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 .
Election/Restrictions
Applicant's election with traverse of Group IV (Claims 15-17 and 23-24) in the reply filed on 29 September 2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden of search and/or consideration to search all claims in their entirety. This is not found persuasive because the examined application is a 371 Application, and the discussion of unity of invention under the Patent Cooperation Treaty Articles and Rules as it is applied as an International Searching Authority, International Preliminary Examining Authority, and in applications entering the National Stage under 35 U.S.C. 371 as a Designated or Elected Office in the U.S. Patent and Trademark Office is covered in MPEP §1850 and is dictated by PCT Rules 13.1 and 13.2. See MPEP § 801. Burden is not a consideration in a finding of lack of inventive unity; rather, according to MPEP § 1850, the only consideration is whether the inventions share a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-14 and 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 29 September 2025.
Claims 15-17 and 23-24, submitted on 29 September 2025, represent all claims currently under consideration.
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.
Priority
This application is a divisional of U.S. Patent 11,630,102, which is a 371 of PCT/US2018/017376, filed 8 February 2018, which claims priority to provisional US 62/457,423, filed 10 February 2017.
The effective filing date is 10 February 2017.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 3 March 2023, is acknowledged and has been considered.
Specification
The use of the term DIAION HP-20, which is a trade name or a mark used in commerce, has been noted in this application (Page 8, Line 30). 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.
Claim Objections
Claims 23 and 24 objected to because of the following informalities: The abbreviations “EtOH” and “EA” have not been defined prior to their use. The abbreviations should be placed after the first mention of ethanol (EtOH) and ethyl acetate (EA). 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 23 and 24 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. Claim 23 contains the trademark/trade name DIAION HP-20. 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 a particular non-polar copolymer styrene-divinylbenzene adsorbent resin and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-17 and 23-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product (an ethanol extract of a plant) without significantly more. The claims recite a composition comprising an effective amount of an ethanol extract of a plant. The compounds, while being obtained via an ethanol extraction, and further formulated in a pharmaceutical composition, are naturally occurring within the three species of plant, and are therefore natural products. This judicial exception is not integrated into a practical application because there is no indication that extraction has caused the compounds which are extracted to have any characteristics that are different from the naturally occurring compounds. The claims do not impart any characteristics that are different from the naturally occurring compounds. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the compositions themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
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 15, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aripin (US 2016/0143982; Publication Date: 26 May 2016).
Aripin discloses a pharmaceutical preparation which includes extract of Curcuma mangga (Abstract). C. mangga is a member of the family Zingiberaceae. Example 2 (Paragraph 0055-0071) discloses the preparation of an ethanol extract of C. mangga using different concentrations of ethanol.
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Aripin is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Aripin. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Claims 15, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brownell (US 2016/0045559; Publication Date: 18 February 2016).
Brownell discloses an ethanol extract of Curcuma longa rhizomes (Paragraph 0224). C. longa is a member of the family Zingiberaceae.
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Brownell is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Brownell. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Claims 15, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimada (US 2014/0348961; Publication Date: 27 November 2014).
Shimada discloses an ethanol extract of Kaempferia parviflora rhizome extracted with various concentrations of ethanol in Example 1 (Paragraphs 0167-0169). K. parviflora is a member of the family Zingiberaceae.
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Shimada is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Shimada. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Claims 15, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rhyu (US 2014/0322366; Publication Date: 30 October 2014).
Rhyu discloses ethanol extracts of Amaranthus mangostanus (member of the Amaranthaceae family). These plant extracts were obtained using different concentrations of ethanol (Paragraphs 0138-0144).
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Rhyu is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Rhyu. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Claims 15, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ojewole (Phytotherapy Research, 20, 764-772, 2006).
Ojewole discloses an ethanol extract of Zingiber officinale dried rhizomes (Abstract). Air dried rhizomes were milled and extracted twice in 96% ethyl alcohol, and this extract was dissolved in warm water for use in experiments (Preparation of Zingiver officinale dried rhizomes ethanol extract).
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Ojewole is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Ojewole. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Claims 15, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ganguly (Asian Pacific Journal of Tropical Disease, Vol 3, Issue 4, August 2013, 301-307).
Ganguly developed ethanolic extracts of Manilkara zapota leaves (member of the Sapotaceae family) and screened for anti-inflammatory and anti-pyretic activity (Abstract). The extracts were extracted using 95% ethanol and concentrated. The extract was then dried and suspended in normal saline using 1.0% Tween-80 (2.2. Extraction of the plant material and sample preparation).
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Ganguly is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Ganguly. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Claims 15-17 and 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Omodamiro (British Journal of Pharmaceutical Research, 9(6):1-12, 2016).
Omodamiro discloses an ethanol extract of Amaranthus viridis leaves (Abstract). Leaves were pulverized and soaked in absolute ethanol, resulting in an extract (Section 2.2, Ethanol Extraction of Amaranthus viridis leaves).
Regarding Claim 17, the ethanol extraction of the leaves of Amaranthus viridis will inherently include pheophorbide a and/or pyropheophorbide a. These compounds are breakdown products of chlorophyll, and from the data provided in the specification of the examined application, ethanol extracts of A. viridis inherently contain these two components (See Page 31, Line 15-Page 32, Line 4).
Regarding Claim 15, the claim is written with intended use language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim, as written, is directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae, Sapotaceae, or Zingiberaceae. The extract/composition of Omodamiro is capable of performing this function, and thus meets the limitations of the claims (See MPEP § 2112.02 (II)).
Regarding Claims 23 and 24, the claims are written as product-by-process claims, and as such, as anticipated by Omodamiro. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP § 2113 I).
Conclusion
Claims 15-17 and 23-24 are rejected.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625