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
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (any paragraphs cited come from PGPUB 2024/0238604, representative of the specification of the instant application):
Claim 1
A securement device configured to allow for removable installation of a respective sensing electrode
This limitation utilizes the generic placeholder “device”, transitional phrase “configured to” and functional language “allow for removable installation”. The preceding term “securement” does not apply specific structure that performs the function.
The specification states the following in paragraph 49: “In one example, the securement device includes a ring formed on the movable portion and configured to engage the respective sensing electrode.”
Claim 6
An attachment device… configured to secure the sensing electrode to the garment
This limitation utilizes the generic placeholder “device”, transitional phrase “configured to” and functional language “secure”. The preceding term “attachment” does not apply specific structure that performs the function.
The specification states the following in paragraph 165: “Referring again to FIG. 5A, in certain examples, the attachment device 504 is made of a flexible material, such as a fabric, Nylon, polymer, or flexible plastic, for example. The holder 502 may be made of a rigid or semi-rigid material.” And also, “In some examples, the holder 502 is made of a thermoplastic or polymer material. In other examples, the holder 502 is made from another type of plastic material or metal.” Paragraph 166 continues to describe the manner by which the attachment device is secured to the garment.
Claim Rejections - 35 USC § 112
Second Paragraph
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 1-20 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 1 is rejected because “a guide” is unclear. In paragraph 137 of the PGPUB of the application, the guide is discussed. However, there is no clear and defining structure described that makes it clear what the guide actually is. “In some examples, the sensing electrode receptacle may include a guide configured to align the respective sensing electrode with one of the plurality of predetermined anatomical locations of the patient's thorax… Accordingly, a benefit to providing such a guide is to assist the patient in achieving the proper placement and alignment of the sensing electrodes quickly and easily. The guide may be implemented as part of the casing in some examples. In some examples, the guide may include an alignment component that is integrated with the garment and configured to engage the sensing electrode so as to align the sensing electrode with respect to the sensing electrode receptacle and/or a selected anatomical location on the patient's thorax.” None of this makes it understandable what the claimed “a guide” truly is.
Paragraph 160 states that “the holder 502 includes one or more features that function as a securement device to removably secure the sensing electrode 112 at least partially within the sensing electrode receptacle 500 and as a guide to align the sensing electrode with one of the predetermined anatomical locations on the patient's thorax.”
Paragraph 164 states that “The second holder portion 514 may function as a guide to align the sensing electrode 112”.
Therefore, it is unclear what actual structure comprises “a guide”.
Claims 2-20 are rejected for their dependency on 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.
Claims 1-6, 9 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al. (US Patent Pub. No. 2019/0298987) in view of Komoto et al. (US Patent Pub. No. 2017/0279230).
Regarding claim 1, Freeman discloses “a wearable cardiac monitoring and treatment device includes a garment, a plurality of ECG electrodes and a plurality of therapy electrodes supported by the garment” (see Abstract). Specifically, Freeman teaches an ambulatory cardiac device (see at least Figures 1, 4A-4B, 12A-12B and paragraph 160, “FIG. 1 illustrates an example medical device 100 that is external, ambulatory, and wearable by a patient”) for providing comfortable, long-term continuous cardiac monitoring and treatment for arrythmia conditions (note: this is intended use and not structurally limiting the device), the device comprising:
a plurality of sensing electrodes configured to detect electrocardiogram (ECG) signals of an ambulatory patient (see numerals 112a-d in Figures 4A and 12A-12B; see paragraph 188, “plurality of sensing electrodes 112 (e.g., 112a-g)”; see paragraph 201, “the ECG sensing electrodes 112 can be disposed at various predetermined locations”);
a garment configured to be worn about the patient’s thorax (see at least Figure 1 illustrating the garment of Freeman being worn around a patient’s thorax);
a plurality of sensing electrode receptacles (see paragraph 192-197, “In examples, the garment 110 includes receptacles, such as pockets or compartments, for receiving one or more of the therapy electrodes 114 and sensing electrodes 112”) configured to
dispose, via the garment, the plurality of sensing electrodes at a plurality of predetermined anatomical locations on the patient’s thorax (see paragraph 201, “the ECG sensing electrodes 112 can be disposed at various predetermined locations”; see at least Figures 1, 4A-4B and 12A-12B illustrating said predetermined locations);
