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 .
Claim Status
Claims 2-3 are cancelled. Claims 1 and 4-16 are pending and under examination.
Priority
This application is a continuation of 18/141,112 filed on 4/28/2023.
Claim Objections
Claim 1 is objected to for inclusion of “thereof” as this is not necessary for this genus of “pharmaceutically acceptable magnesium salts” which is the other option in the Markush group. Applicant should delete “thereof”.
Claim 13 is objected to for “dosage/amount” which should be written as “dosage or amount”.
Claim 13 is objected to for “GFR” which should be spelled out as “glomerular filtration rate” when first mentioned in the claims.
Claims 10 and 14 are objected to for missing the word “of” between “get rid” and “one or more” in the claim.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, and 4-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 1, applicant provides for “colchicine, or an analog or derivative thereof” and in claim 7, applicant provides for “colchicine, or an analog thereof”. All claims are directly or indirectly dependent on claim 1. Applicant has no description or derivative of the term “derivatives” in the specification. Applicant also does not provide a definition of analog in the specification to limit it to a particular type of derivative and only presents one specific species of analog used in figure 2 called AC. However, it is not found what applicant means by AC in terms of the disclosure, and thus, use of AC could be problematic. As applicant does not define “derivatives” or “analogs” in a manner that would define known subgenre where written description would be adequate or presents a large number of species of what would be considered representative of all analogs or derivatives of colchicine. See MPEP 2163 “ The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").” One possible analog will not be representative of all numerous and varying analogs which could involve any number of added groups or other derivations. It should be further noted that applicant cannot add new matter to the disclosure to satisfy description. If applicant has other species in the specification as originally filed then applicant can make a group of colchicine compounds that are supported by the originally filed disclosure. Again, it is reminded that new matter is not allowed.
New Matter
Claims 1, and 4-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 was amended on 7/25/2025 after initial filing of the application on 3/8/2024 so that it would now include “or other pharmaceutically acceptable magnesium salts thereof”. Magnesium chloride is provided in the original specification and originally filed claims. Applicant’s specification does provide for magnesium (as just magnesium) as well but not in the form of other salts or mention of other salts. Since applicant did not mention such other salts originally, this recitation adds new matter to the originally filed claims and specification. Note that any change made to an application after the initial filing date (e.g. later filed preliminary amendments) will constitute new matter if it had not been described at the time of that original filing. Applicant does have support for magnesium chloride and magnesium, but does not have support for other salts.
Claim Rejections - 35 USC § 112(b)
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 and 4-16 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.
Claims 1 and 7 provide for “derivatives” and/or “analogs” of colchicine without providing an applicant definition of what these analogs or derivatives would encompass to read on the claims. Derivatives or analogs can allow for a large number of possible compounds with different types of derivations or added groups which each provide unique functional consequence. Thus, the metes and bounds of the claims based on these terms is unclear. For the purpose of compact prosecution, the examiner will consider any compound that is reasonably considered to provide colchicine.
Claims 4-6 and 8-16 are rejected for being dependent on an indefinite claim without reciting more.
Claims 10, 13 and 14 recites the limitation "the pain" in the claim without reciting a prior recitation of “pain” or a condition where pain would be entirely inherent. There is insufficient antecedent basis for this limitation in the claim. Applicant may simply say “….one or more of pain related to…”. Note that claim 13 is dependent on any one of the preceding claims, and thus, antecedent basis would have had to come from each of them.
Claim 11 recites the limitation "the treatment sessions" in the claim without reciting a prior recitation of “treatment sessions”. There is insufficient antecedent basis for this limitation in the claim. Applicant may simply say “….in each treatment session is variable.”.
Claim 12 recites the limitation "the treatment sessions" in the claim without reciting a prior recitation of “treatment sessions”. There is insufficient antecedent basis for this limitation in the claim. Applicant may simply say “….in each treatment session remains the same.”.
Claim 15 recites the limitation "the treatment sessions" in the claim where the prior recitation is “at least one treatment session” (as claim 15 depends on claim 8). It would be indefinite which of the “at least one sessions” was involved when recited this way in claim 15. There is insufficient antecedent basis for this limitation in the claim. Applicant may say “…the composition in the at least one treatment session…”.
