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 Objections
Claims 42 and 43 are objected to because of the following informalities: the claims recite “said low intensity sweetener(s)” instead of “said at least one low intensity sweetener”. The amendment added “at least one” prior to all the other recitations of “low intensity sweetener”. For the sake of consistency, the claims should employ the same style of language when referencing a given component throughout the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 40 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.
The recitation of claim 40 is circular and unclear. It recites that a liquid lecithin is liquid lecithin and also recites that a combination of liquid lecithin and de-oiled lecithin is liquid lecithin. The applicant may intend to narrow the option of selecting liquid lecithin or a combination of liquid lecithin and de-oiled lecithin such that liquid lecithin is the required choice. However the wording of the claim makes it difficult to understand the intended limitation.
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.
Claims 21-22, 24, 27-32, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. (previously cited) in view of Kariman (previously cited), Ramanathan et al. (previously cited), and Johns et al. (previously cited) as evidenced by Korey et al. (previously cited).
Hewins et al. teach a liquid delivery system that includes a hydrophobic active agent, a surfactant, and sweetener (see paragraphs 11-16, 26, 35, and 51; instant claim 21). The surfactant is present at 0.15 to 1.5 wt% and is preferably lecithin (see paragraphs 26 and 43). Hewins et al. teach the composition as a medicinal drink formulation. In addition, the included active agent is envisioned as a raw ingredient in liquid form (see paragraph 38). The composition is in the form of an emulsion or microemulsion (see paragraph 19). Hewins et al. teach several options for the sweetener including potassium acesulfame, sodium saccharin, aspartame, sugars, stevia extracts, sucralose, and their mixtures (see paragraph 51). They further teach the composition pH to ranges from 1.7 to about 7 (see paragraph 21; instant claim 21). An example is provided with glycerol (low intensity sweetener system) at 54.73 wt%, sorbitol (low intensity sweetener system) at 5 wt%, acesulfame-K (potassium acesulfame), flavor, sucralose (sweetener system, high intensity sweetener), sucrose monoester P90 (emulsifier/surfactant) and lecithin at 0.07 wt% (see example 4.1; instant claims 21-22 and 28-32). Korey et al. detail that aspartame, acesulfame-K, and sodium saccharin are also considered taste masking agents (see paragraph 22). An additional example includes phosphoric acid as a desirable ingredient (see example 7; instant claim 24). A component of Kratom is not taught as the active agent and lecithin is not detailed in liquid form.
Kariman teaches liquid oral preparations of Kratom compounds that include emulsions (see abstract and paragraphs 83-84). The Kratom compounds are taught present in the form of Kratom plant extracts and the compositions may include sweetener and emulsifying agents (see paragraph 84).
Ramanathan et al. teach of the desire to formulate mitragynine, the poorly water soluble active found in Mitragyna speciose (Kratom), into a dosage form due to its anesthetic and analgesic properties (see page 4916-page 4917 first partial paragraph).
Johns et al. teach various forms of lecithin that are envisioned in a liquid food and they include de-oiled lecithin powder and liquid lecithin (see paragraphs 251-252). Their liquid lecithin includes 1% water; 37% triglycerides; 16% phosphatidylcholine; 13% phosphatidylethanolamine; 10% phosphatidylinositol; 5% phosphatidic acid; 2% minor phospholipids; 5% complexed sugars; and 11% glycolipids (see paragraph 254; instant claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare example 4.1 of Hewins et al. where Kratom is included as a poorly water soluble active. This choice would have been obvious because Hewins et al. envision their active as a poorly water soluble liquid form, Kratom compounds are poorly water soluble, and Kariman teaches Kratom compounds in an oral liquid form. Further, the selection of a liquid lecithin as taught by Johns et al. would have been obvious because they teach the exchangeability of solid and liquid forms of lecithin in edible compositions. The choice is obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result is a mixture that includes liquid lecithin, kratom, flavor, glycerol, sucralose, acesulfame-K, as well as sorbitol and an emulsifier. Given the teachings of Hewins et al. of their envisioned alternative sweeteners, an embodiment where sodium saccharin is exchanged for the sucralose would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result would be a composition that is devoid of sucralose and stevia (see instant claim 27). In addition, the inclusion of phosphoric acid as contemplated by Hewins et al. would also follow as would employing in their taught pH range (see instant claim 12). This range overlaps with that instantly claimed, thereby rendering the claimed range obvious. “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)” (see MPEP 2144.05). Therefore claims 21-22, 24, 27-32, and 40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al.
