DETAILED ACTION
Claims 1, 6-7, 9-11, 14, 16, 19-24 and 29-30 are currently pending and under examination.
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 .
Withdrawn Rejections
The prior rejection of claims 3, 20 and 22 under 112(b) are withdrawn based on Applicant’s to cancel claim 3 and correct the priority of pending claim 1.
The prior rejection of claims 3 and 8 under 112(d) is withdrawn based on Applicant canceling claims 3 and 8.
Examiner’s Note
Applicant's amendments and arguments filed 07/13/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 07/13/2026, it is noted that claims 1, 9, 22, 29 have been amended and claim 30 is newly added.
Modified Rejection:
The following rejection is modified based on Applicant’s claim amendment and newly added claims.
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, 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.
Claim(s) 1, 6-7, 9-10, 16, 19-20, 22-24 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0072647 (Applicant provided 01/13/2023) in view WO 01/45716 (Applicant provided 01/13/2023) and US 2015/0150836 (Applicant provided 01/13/2023).
Regarding claims 1 and 29-30, the limitation of a method for the prevention or reduction of stress-induced metabolic derangement in a patient subjected to stress, the method comprising administering to the patient a pharmaceutical composition comprising a physiologically acceptable organic and/or inorganic vanadium compound or complex and further comprising a pharmaceutically acceptable excipient is met by the ‘647 publication teaching a method for maintaining normoglycemia in a mammal in need thereof, preferably a critically ill patient suffering from acute stress (abstract). A high portion of patients suffering from acute stress develop hyperglycemia [0002]. Thus use of vanadium compounds in controlling hyperglycemia in diabetic patients is known in the art [0013]. The composition is taught to comprise a physiologically acceptable organic and/or inorganic vanadium compound or complex administered to said mammal ([0016], [0034]) a pharmaceutically acceptable carrier [0050]. Maintaining normoglycemia would read on preventing or reduction in hyperglycemia, a type of metabolic derangement per instant claim 5.
The limitation of wherein the metabolic derangement comprises hyperglycemia is met by the ‘647 publication teaching maintaining normoglycermia (abstract). Maintaining normoglycemia would read on preventing or reduction in hyperglycemia, the elected metabolic derangement.
Regarding claim 6, the limitation of wherein the physiologically acceptable organic and/or inorganic vanadium compound or complex is bis(maltolato)oxidovandium (BMOV) is met by the ‘647 publication teaching BMOV (claim 45).
Regarding claim 7, the limitation of wherein BMOV is the sole active pharmaceutical ingredient is met by the ‘647 publication teaches BMOV being the only tested active ingredient in the composition [0067].
Regarding claim 9, the limitation of wherein the stress is trauma is met by the ‘647 publication teaching the stress is acute stress caused by trauma [0042].
Regarding claim 10, the limitation of wherein the composition is administered intravenously is met by the ‘647 publication teaching intravenously administration [0055].
Regarding claim 16, the limitation of wherein a dose of pharmaceutical composition comprises between 0.01 mg and 30 mg of vanadium compound per kg body weight of the patient is met by the ‘647 publication teaches 7 mg /kg and 15 mg/kg [0067].
Regarding claim 20, the limitation of wherein the pharmaceutical composition is provided as an aqueous solution and wherein the dose of the pharmaceutical composition comprises between about 0.01 mg and 30 mg of vanadium compound or complex per body weight of the patient is met by the ‘647 publication teaching 7 mg /kg and 15 mg/kg [0067] and the ‘372 publication teaching phosphate buffered saline [0046].
Regarding claim 22, the limitation of wherein the stress to which the patient is subjected to is trauma is met by the ‘647 publication teaching acute stress caused by trauma (claim 34).
