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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 3, 4, 6-13, 15, 19 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al (Stem Cell Research, 2, pgs 219-230; 2009) in view of Mohr et al (biotechnol. Prog. 22, Pgs 825-834; 2006) and Caracci et al (US 2018/0179489; Published 06/28/2018). This rejection was made in the Office Action mailed on 07/29/2025 over claims 7-13, 15, 34 and 40, and has been rewritten to address additional claims as necessitated by the amendment filed on 10/29/2025.
Regarding claim 1, Oh teaches the development of a facile and robust method for
maintaining undifferentiated hESC in three-dimensional (3D) suspension cultures on Matrigelcoated microcarriers achieving 2- to 4-fold higher cell densities than those in 2D colony cultures (Page 219, Abstract). Oh teaches hES cells adhered to matrigel-coated cellulose microcarriers for growth, the cells adhered to the microcarriers are within 3D suspension cultures, where the cells are removed from the microcarriers via mechanical or enzymatic dissociation (Page 220, Column 1, Paragraph 3; Pages 225-227, Microcarrier cultures of hESC in static and agitated conditions). Oh teaches after the removal of the cells from the microcarriers, the cells were re-attached to the microcarriers in a suspension (Page 220, Column 1, Paragraph 4).
Oh does not teach the use of electroporation, after harvesting, for transfection of the adherent cells. Oh does not teach that after electroporation, the cells are recovered on a second substrate in suspension or in another suspension format.
Mohr teaches hESCs cultured on matrigel-coated plates where the adherent hESCs were
mechanically removed from the plates for electroporation of DNA containing an eGFP cassette
(Page 826, Column 1, Paragraph 4). Mohr teaches after electroporation the hESCs were cultured
by adhering back on the matrigel-coated plates (Page 826, Column 1, Paragraph 4). Mohr
teaches that electroporation is effective and an efficient method for loading hESCs with varying
types of molecules (Page 825, Column 2 bridging Page 826, Column 1).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from Oh to include the electroporation for the purpose of effective gene transfer as taught by Mohr on
the cells removed from the microcarriers, where electroporation occurs prior to adhering the cells
again, to the microcarriers, because electroporation is effective and an efficient method for
loading hESCs with varying types of molecules as taught by Mohr. One of ordinary skill in the
art would have had a reasonable expectation of success in doing so because gene transfer can
occur via electroporation by using the electric field to open the pores of the membrane without
destroying the cell due to excess pores in the membrane and transfection to occur.
Oh and Mohr do not teach the process of dissolving the microcarriers from the adherent
cells by use of a chelator.
Caracci teaches a method of culturing cells including culturing the cells on microcarriers
as well as the process of contacting cultured cells with a mixture of pectinase and a chelator to
separate the cells from the article [0009]-[0012]. Caracci teaches the methods ofreleasing the
cell culture from the microcarrier by diluting in a physiological buffer. Caracci teaches in
example 5-b the process of harvesting cultured cells from the microcarrier by dissolving them in
a mixture of pectinase and chelator till the beads are dissolved completely within 10 minutes
[0094]. Caracci teaches that the use of enzymes should be limited due to the damaging effects of
enzymes, such as proteases, on the cells [0005]. Caracci teaches the use of a chelator to dissolve
the microcarriers for the purpose of minimizing damage to the cells [0154]-[0179].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage. One of
ordinary skill in the art would have had a reasonable expectation of success in doing so because
the use of a chelator with an enzyme, such as pectinase, provides the ability to break down the
microcarrier without the possibility of disrupting the stability or structural integrity of the cell
itself.
Regarding claim 3, Oh teaches hES cells adhered to matrigel-coated cellulose
microcarriers for growth, the cells adhered to the microcarriers are within 3D suspension
cultures, where the cells are removed from the microcarriers via mechanical or enzymatic
dissociation (Page 220, Column 1, Paragraph 3; Pages 225-227, Microcarrier cultures of hESC
in static and agitated conditions). Oh teaches after the removal of the cells from the
microcarriers, the cells were re-attached to the microcarriers in the suspension (Page 220,
Column 1, Paragraph 4).