maintain, via the garment, contact between the plurality of sensing electrodes and the plurality of predetermined anatomical locations despite movement of the patient’s thorax (see paragraph 23, which states that Freeman teaches “a wearable cardiac monitoring and treatment device includes a garment configured to be worn about a torso of a patient for an extended period of time, a plurality of ECG sensing electrodes supported by the garment and configured to be in electrical contact with the patient”; also see paragraph 152), wherein each sensing electrode receptable forms an opening in the garment (see at least paragraph 192, “the garment 110 includes receptacles, such as pockets or compartments, for receiving one or more of the therapy electrodes 114 and sensing electrodes 112”; and paragraph 196, “the receiving receptacle or receptacles may be pockets formed so that the pocket narrows from front-to-back depth along the length of the pocket from the opening to the bottom of the receptacle“) and comprises
a securement device… a lock… a guide… (which will each be taught below via the Komoto reference); and
a plurality of removable therapy electrodes (see Figures 1, 4A-4B and 12A-12B; see paragraph 188, “FIGS. 4A and 4B are front and rear views respectively of a patient wearing an example garment 110. As shown, in this example, the plurality of therapy electrodes 114 (e.g., 114a-c)”, and note the teaching of receptacles in paragraphs 192-197, “the garment 110 includes receptacles, such as pockets or compartments, for receiving one or more of the therapy electrodes 114”) configured to deliver a treatment to the patient in response to the ambulatory cardiac device detecting a cardiac arrhythmia condition indicated by the ECG signals (see at least paragraph 36, “The controller is configured to detect an arrhythmia condition of the patient based on the monitored ECG signal of the patient, and cause the therapy delivery circuit to deliver the one or more therapeutic pulses to the patient on detecting the arrhythmia condition.”).
It is noted that Freeman provides details of the garment in which the sensing and/or therapy electrodes are permanently part of the garment, but the teachings in paragraphs 192-197 to the receptacles would make it obvious to one of ordinary skill in the art at the time of filing of the Freeman reference that the use of these receptacles could make the electrodes removable and replaceable (see paragraph 194, “The receiving receptacle or receptacles may be formed on or in the garment and may be sized to tautly hold the received electrical component. For example, the receiving receptacle or receptacles may be pockets formed of an elastomeric fabric or polymer that stretches to receive an electrical component and then contracts around the component to prevent dislodging”).
However, the receptacles are shown and described to be shaped and configured as in Figures 41A-41B, and therefore receptacles for the sensing electrodes do not comprise each of “a securement device”, “a lock” and “a guide”.
Komoto teaches “a slide connector that is to be connected to a wearable device” (see paragraph 1). “Such a wearable device is electrically connected to a device like a measuring device … to be used to transmit detected information … . While the electrical connection can be established via a connector attached to a garment, the connection via a connector has to be disconnected, for example, when the wearable device is removed and when the garment is washed” (see paragraph 2). The slide connector of Komoto comprises
a securement device configured to allow for removable installation of a respective sensing electrode (see garment-side connector portion 11, including Figures 1, 2A, 13, etc.),
a lock configured to inhibit movement of the respective sensing electrode separate from the sensing electrode receptacle (see “a plurality of locking portions 14 formed in the garment-side connector body 12” in paragraph 44 and Figure 2A, also see notches and locking surfaces 19 and 20 in Figures 6-7, within which “the portions to be locked 34 correspond to the locking portions 14 of the garment-side connector portion 11 and also to the notches 19” – see paragraph 61-62 and Figure 11),
a guide configured to align the respective sensing electrode with one of the plurality of predetermined anatomical locations of the patient’s thorax through the opening (see notches 19 within frame member 16, see Figures 6 and 7; also see Figure 8 which illustrates frame member 16 and base member 15 placed within the garment C such that the electrode is placed within an opening in the garment C – see paragraph 54)). In a second interpretation of “a guide”, it can be seen in Figure 8 of Komoto that there is a first annular holder portion 16 located on a top side (i.e., a side facing away from the patient) and a second annular holder portion 15 located on a bottom side (i.e., a side facing the patient), where the second annular holder portion 15 is “a guide”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the electrode slide connector, as taught by Komoto, within the system and methods of Freeman because although Freeman does not expressly teach a receptacle with securement device, lock and guide, the reference does generally teach the use of receptacles for its sensing electrodes, and slide connectors having the claimed features are well known in the art for electrode connectors within garments; accordingly, thus the use of either one to perform the method taught by Freeman would amount to choosing from a finite number of electrode connector mechanisms available in the art at the time of the invention, which has previously been held as unpatentable (KSR v. Teleflex).
