DETAILED ACTION
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 .
Status of the Claims
Claims 1-14 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-4 and 7 are anticipated by Brenner.
Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brenner (Brenner, M., et al.; Journal of Biomedical Optics, v15, article 017001; 2010)1.
Claim 1 is drawn to a method of synthesis, the method comprising the following steps and anticipated or wished-for results:
contacting a hydroxo-cobalamin and a hydrolyzing agent, comprising a metal hydroxide, to form a mixture, the mixture comprising an aquohydroxo-cobinamide; and
separating the aquohydroxo-cobinamide from the mixture to obtain a purified aquohydroxo-cobinamide;
wherein the following results are anticipated or wished-for:
the aquohydroxo-cobinamide is formed in a yield of at least about 20%;
the purified aquohydroxo-cobinamide is at least 80% pure by weight.
The yield and purity results do not further limit the steps of the claimed method and are considered as not further limiting of the claimed method. Brenner teaches a study in the comparative efficacy of cobinamide and hydroxocobalamin in reversing cyanide physiologic effects in rabbits (Abstract), and Brenner teaches a synthetic protocol to prepare cobinamide that includes all the steps of instant claim 1: “Cobinamide was prepared from hydroxocobalamin by base hydrolysis at pH 9.5 using cerium hydroxide. The cobinamide product was separated from unreacted hydroxocobalamin on a weak cation exchange column eluted with a NaCl gradient. It was desalted on a C18 reverse-phase resin column, concentrated on a rotary evaporator, and lyophilized to a solid state. At neutral pH, cobinamide exists as aquohydroxocobinamide, which is referred to as ‘cobinamide’ throughout the text” (page 3, left column, section 2.3). Brenner does not disclose the yield or purity of the cobinamide therein obtained; however, given that the method taught by Brenner includes all the steps of instant claim 1, the teaching of Brenner is considered anticipatory. If Applicant disagrees, Applicant is required to show proof of any disqualifying distinction. Applicant is referred to MPEP 2112.01:
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). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not."
Thus, claim 1 is anticipated by the teaching of Brenner.
Claim 2 further limits claim 1 to wherein the metal hydroxide is cerium hydroxide. As discussed above, Brenner teaches cerium hydroxide as the hydrolyzing agent (page 3, left column, section 2.3).
Claim 3 further limits claim 1 to wherein the purified aquohydroxo-cobinamide has a purity of at least about 95% by weight. As discussed above, limitations of the expected or wished-for results of the method are considered to be not further limiting of the method as they do not structurally alter the method. Thus, claim 3 is met by the teaching of Brenner.
Claim 4 further limits claim 1 to wherein an additional limitation or combination of limitations is selected from a Markush group that includes the contacting of the hydroxo-cobalamin and hydrolyzing agent in an aqueous liquid (page 3, left column, section 2.3). As discussed above, Brenner teaches the hydrolysis in a pH 9.5 solution, which a person of ordinary skill in the art would at once recognize as an aqueous solution since pH is a function of an aqueous solution.
Claim 7 further limits claim 1 to wherein the method further includes lyophilizing the purified aquohydroxo-cobinamide. As discussed above, Brenner teaches lyophilizing the purified aquohydroxo-cobinamide (page 3, left column, section 2.3).
Thus, claims 2-4 and 7 are anticipated by the teaching of Brenner.
Claims 10-14 are anticipated by Hendry-Hofer.
Claims 10-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hendry-Hofer (Hendry-Hofer, T. B., et al.; Annals of the New York Academy of Sciences, v1479, pp159-167; 2020).
Claim 10 is drawn to a pharmaceutical composition, comprising a cobinamide compound, wherein the cobinamide compound is formulated for intramuscular injection. Hendry-Hofer teaches a study of a clinical trial of the treatment for exposure to hydrogen sulfide in swine, wherein the swine were treated by intramuscular administration of aminotetrazole cobinamide, wherein the dose was administered in a 2.9 mL volume at a strength of 18 mg/kg (Abstract, page 159). Hendry-Hofer also teaches that the control group in the study consisted of animals that received no treatment, because it “seemed unlikely that an injection of 2 mL of saline would have an effect, and it did not seem reasonable to do that since it would not happen in humans”, which a person of ordinary skill in the art would at once recognize as indicating that saline, a well-known pharmaceutical excipient is the carrier/excipient for the dose administration in the study, and therefore that the cobinamide agent was administered as a solution in saline.
Thus, claim 10 is anticipated by the teaching of Hendry-Hofer.
