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 the Claims
Amendments to the Claims and Arguments/Remarks filed 26 September 2025, in response to the Office Correspondence dated 27 June 2025, are acknowledged.
The listing of Claims filed 26 September 2025, have been examined. Claims 1, 4, 7-10, and 13-19 remain pending. Claims 1, 4, 7, 8, 9, 13, 15, 17, and 18 are amended and new claim 19 has been added, which are supported by the originally-filed disclosure. Claims 5, 6, 11, and 12 are canceled.
Information Disclosure Statement
The Information Disclosure Statement (IDS), filed 02 July 2025, is acknowledged and has been considered.
Response to Amendment
The issue regarding the priority claim, as detailed in the previous Office Action, remains unresolved. The USPTO was unable to retrieve the certified copies for the foreign applications PCT/CN2022/077108, CN18172020, and CN2022077108 through electronic means and an English translation has not been provided. The Applicant must submit the required certified copies of the priority documents, or a suitable alternative as previously instructed, within two (2) months from the mailing date of the previous Office Action to avoid abandonment of the application. The Applicant's remarks did not address the priority document deficiency noted in the previous Office Action.
The Applicant has amended claims 1 and 15 to clarify that the active ingredient is “β-hydroxybutyric acid (BHB), a pharmaceutically acceptable salt of BHB, an ester of BHB, a liposome containing BHB, or a mixture thereof.” The amendment corrects the previously noted ambiguity and therefore, the objection to claims 1 and 15 is withdrawn. The Applicant has canceled claims 5 and 6. Therefore, the objection to claims 5 and 6 is moot.
Regarding the rejection of claims 1-4, 7-10, and 13-18 as being obvious under 35 U.S.C. § 103 over Millet in view of Kondo, the amendments to clarify “plant-based materials” and “suspending agent 5–35%” do not do not patentably distinguish them over the cited prior art and overcome the rejections as outlined below. The overlap between claimed ranges and the prior art remains. The Applicant's arguments regarding the non-obviousness of the amended claims are not persuasive and the rejections of the claims are maintained.
Regarding the rejection of claims 1, 2, 4, 9 and 14 as being obvious under 35 U.S.C. § 103 over Millet in view of Kondo and in further view of Catalent, the 35 U.S.C. § 103 rejection of claim 9 over Millet in view of Kondo eliminates the need to include the claim in a further rejection and therefore the rejection for claim 9 is withdrawn. Regarding the rejection of claims 1, 2, 4 and 14, in light of the amendments to the claims, the previous rejection is withdrawn and a new rejection under 35 U.S.C. § 103 as being unpatentable over Millet in view of Kondo and in further view of Catalent and Catalent Pharma Solutions has been issued to address the newly introduced claim limitations as detailed below.
Furthermore, the introduction of new claim 19 necessitates a new ground of rejection. The claim has been rejected under 35 U.S.C. § 103 as being unpatentable over Millet in view of Kondo as evidence by NutraPak USA as outlined below.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 27 June 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AlIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-3, 7-10, 13, 15-18 are rejected under 35 U.S.C. § 103 as being unpatentable over Millet (US10736861B2; publication date 08 November 2020) in view of Kondo (US20180214384A1; publication date: 02 August 2018).
