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
Claims 1-18 are pending and being examined on merits herein.
Priority
This Application, 18406671, filed on 01/08/2024, is a continuation of 17157701, filed on 01/25/2021, which is now abandoned, and claims benefit of provisional applications 62/965440, filed on 01/24/2020, and 62971023, filed 02/06/2020.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 01/08/2024, has been considered by the Examiner of the uploaded references in record of parent case 17157701, with the exception of the non-patent literature by Jesse F. Gregory III. This citation fails to comply with the provisions of 37 CFR 1.98 and MPEP §609, because Applicant has failed to provide the date of this publication as required by 37 C.F.R. 1.98(b)(5) and such a date cannot be ascertained from the actual document. It has been placed in the application file, but the information referred to such reference has not been considered as to the merits. Applicant is advised that the date of any resubmission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Objection to Specification
The use of the term EXTRAMEL® and AURORABLUE®, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Objection to Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract recites “[t]he compositions of this disclosure provide” which contains improper phrase and should be avoided.
Proper correction is requested.
Claim Objections
Claims 1, 9-12 and 15-18 are objected to because of the following informalities:
Claims 1, 9-12 and 15-18 are objected to because of inconsistent format of “milligrams” and “mg”. A single format “mg” should be carried through all claims.
Claim 9 is objected to for recitation of acronym “PABA” without definition in detail of the name.
Claim 10 recites “with the addition of” in line 1 and “Concentrate or Extract” in line 4. The phrase “with the addition of” is recommended to rephrase as “further comprises”. The words in “Concentrate or Extract” should not be capitalized.
Claims 9 and 11-12 are also objected to because they have inconsistent capitalization of the “IU” or “iu” unit.
Claim 11 is further objected to because of inconsistent format of lowercase and uppercase seen in words “vitamin” and “Vitamin”, wherein “Vitamin B3” and “Vitamin B12” appear to be uppercase instead of lowercase in all other vitamin species. That is the term “vitamin” should be lowercase.
Claim 15 is objected to because of recitation “comprising hemp oil extract containing of about between …”, wherein the word “containing” should be removed. As Examiner understands that this amount refers to hemp oil extract itself, not something else in hemp oil extract.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
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 2-18 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 2 recites "a broad-spectrum hemp oil extract, magnesium, and a base of synergistic…". There is insufficient antecedent basis for this limitation in the claim because apart from magnesium none of the recited components are in Claim 1. Does it mean the composition further comprises these components? If so, then the claim must recite “further comprises” for clarity. Additionally, if the claim further comprises these components, the claim is also rejected because it is unknown how the magnesium recited in Claim 2 is different from Claim 1. As such, the claim is unclear and indefinite.
The terms of “a broad-spectrum”, “a base of synergistic…” are relative terms which also render the claim indefinite because they are not defined by the claim, and the specification does not provide a standard for ascertaining their requisite degrees, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of spectrum is deemed broad, and what synergistic degree is considered as base.
Claim 2 also recites “, and other nutrients or nutraceuticals”. It is unclear what kind of nutrients or nutraceuticals are supposed to be included or excluded.
Claim 3 recites “comprises a full spectrum of naturally occurring cannabinoids and phytochemicals obtained from hemp oil extract, magnesium, and a base of synergistic …, and other nutrients or nutraceuticals”.
Similar to claim 2 above, there is insufficient antecedent basis for this limitation in the claim, because other than magnesium all other components are not in claim 1, which claim 3 depends upon. If it is meant to comprise these additional components in the composition, then rephrase as “further comprises”. Even if these were additional components with “further comprises” phrase in position, it would be still unclear about “magnesium” in claim 3 as how that differs from the magnesium in claim 1? Is it more magnesium or a different form of magnesium or are applicant’s just referring to the magnesium from claim 1 again?
The term “a full spectrum” and “a base of synergistic” are relative terms which render the claim indefinite because it is not defined by the claim, and the specification does not provide a standard for ascertaining their requisite degrees, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of spectrum is deemed full, and what synergistic degree is considered as base.
The recitation of “other nutrients or nutraceuticals” is indefinite because it is unclear what kinds of nutrients or nutraceuticals are meant to be included.