Regarding claims 23-24, the limitations of the increase in glucose content in the blood of a patient during specific time period compared to a time point before the patient is subjected to stress is an inherent feature in the ‘647 publication as the ‘647 publication teaches the method of administered the claimed composition to the patient subjected to stress, thus the compositions, active step and patient population are taught and therefore must result in the claimed glucose content. In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functional that are newly cited or is identical to a product instant claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristics relied on" (205 USPQ 594, second column, first full paragraph).
The ‘647 publication does not specifically teach administration to a patient before the patient is subjected to stress (claims 1 and 29), the first dose between 72 and 12 h before stress and the second dose 5 h and 2h before patent is subjected to stress (claim 30).
The ‘647 publication does not specifically teach wherein at least two doses (claim 1, 29) of the composition is administered to the patient wherein the first single dose is administered between 96 h and 10 h before the patient is subjected to stress and a second single dose is administered between 8 h and 0 h before the patient is subjected to stress (claim 1 and 29), first dose between 96 h and 10 h, second dose between 8 and 2h and third does administered when the patient is subjected to stress (claim 19).
The ‘716 publication teaches a pharmaceutical composition for the prophylactic treatment of secondary injury of tissue, said secondary injury being induced by primary injury of mainly surrounding tissue and being the result of traumatic event. The composition includes vanadium compound administered in a single dose and preferably before or immediately or shortly after the traumatic event (abstract). The vanadium compound is taught to be preferably bis(maltolato)oxovandium (IV) (page 9, lines 20-25). The ‘716 publication teaches the administration time to be preferably before or immediately or shortly after the traumatic even (abstract) wherein the administration may be at a suitable moment prior to said operation (page 7, lines 10-15), reading on claim 1 and 3. The administration time is taught to be done prior to surgery at a suitable moment and thus teaches a result effective variable and range.
The ‘836 publication teaches dysregulated blood glucose disorder such as transient hyper glycemia that is caused by trauma [0044]. The active agent may be administered intravenously [0057]. The amount of active agent is taught to be vary with the route of administration, nature of the condition being treated and the age and condition of the patient and will ultimately be at the discretion of the attendant physical or clinician [0068]. The suitable dose is generally 10 to 75 mg/kg [0069]. The desired dose may conveniently be presented in a single dose or as a divided doses administered at appropriate interval for example as two, three, four or more sub doses per day [0071].
That being said and in lieu of objective evidence of unexpected results, the administration time can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to administer the composition comprising BMOV prior to trauma such as surgery as the ‘647 publication teaches the administration of BMOV to maintain normoglycermia in response to trauma such as surgery and the ‘716 publication teaches administering BMOV compositions prior to a traumatic event. Thus one of ordinary skill in the art before the filing date of the claimed invention would be motivated and have an expectation of success in administering a BMOV composition prior to a traumatic even such as surgery based on the teachings of the ‘647 publication and the ‘716 publication. The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983) (see MPEP 2144 (II)).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention that multiple doses within a 24 hour period prior to trauma may be used to treat hyperglycemia using the formulation of the ’647 publication because the ‘836 publication teaches that doses of active agent to treat hyperglycemia may be split into two or more doses and administered in 24 hours. One of ordinary skill in the art would have a prima facie obvious expectation of success as the ‘647 publication teaches intravenous administration before stress is applied and the ‘836 publication teaches it is known to split treatment into multiple doses and further teaches that the administration of the active agent is an optimizable parameter determined by the attendant physical or clinician.
That being said and in lieu of objective evidence of unexpected results, the dosage timing can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
Claims 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0072647, WO 01/45716 and US 2015/0150836 as applied to claims 1, 6-7, 9-10, 16, 19-20, 22-24 and 29-30 and in further view of US 6,232,340 (previously applied).
As mentioned in the above 102(a)(1) rejection, all the limitations of claims 1, 6-7, 9-10, 16, 19-20, 22-24 and 29 are taught by the ‘647 publication, the ‘716 publication and the ‘836 patent.
The ‘716 publication teaches administration being oral (page 7, lines 1-10).
