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 .
Information Disclosure Statement
The information disclosure statements filed on September 7, 2023; August 20, 2025; and December 29, 2025 are acknowledged by the examiner. The IDS documents filed on September 7, 2023 and August 20, 2025 have been fully considered by the examiner.
The IDS filed on December 29, 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it fails to include a concise explanation of relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information of each reference listed that is not in the English language.
In this instance, the Japanese Office Action document is provided in a non-English language and no associated explanation of relevance is provided in English. Thus, this IDS has been placed in the application file and the references other than the Japanese Office Action have been considered.
Specification
The use of the term XBRIDGE, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
On page 25 of the specification, Table II defines the “Variation” row as “i-f”. However, no “f” value has been provided elsewhere in the table. Instead, both the “% area ICG prior to storage” and “% area ICG after storage” have been labeled as (i). Correct to provide the appropriate label of (f) so the reader may better understand the calculation of “Variation.”
Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 does not end with a period. Appropriate correction is required.
Claim Interpretation
In claims 7 and 12-14, the phrase “the content of the indocyanine green” is interpreted to refer to the amount of indocyanine green.
Claims 7 and 12-14 are interpreted to recite a functional limitation when referring to the ICG content “measured in % area by HPLC at 240 nm.” A composition and its properties are inseparable (MPEP § 2112.01). Therefore, any composition taught by the art that possesses the property specified in the limitation of the claim reads on the claimed composition. Thus, prior art does not necessarily need to teach measurements of stability specifically using HPLC and a wavelength of 240 nm as long as the composition taught has a stability that would result in the specified % area results if measured by HPLC at 240 nm.
The examiner interprets claim 9 to contain functional language. In this instance, the terms “medicament” and “diagnostic agent” describe an intended use of the claimed indocyanine green formulation and do not provide additional structural restriction on the composition. Please note that a recitation of intended use does not distinguish over the prior art since a composition claim covers what the composition is and not what it is used for. A chemical composition and its properties are inseparable (MPEP § 2112.01). Therefore, as long as the prior art teaches the claimed structural features of the composition that is capable of these functions, it reads on the claim.
The examiner interprets claim 11 to contain functional language. In this instance, the phrase “for preparing the aqueous composition of claim 5” describes an intended use of the claimed kit. The claim is interpreted to be drawn to what the kit is and not what it does. Therefore, as long as the prior art teaches a kit comprising the same components as the ones listed in claim 11, it reads on the claim.
Claim Rejections - 35 USC § 112(a)
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 12-14 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 claims 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 this instance, claims 12-14 are drawn to compositions of claim 1 which have high ICG stability such that the decline in the amount of ICG present in the compound over the course of at least one month is only 10% or less, 5% or less, or 2% or less. However, it is not clear whether all potential combinations of ICG, EDTA, histidine, and sodium chloride allowed by claim 1 would possess these stabilities. Furthermore, only two working examples (C1 and C2 of Table II in the instant specification, pg. 25) are provided. These two examples are not an adequate representative number of species, as just one weight percent of ICG, histidine, and EDTA are provided and two weight percents of sodium chloride; all of which are toward the middle of the claimed ranges. Therefore, it is understood that the specification does not provide sufficient written support to describe all embodiments of the claimed ICG compositions.
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 7 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 requires “a content of the indocyanine green in the aqueous composition prior to storage is greater than or equal to 90% of the content of the indocyanine green.” It is not clear what values are required to be compared to meet this limitation. The percent content language suggests that the ICG content is at least 90% in the state prior to storage compared to some other state (in any single state the content of ICG is 100% of itself), but that other state is not provided. As the comparison group is not provided in the limitation, the metes and bounds are unclear and therefore claim 7 is indefinite. For the purpose of examination, an aqueous composition that reads on claim 5 for which a content measurement has been performed that exceeds 90% in value will be considered to read on claim 7, as it possesses an ICG content wherein the content of greater than or equal to 90% of itself, regardless of how it is measured.
Claims 7 and 12-14 provide limitations related to the content of the ICG “measured as % area by HPLC at 240 nm.” It is not clear what this % area is relative to. A person of ordinary skill in the art would understand that an HPLC measurement at 240 nm will enable the calculation of an area value for a peak assigned to ICG. However, to determine a % area, the area of ICG must be compared to other values. The required comparison groups are not provided in the claim, therefore the metes and bounds of the claim are unclear, rendering these claims indefinite. For the purpose of examination, a percent area value determined by any comparison of values will read on this limitation.
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 1-3, 5-10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kocherlakota (WO 2020240514 A1 – provided by applicant in IDS filed September 7, 2023) in view of Chilakala (US 11,541,066 B2).
