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 .
Status of Claims
The claim listing filed 27 March 2024 is pending. Claims 1-15 are being examined on the merits of this office action.
Priority
The present application claims benefit to International Patent Application No. KR10-2023-0051410 filed on 19 April 2023. Applicants claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365 (c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The use of the term “Korean Pharmacopeia” (Page 16), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 13 is 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 13 recites “wherein the green tea composition is formulated in the form of a composition”. The claim is indefinite because it is unclear which composition the limitation is referencing. The applicant fails to properly state the limitations of the claim. Additionally, claim 13 recites “… of the total weight of the composition”. The claim is indefinite because it is unclear which composition (the green tea peptide composition or the formulated composition) the limitation is referencing.
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, 8-12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.).
Claim Interpretation: The Examiner acknowledges that green tea peptides are inherently within the Camellia sinensis leaves due to the instant specification saying that the green tea peptide composition of the instant invention is derived from Camellia sinensis, supplied from Agricultural Corporation Osulloc Farm, Ltd. See pg. 15, lines 14-16 (“[Example 1] Preparation of green tea peptide composition (GTP): 50 kg of green tea (camelia sinensis, Agricultural Corporation Osulloc Farm., Ltd.)..."). Osulloc Farm is a tea farm that produces matcha powder derived from young green tea leaves (See attached “Simply Angella” webpage; “… Jeju Island was also known for its green tea, called nokcha (녹차) in Korean. My interest piqued when I purchased a highly rated pressed powder from K-beauty brand, Innisfree (now one of my favorites!). They advertised the powder as containing natural minerals & mint originated straight from Jeju Island! For beauty junkies that are familiar with AmorePacific (parent company of Laneige & Etude) you may find it interesting to know they own Innisfree & O’sulloc as well! … The second section of Innisfree Jeju House features the organic Green Cafe, … A cute concept, but much to my disappointment, the matcha was a little stale.”; Also see attached Amore Mall site, where O’sulloc match powder is sold, stating that the matcha powder is made from “the tenderest shade-grown young green tea leaves” (pg. 1, “Immerse yourself in the unparalleled sophistication of our USDA Organic Premium Matcha Powder, crafted from the tenderest shade-grown young green tea leaves.”) For the sake of compact prosecution, the Examiner is interpreting green tea leaves to inherently comprise the peptides of the instant invention due to the teachings of the specification.
Regarding claim 1, El-Elimat teaches that matcha tea has been used in weight loss programs and that the difference between matcha tea and other tea forms this that while the water extract of the tea is consumed, with matcha, water is added to finely ground tea leaves and the whole leaf is consumed (pg. 448, “Tea [Camellia sinensis L. Kuntze (Theaceae)] is one of the most popular drinking beverages all over the world … Matcha tea is different, as well, from other forms of tea in the way of preparation and consumption. While in most types of green teas the water extract of the leaves is consumed, in matcha tea, however, water is added to the finely ground leaves powder and the whole leaves are consumed”).
El-Elimat also teaches that individuals that consumed matcha tea showed a decrease in blood glucose levels (pg. 447, “The matcha tea group showed a potential increase in HDL-C, a potential decrease in blood glucose”; pg. 450, “A significant reduction in the levels of fasting blood glucose was observed in the matcha tea group.”; See pg. 451, table 1).
Regarding claim 8, regarding the limitation “wherein the green tea peptide composition promotes insulin-dependent glucose transport in adipocytes”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The green tea as described in El-Elimat inherently comprises the same peptide described in the instant claim; thus it is interpreted as being sufficient for promotes insulin-dependent glucose transport in adipocytes as described in the instant claim.
Regarding claim 9, regarding the limitation “wherein the green tea peptide composition inhibits glucose synthesis in hepatocytes”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The green tea as described in El-Elimat inherently comprises the same peptide described in the instant claim; thus it is interpreted as being sufficient for inhibiting glucose synthesis in hepatocytes as described in the instant claim.
Regarding claim 10, regarding the limitation “wherein the green tea peptide composition decreases the expression of any one or more of PEPCK and C6Pase”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The green tea as described in El-Elimat inherently comprises the same peptide described in the instant claim; thus it is interpreted as being sufficient for decreasing the expression of any one or more of PEPCK and C6Pase, as described in the instant claim.
