DETAILED ACTION
The receipt is acknowledged of applicant’s election and amendment filed 10/17/2025; and IDS filed 01/12/2023.
Claims 35-46 previously presented. Claims 36-40, 42-43 have been canceled and claims 47-57 are currently added. Claims 35, 41, 44-57 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of invention I and species (a) of any plant, claims 35, 41, 44, 47-56 in the reply filed on 10/17/2025 is acknowledged.
Claims 45-46 and 57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions II and III and species Moringa,, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/17/2025.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the foreign prior-filed application, Application No. GB 2020755.3, filed 07/13/2020, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The generic concept “plant material” claimed by claim 35, and specific plants claimed by claim 56 “macroalgae, microalgae, fungi, spirulina, wheatgrass, UV treated chestnut, Portobello mushrooms, hibiscus flower, seaweed, Chlorella, and baobab” are not described in the GB application 2020755.3 filed 07/13/2020. However, claim 6 of GB application 2103580.3 filed 3/15//2021 recite “macroalgae, microalgae, fungi, spirulina, wheatgrass, UV treated chestnut, Portobello mushrooms, hibiscus flower, seaweed, Chlorella, and baobab”. Further, claims 31 and 32 of the PCT application from which the current application originates, recites: “macroalgae, microalgae, fungi, spirulina, wheatgrass, UV treated chestnut, Portobello mushrooms, hibiscus flower, seaweed, Chlorella, and baobab”.
There is not adequate support for the generic concept of claimed plants in the GB application 2020755.3 filed 07/13/2020 wherein only Moronga plant is disclosed. Applicant first disclosed plant other than Moronga in GB 2103580.3 filed 03/15/2021. However, the filing date of GB 2103580.3 which is 3/15//2021, will be considered for examining instant claims 35, 41, 44, 47-56 that are directed to any plants, not necessary Moronga.
Applicants can add the plants disclosed in GB 2103580.3 and in PCT claims to the current specification.
Claim Rejections - 35 USC § 112(a)
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 35, 41, 44, 47-56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for Moringa plant for encapsulation by the claimed process, does not reasonably provide enablement for any other plant as broadly claimed by claim 35 to be encapsulated by the same process. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims: The claims are directed to a process to encapsulate or microencapsulate plant material, the process comprising the steps of: mixing milled plant material with an encapsulation agent selected from cellulose, cellulose sulphate, methylcellulose, water soluble cellulosic polysaccharides, carboxylmethyl cellulose, sodium carboxylmethyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, hydroxymethyl cellulose, to provide a homogenized mixture wherein the plant material is encapsulated by the encapsulating agent or coated with the microencapsulation agent.
The enabling disclosure must teach the skilled artisan how to make the claimed encapsulated plants to use in nutritional composition. Further, it is well established that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513.
With regard to scope, the specification placed clear boundaries on the plants embraced by the claims but makes clear that Moringa plant is used. Even the original claims of the PCT listed some plants and current claim 56 recites some plant materials, but no plant other than Moringa was actually encapsulated and used to prepare a nutritional composition. Given the divergent nature of the recited plant materials, one would conclude that the genus “plants” embraces essentially all plants in some way that may involve toxic and harmful plants, and genetically modified plants yet to be generated. Thus, it is incumbent upon the disclosure to teach the skilled artisan how to formulate the claimed the vast array of encapsulated plants such that they can be used in nutritional composition without undue experimentation.
Amount of direction provided by the inventor and existence of working examples: At the outset, it is noted that the instant disclosure does not provide a working example wherein any plant or encapsulated plant within the scope of the claims, other than Moringa plant, is produced and used nutritional composition. Although, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), lack of a working example is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. Use of plants and their extracts in pharmaceutical and nutritional arts are generally unpredictable and achieving a useful therapeutic or nutritive outcome is highly unpredictable. Thus, the relevant question in light of the failure of the application to provide a working example is whether the manner and process of making encapsulated plant, is otherwise disclosed such that the skilled artisan would be able to use the invention commensurate with the full scope of what is claimed.
