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 .
Applicant's amendments to the claims and arguments filed on 08-26-2025 have been received and entered. Claims 1, 7 have been amended. Claims 2-6 have been canceled. Claims 1, 7-43 are pending.
Election/Restrictions
Applicant's election without traverse of Group I (claims 1-7) directed to a medium composition for suspension culture of an adherent cell in the reply filed on 02-28-2024 is acknowledged.
Claims 8-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02-28-2024.
Claims 1, 7 are under consideration.
Priority
This application is a 371 of PCT/JP2019/034099 filed on 08/30/2019 which claims priority from foreign applications JP 2018-164042 filed on 08/31/2018 and JP 2019-134058 filed on 07/19/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted, however, that an English-language translation of the priority document has not been received. As per MPEP 2304.01(c), a certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English may be required. See 35 U.S.C. 119(b)(3) and 372(b)(3) and 37 CFR 1.55(g)(3)(i) and 41.154(b). The applicant should provide the required translation if applicant wants the application to be accorded benefit of the non-English language application. Any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b) and 41.202(e).
As a result, the effective filing date of the claimed invention is currently the international filing date of PCT/JP2019/034099 on 08/30/2019.
Maintained in modified form - Claim Rejections - 35 USC § 103-Necessitated by amendments
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi et al (Pub. No.: US 2017/0009201 Al, Pub. Date: Jan. 12, 2017) (applicant’s own work).
Regarding to claim 1, Hayashi et al teaches culture medium composition (Title) and provides a culture method of cells and/or tissues including culturing cells and/or tissues in a suspended state by using a medium composition (Abstract). The medium composition capable of culturing cells or tissues in a suspended state, which comprises a nanofiber. The nanofiber is a polysaccharide comprising chitin and chitosan ([0033], page 3). The animal-derived cells in the present invention include stem cells ([0078], page 5) such as mesenchymal stem cells ([0078], page 5 and [0247], page 28).
Hayashi et al teaches specific preferable examples of the polymer compound to be used in the present invention include, but are not limited to, polysaccharides, polypeptides and the like ([0096], page 7). Preferable non-water-soluble polysaccharide includes chitinous substances such as chitin, chitosan and the like ([0103], page 7). The chitinous substance refers to one or more carbohydrates selected from the group consisting of chitin and chitosan ([0106], page 7). In the present invention, plural kinds (preferably two kinds) of the above-mentioned polymer compounds can be used in combination. The kind of the combination of the polymer compound is not particularly limited as long as the nanofiber is formed or dispersed as nanofibers in a liquid medium, and the cells and/or tissues can be suspended (preferably suspension stood) without substantially increasing the viscosity of the liquid medium ([0113], page 8). Thus, a person of ordinary skill in the art before the effective filing date of the rejected claims would be motivated and able to use combination of chitin and chitosan in a liquid medium can be used according to Hayashi et al.
Additionally, Hayashi et al teaches chitin and chitosan promote cell proliferation: chitin nanofiber showed high proliferative capacity even at 0.001% concentration, and chitosan nanofiber showed high proliferative capacity from 0.01% concentration ([0313], Page 41). Thus, the concentrations of chitin and chitosan was recognized in the prior art to be a result-effective variable for promoting cell proliferation because Hayashi et al specifically teach the concentration of chitin nanofiber showed high proliferative capacity even at 0.001% concentration (at least 0.001% concentration), and chitosan nanofiber showed high proliferative capacity from 0.01% concentration (at least 0.01% concentration). Furthermore, Hayashi et al teach the use of chitin nanofiber concentration at 0.003% and chitosan nanofiber concentration at 0.01% (see Table 63, page 41, also see below). Thus, the ratio of chitin nanofiber : chitosan nanofiber can be 0.003% : 0.01% or 3:10 or 1:3.333. A person of ordinary skill in the art before the effective filing date of the rejected claims would be motivated and be able to optimize and use chitin nanofiber : chitosan nanofiber ratio such as 1:3.333 to increase proliferation according to Hayashi et al.
