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 .
Applicant’s amendment and response filed February 02, 2026 has been received and entered.
Claim(s) 1, 3 and 5-17 are currently pending.
Withdrawn Rejections
Applicant’s arguments filed on February 02, 2026 have been fully considered.
In regards to the rejection under 35 U.S.C. 112(b) for indefiniteness, Applicant has elected to cancel claim 4, the claim that contained the improper dependent language and has amended claim 3 and therefore, the rejection of claim(s) 3-8 under 35 U.S.C. 112(b) has been withdrawn.
In regards to the rejection under 35 U.S.C. 102(a)(1) for anticipation, Applicant has elected to cancel claim 2 and therefore, the rejection of claim 2 under 35 U.S.C. 102(a)(1) has been withdrawn.
Withdrawn Objections
Applicant’s arguments filed on February 02, 2026 have been fully considered.
In regards to the objection of the specification for the term “Korean Pharmacopeia”, Applicant has elected to amend the specification and provide a generic technical term in parenthesis and therefore the objection of the specification has been withdrawn.
In regards to the claim objection for claim 16, Applicant has elected to amend the claim to include necessary verbiage and therefore the objection of claim 16 has been withdrawn.
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 1, 11 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rombi (U.S. Patent No. 6,814,986) with Zhang (Nat Commun. (Year: 2020), vol. 11, no. 3719) providing evidence of inherent characteristics of Rombi.
Regarding claim 1, the Rombi reference teaches treating obesity (Col. 1, line 5), treatment of obesity (Col. 1, lines 6-7), relates to the esthetic treatment of a human being made to enhance his or her figure (Col. 1 lines 7-8), a composition (Claim 1), comprising an extract of green tea (Claim 1).
The reference does not explicitly state that the composition contains peptides or the peptides specifically claimed by applicant in claim 1. However, Zhang demonstrates that the peptide of SEQ ID NO. 1 inherently occurs in green tea (see abstract). Thus, the claimed peptide is naturally found in green tea and would be inherently present in the reference extract.
Regarding claim 11, Rombi teaches that the green tea extract contributes to an increase in the oxidation of lipids (Col. 4, lines 53-54).
Regarding claim 17, Rombi teaches that the composition is an oral composition with pharmaceutical effects (Claim 1; Col. 6, line 7).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 3, 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986) in view of Gyeong (KR 20040037011 – English translation provided).
The teachings of Rombi in regards to claim 1 is discussed above.
In regards to claims 3 and 5-7, Rombi teaches that the green tea is extracted with 80% ethanol (Claim 5). However, the Rombi reference does not teach that the green tea is fermented with a lactic acid bacterium.
The Gyeong reference teaches a food composition that contains a lactic acid bacterium and that the food composition can contain a green tea extract that has an effect on obesity or diabetes (Abstract; Claim 3). The Gyeong reference does teach a mixture that contains a lactic acid bacterium and a green tea extract to achieve its anti-obesity effects.
The Gyeong reference teaches about a food composition that contains a specific lactic acid bacterium, Lactobacillus reuteri, and that the food composition can contain a green tea extract that can have an effect on obesity or diabetes (Abstract; Claim 3). The reference does not teach the same bacterium in the claimed invention (Lactiplantibacillus planatarum also known as Lactobacillus planatarum). However, the reference teaches does that all Lactobacillus species are known to have beneficial effects on the body (page 2 of the translation) and that lactic acid bacteria [in general] can be easily ingested to prevent and treat obesity (page 3).
The person of ordinary skill in the art would have found it obvious that Lactobacillus planatarum and Lactobacillus reuteri are different species but belong to the same genus and therefore share common attributes when or if both lactic-acid bacterium are to be used to obtain a green tea peptide to aid in reducing the likelihood of obesity. In addition, one skilled in the art would have reasonably expected that fermenting a green tea protein with a lactic acid bacterium would have a more pronounced effect in achieving a particular stage of anti-obesity.
Thus, the artisan of ordinary skill would reasonably expect that Lactobacillus planatarum could be used in place of Lactobacillus reuteri. This reasonable expectation of success would have motivated the artisan to modify the references – Rombi and Gyeong to include the use of Lactobacillus planatarum when fermenting with a green tea protein.
