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 .
Response to Amendment
The amendment filed on 3/2/26 has been entered. Applicant amendments to claims 16, 44-45 has overcome the objections set forth in the last Office action. The Specification objection has been withdrawn in view of the identified informalities on the substitute Specification dated 7/8/24 being correct in the Patent Publication No. US 20220061356 A1. Claims 1-3, 5, 7, 13, 15-16, 19-21, 26, 29, 31, 33, 35 and 40-48 are pending with claims 1-3, 5, 7, 13, 15-16, 19-20 and 44-48 being examined on their merits. Claims 21, 26, 29, 31, 33, 35 and 40-43 were previously withdrawn, and claims 4, 6, 8-12, 14, 17-18, 22-25, 27-28, 30, 32, 34, 36-39 were previously canceled.
The affidavit under 37 CFR 1.132 filed 3/2/26 is insufficient to overcome the rejection of claims 1-3, 5, 7, 13, 15-16, 19-20 and 44-48 based upon 35 U.S.C. 103 over Wan et al. [US 20180070611 A1], hereinafter Wan, in view of Zuccarello et al. [US 20080008779 A1], hereinafter Zuccarello as set forth in the last Office action because: showing is not commensurate in scope with the claims. The examiner considered the arguments presented in pages 1-5, elements 1-11, and the data presented on Tables 1-2 (pages 3-4 respectively) of the affidavit, however it is noted that the comparative data of the Control composition with 29.4 g/kg of methionine and the ProTect D composition with 239.71 g/kg is not commensurate with the scope of the claimed range of a composition comprising 200-500 g/kg of methionine, as the control value of methionine is well below the claimed lower limit of 200 g/kg, in fact it is also below the lower limit of 50 g/kg disclosed by the prior art of Zuccarello [Zuccarello, 0007, 0033-0034]. Moreover, given that there is a substantial difference between the Control methionine amount of 29.4 g/kg and the ProTect D (high concentration) methionine amount of 239.71 g/kg, with the Control composition providing standard for feed efficiency, milk composition and health indicators, and only a difference in 4% (1.7 kg) for milk yield (week 6) it is not sufficient to establish unexpected results. The examiner further notes that the data provided is only for methionine while the claim includes other 3 different amino acids such as methionine hydroxy analog, homocysteine and cysteine, which differ chemically and there is no data showing that the same results obtained with methionine would be the same results obtained by compositions comprising methionine hydroxy analog, homocysteine and cysteine.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/2/26 was filed after the mailing date of the Non-Final Office action on 11/28/25. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1, 7, 13, 15-16, 19-20 and 44-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al. [US 20180070611 A1], hereinafter Wan, in view of Zuccarello et al. [US 20080008779 A1], hereinafter Zuccarello.
Regarding claim 1, Wan teach a composition for ruminant animals [Wan, Abstract] comprising:
(i) at least one vitamin selected from vitamin A, vitamin D3 (vitamin D derivative), vitamin B1 and vitamin E [Wan, 0122, 0129];
(ii) at least one trace element selected from Cobalt, Iodine, Manganese, Selenium and Zinc [Wan, 0122, 0130];
(iii) at least one sulphur-containing amino acid selected from methionine [Wan, 0028], methionine precursor/derivative compound [Wan, 0029, 0031], (which encompass the claimed methionine hydroxy analog, see Zuccarello [0033] discussion below), and cysteine [Wan, 0028];
(iv) at least one prebiotic selected from an oligosaccharide prebiotic and a polysaccharide prebiotic [Wan, 0048, 0125]; and
(v) at least one plant extract [Wan, 0047].
Wan teaches the sulfur-containing amino acid but does not explicitly teach the amino acid being in range of 200-500 g/kg as required by claim 1, element (iii).
Zuccarello teach a composition for ruminant animals [Zuccarello, Abstract] comprising:
(iii) at least one sulphur-containing amino acid selected from methionine and/or methionine hydroxy analog [Zuccarello, 0033], in amounts of from about 5-40wt% or 50-400 g/kg [Zuccarello, 0017].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the claimed range of sulfur-containing amino acid into the invention of Wan, in view of Zuccarello, since both are directed to methods of making animal/ruminant feed products comprising sulfur-containing amino acids such as methionine and methionine precursor/derivative compounds as taught by Wan, and methionine hydroxy analog as taught by Zuccarello [Zuccarello, 0033], and because Zuccarello teach that by provision of these amounts of sulfur-containing amino acids in the compositions for ruminant animals of the invention these are capable of delivering undegraded essential amino acids such as methionine to the post-rumen digestive system of the ruminants [Zuccarello, 0001], which not only beneficially improves feed efficiency and body growth [Zuccarello, Abstract] but also beneficially improves milk production and increased production of milk protein in cattle [Zuccarello, 0006-0007]. It is further noted that both Wan and Zuccarello express interest in provision of feed compositions that have a positive effect on ruminant nutrition or production outcomes such as feed efficiency amongst other technical advantages [Wan, 0070], and [Zuccarello, Abstract], which are problems that are reasonably pertinent to the problems faced by Applicant as disclosed on page 1, par.[0001] of the instant Specification.
