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
Claims 1-15 are pending.
Objections to Abstract
The abstract is objected to because it uses the term “B27” (line 6) which is a trade name or mark used in commerce that is not accompanied by the generic terminology and does not 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.
Appropriate Correction is Required.
Objections to the Specification
Trade Name or Marks used in Commerce
The use of the terms B27, DMEM and Primocin, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the 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.
Objections to Specification
The disclosure is objected to because of the following informalities:
Pg. 12 has the following figure embedded into the specification:
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(pg.12).
Drawings must be presented on one or more separate sheets. They may not be included in the description, the claims or the abstract (see MPEP 1825 and 37 CFR 1.437)
Appropriate correction is required.
Claim Interpretation
Claims 1 and 7-15 recite the transitional phrase “characterized in.” Applicant is directed to MPEP 2111.03 (I) for information on transitional phrases. The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim and the determination of what is or is not excluded by a transitional phrase must be made on a case-by-case basis in light of the facts of each case see MPEP 2111.03. Other transitional phrases must be interpreted in light of the specification to determine whether open or closed claim language is intended (see MPEP 2111.03 (V)).
MPEP 2111.03 (I) states the "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03 (I)).
In the instant case, the specification is absent to specific guidance on the breadth of the transitional phrase “characterized in” and therefore, because this phrase most closely resembles the transitional phrase "characterized by," the phrase is interpreted as inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
Claim Objections
Claims 1 and 7-15 are objected to because of the following informalities:
Claims 1, 8-15 recite “characterized in that, comprising” and claim 7 recites “characterized in that, further comprising” which includes two transitional phrases. Because the MPEP states that the transitional term "comprising", is synonymous with "including," "containing," or "characterized by," the scope of the claim is clear since both the recited transitional phrases are open-ended (see MPEP 2111.03 (I)). However, it is unnecessarily redundant to include two synonymous transitional phrases and it is recommended that Applicant amend to one transitional phrase to improve the readability of the claim.
Claim 9 recites “step(1)” which is missing a space and should be written as “step (1).”
Claim 9 recites “(1) culturing primary ovarian cancer cells using the method for culturing primary ovarian cancer cells of claim 8.” It is clear that this limitation includes the method steps of claim 8. To improve the clarity and readability of the claim, it is recommended that Applicant amend to “(1) culturing primary ovarian cancer cells by the culturing method for culturing primary ovarian cancer cells of claim 8.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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.
Claims 1 and 8 recite the trademarked term “B27,” claim 7 recites the trademarked terms DMEM/F12 (which included the trademarked term DMEM), DMEM, and Primocin.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe cell culture additive and, accordingly, the identification/description is indefinite.
Because this reagent was developed by the manufacturer at the time of the applicant’s invention under the trade names and as a result is proprietary, which means what constitutes as B27, or DMEM or Primocin can change, and these changes do not need to be disclosed by these companies to the public. Accordingly, the identification of the trade name is indefinite and the applicant is advised to employ a sequence, the SeqID, IUPAC name and/or CAS number for this agent.
MPEP 2173.05(u) states that if 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 the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). See also Eli Lilly & Co. v. Apotex, Inc., 837 Fed. Appx. 780, 784-85, 2020 USPQ2d 11531 (Fed. Cir. 2020).
Regarding the status of B27 and DMEM as trademarks, Applicant is directed to MPEP 608.01(v) which defines a trademark as follows:
The term "trademark" includes any word, name, symbol, or device, or any combination thereof-
(1) used by a person, or
(2) which a person has a bona fide intention to use in commerce and applies to register on the principal register established by this chapter,
to identify and distinguish his or her goods, including a unique product, from those manufactured or sold by others and to indicate the source of the goods, even if that source is unknown.
Although the Trademarks for DMEM (number 98618988) and B27 (number 77129891) were abandoned, they still meet the definition of a trademark according to the MPEP because they are each a term “which a person has a bona fide intention to use in commerce” “to identify and distinguish his or her goods.” Since the trademark Application was filed (i.e. “applies to register on the principal register” MPEP 608.01(v) above), it falls under the definition of a trademark, even if the Trademark Status is now Dead/Abandoned.
