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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Status of Claims
The amendments and arguments filed on 10/29/2025 are acknowledged and have been fully considered. Claims 1-6, 8-16, and 19-20 are now pending. Claims 7 and 17-18 is canceled; claim 1 is amended.
Claims 1-6, 8-16, and 19-20 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and 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, 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.
Claims 1-4, 8-9, 11-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20150376113 A1 (Duval, 2015) in view of US PGPUB 20090011019 A1 (Jahagirdar, 2009), “The effects of feeding 3-nitrooxypropanol on methane emissions and productivity of Holstein cows in mid lactation” (Haisan, 2014), and WO 2005115474 A1 (Olmstead, 2005).
In regards to claims 1 and 8, Duval teaches that 3-nitrooxypropanol (see Duval, paragraph 0022) is used to reduce the production of methane and/or improve the animal performance by administering the compound to the animal with the feed (see Duval, abstract). Duval teaches that the 3-nitrooxypropanol is used in an amount of 1mg to 10g per Kg of feed (see Duval, paragraph 0037), which would be the equivalent of about 0.0001 to 1 wt.-% of 3-nitrooxypropanol in relation to the total amount of feed. Further, in regards to the edible oil, it is taught that the composition comprises protein rich ingredients such as rapeseed and sunflower (see Duval, paragraph 0058). While the oil is not specifically taught, the oil is understood to be part of the ingredients and as such is part of the composition.
In regards to claims 11-14, Duval teaches that the composition comprises a vitamin or mineral premix (see Duval, paragraph 0041) as well as proteins such as soya bean meal, meat and bone meal, among others (see Duval, paragraph 0043). Duval teaches that the composition comprises a crude protein content of 50 to 800 g/kg feed, which corresponds to about 5 to 80 wt.-% of the composition. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
It is worth noting that Duval does teach that the composition comprises wheat (see Duval, paragraphs 0043 and 0058).
Duval is silent on the use of gluten, the amount of edible oil, the composition being a compressed composition, 3-nitrooxypropanol being absorbed on a carrier and in the amount claimed, and the carrier being used in the amount of 30-60 wt.-%.
In regards to claims 1-4, 8, and 11-14, Jahagirdar teaches a pharmaceutical composition that is in the form of powders, tablets, pellets, (see Jahagirdar, paragraph 0064), specifically compressed tablets (see Jahagirdar, paragraph 0088) comprising a pharmaceutical active (see Jahagirdar, paragraph 0022) and gluten (see Jahagirdar, paragraph 0035). Jahagirdar teaches the use of silicon dioxide (see Jahagirdar, paragraph 0059). Jahagirdar teaches that the composition comprises a binder, such as poly propylene glycol or polyethylene oxide (see Jahagirdar, paragraph 0055), which is used in varying amounts such as 10 w/w% (see Jahagirdar, paragraph 0085) and 20 w/w% (see Jahagirdar, paragraph 0087). More specifically, as the claim requires that the edible is used in an amount of 20 to 50 wt. % of the powderous mixture, which is 1 to 30 % of the compressed tablet, that would mean that in the tablet 6-15 wt.% is the edible oil. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Further in regard to claim 1, as well as claims 19-20, Jahagirdar does not directly teach the amount of gluten used, there are multiple examples, such as example 1, where sodium alginate is used in an amount of 40 w/w% (see Jahagirdar, paragraph 0085). A similar situation is present with xanthan gum in formula 3, where 48.86 w/w% is used (see Jahagirdar, Table 34 Formula 3, following paragraph 0142). Both xanthan gum and sodium alginate, as well as cellulose are listed as equivalents to gluten (see Jahagirdar, paragraph 0035). In Formula 4, both xanthum gum and microcrystalline cellulose (MCC) (see Jahagirdar, paragraph 0140) are used in the amount of 48.86%. Thus, it would In regards to claims 1 and 19-20, MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 9, Jahagirdar teaches the use of a coating (see Jahagirdar, paragraphs 0046-0047).
