DETAILED ACTION
Formal Matters
Claims 1-19 are cancelled. Claims 20-33 are new, pending and under examination.
Priority
The instant application is a continuation of 17/167,265 filed on 2/4/2021, which is a continuation of 16/429685 filed on 6/3/2019, which is a continuation of 15/968,866 filed on 5/2/2018, which is a continuation of 15/660,439 filed on 07/26/2017, which is a divisional of 13/130,336 filed on 08/04/2011, which is a national stage application of PCT/IB09/55402 filed on 11/30/2009, which claims priority from South African application ZA200810426 filed on 12/09/2008.
Information Disclosure Statement
The information disclosure statements filed on 11/12/2024 and 5/27/2025 have been considered by the examiner.
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 24-33 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 24-33 are indefinite for recitation of “ratio” without defining what ratio would encompass to read on the claims. Ratio might refer to weight, mole weight/volume or volume ratio and each would have a different meaning to the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 23, 25, and 27 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Reynolds US 4423012.
If the prior art teaches a composition of the instant claims, it will be reasoned to also be tissue friendly.
Reynolds teaches an aqueous solution with zinc as a metal ion (abstract and claim 1 of Reynolds). Reynolds teaches feed solutions with 100 and 150 g/l (mg/ml) of zinc (column 5, lines 44-50, also see table 5a). Reynolds provides that up to about 10 g/l of manganese can be present (column 5, lines 47-49). Test numbers 6-8 also contain manganese, magnesium and calcium in table 5a. Table 3 also provides for an aqueous zinc solution with 80 g/l (column 8). Note that example 3 provides for an aqueous solution with 127 g/l (mg/ml) zinc, 3.07 g/l manganese and 8.34 g/l magnesium. This represents an aqueous solution (solution is an injectable form) and contains at least 60 mg/ml zinc and two other trace elements.
An aqueous solution of zinc in instantly claimed compositions was available at the instant time of invention. Although Reynolds does not provide for injection of the solution, it is in a solution form that may be injected. Veterinary use is to the intended use of the composition.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 20, 22, 24 and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Fahim US 5372822 and Leech US 20090029942A1.
In regard to tissue friendly, if the composition motivated by the prior art can be used safely in an animal, it would be considered to have tissue friendliness.
Fahim teaches a mineral acetate solution that is injected into testes of farm animals (abstract). Fahim teaches zinc acetate (claim 1 of Fahim, first paragraph of detailed description). Fahim teaches example 2 that provides for 75.24 mg of zinc acetate in 0.3 ml of solution or 250.55 mg in 1 ml of solution. The zinc in zinc acetate represents 35.6% of the compound, and thus, 35.6% of 250.55 mg zinc acetate is 89.2 mg/ml of zinc. Fahim teaches a preferably aqueous solution for the mineral acetate (zinc acetate) (detailed description). Fahim teaches mineral acetate, which allows for various acetates with mineral cations (see mineral acetate such as zinc acetate or calcium acetate, Summary of Invention – “such as” provides that these are two types of mineral acetates that may be utilized). Calcium acetate is provided as another particular option (claim 1 of Fahim).
Fahim teaches 89.2 mg/ml zinc in an aqueous solution that is injectable. Zinc is a trace element.
Fahim does not teach copper.
Leech teaches injectable aqueous solution formulations of copper to animals (abstract and paragraphs 35-36). Leech teaches 0.1 to 10% by weight of copper dextran (claims 24-25 of Leech). Leech teaches 120+/-100 mg of elemental copper (range of 20 to 220 mg) (paragraph 15).
One of ordinary skill in the art at the time of instant invention would have included other types of mineral acetates (acetates having other mineral components) including copper dextran provided by Leech along with the zinc acetate with the expectation of a solution that can be injected as in the teachings of Fahim. Copper dextran is an acceptable form of copper for injection and there would have been a reasonable expectation of success in including it as an acceptable metal compound into injectable compositions of Fahim. Note that although, veterinary use, is an intended use recited in the preamble, Fahim’s and Leech’s composition is for a veterinary use. Additive amounts of Leech’s copper in Fahim’s formulation would produce amounts of above 90 mg/ml for total element concentration. Use of 20 mg of elemental copper in the 89.2 mg/ml formulation of zinc in Fahim would produce a ratio over 4:1 of zinc to copper.
Claims 21, 23, 25, and 27 are rejected under 35 U.S.C. 103(a) as being unpatentable over Fahim US 5372822 and Ionascu US 20040052872.
In regard to tissue friendly, if the composition motivated by the prior art can be used safely in an animal, it would be considered to have tissue friendliness.
Fahim teaches a mineral acetate solution that is injected into testes of farm animals (abstract). Fahim teaches zinc acetate (claim 1 of Fahim, first paragraph of detailed description). Fahim teaches example 2 that provides for 75.24 mg of zinc acetate in 0.3 ml of solution or 250.55 mg in 1 ml of solution. The zinc in zinc acetate represents 35.6% of the compound, and thus, 35.6% of 250.55 mg zinc acetate is 89.2 mg/ml of zinc. Fahim teaches a preferably aqueous solution for the mineral acetate (zinc acetate) (detailed description). Fahim teaches mineral acetate, which allows for various acetates with mineral cations (see mineral acetate such as zinc acetate or calcium acetate, Summary of Invention – “such as” provides that these are two types of mineral acetates that may be utilized). Calcium acetate is provided as another particular option (claim 1 of Fahim).
