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 .
Response to Amendment
Claim 8 was previously objected to for a typographical error and has been amended; the previous objection to claim 8 is accordingly withdrawn.
Applicant has amended the Specification.
Applicant has amended claims 1 and 8 and added claims 9 and 10. No new matter has been entered. Claims 1-10 remain pending.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (US 20070150008, henceforth Jones, previously made of record).
Regarding claim 8, Jones discloses a method for using an automated external defibrillator (AED) system (system of fig. 1) to apply a defibrillation shock to a patient experiencing a cardiac event (voltage pulse of [0055] is a defibrillation shock as claimed where it is an electrical shock coming from a defibrillator), the AED system including shock generating electronics (defibrillator circuitry [0027]) and a pair of cardiac pads (two electrodes 12 and 14, fig. 1) connected with the shock generating electronics (see fig. 1, electrodes 12 and 14 are connected to defibrillator 10 via wires as shown where the defibrillator 10 comprises the claimed electronics), the method comprising: applying the cardiac pads to the patient ([0006], the pads are positioned on and attached to the patient); and delivering the defibrillation shock ([0055]) simultaneously with a medication to the patient via the cardiac pads (the delivery of [0055] is an electroporation of the skin which causes simultaneous delivery of the medicament with a shocking of the patient), wherein each one of the cardiac pads includes a delivery mechanism for administering a medication to the patient (see [0025], the gel layer 20 of the electrode pads includes an active therapeutic agent which is a delivery mechanism as it allows for the drug to be administered) such that applying the cardiac pads to the patient includes administering the medication to the patient simultaneously with delivering the defibrillation shock to the patient (see [0004], [0051], and [0054]-[0055]).
Regarding claim 9, Jones discloses the method of claim 8 wherein delivering the defibrillation shock simultaneously with a medication to the patient via the cardiac pads comprises a single step without introduction of additional steps for medicine delivery (see [0055], the defibrillation shock which causes drug delivery is considered to be a single step at the simultaneous moment; Examiner also notes that the claim does not specify what defines a single step as opposed to multiple steps).
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.
Claim(s) 1-2, 4, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nova et al. (US 20030114885, henceforth Nova) in view of Jones et al. (US 20070150008, henceforth Jones).
Regarding claim 1, Nova discloses an automated external defibrillator (AED) system (integrated component package 10 for use with AED 50, fig. 6) comprising: shock generating electronics (discharge circuit 70, fig. 4) configured to provide at least one defibrillation shock ([0052]) suitable for a patient experiencing a cardiac event (see at least [0003] and [0031]); a battery (power source 32, fig. 6) configured for providing power to the shock generating electronics ([0032], power source 32 provides power to the AED which includes the claimed circuitry); power management circuitry (charge circuit 68, fig. 4) configured for managing the shock generating electronics and the battery (see [0052] and [0053] charging circuit 68 causes energy to be pulled from the battery and stored to allow discharge circuitry 70 to be able to work); a single microprocessor (microprocessor 52, fig. 4) configured for controlling the power management circuitry ([0052]); an enclosure (outer shell 12 of integrated component package 10, lid 72, and the outer shell of AED 50 shown in fig. 6 make up the claimed enclosure) configured to house the shock generating electronics, the battery, the power management circuitry, and the single microprocessor (when the system is fully assembled as shown in fig. 5, no circuitry is shown as being exposed; this is because it is all housed within the cited enclosure structures); and a pair of cardiac pads (pair of transducers 22, fig. 8) configured for electrical connection with the shock generating electronics (see [0031], they are connected via wires 28). Nova additionally discloses that its system comprises transdermal drugs/medications ([0030]).
