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 .
Examiner’s Comment
The Examiner assigned to this case has changed. Please note the Examiner’s contact information at the close of this Office action.
Election/Restrictions
Applicant’s election of Group I in the reply filed on June 5, 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant has amended the (method) claims of Group II as dependent claims (directly or indirectly) of claim 1, and as such the claims of group II have been placed in and examined with the claims of Group I. Claim 39 (Group III) is drawn to a non-elected (product) invention. The election requirement is still deemed proper and therefore made proper.
Claims 1-11,13-14,17,20,23-30,33,35, and 39 are pending, of which claim 39 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Pending claims 1-11,13-14,17,20,23-30,33, and 35 have been examined on the merits.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, the claim recites a plurality of plant names. Please note that:
Scientific names should be recited in italics with the genus capitalized, for example “Helianthemum canadense (L.) Michx.”.
Common names should be in lowercase and not italicized, except for proper names like “California poppy”, to avoid confusion with the scientific names.
Additionally, the terms should map to single species when the common names are placed adjacent to the scientific terms. For example “Camellia sinensis, Tea, Camellia sinensis, Oolong Tea,” should be amended to recite the phrase --Camellia sinensis (Tea), Oolong Tea,--, or similar phrasing.
In claim 14 (at line 9), the phrasing of “Allium sativum (Garlic Aloe vera, Aloe Vera Gel)” should be amended to recite --Allium sativum (garlic), Aloe vera, Aloe vera gel,--.
In claim 14 (page 5 at line 9), the punctuation “, ,” is redundant.
Please note the above are considered necessary grammatical corrections; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection. (See MPEP 601.01(g)). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 1-11, 13-14, 17, 20, 23-30, 33, and 35 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.
In the instant case the claims are drawn to a process comprising the steps of (e.g. in claim 1):
a) solubilizing the starting plant material in a solubilizer and a solvent, to thereby obtain a mixture having non-soluble plant material, one or more solubilized chemical components, and the solvent, wherein the solubilizer is calcium hydroxide, sodium carbonate, sodium hydroxide, potassium hydroxide, potassium carbonate or a combination thereof;
b) separating non-soluble plant material from the one or more solubilized chemical components and the solvent, to thereby obtain a mechanically separated solution;
c) salting the mechanically separated solution with a salting agent and separating the solvent from the one or more solubilized chemical components, to thereby obtain a salted solution having one or more chemical components, and the salting agent;
d) measuring the refractive index, a pH or both of the salted solution, wherein the refractive index, the pH or both meet a criteria to thereby obtain a salted solution meeting the criteria;
e) crystalizing the salted solution having one or more chemical components and the salting agent, to thereby obtain a crystalline solid having the one or more chemical components and the salting agent; and
f) separating the salting agent from the crystalline solid having the one or more chemical components,
to thereby obtain a purified crystalline solid having the one or more chemical components.
However, the claims are unclear for the following:
in claim 1 (at step (a)), the claim is unclear as to what plant material and/or what material(s) “derived from” the plant are intended. In claim 1 (at step (a)), the claim is also unclear what “solvent(s)” and what “component(s)” are intended, because plant deconstruction and extractions are highly variable and dependent upon the source material and the method by which the components are obtained or modified thereby. Consequently, it is further unclear:
in step (b): what the composition of the “solubilized chemical components” within the mechanically separated solution is intended;
in steps (c, e, and f): what material(s) are thereby salted out, crystallized, and separated; and thus, unclear also as to which material(s) comprising the 55-100% w/w chemical components are intended; and
in step (d): what objective “criteria” of pH and refractive index are intended.
Although the dependent claims recite species with regard to the above lack of clarity, they do not resolve the above, and except where expressly recited in combination or where the claim dependency chains so require, potential combinations thereamong which may resolve the clarity are not read into the claims.
For example, whereas the disclosure provides (see figures 1-3) for the aqueous base/alkali extracting of soluble alkaloids from the plant parts containing such alkaloids and the additional methodology to obtain a powdered alkaloid solid (330) and in a preferred embodiment, wherein the a plant material is a kratom powder obtained from Mitragyna speciosa leaves, and the solvent is liminone (see figures 4A-E), such is not recited in the claims, and it is unclear what materials in the steps applicant intends to provide and obtain therein.
Also, for example, in claims 4 and 14, whereas the claims recite plant parts and a Markush group of species of plant source materials, and claim 17 recites a Markush group of species of solvents, however, the novel combinations for obtaining the resultant “55-100% w/w” product are not recited in a generic claim 1 or the other dependent claims depending therefrom not requiring the limitations. Similarly, claims 23 -24 (refractive index and pH) are not required of the generic invention, and claims 30 and 33 (alkaloids and species thereof) are not recited in the generic claims and the additional claims do not require such limitations.