Claim 16 is indefinite for “per a recommended protocol” as it is unclear what the recommended protocols would be and how those define the dosage range. Therefore, for the purpose of compact prosecution, the examiner will read these as the ranges presented in the prior art.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 6, 10, and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition with two products of nature that can exist in plants/plant parts. The claim(s) recite(s) A composition comprising at least 1 mg of colchicine and 1000 mg of magnesium chloride. Dasgeb et al (British Journal of Dermatology, February 2018, volume 178, pages 350-356 (pages 1-15)) teaches colchicine is derived from the Colchicum autumnale plant aka the autumn crocus (abstract and History). Dasgeb provides for colchicine mechanisms of action and indications (pages 2-4 and summary and conclusion). Blatchley, (26th & 27th Annual Reports of the State Geologist of Indiana, Mineral Waters of Indiana, 1903, volume 26, pages 11-158) teaches mineral waters with magnesium chloride and sodium chloride from different natural water sources in Indiana (pages 24, 25, 29, 48, 51, 52, and 74). Colorado State University, (Colorado State University, Extension, Revised 12/14) teaches that magnesium and chloride are both essential for plant growth, although too much of each element can be toxic (MgCl2 Toxicity: Biology and Quick Facts (Trees take up soil magnesium and chloride through roots)). Additionally, Poutaraud et al (Environmental and Experimental Botany, 2005, volume 54, pages 101-108) teaches influence of chemical characteristics of soil on mineral and alkaloid seed contents of Colchicum autumnale (abstract). Poutaraud teaches geographical and chemical soil characteristics with minerals including magnesium and sodium (Table 2 and Results). Poutaraud teaches colchicine (abstract) from colchicum autumnale aka meadow saffron (page 102). Thus, since natural ground water sources having magnesium chloride and sodium chloride exist and plants can uptake minerals from the ground soil, plants including the autumn crocus (aka meadow saffron) would have magnesium chloride and sodium chloride. Plants also have water. The amounts would depend on what is present in the ground or plant. This judicial exception is not integrated into a practical application because these compositions are two natural products that may each have their own pharmaceutical properties. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the autumn crocus plant has the natural components of the claims (colchicine, magnesium chloride, sodium chloride, water). Claims that provide for dosage range which amounts to amounts/concentrations of the composition of natural compounds not affecting their natural characteristics and individual functions. Claims with formulated for “intravenous drip”, “formulated for administration in a controlled amount of up to 57 cc over….” as dictated in claim 7, or “composition released directed, via drip, into a vein of a subject” were deemed to have markedly different characteristics than the products of nature as they are formulated for this use.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis US 20090170952.
In regards to anti-inflammatory, antioxidative, vasodilating and antispasmodic, if the prior art provides such amounts of colchicine and magnesium salt, these effects would be provided.
Davis teaches a tablet composition with 0.6 mg of ultrapure colchicine and 0.6 mg of magnesium stearate (table 7). Magnesium stearate is a salt of magnesium and stearic acid that contains magnesium. Davis also allows for magnesium salts of colchicine (paragraph 56).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4-6, 8-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tardif WO 2021184128A1 and CN107714718A (English translation, Google).
In regards to anti-inflammatory, antioxidative, vasodilating and antispasmodic, if the prior art provides such amounts of colchicine and magnesium salt, these effects would be provided.
In claim 7, the limitation of “up to 57 cc over 10-30 minutes to treat pain..”, this is toward the administration of the composition and not to the composition itself. If the prior art teaches the composition, it is capable of being administered in the manner of the claim.
In regards to claims 8 and 9, “administered to a subject through intravenous drip…” and “treatment session” are to the uses of the composition. If the prior art teaches the composition in a suitable liquid form that can be used in an intravenous drip, then it can be administered by such a manner.
In regards to claims 8-12 and 14-16, treatment sessions are to the treating of the subject and not structural or compositional limitations to the composition. If the composition teaches the composition, it can be used in such treatment sessions.
In regards to diseases or symptoms to be treated in these composition claims, if the prior art teaches the compounds and amounts, it will be capable of treating such diseases or symptoms. These are limitations to a method of use and not compositional or structural limitations to the composition that is being claimed.
Limitations such as evaluated on an individual basis and per a recommended protocol are toward the usage of the composition and not limitations toward the composition itself.