Claims 21-24, 27-32, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. as applied to claims 21-22, 24, 27-32, and 40 above, and further in view of Jeppesen et al. (previously cited).
Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. render obvious the limitations of instant claims 21-22, 24, 27-32, and 40, where a sucrose monoester is present as a surfactant/emulsifier (see example 4.1 and paragraph 25). Hewins et al. also envision the inclusion of glycosylated stevia compounds as sweeteners (see paragraph 51 and claim 8). The presence of polysorbate as an emulsifier/surfactant is not detailed.
Jeppesen et al. teach an oral dosage form that is provided as a liquid that includes glycosylated stevia compounds (see paragraphs 31-32). The liquid preparation includes surfactants that are envisioned as lecithin, sucrose monoesters, and polysorbate (see paragraph 75).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange polysorbate for the sucrose monoester in the composition of Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. This modification would have been obvious in light of Jeppesen et al. as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 21-24, 27-32, and 40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., and Jeppesen et al. as evidenced by Korey et al.
Claims 21-22, 24, 27-33, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. as applied to claims 21-22, 24, 27-32, and 40 above, and further in view of Chen et al. (previously cited).
Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. render obvious the limitations of instant claims 21-22, 24, 27-32, and 40, where saccharin is present. The presence of phyllodulcin is not detailed.
Chen et al. teach a beverage that includes high intensity sweeteners that are envisioned to include saccharin and phyllodulcin (see abstract and paragraph 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange phyllodulcin for the saccharin in the composition of Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. This modification would have been obvious in light of Chen et al. as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 21-22, 24, 27-33, and 40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., and Chen et al. as evidenced by Korey et al.
Claims 21-22, 24-32, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. as applied to claims 21-22, 24, 27-32, and 40 above, and further in view of Bingley et al. (previously cited).
Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. render obvious the limitations of instant claims 21-22, 24, 27-32, and 40 where various sweeteners are included. An obvious embodiment includes liquid lecithin, kratom, flavor, glycerol, sucralose, acesulfame-K, as well as sorbitol and sucrose monoester. The sweeteners are included in combination and Hewins et al. teach stevia compounds, glycyrrhizinate, sucralose, and saccharin as envisioned varieties (see paragraph 51). The presence of neohesperidin dihydrochalchone is not detailed
Bingley et al. teach the inclusion of sweetness potentiators in compositions that contain sweeteners so that the sweetener can be included at a lower proportion, but does not adversely impact taste perception (see paragraph 14-15). These potentiators act to alter the sweetness onset period, the peak sweetness period, and the sweetness decay period as well as increase the sucrose equivalence (see paragraphs 16-18). Bingley et al. go on to teach neohesperidin dihydrochalchone and glycyrrhizinate as sweetness decay period extenders for steviosides (stevia compounds) as well as sucralose and saccharin (see first table 2; instant claims 25-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add neohesperidin dihydrochalchone to the composition of Hewins et al. in view of Ramanathan et al., Kariman, and Johns et al. as evidenced by Korey et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Sweeteners whose sweetness attributes are enhanced by the presence of this compound are included in the composition as is other compounds similar in function to the neohesperidin dihydrochalchone (masking agent). Therefore claims 21-22, 24-32, and 40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., and Bingley et al. as evidenced by Korey et al.
Claims 21-32, 34-37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., and Bingley et al. as evidenced by Korey et al. as applied to claims 21-22 and 24-32, and 40 above, and further in view of Canessa et al. (previously cited).
Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., and Bingley et al. as evidenced by Korey et al. render obvious the limitations of instant claims 21-22, 24-32, and 40, where a sucrose monoester is present as a surfactant/emulsifier (see example 4.1 and paragraph 25). A composition embodiment rendered obvious includes liquid lecithin, kratom, flavor, glycerol, saccharin, acesulfame-K, as well as sorbitol, phosphoric acid, neohesperidin dihydrochalchone (flavanone glycoside), and a sucrose monoester. The limitations recited by claims 34-37, with the exception of a claimed emulsifier, are addressed by these modified teachings. The presence of polysorbate as an emulsifier/surfactant is not detailed.
