DETAILED NOTICE
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 without traverse of Group II, claims 11-14 and 16, drawn to a food composition and a food product in the reply filed on April 27, 2026 is acknowledged. Applicants election of species of the Plant: Coastal Hog Fennel and the Diameter: “wherein 90% or more of the extracellular vesicles have a particle diameter in the range of 50-250 nm” applicant elects 140 nm, in the reply filed on 04/27/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10, 18-21, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 27, 2026.
Pending claims 11-14 and 16 are currently under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). The priority date is 02/28/2023.
Information Disclosure Statement
The Information Disclosure Statement(s) filed on 02/27/2024, 02/26/2026 and 04/24/2026, are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings filed on 09/25/2024 are accepted.
Specification
The disclosure is objected to because of the following informalities: the Brief Description to the Drawings section heading is missing within the specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 11-14 and 16 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.
The term “effective amount” in claim 11 is a relative term which renders the claim indefinite. The term “effective amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much of the extracellular vesicles derived from a plant will be most effective in the given invention. It would be unclear to one of ordinary skill in the art what an “effective amount” comprises of as this quantity could be small or it could be a large quantity. What is the amount suppose to do as a functional effect? Dependent claims 12-14 and 16 are rejected as they do not further explain what an “effective amount” of EVs are.
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.
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 11-14 and 16 are rejected under 35 U.S.C 101 because the claimed invention is directed to a product of nature directed to a product of nature (Coastal Hog Fennel – applicants elected species). The claim(s) recite(s) a food product combination containing “Coastal Hog Fennel”. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). The claims are drawn to a product of “Coastal Hog Fennel” and are thus directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101
follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S.Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v.Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S.127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s
view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a
physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both
naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from its closest naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts
use this analysis to identify product of nature exceptions. If the claim includes a nature- based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product. Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature-based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product. When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of
patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter, which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception (e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., “Coastal Hog Fennel” and Extracellular Vesicles) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products which are plant extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within Coastal Hog Fennel Plants. This equates to a plant extract. The process of creating a plant extract is by partitioning the starting plant material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found in the plant they come from. The combination comprises branched chain fatty acids, which are also found in nature. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the plant extract composition is only comprising the nature-based components. The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims 11-14 and 16 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)). The claims as a whole do not amount to more than the recited exceptions because there aren’t any other additional elements to consider, which does not add an inventive concept to the claims.
Thus, the claims 11-14 and 16 are not eligible subject matter under current 35 U.S.C. 101
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11 and 12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lee (WO2017052267A1).
Lee provides a method for preparing a food composition for preventing, alleviating, or treating hair loss. The present invention relates to a composition containing extracellular vesicles derived from a plant juice and exhibiting excellent skin preventing effect such as hair loss prevention effect by promoting hair growth. In the present invention, the filtrate is obtained through a process of filtering a supernatant with a filtration membrane. The filtrate obtained through the above process contains a large amount of extracellular vesicles and is safe and excellent in promoting hair growth (see para 0051-0053). Lee discloses a food composition for improving hair loss comprising plant juice-derived extracellular vesicles (extracellular vesicles) as an active ingredient (see claim 23-24).
Claim(s) 11, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Jung Soo (WO2019066538A1).
Jung Soo teaches an invention that relates to various uses of compositions comprising plant-derived extracellular vesicles. According to an embodiment of the present invention, there is provided a food composition for improving hair loss comprising plant-derived extracellular endoplasmic reticulum as an active ingredient. The average diameter can encompass 100 to 300 nm (see para 0020 and claims 3 and 9).
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.
The factual inquiries 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 11-14 and 16 are rejected under 35 U.S.C 103 as being unpatentable over Lee (WO2017052267A1).
Lee teaches a method related to a composition containing extracellular vesicles (EV) derived from a plant juice and exhibiting excellent skin preventing effects (see abstract, and Description Technical Field paragraph) In the present invention, the plant juice is preferably obtained by juicing a plant with a screw having a stirring speed of 20 to 100 rpm because it contains a large amount of extracellular vesicles. In the present invention for a food composition, the filtrate is obtained through filtering the supernatant with a filtration membrane containing pores having an average pore size of 0.1 to 1.0 mu to recover the filtrate because this process contains a large amount of extracellular vesicles. In the present invention, the extracellular vesicles have a diameter of about 30 to 1,000nm, preferably an average diameter of 100 to 300nm, and refers to a structure that is fused with the plasma membrane and released into the extracellular environment as an extracellular vesicle (see para 0059-0060.
The kinds of plants that can be used in the present invention include Carrots. Carrots belong to the Apiaceae family, commonly known as the carrot family. Coastal Hog Fennel is also a member of the Apiaceae family as the parsley family. The carrot and the parsley family share several defining traits, they are naturally biocompatible, non-toxic and share strong antioxidant and anti-inflammatory properties. One would be motivated to substitute the coastal hog fennel for the carrot and vice versa as they are both rich in nutrients and are known in the art to provide beneficial food value, and as being in the same family share biological traits. It is also noted in Lee that the kinds of plants which can be used in the present invention are not limited to the above (included) kinds, and can be used without restriction if they belong to plants. Lee also teaches that when the plant-derived extracellular matrix containing the extracellular medium is included in the food composition, the amount may be added in the proportion of 0.1 to 50% of the total weight.
While Lee does not expressly teach wherein 90% or more have a particle size of 50-250nm, the Lee reference particles sizes overlap; The extracellular vesicle in Lee average diameter is preferably 100 to 300 nm.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Therefore, it would have been obvious to the person having ordinary skill in the art to make a food composition comprising plant-derived extracellular vesicles with the claimed size range, because Lee discloses such a food composition for treating hair loss.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARNITIA T WALKER whose telephone number is (571)272-2550. The examiner can normally be reached Monday-Friday 8:00am-5:00pm.
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/Marnitia T Walker/
Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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