DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9 March 2026, has been entered.
Response to Amendments
Status of Claims
The amendment, filed on 9 March 2026, is acknowledged.
Claim 1 has been amended.
Claims 10-12 were previously withdrawn as being drawn to a nonelected invention in the Office Action mailed on 9 July 2025.
Claims 1-9 and 16-26 are pending and under consideration in the instant Office Action, to the extent of the following previously elected species:
the first gelling agent gellan gum C;
the second gelling agent pectin;
the plasticizer glycerol;
the gelatinizable starch hydroxypropyl starch;
the granular starch hydroxypropyl distarch phosphate; and
the soft capsule filling vegetable fat.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejection of claim 1 under 35 U.S.C. § 112 is withdrawn in view of Applicant’s amendment to the claim.
Rejections pursuant to 35 U.S.C. § 103
The rejections of claims 1-9 and 16-26 under 35 U.S.C. § 103 are withdrawn in view of Applicant’s amendment to claim 1 and made anew below.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 16-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 1 was amended to recite “the starch capsule shell has a granule”. Applicant argues in the para. that spans the bottom of pg. 10 and top of pg. 11 of the remarks filed on 9 March 2026, that “a granule” as recited in amended claim 1 does not refer to the gelatinizable starch or granular starch but “may contain the gelling agent, gelatinizable starch, and granular starch that sediment during centrifugation”. Applicant points to pg. 10 of the spec. for support, but the only mention of granules on the pg. 10 are referring to starch granules (e.g., para. 1 of the Examples discloses “the starch granules in the soft capsule shell, the following methods are used to measure the size and content of the granule”). There is no definition of a granule provided in the instant spec. and no other support for Applicant’s argued definition of “a granule” being the gelling agent, gelatinizable starch, and granular starch can be found, therefore the claim is rejected for introducing new matter. Claims 2-9 and 16-26 depend from claim 1, incorporate all of its limitations, and are therefore also rejected.
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.
Claims 1-9 and 16-26 are 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.
Instant claim 1 was amended to recite “the starch capsule shell has a granule”. The meaning of “a granule” is unclear from the original disclosure because a definition is not provided and each instance the word “granule” is recited in the instant spec. appears to refer to a starch granule, yet Applicant argues in the para. that spans the bottom of pg. 10 and top of pg. 11 of the remarks filed on 9 March 2026, that “a granule” as recited in amended claim 1 does not refer to the granular starch, rendering the term unclear.
The amendment to claim 1 also recites “the granule” (e.g., lines 17-18 and 25), “the granular starch” (line 22), and “starch granule” (line 24). The recited “starch granule” does not have antecedent basis in the claim, further rendering the claim indefinite.
Claim 1 was also amended to recite the broad recitation of the granule being present in an amount from 9-40% w/w. Using the definition provided by the Applicant in the para. that spans the bottom of pg. 10 and top of pg. 11 of the remarks filed on 9 March 2026, that “a granule” refers to the gelatinizable starch, granular starch, and gelling agent, 9-40% w/w changes the recited range of components as compared to the earlier recited 2-5% w/w first gelling agent, 18-35% w/w gelatinizable starch, and 4-17% w/w granular starch. Using the ranges recited in lines 2-3 of claim 1, the components must comprise at least 24% w/w of the soft capsule shell and may comprise up to 57% w/w of the soft capsule shell. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by the narrower language is merely exemplary of the remainder of the claim, and therefore not required, or a required feature of the claims, which would conflict with the earlier recited ranges. Claims 2-9 and 16-26 depend from claim 1, incorporate all of its limitations, and do not resolve the issues of indefiniteness, so they are therefore also rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9, and 16-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hunan Er-Kang Pharmaceutical Co Ltd. (Chinese Patent Application Publication No. CN 104721167 A, published on 24 June 2015, provided by Applicant in IDS, references to English translation, hereafter referred to as Hunan Er-Kang) in view of Matsutani Chemical Industry Co., Ltd. (Jpn. Pharmacol. Ther. 2010, 38, 371., hereafter referred to as Matsutani), Dhital et al. (Carbohydr. Polym. 2010, 82, 480., hereafter referred to as Dhital), and Clark et al. (WIPO International Patent Application Publication No. WO 00/31146, published on 2 June 2000, hereafter referred to as Clark).
NOTE: For the purpose of examination, the “granule” recited in instant claim 1 is interpreted as referring to the granular starch because lines 22 and 24 refer to granular starch and a starch granule.