Regarding claim 7, see modified Wan in view of Zuccarello above in claim 1 rejection, where Wan teaches a composition for ruminant animals comprising methionine [Wan, 0028], methionine precursor/derivative compound [Wan, 0029, 0031], (which encompass the claimed methionine hydroxy analog, see Zuccarello [0033] discussion above), and Zuccarello teaches a composition for ruminant animals comprising methionine and/or methionine hydroxy analog [Zuccarello, 0033], in amounts of from about 5-40wt% or 50-400 g/kg [Zuccarello, 0017].
Regarding claim 13, Wan teach the composition for ruminant animals is provided in the form of pellets [Wan, 0005], liquid [Wan, 0073], the composition does not contain antibiotics and/or ionophores; and/or the composition comprises one or more of a protein source [Wan, 0113], roughage [Wan, 0112], and/or additional minerals [Wan, 0122, 0130-0134, 0144].
Regarding claim 15, Wan teach a nutritional supplement for ruminant animals, said supplement comprising the composition of claim 1 [Wan, 0068].
Regarding claim 16, Wan teach the nutritional supplement [Wan, 0068] of claim 15, wherein: the supplement comprises one or more ingredients selected from magnesium oxide, potassium chloride, sodium chloride [Wan, 0134], canola oil [Wan, 0137], canola meal [Wan, 0113], wheat [Wan, 0053]; and/or the supplement comprises one or more of a protein source[Wan, 0113], roughage [Wan, 0112], and/or additional minerals [Wan, 0122, 0130-0134, 0144].
Regarding claim 19, modified Wan teach an animal feed [Wan, Title] comprising the composition of claim 1 [Wan, 0051, 0068, 0119, 0121].
Regarding claim 20, modified Wan teach the animal feed of claim 19, wherein the feed comprises the composition mixed with cereal grain rations and/or provided as part of dietary supplementation [Wan, 0144], (animal feed or full feed ration comprise further ingredients, or as would be understood in the art, animal feeds will typically be nutritionally complete, as disclosed on page 9, par.0077 of the instant Specification).
Regarding claims 44-45, see modified Wan in view of Zuccarello above in claim 1 rejection, where Wan teaches a composition for ruminant animals comprising methionine [Wan, 0028], methionine precursor/derivative compound [Wan, 0029, 0031], (which encompass the claimed methionine hydroxy analog, see Zuccarello [0033] discussion above), and Zuccarello teaches the composition for ruminant animals of claim 1, comprising greater than 200 g/kg and less than 500 g/kg as required by instant claim 44, and 250-500 g/kg as required by instant claim 45 (5-40wt% or 50-400 g/kg) of at least one sulphur-containing amino acid [Zuccarello, 0017] selected from methionine, and methionine hydroxy analog [Zuccarello, 0033].
Regarding claim 46, see modified Wan in view of Zuccarello above in claim 1 rejection, where Wan teaches a livestock feed composition [Wan, Title] for consumption by ruminant animals [Wan, Abstract] as a full feed ration [Wan, 0144], comprising all the limitations from elements (i, ii, iii, iv and v) except the range of 200-500 g/kg of the sulfur-containing amino acid from claimed element (iii), and Zuccarello teach a composition for ruminant animals [Abstract] comprising 50-400 g/kg (which overlaps with the claimed range) of at least one sulphur-containing amino acid [Zuccarello, 0017] selected from methionine and/or methionine hydroxy analog [Zuccarello, 0033].
Regarding claim 47, the claim is rejected for the same reasons given above with respect to claim 1.
Regarding claim 48, the claim is rejected for the same reasons given above with respect to claim 46.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wan, in view of Zuccarello as applied to claim 1 above, and further in view of Hristov et al. [WO 2011153299 A2], hereinafter Hristov.
