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 .
Election/Restrictions
Claims 4-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/04/2025.
Applicant’s election without traverse of Group III, claims 2-3, 8-9 in the reply filed on 12/04/2025 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
The specification refers to methionine-cysteine as an amino acid (see for instance, the bottom of page 5). It appears that the specification discloses the presence of methionine and cysteine in the feed and also discloses a ratio of methionine to cysteine (table on page 5). However, the wording of the specification is confusing and clarification and correction as needed are requested.
Additionally, “cystine” appears to be a typo for –cysteine--.
Appropriate correction is required.
Claim Objections
Claims 2, 3 and 9 are objected to because of the following informalities: “cystine” appears to be a typo for –cysteine--. 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 2, 3, 8 and 9 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.
Independent claim 8 and dependent claims 9, 2 and 3 recite “%” for materials provided in the feed ration, but there is no unit of measurement recited in the claims. For the purpose of examination, the claims are interpreted as measured by weight as best understood. Support from the disclosure for any changes to the claims to reflect a unit of measurement should be provided.
Claims 2, 3 and 9 recite “methionine-cystine” with a percentage, however, such a composition is not known. Methionine and cysteine are two different amino acids. From the instant specification, it appears that applicant has disclosed a ratio of methionine to cysteine as indicated in the Table on page 5. The ratio would be reported as a whole number, not a percentage per se. Based upon the guidance from the instant specification, the claims will be interpreted as a ratio of methionine to cysteine of 0.4-0.9 (claim) and 0.3-0.85 (claims 3 and 9).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over El-Razek, Effect of Split Feeding System on Egg Production and Egg Quality of Dandarawi Layers, Egypt. Poult. Sci. Vol. (40), 2020 (Cited on IDS filed 09/08/2023) in view of CN 109221783 (Qisharina) and US 4086365 (Snetsinger).
El-Razek discloses a method of feeding hens with two daily rations (morning, night) where the morning feed comprises 2838 Kcal (11.87 MJ), 17.7% protein, 2.13 wt% Ca and 0.51wt% phosphorous and the night feed comprises 2664 Kcal (11.14MJ), 14.4wt% protein, 4.18 wt%Ca and 0.47 wt% phosphorous. The values for phosphorous, and the night calcium, fall within the claimed ranges. The values for protein, energy and morning calcium are outside the claimed ranges, but do convey to the ordinary artisan that the morning feed is to have a higher proportion of protein, calcium and energy than the evening feed. El-Razek’s disclosure is limited to a single species of laying hen and a single example and does not explore other species or disclose ranges for feeds in general.
Qisharina discloses a laying hen split-feed where the breakfast feed has 1.5-2.8 wt% calcium, and the pre-dinner feed has 4.5-6.6 wt% calcium both of which overlap with the claimed ranges for morning and afternoon calcium amounts. Qisharina is indicative of a range of acceptable calcium for a split feed ration and both ranges are consistent with the values disclosed by El-Razek. It would have been obvious to one of ordinary skill to vary the morning and afternoon calcium amounts in the feed rations within the ranges of Qisharina with a reasonable expectation of successfully providing the desired amounts of calcium to laying hens via a split-feed ration.
El-Razek discloses that research suggests birds must have access in the morning to a feed rich in protein and amino acids but does not give a range of protein. Snetsinger discloses a two feeds for laying hens where one feed is low in protein (not less than 10%, example of 10-12wt%) and one feed higher in protein (not less than 14wt% and an example of 14-18wt%) (columns 3 and 4). These amounts are indicative of acceptable ranges of protein for laying hens and it would have been obvious to use these known amounts of protein for the morning and night feeds of El-Razek with a reasonable expectation of providing the necessary amount of protein. El-Razek expressly discloses providing a higher amount of protein in the morning and is not limited to the single example given for the species tested. One of ordinary skill would have reasonably looked to the prior art for acceptable values of protein for feeds given to laying hens for guidance. Moreover, as explained in MPEP 2144.05 (II) (A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Here, one of ordinary skill would have found it obvious to vary the content of protein to determine the optimum or workable ranges by routine experimentation to deliver the desired amounts of nutrients to the hen.
Regarding the energy (MJ), El-Razek recognizes research that indicates higher protein and energy in the morning and a decreased level in the afternoon resulted in lower feed costs (page 363, left column). With this teaching in mind, it would have been obvious to one of ordinary skill to modify the morning and evening diets of El-Razek as the disclosure is not seen to be limited to a single example for a single species, but is indicative of a broad teaching of providing increased energy in the morning feed relative to the afternoon feed. El-Razek discloses a control feed with 2695 Kcal/kg (11.27 MJ) and varies the morning and evening rations from this median. Absent a showing of unexpected results, one of ordinary skill would have found it obvious to vary the content of energy to determine the optimum or workable ranges by routine experimentation to deliver the desired amounts of energy to the hen. Moreover, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over van Emous, “Effects of twice a day feeding and split feeding during lay on broiler breeder production performance, eggshell quality, incubation traits, and behavior”, Poultry Science, November 2021 in view of CN 109221783 (Qisharina).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Van Emous discloses a split feed diet for laying hens comprising a morning feed with 2766 Kcal/kg, 14.8 wt% protein, 2.72 wt% Ca, and 0.492 wt% phosphorous. The afternoon feed has 2669 Kcal/kg, 12.9wt% protein, 5.32 wt% calcium, and 0.396 wt% phosphorous. (page 2). Van Emous recognizes a control diet has 3.4wt% Calcium and 2760 Kcal/kg
Qisharina discloses a laying hen split-feed where the breakfast feed has 1.5-2.8 wt% calcium, and the pre-dinner feed has 4.5-6.6 wt% calcium both of which overlap with the claimed ranges for morning and afternoon calcium amounts. Qisharina is indicative of a range of acceptable calcium for a split feed ration and both ranges are consistent with the values disclosed by El-Razek. It would have been obvious to one of ordinary skill to vary the morning and afternoon calcium amounts in the feed rations within the ranges of Qisharina with a reasonable expectation of successfully providing the desired amounts of calcium to laying hens via a split-feed ration.
