DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Receipt and consideration of Applicant’s amended claim set and Applicant’s arguments/remarks submitted on June 30, 2025 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments.
Status of the Claims
Claims 1, 2, 5, and 7 are pending and under consideration in this action. Claims 3, 4, 6, 8, and 9 are cancelled.
Terminal Disclaimer
The terminal disclaimer filed on June 30, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of prior U.S. Patent Nos. 10,542,686; 11,083,147; 11,076,543; and 12,016,283 have been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 1 is objected to because of the following informalities: “lyxitol” in line 7 appears to be a typographical error and should be should be “xylitol”. Appropriate correction is required.
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 1, 2, 5, and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (naturally occurring products) without significantly more.
With regards to claims 1, 5, and 7, the claims recite a composition comprising a bioactive aqueous extract from the roots of a Parthenium argentatum Gray plant. Claim 1 also recites method steps for obtaining the extract. As noted in MPEP 2113,“even 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). In the instant case, because the composition is the product of performing a method of extracting a bioactive composition from a plant, the composition would be made up of naturally occurring compound(s), i.e. compounds naturally occurring in the plant used. With regards to the list of compounds recited in Claims 1 and 7, as evidenced by the instant Specification, each are found in the root extract of guayule (P.G. Pub., para.0115, Table 1), and thus are all naturally occurring.
Such a composition is not markedly different from its naturally occurring counterpart because each of the extracted compound(s) would have the same chemical structure as their naturally occurring counterpart. Furthermore, there is no indication in the specification that a composition comprising a combination of the naturally occurring compounds extracted from the plant would result in any characteristics (structural, functional, or otherwise) that are different form their respective naturally occurring counterparts.
Claim 2 further includes one or more additives. However, the additives also include naturally occurring products, such as plant extracts or water (agricultural carrier).
This judicial exception is not integrated into a practical application because the claims do not recite any meaningful elements in addition to the naturally occurring compounds. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no indication in the specification that the claimed compositions of naturally occurring compound(s) have any characteristics (structural, functional, or otherwise) that are different from their respective naturally occurring counterparts.
Response to Arguments
Applicant's arguments filed June 30, 2025 have been fully considered but they are not persuasive.
(1) Applicant argues that to arrive at the claimed composition, it is necessary to perform a specific process, and each step of the process further removes the composition from anything that might be found in nature. Applicant argues that roots ground to a specific size do not exist in nature, but instead, require the hand of man and a specific selection of roots, as opposed to other parts of the plant, and size.
Applicant argues that the choice of water, instead of, for example, an organic solvent, further distinguishes the composition from any natural counterpart. Applicant argues that only water soluble components are in the composition, making the composition different in its components, as well as its functionality, from what exists in nature. Applicant further argues that it is entirely possible that the grinding and extraction process alter the chemical and/or physical characteristics of the components of the composition compared to what may be found in nature.
Applicant argues that the claimed composition is different from anything that may exist in nature (e.g., contains only water soluble components from guayule roots), and unexpectedly can stimulate plant growth, induce bud and flower formation, and protect against pests.
With regards to Applicant’s argument (1), the traversal argument is not found persuasive. The claims as currently written are not directed to a method, but rather, the composition. Furthermore, the claims recite the transitional phrase “comprising”, which is open-ended and does not exclude additional, unrecited elements. Note: MPEP 2111.03. The composition of claim 1, for example, requires the at least 15 compounds from the list recited in claim. All of the recited compounds recited in, for example, claim 1, are compounds found naturally in Parthenium argentatum Gray plant. An extraction by placing the roots separated from the rest of the plant, milled to a size of ¼ inch or less in an aqueous solvent does not result in any characteristics (structural, functional, or otherwise) that are difference from their respective naturally occurring counterparts.
In particular, such a composition is not markedly different from its naturally occurring counterpart because each of the extracted compound(s) would have the same chemical structure as their naturally occurring counterpart. Furthermore, the mixture of such compounds is also naturally occurring as they are all found in mixture within the guayule plant. There is no indication in the specification that a composition comprising a combination of the naturally occurring compounds extracted from the plant would result in any characteristics (structural, functional, or otherwise) that are different form their respective naturally occurring counterparts.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 5, and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 2, 5, and 7 are directed to a composition comprising an extract from the roots of a guayule plant. The instant Specification discloses the top 30 compounds found in 5%, 10%, and 30% guayule root aqueous extract in Table 1 (pg.23-24). However, the instant claims are directed to encompass all chemicals found in (aqueous) extracts from the roots of a guayule plant. The instant Specification discloses compounds such as those recited in Table 1 of the Specification, which would meet the written description provisions of 35 U.S.C. 112(a). However, the instant claims as currently written are directed to encompass all chemicals found in (aqueous) extracts from the roots of a guayule plant. Various parameters used in extraction methods determine what compounds are and are not present in the resulting extract. As evidenced by, Lapornik et al. (Lapornik) (Journal of Food Engineering; of record), the solvent used and the extraction time, for example, are parameters that impact the components and amount of components found in the resulting extracts (abstract). In Lapornik’s Table 5, for example, extracting with different aqueous solvents (water, 70% ethanol, and 70% methanol) and varying the extraction time when using the same solvent (e.g. 1 hr in water vs. 12 hr in water) varied the anthocyanins found in grape mare extracts. For example, a 1 hour extraction in water showed no delphinidin in the resulting extract, while a 12 hour extraction in water had delphinidin present in the resulting extract; and a 1 hour extraction in water showed no delphinidin in the resulting extract, while a 1 hour extraction in 70% ethanol (aqueous ethanol) had delphinidin present in the resulting extract (pg.219).
Thus, the term “extract” as claimed in the composition of claim 1 (and incorporated by the subsequent dependent claims), does not meet the written description provision of 35 U.S.C. 112(a) due to lacking chemical structural information for what the extract is or is composed of. As discussed above, the instant claims are directed to encompass all chemicals found in (aqueous) extracts from the roots of a guayule plant. However, as evidenced by Lapornik above, varying the parameters of the extraction method (e.g. specific solvent used, extraction time) results in compositions comprising different components. Furthermore, the instant Specification’s Table 1 discloses only the top 30 compounds found in aqueous extracts following specific method steps, not all compounds found in any and all guayule root extracts. Thus, the Specification provides insufficient written description to support the genus encompassed by the claims.
Response to Arguments
Applicant's arguments filed June 30, 2025 have been fully considered but they are not persuasive.
(2) Applicant argues that the Office Action acknowledges that the specification discloses compounds such as those in Table 1, which would meet the written description requirement, and in order to expedite prosecution, claim 1 has now been amended to recite that the composition comprises at least 15 compounds from the compounds listed in Table 1.
With regards to Applicant’s argument (2), the traversal argument is not found persuasive. Claim 1 as currently written recites that the composition “comprises an aqueous extract from the root of a Parthenium argentatum plant … and wherein said composition comprises at least 15 compounds selected from….” Thus, the claim as currently written does not necessarily recite that the recited compounds are part of the extract, but rather, the composition. The claim as currently written may be interpreted as the aqueous extract and the recited compounds as distinct components, and thus may encompass all chemicals found in (aqueous) extracts from the roots of a guayule plant in addition to the at least 15 compounds.
Conclusion
Claims 1, 2, 5, and 7 are rejected. No claims are allowed.
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.
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/MONICA A SHIN/Primary Examiner, Art Unit 1616