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 .
DETAILED ACTION
The Amendments filed on July 29, 2025 has been received and entered.
Claims 1, 3-4, and 6-18 are pending. Claims 1, 3-4, 6-9, 12-13, 15, and 18 are examined on the merits. Claims 10-11, 14, 16 and 17 are withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election of the species of Claim 18 in the reply filed on Aug. 16, 2024 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)).
Claims 10-11, 14, 16 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Aug. 16, 2024.
Response to Amendment
Claim Rejections - 35 USC § 101
Claims 1, 3-4, 6-9, 12-13, 15, and 18 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(s) 1, 3-4, 6-9, 12-13, 15, and 18 are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims recite a food supplement consisting of at least one edible oil, chopped fruit or paste, ground nut or seed meal or seed butter, honey, ginger, fruit powder, pineapple fruit powder. The oil or fruit chop or ground are extracted from the plant) thereof would be a nature-based product limitation (or products of nature when drawn to the extract). As for kilocalories of energy in less than three cubic inches in claims 1, 5, 6, 12, 15, the oil, fruit, butter itself would have an amount of calories. Thus, the claims do recite nature-based product limitation. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should 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.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “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…”.
In this case, the food supplement with 15-25% edible oil, 8-22% chopped fruit or fruit paste, 4-10% fruit powder with polyphenol, 5-11% ginger root or spice, 5-10% pineapple fruit powder is a known food. Fruits, polyphenols, and ginger have anti-inflammatory activities. Anti-inflammatories are known for treating inflammations found in cancers or tumors; therefore, there is no markedly different characteristics than those found in nature. The ingredients are considered by itself, and as added together. 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. The inherent or innate characteristics of the naturally occurring counterpart cannot show a markedly difference. The differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference. There is no difference in function, structure or other properties. Here, the fruits, polyphenols, and ginger have anti-inflammatory activities. The extracts are from natural products. Therefore, there is no markedly different characteristic that is not already found in nature. Applicant needs to demonstrate that the mixture as a whole would result in markedly different characteristics from its natural activities.
Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claim is a combination of different ingredients into a composition for making a food supplement. The claimed composition is a general composition that can be used in any number of applications and is not limited to a particular application like a claim to a specific administration device having the composition. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, it would be conventional in the art to combine different ingredients, such as oils and natural plant extracts for nourishment (see 2024, https://www.tasteofhome.com/collection/easy-desserts-with-5-ingredients-or-less/?srsltid=AfmBOor6_BkYhgceVcDf3JmqoaDZodlnWU1c--xtmNz7Rku4UWuunbOF). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant argues that the form of the products are changed, such as dehydrated fruit powder, ground nuts.
In response to Applicant’s argument, the product is still a form of nature that has not had markedly different characteristic changes because the dried fruit and crushed nuts or seed in a powdered form can be found in nature when the fruit falls and rocks or animals tremble on them. The crushed form does not have any changed markedly different characteristics.
Applicant argues that the product as a whole is not found in nature.
In response to Applicant’s argument, in order for the composition to show markedly difference, the characteristic(s) must be changed as compared to nature. Claims 1, 3-4, 6-9, 12-13, 15, and 18 are directed to a composition consisting of a food supplement with at least one edible oil, chopped fruit or paste, ground nut or seed meal or seed butter, honey, ginger, fruit powder, pineapple fruit powder. An edible oil, chopped fruit or paste, ground nut or seed meal or seed butter, honey is a product of nature. The ingredients are considered by itself, and as added together. 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. The inherent or innate characteristics of the naturally occurring counterpart cannot show a markedly difference. The differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference. There is no difference in function, structure or other properties. Here, the extracts are from natural products. Applicant needs to demonstrate that the mixture as a whole would result in markedly different characteristics from its natural activities.
Regarding the applicant’s arguments drawn to:"... the present claims are directed to a mixture which is not found in nature, and indeed, as reflected in the many Examples in Applicant’s specification, provides unexpected benefits with regard to a composition which are not available in nature. Accordingly, the present claims are different than the individual components and provide markedly different properties than what is available in nature.”, the response to this argument is as follows.
First, this mere allegation of the unexpected benefits, without identifying what they are, and without any evidence that they are markedly different from the characteristics that are inherent from the mere additive mixture of the claimed components, is not persuasive. Second, even if there was of record evidence of unexpected benefits or results, in the claims such as claim 1 where no specific amounts of the components are claimed, the claims would encompass embodiments where there isn't sufficient amount of one or more components to confer unexpected results. In other words, for example, claim 1 would encompass having only trace amounts of one or more of the recited ingredients. Trace amounts of the ingredients would not necessarily have any measurable effects, let alone contribute to unexpected results. To obviate a 101 rejection of this type, the invention needs to be drawn to a scope in which the entire scope has a markedly different characteristic as compared to the sum of the individual components, that that markedly different characteristic is clearly of record and supported by the record.
Applicant argues that the change in physical form of the ingredients for consumption is a markedly distinct characteristic.
In response to Applicant’s argument, the mere change in hydration, particle size, and being blended together do not confer markedly different characteristics. Applicant must show evidence of markedly different characteristics.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655