DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Receipt of Remarks/Amendments filed on 06/04/2026 is acknowledged. Claims 8 and 17-19 are canceled. Claims 1-7, 9-16, and 20-44 are pending. Claims 1-7, 9-14, 28-36 and 42-44 are withdrawn. Claim 15 is amended. Claims 15-16, 20-27 and 37-41 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Rejection As Necessitated by the Amendment Filed 06/04/2026
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-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
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 15-16, 20-22, 26-27, 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Madhavamenon et al. (Of record), hereinafter Madhavamenon, and in view of Alfekaiki, D. (Of record), and Joshi, H. (Of record), and Fang et al. (Of record), herein Fang.
Regarding Claim 15, Madhavamenon discloses a method of making instant water soluble, stable, phytonutrient rich spice/herb extracts exhibiting significant antioxidant and other bioactivities, in a ready to use form and a composition for beverage and food applications to deliver phytonutrients (Abstract). Madhavamenon expressly teaches the preparation of fortified powdered drinks comprising spice extract powder of cumin, coriander, ginger, cardamom etc. (Example 8).
Madhavamenon also teaches other herbs including clove, fennel, ginger, caraway etc. (Claims 1 and 10). The phytonutrient extract comprises polyphenols and volatile oils, such as fatty acids, fatty alcohols, saponins etc. (Claim 11). The composition is incorporated in beverage or food or dairy item or as a capsule or tablet or syrup (Col. 10, lines 14-21).
Regarding the choice of combination of spices, Alfekaiki provides the motivation to try and combine members of Apiaceae family, teaching that plants in these family have the advantage of providing rare fatty oils that are useful in human nutrition and technical applications, for example petroselinic acid (C18:1) (Introduction). Alfekaiki teaches that these plants provide dietary antioxidant (p. 8). Members of the family of Apiaceae include anise, cumin, fennel and caraway (p. 8).
Madhavamenon does not teach the ratio of cumin, caraway and fennel as claimed, and the natural gum.
Joshi teaches a process of making a solid dosage form composition of essential oils comprising the steps of: i) mixing therapeutically effective amount of essential oil or a mixture of essential oils on adsorbents or absorbents; ii) mixing with surfactant; iii) mixing with excipients of solid dosage forms and iv) converting to a solid dosage form as a tablet or capsule (Claim 9). Joshi expressly teaches a tablet composition made by adsorption of essential oils on an adsorbent by mixing of aspartame sweetening agent, a sodium lauryl sulfate surfactant, gum arabica binder and then with sorbitol diluent and then compressed to a tablet [0027]. The tablet comprises 10 mg each of eucalyptus oil, peppermint oil, and clove oil, reading on the 1:1:1 ratio of the three oils [0027]. Joshi also teaches other herbal essential oils including caraway, cumin, clove, eucalyptus, fennel, jasmine, oregano, peppermint, sage etc. and mixtures thereof (Claim 13).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Joshi and Alfekaiki with Madhavamenon and use three Apiaceae seeds at the ratio taught by Joshi in the composition of Madhavamenon. One would have been motivated to do so because Alfekaiki has taught the advantages of using Apiaceae seeds for applications to human nutrition. One would necessarily try the finite combination of seeds, starting with three seeds per the guidance of Joshi, which teaches a ratio of 1:1:1 of three herbs.
One would also include the gum arabica binder taught by Joshi if preparing a tablet composition per the guidance of Joshi [0027]. This is a situation where elements of references are combined in a predictable manner so that the elements retain their function, with the gum arabica being a commonly used binder for tablets, and does not modify the function of the active components. As such, the artisan would enjoy a reasonable expectation of success. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Because Madhavamenon teaches the same seeds cumin, caraway and fennel, which the instant claim and specification notes to contain C16 – C18 fatty acids in percentage greater than 45% with respect to the total fatty acids and containing fatty acids of at least 21% w/w (p. 9), Joshi therefore renders obvious this feature of the claim as it is an inherent property. Because the prior art composition is the identical composition claimed, the composition must necessarily have the characteristics claimed in Claim 15. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the Applicant to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Madhavamenon is silent on the ejection force in Claims 16 and 21. In the absence of a definition of “ejection force” in the instant Specification, ejection force will be interpreted to mean the force applied to move a compressed powder, and will be interpreted to encompass ejection force.
Fang is in a related field and teaches beverage products containing encapsulated probiotic bacteria entrapped within a gelled mixture (Abstract). Fang teaches the use of food grade biopolymers as suitable encapsulating agents for probiotic bacteria, wherein suitable biopolymers include alginate, gum acacia (same as gum arabic), psyllium seed gum, quince seed gum etc., which are natural gum ([0047], [0061]). Fang teaches preparing capsules using food grade biopolymers, whey protein isolate and alginate, as encapsulating agents, and reports the capsule having a trigger force of 0.01N (Examples and 3). Fang also teaches that various combinations of biopolymers produce strong and highly desirable capsules, prepared using an extrusion encapsulation method [0047].
