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 I, claims 14 – 25 and 30 in the reply filed on March 16, 2026 is acknowledged. The traversal is on the grounds that the special technical feature of a combination of melon extract of superoxide dismutase (SOD) and fenugreek is not disclosed by the prior art This is not found persuasive because the independent claims do not require a combination of melon extract and fenugreek, nor do they require the components together in a single composition. Rather the independent claims recites a product containing vegetal extract containing SOD and a fenugreek extract. These components are not required to be “in combination” as a single composition as argued, as supported by claim 21, which states the extracts are in the same composition OR in separate compositions. Further, as discussed in the rejections that follow, the prior art does, in fact, teach the combination of a vegetal extract containing SOD and fenugreek extract.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14 – 32 are pending; claims 26 – 29 and 31 – 32 are withdrawn as being drawn to non elected subject matter; claims 14 – 25 and 30 have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 17, 2024 and November 20, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 14, 18, 21 – 22 and 25 are objected to because of the following informalities:
In claim 14, “SOD” should be first spelled followed by the abbreviation.
In claim 18, line 5, “The” should read “the.”
In claims 21 and 22, “14 ,” should be recited as “14,”.
In claim 25, “beverages,” “juices,” and “bars” do not grammatical conform to the rest of the claim and should read “beverage,” “juice,” and “bar.”
Appropriate correction is required.
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 14 – 25 and 30 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.
Claim 14 and its dependents are drawn to a product containing a “vegetal active extract” and a “fenugreek extract.” These claims are considered genus claims that encompass a wide array of “extracts.” The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of extracts.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all bioactive constituent extracts that might result from a single type of extraction method, let alone any and all methods for extraction. Examples of extraction methods include water extraction, ethanolic extraction, supercritical carbon dioxide extraction, microwave or ultrasound assisted extraction, and Soxhlet extraction. The various methods use different solvents, e.g., polar, intermediate polar, and non-polar, to yield differently soluble components; they may involve different methods of fractionation or purification, e.g., paper chromatography, thin layer chromatography, gas chromatography, and high-performance liquid chromatography; and may be obtained via mass spectrometry, infrared spectrometry, ultraviolet spectrometry, or nuclear magnetic resonances spectrometry (Abubakar et al.). Moreover, the various parameters of any given extraction method significantly influence what “extract” is obtained. The possible variations of extracts are limitless with potentially millions of types of extracts let alone any bioactive component.
The instant disclosure fails to identify a single “vegetal active extract” or how one might be obtained. Instead, the specification identifies a single melon extract, or melon juice concentrate, marketed and sold by BIONOV as EXTRAMEL™ (example 1). Regarding the fenugreek extract, only a single method is disclosed to obtain any particular extract, which requires “a) The fenugreek seeds are extracted with supercritical CO2 extraction, and further delipidated, b) The delipidated fenugreek seeds are further extracted in ethanol 80%, followed by a filtration, a concentration under 20% dry matter, a pasteurization, and finally an atomization with 10% maltodextrin, for obtaining a dry extract of fenugreek (example 1).
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of extracts to reflect this variance in the genus since the specification does not provide any examples of such a genus of “extract.” Accordingly, the specification fails to provide adequate written description for the genus of “vegetal active extract” or “fenugreek extract” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these extracts, the specification does not describe the claimed extracts in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these extracts at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 16 – 20 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 16 and its dependent is drawn to a product containing a melon juice concentrate, however is indefinite for reciting “powder” as the term lacks proper antecedent basis.
In claim 18 (and dependents), the recitation of “The fenugreek seeds” lacks proper antecedent basis.
Claim 20 fails to end with a period.
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 14, 21 – 25 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Step 1: Yes, the claims are drawn to a product containing a vegetal active extract containing superoxide dismutase (SOD) and fenugreek extract, which is a composition of matter.
Step 2A, Prong 1: Yes, claim 14 and 21 are drawn to a product containing a vegetal active extract containing superoxide dismutase (SOD) and fenugreek extract, which is a product of nature. Sangeetha et al. teaches fenugreek seeds contain SOD (p.117), which includes a vegetal active extract containing SOD and any fenugreek seed constituents extracted therefrom. Moreover, the claim reads on a fenugreek seed. Regarding claims 22 – 23, the claims recite an intended use of oral administration which does not markedly change the fenugreek seed. Claims 24 and 30 appear to require a food grade or pharmaceutical excipient, e.g., water, which does not cause a fenugreek seed to exhibit markedly different characteristics. Regarding claim 25, placing a fenugreek seed into a sachet (or a bag) does not cause a fenugreek seed to exhibit markedly different characteristics.
Step 2A, Prong 2: No, claims 14 and 21 do not recite any additional elements, therefore do not recite any elements that integrate the product of nature into a practical application. Regarding claims 22 – 23, the claims recite an intended use of oral administration which does not integrate a fenugreek seed into a practical application. Rather “for oral administration” is merely reciting “apply it” (MPEP 2106.04(d)(I)). Claims 24 and 30 appear to require a food grade or pharmaceutical excipient, e.g., water, which does not integrate a fenugreek seed into a practical application, but only adds insignificant extra solution activity to the fenugreek seed (MPEP 2106.04(d)(I), 2106.05(g)). Regarding claim 25, placing a fenugreek seed into a sachet (or a bag) does not integrate the seed into a practical application but rather only adds insignificant extra solution activity to the fenugreek seed (MPEP 2106.04(d)(I), 2106.05(g)).
