Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on the 9th of June 2026 has been entered.
Priority
This application was filed Jan. 27, 2022, and claims benefit to the 371 application of PCT/CN2019/099246 filed on August 5, 2019.
Claim Status
In the response filed on the 7th of May 2026, Applicants have amended claims 23-27, and 33-34, and canceled claims 1-22, 29-31 and 39-40.
On March 13, 2025, Applicant elected Group II, Claims 25-28 and 32-38, and the species of Method B and Cell culture vessel II, with traverse. As stated in the Non-Final on the 11th of July 2025, Applicants have amended claims 32-35 to the elected species (i.e. the species of Method B and Cell culture vessel II) and are dependent on claim 25. Therefore, claims 32-34 have been rejoined and claims 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (i.e. Group I and method A), there being no allowable generic or linking claim.
Currently, claims 25-28, and 32-38 are under examination in this office action.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The rejection of claims 25-26, 32, and 35-38 under 35 U.S.C. 103 as being unpatentable over Liu et al., (WO2018094410A1, published 2018, prior art of record), Sachs et al., (US2017/0275592A1, published 2017, prior art of record), Herreño, et al. (Cogent Medicine 5.1: 1503071, published 2018, hereinafter as “Herreno”, prior art of record), Willett et al. (American journal of respiratory cell and molecular biology 18.4: 489-496, published 1998, prior art of record), Yoshimura et al. "(Journal of Biological Chemistry 268.21: 15461-15468, published 1993, prior art of record), Inoue et al., (WO2011068183A1, published 2011, prior art of record), Timmins, et al., (WO2017127921A1, published 2017, prior art of record), and Bray et al., (Science 214.4522: 793-795, published 1981, prior art of record), is withdrawn due to Applicants amendments to the claims, where the combination of reciting “consisting of” and adding specific elements circumvents the prior art.
The rejection of claims 27 and 28 under 35 U.S.C. 103 as being unpatentable over Liu et al., (WO2018094410A1, published 2018, prior art of record), Sachs et al., (US2017/0275592A1, published 2017, prior art of record), Herreño, et al. (Cogent Medicine 5.1: 1503071, published 2018, hereinafter as “Herreno”, prior art of record), Willett et al. (American journal of respiratory cell and molecular biology 18.4: 489-496, published 1998, prior art of record), Yoshimura et al. "(Journal of Biological Chemistry 268.21: 15461-15468, published 1993, prior art of record), Inoue et al., (WO2011068183A1, published 2011, prior art of record), Timmins, et al., (WO2017127921A1, published 2017, prior art of record), and Bray et al., (Science 214.4522: 793-795, published 1981, prior art of record), as applied to claims 25-26 and 29-40 above, and further in view of Wu, Han, et al. (Small 14.38: 1802128, published 2018, prior art of record), Leosson, Kristjan, and Björn Agnarsson (Micromachines 3.1: 114-125, published 2012, hereinafter as “Leosson”, prior art of record), Ono et al., (Journal of applied physics 105.1, published 2009, prior art of record), and Polanco, et al. (JoVE 139: 58296, published 2018, prior art of record), is withdrawn due to Applicants amendments to the claims, where the combination of reciting “consisting of” and adding specific elements circumvents the prior art.
Claim Objections
Claims 25, 27-28, 32-34 are objected to because of the following informalities: grammar, typos, and clarity.
Claim 25 appears to be missing an indefinite article. It is suggested that the claim be amended to recite “the cell digestion solution comprises 4-6 mL of an enzymatic dissociation reagent” and “1.5-2.5 mL of a recombinant dissociation solution” (lines 6-9, page 8).
Claim 25 recites “medium. and” (line 40) where the period should instead be a semi-colon.
Claim 25 recites “EDTA” (line 52), which is the first recitation of this abbreviation and should recite “Ethylenediaminetetraacetic acid” (EDTA).
Claim 25 appears “B27 supplement (B27)”, it is unclear what applicant is referring to in the claim. I appears that applicant is using “B27” as an abbreviation for the “B27 supplement,” however; B27 is already an abbreviation.
Claims 25, 34, and 35 recite “DMEM” or “DMEM/F12,” however there is not recitation of “Dulbecco's Modified Eagle Medium/Nutrient Mixture F-12 (DMEM/F12)” in the instant claims. It is suggested that applicant spell out the first reciting of “DMEM/F12.”
Claim 26 recites “a remainder the rest of the cell isolation buffe” (line 14), which should recite “buffer”.