Regarding claim 11, regarding the limitation “wherein the green tea peptide composition inhibits the degradation of GLP1 (Glucagon-like peptide 1)”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The green tea as described in El-Elimat inherently comprises the same peptide described in the instant claim; thus it is interpreted as being sufficient for inhibiting the degradation of GLP1 (Glucagon-like peptide 1) as described in the instant claim.
Regarding claim 12, regarding the limitation “wherein the green tea peptide composition inhibits the expression of DDP-4 (dipeptidyl peptidase 4) in any one or more cells of hepatocytes and macrophages”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim. The green tea as described in El-Elimat inherently comprises the same peptide described in the instant claim; thus it is interpreted as being sufficient for inhibiting the expression of DDP-4 (dipeptidyl peptidase 4) in any one or more cells of hepatocytes and macrophages as described in the instant claim.
Regarding claim 15, El-Elimat teaches that the subjects were given the green tea in a beverage (pg. 448, “Participants in the matcha tea group were asked to follow a specified LCD plan in addition to an oral intake of a beverage of matcha tea [2 g in a cup of water once daily].”).
Claim Rejections - 35 USC § 102/103
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.
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.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.).
Regarding claim 14, El-Elimat teaches that matcha tea has been used in weight loss programs and that the difference between matcha tea and other tea forms this that while the water extract of the tea is consumed, with matcha, water is added to finely ground tea leaves and the whole leaf is consumed (pg. 448, “Tea [Camellia sinensis L. Kuntze (Theaceae)] is one of the most popular drinking beverages all over the world … Matcha tea is different, as well, from other forms of tea in the way of preparation and consumption. While in most types of green teas the water extract of the leaves is consumed, in matcha tea, however, water is added to the finely ground leaves powder and the whole leaves are consumed”) and that individuals that consumed matcha tea showed a decrease in blood glucose levels (pg. 447, “The matcha tea group showed a potential increase in HDL-C, a potential decrease in blood glucose”; pg. 450, “A significant reduction in the levels of fasting blood glucose was observed in the matcha tea group.”; See pg. 451, table 1).
El-Elimat also teaches that the study subjects had to meet the inclusion criteria of being an adult (≥ 18 years) and having a BMI of [Symbol font/0xB3] 28 kg/m2 and that the subjects were administered a matcha tea beverage consisting of 2 grams of matcha in a cup of water once daily (Supplementary Information, “Participants in the study were required to meet the following inclusion criteria: (1) age ≥ 18 years with no gender restrictions, (2) BMI [Symbol font/0xB3] 28 kg/m2. … Participants in the study group were asked to follow a specified low-calorie diet (LCD) plan plus oral intake of a beverage of matcha tea [2 g in a cup of water once daily].”). The average height of an adult male in North America is 5 feet 9 inches (175cm). If an adult male subject having a BMI of 28 kg/m2 (weighing 85.75kg) were to take the dosage as taught by El-Elimat, they would consume 23.32 mg/kg/day.
El-Elimat does not expressly teach the green tea peptide composition being administered in an amount of 1 to 400 mg/kg/day.
It would be obvious to one of ordinary skill in the art before the effective filing date to reasonably believe that the dosage as taught by El-Elimat could fall within the dosage range as taught in the instant claim, due to the dose of El-Elimat falling in the dosage range as taught by the instant claim. See MPEP §2144.05 (“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).”; “[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")”).
One of ordinary skill in the art would have read the teachings of El-Elimat and have arrived at the range as taught in the instant invention with a reasonable expectation of success because "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.".
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.), as applied to claim 1 above, and further in view of Wang et al., (“Green tea fermentation with Saccharomyces boulardii CNCM I-745 and Lactiplantibacillus plantarum 299V”, LWT, Volume 157, 2022, 113081, ISSN 0023-6438, https://doi.org/10.1016/j.lwt.2022.113081.).
The teachings of El-Elimat are described above and applied as before.
El-Elimat does not teach the green teach peptide composition being obtained from fermenting green tea protein with vegetable lactic acid bacteria.