The invention of Madhavamenon is suitable for the preparation of nutritional or functional food and/or beverages with enhanced nutritional quality, say antioxidant effect and bioactivity (Col. 1, lines 23-25). Madhavamenon teaches its extract is blended with additives having encapsulating properties and water solubility enhancing properties to protect the spice/herb phytonutrients and antioxidants for more storage, heat or light stability (Col. 6, lines 61-65). Fang’s invention delivers encapsulated nutrients such as probiotic bacteria in comestible products including juice beverages, utilizing biopolymers in its capsules to protect the probiotic ([0001], [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Fang with Madhavamenon and use food grade biopolymers to encapsulate and protect the nutritional components in the composition of Madhavamenon. By using any of the biopolymers taught by Fang, inter alia seed gums or gum arabic, one would be able to obtain such protection. Further, gums such as gum arabic would also enhance the lubrication of the composition, lowering the ejection/trigger force, as shown by Fang, and would render the instant claim obvious. Because the prior art composition is the identical composition claimed, the composition must necessarily have the characteristics claimed as the property is not severable from the composition. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. Furthermore, regardless of the recitation of its name/role/use, the composition used in the method claims is examined based on the components and not by what it is called, their mechanism of action, or their role.
Regarding Claim 16, Madhavamenon teaches embodiments concentrated seed extracts rich in phytonutrients are directly blended with the additives, but does not require additional lubricating agents, for example, additives with encapsulating properties (Col. 12, lines 21-34).
Regarding Claim 20, Joshi has taught the mixing of components prior to compression tableting [0027].
Regarding Claim 21, steps (i) and (iii) have been addressed supra. Regarding step (ii), while Joshi teaches the mixture with gum, it doesn’t teach the length of time for mixing. However, one of ordinary skill in the art would find it obvious to adjust the mixing time as a matter of experimentation and optimization. The adjustment of particular conventional working is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan in order to obtain the desired homogeneity/heterogeneity. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Furthermore, there appears to be no criticality to the amount of time of mixing. While Applicant notes in the instant specification that times longer than 30 minutes are not useful and “can lead to overmixing, which has a negative impact on the bioavailability”, Applicant does not show any data to corroborate this statement (p. 21).
Regarding Claim 22, Madhavamenon teaches the spice and herb are powdered to appropriate particle size, which the Examiner interprets to mean that the spices have been granulated prior to extraction (Col. 10, lines 62-67; Col. 19, lines 2-6).
Regarding Claim 26, Madhavamenon teaches the preparation of a free flowing fine powder comprising 250 mg of a spice powder blend in a 5 g mixture with cocoa powder, flavor, sugar and vanilla (Example 8). Another example is a combination of 400 mg cumin powder with 25 g potato chips (Example 9). As such, the concentration range of the seed powder in a solid composition is within the 1-35% claimed. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding Claim 27, Joshi has taught gum arabic [0027].
Regarding Claim 37, Joshi has taught herbal oil ratio of 1:1:1 [0027].
Regarding Claims 38-39, the optimization of mixing times have been addressed above. Vide supra.
Claims 23-24 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Madhavamenon in view of Alfekaiki, Joshi, and Fang, as applied to Claims 21-22 above, and in further view of Hayashi, H. (Of record).
The teachings of Madhavamenon, Alfekaiki, and Joshi have been set forth supra.
Regarding 23 iia), Madhavamenon does not teach granulation of a preparation with a natural gum.
Hayashi teaches improving the emulsifying power of gum Arabic by creating particles of gum arabic that do not adhere to one another, and are obtained by granulating the gum arabic and heating to 40°C or higher in an atmosphere having a relative humidity of 30 to 100% (Abstract).
Regarding Claim 24, Hayashi teaches method for modifying gum Arabic to have improved emulsifying ability and stability, which comprises a step of heating the gum arabic at a temperature of not less than 40 ˚C in an atmosphere having a relative humidity of 30-100% (p. 3). Hayashi expressly teaches preparation of gum Arabic samples adjusted to a relative humidity of 30% (pp. 19-25, Example 1). Hayashi also teaches that at 10% and 20%, the preparations are dehydrated on the surface (pp. 33-34, Table 7). Further, increasing the relative humidity condition resulted in a decrease in average particle diameter of the product emulsion (p. 34). The heat treatment is preferably carried out under a relative humidity condition of not less than 20% (p. 35).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Hayashi to that of Madhavamenon and dry the gum arabic granules starting with the conditions of Hayashi. One would modify the conditions according to desired stability, dehydration, and particle diameter of the product, noting that the relative humidity may be at 30%, but not less than 20%.
Regarding Claims 40-41, the optimization of mixing times have been addressed above. Vide supra.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Madhavamenon in view of Alfekaiki, Joshi and Fang, as applied to Claims 21-22 above, and in further view of Kaushal et al. (Of record), hereinafter Kaushal.
The teachings of Madhavamenon, Alfekaiki, and Joshi have been set forth supra. The arts are silent on the type of granulation as claimed in Claim 25. However, Madhavamenon teaches the spice and herb are powdered to appropriate particle size, which the Examiner interprets to mean that the spices have been granulated prior to extraction (Col. 10, lines 62-67).
