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 Rejections - 35 USC § 112
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 15 and 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.
Claim 15 recites the limitation “a pre-marked syringe, a pre-marked vial, or a pre-marked sleeve” in lines 2-3 and again in lines 4-5. It is unclear if the recitation in lines 4-5 is meant to be the same as 2-3, or a second a pre-marked syringe, a second pre-marked vial, or a second pre-marked sleeve.
Claim 16 is similarly rejected by virtue of their dependency upon claim 15.
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.
(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.
Claims 2-4, 6, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hernandez et al. (U.S. Publication No. 20160022912), hereinafter Hernandez.
Regarding claim 2, Hernandez discloses a medical kit (see kit of [0028]; FIG. 7B) comprising:
a pre-marked medicine dosing device (medicine dosing device, see [0028]) with both color-coded zones and volumetric markings calibrated to different drug doses for a drug (“predetermined color-coded volumetric medicine doses 100”, [0029]);
a vessel (“Alternatively, in a syringe in which a plunger serves as a vessel for holding the medicine”, [0044]; “the medicine dosing device can include any vessel, such as for example tube, vial, bag or bottle, capable of containing therein and expelling therefrom a desired medicine”, [0031]) for holding the drug; and
a container (barrel 70 of syringe) for housing the pre-marked medicine dosing device and the vessel.
Regarding claim 3, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 2, and Hernandez further discloses comprising one of a needle (see needle of [0026]), a tip (tip 40), an instruction sheet (claim 13), a holder (“As shown in FIG. 7B, the medical treatment kit may include a container, such as box, bag, pouch or any other suitable container capable of holding the medicine dosing device therein”, [0048]), a tape (“Broselow tape or any other similar type of device that provides color-coded length ranges”, [0049]) and a label (label 300).
Regarding claim 4, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 2, and Hernandez further discloses wherein the vessel is preloaded with the drug (“medicine-dosing device, according to one embodiment, may be further pre-filled with a fluid 105 that corresponds to a medication to be administered to a patient”, [0022]).
Regarding claim 6, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 2, and Hernandez further discloses wherein the vessel (plunger 50) contains a stopper (stopper 52).
Regarding claim 13, Hernandez discloses a method (see method steps in [0010] for drug administration including kit selection and administration) of preparing a medical kit, comprising:
selecting a pre-marked medicine dosing device with both color-coded zones and volumetric markings calibrated to different drug doses for a drug (“medicine dosing device can include any vessel, such as for example tube, vial, bag or bottle, capable of containing therein and expelling therefrom a desired medicine. For example, the medicine dosing device could be a bag containing an IV fluid. According to this embodiment, the bag may be marked with a series of color coded zones along with the traditional volume markings.”, [0031]); `
selecting a vessel for holding the drug (see vessel in [0031]);
packaging the pre-marked medicine dosing device and vessel into a container (see [0031-0032]).
Claims 2 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hernandez et al. (U.S. Publication No. 20190282764), hereinafter Hernandez.
Regarding claim 2, Hernandez discloses a medical kit (see kit of [0014]; FIG. 7B) comprising:
a pre-marked medicine dosing device (dispensing device, see [0014]) with both color-coded zones and volumetric markings calibrated to different drug doses for a drug (“ The medicine dosing device may be marked, for example, with a drug name, concentration, volumetric markings, color coded zones, and/or the like.”, [0042]);
a vessel (“Alternatively, in a syringe in which a plunger serves as a vessel for holding the medicine”, [0060]; “the medicine dosing device can include any vessel, such as for example tube, vial, bag or bottle, capable of containing therein and expelling therefrom a desired medicine”, [0045]) for holding the drug; and
a container (barrel 70 of syringe) for housing the pre-marked medicine dosing device and the vessel.
Regarding claim 12, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 2, and Hernandez further discloses wherein the color-coded zones of the pre- marked medicine dosing device each of the zones having a width corresponding to a pre- determined dose of the drug (see claim 1), wherein the width of each of the zones is calculated based on:
a set of patient characteristics (see [0014]);
the drug;
a dose of the drug corresponding to the set of patient characteristics (see [0012-0013]);
a concentration of the drug (see [0049];
a volume of the vessel (“The volume of the drug filled within the pre-marked medicine dispensing device is verified by ensuring that the filled volume corresponds to the determined color coded zone”, [0016]); and
wherein a first of the zones corresponds to a minimum dose range of the drug for a particular patient population, a second of the zones corresponds to an average dose range of the drug for the particular patient population, and a third of the zones corresponds to a maximum dose range of the particular drug for the particular patient population (claim 1).
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.
Claims 5, 7-11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. (U.S. Publication No. 20160022912), hereinafter Hernandez, in further view of Broselow et al . (U.S. Patent No. 6132416), hereinafter Broselow.
Regarding claim 5, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 2, however, Hernandez does not expressly state a tip that is predetermined based upon one of oral, intravenous or intermuscular use.
Broselow teaches a universal medication dosing system (Col 1 Lines 1-2) comprising a tip that is predetermined based upon one of oral, intravenous or intermuscular use (“intravenous medications are dispensed”, Col 6 Lines 41-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the tip of Hernandez to be predetermined based upon one of oral, intravenous or intermuscular use since it was known in the art that syringe tips for attaching a needle are standard in the art for use for oral, intravenous or intermuscular use.
