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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 February 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicant’s election without traverse of Group I (claims 1, 3, 5-6, 8-9, 11-12, 14-15, 17, and 20-25) in the reply filed on 24 November 2025 is acknowledged.
Status of Application
3. The instant application is a national stage entry of PCT/US2022/014571 filed 31 January 2022. Claims 1, 3, 5-6, 8-9, 11-12, 14-15, 17, 20-25, and 33-35 are currently pending. Claims 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 November 2025. Claims 1, 3, 5-6, 8-9, 11-12, 14-15, 17, and 20-25 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
4. 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.
5. Claims 20-24 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.
6. Claim 20 recites “no more than about 3% of total impurities”. The term “about” is not defined; thus the endpoint of this range is unclear. Does the claim mean no more than 3%, 2.5%, 2%, 3.5%, 4%, etc? Clarification is requested. Claim 22 is included in this rejection for the same deficiencies regarding endpoint.
7. Claim 21 recites “less than about 2%”. The term “about” is not defined; thus the endpoint of this range is unclear. Does the claim mean less than 2%, 2.5%, 3%, 1%, etc? Clarification is requested. Claims 23-24 are included in this rejection for the same deficiencies regarding endpoint.
Claim Rejections – 35 U.S.C. 102
8. 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.
9. Claim(s) 1, 12, and 20-25 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Price et al. (WO2007/142626).
Regarding instant claim 1, Price et al. disclose increasing the bioavailability of thiomolybdate compounds by combining the thiomolybdate compound with an antacid. See abstract. The thiomolybdate compound is bis(choline)tetrathiomolybdate (ATN-224). See paragraph [00162] and claim 4. The antacid is sodium bicarbonate. See claim 12. The composition can be in the form of tablets, pills, pellets, or any other form suitable for use. See paragraph [00131]. Suitable dosage ranges for oral administration depend on the potency of the drug but are generally between 0.01 mg to about 200 mg. Effective doses may be extrapolated from dose response curves. See paragraph [00139]. Suitable dosage ranges of antacids can be readily determined by those skilled in the art. See paragraph [00145]. The composition additionally comprises carriers, auxiliary agents, stabilizing, thickening, lubricating, and coloring agents. See paragraph [00129].
Regarding instant claim 12, when in the form of a pill or tablet, the composition may be coated. See paragraph [00132].
Regarding instant claims 20-24, Price et al. disclose the same combination of ingredients, thus the properties should be the same regarding the claimed impurities. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claim 25, the composition can be in the form of kits comprising containers. See paragraph [00157].
Thus the instant claims are anticipated by Price et al.
Claim Rejections – 35 U.S.C. 103
10. 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.
11. Claim(s) 1, 3, 5-6, 9, 12, 14-15, 17, and 20-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (WO2007/142626).
Regarding instant claim 1, Price et al. teach increasing the bioavailability of thiomolybdate compounds by combining the thiomolybdate compound with an antacid. See abstract. The thiomolybdate compound is bis(choline)tetrathiomolybdate (ATN-224). See paragraph [00162] and claim 4. The antacid is sodium bicarbonate. See claim 12. The composition can be in the form of tablets, pills, pellets, or any other form suitable for use. See paragraph [00131]. Suitable dosage ranges for oral administration depend on the potency of the drug but generally between 0.01 mg to about 200 mg. Effective doses may be extrapolated from dose response curves. See paragraph [00139]. Suitable dosage ranges of antacids can be readily determined by those skilled in the art. See paragraph [00145]. The composition additionally comprises carriers, auxiliary agents, stabilizing, thickening, lubricating, and coloring agents. See paragraph [00129].
Regarding instant claim 12, when in the form of a pill or tablet, the composition may be coated. See paragraph [00132].
Regarding instant claims 20-24, Price et al. teach the same combination of ingredients, thus the properties should be the same regarding impurities. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claim 25, the composition can be in the form of kits comprising containers. See paragraph [00157].
Price et al. do not teach percentages of the buffer, filler, or lubricant component.
Although mini-tablet is found in the preamble, versus the body, lacking patentable weight, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to formulate the tablet as a mini-tablet because Price et al. envision any suitable form of administration. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the amount of each ingredient to achieve the desired consistency and effect of the minitablet formulation.
12. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (WO2007/142626) as applied to claims 1, 3, 5-6, 9, 12, 14-15, 17, and 20-25 above and further in view of Bjartmar et al. (WO2019/110619).
Price et al. do not teach microcrystalline cellulose.
Bjartmar et al. teach tablet or capsules of bis-choline tetrathiomolybdate. See abstract and paragraph [0098]. The composition includes binding agents, fillers such as microcrystalline cellulose, lubricants, disintegrating agents, wetting agents and the like. The tablets may also be coated. See paragraph [0098].
It would have been well within the purview of the skilled artisan to add microcrystalline cellulose to the formulation of Price et al. because Bjartmar et al. teach this is a filler known to be effectively combined with bis-choline tetrathiomolybdate.
13. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Price et al. (WO2007/142626) as applied to claims 1, 3, 5-6, 9, 12, 14-15, 17, and 20-25 above and further in view of Cooper (U.S. Patent Application Publication No. 2009/0093542).
Price et al. do not teach sodium stearyl fumarate.
Cooper teaches tablets comprising copper antagonists. See abstract. Agents capable of reducing copper include thiomolybdates. See paragraph [0028]. Suitable diluents in the core include microcrystalline cellulose. Suitable lubricants include magnesium stearate or sodium stearyl fumarate. See paragraph [0427].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one lubricant for another to yield predictable results.
Conclusion
14. No claims are allowed at this time.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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