Canessa et al. teach a beverage/oral liquid composition that includes a high intensity sweetener and ingredients to offset its aftertaste (see paragraph 10). The liquid preparation includes emulsifiers (surfactants) that are envisioned as lecithin, sucrose monoesters, and polysorbate (see paragraph 143). High intensity sweeteners are envisioned to include saccharine (see paragraph 104 and claims 2-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange polysorbate for the sucrose monoester in the composition of Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., and Bingley et al. as evidenced by Korey et al. This modification would have been obvious in light of Jeppesen et al as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 21-32, 34-37, and 40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al.
Claims 21-38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al. as applied to claims 21-32 and 34-37, and 40 above, and further in view of Chen et al. (previously cited).
Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al. render obvious the limitations of instant claims 21-32, 34-37, and 40 where saccharin is present as a high intensity sweetener. The presence of phyllodulcin is not detailed.
Chen et al. teach a beverage that includes a high intensity sweetener that are envisioned to include saccharin and phyllodulcin (see abstract and paragraph 41; instant claims 33 and 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange phyllodulcin for the saccharin in the composition of Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al. This modification would have been obvious in light of Chen et al. as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 21-38 and 40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., Canessa et al., and Chen et al. as evidenced by Korey et al.
Claims 21-32, 34-37 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al. as applied to claims 21-32, 34-37, and 40 above, and further in view of Bell et al. (previously cited).
Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al. render obvious the limitations of instant claims 21-32 and 34-37, where flavors are included. Hewins et al. go on to teach an embodiment that combines a citrus favor, cola flavor, and caramel color (see example 7). Caramel flavor is not explicitly detailed.
Bell et al. teach beverage products that have a combination of a citrus flavor, a cola, and a caramel flavors (see abstract and table 2)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the flavor combination of example 7 as the flavor combination for the modified example 4.1 of Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., and Canessa et al. as evidenced by Korey et al. This choice would have been obvious because they it is contemplated for the compositions of Hewins et al. It additionally would have been obvious to add caramel flavor to this composition, given that caramel color is already present and Bell et al. detail the utility of the resulting combination in beverages. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement (e.g. desirable flavor combination). This modification would have been obvious in light of Chen et al. as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 21-32, 34-37, and 39-40 are obvious over Hewins et al. in view of Ramanathan et al., Kariman, Johns et al., Bingley et al., Canessa et al., and Bell et al. as evidenced by Korey et al.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Chaydeayne (US PGPub No. 2021/0113644) in view of Rubinstein (WO 2014/0241930) and Johns et al. as evidenced by Adjei et al. (US Patent No. 6,193,954).
Chadeayne teaches a composition that provides Kratom extract compounds for pharmaceutical administration (see abstract and paragraph 28). They further detail that extracts are known for use to treat musculoskeletal pain as an analgesic, depression, and anxiety (see paragraph 4). The predominant component is the alkaloid mitragynine (see paragraphs 6 and 10). Chadeayne details compositions that avoid first pass metabolism via administration routes such as sublingual or buccal (see paragraph 28). A particular formulation for such a composition is not detailed.
Rubinstein teaches a composition that provides pharmaceutical compounds through the oral mucosa in order to avoid first pass metabolism (see abstract and page 12 lines 4-8, 13-14, and 20-22). Specifically, sublingual and buccal mucosa are envisioned (see page 13 lines 1-3). They detail the inclusion of an absorption enhancer to facilitate this process as well as a combination of formulation excipients that yield a desired liquid product (see page 4 lines 23-28, page 5 lines 14-29, and page 6 line 28-page 7 line 4). Rubinstein details a formulation that includes a desired pharmaceutical compound, lecithin at 1 to 20%, polysorbate 80, sucrose as a sweetener, as well as flavoring agent, and glycerol (low intensity sweetener) (see page 6 line 28-page 7 line 4 and page 15 lines 20-28 and claim 13). Particular pharmaceuticals that are envisioned include phytochemicals and analgesics (see page 19 lines 26-31 and page 21 lines 1-4). They detail a more specific example that has a pH of 6.3 and includes 7 wt% lecithin, sucrose (low intensity sweetener), polysorbate 80, menthol crystals (masking agent), cherry flavor, and an envisioned pharmaceutical agent (see example 1; Adjei et al. column 4 lines 62-63).
