DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-20 are pending in the instant invention.
Status of Priority
This invention was filed on July 11, 2023.
Restrictions / Election of Species
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The forthcoming first Office action and prosecution on the merit includes (1) claims 1-11, drawn to a method for preventing and/or treating liver fibrosis, comprising administering… a composition comprising… 6-methoxybenzoxazolinone (6-MBOA), shown to the right above; and (2) claims 12-20, drawn to a method for preventing and/or treating liver fibrosis, comprising administering… a composition comprising… Coix lachrymal-jobi L. extract comprising 6-methoxybenzoxazolinone (6-MBOA), shown to the right above, respectively.
Thus, a first Office action and prosecution on the merits of claims 1-20 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of 6-methoxybenzoxazolinone (6-MBOA) into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A method for treating liver fibrosis in a subject, wherein the method comprises administering to the subject in need thereof a pharmaceutical composition comprising a pharmaceutically acceptable excipient, carrier, or adjuvant, or a combination thereof, and a therapeutically effective amount of 6-methoxybenzoxazolinone (6-MBOA) of the following structural formula:
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Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 1, wherein the pharmaceutical composition is a comestible composition or a topical composition.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 1, wherein the pharmaceutical composition is formulated for oral administration.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 1, wherein the pharmaceutical composition is formulated for parenteral administration.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 7, wherein the comestible composition further comprises a food additive.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 1, wherein the pharmaceutical composition is formulated as a granule, a jelly, a paste, a powder, or a solution.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A method for treating liver fibrosis in a subject, wherein the method comprises administering to the subject in need thereof a pharmaceutical composition comprising a pharmaceutically acceptable excipient, carrier, or adjuvant, or a combination thereof, and a therapeutically effective amount of Coix lachrymal-jobi L. extract comprising 6-methoxybenzoxazolinone (6-MBOA) of the following structural formula:
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Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 12, wherein the pharmaceutical composition is a comestible composition or a topical composition.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 12, wherein the pharmaceutical composition is formulated for oral administration.
Appropriate correction is required. See MPEP § 2173.02.
Claim 19 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 12, wherein the pharmaceutical composition is formulated for parenteral administration.
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 17, wherein the comestible composition further comprises a food additive.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(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.
Claim 2 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 2 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, as recited in claim 1, reduces inflammatory infiltration,… and expression level of TGF-b1-induced fibronectin in the subject in need thereof. Consequently, since the additional physicochemical property of the 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, whereby the 6-methoxy-benzoxazolinone (6-MBOA) reduces inflammatory infiltration,… and expression level of TGF-b1-induced fibronectin in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 1, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 3 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 3 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, as recited in claim 1, negatively regulates expression levels of phosphor-Mothers against decapentaplegic homolog 2 (p-SMAD2) and phosphor-Mothers against decapentaplegic homolog 3 (p-SMAD3) in the subject in need thereof. Consequently, since the additional physicochemical property of the 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, whereby the 6-methoxy-benzoxazolinone (6-MBOA) negatively regulates expression levels of phosphor-Mothers against decapentaplegic homolog 2 (p-SMAD2) and phosphor-Mothers against decapentaplegic homolog 3 (p-SMAD3) in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 1, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 4 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 4 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, as recited in claim 1, increases superoxide dismutase (SOD) activity, catalase (CAT) activity, glutathione (GSH) content, and decreases malondialdehyde (MDA) content in the subject in need thereof. Consequently, since the additional physicochemical property of the 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, whereby the 6-methoxybenzoxazolinone (6-MBOA) increases superoxide dismutase (SOD) activity, catalase (CAT) activity, glutathione (GSH) content, and decreases malondialdehyde (MDA) content in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 1, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 5 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 5 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, as recited in claim 1, inhibits hepatic stellate cell (HSC) activation and epithelial-mesenchymal transition (EMT) in the subject in need thereof. Consequently, since the additional physicochemical property of the 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, whereby the 6-methoxy-benzoxazolinone (6-MBOA) inhibits hepatic stellate cell (HSC) activation and epithelial-mesenchymal transition (EMT) in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 1, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 6 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 6 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, as recited in claim 1, decreases expression levels of Zinc finger protein SNAIL1/2, TWIST1/2, Zinc finger E-box-binding homeobox 1 (ZEB1), and NADPH oxidase 4 (NOX4) in the subject in need thereof. Consequently, since the additional physicochemical property of the 6-methoxybenzoxazolinone (6-MBOA) administered within the method for preventing and/or treating liver fibrosis, whereby the 6-methoxybenzoxazolinone (6-MBOA) decreases expression levels of Zinc finger protein SNAIL1/2, TWIST1/2, Zinc finger E-box-binding homeobox 1 (ZEB1), and NADPH oxidase 4 (NOX4) in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 1, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claims 13 and 16 are rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 13 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional process performed on a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, the Coix lachrymal-jobi L. extract administered within the method for preventing and/or treating liver fibrosis, as recited in claim 12, is obtained by extracting Coix lachrymal-jobi L. with a solvent. Consequently, since the additional process performed on the Coix lachrymal-jobi L. extract administered within the method for preventing and/or treating liver fibrosis, whereby the Coix lachrymal-jobi L. extract is obtained by extracting Coix lachrymal-jobi L. with a solvent, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 12, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 12, it is not given patentable weight and thus, renders the instant dependent claim, and any additional dependent claims therefrom, improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claims, (2) amend the dependent claims to place the dependent claims in proper dependent form, (3) rewrite the dependent claims in independent form, or (4) present a sufficient showing that the dependent claims comply with the statutory requirements, to overcome this rejection.
Claim 14 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 14 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, Coix lachrymal-jobi L. extract administered within the method for preventing and/or treating liver fibrosis, as recited in claim 12, reduces serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), total glyceride (TG) and total cholesterol (TC) in the subject in need thereof. Consequently, since the additional physicochemical property of the Coix lachrymal-jobi L. extract administered within the method for preventing and/or treating liver fibrosis, whereby the Coix lachrymal-jobi L. extract reduces serum levels of alanine amino-transferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), total glyceride (TG) and total cholesterol (TC) in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 12, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 12, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 15 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 15 is rejected under 35 U.S.C. § 112(d) because the recitation of an additional physicochemical property of a compound administered within a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, Coix lachrymal-jobi L. extract administered within the method for preventing and/or treating liver fibrosis, as recited in claim 12, reduces levels of gene expression as well as protein including a-smooth muscle actin (a-SMA), collagen, type 1, alpha 1 (COLIAI), tumor necrosis factor-a (TNF-a), and interleukin-6 (IL-6) in the subject in need thereof. Consequently, since the additional physicochemical property of the Coix lachrymal-jobi L. extract administered within the method for preventing and/or treating liver fibrosis, whereby the Coix lachrymal-jobi L. extract reduces levels of gene expression as well as protein including a-smooth muscle actin (a-SMA), collagen, type 1, alpha 1 (COLIAI), tumor necrosis factor-a (TNF-a), and interleukin-6 (IL-6) in the subject in need thereof, fails to result in a further patentably distinct methodical step in the method for preventing and/or treating liver fibrosis, as recited in claim 12, and/or fails to include all the limitations of the method for preventing and/or treating liver fibrosis, as recited in claim 12, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624