Claim 28 recites the limitation "the method according to claim 27, wherein in (II)” where the addition “in” should be deleted.
Claim 32 recites “a step for passaging the primary tumor cells”, and claims 33 and 34 recite “is used for the passage”. Although a person of ordinary skill in the art could interpret that the solutions are used for the passaging step in claim 32 since both dependent claims 33-34 depend on claim 32. However, it is suggested that claims 33 and 34 be amended to recite “the passaging of the primary tumor cells.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 25-28, and 32-38 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.
This rejection is a new rejection as necessitated by amendments to the claims.
The claims 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06- § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
Claim 25 has been amended to recite “the cell digestion solution comprises 4-6 mL of enzymatic dissociation reagent” and “1.5-2.5 mL of recombinant dissociation solution” (lines 6-9, page 8). The instant amendment to the claims introduces new limitations. It is noted that Applicant has not pointed out where the new (or amended) claim limitations are supported (see remarks filed May 7, 2026), nor does there appear to be a written description of the claim limitation “enzymatic dissociation reagent” and “recombinant dissociation solution” in the application as filed. Further, the specification of the originally filed application fails to support the newly added limitation “enzymatic dissociation reagent” and “recombinant dissociation solution”. In conclusion, the above cited newly added recitation constitutes new matter because neither the specification nor the claims as originally filed provide explicit or implicit support for the recitation. Appropriate correction is required.
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 25-28, and 32-38 are 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.
This rejection is repeated with regard to claims for the same reasons of record as set forth in the Final-Office action mailed on March 9, 2026. A response to applicant' s traversal follows the reiterated rejection below.
Claims 25, recites trademarks/trade names: “B27 supplement” and “B27” (lines 12, 15, and 36)”; “Advanced DMEM/F12 medium” (lines 14, and 40); “ITS-X” (lines 14 and 38). MPEP 2173.05(u): where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Thus, the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claims 25 recites trademarks/trade names “PBS” (line 54) and does not recite “phosphate-buffered saline (PBS) until claim 26. MPEP 2173.05(u): where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Thus, the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claims 27 recites trademarks/trade names, “CYTOP” (line 10)”, which are used to identify/describe compositions comprised within a cell culture medium; accordingly, the identification/description is indefinite. MPEP 2173.05(u): where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Thus, the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claims 28 recites trademarks/trade names, “CYTOP” (lines 2, 6-9), which are used to identify/describe compositions comprised within a cell culture medium; accordingly, the identification/description is indefinite. MPEP 2173.05(u): where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Thus, the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claim 33, recites trademarks/trade names “Accutase”(line 3) and “TrypLE” (line 5), which are used to identify/describe compositions comprised within a cell culture medium; accordingly, the identification/description is indefinite. MPEP 2173.05(u): where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Thus, the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claim 34 recites trademarks/trade names, “Advanced DMEM/F12 medium” (line 5 and 7), which are used to identify/describe compositions comprised within a cell culture medium; accordingly, the identification/description is indefinite. MPEP 2173.05(u): where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Thus, the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Appropriate correction is required.
Response to Traversal:
Applicant asserts that the amendments to the claims as reflected above in the listing of Claims are sufficient to correct the issues, specifically, Applicant submits: "GlutaMax" is amended to "L-alanyl-L-glutamine"; "B27" is amended to "B27 supplement"; "ITS-X" is amended to "insulin, transferrin, selenium, and ethanolamine supplement"; "Advanced DMEM/F12" is amended to "Dulbecco's Modified Eagle Medium"; "Accutase" is amended to "enzymatic dissociation reagent"; "TrypLE" is amended to "recombinant dissociation solution"; and "CYTOP" is amended to "amorphous fluoropolymer".(Remarks, page 12).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
It is acknowledged that Applicant amended the claim to no longer recite "GlutaMax" and GlutaMax has been amended to recite "L-alanyl-L-glutamine", which is sufficient and disclosed in the specification and does not introduce new matter.
Contrary to Applicants belief, as discussed above, the claims still recite the trademarks/trade names, see e.g. “Advanced DMEM/F12” (see claim 25, line 14), “CYTOP” (claim 27), and “TrypLE” (claim 33). As discussed above, this is not sufficient because there are still trademarks present in the instant claims, which does not identify or describe the goods associated with the trademark or trade name.
