DETAILED ACTION
Notice of 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 .
Election/Restrictions
In the Requirement for Restriction dated 1/14/2026, restriction between the following Groups of Invention was required:
Group I, claims 1-4, drawn to a composition comprising plant ingredients;
Group II, claims 5-8, drawn to a composition comprising plant herbs; and
Group III, claims 9-13, drawn to a composition comprising plant herbs for inhibiting corona virus infection.
Yet, considering that each of the compositions of Groups I-III contain the exact same ingredients in the exact same amounts, it is determined that the claims, as currently drafted, do not recite different Groups of Invention.
As such, the Requirement for Restriction is WITHDRAWN.
Claims 1-13 are currently pending and are the subject of this Office Action.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nature-based products without significantly more.
The Supreme Court’s Alice and Mayo Collaborative Services v. Prometheus Laboratories, Inc. decisions provide the two-stage framework by which patent eligibility under § 101 is assessed (see 573 U.S. at 216-218; 566 U.S. 66, 70-80 (2012)). A patent claim falls outside § 101 where:
(1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea; and
(2) if so, the particular elements of the claim, considered “both individually and ‘as an ordered combination,’” do not add enough to “‘transform the nature of the claim’ into a patent-eligible application.”
Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016) (quoting Alice, 573 U.S. at 217).
It is against this framework that the instant claims are analyzed.
Claim 1 is drawn to a composition of plant ingredients, comprising Camellia, lotus seed pod of Nelumbo nucifera, Eucommia ulmoides Oliver, Glechoma hederacea and Angelica keiskei (more specifically, wherein the composition further comprises lotus seed of Nelumbo nucifera and Trigonella foenum-graecum (claim 3) and wherein the ratio of plant ingredients is 3:3:2:3:2:1:1 (claims 2 and 4)).
Claim 5 is similarly drawn to a composition of herbs, comprising Camellia, lotus seed pod of Nelumbo nucifera, Eucommia ulmoides Oliver, Glechoma hederacea and Angelica keiskei (more specifically, wherein the composition further comprises lotus seed of Nelumbo nucifera and Trigonella foenum-graecum (claim 7) and wherein the ratio of plant ingredients is 3:3:2:3:2:1:1 (claims 6 and 8)).
And claim 9 is drawn to a composition of herbs “for inhibiting coronavirus infection”, comprising Camellia, lotus seed pod of Nelumbo nucifera, Eucommia ulmoides Oliver, Glechoma hederacea and Angelica keiskei (more specifically, wherein the composition further comprises lotus seed of Nelumbo nucifera and Trigonella foenum-graecum (claim 11) and wherein the ratio of plant ingredients is 3:3:2:3:2:1:1 (claims 10 and 12)).
Lastly, claim 13 is drawn to the composition of claim 9, wherein the composition of herbs “is used for blocking coronavirus entry, inhibiting syncytia formation, or restricting the forming area of syncytia”.
As to the first inquiry, then, each of the claims are drawn to compositions comprising naturally occurring nature-based products. The courts have held that products of nature fall under the laws of nature or natural phenomena exceptions, which are judicially recognized exceptions.
As to the second inquiry, there is no indication that the instantly claimed compositions comprising a combination of naturally occurring plant ingredients/herbs have markedly different characteristics from the individual nature-based plant ingredients/herbs.
In particular, the Specification (Paragraphs 0022-0027, Example 1) evaluated each of the nature-based plant ingredients/herbs individually (LCV01-LCV07) as well as two combinations thereof, RXC19-A and RXC19-B, in inhibiting WT-GFP-SARS-CoV-2 pseudotyped lentivirus entry and infection of 293T cells, wherein:
RXC19-A comprises Camellia, lotus seed pod of Nelumbo nucifera, Eucommia ulmoides Oliver, Glechoma hederacea and Angelica keiskei as recited by claims 1, 5, 9 and 12; and
RXC19-B comprises Camellia, lotus seed pod of Nelumbo nucifera, Eucommia ulmoides Oliver, Glechoma hederacea, Angelica keiskei, lotus seed of Nelumbo nucifera and Trigonella foenum-graecum as recited by claims 3, 7 and 11.