Regarding claims 4, 6 and 7, Oh teaches hES cells adhered to matrigel-coated cellulose
microcarriers for growth, the cells adhered to the microcarriers are within 3D suspension
cultures, where the cells are removed from the microcarriers via mechanical or enzymatic
dissociation (Page 220, Column 1, Paragraph 3; Pages 225-227, Microcarrier cultures of hESC
in static and agitated conditions). Oh teaches after the removal of the cells from the
microcarriers, the cells were re-attached to the microcarriers in a second suspension (Page 220,
Column 1, Paragraph 4).
Oh and Mohr does not teach wherein the first substrate comprises a first dissolvable microcarrier particle, wherein the second substrate comprises a second dissolvable microcarrier particle and a dissolution process for dissolving the second microcarrier particle to harvest the cells or cell products.
Caracci teaches a method of culturing cells including culturing the cells on microcarriers
as well as the process of contacting cultured cells with a mixture of pectinase and a chelator to
separate the cells from the article [0009]-[0012]. Caracci teaches the methods ofreleasing the
cell culture from the microcarrier by diluting in a physiological buffer. Caracci teaches in
example 5-b the process of harvesting cultured cells from the microcarrier by dissolving them in
a mixture of pectinase and chelator till the beads are dissolved completely within 10 minutes
[0094]. Caracci teaches that the use of enzymes should be limited due to the damaging effects of
enzymes, such as proteases, on the cells [0005]. Caracci teaches the use of a chelator to dissolve
the microcarriers for the purpose of minimizing damage to the cells [0154]-[0179].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage. One of
ordinary skill in the art would have had a reasonable expectation of success in doing so because
the use of a chelator with an enzyme, such as pectinase, provides the ability to break down the
microcarrier without the possibility of disrupting the stability or structural integrity of the cell
itself.
Regarding Claim 8, 11, 12 and 40, Oh teaches the process of lysing the isolated cells
after removal from the second suspension (Page 227, Column 1 bridging Column 2). Oh teaches
hES cells adhered to matrigel-coated cellulose microcarriers for growth, the cells adhered to the
microcarriers are within 3D suspension cultures, where the cells are removed from the
microcarriers via mechanical dissociation (Page 220, Column 1, Paragraph 3; Pages 225-227, Microcarrier
cultures of hESC in static and agitated conditions).
Oh and Mohr do not teach the process of dissolving the microcarriers from the adherent
cells by use of a chelator.
Caracci teaches a method of culturing cells including culturing the cells on microcarriers
as well as the process of contacting cultured cells with a mixture of pectinase and a chelator to
separate the cells from the article without the use of protease [0009-0012 and 0036]. Caracci teaches the methods ofreleasing the cell culture from the microcarrier by diluting in a physiological buffer. Caracci teaches in example 5-b the process of harvesting cultured cells from the microcarrier by dissolving them in a mixture of pectinase and chelator till the beads are dissolved completely within 10 minutes [0094]. Caracci teaches that the use of enzymes should be limited due to the damaging effects of enzymes, such as proteases, on the cells [0005]. Caracci teaches the use of a chelator to dissolve the microcarriers for the purpose of minimizing damage to the cells [0154]-[0179].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage. One of
ordinary skill in the art would have had a reasonable expectation of success in doing so because
the use of a chelator with an enzyme, such as pectinase, provides the ability to break down the
microcarrier without the possibility of disrupting the stability or structural integrity of the cell
itself.
Regarding Claim 9, Oh and Mohr do not teach the method of dissolving the microcarriers
from the adherent cells using a chelator, specifically EDTA.
Caracci teaches the use of dissolving the microcarriers from the adherent cells using a
chelator, specifically EDTA [0178].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage. One of
ordinary skill in the art would have had a reasonable expectation of success in doing so because
EDTA is a commonly used chelating agent for the purpose of dissolving the microcarrier without
damaging the adherent cells.
Regarding Claim 10, Oh and Mohr in combination do not specify the centrifugation of
the cells from the second suspension.