Tardif teaches administering a colchicine to a subject (abstract). Tardif teaches 0.3 to 2.4 mg of colchicine (claim 9 of Tardif). Tardif teaches intravenous administration among others (page 6, lines 33-35). Tardif teaches continuous infusion over a period of time (page 7, line 1). Tardif teaches liquid material (e.g. normal saline) (page 7, lines 10-13). Tardif teaches 1.2 mg to 2.4 mg colchicine for subjects over 12 years old (page 8, lines 30-32). Tardif teaches administering 1, 2 or 3 times a day (pages 8, lines 17-24). Tardif teaches the diluent can change with type of administration (page 7, lines 15-16). Tardif teaches combination with a second therapeutic that can be an anti-inflammatory drug (page 3, lines 27-30). Tardif teaches using normal saline as liquid material (page 7, lines 8-14). Tardif provides for checking glomerulation filtration rate (Method Trial Design). Tardif provides for dosage and adjustment by a physician and that dosage regimes may be adjusted over time (page 8).
Tardif does not teach the amount of magnesium chloride or salt thereof. Tardif allows for saline but does not provide for at least 50 cc.
CN ‘718 teaches a solution of magnesium chloride as an active ingredient with saline as solvent and a concentration of magnesium chloride from 10-20 mmol/L (abstract) and safe amounts below 50 mmol/L (see embodiment 5). 10-20 mmol/L of magnesium chloride is 0.95 g/L to 1.9 g/L. Less than 50 mmol/L magnesium chloride is 4.76 g/L. CN ‘718 teaches injection type (claim 4 of CN ‘718). Embodiment 8 provides for the adjustment effect of magnesium chloride solution to macrophage activation. Embodiment 9 teaches using magnesium chloride solution for regulating osteoarthritic inflammation. Thus, CN’718 teaches treating inflammation with magnesium chloride. CN ‘718 teaches in embodiment 1, various inflammatory conditions for treatment. CN ‘718 teaches arteries and veins injection (English translation). CN ‘718 provides for physiological saline as the solvent for the formulation (abstract). Example 9 teaches 5 ml magnesium chloride. The English translation of CN ‘718 provides that too fast of injection speed and metering will cause hypermagnesemia.
One of ordinary skill in the art at the time of filing would have included magnesium chloride having anti-inflammatory activity into a composition of colchicine for pharmacological purposes as Tardif provides a colchicine composition that would include other anti-inflammatory agents and CN ‘718 provides magnesium chloride as an agent that has suitable anti-inflammatory properties for a subject. Thus, one of ordinary skill in the art would combine the magnesium chloride of CN ‘718 to the colchicine composition of Tardif in order to obtain the anti-inflammatory activity of the magnesium chloride to produce a composition with this added benefit. The number of treatments to treat a certain intensity of inflammatory pain in claims 10 and 12 are related to the method of use of the composition while claims 10 and 12 are toward a composition. If the prior art teaches the components, it will be capable of such intended use if provided in an appropriate number of sessions. A claim provides two limitations with one indicating dosage/amount depends on age and GFR ranges and the other providing for the condition to be treated. Since the prior art teaches amounts overlapping with the instant range and reasons to adjust dosages, the prior art reads on this limitation. Since the prior art teaches the composition, it will be capable of treating disorders as mentioned in claim 13 since one composition may have multiple utilities and this is toward the intended use. One of ordinary skill in the art would adjust the total dose of composition administered based on the physician, the patient’s needs and the need for dosage regime adjustments. Both Tardif and CN ‘718 teach use of saline in a liquid form. Thus, the total volume of a form with saline would be adjusted as needed for the dosing to the patient. As the prior art teaches injectable/intravenous forms with physiological saline, they are compositional forms that can be provided by IV drip.
Claims 7 and 14 in addition to Claims 1, 4-6, 8-13, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tardif WO 2021184128A1, CN107714718A and Healthline (Healthline.com, https://www.healthline.com/health/intravenous-medication-administration-what-to-know, Updated on July 5, 2021).
Tardif and CN ‘718 teach the claims as discussed above.
Tardif and CN ‘718 does not teach intravenous drip controlled release a volume (up to 53 cc) of the composition.