Nova does not disclose the system wherein at least one of the cardiac pads in the pair of cardiac pads includes a medication delivery mechanism configured for delivering a predetermined dose of a medication to a patient simultaneously with delivery of the at least one defibrillation shock. Jones teaches an automated external defibrillator (AED) system (portable defibrillator 10, fig. 1) having a pair of cardiac pads (electrodes pictured as 12 and 14 in fig. 1, or 15 in fig. 2) wherein at least one of the cardiac pads in the pair of cardiac pads includes a medication delivery mechanism (gel layer 20, fig. 2 and [0025], which includes an active therapeutic agent in the chosen embodiment) configured for delivering a predetermined dose of a medication to a patient simultaneously with delivery of at least one defibrillation shock (see the voltage pulse of [0055], this is a defibrillation shock as claimed where it is an electrical shock coming from a defibrillator). Additionally, Jones teaches this delivery to occur whenever a proper amount of voltage has been applied to its electrodes (see [0011] and [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the electrode pads of Jones to the system of Nova and to have configured to microprocessor of Nova to have provided iontophoresis pulses as in Jones for allowing for transdermal emergency doses of medication to be delivered by laypersons instead of trained personnel (Jones [0002], [0003]) with higher drug absorption efficacy in the modified AED system than as patches alone (Jones [0004], [0008], and [0010]), and further because the system of Nova already discloses the use of transdermal drugs in its system (Nova [0030]), so the addition of the electrode pads of Jones would further allow for enhanced permeation and absorption of these transdermal medications as well (Jones [0004], [0008], [0010]).
Regarding claim 2, Nova as modified by Jones (henceforth Nova as modified) discloses the AED system of claim 1 wherein the medication delivery mechanism includes at least one of a medication-impregnated transdermal patch, and a microneedle array (see Jones fig. 2 and [0025], gel layer 20 is a medication-impregnated transdermal patch).
Regarding claim 4, Nova as modified discloses the AED system of claim 1 further comprising a plurality of pairs of cardiac pads (see Jones [0035], “Optionally, different defibrillation electrodes can be provided with different drugs and different doses of drugs, and may thus be preconnected to a particular defibrillation device or may be connectable to the device with instructions as to which of the different drug-carrying electrodes to use”; note also Nova [0031], “One skilled in the relevant art will appreciate that multiple use electrodes may also be utilized within the integrated component package 10”), each one of the plurality of pairs of cardiac pads being configured for electrical connection with the shock generating electronics one at a time (see Nova fig. 8 and [0031], transducers 22 are connected to AED 50 via conductive wires 28 via electrical therapy interface 30; as shown in fig. 4, electrical therapy interface 30 only provides for one set of wires 28 to be connected to it at one time), and wherein each one of the plurality of pairs of cardiac pads includes a different predetermined dose of medication from each other one of the plurality of pairs of cardiac pads (Jones [0035] “different defibrillation electrodes can be provided with different drugs and different doses of drugs”).
Regarding claim 10, Nova as modified discloses the system of claim 1 wherein the medication delivery mechanism is formed of non-metallic components thereby avoiding interference with delivery of the defibrillation shock to the patient (see Jones [0011] which is included in the modification made in claim 1 above, the medication is incorporated into a gel electrode and the gel electrode is thus considered to be nonmetallic as claimed and thus avoids interference with delivery of the defibrillation shock since it is this gel electrode which cooperates with the defibrillation shock to deliver the medication in the modified system).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nova et al. (US 20030114885, henceforth Nova) in view of Jones et al. (US 20070150008, henceforth Jones) as applied to claim 2 above, and further in view of Burton et al. (US 20110213335, henceforth Burton).
Regarding claim 3, Nova as modified discloses the AED system of claim 2 wherein the medication can be chosen for a particular indication (see Jones [0002]-[0004], [0031]), that transdermal delivery of the chosen medication is desired to be efficacious (Jones [0004]), and that its system is for use in medical emergencies (Nova [0003] and Jones [0003]).
Nova as modified does not disclose the system wherein the medication includes naloxone. Burton teaches that naloxone is known to be used in emergency situation such as drug overdoses ([0066]) and that naloxone shows similar administrative results between intravenous injection and subcutaneous injection ([0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the cardiac pads of Jones in the system of Nova to deliver naloxone as claimed as Burton teaches naloxone to be a drug administered in emergency situations ([0066]) and the system of Nova as modified is used in similar emergency situations (Nova [0003] and Jones [0003]) and because Burton teaches that administration of naloxone across the skin barrier by a wearable patch can deliver similar efficacy results to an intravenous injection which is the other known mode of administration ([0069]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nova et al. (US 20030114885, henceforth Nova) in view of Jones et al. (US 20070150008, henceforth Jones) as applied to claim 1 above, and further in view of Savage et al. (US 20100241181, henceforth Savage).
