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 .
DETAILED ACTION
Amendments
In the reply filed 02/03/2026, Applicant has amended claims 1, 2, 6 and 8-14, and added new claims 17-19.
Claim Status
Claims 1-19 are pending. Claims 1, 2, 6, 8-14 have been amended, claims 17-19 have been added by Applicants’ amendment filed on 2/3/2026. No claims were canceled.
Claims 7-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/15/2025.
Claims 1-6 and 17-19 are considered on the merits.
Withdrawn Claim Objections
The prior objection to claims 1 and 6 because of typographical errors is withdrawn in light of Applicant’s amendment to the claims.
Withdrawn Claim Rejections - 35 USC § 112
The prior rejection of claims 1-6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for insufficient antecedent basis is withdrawn in light of Applicant’s amendment to claim 1 to recite “the macrocarrier".
New Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the term “MatrigelTM”, which is a trademark. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the basement membrane matrix and, accordingly, the identification/description is indefinite.
Withdrawn Claim Rejections - 35 USC § 102 and 103
Claim Rejections - 35 USC § 102
The prior rejection of claims 1-2 rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nestor et al., (Stem Cell Research. 2013; 10: 454-463. Cited in IDS 09/01/2022) has been withdrawn.
Claim Rejections - 35 USC § 103
The prior rejection of claims 1-3 rejected under 35 U.S.C. 103 as being unpatentable over Nestor et al., (Stem Cell Research. 2013; 10: 454-463. Cited in IDS 09/01/2022) has been withdrawn.
The prior rejection of claims 1-2 and 4-5 rejected under 35 U.S.C. 103 as being unpatentable over Nestor et al., (Stem Cell Research. 2013; 10: 454-463. Cited in IDS 09/01/2022) ) in view of Mandalam et al., (WO 2007/002086 A2. Cited in IDS 09/01/2022) has been withdrawn.
The prior rejection of claims 1-2 and 6 under 35 U.S.C. 103 as being unpatentable over Haenseler et al., (Stem Cell Reports. 2017; 8: 1727-1742) in view of Nestor et al., (Stem Cell Research. 2013; 10: 454-463. Cited in IDS 09/01/2022) has been withdrawn.
Claim 1 has been amended to recite new limitation “the macrocarrier is a porous mesh membrane having a pore size in the range from about 5 to about 180 µm”, which is not taught by Nestor who teaches a mesh insert having a pore size of 0.4 µm.
A response to Applicant’s arguments with regard to a withdrawn rejection is moot. A response to any argument pertaining to a new or maintained rejection can be found below.
New Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 17-18 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hong et al., (Tissue Eng Part C Methods. 2015;21(3):322-329).
With respect to claim 1, Hong teaches a method of culturing embryoid bodies on a porous membrane (e.g., abstract, also see Fig 1A from Day 8 and Fig 1B), and teaches the embryoid bodies adhere on the porous membrane and migrate through the permeable membrane (see e.g., abstract and Fig 1B), thus teaches a method for providing structural support to embryoid bodies for adherence and outgrowth in preamble of claim 1.
In regard to step (a) providing embryoid bodies, Hong teaches the hESCs are cultured in suspension to form embryoid bodies (see p. 323, left col, last para – right col, para 1, and see Fig 1A for experimental scheme from Day 6-8).
In regard to step (b) seeding the embryoid bodies onto a porous macrocarrier, Hong teaches at Day 8, the embryoid bodies are plated onto the porous membrane transwell inserts with 8 µm pores and teaches the embryoid bodies are attached to the membrane (see p. 323, right col, para 1 and see Fig 1B), thus teaches seeding the embryoid bodies onto a macrocarrier (i.e., the porous membrane) thereby obtaining a macrocarrier with adherent embryoid bodies, wherein the macrocarrier is a porous mesh membrane having a pore size in the range from about 5 to about 180 µm.
In regard to step (c) culturing the macrocarrier with the adherent embryoid bodies in a cell culture medium, Hong teaches the embryoid bodies on the porous membrane are cultured in EGM2-MV for 5 days (see p. 323, right col, para 1 and see Fig 1A).