Wang teaches green tea infusions being fermented with probiotic lactic acid bacteria Lactiplantibacillus plantarum (pg. 2, “Fermentation of green tea infusions was conducted by inoculating green tea infusions with monocultures of S. boulardii CNCM I-745, L. plantarum 299V and a co-culture of them, then incubated at 30 °C for 2 days…”). Wang also teaches that the addition of L. plantarum caused the fermented green tea beverage to have a fruity aroma and in turn a fruity taste with a high number of probiotics (pg. 1, “Abstract … The findings from this research suggest that fermentation of tea infusion with probiotics would be an innovative way to modulate tea flavor and develop a novel tea beverage with high counts of live probiotics.”; pg. 6, “L. plantarum monoculture still showed a stronger fruity note than unfermented sample …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify El-Elimat’s teachings with Wang’s teachings because El-Elimat teaches that green tea matcha reduces blood sugar and Wang teaches that the addition of L. plantarum to a green tea infusion changes the flavor profile and could lead the development of a novel tea beverage with a high probiotic count. One of ordinary skill in the art before the effective filling date of the instant invention would be motivated to add lactic acid bacteria to a composition comprising green tea due to Wang teaching that the addition causes a fruity flavor that normal fermented green tea does not have. One of ordinary skill in the art would think to improve the taste of a composition.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention.
Regarding claim 3, Wang teaches green tea infusions being fermented with probiotic lactic acid bacteria Lactiplantibacillus plantarum (pg. 2, “Fermentation of green tea infusions was conducted by inoculating green tea infusions with monocultures of S. boulardii CNCM I-745, L. plantarum 299V and a co-culture of them, then incubated at 30 °C for 2 days…”).
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.) and Wang et al., (“Green tea fermentation with Saccharomyces boulardii CNCM I-745 and Lactiplantibacillus plantarum 299V”, LWT, Volume 157, 2022, 113081, ISSN 0023-6438, https://doi.org/10.1016/j.lwt.2022.113081.), as applied to claim 2 above, and further in view of Barashkova and Rogozhin, hereafter “Barashkova”, (“Isolation of antimicrobial peptides from different plant sources: Does a general extraction method exist?” Plant Methods. 2020 Oct 23;16:143. doi: 10.1186/s13007-020-00687-1. PMID: 33110440; PMCID: PMC7585225.).
The teachings of El-Elimat and Wang are described above and applied as before.
Regarding claims 4-6, El-Elimat and Wang do not teach the green tea protein is obtained from the residue of a primary extract obtained by extracting green tea with anhydrous or hydrous C1-C6 lower alcohol.
Barashkova teaches that the isolation of microbial peptides from plants can be done using organic solvents, such as ethanol (pgs. 3 and 6, “Organic solvents are the second group of extractants. The most common variant is the aqueous solution of ethanol. … Later, this scheme was improved through the optimization of ethanol to water ratio in the extracting solution, the ratio of plant material and extractant, as well as the time and number of repeated extractions.”). Barashkova also teaches that to extract peptides from fresh leaves, ethanol in 20% and 70% concentrations is needed (pg. 4, “Moringa oleifera, (fresh leaves) … 2. The supernatant was filtered and loaded on C18 flash-column, elution was performed using increase of ethanol concentration (20, 70%)”; See table on page 4).
One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to combine the teaching of El-Elimat, Wang and Barashkova to arrive at the instant invention due to El-Elimat and Wang teaching that green tea can lower blood sugar and that when fermented with Lactiplantibacillus plantarum provides a fruitier taste and Barashkova teaching that a known method of extracting plant peptides is using ethanol while teaching that the water to ethanol ratio can be optimized. One of ordinary skill in the at before the effective filing date of the instant invention would be motivated to combine the two references to apply known technique to a known device to yield predictable results under KSR Rationale D. See MPEP §2143(I)(D).