Kocherlakota teaches formulations of indocyanine green. More specifically, Kocherlakota discloses formulations of indocyanine green further comprising disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride (first paragraph of pg. 4). Kocherlakota teaches five formulations in which the w/w% ranges of the solid (non-water) components (mass of individual component to the total mass of all non-water components) of these compositions is 49-76% for ICG, 9-19% for phosphate buffer (sum of both disodium hydrogen and sodium dihydrogen forms) and 15-32% sodium chloride (Tables from Examples 1, 2, and 3 from pages 6 and 10). Kocherlakota also discloses that these formulations display good stability, only declining in functional ICG amount by 0.4-0.5% over 24 hours when reconstituted in 0.45% sodium chloride (pg. 8, Table 2). Kocherlakota further teaches the lyophilization of these formulations and later reconstitution in water or sodium chloride solutions (pg. 7, Manufacturing Process). Kocherlakota also discloses that the pharmaceutical ICG formulations may further comprise additional excipients, including amino acid buffers such as histidine (third paragraph of pg. 5). Kocherlakota also discloses a kit comprising a vial with lyophilized ICG powder optionally together with excipients and a vial comprising a diluent solution (first paragraph of pg. 3).
Kocherlakota does not teach a formulation of ICG including EDTA or salts thereof. Nor does Kocherlakota teach a relative amount of histidine to add relative to the other formulation components. Kocherlakota also does not teach a composition having a stability in which the active ingredient declines in content less than 2-10% over the course of at least one month.
Chilakala teaches a stable formulation of fosaprepitant, a pharmaceutical compound. More specifically, Chilakala discloses an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). Chilakala discloses several possible excipients for use in the fosaprepitant formulation. Chilakala teaches EDTA salts and amino acids such as arginine and histidine as stabilizing agents (pg. 4, column 5, lines 18-40). Arginine and histidine are also considered options for pH adjusting agents (pg. 4, column 5, lines 41-51). Thus, Chilakala teaches histidine is a reasonable alternative to arginine in the Example 3 formulation. Sodium chloride is taught as a highly preferred isotonic agent (pg. 4, column 5, line 66 to column 6, line 2). Chilakala teaches that the prior standard pharmaceutical preparation was reconstituting lyophilized fosaprepitant in an aqueous sodium chloride solution and that this solution is only stable for 24 hours at ambient room temperature (pg. 2, column 1 line 56 through column 2 line 4). Chilakala teaches that the aforementioned formulation comprising the excipients disodium EDTA, sodium chloride, lactose monohydrate, arginine, and polysorbate 80 in the above concentrations has an extended stability, displaying small decreases in the amount of active pharmaceutical compound over the course of 3 months at room temperature (pg. 5, Table 5).
A person of ordinary skill in the art would have recognized that both Kocherlakota and Chilakala teach formulations of small molecule pharmaceutical compounds. Both pharmaceutical compounds are taught to commonly be provided in lyophilized powder and usually lack of long-term stability once resuspended. One would also recognize that the formulation of Chilakala has much longer stability of the active ingredient than does that of Kocherlakota. One would have been motivated to find formulations that improve upon that of Kocherlakota to extend the shelf life of the reconstituted ICG aqueous formulation to limit waste of material and save money.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation of Kocherlakota with the aqueous pharmaceutical formulation of Chilakala. This would result in the predictable result of an ICG formulation with extended shelf life stability.
Regarding claim 1, Kocherlakota teaches an indocyanine green composition comprising ICG, sodium chloride, disodium hydrogen phosphate, and sodium dihydrogen phosphate (first paragraph of pg. 4). Kocherlakota teaches several specific formulations of this composition with a range of w/w% of the non-water components. F1 has 60.7% ICG, 15% buffer (sum of both phosphate forms – both serve the purpose of pH buffering), and 24% sodium chloride (pg. 6, Example 1). F3 has 66% ICG, 13% buffer, and 21% sodium chloride (pg. 6, Example 2). F4 has 58% ICG, 16% buffer, and 26% sodium chloride (pg. 10, Example 3). F5 has 50% ICG, 19% buffer, and 32% sodium chloride (pg. 10, Example 3).
Chilakala discloses a specific example of an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). This is a formulation comprising an EDTA salt and sodium chloride. Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). Substituting histidine for arginine in the diluent of Chilakala and applying it to ICG instead of fosaprepitant would result in a solution in which for every 1 mg of ICG, there would be 0.036 mg disodium EDTA, 8 mg sodium chloride, and 1 mg histidine. This would be equivalent to a composition in which the mass of the individual component relative to the total weight of ICG, EDTA, histidine, and sodium chloride would be 10% ICG, 0.35% disodium EDTA, 80% sodium chloride, and 10% histidine. Furthermore, if instead substituting ICG (molecular weight = 774.96 g/mol) for fosaprepitant (MW = 614.4 g/mol) and histidine (MW = 155.15 g/mol) for arginine (MW = 174.2 g/mol) by molar equivalents instead of mass equivalents, the composition would have, per mL of solution, 1.26 mg ICG, 0.036 disodium EDTA, 8 mg sodium chloride, and 0.89 mg histidine. This is equivalent to w/w percentages of 12% ICG, 0.35% disodium EDTA, 79% sodium chloride, and 8.7% histidine. Thus, whether the histidine-substituted solution of Chilakala is applied to the ICG solution of Kocherlakota by mass equivalents or molar equivalents, these w/w% values read on claim 1. Therefore, the combined teachings of Kocherlakota and Chilakala render claim 1 obvious.