In regards to claims 1, Haisan teaches that the 3-nitroxypropanol is fed to cows on silicon dioxide (see Haisan, abstract). Further, Haisan teaches that 2,500 mg/d of 3-nitrooxypropanol (fed as 25 g of 10% 3-nitrooxypropanol on silicon dioxide) was fed to the cows (see Haisan, abstract). This would mean that 250g of 10% 3-nitrooxypropanol/silicon dioxide was given to the cows, after being mixed with 80 g of ground barley grain, 50 g of wet molasses, and 40 g of canola oil, for a total weight of 420 g (see Haisan, page 3111, column 2, paragraph 2), with the silicon dioxide making up 225 g, which is about 53 wt.% of the total. Further, with 3-nitrooxypropanol being 25 g of the total 420 g, the amount is about 6%. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Olmstead teaches a compressed tablet composition (see Olmstead, page 47, Exemplary solid oral dosage composition, paragraphs 1-2). Further, it is taught that glycerol and polypropylene glycol are equivalents of one another as plasticizers (see Olmstead, page 47, lines 1-4).
In regards to claims 1-4, 8-16, 19-20, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Duval, Jahagirdar, Haisan, and Olmstead to formulate the composition as instantly claimed, e.g. a composition comprising from about 6-% 3-nitrooxypropanol and about 53 wt.-% of silica, from 40 to 97.72 wt.-% of gluten, about 20% poly propylene glycol, and as Jahagirdar teaches a wide range of pharmaceutical actives that can be used with in the composition and that the goal of the composition is to increase the residence time of the active in the gastrointestinal tract (see Jahagirdar, paragraph 0020). This is particularly useful to the inventions of Duval and Haisan, as both references teach that 3-nitrooxypropanol is used to reduce the methane production from the digestive activities of ruminants (see Duval, paragraph 0012; Haisan, abstract). Further, in regards to the poly propylene glycol in Jahagirdar, it would be within the purview of one with ordinary skill in the art to use the teachings of Olmstead to simply substitute the polypropylene glycol in the composition discussed above with glycerol as they are taught as equivalents. Further in regards to claims 15-16, Jahagirdar teaches that the "Therapeutically effective amount" means that the amount of active agent, which halts or reduces the progress of the condition being treated or which otherwise completely or partly cures or acts palliatively on the condition. A person skilled in the art can easily determine such an amount by routine experimentation and with an undue burden (see Jahagirdar, paragraph, 0024) and Haisan gives a reasonable starting place for the routine experimentation. One with ordinary skill in the art would be motivated to combine the teachings of Duval, Jahagirdar, Haisan, and Olmstead according to the known methods of formulating a compressed tablet (see Jahagirdar, paragraph 0088) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further, in regards to claim 1, as the combination of teachings of Duval, Jahagirdar, Haisan, and Olmstead would yield an identical compressed composition as instantly claimed, the properties, such as staying intact in water after 24 hours would be present since physical properties are not separable from the products themselves. As the prior art renders obvious the instant composition, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties as instantly claimed.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20150376113 A1 (Duval, 2015) in view of US PGPUB 20090011019 A1 (Jahagirdar, 2009), “The effects of feeding 3-nitrooxypropanol on methane emissions and productivity of Holstein cows in mid lactation” (Haisan, 2014), and WO 2005115474 A1 (Olmstead, 2005) as applied to claims 1-4, 8-9, 11-16, and 19-20 above, and further in view of US 3925343 (Hampton, 1975).
The teachings of Duval, Jahagirdar, Haisan, and Olmstead have been described supra.
The combination of Duval, Jahagirdar, Haisan, and Olmstead is silent on the compressed tablet comprising wheat gluten.
In regards to claims 5-6, Hampton teaches that vital wheat gluten is used as a binder or diluent in pharmaceutical tablet formulations (see Hampton, column 1, lines 43-58).