Claim 11 further limits claim 10 to wherein the cobinamide compound is selected from a Markush group that includes amino-tetrazole-cobinamide and di-(amino-tetrazole)-cobinamide. Hendry-Hofer does not indicate how many aminotetrazole groups are present in the “aminotetrazole cobinamide” compound of the reported study; however, a person of ordinary skill in the art would at once recognize that an aminotetrazole cobinamide would have either one or two aminotetrazole compounds, because the coordination geometry of cobinamide is an inherent aspect of the compound, was known in the art, including in the context of cobinamide bearing tetrazole ligand(s), as evidenced by Fedosov (Fedosov, S. N., et al.; Journal of Organometallic Chemistry, v692, pp1234-1242; 2007). Fedosov teaches a study in the binding of tetrazole compounds and/or tetrazole-bearing materials to cobalamin and cobinamide (Abstract, page 1234). Fedosov illustrates the coordination geometry of cobinamide binding tetrazole ligands in Fedosov’s Figure 1d, shown below, wherein cobinamide is shown as a planar-four coordinate cobalt complex capable of accepting tetrazole ligands at one or both axial positions (page 1235):
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Thus, claim 11 is anticipated by the teaching of Hendry-Hofer.
Claim 12 further limits claim 10 to a method of treatment comprising administering the pharmaceutical composition of a cobinamide compound to a patient, wherein the patient has been exposed to a Markush group of chemical agents that includes sulfide. As discussed above, Hendry-Hofer teaches the treatment of swine that are exposed to hydrogen sulfide (Abstract).
Claim 13 further limits claim 12 to wherein the cobinamide compound is administered at a dose within the range of 1-600 mg/kg. As discussed above, Hendry-Hofer administers aminotetrazole cobinamide at a dose of 18 mg/kg (Abstract).
Claim 14 further limits claim 12 to wherein the cobinamide compound is administered intramuscularly. As discussed above, Hendry-Hofer administers the aminotetrazole cobinamide intramuscularly.
Thus, claims 12-14 are anticipated by the teaching of Hendry-Hofer.
Claims 10 and 12-14 are anticipated by Boss.
Claims 10 and 12-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Boss (U.S. Patent No. 9,534,007 B2).
The limitations of claims 10 and 12-14 are discussed in the rejection above and hereby incorporated into the instant rejection.
Boss discloses a composition and method for treating excess cyanide and hydrogen sulfide comprising administering a cobinamide (Abstract). Boss further discloses that cobinamide bound to nitrite ligands is absorbed more readily than hydroxoaquocobinamide, and that a composition comprising dinitrocobinamide with excess nitrite is absorbed more readily after intramuscular injection (Cols. 6-7, bridging paragraph), and Boss further discloses pharmaceutical compositions comprising the cobinamide compounds disclosed therein, including for various routes of administration, including intramuscular injection (Col. 22, lines 42-67).
Thus, claim 10 is anticipated by the disclosure of Boss.
Regarding the method of claim 12 of treating a patient exposed to a Markush group of chemical agents, including cyanide, Boss provides a method for treating a disease state in a subject caused or exacerbated by the presence of excess cyanide in the subject comprising administering a therapeutically effective amount of the compound of formula I (Col. 2, lines 6-11), wherein Formula I is dinitrocobinamide, as shown by Boss (Col. 1, lines 50-67) and shown here below:
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(Formula I).
Regarding claims 13-14, Boss discloses that the method of treating a disease state in a subject caused or exacerbated by the presence of excess cyanide comprising administering said compound of Formula I (shown above) in a therapeutically effective amount includes administering the compound intravenously or intramuscularly, and in a dose between 2 mg/kg and 25 mg/kg, between 2 mg/kg and 17 mg/kg, between 2 mg/kg and 15 mg/kg or between 15 mg/kg and 17 mg/kg (Col. 2, lines 6-16), and as discussed above, Boss discloses that the compound is absorbed more rapidly by intramuscular injection.
Thus, claims 12-14 are anticipated by the disclosure of Boss.
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.
Claims 1-7 and 9 are unpatentable over Brenner in view of Ishida and Li.
Claims 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Brenner (Brenner, M., et al.; Journal of Biomedical Optics, v15, article 017001; 2010)2 in view of Ishida (Ishida, A., et al.; Journal of Nutritional Science and Vitaminology, v39, pp115-125; 1993) and Li (Li, Z., et al.; Journal of Biological Chemistry, v293, pp9733-9744; 2017).
The limitations of claims 1-4 and 7 and the teaching of Brenner are discussed in the rejection above and hereby incorporated into the instant rejection.
