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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 filed on August 18, 2026 has been entered. By this amendment, claims 1, 6, 7, 10, 11, 14, 16, and 17 are amended, claims 2 and 15 are cancelled, and claims 1, 3-14, 16, and 17 are now pending in the application.
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)(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, 3-5, 8-10, 14, 16, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Trapero Martin (U.S. 2022/0128950) under Interpretation A. Regarding claim 1, Trapero Martin discloses a sensing system for sensing biological signals externally on a patient, comprising: a medical device 100/100a/100b/100c/100d comprising at least one electrode 224/304 for sensing biological signals on a patient (see Figures 1, 3-6, and 12, “the connecting member 224 can be a metal electrode”, paragraph [0061], and “one or more lateral electrodes 304”, paragraph [0067]); an adapter element 224/225/227 mountable on said at least one electrode to electrically contact with the at least one electrode (connecting member 224 is described as “the connecting members 224 are electrodes in contact with snap electrode buttons that facilitate connecting the connecting member 224 to the adhesive patch. The snap electrode buttons include conductive materials, e.g., silver or silver chloride.”, paragraph [0069], and thus the adapter portion of element 224 is the snap button, while the electrodes are the electrode portion); a fastening component 1225 mountable on said adapter element and configured to attach the medical device externally to the patient (see Figures 12, 14 and 16 and “connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100.”, paragraph [0093]); a contact element 1202 mountable to the fastening component and configured to attach externally to the patient's skin, the contact element including a skin surface electrode for receiving skin surface biological signals and conducting said skin surface biological signals to the adapter element (“The electrodes 1202 can make physical contact to the skin of the user through the second surface (not shown) of the substrate, and the connecting members 1225 are provided on the first Surface 1210 of the substrate.”, paragraph [0093]); and a casing 102/1500 for encasing the medical device and the adapter element in a mounted state in which the adapter element is mounted on said at least one electrode (see Figures 1, 3-6, 12, 15, and 16). It is respectfully submitted that the recitations “implantable electrode for sensing biological signals inside a patient”, “wherein the medical device is implantable into the patient, said at least one implantable electrode being configured to electrically contact internal biological tissue to sense biological signals in an implanted state of the medical device” and “with the medical device in an unimplanted state” fail to further define the claimed invention over that of the prior art because they are directed to intended uses of the device and the intention for the device to be a device capable of being implanted (“implantable”), but the device being used in an unimplanted state. The device of Trapero Martin would be capable of implantation and the electrodes, which are intended to contact biological tissue to sense biological signals would be configured to measure such signals whether externally located or implanted. As such, Trapero Martin is considered to satisfy these claim limitations.
Regarding claim 3, Trapero Martin discloses that the medical device is a bio-sensor for sensing electrocardiogram signals (“the connecting members 224 and the lateral electrodes 304 can be used for either ECG measurements”, paragraph [0068]).
Regarding claim 4, Trapero Martin discloses that the fastening component is releasably connectable to said adapter element (“the connecting members 1225 are male snap connectors, other embodiments where the connecting members 1225 are female snap connectors or flat electrodes can be contemplated”, paragraph [0093], where snap connectors are known to be “releasably connectable” to corresponding snap connectors).
Regarding claim 5, Trapero Martin discloses that at least one of the medical device and the adapter element are removable from the casing (casing 1500 is shown in Figure 16 of going over medical device 100 and, thus, medical device 100 and adapter element 224 within medical device 100 are considered “removable from the casing”).
Regarding claim 8, Trapero Martin discloses that the medical device comprises a housing forming a main housing portion and a header portion extending from the main housing portion (designation of “main housing portion” and “header portion” are arbitrary designations that fail to limit the structure of the medical device), and an electronics module 206/208 being arranged in or on the main housing portion (see annotated Figure 8 below).
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Regarding claim 9, Trapero Martin discloses that the header portion linearly extends from the main housing portion (see annotated Figure 8 above).
Regarding claim 10, Trapero Martin discloses that a first electrode is placed on the header portion and a second electrode is placed on the main housing portion (see annotated Figure 8 above where electrodes 225 are shown in both the main housing portion and the header portion).
