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 .
This office action is in response to the application filed on October 19, 2023. The earliest effective filing date of the application is June 16, 2023.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d), filed on June 16, 2023.
Status of Application
The amendment filed June 24, 2026 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 2, 5 – 7, and 10 – 14
Withdrawn claims: 13 and 14
Amended claims: 1, 2, 5 – 7, 10, and 11
Cancelled claims: 3, 4, 8, and 9
Claims currently under examination: 1, 2, 5 – 7, and 10 – 12
By not repeating the previously presented objection/rejection(s), it is sufficiently clear that said objection/rejection(s) are withdrawn.
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.
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 – 4 and 6 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over Prasad et al. (U.S. Patent No. 6,287,603 B1) in view of Shen et al. (CN 102512459 A – WIPO Machine Translation), and Tingting et al. (Effect of calcium ions on the acid resistance and heat resistance of xanthan gum solution. Fermentation Technology Communication. Vol 45. Pp. 157 – 169. (2016) – Google Machine Translation).
Regarding claim 1, Prasad teaches a method of making a cyclodextrin inclusion complex comprising the steps of:
a) dissolving γ-cyclodextrin in water in a reaction vessel to form a first solution (Claim 1; col. 5, lines 57 – 61); adding one or more actives to the first solution with stirring to form a second solution of the one or more actives and γ-cyclodextrin (Claim 1); and stirring the second solution for a sufficient amount of time and at a sufficient temperature to form inclusion complexes between the cyclodextrin and the one or more actives (Claim 1 – i.e., mixing an active ingredient, γ-cyclodextrin, and a part of water to allow embedding to obtain a first feed liquid);
b) adding guar gum, locust bean gum, carrageenan and xanthan gum to the solution of step (a) to form a solution having an increased solids content (Claim 1; col. 5, lines 41 – 56 – i.e., mixing the first feed liquid with a composite colloid stabilizer solution to obtain a second feed liquid, wherein a colloid stabilizer in the composite colloid stabilizer solution comprises at least three selected from the group consisting of agar, guar gum, locust bean gum, carrageenan, and xanthan gum).
Prasad does not teach the active ingredient is a superfine powder of a Ganoderma lucidum fruiting body.
Shen teaches an ultrafine (i.e., superfine) Ganoderma lucidum powder. Shen teaches Ganoderma lucidum has functions such as inhibiting tumors, regulating immune capabilities, regulating blood lipids, delaying aging, among other effects (p. 1, paragraph 2). Shen teaches the ultrafine (i.e., superfine) Ganoderma lucidum powder is made from mature Ganoderma lucidum subentities (i.e., fruiting bodies – p. 3, Detailed Description of the Embodiments, Steps 1 – 4).
Prasad and Shen are combinable because they are concerned with the same field of endeavor, namely, pharmaceutical powders. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected the ultrafine Ganoderma lucidum powder of Shen as the active ingredient in the cyclodextrin inclusion complex of Prasad because Ganoderma lucidum has functions such as inhibiting tumors, regulating immune capabilities, regulating blood lipids, delaying aging, among other effects.
Prasad does not teach mixing the solution of step (b) (i.e., the second feed liquid) with a metal ion solution wherein metal ions in the metal ion solution comprise iron ions, calcium ions, or zinc ions.
Tingting investigates the impact of calcium ions on the viscosity of xanthan gum. Tingting teaches the main chain and side chains of xanthan gum are connected by hydrogen bonds to form a double helix structure, and the hydroxyl groups on the molecular side chains make it easy to form metal salts such as calcium, sodium, and potassium have negatively charged glucuronic acid groups on their side chains (p. 157, paragraph 1). Tingting teaches in order to form a homogeneous solution with optimal rheological properties, some types of salts are usually present in the xanthan gum application system (p. 157, paragraph 2). Tingting teaches under acidic and high-temperature conditions, the presence of a certain concentration of calcium ions can reduce the decrease in viscosity of xanthan gum solutions, thereby improving their acid and heat resistance (p. 160, paragraph 5).