Hunan Er-Kang teaches starch soft capsules comprising starch, a plasticizer, vegetable gelatine, and water for use in the industries of medicine, health products, and foods (Abstract). The object of the invention of Hunan Er-Kang is to provide starch soft capsules that replace animal gelatin with non-animal-derived components to avoid issues related to religious beliefs of users, allergies, non-renewability, and shelf stability (pg. 1, final para. - pg. 2, para. 4). The starch is taught to be present in the soft capsule exterior in the amount of 20-95 parts, in addition to 5-55 parts plasticizer, 1-10 parts plant gum, and 30-90 parts deionized water (pg. 2, para. 5). Taken together, this results in the capsule shell-forming composition comprising ~11.4-72.5% starch, 2.5-51.9% plasticizer, 0.41-15.4% plant gum, and 15.8-77.6% water, significantly overlapping with the ranges recited in instant claim 1. The ratio of gellan gum to total starch in the above para. is 0.01-0.5, which encompasses the ratio recited in instant claim 22. Hunan Er-Kang further teaches the starch in the composition to comprise both modified starch at 10-125 parts and common starch at 1-35 parts, resulting in a starch mixture that is 22.2-99.2% modified starch and 0.8-77.8% common starch (pg. 2, para. 5).
In some embodiments of the invention, the modified starch may be hydroxypropyl starch (pg. 2, para. 7 and Embodiments 1-2, 4-5, and 7-8). The common starch is taught to derive from rice, starch, tapioca, sweet potatoes, or wheat (pg. 2, para. 8) and in some embodiments the plasticizer is glycerol (pg. 2, para. 9 and Embodiments 2-4, 7-8, and 14). The plant gum is in some embodiments pectin and/or gellan gum (pg. 2, para. 11 and claim 6). In Embodiment 11, a composition is taught that comprises 4 parts gellan gum and 4 parts pectin as gelling agents in 233 parts total, resulting in ~2% of each gelling agent in the composition.
Guidelines on the obviousness of similar and overlapping ranges, amounts, and proportions are provided in MPEP § 2144.05. With respect to claimed ranges which “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 the above decisions, “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.” With respect to ranges or amounts that do not overlap but are merely close, courts held that a prima facie case of obviousness also exists. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).These guidelines apply to the ranges of mass percentage of the plasticizer, starch, and gelling agents – in each case, the range taught by Hunan Er-Kang either overlaps with, encompasses, or are approximately equal to the range recited in the instant claims.
Hunan Er-Kang does not teach a composition comprising hydroxypropyl distarch phosphate, the size of starch granules, nor the weight-average molecular weight of the gellan gum used. These deficiencies are offset by the teachings of Matsutani, Dhital, and Clark.
Matsutani teaches the glycemic response in humans to ingesting cross-linked starch phosphate (XLS) and hydroxypropyl distarch phosphate (HDP) as compared to unmodified tapioca starch (TS) and microcrystalline cellulose (MCC) (Abstract). The impact of diet on glycemic control is taught to important, particularly in humans with diabetes mellitus, a “major problem pertinent to healthcare in the developed countries” (pg. 731, Introduction, para. 1). Cross-linked starch phosphate is taught to be advantageous in foods designed for patients with diabetes mellitus due to its resistance to digestion with a-amylases, leading to attenuated blood glucose levels following digestion (pg. 731-732, Introduction, para. 2). Matsutani teaches that food containing HDP that was fed to rat subjects resulted in a flattened glucose response curve as compared to food with TS, leading to the conclusion that HDP elicits a lower blood glucose response in vivo as compared to unmodified starches (pg. 735, para. 1-4).
Dhital teaches the relationship between potato and maize starch granule size and in vitro digestibility (Abstract). Starch granules in nature are taught to have sizes varying from 1-100 mm, and the enzymatic hydrolysis of starches during digestion is impacted by the size (pg. 480, para. 1). Utilizing size separation techniques and a model for in vitro digestion, Dhital investigated the relationship between the size of starch granules and the rate of digestion, and found an inverse correlation between the two parameters (pg. 481-482, 2. Experimental and Table 1). Starches ranging from 9-67.5 mm were studied, with >70% of maize starch being 13-16 mm and having an average of 13.6 mm, and >90% of potato starch being 16-50 mm and having an average of 30.5 mm (Table 1). Dhital concluded from these experiments that the digestibility data is “well fitted by an inverse square relationship between digestibility coefficient and granule size, consistent with a surface area-controlled mechanism” (Table 1 and pg. 487, Conclusions).
