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 .
Status of Application
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/16/2025 has been entered.
This Official Action is issued in the interest of advancing prosecution. However, the manner in which the amendments were made are unclear. (a1i) recites silica as an absorbate AND the compound of the formula. Given (a1ii) requires PDMN, the claim is interpreted in a manner where the formula was meant to be deleted.
Claim Rejections - 35 USC § 112
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.
Claims 22-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 is dependent on canceled clam 5. It is unclear what claim should claim 22 be dependent upon. Claims 23 -26 are rejected as they rely on claim 22 as a base claim.
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. 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.
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 + 40b of oil = 40g/170gg). 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 and BALCELLS TERES as applied to claim 22 above, and further in view of 2003/0170342 (RAZCEK).
The reference 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, 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 5/16/2025 have been fully considered but they are not persuasive.
The applicant argues that Haisan et al is not concerned at all and provides no guidance whatsoever with respect to the storage stability of PDMN per se, let alone storage stability of PDMN when absorbed onto a carrier system that includes bentonite and sepiolite.
However, BALCELL TERES is cited to teach that sepiolite (i.e., a clay mineral) can be an effective carrier.
RACZEK is still cited but only to teach thickeners can be added [0026].
TOOKER is no longer cited.
Conclusion
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/PHILIP A DUBOIS/Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791