The combination of references does not specifically teach wherein the pharmaceutical composition is provided as a capsule, a tablet, a pill or water-soluble powder for oral administration (claim 14).
The ‘340 patent teaches vanadium complexes are provided and may be formulated into a pharmaceutical composition. The complexes or compositions may be used in the treatment of a variety of disease states including treatment of diabetes (abstract). Administration may be parenteral, intravenous or may take the form of tablet being a single dosage or multiple dosage units (column 8, lines 34-50). Solid dosage form in the form of a pressed tablet is taught (column 9, lines 1-30).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the vanadium compound in the form of a tablet as the ‘716 publication teaches the use of vanadium compounds to be administered orally and the ‘340 patent specifically teaches and oral form to be a tablet. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘340 publication teaches multiple administration forms are known to be used for vanadium compounds including intravenous and oral forms such as tablets and the ‘647 publication teaches intravenous dosing, thus teaching it would be obvious to use known forms of administration interchangeable for the process of the ‘647 publication and the ‘716 publication to administer a vanadium compound including intravenously and orally.
Claims 11 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0072647, WO 01/45716 and US 2015/0150836 as applied to claims 1, 6-7, 9-10, 16, 19-20, 22-24 and 29-30 and in further view of US 6,268,357 (Applicant provided 01/13/2023) and US 2009/0317372 (Applicant provided 01/13/2023).
As mentioned in the above 102(a)(1) rejection, all the limitations of claims 1, 6-7, 9-10, 16, 19-20, 22-24 and 29-30 are taught by the ‘647 publication, the ‘716 publication and the ‘836 patent.
Regarding claim 21, the limitation of the composition comprises between about 0.01 mg and 30 mg per kg body weight of a patient, wherein administering a dose of the pharmaceutical composition provides for a plasma exposure level of between 25 ng/ml and 2500 ng/ml elemental vanadium is met the ‘647 publication teaches 7 mg /kg and 15 mg/kg [0067] which is administered intravenously to a subject in need thereof (abstract, [0055]). The ‘647 publication teaches the claimed composition being administered at the claimed concentration by the claimed method, intravenous, and thus would result in the plasma exposure level claimed absent factual evidence to the contrary.
The ‘647 publication does not specifically teach the composition is an aqueous solution (claim 11)
The ‘357 patent teaches organic vanadium complex used to treat elevated blood glucose and related disorders (abstract). The dosage of therapeutic formulation will vary widely depending upon the nature of the disease and frequency of administration, the manner of administration (column 5, lines 1-12). Carriers are taught to be prepared as liquids (column 5, lines 15-25) and may be prepared as aqueous injections (column 5, lines 49-55). BMOV is taught to be administered in saline (column 14, lines 5-20).
The ‘372 publication teaches compounds for treatment of hyperglycemia (abstract). The compositions may be applied via intravenous delivery routes. The injectable solution may be prepared by dissolving or dispersing a suitable preparation of the compound in water or water based carrier such as phosphate buffered saline [0046].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use phosphate buffered saline for the pharmaceutically acceptable carrier taught by the ‘647 publication because the ‘357 publication teaches it is known to use saline with BMOV and the ‘372 publication teaches specifically phosphate buffered saline is a form of saline known to be used for compounds treating hypertension. One of ordinary skill in the art before the filing date of the claimed invention would have an expectation of success in using phosphate buffered saline because the ‘647 publication does not limit the carrier used and the composition is administered intravenously and the ‘372 publication teaches the use of phosphate buffered saline for intravenous administration. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘647 publication teaches administering BMOV and the ‘357 publication teaches saline is known to be used with BMOV.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
Double Patenting
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 7 and 29 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,449,204 in view of WO 01/45716 and US 2015/0150836. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘204 patent are directed to maintaining normoglycemia or preventing hyperglycemia in a patient exposed to trauma by administering BMOV as the sole active ingredient. The ‘204 patent does not specifically teach administration to the patient before the patient is subjected to trauma wherein the at least two doses of the pharmaceutical composition is administered to the patient before the patient is subjected to the stress. The ‘716 publication teaches a pharmaceutical composition for the prophylactic treatment of secondary injury of tissue, said secondary injury being induced by primary injury of mainly surrounding tissue and being the result of traumatic event. The composition include vanadium compound administered in a single dose and preferably before or immediately or shortly after the traumatic event (abstract). The vanadium compound is taught to be preferably bis(maltolato)oxovandium (IV) (page 9, lines 20-25). The ‘716 publication teaches the administration time to be preferably before or immediately or shortly after the traumatic even (abstract) wherein the administration may be at a suitable moment prior to said operation (page 7, lines 10-15), reading on claim 1 and 3. The administration time is taught to be done prior to surgery at a suitable moment and thus teaches a result effective variable and range. The ‘836 publication teaches dysregulated blood glucose disorder such as transient hyper glycemia that is caused by trauma [0044]. The active agent may be administered intravenously [0057]. The amount of active agent is taught to be vary with the route of administration, nature of the condition being treated and the age and condition of the patient and will ultimately be at the discretion of the attendant physical or clinician [0068]. The suitable dose is general be 10 to 75 mg/kg [0069]. The desired dose may be conveniently be presented in a single dose or as a divided doses administered at appropriate interval for example as two, three, four or more sub doses per day [0071].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to administer the composition comprising BMOV prior to trauma such as surgery as the ‘204 patent teaches the administration of BMOV to maintain normoglycermia in response to trauma such as surgery and the ‘716 publication teaches administering BMOV compositions prior to a traumatic event. It would have been prima obvious to one of ordinary skill before the effective filing date of the claimed invention to administer at least two doses prior to stress as the ‘836 publication teaches that doses of active agent to treat hyperglycemia may be split into two or more doses and administered in 24 hours and it is known to split treatment into multiple doses and further teaches that the administration of the active agent is an optimizable parameter determined by the attendant physical or clinician.
Claims 1 and 7 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US patent 11,179,401 in view of WO 01/45716 and US 2015/0150836. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘401 patent are directed to maintaining normoglycemia or preventing hyperglycemia in a patient exposed to trauma by administering BMOV as the sole active ingredient intravenously. The ‘401 patent does not specifically teach administration to the patient before the patient is subjected to trauma, wherein at least two doses of the pharmaceutical composition is administered to the patient before the patient is subjected to the stress. The ‘716 publication teaches a pharmaceutical composition for the prophylactic treatment of secondary injury of tissue, said secondary injury being induced by primary injury of mainly surrounding tissue and being the result of traumatic event. The composition include vanadium compound administered in a single dose and preferably before or immediately or shortly after the traumatic event (abstract). The vanadium compound is taught to be preferably bis(maltolato)oxovandium (IV) (page 9, lines 20-25). The ‘716 publication teaches the administration time to be preferably before or immediately or shortly after the traumatic even (abstract) wherein the administration may be at a suitable moment prior to said operation (page 7, lines 10-15), reading on claim 1 and 3. The administration time is taught to be done prior to surgery at a suitable moment and thus teaches a result effective variable and range. The ‘836 publication teaches dysregulated blood glucose disorder such as transient hyper glycemia that is caused by trauma [0044]. The active agent may be administered intravenously [0057]. The amount of active agent is taught to be vary with the route of administration, nature of the condition being treated and the age and condition of the patient and will ultimately be at the discretion of the attendant physical or clinician [0068]. The suitable dose is general be 10 to 75 mg/kg [0069]. The desired dose may be conveniently be presented in a single dose or as a divided doses administered at appropriate interval for example as two, three, four or more sub doses per day [0071].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to administer the composition comprising BMOV prior to trauma such as surgery as the ‘401 patent teaches the administration of BMOV to maintain normoglycermia in response to trauma such as surgery and the ‘716 publication teaches administering BMOV compositions prior to a traumatic event. It would have been prima obvious to one of ordinary skill before the effective filing date of the claimed invention to administer at least two doses prior to stress as the ‘836 publication teaches that doses of active agent to treat hyperglycemia may be split into two or more doses and administered in 24 hours and it is known to split treatment into multiple doses and further teaches that the administration of the active agent is an optimizable parameter determined by the attendant physical or clinician.