Regarding claim 2, the formulation taught in Example 3 of Chilakala contains disodium EDTA (pg. 6). For the reasons explained above, applying the Chilakala excipient-containing diluent of Example 3 to ICG teaches a formulation comprising ICG, an EDTA salt, histidine, and sodium chloride in relative amounts that read on the claimed ranges. Therefore, the combined teachings of Kocherlakota and Chilakala render claim 2 obvious.
Regarding claim 3, the aqueous formulation of Chilakala described above that reads on claims 1 and 2 comprises the disodium EDTA (pg. 6, Example 3, first table). Chilakala also discloses that alternative stabilizing agents include calcium disodium EDTA (which is the same as the claimed calcium sodium EDTA) (pg. 4, column 5, lines 19-22). Therefore, the combined teachings of Kocherlakota and Chilakala render claim 3 obvious.
Regarding claim 5, Kocherlakota teaches an aqueous composition of indocyanine green (pg. 7, Manufacturing Process). Furthermore, Chilakala teaches an aqueous pharmaceutical composition comprising histidine, disodium EDTA, and sodium chloride (pg. 4, column 5, lines 22-49 and pg. 6, Example 3). Therefore, the combined teachings of Kocherlakota and Chilakala render claim 5 obvious.
Regarding claim 6, Kocherlakota teaches several formulations (F1-F5) with the indocyanine green concentration of 25 mg/mL (pg. 6, Examples 1 and 2 and pg. 10, Example 3). Chilakala teaches a pharmaceutical formulation comprising histidine, disodium EDTA, sodium chloride, and a small-molecule pharmaceutical compound in which the pharmaceutical compound is 1 mg/mL (pg. 4, column 5, lines 22-49 and pg. 6, Example 3). Both of these ranges are between 0.1 and 50 mg/mL. Therefore, the combined teachings of Kocherlakota and Chilakala render claim 6 obvious.
Regarding claim 7, Kocherlakota discloses the stability of ICG in the aqueous formulation F3 over time (pg. 9, Table 2). The initial measurement of ICG content was 102% and 99.2% when ICG was prepared at 1.25 mg/mL and 5 mg/mL, respectively. This initial measurement reads on claim 7 because this measurement was taken prior to letting the sample sit for longer periods to time to test the stability, which reads on the concept of “storage.” Similarly, the initial fosaprepitant measurement in Chilakala averaged a value of 103.3% prior to letting the sample sit (pg. 6, Table 5). These values are greater than 90%. Therefore, the combined teachings of Kocherlakota and Chilakala render claim 7 obvious.
Regarding claim 8, Kocherlakota teaches the lyophilization of an indocyanine green composition (pg. 7, Manufacturing Process). If the excipient-containing solution of Chilakala was used in place of the formulation of Kocherlakota prior to lyophilization, this would read on claim 8. Therefore, the combined teachings of Kocherlakota and Chilakala render claim 8 obvious.
Regarding claim 9, Kocherlakota describes the compositions taught as pharmaceutical formulations (pg. 5, paragraph 2) and describes ICG as a drug used to perform imaging (pg. 6, line 2). Drugs are medicaments and imaging agents are often used as diagnostic agents. Additionally, Chilakala teaches using the disclosed buffer composition for increasing the stability of a medicament pharmaceutical compound, fosaprepitant, in a ready-to use (administer to subjects) form (pg. 2, column 1, lines 6-11). Therefore, the combined teachings of Kocherlakota and Chilakala render claim 9 obvious.
Regarding claim 10, Kocherlakota teaches a kit comprising a stable formulation of indocyanine green optionally together with excipients as a lyophilized powder in one vial and a separate vial comprising a diluent solution (pg. 3, first paragraph). As Kocherlakota discloses that this kit is for an alcohol-free formulation and all provided diluents in the taught examples are aqueous, this reads on claim 10. Therefore, the combined teachings of Kocherlakota and Chilakala render claim 10 obvious.
Regarding claims 12-14, Chilakala teaches that the disclosed formulation of Example 3 (pg. 6) displays remarkable stability at ambient room temperature (25 ± 2°C) over three months (pg. 6, Table 5). The “Assay” row in the table describes how much of the active fosaprepitant remains at each timepoint compared to the initial measurement. Data is provided in triplicate using three different batches of the composition in Example 3. At months 2 and 3, the average drop in fosaprepitant content is 1.35% and 0.74%, respectively (pg. 6, Table 5). While the assay method for measuring the fosaprepitant content is not specified, if an ICG composition displayed the same stability of the active molecule over that time period, it would display a less than 2% decline in % area as measured by HPLC at 240 nm. Therefore, the combined teachings of Kocherlakota and Chilakala render claims 12-14 obvious.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kocherlakota (WO 2020240514 A1 – provided by applicant in IDS filed September 7, 2023) in view of Chilakala (US 11,541,066 B2) as applied to claims 1-3, 5-10, and 12-14 above and further in view of Vyas (WO 2017093889 A1 – provided by applicant in IDS filed September 7, 2023).
