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 .
Detailed Action
Previous Rejections
Applicants' arguments, filed 06/30/25 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18-21, 24-30 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Mangos et al. (US PG Pub. 2004/0191366 A1) in view of Borkan et al. (EP 0 374 359 A2, presented in IDS); in view of Zhu et al. (Effect of a new shell material-Jackfruit seed starch on novel flavor microcapsules containing vanilla oil; Industrial Crops & Products 112 (2018) 47-52, presented in IDS), Tran et al. (Physicochemical properties of native and partially gelatinized high-amylose jackfruit (Artocarpus heterophyllus Lam.) seed starch, PL. Tran et al. / LWT - Food Science and Technology xxx (2015) 1-8, presented in IDS) and Pagola et al. (Journal of Food Engineering 91 (2009) 380-386, presented in IDS).
Mangos teaches seamless microcapsules which comprise a hardened capsule and a core of filler material which may be a flavor making it suitable for an oral care product (i.e. an aromatic/ fragrance molecule; abstract). Mangos in Example 2-table 1 teaches the flavoring of the core is peppermint oil (i.e. an oily core comprising an aromatic/fragrance molecule). With regard to the limitation that the capsule be breakable, Mangos teaches the capsule comprises a flavoring, thus the capsule must necessarily be breakable in order to permit the flavoring to be released so that it may flavor the compositions/foodstuff in which it is to be used. Mangos teaches the capsule material is preferably alginate, pectate, pectinate (i.e. pectins), gellan and mixtures (i.e. gellan alone and gellan in combination with another gelling agent, [0063]) (gellan gum is a crosslinked hydrocolloid gelling agent). Mangos in Example 8 teaches a capsules shell comprising a mixture of sodium alginate (i.e. alginate) and gellan gum together in the capsule shells of ([0168]). Mangos in Example 8 teaches the water content of the dried shell is 4.6% water ([0168]). Mangos teaches inclusion of additives in the capsule shells which may be cellulose derivatives including carboxymethylcellulose, starches (i.e. starch derivatives/fillers), and maltodextrin (filler) to improve the barrier function of the capsule shell by filling the pores of the shell (i.e. the shell composition is water-impermeable; [ 90]). Mangos teaches inclusion of cellulose derivatives; Mangos teaches inclusion of anti-gelling agents such as sodium and magnesium as well as calcium complexing compounds (i.e. divalent metal sequestering agents calcium is a known divalent metal; [86]). Mangos teaches that the primary task of his invention "to provide a flavor release system ([23]).
Mangos suggests use of starches in the capsule shell and the following references teach use of various starches in capsule shell as discussed below:
Borkan et al. describes soft edible, chewable gelatin capsules, the shell of which comprises gelatin, water, a plasticizer and a hydrogenated starch hydrolysate. Example 1 (p.6) discloses the preparation of a soft capsule having vegetable oil in its core and the composition of the shell comprises gelatin (cross-linked hydrocolloid), hydrogenated starch hydrolysate (partially gelatinized).
Zhu teaches “Effect of a new shell material, Jackfruit seed starch on novel flavor microcapsules containing vanilla oil”, see title. The reference teaches that Vanilla essential oil was microencapsulated by different shell materials including jackfruit seed starch (JM), chitosan (CM), and B-cyclodextrin (8M) based on the ultrasonic method. The effects were compared among the different shell materials when the yield, encapsulation efficiency, storage stability and slow-releasing potential were used as evaluation indexes, see abstract.
