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 .
Claim Status
Applicant’s election of (3) including PKC activator in the reply filed on 14 September, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 8, 9, 12, 13, 15, 17, and 19-26 were previously pending.
Receipt is acknowledged of the amendments to the claims filed 14 September, 2025. Claims 15 and 17 are amended. Claims 27-38 are newly added. Claims 8, 12, 21-23, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Therefore, claims 1, 9, 13, 15, 17, 19-20, 24-25, and 27-38 are pending and are the subject of the present Official Action. Claims 1, 15, and 17 are independent claims.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2021/018542, filed 17 May, 2021, which claims priority to Japan Application No. JP2020-086836, filed 18 May, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified untranslated copies of papers required by 37 CFR 1.55 have been filed in this application on 11 November, 2022.
Therefore, the earliest possible priority for the instant application is 18 May, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 November, 2022, 01 February, 2023, 03 February, 2023, 21 February, 2023, 04 September, 2024, and 30 September, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Examiner Comments
It is noted that, where reference is made to the Instant Specification in the present Official Action, the Examiner will be citing to the publication of the instant application (US2023/0242882).
Drawings
The drawings submitted on 11 November, 2022 are accepted by the Examiner.
Specification
The use of the terms “Essential 8 medium”, “FUJIFILM Wako Pure Chemical Corporation”, “Sigma-Aldrich”, “R&D Systems”, “Invitrogen”, “Nissan Chemical Corporation”, “GLPBIO”, “Santa Cruz Biotechnology”, “Selleck Biotechnology Co., Ltd”, “Yoshindo Inc.”, “Wako”, “Kaken Pharmaceutical”, “Calbiochem”, “MedChemExpress”, “Cosmo Bio”, “Corning”, “Yokogawa Electric Corporation”, “Sony”, and “DRAQ5”, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by their generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 13, 15, 17, 19-20, 24-25, and 27-38 are objected to because of the following informalities: Acronyms/Abbreviations need to be spelled out upon their first encounter in the claims (for example: “Src”, “PKC”, “iPS”). Appropriate correction is required.
Claims 1, 15, and 17 are objected to because of the following informalities: “human serum albumin”, “recombinant human serum albumin”, “non-human animal serum albumin” are missing a definite article (e.g. “a”, “an”). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the claim uses “according to” twice which is redundant. Please replace the second “according to” with “of”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Applicant is advised that should claim 15 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The same applies to dependent claims 31-34 as being substantial duplicates of claims 35-38.
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.
Claims 1, 9, 13, 15, 17, 19-20, 24-25, and 27-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A method of producing a target cell, the method comprising producing the target cell by culturing a raw material cell in a serum-free medium containing:
A DMEM medium;
A human serum albumin; and
At least one additive selected from a group consisting of a Src inhibitor, a PKC activator, a recombinant human serum albumin, and a non-human animal serum albumin,
Wherein the raw material cell and the target cell are both either an iPS cell or a mesenchymal stem cell,
And
A serum-free medium comprising:
A DMEM medium;
A human serum albumin; and
At least one additive selected from a group consisting of a Src inhibitor, a PKC activator, a recombinant human serum albumin, and a non-human animal serum albumin,
does not reasonably provide enablement for (1) a method of producing a target cell from a raw material cell wherein the target cell and the raw material cell are an iPS cell and a mesenchymal stem cell respectively and in the alternative, (2) a method of doing the same with any “growth factor” or a medium comprising any “growth factor”, nor (3) any method at all of producing a product from an iPS cell or a mesenchymal stem cell.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims as elected.
Claims 1, 9, 13, 15, 17, 19-20, 24-25, and 27-38 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 claims contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
While the written description and enablement requirements are separate and generally separable requirements, the instant application fails to meet either requirement for essentially the same reasons, as set forth below.
Instant claim 1 is broadly directed to a genus of methods of producing a target cell from a raw material cell encompassing wherein the target cell and the raw material cell are an iPS cell and a mesenchymal stem cell respectively and in the alternative (encompassing a method of producing a mesenchymal stem cell comprising the single step of culturing an iPS cell). Instant claim 13 is directed to a vast genus of methods of producing any product (literally anything that a cell produces) using a target cell produced according to claim 1 comprising the single command of “producing the product” (without any steps claimed for accomplishing such a production. Claim 17 is an independent claim which is directed to a serum-free medium which recites in the same way as independent claim 13 recites, a genus of producing a genus of products. None of dependent claims 9, 27-30, and 35-38 remedy the vast genus of methods claimed and/or limit the scope of the methods to require both the target cell and the raw material be either an iPS cell or a mesenchymal stem cell.