MPEP: 216.07(b): Instead of repeating some information contained in another document, an application may attempt to incorporate the content of another document or part thereof by reference to the document in the text of the specification. The information incorporated is as much a part of the application as filed as if the text was repeated in the application, and should be treated as part of the text of the application as filed. Replacing the identified material incorporated by reference with the actual text is not new matter. See 37 CFR 1.57 and MPEP § 608.01(p) for Office policy regarding incorporation by reference. See MPEP § 2181 for the impact of incorporation by reference on the determination of whether applicant has complied with the requirements of 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is invoked
In the instant case, it is noted that the specification does not recite “incorporation by reference.” Further, the examiner has not found any explicit recitation of “incorporation by reference” in the specification. Further, it is acknowledged that applicant has amended claim 25 to recite the components of B27, which is sufficient, and has support in the specification (see e.g. para. 10). However, the claims still recite “B27” as discussed above, which is a trademark/trade name that is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. It is noted that applicant’s amendments to the claims to include the components of the trademarks/tradenames which could potentially offer a pathway forward to allowance, however, the amendments would have to have adequate written description and follow the new matter guidelines.
Applicant asserts that the amendments of "the cell digestion solution" in claim 33 is amended to "a cell digestion solution is used for the passage"; and "digestion termination solution" in claim 34 is amended to "a digestion termination solution is used for the passage" to provide a proper antecedent basis (Remarks, page 12). Applicant asserts that the amendments to the claims are sufficient to correct the issued as noted by the office and that the 112b rejection should be withdrawn (Remarks, page 12).
Applicant arguments are acknowledged, have been fully considered, and have been deemed unpersuasive.
It is acknowledged that Applicant asserts that "Advanced DMEM/F12" is amended to "Dulbecco's Modified Eagle Medium"; "Accutase" is amended to "enzymatic dissociation reagent"; "TrypLE" is amended to "recombinant dissociation solution"; and "CYTOP" is amended to "amorphous fluoropolymer". Contrary to Applicants belief, as discussed above, there are still claims that recite these trademarks. Further, the amendments of Accutase" to "enzymatic dissociation reagent", and "TrypLE" to "recombinant dissociation solution" introduces new matter. As discussed above, the instant amendment to the claims introduces new limitations. It is noted that Applicant has not pointed out where the new (or amended) claim limitations are supported, nor does there appear to be a written description of the claim limitation “enzymatic dissociation reagent” and “recombinant dissociation solution” in the application as filed. Thus, the specification of the originally filed application fails to support the newly added limitation “enzymatic dissociation reagent” and “recombinant dissociation solution”. In conclusion, the above cited newly added recitation constitutes new matter because neither the specification nor the claims as originally filed provide explicit or implicit support for the recitation.
Claims 25-28, and 32-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
This rejection is a new rejection necessitated by amendments to the claims.
Claim 25 recites : “wherein the medium consists of a dual-antibiotics penicillin-streptomycin (P/S), 4-(2-hydroxyethyl)-l-piperazineethanesulfonic acid (HEPES), a non-essential amino acid solution, L-alanyl-L glutamine supplement, human recombinant protein Epidermal Growth Factor (EGF), human recombinant protein basic Fibroblast Growth Factor (bFGF), human recombinant protein Macrophage Stimulating Protein (MSP), cortisol, B27 supplement (B27), Insulin Transferrin
Selenium Ethanolamine Solution insulin, transferrin, selenium, and ethanolamine supplement
(ITS-X), Y-27632, a cell digestion solution and an Advanced DMEM/F12 medium; wherein the B27 supplement comprises” (lines 7-15).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 25 recites the broad recitation of “a method comprising the following steps” (lines 1-6), the narrow recitation of “wherein the medium consists of” (line 7), the broad recitation of “wherein the B27 supplement comprises” (line15), the broad recitation of “the non-essential amino acid solution comprises” (line 41), and the broad recitation of “the cell digestion solution comprises” (line 50). Therefore, the claims 25-28, and 32-38 are considered indefinite because there is a question or doubt as to whether the features (i.e. the medium and supplements) introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Further, it is noted that the specification recites that the B27 is “B-27™ Supplement (50×), minus vitamin A” (such as Gibco #12587010)”(see e.g. specification para. 10), however the claim recites “Vitamin A (acetate)”(claim 25, line 17). Thus, the narrow recitation of a medium falling within the broad range of the limitation of a B27 supplement, a broad range of the limitation of a non-essential amino acid solution, and a broad range of the limitation of a cell digestion solution render the claim indefinite because one of ordinary skill in the art would not be able to ascertain the meets and boards of what is actually included in the medium.
