,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 Objections
Claim 17 is objected to because of the following informalities:
The last line of claim 17 refers to “soyabean”. It appears this should be –soybean--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 10 includes the range of “from about 4% to about 30% by weight” for the carbohydrate source. The claims were amended in a paper filed 08/09/2024 which was after the filing of the application on 12/20/2023. Support for a range of about 5% to about 30% by weight for the carbohydrate source is found in the originally filed application, but support has not been found for a lower limit of “about 4%” by weight. Applicant states in the paper filed 08/09/2024 that support for claim 10 is found in original claim 11. However, claim 11 also recites “about 5%”. See MPEP 608.04(b).
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 8, 10, 14, and 17 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.
Claims 8, 10 and 14 refer to percentages of water, oil and carbohydrate source as amounts in “the crumble feed formulation”. In light of the specification, as well as the language of claims 19, 20, 46 and 49, it is not clear if the claimed amounts are of the crumble nutrient or the feed formulation. The instant specification refers to these same amounts cited in claims 8, 10 and 15 as amounts of the crumble nutrient, not the feed formulation which comprises the crumble nutrient and the macroalgae. See paragraphs [0029, 0030, 0056] of the instant specification.
Claim 17 refers to “protein meals (cottonseed meal, canola meal, soyabean meal)”. It is not clear if the recitation “protein meals” is limited to the specific meals cited in parenthesis, if all three meals must be present, or if they are merely exemplary.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 17, 42, 43, 47 and 53 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/205420, relying on the filing date of 04/12/2021, (Hay).
Regarding claims 1 and 42, Hay discloses compositions comprising algae, including red algae provided in feed supplements for methane reduction [abstract, 0028]. The red algae provide bromoform (abstract, [00120]). Hay specifically discloses an algal feed supplement for beef cattle, dairy cattle and other ruminants comprising a minimum of 2.5% of bromoform by dry weight [00227] and 3.5% of bromoform by dry weight [00228]. This amount is seen to meet the claimed amount of 50mg/kg which converts to 0.005wt%. See also, [00318-00328] for dosages of target components up to 100,000 mg. The feed supplement may be in solid form and include lipid mixtures (considered nutrients) [00328-00330]. While not expressly stated, the solid form is considered to meet the claimed crumble due to being in solid form and thus considered to have more dry components than water.
Regarding claim 2 and 43, Hay teaches Asparagopsis taxiformis [0003-0005, 0120, claim 1].
Regarding claim 4 and 47, the solid lipid mixture formulations may be freeze dried [00332].
Regarding claims 17 and 53, Hay discloses the feed supplement may further comprise nutrient sources and excipients such as minerals and vitamins, protein, oilseed meals, grains, etc. [0260-0291].
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.
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 1-3, 8, 17, 42-44, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/135857 (Fennessy) (claiming priority to December 21, 2020, thus applicable under 102(a)(2) (MPEP 2152.01)).
Regarding claims 1, 2, 42 and 43, the instant claim is to a crumble feed formulation. A specific definition of “crumble” is not found in the instant specification; thus, the term “crumble” is interpreted as having a higher dry matter content than water. The phrase “effective amount” is defined in the specification as indicating a quantity of at least one species of red marine macroalgae sufficient to allow improvement, e.g., reduction in the amount of methane production in comparison with a reference or control [0082]. The amount of reduction is not defined, thus demonstration of any reduction in methane production is considered to meet the “effective amount” limitation. The claim does not limit the manner in which the species of red macroalgae is provided, thus any presence of red macroalgae is considered to meet the claim. The phrase “crumble nutrient” is also not defined in the context of “nutrient”; thus, any material provided in combination with the macroalgae that can reasonable be considered a nutrient is considered to meet the limitation.
Fennessy discloses composition or animal feed supplements for reducing methane emission of ruminant animals (abstract). The composition comprises bromoform from red macroalgae and may be added to an animal feed (abstract). Since the inclusion of the bromoform in the form of a red macroalgae is taught by Fennessy, it is understood to be present in an “effective amount”. The composition may be in dry solid form with dimensions and/or textures suitable for consumption by an animal (page 27) thus understood to meet the claimed “crumble”. Fennessy discloses other additives, such as vitamins, minerals etc., as well as other feed materials such as sugars, starches, cereal grains etc., may be added to the composition, all of which are considered nutrients (page 17). Thus, Fennessy is seen to disclose a crumble nutrient in combination with a macroalgae, where the preferred macroalgae is red. The composition or animal feed supplements may be made by combining one or more organohalogen-rich (preferably bromoform) marine macroalgae and one or more organosulfur-rich plant (page 27). The components are combined in suitable amounts to obtain a composition having the desired quantity of each component. The organohalogen compounds from Asparagopsis species (red algae) include bromoform which inhibits methane production (page 30) and the organohalogen-rich macroalgae may be selected from a group including Asparagopsis armata and Asparagopsis taxiformis (page 5).