Prasad and Tingting are combinable because they are concerned with the same field of endeavor, namely, the behavior of hydrocolloids. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have mixed the solution of step (b) with calcium ions, as taught by Tingting in the method of Prasad because calcium ions can reduce the decrease in viscosity of xanthan gum solutions, thereby improving their acid and heat resistance.
Prasad does not teach subjecting the solution of step (b) (i.e., the second feed liquid) further comprising calcium ions to adjustment to acidic and shearing sequentially to obtain a third feed liquid.
Tingting teaches xanthan gum is an anionic polymer, and its viscosity is sensitive to pH because changes in pH can lead to changes in the charge density on the xanthan gum molecular chain. The decrease in pH causes the carboxyl groups in the xanthan gum molecule to change from an ionized state to a non-ionized state, thereby inhibiting the electrostatic repulsion of the side chains, making the molecular chain shape more compact, resulting in a decrease in solution viscosity (p. 159, paragraph 2). Tingting teaches after adding calcium ions to a xanthan gum solution, 20% citric acid solution was added to adjust the pH to 3.0, 4.0, and 5.0, respectively; then stirring was continued for 15 min (i.e., the solution of step (b) is subjected to adjustment to acidic and shearing sequentially to obtain a third feed liquid – p. 158, paragraphs 8 and 9).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the pH of a solution comprising xanthan gum and calcium ions, then sheared, as taught by Tingting in the method of Prasad because performing the recited steps in sequence is known to produce xanthan gums with the desired beneficial effects of calcium ions.
While Prasad does not teach mixing the third feed liquid with remaining water to obtain a second mixture, MPEP § 2144.04.IV.C states selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP § 2144.04.IV.C also states the selection of any order of mixing ingredients is prima facie obvious. Therefore, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added water during any step of the process, given that water is added during step (a), including splitting the addition of water between steps (a) and after the pH adjustment and shearing (i.e., mixing the third feed liquid with remaining water to obtain a second mixture).
Furthermore, while Prasad does not teach homogenization and heating sequentially after mixing the third feed liquid with remaining water to obtain a second mixture, Tingting teaches after adding calcium ions to the solution, it is stirred, then heated (p. 158, paragraph 10). MPEP § 2144.04.IV.C states selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP § 2144.04.IV.C also states the selection of any order of mixing ingredients is prima facie obvious. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have stirred (i.e., homogenized) then heated the third feed liquid after adding water.
With respect to the amount of γ-cyclodextrin in the third feed liquid, Prasad teaches the ratio of active ingredient (i.e., superfine powder of Ganoderma lucidum fruiting body) to γ-cyclodextrin is between about 0.001:1 and 100:1 (Claim 3). Prasad teaches a further economic benefit of using cyclodextrin complexes is that less of the cyclodextrin complex is needed to flavor food compared to the natural spice or flavor (col. 2, lines 8 – 11).
Therefore, while Prasad does not teach the tea comprises 0.1 wt% to 0.2 wt% γ-cyclodextrin, one of ordinary skill in the art would have adjusted the amount of Ganoderma lucidum ultrafine powder (i.e., superfine powder of Ganoderma lucidum fruiting body) and γ-cyclodextrin included in the cyclodextrin inclusion complex during routine optimization to find the Ganoderma lucidum composition with the desired flavor. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed γ-cyclodextrin wt%, 0.1 wt% to 0.2 wt%, would thus be obvious.
Regarding the amount of metal salt additive in the third feed liquid, Tingting teaches the calcium is analytical grade CaCl2 (i.e., a metal salt additive – p. 158, paragraph 2).
Tingting does not teach the CaCl2 is food grade, however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected a food grade CaCl2 for the purpose of producing a food product.
While Tingting is silent with respect to whether the CaCl2 is provided as an aqueous solution, it would have been obvious to one of ordinary skill in the art to have provided the CaCl2 as an aqueous solution because the method of Prasad produces an aqueous solution, and an aqueous salt solution would have been as suitable to deliver salt to the composition as solid salt in a method which produces an aqueous solution.
Tingting teaches an increase in calcium concentration results in a higher viscosity of the xanthan gum (p. 159, Figures 1 and 2). Therefore, the calcium concentration of the solution is a result-effective variable.
