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 .
Claims 1-5, 7-9, 11-14, 16-18, 20, 21 are pending and under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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 1-5, 7-9, 11-14, 16-18, 20, 21 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.
Claims 1, 4, 8, 13, 17 recite the phrase “exhibiting stability” which renders the claim vague and indefinite since it unclear if the formulation has the property of stability or any other limitation after the phrase “exhibiting”. Dependent claims 2-5, 7-9, 11-14, 16-18, 20, 21 are also rejected because they do not correct the defect.
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 1-5, 7-9, 11-14, 16-18, 20, 21 are rejected under 35 U.S.C. 103 as being unpatentable over US20060034823 (02/16/2006; PTO 892) in view of SU150581 (11/30/1961; IDS filed 10/09/2024, see English language translation), Macht et al. ("Pharmacological interactions of cobra venom and thiamine," May 1942 (05 1942) Journal of the American Pharmaceutical Association, 31(5), 146-150; IDS filed 10/09/2024).
US20060034823 teaches a pharmaceutical composition including one of crotoxin, mojavetoxin or a related toxin and a carrier for use in the treatment of chronic pain where the crotoxin is preferably obtained from the snake Crotalus durissus terrificus and the mojavetoxin is obtained from the rattlesnake Crotalus scutulatus scutulatus; and the composition further comprises an effective amount of acetylsalicylic acid whereby the toxin and acetylsalicylic acid together produce a synergistic effect providing enhanced pain relief (see entire publication, abstract, and claims especially paragraphs [0001]-[0024] and claims 1-6). US20060034823 teaches a formulation of Crotoxin having stability comprising a saline solution, benzalkonium chloride (abstract, "Disclosed a pharmaceutical composition including one of crotoxin"; see paragraph [0041]-[0042], "The carrier solution chloride (0.9%) suitable for injection ... The preferred preservative is benzalkonium chloride"; para [0047], "sterile saline as the suspension buffer. Saline for irrigation or injection"). US20060034823 teaches the formulation comprising about 0.9 wt.% saline solution (see [0047], "0.9% sterile saline"). US20060034823 teaches the formulation comprising benzalkonium at a concentration of 0.001% chloride ( [0042], "benzalkonium chloride at a concentration of 0.001 %"). US20060034823 teaches in paragraph [0037]: "The solution needs to be diluted usually to between 500 and 2000 mcg/ml prior to filling and administration (1 mg/ml crotoxin approximates to 1.7 optical density units at A280 nm)"). US20060034823 teaches the following in the claims:
1. A pharmaceutical composition comprising a therapeutically effective amount of toxin from the group including crotoxin and mojavetoxin having corresponding biological activity and a pharmaceutically acceptable carrier for use in inhibiting or controlling pain.
2. The composition of claim 1 wherein the crotoxin is obtained from the snake Crotalus durissus terrificus and the mojavetoxin is obtained from the snake Crotalus scutulatus scutulatus.
3. The composition of claim 1 which further comprises a therapeutically effective amount of acetylsalicylic acid whereby the toxin and acetylsalicylic acid together produce a synergistic effect providing enhanced pain relief.
4. The composition of claim 1 for parenteral (intravenous, intramuscular or subcutaneous) administration delivering between 0.13 mcg.kg−1 of body weight per day up to a maximum of 40 mcg.kg−1 of body weight per day.
5. The composition of claim 1 for topical administration comprising substantially between 6 mcg and 1 mg of toxin per gram of base.
6. The composition of claim 5 in which the toxin is crotoxin at a concentration of 100-200 mcg per gram of base.
The teachings of the reference differ from the claims in that the reference does not teach the claimed formulation of Crotoxin comprising a saline solution, benzalkonium chloride and a pH of about 1.5 to about 4.5, wherein the formulation is acidified using HCl.
SU150581 teaches acidified formulation using HCI with pH of about 1.5 to about 4.5 (see entire publication and claims). SU150581 teaches the following in the claims:
1. A method of obtaining a therapeutic drug Vipratox from snake venom, characterized in that, in order to reduce the toxicity of the drug, glycerol, double distilled water, 0.1 N is added to it. hydrochloric acid and tricresol.
2. A method of obtaining a therapeutic preparation according to claim 1, characterized in that they take dry snake skin and 0.1 g, glycerol 100 bidistilled water, 4.9 liters, perform biological standardization by adding water to the mouse unit, add 0.1 n hydrochloric acid to pH 3, 5 and tricresol to 0.3 / 0 content in the final preparation, filtered through a Seitz filter, incubated for 72 hours and amplified by biological control.
Macht et al. teach combination of snake venom and thiamine where Macht et al. states on
pg 149 col 2 para 2: "It was found that suitable doses of vitamin B, given to mice for two or three days prior to their injection with cobra neurotoxin rendered them more resistant to the venom as their lowered mortality indicated. Much larger doses of thiamine, however, produced a hypervitaminotic condition which, though not apparent under ordinary conditions, was much enhanced and thus brought to light by administration of cobra venom". Macht et al. teach onf pg 149 col 2 para 4- pg 150 col 1 para 3: "Administration of suitable amounts of vitamin B1 to mice makes them more resistant to cobra neurotoxin while excessive doses of thiamine are toxic in this respect...Mice maintained on diets deficient in vitamin B1 are less resistant to cobra venom". See entire publication and abstract especially pg 149 col 2 para 2, p 149 col2 para 4-p 150 col 1 para 3.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by acidifying the composition of US20060034823 with HCl as taught by SU150581 and adding thiamine to the composition as taught by Macht et al. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to a obtain a stabilized composition comprising crotoxin having stability under refrigerated conditions as the recited in the claims that can be used for providing enhanced pain relief as taught by US20060034823. It would have been obvious to adjust the amounts of all recited components including concentration of Crotoxin as measured at A280nm absorbance, concentration of benzalkonium chloride, concentration of saline solution, and concentration of thiamine recited in the claims as routine optimization and/or as desired in view of the reference teachings. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because making stabilized compositions comprising Crotoxin are known in the art as shown by the reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
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 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 1-5, 7-9, 11-14, 16-18, 20, 21 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6, 10, 15, 19 of copending Application No. 18855454. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or specification of the copending application teach and/or suggest the claimed formulation of Crotoxin exhibiting stability comprising a saline solution, benzalkonium chloride and a pH of about 1.5 to about 4.5, wherein the formulation is acidified using HCl. Thus, the teachings anticipate the claimed invention.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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