Johns et al. teach various forms of lecithin that are envisioned in a liquid food and they include de-oiled lecithin powder and liquid lecithin (see paragraphs 251-252). Their liquid lecithin includes 1% water; 37% triglycerides; 16% phosphatidylcholine; 13% phosphatidylethanolamine; 10% phosphatidylinositol; 5% phosphatidic acid; 2% minor phospholipids; 5% complexed sugars; and 11% glycolipids (see paragraph 254).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the vehicle of Rubinstein to provide the Kratom extract compounds of Chadeayne This choice would have been obvious as a particular vehicle that avoids first pass metabolism as Chadeayne desires. In addition, the Kratom extract compounds of Chadeayne fall into two categories of particular pharmaceutical compounds that Rubinstein envisioned to be provided by their vehicles, namely analgesics and phytochemicals. The selection of a vehicle formulation based on the example of Rubinstein where glycerin is also included and the proportion of lecithin is adjusted from the exemplified 7 wt% to another value within the taught range would have been obvious because Rubinstein suggests a range of alternate lecithin proportions and the presence of glycerin. The result is a value adjacent to the claimed proportions and range of proportions that embrace the claimed range which render the claimed range obvious. “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)…Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) ” (see MPEP 2144.05). It additionally would have been obvious to select liquid lecithin as the lecithin of Rubinstein as a known variety of lecithin to include in a liquid composition administered via the mouth in light of Johns et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield predictable outcome. Therefore claims 40 and 41 are obvious over Chaydeayne in view of Rubinstein and Johns et al. as evidenced by Adjei et al.
Claims 40 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Skiff et al. (US PGPub No. 2010/0136175) in view of Lee (US PGPub No. 2017/0247647), Kariman, Ramanathan, and Johns et al. as evidenced by Wang (US PGPub No. 2006/0051462), the Glycerol Safety Data Sheet (2014) and the Propylene Glycol Safety Data Sheet (2020).
Skiff et al. teach clear flavor emulsion concentrates for beverages and food that includes lecithin, sugar fatty acid ester surfactant, and a polyol (see abstract and paragraphs 8-12, 25, and 34). Envisioned polyols include sorbitol, glycerol, propylene glycol, mannitol, and xylitol (see paragraph 34). The lecithin may be present at 0.5 to 10 wt% and more preferably at 0.5 to 5 wt% (see paragraph 33). An example includes lecithin at 1.43 wt%, glycerol (sweetener) at 43.6 wt%, propylene glycol (sweetener) at 31.47 wt%, fatty acid ester surfactant at 17.75 wt%, lemon oil flavoring at 5.7 wt%, and vitamin E as the remainder (see table I sample H; Wang paragraph 68). In beverages, the composition is employed at 0.01 to 0.15 wt% (see paragaph 43). The presence of a taste masking agent and Kratom are not detailed.
Lee et al. teach clear flavor emulsion concentrates for beverages and food that includes lecithin, sugar fatty acid ester surfactant, and polyol (see abstract and paragraphs 5 and 9). They additionally detail the utility of the flavor emulsion as a carrier of active agents that include analgesics (see paragraph 22-23). They also teach the inclusion of taste masking agents as active agents to mask any unpleasant tase sensations (see paragraph 65-66). Additive (adjuvant) components are envisioned present at 0.01 to 25 wt% (see paragraph 96).
Kariman teaches liquid oral preparations of Kratom compounds that include emulsions (see abstract and paragraphs 83-84). The Kratom compounds are taught present in the form of Kratom plant extracts and the compositions may include sweetener and emulsifying agents (see paragraph 84). Within an envisioned drink, the Kratom compounds are detailed as present at about 60 mg in 355 ml (see paragraph 37). The Kratom compounds/extracts can be bitter (see Singh 42 second column third full paragraph)
Ramanathan et al. teach of the desire to formulate mitragynine, the poorly water soluble active found in Mitragyna speciose (Kratom), into a dosage form due to its anesthetic and analgesic properties (see page 4916-page 4917 first partial paragraph).