Significantly, “[t]he rates of inhibition of viral entry of the plant ingredients LCV01 to LCV02 and the compositions RXC19-A and RXC19-B in 10 µg/mL are about 83%, 81%, 76%, 86%, 81%, 72%, 85%, 88% and 82%, respectively” (Paragraph 0027; see also Figure 1(B)).
As such, in Example 1, the instantly claimed compositions comprising a combination of naturally occurring plant ingredients/herbs do not exhibit markedly different characteristics from the individual nature-based plant ingredients/herbs.
Next, “GFP-SARS-CoV-2 pseudotyped lentivirus were incubated... with serial dilutions of the plant ingredients LCV01 to LCV07, as well as the compositions RXC19-A and RXC19-B, to pre-treat the SARS-CoV-2 pseudotyped lentivirus” and “[t]hen pseudovirus-plant ingredients mixture was added into 293T cells... to observe whether the plant ingredients and compositions could effectively inhibit the viral entry and infection... in the same way as Example 1” (Paragraph 0028; Example 2).
Again, “increases in the concentrations of the plant ingredients LCV01, LCV03, LCV05, LCV06, and LCV07, as well as the compositions RXC19-A and RXC19-B, resulted in... fewer 293T cells... infected by SARS-CoV-2 pseudotyped lentivirus” which “suggest that the pre-treatment with the plant ingredients LCV01, LCV03, LCV05, LCV06, and LCV07, and the compositions RXC19-A and RXC19-B can inhibit the entry of SARS-CoV-2 pseudotyped lentivirus” (Paragraph 0032; see also Figure 2).
Finally, investigating “whether the plant ingredients LCV01 to LCV07 and the compositions RXC19-A and RXC19-B have the ability to inhibit the spike-mediated syncytia formation” (Paragraph 0036), the Specification teaches that “[t]he number of mediated syncytia formation was significantly reduced when cells were pre-treated with plant ingredients LCV03... LCV07... and compositions RXC19-A and RXC19-B” which “indicated that the palnt ingredients LCV01 and LCV07 and compositions RXC19-A and RXC19-B can effectively restrict the forming area of syncytia, demonstrating their ability to suppress syncytia formation” (Paragraph 0039).
Based on all of the foregoing, there is nothing to indicate that the claimed compositions possess any characteristics that are different from the naturally occurring plant ingredients/herbs. There is no difference in structure, no difference in function, and no difference in other properties. Because there are no different characteristics, there are no markedly different characteristics and, as such, the claimed compositions entail a product of nature exception.
Accordingly, claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim Rejections - 35 USC § 112
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.
Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites “A composition of herbs for inhibiting coronavirus infection, further comprising Camellia, lotus seedpod of Nelumbo nucifera...” and so on.
The recitation of the composition “further comprising” Camellia, lotus seedpod of Nelumbo nucifera, and so on renders the claim indefinite because it requires the composition to comprise other ingredients which are undefined by the claim. It is unclear what other ingredients are present in said composition “further comprising” Camellia, lotus seedpod of Nelumbo nucifera, and so on.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hatab et al (Foodborne Pathogens and Disease 15:498-505, 2018), Ruvanthika et al (Asian J of Pharm Clin Res 12:164-167, 2019), Wu et al (Molecules 1898:16 pages, 2018), Kumarasamy et al (Fitoterapia 73:721-723, 2002), Caesar et al (Planta Med 84:721-728, 2018), and Arooj et al (Food Sci Nutr 9:3971-3987, published 5/06/2021).
Claims 1 and 3 are drawn to a composition of plant ingredients, comprising:
(a) Camellia;
(b) lotus seed pod of Nelumbo nucifera (aka Padma, Kamal, sacred lotus, pink lotus, Indian lotus, and lotus)
(c) Eucommia ulmoides Oliver (aka Hardy Rubber Tree);
(d) Glechoma hederacea (aka Ground Ivy and Creeping Charlie);
(e) Angelica keiskei (aka ashitaba);
(f) lotus seed of Nelumbo nucifera (aka Nelumbinis semen); and
(g) Trigonella foenum-grecum (aka fenugreek).