Healthline teaches intravenous medication administration with intravenous injection or infusion into a vein Health line teaches IV drip infusion. Healthline teaches drugs typically given by IV include antibiotics and pain relief drugs. Healthline teaches IV medications control the medication dosing to make it quick or to give it slow but constantly over time. Healthline also provides that the drugs may be better received than by orally.
One of ordinary skill in the art at the time of filing would have utilized the composition motivated by Tardif and CN’718 into the form of an intravenous drip as taught by Healthline as both Tardif and CN’718 allow for intravenous/vein administration while Healthline motivates that intravenous administration is advantageous to control delivery of the dosage while also avoiding first pass effects associated with oral administration. Healthline provides for IV drip as one such intravenous formulation. Thus, one of ordinary skill in the art would have produced an intravenous drip formulation with colchicine and magnesium chloride by the combined teachings of the prior at. Claim 8 provides for at least one treatment session to initiate effective treatment followed by instruction for further treatment, which relates to steps toward a method of use. Since the prior art teaches the formulation, it will be capable of being used in such methodologies. Note that Tardif allows for 1, 2 or 3 administrations per day. Claim 9 provides for providing effective treatment to get rid of or prevent one or more of a plurality of disorders related to pain in the spine, which is toward a function related to use of the composition. Since the prior art teaches the composition, it would effectively treat such a condition. As Tardif and CN ‘718 allows for different doses per days and dosages based on ranges, it allows for treatment sessions that are variable, but would also allow one to have the sessions be consistent.
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 1, 5, 6, and 8-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No 11951084. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘084 provides for a method of using a composition with colchicine and magnesium chloride in amounts of the claims by and IV treatment where the composition is in an IV bag. The IV bag would contain a liquid fluid. Thus, ‘084 provides for the claimed compositions.
Claims 1, 5, 6, and 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No 11951084. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘084 provides for a method of using a composition with colchicine and magnesium chloride in amounts of the claims by and IV treatment where the composition is in an IV bag. The IV bag would contain a liquid fluid for IV administration. Thus, ‘084 provides for the claimed compositions.
Claims 4 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No 11951084 in view of CN107714718A and Healthline (Healthline.com, https://www.healthline.com/health/intravenous-medication-administration-what-to-know, Updated on July 5, 2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘084 provides for a method of using a composition with colchicine and magnesium chloride in amounts of the claims by and IV treatment where the composition is in an IV bag. The IV bag would contain a liquid fluid. Thus, ‘084 provides for the claimed compositions.
Claims of ‘084 do not teach saline and the limitation of claim 7.
CN ‘718 teaches a solution of magnesium chloride as an active ingredient with saline as solvent and a concentration of magnesium chloride from 10-20 mmol/L (abstract) and safe amounts below 50 mmol/L (see embodiment 5). 10-20 mmol/L of magnesium chloride is 0.95 g/L to 1.9 g/L. Less than 50 mmol/L magnesium chloride is 4.76 g/L. CN ‘718 teaches injection type (claim 4 of CN ‘718). Embodiment 8 provides for the adjustment effect of magnesium chloride solution to macrophage activation. Embodiment 9 teaches using magnesium chloride solution for regulating osteoarthritic inflammation. Thus, CN’718 teaches treating inflammation with magnesium chloride. CN ‘718 teaches in embodiment 1, various inflammatory conditions for treatment. CN ‘718 teaches arteries and veins injection (English translation). CN ‘718 provides for physiological saline as the solvent for the formulation (abstract). Example 9 teaches 5 ml magnesium chloride.
Healthline teaches intravenous medication administration with intravenous injection or infusion into a vein Health line teaches IV drip infusion. Healthline teaches drugs typically given by IV include antibiotics and pain relief drugs. Healthline teaches IV medications control the medication dosing to make it quick or to give it slow but constantly over time. Healthline also provides that the drugs may be better received than by orally.
One of ordinary skill in the art before the time of filing would use saline, adjust the dosage for treatment and provide controlled IV drip infusion based on the combined teachings with CN ‘718 and Healthline that teaches these types of administration with saline being a carrier ingredient. There was a reasonable expectation of success in using such conventional techniques and carriers such as physiological saline of the prior art and making adjustments in dosing amounts to the subject in combination with the claims of ‘084 toward administration of a composition with colchicine and magnesium chloride by an IV bag.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613