Claim 25 recites the limitation "cancer in step (b1)” (see line 6). There is a lack of insufficient antecedent basis for this limitation in the claim and renders the claim indefinite because there is no prior recitation or any other recitation to “step (b1). As such the recitation is indefinite because it is not apparent to what "step (b1)” is referring to, given the independent claim does not require one. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites “% (volume percentage),” (lines 28, 36, and 38), but the symbol of “%” does not mean “volume percent.” It is unclear to a person of ordinary skill in the art that the scope of the percent symbol “%” is meant to be volume percent, because the symbol of a percent sign does not indicate a volume percentage, it is just a symbol/sign for percent. Therefore, a person of ordinary skill in the art would know what the percent symbol would indicate. An appropriate recitation of volume percent is “ vol%”, “% v/v” or “volume percentage” without the parenthesis.
Claim 26 recites “according to a method” (line 3), claim 27 recites “according to a method” (line 3), and claim 28 recites “according to a method” (line 2). However, it is unclear to a person of ordinary skill in the art if the claims 26-28 are referring to “any” method. A person of ordinary skill in the art would not know if the claims if the claims are referring to the method of claim 25, since claims 26-28 ultimately depend from claim 25, or if the claims are referring to a new method.
Claim 27 recites “according to a method” (line 3). However, it is unclear to a person of ordinary skill in the art if the claims 26-28 are referring to “any” method. A person of ordinary skill in the art would not know if the claims if the claims are referring to the method of claim 25, since claims 26-28 ultimately depend from claim 25, or if the claims are referring to a new method.
Claim 28 recites the limitation "the method according to claim 27, wherein (II)”. There is a lack of insufficient antecedent basis for this limitation in the claim and renders the claim indefinite because there is no prior recitation of any roman numeral two "(II)” that could be interpreted as the roman numeral two. As such the recitation is indefinite because it is not apparent to what the roman numeral two is referring, given the base claims does not require one. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "on the cell culture vessel in (I)”. There is a lack of insufficient antecedent basis for this limitation in the claim and renders the claim indefinite because there is no prior recitation of any "cell culture vessel in (I)” that could be interpreted as the cell culture vessel with the roman numeral one. As such the recitation is indefinite because it is not apparent to what the roman numeral one is referring, given the base claims does not require one. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites “according to a method” (line 2). However, it is unclear to a person of ordinary skill in the art if the claims 26-28 are referring to “any” method. A person of ordinary skill in the art would not know if the claims if the claims are referring to the method of claim 25, since claims 26-28 ultimately depend from claim 25, or if the claims are referring to a new method.
Claim 32 recites “wherein step (b2)” (line 1), and since there is no recitation of the method step (b2), there is a lack of insufficient antecedent basis for this limitation in the claim and renders the claim indefinite because there is no prior recitation of any "(b2)” that could be interpreted as the step (b2). As such the recitation is indefinite because it is not apparent to what the b2 step is referring, given the base claims does not require one. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites “a cell digestion solution”. However, it is unclear to a person of ordinary skill in the art if “a cell digestion solution” is the same solution since claim 33 ultimately depends on claims 25. Thus, a person of ordinary skill in the art would not know if it were a new cell digestion solution or the same cell digestion solution in claim 25.
Claim 34 recites “% (volume percentage),”(lines 28, 36, and 38), but the symbol of “%” does not mean “volume percent.” It is unclear to a person of ordinary skill in the art that the scope of the percent symbol “%” is meant to be volume percent, because the symbol of a percent sign does not indicate a volume percentage, it is just a symbol/sign for percent. Therefore, a person of ordinary skill in the art would know what the percent symbol would indicate. An appropriate recitation of volume percent is “ vol%”, “% v/v” or “volume percentage” without the parenthesis.
Appropriate correction is required.
