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 .
Status of Application
Claims 1-14 are included in the prosecution.
Priority
This Application is a 371 of PCT/KR2022/006674 filed on 05/10/22. This Application also claims foreign priority to KR 10-2022-0021852 filed on 02/21/22 and KR 10-2022-0037112 filed on 03/25/22. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) English translations of the foreign applications must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide translations may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/08/23 and 06/12/23 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 6,045,800 – “Kim”).
The claimed invention is a pharmaceutical composition for anti-obesity and preventing or treating muscle loss, comprising an extract of a plant in the genus Ulmus as an active ingredient.
Kim discloses a composition comprising an extract of Ulmus cortex (Abstract). The extract is a lower alkyl alcohol extract of Ulmus cortex (claim 1), wherein a preferred lower C1 to C4 alcoholic solvent is ethanol (Col. 4, lines 40-44, Preparative Example 2 – Col. 7, line 63 to Col. 8, line 2, Example 1-2 – Table 1, claims 13, 15, and 17). The extract is prepared from the roots of plants of the Ulmaceae family such as Ulmus macrocarpa, Ulmus pumila, Ulmus americana, Ulmus davidiana, etc. (Col. 4, lines 11-17).
Regarding instant claim 1, the limitation of a pharmaceutical composition for anti-obesity and preventing or treating muscle loss, comprising an extract of a plant in the genus Ulmus as an active ingredient is anticipated by the composition comprising an extract of Ulmus cortex (Abstract, Example 1-2 – Table 1, claim 1), as taught by Kim. The limitation of "anti-obesity and preventing or treating muscle loss" denotes a future-intended use and thus, does not accord patentable weight to the claims. The recited intended use does not alter the structure of the claimed composition.
Regarding instant claims 3 and 5, the limitation of an alcohol extract of the branch or root of elm and the limitation of ethanol are anticipated by the extract which is a lower alkyl alcohol extract of Ulmus cortex (claim 1), wherein a preferred lower C1 to C4 alcoholic solvent is ethanol (Col. 4, lines 40-44, Preparative Example 2 – Col. 7, line 63 to Col. 8, line 2, Example 1-2 – Table 1, claims 13, 15, and 17), and wherein the extract is prepared from the roots of plants of the Ulmaceae family such as Ulmus macrocarpa, Ulmus pumila, Ulmus americana, Ulmus davidiana, etc. (Col. 4, lines 11-17), as taught by Kim.
Claims 1, 3, 5, 7, 9, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (KR 2013 0060806 A – English Espacenet Translation – “Kim ‘13”).
Kim ‘13 discloses a composition comprising an extract of Ulmus cortex for preventing and treating obesity to suppress accumulation of neutral fat and differentiation of adipocytes without toxicity (Abstract). Preferably, the extract is prepared with ethanol ([0019]). The root and bark of the elm tree Ulmus davidiana var. japonica Nakai is used for the extraction ([0007]-[0008], [0019]-[0020], Example 1 – [0033]). A health functional food for preventing and improving obesity, which comprises a root bark extract as an active ingredient is disclosed ([0025]-[0026] and claim 5).
Regarding instant claim 1, the limitation of a pharmaceutical composition for anti-obesity and preventing or treating muscle loss, comprising an extract of a plant in the genus Ulmus as an active ingredient is anticipated by the composition comprising an extract of Ulmus cortex for preventing and treating obesity to suppress accumulation of neutral fat and differentiation of adipocytes without toxicity (Abstract), as taught by Kim ’13.
Regarding instant claims 3, 5, 7, 9, and 11, the limitations of an alcohol extract of the branch or root of elm and the limitation of ethanol are anticipated by the extract which is prepared with ethanol ([0019]), and the root and bark of the elm tree Ulmus davidiana var. japonica Nakai which is used for the extraction ([0007]-[0008], [0019]-[0020], Example 1 – [0033]), as taught by Kim ’13.