Regarding claim 7, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 2, however, Hernandez does not expressly state a second pre-marked medicine dosing device with both color-coded zones and volumetric markings calibrated to different doses for a second drug.
Broselow teaches a universal medication dosing system (Col 1 Lines 1-2) comprising a second pre-marked medicine dosing device (syringes 21, 22, and 23) with both color-coded zones and volumetric markings calibrated to different doses for a second drug (see FIG. 1; see Col 4 Line 53 – Col 5 Line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Hernandez to include a second pre-marked medicine dosing device with both color-coded zones and volumetric markings calibrated to different doses for a second drug. Doing so would provide a drug dosing system which is color-coded so as to be usable by individuals who do not read, or who cannot read a particular language in which dosing instructions would ordinarily be given, as taught by Broselow (see Col 4 Lines 39-44).
Regarding claim 8, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 7, and Broselow further teaches a second vessel (reservoir 31) for holding the second drug, wherein the second vessel is preloaded with the drug (medicine of 40).
Regarding claim 9, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 7, and Broselow further teaches wherein the vessels and medicine dosing devices are positioned within the container to ensure that there is no confusion as to which vessel corresponds to which medicine dosing device (“intravenous medications are dispensed by matching a syringe 21 with the number "1" on it is used only to dispense from bottle 11 with a "1" on it. Likewise, syringe 22 is used to dispense only from a bottle 12 with a "2" on it, and a syringe 23 is used to dispense only from a bottle 13 with a "3" on it.”, Col 6 Lines 41-46).
Regarding claim 10, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 8, and Broselow further teaches wherein the vessel contains a first stopper and wherein the second vessel contains a second stopper, and wherein the first stopper is different from the second stopper (the Examiner notes FIG. 1 displays three syringes having three different respective plungers, therefore having three different stoppers at the distal end of plungers).
Regarding claim 11, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 10, and Hernandez further teaches wherein the first stopper is color coordinated the vessel and the second stopper is color coordinated to the second vessel (“According to yet another embodiment of the current disclosure the plunger and/or plunger stopper can be color coded based on the medication contained in the barrel. Such color coding of the plunger can further increase efficiency with which medication is administered and can make the administration even less error prone as visual inspection of the plunger can provide a quick verification of the correctness of the medication to be administered.”, [0030]).
Regarding claim 14, Hernandez discloses the claimed invention as discussed above concerning the rejection of claim 13, however, Hernandez does not expressly state comprising: selecting a second pre-marked medicine dosing device with both color-coded zones and volumetric markings calibrated to different doses for a second drug; selecting a second vessel for holding the second drug, wherein the second vessel is preloaded with the drug; and packaging the second pre-marked medicine dosing device and the second vessel into the container.
Broselow teaches a universal medication dosing system (Col 1 Lines 1-2) comprising a second pre-marked medicine dosing device (syringes 21, 22, and 23) with both color-coded zones and volumetric markings calibrated to different doses for a second drug (see FIG. 1; see Col 4 Line 53 – Col 5 Line 2);
selecting a second vessel (reservoir 31) for holding the second drug (medicine of 40), wherein the second vessel is preloaded with the drug; and
packaging the second pre-marked medicine dosing device and the second vessel into the container (barrels of syringes 21, 22, and 23; “intravenous medications are dispensed by matching a syringe 21 with the number "1" on it is used only to dispense from bottle 11 with a "1" on it. Likewise, syringe 22 is used to dispense only from a bottle 12 with a "2" on it, and a syringe 23 is used to dispense only from a bottle 13 with a "3" on it.”, Col 6 Lines 41-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Hernandez to include a second pre-marked medicine dosing device with both color-coded zones and volumetric markings calibrated to different doses for a second drug; selecting a second vessel for holding the second drug, wherein the second vessel is preloaded with the drug; and packaging the second pre-marked medicine dosing device and the second vessel into the container. Doing so would provide a drug dosing system which is color-coded so as to be usable by individuals who do not read, or who cannot read a particular language in which dosing instructions would ordinarily be given, as taught by Broselow (see Col 4 Lines 39-44).
Regarding claim 15, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 14, and Broselow further teaches wherein the step of selecting the pre-marked medicine dosing device comprises selecting one of a pre-marked syringe, a pre-marked vial, or a pre-marked sleeve and step of selecting the second pre-marked medicine dosing device comprises selecting one of a pre-marked syringe, a pre-marked vial, or a pre-marked sleeve (see FIG. 1 where in syringes 21, 22, and 23 are used to siphon medicine from marked bottles 11, 12, and 13).
Regarding claim 16, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 15, and Hernandez further teaches comprising selecting at least one additional element from the group of: a tape (“Broselow tape or any other similar type of device that provides color-coded length ranges”, [0049]) and a label (label 300), an instruction sheet (claim 13), a tip (tip 40), a holder (“As shown in FIG. 7B, the medical treatment kit may include a container, such as box, bag, pouch or any other suitable container capable of holding the medicine dosing device therein”, [0048]), and a label and packaging the at least one additional element into the container (label 300).
Regarding claim 17, Hernandez in view of Broselow teaches the claimed invention as discussed above concerning the rejection of claim 14, and Broselow further teaches comprising preloading the pre-marked medicine dosing device with the drug and preloading the second pre- marked dosing device with the second drug (the Examiner notes user syphons medicine from bottles into syringe for use in patient administration, therefore the dosing devices will be preloaded; see Col 7 Lines 1-7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744.The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
04/04/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783