The instant specification provides 3 examples. In the first example, a method of differentiating megakaryocytes from megakaryocyte progenitor cells is taught (Specification, [0175]-[0238]). In the second example, a method of producing platelets from megakaryocytes is taught (Specification, [0239]-[0257]). Neither of these methods appears to support the methods and compositions instantly claimed because, in each example, megakaryocytes are used which are not claimed. Example 3 appears to be the example supporting the instant invention and describes the “Proliferation Culture of iPS Cells and Proliferation Culture of Mesenchymal Stem Cells” (Specification, [Example 3]). Example 3 teaches that iPS cells seeded at 1x10e4 cells/well in a 96 well plate and cultured for 5 days in DMEM/F12 medium supplemented with either 0.125 mass % human serum albumin (HSA) alone, 0.1 mass % HSA with 0.025 mass % rice-derived recombinant human serum albumin, 0.075 mass % HSA with 0.05 mass % yeast-derived recombinant human serum albumin, or 0.125 mass % HSA with 0.05 mass % prostratin resulted in a significant increase in iPS cells whereas culture in the recombinant HSA’s alone or prostratin alone had no such effect (Specification, [0259]-[0268], [0279], FIG. 7). Example 3 also teaches that mesenchymal stem cells (MSC) seeded at 1x10e4 cells/well in a 96 well plate and cultured for 5 days in DMEM/F12 medium supplemented with either 0.125 mass % human serum albumin (HSA) alone, 0.1 mass % HSA with 0.025 mass % rice-derived recombinant human serum albumin, 0.075 mass % HSA with 0.05 mass % yeast-derived recombinant human serum albumin, or 0.125 mass % HSA with 0.05 mass % A419259 (A Src inhibitor) resulted in a significant increase in MSCs whereas culture in the recombinant HSA’s alone or A419259 alone had no such effect (Specification, [0269]-[0279], FIG. 8). Example 3 is noticeably devoid of the term “growth factor”. The specification, in a nonlimiting embodiment, describes “growth factor” as having “an action of promoting the proliferation of raw material cells” (Specification, [0030]) and defined growth factor as “any substance that contributes to the proliferation of cells, such as a substance serving as a nutrient for the proliferation of cells” (Specification, [0069]). It is noted that this definition does not appear to narrow the immense breadth of the term “growth factor” and appears to embrace a reading of “growth factor” as being merely water, or even CO2 or glucose. The specification does not teach iPS cells cultured with a Src inhibitor or MSCs cultured with a PCK activator. Further, the only PCK activator the specification teaches is prostratin. Nowhere in the instant specification is there a teaching of a method of producing an MSC comprising culturing an iPS cell or vice versa. Further, there is no teaching anywhere in the specification of a method of producing any product at all from either iPS cells or MSCs. The closest the instant specification comes to teaching a method of producing a product is in example 2 with the method of producing platelets. However, as discussed, this teaching is specific to megakaryocytes which are not claimed. Finally, the only “growth factor” taught in Example 3 appears to be DMEM/F12 medium.
To summarize, the specification lacks sufficient guidance for determining whether the medium claimed can merely comprise any amount of just water, or even solely any amount of glucose and still allow for a method of producing a target cell from a raw material cell. The specification lacks any guidance at all for any method of producing an MSC from an iPS cell or vice versa. The specification lacks any guidance at all with respect to any methods of producing a product from iPS cells or MSCs, and the specification defines growth factor so broadly as to encompass mere water while providing only a single example for a growth factor falling within said definition (DMEM/F12).
With respect to the genus of “growth factor” and the genus of methods of producing a target cell, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021). Further, A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). See MPEP 2163(II)(A)(3)(a)(ii).
Here, Applicants have only described a single species of “growth factor” having the function of “an action of promoting the proliferation of raw material cells”, said species being DMEM/F12 medium. Applicants have also described only a single species of methods of producing a target cell using a PKC activator, said species being a method of culturing iPS cells in prostratin and HSA. There is no described species at all for the genus of methods of producing a target cell from MSCs cultured with a PKC activator as the only methods described for MSCs are either HSA alone, HSA in combination with recombinant HSA, or HSA in combination with a Src inhibitor.