Regarding claim 7, Barashkova teaches that the isolation of microbial peptides from plants can be done using organic solvents, such as ethanol (pgs. 3 and 6, “Organic solvents are the second group of extractants. The most common variant is the aqueous solution of ethanol. … Later, this scheme was improved through the optimization of ethanol to water ratio in the extracting solution, the ratio of plant material and extractant, as well as the time and number of repeated extractions.”). Barashkova also teaches that to extract peptides from fresh leaves, ethanol in 20% and 70% concentrations is needed (pg. 4, “Moringa oleifera, (fresh leaves) … 2. The supernatant was filtered and loaded on C18 flash-column, elution was performed using increase of ethanol concentration (20, 70%)”; See table on page 4). The reference does not teach a specific extraction method (e.g. hydrothermally extracting the residue of the primary extract), 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 7.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.), as applied to claim 1 above, in further view of Burcuș et al., hereafter “Burcuș” ("Antioxidant, anti-inflammatory, and antibacterial potential of different drinks based on Matcha tea." IOP Conference Series: Materials Science and Engineering. Vol. 374. No. 1. IOP Publishing, 2018.).
Regarding claim 13, the teaching of El-Elimat is described above and applied as before.
El-Elimat teaches that matcha tea has been used in weight loss programs and that the difference between matcha tea and other tea forms this that while the water extract of the tea is consumed, with matcha, water is added to finely ground tea leaves and the whole leaf is consumed (pg. 448, “Tea [Camellia sinensis L. Kuntze (Theaceae)] is one of the most popular drinking beverages all over the world … Matcha tea is different, as well, from other forms of tea in the way of preparation and consumption. While in most types of green teas the water extract of the leaves is consumed, in matcha tea, however, water is added to the finely ground leaves powder and the whole leaves are consumed.”), that individuals that consumed matcha tea showed a decrease in blood glucose levels (pg. 447, “The matcha tea group showed a potential increase in HDL-C, a potential decrease in blood glucose …”; pg. 450, “A significant reduction in the levels of fasting blood glucose was observed in the matcha tea group.”; See pg. 451, table 1), and that the subjects were given the green tea in a beverage comprising 2 g of matcha in a cup of water (pg. 448, “Participants in the matcha tea group were asked to follow a specified LCD plan in addition to an oral intake of a beverage of matcha tea [2 g in a cup of water once daily].”).
El-Elimat also teaches that individuals that consumed matcha tea showed a decrease in blood glucose levels and could potentially have anti-inflammatory properties (pg. 447, “The matcha tea group showed a potential increase in HDL-C, a potential decrease in blood glucose”; pg. 450, “A significant reduction in the levels of fasting blood glucose was observed in the matcha tea group. … The data suggest that matcha tea may have some potential effect on weight loss, along with anti-inflammatory properties”; See pg. 451, table 1).
El-Elimat does not teach the green tea peptide composition being 1 to 50 wt.% based of the total weight of the composition.
Burcuș teaches the matcha based drinks having anti-inflammatory properties (pg. 4, “3.2. Evaluation of anti-inflammatory activity - A significant number of studies proved the direct link between antioxidant activity and anti-inflammatory activity. … The anti-inflammatory potential proven in vivo and in vitro exhibited the same tendency (Figure 2). M4 and M5 presented maximum values. The correlation between methods and Matcha tea samples was significant. … Similar to previous studies [14], non-polar solutions (M3, M4, and M5) had the highest anti-inflammatory activity…”). Burcuș also teaches that the samples were prepared by taking 2 g of dried matcha powder and adding boiling water to make a 200 mL solution (pg. 2, “The samples (aqueous extracts) were prepared in accordance with previously described research [6]. For the dried powder Matcha tea, 2 g were mixed with 20 mL of boiling water and vertexing to obtain a homogeneous mixture; after that, boiling water was added to 200 mL.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify El-Elimat’s teachings with Burcuș’ teachings because El-Elimat teaches that green tea reduces blood sugar and that the consumption is associated with anti-inflammatory properties, while Burcuș also teaches that matcha based beverages have anti-inflammatory properties when boiling water is added to 2 g of dried matcha powder to make a 200 mL solution, which is 1 wt.% of the total weight of the composition. One of ordinary skill in the art before the effective filling date of the instant invention would be motivated to administer the green tea peptide composition in an amount of 1 wt.% based of the total weight of the composition due to both El-Elimat and Burcuș teaching the administration of green tea to combat inflammation.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5- 17 of copending Application No. 18/515,599 (hereafter ‘599) in view of El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘599 teaches a method of preventing, ameliorating, or treating obesity, the method comprising: administering an active amount of a green tea peptide composition to a subject in need thereof, wherein the green tea peptide composition comprises one or more species of green tea peptides comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO:7, and wherein the green tea peptide composition is obtained by fermenting a green tea protein with Lactiplantibacillus plantarum (see claim 1).