Johns et al. teach various forms of lecithin that are envisioned in a liquid food and they include de-oiled lecithin powder and liquid lecithin (see paragraphs 251-252). Their liquid lecithin includes 1% water; 37% triglycerides; 16% phosphatidylcholine; 13% phosphatidylethanolamine; 10% phosphatidylinositol; 5% phosphatidic acid; 2% minor phospholipids; 5% complexed sugars; and 11% glycolipids (see paragraph 254; instant claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the flavoring composition of Skiff et al. to provide active agents based on the teachings of Lee et al.. This modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. Thus the inclusion of a taste masking agent and analgesic would have been obvious. Ramanathan et al. detail the recognized utility of the Kratom compound mitragynine as an analgesic while Kariman teach its known inclusion in beverages as well as known bitterness. Thus the inclusion the mitragynine and a taste masking agent in the composition of Skiff et al. would have been obvious as the simple substitution of one known element for another in order to yield predictable result. Inclusion of the compounds within the proportion range Lee et al. suggest for additive components would then follow and provides a composition with greater than 40 wt% sweetener. It additionally would have been obvious to select liquid lecithin as the lecithin of Skiff et al. as a known variety of lecithin to include in a liquid composition administered via the mouth in light of Johns et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield predictable outcome. While Skiff et al. is silent in regard to the composition pH, the Propylene Glycol Safety Data Sheet states that propylene glycol has a pH of 7 and the Glycerol Safety Data Sheet states that glycerol has a pH of 5.5 to 8 ( (Propylene Glycol Safety Data Sheet page 3; Glycerol page 4). Given the proportion of propylene glycol and glycerol as well as their known pH levels, the modified composition of Skiff et al. would have a pH that is greater than 5. Further, it would have been obvious to add mannitol (sweetener), sorbitol (sweetener), or xylitol (sweetener) to the composition as polyols along with glycerol and propylene glycol of Skiff et al. as options they also envisioned. Their presence when dissolved in the glycerol and propylene glycol, would provide a range of pH values that would at least overlap with or be fully inside the claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 40 and 42-43 are obvious over Skiff et al. in view of Lee, Kariman, Ramanathan, and Johns et al. as evidenced by Wang, the Glycerol Safety Data Sheet and the Propylene Glycol Safety Data Sheet.
Response to Arguments
Applicant's arguments filed October 2, 2025 have been fully considered but they are not persuasive.
The applicant argues that Hewins et al. do not teach a composition with a pH greater than 5, but instead teach a concentrate where its dilution can have a pH up to 7. Hewins et al. teach both beverage/drink concentrates and the beverage/drink that occur due to dilution of the concentrate. If a dilution of the concentrate with water has a pH that ranges up to 7, Hewins et al. embraces adjusting the pH of the concentrate or dilution in whatever manner is necessary to yield this outcome. The steps necessary to adjust the pH of such composition are well known to the artisan of ordinary skill. The result is a set of compositions whose pH ranges overlap with the instantly claimed range. The concentrate of Hewins et al. has the claimed excipient components, thus its dilutions also have the claimed excipients
The applicant also argues that there would not have been an expectation of success for adding Kratom to the composition of Hewins et al because the active agents of Hewins et al. are flavors. To the contrary, Hewins et al. teach their formulation as a medicinal drink formulation which implicitly requires the presence of a medicinal active. Further, the hydrophobic active ingredient that teach being present is not limited to flavors with a particular log P, but instead includes these flavor as an option from which to select. The composition is clearly not limited to hydrophobic components, given the inclusion of water soluble components such as glycerin.
The applicant further argues that Kariman does not provide a reasonable expectation of success of including Kratom in the composition of Hewins. MPEP 2143.02 details that “[t]he reasonable expectation of success requirement refers to "the likelihood of success" in combining or modifying prior art disclosures to meet the limitations of the claimed invention. Here, the claim limitations only require a combination of components as a liquid having a pH in a particular range. Kariman describe beverages as vehicles of Kratom compounds which supports the expectation for the artisan of ordinary skill that one could make such a beverage. Hewins et al. teach a particular beverage vehicle that can have a pH that overlaps with the instantly claimed range. In combination, the teachings provide a reasonable expectation of success of making the claimed invention. The absence of discussion of a liquid form of lecithin in the composition of Hewins in light of Kariman, noted by the applicant, is addressed by Johns et al.