Tran et al. teaches use of partially-gelatinized high-amylose starch. The reference teaches that the modified starches have been prepared by various techniques, such as enzymatic, chemical, and physical treatments and partial gelatinization, and have been used widely in the food and pharmaceutical industries (Abiaas, Khalil, & Hassin, 2499). There are many processes for starch modification, one of which is hydrothermal treatment (Chum. Yim. & bin, 20°55). Traditionally, the preparation of partially-gelatinized starch was carried out with heat treatment of varying duration at the gelatinization temperature of the relevant starch. The characteristics of the resulting products varied, depending on the processing parameters such as the processing time and temperature. Difficulties in controlling the processing may lead to a degree of gelatinization that is higher than planned or desirable for the product. Partial gelatinization of starch provides a mixture of the properties of both native and fully gelatinized starches, see page 1, column 2. The reference teaches in conclusion section that due to its unique molecular structure, the gelatinized JFSS formed a highly soft and elastic gel. The JFSS showed two separate DSC endotherms of similar enthalpies. The partial gelatinization of the JFSS at 70 °C completely removed the first endotherm while maintaining relatively high crystallinity and granular integrity. The partially-gelatinized JFSS showed only a slight change in pasting profile compared to that of the native JFSS. Additionally, the partially-gelatinized JFSS was successfully used to enzymatically produce genistincycloamylose (CA) complex. Water sorption isotherms of the partially gelatinized JFSS showed higher water-holding capacity than that of the native starch. Unique physicochemical properties of the Vietnamese JFSS and the temperature-controlled partial gelatinization of the JFSS could benefit various industries searching for new starch materials.
Pagola teaches preparation of starch derivatives using reactive extrusion and evaluation of modified starches as shell materials for encapsulation of flavoring agents by spray drying, see title. Starch acetylation can be performed to improve significantly the physicochemical and functional properties of the starch, even with a low degree of substitution (Xu et al., 2004), Starch acetates with degree of substitution of 0.01-0.2 have been prepared for food use to improve film forming, binding, thickening, stability, and texturizing (de Graaf et al., 1998), see page 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the modified starch in the capsule shell of Mangos et al. One of ordinary skill would have been motivated to do so because Mangos suggests use of starches in the capsule shell and Borkan teaches use of hydrogenated starch hydrolysate in making a shell, Zhu teaches starch as encapsulating material which provides encapsulation efficiency and storage stability,
Tran et al. teach use of partially-gelatinized high-amylose starch for making highly soft and elastic shell and Pagola teaches shell materials for encapsulation of flavoring agents by using acetylated starch to improve functional properties. The property of the amylose and capsule can be optimized by varying the amount of the gelling agent, filler and cross-linked hydrocolloid and partially gelatinized high amylose starch. Claim 20 recites process step. “[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), see MPEP2113. (citations omitted). In the instant case the reference provides guidance as to how to use selected percentage of amylose and Tran teaches heat gelatinization of starch as discussed above, therefore it would be within skill of an artisan to manipulate the property by varying gelatinization and amounts of the components.
Applicant argues that there is no motivation to combine the teachings of any of the secondary references with Mangos et al. which do not teach use of the claimed high amylose starch comprising at least 50% wt.% amylose.
These arguments are not persuasive. Tran et al. explicitly teaches use of partially-gelatinized high-amylose starch. The reference teaches that the modified starches have been prepared by various techniques, such as enzymatic, chemical, and physical treatments and partial gelatinization, and have been used widely in the food and pharmaceutical industries (Abiaas, Khalil, & Hassin, 2499).Tran teaches that the partial gelatinization of the JFSS at 70 °C completely removed the first endotherm while maintaining relatively high crystallinity and granular integrity and further teaches that water sorption isotherms of the partially gelatinized JFSS showed higher water-holding capacity than that of the native starch. Thus, in order to manipulate the physicochemical properties of the shell, it would have been obvious to one of ordinary skill in the art to have utilized high amylose (50, 60 or 80 wt. % amylose) containing starch in preparing the capsule shell absent indication of unexpected results.