‘599 does not teach the fermented green tea peptide composition being used to lower blood sugar.
El-Elimat teaches that matcha tea has been used in weight loss programs and that the difference between matcha tea and other tea forms this that while the water extract of the tea is consumed, with matcha, water is added to finely ground tea leaves and the whole leaf is consumed (pg. 448, “Tea [Camellia sinensis L. Kuntze (Theaceae)] is one of the most popular drinking beverages all over the world … Matcha tea is different, as well, from other forms of tea in the way of preparation and consumption. While in most types of green teas the water extract of the leaves is consumed, in matcha tea, however, water is added to the finely ground leaves powder and the whole leaves are consumed”).
El-Elimat also teaches that individuals that consumed matcha tea showed a decrease in blood glucose levels (pg. 447, “The matcha tea group showed a potential increase in HDL-C, a potential decrease in blood glucose”; pg. 450, “A significant reduction in the levels of fasting blood glucose was observed in the matcha tea group.”; See pg. 451, table 1) and that the patient population included overweight and obese adults (pg. 448, “A total of 27.8% of the control group and 37.5% of the matcha tea group were obese class I.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the composition of ‘599 in a method of lowering blood sugar due to both ‘599 and El-Elimat teaching the administration of green tea to obese populations and El-Elimat teaching that the administration of green tea lowers blood glucose, while also stating that multiple studies included obese subjects in their patient population.
Regarding claims 2 and 3, ‘599 teaches that the green tea peptide composition is obtained by fermenting a green tea protein with Lactiplantibacillus plantarum. (See claim 1)
Regarding claim 4, ‘599 teaches the green tea protein is obtained from a residue of a primary extract that is extracted from green tea with anhydrous or hydrous C1-C6 low carbon alcohol. (See claim 5)
Regarding claim 5, ‘599 teaches wherein a concentration of alcohol in the hydrous C1-C6low carbon alcohol is 20 to 80 % (v/v). (See claim 6)
Regarding claim 6, ‘599 teaches the hydrous C1-C6 low carbon alcohol is a 20 to 80 % (v/v) ethanol aqueous solution. (See claim 7)
Regarding claim 7, ‘599 teaches the green tea protein being obtained from a residue of a secondary extract which is hydrothermally extracted from the residue of the primary extract. (See claim 8)
Regarding claims 8-12, ‘599 teaches the method of using a green tea peptide. Claims 8-12 of the instant application are drawn to the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim.
Regarding claim 13, ‘599 teaches that the green tea peptide composition is formulated as a composition and is contained in an amount of 1 to 50 wt.% based on the total weight of the composition. (See claim 15)
Regarding claim 14, ‘599 teaches the green tea peptide composition being administered in an amount of 1 to 400 mg/kg/day to a subject in need thereof. (See claim 16)
Regarding claim 15, ‘599 teaches the green tea peptide composition being formulated in the form of a pharmaceutical or health functional food composition. (See claim 17)
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/536,404 (hereafter ‘404) in view of El-Elimat et al., hereafter “El-Elimat” (“A Prospective Non-Randomized Open-Label Comparative Study of The Effects of Matcha Tea on Overweight and Obese Individuals: A Pilot Observational Study.” Plant Foods Hum Nutr. 2022 Sep;77(3):447-454. doi: 10.1007/s11130-022-00998-9. Epub 2022 Aug 3. PMID: 35921023; PMCID: PMC9362463.) and Umegaki (“Sarcopenia and diabetes: Hyperglycemia is a risk factor for age-associated muscle mass and functional reduction.” J Diabetes Investig. 2015 Nov;6(6):623-4. doi: 10.1111/jdi.12365. Epub 2015 Jun 1. PMID: 26543534; PMCID: PMC4627537.).
This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘599 teaches a method of preventing, improving or treating muscle loss, the method comprising: administering an active amount of a green tea peptide composition (shown in SEQ ID NOs: 1-7) to a subject in need thereof, wherein the green tea peptide composition is obtained by fermenting a green tea protein with a plant-based lactic acid bacterium of the genus Lactiplantibacillus. (see claims 1 and 2).