Regarding the type of granulation, Kaushal teaches drying slices of ginger, which were then pulverizered into powder, sieved, and packed (p. 238). Ginger tablets (gingoli) were prepared by wet granulation method with varying concentrations of ginger powder and comparing three different binding agents (p. 238).
One with ordinary skill in the art would have applied the known technique of wet granulation of a spice according to the method taught by Kaushal, to the method of Madhavamenon in order to granulate the cumin, fennel, and/or caraway. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Response to Arguments:
Applicant traversed the 103 rejection over Madhavamenon in view of Alfekaiki and Joshi, and Fang. Specifically:
Applicant argued that Madhavamenon does not relate to lubricating agents and relates instead to a method of phytonutrients extraction in which, in some preparations, de-oiling of spices can be employed prior to extraction. Applicant further argued that Madhavamenon solely mentions the term "encapsulation" to state that extracts and additives can be homogenized to effect good encapsulation.
The Examiner has considered the argument but found it unpersuasive. Madhavamenon clearly discloses a method of making phytonutrient rich spice/herb extracts exhibiting significant antioxidant and other bioactivities…for beverage and food applications to deliver phytonutrients (Abstract; italicized for emphasis). Madhavamenon expressly teaches compositions comprising the spice extract powder of cumin, coriander, ginger, cardamom etc., and incorporating in beverage or food or dairy item or as a capsule or tablet or syrup.
Regarding the argument that Madhavamenon teaches some preparations with de-oiling the extract, Applicant appears to be of the persuasion that, because the reference some preparations with de-oiling the extract, this somehow constitutes a teaching away from the claim. This is not persuasive. Even preferred or exemplified embodiment does not constitute a teaching away from other embodiments disclosed within the four corners of the reference, including non-preferred embodiments. Applicant is reminded that the disclosure of a reference must be considered as expansively as is reasonably possible to determine the full scope of the disclosure. Thus, the fact that Madhavamenon teaches some preparations with de-oiling the extract does not negate or direct the artisan away from the broader teaching of the reference, which expressly provides for, and, thus, clearly contemplates the use of phytonutrient rich spice/herb extracts in beverage, food item, or as a capsule, tablet, or syrup.
Lastly, because the prior art composition is the identical composition claimed, the composition must necessarily have the characteristics claimed as the property is not severable from the composition. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. Regardless of the recitation of its name/role/use, the composition used in the method claims is examined based on the components and not by what it is called, their mechanism of action, or their role. Therefore, Madhavamenon does not need to label its components as “lubricating agent”. The fact that the same components are taught by Madhavamenon as the instant claims would mean that the components would exert the same properties.
Applicant appears to argue that argued that Alfekaiki teaches the use the seed oils as antioxidants, and only discloses that seeds are a valuable resource for the production of vegetable oils that can be used as "suppliers of fatty acids in human nutrition or technical applications", but that this disclosure does not teach the lubricating action of fruits containing the seeds or of the seeds.
Firstly, as above, Alfekaiki does not need to label its components as “lubricating agent”. Secondly, Alfekaiki is relied on to provide the motivation to combine members of Apiaceae family, because they providing fatty oils that are useful in human nutrition and technical applications. See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996)(“[T]he motivation in the prior art…does not have to be identical to that of the applicant to establish obviousness.” Applicant is further reminded that “[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls… [A]ny need or problem known in the field of endeavor at the time of the invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419-20 (2007).
Applicant appears to claim unexpected result. Applicant states that the inventors of the present invention were the first to analyze the fatty acid content of cumin, caraway, and fennel in comparison with the fatty acid content of magnesium stearate, which is one of the most used lubricating agents in the world. Applicant claims that the amount and ratio of the different species in the mixture are critical.
The Examiner was not persuaded for many reasons. First, it is noted that the features upon which applicant relies (i.e., comparing the fatty acid content of the seed to magnesium stearate) is not recited in the rejected claims. Second, in order to be persuasive, Applicant must compare the its method with the closest prior art, i.e. Madhavamenon. Please see MPEP §716.02(b)[R-2], which states, “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’ Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. At this time, Applicant has not shown such difference, and is deemed expected from the prior art. The establishment of a property that is also found in the prior art fails to provide a patentable distinction between the products and, therefore, is insufficient to rebut the evidence of obviousness. Please see MPEP §716.02(c)[R-2] (“Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. [n re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977).”)
Applicant remarks that Joshi’s method describing making solid dosage forms of essential oils is based on the absorption or adsorption of the essential oils on a solid matrix and is different from the claimed processes. Further, Joshi expressly discloses that the tablets disclosed therein contain "lubricants" in addition to the essential oils, therefore, Joshi does not even suggest that the essential oils can act as lubricants. Further, Applicant notes that the Examiner admits Joshi teaches gum arabica as binder and not as lubricating agent.
The Examiner has addressed the argument about the lack of teaching of the oils as “lubricants” in the responses supra. Similar rationale applies to Joshi’s teaching of gum arabica as binder and not as lubricating agent, i.e. regardless of the recitation of its name/role/use, the composition used in the method claims is examined based on the components and not by what it is called or their mechanism of action.
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 (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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