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 .
DETAILED ACTION
A request for continued examination under 37 C.F.R. 1.114, including the fee set forth in 37 C.F.R. 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. 1.114, and the fee set forth in 37 C.F.R. 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 C.F.R. 1.114. Applicant’s submission filed Nov. 18, 2025 has been received and entered into the present application.
Status of claims
The amendment filed on Nov. 18, 2025 is acknowledged. Claims 4, 13 and 17-25 have been canceled and claims 5-7 and 12 have been withdrawn. New claims 26-28 are added. Claims 1-3, 8-11, 14-16, and 26-28 are under examination in the instant office action.
Applicants' arguments, filed on Nov. 18, 2025, have been fully considered but they are moot in view of new grounds of rejections necessitated by the amendments. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied in view of the amendments. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 (b)
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 28 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 pre-AIA the applicant regards as the invention.
Claim 28 recites “the larch arabinogalactan as the dietary fiber component” in lines 1-2. There is insufficient antecedent basis for this limitation in claim 1 from which it depends because claim 1 does not recite larch arabinogalactan as a dietary fiber component.
The rejection may be overcome by amending the claim to be dependent from claim 27.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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
New matter Rejection
Claims 1-3, 8-11, 14-16, and 26-28 are rejected 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. All the dependent claims are included.
Claim 1 recites “the feed mitigant composition comprises about 2 wt% to about 20% wt % of an emulsion of an essential oil composition”. However, the original application provides no support for the recited range, especially the lower limit of the range. According to the paragraph [0019] of the instant specification discloses that the feed mitigant composition includes from about 10% to 90% by weight an essential oil composition, at least 10% by weight an essential oil composition, or at least any one of, equal to any one of, or between any two of 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, and 90% by weight the essential oil composition. In addition, the paragraph [0041] discloses only the weight percent of the essential oil composition by total weight of the feed composition, not of the feed mitigant composition. The feed composition differs from the feed mitigant composition since the feed composition comprise a feed, feed mitigant composition and other components. Thus, the specification does not disclose the range of “about 2 wt% to about 10% wt %”. Therefore, it is considered as new matter.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 (a) to § 608.04(c).
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 8-11, 14-16, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0157190 (hereafter, Lamb; cited in the IDS filed on 8/2/2021) in view of WO 2019/169256 (hereafter, Niederwerder; cited in the IDS filed on 8/2/2021) in further view of US 2014/0288021 (hereafter, Freitas; prior art of record) and US 2013/0331354 (hereafter, Philippov, cited in the IDS filed on 6/5/2023).
Lamb teaches an antiviral essential oil composition and methods of making and using the same, wherein the composition comprises: one or more essential oils (EO) such as thyme essential oil, oregano essential oil, and/or cinnamon essential; in combination with one or more emulsifiers such as larch arabinogalactan (feed mitigant composition) and the essential oil compositions can be in the form of an emulsion, which have droplet sizes less than about 25 microns (abstract and [0065]). Lamb further teaches that the EO compositions are effective against enveloped viruses, non-enveloped viruses or both, including porcine respiratory & reproductive syndrome and porcine epidemic diarrhea virus (swine virus) and can provide an antiviral effect in humans, and ruminant and non-ruminant animals, including swine ([0029], [0033] and [0059]). Lamb further teaches that the smaller droplet size allows for a more stable emulsion and one that previously could not be utilized for antiviral uses due to instability and high volatilization rates ([0069]).
Lam further teaches that arabinogalactan and tannin compounds are particularly suitable for use as emulsifiers as they exhibit low cytotoxicity, are palatable to animals and facilitate small EO droplet sizes ([0067]). Lamb specifically discloses EO composition comprising about 67.9 wt. % RO water, 12.75 wt. % commercial product Larafeed powder (Larch tree arabinogalactan) extract, 0.60 wt. % TIC gum, and 18.75 wt. % EOs wherein the EOs fraction comprised a combination of 50% oregano oil and 50% thyme oil (60.4 wt. % carvacrol, 10.8 wt. % thymol, 9.9 wt. % paracymene, and 18.9 secondary oil constituents from oregano oil and thyme oil) ([072]).
