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 .
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 9, 11-12, 18-20, 22-23 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over J. HAISAN ET AL: "The effects of feeding 3-nitrooxypropanol on methane emissions and productivity of Holstein cows in mid lactation", JOURNAL OF DAIRY SCIENCE, vol.97, no.5, May 2014, p.3110-3119, XP055308189, DOI: 10.3168/jds.2013-7834 (HAISAN) in view of United States Patent Application Publication No. 2015/0132432 (BALCELLS TERES).
As to claim 1, HAISAN (abstract; p.3111 col.1 par. 4 - col.2 par.2; table 1) discloses a treatment formulation of 10% 3- nitrooxypropanol (NOP) (i.e., a synonym for propanediol mononitrate (PDMN)) on SiO2 (i.e., silica, wherein both NOP and Si02, are in powder form (p.3111 col. 2 par. 2). Thus, the PDMN is an amount of 10%. This falls within that claimed. The silica is in an amount of 90% SiO2, which is at least 25%.
The composition reduces methane emissions in cows (abstract). Cows were fed a diet containing 38% forage on a dry matter basis with either 2,500 mg/d of 3-nitrooxypropanol (fed as 25 g of 3-nitrooxypropanol on silicon dioxide) .
HAISAN also discloses a method of preparing the above storage stable mixture by admixing NOP in SO2 (powderous formulation) with limestone (abstract; p.3111 col.1 par.4 - col.2 par.2; table 1).
While HAISAN teaches that limestone (i.e., which includes minerals) is present, HAISAN is silent as to specific clay minerals.
However, BALCELLS TERES disclose a method for reducing methane production in ruminants by administering a feed composition comprising a flavanone glycoside. BALCELLS TERES discloses the composition comprises a carrier which is a sepiolite. It is a non-swelling, lightweight, porous clay with a large specific area. The high surface area and porosity of this clay accounts for its outstanding absorption capacity. These properties make it a valuable material for a wide range of applications such as animal feed additive, carriers. BALCELLS TERES also discloses 25-55% naringin, 10-20% neohesperidin, 1-5% poncirin and sufficient quantity up to 100% of a carrier [0013], [0033]. Thus, when naringin and neohesperidin are in lower amounts (i.e., 35% combined with 1% poncirin, providing 64% sepiolite), BALCELLS TERES teaches that carrier ratio of 1:1 and greater. Providing sepiolite in the claimed amounts would naturally result in the retention of at least 80% ingredients such as PDMN.
It would have been obvious to combine BALCELLS TERES with HAISAN, as BALCELLS TERES teaches sepiolite is a non-swelling, lightweight, porous clay with a large specific area. The high surface area and porosity of this clay accounts for its outstanding absorption capacity.
Moreover, as to the retention, applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
As to claim 4, HAISAN (abstract; p.3111 col.1 par. 4 - col.2 par.2; table 1) discloses a treatment formulation of 10% 3- nitrooxypropanol (NOP) (i.e., a synonym for propanediol mononitrate (PDMN)) on SiO2 (i.e., silica, wherein both NOP and SiO2, are in powder form (p.3111 col. 2 par. 2). Thus, the PDMN is an amount of 10%. This falls within that claimed. The silica is in an amount of 90% SiO2, which is at least 25% (i.e., would result in a 9:1 ratio).
As to claim 9, HAISAN (abstract; p. 3111 col. 1 par. 4 - col.2 par. 2; table 1) discloses a treatment formulation of 10% 3- nitrooxypropanol (NOP) (i.e., a synonym for propanediol mononitrate (PDMN)) on SiO2 (i.e., silica, wherein both NOP and SiO2, are in powder form (p. 3111 col. 2 par. 2). Thus, the PDMN is an amount of 10%. This falls within that claimed. The silica is in an amount of 90% SiO2, which is at least 45%.
As to claim 11, in Table 1 of HAISAN, canola oil is added to improve adhesion (pg. 3111, right column, last paragraph). Table 1 also indicates that the fat soluble vitamin – Vitamin A is present (see pg. 3112). Moreover, it would have been obvious that the ingredients form 100 wt% of the composition.
As to claim 12, in Table 1 of HAISAN, canola oil is added to improve adhesion (pg. 3111, right column, last paragraph). Table 1 also indicates that the fat soluble vitamin – Vitamin A is present (see pg. 3112). Table1 also indicates that roughage such as barley silage is added.
As to claims 18-20, HAISAN also discloses a method of preparing the above storage stable mixture by admixing NOP in SiO2 (powderous formulation) with limestone (abstract; p. 3111 col.1 par. 4 - col. 2 par. 2; table 1).
While HAISAN teaches that limestone (i.e., which includes minerals) is present, HAISAN is silent as to specific clay minerals.
However, BALCELLS TERES disclose a method for reducing methane production in ruminants by administering a feed composition comprising a flavanone glycoside. BALCELLS TERES discloses the composition comprises a carrier which is a sepiolite. It is a non-swelling, lightweight, porous clay with a large specific area. The high surface area and porosity of this clay accounts for its outstanding absorption capacity. These properties make it a valuable material for a wide range of applications such as animal feed additive, carriers. BALCELL TERES discloses 25-55% naringin, 10-20% neohesperidin, 1-5% poncirin and sufficient quantity up to 100% of a carrier [0013] [0033]. Thus, when naringin and neohesperidin are in lower amounts (i.e., 35% combined with 1% poncirin, providing 64% sepiolite), BALCELL TERES teaches that carrier a ratio of 1:1 and greater. Providing sepiolite in the claimed amounts would naturally result in the retention of at least 80% ingredients such as PDMN.