Therefore, while Prasad does not teach the composition comprises 0.01 wt% to 0.02 wt% CaCl2 (i.e., food-grade metal salt additive), one of ordinary skill in the art would have adjusted the amount of CaCl2 in the cyclodextrin inclusion complex during routine optimization to find the Ganoderma lucidum tea with the desired viscosity. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed food-grade metal salt additive wt%, 0.01 wt% to 0.02 wt%, would thus be obvious.
In summary, by applying the obvious modifications as described above to the method of Prasad, one of ordinary skill in the art would have arrived at the following method before the effective filing date of the instant invention:
a) dissolving γ-cyclodextrin in water in a reaction vessel to form a first solution; adding ultrafine (i.e., superfine) Ganoderma lucidum fruiting body powder to the first solution with stirring to form a second solution of the one or more actives and γ-cyclodextrin; and stirring the second solution for a sufficient amount of time and at a sufficient temperature to form inclusion complexes between the cyclodextrin and the one or more actives (i.e., mixing an active ingredient, γ-cyclodextrin, and a part of water to allow embedding to obtain a first feed liquid);
b) adding guar gum, locust bean gum, carrageenan and xanthan gum to the solution of step (a) to form a solution having an increased solids content (i.e., mixing the first feed liquid with a composite colloid stabilizer solution to obtain a second feed liquid, wherein a colloid stabilizer in the composite colloid stabilizer solution comprises at least three selected from the group consisting of agar, guar gum, locust bean gum, carrageenan, and xanthan gum);
c) adding calcium ions to the solution of step (b), adjusting the acidity of the resulting solution, and stirring (i.e., shearing – mixing the second feed liquid with a metal ion solution to obtain a first mixture, and subjecting the first mixture to adjustment to acidic and shearing sequentially to obtain a third feed liquid, wherein metal ions in the metal ion solution comprise iron ions, calcium ions, or zinc ions);
d) adding water to the solution of step (c) (i.e., mixing the third feed liquid with remaining water to obtain a second mixture);
e) stirring (i.e., homogenizing) the solution of step (d); and
f) heating the solution (i.e., liquid Ganoderma lucidum compound preparation) of step (e);
wherein the liquid Ganoderma lucidum compound preparation comprises 0.1 wt% to 0.2 wt% of the y-cyclodextrin, and the metal ion solution is an aqueous solution of a food-grade metal salt additive, and the liquid Ganoderma lucidum compound preparation comprises 0.02 wt% to 0.04 wt% of the food-grade metal salt additive.
Regarding claim 2, Shen teaches the Ganoderma lucidum ultrafine powder has 100% of the particle size is less than 9.96 μm, a median particle size (D50) of 2.92 μm, and a specific surface area of 3.63 μm/g (p. 2, final paragraph).
The range of average particle size of the Ganoderma lucidum ultrafine powder, less than 9.96 μm, as disclosed by Shen, overlaps with the claimed range of 2 μm to 5 μm. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
While Prasad does not teach the resulting tea comprises 3 wt% to 6 wt% Ganoderma lucidum ultrafine powder (i.e., superfine powder of Ganoderma lucidum fruiting body), it would have been obvious to one of ordinary skill in the art at the time the application was filed to have optimized the concentration of fruiting bodies dependent on the intensity of Ganoderma lucidum flavor desired. Therefore, the proportion of superfine powder merely reflects the obvious optimization of the prior art.
Regarding claims 6 and 7, Prasad teaches without wishing to be bound by theory it is believed that the increased efficiency is the result of a second coating of gum acacia, maltodextrin, modified dextrins, or mixtures thereof forming on the cyclodextrin-active inclusion complex (col. 7, lines 48 – 52). Prasad teaches the increased efficiency may also be partly due to free active, i.e., active not complexed with cyclodextrin, being adsorbed onto the surface of or encapsulated in the pores of the gum acacia, maltodextrin, modified dextrins, or mixtures thereof (col. 7, lines 52 – 56).