Claim 5 recites “of claim 4, wherein the magnesium compound or chelate”, there is insufficient antecedent basis for this limitation in the claim, because “magnesium compound or chelate” is not mentioned in both claims 1 and 4, which claim 5 directly or indirectly depend on. Especially in light of claim 7, which depends on claim 4, it indicates that magnesium can be elemental, and it does not have to be compound or chelate. Hence, the magnesium present in both claims 1 and 4 do not necessarily imply magnesium as compound or chelate, and therefore, claim 5 lacks antecedent basis for the limitation and renders the claim indefinite.
Claims 2-3, 9-12 are rejected because of the use of parentheses. Within parentheses the phrase led by “e.g.” (Claims 2-3), “per serving” (Claims 9-10), “as a source of…” (Claims 9 and 12), or “as well as…” (Claims 11-12), render the claim indefinite because it is unclear whether the limitation within parentheses is part of the claimed invention. See MPEP § 2173.05(d). The claim is considered indefinite because there is question or doubt as to whether the feature introduced by such language is a required feature of the claims, or it is optional explanation or merely exemplary and therefore not required.
Claim 9 also recites in the parentheses “tocopherols and/or tocotrienols”, “Mk-7”, “glycinate”, “nicotinate glycinate or polynicotinate”, which are narrower in scope, e.g., defined categories, of the broad genus outside the parentheses. Claim 11 also recites “Mk-7” in parentheses. All these cited phrases result in both broad and narrow features coexist in the limitation scope. 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).
For examination purposes, the features inside parentheses, except the acronyms, are considered optional, and therefore they are not required for the claim scopes.
Claim 9 also recites the limitation of “with the base of synergistic vitamins, minerals, and other nutrients including …”. There is insufficient antecedent basis for this limitation in the claim, because “the base of synergistic vitamins, minerals, and other nutrients” are not mentioned in claim 1, which claim 9 depends upon. If these components are meant to be additional components of claim 1, “further comprises base of …” language is required. The claim is indefinite for lacking antecedent basis.
Claim 9 also recites “more specifically”. It is a relative term which renders the claim indefinite. The term is not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 10 recites the trademark/trade names EXTRAMEL® and AURORABLUE®. When a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirement of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. The claim scope is therefore indefinite.
Claim 11 recites “comprising iodine as potassium iodide, 50-500 mcg” in lines 1-2, “folic acid or methyl-folate or folinic acid, 10-1,000 mcg; 25-1,000 mcg” in lines 5-6. These components are not mentioned in claims 9 and 10, which claim 11 directly or indirectly depend on. There is insufficient antecedent basis for this limitation in the claim. If these were meant to be additional components, language “further comprise” is required for clarity. However, many ingredients from claim 9 are present in claim 11, while other ingredients from claim 10 do not appear in claim 11. Therefore, the claim scope is unclear even with “further comprise” in position for comprising the two additional components mentioned above. Also, it is unclear why the two amount ranges “or folinic acid, 10-1,000 mcg; 25-1,000 mcg” showing up in tandem and what each range refers to which component in the claim.
Claim 12 recites “of claim 1, comprising vitamin A …”. There is …”. There is insufficient antecedent basis for this limitation in the claim, because many of the ingredients are not mentioned in claim 1, which claim 12 depends on. If these were supposed to be additional components, “further comprise” language is required for clarity.
Claim 13 recites “a soft chew, gummy, or tableting agent and an excipient”. The words “or” and “and” render the claim indefinite. Because it is unclear whether it is supposed to mean “a soft chew” , “gummy”, “tableting agent”, or “an excipient” as four alternatives, or it means one of three components, “a soft chew, gummy, tableting agent”, plus “an excipient”. For the purpose of examination, one out of the four agents is interpreted as required for the composition.
Claims 11, 12, 14, and 18 each recites features with “and/or”, which makes each claim indefinite. In detail, Claim 11 recites “vitamin E as d-alpha tocopherol or di-alpha tocopherol and/or mixed tocopherols and/or tocotrienols”; Claim 12 recites “vitamin E as d-alpha tocopherol succinate and/or mixed tocopherols and/or tocotrienols”; Claim 14 recites “soy and/or sunflower lecithin”; Claim 18 recites “hemp oil extract …, and niacinamide…, and/or nicotinamide riboside”. Taking claim 18 as an example for interpretation, it is unclear if the “hemp oil extract, … niacinamide… and/or nicotinamide” are all required, or whether it is the hemp oil extract and niacinamide are required, while nicotinamide is optional, or hemp oil extract with either niacinamide or nicotinamide riboside, or either hemp oil extract and niacinamide together or nicotinamide riboside alone, or all of them are alternates. The phrase is thus ambiguous and renders each claim indefinite.