The skilled artisan at the time of filing knew that typically MSCs are cultured in at least a basal medium that is then supplemented with growth factors (Xu et al. Stem Cell Res Ther 11, 125 (2020), hereinafter “Xu”). Xu teaches the screening of a large list of “growth factors” in a basal DMEM medium (Xu, pages 2-3, last para and first para respectively). They also knew that serum-free chemically defined medium at least comprises a basal medium and that DMEM is a typical basal medium (US2013/0089928, hereinafter “An”). An teaches chemically defined media for the culture of MSCs wherein the media comprise nutrients and growth factors and methods of expanding MSCs in said media (An, Abstract). The basal medium used in An is DMEM (An, [0027]). Thus, with respect to MSCs, a skilled artisan at the time of filing knew that typically, their culture requires at least a basal medium and common basal media are DMEM-type media. See also: Gottipamula et al. Cell proliferation 46.6 (2013): 608-627., page 611, of record (IDS: 04 September, 2024), first full paragraph. With respect to iPS cells, the skilled artisan at the time of filing knew that the same principles apply (WO 2019078278, English Machine Translation, hereinafter “Li”). Li teaches methods for producing iPS cells, teaches that any medium suitable for the culture of pluripotent cells generally can be used for the culture of iPS cells and teaches DMEM/F-12 basal medium (Li, page 5, fourth full paragraph, Abstract, page 3, second paragraph). The art at the time of filing was devoid of any teaching for the production of MSCs from iPS cells or vice versa comprising the mere step of culturing. The art at the time of filing was also devoid of teachings for culturing either iPS cells or MSCs in just water supplemented with HSA and at least one of the claimed additives. Rather, the skilled artisan understood that DMEM was a typical basal medium required for culture of MSCs and iPS cells, and they would have understood that attempts to culture stem cells in just water, or even just salts or just glucose, would not have allowed for the production of more cells.
In regard to the methods of producing a product, as discussed above, the specification has no such teaching in support of doing so with MSCs or iPS cells. Thus, the application is lacking description all together. According to the breadth of the term “product”, and the lack of teachings in the specification, the application alto lacks an enabling disclosure for such methods or such a genus of “products”.
Therefore, in view of the breadth of the claims, the lack of sufficient guidance in the specification, or any guidance at all for methods of producing a product from MSCs or iPS cells, methods of producing MSCs from iPS cells or vice versa, methods of producing any target cell with a medium comprising anything other than DMEM at minimum supplemented with HSA and one of the claimed additives, and the unpredictability evidenced by the prior art at the time of filing with respect to pluripotent cells able to be cultured in just water, or just glucose, etc. (which fall within the instant specification’s definition of “growth factor”), and the teachings for iPS cells and MSCs cultured in at minimum a basal medium which is typically DMEM, it would require undue experimentation to use the invention commensurate in scope with the claims.
Further, the specification describes only a limited number of species for “growth factor” having the described function of “an action of promoting the proliferation of raw material cells” insofar as it only discloses DMEM/F12, only a limited number of species for methods of producing a target cell insofar as it only describes methods for producing iPS cells from iPS cells cultured with prostratin and MSCs from MSCs cultured with A419259, and describes no species for any method of producing any product at all from iPS cells or MSCs nor any species for producing MSCs comprising culturing MSCs with prostratin, let alone an entire genus of PCK activators. Therefore, the specification lacks sufficient description to show the inventor was in possession of the claimed genera.
Claim Rejections - 35 USC § 102
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 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.
To the extent claim 1 reads on a method of producing a mesenchymal stem cell comprising culturing a mesenchymal stem cell in a medium comprising a growth factor, a human serum albumin, and a recombinant human serum albumin, to the extent claim 13 reads on a method of producing an exosome, and to the extent claims 15, and 17 read on a medium comprising a growth factor, a human serum albumin, and a recombinant human serum albumin, the following rejection applies.
Claims 1, 13, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2013/0089928, published: 11 April, 2013, hereinafter “An” as evidenced by Lai et al. Seminars in cell & developmental biology. Vol. 40. Academic Press, 2015., hereinafter “Lai”.
Claims 15 and 17 recite the same fundamental medium with identical structure but with different recited intended uses. It is noted that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). The intended uses are afforded no patentable weight if they do not distinguish the composition claimed from that recited in the prior art. Thus, for the purpose of applying prior art, claims 15 and 17 are interpreted as being directed to the same media.
An discloses media for the culture of MSCs and discloses that the media comprises DMEM and human serum albumin wherein the human serum albumin can be recombinant human serum albumin (An, [0036]-[0037], Table 1). An also discloses that the medium comprises growth factors (An, [0040]). Recombinant human serum albumin is encompassed by the broadest reasonable interpretation of a human serum albumin, therefore, in disclosing recombinant serum albumin, An discloses a medium comprising both a human serum albumin and a recombinant serum albumin. An also discloses culturing MSCs in the medium (An, [0037]). In disclosing culturing MSCs, An necessarily discloses a method of producing a product using the MSCs because MSCs secrete exosomes as evidenced by Lai and exosomes fall within the broadest reasonable interpretation of “product” (Lai, Abstract). Therefore, An discloses all of the elements of instant claims 1, 13, 15, and 17.
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.