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With respect to claim 2 (ii) directed to the macrocarrier being coated with a material facilitating cell adherence, claim 17 directed to the material facilitating cell adherence being an extracellular matrix component, and claim 18 directed to the extracellular matrix component being collagen, Hong teaches the porous membrane of the transwell inserts is coated with 0.1% gelatin (it is noted that gelatin is a partially hydrolyzed form of collagen) and teaches the embryoid bodies are attached to the membrane (see p. 323, right col, para 1), thus teaches the macrocarrier is coated with a material facilitating cell adherence that is an extracellular matrix component being collagen.
Accordingly, Hong anticipates instant claims.
Response to Traversal:
Applicant’s arguments filed on 02/03/2026 are acknowledged.
Applicant argues that Nestor teaches a mesh insert having a pore size of 0.4 µm, but does not teach or suggest the new limitation “a porous mesh membrane having a pore size in the range from about 5 to about 180 µm” (Remarks, p. 6-7).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection by Nestor is withdrawn. However, as necessitated by amendment, a new ground of rejection is made by Hong, who teaches a method for providing structural support for embryoid bodies on a porous membrane having a pore size of 8 µm, within the claimed range.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al., (Tissue Eng Part C Methods. 2015;21(3):322-329) in view of Nestor et al., (Stem Cell Research. 2013; 10: 454-463. Cited in IDS 09/01/2022) and Mandalam et al., (WO 2007/002086 A2. Cited in IDS 09/01/2022).
Claims 1-2 and 17-18 are anticipated by Hong. Thus, Hong makes obvious claims 1-2 and 17-18.
With respect to claim 3 directed to the seeding density, however, Hong does not specifically teach the seeding density of the embryoid bodies on the macrocarrier.
Nestor teaches a method of culturing embryoid bodies on a mesh insert in a 6-well plate (see e.g., abstract and p. 455, left col, para 3), and teaches the mesh insert provides a physical support for the tissue to spread out and grow in a non-spherical manner (see p. 462, left col, last para). Nestor teaches multiple embryoid bodies are seeded on one mesh insert (see e.g., Fig 1A for at least 4 embryoid bodies seeded at Day 14) and suggests the seeding density of the embryoid bodies on the insert shown in Fig 1A is at least about 4 / 4.5 cm2 = 0.9 per cm2, within the claimed range of about 1 embryoid body per cm2 (it is noted that Fig 1B shows the diameter of the insert is about 2/3 of the diameter of the well in a 6-well plate, which is known to be about 3.6 cm, thus the diameter of the insert is about 2.4 cm and the area of the insert is about 4.5 cm2).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for providing structural support to embryoid bodies by seeding them onto a macrocarrier disclosed by Hong, by choosing to seed the embryoid bodies at a density within the claimed range as suggested by Nestor with a reasonable expectation of success. Since Nestor suggests a seeding density within the claimed range (see above), one of ordinary skill in the art would have had a reason to seed the embryoid bodies at the claimed density in order to provide suitable support for the embryoid bodies to spread out and grow on the macrocarrier (see Nestor, p. 462, left col, last para).
Furthermore, MPEP states “generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” and “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. See MPEP 2144.05(II)(A). In the instant case, both Hong and Nestor teach multiple embryoid bodies are seeded onto the macrocarrier to provide physical support for the embryoid bodies to adhere and grow (see Hong Fig 1B and Nestor Fig 1A). Therefore, it would have been obvious for one ordinary skill in the art to apply the claimed seeding density because they are the results of “routine optimization”.
With respect to claim 4 directed to the macrocarrier floating freely in the medium and claim 5 directed to the macrocarrier being subject to dynamic movement during step (c), however, Hong uses a transwell insert to culture EBs for 5 days, but is silent on the macrocarrier floating freely in the medium in claim 4 or the macrocarrier being subject to dynamic movement during culturing in claim 5.
Nestor teaches the embryoid bodies rest on the surface of the mesh insert with the medium underneath (p. 455, left col, “Material/methods”, para 2, and see Fig 1B diagram), indicating the macrocarrier floats in cell culture medium.