Accordingly, for the reasons stated above, the claims are indefinite due to the presence of the trademark terms.
By nature of their ultimate dependency on claim 1, claims 2-15 are also rejected because they do not clarify the issue.
By nature of its dependency on claim 7, claim 15 is also rejected because it does not clarify the issue.
By nature of its dependency on claim 8, claim 9 is also rejected because it does not clarify the issue.
Claim 6 recites preferential language (“preferably”). If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim (see MPEP 2173.05(d). Therefore, it is unclear which aspect(s) of the claim is/are intended to be within the scope(s) of the claim(s) (see also MPEP 2173.05(b)).
Claim 7 recites the term “initial medium,” while the instant specification is silent to a definition of the phrase “initial medium.” The scope of claim 7 is indefinite because the term “initial” suggests a timing, while the claim is drawn to a single medium. The metes and bounds of the structure of the claims is indefinite because it is unclear whether the mediums recited in claim 7 are required at a particular timing and it is unclear how that structure would be incorporated into the composition of instant claims.
Claims 8 and 10-15 recites “preparing the primary cell culture medium,” which makes the scope of the claim unclear because it appears to require additional unrecited steps of preparing and therefore, because specific steps of preparing are not provided, this makes the scope of the claim unclear.
To overcome this rejection, is recommended that Applicant amends to “providing the primary cell culture medium.”
Claim 9 recites the preamble of “method for evaluating or screening a drug for treating ovarian cancer” and claim 9 recites the active method step of “detecting the cell viability” which appears to be the metric of the claimed method. The scope of the claimed method is indefinite because there is no nexus between the active method step of “detecting the cell viability” and the preamble of “evaluating or screening a drug for treating ovarian cancer.” In other words, the scope is unclear because it is unclear how the result of the cell viability detection relates to the evaluation or screen of a drug.
Claim 9 recites “adding the drug which has been diluted into various concentration gradients to the primary ovarian cancer cells” which makes the scope of the claim indefinite because the configuration of the drug which has been diluted to gradients in unclear. Specifically, the step (3) is indefinite because it is unclear whether all the gradients are added at once, or whether they are added to different samples of the lung cancer epithelial cells.
Claim 9 recites the subjective terminology “desired” as part of the phrase “desired concentration gradients” with no corresponding definition. Therefore the scope of the claim is unclear. A claim may be rendered indefinite by reference to subjective phrase (see MPEP 2173.05(b), IV). Specifically, the term “desired” is a subjective phrase which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for some standard for measuring the scope of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Pertinent Co-Pending Applications
The following co-pending Applications are made of record because they are pertinent to Applicant’s disclosure but are not relied upon for a rejection.
U.S. Co-pending Application Nos 17918971, 17927530, 18577457, 18690412 and 18692569 each claim cell culture medias comprising an MST1/2 kinase inhibitor identical to the instantly claimed Formula (I) as well as a method of culturing using the medium and a method of screening using the medium. Each of the claimed cell culture medias recites an intended use of a specific cell type.
U.S. Co-pending Application No. 17918971
U. S. Co-pending App ‘971 (claim set filed 25th, February, 2026) claims a cell culture media comprising an MST1/2 kinase inhibitor of Formula (I); a ROCK inhibitor; insulin-transferrin-selenium supplement (insulin-transferrin-selenium complex); insulin (as insulin-transferrin-selenium complex); epidermal growth factor; and at least one additive selected from a B27 additive and an N2 additive (claim 1).
U. S. Co-pending App ‘971 does not claim the required elements of instant Application claims of prostaglandin E2, gastrin, insulin-like growth factor-1, cholera toxin and amphiregulin and these are not fairly taught or suggested by the prior art.