Regarding instant claim 1, Millet teaches the use of beta-hydroxybutyrate mixed salt composition in solid or powder form comprising: sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, and magnesium beta-hydroxybutyrate (claim 1), wherein “In a preferred embodiment, a ketogenic composition is administered via oral administration of the composition in a solid and/or powdered form, such as in a powdered mixture (e.g., powder filled capsules), hard-pressed tablets, or other oral administration route known to those skilled in the art.” (page 8, column 12, lines 29-35). Further, Millet teaches, “The foregoing compounds [beta-hydroxybutyric acids, beta-hydroxybutyrate salts, or beta-hydroxybutyrate esters] can be in any desired physical form, such as crystalline, powder, solid, liquid, solution, suspension, or gel.” (page 4, column 4, lines 54-56) and wherein 1-50 g [1000-50,000 mg] unit dose of mixed beta-hydroxybutyrate compounds is placed in a container for administration to a subject (claim 18; see also ¶[0073] wherein a single dose is from about 1-50 grams that can be administered together with other additives and ¶[0031] wherein the unit dose may be configured to provide a full unit dose or fraction thereof, e.g., 1/2, 1/3, or 1/4 of a unit dose [250-25,000 mg; 250-2500 mg is within the range of instant claim 14]), the beta-hydroxybutyrate mixed acid-salt composition may comprise a pharmaceutically acceptable carrier selected as a capsule (claim 17) and various flow agents, in types and amounts that are safe for consumption, may be included (¶[0072]).
In Example 12, medium chain fatty acids may be mixed with any beta-hydroxybutyrate mixed salt-acid compositions (thereby suspending the solid or powder in the medium chain fatty acid, or triglyceride of the medium chain fatty acid) (¶[0091]). Evidentiary reference Naharros-Molinero et al. (Naharros-Molinero et al.,Shell Formulation in Soft Gelatin Capsules: Design and Characterization. Adv Healthc Mater. 2024 Jan;13(1):e2302250; electronically published 2023 Oct 18, page 7, section 3.2, paragraph 2 within the section), describes the use of MCT as a common fill suspending agent to create a lipophilic suspension, wherein if a hydrophilic suspension is desired PEG 400 and glycerin are commonly used- one would be motivated to change the suspending agent for a beta-hydroxybutyrate or mixed salt-acid formulation from MCT oil to glycerin, PEG 400, or sorbitol, when using a plant-based soft shell capsule for compatibility, stability, and processing advantages as wherein plant-based capsules can be more sensitive to moisture content and glycerin and sorbitol humectants aid in managing water activity within the shell, preventing it from becoming too brittle or too soft- they can ensure flexibility of the capsule by providing plasticizing effects that MCT oil does not provide and reduce oxygen permeability to improve stability and shelf-life. Glycerin and PEG 400 use can improve the uniformity of the suspension over MCT oil and improve flow during the manufacturing process. One of skill in the art would reasonably substitute these suspending agents for MCT oil to ensure better physical and chemical stability of the product, address specific compatibility issues with the non-gelatin shell, and optimize the manufacturing process for consistency and quality with a high likelihood of success in doing so.
However, Millet does not explicitly teach the composition of outer soft capsules or the use of fill suspending agent as glycerin, polyethylene glycol 400 or sorbitol at 5-35% of the total weight of the capsule.
Kondo teaches “a composition for a soft capsule shell comprising a base containing either gelatin or a mixture of starch and carrageenan as a main component and a plasticizer containing sorbitol, maltitol and glycerin as main components…” (Abstract), wherein a starch in the soft capsule formulation can be selected from one or more starches of oxidized starch, starch dispersion, moist heat-treated starch and acid treated starch (claim 7) or processed starch described in the specification as, “such as starches obtained by subjecting these starches to any one of various processing such as physical or chemical processing or the combination of two or more thereof” (¶[0029]; such has hydrolysis to form a starch hydrolysate). Kondo also further defines acid treated starch as, “The acid treated starch is starch obtained by treating starch with an acid. Examples of the acid include inorganic acid or organic acid such as sulfuric acid, hydrochloric acid, phosphoric acid and acetic acid.” (¶[0033]), wherein cleavage of the starch molecules by acid is a chemical form of hydrolysis. In fact, in the Examples provided by Kondo disclose the use of D-sorbitol (manufactured by Mitsubishi Shoji Foodtech Co., Ltd.) (¶[0085]), maltitol “LESYS” (manufactured by MC-Towa International Sweeteners. Co., Ltd.) (¶[0086]) and reduced starch syrup (manufactured by B Food Science Co., Ltd.) (¶[0087]) in the capsule shell formulation, which are starch hydrosylates produced by hydrogenation.