Fennessy teaches that the organohalogen and organosulfur components may be added to an animal feed which may be in the form of roughages, concentrates and mixed feeds. The roughage is in the form of hay, strawy and artificially dehydrated forages) and are considered a nutrient. Concentrates contain a relatively lower percentage of crude fiber and a higher percentage of digestible nutrients than roughages. For example, concentrates may be defined as containing less than 20 wt% crude fiber and greater than 60 wt% total digestible nutrients. Concentrates may include, for example, energy-rich grains and molasses. Corn, wheat, oats, barley and milo (sorghum grain) are energy-rich grains, containing about 70 to 80 wt% total digestible nutrients. Fennessy teaches that the composition may be provided to a feedlot and may be added as a top-dress to a ruminant feedlot ration or blended into a total mixed ration (page 18).
Regarding the amount of antimethanogenic agent in the crumble feed formulation, Fennessy discloses that the feed may contain about 0.0001-10wt% of the organosulfur compound (page 18) and that the ratio of organohalogen to organosulfur is 1:10 to 1:3500. Thus, if the feed contains organosulfur in an amount of 10wt%, the organohalogen content may be 1wt%. The instant claim requires at least about 50mg/kg which converts to 0.005wt%. Thus, the amount of organohalogen that may be provided in the feed of Fennessy overlaps the claimed range, thus presenting a prima facie case for obviousness.
Regarding claims 3, 8, and 44, Fennessy discloses the organohalogen containing composition (macroalgae) may be added to roughages which include dehydrated forages containing at least 90wt% dry matter. This indicates a content of water of less than 10wt%, thus overlapping the range
Regarding claim 8, Fennessy discloses roughages contain at least 90wt% dry matter, thus would have 1-10wt% water content (page 18).
Regarding claims 17 and 53, as stated above, Fennessy discloses additives including vitamins, minerals etc. (page 17).
Claims 1, 2, 17, 42, 43, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/218967, relying on the priority date of 04/15/2021, (Kindermann).
Regarding claims 1, 2, 42 and 43, Kindermann teaches a ruminant feed or additive comprising a methane inhibitor (bromoform) vitamins and minerals (nutrients) (page 8). The feed may further comprise one or more of protein (50-80wt%), fat (5-10wt%), NDF (15-70wt%), TDN (30-80wt% and starch (15-70wt%). The ruminant feed comprises the methane inhibitor (bromoform from Asparagopsis such as A. taxiformis) (page 4) may be delivered in an amount of 0.01g to 100 grams/animal/day (page 5). An animal of 500 kg live weight fees about 7.5-17.5 kg/dry matter/day (page 11). Assuming 10kg per day, the necessary dosage would appear to be 0.01-100g/10 kg which converts to 0.001-10 g/kg which overlaps the claimed range. If the bromoform is taken as present only as a concentration of bromoform in Asparagopsis of 1-7mg/g (page 4), the range would be 0.007-70mg/kg of bromoform which also overlaps the claimed range.
Regarding claims 17 and 53, the methane inhibitor may be used in combination with conventional ingredients present in an animal feed composition (diet) such as forages (raw, grass, hay, silages), coproducts from industry (citrus pulp, soybean hulls, distillers dried or wet grains with solubles, minerals (calcium carbonates, electrolytes such as ammonium chloride, macro and trace minerals and in all forms, inorganic and organic), proteins such as soya bean meal, sunflower meal, meat and bone meal, fish meal, amino acids and others, energy ingredients such as grains, wheat, starch, barley, millet, sorghum, corn, animal and plants fat or oils, and vitamins without being limited thereto (page 8).
Claims 1, 2, 4, 6, 17, 42, 43, 47, 53 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/018062 (Tomkins) evidenced by Kinderman (WO 2022/218967).
Regarding claims 1, 2, 42 and 43, Tomkins discloses using red macroalgae in ruminant feed that may be in the form of pellets or crumbles (page 8). Tomkins discloses an animal is provided a feedlot ration twice per day amounting to a total daily amount of 10-12kgs, and amounting to about 200-600 g Asparagopsis taxiformis/day (page 13). Taking for example 10 kg total of feed and an expected delivery of 500 g red algae and if bromoform is taken as present only as a concentration of bromoform in Asparagopsis of 1-7mg/g (page 4 of Kinderman), the dosage of algae should be 500g/10kg resulting in 50-350 mg/kg of bromoform. While this is taken as an example from within the ranges of Tomkins, it is indicative that the range of Tomkins overlaps the claimed dosage of bromoform.
Regarding claims 4 and 17, the red algae may be freeze dried (Example 1).
Regarding claims 17 and 53, the feed may include 75% grain, roughage 20% and minerals and vitamins (5wt%), considered nutrients.