Mandalam teaches a method of suspension culture of embryonic stem cells (see e.g., abstract). Mandalam teaches the suspension culture may contain particulate carriers that create surfaces within the suspension, but still provide the benefits of culturing the cells in a three-dimensional space, and one type of such carriers is disk-shaped culture plastic, such as the Fibra-cel Disks (p. 9, lines 15-16 and 20-21). Mandalam teaches the suspension culture may be on a shaker for long-term culture (see Example 4 in page 17 and Fig 7). Thus, Mandalam suggests a method of suspension culture for stem cells using a macrocarrier on a shaker, thus suggests the macrocarrier floats freely in the cell culture medium (i.e., in suspension culture, related to claim 4), and the macrocarrier is subject to dynamic movement during culturing (e.g., on a shaker, related to claim 5).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for providing structural support to embryoid bodies by seeding them onto a porous membrane assembled in a transwell insert disclosed by Hong, by substituting with a form of stand-alone porous membrane as suggested by Nestor and by combining suspension culture on a shaker such that the macrocarrier floats freely in the cell culture medium and is subject to dynamic movement during culturing as suggested by Mandalam with a reasonable expectation of success. Since Nestor reduces to practice a form of stand-alone porous membrane to support embryoid bodies that may float in cell culture medium (p. 455, left col, “Material/methods”, para 2, and see Fig 1B diagram), and since Mandalam teaches the suspension culture maximizes the production capacity of the culture environment and allows for bulk proliferation in a more cost-effective manner, which facilitates commercial production of important products for use in human therapy (e.g., abstract) and the suspension culture on a shaker is suitable for long-term culture (e.g., Example 4), one of ordinary skill in the art would have had a reason to substitute with a form of stand-alone porous membrane as suggested by Nestor and combine suspension culture on a shaker as suggested by Mandalam in the method of Hong in order to maximize the production capacity and to enable long-term culture of embryoid bodies.
With respect to claim 19 directed to the material facilitating cell adherence being a synthetic coating of poly-ornithine, however, Hong is silent on the material facilitating cell adherence being a synthetic coating of poly-ornithine.
Mandalam teaches a method of culturing hESCs to form embryoid bodies and replating the embryoid bodies onto polyornithine-coated chambers (see e.g., p. 16, the 2nd last para and p. 6, the 3rd last para).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for providing structural support for embryoid bodies adherence by substituting the coating a porous membrane with gelatin disclosed by Hong, by coating the porous membrane with polyornithine as suggested by Mandalam with a reasonable expectation of success. Since Mandalam reduces to practice coating a macrocarrier with polyornithine that is suitable for embryoid bodies adherence and growth (see e.g., p. 16, the 2nd last para and p. 6, the 3rd last para), one of ordinary skill in the art would have had a reason to substitute with coating the porous membrane with polyornithine as suggested by Mandalam in order to improve adherence and growth of embryoid bodies.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 02/03/2026 are acknowledged.
Applicant argues that Nestor teaches a mesh insert having a pore size of 0.4 µm, but does not teach, suggest or make obvious the new limitation “a pore size in the range from about 5 to about 180 µm”, and Mandalam does not cure the deficiencies of Nestor (Remarks, p. 7, section A – p. 8, section B).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection over Nestor and Mandalam is withdrawn. However, as necessitated by amendment, a new ground of rejection is made by Hong in view of Nestor and Mandalam. Specifically, Hong teaches a method for providing structural support for embryoid bodies on a porous membrane having a pore size of 8 µm, within the claimed range.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Haenseler et al., (Stem Cell Reports. 2017; 8: 1727-1742. Prior art of record) in view of Hong et al., (Tissue Eng Part C Methods. 2015;21(3):322-329).
With respect to claim 6, Haenseler teaches a method for producing microglial precursor cells and microglia cells (see e.g., abstract and Fig 1C), thus teaches the preamble of claim 6.
In regard to claim 6 (i) referring to the steps of claim 1, Haenseler teaches defined-size embryoid bodies (EBs) are formed using Aggrewells (p. 1728, right col, “Results” para 1, see Fig 1C), thus teaches providing embryoid bodies in claim 1 (a).
However, although Haenseler teaches the embryoid bodies are plated into large-format flasks (i.e., a macrocarrier) with medium and most EBs adhere (p. 1728, right col, “Results” para 1), thus teaches seeding the EBs onto a macrocarrier thereby obtaining a macrocarrier with adherent EBs in claim 1 (b), Haenseler is silent on the macrocarrier being a porous mesh membrane having a pore size in the range from about 5 to about 180 µm in claim 1 (b) or being coated with a material facilitating cell adherence such as an extracellular matrix component collage as set forth in the 102 rejection of claims 2 and 17-18 above.