The instant disclosure describes how to encapsulate Moringa plant using the claimed method of milling and homogenization of the milled Moringa with specific cellulose and cellulose derivatives. Not all plants can be encapsulated with cellulose because different plants have different properties in terms of affinity to hydrophilic or lipophilic coatings. Further not all the plants can be encapsulated with the same technique using the same materials. The specification describes only Moringa encapsulated in cellulose and derivative by milling the Moringa and homogenizing the milled Moringa with cellulose and derivatives. The specification does not teach any other plant was milled or mixed with the cellulose derivatives, then homogenized to provide the encapsulated plant material.
With regard to actually encapsulating any plant material, the application provides only speculation, and the application appears to assert a hypothetical possibility that any plant can be encapsulated by the claimed method.
State of the prior art and level of predictability in the art: The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.
The botanical art and pharmaceutical art are recognized as unpredictable. In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.
In the instant case, at the time the instant application was filed the state of the art with regard to preparing and using plant material in pharmaceutical and nutritional compositions, was at an early stage of development and preparing therapeutically effective plant material by the claimed method using any plant as currently claimed was highly unpredictable.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: Although the relative level of skill in the art is high, one of ordinary skill would not have been able encapsulate or microencapsulate any plant material encompassed by the claims using the claimed method without undue experimentation. The instant application describes Moringa plant only as a plant material encapsulated by milling the plant and mixing the milled plant with cellulose or its derivatives to provide homogenized encapsulated Moringa plant material. The guidance provided in the specification regarding encapsulating any other plant material is lacking. However, given the highly unpredictable state of the art, the skilled artisan clearly would not be able to extend these teachings and develop encapsulated broad scope of any plant material, useful or harmful, covered by the claims without extensive trial and error experimentation.
In fact, what is disclosed in the instant application with respect to encapsulating plant material amounts to no more that theoretical speculation in a highly unpredictable art. The law is clear that the first paragraph of 35 USC § 112 requires more that the disclosure of a theoretical possibility. “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that ‘a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’) Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, 1005. See also Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297 (Fed. Cir. 2005) (In response to Rasmusson’s argument that the enablement requirement of section 112 does not mandate a showing of utility or, if it does, it mandates only a showing that it is “not implausible” that the invention will work for its intended purpose, the Court states, “As we have explained, we have required a greater measure of proof, and for good reason. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.”)
In view of the broad scope of the claims, the nascent and unpredictable state of the art and the failure of the application to teach one of skill in the art how to make and use the claimed invention as asserted in the disclosure in clear, concise and exact terms, it must be concluded that one would not be enabled to make and use the invention as broadly as claimed.
Claim Rejections - 35 USC § 112(b)
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 35, 41, 44, 47-56 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 35 recites the broad recitation “cellulose”, and the claim also recites “cellulose sulphate, methylcellulose, water soluble cellulosic polysaccharides, carboxylmethyl cellulose, sodium carboxylmethyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, hydroxymethyl cellulose” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 44 depends on canceled claim 43.
Claim 44 recites the limitation "the pretreatment step" in first line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 51 is confusing as the claim recites “weight of the cellulose coating”, while the claim depends on claim 35 that recites cellulose as a member of Markush group of encapsulating agent. Is the claimed weight only of cellulose? Or the weight of any encapsulating material?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 56 recites the broad recitation, e.g. “macroalgae and microalgae”, and the claim also recites “spirulina seaweed and chlorella” which is the narrower statement of the range/limitation algae. The claim recites the broad recitation “fungi”, and the claim also recites “mushroom” which is the narrower statement of the range/limitation fungus. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 56 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of: “plant material is selected from a group consisting of macroalgae, microalgae, fungi, spirulina, wheatgrass, UV treated chestnut and Portobello mushrooms, hibiscus flower, Moringa, seaweed, Chlorella, and baobab” is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the claim recites plants, e.g. hibiscus, Moringa; and the claim recites algae, macroalgae, and microalgae, e.g. seaweed, spirulina, chlorella; the claim recites fungi, e.g. mushroom; and the claim also recites unnatural chemically treated material, e.g. UV treated chestnuts.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Regarding claim 56, according MPEP § 2171.05(h), one acceptable form of alternative expression, which is commonly referred to as a Markush group, recites members as being “selected from the group consisting of A, B and C.” See Ex parte Markush, 1925 C.D. 126 (Comm’r Pat. 1925). Only the last two members of the group are separated by the operator “AND” or “OR”. Claim 56 recites the operator “and” twice within the group: “group consisting of macroalgae, microalgae, fungi, spirulina, wheatgrass, UV treated chestnut and Portobello mushrooms, hibiscus flower, Moringa, seaweed, Chlorella, and baobab”. Furthermore, the claim rendered indefinite and confusing by the presence of “and” between “UV treated chestnut” and “Portobello mushrooms” because the claim can be interpreted as both chestnut and portobello mushroom are UV treated.