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Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Hayashi et al by combine and use chitin nanofiber : chitosan nanofiber ratio of 1:3.333 in a liquid medium for promoting cell proliferation, with a reasonable expectation of success, before the effective filing date of instant application. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Hayashi et al teach both chitin and chitosan promote cell proliferation ([0313], Page 41). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Hayashi et al were successful in generation of a medium composition with nanofibers uniformly dispersed in the liquid medium for promoting cell proliferation with detailed instruction for using chitin and chitosan for cell culture medium.
Regarding to claim 7, Hayashi et al teaches suspension culture of animal cells with a nanofiber composed of polysaccharides such as cellulose, chitin and the like, and the proliferation activity of the cell is promoted by culture using this medium composition ([0032], page 2). Additionally, the medium composition of the present invention can maintain cells or tissues in an environment close to the biological environment, it is useful for the preservation and transport of cells and tissues, and the cells can be preserved and transported while maintaining the inherent functions thereof ([0035], page 3). The animal-derived cells in the present invention include stem cells ([0078], page 5) such as mesenchymal stem cells ([0078], page 5 and [0247], page 28).
Response to Arguments
Applicant's arguments filed on 08-26-2025 have been fully considered but they are not persuasive.
1. Applicant argue that applicant has unexpectedly discovered that, when mesenchymal stem cell are suspension cultured in a medium composition containing chitin nanofibers and chitosan nanofibers combined at a specific ratio, (a) the proliferation rate of the mesenchymal stem cells is high and (b) expression of genes responsible for maintaining pluripotency, such as the OCT4 gene, SOX2 gene, and NANOG gene, is increased in the suspension cultured mesenchymal stem cells. In that respect, Table 4 of the present application shows that medium compositions comprising only chitin nanofibers exhibit excellent proliferation rates. See, for example, sample 1 of Table 4. However, as shown in Table 6 of the present application, medium compositions comprising only chitin nanofibers produced low quality cells, which do not exhibit good gene expression (Remarks, page 8-9).
Response to Arguments:
The results from ratio of chitin nanofibers and chitosan nanofibers of the claimed invention are not unexpected because as described above Hayashi et al teaches chitin and chitosan promote cell proliferation: chitin nanofiber showed high proliferative capacity even at 0.001% concentration, and chitosan nanofiber showed high proliferative capacity from 0.01% concentration ([0313], Page 41). Thus, Hayashi et al specifically teach the concentration of chitin nanofiber showed high proliferative capacity even at 0.001% concentration (at least 0.001% concentration), and chitosan nanofiber showed high proliferative capacity from 0.01% concentration (at least 0.01% concentration). Thus, combination of chitin nanofiber with at least 0.001% concentration and chitosan nanofiber with at least 0.01% concentration is expected to have high proliferative capacity.
Furthermore, Hayashi et al teach the use of chitin nanofiber concentration at 0.003% and chitosan nanofiber concentration at 0.01% (see Table 63, page 41, also see below). Thus, the ratio of chitin nanofiber : chitosan nanofiber can be 0.003% : 0.01% or 3:10 or 1:3.333. A person of ordinary skill in the art before the effective filing date of the rejected claims would be motivated and be able to use chitin nanofiber : chitosan nanofiber ratio such as 1:3.333 to increase proliferation according to Hayashi et al.
Applicant also argue that expression of genes responsible for maintaining pluripotency, such as the OCT4 gene, SOX2 gene, and NANOG gene is increased. This is not found persuasive because, for example, sample 2 comprising only chitosan nanofibers (not even in combination with chitin, see table 3) shows significant higher gene expression, as compared to other samples with combination of chitin and chitosan such as sample 5 (see table 6 and table 3 below). Thus, the applicant own disclosure provides evidence for the unpredictability of gene expression of marker of pluripotency under presence of chitosan.