Hong teaches a method of culturing embryoid bodies on a porous membrane (see e.g., abstract and Fig 1B), and teaches the embryoid bodies adhere on the porous membrane (see e.g., abstract and Fig 1B), thus teaches a method for providing structural support to embryoid bodies for adherence and outgrowth in preamble of claim 1. In regard to claim 1 (b) seeding the embryoid bodies onto a porous macrocarrier, Hong teaches at Day 8, the embryoid bodies are plated onto the porous membrane transwell inserts with 8 µm pores and teaches the embryoid bodies are attached to the membrane and are cultured in EGM2-MV medium for 5 days (see p. 323, right col, para 1 and see Fig 1B and 1A), thus teaches seeding the embryoid bodies onto a macrocarrier thereby obtaining a macrocarrier with adherent embryoid bodies, wherein the macrocarrier is a porous mesh membrane having a pore size in the range from about 5 to about 180 µm in claim 1 (b). Hong teaches the porous membrane is coated with 0.1% gelatin (it is noted that gelatin is a partially hydrolyzed form of collagen) and teaches the embryoid bodies are attached to the membrane (see p. 323, right col, para 1), thus teaches the macrocarrier is coated with a material facilitating cell adherence that is an extracellular matrix component being collagen in claims 2 and 17-18.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for producing microglial precursor cells and microglia cells through embryoid bodies disclosed by Haenseler, by substituting the culture macrocarrier with a porous mesh membrane having pore size in the claimed range and coated with the claimed material as suggested by Hong with a reasonable expectation of success. Since Haenseler aims to culture the adherent embryoid bodies to differentiate into embryonic macrophage precursors and further into microglia (see Fig 1C) and teaches the embryonic-like macrophage precursors (i.e., microglia precursors) emerge into the supernatant (p. 1728, right col, “Results” para 1), and since Hong reduces to practice a porous membrane for supporting embryoid bodies that facilitates collecting cells migrating out from the embryoid bodies through the permeable membrane (see e.g., abstract), one of ordinary skill in the art would have had a reason to substitute with a porous membrane suggested by Hong in the method of Haenseler in order to facilitate collecting cells emerging from the embryoid bodies using a permeable membrane (see e.g., Hong abstract).
In regard to claim 1 (c), Haenseler teaches culturing the adherent EBs in cell-culture medium (p. 1728, right col, “Results” para 1), and Hong teaches the EBs are cultured in EGM2-MV for 5 days (see p. 323, right col, para 1 and see Fig 1A).
In regard to claim 6 (ii), Haenseler teaches continuing cultivation of the adherent embryoid bodies in cell culture medium with M-CSF and IL-3 (see Fig 1C) to differentiate into embryonic macrophage precursors (see Fig 1C “pMacpre”, which stands for PSC derived macrophage/microglia precursors) and further differentiate into microglia (“co-pMG”, which stands for PSC derived microglia in co-culture with pNeuron, see Fig 1C rightmost panel and see the acronyms in Fig 1B). Haenseler teaches the embryonic-like macrophage precursors (i.e., PSC derived macrophage/microglia precursors) emerge into the supernatant (p. 1728, right col, “Results” para 1).
In regard to claim 6 (iii), Haenseler teaches the macrophage/microglia precursors can simply be harvested by collecting the supernatant without disrupting the EBs (p. 1728, right col, “Results” para 1), thus teaches claim 6 (iii) harvesting the microglial precursor cells released into the medium.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 02/03/2026 are acknowledged.
Applicant first argues that Haenseler does not teach, suggest or make obvious the limitation the “macrocarrier is a porous membrane having a pore size in the range from about 5 to about 180 µm”, and Nestor does not cure the deficiencies of Haenseler (Remarks, p. 8, section C).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection over Haenseler and Nestor is withdrawn. However, as necessitated by amendment, a new ground of rejection is made over Haenseler in view of Hong. Specifically, Hong teaches a method for providing structural support for embryoid bodies on a porous membrane having a pore size of 8 µm.