Therefore, while Prasad does not teach the composition comprises 0.21 wt% to 0.69 wt% colloid stabilizer, one of ordinary skill in the art would have adjusted the amount of colloid stabilizer included in the cyclodextrin inclusion complex during routine optimization to find the Ganoderma lucidum tea with the desired complexation efficiency. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed colloid stabilizer wt%, 0.21 wt% to 0.69 wt%, would thus be obvious.
Regarding claims 10 and 11, while the modified method of Prasad is silent with respect to the proportion of water added in step (a) of the modified method relative to the total volume of the composition, MPEP § 2144.04.IV.C states selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. MPEP § 2144.04.IV.C also states the selection of any order of mixing ingredients is prima facie obvious. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added 50 to 60% of the volume of the tea of the modified method of Prasad as water during step (a) of the modified method.
Tingting teaches the pH of the solution comprising the xanthan gum complexed with calcium resulted in an increase in viscosity with an increase in pH (p. 159, Figures 1 and 2). Therefore, the pH of the solution is a result-effective variable.
Therefore, while Prasad does not teach the adjustment to acidic condition adjusts to pH to between 4.1 to 4.2, one of ordinary skill in the art would have adjusted the acidic conditions to a pH of 4.1 to 4.2 during routine optimization to find the Ganoderma lucidum tea with the desired viscosity. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed adjustment to acidic conditions pH, between 4.1 to 4.2, would thus be obvious.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Prasad et al. (U.S. Patent No. 6,287,603 B1) in view of Shen et al. (CN 102512459 A – WIPO Machine Translation), and Tingting et al. (Effect of calcium ions on the acid resistance and heat resistance of xanthan gum solution. Fermentation Technology Communication. Vol 45. Pp. 157 – 169. (2016) – Google Machine Translation), as applied to claim 1 above, and further in view of Cid-Samamed (Cyclodextrins inclusion complex: Preparation methods, analytical techniques and food industry applications. Food Chemistry. Vol 384. (2022)) and Zijlstra (Wattage and Amplitude for Ultrasonic Homogenizers. Laboratory Supply Network. (2017). Retrieved from: https://labsup.net/blogs/blog/wattage-and-amplitude-for-ultrasonic-homogenizers).
Prasad teaches the complexation (i.e., embedding) temperature is generally between about 4 °C and 75 °C (col. 6, lines 38 – 41). Prasad teaches the time for forming the complex is typically between 15 minutes and about 24 hours (col. 6, lines 41 – 43).
The range of complexation (i.e., embedding) temperatures, between about 4 °C and 75 °C, as disclosed by Prasad, overlaps with the claimed range of 50 °C to 60 °C. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
The range of complexation (i.e., embedding) times, between about 15 minutes and 24 hours, as disclosed by Prasad, overlaps with the claimed range of 40 minutes to 60 minutes. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Prasad does not teach the complexation (i.e., embedding) is conducted under an ultrasonic treatment. Prasad teaches the complexation (i.e., embedding) is conducted under stirring (i.e., shearing – col. 6, lines 7 – 8).
Cid-Samamed investigates the production of cyclodextrin complexes for use in beverages. Cid-Samamed teaches cyclodextrin complexes for use in beverages may be produced by ultrasonic homogenization (p. 5, col. 2, paragraph 3).
Prasad and Cid-Samamed are combinable because they are concerned with the same field of endeavor, namely, beverages comprising cyclodextrin complexes. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize an ultrasonic homogenizer during the complexation (i.e., embedding) in the method of Prasad, as taught by Cid-Samamed, because ultrasonic treatment is a known technique to assist the complexation of cyclodextrin around an active ingredient.
Prasad does not teach the ultrasonic treatment has an ultrasonic power of 300 W to 500 W.