Lamb also teaches that the compositions can be prepared using carrier and the carrier includes animal feeds ([0055] and [0056]). Lamb teaches the carrier is used to dilute the EO fraction within an EO composition to less than about 1000 ppm or less than about 500 ppm ([0061]). The amount of EO in the essential oil composition overlap the range recited in claim 9.
Lamb further teaches the feed can comprise milk, or other heterogeneous liquid feeds such as a grain and/or protein slurry and solid matter such as barley, corn, soy, oats, or hay (feed ingredients) ([0061]). In addition, Lamb teaches that the EO composition may include a stabilizer such as polysaccharide ([0065]). Further, Lamb discloses that the EO composition can further comprises rosemary EO ([0044]). The EO composition of Lamb does not comprises an organic acid or formaldehyde, thus it provides anti-viral effects without them.
As to the percentage of the emulsion in amended claim 1, Lamb teaches that an emulsion can comprise less than about 20%, less than about 15%, less than about 10%, about 5%, or less than about 5% EO fraction and emulsifier, with the balance comprising a liquid carrier ([0063]). The range falls within the claimed range.
Lamb does not specifically disclose applying of the EO composition (feed mitigant composition) to a contaminated feed including active swine virus such as African swine fever virus to form a feed mixture for inactivating them.
Niederwerder teaches a method of inhibiting African swine fever virus and/or classical swine fever virus in animal feed or animal feed ingredients, said method comprising: introducing a chemical mitigant to said feed or feed ingredients, said chemical mitigant comprising a medium chain fatty acid and/or an essential oil, wherein the animal feed or animal feed ingredients may be selected from the group consisting of complete swine diet, blood meal, porcine meat and bone meal (MBM), and spray-dried animal plasma (abstract and claims 1 and 8). Niederwerder discloses teaches that the phrase “and/or,” when used in a list of two or more items, means that any one of the listed items can be employed by itself or any combination of two or more of the listed items can be employed (p9, lines 20-22). Niederwerder further teaches that the chemical mitigant consists essentially or even consists of essential oils, and more specifically at least one essential oil and one or more essential oils include wild oregano essential oil, cinnamon oil, thyme oil, capsicum oleoresin, rosemary extract, and mixtures thereof (p5, lines 5-30 and claims 1 and 6). When the chemical mitigant comprises essential oils alone, the composition is without an organic acid such as medium fatty acid, thus meeting claim 15.
Niederwerder further teaches that feed or ingredients may become contaminated with ASFV and/or CSFV at the point of processing and the present invention are particularly suitable to inactivate and inhibit the spread of these contaminants, thus methods in accordance with the present invention comprise introducing the chemical mitigant to the feed or feed ingredients after processing and the chemical mitigant may be mixed with the feed or feed ingredients for sufficient time so as to provide a homogeneous mixture (p8, line 23-p9, line 1). Niederwerder teaches that the present invention avoids the use of toxic chemicals, such as formaldehyde, which are not introduced to the animal feed, feed ingredients, or pet food (p6, lines 10-12).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the antiviral EO composition (feed mitigant composition) of Lamb to a feed contaminated with African swine fever virus to form a feed mixture because of the following reasons. Lamb already teaches that the EO emulsion compositions comprising the same EOs and larch arabinogalactan as an emulsifier having the same droplet size as claimed can be added to animal feeds and the EO compositions are effective against various viruses, including porcine respiratory & reproductive syndrome and porcine epidemic diarrhea virus (swine virus) in animals such as swine. Also, Niederwerder teaches introducing a chemical mitigant comprising the same EOs to feed or feed ingredients contaminated with ASFV and/or CSFV at the point of processing for inactivating and inhibiting the spread of these contaminants. In addition, Lamb teaches that larch arabinogalactan is a suitable emulsifier and carrier for an antiviral treatment composition comprising one or more essential oils since they exhibit low cytotoxicity, are palatable to animals and facilitate smaller EO droplet size, which allows for a more stable emulsion and makes it more suitable for antiviral uses. Thus, the skilled artisan would have been motivated to introduce the EO antiviral composition of Lamb into a feed contaminated with swine (porcine) virus such as African swine fever virus for inactivating the virus as taught by Niederwerder and then to administer the feed mixture to a swine on the reasonable expectation that it would be useful for inhibiting and inactivating the swine virus in the animal feed.