Claim 14 is rejected for indefiniteness because it is unclear whether “tapioca syrup, …” and “the following sugar alcohols … combined with any combination of the following: palm oil, etc.” as one whole alternative group being defined by “comprises one or more of”, or they are supposed to be two components as “tapioca …” and the resulting component from combination like “sugar alcohols combined with palm oil”, or they are supposed to be three independent components such as “tapioca …”, “sugar alcohols”, and “palm oil”. Accordingly, one of ordinary skill in the art at the time of the invention would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant is presently seeking protection. For compact prosecution, the claims will be deemed to require three separate groups – the tapioca syrup through tagatose syrup; sugar alcohols through the recitation of inositol; and palm oil through sucralose.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites “Vitamin B3, 0.5-250 mg” in lines 3-4, “Vitamin B12, 3-5,000 mcg” in line 4, “vitamin C, 25-1,000 mg” in line 6 (Line number refers to line counts in claim 11 alone), while the corresponding amount ranges in claims 9 and 10, which claim 11 directly or indirectly depend upon, appear to have narrower ranges as “vitamin B3, 5-250 mg” (Claim 9 line 4), “vitamin B12, 5-5,000 mcg” (Claim 9 line 5), “vitamin C, 50-5,000 mg” (Claim 9 line 6), indicating the lower end of each range in claim 11 rather broadens that in claim 9 and hence fails to further narrow the subject matter.
Claim 11 recites “iodine as potassium iodide” in line 1 and “folic acid or methyl-folate or folinic acid …” in lines 5-6 of instant claim. Both of these components are not present in claims 1, 9, or 10, which claim 11 directly or indirectly depend on. Because “further comprising” language is not in position to indicate these are additional components, and the information provided in parentheses in claims 1, 9, or 10 has been considered optional and not required as addressed above, the claim scope with these additional ingredients rather broadens and hence fails to further limit the subject matter of the claims upon which it depends.
Claim 12 recites “of claim 1, comprising vitamin A as …”. Depending on claim 1, claim 12 recites many ingredients that are not present in claim 1. Because “further comprising” language is not in position to indicate these are additional components, the claim scope with these additional ingredients rather broadens and hence fails to further limit the subject matter of the claim 1. Therefore, claim 12 is rejected for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 2-3, 10, and 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled for hemp oil and for commercial products Extramel® and AuroraBlue® in claim 10, does not reasonably provide enablement for any extract from hemp present in claims 2-3, 10, 15-18, melon in claim 10, blueberry in claim 10, stevia in claim 14, or monk fruit in claim 14; all cannabinoids in claims 3 and 10; and phytochemicals in claims 3 and 10. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 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 USPQ2d 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). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
Applicant claims a composition comprising hemp oil extract, a full spectrum of naturally occurring cannabinoids and phytochemicals obtained from hemp oil extract, melon extract, blueberry concentrate or extract, stevia extract, monk fruit extract in Claims 2-3, 10, and 14-18. However, it is unclear from the specification, what the extraction solvent is, and what the components of extract are.
As MPEP 2164.03 states that “[T]he scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The state of the art is unpredictable with regard to plant extracts. It is well known in the art that polarity of solvents plays a key role in determining final product obtained by an extraction. However, because many phytochemicals remain undiscovered, the skilled artisan has to make his best educated guess as to what types of phytochemicals will be successfully extracted with a solvent of a particular polarity. Often times, unless the constituents in a particular plant extract have been well evaluated and documented in the literature, the skilled artisan must adhere to trial and error protocols in order to quantitatively determine phytochemical constituents present in samples obtained from respective extraction procedures. These procedures are common when, for example, a plant or part thereof has been documented in the literature as possessing some medicinal quality. The skilled artisan will attempt numerous extraction protocols in attempt to isolate the particular ingredient which has this medicinal quality. Typically, beginning with the first crude extraction, it is a guess as to whether or not the extract will possess certain phytochemical constituents. It is noted that the Instant specification does not disclose extraction process and does not specify solvents corresponding to effective ingredients, and only teaches certain extracts which provide for the effective ingredient.