Thus, one would not be apprised as to the metes and bounds and what applicant intends by the claims, as presently drafted.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11, 13-14, 17, 20, 23-30, 33, and 35 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 specific species of alkaloids in the amounts claimed, obtained from specific species of plants and from specific sequences of steps and conditions consistent therefor, does not reasonably provide enablement for obtaining the genus/all crystalline materials and products, from the broad and variable genus of processes, conditions, and materials presently embraced by these generic claims. 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.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to In the instant case the claims are drawn to a process comprising the steps of (e.g. in claim 1):
a) solubilizing the starting plant material in a solubilizer and a solvent, to thereby obtain a mixture having non-soluble plant material, one or more solubilized chemical components, and the solvent, wherein the solubilizer is calcium hydroxide, sodium carbonate, sodium hydroxide, potassium hydroxide, potassium carbonate or a combination thereof;
b) separating non-soluble plant material from the one or more solubilized chemical components and the solvent, to thereby obtain a mechanically separated solution;
c) salting the mechanically separated solution with a salting agent and separating the solvent from the one or more solubilized chemical components, to thereby obtain a salted solution having one or more chemical components, and the salting agent;
d) measuring the refractive index, a pH or both of the salted solution, wherein the refractive index, the pH or both meet a criteria to thereby obtain a salted solution meeting the criteria;
e) crystalizing the salted solution having one or more chemical components and the salting agent, to thereby obtain a crystalline solid having the one or more chemical components and the salting agent; and
f) separating the salting agent from the crystalline solid having the one or more chemical components,
to thereby obtain a purified crystalline solid having the one or more chemical components.
However, the claims taken together with the specification imply a breadth greater than supported by the disclosure.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art is such that, in general, treating and extracting plant materials with solvents and separating and purifying components therefrom, with one or more of physical treatments (e.g. grinding, mixing), solubilizing/dissolving, and separating (e.g. pH adjusting, partitioning, precipitating, salting out, recrystallizing) was known in the art.
For example, Boulware (Vipont Pharma Inc, EP 0 379 623; IDS), teaches obtaining an amount of alkaloids from a plant material, including (see entire document, esp. claim 1 for example)
“1. A method for extracting an alkaloid from a plant containing the alkaloid, which alkaloid forms a free base soluble in non-polar solvents and a water soluble acid salt, comprising grinding the plant material, slurrying the plant material in a mixture of water, water immiscible non-polar solvent and a cosolvent at a pH of about 8.5, dissolving the alkaloid in a nonpolar solvent which is insoluble in water, extracting the alkaloid into water by lowering the pH of the solution with acid, adding the salt of a mineral acid or a mineral acid to precipitate the alkaloid, and collecting the precipitated alkaloid.”
However, by contrast as instantly claimed the myriad of compositions (and plant component materials) obtainable from the broad and highly-variable genus of plants and processes implied by the claims, which remained unresolved at the time of the instant application effective filing date, and as such means for obtaining such compositions in the requisite quantities, therefore also is highly unpredictable.
It is also noted that the instant disclosure admits that obtaining greater the 45% by weight alkaloids remained unresolved (“In particular, purifying alkaloids and similar chemical components from plant material in high concentrations and in large quantities has generally been difficult. Many have tried to do so but often with little success. Prior to the present invention, extraction techniques often resulted in a purity of the alkaloid from about 1-45% by weight.”)
(5) The relative skill of those in the art:
The relative skill of those in the art is high, in general with regards to plant extractions and separations. However, the processes providing the genus of crystalline solids and of 55% (w/w) to 100% (w/w) therefrom was not recognized and, as claimed, remained beyond the purview of one of ordinary skill in the art. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided for finite guidance and working examples, including providing a process comprising providing (e.g. see figures and examples): aqueous base/alkali extracting of soluble alkaloids from the plant parts containing such alkaloids and the additional methodology to obtain a powdered alkaloid solid (330) and in a preferred embodiment, wherein the a plant material is a kratom powder obtained from Mitragyna speciosa leaves, and the solvent is liminone (see figures 4A-E).
However, the such is not recited in the claims, and it is not recited in the generic claims what materials in the steps applicant intends to provide and obtain therein, nor do the generic claims recite, materially, the product and steps with sufficient detail as to identify the specific products embraced. Also whereby the specification provides limited guidance and examples, the specification does not provide definitions limiting the terms claimed or working examples commensurate with the claims. Additionally, the limitations from the specification are weighed, but not read into the claims.
(8) The quantity of experimentation necessary:
Considering the state of the art and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention for the scope claimed.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655
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