Claims 1, 6-7, 9-10 and 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9 of copending Application No. 17/508,481 (reference application) in view of WO 01/45716 and US 2015/0150836. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘481 publication are directed to maintaining normoglycemia or preventing hyperglycemia in a patient exposed to trauma by administering BMOV as the sole active ingredient intravenously. The ‘481 publication does not specifically teach administration to the patient before the patient is subjected to trauma. The ‘716 publication teaches a pharmaceutical composition for the prophylactic treatment of secondary injury of tissue, said secondary injury being induced by primary injury of mainly surrounding tissue and being the result of traumatic event. The composition include vanadium compound administered in a single dose and preferably before or immediately or shortly after the traumatic event (abstract). The vanadium compound is taught to be preferably bis(maltolato)oxovandium (IV) (page 9, lines 20-25). The ‘716 publication teaches the administration time to be preferably before or immediately or shortly after the traumatic even (abstract) wherein the administration may be at a suitable moment prior to said operation (page 7, lines 10-15), reading on claim 1 and 3. The administration time is taught to be done prior to surgery at a suitable moment and thus teaches a result effective variable and range. The ‘836 publication teaches dysregulated blood glucose disorder such as transient hyper glycemia that is caused by trauma [0044]. The active agent may be administered intravenously [0057]. The amount of active agent is taught to be vary with the route of administration, nature of the condition being treated and the age and condition of the patient and will ultimately be at the discretion of the attendant physical or clinician [0068]. The suitable dose is general be 10 to 75 mg/kg [0069]. The desired dose may be conveniently be presented in a single dose or as a divided doses administered at appropriate interval for example as two, three, four or more sub doses per day [0071].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to administer the composition comprising BMOV prior to trauma such as surgery as the ‘481 publication teaches the administration of BMOV to maintain normoglycermia in response to trauma such as surgery and the ‘716 publication teaches administering BMOV compositions prior to a traumatic event. It would have been prima obvious to one of ordinary skill before the effective filing date of the claimed invention to administer at least two doses prior to stress as the ‘836 publication teaches that doses of active agent to treat hyperglycemia may be split into two or more doses and administered in 24 hours and it is known to split treatment into multiple doses and further teaches that the administration of the active agent is an optimizable parameter determined by the attendant physical or clinician.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: the ‘647 publication, the ‘716 publication and the ‘836 publication
Applicant argues the specification demonstrates unexpected results that rebut any prima facie case of obviousness. Applicant points to Example 2 of the specification, subjects receiving two doses of BMOV at 16-24 h and 3 h before adrenaline-induced stress experience only about 28% increase in blood glucose compared to approximately 260% increase in untreated subjects. This dramatic reduction in stress induced hyperglycemia demonstrates that the claimed two-dose pre-stress timing regimen is critical to achieve the therapeutic effect and not merely routine optimization. Applicant argues the data directly tests the key distinguishing feature of the claims, the two dose pre-stress timing regimen which is the very feature that distinguishes claims form the prior art. This critical variable is not merely the total amount of active administered by rather the timing of administration before stress. The ‘647 publication did not achieve the same prophylactic effect as the claimed pre-treatment regimen. The specification data demonstrates that administering vanadium compounds at specific time points before stress, rather than during or after stress as taught by the prior art, produces unexpectedly superior results in preventing stress induced hyperglycemia.
