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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on October 4, 2024, November 8, 2024, and April 9, 2025 have been entered.
3. The declaration of Jordan Rubin, filed October 4, 2024, has been received and considered.
4. Claims 18-20 and 22-33 are examined on the merits.
Election/Restrictions
5. Applicant’s election with traverse of the combination of Mulberry, Blackberry, Hawthorn, Apple, Aronia, Persimmon, Noni, Guava, Papaya, Soursop, Fig and Pomegranate, in the reply filed on April 9, 2025 is acknowledged.
6. Newly submitted claims 29-33 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The claims are originally presented were drawn to solely to composition claims. Composition claims 18-20 and 22-28 and newly presented method claims 29-33 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product can be used for a different purpose such as in cooking.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 29-33 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
7. Claims 23 and 29-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
8. Claims 18-20, 22, and 24-28 are examined on the merits.
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.
9. Claims 18-20, 22, and 24-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection, rather than an enablement rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, first paragraph, "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
The claims are drawn to a combination of twelve different leaf types from any type of perennial plant or tree that is able to bear edible fruit. However, the specification only discloses an actual combination of leaves from soursop, moringa, pomegranate, jabuticaba, tamarillo, key lime, mango, baobab, fig, loquat, and olive and discusses that potentially about 100 other species may be useful (see Examples 1 and 2). In analyzing whether the written description requirement is met for genus claims, it is first determine whether a representative number of species have been sufficiently described. In this case, only a limited number of plant leaves have been described while there are over 2,000 types of edible fruit (see “How Many Different Fruits Are There On Earth?” - https://www.exoticfruitscambridge.com/blog/how-many-different-fruits-are-there-on-plantet-earth#:~:text=There%20are%20around%202000%20types,fruit%20on%20this%20beautiful%20planet.). Applicant has only demonstrated the specific combination of soursop, moringa, pomegranate, jabuticaba, tamarillo, key lime, mango, baobab, fig, loquat, and olive is useful. This limited information is not deemed sufficient to reasonably convey to one skill in the art that applicant was in possession of combining leaves from the thousands of other plants that are able to bear fruit at the time the application was filed. As discussed in MPEP section 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species… A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)…
Since there are thousands of types of plants that bear fruit, there would be considerable variation within this large grouping. This variation is demonstrated by Hodgson (https://laidbackgardener.blog/2021/08/29/plants-that-are-both-edible-and-poisonous/ ) which teaches that numerous plants which bear edible fruit have leaves that are toxic. The reference states that almond plants, elderberry plants, prunes, plums, and cherry trees all have edible fruits but have poisonous leaves (see pages 3, 9, and 11). Thus, these leaves would meet the requirements of applicant’s claims but would seemingly be unsuitable for an oral medicament. Thus, the description of a small subset of plant leaves within this large grouping is not considered to adequately describe the entire genus. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
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.
10. Claims 18-20, 22, and 24-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 is indefinite because at lines 6-7, the term “potent” is a relative term which renders the claim indefinite. The term “potent” is not defined by the claim, 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. It is unclear what characteristics a liquid must have in order to be a “potent” liquid.
Claim 18 at line 7 is also indefinite because it is unclear which elements are being referred to in the limitation of “any of which”. It is unclear if this encompasses the “liquid medicament suitable for direct administration as a beverage”, “potent liquid”, “powder,” and “powdered extract”. Or if this limitation encompasses a different combination of these elements.
Claim 18 at lines 9-10 is indefinite because it is unclear which animals or humans are considered to be “in need of a broad spectrum herbal medicament.” In addition, it is unclear what characteristics the medicament must have in order to be considered “broad spectrum”.
Claim 18 at line 12 is indefinite because it states that the leaves are rendered into a “composite for subsequent brewing”. It is unclear how the leaves are “rendered into a composite” and if the “subsequent brewing” step is referring to the boiling and simmering step recited in line 5.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
11. Claim(s) 18-20, 22, and 24-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mazed (US 2009/0252796), Wang (J. Agric. Food Chem., 48:140 (2000)) and Chang (US 2015/0181917).
Mazed teaches a combination of at least ten different botanical species where the botanical ingredient can be leaves from the plants. The reference specifically teaches the use of Soursop (Annona muricata), Aronia, Hawthorn (Crataegus), Fig (Ficus indica), Apple (Malus domestica), Noni (Morinda citrifolia), Mulberry (Morus alba), Guava (Psidium guajava), Persimmon, Papaya, Pomegranate (Punica granatum), and Blackberry (Rubus villosus) (see claim 1 and paragraph 346). The reference teaches that the ingredients can be formulated into a food, drink, supplement, or pharmaceutical. In addition, the reference teaches that each of the individual ingredients adds distinct phytochemicals to the combination. Thus, the reference combination would meet the phytochemical requirements of claims 24-28.
The reference does not teach that the leaves are harvested prior to the ripening of the fruit. However, the concept that fruiting plant leaves remain rich in chemicals until the fruit begins to ripen is well known. As the applicant’s specification correctly notes, chemicals in plants are enriched in the leaves until the fruit begins to ripen and become enriched in those chemicals, depleting the leaves. ([006]). This property of fruiting plants is confirmed in Wang, which demonstrates that as fruiting plants become older and fruits ripen, nutraceutical compounds decrease in leaves and increase in fruits. (Abstract; p. 145, column 2, 24 full paragraph). As such, as in claim 18, it is obvious to choose leaves prior to the ripening of the fruit, in order to maximize nutraceutical content. Moreover, regarding the claimed range of time prior to leaf harvest recited in claims 19 and 20, generally, differences in degrees of reaction conditions will not support patentability in the absence of evidence indicating such conditions are critical.
The references also do not specifically teach that the leaves are pretreated as claimed or mixed with water, brought to a boil, and simmered for 12 minutes. However, Chang teaches making plant based compositions by drying plant leaves and brewing the plant leaves in boiling water for 5 to 30 minutes (see paragraph 21). Thus, an artisan of ordinary skill would reasonably expected that the plant leaf composition taught by Mazed could be formulated by drying the leaves with heat, mixing the leaves with water, and boiling/simmering the leaves for any length of time within the range taught by Chang. As discussed in MPEP section 2144.05(II)(A), “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. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
It is noted that in the response filed October 4, 2024 applicant argues that the declaration of Jodan Rubin (filed October 4, 2024) shows that the claimed combination of 12 leaves is patentable based on unexpected results. However, the declaration is not considered to support a claim for patentability based on unexpected results because the declaration does not state the specific ingredients that are used in the compositions. Without knowing what ingredients are administered, the results cannot be evaluated for the presence of any properties, unexpected or otherwise.
12. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0775. 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
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