In regards to claim 8, Rombi teaches examples of obtaining an extract from green tea, these examples are not limiting, and other extraction processes for obtaining an extract which is sufficiently rich in catechols can be used, in particular by varying the proportions of water and ethanol, or by using other solvents such as water, ethyl acetate, methanol, etc., alone or in combination. (Col. 5, lines 61-66). The reference does not teach a specific extraction method (e.g. hot-water), however, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. '[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." Therefore, an artisan of ordinary skill would be motivated to optimize the extraction temperature through routine experimentation to include hydrothermal extraction as claimed in claim 8.
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986) in view of Gardiner (CA Patent No. 2 530 093).
The teachings of Rombi are discussed above.
Rombi teaches a composition of a green tea extract that contains catechols that are involved in the treatment of obesity (Abstract).
Gardiner teaches a composition that comprises three sources of calcium and at least a caffeine-free green tea (Abstract). In addition, Gardiner teaches that studies have shown that green tea extract increases fat oxidation in subjects who used a placebo or caffeine (Under section B.1.).
It would have been obvious to combine Rombi's green tea extract for treatment of obesity with Garinder's study that clarifies that green tea extracts increases fat oxidation in subjects in need. In this combination, both Rombi and Gardiner's information proves that separately, green tea extract would have the same effect. The person of ordinary skill in the art would have found it obvious to combine the elements because ordinarily skilled artisans would have recognized the reasons for applying Rombi's method with Gardiners explanation to achieve an increase of fat oxidation. When referring to fat oxidation, fat oxidation and lipid synthesis are opposing processes, therefore, lipid synthesis means the creation of fat whereas fat oxidation can refer to the breakdown of triglycerides into energy for use within a cell. Thus, when the claimed invention refers to the inhibition of lipid synthesis (the prevention of the creation of fat), this means that the fat oxidation process is occurring. The person of ordinary skill in the art would further have predicted that the combination would promote fat oxidation because both Rombi and Gardiner teaches that one of the many effects of green tea extracts is ameliorating obesity.
Claims 1, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986), Gardiner (CA Patent No. 2 530 093), in view of Yu et al (Chinese Journal of Animal Nutrition (Year 2018), vol. 30, no. 12, pp 5107-5117 - English translation).
Rombi teaches a composition of a green tea extract that contains catechols that are involved in the treatment of obesity (Abstract).
Gardiner teaches a composition that comprises three sources of calcium and at least a caffeine-free green tea (Abstract). In addition, Gardiner teaches that studies have shown that green tea extract increases fat oxidation in subjects who used a placebo or caffeine.
Yu et al teaches through experimental results that both green tea powder and green tea phenols could reduce the levels of ACC and FAS, two cellular molecules involved in lipid synthesis (Abstract).
It would have been obvious to combine Rombi's green tea extract for treatment of obesity, Gardinder's study that clarifies that green tea extracts increases fat oxidation in subjects in need, and Yu et al's experimental results using a green tea powder and green tea polyphenols to achieve the inhibition of cellular molecules involved in fat synthesis. In this combination, Rombi, Gardiner and Yu et al proves that separately, varying compositions of green tea (an extract, powder form, or particular components) are involved inhibiting the generation of fat within a cell.
Claims 1, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986) in view of Yu et al (Chinese Journal of Animal Nutrition (Year 2018), vol. 30, no. 12, pp 5107-5117 - English translation).
Rombi teaches a composition of a green tea extract that contains catechols that are involved in the treatment of obesity (Abstract). In addition, the green tea extract contributes to an increase in the oxidation of lipids (Col. 4, lines 53-54).
Yu et al teaches through experimental results that green tea powder or green tea phenols could increase the levels of ACO, a cellular molecule involved in promoting fat oxidation within dog liver tissue (Abstract).
It would have been obvious to combine Rombi's green tea extract for treatment of obesity in human subjects with Yu et al's experimental results with a green tea powder or green tea polyphenols to induce the expression of ACO.
The person of ordinary skill in the art would further have predicted that the combination would promote the expression of cellular molecules, like ACO, that is involved in fat oxidation.
Claims 1 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986), Molino (CA Patent No. 2588436), Rehman et al (PLOS One (Year: 2013), vol. 8, no. 6, e65029), and Chacko et al (Chinese Medicine (Year: 2010), vol. 5, no. 13).
Rombi teaches a composition of a green tea extract that contains catechols that are involved in the treatment of obesity (Abstract).
Rehman et al teaches that the C. sinensis (green tea) plant contains several polyphenols in which those polyphenols are stimulators of mitochondrial biogenesis (Abstract).
Molino teaches that overall, a composition of an effective amount of a green tea extract and gamma.-butyrobetaine (Abstract) will increase fatty acid metabolism by enhancing mitochondrial biogenesis and oxidative phosphorylation (Claim 3).