As described above, Kocherlakota teaches formulations of indocyanine green and Chilakala teaches a diluent formulation for increased stability of a pharmaceutical compound. Substituting the phosphate and sodium chloride diluent of Kocherlakota (first paragraph of pg. 4) with the one of Example 3 (pg. 6) of Chilakala (substituting arginine with histidine, which is permissible according to pg. 4, column 5, lines 22-49) would produce an indocyanine green composition that reads on claim 1.
Kocherlakota and Chilakala do not teach compositions further comprising up to 5% sodium iodide based on the weight ratio of sodium iodide to indocyanine green.
Vyas teaches a method of making indocyanine green (first paragraph of pg. 3). Vyas further discloses that indocyanine green is normally available in a sodium iodide salt form at less than or equal to 5% sodium iodide and that the sodium iodide improves the ICG solubility (pg. 1, lines 19-21).
A person of ordinary skill in the art would have recognized that Kocherlakota, Chilakala, and Vyas teach formulations of small molecule pharmaceutical compounds. Both Kocherlakota and Vyas specifically teach compositions comprising indocyanine green. One would also recognize that the formulation of Chilakala is an aqueous (water-based) formulation. As indicated by Vyas, it is known in the art that sodium iodide increases increased aqueous solubility of ICG.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation taught by the combination of Kocherlakota and Chilakala with the addition of sodium iodide as taught by Vyas. This would result in the predictable result of an easier to prepare stable ICG formulation due to increased solubility. Therefore, the combined teachings of Kocherlakota, Chilakala, and Vyas render claim 4 obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tinnefeld (US 20100181535 A1 – provided by applicant in IDS filed September 7, 2023) in view of Chilakala (US 11,541,066 B2).
Tinnefeld discloses a method of enhancing the fluorescence intensity of dyes. Tinnefeld teaches that mixing a fluorescent dye with a redox buffer can increase its stability by 10% to 20% (paragraph 47, pg. 3). Indocyanine green is among the dyes for which this redox buffer improved stability (paragraph 140, pg. 8). Tinnefeld also discloses several embodiments for a kit for combining a fluorescent dye with a diluent solution (paragraphs 180-183, pg. 10-11).
Tinnefeld does not teach a formulation of ICG including EDTA or salts thereof, histidine, or sodium chloride. Nor does Tinnefeld teach a relative amount of these components to add relative to the other formulation components.
Chilakala teaches a stable formulation of fosaprepitant, a pharmaceutical compound. More specifically, Chilakala discloses an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). Chilakala discloses several possible excipients for use in the fosaprepitant formulation. Chilakala teaches EDTA and salts thereof and amino acids such as arginine and histidine as stabilizing agents (pg. 4, column 5, lines 18-40). Arginine and histidine are also considered options for pH adjusting agents (pg. 4, column 5, lines 41-51). Sodium chloride is taught as a highly preferred isotonic agent (pg. 4, column 5, line 66 to column 6, line 2). Chilakala teaches that the aforementioned formulation comprising the excipients disodium EDTA, sodium chloride, lactose monohydrate, arginine, and polysorbate 80 in the above concentrations has an extended stability, displaying small decreases in the amount of active pharmaceutical compound over the course of 3 months at room temperature (pg. 5, Table 5).
A person of ordinary skill in the art would have recognized that both Tinnefeld and Chilakala teach formulations of small molecule pharmaceutical compounds. Both pharmaceutical compounds are taught to generally be unstable in storage in resuspended form. One would also recognize that the formulation of Chilakala resulted in a dramatically increased stability compared to the prior standard preparation of fosaprepitant. One would have been motivated to find formulations that improve upon that of Tinnefeld to extend the shelf life of fluorescent dyes such as ICG to limit waste of material and save money.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation of Tinnefeld with the aqueous pharmaceutical formulation of Chilakala. This would result in the predictable result of an ICG formulation with extended shelf life stability.
Regarding claim 11, Tinnefeld teaches kits comprising fluorescent dyes and diluent solutions. One such embodiment is one in which the kit contains one reagent comprising a fluorescent dye and at least one reagent comprising a redox buffer (paragraph 181, pg. 11). Since the reagents are described separately by Tinnefeld, this reads on a kit in which one compartment contains a fluorescent dye such as ICG and the other compartment contains an aqueous diluent. As described above, Chilakala teaches an aqueous diluent that reads on the required excipients and relative amounts of claim 1. Combining the idea of the kit of Tinnefeld with the aqueous diluent of Chilakala would result in a kit with a compartment of ICG and a separate compartment with a diluent comprising histidine, EDTA, and sodium chloride. Therefore, the combined teachings of Tinnefeld and Chilakala render claim 11 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 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 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/549,378 in view of Chilakala (US 11,541,066 B2).