Moreover, as applicant cited table 4 of the claimed invention, it is noted that the instant disclosure teaches “The RLU values (ATP measurement, luminescence intensity) in respective cultures are shown in Table 4.” ([0091] – [0092], page 44). However, the RLU values of the claimed invention in table 4 are significantly lower than the RLU values in table 63 as taught by Hayashi et al even when RLU value is measured when only individual chitin or chitosan is present. It appears the results on day 7 in table 63 (RLU value/ proliferation) as taught by Hayashi et al are more superior (more proliferation) than the claimed invention (see below for day 7 column for comparison between table 63 of Hayashi et al and table 4 of the claimed invention).
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Thus, it appears that the results of the claimed invention are not unexpectedly discovered.
Additionally, Applicants use Table 6, which is showing gene expression, to compare with table 4 which is showing RLU value. Since they are not measuring the same value, it is not persuasive to make conclusion that “Table 6 of the present application, medium compositions comprising only chitin nanofibers produced low quality cells”. There is no guidance/standard in the instant disclosure to show (RLU value/ proliferation) and gene expression as a standard for low quality cells without comparing with a control. As mentioned above, sample 2 which is only exposed to chitosan without chitin has strongest expression of the pluripotency marker, would sample 2 be considered to be highest quality cells according to applicants’ reasonings ? (see table 6 below).
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2. Applicant argue that “Applicant has unexpectedly discovered that medium compositions having the claimed chitin nanofiber: chitosan nanofiber weight ratio of 1:3 to 1:6 provide comparable proliferation rates to chitin nanofiber only compositions, while still producing cells with high levels of gene expression. See, e.g., samples 5-8 of the present application, which have chitin nanofiber: chitosan nanofiber weight ratios of 1:3 to 1:6, respectively, and which exhibit comparable proliferation rates to chitin nanofiber only compositions, and sample 5, which has a nanofiber : chitosan nanofiber weight ratio of 1:3, and which produces cells with improved gene expression, as compared to samples 3 and 4, which have chitin nanofiber : chitosan nanofiber weight ratios of 1: 1 and 1:2, respectively.” (Remarks, page 9-10).
Response to Arguments:
As described above, Hayashi et al teaches medium composition capable of culturing cells or tissues in a suspended state, which comprises a nanofiber. The nanofiber is a polysaccharide comprising chitin and chitosan ([0033], page 3). Hayashi et al teaches specific preferable examples of the polymer compound to be used in the present invention include, but are not limited to, polysaccharides, polypeptides and the like ([0096], page 7). Preferable non-water-soluble polysaccharide includes chitinous substances such as chitin, chitosan and the like ([0103], page 7). The chitinous substance refers to one or more carbohydrates selected from the group consisting of chitin and chitosan ([0106], page 7). In the present invention, plural kinds (preferably two kinds) of the above-mentioned polymer compounds can be used in combination. The kind of the combination of the polymer compound is not particularly limited as long as the nanofiber is formed or dispersed as nanofibers in a liquid medium, and the cells and/or tissues can be suspended (preferably suspension stood) without substantially increasing the viscosity of the liquid medium ([0113], page 8). Furthermore, the concentrations of chitin and chitosan was recognized in the prior art to be a result-effective variable for promoting cell proliferation because Hayashi et al teach the use of various concentrations of chitin and chitosan (see Table 63, page 41): in one example, Hayashi et al teach the use of chitin nanofiber concentration at 0.003% and chitosan nanofiber concentration at 0.01% (see Table 63, page 41). Thus, the ratio of chitin nanofiber : chitosan nanofiber can be 0.003% : 0.01% or 3:10 or 1:3.333. A person of ordinary skill in the art before the effective filing date of the rejected claims would be motivated and be able to optimize and use chitin nanofiber : chitosan nanofiber ratio such as 1:3.333 to increase proliferation according to Hayashi et al.
Thus, as discussed above, given that table 63 shows better RLU value (proliferation) than the claimed invention, it is expected that a person of ordinary skill in the art who follow instructions of Hayashi et al. would arrive at the same results as the claimed invention or even better.