Regarding claim 2, Komoto teaches a securement device that includes a first annular holder (see numeral 16 in Figure 8) at least partially surrounding the opening (see opening in garment C within Figure 8).
Regarding claim 3, Komoto teaches notches 19 and corresponding locking surfaces 20 within the holder (see Figures 6-7), which is a plurality of grooves as claimed, and within which “the portions to be locked 34 correspond to the locking portions 14 of the garment-side connector portion 11 and also to the notches 19” (see paragraph 61-62 and Figure 11), where “the portions to be locked 34” are on the housing of the electrode housing 31 itself.
Regarding claim 4, it can be seen in Figure 8 of Komoto that there is a first annular holder portion 16 located on a top side (i.e., a side facing away from the patient) and a second annular holder portion 15 located on a bottom side (i.e., a side facing the patient). Both of these annular holder portions fully surround the opening in the garment.
Regarding claim 5, Freeman teaches that “the embodiment of the device 100 of FIG. 12A includes a plurality of soft-molded mounting pods 113a-h (collectively 113) configured to receive the plurality of sensing electrodes 112 and therapy electrodes 114… The soft-molded mounting pods 113 may be manufactured of a flexible thermoform material for holding an inserted element securely in tension on or within the garment 110” (see paragraph 223). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a thermoplastic as the specific thermoform material, as thermoplastics are flexible and provide for the requirements described by Freeman in paragraph 223.
Regarding claim 6, while Komoto does not explicitly teach how the garment-side connector portion 11 is attached to the cloth C (see Figure 8 of Komoto), Freeman teaches that “The mounting pods 113 may be sewn, glued, or welded to the garment 110 of the device 100” (see paragraph 223 of Freeman).
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Regarding claim 9, Freeman teaches the configuration of the garment as claimed, as illustrated in the annotated reproduction of Figure 12A to the right.
Regarding claim 12, it is noted that Figure 12A of Freeman (illustrated immediately above) clearly illustrates “a cabling harness coupled to the plurality of sensing electrodes, the cabling harness including at least one wire electrically connected to each respective sensing electrode”, as claimed. Also see paragraph 228 which mentions “Concealing the wire 121 and/or routing the wire 121 elsewhere other than against the skin of the patient improves comfort during the prescribed duration of wear. In implementations, the garment 110 includes one or more wire compartments and/or retention loops for routing one or more wire or wires 121”.
Regarding claim 13, it is noted that Komoto teaches that the frame member 16 includes a plurality of fitting holes 21,22 that correspond to external connection portions 13 (see Figures 4 and 5A), which are shown in Figure 8 as connecting to wiring within the cloth C. As such, Komoto teaches a cable guide, as the cables in Komoto are the combination of connectors 13 and wiring 24, which are guided by the fitting holes and the general configuration of the device as shown in Figures 3-8.
Regarding claim 14, Freeman teaches that “In some examples, at least some of the components of the medical device 100 can be configured to be affixed to the garment 110 (or in some examples, permanently secured into the garment 110), which can be worn about the patient's torso. Additional implementations of sensing electrode arrangements and therapy electrode arrangements on a patient-worn medical device are provided herein in subsequent sections” (see paragraph 161). Additionally, Freeman teaches that “In some implementations, the sensing electrodes 112 can be a permanent portion of the garment 110” and “the therapy electrodes 114 can be a permanent portion of the garment 110” (see paragraph 162). Additionally, “In embodiments, the sensing electrodes 112 are assembled into the garment 110 or removably attached to the garment” (see paragraph 161), and “In these examples components of the device, such as the sensing electrodes 112 and therapy electrodes 114, are removably disposed on the garment 110 at selective positions of engagement” (see paragraph 264). As such, Freeman contemplates both permanently affixed and removable sensing electrodes, and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that to provide one (i.e., permanent), the other (i.e., removable), or a combination of both (i.e., any combination of permanent and removable) sensing electrodes as deemed necessary or desirable by one of ordinary skill in the art, as such a modification amounts to substitution of known equivalents to yield predictable results (KSR v. Teleflex).