Applicant argues that Borkan et al. teaches that hydrogenated starch hydrolysates include those which contain less than 3% of polyols whose degree of polymerization (DP) is higher than 20, about 35-60% maltitol (DP 2), about 0.1-20% of sorbitol (DP 1), and the balance being constituted by a mixture of polyols of DP 3 to 20. [See Page 4, lines 27-29.) Even if one skilled in the art may characterize a hydrogenated starch hydrolysate as a type of starch derivative, the fact that Mangos explicitly and distinctly teaches that “maltodextrin, starches, ... cellulose derivatives” are exemplary “fillers”, it is not permissible to over-generalize the teachings of Mangos to include all “starch derivatives” and then turn to Borkan et al. (or any of the other cited references). Applicant further argues that the process of making hydrogenated starch hydrolysate in Borkan is different from the instant process. Applicant argues that while Zhu et al. may describe encapsulating vanilla essential oil, it is achieved by a completely different process and there is no teaching or suggestion in Mangos et al., Borkan et al., or Zhu et al. that would lead a person having ordinary skill in the art to use (or even try to use) jackfruit seed starch toward achieving the formation of seamless capsules. Zhu et al. describes encapsulating vanilla essential oil by first dissolved in a supersaturated solution prepared by the shell materials….Applicant further argues that a person having ordinary skill in the art would find no teaching, suggestion, or motivation to rely upon the teachings of Zhu et al. to modify the teachings of Mangos et al. and/or Borkan et al. Furthermore, while Zhu et al. teaches that Jackfruit seed is rich in starch (approximately 60-80% by dry weight), its amylose content is reported to only be 32% (see end of section 3.4 on page 52), and thus Zhu et al. does not teach or suggest a high amylose starch comprising at least 50 wt% amylose, as required by Claim 1. Applicant argues that Tran et al. does not teach or suggest using native or partially- gelatinized JFSS for any particular purpose, except that the partially-gelatinized JFSS was successfully used to enzymatically produce genistine-cycloamylose (CA) complex, which is unrelated to Applicant’s claimed invention. Tran et al. teaches that, in comparison to native JFSS, the partially-gelatinized JFSS showed only a slight change in pasting profile compared to that of the native JFSS, and the water sorption isotherms of the partially gelatinized JFSS showed higher water- holding capacity than that of the native starch. (See section 3.10.) However, neither of those “differences” would guide a person having ordinary skill in the art to rely upon the teachings of Tran et al. to modify the teachings of Mangos et al., Borkan et al., and/or Zhu et al. And while Tran et al. concludes that “[u]nique physicochemical properties of the Vietnamese JFSS and the temperature- controlled partial gelatinization of the JFSS could benefit various industries searching for new starch materials”, this extremely broad suggestion hardly rises the requirement of providing an articulated reason.
Applicant argues that Murua-Pagola et al., this non-patent literature describes preparing starch derivatives using reactive extrusion and evaluation of modified starches as shell materials for encapsulation of flavoring agents by spray drying. In fact, the starches that are explored in Murua-Pagola et al. are reported to be “waxy starches”. While Murua-Pagola et al. does not disclose the amylose content or amylose:amylopectin weight ratio of its waxy starch, Applicant respectfully submits that the term “waxy starch” is very distinct and different from a high amylose starch.
These arguments are not persuasive. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the rejections above, Borkan, Zhu, Tran and Murua-Pagola et al. have been cited to show that use of various starches were known in the art to have used for making a capsule shell for their known properties of providing soft edible, chewable gelatin capsules as taught by Borkan, for encapsulation efficiency, storage stability as taught by Zhu, widely in the food and pharmaceutical industries as taught by Tran, and for improved film forming, binding, thickening, stability, and texturizing by acetylation as taught by Pagola et al. As stated in the rejections above, the references provide guidance as to how to use selected percentage of amylose and use various starches (including waxy), therefore, it would be within skill of an artisan to utilize and manipulate the amylose content of starch in order to manipulate physicochemical properties of the capsule shell and since Tran teaches heat gelatinization of starch as discussed above, therefore it would be within skill of an artisan to manipulate the property by varying gelatinization and amounts of the components/starch and come to he claimed invention.
In response to applicant’s arguments that the process of making hydrogenated starch hydrolysate in Borkan is different from the instant process, it is pointed out that the independent claim does not recite any process steps. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies the process of making the hydrolyzed starch are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Action is final
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612