U.S. Co-pending Application No. 17927530
U. S. Co-pending App ‘530 (claim set filed 3rd, February, 2026) claims a cell culture media comprising an MST1/2 kinase inhibitor of Formula (I); a ROCK inhibitor selected from at least one of Y27632, Fasudil, or H-1152; insulin-transferrin-selenium complex; insulin (as insulin-transferrin-selenium complex); and insulin-like growth factor 1 (claim 1).
U. S. Co-pending App ‘530 does not claim the required elements of instant Application claims of prostaglandin E2; epidermal growth factor; gastrin; cholera toxin; amphiregulin; N2 and B27 and these are not fairly taught or suggested by the prior art.
U.S. Co-pending Application No. 18577457
U. S. Co-pending App ‘457 (claim set filed 8th, January, 2024) claims a cell culture media comprising an MST1/2 kinase inhibitor of Formula (I);at least one ROCK inhibitor selected from the group consisting of Y27632, fasudil, and H-1152; insulin-like growth factor 1; and at least one additive selected from the group consisting of B27 additive and N2 additive (claim 1).
U. S. Co-pending App ‘457 does not claim the required elements of instant Application claims of insulin-transferrin-selenium supplement; insulin; prostaglandin E2; epidermal growth factor; cholera toxin and amphiregulin and these are not fairly taught or suggested by the prior art.
U.S. Co-pending Application No. 18690412
U. S. Co-pending App ‘412 (claim set filed 8th, March, 2024) claims a cell culture media comprising an MST1/2 kinase inhibitor of Formula (I); a ROCK Inhibitor (Y27632); an ITS cell culture additive; insulin (as an ITS cell culture additive); an epidermal cell growth factor; and at least one cell culture additive selected from N2 and B27 (claim 1).
U. S. Co-pending App ‘412 does not claim the required elements of instant Application claims of prostaglandin E2, gastrin, cholera toxin and amphiregulin and these are not fairly taught or suggested by the prior art.
U.S. Co-pending Application No. 18692569
U. S. Co-pending App ‘569 (claim set filed 15th, March, 2024) claims a cell culture media comprising an MST1/2 kinase inhibitor of Formula (I); a ROCK kinase inhibitor selected from at least one of Y27632, Fasudil, and H-1152; an epidermal growth factor; gastrin; and at least one additive selected from a B27 additive and an N2 additive (claim 1).
U. S. Co-pending App ‘569 does not claim the required elements of instant Application claims of insulin-transferrin-selenium supplement; insulin; prostaglandin E2; insulin-like growth factor-1; cholera toxin and amphiregulin; and these are not fairly taught or suggested by the prior art.
Pertinent Art
The following prior art made of record but not relied upon is considered pertinent to Applicant’s disclosure.
Triastuti
Triastuti et al. (Br J Pharmacol. 2019 Oct 8;176(20):3956–3971.; henceforth “Triastuti”) discloses a cell culture media comprising an MST1 kinase inhibitor (XMU-MP-1 cultured 72 hours with “the addition of XMU‐MP‐1 at 1–5 μM” pg. 3958 col. 1 3rd para.).
Liu
Liu et al. (WO-2020073906-A1; henceforth “Liu”) discloses a pharmaceutical composition comprising an MST kinase inhibitor of the following structure:
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(abstract; claims;)
Which encompasses embodiments of the instantly claimed Markush structure of Formula (I), copied below for reference.
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(from instant claim 1).
The MST kinase inhibitor structure disclosed by Liu comprises the structure of Formula (I) of instant claim 1 where:
R1 (of instant claims, R4 of Liu reference) is selected from C1-C6 alkyl, C3-C6 cycloalkyl, C4-C8 cycloalkylalkyl, C2-C6 spirocycloalkyl, heteroaryl, or aryl (claims; pg. 1);
R2 and R3 (of instant claims, R2 and R3 of Liu reference) are each independently selected from Cl-C6 alkyl (claims);
R4 and R5 (of instant claims, R5 and R6 of Liu reference) are each independently selected from hydrogen, C1- C6 alkyl, C3-C6 cycloalkyl, C4-C8 cycloalkylalkyl, C3-C6 heterocycloalkyl, C1 -C6 alkylamino C1-C6 alkyl, C1-C6 alkoxy Cl-C6 alkyl, and C3-C6 heterocyclyl Cl-C6 alkyl (claims) (see also specifically recited structures in the tables which recite specific structures within the claimed Markush).