Clark teaches reduced molecular weight gellan gums, methods of their production, and their use in compositions such as solutions and gels (Abstract). Gellan gum is taught to be a high molecular weight polysaccharide consisting of glucose, glucuronic acid, and rhamnose in a ratio of 2:1:1 (pg. 3, lines 16-20). Gellan gum is taught as a desirable substitute for gelatin, the most common gelling agent, because the latter is animal-derived while the former is produced by bacterial fermentation (pg. 5, line 26 - pg. 6, line 10). However, solutions prepared using native gellan gum, that is its high acyl form (pg. 4, lines 4-8), are “highly viscous even at elevated temperatures” and also gel at elevated temperatures, leading to the need for lower molecular weight gellan gums (pg. 6, lines 10-13). The gellan gums taught by Clark have a “weight average molecular weight of less than or equal to about 1.7 x 106” (pg. 6, lines 20-21), often in a range from 4.0 x 105 to 1.4 x 106 (pg. 7, lines 27-28). These lower molecular weight gellan gums are taught to provide several advantages over native gellan gum, including reduced viscosity at elevated temperatures, which is important for processing and solutions containing high concentrations of sugar (pg. 7, line 30 - pg. 8, line 2).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to modify the invention of Hunan Er-Kang with the teachings of Matsutani, Dhital, and Clark to arrive at the invention of claims 1-7, 9, and 13-20 because the combination of elements known in the art according to known methods yields predictable results. An artisan would be motivated to use hydroxypropyl distarch phosphate as a granular starch in view of the teachings of Matsutani because the reference teaches its benefits to the health of subjects with diabetes mellitus, which is particularly important when the invention is used in the field of medicine. In view of the teachings of Dhital, one of ordinary skill would be motivated to select hydroxypropyl distarch phosphate granular starch of average particle size 13-31 mm, and no smaller than ~9 mm, because Dhital teaches starches of these smaller sizes to be easier to digest. The ordinary artisan would desire the starches in their capsules to be easy for a consumer to digest, and Hunan Er-Kang and Matsutani do not teach average particle sizes for starches, so the teachings of Dhital provide necessary missing information.
An artisan further would be motivated to use the lower molecular weight gellan gums taught by Clark in the invention of Hunan Er-Kang because the latter taught the use of gellan gum, but did not specify the preferred molecular weight of the large polysaccharides. Clark taught that the lower molecular weight gellan gums of their invention reduced the risk of unwanted thickening at elevated temperatures and subsequently aided the manufacturing process, which would be desirable to an artisan.
With respect to claims 7, 20, and 26, the claims are interpreted as product-by process claims where the patentability is based on the product and are not limited to the manipulations of the recited steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-7, 9, and 16-26 in view of the teachings of Hunan Er-Kang, Matsutani, Dhital, and Clark.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hunan Er-Kang (Chinese Patent Application Publication No. CN 104721167 A, published on 24 June 2015, provided by Applicant in IDS, references to English translation) in view of Matsutani (Jpn. Pharmacol. Ther. 2010, 38, 371.), Dhital (Carbohydr. Polym. 2010, 82, 480.), and Clark (WIPO International Patent Application Publication No. WO 00/31146, published on 2 June 2000) as applied to claims 1-7, 9, and 16-26 above, and further in view of Kuusisto (U.S. Patent Application Publication No. US 2017/0224707 A1, published on 10 August 2017).
Hunan Er-Kang, Matsutani, Dhital, and Clark teach the above, and particularly relevant to claim 8, Hunan Er-Kang teaches that non animal-derived components are preferable to animal-derived components and that soft capsules are useful in the medical and health product industries due to their low breakage rate and good disintegration performance (Abstract).
Hunan Er-Kang, Matsutani, Dhital, and Clark do not teach the soft capsule shell to be filled with vegetable fat. This deficiency is offset by the teachings of Kuusisto.
Kuusisto teaches a capsule, consisting of a shell and filling which comprises a plant sterol/stanol ester and emulsifier, for the purpose of lowering LDL cholesterol levels (Abstract). Lowering LDL cholesterol levels is taught to be “the most effective single measure regarding both prevention and effective treatment of cardiovascular disease”, but the drug class commonly prescribed to treat this condition, statins, is known to cause gastrointestinal side effects, may cause liver damage, and has also been reported to increase the risk of type II diabetes (para. [0002-0003]). Kuusisto teaches an alternative treatment comprising dietary supplements, in their invention taking the form of softgel capsules comprising a shell and a filling, the latter being a composition with an active ingredient of plant sterol esters and/or plant stanol esters (para. [0004-0009]).
Kuusisto teaches their softgel capsule to comprising a filling that is ≥85% by weight plant sterol ester and/or plant stanol ester and ≥1.0% by weight an emulsifier (para. [0013]). The capsule comprising the above filling was found to rapidly disintegrate in a simulated gastric fluid test, which is beneficial for treating LDL cholesterol levels (para. [0015]). In addition to the emulsifier and plant sterol/stanol ester(s), the filing is taught to optionally comprise an edible fat, which in a preferred embodiment is vegetable oil (para. [0040-0042] and claim 19). The filing is taught to comprise 0.1-10% by weight vegetable oil, in certain embodiments 2-4 or 8% (claim 17 and Examples 3-4).
