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
Status of claims
The amendment filed on June 3, 2026 is acknowledged. Claims 3-4, 9, 13, 17-25, and 27-28 have been canceled and claims 5-7 and 12 have been withdrawn. New claims 29-33 are added. Claims 1-2, 8, 10-11, 14-16, 26, and 29-33 are under examination in the instant office action.
Applicants' arguments, filed on June 3, 2026, have been fully considered but they are not found to be persuasive or moot in view of new grounds of rejections necessitated by the amendments (newly added limitations in claim 1 and new claims). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 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 1-2, 8, 10-11, 14-16, 26, and 29-33 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 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]).
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 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) ([0072]).
As to the new limitation, the weight ratio of essential oil to emulsifier, Lamb discloses that the emulsifier can be combined with an EO fraction in a ratio of about 3:1 to about 1:3 ([0062]).
As to new claims 29-31, Lamb discloses that solid carriers such as limestone and diatomaceous earth can be utilized and solid carriers can be utilized for practical purposes, such as machinery used to coat seeds with EO compositions or distribute EO compositions into a field ([0057]). Lamb further discloses that solid carriers can include animal feeds, such as wheat, barely, or hay ([0057]). In some embodiments the composition can be at least about 30% solid carrier by weight, at least about 55% solid carrier by weight, at least about 75% solid carrier by weight, or at least about 80% solid carrier. In some embodiments, the composition will be about 80% to about 99% solid carrier, about 70% to about 99% solid carrier, about 60% to about 99% solid carrier, or about 40% to about 99% solid carrier ([0057]).
As to claim 32, s Lamb further discloses that some emulsions can further comprise dispersed insoluble particles such as solid carriers, mineral chelates, mineral salts ([0023]).
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.
Lamb discloses Ralco commercial product PacifiED comprising 48.7 wt. % commercial product Larafeed solids (Larch tree arabinogalactan) and EO oil and Ralco commercial product First Pulse D comprising 49 wt. % commercial product Larafeed solids (Larch tree arabinogalactan) and EO, which are used for anti-viral efficacy against porcine epidemic diarrhea virus (PEDV) (Example 5, [0085]). The term “dietary fiber component” in the claim simply states an inherent property of Larch tree arabinogalactan. Larafeed powder (Larch tree arabinogalactan) is a dry solid as claimed and its percentage falls within the claimed range in amended claim 1 and new claim 33. While the prior art does not identify it as a dietary fiber component, it is the same compound as claimed, thus it necessarily works as dietary fiber component as well as emulsifier. It is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
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 a dietary fiber such as dry 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). Also, 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. In addition, Lamb already discloses commercial products comprising Larafeed solids (Larch tree arabinogalactan) with EO oil for anti-viral efficacy against porcine epidemic diarrhea virus (PEDV). 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.
Response to Applicants' argument:
Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is important to note that in an obvious rejection, it is not necessary that one reference addresses any limitation in a particular claim but that the references, when combined, do so.
"[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR V. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is a person of ordinary creativity, not an automaton." Id. at 1742. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. Id. at 1366, 80 USPQ2d at 1649. "[A]n implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the improvement' is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In such situations, the proper question is whether the ordinary artisan possesses knowledge and skills rendering him capable of combining the prior art references." Id. at 1368, 80 USPQ2d at 1651.
In this case, Lamb teaches and suggest an antiviral composition (feed mitigant composition) comprising the same essential oils (thyme essential oil, oregano essential oil, and/or cinnamon essential oil) and larch arabinogalactan as emulsifier as claimed. Also, 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. In addition, Lamb already discloses commercial products comprising Larafeed solids (Larch tree arabinogalactan) with EO oil for anti-viral efficacy against porcine epidemic diarrhea virus (PEDV). Further, the term “dietary fiber component” in the claim simply states an inherent property of Larch tree arabinogalactan. Larafeed powder (Larch tree arabinogalactan) is a dry solid as claimed and its percentage falls within the claimed range in claim 1 as amended. While the prior art does not identify it as a dietary fiber component, it is the same compound as claimed, thus it necessarily works as dietary fiber component as well as emulsifier. It is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Niederwerder does teach that the chemical mitigant consists essentially or even consists of essential oils, and more specifically at least one essential oil wherein one or more essential oils include wild oregano essential oil, cinnamon oil, thyme oil and mixtures thereof (see p6, lines 1-2 and claims 1 and 6) on the contrary to Applicant's assertion. Niederwerder further teaches the use of the chemical mitigant by mixing with the animal feed or feed ingredients. While Niederwerder docs not specifically disclose a dietary fiber component such as larch arabinogalactan, larch arabinogalactan was 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. Freitas and Philippov was further cited for demonstrating that the use of larch arabinogalactan for animal feed compositions was well known. Thus, one of ordinary skill in the art would have been motivated to combine dietary fiber components comprising larch arabinogalactan as a dry solid (Larafeed powder) with EOs for preparing a feed mitigant composition for addition to animal feed mixture on the reasonable expectation that the resulting combination would provide antiviral effects and boost immune response in a subject while improving feed efficiency, efficiency of digestion and overall health of animals.
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. The examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). It is also noted that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
As to the arguments regarding the new limitations (the ratio of emulsifier to essential oil and emulsion particle size), those limitation are already taught by Lamb and addressed by the above rejection modified in view the amendments.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See MPEP 2145(X)(A) (citing In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971)). As set forth in the rejection of the claims, the combination of each teaching was properly motivated by a rationale derived independently of applicant’s disclosure.
For the foregoing reasons, Applicant's arguments have not been found to be persuasive.
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 1-2, 8, 10-11, 14-16, 26 and 29-33 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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