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. The amendment filed November 5, 2025 has been received and entered.
3. Claims 43-62 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of Group I, claims 43-53, and “Combination 10” comprising extracts from the Violaceae, Myrtaceae, Moraceae, Iridaceae, and Zingiberaceae plant families in the reply filed on November 5, 2025 is acknowledged.
5. Claims 44, 45, and 54-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Please note that claim 44 is withdrawn because it does not require the presence of all of the elected species.
6. Claims 43 and 46-53 are examined on the merits in regards to the elected species.
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.
7. Claims 43 and 46-53 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 composition comprising extract from plants from the Violaceae, Myrtaceae, Moraceae, Iridaceae, and Zingiberaceae plant families. However, the specification only discloses one member of the Violaceae family, Viola odorata, while there are at least 1,000 species within this plant family (see https://en.wikipedia.org/wiki/Violaceae). In addition, the specification only discloses one member of the Myrtaceae family, manuka honey from Leptospermum scoparium, while there are at least 5,900 species within this plant family (see https://en.wikipedia.org/wiki/Myrtaceae). The specification only discloses one member of the Moraceae family, Ficus carica, while there are at least 1,100 species within this plant family (see https://en.wikipedia.org/wiki/Moraceae). The specification only discloses one member of the Iridaceae family, Crocus sativus, while there are at least 2,500 species within this plant family (see https://en.wikipedia.org/wiki/Iridaceae). The specification only discloses one member of the Zingiberaceae family, Elettaria cardamomum, while there are at least 1,600 species within this plant family (see https://en.wikipedia.org/wiki/Zingiberaceae). 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 one species from each plant family has been described while each plant family contains thousands of species. Applicant has only demonstrated that extracts from these specific plant species are useful in the invention. This limited information is not deemed sufficient to reasonably convey to one skill in the art that applicant was in possession of extracts from all other plant species within the plant families 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 species within each of the claimed plant families, there would be considerable variation within these plant families. The description of one species within this large genera is not considered to adequately describe the entire genus. Thus, it is concluded that the written description requirement is not satisfied for the claimed genera.
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.
8. Claims 43 and 46-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products 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 extracts from Violaceae, Myrtaceae, Moraceae, Iridaceae, and Zingiberaceae plant families. The elected species is “Combination 10” defined in the specification as Viola odorata, Manuka honey, Ficus carica, Crocus sativus, and Elettaria cardamomum (see Table 1). Each of these is a naturally occurring plant. 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, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the particular plants. Combining the extracts from the individual plants leads to a combination of the naturally occurring compounds from each of the plants. Thus, the claims are drawn to mixtures of naturally occurring products.
There is no indication that mixing the specified extracts together as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for each extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant. Each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations 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 suppressing a coronavirus protease, inhibiting spike protein binding, inhibiting coronavirus replication, inhibiting protease enzymes, and inhibiting cytokine storm. 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 extracts. 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 compounds 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, adding ingredients such as binders and carrier is also routine. 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 uses are 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claim(s) 43 and 46-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (KR 20040010390 A – 1/31/2004 – English translation), Yu (KR 101627065 B1 – 6/2/2016 – English translation), Gopinathan (US 2009/0263514), and Li (CN 102552789 A – 7/11/2012 – English translation).
Applicant has elected the species of “Combination 10” which is defined in the specification as a combination of extracts from Viola odorata, Manuka honey, Ficus carica, Crocus sativus, and Elettaria cardamomum (see Table 1).
Shimizu teaches a composition for treating the flu comprising extracts from Viola odorata and Ficus carica in combination with carriers, diluents, and stabilizers (see abstract and page 4 of the translation).
Yu teaches a composition for treating the flu comprising an extract from manuka honey (see abstract and claim).
Gopinathan teaches a composition for treating the flu comprising an extract from saffron (C. sativus) (see claims 3 and 23).
Li teaches a composition for treating the flu comprising an extract from cardamom (E. cardamomum) (see paragraphs 9-13, 35-38).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that treat the flu. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to treat the flu, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat the flu. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The reference does not specifically teach that the composition has the same effects on coronavirus as claimed. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The composition taught by the combination of the references is structurally the same as the claimed invention. Thus, the prior art composition should be capable of performing the intended uses if applicant’s invention functions as claimed.
10. No claims 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.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655