As to the limitations, “1 pound to 6 pounds of the feed mitigant composition per ton of contaminated feed”, it is an inclusion rate and is converted to about 0.05% to about 0.3%. Niederwerder discloses the chemical mitigant is introduced at an inclusion rate of from about 0.05 weight % to about 5 weight %, or from about 0.1 weight % to less than 2 weight %, based upon the total weight of the animal feed or feed ingredient taken as 100% by weight, preferably (abstract, p6, lines 16-29, and claim 1). The inclusion rate of Niederwerder overlaps those recited in claims 1 and 16. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Also, Lamb discloses that the EO composition at 1000 ppm (0.1%) in the test system showed 99.99% reduction of porcine epidemic diarrhea virus (PEDV) ([0080] and Table 5). Thus, it would have been customary for an artisan of ordinary skill to determine an optimal concentration of the EO composition (active ingredient) needed to achieve an effective concentration in the final feed mixture for providing their antiviral effects based on the inclusion rate taught by Niederwerder and the effective concentration taught by Lamb.
Also, Lamb does not specifically disclose the addition of dietary fiber component such as dry larch arabinogalactan and its percentage as amended.
Freitas teaches a composition and method of treatment having arabinogalactan and polyphenols from larch trees for the use in prophylactic treatment of upper respiratory tract infections caused by virus and further teaches that the composition containing arabinogalactan for enhancing the adaptive immune response in subjects including swine (abstract, [0002], [0010] and [0012]). Freitas further teaches that the instant composition expediently is administered in liquid or solid form and it can be mixed with food and feed and any kind of beverage ({0027] and [0031).
Philippov teaches a feed additive composition having a combination of a dietary fiber and a flavonoid to an animal wherein the animal feed composition includes a Larch Arabinogalactan in an amount between 0.1% and 30% of the animal feed composition (abstract). Philippov further teaches the addition of an inexpensive feed additives such as larch wood extracts within animal feed diets provides numerous benefits for improving feed efficiency, efficiency of digestion and overall health of animals ([0048]). Philippov discloses that larch arabinogalactan can be defined as a fiber containing significant amounts of natural antioxidants ([0064]). In addition, Philippov discloses the use of a granulated larch wood extract (dry solid), which may readily be mixed with feed components, or more preferably, form a component of a premix ([0062]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add larch arabinogalactan to the composition comprising essential oils taught by Lamb because larch arabinogalactan is taught to be useful for prophylactic treatment of upper respiratory tract infections caused by virus and enhancing adaptive immune response in subjects such as swine and the addition of larch arabinogalactan as a dietary fiber to animal feed composition provides numerous benefits such as improved feed efficiency, efficiency of digestion and overall health of animals as evidenced by Feitas and Philippov. Thus, one of ordinary skill in the art would have been motivated to combine a dietary fiber such as larch arabinogalactan with the emulsion of the essential oils taught by Lamb for preparing a feed mitigant composition which can be added to animal feed mixture on the reasonable expectation that the resulting combination would provide antiviral effects and boost immune response in a subject such as swine while improving feed efficiency, efficiency of digestion and overall health of animals. According to M.P.E.P. § 2144.06, “It 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, 850, 205 USPQ 1069, 1072 (CCPA 1980). In addition, Lamb teaches that larch arabinogalactan is a suitable emulsifier and carrier for an antiviral treatment composition comprising one or more essential oils since they exhibit low cytotoxicity, are palatable to animals and facilitate small EO droplet. Thus, the skilled artisan would have been further motivated to use larch arabinogalactan in combination with the essential oils on the reasonable expectation that it would improve the delivery of EOs as carrier/emulsifier with additional benefits of enhancing antiviral effect and adaptive immune response and providing a dietary fiber for animal feed.
