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 .
Claim(s) 1 and 5-17 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on June 11, 2026 has been entered.
Withdrawn Rejections
Applicants’ arguments filed on May 18, 2026 have been fully considered.
In regard to the rejection under 35 U.S.C. § 102(a)(1) for anticipation, applicant has elected to amend claim 1, and therefore, the rejection of claim of claim(s) 1, 11 and 17 has been withdrawn.
Pending Rejections:
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, 5-8, 11-12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986) in view of Choi (KR 20130039595 A – English translation provided), Gyeong (KR 20040037011 – English translation provided), Zhang (Nat Commun., (Year: 2020), vol. 11, no. 3719) and Yu et al (Chinese Journal of Animal Nutrition, (Year: 2018), vol. 30, no. 12, pp. 5107-5117).
Regarding claim 1, the Rombi reference teaches treating obesity (col. 1, line 5). Rombi teaches the treatment of obesity (col. 1, lines 6-7). Rombi teaches that the composition relates to the esthetic treatment of a human being made to enhance his or her figure (col. 1, lines 7-8). Rombi teaches a composition comprising an extract of green tea (claim 1). Rombi teaches an extraction with 80% ethanol (par. 4). Rombi teaches other extraction processes for obtaining an extract…in particular by varying the proportions of water and ethanol, or by using other solvents such as water, alone or in combination (par. 5). Rombi teaches a composition for the treatment of obesity, suitable for oral administration (claim 1). Rombi teaches a composition of a green tea extract that contains catechols that are involved in the treatment of obesity (abstract). Rombi teaches [that] the green tea extract contributes to an increase in the oxidation of the lipids (col. 4, lines 53-54).
The Rombi reference does not explicitly state that the composition contains peptides specifically claimed by the applicant (as stated within claim 1 of the present invention). Rombi does not explicitly teach that the green tea peptide composition is obtained by fermenting a green tea protein with Lactiplantibacillus plantarum (also stated within claim 1 of the present invention). Rombi does not explicitly teach that the green tea protein is obtained from a residue of a secondary extract which is hydrothermally extracted from the residue of the primary extract (as stated within claim 8 of the present invention). Rombi does not explicitly teach that the green tea peptide composition inhibits lipid synthesis in a fat cell (as stated within claim 9 of the present invention). Rombi does not explicitly teach that the green tea peptide composition reduces an expression of one or more of SREBP1c, ACC, FAS, and SCD1 (as stated within claim 10 of the present invention). Rombi does not explicitly teach that the green tea peptide composition promotes fat oxidation in a fat cell (as stated within claim 11 of the present invention). Rombi does not explicitly teach that the green tea peptide composition increases an expression of one or more of ACO, CPT, mCAD, and PPARα (as stated within claim 12 of the present invention). Rombi does not explicitly teach that the green tea peptide composition promotes mitochondrial biosynthesis in a fat cell (as stated within claim 13 of the present invention). Rombi does not explicitly teach that the green tea peptide composition increases an expression of one or more of TFAM, NDUFA9, COX4, ATP5a, and UCP2 (as stated within claim 14 of the present invention). Rombi does not teach that the green tea peptide composition is formulated as a composition for anti-obesity, and the green tea peptide composition is contained in an amount of 1 to 50 wt% based on the total weight of the composition for anti-obesity (as stated within claim 15 of the present invention). Rombi does not teach that the green tea peptide composition is administered in an amount of 1 to 400 mg/kg/day to a subject in need thereof (as stated within claim 16 of the present invention).
Choi teaches a fermented green tea extract (abstract). Choi teaches a method for preparing a fermented green tea extract comprises: a step of inoculating lactic acid bacteria such as Lactobacillus plantarum (abstract) into a green tea extract (abstract).
The Gyeong reference teaches a food composition that contains a lactic acid bacterium ([Lactobacillus reuteri]) 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 teaches that all Lactobacillus species are known to have beneficial effects on the body (pg. 2 of the translation) and that lactic acid bacteria [in general] can be easily ingested to prevent and treat obesity (pg. 3).
Zhang et al demonstrates that the peptide of SEQ ID NO. 1 intrinsically occurs in green tea (see abstract). [Thus, the claimed peptide is naturally found in green tea and would be intrinsically present in the Rombi reference extract].
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). 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).
