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 .
Election/Restrictions
Applicant’s election without traverse of Species A (directed to claims 1, 2, 5-8, 10-12, 14, and 15) in the reply filed on 06/02/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement (IDS) dated 06/06/2024 has been considered by the Examiner.
Claim Objections
Claim 15 objected to because of the following informalities: “configured generate ECG information” should read “configured to generate ECG information”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, 8, 10, and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hulings et al (US 6065154 A).
Regarding claim 1, Hulings teaches a non-invasive wearable ambulatory cardiac defibrillator (10) comprising:
a garment (26) configured to be worn around a torso of a patient (see Fig. 1; chest garment 26);
at least one sensing electrode (46) attached to the garment and configured to sense electrical signal(s) at the surface of the patient's skin indicative of electrical activity of the patient's heart (see [Col 6, lines 24-25]; the signal is sensed by the sensing electrodes 46 in real time);
at least one therapy electrode attached to the garment (see Fig. 5, [Col 5, lines 30-31]; two rear energy delivery electrodes 38 and the front energy delivery electrode 56) and configured to deliver one or more defibrillation pulses to the patient; and
a controller (monitor-defibrillator 12) in communication with the at least one sensing electrode and the therapy electrodes,
the controller configured to receive the electrical signal(s) from the at least one sensing electrode and to cause delivery of the one or more defibrillation pulses from the at least one therapy electrode based on the controller detecting a cardiac arrhythmia in the received electrical signal(s) (see [Col 4, lines 4-10]; the housing of energy delivery electrodes 38 releases a conductive gel upon receipt of a signal from the monitor-defibrillator 12 after declaration by the detection circuitry within the monitor-defibrillator of the occurrence of a treatable cardiac condition);
wherein the garment (10) comprises:
a main garment portion configured to engage the torso of the patient (see Fig. 3; chest garment 26);
an isolation zone material (see Fig. 4a; port 62) disposed within the main garment portion and to which one of the sensing electrodes (46) is attached (see Fig. 4a, [Col 4, lines 36-50]; electrode ports include elastomeric O-ring 66 sandwiched between the inner layers of the garment which impart shape to the electrode port 62 so that the electrode 46 may be removably attached to port 62); and
at least one movement absorption region (98) connecting the main garment portion to the isolation zone material (see Fig. 4a; elastomer 98 disposed between the electrode port and the main garment),
the at least one movement absorption region having a different elasticity than the main garment portion and the isolation zone material (see [Col 6, lines 13-16]; the areas surrounding sensing electrode zones 44 may be covered or coated with a high-friction elastomer 98 which surrounds the electrode housings to preclude movement relative to the skin, wherein it can be appreciated that the main garment 42 is made of a soft, body-contacting fabric, preferably a Coolmax-Lycra blend, which would exhibit a different elasticity than the high-friction elastomer 98 by nature of their purposes within the garment wherein the elastomer 98 is used to preclude movement relative to the skin and the main garment is made of fabric with the goal of conforming to the shape of the user).
Regarding claim 2, Hulings teaches the defibrillator of claim 1, wherein the at least one movement absorption region (98) comprises:
a different stiffness than at least one of the main garment portion and the isolation zone material (see [Col 6, lines 13-16]; the areas surrounding sensing electrode zones 44 may be covered or coated with a high-friction elastomer 98 which surrounds the electrode housings to preclude movement relative to the skin, [Col 4, lines 18-23]; chest garment 26 includes inner layer 42 on which the electrodes are disposed, and the inner layer 42 is preferably assembled from a soft, body-contacting fabric, most preferably a Coolmax-Lycra blend; therefore it can be appreciated that the high-friction elastomer 98 exhibits a different stiffness than the soft conformable fabric of the main garment by nature of their purposes within the garment wherein the elastomer 98 is used to preclude movement relative to the skin and the main garment is made of fabric with the goal of conforming to the shape of the user).
Regarding claim 5, Hulings teaches the defibrillator of claim 1, wherein the garment further comprises a plurality of connecting portions (44) extending between the main garment portion (42) and the isolation zone material (62, see [Col 4, lines 21-22]; zones 44 are provided in the inner layer 42 for placement of sensing electrodes 46).
Regarding claim 8, Hulings teaches the defibrillator of claim 1, wherein the isolation zone material is rectangular or circular (see Fig. 4a; isolation zone/port 62 is circular).
Regarding claim 10, Hulings teaches the defibrillator of claim 1, wherein the isolation zone material (62) comprises a reinforcing support film (66) to which the one of the sensing electrodes (46) is attached (see Fig. 4a, [Col 4, lines 37-40]; holes or ports 62 include elastomeric o-rings 66 sandwiched between the inner Coolmax-Lycra layers in order to impact shape for the port 62 and provide a retaining member surrounding the sensing electrode button heads).
Regarding claim 14, Hulings teaches the defibrillator of claim 1, wherein the garment further comprises a plurality of isolation zones (62), wherein each of the at least one sensing electrode (46) is attached to one of the plurality of isolation zone materials (see Fig. 3 and Fig 5; wherein there are multiple electrode zones 44 on the chest garment 26, wherein each electrode zone 44 has a port 62 in order to removably attach electrode 46).
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 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Huling et al (US 6065154 A).
Regarding claims 6 and 7, Huling teaches the defibrillator of claim 1. Huling is silent regarding
wherein the at least one movement absorption region comprises a plurality of movement absorption regions arranged around a perimeter of the isolation zone material, and
wherein each of the plurality of movement absorption regions is arcuate.