‘404 does not teach the fermented green tea peptide composition being used to lower blood sugar.
Umegaki teaches that skeletal muscle loss associated with aging (sarcopenia) is a problem, especially for those with type 2 diabetes. (pg. 623, “The age-associated decrease of muscle mass and function is called sarcopenia. … It has been well established that type 2 diabetes mellitus is a risk factor for functional disability and for mobility limitations. Several reports have shown that type 2 diabetes mellitus is associated with sarcopenia and frailty. ”). Umegaki also teaches that studies have shown that lowering the blood glucose of could improve muscle function or attenuate the loss of muscle mass (pg. 624, “Several studies have suggested that blood glucose-lowering therapy … could improve muscle function or attenuate the loss of muscle mass.”).
El-Elimat teaches that matcha tea has been used in weight loss programs and that the difference between matcha tea and other tea forms this that while the water extract of the tea is consumed, with matcha, water is added to finely ground tea leaves and the whole leaf is consumed (pg. 448, “Tea [Camellia sinensis L. Kuntze (Theaceae)] is one of the most popular drinking beverages all over the world … Matcha tea is different, as well, from other forms of tea in the way of preparation and consumption. While in most types of green teas the water extract of the leaves is consumed, in matcha tea, however, water is added to the finely ground leaves powder and the whole leaves are consumed”).
El-Elimat also teaches that individuals that consumed matcha tea showed a decrease in blood glucose levels (pg. 447, “The matcha tea group showed a potential increase in HDL-C, a potential decrease in blood glucose”; pg. 450, “A significant reduction in the levels of fasting blood glucose was observed in the matcha tea group.”; See pg. 451, table 1) and that the patient population included overweight and obese adults (pg. 448, “A total of 27.8% of the control group and 37.5% of the matcha tea group were obese class I.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the composition of ‘404 in a method of lowering blood sugar due to both ‘404 and El-Elimat teaching the same compound, El-Elimat teaching that the administration of a green tea peptide lower blood glucose and Umegaki teaching that that studies have shown that lowering the blood glucose of could improve muscle function or attenuate the loss of muscle mass.
Regarding claims 2 and 3, ‘404 teaches that the green tea peptide composition is obtained by fermenting a green tea protein with Lactiplantibacillus plantarum. (See claims 1 and 4)
Regarding claim 4, ‘599 teaches the green tea protein is obtained from a residue of a primary extract that is extracted from green tea with anhydrous or hydrous C1-C6 low carbon alcohol. (See claim 5)
Regarding claim 5, ‘599 teaches wherein a concentration of alcohol in the hydrous C1-C6low carbon alcohol is 20 to 80 % (v/v). (See claim 6)
Regarding claim 6, ‘599 teaches the hydrous C1-C6 low carbon alcohol is a 20 to 80 % (v/v) ethanol aqueous solution. (See claim 7)
Regarding claim 7, ‘599 teaches the green tea protein being obtained from a residue of a secondary extract which is hydrothermally extracted from the residue of the primary extract. (See claim 8)
Regarding claims 8-12, ‘599 teaches the method of using a green tea peptide. Claims 8-12 of the instant application are drawn to the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art peptide is capable of performing the intended use, then it meets the claim.
Regarding claim 13, ‘599 teaches that the green tea peptide composition is formulated as a composition and is contained in an amount of 1 to 50 wt.% based on the total weight of the composition. (See claim 12)
Regarding claim 14, ‘599 teaches the green tea peptide composition being administered in an amount of 1 to 400 mg/kg/day to a subject in need thereof. (See claim 13)
Regarding claim 15, ‘599 teaches the green tea peptide composition being formulated in the form of a pharmaceutical or health functional food composition. (See claims 14 and 15)
Status of Claims
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claims 1, 8-12 and 15 are rejected under 35 U.S.C. 102(a)(1). Claims 2-7, and 13-14 are rejected 35 U.S.C. 103. Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daliyah M. Brown whose telephone number is (571)272-0136. The examiner can normally be reached Monday-Thursday 9:00 am - 4:30 pm.
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, Lianko Garyu can be reached at (571) 270-7367. 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.
/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
Prosecution Insights