In response, regarding the unexpected results, the data presented is not commensurate in scope with the instant claims. The data provided is the testing of a specific vanadium compound (BMOV) intravenously administered in a specific concentration at a specific time point to reduce hyperglycemia. The instant claims are more broadly directed to reduction of metabolic derangement through administration prior to the patient is subjected the stress. The instant claims are not specific for method of administration, the compound, the concentration, nor the time period which is broadly claimed and tested only a single specific two dose time period. Thus the instant claims are much broader then the provided data.
Further, the data demonstrates administering BMOV 2x results in a greater reduction in blood glucose when subjected to stress. The ‘647 publication demonstrates BMOV is known to be used to maintain normoglycemia when subjected to acute stress (abstract claim 45), wherein a broad concentration range is taught to be used. It is not considered unexpected to administer 2x the amount of active agent and obtain a greater response, i.e. reduction in glucose rise in response to trauma. The data presented does not indicate if the addition amount of drug used results in the higher response, which would be taught by the ‘647 publication concentration range, or if it a result of the specific time period of administration. Thus the presented data is not considered persuasive.
Applicant argues the ‘647 publication does not teach or suggest the claimed two dose pre-stress timing regimen and is directed to maintaining normoglycemia in a mammal in need thereof. The treatment of patient who are already suffering from acute stress and experiencing hyperglycemia, not prophylactic pre-treatment administered hours to days before the stress occurs. The ‘716 publication does not remedy the deficiencies as it teaches administration as a single dose before or immediately or shortly after the traumatic event which provides no specific time window. The ‘836 publication is directed to a different class of compounds from vanadium compounds recited in the claims.
In response, It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to administer the composition comprising BMOV prior to trauma such as surgery as the ‘647 publication teaches the administration of BMOV to maintain normoglycermia in response to trauma such as surgery and the ‘716 publication teaches administering BMOV compositions prior to a traumatic event. Thus one of ordinary skill in the art before the filing date of the claimed invention would be motivated and have an expectation of success in administering a BMOV composition prior to a traumatic event such as surgery based on the teachings of the ‘647 publication and the ‘716 publication. The ‘716 publication teaches bis(maltolato)oxovandium being administered before traumatic event wherein the administration may be suitable moment prior to said operation (abstract, page 7, lines 10-15). The administration time is taught to be done prior to surgery at a suitable moment and thus teaches a result effective variable and range. The ‘836 publication teaches treatment of hyper glycemia that is caused by trauma [0044] which is administered in a single dose or as dived doses administered at appropriate interval for example as two, three, four or more sub doses per day [0071]. One of ordinary skill in the art would have a prima facie obvious expectation of success as the ‘647 publication teaches intravenous administration before stress is applied and the ‘836 publication teaches it is known to split treatment into multiple doses and further teaches that the administration of the active agent is an optimizable parameter determined by the attendant physical or clinician.
Applicant argues new claim 30 contains narrow windows fall entirely within and Furter specify the timing regimen of claim 1. Applicant argues none of the prior art discusses two dose time frame and the ‘836 publication is directed to an entirely different active agent. The Examiner’s characterization of the claimed timing regimen as routine optimization is not supported by the prior art, which provides no starting point or direction arriving at the specific timing windows recited int eh claimed. This is reinforced by the unexpected results.
In response, Applicant is referred to the unexpected results discussion above. Further It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention that multiple doses within a 24 hour period prior to trauma may be used to treat hyperglycemia using the formulation of the ’647 publication because the ‘836 publication teaches that doses of active agent to treat hyperglycemia may be split into two or more doses and administered in 24 hours. One of ordinary skill in the art would have a prima facie obvious expectation of success as the ‘647 publication teaches intravenous administration before stress is applied and the ‘836 publication teaches it is known to split treatment into multiple doses and further teaches that the administration of the active agent is an optimizable parameter determined by the attendant physical or clinician. Thus the ‘647 publication and the ‘836 publication are directed to maintaining normoglycemia in response to trauma.
Applicant has presented no double patenting rejection arguments and thus the rejection are maintained for reasons of record.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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