A person of ordinary skill in the art would reasonably expect to use Choi’s Lactobacillus (i.e. Lactiplantibacillus) plantarum and the method of fermenting the green tea extract with L. plantarum within Rombi’s green tea extract composition that can be administered to a subject in need that would treat obesity with additional teachings from Gyeong that all Lactobacillus species are known to have beneficial effects on the body and that lactic acid bacteria can be easily ingested to prevent and treat obesity. In addition, although the Rombi reference does not explicitly state the peptide of SEQ ID NO. 1, through a sequence search by STIC, STIC revealed that one of the green tea peptide sequences claimed by the applicant, e.g. SEQ ID NO. 1 (AYKRRKGKFA) (NPL – Seq ID No 1 Results GenBase UniProt; Date Accessed: March 27, 2026; found within the prosecution history (March 31, 2026)) is a natural property of green tea. Within the NPL from March 31, 2026, the sequence results for Seq ID NO. 1 show that the Zhang et al article provides proof that Seq ID NO. 1 is intrinsically occurring. Moreover, it would have been obvious to include Yu et al’s experimental results with a green tea powder or green tea polyphenols to induce the expression of ACO. A person of ordinary skill in the art would further have predicted that the combination of the aforementioned references would promote the expression of cellular molecules, like ACO, that are involved in fat oxidation within a fat cell of a subject who ingests the green tea peptide (that is in the form of an oral composition) that was obtained from a fermented green tea extract. In addition, one of ordinary skill in the field of analytical chemistry would reasonably expect to conduct a primary and a secondary extraction in order to extract the full range of components desired in order to have an intended effect within the composition.
Regarding claim(s) 15-16, the combined aforementioned references does not specifically teach administering the green tea composition in the concentration and dosages claimed by applicant in claim(s) 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.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986) in view of Choi (KR 20130039595 A – English translation provided), Gyeong (KR 20040037011 – English translation provided), Zhang (Nat Commun., (Year: 2020), vol. 11, no. 3719) and Yu et al (Chinese Journal of Animal Nutrition, (Year: 2018), vol. 30, no. 12, pp. 5107-5117) as applied to claim(s) 1, 5-8, 11-12 and 15-17 above, and further in view of Gardiner (CA Patent No. 2,530,093).
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 include information from Garinder's study that clarifies that green tea extracts increase fat oxidation in subjects in need, and to include 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, the combined aforementioned references prove that separately, varying compositions of green tea (an extract, powder form, or particular components) are involved inhibiting the generation of fat or lipid synthesis (through reducing the expression of the molecules ACC and FAS) within a cell. Furthermore, 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) within a fat cell, 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 the combined aforementioned references teach that one of the many effects of green tea extracts is ameliorating obesity.
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rombi (U.S. Patent No. 6,814,986) in view of Choi (KR 20130039595 A – English translation provided), Gyeong (KR 20040037011 – English translation provided), Zhang (Nat Commun., (Year: 2020), vol. 11, no. 3719) and Yu et al (Chinese Journal of Animal Nutrition, (Year: 2018), vol. 30, no. 12, pp. 5107-5117) as applied to claim(s) 1, 5-8, 11-12 and 15-17 above, and further in view of Molino (CA Patent No. 2588436), Rehman et al (PLOS One (Year: 2013), vol. 8, no. 6, e65029), Chacko et al (Chinese Medicine (Year: 2010), vol. 5, no. 13) and Torres-Ferreira et al (ScienceDirect (Year: 2020), vol. 64, pp. 103679).
The teachings of Rombi, Choi, Gyeong, Zhang et al and Yu et al are above.
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).
Rehman et al teaches that the C. sinensis (green tea) plant contains several polyphenols in which those polyphenols are stimulators of mitochondrial biogenesis (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 (pg. 2).
Torres- Ferreira et al teaches the effects of green tea through examining adiponectin responses through mice (abstract and page 1).
It would have been obvious to combine the aforementioned references to show 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) and that green tea has the ability 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 mitochondria, necessary for overall cellular functioning. 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 all of the aforementioned references in order to acknowledge the broad effects of green tea and the green tea extract in order to induce mitochondrial synthesis and to induce the protein expression of UCP2.
Response to Amendment
The declaration under 37 CFR 1.132 filed May 18, 2026 has been considered and the rejection under 35 U.S.C. 102(a)(1) has been withdrawn. In addition, examiner will further address the declaration as a result of claim 1 being amended and subjected to the rejection under 35 U.S.C § 103 for obviousness.