Claim 5 further limits the cobinamide preparation method of claim 1 to wherein the separating of the aquohydroxo-cobinamide from the mixture comprises centrifuging the mixture to produce a supernatant, wherein the supernatant includes an amount of the hydrolyzing agent that is less than an amount of the hydrolyzing agent in the mixture. Regarding the claim limitation that the amount of cerium hydroxide separated from the mixture is less than the amount of cerium hydroxide in the mixture, this limitation is understood as an expected or wished-for result of the step to be performed, and is thus not further limiting. Brenner teaches the purification of aquohydroxo-cobinamide over a cation exchange column, but does not teach the separation of cerium hydroxide from the crude reaction mixture. However, a person of ordinary skill in the art would have a reasonable expectation of success in modifying the protocol of Brenner to include a centrifugation step to separate cerium hydroxide from the crude reaction mixture, because it was known in the art that cerium hydroxide has poor solubility in aqueous media and solid cerium hydroxide can be physically separated from a post-hydrolysis reaction mixture including a cobinamide product, including wherein the product is aquohydroxo-cobinamide, per the teachings of Ishida and Li.
Ishida teaches a study in the coordination geometry and catalytic activity of adenosylcobalamin analogs (Abstract). Ishida teaches the structural and activity comparison of the corrinoid core bearing various iterations of the complete or incomplete structure of cobalamin and/or cobinamide, including intact or separated nucleotide loop fragment(s), as shown in Ishida’s Figure 1, shown below (page 117, bottom):
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Ishida teaches the hydrolysis of cyano-cobalamin in aqueous solution to cleave and isolate the ribazole loop fragment “a-ribazole” using cerium hydroxide as the hydrolyzing agent, and teaches that “After removal of cerous hydroxide by filtration, the filtrate was diluted fivefold with water and applied to a Dowex 50 (H+) column” (page 120, third paragraph). Ishida also teaches the hydrolysis of cyanocobalamin using cerium hydroxide (“cerous hydroxide”) to prepare cyano-aquo-cobinamide, and follows by filtration of the crude reaction mixture (page 118, top paragraph). Thus, a person of ordinary skill in the art would understand from the teaching of Ishida that cerium hydroxide has poor solubility in water and can be at least partially separated from the crude reaction mixture by physical separation.
Li teaches a study in the coordination chemistry and catalytic activity of a of Cobalamin C, or “CblC” (Abstract), and as part of the methods in the study, Li teaches the preparation of chloro-diaquo-cobinamide (OH2Cbi·Cl), very similar to the preparation of aquo-hydroxocobinamide by Brenner, wherein cobalamin is hydrolyzed with cerium hydroxide in alkaline aqueous solution, and upon completion of the reaction, the crude mixture is centrifuged, and the supernatant is separated and desalted over a reverse phase column and further purified by additional chromatographies including with a saline eluent until being lyophilized to obtain solid OH2Cbi·Cl product (page 9740, lower half, section “Synthesis of OH2Cbi”). A person of ordinary skill in the art would recognize that the initial product of the process would be the same as for Brenner, with the substitution of hydroxo- for chloro- ligand occurring in the saline-eluted chromatography step. Thus, Li shows that centrifugation is an effective method to separate undissolved solids from the reaction mixture of the hydrolysis of cobalamin to produce aquo-hydroxo-cobinamide.
Applicant’s invention is unpatentable over the teaching of Brenner in view of the teachings of Ishida and Li, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in modifying the protocol of Brenner to include a centrifugation step to separate cerium hydroxide from the crude reaction mixture, because it was known in the art that cerium hydroxide has poor solubility in aqueous media and solid cerium hydroxide can be physically separated from a post-hydrolysis reaction mixture including a cobinamide product, per the teaching of Ishida, and it was known in the art that centrifugation can be included as a step to remove insoluble reaction products from the hydrolysis of cobalamin with cerium hydroxide, the same reaction taught by Brenner, per the teaching of Li.
Thus, the invention was prima facie obvious at the time of filing.
Claim 6 further limits claim 5 to wherein the purification of aquohydroxo-cobinamide includes successive reverse-phase chromatography passages. Brenner teaches a single passage over a C18 reverse-phase resin column to “desalt” the product (page 3, left column, section 2.3). However, a person of ordinary skill in the art would have a reasonable expectation of success in modifying the procedure of Brenner to include a second purification over a reverse phase column, because it was known in the art that an aquo-cobinamide compound could be further purified by such a procedure, because Li teaches the initial purification and lyophilization of diaquo-chloro-cobinamide using an RP-18 column, and then proceeds to teach that “Further purification was achieved by preparative HPLC on an RP-18 column”. Thus Li shows that repetitive chromatographic purification over reverse phase column has no detrimental effect, and indeed may further purify the cobinamide product of cobalamin hydrolysis by cerium hydroxide.
