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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application Nos. 62/516,575 and 62/653,332, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The earliest appearance of the use of an open reading frame (ORF) and use of a regulatory factor configured to inactivate a pluripotency gene appears in PCT/US2018/036552, filed 6/7/18. Claims 10, 12-14, are therefore accorded an earliest priority dated of 6/7/18. The earliest appearance of differentiation resulting in generation of myotubes appears in 62/653,332, filed 4/5/18. Claim 19 is therefore accorded and earliest priority dated of 4/5/18.
Claim Status
Applicant’s arguments and amendments dated 6/27/25 have been received and entered in the application.
Claims 1, 4-5, 10, 12-14, 19, 21, 32, 35, 43-51 are currently pending.
Claims 1, 32 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
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.
Claims 1, 4-5, 10, 12-14, 19, 21, 32, 35, 43-51 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 1 contains the limitation “culturing a population of self-renewing cells… without the use of a scaffold or extracellular matrix”. It is unclear whether this limitation is indicating that the culturing occurs without the presence of any exogenous extracellular matrix (ECM), or whether this limitation is requiring the complete absence of any ECM, including ECM naturally produced by the cultured cells. For examination purposes, this limitation is interpreted as comprising “culturing a population of self-renewing cells… without the use of a scaffold or exogenous extracellular matrix”
Claim Rejections - 35 USC § 112(a)/1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1, 4-5, 10, 12-14, 19, 21, 32, 35, 43-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish if). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G. D. Searie & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See MPEP § 2163.
Claim 1 contains the limitation “without the use of a scaffold or extracellular matrix”. The specification as originally filed is silent as to suspension culture without the use of either a scaffold or ECM as produced by cellular aggregates. The specification describes suspension culture as being performed utilizing a hanging drop or bioreactor. The specification explicitly states that hanging drops result “in spontaneous formation of spheroids”, wherein the cells are “in direct contact and with extracellular matrix components” (([0132], [0216]). With respect to suspension culture in bioreactors, the specification is limited to culture with “micro-scaffolds” or wherein the cells are “induced to form spheroids for propagation in a bioreactor” ([0132], [0144], [0173], Fig. 7). Therefore, it is not clear that at the time of filing applicants had full possession of the invention as presently claimed.
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.
Claim(s) 1, 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa et al., (2001) Tissue-engineered skin aggregates of normal human skin fibroblasts and biodegradable material. J Artif Organs, 4: pp353-356 (hereinafter Furukawa) in view of Lin et al., (2012) Alimentary ‘green’ proteins as electrospun scaffolds for skin regenerative engineering. J Tissue Eng Regen Med, 7: pp. 994-1008 (hereinafter Lin 2012).
Regarding claims 1, 45, Furukawa discloses methods of culturing fibroblasts for use in scaffold based tissue engineering applications (Abstract, Introduction). Furukawa discloses suspending isolated fibroblasts in a rotational culture and cultured until aggregates form, about 24 to 36 hours (Suspension culture, Formation of aggregates of normal human skin fibroblasts, Fig. 1). Furukawa explains that the diameter of aggregates increases with time (Formation of aggregates of normal human skin fibroblasts, Fig. 2). The aggregates are then inoculated into a scaffold composed of polyglycolic acid coated with collagen (Suspension culture, Inoculation of aggregates into the scaffold).
Furukawa does not disclose that the scaffold is a plant based scaffold.
Lin 2012 discloses plant protein based scaffolds for the culture of fibroblasts (Abstract). Lin 2012 explains that allogeneic and xenogeneic scaffolds pose cost and availability limitations, while synthetic alternatives may not possess the necessary biological properties (Introduction). Lin 2012 suggests that plant proteins may be a viable substitute for tissue engineering scaffolds (Introduction). Lin 2012 discloses seeding culturing human dermal fibroblasts on electrospun plant protein scaffolds (2.1.1, 2.3.1-2.3.2). Both corn and soy protein based scaffolds support fibroblast adhesion, spreading, growth and proliferation (3.4.1-3.4.2). Lin 2012 concludes that green proteins are at least as well suited as other known scaffold materials for fibroblast and other cell cultures (3.4.2, Conclusions).
As both Furukawa and Lin 2012 are directed to culture of fibroblasts on scaffolds, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to combine the references as Lin 2012 discloses that plant protein scaffolds may advantageously be used in place of synthetic scaffolds.
Claim(s) 44, 47-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa and Lin 2012 as applied to claims 1, 45 above, and in further view of Lin et al., (2008) Recent advances in three-dimensional multicellular spheroid culture for biomedical research. Biotechnology Journal, 3:pp. 1172-1184 (hereinafter Lin 2008).
Regarding claims 44, 47-48, the combination does not disclose that the bioreactor is a hanging drop bioreactor or a stirred tank bioreactor.