Chacko et al teaches about the general compositions of green tea including but not limited to proteins (15- 20%), amino acids (1-4% dry weight), etc (Page 2).
It would have been obvious to combine Rombi's green tea extract that is involved with treating obesity with Rehman, Molino, and Chacko et al. Rombi's method combined with Rehman, Molino, and Chacko et al shows that as long as a component of green tea is included within the composition, there will always be an increase of mitochondrial biogenesis and/or increase in mitochondrial synthesis (the components that make the mitochondria). In addition, it is also key to know that green tea can also include proteins in achieving anti-obesity effects. The person of ordinary skill in the art would have found it obvious to combine all elements because ordinarily skilled artisans would have recognized the reasons for applying Rombi, Rehman, Chacko et al, and Molino to recognize the broad effects and various compositions of green tea in order to induce mitochondrial synthesis.
Claims 1, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986), Chacko et al (Chinese Medicine (Year: 2010), vol. 5, no. 13), and Torres-Ferreira et al (ScienceDirect (Year: 2020), vol. 64, pp. 103679).
Rombi teaches a composition of a green tea extract that contains catechols that are involved in the treatment of obesity (Abstract).
Chacko et al teaches about the general compositions of green tea including but not limited to proteins (15-20%), amino acids (1-4% dry weight), etc (Page 2).
Torres- Ferreira et al teaches the effects of green tea through examining adiponectin responses through mice.
It would have been obvious to combine Rombi's green tea extract that is involved with treating obesity with Chacko et al and Torres-Ferreira et al. The person of ordinary skill in the art would have found it obvious to combine all methods to effectively recognize that green tea has diverse effects regardless of the type of composition being used to induce effects on cellular molecules, more specifically, molecules associated with the building blocks of a mitochondria such as UCP2, which in turn, contributes to the biosynthesis of mitochondrial, necessary for overall cellular functioning. The person of ordinary skill in the art would further have predicted that just one of the many effects of green tea is to induce the protein expression of UCP2.
Claims 1, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986).
Rombi teaches a specified composition of a green tea extract that contains catechols that are involved in the treatment of obesity (Abstract).
The reference does not specifically teach administering the green tea composition in the concentration and dosages claimed by applicant in claims 15 and 16. However, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. '[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention.
Response to Arguments
Applicant’s arguments filed February 02, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C. 102 and 35 U.S.C. 103 are found to be non-persuasive.
Regarding applicant’s remarks for the 35 U.S.C. 102 rejection wherein anticipation by Rombi with Zhang providing inherent characteristics of Rombi, in which, Rombi fails to teach that the green tea extract composition contains the peptide of SEQ ID NO: 1 and that also, Zhang fails to cure Rombi’s deficiency based on a theory of inherent anticipation.
Based on the information set forth by a sequence search by STIC revealed that one of the green tea peptide sequences claimed by the applicant, e.g. SEQ ID NO: 1 (NPL - Seq ID No 1 Results GenBase UniProt; Date Accessed: March 27, 2026) is a natural property of green tea. Within the attached NPL, the sequence results for Seq ID No: 1 show that the Zhang article contains Seq ID No: 1.
Rombi teaches a green tea extract to treat obesity and combined with Zhang, Zhang further proves that the green tea peptide (also claimed by the Applicant) is naturally occurring within that of a green tea extract, especially since Rombi’s composition has the ability to reduce obesity. In addition, fat oxidation (or β-oxidation) is the breakdown of lipids in order to generate energy (or ATP) for use. If it is inherent that a green tea extract can treat obesity, then the β-oxidation pathway would obviously be affected – from a biochemistry perspective, weight loss and β-oxidation go hand-in-hand, you can’t have one without the other. To add on, Rombi’s composition is a health food based on the health food that comprises a green tea extract being geared towards reducing weight gain. Further, the combination of the two elements – Rombi and Zhang et al is sufficient to establish inherent anticipation regardless of applicant’s remarks that the green tea peptide is novel when it is not novel and the green tea peptide does not need to undergo fermentation to be naturally present. Furthermore, the green tea peptide has been shown through sequence search and prior art, both proof of extrinsic evidence that the green tea peptide is naturally occurring within green tea before extraction and after extraction because in this context, the end result of the green tea extract is treating obesity.
Regarding applicant’s remarks for the 35 U.S.C. 103 rejection wherein the combination of prior art of Rombi, Gyeong, Gardiner, Yu et al, Chacko et al and Torres-Ferreira et al for certain claims fails to teach the motivation to combine such references.