However, it can be appreciated that as seen in Figs. 3 and 4a, the movement absorption region 98 has a circular shape which is arranged around a perimeter of the isolation zone material.
Therefore, in this instance, a device having the claimed arrangement/shape of the movement absorption region(s) would not perform differently from the prior art device disclosed by Huling, at least because both elements define a region surrounding the isolation zone and absorbing motion so that the electrode may remain in the desired location regardless of patient motion. Dividing the circular movement absorption region taught by Huling into a plurality of arc-shaped regions would have no patentable effect on the device or its expected function, and therefore the claimed invention is obvious over and not patentably distinct from the prior art device.
See MPEP 2144.04(IV)(A) which states: In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
See MPEP 2144.04(IV)(B) which states: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Huling et al (US 6065154 A) in view of Volpe et al (US 20130085538 A1).
Regarding claims 11 and 12, Huling teaches the defibrillator of claim 1, wherein the movement absorption region and the garment are configured to induce a normal force on the electrodes to keep the electrodes in the desired place (see [Col 4, lines 64-66]; unequal omnidirectional and bi-directional stretch of the fabrics has been implemented to apply the necessary forces onto the various electrodes in the harness, [Col 6, lines 13-17]; the areas surrounding the sensing electrode zones 44 may be covered or coated with a high-friction elastomer 98 which surrounds the electrode housing to preclude movement relative to the skin).
Huling is silent regarding wherein the normal force induced on one of the sensing electrodes ranges from about 0.1 psi to about 0.6 psi, or about 0.3 psi to about 0.6 psi.
Volpe teaches a wearable therapeutic device configured to be worn on the torso of a patient (see Volpe Fig. 2) and
comprising at least one sensing electrode (135) and at least one therapy electrode (140), and
a controller configured to evaluate information received from the sensing electrode to determine that subject is or is not in need of therapy to treat a cardiac event, and
can direct therapy electrode and defibrillator to apply treatment to subject (Volpe [0064]),
wherein the garment has stretchable portions which apply a force on the subject’s body in order to maintain the desired position of the electrodes, wherein the garment may exert between 0.050 lb and 1.70 lb of force on the subject’s body (Volpe [0065]).
Both Huling and Volpe seek to maintain the position of the electrodes on the patient’s body regardless of patient motion, and do so by applying a force to the electrodes to hold them in place. Neither Huling or Volpe disclose wherein the force applied to the electrodes is between about 0.1 psi to about 0.6 psi, or about 0.3 psi to about 0.6 psi. However, MPEP 2144.05(II)(A) states that: "[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). The general conditions of applying a normal force to the sensing electrodes in a wearable garment are disclosed by the prior art, and determining the optimum or workable ranges for the applied force would only require routine experimentation by someone of ordinary skill in the art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Huling et al (US 6065154 A) in view of Freeman et al (US 20190298987 A1).
Regarding claim 15, Huling teaches the defibrillator of claim 1, wherein the controller is configured to receive an electrical signal from the at least one sensing electrode and to cause delivery of the one or more therapeutic pulses from the at least one therapy electrode (see [Col 4, lines 4-10]; the housing of energy delivery electrodes 38 releases a conductive gel upon receipt of a signal from the monitor-defibrillator 12 after declaration by the detection circuitry within the monitor-defibrillator of the occurrence of a treatable cardiac condition).
Huling is silent regarding wherein the controller is configured to generate ECG information from the electrical signals received from the at least one sensing electrode.
Freeman teaches a non-invasive wearable ambulatory cardiac defibrillator (see Freeman [0160]; medical device 100 is external, ambulatory, and wearable by a patient) comprising:
a garment (110) configured to be form around the torso of a patient (see Freeman Figs. 1 and 4a),
at least one sensing electrode (112) attached to the garment and configured to sense electrical signal(s) at the surface of the patient's skin indicative of electrical activity of the patient's heart (see Freeman [0162-0163]; the sensing electrodes 112 are assembled into the garment 110 or removably attached to the garment, and can be configured to detect one or more cardiac signals such as ECG signals);
at least one therapy electrode (114) attached to the garment and configured to deliver one or more defibrillation pulses to the patient (see Freeman [0164]; therapy electrode 114 is configured to deliver one or more therapeutic defibrillating shocks to the patient); and
a controller (120) in communication with the at least one sensing electrode and the therapy electrodes,
wherein the controller is configured generate ECG information from the electrical signal(s) received from the at least one sensing electrode and to cause delivery of the one or more therapeutic pulses from the at least one therapy electrode (see [0164]; therapy electrode 114 is configured to deliver one or more therapeutic defibrillating shocks to the body 102 of the patient when the medical device 100 determines that such treatment is warranted based on the signals detected by the sensing electrodes 112 and processed by the medical device controller 120).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Huling’s sensing electrodes with Freeman’s ECG sensing electrodes. One of ordinary skill in the art would have been motivated to make this modification in order to continually monitor the patient and receive up to date cardiac information regarding the patient’s physiological state and to detect a cardiac event and deliver the appropriate care (Freeman [0157]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kaib et al (US 20110288604 A1) which teaches a wearable therapeutic device that includes a garment configured to contain an external defibrillator.
Hill et al (US 20180243549 A1) which teaches a support garment for a wearable medical device.
Leonhardt et al (US 7315754 B2) which teaches an electrode belt having at least one elastic portion.
Freeman et al (US 20200206518 A1) which teaches a wearable medical device response mechanism.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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