Regarding claim 15, Freeman teaches that “In some implementations, the therapy electrodes 114 and sensing electrodes 112 are supported between layers of the garment 110, for example, by stitching the layers around the edges of the therapy electrodes 114 or sensing electrodes 112” (see paragraph 188).
Regarding claim 16, Freeman teaches that “In examples, the garment 110 includes receptacles, such as pockets or compartments, for receiving one or more of the therapy electrodes 114 and sensing electrodes 112” (see paragraph 192).
Regarding claim 17, Freeman teaches “The medical device 100 can include one or more of the following: a garment 110, one or more sensing electrodes 112 (e.g., ECG sensing electrodes) configured to be in electrical contact with the patient” (see paragraph 161, emphasis added). Additionally, Freeman teaches that “some embodiments, such as that of FIG. 18, the device 100 includes a garment 110 comprised of or including compartments 152, 153 configured to receive one or more components, such as the sensing electrodes 112… the compartments 152, 153 include one or more conductive resealable closures 104, such as a snap. The one or more resealable closures 104 mate with the component, such as the sensing electrode 112 of FIG. 18C, received in the compartment 152, 153. The one or more resealable closures 104 simultaneously fasten the sensing electrode 112 to the garment 110 and completes an electrical circuit” (see paragraph 240). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that this compartment illustrated in Figure 18C housing a sensing electrode would comprise an additional opening that allows the sensing electrode to “be in electrical contact with the patient” (see paragraph 161), because if this did not occur then it would not result in the stated garment 100 described in paragraph 161. In paragraph 229, Freeman also teaches that in another embodiment with a sensing electrode enclosure, “the sensing electrode 112, for example an ECG sensing electrode, is configured to be held in a resealable compartment 152 and pressed through an aperture 105, or opening, in the garment 110 to contact the skin of the patient.”
Regarding claim 18, Freeman teaches that “receiving receptacle or receptacles may be pockets formed of an elastomeric fabric or polymer that stretches to receive an electrical component and then contracts around the component to prevent dislodging” (see paragraph 194).
Regarding claim 19, Freeman teaches that “some embodiments, such as that of FIG. 18, the device 100 includes a garment 110 comprised of or including compartments 152, 153 configured to receive one or more components, such as the sensing electrodes 112… the compartments 152, 153 include one or more conductive resealable closures 104, such as a snap. The one or more resealable closures 104 mate with the component, such as the sensing electrode 112 of FIG. 18C, received in the compartment 152, 153. The one or more resealable closures 104 simultaneously fasten the sensing electrode 112 to the garment 110 and completes an electrical circuit” (see paragraph 240).
Regarding claim 20, Freeman teaches that “In some examples, the receiving receptacle or receptacles are shells formed of a polymer and sized and shaped to receive an electrical component in only one direction and orientation. The formed receptacle may include one or more features for accommodating orienting features on the surface of the electrical component, such a surface bevel or a protruding electrical connector” (see paragraph 197). These protruding electrical connectors are illustrated as numerals 5012a and 5012b in Figures 41A and 41B, respectively. This reads on “at least one protrusion formed on an interior of the pouch at an end of the pouch opposing the first opening, the at least one protrusion configured to engage the respective sensing electrode to secure the respective sensing electrode within the pouch.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Komoto as applied to claim 9 above, further in view of Divinksy et al. (WO 2019/159009).
Freeman in combination with Komoto is described above with respect to claim 6. However, it is noted that neither Freeman nor Komoto teaches an attachment device made of fabric.