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 35, 41, 44, 47-56 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (US 2014/0087026), combined with the article by Melegari (Study of technologies for film coating of drug layered pellets using ethylcellulose as functional polymer), or the article by Katarzyna et al. (Ethylcellulose- A pharmaceutical excipient with multidirectional application in drug dosage forms development), and further combined with the article by Kibbelaar (Fully biobased size-tunable UV-absorbing nanoparticles for photoprotection) or Millikin et al.(US 10,857,101), all the references are currently cited in PTO 892, and copy of each NPL is currently provided.
Applicant Claims
Claim 35 is directed to a process to encapsulate or microencapsulate plant material the process comprising the steps of:
- mixing milled plant material with an encapsulation agent selected from cellulose, cellulose sulphate, methylcellulose, water soluble cellulosic polysaccharides, carboxylmethyl cellulose, sodium carboxylmethyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, hydroxymethyl cellulose, to provide a homogenized mixture wherein the plant material is encapsulated by the encapsulating agent or coated with the microencapsulation
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Yoon teaches products useful as food ingredients include undifferentiated, heterotrophically produced whole plant cells that are derived from one or more of numerous genera and species of edible plants having nutritionally bioactive plant cell ingredients and functional activity useful for promoting public health. The whole plant cell-derived product can be produced with desired levels of nutrients and bioactives, which can improve human nutrition. The reference teaches the use of the whole cells in food products. Rather than extract nutrients from the cells, the whole cells of the present invention are processed to make the cells suitable for use as an ingredient in food products. The heterotrophic plant cells may be harvested, washed, dried, and/or pasteurized to produce a food ingredient or food product suitable for human consumption (abstract; ¶¶ 0020-0021). The undifferentiated cells are used without extraction because extraction lose useful trace elements (¶ 0023). The plant cells are propagated and harvested, i.e. growing the whole plant without unused plant parts. The plant cells are dried under high temperatures, pasteurized and milled (¶¶ 0024-0025). The plant cells include vegetables, grains and fruits (¶¶ 0034-0037). The milling process reduces size of harvested plant cells to particle sizes less than 850 µm and more than 0.5 µm (¶¶ 0048-0050). The reference teaches encapsulating the milled dried plant cells to provide pharmaceutical dosage form (example 6 at ¶ 0068).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Yoon suggests encapsulating the milled plants, the reference does not explicitly teach cellulose or its derivatives as encapsulating materials that is mixed with the milled plants to provide homogenized mixture of encapsulated plants by cellulose or derivatives of cellulose as claimed by claim 35.
Melegari teaches coating of microparticles of pharmaceuticals using ethyl cellulose. Ethyl cellulose is used as solution in ethanol. Ethyl cellulose is biocompatible and useful as sustained release film coating (Page 56-68, paragraph 4.3.2.1).
Katarzyna teaches ethyl cellulose is used to encapsulate bioactive materials to provide sustained release microparticles (see the entire document, and in particular: abstract; pages 3, 4, 6).
Kibbelaar teaches that milling and homogenization is one of the top encapsulation technique (page 1, second full paragraph).