Applicant further argues that the present invention provides unexpected and surprising results: (1) mesh membranes with a pore size between 5 μm and 180 μm provide excellent supports to generate human iPSC-derived macrophage- and microglia-like/-precursor cell types in dynamic culture. (2) the seeded meshes can be placed in a non-tissue culture format to ease the accessibility and harvest of the derived cells from the supernatant. The non-tissue culture format and dynamic culture also prevent the released cells from adhering to the plate or meshes, therefore easing the harvesting procedure further, with a high degree of purity. (3) the claimed novel protocol allows for upscaling of the production of microglial precursors, microglia/-like and macrophage-like cells and is also suitable for long-term cell differentiation. (4) microglia cells and microglial precursors cells produced by the methods of the invention are surprisingly well-suited for cryopreservation resulting in higher cell recovery rates after cryopreservation as compared to cells prepared by methods of the prior art.
Applicant’s arguments have been fully considered but they are not persuasive.
In response to Applicant’s arguments, as a first matter, it is well established that the burden for establishing unexpected results lies with applicant. Applicant's attention is also directed to M.P.E.P. 716.02(b), which teaches that “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.' Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). In the instant case, Applicant merely states that the invention “provides excellent supports”, “eases the accessibility”, and “allows for upscaling” in the above (1), (2) and (3) arguments, but does not provide any factual evidence supporting that they are unexpected, because there has been no provided indication of what one of ordinary skill in the art would expect with regard to a mesh membrane supporting EBs or a dynamic culture allowing for upscaling, or whether the seeded meshes can be placed in a “non-tissue culture format” (it is noted that this “non-tissue culture format” is not defined in the specification, and the plain meaning simply refers to a format that is NOT suitable for tissue culture. Thus, one of ordinary skill in the art would not have apprised how the EBs can be cultured in a “non-tissue culture format” as argued by Applicant). In regard to (4) microglia cells and microglial precursors cells produced by the methods of the invention are surprisingly well-suited for cryopreservation as compared to cells prepared by methods of the prior art. As discussed above, M.P.E.P. guidance makes clear that 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. Applicant has not established that the observed differences are unexpected.
Furthermore, MPEP § 2145 states that a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements that claimed compound possesses unusually low immune response or unexpected biological activity that is unsupported by comparative data held insufficient to overcome prima facie case of obviousness). In the instant case, regarding Argument (1), as stated supra, Hong teaches mesh membranes with a pore size between 5 μm and 180 μm provide excellent supports to embryoid bodies (see above). Regarding Argument (2), Hong specifically teaches that “[o]ur findings demonstrate an ease with which hESCs-MSCs can be effectively isolated using the porous membrane”, thus teaches that the seeded meshes enable easing accessibility and harvest of the derived cells. Additionally, Haenseler teaches the macrophage/microglia precursors can simply be harvested by collecting the supernatant without disrupting the EBs (p. 1728, right col, “Results” para 1). Regarding Argument (3) of upscaling, Mandalam teaches the suspension culture maximizes the production capacity of the culture environment and allows for bulk proliferation in a more cost-effective manner, which facilitates commercial production of important products for use in human therapy (e.g., abstract). Thus, one of ordinary skill in the art would have expected the results based on the teaching from the prior art. Regarding (4) cells produced in this invention are surprisingly well-suited for cryopreservation as compared to cells prepared by methods of the prior art, Applicant seems to refer to the specification page 24 comparing the instant method with the method of Haenseler. It is noted that Applicant states that “the protocol used in the present application was based on the protocol of WO 2010/125110 A1 with some modifications” (specification, p. 23, last para), and the protocol of WO 2010/125110 A1 differs substantially from Haenseler in regard to culturing with different growth factors and isolating with different methods. Thus, Applicant does not provide side-by-side comparable data supporting the argument that the instant method produces advantageous cells compared to prior art, that is due to the use of a porous membrane.
Finally, MPEP 716.02(d), states that unexpected results must be commensurate in scope with the claimed invention. In the instant case, the purported unexpected results presented by the Applicant were studies performed to produce human iPSC-derived macrophage- and microglia-like/-precursor cell types from embryoid bodies using a mesh membrane in dynamic culture, the seeded meshes being placed in a non-tissue culture format and further comprising cryopreservation and recovery, which is not commensurate in scope with the claimed method for providing structural support to any embryoid bodies for adherence and outgrowth, that does not require dynamic culture, or a non-tissue culture format, or cryopreservation/recovery, nor require the embryoid bodies being differentiated into human iPSC-derived macrophage- and microglia-like/-precursor cell types.
Conclusion
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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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