Nevertheless, a person skilled in the art at the time of the invention would recognize the well-known plant-based material colloids like mannan gum, xanthan gum, alginate as suitable alternatives to the specific use of carrageenan. One would be motivated to substitute a mixture of starch and carrageenan in the soft capsule shells taught by Kondo for a plant-based starch hydrolysates or colloids like mannan gum, xanthan gum, alginate, or a mixture thereof when encapsulating B-hydroxybutyric acid- based active ingredients due to processing advantages (e.g., more consistent batch-to-batch processing compared to some starch/carrageenan blends), enhanced physical stability/improved release profile control (e.g., other plant-based hydrocolloids may provide superior resilience to moisture migration or degradation under a wider range of temperature conditions or offer better compatibility and acid resistance to an acidic B-hydroxybutyric acid fill than standard starch/carrageenan blends, preventing the shell from premature disintegration), or consumer preference for carrageenan-free products. Substituting one know plant-based colloid used in the art for another to optimize the formulation does not confer patentable weight in the absence of evidence of criticality or unexpected results.
In fact, half of the example embodiments provided in the specification for the instant invention do not use an outer shell comprising a plant-based material selected from a starch hydrolysate or colloid of mannan gum, xanthan gum, alginate, or a mixture thereof, indicating that this limitation is not required for the invention. Examples 1-4 of the instant invention recite that the outer shell comprises gelatin rather than a plant-based material. Examples 5-8 of the instant invention recite that the outer shell comprises a plant-based material but fail to specify the plant-based material specifically as a starch hydrolysate or colloid of mannan gum, xanthan gum, alginate, or a mixture thereof, indicating a lack of criticality in specifically using a starch hydrolysate or colloids recited in the instant claims as the plant-base material. Further, the instant specification teaches the acceptable use of gelatin, oxidized starch, starch dispersion, starch derivatives, starch hydrolysate, wet heat-treated starch, acid-treated starch, or a mixture thereof and colloids selected from carrageenan, mannan gum (locust bean gum, konjac gum, or guar gum), xanthan gum, sodium alginate, or a mixture thereof for embodiments of the invention (¶[0014] and [0015]).
Kondo also teaches, “Examples of a moisturizing agent which can be contained in the capsule fill include glycerin, propylene glycol, 1,3-butylene glycol, polyethylene glycol, caprylic/capric triglycerides, glycolic acid (a-hydroxy acid), hyaluronic acid or its salts, chondroitin sulfate or its salts, water-soluble chitin or its derivatives or a chitosan derivative, pyrrolidone carboxylic acid or its salts, sodium lactate, urea, sorbitol…” (¶[0070]), glycerin and sorbitol excipients can also function as indirect suspension agents and polyethylene glycol functions as both a humectant and suspending agent.
Kondo also teaches, “The soft capsule formulation according to the present invention can find a wide variety of uses such as a pharmaceutical, a quasi-drug, a cosmetic, a food or the like. The composition of the capsule fill is appropriately determined depending on its use. The capsule fill may be in the form of any of solution, suspension, paste, a powder, granule or the like, and is preferably in the form of solution, suspension or paste.” (¶[0049]).
In the Examples, the total shell parts by mass range from 144.9-180 parts (pages 7-8, Table 1), representing the proportional mass of one unfilled dry shell capsule. With a scaling factor of approximately 0.403 mg per part the calculated shell weights before fill would be approximately 60-73 mg for the working examples of oval 5 soft capsules, more specifically, 64.5 mg and 62.5 mg, respectively, for Examples 1 and 2 with a corresponding total fill mass of 280 mg (pages 8-9, Table 2), yielding a total capsule mass of 344.5 mg and 342.5 mg, respectively, for Examples 1 and 2. Beeswax, glycerin fatty acid ester and Japanese basil oil were used as a fill material suspending agent (¶[0090]) in Examples 1 and 2 totaling 112.5 mg (pages 8-9, Table 2), thus yielding a 32.7% and 32.8% total suspending agent fill material mass relative to the total capsule mass, respectively, both encompassed within the instant claimed range.