Regarding Rombi and Gyeong, as previously stated in the first action non-final, dated December 10, 2024, Gyeong teaches that all Lactobacillus species are known to have beneficial effects on the body, thus, the combination of a lactobacillus bacterium with a green tea extract would yield desirable effects, such as treating obesity as taught by Gyeong. In addition, from a microbiology perspective, generally, fermentation with a green tea protein using a lactic acid bacterium in this case, would allow larger protein molecules to be broken down into smaller peptides which would allow the presence of specific peptides. However, it is clear that without the lactic acid bacterium, the green tea peptide (as claimed in the present invention) would have already been present (based on the sequence search and prior art provided within the rejection). Essentially, applicant made a discovery that fermentation with a lactic acid bacterium produces weight loss, that can be true, only if the peptide was not already naturally present within the green tea composition already.
Regarding Rombi and Gardiner, Gardiner’s study teaches that green tea extracts have the ability to increase fat oxidation (e.g. β-oxidation) and to combine Gardiner’s information with Rombi’s green tea extract to treat obesity further proves that treating obesity using a green tea composition that contains a peptide (e.g. such as SEQ ID NO: 1) will allow for weight loss. In addition, applicant stated that fat oxidation does not equate to the inhibition of lipid synthesis – these two processes are the opposite of one another, therefore, both of these processes cannot occur at the same time, from a biochemistry perspective. In other words, the breakdown of fat into energy and the buildup of lipids, if these processes were to occur at the same time, this would cause a strain to the cells. Thus, by natural process, if there is fat oxidation, that means lipid synthesis is paused.
Regarding Rombi and Yu et al, Yu et al’s study further proves that a different physical form of green tea (e.g. in powder form) has the ability to increase levels of ACO, a cellular molecule involved in β-oxidation. Although Yu et al does not disclose the use of the peptide sequence, peptide, or fermentation-derived compositions, that still does not negate the fact that green tea overall has a weight loss benefit.
Regarding Rombi, Molino, Rehman and Chacko et al, the combination of these references is sufficient to conclude that mitochondrial biosynthesis (e.g. mitochondrial biogenesis can sometimes be used in place of mitochondrial biosynthesis) will happen as a result of ingesting a green tea extract due to the extract naturally having certain types of components within them (e.g. proteins, polyphenols, etc) that are attributable to weight loss.
Regarding Rombi, Chacko et al and Torres-Ferreira et al, the combination of these references is sufficient to conclude that a green tea composition (on a broad and smaller scale) that is ingested would produce a multitude of effects, especially on a cellular level. With Torres-Ferreira et al, the abstract demonstrates that green tea has the ability to stimulate molecules associated with oxidative lipid pathways such as UCP2. From a biochemistry standpoint, the actions of UCP2 would also work to influence mitochondrial biogenesis (e.g. mitochondrial biogenesis can sometimes be used in place of mitochondrial biosynthesis). Thus, it makes sense that the use of the green tea extract would be capable of inducing these cellular effects on a molecular and cellular biology scale.
Lastly, regarding applicant’s remarks wherein the use of Rombi does not specifically teach administering the green tea composition in the concentration and dosages claimed by applicant, the prior office action filed November 10, 2025 acknowledges this and states that the values of the concentration and dosages within a composition is not enough to demonstrate a patentably distinct product. Per MPEP 2144.05(II)(A), "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. '[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)." The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention.
Applicant remarks regarding that a fact-specific technical analysis was conducted through referencing the results of concentration-dependent reduction in expression of lipid synthesis-related genes and concentration-dependent increase in fat oxidation related genes in experimental example 1 of the specification of the present invention are not persuasive. As stated throughout the response to arguments, one skilled in biochemistry and molecular biology would reasonably expect that weight loss in general is governed by specific and regulated biochemical pathways and molecular molecules. Given that the green tea peptide, e.g. SEQ ID NO:1 for example, is natural, what this means in turn is that the consumption of the peptide would naturally trigger specific pathways and molecules. It is obvious to one skilled in biochemistry and molecular biology to optimize dosages of a green tea peptide composition needed to produce an expected result within a subject that wants to lose weight. Needless to say, depending on the subject, a subject may require more or less of the green tea peptide composition to exhibit certain results, therefore, no result can be unexpected because the end result will always be weight loss, so, optimization of dosages is considered obvious and required and nothing would be unexpected. Thus, the 103 rejection is maintained.
Conclusion
No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655