Regarding the energy amounts, the morning feed of van Emous is slightly higher than the claimed range (2766 vs 2700 Kcal/kg) and van Emous recognizes that the diet is tailored to meet the requirements for albumen formation in the morning (higher protein and energy) and a different diet to facilitate eggshell formation in the afternoon (more calcium and less energy and protein (page 2). Absent a showing of unexpected results, one of ordinary skill would have found it obvious to vary the content of energy to determine the optimum or workable ranges by routine experimentation to deliver the desired amounts of energy to the hen. Moreover, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Here, van Emous is not seen to be limited to the single example and one of ordinary skill would have found it obvious to determine the workable energy amounts by routine experimentation.
Claims 2, 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over El-Razek, Effect of Split Feeding System on Egg Production and Egg Quality of Dandarawi Layers, Egypt. Poult. Sci. Vol. (40), 2020 (Cited on IDS filed 09/08/2023) in view of CN 109221783 (Qisharina) and US 4086365 (Snetsinger) and further in view of US 20010026797 (Sjoeholm) and US 5362753 (Blum) and US 2013/0330308 (Millan).
El-Razek discloses lysine in an amount of 0.94 and 0.8 wt% which falls within the claimed ranges; methionine of 0.52 and 0.47wt% which are within or so close as to not present a patentable distinction from the claimed ranges as one would expect the properties of the feed to be the same (0.5wt% vs 0.52wt% for morning feed). El-Razek discloses fiber of 2.5 wt% and 4.53 wt% for morning and night. The amounts of fiber are considered optimizable based on the control diet of 3.98wt%, one of ordinary skill would find it obvious to determine the optimal or workable amounts of fiber between the morning and night feed to deliver the necessary amount of fiber needed. El-Razek discloses 3.19 wt% and 2.73 wt% fat which falls within the claimed ranged.
El-Razek does not disclose amounts of the remaining material in claims 2, 3 and 9.
Sjoeholm discloses poultry diets have exemplary amounts of methionine of 0.32-0.55 wt%,and methionine plus cysteine of 0.4-0.9 wt% (0.08-0.35 wt% cysteine) which overlaps with the claimed ranges and also provides a ratio (for instance (0.32/0.3.5) = 0.9) that is so close as to not present patentable distinction from the claimed amounts. It would have been obvious to provide the exemplary and known amino acid amounts of methionine and cysteine to the feeds of El-Razek as Sjoeholm discloses these amounts are known and useful for poultry feeds.
Blum discloses a feed for layer hens comprising 89-90 dry matter and 9.83-10.56 ash as exemplary feeds (Table 2). It would have been obvious to one of ordinary skill to provide dry matter and ash in the ranges disclosed by Blum in the feeds of El-Razek as they are demonstrated by Blum as known amounts for feed for hens and would have been reasonably expected to provide a diet suitable for hens.
Regarding threonine, Millan discloses a diet for chickens including 0.76 and 0.68 wt% threonine [0253] and 0.60 for laying hens [0255]. It would have been obvious to one of ordinary skill to provide the amount of threonine disclosed by Millan to the diet of El-Razek as Millan discloses the amount is a known and useful amount of the amino acid specifically for laying hens. Millan further discloses that the feedstuff may contain at least 30-60wt% corn [0220] which is seen as a teaching of the amount of starch present. Moreover, Sjoeholm discloses an example with maize starch of 45.8wt% (Table 5). It would have been obvious to one of ordinary skill to provide starch in the amounts suggested by Millan and Sjoeholm in the diet of El-Razek with a reasonable expectation of providing a suitable diet to the hens as demonstrated by the known amount used in the prior art.
The amount of sodium is considered to be reasonably optimizable by one of ordinary skill based upon the variations of the amounts of salt in the prior art (0.2wt% in Sjoeholm, 0-0.5 parts NaCl in Qisharina, 0.3wt% in El-Razek).
Regarding the apparent metabolizable energy correction, the value is considered to be inherent to the combination based on the prior art above as the value is derived from the ingredients in the feed.
Claims 2, 3 and 9 is rejected under 35 U.S.C. 103 as being unpatentable over van Emous, “Effects of twice a day feeding and split feeding during lay on broiler breeder production performance, eggshell quality, incubation traits, and behavior”, Poultry Science, November 2021 in view of CN 109221783 (Qisharina) and further in view of US 20010026797 (Sjoeholm).
Van Emous discloses all of the claimed ingredients of claims 2, 3 and 9 in overlapping ranges with the exception of a ratio of methionine to cysteine.
Sjoeholm discloses poultry diets have exemplary amounts of methionine of 0.32-0.55 wt%,and methionine plus cysteine of 0.4-0.9 wt% (0.08-0.35 wt% cysteine) which overlaps with the claimed ranges and also provides a ratio (for instance (0.32/0.3.5) = 0.9) that is so close as to not present patentable distinction from the claimed amounts. It would have been obvious to provide the exemplary and known amino acid amounts of methionine and cysteine to the feeds of van Emous as Sjoeholm discloses these amounts are known and useful for poultry feeds.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793