motivated to employ the vessel as taught by Ejiri because Ejiri teaches that it can prevent spheroid necrosis (paragraphs [0062-0063]).
Furthermore, because Ejiri teaches that the vessel is specifically designed for culturing large numbers of spheroids with uniform sizes (paragraphs [0012, 0033]), and indicates that it is suitable for culturing stem cells specifically (paragraphs [0002, 0012]), it could have been done with predictable results and a reasonable expectation of success.
In regards to the three ELP 400, ELP 500, and ELP 900 plates, not only is this a limited number of options, but as above, Eijiri explicitly gives 500 µm (the dimension of an ELP 500 plate) as a preferred embodiment.
In regards to Moon, it is noted that Moon is not relied upon in the Office Action, and as discussed above, Eijiri explicitly teaches that stem cell derived spheroids can grow in 500 µm wells as a preferred embodiment.
Additionally, the teachings of Moon do not constitute a teaching away from using a plurality of depressed portions that has a circle-equivalent diameter of from 450 µm 700 µm, as Moon does not “criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) (“a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.”) (See MPEP2145).
Indeed, as Moon demonstrates, embryoid bodies derived from stem cells can effectively grow in wells with dimensions of 300 µm, 500 µm, and 1000 µm, with viabilities of greater than 90% for all well-sizes (Fig. 2D,E, p5991).
Therefore, because Ejiri teaches that the vessel is specifically designed for culturing large numbers of spheroids with uniform sizes (paragraphs [0012, 0033]), and indicates that it is suitable for culturing stem cells (paragraphs [0002, 0012]), a person of ordinary skill in the art could have modified the method of Egusa and used the wells as taught by Ejiri with predictable results and a reasonable expectation of success.
Conclusion
No claims are 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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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631