Each successive extraction of plant matter yields different products due to the exclusion of ingredients based on polarity of the solvents solvating constituents with similar polarities. Subsequently, the properties of each respective product are unpredictable and would need to be evaluated for chemical constituents. The following is an illustrative example of the many products which may be produced by different successive extraction protocols:
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In this example, assume that A= the initial water extract from a homogenized sample of grape. The water extract from the grape is then subjected to a methanol/water extraction to form products B (soluble with methanol) and C (more soluble with water). Product C is then extracted in a separatory funnel with three organic solvents: chloroform, benzene and ethyl ether to form products G, H and I which solvate with the respective solvents based on the polarity of the inherent constituents. Product H, which we will assume is the product obtained in the benzene fraction, is extracted again in a separatory funnel with benzene and methanol to remove any residual methanol-soluble constituents. The additional circles represent extractions which may be done to obtain different products, using similar solvents as discussed previously, or entirely different solvents. Consequently, the characteristics of each respective product would need to be evaluated for chemical constituents. This representation is indicative of the vast array of distinct products which may be obtained due to the enormity of possible extraction permutations.
Further, it is well known in the art of phytochemistry that the chemical nature regarding different parts of the same plants is unpredictable. While the structure of the plant is a whole entity comprising attached appendages such as the root, rhizome, stem, leaves, seeds and flowers, each respective part of the plant provides for different phytochemicals which will necessarily provide for different pharmacological effects. It is deemed that the method for extraction, the part of the plant such as the leaves or the root for example, the amount of the starting material and the amount of solvent added and final concentration of the extract are of utmost importance regarding the nature of the extracts. This is due to the fact that different parts of the plant have varying types and amounts of endogenous phytochemicals:
The binding studies using selected receptors occurring in the central nervous system showed the unexpected in vitro pharmacological action of leaf extracts of Piper methysticum G. Forster in comparison with the root extracts. Since the content of the six kavapyrones (considered to be the active constituents) is lower in the leaf extracts than in the root extracts of Piper methysticum G. Forster (calculation based on dry weight), these pharmacological results obtained from the binding studies are surprising and interesting. The non-existing correlation between the pharmacological potency of the extracts (as determined by the receptor binding studies) and the kavapyrone content of these extracts (determined by HPLC measurements) is surprising, since kavapyrones generally are held responsible for the pharmacological efficacy of Kava extracts; the result suggests the presence of additional pharmacologically active substances occurring in the leaf extracts. Bueter (US 20030180395 A1, 09/25/2003) [0063] emphasis added.
Applicant has not disclosed any active compounds in the extract apart from cannabidiol from the hemp oil extract. Undue experimentation involved with elucidating an active ingredient of plant material is well established, as explained by H.B. MacPhillamy (1963) (PTO-892):
When activity is found, it is then the chemist's task to isolate the chemical individual responsible for this particular effect. This is highly desirable for a number of reasons. The use of medicinal plants in their natural state, or as crude extracts, presents several difficulties. The actual content of the drug may vary with both the locality and the season in which the plant is gathered. As the active principles of many plants are powerful poisons when taken in excess, the dangers of prescribing drugs of uncertain origin are obvious. Equally, the patient may suffer if the drug is of lower activity than usual. Then too, the plant may contain variable amounts of other substances which have only harmful effects. These difficulties can, of course, be overcome by means of suitable biological control tests, but they have the disadvantage that they are rarely capable of high accuracy and are usually time-consuming and expensive. (see page 6) emphasis added.
Due to the unpredictable nature of plant extracts, it is deemed that the skilled artisan would need to perform undue experimentation in order to ascertain what components of the extracts, in which plants and plant parts, and the solvent would provide for the intended use. Unpredictability with regard to plant extracts due to their highly complex nature has been well documented in the art. Pekic et al. for example (1998, IDS of 01/08/2024, copy uploaded for viewer convenience, PTO-892) showed that the slightest variations in polarity of solvent and reaction time upon grape extraction provided respective products with unique characteristic properties (See Tables 1, 2, 4, 5, 6 and 7). In turn, each product would possess varying pharmacological properties based upon their respective methods of extraction.