Regarding instant claims 7 and 13, the limitations of a functional health food and animal feed are anticipated by the health functional food for preventing and improving obesity, which comprises a root bark extract as an active ingredient is disclosed ([0025]-[0026] and claim 5) and wherein the root and bark of the elm tree Ulmus davidiana var. japonica Nakai is used for the extraction ([0007]-[0008], [0019]-[0020], Example 1 – [0033]), as taught by Kim ’13.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 6,045,800 – “Kim”), as applied to claims 1, 3, and 5 above, in view of Jeon et al. (Toxicology and Environmental Health Sciences (2020) 12:325-329 – “Jeon”).
Instant claim 2 is drawn to the pharmaceutical composition for anti-obesity and preventing or treating muscle loss according to claim 1, wherein the extract of a plant in the genus Ulmus is an extract of a supercritical extract residue of a plant in the genus Ulmus.
The teaching of Kim is discussed above.
Kim does not expressly teach a supercritical extract residue of a plant in the genus Ulmus.
Jeon teaches supercritical fluid extraction of Ulmus davidiana branch (Abstract). Jeon teaches that supercritical extraction method is used because it is environmentally friendly, and keeps humans safe from organic solvents and environmental pollutants (Page 325, Introduction, 1st ¶). The supercritical extraction process is disclosed (Page 327, Col. 2, under Materials and Methods). Figure 5 shows the scheme for the supercritical extraction of Ulmus species.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising an extract of Ulmus species, as taught by Kim, in view of the supercritical extraction of Ulmus species, as taught by Jeon, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this since Jeon teaches that the supercritical extraction method is advantageous because it is environmentally friendly, and keeps humans safe from organic solvents and environmental pollutants (Page 325, Introduction, 1st ¶).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 2, the limitation of the supercritical extract residue of a plant in the genus Ulmus would have been obvious over the supercritical extraction of Ulmus species, as taught by Jeon (Abstract, Page 325, Introduction, 1st ¶, Page 327, Col. 2, under Materials and Methods, and Figure 5).
Instant claim 4 is set forth in the form of product-by-process claim, which is considered a product claim by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), supra; In re Dike (CCPA 1968) 394 F2d 584, 157 USPQ 581; Tri-Wall Containers, Inc. v. United States et al. (Ct Cls 1969) 408 F2d 748, 161 USPQ 116; In re Brown et al. (CCPA 1972) 450 F2d 531, 173 USPQ 685; Ex parte Edwards et al. (BPAI 1986) 231 USPQ 981. Nevertheless, Jeon teaches the method steps (a) and (b) (Figure 5 of Jeon).
Claims 2, 4, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 2013 0060806 A – English Espacenet Translation – “Kim ‘13”), as applied to claims 1, 3, 5, 7, 9, 11, and 13 above, in view of Jeon et al. (Toxicology and Environmental Health Sciences (2020) 12:325-329 – “Jeon”).
The teaching of Kim ‘13 is discussed above.
Kim ’13 does not expressly teach a supercritical extract residue of a plant in the genus Ulmus.
The teaching of Jeon with respect to the supercritical fluid extraction of Ulmus davidiana branch is also discussed in detail above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an extract of Ulmus cortex for preventing and treating obesity to suppress accumulation of neutral fat and differentiation of adipocytes without toxicity, as taught by Kim ‘13, in view of the supercritical extraction of Ulmus species, as taught by Jeon, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this since Jeon teaches that the supercritical extraction method is advantageous because it is environmentally friendly, and keeps humans safe from organic solvents and environmental pollutants (Page 325, Introduction, 1st ¶).
Regarding instant claims 2 and 8, the limitations of the supercritical extract residue of a plant in the genus Ulmus would have been obvious over the supercritical extraction of Ulmus species, as taught by Jeon (Abstract, Page 325, Introduction, 1st ¶, Page 327, Col. 2, under Materials and Methods, and Figure 5).
Instant claims 4 and 10 are set forth in the form of product-by-process claims, which are considered product claims by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), supra; In re Dike (CCPA 1968) 394 F2d 584, 157 USPQ 581; Tri-Wall Containers, Inc. v. United States et al. (Ct Cls 1969) 408 F2d 748, 161 USPQ 116; In re Brown et al. (CCPA 1972) 450 F2d 531, 173 USPQ 685; Ex parte Edwards et al. (BPAI 1986) 231 USPQ 981. Nevertheless, Jeon teaches the method steps (a) and (b) (Figure 5 of Jeon).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 6,045,800 – “Kim”), as applied to claims 1, 3, and 5 above, in view of Kim et al. (J. Korean Wood Sci. Technol. 2020, 48(6): 888-895 – “Kim ‘20”).