It would have been prima facie obvious to a person of ordinary skill in the art to modify the invention rendered obvious by the teachings of Hunan Er-Kang, Matsutani, Dhital, and Clark with the teachings of Kuusisto to arrive at the invention of claim 8 because combining prior art elements according to known methods yields predictable results. Hunan Er-Kang teaches a starch soft capsule shell and its use in medical or health product fields, but does not teach a filling for the shell. An artisan would be motivated to fill the shell rendered obvious by the teachings of Hunan Er-Kang, Matsutani, Dhital, and Clark with a filling comprising vegetable fat because Kuusisto teaches that a filling comprising vegetable fat and plant sterol/stanol ester(s) is effective at lowering LDL cholesterol levels in users following ingestion. Lowering the cholesterol levels would be desirable to an artisan because Kuusisto teaches the process to decrease the risk of cardiovascular disease in users. As a result, there is a reasonable expectation of success in arriving at the invention of claim 8 in view of the teachings of Hunan Er-Kang, Matsutani, Dhital, and Clark and further in view of the teachings of Kuusisto.
Claims 1-7, 9, and 16-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hunan Er-Kang (Chinese Patent Application Publication No. CN 104721167 A, published on 24 June 2015, provided by Applicant in IDS, references to English translation) in view of Matsutani (Jpn. Pharmacol. Ther. 2010, 38, 371.), Dhital (Carbohydr. Polym. 2010, 82, 480.), Clark (WIPO International Patent Application Publication No. WO 00/31146, published on 2 June 2000), Sydow et al. (European Patent Application No. EP 2815744 A1, published on 24 December 2015, provided by Applicant in IDS, hereafter referred to as Sydow), and Myers et al. (U.S. Patent No. 8,765,167 B2, published on 1 July 2014, hereafter referred to as Myers).
NOTE: For the purpose of examination, the “granule” recited in instant claim 1 is interpreted as referring to the granular starch because lines 22 and 24 refer to granular starch and a starch granule. In addition, it is noted that the instant rejection is based on a different interpretation of claims 7 and 20, therefore the process steps in claims 7 and 20 are given weight and rendered obvious in view of the prior art.
The teachings of Hunan Er-Kang have been described supra and particularly relevant to claim 8, Hunan Er-Kang teaches that the soft capsules of their invention are produced via “the preparation method of conventional soft capsules” (claim 7).
The teachings of Matsutani, Dhital, and Clark have been described supra.
Hunan Er-Kang, Matsutani, Dhital, and Clark do not teach the specific method of producing soft capsules. This deficiency is offset by the teachings of Sydow and Myers.
Sydow teaches gastro-resistant soft shell capsules, which consist of a shell comprising at least one starch, gellan gum, and plasticizer, and a method for their manufacture (Abstract). The gellan gum in the soft shell capsule is taught to comprise both a high acyl gellan gum and low gellan acyl gum (para. [0018] and claim 7). To manufacture the soft shell capsule, Sydow teaches mixing the plasticizer with the high acyl gellan gum and low acyl gellan gum, separately mixing the starch with the water to create a homogenous suspension, combining the two mixtures above, and then heating to 96-99 °C while mixing (claims 12 and 14). This temperature range overlaps with the ranges recited in instant claims 7, 20, and 26 and, as stated in MPEP § 2144.05, renders the range in instant claims 7, 20, and 26 prima facie obvious (vide supra-). Following the creation of the heated suspension, it is taught to be encapsulated and dried (claims 12-13).
While the method taught by Sydow includes the starch in the water that is added to the plasticizer and gellan gum gelling agent, rather than adding the starch after the water has been added to the plasticizer and gellan gum mixture, changing the sequence of adding ingredients would have been prima facie obvious at the time of filing. This is supported by previous board and court decisions, including in Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959), where the Board of Appeals held that the “order of performing process steps is prima facie obvious in the absence of new or unexpected results” (see MPEP § 2144.04.IV.C.) In addition, the Court of Customs and Patent Appeals held that the selection of ay order of mixing ingredients is prima facie obvious in In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), again in the absence of new or unexpected results. The order of adding the starch to the mixture during mixing is considered to not produce new or unexpected results, therefore the method of Sydow is determined to be analogous to the method of instant claims 7 and 20.