Citation of Relevant Prior Art
The prior art made of record, and not relied upon is considered pertinent to applicant's disclosure:
Liu et al., (WO2018094410A1, 2018, prior art of record) is considered relevant prior art for having disclosed a method for culturing primary cells from cancer, such as lung cancer and non-small-cell lung cancer squamous cell carcinoma. (i.e. human epithelial tumor cells), culturing primary tumor cells from pleural effusion of lung cancer are suspension-cultured with a cell culture medium (see Liu e.g. abstract, page 2, 10, 22, 28 and claim 1-2, 9, and 20). See e.g. abstract, page 22). Liu discloses a growth medium with defined medium such as Dulbecco's Modified Eagles Medium (DMEM), Ham's Nutrient Mixture (F12) (DMEM/F12) that utilizes a ROCK inhibitor Y-27632 in a final concentration range of 5-20 μM (see e.g. pages 3, 4, 7, 15, 18, 19, 25, Example 1, figs. 3-5, 8). Liu discloses that the DMEM/F12, which is supplemented with additional components, for example, growth factors, antioxidants, and/or energy sources (see e.g. page 15). Liu discloses suspension-culturing the dissociated primary cells from solid tumor of lung cancer and incubated at 37°C on low-cell binding plates (i.e. low adsorption surface) (see e.g. page 28, claim 1 and reprogramming single cell cultures). Further, Liu discloses culturing in low-cell binding plates (i.e. low adsorption surface) (see e.g. page 28, claim 1 and reprogramming single cell cultures).
Sachs et al., (US2017/0275592A1, 2017, prior art of record) is considered relevant prior art for having disclosed a culture medium for epithelial cells with improved culture methods for expanding epithelial cells (See e.g. abstract, para. 15-26, 296, 478) with penicillin/streptomycin (see e.g. para. 105, fig. 14), HEPES is 10mM (para. 639-640), about 1% GlutaMax (e.g. para. 104, 196-197, 639-640), and non-essential amino acids: glycine, L-alanine, L-asparagine, L-aspartic acid, L-glutamine acid, L-proline, and L-serine with water (see e.g. para. 197 and 306). Sachs discloses collagenase and Accutase digestion are used to obtain the epithelial stem cells (see e.g. para. 328), and that dense organoids were digested in 2 mL TrypLE™ Express (see e.g. para. 626). Sachs discloses passaging samples having an average size of 100-200 μm (see e.g. para. 403). Further, Sachs et al., discloses cell culture surfaces may be treated with components such as co-polymers or any suitable biodegradable polymer, including but not limited to alginates, poly-ethylene glycol (PLGA), and polyurethanes (see e.g. para. 536-537).
Herreño, et al. (Cogent Medicine 5.1: 1503071, 2018, prior art of record) is considered relevant prior art for having disclosed a primary lung cancer cell culture with a medium comprising 100nM of hydrocortisone (i.e. cortisol), Insulin is 5 μg/ml, Transferrin is 5 μg/ml sodium selenite (i.e. selenium) is 30nM, and Ethanolamine (10 μM), (i.e. ITS-X) is 0.8-1.2% (volume percentage)(see page 4, Table 1).
Willett et al. (American journal of respiratory cell and molecular biology 18.4: 489-496, 1998, prior art of record) is considered relevant prior art for having disclosed a method of culturing lung tumor cell lines with Macrophage stimulating protein (MSP) at 1nM, 3nM, and 5nM (see e.g. page 491).
Timmins et al., (WO2017127921A1, 2017, prior art of record), is considered relevant prior art for having disclosed a 10 mL dissociation reagent solution including one or more reagent such as Trypsin, EDTA, TrypLE™ Select, and Accutase™ with each reagent at 0.5x with Phosphate buffered saline (PBS)(see e.g. para. 65-70, page 13). Further, Timmins discloses passaging the aggregates over five passages (i.e. after 2-3 passages) and that the that the full cell culture may be washed and utilized for an end product, such as cryopreserved product (See e.g. page 22).
Inoue et al. (WO2011068183A1, 2011, prior art of record), is considered relevant prior art for having disclosed that the tumor cells may be cryopreserved in a cultural state (see e.g. Example 14). “1% Pen and Strep (both 100 units/ml) and 100 μg/ml as concentrations”(see e.g. page 8).
Leosson, Kristjan, and Björn Agnarsson (Micromachines 3.1: 114-125, 2012, prior art of record) is considered relevant prior art for having disclosed polymers such as poly(methyl methacrylate) (PMMA), polystyrene (PS) or polycarbonate (PC), were known for sensing and monitoring applications, and that the amorphous fluoropolymer CYTOP could be used as a cladding material to the polymers in order to optically probe a sample solution when performing imaging experiments (see e.g. abstract, page 115).
Ono et al., (Journal of applied physics 105.1, 2009, prior art of record) is considered relevant prior art for having disclosed etching using the amorphous fluoropolymer (i.e. CYTOP) with an etching power of about 8W (see e.g. abstract, pages 1-2) and discloses an etching range of 30 second to 6 mins (see e.g. fig 4).
Conclusion
No claim is allowed.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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