The claims of copending application 18/549,378 are drawn toward compositions of indocyanine green. The claimed compositions comprise histidine and may further comprise other excipients, including EDTA and sodium chloride. The claims are further drawn to formulations with certain stabilities measured by HPLC and a kit related to the claimed composition.
The copending application does not have claims to an ICG composition specifically required to comprise EDTA, histidine, and sodium chloride at specific weight percentages (10-70% indocyanine green, 0.1-15% EDTA, 1-20% histidine, and 20-80% sodium chloride).
As described above, Chilakala teaches a stable formulation of fosaprepitant, a pharmaceutical compound. More specifically, Chilakala discloses an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). Chilakala describes that this formulation significantly improved the stability of fosaprepitant from ~24 hours to over 3 months (pg. 5, Table 5).
A person of ordinary skill in the art would have recognized that both copending application 18/549,378 and Chilakala teach formulations of small molecule pharmaceutical compounds. One would also recognize that the formulation of Chilakala has remarkable stability of the active ingredient. One would have been motivated to find formulations that extend the shelf life of the ICG formulation to limit waste of material and save money.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation of copending application 18/549,378 with the aqueous pharmaceutical formulation of Chilakala. This would result in the predictable result of an ICG formulation with extended shelf life stability.
Regarding instant claim 1, conflicting claim 4 of the reference application teaches an ICG composition comprising ICG and histidine that can further comprise a mixture of EDTA (and salts thereof) and sodium chloride. Chilakala discloses a specific example of an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). This is a formulation comprising an EDTA salt, sodium chloride, and an amino acid buffering agent. Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). As described above, substituting histidine for arginine in the diluent of Chilakala and applying it to ICG instead of fosaprepitant would result in a composition that reads on instant claim 1.
Regarding instant claim 2, conflicting claim 4 of the copending application allows for the inclusion of salts of EDTA in the ICG composition. Furthermore, Example 3 of Chilakala teaches using the disodium EDTA salt for the stable pharmaceutical composition (pg. 6, first table of Example 3).
Regarding instant claim 3, Chilakala teaches using the disodium salt of EDTA (pg. 6, first table of example 3).
Regarding instant claim 4, conflicting claim 7 teaches further including up to 5% by weight of sodium iodide based on the weight of indocyanine green.
Regarding instant claim 5, conflicting claim 8 teaches making the indocyanine green formulation an aqueous composition.
Regarding instant claim 6, conflicting claim 9 teaches preparing the composition such that the indocyanine green concentration is between 0.1 and 50 mg/mL.
Regarding instant claim 7, conflicting claim 10 teaches an indocyanine green composition in which the ICG content is greater than or equal to 90% prior to storage as measured by % area by HPLC at 240 nm.
Regarding instant claim 8, conflicting claim 11 teaches preparing a lyophilized form of the indocyanine green composition.
Regarding instant claim 9, conflicting claim 12 teaches an indocyanine green composition that is a medicament or diagnostic agent.
Regarding instant claim 10, conflicting claim 13 teaches a kit comprising in separate compartments an indocyanine green composition and an aqueous diluent.
Regarding instant claim 11, conflicting claim 14 teaches a kit comprising in separate compartments indocyanine green and an aqueous diluent. Chilakala teaches an aqueous diluent comprising histidine, sodium chloride, and EDTA.
Regarding instant claim 12, conflicting claim 18 teaches an indocyanine green composition wherein the drop in ICG content measured by % area by HPLC at 240 nm is less than or equal to 10% when the aqueous composition is stored at ambient temperature for at least one month.
Regarding instant claim 13, conflicting claim 19 teaches an indocyanine green composition wherein the drop in ICG content measured by % area by HPLC at 240 nm is less than or equal to 5% when the aqueous composition is stored at ambient temperature for at least one month.
Regarding instant claim 14, conflicting claim 20 teaches an indocyanine green composition wherein the drop in ICG content measured by % area by HPLC at 240 nm is less than or equal to 2% when the aqueous composition is stored at ambient temperature for at least one month.
This is a provisional nonstatutory double patenting rejection.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/549,369 in view of Chilakala (US 11,541,066 B2).
The claims of copending application 18/549,369 are drawn toward compositions of indocyanine green. The claimed compositions may comprise excipients including histidine and sodium chloride. The claims are further drawn to formulations with certain stabilities measured by HPLC and a kit related to the claimed composition.
The copending application does not have claims to an ICG composition comprising EDTA or a composition specifically required to comprise EDTA, histidine, and sodium chloride at specific weight percentages (10-70% indocyanine green, 0.1-15% EDTA, 1-20% histidine, and 20-80% sodium chloride).
As described above, Chilakala teaches a stable formulation of fosaprepitant, a pharmaceutical compound. More specifically, Chilakala discloses an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). Chilakala describes that this formulation significantly improved the stability of fosaprepitant from ~24 hours to over 3 months (pg. 5, Table 5).
