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 .
In view of the amendment, previous 112(a) rejection on claims 1-12, 16, 17 and 22-32 is hereby withdrawn.
In view of the amendment, previous 112(b) rejection on claims 22 and 29-31 (see Paragraph 8 of the last Office Action) and previous 112(b) rejection on claim 32 (see Paragraph 9 of the last Office Action) are hereby withdrawn.
In view of the amendment, previous 112(d) rejection on claims 4 and 18-20 (see Paragraph 11 of the last Office Action) is hereby withdrawn.
Even though applicant filed a statement pursuant to 35 USC 102(b)(2)(C) establishing common ownership, such statement was not sufficient to overcome instant 103 rejection over Brunner et al (US 2020/0155462 A1) (as well as US 2024/0342095 A1). In order to overcome instant 103 rejection over these references, applicant need to file (again) a statement of common ownership, which states in a clear and conspicuous matter that: “the subject matter disclosed in US 2020/0155462 A1 and US 2024/0342095 A1 and the claimed invention were, not later than the effective filing date of the claimed invention, owned by the same entity (DSM IP Assets B.V.)”. Until then, instant 103 rejection still stands.
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 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.
Claim Objections
Claims 28-31 are objected to because of the following informalities: applicant need to insert --- after storage for 4 weeks in a closed container at 25oC and 50% relative humidity --- between “at least 80%” (of claim 28), “at least 75%” (of claim 29), “at least 90%” (of claim 30), “at least 95% (of claim 31) and the periods. Appropriate correction is required.
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 10 and 11 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 10 recites that the premix of claim 1 “consists essentially of: (a1) . . . , (a2) . . . , (a3) . . . , and (a4) optionally, at least one edible oil, with the proviso that the amounts of ingredients (a1) to (a4) sum up to 100 wt.%”. Claim 10 is confusing because the premix consisting essentially of (a1), (a2), (a3) and (a4) can have additional ingredients (i.e., in addition to (a1) – (a4)) as long as such additional ingredients do not affect the material characteristics of the premix composition. Yet, the provisional clause of claim 10 states that the total amount for the sum of ingredients (a1)-(a4) is already 100 wt.% (which means that there cannot be any ingredient other than (a1)-(a4)). Thus, the transitional phrase “consists essentially of” and the provisional clause, both of which are present in claim 10, contradict each other, thus rendering the scope of instant claim 10 indefinite.
Instant 112(b) rejection on claims 10 and 11 can be overcome by changing the transitional phrase “consists essentially of” in claim 10 to --- consists of ---.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10, from which instant claim 11 depends, recites that “the premix consists essentially of: (a1) the powderous formulation, (a2) the at least one inorganic phosphate, (a3) at least one active ingredient selected from . . ., and (a4) optionally, at least one edible oil, . . .”. Thus, Claim 10 requires the presence of (a1), (a2), (a3) and (a4). However, claim 11, which depends from claim 10, requires the presence of (a1) and (a2) only. Thus, claim 11 fails to further limit the subject matter of instant claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 recites “The method comprises forming a premix according to claim 1 by . . .”. The premix of claim 1 consists essentially of a mixture of (a1), (a2), (a3) and (a4). However, claim 26, as currently written, fails to further limit the subject matter of claim 1 because (i) claim 26 does not specify the amount (i.e., at least 5 wt.%, based on the total weight of the premix) for the powderous formulation which is being mixed with 15-70 wt.% of the at least one inorganic phosphate; and also because (ii) claim 26 does not mention instant component (a3) and instant component (a4), both of which are listed in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-12, 16-20 and 22-32 are rejected under 35 U.S.C. 103 as being obvious over Brunner et al (US 2020/0155462 A1 or US 2024/0342095 A1, which is a child application of US 2020/0155462 A1).
The applied references have a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed (in US 2020/0155462 A1 and US 2024/0342095 A1) and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Brunner teaches (claim 1) a compressed table tablet as shown below:
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The range (1-46) for the variable “n” in Brunner overlaps with instant range (1-15) for the variable “n”, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Brunner further teaches (claims 11-12, [0049], [0054]) that the compound of formula (I) shown in its claim 1 is preferably incorporated into the tablets as a powderous formulation consisting essentially of 5-20 wt.% of the compound of formula (I), 20-50 wt.% of propylene glycol and 30-60 wt.% of silica. Brunner also teaches ([0056]) that the amount of the powderous formulation to be incorporated into the tablets preferably ranges from 5-20 wt.% based on the compressed tablet. Thus, Brunner teaches instant component (a1) - at least 5 wt.% of powderous formulation containing (i) the compound of formula (I) and (ii) silica.