Furthermore, applicants argue that sample 5, which has a nanofiber : chitosan nanofiber weight ratio of 1:3, and which produces cells with improved gene expression, as compared to samples 3 and 4, which have chitin nanofiber : chitosan nanofiber weight ratios of 1: 1 and 1:2, respectively. This is not found persuasive because sample 2 comprising only chitosan nanofibers (not even in combination with chitin) shows significant higher gene expression, as compared to sample 5 (see table 6 and table 3 below)
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3. Applicant argue that Hayashi et al. does not disclose that the chitin nanofiber and the chitosan nanofiber are present in the medium composition in a chitin nanofiber: chitosan nanofiber weight ratio of 1:0.5 to 1:20, much less a medium composition for suspension culture of a mesenchymal stem cell, wherein the medium composition has a chitin nanofiber : chitosan nanofiber weight ratio of 1:3 to 1:6, as required by the pending claims as amended herein (Remarks, page 10-11)
Response to Arguments:
As described above, the concentrations of chitin and chitosan was recognized in the prior art to be a result-effective variable for promoting cell proliferation because Hayashi et al teach the use of various concentrations of chitin and chitosan (see Table 63, page 41): in one example, Hayashi et al teach the use of chitin nanofiber concentration at 0.003% and chitosan nanofiber concentration at 0.01% (see Table 63, page 41). Thus, the ratio of chitin nanofiber : chitosan nanofiber can be 0.003% : 0.01% or 3:10 or 1:3.333.
4. Applicant argue that Hayashi et al. does not provide any teaching or suggestion to use a chitin nanofiber and a chitosan nanofiber in combination, much less in the specific weight ratio required by the pending claims as amended herein.
A person of ordinary skill in the art, upon reading the disclosure of Hayashi et al., would not have been motivated to modify the medium composition disclosed therein to use a chitin nanofiber and a chitosan nanofiber in combination. Rather, a person of ordinary skill in the art, upon reading the disclosure of Hayashi et al., would have been motivated to use chitin in combination with a polymer other than chitosan. In that respect, Hayashi et al. states: …. (Hayashi et al. at paragraph 0113 (emphasis added)). Thus, Hayashi et al. discloses that, when a plurality of polymer compounds is used, the plurality of polymer compounds includes cellulose, chitin, collagen, or deacylated gellan gum, and other polymer compounds (e.g., xanthan gum, alginic acid, carageenan, diutan gum, methylcellulose, locust bean gum, or a salt thereof). In other words, the plurality of polymer compounds does not include chitosan despite Hayashi et al. disclosing chitosan as an alternative to chitin (Remarks page 11-12).
Response to Arguments:
Hayashi et al teach specific preferable examples of the polymer compound to be used in the present invention include, but are not limited to, polysaccharides, polypeptides and the like ([0096], page 7). Preferable non-water-soluble polysaccharide includes chitinous substances such as chitin, chitosan and the like ([0103], page 7). The chitinous substance refers to one or more carbohydrates selected from the group consisting of chitin and chitosan ([0106], page 7). In the present invention, plural kinds (preferably two kinds) of the above-mentioned polymer compounds can be used in combination. The kind of the combination of the polymer compound is not particularly limited as long as the nanofiber is formed or dispersed as nanofibers in a liquid medium, and the cells and/or tissues can be suspended (preferably suspension stood) without substantially increasing the viscosity of the liquid medium ([0113], page 8). Thus, a person of ordinary skill in the art before the effective filing date of the rejected claims would be motivated and able to use combination of chitin and chitosan in a liquid medium can be used according to Hayashi et al.
Applicants have further engaged in selective reading of paragraph 0113 of the teachings of Hayashi et al to formulate the grounds for not teaching chitin and chitosan in combination. It is noted that paragraph 0113 recites “Preferably, the combination includes at least cellulose, chitin, collagen, ……. a preferable combination of polymer compound includes cellulose, chitin, collagen, or deacylated gellan gum, and other polymer compound”. Hayashi et al also teach that preferable non-water-soluble polysaccharide includes chitinous substances such as chitin, chitosan and the like ([0103], page 7), and the chitinous substance refers to one or more carbohydrates selected from the group consisting of chitin and chitosan ([0106], page 7).