A person of ordinary skill in the art would have recognized that both copending application 18/549,369 and Chilakala teach formulations of small molecule pharmaceutical compounds. One would also recognize that the formulation of Chilakala has remarkable stability of the active ingredient. One would have been motivated to find formulations that extend the shelf life of the ICG formulation to limit waste of material and save money.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation of copending application 18/549,369 with the aqueous pharmaceutical formulation of Chilakala. This would result in the predictable result of an ICG formulation with extended shelf life stability.
Regarding instant claim 1, conflicting claim 6 of the reference application teaches an ICG composition that can further comprise a mixture of histidine and sodium chloride. Chilakala discloses a specific example of an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). This is a formulation comprising an EDTA salt, sodium chloride, and an amino acid buffering agent. Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). As described above, substituting histidine for arginine in the diluent of Chilakala and applying it to ICG instead of fosaprepitant would result in a composition that reads on instant claim 1.
Regarding instant claim 2, Example 3 of Chilakala teaches using the disodium EDTA salt for the stable pharmaceutical composition (pg. 6, first table of Example 3).
Regarding instant claim 3, Chilakala teaches using the disodium salt of EDTA (pg. 6, first table of Example 3).
Regarding instant claim 4, conflicting claim 8 teaches further including up to 5% by weight of sodium iodide based on the weight of indocyanine green.
Regarding instant claim 5, conflicting claim 1 teaches making the indocyanine green formulation an aqueous composition.
Regarding instant claim 6, conflicting claim 9 teaches preparing the composition such that the indocyanine green concentration is between 1 and 25 mg/mL. This range is within the instantly claimed range of 0.1 to 50 mg/mL.
Regarding instant claim 7, conflicting claim 10 teaches an indocyanine green composition in which the ICG content is greater than or equal to 90% prior to storage as measured by % area by HPLC at 240 nm.
Regarding instant claim 8, conflicting claim 12 teaches preparing a lyophilized form of the indocyanine green composition, which is required as a component of the kit claimed in the copending application.
Regarding instant claim 9, conflicting claim 11 teaches an indocyanine green composition that is a medicament or diagnostic agent.
Regarding instant claim 10, conflicting claim 12 teaches a kit comprising in separate compartments an indocyanine green composition and an aqueous diluent.
Regarding instant claim 11, conflicting claim 13 teaches a kit comprising in separate compartments indocyanine green and an aqueous diluent. Chilakala teaches an aqueous diluent comprising histidine, sodium chloride, and EDTA.
Regarding instant claim 12, conflicting claim 17 teaches an indocyanine green composition wherein the drop in ICG content measured by % area by HPLC at 240 nm is less than or equal to 10% when the aqueous composition is stored at ambient temperature for at least one month.
Regarding instant claim 13, conflicting claim 18 teaches an indocyanine green composition wherein the drop in ICG content measured by % area by HPLC at 240 nm is less than or equal to 5% when the aqueous composition is stored at ambient temperature for at least one month.
Regarding instant claim 14, conflicting claim 19 teaches an indocyanine green composition wherein the drop in ICG content measured by % area by HPLC at 240 nm is less than or equal to 2% when the aqueous composition is stored at ambient temperature for at least one month.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5-7, 9, and 12-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18/862,314 in view of Chilakala (US 11,541,066 B2).
Claim 42 of copending application 18/862,314 is drawn toward the compound indocyanine green.
The copending application does not have claims directed to an ICG composition comprising EDTA, histidine, and sodium chloride at specific weight percentages (10-70% indocyanine green, 0.1-15% EDTA, 1-20% histidine, and 20-80% sodium chloride).
As described above, Chilakala teaches a stable formulation of fosaprepitant, a pharmaceutical compound. More specifically, Chilakala discloses an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). Chilakala describes that this formulation significantly improved the stability of fosaprepitant from ~24 hours to over 3 months (pg. 5, Table 5).
A person of ordinary skill in the art would have recognized that both copending application 18/862,314 and Chilakala relate to small molecule pharmaceutical compounds. One would also recognize that the formulation of Chilakala has remarkable stability of the active ingredient. One would have been motivated to find formulations that extend the shelf life of the ICG to limit waste of material and save money.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green of copending application 18/862,314 with the aqueous pharmaceutical formulation of Chilakala. This would result in the predictable result of an ICG formulation with extended shelf life stability.
Regarding instant claim 1, conflicting claim 42 of the reference application is drawn toward the compound indocyanine green. Chilakala discloses a specific example of an aqueous formulation of 1 mg/mL fosaprepitant, 0.036 mg/mL disodium EDTA, 8 mg/mL sodium chloride, 2.5 mg/mL lactose monohydrate, 1 mg/mL arginine, and 0.5 mg/mL polysorbate 80 (pg. 6, Example 3, first table). This is a formulation comprising an EDTA salt, sodium chloride, and an amino acid buffering agent. Chilakala also teaches that histidine is an alternative to arginine as both a stabilizing agent and a pH adjusting agent (pg. 4, column 5, lines 22-51). As described above, substituting histidine for arginine in the diluent of Chilakala and applying it to ICG instead of fosaprepitant would result in a composition that reads on instant claim 1.