As to claims 22-23, HAISAN (abstract; p. 3111 col. 1 par. 4 - col. 2 par. 2; table 1) further discloses that the above powderous treatment formulation is first hand mixed with ground barley grain, wet molasses and canola oil. Both NOP and SiO2, in powder form, were hand-mixed with 80 g of ground barley grain, 50 g of wet molasses, and 40 g of canola oil. Thus, the amount of oil can be (i.e., 80g+ 50g + 40g of oil = 40g/170g). Thus, oil can be in an amount of 23.5%.
As to the additive, 0 to 10 wt% includes zero meaning the additive is optional and does not need to be present.
As to claims 31-33, while HAISAN teaches that limestone (i.e., which includes minerals) is present, HAISAN is silent as to specific clay minerals.
However, BALCELLS TERES disclose a method for reducing methane production in ruminants by administering a feed composition comprising a flavanone glycoside. BALCELLS TERES discloses the composition comprises a carrier which is a sepiolite. It is a non-swelling, lightweight, porous clay with a large specific area. The high surface area and porosity of this clay accounts for its outstanding absorption capacity. These properties make it a valuable material for a wide range of applications such as animal feed additive, carriers. BALCELL TERES discloses 25-55% naringin, 10-20% neohesperidin, 1-5% poncirin and sufficient quantity up to 100% of a carrier [0013] [0033]. Thus, when naringin and neohesperidin are in lower amounts (i.e., 35% combined with 1% poncirin, providing 64% sepiolite), BALCELL TERES teaches a ratio of 1:1 and greater. Providing sepiolite in the claimed amounts would naturally result in the retention of at least 85%, 90% and 95% ingredients such as PDMN.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over HAISAN in view of BALCELLS TERES as applied to claim 22 above, and further in view of 2003/0170342 (RAZCEK).
The references above are silent as to adding thickeners.
However, RACZEK teaches that xanthan gum can be added to as thickener so one can add additives so that once can improve processing.
It would have been obvious to one skilled in the art to add xanthan gum, as RACZEK teaches that xanthan gum acts a thickening and gelling agent to improve the processing of additives. Thus, it would have been obvious to vary the gum based an amount of gelling needed.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over HAISAN in view of BALCELLS TERES as applied to claims 1 and 22 above, and further in view of United States Patent Application Publication No. 2005/0153018 (UBBINK).
As to claims 26 and 27, HAISAN (abstract; p.3111 col.1 par. 4 - col.2 par.2; table 1) discloses a treatment formulation of 10% 3- nitrooxypropanol (NOP) (i.e., a synonym for propanediol mononitrate which is a preferred embodiment of formula (1)) in claim 1) in SiO2 (i.e., silica and a1ii). Both NOP and SiO2, are in powder form (p.3111 col. 2 par. 2).
The composition reduces methane emissions in cows (abstract). Cows were fed a diet containing 38% forage on a dry matter basis with either 2,500 mg/d of 3-nitrooxypropanol (fed as 25 g of 10% 3-nitrooxypropanol on silicon dioxide) .
HAISAN is silent as to adding propylene glycol.
UBBINK teaches that binders and/or plasticizers may be added to the components of the inner matrix, if necessary, to improve the compaction properties of the components of the inner matrix. It may be, however, that the further components and/or the micro-organisms are themselves sufficiently "sticky" or adhesive to allow for compaction. In this case, a specific "binding component" may be omitted. However, if one or several binders and/or plasticizers are added to support the formation of pellets by compaction, preferably food-grade ingredients are used. Examples for plasticizers may be selected from the group comprising polyols (for example, glycerol, sorbitol, propyleneglycol), alcohols (for example, ethanol, propanol, butanol, isopropanol, isobutanol, butanediol) [0081]-[0082].
Thus, it would have been obvious to add and vary the amount of propylene glycol based on amount need as a plasticizer.
Given the additive is no longer in a powderous formulation but in the mixture, the amounts would no longer be based on the powderous formulation itself.
Response to Arguments
Applicant's arguments filed 4/21/2026 have been fully considered but they are not persuasive.
The applicant argues that the Office Action presents details about Haisan and then separately presents details about Balcells Teres, but does not provide any clear rationale for why these teachings would be combined to arrive at the claimed subject matter. It is argued that Balcells Teres teaches that sepiolite has good absorption capacity and would be a good carrier. Yet, Haisan does not disclose any problems with absorption of 3-NOP on SiO2 or any other challenges with the formulation that would require the addition of another ingredient having these properties. The applicant conclude that if the Office Action is proposing that the skilled artisan would be motivated to use sepiolite as the carrier for 3-NOP, then Haisan would be modified to exclude SiO₂.
However, HAISAN discloses a treatment formulation of 10% 3- nitrooxypropanol (NOP) (i.e., a synonym for propanediol mononitrate (PDMN)) on SiO2 (i.e., silica, wherein both NOP and Si02, are in powder form (p.3111 col. 2 par. 2). The silica is in an amount of 90% SiO2, which is at least 25%. HAISAN also discloses a method of preparing the above storage stable mixture by admixing NOP in SO2 (powderous formulation) with limestone (abstract; p.3111 col.1 par.4 - col.2 par.2; table 1). HAISAN is silent as to specific clay minerals.
BALCELLS TERES disclose a method for reducing methane production in ruminants by administering a feed composition comprising a flavanone glycoside. BALCELLS TERES discloses the composition comprises a carrier which is a sepiolite. It is a non-swelling, lightweight, porous clay with a large specific area. The high surface area and porosity of this clay accounts for its outstanding absorption capacity. It would have been obvious to combine BALCELLS TERES with HAISAN, as BALCELLS TERES teaches sepiolite is a non-swelling, lightweight, porous clay with a large specific area. The high surface area and porosity of this clay accounts for its outstanding absorption capacity.
“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) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). **
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached on 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP A DUBOIS/Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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