4. Applicant argue that as demonstrated by Example 15 of the present application, the benefits provided by the claimed combination of chitin nanofiber and chitosan nanofiber are not provided by combinations of chitin and other additives such as, for example, methylcellulose, deacylated gellan gum, and alginic acid as disclosed by Hayashi et al. In particular, Tables 24 and 26 show that sample 6 comprising chitin nanofiber and chitosan nanofiber in amounts that satisfy the claimed weight ratio exhibits higher proliferation rates and improved gene expression than samples 16, 17, and 18 comprising chitin nanofiber and methylcellulose, deacylated gellan gum, and alginic acid, respectively.
Even if, for the sake of argument, a person of ordinary skill in the art were to have disregarded the teachings of paragraph 0113 of Hayashi et al. and nevertheless combined chitin nanofiber and chitosan nanofiber, as suggested by the Office, the person of ordinary skill in the art would not have arrived at the claimed invention.
In that respect, Hayashi et al. does not provide any teaching or motivation to use chitin nanofiber and chitosan nanofiber in combination at a chitin nanofiber : chitosan nanofiber weight ratio of 1:3 to 1:6, as required by the pending claims as amended herein, much less recognize the unexpected benefits, e.g., high cell proliferation rates and improved gene expression, provided thereby
The Office contends that Hayashi et al. discloses that chitin nanofiber showed high proliferative capacity at 0.001% concentration and that chitosan nanofiber showed high proliferative capacity from 0.01% concentration such that it would have been obvious to use a chitin nanofiber: chitosan nanofiber weight ratio of 1: 10 (remarks, page 12).
Response to arguments:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the benefits”, “proliferation rates”, “good gene expression”, “desirable effects”, etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, applicant arguments and the instant disclosure are not commensurate with the scope of the claims: The claims recite any medium with any amount of ingredients while the instant disclosure provides specific medium comprising specific ingredients; for example, example 1-2 teaches mesenchymal stem cell proliferation medium (C-28009) which is a serum medium with further addition of an ATP reagent ([0084], page 39 and [0090], page 43). Example 3-4 teaches mesenchymal stem cell proliferation medium (150 µL) and ATP reagent (150 µL) ([0096], page 46 and [0101], page 48). Example 6 teaches low serum concentration in medium composition containing chitin nanofiber and chitosan nanofiber with the medium being DMEM medium ([0112], page 54). Thus, medium other than mesenchymal stem cell proliferation medium such as differentiation/maturation medium would not be favorable for mesenchymal stem cell proliferation.
As described above, Hayashi et al teaches chitin and chitosan promote cell proliferation: chitin nanofiber showed high proliferative capacity even at 0.001% concentration, and chitosan nanofiber showed high proliferative capacity from 0.01% concentration ([0313], Page 41). Thus, the concentrations of chitin and chitosan was recognized in the prior art to be a result-effective variable for promoting cell proliferation because Hayashi et al specifically teach the concentration of chitin nanofiber showed high proliferative capacity even at 0.001% concentration (at least 0.001% concentration), and chitosan nanofiber showed high proliferative capacity from 0.01% concentration (at least 0.01% concentration). Furthermore, Hayashi et al teach the use of chitin nanofiber concentration at 0.003% and chitosan nanofiber concentration at 0.01% (see Table 63, page 41, also see below). Thus, the ratio of chitin nanofiber : chitosan nanofiber can be 0.003% : 0.01% or 3:10 or 1:3.333. A person of ordinary skill in the art before the effective filing date of the rejected claims would be motivated and be able to optimize and use chitin nanofiber : chitosan nanofiber ratio such as 1:3.333 to increase proliferation according to Hayashi et al.