To the extent claims 1, 9, 13, 15, 17, 19-20, 24-25, and 27-38 read on a method of culturing an MSC, a method of culturing an iPS cell, methods of producing exosomes using MSCs or iPS cells, and a medium comprising a growth factor, a human serum albumin, and prostratin, the following rejection applies.
Claims 1, 9, 13, 15, 17, 19-20, 24-25, and 27-38 are rejected under 35 U.S.C. 103 as being unpatentable over US2013/0089928, published: 11 April, 2013, hereinafter “An” in view of Lai et al. Seminars in cell & developmental biology. Vol. 40. Academic Press, 2015., hereinafter “Lai”, Vermeulen et al. bioRxiv (2020): 2020-01., available online: 13 January, 2020, hereinafter “Vermeulen”, US 20100279403 (hereinafter “Rajesh”), and Sun et al. Journal of Molecular Medicine 97.6 (2019): 829-844. (hereinafter “Sun”).
Claims 15 and 17 recite the same fundamental medium with identical structure but with different recited intended uses. It is noted that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). The intended uses are afforded no patentable weight if they do not distinguish the composition claimed from that recited in the prior art. Thus, for the purpose of applying prior art, claims 15 and 17 are interpreted as being directed to the same media and claims 31-38 are interpreted as being directed to a media comprising a growth factor, a human serum albumin, and either a PCK activator generally or prostratin specifically (the former applying to claims 31, 33, 35, and 37 with the latter applying to claims 32, 34, 36, and 38).
An discloses media for the culture of MSCs and discloses that the media comprises DMEM and human serum albumin wherein the human serum albumin can be recombinant human serum albumin (An, [0036]-[0037], Table 1). An also discloses that the medium comprises growth factors (An, [0040]). Recombinant human serum albumin is encompassed by the broadest reasonable interpretation of a human serum albumin, therefore, in disclosing recombinant serum albumin, An discloses a medium comprising both a human serum albumin and a recombinant serum albumin. An also discloses culturing MSCs in the medium (An, [0037]). In disclosing culturing MSCs, An necessarily discloses a method of producing a product using the MSCs because MSCs secrete exosomes as evidenced by Lai and exosomes fall within the broadest reasonable interpretation of “product” (Lai, Abstract). Therefore, An discloses all of the elements of instant claims 1, 13, 15, and 17. An teaches that the technical field in which improved MSC cell culture methods are sought is the field of tissue repair using said cells (An, [0003]-[0006]).
An does not teach the addition of a PCK activator to the medium or wherein the PCK activator is prostratin.
Vermeulen teaches the culturing of MSCs and fibroblasts in a medium comprising DMEM and prostratin (Vermeulen, pages 16-17, “Cell Culture” heading). Vermeulen teaches that the addition of prostratin to cell culture medium for pluripotent cells may might improve current clinical treatments using said cells for tissue repair because prostratin mimics the synergistic effects that micro-topographies have on the cells in culture (Vermeulen, pages 14-15, last partial and first partial paragraphs respectively). Thus, a person having ordinary skill in the art would have been motivated to add prostratin to the cell culture medium of An to provide a medium which might improve current clinical treatments using said cells for tissue repair.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have added prostratin as taught by Vermeulen to the medium of An and to have arrived at the invention claimed in instant claims 1, 9, 13, 15, 17, 24-25, 29-30, and 31-38 with a reasonable expectation of success because they would have been motivated to do so to provide a medium which might improve current clinical treatments using said cells for tissue repair. There would have been a reasonable expectation of success insofar as Vermeulen and An teach the same technical field of tissue repair using stem cells and Vermeulen teaches that adding prostratin can be reasonably expected to provide the same synergistic effects that micro-topographies have on the cells in culture.
Regarding claims 19-20, and 27-28, An and Vermeulen do not teach or suggest to culture iPS cells with prostratin.
Rajesh teaches methods for culturing iPS cells (Rajesh, Abstract). Rajesh specifically teaches to culture iPS cells in a medium comprising oleic acid (Rajesh, Table 1, [0052]). Oleic acid is a PKC activator. Thus, Rajesh teaches to culture iPS cells with a PKC activator. In teaching the culture of iPSCs, Rajesh necessarily teaches a method of producing a product from iPSCs because iPSCs necessarily produce exosomes as evidenced by Sun and exosomes fall within the broadest reasonable interpretation of “product” (Sun, Abstract). Therefore, the combined teachings of An, Vermeulen, and Rajesh suggest to a person having ordinary skill in the art before the effective filing date of the claimed invention that one could reasonably expect iPS cells cultured in the medium of An and Vermeulen to produce more iPS cells as in instant claims 19-20, and 27-28.
Conclusion
No claim is allowed.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634