Millikin teaches milling of whole plant and coating the produced plant powder by mixing and homogenizing the milled plant with the coating material. The coated milled plant matter is advantageously suitable for pharmaceutical and food material. The coating can be double layer coating (col.1, lines 45-60; col.3, lines 45-62; col.5, lines 1-24, 59; col.6, lines 61-64).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide encapsulated milled plant material as taught by Yoon, and use ethyl cellulose to encapsulate the plant material as taught by any of Melegari and Katarzyna, and further homogenize a mixture of milled plant material and ethyl cellulose to encapsulate the plant material as taught by any of Kibbelaar and Millikin. One would have been motivated to do so because Melegari and Katarzyna both teach suitability of ethylcellulose as coating or encapsulating material for microparticles to provide sustained release of the coated or encapsulated material; and further one having ordinary skilled in the art would have homogenized the mixture of the milled plant material with the ethyl cellulose as taught by Kibbelaar and Millikin because Kibbelaar teaches one of the top encapsulation technique is “milling and homogenization”, and because Millikin teaches coating the milled plant powder by mixing and homogenizing the milled plant with the coating material is advantageously suitable for pharmaceutical and food material. One would reasonably expect producing encapsulated plant material by steps of milling the plant, mixing the milled plant with ethylcellulose and homogenizing the mixture wherein the produced coated particles are useful for sustained release of pharmaceuticals and food materials.
The step of milling the plant material and homogenization as claimed by claim 35 is taught by Yoon, Millikin and Kibbelaar.
Regarding coating materials as claimed by claims 35 and 53, both Melegari and Katarzyna teach ethyl cellulose.
Regarding claim 41 that the plant material is a whole plant, Yoon teaches harvested cells that provide a whole plant without unused plant parts. Millikin teaches milling the whole plant.
Regarding claim 44, the step of pretreatment by hot water for 3 minutes in water bath at 100oC, the heating after washing is suggested by Yoon. Regarding the claimed temperature and time of heating as claimed by 44, the temperature and time of pretreatment will depend on the used plant material, and the claims embrace any plant material that may vary in the needed heat and time and can be determined by one skilled in the art. No unexpected results are obtained from the pretreatment under the claimed temperature for the claimed time. Note that the phrase ”optionally Moringa” is not given any weight in rejecting the claims. Further Moringa is directed to non-elected plant species any way.
Regarding claim 47 that the plant milled material has not gone extraction, fractioning, alternation, Yoon teaches the plants are milled without extraction.
Regarding the size of the particles of plant material of 2-1000 µm, 150-300 µm, and 170-210 µm as claimed by claims 48, 49 and 50, respectively, Yoon teaches less than 850 µm and more than 0.5 µm that embraced the claimed particle sizes. 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 [R-5]. Further, based on the used plant one having ordinary skill in the art would have determined the size in light of the sizes taught by Yoon.
Regarding the amount of cellulose coating claimed by claim 51, one having ordinary skill in the art would have determined the amount of cellulose required for coating based on the plant material to be coated and the intended use of the coated particles.
Regarding claim 52 that adding an additional encapsulation layer, this is taught by Millikin.
Regarding claim 54 using 10% solution of ethyl cellulose, Melegari teaches using solution of ethyl cellulose for coating particles. Regarding the 10% solution as claimed, one having ordinary skill in the art would have determined the concentration of the solution used of coating based on the intended use of the microparticles and the desired properties of the microparticles, e.g. release rate, and based on the used plant particle.
Regarding using warm air to evaporate the solvent of ethyl cellulose, Yoon teaches drying the particles using temperature, and this would motivated one having ordinary skill in the art to dry the coated particles using temperature also. No unexpected results obtained from using warm air to dry the coated particles.
Regarding the plants claimed by claim 56, the broad teaching of Yoon suggests any plant material. One having ordinary skill in the art would have determined which plant to be used based on the intended use of the produced product. Applicants failed to show any unexpected result obtained from the plants claimed by claim 56.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./