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Maintained in modified form - Obviousness Type Double Patenting - necessitated by amendments
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Pending claims 1, 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Co-Pending claims 9, 12, 14 of co-pending Application No. 17624744 (reference application) for the reasons of record in view of Hayashi et al (Pub. No.: US 2017/0009201 Al, Pub. Date: Jan. 12, 2017) (applicant’s own work). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pending claim 1 is directed to a medium composition for suspension culture of a stem cell, comprising (1) a stem cell; (2) a chitin nanofiber; and (3) a chitosan nanofiber, wherein the chitin nanofiber and the chitosan nanofiber are present in the medium composition in a chitin nanofiber : chitosan nanofiber weight ratio of 1:3 to 1:6, and wherein the stem cell is a mesenchymal stem cell.
Pending claim 7 is directed to the medium composition according to claim 1, wherein the suspension culture is for proliferating the stem cell, and maintaining pluripotency and chemotacticity of the stem cell.
Co-Pending claim 9 is directed to a medium additive composition comprising a chitin nanofiber carrying vitronectin and a chitosan nanofiber.
Co-Pending claim 12 is directed to the composition according to claim 9, wherein a content ratio (weight) of the chitin nanofiber carrying vitronectinand the chitosan nanofiber contained in medium composition is chitin nanofiber carrying vitronectin: chitosan nanofiber = 1:0.5 - 20.
Co-Pending claim 14 is directed to a medium composition for suspension culture of an adherent cell, comprising the composition according to claim 9.
Although the pending claims do not recite vitronectin, and the co-pending claims 9, 12, 14 of co-pending Application No. 17624744 do not recite a stem cell such as mesenchymal stem cells in the medium composition, the addition of vitronectin and stem cell in a medium composition for cell culture has been taught in teaching of Hayashi et al as explain below:
Regarding to claim 1, Hayashi et al who teach culture medium composition (Title). The medium composition capable of culturing cells or tissues in a suspended state, which comprises a nanofiber which is a polysaccharide ([0033], page 3). Preferable non-water-soluble polysaccharide includes chitinous substances such as chitin, chitosan and the like ([0103], page 7). The chitinous substance refers to one or more carbohydrates selected from the group consisting of chitin and chitosan ([0106], page 7). The animal-derived cells in the present invention include stem cells such as mesenchymal stem cells ([0078], page 5). Examples of the various extracellular matrices and various cell adhesion molecules include … vitronectin …. chitin, chitosan…. ([0146], page 11).
Regarding to claim 7, it is noted that claim 7 recite the intended use “for proliferating the stem cell” that does not result in a structural difference between the claimed product and the prior art in order to patentably distinguish the claimed product from the prior art. Hayashi et al teaches suspension culture of animal cells with a nanofiber composed of polysaccharides such as cellulose, chitin and the like, and the proliferation activity of the cell is promoted by culture using this medium composition ([0032], page 2). Additionally, the medium composition of the present invention can maintain cells or tissues in an environment close to the biological environment, it is useful for the preservation and transport of cells and tissues, and the cells can be preserved and transported while maintaining the inherent functions thereof ([0035], page 3).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to utilize the claimed cell culture medium from the co-pending claims to culture stem cells such as mesenchymal stem cells with the presence of vitronectin as taught by Hayashi et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Hayashi et al suggest that such a cell culture media can be used to culture stem cells in suspension culture, which can then be used for a variety of purposes. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Hayashi et al teach that it is within the skill in the art to use an analogous cell culture medium to culture stem cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on 08-26-2025 have been fully considered but they are not persuasive.
Applicants argue that the present application has a patent term filing date of August 30, 2019, whereas the '744 application has a later patent term filing date of July 3, 2020. Thus, the present application should be passed to issuance without the need to address the obviousness-type double patenting rejection (remarks, page 14).
Response to Arguments
Since the 35 USC § 103 rejection of record has been maintained as described above, Applicants’ arguments regarding to the '744 application has a later patent term filing date of July 3, 2020 are moot. The obviousness type double patenting is maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA NHAT TRAN whose telephone number is (571)270-0201. The examiner can normally be reached M-F (9-5).
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632