Caracci teaches the use of separation of the cells from the remnants of the microcarriers
by centrifugation, decantation, filtration, or a similar process [0070]. More specifically, Caracci
teaches in example 19 after re-suspension in a second culture medium with microcarriers, the
process of separating the cells from the second suspension via centrifugation [0133].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the process of
centrifugation because the process of centrifugation is to remove remnants of the microcarriers
from the adherent cells as well as remove the cells from the second suspension as taught by
Caracci. One of ordinary skill in the art would have had a reasonable expectation of success in
doing so because in order to completely separate the cells from the microcarriers as well as the
second suspension, the cells would need to be centrifugated out.
Regarding Claim 13, Oh and Mohr do not teach a dissolution step that does not including
washing.
Caracci teaches in example 12 of the dissolution process that the microcarriers are
dissolved without the process of a washing step [0114].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the processes listed
above as well as not including a washing step within the process of dissolution of the microcarriers from the adherent cells because extensive cell loss due to the extensive process of
removing the adherent cells from the microcarriers as taught by Caracci. One of ordinary skill in
the art would have had a reasonable expectation of success in doing so because extensive cell
loss due to the extensive process of removing the adherent cells from the microcarriers.
Regarding Claim 15, Oh and Mohr do not teach a predetermined time for the dissolution
process.
Caracci teaches the use of the chelator for the process of dissolving the
beads/microcarrier for a predetermined amount of time that is less than one hour [0071]. As per
MPEP 2131.03 Anticipation of Ranges, prior art which teaches a range overlapping the claimed
range anticipates if the prior art discloses the claimed range with sufficient specificity.
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the processes listed
above as well as including a predetermined amount of time for the process of dissolution of the
microcarriers from the adherent cells because the chemical reaction that occurs when an enzyme
is added to a substrate to catalyze a reaction creates a known window of time as taught by
Caracci. One of ordinary skill in the art would have had a reasonable expectation of success in
doing so because the chemical reaction that occurs when an enzyme is added to a substrate to
catalyze a reaction creates a known window of time. Thus, it would be expected to include a
known or predetermine amount of time that it takes to dissolve the microcarrier from the
adherent cells.
Regarding claim 19, Oh does not teach the use of electroporation or the time in which
electroporation needs to be used.
Mohr teaches electroporation is completed in short pulse times of 0.5ms or more was
required for GST-GFP loading and DNA transfection (Page 830, Column 2).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the processes listed
above as well as the process of electroporation for the purpose of effective gene transfer taught
by Mohr. One of ordinary skill in the art would have had a reasonable expectation of success in
doing so because gene transfer can only occur via electroporation within a certain time window
due to the electric field opening the pores of the membrane without destroying the cell due to
excess pores in the membrane.
Claims 30, 34, 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al (Stem Cell Research, 2, pgs 219-230; 2009; Cited in a prior action) in view of Mohr et al (biotechnol. Prog. 22, Pgs 825-834; 2006; cited in a prior action) and Caracci et al (US 2018/0179489; Published 06/28/2018; cited in a prior action) as applied to claims 1, 3, 4, 6-13, 15, 19 and 40 and in further view of Maxwell et al (Journal of Virological Methods 63 (1997) l 29-136). This is a new rejection, necessitated by the amendment filed 10/29/2025.
The teachings of Oh, Mohr and Caracci are described and applied above.
Regarding claim 30, Oh teaches the development of a facile and robust method for maintaining undifferentiated hESC in three-dimensional (3D) suspension cultures on Matrigelcoated microcarriers achieving 2- to 4-fold higher cell densities than those in 2D colony cultures (Page 219, Abstract). Oh teaches hES cells adhered to matrigel-coated cellulose microcarriers for growth, the cells adhered to the microcarriers are within 3D suspension cultures, where the cells are removed from the microcarriers via mechanical or enzymatic dissociation (Page 220, Column 1, Paragraph 3; Pages 225-227, Microcarrier cultures of hESC in static and agitated conditions). Oh teaches after the removal of the cells from the microcarriers, the cells were re-attached to the microcarriers in a suspension (Page 220, Column 1, Paragraph 4).
Oh does not teach the use of electroporation, after harvesting, for transfection of the adherent cells. Oh does not teach that after electroporation, the cells are recovered on a second substrate in suspension or in another suspension format.
