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 1-14, 16, and 18-23 have been cancelled. Claims 15, 17 and 24 have undergone amendments. Thus, Claims 15, 17, and 24, submitted on 7 May 2026, 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.
Election/Restrictions
The restriction and election of species requirement, mailed 28 July 2025, is withdrawn as Applicant has cancelled all claims which are drawn to the non-elected groups.
Response to Amendment
The objection to the specification is withdrawn. Applicant has amended the specification to indicate the correct usage of the trademarked name DIAION HP-20.
The objections to Claims 23 and 24 are each withdrawn. Applicant has cancelled claim 23, rendering that objection moot. Applicant has amended claim 24 to recite ethanol/ethyl acetate to indicate EtOH/EA.
The 35 U.S.C. § 112(b) rejection of Claim 15 is withdrawn. Applicant has removed the tradename, correcting the issue of indefiniteness.
Response to Arguments
The 35 U.S.C. § 101 rejection of Claims 15-17 and 23-24 is maintained. Applicant argues that the composition of the present invention comprises a fraction obtained by certain processes, and is not present in nature. The Examiner does not find this argument to be persuasive. The claims themselves are drawn to a composition of an ethanol extract of A. viridis, with an intended use. The fraction that is extracted does exist in nature, and the claims are merely drawn to a concentrated form of this extract which is naturally found within A. viridis. The Examiner does not find the argument that this product is similar to the “texiol in a controlled release formulation” and should be considered patent eligible as the current claims are drawn to a concentrated form of a natural product, and the Examiner believes this is still a product of nature regardless of the method of extraction.
The 35 U.S.C. § 102 rejections of Claims 15, 23, and 24 over Aripin, Brownell, Shimada, Rhyu, Ojewole, and Ganguly are each withdrawn. Applicant has amended the claims to specify that the extract is of A. viridis, which is not disclosed by these references.
The 35 U.S.C. § 102 rejection of Claims 15-17 and 23-24 over Omodamiro is maintained. The claims as currently written are drawn to an ethanol extract of A. viridis with an intended use. The claims are product-by-process claims, and thus, this extract of Omodamiro anticipates the claims as currently written. In regards to Applicant’s argument that there is no evidence that the extraction product of Omodamiro is inherently the same as the present evidence, and that there is evidence in Applicant’s specification that shows the properties of the various ethanol extracts are different and have markedly different characteristics, it is noted that the features upon which applicant relies (i.e., different properties of the extract of Omodamiro) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 101- REJECTIONS MAINTAINED
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 15, 17 and 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 A. viridis, 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- REJECTIONS MAINTAINED
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 15, 17 and 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 Claims 15, 17 and 24, the claims are 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 claims, as written, are directed to a composition of an effective amount of an ethanol extract of a plant belonging to the family Amaranthaceae. 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 15, 17, and 24, the claims are written as product-by-process claims, and as such, are 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). Claim 15 claims the ethanol extract (“product”) which is obtained by a process of extracting a chopped material with ethanol and fractionating this extract, with Claim 24 further defining this process by which the extract (“product”) is obtained.
Conclusion
Claims 15, 17, and 24 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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