Regarding instant claim 2, the formulation taught in Example 3 of Chilakala contains disodium EDTA (pg. 6).
Regarding instant claim 3, the formulation of Chilakala described above that reads on claims 1 and 2 comprises the disodium EDTA (pg. 6, Example 3, first table). Chilakala also discloses that alternative stabilizing agents include calcium disodium EDTA (which is the same as the claimed calcium sodium EDTA) (pg. 4, column 5, lines 19-22).
Regarding instant claim 5, Chilakala teaches an aqueous pharmaceutical composition comprising histidine, disodium EDTA, and sodium chloride (pg. 4, column 5, lines 22-49 and pg. 6, Example 3).
Regarding instant claim 6, Chilakala teaches a pharmaceutical formulation comprising histidine, disodium EDTA, sodium chloride, and a small-molecule pharmaceutical compound in which the pharmaceutical compound is 1 mg/mL (pg. 4, column 5, lines 22-49 and pg. 6, Example 3). If the ICG of the copending application was switched with the fosaprepitant by mass equivalence, it would be 1 mg/mL and if it was substituted by molar equivalence (see math above), it would be at 1.26 mg/mL. Both of these values are between 0.1 and 50 mg/mL.
Regarding instant claim 7, Chilakala discloses the initial fosaprepitant content measurement prior to allowing the sample to sit for the stability study (which reads on the concept of “storage”) averaged a value of 103.3% (pg. 6, Table 5). This value is greater than 90%.
Regarding instant claim 9, the copending application claim 42 is drawn to the compound indocyanine green, which is a fluorescent molecule used for biological imaging and is thus a diagnostic agent. Additionally, Chilakala teaches using the disclosed buffer composition for increasing the stability of a medicament pharmaceutical compound, fosaprepitant, in a ready-to use (administer to subjects) form (pg. 2, column 1, lines 6-11).
Regarding claims 12-14, Chilakala teaches that the disclosed formulation of Example 3 (pg. 6) displays remarkable stability at ambient room temperature (25 ± 2°C) over three months (pg. 6, Table 5). The “Assay” row in the table describes how much of the active fosaprepitant remains at each timepoint compared to the initial measurement. Data is provided in triplicate using three different batches of the composition in Example 3. At months 2 and 3, the average drop in fosaprepitant content is 1.35% and 0.74%, respectively (pg. 6, Table 5). While the assay method for measuring the fosaprepitant content is not specified, if an ICG composition displayed the same stability of the active molecule over that time period, it would display a less than 2% decline in % area as measured by HPLC at 240 nm.
This is a provisional nonstatutory double patenting rejection.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18/862,314 in view of Chilakala (US 11,541,066 B2) and further in view of Vyas (WO 2017093889 A1 – provided by applicant in IDS filed September 7, 2023).
As described above, claim 42 of copending application 18/862,314 is drawn to the compound of indocyanine green. Additionally, Chilakala teaches a diluent formulation for increased stability of a pharmaceutical compound. Applying the diluent of Chilakala (pg. 6, Example 3) (substituting arginine with histidine, which is permissible according to pg. 4, column 5, lines 22-49) would produce an indocyanine green composition that reads on claim 1.
Copending application 18/862,314 and Chilakala do not teach compositions further comprising up to 5% sodium iodide based on the weight ratio of sodium iodide to indocyanine green.
Vyas teaches a method of making indocyanine green (first paragraph of pg. 3). Vyas further discloses that indocyanine green is normally available in a sodium iodide salt form at less than or equal to 5% sodium iodide and that the sodium iodide improves the ICG solubility (pg. 1, lines 19-21).
A person of ordinary skill in the art would have recognized that the copending application, Chilakala, and Vyas relate to small molecule pharmaceuticals. Both copending application 18/862,314 and Vyas specifically teach methods of preparing indocyanine green. One would also recognize that the formulation of Chilakala is an aqueous (water-based) formulation. As indicated by Vyas, it is known in the art that sodium iodide increases increased aqueous solubility of ICG.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation taught by the combination of copending application 18/862,314 and Chilakala with the addition of sodium iodide as taught by Vyas. This would result in the predictable result of an easier to prepare stable ICG formulation due to increased solubility.
This is a provisional nonstatutory double patenting rejection.
Claims 8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18/862,314 in view of Chilakala (US 11,541,066 B2) and further in view of Kocherlakota (WO 2020240514 A1 – provided by applicant in IDS filed September 7, 2023).
As described above, claim 42 of copending application 18/862,314 is drawn to the compound of indocyanine green. Additionally, Chilakala teaches a diluent formulation for increased stability of a pharmaceutical compound. Applying the diluent of Chilakala (pg. 6, Example 3) (substituting arginine with histidine, which is permissible according to pg. 4, column 5, lines 22-49) would produce an indocyanine green composition that reads on claim 1.