Applicant’s invention is unpatentable over the teaching of Brenner in view of the teachings of Ishida and Li, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in further modifying the protocol of Brenner to include serial reverse phase chromatography in the purification of the cobinamide product, because it was known in the art serial reverse phase chromatography can yield a further purified cobinamide product, per the teaching of Li.
Thus, the invention was prima facie obvious at the time of filing.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 10, 12 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14-16, 18-22, 24-28 and 30 of U.S. Patent No. 8,431,561 B2 (hereafter referred to as “Sharma”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Sharma anticipate the instant claims.
The limitations of instant claims 10, 12 and 14 are discussed in the rejections above and hereby incorporated into the instant rejection.
Sharma’s claims 1, 6 and 11 each describe a method that comprises administering an effective amount of cobinamide to a patient/subject who is (respectively):
in need of the delaying or inhibiting of a disease state cause or exacerbated by the presence of excess cyanide in the subject; or
in need of alleviating the symptoms of a disease state caused or exacerbated by the presence of excess cyanide in the subject; or
in need of delaying or inhibiting cyanide toxicity in the subject.
Sharma’s claims 2-5 and 14 further limit claim 1 with respect to causes of the need for treatment. Sharma’s claims 15 and 18 further limit claim 1 to wherein the cobinamide is administered with a pharmaceutically acceptable carrier or excipient, respectively, and while only claim 15 refers to a “pharmaceutical composition”, a person of ordinary skill in the art would at once recognize that including a pharmaceutically acceptable excipient (in claim 18) would also render a pharmaceutical composition comprising the cobinamide. Sharma’s claims 16 further limits claim 1 to wherein the cobinamide is injected intramuscularly.
Sharma’s claims 7-9 and 20 further limit claim 6 with respect to causes of the need for treatment. Sharma’s claims 21 and 24 further limit claim 6 to wherein the cobinamide is administered with a pharmaceutically acceptable carrier or excipient, respectively, and while only claim 21 refers to a “pharmaceutical composition”, a person of ordinary skill in the art would at once recognize that including a pharmaceutically acceptable excipient (in claim 24) would also render a pharmaceutical composition comprising the cobinamide. Sharma’s claim 22 further limits claim 6 to wherein the cobinamide is injected intramuscularly.
Sharma’s claim 26 further limits claim 11 with respect to causes of the need for treatment. Sharma’s claims 27 and 30 further limit claim 11 to wherein the cobinamide is administered with a pharmaceutically acceptable carrier or excipient, respectively, and while only claim 27 refers to a “pharmaceutical composition”, a person of ordinary skill in the art would at once recognize that including a pharmaceutically acceptable excipient (in claim 30) would also render a pharmaceutical composition comprising the cobinamide. Sharma’s claim 28 further limits claim 11 to wherein the cobinamide is injected intramuscularly.
Claims 10 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 9-13 and 19 of U.S. Patent No. 9,534,007 B2 (hereafter referred to as “Boss”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Boss anticipate the instant claims.
The limitations of instant claims 10 and 12-14 are discussed in the rejections above and hereby incorporated into the instant rejection.
Boss’s claim 5 is drawn to a method for treating sulfide poisoning or cyanide exposure in a subject comprising administering a therapeutically effective amount of a cobinamide to the subject, wherein the cobinamide is aquohydroxocobinamide, dinitrocobinamide or sulfitocobinamide. Boss’s claim 19 further limits claim 5 to 19. The method of claim 5, wherein the cobinamide is dinitrocobinamide, the dinitrocobinamide is administered intramuscularly, the dinitrocobinamide is administered as a pharmaceutical composition comprising the dinitrocobinamide and nitrite ions, and the molar ratio of the dinitrocobinamide to the nitrite ions is between 1:1 and 1:2. Boss’s claim 9 further limits claim 5 to wherein the cobinamide is administered intramuscularly. Boss’s claim 10 further limits claim 9 to cobinamide is administered in a dose range of 2-25 mg/kg, which is fully within the dose range of instant claim 13. Boss’s claims 11-13 further limit the dose range to narrower ranges that also anticipate instant claim 13.
Claims 10-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,005,066 B2 (hereafter referred to as “Chan”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Chan anticipate the instant claims.