One skilled in the art would recognize that the moisturizing fill excipient agents taught by Kondo including glycerin, polyethylene glycol, and sorbitol (¶[0070]), can also function as suspension agents and be used as such as a substitute for the beeswax, glycerin fatty acid ester, and Japanese basil oil use in the embodiment of the invention examples of Table 1 and 2. Motivations to substitute the well-known and commonly used suspending agents in the art, PEG 400, glycerin, or sorbitol for beeswax, glycerin fatty acid ester, and Japanese basil oil include the potential for enhanced drug solubility, dispersion and a different release profile (e.g., PEG 400 can improve solubility, dispersion, and faster gastrointestinal transit resulting in faster and improved absorption), or provide different physical properties like moisture content (e.g., glycerin and sorbitol are suitable hygroscopic excipients) and viscosity (e.g., PEG 400, glycerin, and sorbitol offer a range of viscosities that can be used to adjust the fill consistency and flow properties) for the B-hydroxybutyric acid-based active ingredient. These alternatives may be chosen over the beeswax, glycerin fatty acid ester, and Japanese basil oil to prevent any potential interactions between the example embodiment suspending agents and the B-hydroxybutyric acid-based active ingredient that alter stability or release of the active ingredient. The alternative PEG 400, glycerin, and sorbitol suspending agents may also be chosen for cost, manufacturing efficiency, or to optimize the function of the capsule in some other way.
One skilled in the art would also know that the suspending agent concentration in a formulation is determined by the active ingredient characteristics and would consider it routine to adjust the concentration to ensure homogeneity of the suspension, optimal viscosity for the fill machine without causing sedimentation and required stability. Determining the optimal suspending agent and the amount of a suspending agent to achieve a stable suspension is a routine and predictable formulation step for one skilled in the art that does not require undue experimentation. The instant application does not provide any data or technical reasoning demonstrating that suspending agents within 5-35% yield results unexpected relative to the formulations disclosed in the prior art. In fact, the instant specification example embodiments as Examples 2, 6 and 8 fail to use a 5-35% suspending agent, indicating that the suspending agent is not required for the invention, much less at the specified concentration of 5-35%.
Kondo also teaches wherein the listed plasticizer glycerin, which also serves as a humectant (¶[0003]), or glycerin in combination with sorbitol are often used in a shell of a soft capsule formulation (¶[0003]-[0004]), however to the prevent precipitation as a crystal of sorbitol during drying conditions, a blend of sorbitol and sorbitan), maltitol with or without glycerin (gelatin-based or carrageenan-based, respectively) is preferable (¶[0006]). The instant claims do not expressly prohibit the addition of sorbitan to the outer shell humectant/plasticizer. The soft capsule outer shell is prepared by dispersing either gelatin or a mixture of starch and plant-based colloid (carrageenan), sorbitol, maltitol and glycerin in water (¶[0044]). Kondo teaches, “The composition for a soft capsule shell according to the present invention may further comprise water and any additive in addition to the above-described base and plasticizer.” (¶[0026]), wherein, “An appropriate amount of water (water to be charged) was provided, and glycerin, sorbitol, maltitol and reduced starch syrup in the amount (parts by mass).” (¶[0088]).