Further contributing to the unpredictability of plant extracts, the active agent may not constitute only a single ingredient, but a combination of ingredients working synergistically to provide a therapeutic effect.
It is the opinion of the Examiner, taking in consideration of the grave unpredictability in the art with regard to plant extracts, coupled with the unpredictability as set forth in the Instant specification itself, that Applicant is not enabled for any extract as instantly claimed. Each product obtained from an extraction is unpredictable in nature. Even the most skilled of artisans would need to quantify each product for constituents as well as efficacy. Considering this evidence, the skilled artisan, lacking guidance with regard to any solvents and parts and types of plants which will provide for the intended use of the claims, would necessarily need to perform tedious trial and error protocols without expectation of success in order to ascertain what other extracts would provide for the specific uses as described in the specification.
Claim Interpretation
For compact prosecution, and because the definition is absent in the disclosure, the Examiner will interpret “PABA” to mean para-aminobenzoic acid (PABA).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gorsek et al. (US 6103756, 08/15/2000, IDS of 01/08/2024).
Gorsek relates to a composition for the prevention, stabilization, reversal and treatment of age related macular degeneration, cataracts, elevated ocular pressure, diabetic retinopathy and glaucoma (Col. 1, 1st paragraph). Gorsek expressly teaches a formulation comprising 100 mg glycine, 900 mg taurine, 325 mg malic acid, and 300 mg magnesium (as taurate) (Col. 2, Table 1, snapshot as shown). MPEP 2131.03.I states that "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). Since prior art (Table 1) teaches the component amounts falling within the claimed ranges, claim 1 is anticipated.
Gorsek also specifies in a formulation comprising 100-1000 mg of magnesium (as elemental magnesium, corresponding to instant claim 7), 100-3000 mg taurine, with other ingredients (Col. 1, Lines 56-66) (corresponding to instant claims 4-8). Therefore, Gorsek anticipates the claimed elemental magnesium, organic magnesium taurine (as taurinate, evidenced by instant spec. Pg. 8, line 21) and taurate chelating compound. Maximum therapeutic efficacy does not provide structural limitation of claim 8, it is inherent property of the same compounds that are taught by prior art.
MPEP 2144.01 points out "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). For this instance, the teaching of Gorsek provides magnesium taurate or magnesium taurinate, and magnesium formats, skilled in the art would reasonably draw chelating groups for magnesium, and both elemental or chelated magnesium are suitable formats in the composition.
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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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-8 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gorsek et al. (US 6103756, 08/15/2000, IDS of 01/08/2024), in view of Estey et al. (US 20170368020, 12/28/2017, IDS of 01/08/2024), and Tomida et al. (British journal of ophthalmology 88.5 (2004): 708-713, IDS of 01/08/2024, uploaded copy for convenience, PTO-892).
Gorsek discloses an orally ingestible ocular composition for prevention, stabilization, reversal and treatment of age-related macular degeneration, cataracts, elevated ocular pressure, diabetic retinopathy and glaucoma (Abstract; Title). Gorsek teaches compositions comprising glycine, taurine, malic acid, magnesium taurate or elemental magnesium in specified amounts as described above in detail (e.g., Col. 2, Table 1, snapshot shown above) (corresponding to instant claims 1 and 4-8) and incorporated herein.
Gorsek exemplifies a base of synergistic vitamins, minerals, nutrients or nutraceuticals in the composition including 25 mg zinc, 200 mcg selenium, 1.5 g vitamin C, and bilberry extract, lutein extract, lycopene extract, black pepper extract, etc. (as phytochemicals) (Table 1) (corresponding to ingredients of magnesium, vitamins, minerals, and other nutrients in Claims 2 and 3).
Gorsek teaches 70 mg niacinamide (Table 1), with amount falling within ranges of about 1.0 to 250 mg, about 5 to 100 mg, about 10 to 100 mg, about 2 to 250 mg in instant claims 15, 16, 17, and 18 respectively, corresponding to niacinamide in Claims 15-18.