Step 2B: No, claims 14 and 21 do not recite any additional elements and therefore do not recite any additional elements that amount to significantly more than the product of nature. Regarding claims 22 – 23, the claims recite an intended use of oral administration which does not amount to significantly more than the product of nature itself. These claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP 2106.05 (I)(A)). Claims 24 and 30 appear to require a food grade or pharmaceutical excipient, e.g., water, which merely adds well-understood, routine, conventional components previously known to the industry (MPEP 2106.05 (I)(A)). Regarding claim 25, placing a fenugreek seed into a sachet (or a bag) does not qualify as “significantly more” than the natural product as it adds insignificant extra solution activity to the fenugreek seed (MPEP 2106.04(d)(I); 2106.05 (I)(A); 2106.05(g)).
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.
Claims 14, 18 – 25 and 30 are rejected under 35 U.S.C. 102a1 as being anticipated by Sangeetha et al. (2010).
Regarding claim 14, Sangeetha teaches a fenugreek seed, which is a product containing a vegetal active extract containing superoxide dismutase (SOD) (p.117) and all extracts within fenugreek (p.116 – 117).
Regarding claims 18 – 20, Sangeetha does not teach the method by which a fenugreek extract is obtained. However, the recited steps are interpreted as product by process limitations. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), then the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper (MPEP 2113). Notwithstanding, the fenugreek seeds of Sangeetha inherently include all of the recited substances as they are constituents within the fenugreek seed.
Regarding claim 21, the vegetal extract containing SOD and fenugreek extract are in the same seed, or same composition.
Regarding claims 22 – 23, Sangeetha teaches fenugreek seeds are used in food preparations (e.g., oral administration) (p.116).
Regarding claims 24, 25 and 30, the seeds are added to water, or a food grade and pharmaceutical excipient or beverage (p.117).
The reference anticipates the claimed subject matter.
Claims 14, 21 – 25 and 30 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Holstein et al. (US 2019/0000930) as evidenced by Hamissou et al. (2013).
Regarding claim 14, Holstein teaches dietary supplements (products) containing bitter melon and fenugreek extract (0018, 0019, 0083, 0130, Table B, Table C, claim 1). Although Holstein does not teach the bitter melon contains superoxide dismutase (SOD), it was known in the art that bitter melon comprises SOD, and is therefore a vegetal extract containing SOD. In support, Hamissou teaches bitter melon contains SOD (p.644 – 645).
Regarding claim 21, the components are in the same composition (claim 1).
Regarding claims 22 – 23, the supplements are dietary (abstract, claims) which are for oral administration (0236).
Regarding claims 24 and 30, the supplements may include excipients such as water, which are food grade and pharmaceutical (0242).
Regarding claim 25, the supplements are nutritional products with excipients (or are food grade) in the form of tablets, capsules, granules, suspensions (juice), syrup (confection), lemonade (beverage) (0236).
The reference anticipates the claimed subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14 – 25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hossain et al. (WO 2020/252051) in view of Venkata et al. (2017).
Regarding claims 14 and 21, Hossain teaches compositions (products) comprising superoxide dismutase (SOD) and soluble fiber (abstract), wherein the SOD is from melon (0009 – 0010) (a vegetal active extract containing SOD) and the soluble fiber is from plants containing galactopolysaccharides (0014). Hossain does not teach the plant fiber source is extracted from fenugreek. However, Venkata teaches fenugreek is a good source of dietary fiber, specifically soluble fiber such as galactomannan, or galactopolysaccharides (p.3). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated to use fenugreek fiber (a fenugreek extract) in the compositions of Hossain for its well-known source of soluble fiber, or galactopolysaccharides. One of ordinary skill in the art would have been further motivated to use fenugreek in the supplements of Hossain because Hossain intends the compositions to reduce free radicals (or are antioxidant), reduce inflammation and reduce viral symptoms (p.7 – 8), whereby the soluble fiber is antioxidant, anti-inflammatory and anti-infective (p.20). Venkata teaches fenugreek is an active antioxidant, anti-inflammatory agent, and antimicrobial (abstract, p.6 – 8), meeting each of the preferred fiber attributes of Hossain. Moreover, in considering the prior art at the time the claims were filed, one of ordinary skill in the art would have been motivated by the cited references to combine a melon containing SOD and fenugreek extracts with a reasonable expectation for successfully obtaining an effective dietary supplement.
Regarding claims 15 – 17, Hossain teaches the melon extract is EXTRAMEL™ SOD (Table 1, example 1), which is the same melon juice concentrate used by applicant (instant specification, example). In this regard, the vegetal active extracts are the same as claimed.
Regarding claims 18 – 20, the combined references do not teach the fenugreek component that is obtained as claimed. However, these limitations are regarded as product by process limitations. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), then the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper (MPEP 2113). Notwithstanding, Venkata teaches fenugreek seeds contain the desired soluble fiber (p.3) and would inherently include each of the recited substances as they are constituents within the fenugreek seed.
Regarding claims 22 – 23, Hossain teaches the compositions are dietary supplements, or are for oral administration (abstract, 0001).
Regarding claims 24 and 30, the compositions include excipients suitable for food such as water or xanthan (or are food grade and pharmaceutical) (p.17, Table 1, example 1).
Regarding claim 25, the compositions are in the form of juices (beverages, juices) (p.15, Table 1, example 1).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
Prosecution Insights