Kondo outlines the process of preparing active ingredients to form a fill composition, preparing and formulating an outer shell using a plant-based material, encapsulating the fill material into the outer shell, shaping, drying (¶[0044]-[0050] and [0088]-[0092], quality inspection tests (i.e., softness, appearance, impact resistance; ¶[0093]-[0094], [0098]), packaging and storage (¶[0075] and [0098]). Kondo describes mixing the active ingredient for the capsule fill with suspending agents heating them to about 70° C, cooling with stirring to 30° C to obtain a homogenously mixed viscous liquid (¶[0090]). These temperatures encompass the 35-60° C range of instant claim 17 for the active ingredient. Further, Kondo teaches mixing the plant-based material with a humectant and water together to form the outer shell liquid, stirring and heated to 60-98° C (encompassed within the 50-100° C range of instant claim 18), vacuum degassed, wherein degassing is a form of filtration to remove air bubbles (¶[0088]-[0089]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the active ingredient taught by Miller using a standard suspension agent within the art with the soft capsule taught by Kondo to obtain predictable results. One would be motivated to do so to improve palatability, enhance stability during storage, and provide a commercially desirable aesthetic appearance (see Kondo, ¶[0100]).
New Rejections
The following new rejections are made from the previous Office Correspondence dated 27 June 2025, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AlIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1, 2, 4 and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Millet (US10736861B2; publication date 08 November 2020) in view of Kondo (US20180214384A1; publication date: 02 August 2018), in further view of Catalent (RP Scherer Softgel; publication date 2016) and Catalent Pharma Solutions (Catalent AAPS 09 FL-handout, Gelatin-Free Softgel Studies by Stroud et al.; published January of 2011).
Millet in view of Kondo teaches the limitations of instant claims 1 and 2, as described above, from which instant claim 4 or 14 depend, however do not teach specific limitations of instant claim 4 and 14.
Millet teaches, “The amount of the composition to be administered can vary according to factors such as the degree of susceptibility of the individual, the age, sex, and weight of the individual, idiosyncratic responses of the individual, and the like. The “therapeutically effective amount” is that amount necessary to promote a therapeutically effective result in vivo (i.e., therapeutic ketosis). In accordance with the present disclosure, a suitable single dose size is a dose that is capable of preventing or alleviating (reducing or eliminating) a symptom in a patient when administered one or more times over a suitable time period. The amount of composition administered will depend on potency, absorption, distribution, metabolism, and excretion rates of the BHB salts and/or corresponding electrolytes, the method of administration, and the particular disorder being treated, as well as other factors known to those of skill in the art. The dose should be sufficient to affect a desirable response, such as a therapeutic or prophylactic response against a particular disorder or condition, taking into account the severity of the condition to be alleviated. The compounds may be administered once, or may be divided and administered over intervals of time. It is to be understood that administration may be adjusted according to individual need and professional judgment of a person administrating or supervising the administration of the compositions.” (page 8, column 12, line 36- page 9, column 13, line 3).
Millet teaches, “The foregoing compounds [beta-hydroxybutyric acids, beta-hydroxybutyrate salts, or beta-hydroxybutyrate esters] can be in any desired physical form, such as crystalline, powder, solid, liquid, solution, suspension, or gel.” (page 4, column 4, lines 54-56) and wherein 1-50 g [1000-50,000 mg] unit dose of mixed beta-hydroxybutyrate compounds is placed in a container for administration to a subject (claim 18; see also ¶[0073] wherein a single dose is from about 1-50 grams that can be administered together with other additives and ¶[0031] wherein the unit dose may be configured to provide a full unit dose or fraction thereof, e.g., 1/2, 1/3, or 1/4 of a unit dose [250-25,000 mg; 250-2500 mg is within the range of instant claim 14]), the beta-hydroxybutyrate mixed acid-salt composition may comprise a pharmaceutically acceptable carrier selected as a capsule (claim 17) and various flow agents, in types and amounts that are safe for consumption, may be included (¶[0072]).
In Example 12, medium chain fatty acids may be mixed with any beta-hydroxybutyrate mixed salt-acid compositions (thereby suspending the solid or powder in the medium chain fatty acid, or triglyceride of the medium chain fatty acid) at a ratio of 4:1, 3:1, 2:1, 1 :1 or 1:2 (¶[0091]; wherein 250-50,000 mg beta-hydroxybutyrate mixed salt-acid composition is used configured as a full or fractional dose the amount of suspending agent at the provided ratio range would be 125-200,000 mg and thus a soft capsule containing the mixture would need to accommodate a total fill capacity of 375-250,000 mg. As discussed above for instant claim 1, it would be obvious to substitute the common suspending agent’s glycerin, PEG 400 or sorbitol for that of the medium chain fatty acid oil taught by Millet.