Myers teaches water-soluble films that are used to deliver active components, such as cosmetic agents, pharmaceutical agents, or vitamins, and methods of their production (Abstract). The films are formed from polymers, which in some embodiments include starches (column 12, line 46) and gellan gums (column 14, line 10), at least one anti-tacking agent, which in some embodiments includes vegetable oil (claim 1), and one or more active components (claim 1). Myers also teaches that pectin may be included in their film composition as a thermos-setting gel (column 21, line 33) and that glycerol can be included as a plasticizer (column 22, line 22). During the manufacture process, Myers teaches that air bubble can be trapped in the mixture, which is undesirable because it can cause uneven surfaces, non-uniformity in the final product, and even structural collapse (column 3, lines 32-47). Myers teaches that multiple techniques can be employed to prevent air bubble inclusion, including addition of an anti-foaming or surface-tension reducing agent to the composition, controlling the speed of mixing to prevent cavitation, and “allowing the mix to stand for a sufficient time for bubbles to escape prior to drying” (column 9, lines 23-38).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to employ the teachings of Sydow and Myers to produce the invention rendered obvious by the teachings of Hunan Er-Kang, Matsutani, Dhital, and Clark because the use of a known method to produce a similar product in the same way yields predictable results. Hunan Er-Kang teaches that the soft shell capsules of their invention are produced via “the preparation method of conventional soft capsules”, but does not provide any details of said preparation method. An artisan would be motivated to utilize the method taught by Sydow because it is taught to successfully produce soft shell capsules consisting of a shell comprising at least one starch, gellan gums as gelling agents, and a plasticizer - components present in the invention rendered obvious by the teachings of Hunan Er-Kang, Matsutani, and Clark. An artisan would further be motivated to use the teachings of Myers because the reference teaches the deleterious effects of air bubbles in cooling mixtures, which none of the other references teach. In view of the teachings of Myers, an artisan could employ one of the techniques described above to eliminate air bubbles and avoid related issues during manufacture. As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 7 and 20 in view of the teachings of Hunan Er-Kang, Matsutani, Dhital, and Clark and further in view of the teachings of Sydow and Myers.
Response to Arguments
The Applicant’s arguments, filed on 9 March 2026, have been fully considered but are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the Hunan Er-Kang and Matsutani references from para. 2 of pg. 11 to para. 3 of pg. 12, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Hunan Er-Kang reference states in the Abstract that the taught invention “relates to capsules widely used in the industries of medicines, health products and foods, and particularly relates to starch soft capsules”. The Matsutani reference teaches the glycemic response in humans to digesting various starches. An ordinary artisan would recognize the link between the two references above because Hunan Er-Kang specifically states that starch is used in their invention and that their invention relates to health and food products and the Matsutani reference discusses starch in the context of human health and foods. Applicant is also reminded that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." (bold added for emphasis) Id. at 418, 82 USPQ2d at 1396. Therefore, Applicant’s argument is found to be unpersuasive.
Applicant argues in para. 4-5 of pg. 12 that a person of ordinary skill in the art “would be unable to determine the specific ratio of hydroxypropyl starch to hydroxypropyl distarch phosphate” as claimed in the instant application. This is not found to be persuasive because Hunan Er-Kang teaches the starch in their invention to comprise a mixture of modified and common starches, the former being 22.2-99.2% w/w and the latter being 0.8-77.8% w/w. Because the prior art teaches ranges that encompass the ranges recited in the instant claims, a person of ordinary skill would be able to optimize within prior art conditions to arrive at the ratios argued in para. 2-3 of pg. 12 of the remarks. See MPEP § 2144.05. Further, the person of ordinary skill in the art is presumed to have known the relevant art, the types of problems encountered in the art, and solutions to those problems. See MPEP § 2141.03. ”A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Therefore, the argument is found to be unpersuasive.
In the penultimate para. of pg. 12, Applicant argues that “the particle size is not inherent because it is not necessarily and always in the claimed range when in the claimed content range”. The particle size was not argued to be inherent in the previous Office Action, and the meaning of the argument that size is not necessarily in the claimed range when in the claimed range is unclear. The limitation directed to particle size in claim 1 has been addressed with the Dhital reference.
From the final para. of pg. 12 to para. 2 of pg. 13, Applicant argues that the method used to measure granule sizes in the Dhital reference is “completely different from the claimed method”, that the granule “may contain other components besides starch” while Dhital only teaches starches, and that one of ordinary skill in the art would have “no reasonable expectation of success” in concluding that a “minimal amount of starch in the capsule would have meaningful effect on digestibility”. Regarding the method used to measure granule size, the patentability of the size limitation is dictated by the size ranges recited, not the method by which they are measured, and the argument is not persuasive. Regarding the granule containing components other than starch, this has been addressed above – in brief, the recitation of “the granule” is indefinite and for the purpose of examination the limitations drawn to size and amount has been interpreted as referring to granular starch, which are obvious in view of the prior art (vide supra). Finally, regarding the reasonable expectation of success that small amounts of starch have an impact on digestibility, Applicant is reminded that an argument by the Applicant “does not replace evidence where evidence is necessary” and “[a]rguments presented by applicant cannot take the place of evidence in the record.” See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) and MPEP § 2145.I. Applicant has not provided evidence that a threshold of starch in a capsule is needed to achieve an impact on digestibility and the Applicant’s argument is found unpersuasive.