The prior art teaches that each of the instantly claimed plant ingredients possess antibacterial activity against gram positive bacteria and, in particular, against Staphylococcus aureus as follows:
(a) Hatab et al, “[e]thanolic extracts of green tea leaves [i.e., Camellia sinensis]... revealed antimicrobial activity against selected bacterial strains” including “Staphylococcus aureus” (Abstract);
(b) As taught by Ruvanthika et al, “ethanolic extracts of Nelumbo nucifera (EENN) seedpod” (Abstract) provide a “moderate zone of inhibition... against S. aureus” (Page 165, Column 2; see also Page 166, Table 1);
(c) As taught by Wu et al, “previous studies have shown that ethyl acetate extract of E. ulmoides flowers had good antibacterial activities against Staphylococcus aureus” (Page 2);
(d) As taught by Kumarasamy et al, “extracts of the aerial parts of Glechoma hederacea... screened for antibacterial... activity” (Abstract) demonstrate activity against Staphylococcus aureus (Page 722, Table 1);
(e) As taught by Caesar et al, “A. keiskei (AK) crude extract (CR)” provided 99% growth inhibition of MRSA (Page 722, Table 1);
(f) As taught by Arooj et al, “[l]otus seeds oil... inhibited the microbial strain... Staphylococcus aureus” (Page 3981, Column 1); and
(g) As further taught by Hatab et al, “[e]thanolic extracts of... fenugreek seeds... revealed antimicrobial activity against selected bacterial strains” including “Staphylococcus aureus” (Abstract).
Accordingly, in view of all of the foregoing, it would have been prima facie obvious to combine each of the plant ingredients, each of which are individually taught as possessing antibacterial activity against gram positive bacteria and, in particular, against Staphylococcus aureus, to form a single composition. As stated in MPEP 2144.06, “[i]t 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 their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846 (CCPA 1980).
As such, claims 1 and 3 are rejected as prima facie obvious.
Claims 2 and 4 are drawn to the compositions of claims 1 and 3, wherein the ratio of (a):(b):(c):(d):(e):(f):(g) is 3:3:2:3:2:1:1.
As stated by MPEP 2144.05, “[g]enerally, 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” (see also In re Aller (220 F.2d 454 (CCPA): “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the amounts of active ingredients in a pharmaceutical formulation is clearly a result-effective variable. Indeed, as stated by the court in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015), every ordinary artisan in medicine performs “merely routine optimization of drug dosage to maximize therapeutic effect.” Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal amounts of each of the plant ingredients to include in the composition in order to best achieve the desired results.
As such, claims 2 and 4 are also rejected as prima facie obvious.
Claims 5-8 are drawn to “[a] composition of herbs” – as opposed to “[a] composition of plant ingredients”, as recited by claims 1-4 – but are otherwise identical to claims 1-4.
Since there is nothing structurally distinguishable between the “herbs” (of claims 5-8) and the “plant ingredients” (of claims 1-4), claims 5-8 also are rejected as prima facie obvious for the same reasons as applied to claims 1-4.
Claims 9-13 are drawn to “[a] composition of herbs for inhibiting coronavirus” (more specifically, “wherein the composition of herbs is used for blocking coronavirus entry, inhibiting syncytia formation, or restricting the forming area of syncytia” (claim 13)), but are otherwise identical to claims 1-4 and 5-8.
Again, there is nothing structurally distinguishable between the “herbs” (of claims 9-13) and the “plant ingredients” (of claims 1-4). Additionally, a preamble is generally not accorded any patentable weight where it merely recites the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). And, even when an intended use of the structure is recited in the body of the claim (as in claim 13), use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results 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.
Since there is nothing structurally distinguishable between the “herbs” (of claims 9-13) and the “plant ingredients” (of claims 1-4), and since the recitation of an intended use “for inhibiting coronavirus” (in the preamble of claim 9) and “wherein the composition of herbs is used for blocking coronavirus entry, inhibiting syncytia formation, or restricting the forming area of syncytia” (in the body of claim 13) do not carry patentable weight, claims 9-13 also are rejected as prima facie obvious for the same reasons as applied to claims 1-4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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