The Catalent reference teaches standard 7.5-30 oval, 8-22 oblong or 7-40 round soft-shell capsules have a maximum fill capacity ranging from 1355-2526 mg, therefore a range of 375-2526 mg is practical for standard capsule sizes in the art (375-2500 mg overlaps with the 80-2500 mg range of instant claim 14). A further reference from Catalent Pharma Solutions provides evidence that a typical loading of these type of soft-shell capsules using a hydrophilic vehicle fill preparation (e.g., active ingredient such as beta-hydroxybutyrate or a mixed salt-acid compositions suspended in glycerin, PEG 400 or sorbitol) is 35-45% w/w of the total capsule weight and 45-50% w/w for fill formulations having hydrophilic and lipophilic characteristics (e.g., active ingredient such as beta-hydroxybutyrate or a mixed salt-acid compositions suspended in MCT oil) (Fill Formulation Development section following Table 2). Thus, the total capsule weight range for a fill formulation using hydrophilic vehicles like PEG 400 or glycerin would then be approximately 870-7220 mg and approximately 750-5610 mg when using MCT oil as a suspending agent- 870-3750 mg overlaps with the 120-3750 mg range of instant claim 14 and the percentage active ingredient relative to the total capsule weight would then be approximately 3.5-28.7% using hydrophilic vehicles like PEG 400 or glycerin or approximately 4.5-33.3% using MCT oil vehicle, wherein 20-33.3% active ingredient weight relative to the total capsule weight in within the 20-80% weight range limitation of instant claim 4.
The disclosure by Catalent Pharma Solutions describes the plant-based starch and colloid (iota-carrageenan) having a total 40-49% w/w weight of the dry unfilled shell (Experimental Studies, Capsule Shell Development, Table 1), the plasticizer/humectant a 36-42% w/w weight of the dry unfilled shell and water a 10-12% w/w weight of the dry unfilled shell. Given a fill loading percentage of 35-45% w/w of the total capsule for a hydrophilic vehicle such as PEG 400 or glycerin, the shell weight is then 55-65% of the total capsule weight. As such, the total plant-based material starch and colloid weight is 22-31.9% based on the total weight of the capsule, squarely falling within the 10-40% range of instant claim 4. The plasticizer/humectant is 19.8-27.3% based on the total weight of the capsule, overlapping with the 2-20% range of instant claim 4. The water is 5.5-7.8% based on the total weight of the capsule, squarely falling within the 2-20% range of instant claim 4.
All the ranges of instant claims 4 and 14 are encompassed values that are close to the numbers one could calculate from the prior art. Wherein, overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection (In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941), particularly when there was no showing of criticality of the claimed range. More so, a person of ordinary skill in the art would understand that optimum and workable ranges are a matter of routine formulation and claimed ratios are obvious as being reached by routine procedures producing predictable results in the art (see In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the active ingredient taught by Miller in view of standard fill capsules and standard capsule weight ratios from the Catalent and Catalent Pharma Solutions references with the soft capsule taught by Kondo to arrive at the instant invention by routine experimental optimization of the workable ranges of ingredients, routine in the art of capsule formulation, to obtain predictable results. One would be motivated to do so to improve palatability, enhance stability during storage, and provide a commercially desirable aesthetic appearance (see Kondo, ¶[0100]).
Claim 19 is rejected under 35 U.S.C. § 103 as being unpatentable over Millet (US10736861B2; publication date 08 November 2020) in view of Kondo (US20180214384A1; publication date: 02 August 2018), as evidence by NutraPak USA (https://nutrapakusa.com/4-benefits-of-softgel-capsules/; published 11 May 2022, accessed 07 November 2025).