Zijlstra teaches the wattage used by an ultrasonic homogenizer operating at constant amplitude can vary during processing (p. 1, paragraph 1). Zijlstra teaches this happens because the resistance to the movement of the probe determines how much power needs to be delivered to maintain the desired amplitude (p. 1, paragraph 1). Zijlstra teaches the amount of energy required to maintain a given amplitude will change depending on the viscosity of a liquid sample and, in turn, other factors which may affect viscosity such as temperature (p. 1, paragraph 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have performed the ultrasonication at 300 W to 500 W in the modified method of Prasad to accommodate the probe and amplitude needs to achieve the desired ultrasonication intensity.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Prasad et al. (U.S. Patent No. 6,287,603 B1) in view of Shen et al. (CN 102512459 A – WIPO Machine Translation), and Tingting et al. (Effect of calcium ions on the acid resistance and heat resistance of xanthan gum solution. Fermentation Technology Communication. Vol 45. Pp. 157 – 169. (2016) – Google Machine Translation), as applied to claim 1 above, and further in view of Genizer (High Pressure Homogenizer. Genizer. (December 28, 2022). Retrieved from Wayback Machine Archive - https://web.archive.org/web/20221228222318/https://www.genizer.com/art/high-pressure-homogenizer-introduction_a0049.html), O’Driscoll (The Forces Involved in Homogenization Explained. Laboratory Supply Network. (2019). Retrieved from: https://labsup.net/blogs/blog/forces-involved-in-homogenization), and Partridge et al. (16.4.4 Tunnel Pasteurization. In: Handbook of Brewing (3rd Edition). Taylor & Francis. P. 509. (2018)).
Prasad teaches the mixture is typically stirred at a rate of between about 300 rpm and 1500 rpm (col. 6, lines 7 – 8). Prasad teaches the higher the agitation rate the faster the rate of formation of the cyclodextrin-active inclusion complex (col. 6, lines 8 – 10). Prasad teaches the stirring rate, however, cannot be so high as to create sufficient shear to breakdown the cyclodextrin molecules (col. 6, lines 10 – 12). Prasad teaches the stirring rate should be as high as possible without damaging the cyclodextrin molecules (col. 6, lines 12 – 14).
While Prasad does not teach the shearing during step (c) of the modified method of Prasad is completed at 3,000 rpm to 5,000 rpm, one of ordinary skill in the art would have adjusted the shearing rate during routine optimization to find the desired rate at which the calcium and xanthan gum interact without breaking down the cyclodextrin molecules. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed shearing speed, 3,000 rpm to 5,000 rpm, would thus be obvious.
With respect to the shearing time, Tingting teaches the shearing time after pH adjustment is 15 minutes (p. 158, paragraphs 8 and 9).
Prasad does not teach the homogenization of the composition is conducted at a pressure of 20 MPa to 25 MPa.
Genizer teaches homogenization and emulsification in the food and beverage industry to improve stability, taste, appearance, and encapsulation of nutrients in food products (p. 2, bullet 3). Genizer teaches during the homogenization process, changes in physical, chemical, structural properties occur, and as a result, homogeneous suspension takes place at nanoscale (p. 1, paragraph 1). Genizer teaches the pressure of a conventional homogenizer is within (i.e., up to) 15,000 psi (103 MPa – p. 1, paragraph 1).
Prasad and Genizer are combinable because they are concerned with the same field of endeavor, namely, beverages comprising encapsulated nutrients. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to homogenize the tea, as taught by Genizer in the method of Prasad to achieve the desired stability, taste, appearance, and encapsulation of nutrients. Furthermore, the range of homogenization pressure, up to 15,000 psi (103 MPa), as disclosed by Genizer, overlaps with the claimed range of 20 to 25 MPa. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Prasad does not teach the homogenization of the composition is conducted for 5 to 10 minutes.
O’Driscoll teaches during homogenization, particles are traveling at high speeds (p. 2, paragraph 8). O’Driscoll when particles collide with one another, the force of the impact may be enough to erode the surface of the particle or facilitate complete breakup of the particle or an agglomerate (p. 2, paragraph 8). O’Driscoll teaches this is a factor in all types of homogenization involving particles traveling at high speeds (i.e., high pressure homogenization – p. 2, paragraph 8). Therefore, because impacts are continuously occurring during homogenization, the duration of homogenization affects the degree of homogenization, and therefore the resulting final texture of the resulting beverage.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have homogenized the tea of the modified method of Prasad for 5 to 10 minutes because the degree of homogenization is time-based, therefore one of ordinary skill in the art would have selected the appropriate amount of homogenization time to arrive at a desired texture.