Mohr teaches hESCs cultured on matrigel-coated plates where the adherent hESCs were
mechanically removed from the plates for electroporation of DNA containing an eGFP cassette
(Page 826, Column 1, Paragraph 4). Mohr teaches after electroporation the hESCs were cultured
by adhering back on the matrigel-coated plates (Page 826, Column 1, Paragraph 4). Mohr
teaches that electroporation is effective and an efficient method for loading hESCs with varying
types of molecules (Page 825, Column 2 bridging Page 826, Column 1).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from Oh to include the electroporation for the purpose of effective gene transfer as taught by Mohr on
the cells removed from the microcarriers, where electroporation occurs prior to adhering the cells
again to the microcarriers, because electroporation is effective and an efficient method for
loading hESCs with varying types of molecules as taught by Mohr. One of ordinary skill in the
art would have had a reasonable expectation of success in doing so because gene transfer can
occur via electroporation by using the electric field to open the pores of the membrane without
destroying the cell due to excess pores in the membrane and transfection to occur.
Oh and Mohr do not teach the process of dissolving the microcarriers from the adherent
cells by use of a chelator.
Caracci teaches a method of culturing cells including culturing the cells on microcarriers
as well as the process of contacting cultured cells with a mixture of pectinase and a chelator to
separate the cells from the article [0009]-[0012]. Caracci teaches the methods ofreleasing the
cell culture from the microcarrier by diluting in a physiological buffer. Caracci teaches in
example 5-b the process of harvesting cultured cells from the microcarrier by dissolving them in
a mixture of pectinase and chelator till the beads are dissolved completely within 10 minutes
[0094]. Caracci teaches that the use of enzymes should be limited due to the damaging effects of
enzymes, such as proteases, on the cells [0005]. Caracci teaches the use of a chelator to dissolve
the microcarriers for the purpose of minimizing damage to the cells [0154]-[0179].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage. One of
ordinary skill in the art would have had a reasonable expectation of success in doing so because
the use of a chelator with an enzyme, such as pectinase, provides the ability to break down the
microcarrier without the possibility of disrupting the stability or structural integrity of the cell
itself.
Oh, Mohr and Caracci does not teach wherein the transfected adherent cells produce viral vectors.
Maxwell teaches AA V recombinants are generally produced by transient co-transfection methods since it has proven difficult to generate stable packaging cell lines (Page 129, Abstract). Maxwell teaches substantially higher yields of transducing virus can be obtained using electroporation of the NB324K cell line for the production of viral vectors (Page 130, Column 1).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage taught from Caracci, to include the production of viral vectors from the cell culture line. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because the substantially higher yields of transducing virus can be obtained using electroporation of the NB324K cell line for the production of viral vectors.
Regarding Claim 34, Oh and Mohr do not teach specifically the use of a chelator to
dissolve the microcarrier from the adherent cells.
Caracci teaches the process of harvesting cultured cells from the microcarrier by
dissolving them in a mixture of pectinase and chelator [0065].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, to include the processes listed
above as well as the process of dissolving the microcarriers using a chelator and pectinase in
order to retrieve the adherent cells without causing damage. One of ordinary skill in the art
would have had a reasonable expectation of success in doing so because EDTA is a commonly
used chelating agent because of its ability to dissolve the microcarriers without damaging the
adherent cells as taught by Caracci. One of ordinary skill in the art would have had a reasonable
expectation of success in doing so because EDTA is a commonly used chelating agent for the
purpose of dissolving the microcarrier without damaging the adherent cells.
Regarding claim 41 and 42, Oh, Mohr and Caracci do not teach transfecting the adherent cells with a viral vector.
Maxwell teaches substantially higher yields of transducing virus can be obtained using electroporation, rather than calcium phosphate transfection (Page 129, Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the process of culturing the adherent cells from
Oh with the process of transfection of the cells taught from Mohr, the process of
dissolving the microcarriers using a chelator and pectinase because using a chelator and
pectinase is needed in order to retrieve the adherent cells without causing damage taught from Caracci, to include the production of viral vectors from the cell culture line. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because the substantially higher yields of transducing virus can be obtained using electroporation of the NB324K cell line for the production of viral vectors.