Lin 2008 reviews methods of performing non-adherent, suspension cultures (Abstract). Lin 2008 discloses that rotary systems, hanging drop systems, and spinner flasks are all known means by which to perform suspension culture (4.1, 4.4, Table 1, Fig. 3). Lin 2008 further discloses that spinner flasks and roller bottles are both simple to use and allow for the production of large quantities of cells (4.4, Table 1, Fig. 3). Lin also explains that hanging drop culture allows for precise control of spheroid formation, is inexpensive, and simple to perform (4.1, Table 1, Fig. 3). As Furukawa and Lin each disclose methods of suspension culture it would be obvious to one of ordinary skill in the art that the references could be combined. Lin discloses that each of rotary systems, hanging drop systems, and spinner flasks are well-known equivalents for the formation of spheroid cultures. Therefore, it would be obvious to one of ordinary skill in the art that the systems could be substituted for each other with a reasonable expectation of producing suspension cultures.
The combination of Furukawa, Lin 2012, and Lin 2008 does not disclose that the culture produces a certain amount of cells or that the bioreactor has a certain volume. However, as per MPEP § 2144.04 changes in size or proportion are considered routine expedients requiring no more than ordinary skill in the art. Further, Lin 2008 discloses that both spinner flasks and rotary cultures may be used for large scale production of cells. Therefore, there is a suggestion present in Lin that the culture may be scaled-up as needed.
Claim(s) 1, 32, 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marga et al., US Publication No. 2015/0079238 (hereinafter Marga) over Furukawa et al., Formation of human fibroblast aggregates (spheroids) by rotational culture. Cell Transplantation, 10: pp. 441-445 (hereinafter Furukawa 2001).
Regarding claim 1, Marga discloses edible microcarriers appropriate for use in a bioreactor and edible engineered meat products produced thereon (Abstract, [0020]). Marga explains that many microcarriers are not suitable for use in comestible products as the microcarriers are not edible, are not animal product-free, or raise issues of contamination and/or allergies ([0007]). Therefore, the microcarriers must be removed from the cells in order to form a viable meat product ([0007]). Marga discloses forming microcarriers from materials that are derived only from vegetable and/or non-animal sources ([0015], [0038]). The microcarriers may be formed of plant-derived polysaccharides or polypeptides, such as pectin ([0015], [0017]-[0018]). The microcarrier may also include additives such as flavoring, flavor enhancer, or nutritional enhancer ([0019], [0039]). Cells cultured on the microcarriers may comprise any appropriate cells, such as smooth muscle cells, fibroblasts, satellite cells, or adipocyte precursor cells, and may be derived from animal sources, such as cows or fish ([0020], [0069], [0077]). In some embodiments, several cell types may be cultured simultaneously ([0077]). Preferably, the cells and the microcarriers are cultured in a bioreactor ([0053)]. Once the cells have divided and grown for a sufficient time period, the microcarriers may be combined into an appropriate shape to form an edible meat product ([0050], [0053]-[0057]). Marga explains that advantageously the cells do not have to be removed from the microcarriers as the carriers are edible [0070].
Regarding claim 32, cells cultured on the microcarriers may be derived from animal sources, such as cows or fish ([0020], [0069], [0077]).
Regarding claim 45, the microcarriers may be formed of plant-derived polysaccharides or polypeptides, such as pectin ([0015], [0017]-[0018]).
Regarding claim 46 Marga does not explicitly disclose, that the cells may be derived from salmon, tuna, or shrimp. However, Marga discloses, that cells cultured on the microcarriers may be derived from animal sources, such as cows or fish ([0020], [0069], [0077]). A skilled artisan would understand that the species of salmon and tuna would fall within the discloses genus of fish.
Marga does not disclose that fibroblasts are cultured in a suspension bioreactor without the use of a scaffold prior to seeding on the plant based scaffold.
Furukawa 2001 discloses methods of making human fibroblast aggregates (Abstract, Introduction). Furukawa 2001 explains that aggregates of anchorage dependent cells, like fibroblasts, demonstrate higher retention and viability in suspension cultures than in two dimensional culture (Introduction). Furukawa explains that cells grown in aggregate are consequently highly useful for large scale culture applications (Introduction). Furukawa 2001 discloses suspending individual cells in rotational culture for at least 12 hours (Cell culture). Furukawa 2001 explains that the diameter of aggregates increases over hand (Formation of aggregates of normal human skin fibroblasts). The resultant aggregates demonstrate good viability and ability to migrate onto scaffolds (Discussion).
A skilled artisan would be motivated to use the fibroblasts of Furukawa 2001 in the methods of Marga, as Furukawa 2001 discloses that large numbers of cells may be effectively produced using the disclosed methods. Furukawa also discloses that the cells demonstrate good migratory ability onto scaffolds for further applications.