In response to applicant’s argument that there is “no motivation” to combine the Hunan er-Kang and Clark references from the penultimate para. of pg. 13 to para. 4 of pg. 14, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Hunan Er-Kang reference teaches starch soft capsules that comprise a plant-derived gum, rather than an animal-derived product, and that the plant-derived gum may be a gellan gum. The Clark reference teaches properties of different gellan gums, and the link between gellan gums would be obvious to one of ordinary skill in the art. Therefore, the above argument is found to be unpersuasive.
In the para. spanning the end of pg. 13 and the top of pg. 14, Applicant argues that the combination of the Hunan Er-Kang and Clark references would not motivate an ordinary artisan to use a gellan gum of the claimed weight-average molecular weight and the claimed coefficient of molecular weight distribution of 1.0-6.0. However, the instant specification defines the molecular weight distribution as the weight-average molecular weight (Mw) divided by the number average molecular weight (Mn), or Mw/Mn (para. [0053]). While Clark does not specifically teach the coefficient above, they teach both the Mw and Mn, such as in Table 3, where the coefficient is from 1.09-1.22, which falls within the claimed range.
Applicant also argues in para. 2-3 of pg. 14 that despite the Clark reference teaching that that gels prepared with reduced molecular weight gellan gums “have a better mouth feel than do gels prepared from native gellan gum”, an ordinary artisan would understand that “soft capsules are designed to be directly swallowed by humans” and “when a soft capsule is swallowed in an extremely short time, the capsule incorporating Clark’s gellan gum with reduced molecular weight will not alter the user’s mouthfeel”. The Clark reference does not teach a minimum amount of time required for a user to experience a “better mouth feel” and further, an argument by the Applicant “does not replace evidence where evidence is necessary” and “[a]rguments presented by applicant cannot take the place of evidence in the record.” See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) and MPEP § 2145.I. Applicant has not provided evidence that the reduced weight gellan gums taught by Clark require a minimum amount of time in the mouth of users to improve the mouth feel and the Applicant’s argument is found unpersuasive.
The section titled “Unexpected Results and Criticality” spanning pg. 14-17 argues that the instant invention presents unexpected results. Guidelines on determining whether results are expected or unexpected are provided in MPEP § 716.02. To demonstrate that results are unexpected and significant, the Applicant has the responsibility of presenting evidence that establishes “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” (bold added for emphasis). Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims” (bold added for emphasis). See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and See MPEP § 716.02(d) - § 716.02(e).
In para. 1-2 of pg. 15, Applicant cites Control Examples 1 and 2, comprising gellan gum G and H, respectively, as demonstrating the criticality of the claimed weight average molecular weight range when compared to Examples 1-6 which comprise gellan gums A-F. Gellan gum G is below the claimed range and gellan gum H is above the claimed range while gums A-F are within the claimed range. “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.” In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). One data point above and one data point below the claimed range is not a sufficient number of tests outside the claimed range to show criticality when the range spans 7.5 x 106 g/mol. Further, the range is not unexpected or unobvious because Clark teaches gellan gums with an average molecular weight range from 4.0 x 105 to 1.4 x 106 g/mol, nearly the entirety of which falls within the range recited in instant claim 1.
In the para. that spans the bottom of pg. 15 and top of pg. 16, Applicant compares Control Example 3 and Example 3, which use gellan gums I and C, respectively, with gum I having a molecular weight distribution coefficient outside the range claimed in instant claim 1 and gum C having a coefficient inside the claimed range. This is not a showing of a sufficient number of examples outside the claimed range to demonstrate criticality. Further, the data in Table 3 are not commensurate in scope with the claimed range of molecular weight distribution coefficients. See MPEP § 716.02(d). The claimed range is 1.0-6.0 and gellan gums A-H span coefficients from 1.07-2.89 while gellan gum I, the only data point outside the claimed range, has a coefficient of 6.32. There are no gellan gums with coefficients in the range of 2.9-6.0 and Applicant has not demonstrated unexpected results commensurate in scope with the claimed range.
In para. 3 of pg. 16, Applicant cites Control Example 6, with an average “particle size” of 70 mm, and Control Example 5, with an average “particle size” of 5 mm, from Table 4 as demonstrating the criticality of the claimed size range of 10-50 mm because the former failed to form a soft capsule and the latter failed to do so in simulated gastric juice. Applicant is advised that Table 4 does not disclose “particle” size but instead discloses “starch granule” size, which is related to the issue of indefiniteness with “the particle” discussed above. In addition, this argument is not a persuasive demonstration of the criticality of the range because Table 4 also shows that Examples 15 and 20, with sizes of 60 mm and 55 mm, respectively, also form soft capsules and disintegrate in the required time in water and simulated gastric juice. The metric used to demonstrate success or failure (i.e., forming a soft capsule in a given media) does not demonstrate success only in the claimed range and Applicant has therefore failed to demonstrate the criticality of the range.