Regarding claims 2-3, modified Wan teach the composition for ruminant animals comprising a plant extract as discussed above in claim 1, element (v), but is silent regarding the plant extract being one selected from the claimed group recited in claim 2, and the composition comprising at least three plant extracts; and/or at least one plant extract is an essential oil as required by claim 3.
Hristov teach a composition for ruminant animals [Title], comprising one or more plant extracts from Origanum species [Abstract] such as Origanum vulgare species extract and any and all species and/or subspecies from the Origanum genus [p.8, l.8-25], and/or at least one plant extract is an essential oil [p.4, l.6-7, l.32, and p.8, l.26-32].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the claimed plant extracts and at least three plant extracts and/or at least one plant extract as an essential oil into the invention of Wan, in view of Hristov, since both are directed to methods of making ruminant animal feed products, and because Hristov teach that these plant extracts and/or essential oils from said plant extracts are suitable for decrease methane emissions or production by the ruminant animals [Abstract], which is a problem that is also reasonably pertinent to the problem faced by Applicant as disclosed on page 1, par.[0001-0003], page 2, par.[0006], and page 5, par.[0042] of the instant Specification.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wan, in view of Zuccarello as applied to claim 1 above, and further in view of Wan et al. [US 20180070612 A1], hereinafter Wan 612’.
Regarding claim 5, modified Wan teach the composition for ruminant animals comprising a plant extract as discussed above in claim 1, but is silent regarding the composition further comprising a dust control agent and/or a carrier, optionally wherein the carrier is wheat pollard and/or rice hull.
Wan 612’ teach a composition for ruminant animals [Title], comprising a carrier [0028, 0108, 0133] and rice hulls [0128, 0132].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the claimed carrier into the invention of Wan, in view of Wan 612’, since both are directed to methods of making ruminant animal feed products, and because Wan 612’ teach that the nutritional composition of the invention may comprise a carrier in combination with other various ingredients to provide a nutritional composition that is capable of bypass the rumen when administered to a ruminant [0005], which would allow for the transfer of a nutritional agent from via the digestive tract into the blood circulation of a ruminant [0068].
Response to Arguments
Applicant's arguments filed 3/2/26 have been fully considered but they are not persuasive.
On page 9, last paragraph, and page 10, paragraphs 1-2, Applicant urges that Zuccarello fails to teach the claimed “200-500 g/kg of at least one sulphur-containing amino acid selected from methionine, methionine hydroxy analog, homocysteine and cysteine” because Zuccarello states “between about 5-40 weight percent of amino acid in paragraph [0017] without specifying the amino acid is sulphur-containing, and because Zuccarello separately describe a list of 15 different amino acids where methionine and methionine hydroxy analog are only two out of the 15 species recited in Zuccarello’s list.
In response to Applicant's arguments that Zuccarello does not specifically recites “the amino acid is sulphur-containing”, and that Zuccarello teaches amino acid in amounts of from 50-400 g/kg in one paragraph [0017] and then names the specific amino acids in separate paragraphs [0033-0034], the arguments are not persuasive because while Zuccarello does not use the same claim language as Applicant or specifically mentions the term “sulphur containing amino acid”, Zuccarello does teach some of the same claimed specific amino acids which are sulphur containing amino acids. Further, the examiner notes that Zuccarello clearly includes methionine and methionine hydroxy analog in amounts that overlaps and/or falls within the claimed range of 200-500 g/kg. Moreover, as recognized by Applicant, Zuccarello also recognize that lysine, methionine, and methionine hydroxy analog (which are all sulphur containing amino acids, NOTE: the see claim set dated 2/21/24 also claims lysine as being a sulphur containing amino acid) are valuable amino acids for dairy cattle feedstocks and suitable for improving the milk yield, milk composition (4% fat corrected milk production) and improved health [Zuccarello, 0007, 0011, 0033-0034]. Therefore, there is reasonable basis to conclude that Zuccarello has knowledge of sulphur containing amino acids, particularly methionine and methionine hydroxy analog, at the range of up to 400 g/kg being advantageously suitable for use as ruminant feed.
