DETAILED ACTION
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 .
Applicants’ amendment to the claims filed on 5/9/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-9 are pending.
Claims 10-20 are canceled.
Election/Restrictions
Applicant’s election of Group I, claims 1-9 in the reply filed on 5/9/2026 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)).
Applicant cancels claims 10-20 without prejudice and reserves the right to reintroduce the non-elected claims in one or more continuation or divisional applications at a later date.
Claims 1-9 are pending and examined on the merits.
Claims 10-20 are canceled.
Claim Objections
In claims 1-4, 9, “Litsea rubescensLeeomte” should be spelled “Litsea rubescens Lecomte.”
Claim 4 is objected to in view of the recitation “grinded.” Said term is an incorrect past tense of "grind." It is recommended Applicant amend the term to “ground.”
Claims 1, 4, 9 are objected to due to the recitation of the phrase “killing viruses.” Said phrase is not scientifically correct as viruses are well-known in the art to be non-living entities. It is recommended that Applicant replace the phrase with ‘“inactivating viruses.”
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is a naturally occurring plants and plant extracts.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is drawn to a composition of matter, which is one of the four statutory categories.
Step 2, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim is directed to a natural phenomenon. Said natural phenomenon are plants and plant extracts.
Claims 1-9 are directed towards a biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw materials: Artemisia argyi, Lactuca sativa, Allium tuberosum, Allium cepiforme, Litsea rubescens Leeomte, Glycyrrhiza uralensis, Allium sativum, Mentha canadensis, Allium mongolicum, Lonicera japonica , Sargassum, monazite, calcium carbonate, fructo oligosaccharide (FOS), isomaltooligosaccharide (IMO), and organic selenium for the killing (inactivation) of viruses. Said ‘biological enzyme’ is naturally occurring. A ‘biological enzyme’ is interpreted as a consortium of naturally occurring plants and plant extracts that are obtained within the same environment, based on the instant application claim language. There is no indication in the specification that the claimed mixture of plants and plant extracts have any characteristics (structural, functional, or otherwise) that are different from the naturally occurring plants and plant extracts. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception.
Step 2, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1-9 include the additional element of differing amounts and ratios of Artemisia argyi, Lactuca sativa, Allium tuberosum, Allium cepiforme, Litsea rubescens Leeomte, Glycyrrhiza uralensis, Allium sativum, Mentha canadensis, Allium mongolicum, Lonicera japonica , Sargassum, monazite, calcium carbonate, fructo oligosaccharide (FOS), isomaltooligosaccharide (IMO), and organic selenium for the killing (inactivation) of viruses. Such a limitation does not amount to a judicial exception as the ‘biological enzymes’ are native to the plants and plant extracts. Therefore, it does not integrate the judicial exception into a practical application for the same reasons discussed above.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exception are considered to be native to the plant and plant extracts on which the judicial exception is to be performed as noted in Step 2A, Prong 2, and, therefore, do not amount to significantly more than the judicial exception that is claimed because the claim does not include any additional features that could add significantly more to the exception.
In reference to claim 1 of Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), which recites ‘an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific,’ the inoculant of claim 1 was held to be ineligible subject matter.
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.
Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Myriad, 133 S. Ct. at 2117.
In this regard, as the instant claims recites judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
Written Description
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.
Claims 1-9 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claims 1-9 are drawn to a biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw materials: 300-500 grams (g) of Artemisia argyi, 200-300 g of Lactuca sativa, 200-300 g of Allium tuberosum, 300-400 g of Allium cepiforme, 200-300 g of Litsea rubescens Leeomte, 50-150 g of Glycyrrhiza uralensis, 50-100 g of Allium sativum, 75-150 g of Mentha canadensis, 100-200 g of Allium mongolicum, 50-150 g of Lonicera japonica , 80-120 g of Sargassum, 20-30 g of monazite, 25-35 g of calcium carbonate, 10-20 g of fructo oligosaccharide (FOS), 8-12 g of isomaltooligosaccharide (IMO), and 20-40 g of organic selenium. The structure of a “biological enzyme” encompasses a large number of ‘enzymes.’ It is noted that it appears that the claims are actually drawn to a loose mixture of plants and plant extracts without a specific and characteristic agent which can be called or identified as a “biological enzyme” having a specific structure.