The applicant notes that Ramanathan comments on of the degradation of Kratom at pH values under 4 in support of their argument that it would not have been obvious to include it in the composition of Hewins. This argument is unpersuasive because Hewins et al. teach a pH range up to 7 for drink compositions they envision. Thus this pH sensitivity of Kratom would not direct away from its inclusion in the compositions of Hewins et al. since there are several values that accommodate its sensitivity in their taught range
The applicant also argues that Kratom is bitter and for this reason would have been illogical to include in the flavoring composition of Hewins et al. However, the presence of a component with recognized bitter flavor was contemplated by Hewins et al., as demonstrated by their example 6 which includes green tea powder. Oral compositions with green tea powder were known to address the recognized bitterness of green tea powder with various sweeteners and flavorings (see Aslani et al. Advanced Biomedical Research 2014 3(1):142-150(1-9), Table 1 and page 8 first column fifth full paragraph and second column first full paragraph). Hewins et al teach a number of sweeteners and flavors in their composition. Therefore the presence of bitterness would not have dissuaded the artisan of ordinary skill from including Kratom in the composition of Hewins et al.
The applicant further argues that aspartame, sodium saccharin, and acesulfame potassium cannot be considered taste masking agents based on Korey because Korey lists then as sweeteners that have taste masking effect. To the contrary, more than one adjective can be assigned to a single compound and the presence of one moniker does not negate the other. If a compound can taste mask, then it can be considered a taste masking agent. Korey explicitly state that aspartame, sodium saccharin, and acesulfame potassium can taste mask, therefore they are taste masking agents and fall within the scope of the broadest reasonable interpretation of this functional terminology employed the instant claims. In addition, Korey is not alone in categorizing these components as taste masking agents (see Ream et al. US PGPub No. 2001/0002998 claim 12 and Jimenez Redondo et al. EP 1452169 paragraph 22).
The applicant argues that the teachings of Johns et al. are general in regard to the utility of de-oiled (solid) liquid lecithin in food, while the applicant found liquid lecithin particularly well suited for masking off tastes from Kratom. It is not clear if this touted difference is significant and unexpected nor whether it occurs across the claim scope. A distinction between the performance of solid versus liquid lecithin could be an indicator of non-obviousness if the difference is significant, unexpected, and its occurrence is commensurate in scope with the claims.
The applicant notes that the teachings of Chen et al., Canessa et al., Bingley et al. and Jeppsen et al. do not teach Kratom in a liquid oral formulation. While this observation is correct, these teachings were relied upon to teach other aspects of the claimed invention. Thus the absence of Kratom in their discussions does not preclude them from supporting the rejection of the claimed Kratom containing composition as an addition to the teachings of Kariman and Ramanathan that discuss Kratom containing oral liquid compositions.
The applicant argues that the multiple references in the rejection that discuss Kratom compounds are insufficient to motivate the inclusion of Kratom compounds in any specific composition. To the contrary, Kariman explicitly sets forth the contemplation of the compounds in an oral liquid. They additionally detail a drink with about 0.2 mg/ml mitragynine (see paragraph 37). The applicant argues that an unexpected reduction in off flavors are attained by the claimed combination of excipient components mixed with Kratom; however, the claim scope and this outcome do not align. Instant table A1 indicates that the amount of mitragynine present in the Kratom has a considerable impact on the presence and intensity of off-flavors. The discussion is suggestive that a suspension at 4.5 mg/ml in a mixture of water and water soluble solvents may not have any off-flavor while a solution/transparent liquid preparation at a higher concentration in the same medium has several. The claims do not recite any particular concentration of Kratom or any particular compound it contains nor do they require that the composition be a solution or transparent, thus the occurrence and significance of an improvement in palatability is not seen across the current claim scope.
Conclusion
No claim is 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.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615