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). The rejection is over Wan in view of Zuccarello, where Wan specifically teaches that amino acid animal feed compositions comprising sulphur containing amino acids including methionine [Wan, 0028], methionine precursor/derivative compound [Wan, 0029, 0031], (which encompass the claimed methionine hydroxy analog), and cysteine [Wan, 0028], are suitable for improving milk yield (increased milk production), feed efficiency, milk composition (milk protein and fat) [Wan, 0070] and improved health [Wan, 0069] by providing the amino acid feed composition of Wan and Zuccarello also disclose the animal feed composition comprising the claimed amino acids in the claimed amounts also for improving milk yield, milk composition (4% fat corrected milk production) and improved health [Zuccarello, 0007, 0011, 0033-0034], which are the same beneficial effects Applicant is interested as disclosed on Table 2 page 4 of the affidavit dated 3/2/26 and on paragraph [0098] of the instant specification.
On page 10, paragraphs 2-4, Applicant additionally urges that Zuccarello generally states with respect to methionine and methionine hydroxy analog in a shorter list of a total of 4 amino acids being lysine, methionine, methionine hydroxy analog as these being additional supplements in combination with others that deliver high levels of post-rumen content of C12-C22 fatty acids which are valuable for dairy cattle feedstocks (see Zuccarello [0034]), and that nowhere in Zuccarello’s disclosure is described with any specificity the higher range concentration of specific sulfur-containing amino acids as presently claimed by Applicant, let alone the benefits thereof, and that Zuccarello merely describes 50-400 g/kg, which is a range different than the claimed high range (200-500 g/kg) of sulphur-containing amino acid content, thus, failing to teach or suggest the specific high range, let alone the associated unexpected properties in ruminant production systems of the claimed feed composition.
In response to applicant's argument that nowhere in Zuccarello’s disclosure is described with any specificity the higher range concentration of specific sulfur-containing amino acids as presently claimed by Applicant, the benefits thereof, and that Zuccarello describes a range different than the claimed high range, thus, failing to teach or suggest the specific high range, and the associated unexpected properties in ruminant production systems of the claimed feed composition, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Moreover, this argument is not persuasive because while Zuccarello does not explicitly teaches the exact range of “200-500 g/kg of at least one sulphur-containing amino acid selected from methionine, methionine hydroxy analog, homocysteine and cysteine” as recited by instant claim 1 step (iii), Zuccarello teaches the same amino acids methionine and methionine hydroxy analog in amounts that overlaps and/or falls within the claimed range of 200-500 g/kg as explained above. Further, as stated above both Wan and Zuccarello already recognize the benefits of the claimed amino acids at the claimed amounts for achieving the positive effects of improved milk yield (increased milk production), feed efficiency, milk composition (milk protein and fat) [Wan, 0070] and improved health [Wan, 0069; Zuccarello, 0007, 0011, 0033-0034], which are the same beneficial effects Applicant is interested in. Therefore, it would have been obvious to one of ordinary skill in the art to have used 400 g/kg of methionine, methionine hydroxy analog and any of the amino acids taught by Wan and Zuccarello in ruminant feed compositions, as these amino acids are recognized as valuable to provide positive beneficial results/effects (i.e., improved milk yield, feed efficiency, milk composition, improved health) in ruminant animals that consume the feed compositions comprising these as taught by Wan and Zuccarello.
On page 10, last paragraph, Applicant urges that Hristov and Wan 612’ fail to teach the deficiencies of Wan and Zuccarello. This argument is not persuasive because Wan in view of Zuccarello (both in the field of animal (ruminant) feed compositions) teach each and every limitation of instant claim 1, and Hristov and Wan 612’ which are both in the field of animal (ruminant) feed compositions are relied upon for the claim limitations of dependent claims, and one of ordinary skill in the art would look into Zuccarello, Hristov, and Wan 612’ to modify Wan in order to produce a composition for ruminant animals with advantageous and positive health, milk and meat production effects.
On pages 11-12, Applicant argues the references of Buchholz [US 20050271768 A1] and Mantha [US 4175121 A]. The examiner notes that the Buchholz and Mantha references were relied upon in prior Office actions and are not part of the current rejection. Moreover, Buchholz teaches ranges that encompass and/or overlaps with the claimed ranges (200-500 g/kg sulfur-containing amino acid) as well as ranges outside the lower and upper ranges instantly claimed, and the reference was being relied upon for limitations not directed to amino acids in the prior Office action.
On pages 12-14, Applicant discuss the results and arguments presented in the affidavit of 3/2/26, which has been addressed by the examiner at the beginning of this Office action under Response to Amendments.
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 LUIS EUGENIO DIOU BERDECIA whose telephone number is (571)270-0963. The examiner can normally be reached Monday-Friday 7:30-4:30.
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/L.E.D./Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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