DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/24/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 02/24/2026 in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-7, 9-20 are pending of which claims 13-14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 09/25/2024.
Claims 1-7, 9-12 and 15-20 are being examined on the merits.
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 1-7, 9-12 and 15-20 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.
Claim 1 recites “wherein a pharmaceutical composition comprising an effective amount of bis (maltolato) oxovanadium (IV) (BMOV) as sole ingredient”, but the claim also uses “comprising” in the claim language for the composition and so these limitations appear to be counterintuitive and opposing each other which makes the claim indefinite. Does the claim allow for additional ingredients in the composition or not?
Claims 5-6 recites the limitation " wherein the physiologically acceptable organic and/or inorganic vanadium compound or complex" in line 1 of each claim. There is insufficient antecedent basis for this limitation in the claim because this limitation is not required of claim 1.
Claim 12, in the last line recites “so that NGAL levels are decreased” and it is unclear what NGAL is referring to.
Claim 15, recites [page 16 - 18] and it is unclear as to what this limitation is referring to. The claim is indefinite. Additionally claim 15 recites “iNOS expression is decreased/inflammatory activation is decreased” and it is unclear how the “/” is intended to be interpreted. Does it represent “and”, “or” or both?
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 12 and 15-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gho (from IDS, US6579540B1) and John McNeill and Chris Orvig (US5527790A). This is a new rejection due to the amendments filed on 02/24/2026.
Regarding claim 1-3, Gho teaches the use of vanadium compounds and its salts or complex as active components for treatments of secondary injuries caused by primary injuries from traumatic events (see claim 1). Gho teaches the vanadium compound is bis(maltolato)oxovanadium(IV) or the corresponding bis(maltolato)oxovanadate salt (see claim 4) which appears to be the same compound tested in the instant invention. Gho teaches the traumatic event can be caused by the consequence of ischaemia, which is followed by reperfusion or operation (surgery) (see col. 4, lines 37-57). The patient population is critically ill patients suffering from acute stress. Acute stress is not defined in the specification however the applicant gives exemplary statuses of what may cause acute stress, events such as: injury, an insult, a trauma, a medical treatment, an infection, a stroke, coronary bypass surgery or a treatment of myocardial infarction (see specs 0043 and 0054 and instant claim 3). Thus, it can be appreciated from the applicant’s own exemplary statements that injuries, medical treatments and myocardial infarctions are all components causing acute stress. The stress-induced hyperglycemia appears to be induced by myocardial infarctions as can be appreciated from the applicant’s own recitation of “stress-induced hyperglycemia is associated with a high risk of mortality after both stroke and myocardial infarction” (see 003).
Gho teaches wherein vanadium compounds, salts, complexes can be used as insulin simulators in treatments for diabetes and hypertension (see column 3, lines 9-11), and as insulin mimicking agents, and for treating injured tissues from trauma (see column 2, lines 4-10). Gho teaches that numerous vanadium compounds, salts and complexes which are effective in the treatment of diabetes, hypertension and obesity (see column 3, second full para.).
Regarding claim 2, Gho teaches that vanadium compounds, salts and complexes are effective in the treatment of diabetes, hypertension and obesity (see description, para. 9), and so it can be appreciated that the composition can be used when treating a patient suffering only from hypertension and/or obesity that also does not have to be a diabetic as these patient populations are not the same.
Regarding claims 5-6, Gho teaches wherein very good results of treatment are obtained when the vanadium compound is administered intravenously (see column 4, lines 15-25).
Regarding claim 7, Gho teaches administering the vanadium compounds from 4-5 days (see column 4, lines 51-54).
Regarding claim 12 and 17, wherein the method is for limiting renal ischemia-reperfusion, Gho teaches wherein the compounds are useful in treating reperfusion after ischemia and specifically teaches that the components are for protecting non-proliferative tissues of the kidney (see column 5, lines 1-15).
Regarding claims 15-16, wherein the method is for preventing, limiting or treating of cardio-renal disorders in a mammal, Gho teaches wherein the compounds are useful in treating reperfusion after ischemia and specifically teaches that the components are for protecting non-proliferative tissues of the kidney and heart (see column 5, lines 1-15).