In para. 4 of pg. 16, Applicant compares Example 19 and Control Example 4, which have the same “particle” size of 35 mm, but Applicant argues that because only Example 19 “forms a soft capsule soluble in both water and simulated gastric juice” they have demonstrated the criticality of the “starch granule content”. This is related to the issue of indefiniteness with “the particle” discussed above and for the purpose of examination, the range of 9-40% w/w of “a particle” was interpreted as referring to the content of the granulated starch and was rendered obvious (vide supra).
In para. 2-3 of pg. 17, Applicant argues that because the Hunan Er-Kang reference “only verified the disintegration and rupture effects in water”, the reference did not demonstrate that they produced starch soft capsules with high toughness, low breakage rates, and accelerated disintegration in the digestive tract. Because Hunan Er-Kang teaches that their invention does exhibit the above advantages in the digestive tract, this amounts to an argument against the operability of a reference, which is addressed in MPEP § 716.07. To demonstrate the inoperability of the reference, Applicant is required to present an affidavit or declaration which “must rebut the presumption of operability by a preponderance of the evidence.” In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). Because Applicant has not presented such an affidavit or declaration, the argument is not found persuasive.
Finally, in the penultimate para. of pg. 17 Applicant argues that one of ordinary skill in the art would be “discouraged from employing pectin in soft capsule shells intended to disintegrate in the stomach” because pectin renders the capsules insoluble in simulated gastric juice, “a phenomenon already established in the prior art”. As stated above, an argument by the Applicant “does not replace evidence where evidence is necessary” and “[a]rguments presented by applicant cannot take the place of evidence in the record.” See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) and MPEP § 2145.I. The para. also argues that Examples 26-28 demonstrate that their invention can disintegrate in gastric juice “even in the presence of pectin”, demonstrating a “further unexpected technical effect”. This is not found to be persuasive because Hunan Er-Kang teaches their soft capsules to comprise pectin and to disintegrate in the stomach, demonstrating the effect is not unexpected.
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 1-9 and 16-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 10, and 14 of U.S. Patent No. 12,661,406 in view of Hunan Er-Kang (Chinese Patent Application Publication No. CN 104721167 A, published on 24 June 2015, provided by Applicant in IDS, references to English translation), Dhital (Carbohydr. Polym. 2010, 82, 480.), Clark (WIPO International Patent Application Publication No. WO 00/31146, published on 2 June 2000), and Kuusisto (U.S. Patent Application Publication No. US 2017/0224707 A1, published on 10 August 2017).
U.S. Patent No. 12,661,406 recites a capsule shell comprising a starch film-forming composition, said composition comprising a first gelling agent, starch, a plasticizer, and water (claims 1 and 14). The first gelling agent is a gellan gum and is present in an amount of 2-6.0% by weight, the starch in an amount of 10-50% by weight, the plasticizer in an amount of 10-30% by weight, and the water in an amount of 33-70% by weight (claim 2). In one embodiment, the starch of the composition is recited as being hydroxypropyl starch and hydroxypropyl distarch phosphate present in a weight ratio of 2:1 to 9:1 (claim 1). The plasticizer of the invention is recited as being glycerol in one embodiment (claim 7) and the ratio of the first gelling agent to the starch is recited as “from 0.05-0.10” (claim 1). The composition is recited as comprising a second gelling agent, which is present in an amount of 0.1-5.0% by weight of the composition, and in one embodiment is a gellan gum or pectin (claim 10).
U.S. Patent No. 12,661,406 does not recite the molecular weight of the gellan gum that is the first gelling agent, the distribution coefficient of the molecular weight of the gellan gum, the size of starch granules in the capsule shell, nor the capsule shell to contain a filling. These deficiencies are offset by the teachings of Dhital, Clark, and Kuusisto.
Dhital, Clark, and Kuusisto have been described above.
It would have been prima facie obvious to one of ordinary skill in the art to modify the invention of copending Application ‘644 with the teachings of Dhital because Patent ‘406 does not recite particle sizes appropriate for soft shell capsules and Dhital teaches that starches of average particle size 13-31 mm, and no smaller than ~9 mm, are easier to digest. The ordinary artisan would desire the starches in their capsules to be easy for a consumer to digest and the teachings of Dhital provide necessary missing information which would motivate one of ordinary skill to utilize the teachings of Dhital.
An artisan of ordinary skill would further be motivated to use the lower molecular weight gellan gums taught by Clark in the invention of Patent ‘406 because the latter recited the use of gellan gums, but did not specify the preferred molecular weight of the large polysaccharides. Clark taught that the lower molecular weight gellan gums of their invention reduced the risk of unwanted thickening at elevated temperatures and subsequently aided the manufacturing process, which would be desirable to an ordinary artisan. Finally, one of ordinary skill in the art would be motivated to fill the shell of Patent ‘406 with a filling comprising vegetable fat because Kuusisto teaches that a filling comprising vegetable fat and plant sterol/stanol ester(s) is effective at lowering LDL cholesterol levels in users following ingestion. Lowering the cholesterol levels would be desirable to an artisan because Kuusisto teaches the process to decrease the risk of cardiovascular disease in users.