With respect to instant component (a2) 15-70 wt.% of the at least one inorganic phosphate, Brunner teaches ([0024], [0032]-[0034]) that its tablets may further contain additives, such as fillers, and among examples for particularly suitable fillers, Brunner teaches mono-, di- or tri-calcium phosphate (instant at least one inorganic phosphate). Brunner furthermore teaches ([0034]) that the total amount of filler(s) (such as mono-, di- or tri-calcium phosphate) can range from 0 to 30 wt.% based on the total weight of the compressed tablet. It would have been obvious to one skilled in the art to use up to 30 wt.% of mono-, di- or tri-calcium phosphate (as the filler) in Brunner’s tablet with a reasonable expectation of success. Brunner’s range (0-30 wt.%) for the amount of filler overlaps with instant range 15-70 wt.% (as well as with instant range 20-50 wt.% of claim 32) for the amount of the at least one inorganic phosphate, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Brunner renders obvious instant component (a2) 15-70 wt.% of the at least one inorganic phosphate.
With respect to instant limitation “wherein the amount of the at least one inorganic phosphate is sufficient such that the powderous formulation retains at least 70% of the compound of formula (I) after storage for 4 weeks in a closed container at 25oC and 50% relative humidity”, since Brunner’s range (up to 30 wt.%) for the amount of the filler (mono-, di- or tri-calcium phosphate – instant at least one inorganic phosphate) overlaps with instant range (15-70 wt.%) for the at least one inorganic phosphate, it follows that in Brunner’s tablet (which contains (i) the powderous formulation consisting essentially of 5-20 wt.% of the compound of formula (I), 20-50 wt.% of propylene glycol and 30-60 wt.% of silica and (ii) up to 30 wt.% of mono-, di- or tri-calcium phosphate (instant at least one inorganic phosphate)), the retention percentage range for the compound of its formula (I) after storage for 4 weeks in a closed container at 25oC and 50% relative humidity would at least overlap with instant range (at least 70%) of claim 1, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Brunner’s teaching teaches or renders obvious instant limitation (by the same logic, the retention percentage range for the compound of its formula (I) would also overlap with instant ranges (at least 80%, at least 85%, at least 90% and at least 95%) of claims 22-25).
With respect to instant “premix”, Brunner teaches ([0076]) that the tablets of its invention may be admixed with customary feed compositions for ruminants (so as to form a feed product), in which case, Brunner’s tablets as discussed above would be used as a premix.
Thus, Brunner renders obvious instant claims 1, 3, 10, 17, 22-25 and 32.
With respect to instant claims 2 and 16, Brunner teaches ([0017]) that most preferred compound of its formula (I) is 3-nitrooxypropanol (another name for instant propandiol mononitrate of claim 2). Thus, Brunner renders obvious instant claims 2 and 16 (instant claim 16 does not require instant R1 of claim 1 to be -O(C=O)R8, -NHC(=O)R8 or SO2NHR8. It only requires that if R1 of claim 1 is -O(C=O)R8, -NHC(=O)R8 or SO2NHR8, then R8 has to be 2-pyridyl group. Since R1 is -OH for Brunner’s 3-nitrooxypropanol, Brunner still teaches instant limitation of claim 16).
With respect to instant claims 4 and 18-20, as already discussed above, Brunner teaches that the amount of the powderous formulation to be incorporated into the tablets preferably ranges from 5-20 wt.% based on the compressed tablet and that the total amount of filler(s) (such as mono-, di- or tri-calcium phosphate – instant inorganic phosphate) can range from 0 to 30 wt.% (i.e., up to 30 wt.%) based on the total weight of the compressed tablet. Thus, the ratio of instant at least one inorganic phosphate to the powderous formulation would be 6 or less (as calculated by the Examiner). Such range overlaps with instant ranges of claim 4 (50:1 to 1:5), claim 18 (40:1 to 1:2), claim 19 (30:1 to 1:1) and claim 20 (20:1 to 1:1). Thus, Brunner renders obvious instant claims 4 and 18-20.
With respect to instant claims 5-8 and 21, as already discussed above, Brunner teaches that its powderous formulation consists essentially of 5-20 wt.% of the compound of formula (I), 20-50 wt.% of propylene glycol and 30-60 wt.% of silica. The ranges for the compound of formula (I) and the silica as taught by Brunner fall within instant ranges for the compound of formula (I) and the silica and thus teach instant ranges. The range (20-50 wt.%) of propylene glycol (instant edible oil) as taught by Brunner overlap with instant range (10-45 wt.%) for the edible oil, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Brunner renders obvious instant claims 5-8 and 21 (instant claims 7 and 21 do not require the presence of the additive in claim 5: it only requires that if the additive is present, then the additive has to be a thickener chosen from gums and cellulose derivatives as recited in claim 7 and chosen from xanthan gum, karaya gum and ethyl cellulose as recited in claim 21).