The limitations of instant claims 10-14 are discussed in the rejections above and hereby incorporated into the instant rejection.
Chan’s claim 1 claims a method for ameliorating one or more symptoms associated with cyanide exposure, sulfide exposure, or methane thiol exposure in a subject, comprising administering to the subject an effective amount of a pharmaceutical composition comprising an effective amount of one or more cobinamide compounds; wherein the one or more cobinamide compounds is selected from the group consisting of amino-tetrazole-cobinamide, a di-(amino-tetrazole)-cobinamide, an acetyl-tetrazole-cobinamide, and a di-(acetyl-tetrazole)-cobinamide. Chan’s claims 2-5 further limit claim 1 to wherein the cobinamide compound is further limited to specific compound(s) that continue to anticipate the Markush group of cobinamide compounds of instant claim 11. Chan’s claim 6 further limits the method of claim 1 to wherein the dose administered is within the range of 8-24 mg/kg, which anticipates the dosing range of instant claim 13. Chan’s claim 7 further limits claim 1 to wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier. Chan’s claim 8 further limits claim 1 to wherein the pharmaceutical composition is a sterile solution or a sterile suspension. Chan’s claim 9 is drawn to a pharmaceutical composition comprising a Markush group of the same cobinamide compounds as found in Chan’s claim 1. Chan’s claims 10-13 further limit claim 9 to specific compound(s) that continue to anticipate the Markush group of cobinamide compounds of instant claim 11. Chan’s claim 14 further limits claim 9 to wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier. Claim 15 further limits claim 9 to wherein the pharmaceutical composition is a sterile solution or a sterile suspension. Chan’s claim 16 further limits claim 9 to wherein the pharmaceutical composition is formulated for intramuscular injection.
Claims 10 and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 10, 12 and 14 of copending Application No. 19/148,610 (hereafter referred to as “Tat”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Tat anticipate all the limitations of the instant claims with exception of a pharmaceutical composition “formulated for intramuscular administration”, and person of ordinary skill in the art would have a reasonable expectation of success in applying the claims of Tat to a composition “formulated for intramuscular administration”, as explained below.
The limitations of instant claims 10 and 12-13 are discussed in the rejections above and hereby incorporated into the instant injection. Among the chemical agents for which exposure to the chemical agent is treated in instant claim 12, azide is included.
Tat’s claim 1 is drawn to a method of treating azide poisoning in a subject comprising administering to the subject an effective amount of cobinamide, a cobinamide derivative, or a salt thereof. Tat’s claim 10 is drawn to a pharmaceutical composition comprising an effective amount of cobinamide, a cobinamide derivative, or a salt thereof, and Tat discloses that the term “pharmaceutical composition” refers to a composition comprising a pharmaceutically active agent and a pharmaceutically acceptable carrier (paragraph [0031]). Tat’s claims 3 and 12 further limit claims 1 and 10, respectively, to dose ranges of 20-40 mg/kg or a preferable dose of 30 mg/kg, each of which anticipate the dose range of instant claim 13.
While Tat does not claim intramuscular injection, or a composition that is “formulated for intramuscular injection”, a person of ordinary skill in the art would have a reasonable expectation of success in applying the claimed method and/or composition of Tat to intramuscular injection, because Tat claims a further limitation of the method of claim 1 and/or the composition of claim 9, each for intravenous injection, in claims 5 and 14, respectively, and a person of ordinary skill in the art would recognize that the similarity between intravenous injection and intramuscular injection is that they are both parenteral administrations, and that the only anticipated difference between them is that an intramuscular injection could not be as large a volume as an intravenous injection, and would therefore require the opportunity for a more concentrated dose, and Tat discloses specifically that cobinamide is an advantageous agent in that compared to cobalamin, cobinamide is more water soluble, thereby providing the potential for intramuscular administration (paragraph [0007]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims Free of the Prior Art
Claim 8 is allowed. The following is an examiner’s statement of reasons for allowance: Prior art does not teach or reasonably suggest, alone or in combination, a method of forming a cobinamide compound, the method comprising:
providing a first aqueous liquid comprising aquohydroxo-cobinamide;
providing a second aqueous liquid comprising 5-aminotetrazolate-deoxyribose;
contacting the first aqueous liquid and the second aqueous liquid to form a mixture comprising the cobinamide compound;
wherein the aquohydroxo-cobinamide is present in the first aqueous liquid at a concentration about 350 mM to about 450 mM.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 Cited in Applicant’s Information Disclosure Statement dated 11/21/2024.
2 Cited in Applicant’s Information Disclosure Statement dated 11/21/2024.
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