Millet teaches beta-hydroxybutyrate mixed salt composition in solid or powder form comprising: sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, and magnesium beta-hydroxybutyrate (claim 1), wherein “In a preferred embodiment, a ketogenic composition is administered via oral administration of the composition in a solid and/or powdered form, such as in a powdered mixture (e.g., powder filled capsules), hard-pressed tablets, or other oral administration route known to those skilled in the art.” (page 8, column 12, lines 29-35). Further, Millet teaches, “The foregoing compounds [beta-hydroxybutyric acids, beta-hydroxybutyrate salts, or beta-hydroxybutyrate esters] can be in any desired physical form, such as crystalline, powder, solid, liquid, solution, suspension, or gel.” (page 4, column 4, lines 54-56).
Millet does not explicitly teach using the beta-hydroxybutyrate fill composition with preparing and formulating an outer shell using gelatin or a plant-based material and encapsulating the fill material into the outer shell as a method to mask the taste of the fill material.
Kondo teaches “a composition for a soft capsule shell comprising a base containing either gelatin or a mixture of starch and carrageenan as a main component and a plasticizer containing sorbitol, maltitol and glycerin as main components…” (Abstract). Kondo outlines the process of preparing active ingredients to form a fill composition, preparing and formulating an outer shell using a plant-based material, encapsulating the fill material into the outer shell, shaping, drying (¶[0044]-[0050] and [0088]-[0092], quality inspection tests (i.e., softness, appearance, impact resistance; ¶[0093]-[0094], [0098]), packaging and storage (¶[0075] and [0098]). NutraPak USA provides evidence that it was known in the art at the time of the invention that the use of soft-shell/softgel capsules (e.g., as those taught by Kondo) imparts the benefit of “mostly cover any unpleasant tastes and odors that may be present” and are used in the art to mask unwanted flavors (page 2, point number 3).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine the active ingredient taught by Miller with the soft capsule taught by Kondo, having the known benefit of imparting taste masking of unpleasant fill material tastes, to obtain predictable expected results. It is well-established that soft capsule encapsulation inherently masks or reduces the taste of the fill composition by physically isolating it from oral contact. The method of masking a taste by encapsulating a material with a known unpleasant taste is a conventional and obvious application of encapsulation technology. One would be motivated to do so to improve palatability, enhance stability during storage, and provide a commercially desirable aesthetic appearance (see Kondo, ¶[0100]).
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 26 September 2025, have been fully considered.
The priority claim remains unverified pending submission of the required certified documents or a statement clarifying that this application is the first filing in a Paris Convention country, as discussed above.
The Applicant traverses the rejections of claims 1-4, 7-10, and 13-18 over Millet in view of Kondo, and the rejection of claims 1, 2, 4 and 14 over Millet in view of Kondo and Catalent. The Applicant asserts that the cited references do not teach or suggest the use of “starch hydrolysate or a colloid selected from mannan gum, xanthan gum, alginate, or mixtures thereof,” for forming the capsule shell and a suspending agent present at “5–35% of total capsule weight” fill material. The Applicant's arguments are not persuasive.
While Kondo explicitly teaches "a mixture of starch and carrageenan" (a colloid) as a plant-based shell material, the Examiner acknowledges that Kondo does not expressly list the specific colloids now claimed. Kondo discloses the use of starch hydrolysates in the invention as described above in the rejection and plant-derived polysaccharides, including mixtures of starch with carrageenan, wherein mannan gum, xanthan gum, and alginate are all recognized, well-known, commercially available alternative hydrocolloids used in the art of soft capsule formulation as gelling agents, thickeners, and stabilizers, functionally equivalent to carrageenan. The selection of a particular colloid (e.g., xanthan or mannan gum) from among known hydrocolloids in the art would have been an obvious substitution of one known equivalent for another with predictable results (see MPEP § 2144.06; In re Fout, 675 F.2d 297 (CCPA 1982)). No evidence of unexpected results or criticality has been provided for these specific plant-derived polysaccharides. It would have been prima facie obvious to a person of ordinary skill in the art to substitute one known, functionally equivalent plant-based gelling agent (carrageenan) for another (e.g., alginate, xanthan gum) to achieve the same result of forming a stable softgel shell, based on factors like cost, availability, or desired release profile (see In re Leshin, 277 F.2d 197, 200 (CCPA 1960); substitution of one known element for another is prima facie obvious).