Gho does not particularly teach wherein the blood glucose levels are maintained between about 80 and about 110 mg/dl or administering insulin or insulin analogues, nutritional supplements or nutritional supplement to the critically ill patients.
McNeill’s general disclosure is to Bis(maltolato)oxovanadium compositions for the treatment of elevated blood sugar (see abstract).
McNeill teaches the use of BMOV for treating elevated blood sugar (hyperglycemia) and teaches administration amounts of a daily dose between 0.0007 to 2.0 mg/kg (see claim 1).
McNeill teaches effective ranges of administering bis(maltolato)oxovanadium(IV) may be about 15 mg V/kg (see column 9, lines 54-56), and this appears to be the effective amount to reduce iNOS and NGAL levels as can be appreciated from the applicant’s own figures (see instant figures 6 and 7), because 15 mg/kg of BMOV is shown to significantly reduce NGAL and iNOS expression.
It would have been obvious to persons skilled in the art before the effective filing date to administer the vanadium compound to critically ill patients suffering from acute stress and for normalizing glycemic levels, because Gho teaches the administration of vanadium is known for acting as an insulin memetic/stimulator which are known to normalize blood glucose levels and teaches administering the compounds to patients suffering from ischemic infarctions and those who had undergone surgery. The current application recites statuses of “acute stress” which are due to ischemic events and surgeries, thus it would be understood that the patients of the prior art are experiencing acute stress. Administering these compounds to critically ill patients as opposed to non-critically ill patients would both have been obvious given the prior art because both patients can benefit from the treatment. Additionally, administering these compounds to non-diabetic patients would have been obvious because Gho teaches vanadium compounds are useful for the treatment of hypertension and/or obesity and these patients do not need to have diabetes for the treatment to be effective for treatment of hypertension and obesity. Administering these compounds which are described as insulin mimicking agents to patients who are in need of maintaining normoglycemia would have been obvious because one of the roles of insulin is to maintain glycemic levels.
The stress-induced hyperglycemia appears to be induced by myocardial infarctions as can be appreciated from the applicant’s own recitation of “stress-induced hyperglycemia is associated with a high risk of mortality after both stroke and myocardial infarction” and Gho teaches the traumatic event can be caused by the consequence of ischaemia, and teaches that the compounds act as insulin mimetics and so limiting stress-induced hyperglyemia would have been obvious given the prior art.
It would also have been obvious to administer the composition as a method of treatment or limiting renal ischemia-reperfusion because Gho teaches wherein the methods are known for treating ischemic reperfusions and teaches the targeted tissues are non-proliferative tissues such as the kidneys and heart, so using the method steps for cardio-renal disorders and for renal ischemic-reperfusion would have been prima facie obvious given the prior art.
It would have also been obvious to administer insulin or insulin analogous and to maintain the blood glucose levels between about 80 and about 110 mg/dl because within this range is known to exist normal or safe blood glucose levels for individuals and thus having a treatment that creates normal blood glucose levels to be within this range is prima facie obvious. Insulin administration is also known to those having skill in the art to normalize blood glucose levels and thus administering this would have been prima facie obvious. Also McNeill teaches administering amounts which are the same amounts that the applicant has administered to bring about a decrease in NGAL and iNOS levels, because McNeill teaches administering BMOV at 15 mg/kg.
There would have been a reasonable expectation of success in arriving at the instant invention because the administration of vanadium compounds for maintaining normoglycemia in critically ill patients has already been disclosed in the prior art.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gho (from IDS, US6579540B1) and John McNeill and Chris Orvig (US5527790A) as applied to claims 1-7, 12 and 15-17 above, and further in view of Cross et. Dickinson (US4788196A). This is a new rejection due to the amendments filed on 02/24/2026.
Gho and McNeill teach the method for maintaining normoglycemia in a critically ill patient suffering from acute stress comprising administering to the patient a composition comprising BMOV, however are silent on administering an anti-arrhythmic drug.
