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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission has been entered.
This Office Action is in response to Applicant’s response filed on 10/10/2025, wherein claims 1, 3, 5, 6, 9, 11 are canceled, claims 12, 14, 20, 22 and 24 are amended and claims 25-29 are newly added.
Claims 12 and 14-29 are pending in the instant application.
Claims 14-24 remain withdrawn as being drawn to a nonelected invention.
Claims 12 and 25-29 will be examined on the merits herein.
Priority
The application claims benefit to provisional application US 63/382350 filed on 11/4/2022.
Withdrawn Rejections
All rejection(s)/objection(s) of record for claim(s) 1, 3, 5, 6, 9, 11 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 10/10/2025, with respect to the rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Kuniko et al. (JP 2006151968 A, 2006), in view of Hamacher (US 5,102,408; 1992), further in view of Boyd et al. (US 2007/0265293A1), is persuasive. The combined prior art does not reasonably suggest a intravenous fluid bag as a vessel for a composition. The rejection is hereby withdrawn.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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.
Claims 12 and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Klein et al. (US 2017/0100331A1, PTO-892), in view of Klein (US 10,322,083 B2; 2019, PTO-892), further in view of Tiwari et al. (US 2008/0292558 A1, PTO-892).
Klein 331 discloses tumescent composition comprising a vasoconstrictor, (specifically epinephrine at 0.4-1.2 mg/L), a local anesthetic (specifically lidocaine at 30-1500 mg/L), a pharmaceutically acceptable carrier and a drug, where a tumescent concentration of the drug is simultaneously: 1) below a threshold for local, subcutaneous tissue toxicity, 2) above a threshold for positive local therapeutic effect, and 3) above a concentration safely achievable by intravenous (IV), intramuscular (IM) or oral (PO) delivery, further where the drug may be an antibiotic, antiviral, antifungal, anticancer, analgesic, local anesthetic, biologic, anti-venom, anti-seizure, SSRI, etc.. (¶0028-0034; 0101, 0117-0120; 0210, 0216, 0294-0295, 0337) Klein further discloses that it is standard procedure to incorporate the tumescent composition into av intravenous fluid bag for delivery. (¶0451) Klein 331 also teaches that, “Human error is the most dangerous aspect of tumescent antibiotic delivery (TAD). Legible written signed physician orders are absolutely essential. Orders must specify the amount of lidocaine in terms of milligrams. It is unsafe to order 1000 mg of lidocaine per bag in terms of 100 ml of 1 % lidocaine; Murphy's Law assures us that someone will inadvertently use 100 ml of2% lidocaine. Every bag of TAD solution must be clearly labeled on both sides with tumescent safety labels that state, "Subcutaneous Tumescent Lidocaine, Not for W." IV delivery of a TAD solution may be fatal.” (¶0489)
Klein 331 does not disclose that the tumescent composition comprises vitamin B12 or vitamin B2, to impart a visible color to the IV bag.
Klein 083 discloses an IV bag comprising a composition for tumescent antibiotic delivery comprising: (a) an antibiotic component; (b) an anesthetic component; (c) a vasoconstrictor component; and (d) a pharmaceutically acceptable solvent, where preferably, the bag is visually distinguishable from IV bags, specifically the bag and/or the composition therein comprises a distinctive color. (Col. 7)
Tiwari et al. discloses a means for distinguishing drug compositions from one another using a color additive, where the color additives or agents used in the present invention are non-toxic and approved for parenteral administration including intravenous administration. Color agents include, but are not limited to, cyanocobalamin, indigo carmine, patent blue, indocyanine green, phenopheylene, and hemoglobin…A preferred set of colorants that may be useful in the present invention include the vitamin-based agents, including, but not limited to, Vitamin B12 (cyanocobalamin-pink in color), Vitamin B2 (riboflavin-orange in color). Other preferred colorants can include naturally occurring mineral based colorants. The colorants listed and including those listed at the FDA website may be useful in the present invention so long as the colorants provide sufficient differentiating color, versus a clear solution, and are pharmaceutically acceptable for parenteral administration to a subject. (¶0018, emphasis added) Tiwari further discloses that suitable containers for housing the colored composition concentrate are known in the art. They include vial, syringe, bag, bottle and ampul presentations and should be transparent or have a transparent portion to permit visually identification of the color… In one embodiment the colored concentrate is housed in a clear glass or polymer based syringe and terminally sterilized. These pre-filled syringes can be provided in various volumes to permit quick and easy preparation of either small volume or large volume parenteral dosage by dispensing the contents of the pre-filled syringes into standard pre-filled intravenous fluid bags. (¶0024-0026) Tiwari particularly envisions cyanocobalamin as the color additive. (Example 1; Claim 8)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the IV bag comprising the tumescent solution of Klein 331, to add a color additive to the solution, preferably cyanocobalamin or riboflavin, thereby arriving at the instant invention. One would have been motivated to add a color additive to the tumescent solution of Klein 331 because Klein 083 suggests making a tumescent solution colored to provide a distinctive visual indicator, to address the known dangers, potentially fatal dangers, of confusing tumescent IV solutions with standard IV solutions. One would find it obvious to look to Tiwari for guidance on what color additives are acceptable for use in IV solutions because Klein 083 is silent on specific additives. Tiwari motivates one to select cyanocobalamin or riboflavin as a color additive because: 1) they are established as non-toxic and pharmaceutically acceptable for parenteral administration to a subject and 2) they are clearly envisioned by Tiwari as preferred color additives.
With respect to the claimed range for lidocaine and epinephrine, the ranges overlap that of the prior art. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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/DALE R MILLER/Primary Examiner, Art Unit 1693