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 . Claims 1-20 filed July 13, 2023 are currently pending. Claims 1, 13 and 19 are independent.
Election/Restrictions
Applicant’s election without traverse of Group (II) claims 13-18 in the reply filed on 12/08/2025 is acknowledged.
Claims 1-12 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/08/2025.
Priority
Acknowledgement is made of the national stage entry of PCT/KR2022/000507 filed 01/11/2022 which claims foreign priority to Application 10-202109994607 filed 01/13/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112-Paragraph 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.
Claim 15 is 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.
Claim 15 contains the trademark/trade name “Tween”. See “Tween 20”, “Tween 40”, “Tween 60” and “Tween 80”. 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 the non-ionic surfactant polyoxyethylene sorbitan monooleate (“Tween 80”/polysorbate 80) or polyoxyethylene sorbitan monolaurate (“Tween 20”/polysorbate 20). See Kerwin et al., (J. Pharmaceutical Sciences Vol. 97 pages 2924-2935 (2007)). Accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang (Lab Animal Research Vol. 30 pages 84-89 published 2014).
Jang (Lab Animal Research Vol. 30 pages 84-89 published 2014; NPL #2 in IDS of 07/13/2023) teaches administering an ethanolic extract of Angelica gigas improves atherosclerosis by inhibiting vascular smooth muscle cell proliferation in an afflicted subject (title, abstract).
As shown in [0050]-[0053] of the instant specification and in Jang, an ethanolic extract of Angelica gigas comprises the claimed coumarin decursinol (Jang: page 85 left col.).
Jang teaches administration of the ethanolic extract of Angelica gigas to patients comprising hypercholesterolemia and containing atheromatous plaques covering 28.4% of the aortic arch and abdominal artery (pages 85-86, 88). As shown in Figure 3, oral administration of an ethanolic extract of Angelica gigas reduced the degree of atherosclerotic plaques by 16% in the afflicted subject, inhibited VMSC proliferation and yielded anti-atherosclerotic effects in the afflicted patient (page 85-86, 88, Figure 3).
Regarding claim 18, as evidenced by National Heart Lung and Blood Institute (published 2024), atherosclerosis is a species of the genus “arteriosclerosis” as found within claim 18 of the pending claims (pages 1-3). As such, the administered the ethanolic extract of Angelica gigas that reduced atherosclerotic plaques by 16% in induced atherosclerosis patients reads on the treatment of arteriosclerosis as found in claim 18 of the present claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 13-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kang (KR20170064322 published 06/09/2017; machine translation provided, referred to as Kang 2017) and Kang (KR2019/0038410 published 04/18/2019; machine translation provided, referred to as Kang 2019).
Kang 2017 teaches a composition comprising extract of Angelicae gigantis and red ginseng extract for treating diseases comprising vascular smooth muscle cell proliferation in a subject in need (page 15, claims). Embraced within said vascular smooth muscle cell proliferation disorders to be treated with the composition comprising extract of Angelicae gigantis and red ginseng extract includes angina pectoris, cerebral infarction and arteriosclerosis. Kang 2017 teaches that extract of Angelicae gigantis comprises decursinol (page 16). Kang 2017 teaches that the extract of Angelicae gigantis is prepared by extracting mixing the plant with a C1-C4 alcohol, followed by drying the alcohol extraction solvent, and pulverizing the evaporated solvent to yield the desired Angelicae gigantis extract containing decursinol (page 18).
The difference between the presently claimed methodology and that of Kang 2017 is that Kang 2017 does not specifically teach the preparation steps of (i) mixing decursinol with a detergent, such as polysorbate 80, to give a first mixture; (ii) adding ethanol to the first mixture and mixing chitosan therewith to give a second mixture and (iii) dissolving the second mixture by adding a basic amino acid and purified water, followed by adjusting the pH to 8.6 to give a third mixture and (iv) sterilizing the third mixture.
Kang (KR2019/0038410 published 04/18/2019; machine translation provided, referred to as Kang 2019) teaches the method of preparing a composition comprising decursinol. Kang 2019 teaches that mixing decursinol with a surfactant or detergent with decursinol to prepare a first mixture, followed by adding ethanol to the first mixture, followed by adding chitosan to the ethanol/decursinol/surfactant or detergent mixture to yield a second mixture. Kang 2019 additionally teaches adding a basic amino acid and purified water to the second mixture to dissolve the ethanol/decursinol/surfactant or detergent and chitosan mixture followed by adjusting the pH to 8.6 to yield a third mixture. Kang 2019 further teaches sterilizing the third mixture (claims). Kang 2019 teaches that polysorbate 80/polyoxyethylene sorbitan monooleate is a suitable non-ionic surfactant/detergent to mix with decursinol and that arginine or lysine are each suitable basic amino acids to mix with the second mixture containing the ethanolic extract comprising decursinol/detergent and chitosan (claims).