Claim(s) 1, 4-5, 10, 12, 14, 19, 21, 32, 35, 43-45, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vein, J., US Publication No. 2005/0010965 (hereinafter Vein) in view of Boularaoui et al, (2017) Efficient transdifferentiation of human dermal fibroblasts into skeletal muscle. Tissue Engineering and Regenerative Medicine, 12(2): pp. e918-e936 (hereinafter Boularaoui), Furukawa 2001, and Marga.
Vein discloses methods of making an edible tissue engineered meat product (Abstract). Vein discloses culturing muscle stem cells in vitro and inducing the cells to differentiate into specific types of muscle cells, such as skeletal muscle cells, or smooth muscle cells ([0011], ([0026]). In some embodiments the muscle cells may be combined with other cells such as fat or cartilage cells ([0008]). Vein explains that fattier muscle tissue is generally regarded as tastier, but comes with increased adverse health consequences ([0016]). Therefore, the ratio of muscle to fat cells may be optimized for optimal flavor and health effects ([0016]). Meat products with the desired fat content may be produced by seeding and co-culturing muscle cells and adipocyte cells at a particular ratio ([0037]). Adipocytes may be produced by differentiating stem cells to induce commitment to adipocyte lineage (i.e., pre-adipocytes) and further differentiating to adipocytes ([0033]-[0038]). In some embodiments, the cells may be grown on or in a three-dimensional support structure ([0013]). The support structure may be may of natural or synthetic biomaterials, such as collagen, fibronectin, laminin, or other extracellular matrix proteins ([0013]). Vein explains that bioreactors may be used to provide appropriate physical and mechanical signals for the cells in culture ([0015]). In some embodiments, additional nutrients that are normally lacking in meat products may be added to the product ([0020]).
Regarding claims 32, and 46, Vein discloses that the cells may be derived from any non-human animal cells, including mammals, fish, invertebrates, reptiles, and amphibians ([0009), (0011)].
Regarding claim 43, Vein does not explicitly disclose that the media may contain certain components. However, Vein discloses that stem cells may be cultured in DMEM, Ham’s F-12, or a combination thereof ([0033]). Both DMEM and Ham’s F-12 contain pyruvic acid (i.e., pyruvate). Therefore, it is implicit that Vein discloses culturing the cells in a media containing pyruvate.
Vein does not disclose that the muscle cells are obtained by transdifferentiation of fibroblasts.
Boularaoui discloses methods of efficiently transdifferentiating fibroblasts into skeletal muscle (Abstract). Boularaoui explains that there is a need for a cell population with in vitro myogenic differentiation capacity which is easily accessible and readily expandable as compared to pluripotent stem cells or satellite cells (i.e., muscle stem cells) (Abstract, Introduction). Boularaoui discloses transducing human dermal fibroblasts with lentiviral vectors, such as MYOD1, on several extracellular matrix (ECM) components (2.1, 2.5, 2.10). Use of ECM substrates, such as laminin and fibronectin, induces a significant increase in conversion to myotubes (3.3, Fig. 3). Boularaoui concludes that fibroblasts may be efficiently transdifferentiated into skeletal muscle via induced transgenic expression of MYOD1 (Discussion). Boularaoui further suggests that the disclosed methods may be used to generate large numbers of skeletal muscle cells for the generation of skeletal biosynthetic tissue (e.g., ex vivo meat products). A skilled artisan would be motivated to combine the methods of Boularaoui and Vein to generate large quantities of skeletal muscle tissue for the production of tissue engineered meat products.
The combination of Vein and Boularaoui does not disclose that the fibroblasts are cultured in suspension prior to transdifferentiation.
Furukawa 2001 discloses methods of making human fibroblast aggregates (Abstract, Introduction). Furukawa 2001 explains that aggregates of anchorage dependent cells, like fibroblasts, demonstrate higher retention and viability in suspension cultures than in two dimensional culture (Introduction). Furukawa explains that cells grown in aggregate are consequently highly useful for large scale culture applications (Introduction). Furukawa 2001 discloses suspending individual cells in rotational culture for at least 12 hours (Cell culture). Furukawa 2001 explains that the diameter of aggregates increases over hand (Formation of aggregates of normal human skin fibroblasts). The resultant aggregates demonstrate good viability and ability to migrate onto scaffolds (Discussion). Furukawa 2001 concludes that the disclosed methods are useful for the production of large quantities of fibroblasts for further applications (Discussion). A skilled artisan would be motivated to use the fibroblasts of Furukawa 2001 in the methods of combination, as Furukawa 2001 discloses that large numbers of cells may be effectively produced using the disclosed methods and the combination indicates that large quantities of cells are necessary for the production of tissue engineered meat products.
The combination of Vein, Boularaui, and Furukawa 2001 does not disclose that the transdifferentiation is performed on a plant based scaffold.