Instant claim 6 is drawn to the pharmaceutical composition for anti-obesity and preventing or treating muscle loss according to claim 1, wherein the extract of a plant in the genus Ulmus comprises catechin 7-O-ß-D-apiofuranoside.
The teaching of Kim is discussed above.
Kim does not expressly teach that the extract of Ulmus comprises catechin 7-O-ß-D-apiofuranoside.
Kim ’20 teaches the extraction of catechin 7-O-beta-D-apiofuranoside from Ulmus species (whole document), and that “Ulmus genus has excellent various physiological activities, including anti-ulcer, antioxidant, antibacterial, anti-cancer, immunity, and homeostasis maintenance effects, and it is known to have many additional drug effects. And one of reasons for these excellent biological activities is a flavan-3-ol chemical group in the Ulmus genus … a new flavan-3-ol compound was identified in Ulmus davidiana var. japonica. A flavan-3-ol,(2R,3S)-7-[(2S,3R,4R)-3,4-dihydroxy-4- (hydroxymethyl)oxolan-2-yl]oxy-2-(3,4-dihydroxyphenyl)-3,4-dihydro-2H-chromene-3,5-diol, named as catechin 7-O-beta-D apiofuranoside, was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, which is a species belonging to the genus Ulmus, growing throughout the Korea peninsula” (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising an extract of Ulmus species, as taught by Kim, in view of the catechin 7-O-beta-D apiofuranoside which was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, as taught by Kim ‘20, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Kim ’20 teaches the advantages of the catechin 7-O-beta-D apiofuranoside which was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, including “excellent various physiological activities, including anti-ulcer, antioxidant, antibacterial, anti-cancer, immunity, and homeostasis maintenance effects, and it is known to have many additional drug effects (Abstract).
Regarding instant claim 6, the limitation of the catechin 7-O-ß-D-apiofuranoside would have been obvious over the catechin 7-O-beta-D apiofuranoside which was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, and which has “excellent various physiological activities, including anti-ulcer, antioxidant, antibacterial, anti-cancer, immunity, and homeostasis maintenance effects, and it is known to have many additional drug effects (Abstract), as taught by Kim ’20.
Claims 6, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 2013 0060806 A – English Espacenet Translation – “Kim ‘13”), as applied to claims 1, 3, 5, 7, 9, 11, and 13 above, in view of Kim et al. (J. Korean Wood Sci. Technol. 2020, 48(6): 888-895 – “Kim ‘20”).
The teaching of Kim ‘13 is discussed above.
Kim ’13 does not expressly teach that the extract of Ulmus comprises catechin 7-O-ß-D-apiofuranoside.
The teaching of Kim ’20 with respect to the extraction of catechin 7-O-beta-D-apiofuranoside from Ulmus species is discussed in detail above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an extract of Ulmus cortex for preventing and treating obesity to suppress accumulation of neutral fat and differentiation of adipocytes without toxicity, as taught by Kim ‘13, in view of the catechin 7-O-beta-D apiofuranoside which was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, as taught by Kim ‘20, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Kim ’20 teaches the advantages of the catechin 7-O-beta-D apiofuranoside which was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, including “excellent various physiological activities, including anti-ulcer, antioxidant, antibacterial, anti-cancer, immunity, and homeostasis maintenance effects, and it is known to have many additional drug effects (Abstract).
Regarding instant claims 6, 12, and 14, the limitations of the catechin 7-O-ß-D-apiofuranoside would have been obvious over the catechin 7-O-beta-D apiofuranoside which was isolated from the stems and barks of Ulmus davidiana var. japonica for. suberosa, and which has “excellent various physiological activities, including anti-ulcer, antioxidant, antibacterial, anti-cancer, immunity, and homeostasis maintenance effects, and it is known to have many additional drug effects (Abstract), as taught by Kim ’20.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615