Fahim teaches 89.2 mg/ml zinc in an aqueous solution that is injectable. Zinc is a trace element.
Fahim does not teach manganese.
Ionascu teaches an injectable pharmaceutical solution that has manganese along with other minerals/trace elements (abstract and paragraph 8 and claim 2 of Ionascu). The manganese is part of an active powder of inorganic salts. Ionascu teaches 0.012% manganese (0.12 mg/ml) (paragraph 8).
One of ordinary skill in the art at the time of instant invention would have included other types of minerals like manganese provided by Ionascu along with the zinc acetate with the expectation of a solution that can be injected as in the teachings of Fahim. Both references are to injectable formulations for animals. Note that although, veterinary use, is an intended use recited in the preamble, Fahim’s composition is for a veterinary use.
Claims 20-33 are rejected under 35 U.S.C. 103(a) as being unpatentable over Laurie US 20050244511.
Laurie teaches “a trace element solution, which comprises at least one metal selected from the group comprising selenium, copper, zinc, manganese and chromium and which comprises a concentration of the metal(s) of at least 60 mg/ml. The solution further comprises at least one compound selected from the group comprising iodine, potassium iodide, sodium iodide, iron, iron chloride, zinc oxide, manganese sulphate, sodium selenite, copper carbonate, sodium carbonate, anhydrous disodium EDTA and sodium hydroxide.” (abstract). Laurie teaches an exemplary formulation with 35-50 mg/ml zinc, 10-15 mg/ml manganese, 5-10 mg/ml selenium, 10-20 mg/ml copper, 5-10 mg/ml chromium, 5-50 mg/ml iron and 20-400 mg/ml iodine (paragraphs 128-135, also see claim 41 of Laurie). Using high endpoints of these ranges, there can be solutions with well over 90 mg/ml trace elements when added. This example provides zinc to manganese with 50 mg/ml zinc and 10 mg/ml manganese (5:1 ratio) as well as 50 mg/ml zinc and 10 mg/ml copper (5:1 ratio). Examples provide making the formulation with water (e.g. see examples 1 and 2).
Laurie does not provide an embodiment with 60 mg/ml zinc, however, Laurie does teach that “a trace element solution, which comprises at least one metal selected from the group comprising selenium, copper, zinc, manganese and chromium and which comprises a concentration of the metal(s) of at least 60 mg/ml” This allows zinc to be a metal with at least 60 mg/ml concentration.
One of ordinary skill in the art before the time of invention would have included zinc at 60 mg/ml in an aqueous trace element solution and was capable of making solution with greater than 90 mg/ml total trace elements based on teachings of Laurie in regard to the trace elements and ranges of concentrations for use. Therefore, there would be a reasonable expectation of success in utilizing the teachings of Laurie to make aqueous solutions having the elements and concentrations of the claims based on overlapping amounts of trace elements (generally in group that includes zinc), copper, and manganese.
Obviousness-Type Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 20-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent 9750764. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘764 provides claims with the same metal elements in solution and a zinc content of at least 60 mg/ml in the solution and also provides for ratios and total element concentrations of at least 90 mg/ml.
Claims 20-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent 10350241. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘241 provides claims with the same metal elements in solution with zinc of at least 60 mg/ml in the solution. The claims of ‘241 provide amounts that would create overlapping ratios and the ability to have at least 90 mg/ml of trace elements. ‘241 also provides for administering the solution to an animal.
Claims 20 and 22 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2 of U.S. Patent 11000544. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘544 provides claims with copper and at least one other trace element in solution with zinc of at least 60 mg/ml in the solution. The intended use limitations of “veterinary use” and “injectable” in claim 2 of ‘544 make it obvious that the solution will be administered to an animal resulting in an improvement/increase of trace element amounts in the animal.
Claims 20-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent 12168025. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘025 provides claims with copper, manganese and at least one other trace element in solution with zinc of at least 60 mg/ml in the solution. ‘025 claims also provide for ranges that would allow for overlapping ranges of ratios of zinc to copper and zinc to manganese.
Claims 20-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 and 4-5 of U.S. Patent 10729772. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘772 provides claims with copper, manganese and at least one other trace element in solution with an amount of at least 60 mg/ml in the solution.
Claims 20-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent 8377482. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘482 provides claims with copper, manganese and at least one other trace element in solution with an amount of at least 60 mg/ml in the solution.
Claims 20-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 7 of U.S. Patent 10286006. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘006 provides claims with copper, manganese and at least one other trace element in solution with an amount of at least 60 mg/ml in the solution.
Claims 20-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent 10799531. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘531 provides for formulations that provide for compositions with elements, concentrations and ratios of applicant’s claims.
Claims 20-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of U.S. Patent 11564940. Although the conflicting claims are not identical, they are not patentably distinct from each other because patent ‘940 provides for formulations that provide for compositions with elements, concentrations and ratios of applicant’s claims.
Conclusion
No claims are allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
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