DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 2, 2025 has been entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-13 and 15-20 are pending.
4. In the reply filed on January 6, 2023, applicant elected the combination of lobelia herb powder, plantain leaf powder, and mullein leaf powder without traverse.
5. Claims 1-8, 16, 17, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim 17 is now withdrawn because would be allowable if limited to the elected species. However, claim 17 depends from claim 9 which is not allowable and also contains species that have not been examined. Claims 19 and 20 are withdrawn because the do not require all three of the elected species. The search has not been extended to encompass the non-elected species; thus, these claims are withdrawn until such time.
6. Claims 9-13, 15, and 18 are examined on the merits solely in regards to the elected species.
Claim Rejections - 35 USC § 101
7. Claims 9-13, 15, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
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.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite lobelia herb powder, plantain leaf powder, and mullein leaf powder. Lobelia, plantain, and mullein are all naturally occurring plants. Thus, the claims do recite products of nature. 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, there is no indication that mixing the specified ingredients together as commensurate in scope with the stated claims changes the structure, function, or other properties of the powdered plants in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each of the powdered plants is the plant itself. Each plant ingredient appears to maintain its naturally occurring structure and properties and is merely present in the combination. There is nothing to show that mixing the ingredients in together produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. 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, applicant’s claims are directed to a composition with an intended use of an oral medication for clarifying the skin and functioning as an anti-inflammatory agent. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must 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, the additional element in the claims is the combination of the ingredients. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific ingredients does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s intended use of skin clarifying and anti-inflammation is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Response to Arguments
Applicant's arguments filed Septebmer 2, 2025 have been fully considered but they are not persuasive. Applicant argues:
Applicant contends that the claim defines a structurally novel composition. The
claims recites a specific physical composition with a structure that does not exist in
nature. The Examiner's rejection fails to appreciate the dispositive weight of the claim's
structural limitations that at least two components are provided in the oral supplement
in substantially equal proportions by weight.
This is a precise, quantitative, and entirely artificial structural arrangement.
Nature does not produce a mixture of lobelia, plantain leaf, or any of the other claimed
powders in a 1:1 ratio ("substantially equal proportions by weight). This specific
formulation is the "markedly different characteristic" (that the Examiner alleges the
Applicant has not provided) from the components as they are found in nature.
The Examiner's reasoning is analogous to saying because copper and tin are
both naturally occurring elements, a claim to a random rock containing both copper and
tin would be a natural product. Applicant would agree. But a claim to a bronze alloy
comprising a specific ratio of copper and tin is patentable because that precise ratio
creates a new material with new structural properties (hardness, melting point, etc.).
The claim to a 1:1 ratio of specific plant powders in Applicant's claims is analogous in
that it defines a new composition with a structure not found in nature…
…This language requires that the final, formulated composition actually possesses
the ability to activate D1 receptors. This functional property is a direct result of the
specific, man-made combination and ratio of ingredients Applicant has selected for
this oral supplement…
…Applicant is not merely claiming a pile of herbs and hoping it has an effect.
Applicant is claiming a specifically engineered composition that, due to its unnatural
structure (the 1:1 ratio and specific combination), exhibits a particular functional
property (D1 activation). This functional attribute is an inherent characteristic of the
specific formulation as claimed (not the naturally occurring plant), thereby
distinguishing it from a simple mixture of the individual components.
This ties the unnatural structure (the specific 1:1 ratio) to an unnatural function
(the targeted D1 activation). The Examiner cannot properly disregard these limitations
as mere intended use - it is a defining property of the matter being claimed.
The Office Action further alleges "applicant has not provided any evidence to
support the assertions regarding "lobelia toxicity" and the claimed invention's ability to
overcome this toxicity" and "applicant has not provided any evidence to support the
assertions regarding the side effects associated with plantain leaf ingestion and the
claimed invention's ability to overcome these side effects." Applicant uses less than a
toxic level of each ingredient because the claims combine multiple different ingredients together that can achieve the same goal. Each ingredient amount was able to be
reduced to below a toxic level due to the synergistic effects of the 2-3 in combination.
Applicant has made such statements of record.
However, the analysis is not whether or not the product is found in nature, the analysis is whether or not a combination of naturally occurring products produces a combination with markedly distinct characteristics. As discussed above, and in the previous Office actions, there is not considered to be sufficient evidence to show that the claimed combination of ingredients produces a composition with a markedly distinct characteristic. Applicant’s claims are similar in fact pattern to Nature-Based Product example number 1 issued by the USPTO (see https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.pdf). This example has a mixture of three naturally occurring powders. The example states:
…there is no naturally occurring counterpart to the claimed combination (the components do not occur together in nature), so the combination is compared to the individual components as they occur in nature. None of the three claimed substances are explosive in nature. When the substances are finely-ground and intimately mixed in the claimed ratio, however, the claimed combination is explosive upon ignition. This explosive property of the claimed combination is markedly different from the non-explosive properties of the substances by themselves in nature. Accordingly, the claimed combination has markedly different characteristics, and is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter.
Thus, this example shows that when a nature based product does not occur in nature (as with applicant’s claims), each component must be compared to the individual component as they occur in nature to determine if the combination is markedly distinct. In the example, the product was found eligible because there was evidence that showed while each individually was not explosive, the combination of the three component was explosive. However, in the current application, applicant has not provided any specific evidence to support the various assertions that the combination of the three ingredients is markedly distinct from the individual ingredients. Applicant has not shown results for the combination in comparison with the individual ingredients. This comparison is needed in order to determine if the combination actually produces a markedly distinct characteristic.
8. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655