In this case, the specification discloses the following representative species of ‘biological enzymes’ as encompassed by the claims (i.e. the biological enzyme is made from the following raw materials: Artemisia argyi, Lactuca sativa, Allium tuberosum, Allium cepiforme, Litsea rubescens Leeomte, Glycyrrhiza uralensis, Allium sativum, Mentha canadensis, Allium mongolicum, Lonicera japonica , Sargassum, monazite, calcium carbonate, fructo oligosaccharide (FOS), isomaltooligosaccharide (IMO), and organic selenium). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the infinite number of ‘biological enzymes’ for the killing (inactivation) of viruses.
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Here, the disclosure fails to teach which biological enzymes out of the numerous possibilities for the killing (inactivation) of viruses.
Accordingly, one of skill in the art would not accept the disclosure of ‘biological enzymes’ made from Artemisia argyi, Lactuca sativa, Allium tuberosum, Allium cepiforme, Litsea rubescens Leeomte, Glycyrrhiza uralensis, Allium sativum, Mentha canadensis, Allium mongolicum, Lonicera japonica, Sargassum, monazite, calcium carbonate, fructo oligosaccharide (FOS), isomaltooligosaccharide (IMO), and organic selenium for the killing (inactivation) of viruses as being representative of all biological enzymes for the killing (inactivation) of viruses as encompassed by the claims. As such, the specification, taken with the pre-existing knowledge in the art of biological enzymes, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph.
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.
Claim 4 is 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.
The term “warm” in claim 4 is a relative term which renders the claim indefinite. The term “warm” is not defined by the specification. There is no specific definition in quantitative terms with reference to what specific temperature is considered as “warm” by the Applicant. Appropriate correction is suggested.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 are rejected under 35 U.S.C. 103 as being obvious over He at al (CN112956588A, Date of Publication: 2021-06-15, Examiner cited) {herein He) in view of Li et al (CN114470148A, Date of Publication: 2022-05-13, Examiner cited) {herein Li) and Wang et al (CN104547174B, Date of Publication: 2015-04-29, Examiner cited) {herein Wang}.
Claims 1-9 are drawn to a biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw materials: 300-500 grams (g) of Artemisia argyi, 200-300 g of Lactuca sativa, 200-300 g of Allium tuberosum, 300-400 g of Allium cepiforme, 200-300 g of Litsea rubescens Leeomte, 50-150 g of Glycyrrhiza uralensis, 50-100 g of Allium sativum, 75-150 g of Mentha canadensis, 100-200 g of Allium mongolicum, 50-150 g of Lonicera japonica , 80-120 g of Sargassum, 20-30 g of monazite, 25-35 g of calcium carbonate, 10-20 g of fructo oligosaccharide (FOS), 8-12 g of isomaltooligosaccharide (IMO), and 20-40 g of organic selenium.
With respect to claims 1- 5, He teaches an antiviral animal feed additive comprising Artemisiae Argyi, lettuce (Lactuca sativa), Allii tuberosi (Allium tuberosum), Litseae Rubescentis (Lecomte), Glycyrrhrizae, seaweed (Sargassum), monazite, calcium carbonate, fructo-oligosaccharide, isomaltooligosaccharide and organic selenium (page 1, claims 5-7; page 2, claims 8-9).
With respect to claim 4, He teaches an antiviral (biological enzyme for killing viruses) animal feed additive, the method comprising: (step 1) providing Artemisiae Argyi, lettuce (Lactuca sativa), Allii tuberosi (Allium tuberosum), Litseae Rubescentis (Lecomte), Glycyrrhrizae, seaweed (Sargassum), monazite, calcium carbonate, fructo-oligosaccharide, isomaltooligosaccharide and organic selenium (page 1, claims 5-7; page 2, claims 8-9); (step 2 – 3) pulverizing the herbs into a slurry, filtering to obtain combined juices (page 2); (step 4) adding seaweed to the juice, cooking (stewing), filtering and cooling (page 2); (step 5) adding 30% each fructo-oligosaccharide (FOS) and isomaltooligosaccharide (IMO) to the cooled liquid, stirring, fermenting to obtain a fist fermentation liquid, filtering adding the remaining FOS and IMO and fermenting for a second broth (page 2); (step 6) crushing monazite and calcium carbonate, placing the resulting powder into a furnace at 1800 – 2200°C, firing (sintering) for 75 – 105 minutes, cooling, placing into a cloth bag with 800 – 1200 meshes, distilling via steam distillation to obtain a distillate (liquid) (page 2); (step 7) distilling additional fermentation broths until no distillate is left to obtain a fermentation liquor (broth), adding the organic selenium and wild camellia oil in a ratio or 1:5-10 (mixed solution: oil) (page 2).
