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 .
Claims 1 – 3 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 27, 2025 is being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
The drawings were received on December 18, 2023. These drawings are acceptable.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 1 (and claims dependent thereon) are directed to a method for treating neurological signs and symptoms in neurodegenerative diseases and developmental disorders comprising concomitantly administering to a subject in need thereof an effective amount of natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See e.g. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
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It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from its closest naturally occurring counterpart.
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When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
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Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
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When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
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If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
The claims are directed to a method of treating comprising nature-based compounds (i.e. turmeric oil, sacha inchi oil, and cannabidiol), which is not markedly different from its closest naturally-occurring counterpart because there is no indication that their combination or preparation has caused the nature-based product to have any characteristics that are markedly different from the closest naturally-occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rationale for this determination is explained below:
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a process, which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea). YES, the claims are drawn to a process of administering something that appears to be a nature-based product (i.e., turmeric oil, sacha inchi oil, and cannabidiol) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Note: with respect to extracts of natural products such as plants, the closest naturally-occurring counterpart is always the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made simply by separating the extracted components from the non-extracted components, is a partitioning process that absent any specific chemical modification, merely separates the compounds leaving their activities unchanged.
Ingredients recited in the claims are natural products that would occur naturally; thus, the claims involve the use of judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record of a structural difference between the extract(s) in the claimed composition and that of their nature-based counterparts. Consequently, the claimed compositions are structurally the same as their closest naturally- occurring counterparts.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared it closest natural-occurring counterpart. For example, and assertion of changed functionality must be accompanied with evidence of a comparison of the claimed composition with its closest naturally-occurring counterpart and should apply to the full scope of the claim. Furthermore, inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
The recitation of specific amounts of the ingredients does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients. Therefore, the claim is not meaningfully limited and does not amount to significantly more than each product of nature by itself. Finally, the claimed mixture is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the instantly claimed mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117. While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, functionally, then its closest naturally occurring counterpart.
PRONG TWO: Evaluate whether the judicial exception is integrated into a practical application. The claims are directed to a method of treatment concomitantly administering to a subject a nature based composition, this administration step is not particular.
Thus, the cited claims are directed to a judicial exception to patentable subject matter.
Step 2b: Determine whether the claim directed to a judicial exception provides an inventive concept. For example, the claims may recite additional elements that amount to significantly more than the judicial exception. In the instant case, NO, the claims are directed to an extract composition without any other components that could add significantly more to the exception. No other specific limitations other than what is well-understood, routine and conventional in the field at a high level of generality have been added to the claimed nature-based product (e.g., addition of well-known ingredients).
Thus, the claimed product is not eligible subject matter under current 35 USC 101 standards.
Claim Rejections - 35 USC § 112
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 1 is 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 a method for treating neurological signs and symptoms in neurodegenerative diseases and developmental disorders comprising concomitantly administering to a subject in need thereof an effective amount of turmeric oil, sacha inchi oil, and cannabidiol, does not reasonably provide enablement of treating diseases as recited in instantly claimed, and to prepare a composition of turmeric oil, sacha oil, and cannabidiol for administering to the subject. 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.
The nature of the invention and (2) the breadth of the claims:
The claim is drawn to a method for treating neurological signs and symptom in neurodegenerative diseases and developmental disorders comprising concomitantly administering to a subject in need thereof an effective amount of turmeric oil, sacha inchi oil, and cannabidiol. The breadth of the claims are broad in that claim 1 is not limited to the type of neurological signs and symptoms in neurodegenerative diseases and developmental disorders.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art (including as cited in the instantly made of record below) is such that a singular effector for treating neurological signs and symptoms in neurodegenerative diseases and developmental disorders, was not known and the providing turmeric oil, sacha oil, and cannabidiol was known to the extent as taught in the prior art, including as instantly discussed herewith as taught by Rodriguez et al and Koren (Rodriguez et al “Nutraceutical To Prevent And Treat Cognitive Impairment (CN-120359041 A); Koren. “COMPOSITIONS AND METHODS FOR TREATMENT OF NEURODEGENERATIVE DISEASES (WO-2019159176A1)).
Since the turmeric oil, sacha oil, and cannabidiol are suitable for treating the claimed diseases remained largely unsolved, means for providing treating of the diseases by the administration thereof is highly unpredictable Cited reference mentions that there is no drug, nutraceutical, pharmaceutical food or effective food to prevent, stop, eliminate or reverse cognitive disorders or related neurodegenerative diseases, Rodriguez et. Al. ‘041, (Description [line 153-154]).
(5) The relative skill of those in the art:
The relative skill of those in the art is high. However, the treating of the instantly claimed group of diseases administering of turmeric oil, sacha oil, and cannabidiol remained beyond the purview of the skilled artisan. Accordingly, one who would have turned to the instant disclosure for additional direction and guidance would have found the disclosure lacking for the genus of treating any neurological signs and symptoms in neurodegenerative diseases and developmental disorders as currently encompassed by the claims pending.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided limited guidance (see esp. at detailed description of the invention). However, the specification does not provide support for additional direction and guidance commensurate in scope with the instant claims for treating neurological signs and symptoms in neurodegenerative diseases and development disorders. Additionally, the claim does not specify dosage of administration of the composition and remains inclusive of diseases as set forth by instant claims. The examples provided in the specification are mere data gathering and does not enable one skilled in the art which it pertains, or to make and/or use of the invention.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Rodriguez and Koren, 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.
Therefore, one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez Martinez et al. (CN-120359041-A) and Zohar (WO 2019/159176 A1).
The instant claims are drawn to treating neurological signs and symptoms in neurodegenerative diseases and developmental disorders by administering an effective amount of turmeric oil, sacha inchi oil, and cannabidiol (claim 1), administration is oral (claim 2), and based on defined neurological signs and symptoms enumerated (claim 3).
Rodriguez Martinez et al. teach that the natural products are useful in treating and preventing of cognitive impairment related to neurodegenerative diseases. “nutraceutical composition to prevent and treat cognitive impairment, which is composed of a mixture of emulsion, Plukenetia volubilis oil (another name for sacha inchi oil as in instant claim); extracts of plant origin, such as Curcuma longa (another name for turmeric as in instant claim). The nutraceutical is suitable for preventing and treating: Alzheimer's disease; and mental, behavioural and developmental disorders, including depressive disorders; disorders of the nervous symptoms (see abstract).
Zohar ‘176 teaches the importance of cannabidiol in treating neurological and neurodegenerative conditions; “Cannabis plants produce many compounds of possible medical importance such as cannabinoids, which have been shown to be promising agents in treating different neurological and neurodegenerative conditions. (see background art line 1-3). Therefore, administration of turmeric oil, sacha inchi oil, and cannabidiol were already known to be therapeutically effective prior to the effective filling date of the instant claims.
"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.... [T]he idea of combining them flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
It would have been obvious to a person of ordinary skilled in the art to treat neurological signs and symptoms in neurodegenerative diseases and developmental disorders comprising concomitantly administering to a subject in need thereof an effective amount of turmeric oil, sacha inchi oil, and cannabidiol, because Roderiquez Martinez et al. and Zohar teach the method of treating using the components for the same diseases or disorders.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/ALPA NILESH AMIN/ Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655