With respect to claims 7, 20, and 26, the claims are interpreted as product-by process claims where the patentability is based on the product and are not limited to the manipulations of the recited steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-9 and 16-26 in view of claims 1-2, 7, 10, and 14 of U.S. Patent No. 12,661,406 and further in view of the teachings of Dhital, Clark, and Kuusisto.
Claims 1-9 and 16-26 are directed to an invention not patentably distinct from claims 1-2, 7, 10, and 14 of commonly assigned U.S. Patent No. 12,661,406 in view of Dhital, Clark, and Kuusisto. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned commonly assigned U.S. Patent No. 12,661,406, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Claims 1-9 and 16-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-9, 12, 15-17, and 22-24 of U.S. Patent No. 12,636,256 in view of Dhital (Carbohydr. Polym. 2010, 82, 480.), Clark (WIPO International Patent Application Publication No. WO 00/31146, published on 2 June 2000), and Kuusisto (U.S. Patent Application Publication No. US 2017/0224707 A1, published on 10 August 2017).
U.S. Patent No. 12,636,256 recites a starch film-forming composition comprising a first gelling agent, a starch, a plasticizer, and a second gelling agent (claims 1 and 7-8). The first gelling agent is a gellan gum and is present in an amount of 1-8% by weight, with a weight ratio of 0.02-0.5 with respect to the weight of starch (claims 1 and 4). The starch is present in an amount of 15-50% by weight and may be hydroxypropyl starch and/or hydroxypropyl distarch phosphate (claims 3, 6, and 15-17). The plasticizer is present in an amount of 10-35% by weight and may be glycerol (claims 7 and 22). The second gelling agent may be pectin and is present in an amount of 0.2-3.5% by weight (claims 8 and 23-24). Finally, the composition is recited as comprising 35-60% by weight of water (claim 9) and being used in a capsule shell (claim 12).
U.S. Patent No. 12,636,256 does not recite the molecular weight of the first gelling agent gellan gum, the coefficient of molecular weight distribution of the gellan gum, nor the capsule shell to contain a filling. These deficiencies are offset by the teachings of Dhital, Clark, and Kuusisto.
Dhital, Clark, and Kuusisto have been described above.
It would have been prima facie obvious to one of ordinary skill in the art to modify the invention of U.S. Patent No. 12,636,256 with the teachings of Dhital because Patent ‘256 does not recite a particle size for starch granules and Dhital teaches that granular starch of average particle size 13-31 mm, and no smaller than ~9 mm, are easier to digest. The ordinary artisan would desire the starches in their capsules to be easy for a consumer to digest, and Patent ‘256 does not recite average particle sizes for starches, so Dhital provides necessary missing information which the artisan of ordinary skill would require to complete their invention.
A person of ordinary skill would further be motivated to modify the invention of copending Patent ‘256 with the teachings of Clark because ‘256 does not recite a molecular weight of the gellan gum used and the Clark reference teaches lower molecular weight gellan gums to reduce the risk of unwanted thickening at elevated temperatures and subsequently aided the manufacturing process, which would be desirable to an artisan. In addition, one of ordinary skill in the art would be motivated to fill the shell of Patent ‘256 with a filling comprising vegetable fat because Kuusisto teaches that a filling comprising vegetable fat and plant sterol/stanol ester(s) is effective at lowering LDL cholesterol levels in users following ingestion. Lowering the cholesterol levels would be desirable to an ordinary artisan because Kuusisto teaches the process to decrease the risk of cardiovascular disease in users.
With respect to claims 7, 20, and 26, the claims are interpreted as product-by process claims where the patentability is based on the product and are not limited to the manipulations of the recited steps. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As a result, there is a reasonable expectation of success in arriving at the invention of instant claims 1-9 and 16-20 in view of claims 1, 3-4, 6-9, and 12 of commonly assigned U.S. Patent No. 12,636,256 and the teachings of Dhital, Clark, and Kuusisto.
Claims 1-9 and 16-26 are directed to an invention not patentably distinct from claims 1, 3-4, 6-9, 12, 15-17, and 22-24 of commonly assigned U.S. Patent No. 12,636,256 in view of the teachings of Dhital, Clark, and Kuusisto. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 12,636,256, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
The Applicant’s arguments, filed on 9 March 2026, have been fully considered but are not persuasive.
On pg. 18, Applicant reiterates their arguments from above that one of ordinary skill in the art would not rely on the teachings of Clark and Dhital because Clark “is directed to a liquid food product” and Dhital does not teach the content and size of “the granule”. These arguments were addressed above (vide supra) and are not found to be persuasive.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
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