Prasad does not teach the heating of the tea is conducted at 90 °C to 100 °C minutes.
Partridge teaches bottle pasteurization achieved via a tunnel pasteurizer is the most reliable way of producing a long shelf life product (p. 509, paragraph 3). Partridge teaches bottle pasteurization is time dependent because the heat needs to gradually penetrate through the container substrate to the core of the container, while avoiding thermal shock to the container (p. 509, paragraph 3). Partridge teaches the superheat zone is critical as it is here that the final heating to achieve a temperature greater than 60 °C occurs (p. 510, paragraph 3). Partridge teaches the superheat zone is critical as it is here that the final heating to achieve a temperature greater than 60 °C occurs (p. 510, paragraph 3).
Prasad and Partridge are combinable because they are concerned with the same field of endeavor, namely, beverages. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have bottle pasteurized (i.e., heated) the modified tea of Prasad, as taught by Partridge after homogenization because bottle pasteurization achieved via a tunnel pasteurizer is the most reliable way of producing a long shelf life product. Furthermore, the range of pasteurization (i.e., heating) temperature, greater than 60 °C, as disclosed by Partridge, overlaps with the claimed range of 90 °C to 100 °C. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Prasad does not teach the pasteurization (i.e., heating) of the composition is conducted for 15 to 30 minutes.
Partridge teaches bottle pasteurization is time dependent because the heat needs to gradually penetrate through the container substrate to the core of the container, while avoiding thermal shock to the container (p. 509, paragraph 3).
While Partridge does not teach the precisely claimed duration of pasteurization, one of ordinary skill in the art would have adjusted the pasteurization (i.e., heating) time during routine optimization to find the pasteurization (i.e., heating) time that balances heat penetration without thermal shock. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed pasteurization (i.e., heating) time, 15 to 30 minutes, would thus be obvious.
Response to Arguments
Applicant's arguments filed June 24, 2026 have been fully considered but they are not persuasive.
Applicant argues a person of ordinary skill in the art has no motivation to obtain a liquid preparation on the basis of Prasad (p. 7, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. The result of the above modified method of Prasad is a liquid, therefore, the teachings of Prasad, in combination with the additional cited references, results in a liquid Ganoderma lucidum compound preparation.
Applicant argues the y-cyclodextrin, composite colloid stabilizer, and metal ions are to protect active ingredients of Ganoderma lucidum, and prevent insoluble fibers from settling in the system, so as to finally obtain the Ganoderma lucidum compound preparation with high content of active ingredients and desirable stability (p. 7, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. In response to applicant's argument that the y-cyclodextrin, composite colloid stabilizer, and metal ions are to protect active ingredients of Ganoderma lucidum, and prevent insoluble fibers from settling in the system, so as to finally obtain the Ganoderma lucidum compound preparation with high content of active ingredients and desirable stability, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues the amount of cyclodextrin in the feed liquid of Prasad is significantly higher than claimed, therefore a person of ordinary skill in the art would have no motivation to arrive at the presently claimed invention (p. 7 paragraph 3; p. 8, paragraph 1).
Applicant’s argument has been carefully considered however the argument is not persuasive. MPEP § 2144.05.III.C states “Applicants may rebut a prima facie case of obviousness based on optimization of a variable disclosed in a range in the prior art by showing that the claimed variable was not recognized in the prior art to be a result-effective variable.” Applicant has not offered evidence that the amount of cyclodextrin is not result-effective. Therefore, Applicant’s argument is not persuasive.
Applicant argues a person of ordinary skill in the art would have had no motivation to select a CaCl2 concentration of 1.0 to 2.5% (p. 8, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. MPEP § 2144.05.III.C states “Applicants may rebut a prima facie case of obviousness based on optimization of a variable disclosed in a range in the prior art by showing that the claimed variable was not recognized in the prior art to be a result-effective variable.” Applicant has not offered evidence that the amount of CaCl2 is not result-effective. Therefore, Applicant’s argument is not persuasive.
Conclusion
No claims are allowed.
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.
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/L.J.M./Examiner, Art Unit 1793
/Michele L Jacobson/Primary Examiner, Art Unit 1793
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