With respect to instant claim 9, as already discussed above, Brunner teaches that its powderous formulation consists essentially of 5-20 wt.% of the compound of formula (I), 20-50 wt.% of propylene glycol and 30-60 wt.% of silica. The ranges for the compound of formula (I), propylene glycol and silica either overlap with (thus rendering instant ranges prima facie obvious) or fall within (thus teaching) instant ranges for the corresponding components as recited in claim 9. Thus, Brunner renders obvious instant claim 9.
With respect to instant claim 11, as already discussed above, Brunner teaches a compressed tablet containing instant powderous formulation (a1) containing (i) the compound of formula (I) and (ii) silica and instant at least one inorganic phosphate (a2). As also discussed above, Brunner teaches that the tablets of its invention may be admixed with customary feed compositions for ruminants (so as to form a feed product), which means that Brunner’s tablets as discussed above would be used as a premix. With respect to instant component (a3), Brunner teaches (claims 1, 8 and 9) that its compressed tablet (which can be used as a premix as explained above) may further contain additives such as vitamins. Brunner further teaches ([0038]) that such vitamins can be fat-soluble vitamins as well as water-soluble vitamins. Thus, Brunner teaches instant component (a3). With respect to instant component (a4), as already mentioned above, Brunner’s powderous formulation contains propylene glycol (instant edible oil). Thus, Brunner renders obvious instant claim 11.
With respect to instant claim 12, as already discussed in the paragraph above, Brunner teaches that is tablet may further contain additives such as fat-soluble or water-soluble vitamins (instant component (a3/1)). As also discussed above, Brunner teaches ([0076] that tablets of its invention may be admixed with customary feed composition for ruminants (so as to form a feed product) and teaches ([0077]) that as regards such feed composition for ruminants, the ruminant diet is usually composed of an easily degradable fraction (named concentrate) and a fiber-rich less readily degradable fraction (named hay, forage, or roughage). Thus, Brunner teaches instant component (a3/2). Thus, Brunner renders obvious instant claim 12.
With respect to instant claims 26 and 28-31, as already explained above, Brunner teaches a tablet containing 5-20 wt.% of instant powderous formulation comprising (i) instant compound of formula (I) and (ii) silica. As also discussed above, Brunner teaches that its tablets may further contain fillers such as mono-, di- or tri-calcium phosphate (instant at least one inorganic phosphate) in the amount of up to 30 wt.%. Based on Brunner’s teaching, it would have been obvious to one skilled in the art to mix Brunner’s powderous formulation (which is present in the amount of 5-20 wt.%) with up to 30 wt.% of mono-, di- or tri-calcium phosphate (as the filler) in Brunner’s tablet (which may be used as a premix) with a reasonable expectation of success. Brunner’s range up to 30 wt.% for the amount of mono-, di-, or tri-calcium phosphate (instant inorganic phosphate) overlaps with instant range 15-70 wt.% for the amount of the at least one inorganic phosphate, thus rendering instant range prima facie obvious (In re Wertheim, supra) and the ratio of the mono-, di- or tri-calcium phosphate (instant inorganic phosphate) to the powderous formulation would be 6 or less (as calculated by the Examiner). Such range (6 or less) overlaps with instant range at least 1:1 for the ratio of the at least one inorganic phosphate to the powderous formulation, thus rendering instant range prima facie obvious. In re Wertheim, supra., and therefore, it follows that when stored for 4 weeks in a closed container at 25oC and 50% relative humidity, the retention percentage range for Brunner’s compound of formula (I) in the powderous formulation would at least overlap with instant ranges, at least 70% of claim 26, at least 80% of claim 28, at least 85% of claim 29, at least 90% of claim 30 and at least 95% of claim 31. Thus, Brunner renders obvious instant method of claims 26 and 28-31.
With respect to instant claim 27, as discussed above, Brunner teaches ([0017]) that most preferred compound of its formula (I) is 3-nitrooxypropanol (another name for instant propandiol mononitrate), and for such compound, instant R1 of formula (I) is -OH. As to instant limitation of claim 27, the claim language of claim 27 does not require instant R1 of claim 26 to be -O(C=O)R8, -NHC(=O)R8 or SO2NHR8. It only requires that if R1 of claim 26 is -O(C=O)R8, -NHC(=O)R8 or SO2NHR8, then R8 has to be 2-pyridyl group. Since R1 of formula (I) is -OH for Brunner’s 3-nitrooxypropanol, Brunner still teaches instant limitation of claim 27. Thus, Brunner renders obvious instant claim 27.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
January 24, 2026