Based on applicant’s declaration, overall, applicant conducted an assessment to see whether SEQ ID NO: 1 (amino acid sequence: AYKRRKGKFA; 10 amino acids) is known to exist as a free peptide in Camellia sinensis (green tea) and conducting a protein sequence similarity search using the BLASTP program provided by the National Center for Biotechnology Information (NCBI), National Library of Medicine, U.S. National Institutes of Health (pg. 2 of declaration). Based upon examiners interpretations, applicant states in the beginning of pg. 3 of the declaration that “critically, in every case, the matching sequence constitutes a short internal segment of a substantially larger protein”. Moreover, onto pg. 4 of the declaration, the applicant also states that “the peptide sequence of SEQ ID NO: 1 exists in Camellia sinensis solely as an internal subsequence within larger, intact proteins” and that on pg. 5 of the declaration, applicant states that “no scientific literature, including Zhang (Nat. Commun. (2020), vol. 11, no. 3719), establishes that hypothetical protein HYC85_006447 undergoes proteolytic processing to release AYKRRKGKFA as a free peptide in vivo or under any conditions of extraction”. The statements provided by the applicant within the declaration are not convincing solely off the premise that based on the UniProt results provided by the examiner on March 31, 2026, the letter “i” right after the “m” in “organism” on the UniProt page, gives an explanation regarding organism and the explanation is: “section provides information on the name(s) of the organism that is the source of the protein sequence”. Therefore, the search conducted by the examiner adequately traced the sequence back to Camella sinensis in which, the sequence is connected to the Zhang et al article and thus, the sequence, namely SEQ ID NO: 1 is not only known in the art but is also a naturally occurring peptide sequence within the Camellia sinensis plant. Although applicant has provided proof that the SEQ ID NO: 1 peptide is occurring within a larger sequence and that the presented article, namely, Zhang et al does not discuss proteolytic processing to release the peptide sequence (AYKRRKGKFA) as a free peptide is not commensurate in scope or in other words, the claim(s) presented by the applicant are much broader than what the applicant is presenting within the declaration. Regardless if peptide sequence SEQ ID NO: 1 is part of a larger protein or not, the sequence has been shown to be known in the art and therefore, applicants’ declaration is not persuasive.
Response to Arguments
Applicants’ arguments filed May 18, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C § 103 for obviousness are found to be non-persuasive.
Regarding applicants’ remarks for the 35 U.S.C § 103 rejection wherein the references used, namely, “Rombi and Zhang fail to establish the inherent presence of free SEQ ID NO: 1 peptide in Rombi’s green tea extract. Zhang is a genome assembly paper that contains no peptide identification data and provides no evidence that SEQ ID NO: 1 exists as a free peptide in any green tea extract. The only protein purported to contain SEQ ID NO: 1 with statistical significance is a hypothetical protein of unknown function with no known proteolytic processing. Furthermore, Rombi’s 80% ethanol extraction conditions are not conducive to generating free peptides from intact proteins”. Based on the information and response provided by examiner within the “Response to Amendment”, one of ordinary skill in the art would have found it obvious to use Rombi’s ethanol extraction conditions in order to achieve a green tea extract and in combination, using the method found within Choi in terms of fermenting that green tea extract found within Rombi with a lactic acid bacterium, namely, Lactobacillus plantarum (i.e. Lactiplantibacillus plantarum) from Choi in order to retrieve the peptide sequence, SEQ ID NO: 1 (AYKRRKGKFA) that would be present within the composition. Considering applicants’ arguments regarding the use of a different bacterium, Lactobacillus reuteri as opposed to Lactobacillus plantarum, the 35 U.S.C § 103 rejection includes Choi; Choi does teach a fermented green tea extract in which, the green tea extract was fermented with Lactobacillus plantarum. Given that the amendment was for claim 1 (e.g. applicants’ claim set from May 18, 2026 only includes one modification: moving claim 3 limitations into claim 1), Choi does meet the claim limitations in terms of providing the same bacterium, L. plantarum in combination with Rombi and additional references that further establish that one skilled in the art would make the combination of those references in order to achieve SEQ ID NO: 1 (AYKRRKGKFA) which would be produced by a specific lactic acid bacterium (i.e. L. plantarum) in which, that peptide sequence would intrinsically be present within a composition that can be administered to a subject in need of treating obesity. Overall, although Gyeong does focus on a specific bacterium, namely L. reuteri, Gyeong does state that all Lactobacillus species are known to have beneficial effects on the body and that lactic acid bacteria can be easily ingested to prevent and treat obesity thus, providing a greater emphasis on why the combination of the aforementioned references (especially including Choi’s Lactobacillus plantarum bacterium) would be obvious to one skilled in the art. Moreover, given that the claim(s) of the present invention (i.e. claim 1) are now rejected under 35 U.S.C § 103 instead of 35 U.S.C § 102 and the Choi reference has been added in order to prove obviousness, the remainder of the claim(s), namely claim(s) 5-17 will use the same explanation from the final rejection dated March 31, 2026 under “Response to Arguments” for why the references (Gardiner, Yu et al, Chacko et al, Torres-Ferreira et al, Molino, Rehman et al) were chosen to reject the remainder of the claim(s) outside of claim 1. Furthermore, for claim(s) 15-16, the combined aforementioned references does not specifically teach administering the green tea composition in the concentration and dosages claimed by applicant in claim(s) 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. Thus, applicants’ arguments are not persuasive and the rejection under 35 U.S.C § 103 for obviousness is maintained.
No claim(s) are allowed.
Conclusion
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.
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, Anand U Desai can be reached at (571)272-0947. 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.
NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Prosecution Insights