As to the concentrations of the essential oil emulsion and the Larch Arabinogalactan in claim 1, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine an optimal concentration of those ingredients needed to achieve an effective concentration in the final feed mixture for providing their beneficial effects based on the inclusion rate taught by the prior art. Niederwerder teaches that the chemical mitigant comprising essential oil is introduced at an inclusion rate of from about 0.05 weight% to about 5 weight% based on the total weight of the feed mixture. In addition, Philippov teaches that the animal feed composition includes a larch arabinogalactan in an amount between 0.1% and 30% of the animal feed composition. The percentage is based on the total weight of the feed mixture comprising a mitigant composition and feed, thus corresponds to claimed inclusion rate. The skilled artisan would have known that the concentration of the larch arabinogalactan and essential oils in the feed mitigant composition should be higher than the inclusion rate because it is diluted by feed. One of ordinary skill in the art would been motivated to prepare a feed mitigant composition in a concentrated composition comprising essential oils and larch arabinogalactan in sufficiently higher concentration based on the inclusion rate in order to obtain a feed mixture having the target concentrations of the dietary fiber and essential oils in the final feed mixture as taught by the prior art. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient in a concentrate needed to achieve the desired concertation in the final feed mixture for providing their beneficial effects. 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. See MPEP 2144.05 IIA.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 8-11, 14-16 and 26-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US patent 10,512,664 in view of WO 2019/169256 (hereafter, Niederwerder).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘664 patent are drawn to a method of inhibiting a virus within a subject or system, the method comprising: administering a treatment composition combined with a carrier such as animal feed to a subject or system, wherein the treatment composition is an emulsion consisting of thyme essential oil, oregano essential oil, and larch arabinogalactan (emulsifier/dietary fiber), the subject include swine, and wherein the essential oils are present as an emulsion and the average particle size of the essential oils in the emulsion is 25 microns or less. The claims of ‘664 patent do not specifically recite that the virus is African swine fever virus. It was known in the art that EO compositions comprising one or more essential oils such as thyme essential oil and oregano essential oil are useful as a chemical mitigant for inhibiting African swine fever virus and/or classical swine fever virus in animal feed or animal feed ingredients as evidenced by Niederwerder (abstract p5, lines 5-30, and claims 1, 6, and 8). Niederwerder further discloses introducing a chemical mitigant comprising EO to a feed or feed ingredients, wherein the animal feed or animal feed ingredients may be selected from the group consisting of complete swine diet, blood meal, porcine meat and bone meal (MBM), and spray-dried animal plasma (abstract and claims 1 and 8). Niederwerder further teaches that feed or ingredients may become contaminated with ASFV and/or CSFV at the point of processing and the compositions are particularly suitable to inactivate and inhibit the spread of these contaminants, thus introducing the chemical mitigant to the feed or feed ingredients after processing and the chemical mitigant may be mixed with the feed or feed ingredients for sufficient time so as to provide a homogeneous mixture (p8, line 23-p9, line 1). Niederwerder teaches that said chemical mitigant comprises a blend of medium chain fatty acids comprising caproic acid (hexanoic acid), caprylic acid (octanoic acid), capric acid (decanoic acid), lauric acid, and mixtures thereof (claim 12). Niederwerder teaches that the present invention avoids the use of toxic chemicals, such as formaldehyde, which are not introduced to the animal feed, feed ingredients, or pet food (p6, lines 10-12). Niederwerder discloses the chemical mitigant is introduced at an inclusion rate of from about 0.05 weight % to about 5 weight %, or from about 0.1 weight % to less than 2 weight %, based upon the total weight of the animal feed or feed ingredient taken as 100% by weight, preferably (abstract, p6, lines 16-29, and claim 1). The inclusion rate falls within the claimed range.
Thus, one of ordinary skill in the art would have been motivated to use the anti-viral EO composition of ‘664 patent for inhibiting a virus including ASFV in feed or ingredients contaminated with ASFV on the reasonable expectation that it would be also useful for inhibiting and deactivating ASFV in a swine feed mixture contaminated with ASFV as evidenced by Niederwerder. As to the concentrations of the dietary fiber components and the essential oil composition by weight of feed mitigant composition in claim 1, it would have been customary for an artisan of ordinary skill to determine an optimal concentration of those ingredients needed to achieve an effective concentration in the final feed mixture for providing their beneficial effects based on the inclusion rate taught by Niederwerder. 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. See MPEP 2144.05 IIA.
Response to Applicants’ argument:
Applicant again stated that Applicant would file a terminal disclaimer (TD) once there is an indication of allowable subject matter. Since such statement is not a persuasive argument and a TD has not been filed, the ODP rejection is properly maintained in this Office Action.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611