Liu discloses the composition comprises Ringer’s injection or lactated Ringer’s injection.
Liu2
Liu et al. (US-20230235283-A1; Published 17th, October 2024 with priority to 8th, July, 2021; henceforth “Liu2”) discloses a primary cell culture medium comprising an MST 1/2 Kinase Inhibitor of Formula I, ROCK inhibitor selected from the group consisting of Y27632, Fasudil, and H-1152, fibroblast growth factor (Tables 3 and 5);
B27 additive and/or N2 additive (para. [0019]);
an epidermal growth factor (EGF; para. [0019, 0097, 0108, 0113, 0122, 0129]; tables 6-7);
insulin-transferrin-selenium complex (para. [0019-0020, 0097, 0108, 0112, 0121, 0129]; Tables 3,5 and 7; claims 8-9);
insulin-like growth factor 1 (para. [0097]); and/or
Cholera Toxin (para. [0097])
Hoffman
Hoffman et al. (WO-2003020722-A1; citations refer to attached translation; henceforth “Hoffman”) teaches dihydropteridinones of formula (I)
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wherein R1 is a radical selected from the group consisting of hydrogen, NH, XH, halogen and a C 1 -C 3 -alkyl group which is optionally substituted by one or more halogen atoms,
R is a radical selected from the group consisting of hydrogen, CHO, XH, -X-C 1 -C 2 -alkyl and an optionally substituted CrC 3 -alkyl group,
R3 , R4 are identical or different , a radical selected from the group consisting of optionally substituted C 1 -C 8 -alkyl, C 2 -C 8 alkenyl, C 2 -C 8 alkynyl, aryl, Heteroaryl, C 3 -C 8 cycloalkyl, C 3 -C 8 heterocycloalkyl, -X-aryl, -X-heteroaryl, -X-cycloalkyl, -X-heterocycloalkyl, -NR 8 -aryl, -NR 8 -heteroaryl, -NR 8 -cycloalkyl, and -NR 8 heterocycloalkyl, or a radical selected from the group consisting of hydrogen, halogen, COXR 8 , CON (R 8 ) 2) COR 8 and XR 8 ,
or R 3 and R 4 together form a 2- to 5-membered alkyl bridge which can contain 1 to 2 heteroatoms,
R5 is hydrogen or a radical selected from the group consisting of optionally substituted Cι-Cι 0 alkyl, C 2 -Cι 0 alkenyl, C 2 -C 10 alkynyl, aryl, heteroaryl and -C 3 -C 6 cycloalkyl,
or R3 and R5 or R4 and R5 together form a saturated or unsaturated C 3 -C 4 alkyl, which may contain 1 to 2 heteroatoms,
R6 optionally substituted aryl or heteroaryl,
R7 is hydrogen or -CO-XC 1 -C 4 alkyl, and X each independently of one another, O or S,
R8 selected each independently, hydrogen or a radical from the group consisting of optionally substituted Cι-C 4 alkyl, C 2 -C 4 alkenyl, C 2 -C 4 -alkynyl and phenyl, if appropriate in the form of their tautomers, their racemates, their enantiomers, their diastereomers and their mixtures, and if appropriate their pharmacologically acceptable acid addition salts (claim 1 and Description; see in particular Table 1).
Embodiments of the structure of Hoffman are encompassed by the structure of Formula (I) of instant claims (see claim 1 and table 1).
Hoffman teaches a composition comprising a cell culture media (F12 medium) and the dihydropteridinones (“active substances were added to the cells”) for cancer cells (cervical carcinoma tumor cell line HeLaS3) (pg. 109 7th para.).
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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