DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/22/2025 and 06/20/2023 have been considered by the examiner.
Status of the Claims
The response filed 10/22/2025 is acknowledged.
The amended claims filed 06/20/2023 are under consideration.
Claims 14-32 are pending.
Applicant’s election without traverse of the species sodium vanadate (Na3VO4) in the reply filed on 10/22/2025 is acknowledged.
Applicant has indicated the claims 14-17, 19, 21-22, and 27-32 read on the elected species.
Claims 18, 20, and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/22/2025.
Note: US 12383562 may be relevant for double patenting if withdrawn species are rejoined.
Claims 14-17, 19, 21-22, and 27-32 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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 14-17, 19, 21-22, and 27-32 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 pre-AIA the applicant regards as the invention.
The scope of claim 14 is unclear because the claim does not include a transitional phrase, e.g., comprising. The skilled artisan is unable to determine if the claim is inclusive or exclusive to additional, unrecited method steps. See MPEP 2111.03.
Claim 14 further implies an active step with a passive verb (is administered) rather than a positively recited action, e.g., administering, and the step is present in a wherein clause.
If Applicant intended the method to be inclusive to additional, unrecited method steps, it is suggested to amend claim 14 to say:
A method for treating pain, the method comprising: administering a therapeutically effective amount of a positive-tetravalent vanadium compound or a positive-pentavalent vanadium compound comprising a vanadium-oxygen bond to a patient suffering from pain.
If Applicant intended the method to be exclusive to additional, unrecited method steps, it is suggested to amend claim 14 to say:
A method for treating pain, the method consisting of: administering a therapeutically effective amount of a positive-tetravalent vanadium compound or a positive-pentavalent vanadium compound comprising a vanadium-oxygen bond to a patient suffering from pain.
Dependent claims do not clarify this issue.
Clarification is required.
Claim 30 is 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 pre-AIA the applicant regards as the invention.
Claim 30 contains the limitation wherein the compound is administered orally, intravenously, subcutaneously, transdermally, sublingually, and by inhalation.
It is not clear if Applicant intended the claim to require all of the administration routes named or if Applicant intended the claim to require the named routes of administration as alternatives. If Applicant intended the routes of administration to be alternatives, the conjunction “and” should be replaced by “or.”
Clarification is required.
Claim 31 is 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 pre-AIA the applicant regards as the invention.
Claim 31 includes the limitation wherein the positive-tetravalent vanadium compound or the positive-pentavalent vanadium compound is used in an amount of 0.00001 mg/kg body weight to 5 mg/kg body weight, based on the mass of vanadium.
It is not clear how the amount of 0.00001 mg/kg body weight to 5 mg/kg body weight, based on the mass of vanadium “is used.” The step required by the claim is unclear. If Applicant intended this range to refer to the dose administered, the claim should be amended to replace is used with is administered.
Clarification is required.
Claim Rejections - 35 USC § 102
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 14-17, 19, 21-22, 27-29, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li, Chinese Pharmacological Bulletin, 2011 (cited on Applicant’s IDS dated 10/22/2025).
Li teaches administering sodium orthovanadate to a subject suffering from pain by injection (intrathecal) and reports a significant analgesic effect (Li, entire document, e.g., Abstract and conclusion).
Li’s method anticipates the subject matter of claims 14-16, 17, 19, 21-22, 27-29, and 32.
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 14-17, 19, 21-22, 27-29, 30-31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Li, Chinese Pharmacological Bulletin, 2011 (cited on Applicant’s IDS dated 10/22/2025) in view of Cruz, US 5871779.
The teachings of Li enumerated above apply here.
Applicable to claim 30: Li teaches administration by injection but does not expressly teach administering orally, intravenously, subcutaneously, transdermally, sublingually, or by inhalation.
Cruz teaches methods of administering vanadate compounds for treating cancer or arthritis, wherein the vanadate compounds are administered topically (transdermal), intravenously, subcutaneously (Cruz, e.g., c8:14-29). The skilled artisan may select these administration options for slow, continuous release (Cruz, e.g., c8:14-29). Slow administration reduces toxicity of vanadate administration (Cruz, e.g. Example 9). Cruz provided the skilled artisan a suggestion to administer vanadates, like sodium orthovanadate, to subject by transdermal, intravenous or subcutaneous administration to reduce toxicity.
It would have been obvious before the effective filing date of the presently claimed invention to modify Li’s method for treating pain by administering sodium orthovanadate using the teachings of Cruz with a reasonable expectation of success. The skilled artisan would have been motivated to modify Li’s method by administering sodium orthovanadate intravenously or subcutaneously to enable treatment with lower toxicity. The skilled artisan would have had a reasonable expectation of success because Cruz also teaches therapeutic methods of administering orthovanadates.
Applicable to claim 31: Li does not expressly teach the dose recited in claim 31.
However, Cruz teaches doses within the range recited in claim 31 were known and used to administer vanadate compounds for a variety of conditions. For example, for treating tumors, arteriosclerosis, and mental syndromes, doses ranging from 0.0043 mg/kg to 0.14 mg/kg were suggested (Cruz, e.g., c2:22-30). Further, Cruz teaches effective doses generally ranging from 0.2 mg/kg to 25 mg/kg (Cruz, entire document, e.g., c8:43-63) for a variety of administration routes. Cruz suggests the doses are effective to reduce symptoms in subjects having arthropathy, e.g., arthritis, wherein the symptom is pain (Cruz, e.g., c13:1-15).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious before the effective filing date of the presently claimed invention to optimize Li’s method starting from known safe and effective dosing ranges suggested by the prior art for other vanadate treatments with a reasonable expectation of success. Since vanadate has a known dose dependent toxicity, the skilled artisan would have looked to the prior art, such as Cruz, to determine safe dosing ranges within which to optimize the dose of sodium vanadate for treating pain with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Cruz suggests doses which may be effective to reduce symptoms such as pain.
Accordingly, the subject matter of claims 14-17, 19, 21-22, 27-29, 30-31 and 32 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615