Therefore, one of ordinary skill in the art prior to the time of the invention knowing that C1-C4 alcohol extracts of Angelicae gigantis comprise decursinol as taught by Kang 2017, said skilled artisan would have found it prima facie obvious to administer said C1-C4 alcohol extract of Angelicae gigantis comprising decursinol to treat angina pectoris, cerebral infarction and arteriosclerosis in a subject in need as Kang 2017 teaches that said C1-C4 alcohol extract of Angelicae gigantis is efficacious at treating said vascular smooth muscle cell proliferation disorder in an afflicted patient.
Secondly, said skilled artisan would have found it prima facie obvious to prepare the Angelicae gigantis extract containing decursinol for treating angina pectoris, cerebral infarction and arteriosclerosis in a subject, wherein the decursinol is prepared by mixing decursinol with a detergent polysorbate 80, to give a first mixture; (ii) adding ethanol to the first mixture and mixing chitosan therewith to give a second mixture and (iii) dissolving the second mixture by adding a basic amino acid and purified water, followed by adjusting the pH to 8.6 to give a third mixture and (iv) sterilizing the third mixture in view of Kang 2019.
MPEP 2143 provides rationale for a conclusion of obviousness including (C): Use of a known technique to improve similar methods in the same way;
In the instant case, Kang 2019 teaches the known technique of preparing a composition comprising decursinol by mixing decursinol with the surfactant polysorbate 80 to prepare a first mixture, followed by adding ethanol to the first mixture, followed by adding chitosan to the ethanol/decursinol/surfactant or detergent mixture to yield a second mixture. Kang 2019 additionally teaches adding a basic amino acid arginine and purified water to the second mixture to dissolve the ethanol/decursinol/surfactant or detergent and chitosan mixture followed by adjusting the pH to 8.6 to neutralize the water soluble chitosan and yielding a third mixture, followed by sterilizing the third mixture (claims). Consistent with this reasoning, it would have been obvious to have selected various decursinol extraction and preparation techniques from within the prior art of Kang 2019 above and apply them to the angina pectoris, cerebral infarction and arteriosclerosis treating C1-C4 alcohol extracts of Angelicae gigantis comprising decursinol of Kang 2017, arriving at the claimed methodology “yielding no more than one would expect from such an arrangement”.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kang (KR20170064322 published 06/09/2017; machine translation provided, referred to as Kang 2017) and Kang (KR2019/0038410 published 04/18/2019; machine translation provided, referred to as Kang 2019) as applied to claims 13-15 and 17-18 above, in view of Li (Clinical and Developmental Immunology Vol. 2013 article 387023 published 2013).
As disclosed above, the combination of Kang 2017 and Kang 2019 render obvious the treatment of angina pectoris, cerebral infarction and arteriosclerosis treating C1-C4 alcohol extracts of Angelicae gigantis which contain the claimed decursinol, wherein the decursinol is mixed with the surfactant polysorbate 80 to prepare a first mixture, followed by adding ethanol to the first mixture, followed by adding chitosan to the ethanol/decursinol/surfactant or detergent mixture to yield a second mixture. Kang 2019 additionally teaches adding a basic amino acid arginine and purified water to the second mixture to dissolve the ethanol/decursinol/surfactant or detergent and chitosan mixture followed by adjusting the pH to 8.6 to neutralize the water soluble chitosan and yielding a third mixture, followed by sterilizing the third mixture.
The difference between the present claims and that of the combination of Kang 2017 and Kang 2019 is that the combination of Kang 2017 and Kang 2019 does not specifically teach wherein the chitosan comprises a molecular weight of less than 20,000 Daltons.
Li (Clinical and Developmental Immunology Vol. 2013 article 387023 published 2013), teaches that chitosan comprising a molecular weight of 3800-20,000 Daltons is biocompatible and biodegradable in mammalian patients (page 2 left col. through right col.)
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to employ a chitosan with a molecular weight of less than 20,000 Daltons during the extraction of decursinol from for the preparation of angina pectoris, cerebral infarction and arteriosclerosis treating C1-C4 alcohol extracts of Angelicae gigantis as taught by Kang 2017 and Kang 2019 above, in view of Li. Accordingly, said artisan would have been motivated to formulate the angina pectoris, cerebral infarction and arteriosclerosis treating decursinol extract composition comprising chitosan with a molecular weight of 20,000 Daltons or less to take advantage of the desirable biocompatible and biodegradable properties of the chitosan in the pharmaceutically administered composition.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621