Gorsek is silent on the hemp oil extract in instant claim 2, cannabinoids from hemp oil extract in instant claim 3, hemp oil extract and cannabidiol in instant claims 15-18. Gorsek does not teach the composition further comprising a soft chew, gummy, or tableting agent and an excipient that facilitates oral bioavailability as recited in instant claim 13, Gorsek also does not teach the excipient species as recited in instant claim 14.
Estey teaches oral compositions effective for prevention and treatment of diseases including aging and neurodegenerative diseases, wherein the oral compositions comprise cannabinoid (Abstract, [0050]). Estey teaches embodiments wherein the composition comprising hemp oil/cannabinoids (corresponding to instant claims 2-3), sugar blends, tableting lubricants, and further comprises dietary supplements including vitamins, minerals, inositol (corresponding to instant claim 14), kelp, selenium, silicon dioxide, Coenzyme Q10 etc. (Claims 11-27; [0064]-[0065]). Estey also teaches maltodextrin as part of the excipient, and microcrystalline cellulose as filler ([0062]; Claim 8) (corresponding to instant claims 13-14), with inherent property of excipients for facilitating oral bioavailability through mucosal absorption from within the oral cavity. Estey discloses composition comprising about 0.1%-20% weight of hemp oil, and wherein the hemp oil comprises about 0.1-80% cannabidiol (CBD) (Claims 11-15) (corresponding to instant claims 15-18).
Tomida describes that cannabinoids are useful for treating glaucoma, reducing intraocular pressure, and are neuroprotective (e.g., Abstract; p. 711, last 2 sections).
It would have been prima facie obvious for a person with ordinary skill in the art prior to filing date to incorporate teachings of hemp oil extract components, e.g., cannabinoids, cannabidiol, and excipients from Estey into the composition taught by Gorsek to arrive at current invention. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Regarding the excipients, 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).
Because Gorsek teaches a composition comprising glycine, taurine, malic acid, magnesium, etc. for orally treating ocular disease including glaucoma (Col. 1, 1st paragraph), while cannabinoids are also useful for treating glaucoma as taught by Tomida. As such, Estey is compatible with Gorsek as its composition can be combined with vitamins and minerals. As a general principle it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, the idea of combining them flows logically from their having been individually taught in the prior art. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) MPEP 2144.06. The references are in the same field of endeavor and they provide a reasonable expectation of success.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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. For this instance, niacinamide amount ranges overlap with that taught by prior art. Estey provides percentages of hemp oil and cannabidiol contents. As Gorsek points out that the compositions set forth are exemplary and not provided for limitation, and that one skilled in the art can easily modify or change the formulation to provide a unique desired product which falls within the scope of the claims (Col. 2, Lines 21-28). Artisans in field would be easily adjust and optimize ingredient amounts for desired product serving needs, and have reasonable expectation of success resulting from the optimization. “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gorsek et al. (US 6103756, 08/15/2000, IDS of 01/08/2024), in view of Estey et al. (US 20170368020, 12/28/2017, IDS of 01/08/2024), and Tomida et al. (British journal of ophthalmology 88.5 (2004): 708-713, IDS of 01/08/2024, uploaded copy for convenience, PTO-892) as applied to claims 1-8 and 13-18 above, and further in view of Slaga et al. (WO 91/11117, 08/08/1991, PTO-892).
Combined teachings of Gorsek, Estey, and Tomida teach oral compositions comprising glycine, taurine, malic acid, and magnesium, as well as hemp oil extract, cannabinoids, cannabidiol, and nicotinamide, together with a base of synergistic ingredients including but not limited to vitamins, minerals, other nutrients, and excipients, as applied to claims 1-8 and 13-18 described above in detail and incorporated herein.
Gorsek further exemplifies in Table 1 of the composition (per six capsules serving amount) comprising 17,500 IU of vitamin A as beta carotene etc., 50 mg vitamin B1, 10 mg vitamin B2, 70 mg vitamin B3, 50 mg vitamin B5, 50 mg vitamin B6, 500 mcg vitamin B12 as methyl cobalamin, 300 mcg biotin, 1.5 g vitamin C, 400 IU vitamin D3, 500 IU, vitamin E as d-alpha tocopherol succinate etc., 2 mg boron, 1 mg copper, 25 mg zinc, 2 mg manganese, 200 mcg selenium, 75 mcg molybdenum as chelate, 200 mcg chromium as polynicotinate, 75 mcg iodine as kelp, and 800 mg folic acid. Gorsek also teaches 150 mg [Symbol font/0x61]-lipoic acid (corresponding to ingredients with most amounts falling within ranges in instant claims 9 and 11-12).