Regarding the use of a suspending agent comprising 5–35% of the total capsule weight, the claimed range of 5–35% overlaps with or is immediately adjacent to the range taught or calculated from the prior art as outlined in the claim rejection above. As established in In re Peterson, 315 F.3d 1325, 65 USPQ2d 1379 (Fed. Cir. 2003) and In re Aller, 220 F.2d 454, 105 USPQ 233 (CCPA 1955), overlapping or close ranges are prima facie obvious absent a showing of criticality or unexpected results. In addition, determining the optimal amount of a suspending agent to achieve a stable suspension is a routine and predictable formulation step for one skilled in the art that does not require undue experimentation. The Applicant has not provided any data or technical reasoning demonstrating that suspending agents within 5-35% yield results unexpected results. Accordingly, the limitation does not confer patentable distinction.
The Applicant argues that the prior art, specifically Catalent, teaches a suspending agent mass percentage of only 3.1-4%, which is outside the claimed range of 5-35%. However, the previous rejection established that the mass percentages of the capsule components, including the suspending agent, are the result of routine optimization. A person of skill in the art would understand that a higher concentration of suspending agent might be required for different active ingredients (like BHB salts) with different physical properties (e.g., particle size, density) to prevent settling. Increasing the amount of a known suspending agent to ensure a homogenous suspension is an obvious, routine step in formulation science (see In re Aller, 220 F.2d 454, 456 (CCPA 1955)). Therefore, the rejection of claims 1-4, 7-10, 13-18 under 35 U.S.C. § 103 as being unpatentable over Millet in view of Kondo is maintained.
The rejection of claims 1, 2, 4, 9, and 14 under 35 U.S.C. § 103 as being unpatentable over Millet in view of Kondo and further in view of Catalent have been withdrawn to address the new limitations of the amended claims. Claim 9 has be addressed in the 35 U.S.C. § 103 rejection over Millet and Kondo and does not require further rejection. A new rejection of claims 1, 2, 4, and 14 under 35 U.S.C. § 103 as being unpatentable over Millet in view of Kondo and further in view of Catalent and Catalent Pharma Solutions has been issued.
The new claim 19 has been added. The Applicant argues that neither Millet nor Kondo explicitly describe “taste masking” as an objective. The Examiner maintains that a key purpose of an encapsulating shell, whether gelatin or plant-based, is to separate the fill material from the oral cavity, thereby masking taste. It is well-established that soft capsule encapsulation inherently masks or reduces the taste of the fill composition by physically isolating it from oral contact (see evidentiary reference NutraPak USA). Therefore, the claimed “method of masking taste” is viewed as an inherent property of the known encapsulation process and would have been obvious and predictable to one skilled in the art (see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977)). As such the new claim 19 has been rejected under 35 U.S.C. § 103 as being unpatentable over Millet in view of Kondo, as evidence by NutraPak USA outlined above.
In summary, Applicant’s amendments to clarify claim language and to narrow certain compositional ranges have been fully considered but do not overcome the prima facie case of obviousness. No evidence of unexpected results or criticality for the newly introduced limitations has been provided. Each claim element is expressly, inherently taught or would have been obvious to one of ordinary skill in the art from the combined teachings of Millet, Kondo, Catalent and Catalent Pharma Solutions. All claims are rejected under 35 U.S.C. § 103.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (87 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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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