Regarding claims 6 and 56, Tomkins teaches freeze drying the red macroalgae which is expected to extend the storage life of bromoform, thus one would reasonably expect the feed/feedlot of Tomkins to provide the storage stability cited in claims 6 and 56. No specific method for freeze drying the red algae is disclosed, thus the provision of freeze drying is taken to meet any required treatments of the red algae to confer the required stability of bromoform.
Claims 1-4, 6, 8, 10, 13, 17, 19, 42-44, 46, 47, 53, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley, “Asparagopsis feedlot feeding trial”, May 31, 2018 (cited on IDS filed 12/20/2023) in view of Tomkins WO 2018/018062.
Regarding claims 1, 2, 42 and 43, Kinley discloses Asparagopsis taxiformis biomass was gathered and frozen to retain volatile bioactive compounds and was milled and prior to feeding was incorporated into a high grain total mixed ration (TMR) (3.1). As disclosed in Table 3, the bromoform content ranges from 6.31-25.2 mg/kg. The relatively low amount of water (11.5wt%) is considered disclosure of a crumble.
Kinley does not teach increasing the bromoform content. Tomkins discloses an animal is provided a feedlot ration twice per day amounting to a total daily amount of 10-12kgs, and amounting to about 200-600 g Asparagopsis taxiformis/day (page 13). Taking for example 10 kg total of feed and an expected delivery of 500 g red algae and if bromoform is taken as present only as a concentration of bromoform in Asparagopsis of 1-7mg/g (page 4 of Kinderman), the dosage of algae should be 500g/10kg resulting in 50-350 mg/kg of bromoform. While this is taken as an example from within the ranges of Tomkins, it is indicative that the range of Tomkins overlaps the claimed dosage of bromoform. It would have been obvious to one of ordinary skill to increase the amount of red macroalgae/bromoform in the feed of Kinley to levels disclosed by Tomkins with a reasonable expectation of increasing the effect of methane reduction as the effective range of Tomkins indicates the expectation that increased levels of bromoform would provide increased antimethanogenesis.
Regarding claims 3 and 44, the water content in the example of Kinley is 11.5 wt% moisture, or 88.5% dry matter.
Regarding claims 4 and 47, Tomkins teaches freeze drying the red algae.
Regarding claims 6 and 56, Kinley teaches freeze drying the red macroalgae which is expected to extend the storage life of bromoform, thus one would reasonably expect the feed/feedlot of Kinley to provide the storage stability cited in claims 6 and 56. No specific method for freeze drying the red algae is disclosed, thus the provision of freeze drying is taken to meet any required treatments of the red algae to confer the required stability of bromoform.
Regarding claim 8, 11.5wt% water is considered “about” 10 wt%. Moreover, the 11.5wt% is taken as exemplary and adjusting the water content is considered within the purview of one of ordinary skill in the art since the moisture content affects the texture of the feed and can be readily adjusted to the desired texture and moisture contents.
Regarding claims 10 and 13, Kinley teaches molasses (considered a carbohydrate) in an amount of 8wt%.
Regarding claims 17 and 53, Kinley teaches vitamins and minerals may be added.
Regarding claims 19 and 46, Kinley teaches molasses at 8wt%, water at 11.5wt% and oil at 3.2wt%. As noted above, the 11.5wt% water is taken as exemplary and adjusting the water content is considered within the purview of one of ordinary skill in the art since the moisture content affects the texture of the feed and can be readily adjusted to the desired texture and moisture contents.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kinley, “Asparagopsis feedlot feeding trial”, May 31, 2018 (cited on IDS filed 12/20/2023) in view of Tomkins and further in view of US 2022/0088110 (McNeff).
Regarding claim 14, Kinley teaches vegetable oil in an amount of 3.2 wt% but does not specify the type of vegetable oil. McNeff discloses and animal feed material including compositions for mitigating methanogenesis and discloses that the animal feed may include vegetable oils such as canola, sunflowers, safflower and soybean. It would have been obvious to use known vegetable oils such as those taught by McNeff in the animal feed of Kinley with a reasonable expectation of success based upon McNeff’s successfully use in forming animal feeds that are also comprised of methanogenesis mitigating components.
Claims 20 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Kinley, “Asparagopsis feedlot feeding trial”, May 31, 2018 (cited on IDS filed 12/20/2023) in view of Tomkins and further in view of US 4704287 (Meyer).
Kinley teaches the feed formulation above including molasses (8wt%) and grains, but does not teach the use of canola meal in combination with molasses. Meyer teaches a ruminant feed that is a mixture of oilseed meal, such as canola, where the oilseed meal may comprise the only feed ingredient in the admixture with zinc or it may be combined with other feed ingredients (col. 3, lines 16-32, and lines 50-53). In other words, the predominant substance may be the oilseed meal to provide high protein in the ruminant feed. It would have been obvious to one of ordinary skill to provide the oilseed meal in higher relative amounts to increase the amount of protein provided, depending upon the nutrition needs of the recipient animal. Example 1 of Meyer also indicated molasses used in combination with the oilseed meal.
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