Estey discloses composition comprising about 0.1%-20% weight of hemp oil, and wherein the hemp oil comprises about 0.1-80% cannabidiol (CBD) (Claims 11-15) as discussed above (corresponding to instant claim 10).
Combined teachings of Gorsek, Estey, and Tomida do not teach PABA in instant claim 9 and vitamin K2 in instant claims 9 and 11-12, or iodine as potassium iodide in instant claim 11.
Slaga teaches dietary supplements for longevity, protection against diseases such as certain cancers and cardiovascular disorders, and for immunological integrity in humans (Abstract; Pg. 4-5). Slaga teaches a preferred embodiment wherein the formulations are in sustained-release tableted dietary supplement form. The multivitamin and mineral supplement comprises taurine, vitamins A, E, etc. potassium, iodine, magnesium, boron, chromium, PABA, etc. (Claims 1-4). Slaga teaches molybdenum glycinate (Pg. 29, line 14); cupric glycinate (Pg. 19, line 3); manganese glycinate (Pg. 20, line 1); and selenium glycinate (Pg. 20, line 22).
Slaga teaches that the core antioxidants can interact synergistically with certain components including inositol (as an excipient in instant claim 14), vitamin A, B-carotene, vitamin E, Ca ascorbate, copper, zinc, manganese, selenium, omega-3 fish oil, and PABA, and that PABA is important for the prevention of cancer and cardiovascular disorders, and is essential in the metabolism of proteins and formation of red blood cells (Pg. 16, Lines 11-25; Pg. 21, lines 8-28). Slaga discloses a formulation comprising 40 mg of PABA (Pg. 44; Claim 13) (within the claimed range of 0.5-100 mg in Claim 9).
Slaga recognizes that iodine is essential for proper thyroid functioning, and teaches its inclusion in the formulation from 5-500 mcg as potassium iodide, kelp, etc. but most preferably at 150 mcg as potassium iodide (Pg. 26, last paragraph- Pg. 27, 1st paragraph) (corresponding to iodine being in the form of potassium iodine with overlapping range of 50-500 mcg in Claim 11). Slaga also teaches the inclusion of vitamin K2 and relates that vitamin K-dependent protein in bone has a complex role (Pg. 25, 2nd paragraph). Slaga also discloses suitable amount for vitamin K is 3-100 mcg, overlapping with the claimed ranges of 5-500 mcg in instant claims 9 and 11, or 45-200 mcg in instant claim 12.
Slaga relates that inositol plays a vital metabolic role at the cellular level, particularly in membrane and lipoprotein function, thereby providing a motivation for its inclusion in the formulation of Gorsek, Estey, and Tomida, and also rendering the sugar alcohol in Claim 14 obvious. Further relating to instant Claims 13 and 14, Slaga teaches hydroxypropyl methylcellulose as excipient for sustained release tablet (Pg.41, lines 28-32).
It would have been prima facie obvious for a person with ordinary skills in the art before the effective filing date to incorporate the specific ingredients, e.g., PABA, vitamin K2, potassium iodide, taught by Slaga into the composition established by Gorsek, Estey, and Tomida to arrive at current invention. One would have been motivated to do so because Slaga has taught their multiple advantages including synergistic effects on combining such ingredients into the composition as discussed above and functions as being important for the prevention of cancer and cardiovascular disorders. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). 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. For this instance, most ingredient amounts overlap with those taught by prior art. For the agent amounts do not overlap, e.g., vitamin A in prior art as 17,500 iu vs. 250-10,000 iu in instant claim 9 or 500-5,000 iu in instant claim 11, as Gorsek emphasizes that the compositions set forth are exemplary and not provided for limitation, and that one skilled in the art can easily modify or change the formulation to provide a unique desired product which falls within the scope of the claims (Col. 2, Lines 21-28). “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not