Regarding claim 5, Nova as modified discloses the AED system of claim 1.
Nova as modified does not disclose the system further comprising a clip mounted to an exterior of the enclosure, wherein the clip is configured for clipping the AED system to a location for carrying the AED system. Savage teaches an AED system (defibrillator 1100, figs. 11A and 11B) comprising a clip ([0085]) mounted to an exterior of an enclosure (see [0085] and figs. 11A and 11B, the clip taught in Savage is understood to be on the exterior part of the housing of defibrillator 1100 such as to be wearable on a belt as shown in the figures; if the clip were not arranged on an exterior, it would not be functional as there would be no means for the clip to reach the belt 1102 if it weren’t externally arranged) wherein the clip is configured for clipping the AED system to a location for carrying the AED system (see figs. 11A and 11B, the location for carrying defibrillator 1100 is belt 1102 and the clip is configured as claimed, see also [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a clip to the exterior of the enclosure for clipping the AED system to a location for carrying the AED system as in Savage as the clip allows the AED to be wearable by a user and increases portability (see Savage [0050]-[0052] and [0085]), where increasing portability allows a user to comfortably carry the system while pursuing activities of daily living, and where this convenience increases accessibility in time critical emergency situations (Savage [0050]-[0052]).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nova et al. (US 20030114885, henceforth Nova) in view of Jones et al. (US 20070150008, henceforth Jones) as applied to claim 1 above, and further in view of McAllister et al. (US 20160213908, henceforth McAllister).
Regarding claim 6, Nova as modified discloses the AED system of claim 1 wherein different drugs are used across multiple sets of defibrillation electrodes and instructions are present for a user to know which set of electrodes to use (Jones [0035]). Nova as modified additionally discloses that its electrodes must be packaged to remain sterile (Nova [0048]).
Nova as modified does not explicitly disclose the system wherein at least one of the cardiac pads in the pair of cardiac pads includes a medication identification feature for identifying the medication integrated thereon. McAllister teaches a patch (patch 100A, fig. 1A) which is adhered to the skin (see fig. 11) and delivers a drug across the skin barrier ([0009]). McAllister teaches that packaging for this patch, which is a part of the patch, includes a medication identification feature for identifying the medication integrated thereon (label on backing layer as in [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a medication identification feature for identifying the medication integrated onto the electrode patches of Jones as in McAllister for providing drug identity and dosage, especially where multiple drugs are integrated into varying electrode sets, for providing manufacturing information, for providing instructions, or for providing expiration dates as in McAllister ([0039]). Addition of such an information feature could be added to the packaging for the electrode patches such as backings for the electrodes as the electrodes are adhesive and would need some kind of backing or packaging to prevent them from sticking to each other or losing sterility.
Regarding claim 7, Nova as modified discloses the AED system of claim 6 wherein the medication identification feature includes at least one of a radio frequency identification (RFID) chip, a near infrared (NIR) chip, an identification circuit, a liner label, an electrode protector label, an adhesive label, and a package label (liner adhesive label as in McAllister [0039]).
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicant has argued that the teachings of Jones do not teach the claimed limitations where the claimed defibrillation shock is different from the electromotive force applied from the teachings of Jones. Examiner respectfully disagrees as a defibrillation shock is considered to be an electrical shock from a defibrillator, and this interpretation is met in the rejections above since an electromotive force provided from an electric field from a defibrillator is thus a shock from a defibrillator and is thus a defibrillator shock as claimed. The claim does not provide specific values or durations which the defibrillator shock must meet.
Additionally, regarding claim 2, Applicant argues that Jones does not teach a transdermal patch as claimed. Examiner respectfully disagrees as the gel layer is a patch which is configured for moving medication transdermally when the defibrillator shock is applied such that the medication in the gel layer can be administered to the patient.
Thus, Examiner respectfully finds Applicant’s arguments unpersuasive and rejects the pending claims as indicated in the rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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