Copending application 18/862,314 and Chilakala do not teach multi-compartment kits comprising the indocyanine green composition and a diluent nor lyophilizing a formulated indocyanine green composition.
Kocherlakota teaches formulations of indocyanine green. More specifically, Kocherlakota discloses formulations of indocyanine green further comprising disodium hydrogen phosphate, sodium dihydrogen phosphate, and sodium chloride (first paragraph of pg. 4). Kocherlakota further teaches the lyophilization of these formulations and later reconstitution in water or sodium chloride solutions (pg. 7, Manufacturing Process). Kocherlakota also discloses a kit comprising a vial with lyophilized ICG powder optionally together with excipients and a vial comprising a diluent solution (first paragraph of pg. 3).
A person of ordinary skill in the art would have recognized that the copending application, Chilakala, and Kocherlakota relate to small molecule pharmaceuticals. Both copending application 18/862,314 and Kocherlakota specifically relate to indocyanine green. One would also recognize that the lyophilization and preparation of kits of Kocherlakota would produce a compact and stable product useful for transporting the ICG product.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation taught by the combination of copending application 18/862,314 and Chilakala with the lyophilization and kit preparation as taught by Kocherlakota. This would result in the predictable result of a ready to transport and use kit for local end-user preparation of ICG solutions.
Regarding instant claim 8, Kocherlakota teaches the lyophilization of an indocyanine green composition (pg. 7, Manufacturing Process). If the excipient-containing solution of Chilakala was used in place of the formulation of Kocherlakota prior to lyophilization, this would read on claim 8.
Regarding instant claim 10, Kocherlakota teaches a kit comprising a stable formulation of indocyanine green optionally together with excipients as a lyophilized powder in one vial and a separate vial comprising a diluent solution (pg. 3, first paragraph). As Kocherlakota discloses that this kit is for an alcohol-free formulation and all provided diluents in the taught examples are aqueous, this reads on claim 10.
This is a provisional nonstatutory double patenting rejection.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 42 of copending Application No. 18/862,314 in view of Chilakala (US 11,541,066 B2) further in view of Kocherlakota (WO 2020240514 A1 – provided by applicant in IDS filed September 7, 2023) and further in view of Tinnefeld (US 20100181535 A1 – provided by applicant in IDS filed September 7, 2023).
As described above, claim 42 of copending application 18/862,314 is drawn to the compound of indocyanine green. Additionally, Chilakala teaches a diluent formulation for increased stability of a pharmaceutical compound. Applying the diluent of Chilakala (pg. 6, Example 3) (substituting arginine with histidine, which is permissible according to pg. 4, column 5, lines 22-49) would produce an indocyanine green composition that reads on claim 1. Furthermore, Kocherlakota teaches a kit comprising a vial with lyophilized ICG powder optionally together with excipients and a vial comprising a diluent solution (first paragraph of pg. 3).
The combined teachings of copending application 18/862,314, Chilakala, and Kocherlakota do not teach multi-compartment kits comprising the indocyanine green compound and a diluent containing the excipients of EDTA, histidine, and sodium chloride.
Tinnefeld discloses a method of enhancing the fluorescence intensity of dyes. Tinnefeld teaches that mixing a fluorescent dye with a redox buffer can increase its stability by 10% to 20% (paragraph 47, pg. 3). Indocyanine green is among the dyes for which this redox buffer improved stability (paragraph 140, pg. 8). Tinnefeld also discloses several embodiments for a kit for combining a fluorescent dye with a diluent solution (paragraphs 180-183, pg. 10-11).
A person of ordinary skill in the art would have recognized that the copending application, Chilakala, Kocherlakota, and Tinnefeld relate to small molecule pharmaceuticals. Both copending application 18/862,314 and Kocherlakota specifically relate to indocyanine green and Tinnefeld relates to fluorescent molecules in general and includes specific teachings of indocyanine green. Both Kocherlakota and Tinnefeld disclose kits comprising fluorescent dyes and aqueous diluents. One would also recognize that the and preparation of kits of Tinnefeld would produce a compact and stable product useful for transporting the ICG product.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the indocyanine green formulation taught by the combination of copending application 18/862,314, Chilakala, Kocherlakota with the kit preparation as taught by Tinnefeld. This would result in the predictable result of a ready to transport and use kit for local end-user preparation of ICG solutions.
Regarding instant claim 11, Tinnefeld teaches kits comprising fluorescent dyes and diluent solutions. One such embodiment is one in which the kit contains one reagent comprising a fluorescent dye and at least one reagent comprising a redox buffer (paragraph 181, pg. 11). Since the reagents are described separately by Tinnefeld, this reads on a kit in which one compartment contains a fluorescent dye such as ICG and the other compartment contains an aqueous diluent. As described above, Chilakala teaches an aqueous diluent that reads on the required excipients and relative amounts of claim 1. Combining the idea of the kit of Tinnefeld with the aqueous diluent of Chilakala would result in a kit with a compartment of ICG and a separate compartment with a diluent comprising histidine, EDTA, and sodium chloride.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/E.P.M./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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