In regards to claims 5-6, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Hampton with Duval, Jahagirdar, Haisan, and Olmstead to formulate a compressed tablet using vital wheat gluten instead of gluten as vital wheat gluten is used to increase the protein content in food applications and it is used in pharmaceutical tablet formulations (see Hampton, column 1, lines 43-58). One with ordinary skill in the art would be motivated to combine the vital wheat gluten of Hampton with the compressed tablet of Duval, Jahagirdar, Haisan, and Olmstead according to the known methods of formulating a compressed tablet (see Jahagirdar, paragraph 0088) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20150376113 A1 (Duval, 2015) in view of US PGPUB 20090011019 A1 (Jahagirdar, 2009), “The effects of feeding 3-nitrooxypropanol on methane emissions and productivity of Holstein cows in mid lactation” (Haisan, 2014), and WO 2005115474 A1 (Olmstead, 2005) as applied to claims 1-4, 8-9, 11-16, and 19-20 above, and further in view of US PGPUB 20060127480 A1 (Tobyn, 2006).
The teachings of Duval, Jahagirdar, Haisan, and Olmstead have been described supra.
The combination of Duval, Jahagirdar, Haisan, and Olmstead is silent on the compressed tablet comprising a coating consisting of glycerine monostearate, carnauba wax, candelilla wax, sugarcane wax, palmitic acid, stearic acid, hydrogenated cottonseed oil, hydrogenated palm oil, hydrogenated rapeseed oil, and mixtures thereof.
Tobyn teaches a pharmaceutical composition in the form a compressed tablet (see Tobyn,
paragraph 0002) with a coating of carnauba wax (see Tobyn, paragraph 0144).
In regards to claim 10, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Tobyn with the compressed tablet of Duval, Jahagirdar, Haisan, and Olmstead as there is an overlap of materials taught as coating agents between Jahagirdar and Tobyn, such as gelatin, cellulose acetate phthalate, among others (see Tobyn, paragraph 0144; Jahagirdar, paragraph 0047). One with ordinary skill in the art would be motivated to simply substitute the carnauba wax with the coating agents of Duval, Jahagirdar, Haisan, and Olmstead to obtain predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivate to simply substitute one known element for another to obtain predictable results.
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that Duval does not teach an edible oil, rather a cereal, it is pointed out that in regards to the edible oil, it is taught that the composition comprises protein rich ingredients such as rapeseed and sunflower (see Duval, paragraph 0058). While the oil is not specifically taught, the oil is understood to be part of the ingredients and as such is part of the composition. Further, the rejection is made over all of the references not just Duval. Jahagirdar teaches that the composition comprises poly propylene glycol in an amount of about 10% to 20% by weight of the composition. Olmstead teaches that poly propylene glycol and glycerol are equivalents. As such it would be obvious to one with ordinary skill in the art to simply substitute one for another in the composition. Further, applicant argues that the teachings of Jahagirdar teaches that the poly propylene glycol is taught as being used in the whole composition not the powderous formulation. It is pointed out that the claim requires that the edible oil is used in an amount of 20 to 50 wt. % of the powderous mixture, which is 1 to 30 % of the compressed tablet, that would mean that in the tablet 6-15 wt.% of the edible oil in the compressed composition. As such, the amount of poly propylene glycol overlaps with the amount taught in the instant claims. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Examiner appreciates applicant’s point that poly propylene glycol is a polymeric binder and the claim is drawn to propylene glycol. To that point, the rejection now includes the teachings of Olmstead as discussed above.
In regards to applicant’s argument that the claims have been amended so that the amount of gluten is at least 50% by weight of the composition, it is pointed out that in Formula 4, both xanthum gum and microcrystalline cellulose (MCC) (see Jahagirdar, paragraph 0140) are used in the amount of 48.86% (i.e., a total of 97.72% of the natural polymer). It would be within the purview of one with ordinary skill in the art simply substitute the gluten for both of these polymers as taught by Jahagirdar (see Jahagirdar, paragraph 0035) to obtain predictable results with a reasonable expectation of success. In regards to claims 1 and 19-20, MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In regards to the applicant’s argument that Jahagirdar does not teach that the different natural polymers listed can be used in equal amounts and would yield equivalent results, however the teachings of Jahagirdar would be enough to give one with ordinary skill in the art motivation to simply substitute one of the natural polymers for another to obtain predictable results with a reasonable expectation of success.
Conclusion
No claims allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.A.A./Examiner, Art Unit 1611