Cross teaches “a series of pyridyl or imidazolyl substituted phenyl piperazines having utility as anti-arrhythmic agents is disclosed” (see abstract) and teaches “because they do not alter the speed at which impulses are conducted, they have less propensity than current drugs (mostly Class I) to precipitate or aggravate arrhythmias, and they also produce less neurological side effects. Some of the compounds also have positive inotropic activity and therefore are particularly beneficial in patients with impaired cardiac pump function” (see background of the invention).
Therefore, it would have been obvious to persons having skill in the art before the effective filing date to administer anti-arrhythmic agent taught by Feher along with the method steps of administering the vanadium compound taught by Gho for treating patients who had suffered from ischemia infarctions because anti-arrhythmic drugs are known for treating ischemic heart diseases and combining methods known for treating the same diseases are prima facie obvious. Additionally, anti-arrhythmic drugs are known to prevent and treat heart rhythm that’s too fast or irregular and thus this administration would be precautionary and obvious.
Claims 10-11 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gho (from IDS, US6579540B1) and John McNeill and Chris Orvig (US5527790A) as applied to claims 1-7, 12 and 15-17 above, and further in view of Janos Feher (from IDS, US20110027348). This is a new rejection due to the amendments filed on 02/24/2026.
Gho teaches the method of maintaining normoglycemia in a critically ill patient suffering from acute stress comprising administering a physiologically acceptable organic and/or inorganic vanadium compound or complex, however does not specifically teach administering a nutritional supplement to the patient.
Feher teaches a method for treating, preventing or attenuating ischemia-perfusion and stroke (see 0132) through administering compositions comprising omega-3 fatty acids and vitamin E (see claim 1).
Feher teaches “fish oil may be used for enteral or parenteral nutrition for critically ill patients. When fish oil was added to the composition the nutritive effects were accompanied with some decrease of inflammation” (see 0069).
Therefore, it would have been obvious to persons having skill in the art before the effective filing date to administer nutritional supplements such as compositions taught by Feher which comprise vitamin E and omega-3 fatty acids. Feher teaches that fish oils when used for critically ill patients decreased inflammation.
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered but they are not persuasive. The applicant argues that the art does not teach limiting stress-induced hyperglycemia by administering an effective amount of BMOV as a sole ingredient. The Office relies on McNeill to teach the same effective amount or range as what is being argued and not necessarily claimed. The applicant argues that the art does not teach administering the BMOV composition in amounts to control blood sugar below 110 mg/dl, however this limitation would have been obvious to any skilled artisan as the art already teaches administering the BMOV composition for controlling blood sugar. This range would be a target range notable to any skilled artisan for keeping blood sugar at healthy levels. Additionally, the applicant has no evidence for controlling blood sugar at this level as can be appreciate from their own figures and specifications. They have not tested the compound for control of blood sugar or for bringing down blood sugar levels as claimed. The prior art already discloses the same compound being useful for the same purposes which is lowering blood sugar and so finding an effective amount to reach a healthy blood sugar range is prima facie obvious. The applicant argues that the mere fact that a blood range from 80-110 mg/dl is a normal range does not make it obvious. This however is not true because any skilled artisan would recognize this range as being a health and normal range and one that is indeed obvious. The applicant gives no working examples to support this and thus cannot even say what that amount of administration would be to bring about this range.
The applicant argues that one could not predict that BMOV could treat stress-induced hyperglycemia. Given the prior art one indeed could assume that BMOV could treat stress-induced hyperglycemia. Gho teaches it to treat stress-induced events from ischemia and for mimicking insulin which lowers blood sugar. McNeill teaches it to treat hyperglycemia and teaches administering the same effective amounts being shown in the instant examples. Given these two pieces of art the instant claims are obvious. Furthermore the applicant does not show any evidence of treating stress-induced hyperglycemia through administering BMOV.
Also McNeill teaches administering amounts which are the same amounts that the applicant has administered effective to bring about a decrease in NGAL and iNOS levels, because McNeill teaches administering BMOV at 15 mg/kg, which appears to be the effective amount being administered by the applicant (see figures 6 and 7).
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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