Divinsky teaches a garment that includes a sensor attachment portion including a sensor mount configured to receive and retain a sensor therein (see Abstract). “FIG. 18 shows a top view of a portion of the sensor attachment portion 1750. The sensor attachment portion 1750 is surrounded by a multi-layered structure including a first fabric layer 1800, a second fabric layer 1810, a flexible printed circuit board 1820, an elastic polymer sheet 1830, a third fabric layer 1840, and a fourth fabric layer 1850” (see paragraph 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use fabric located at the outer perimeter of a sensor or electrode holder/mount, as taught by Divinsky, within the system and methods of Freeman with Komoto to add additional securing measures to ensure the electrodes remain securely on the garment and in contact with the patient (see Title of Divinsky).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Komoto as applied to claim 9 above, further in view of Skeros et a. (CN 205163920 U).
Freeman in combination with Komoto is described above with respect to claim 1. Freeman teaches “the device 100 includes relational numbering for pairing electronic components (e.g., sensing electrodes 112, therapy electrodes 114, and connection pod 130, among others) with associated soft-molded mounting pods 113. The patient assembles the device 100 from left to right in numbered order” (see paragraph 223), but does not teach that these are color-coded.
Skeros teaches a vest-type garment and electrode assembly (see Abstract and Figures 1-4). “In one embodiment, as the example mark, the side of four hook-and-loop fastener fitting 106 on 114 are color-coded red, yellow, green and blue. guiding patient sensing electrode such as energy transmitting device may use hook-and-loop fastener fitting various colours 114 to match the corresponding color of a cardiac sensor, as shown in FIG. 2B” (see page 5, the first paragraph starting with the number “100”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use color-coding of mounting members to electrode pairs, as taught by Skeros, in place of or in addition to the number-coding taught by Freeman, thereby removing the need for the patient to “assemble the device 100 from left to right in numbered order” and provide more ease of use.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Freeman in view of Komoto as applied to claim 9 above, further in view of Itagaki et al. (WO 2021/177171).
Freeman in combination with Komoto is described above with respect to claim 9. However, there is no teaching of a flap in either of these references as required by claim 10.
Itagaki teaches a biosignal monitoring wearable item (see Abstract and Title) which is a vest type garment (see Figure 1). “As shown in FIG. 4, the front body 31 includes a cloth mount 38 to which the conduction unit 10 is attached, a unit cover 39 that covers the conduction unit 10, and a fixing portion 41” (see page 7, last paragraph). In Itagaki, the cloth mount 38 connects to the conduction unit 10, to which the electrodes are connected. As seen in Figure 5, the conduction unit 10 is covered by the unit cover 39, which reads on the claimed “belt flap”, and within which “electrode connector hole 58 exposes the electrode connector 2b from the unit cover 39” (see page 9, second full paragraph beginning “The electrode connector holes 57-59…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a unit cover (i.e., flap), as taught by Itagaki, within the system and methods of Freeman as combined with Komoto in order to provide additional protection from electrical components (see page 9, paragraph beginning “FIG. 5 is a diagram…”).
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Regarding claim 11, it is re-iterated that Itagaki teaches “a unit cover 39 that covers the conduction unit 10” (see page 7, last paragraph; see rejection of claim 10 immediately above). Specifically, it is noted that the purpose of this unit cover (i.e., a covering component) is to cover the electrical components that provide connectivity to the electrodes. In a first interpretation of the claim and prior art, the flap of Itagaki reads on the claimed subject matter of claim 11, because based on the reproduced Figure 12A of Freeman above, the corresponding locations of the Itagaki garment would be as shown to the left. However, in the event that the applicant disagrees with this characterization and application of Itagaki, then it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide either a single larger unit cover 39 when Itagaki is combined with the teachings of Freeman, or to provide additional unit cover(s) 39, because Freeman includes additional electrodes on an upper body portion of its garment, to which electrical connectivity will be required. When additional electrodes and connectivity are required by Freeman in this way, then the teaching of the unit cover 39 of Itagaki would make it obvious to one of ordinary skill in the art to provide the benefit of covering the electrical components anywhere/everywhere the additional electrodes are located, including on the body region, the shoulder portion(s) the side portion(s), or any other location of electrodes, to provide the same benefits to those electrodes and locations as is provided to the region expressly illustrated and taught by Itagaki.
Conclusion
Additional prior art made of record as considered pertinent to applicant's disclosure, but not relied upon in the rejections above, can be found on the PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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