Response to Arguments - Claim Rejections - 35 USC § 103
The previous rejection of the claims 1-6, 19 and 30 under 35 U.S.C. 103 as being unpatentable over Oh et al (Stem Cell Research, 2, pgs 219-230; 2009) in view of Mohr et al (biotechnol. Prog. 22, Pgs 825-834; 2006) has been withdrawn in view of Applicant’s amendments to the claims filed on 10/29/2025.
The previous rejection of claims 7-13, 15, 34 and 40 under 35 U.S.C. 103 as being unpatentable over Oh et al (Stem Cell Research, 2, pgs 219-230; 2009) in view of Mohr et al (biotechnol. Prog. 22, Pgs 825-834; 2006) as applied to claims 1-6, 19 and 30 and in further view of Caracci et al (US 2018/0179489; Published 06/28/2018) has been maintained and rewritten to address the amendments to the claims filed on 10/29/2025.This rejection was made in the Office Action mailed on 07/29/2025 over claims 7-13, 15, 34 and 40, and has been rewritten as claims 1, 3, 4, 6-13, 15, 19 and 40 under 35 U.S.C. 103 as being unpatentable over Oh et al (Stem Cell Research, 2, pgs 219-230; 2009) in view of Mohr et al (biotechnol. Prog. 22, Pgs 825-834; 2006) and Caracci et al (US 2018/0179489; Published 06/28/2018) to address additional claims as necessitated by the amendment filed on 10/29/2025.
The response asserts the examiner failed to establish a case of prima facie obviousness because the examiner failed to consider each and every element of the independent claims 1 and 30 in the office action, and therefore, failed to articulate reasons why each and every element in claims 1 and 30 would have been obvious based on the applied references.
The response asserts that for the same reasons as claim 1, Oh and Mohr fail to disclose or render obvious all the limitations of the claim as a whole and therefore does not show prima facie obviousness. The response continues to assert that the references Oh and Mohr do not provide the teachings of the instant claim 1, alone or in combination, and the rejection should therefore be withdrawn.
The response asserts that, with regards to claim 30, the references Oh and Mohr fail to disclose or render obvious "culturing the adherent cells on microcarriers in an initial suspension, harvesting adherent cells from the microcarriers in the initial suspension, after harvesting the adherent cells, transfecting adherent cells using electroporation; after the step of transfecting, suspending the transfected adherent cells in a culturing suspension, and contacting the transfected adherent cells with microcarrier particles to adhere the cells thereto, wherein the microcarrier particles with the adhered cells are suspended in the culturing suspension.".
Applicant argues that the claims must be read as a whole-not just as independent elements. The response asserts that due to the request of withdrawal of the rejection of the independent claims 1 and 30, that all other dependent claim rejections be withdrawn as well.
Applicant’s arguments are not found to be persuasive because the previous rejection has been rewritten to address the limitations added due to the amendments filed on 10/29/2025.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, and as established above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process of culturing the adherent cells from Oh with the process of transfection of the cells taught from Mohr, to include the process of dissolving the microcarriers using a chelator and pectinase because using a chelator and pectinase is needed in order to retrieve the adherent cells without causing damage. One would have been motivated to do so because the use of a chelator with an enzyme, such as pectinase, provides the ability to break down the microcarrier without the possibility of disrupting the stability or structural integrity of the cell itself as taught by Caracci.
The previous rejection of claims 41 and 42 under 35 U.S.C. 103 as being unpatentable over Oh et al (Stem Cell Research, 2, pgs 219-230; 2009) in view of Mohr et al (biotechnol. Prog. 22, Pgs 825-834; 2006) as applied to claims 1-6, 19 and 30 and in further view of Yang et al (US 2016/0017291 Al; Published 01/21/2016) is withdrawn in view of the amendments to the claims filed on 10/29/2025.
Citation of Pertinent Prior Art
Rodrigues et al (Biotechnology Journal 14(4), pgs. 1-12) teaches a comparison analysis of static methods of hiPSCs versus the use of culturing hiPSCs on dissolvable microcarriers where the results showed 92% harvesting yield when using dissolvable microcarriers versus static culturing methods resulting in 45% harvesting yield (Page 1, Abstract). This art is cited for the record of another prior art that teaches elements of the claimed invention.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER A DUNSTON can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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