With respect to claims 6-8, He teaches said enzyme is effective against influenza A viruses H1N1 (page 2, para 3).
However, He does not teach the “biological enzyme for killing viruses”, wherein the biological enzyme is made from the following raw materials: 300-400 g of Allium cepiforme, 50-100 g of Allium sativum, 75-150 g of Mentha canadensis, 100-200 g of Allium mongolicum (claims 1, 4). The biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw materials: 300g of Allium cepiforme, 50 g of Allium sativum, 75 g of Mentha canadensis, 100g of Allium mongolicum (claim 2). The biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw materials: 400g of Allium cepiforme, 100 g of Allium sativum, 150 g of Mentha canadensis, 200g of Allium mongolicum (claim 3). The biological enzyme for killing viruses, wherein a preparation method comprises Allium mongolicum and Lonicera japonica (claim 4). The biological enzyme is made for killing viruses, wherein a weight ratio of the Lactuca sativa: the Allium tuberosum: the Litsea rubescensLeeomte is 1 :1: 1, and a weight ratio of the Glycyrrhiza uralensis and the Lonicerajaponica is 1 :1 (claim 9).
With respect to claims 1, 2, 3, 4 Li teaches an antiviral animal feed additives wherein active components include garlicin (Allium sativum), honeysuckle (Lonicera japonica), onion (Allium mongolicum and Allium cepiforme) (abstract).
However, Li does not teach the biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw material: 75-150 g of Mentha canadensis (claims 1, 4). The biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw material: 75 g of Mentha canadensis (claim 2). The biological enzyme for killing viruses, wherein the biological enzyme is made from the following raw material: 150 g of Mentha canadensis (claim 3). The biological enzyme is made for killing viruses, wherein a weight ratio of the Lactuca sativa : the Allium tuberosum : the Litsea rubescensLeeomte is 1 :1: 1, and a weight ratio of the Glycyrrhiza uralensis and the Lonicerajaponica is 1 :1 (claim 9).
With respect to claims 1, 2, 3, 4, Wang teaches antiviral animal feeds additives wherein the active components include Herba Menthae (Menthae canadensis), Glycyrrhizae (abstract).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of He et al. of an antiviral animal feed additive comprising Artemisiae Argyi, lettuce (Lactuca sativa), Allii tuberosi (Allium tuberosum), Litseae Rubescentis (Lecomte), Glycyrrhrizae, seaweed (Sargassum), monazite, calcium carbonate, fructo-oligosaccharide, isomaltooligosaccharide and organic selenium (p.1 of English Translation) or combine the teachings of Li and Wang because Li teaches antiviral animal feed additives wherein active components include garlicin (Allium sativum), honeysuckle (Lonicera japonica), onion (Allium mongolicum and Allium cepiforme). Whereas, Wang teaches antiviral animal feeds additives wherein the active components include Herba Menthae (Menthae canadensis), Glycyrrhizae (abstract).
One of ordinary skill in the art would be motivated to either use the teachings of He et al. by itself or combine the teachings of Li and Wang because although the references do not teach the antiviral animal feed additives comprising all of the claimed components together in a single composition. It is the Examiner’s position that at the time the claims were filed it would have been obvious to one of ordinary skill in the art to combine the instant ingredients for their known antiviral benefit, as disclosed by the cited references above, since each is well known in the art for their claimed antiviral properties. It would have been further obvious to optimize the amounts of each component since they are all identified as active components and thus have identified effective variables/ratios. One of ordinary skill in the art knowing the benefit of antiviral animal feed additives based on the teachings of He, Li and Wang would have a reasonable expectation of success to combine Artemisia argyi, Lactuca sativa, Allium tuberosum, Allium cepiforme, Litsea rubescens Leeomte, Glycyrrhiza uralensis, Allium sativum, Mentha canadensis, Allium mongolicum, Lonicera japonica , Sargassum, monazite, calcium carbonate, fructo oligosaccharide (FOS), isomaltooligosaccharide (IMO), and organic selenium as it has been well established that all are utilized in medicinal herbs for their antiviral properties in animal feed.
This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients (MPEP 2144.06 I). The idea for combining them flows logically from their having been used individually in the prior art. Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Although the references of Anton in view of He, Li and Wang do not explicitly teach the limitations of claims 1, 2, 3, 4, 9, MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the raw materials depending on the particular application. It would be routine for one to arrive at the concentration and ratios for the application they intend on using the enzymes. Therefore, the above invention would have been prima facie obvious.
Conclusion
Status of claims
Claims 1-9 are pending.
Claims 10-20 are canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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