Marga discloses edible microcarriers appropriate for use in a bioreactor and edible engineered meat products produced thereon (Abstract, [0020]). Marga explains that many microcarriers are not suitable for use in comestible products as the microcarriers are not edible, are not animal product-free, or raise issues of contamination and/or allergies ([0007]). Therefore, the microcarriers must be removed from the cells in order to form a viable meat product ([0007]). Marga discloses forming microcarriers from materials that are derived only from vegetable and/or non-animal sources ([0015], [0038]). The microcarriers may be formed of plant-derived polysaccharides or polypeptides, such as pectin ([0015], [0017]-[0018]). The microcarrier may also include additives such as flavoring, flavor enhancer, or nutritional enhancer ([0019], [0039]). Cells cultured on the microcarriers may comprise any appropriate cells, such as smooth muscle cells, satellite cells, or adipocyte precursor cells, and may be derived from animal sources, such as cows or fish ([0020], [0069], [0077]). In some embodiments, several cell types may be cultured simultaneously ([0077]). Preferably, the cells and the microcarriers are cultured in a bioreactor ([0053)]. Once the cells have divided and grown for a sufficient time period, the microcarriers may be combined into an appropriate shape to form an edible meat product ([0050], [0053]-[0057]). Marga explains that advantageously the cells do not have to be removed from the microcarriers as the carriers are edible [0070].
As both Vein and Marga are directed to methods of making ex vivo meat products, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the plant based scaffold of Vein in the methods of Marga to ensure that the meat product is edible without having to remove the scaffold.
Regarding claim 44, the combination does not disclose that the stem cells may undergo at least 50 cell divisions during the culturing step. However, both Vein and Marga disclose that the cells may be grown to the desired number ([0029] and [0049] respectively). Further, Marga states that the cells may be cultured for at least 12 days ([0049]). Thus, there is a suggestion present in each of Vein and Marga that cell doublings are a result-effective variable. A skilled artisan would understand that the number of doublings could therefore be optimized through routine experimentation requiring no more than ordinary skill in the art (See MPEP § 2144.05).
Response to Arguments
Applicant’s arguments and amendments dated 6/27/25 have been fully considered but are not persuasive as explained in detail below.
Claim(s) 1, 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa) in view of Lin 2012.
Applicant argues that there is no teaching present in Furukawa that the cells cultured therein undergo proliferation as required by the present claims (Response p2-3). Applicant argues that Furukawa merely discloses forming aggregates with no evidence of proliferation (Response p2-3).
Furukawa explicitly states that the “diameters of the aggregates increased with time”, with a significant increase occurring between 24 and 36 hours (Formation of aggregates of normal human skin fibroblasts, Fig. 2). Therefore, there is a suggestion present in Furukawa that the fibroblasts proliferate according to the disclosed methods.
Applicant argues that cells cultured in aggregate there are in contact with ECM components, unlike the present claims (Response p3).
As noted in the rejections above under 35 U.S.C. 112 it is unclear what applicants are intending by the limitation “without the use of a scaffold or extracellular matrix”. Further applicants do not have written support for suspension culture wherein there is a complete absence of ECM components produced by the cultured cells. Therefore, claim 1 was interpreted as indicating that the culturing is performed without the use of exogenous ECM components. As noted in the art rejections, Furukawa obviates the claims according to this interpretation.
Applicant argues that nothing in the prior art discloses or suggests that fibroblasts that do not require adhesion to a scaffold or ECM for proliferation can subsequently adhere to a scaffold (Response p3).
Furukawa discloses that the cellular aggregates produced may be successfully ”reinoculated into tissue culture-treated culture dishes and scaffolds” (Results).
Claim(s) 44, 47-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furukawa, Lin 2012 and Lin 2008.
Applicant argues that the teachings of Line 2008 do not remedy the deficiencies noted in the combination of Furukawa and Lin 2012 (Response p3-4).
As discussed supra, the examiner believes that the combination of Furukawa and Lin 2012 obviates the claims as presented.
Claim(s) 1, 32, 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marga in view of Furukawa 2001.
Applicant argues that the combination fails to disclose or suggest culturing without the use of a scaffold or ECM (Response p4-5).
Furukawa 2001 explicitly discloses that the diameters of aggregates increases over time (Formation of aggregates of normal human skin fibroblasts). Therefore, there is a suggestion present in Furukawa 2001 that the fibroblasts proliferate according to the disclosed methods.
Claim(s) 1, 4-5, 10, 12, 14, 19, 21, 32, 35, 43-45, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vein in view of Boularaoui, Furukawa 2001, and Marga.
Applicant argues that the combination fails to disclose or suggest culturing without the use of a scaffold or ECM (Response p5).
As noted above, the examiner disagrees that the combination fails to disclose or suggest performing suspension culture without the use of a scaffold or ECM.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/ Primary Examiner, Art Unit 1632