Regarding claim 14, Trapero Martin discloses a method for providing a sensing system for sensing biological signals externally on a patient, comprising: providing a medical device 100/100a/100b/ 100c/100d comprising at least one electrode 224/304 for sensing biological signals on a patient (see Figures 1, 3-6, and 12, “the connecting member 224 can be a metal electrode”, paragraph [0061], and “one or more lateral electrodes 304”, paragraph [0067]); mounting an adapter element 224/225/227 on said at least one electrode to electrically contact with the at least one electrode (connecting member 224 is described as “the connecting members 224 are electrodes in contact with snap electrode buttons that facilitate connecting the connecting member 224 to the adhesive patch. The snap electrode buttons include conductive materials, e.g., silver or silver chloride.”, paragraph [0069], and thus the adapter portion of element 224 is the snap button, while the electrodes are the electrode portion); providing a fastening component 1225 mountable on said adapter element and configured to attach the medical device externally to the patient (see Figures 12, 14 and 16 and “connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100.”, paragraph [0093]); providing a contact element 1202 mountable to the fastening component and configured to attach externally to the patient's skin for receiving biological signals and conducting said biological signals to the adapter element (“The electrodes 1202 can make physical contact to the skin of the user through the second surface (not shown) of the substrate, and the connecting members 1225 are provided on the first Surface 1210 of the substrate.”, paragraph [0093]); and encasing, using a casing 102/1500, the medical device and the adapter element in a mounted state in which the adapter element is mounted on said at least one electrode (see Figures 1, 3-6, 12, 15, and 16). Further, it is respectfully submitted that the broadest reasonable interpretation for the term “implantable” is something that is capable of being implanted or inserted into a body, i.e. something that is of an appropriate size and shape to be placed inside the body. As such, it is respectfully submitted that the medical device Trapero Martin is of an appropriate size and shape such that it is capable of being implanted into a patient, and, thus, Trapero Martin is considered to disclose that the medical device is implantable into a patient, said at least one electrode being configured to electrically contact internal biological tissue to sense biological signals in an implanted state of the medical device.
Regarding claim 16, Trapero Martin discloses that the medical device comprises an elongate housing, and wherein the at least one electrode 224/304 comprises at least two electrodes provided on the housing and spaced from one another (see Figures 2-6), where the broadest reasonable interpretation for an elongate housing is one having a length greater than its width, whereby the annotated length and width shown in Figure 1 below satisfies this limitation.
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Regarding claim 17, Trapero Martin discloses that the at least two electrodes comprises two electrodes provided on each on either end of the elongate housing (see Figures 3-6).
Claims 1, 3, 5-14, 16, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Trapero Martin (U.S. 2022/0128950) under Interpretation B. Regarding claim 1, Trapero Martin discloses a sensing system for sensing biological signals externally on a patient, comprising: a medical device 100/100a/100b/100c/100d comprising at least one electrode 224/304 for sensing biological signals on a patient (see Figures 1, 3-6, and 12, “the connecting member 224 can be a metal electrode”, paragraph [0061], and “one or more lateral electrodes 304”, paragraph [0067]); an adapter element 1225 mountable on said at least one electrode to electrically contact with the at least one electrode (“connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100.”, paragraph [0093]); a fastening component (first surface 1210 and second surface (not shown)) mountable on said adapter element and configured to attach the medical device externally to the patient (“the patch assembly 1200 includes a substrate with a first surface 1210 and a second surface (not shown) below the first surface 1210”, paragraph [0093] and “Referring to the second surface of the patch assembly 1200c, adhesive coverage is provided everywhere on the surface except where the lateral portion electrode contacts 1204 and electrode contacts 1202 (which could be, for example, dry electrodes, wet electrodes, semi-dry electrodes, etc.) are present.”, paragraph [0100]); a contact element 1202 mountable to the fastening component and configured to attach externally to the patient's skin for receiving biological signals and conducting said biological signals to the adapter element (“The electrodes 1202 can make physical contact to the skin of the user through the second surface (not shown) of the substrate, and the connecting members 1225 are provided on the first Surface 1210 of the substrate.”, paragraph [0093]); and a casing 1500 for encasing the medical device and the adapter element in a mounted state in which the adapter element is mounted on said at least one electrode (see Figures 15 and 16 It is respectfully submitted that the recitations “implantable electrode for sensing biological signals inside a patient”, “wherein the medical device is implantable into the patient, said at least one implantable electrode being configured to electrically contact internal biological tissue to sense biological signals in an implanted state of the medical device” and “with the medical device in an unimplanted state” fail to further define the claimed invention over that of the prior art because they are directed to intended uses of the device and the intention for the device to be a device capable of being implanted (“implantable”), but the device being used in an unimplanted state. The device of Trapero Martin would be capable of implantation and the electrodes, which are intended to contact biological tissue to sense biological signals would be configured to measure such signals whether externally located or implanted. As such, Trapero Martin is considered to satisfy these claim limitations.
Regarding claim 3, Trapero Martin discloses that the medical device is a bio-sensor for sensing electrocardiogram signals (“the connecting members 224 and the lateral electrodes 304 can be used for either ECG measurements”, paragraph [0068]).
Regarding claim 5, Trapero Martin discloses that at least one of the medical device and the adapter element are removable from the casing (casing 1500 is shown in Figure 16 of going over medical device 100 and patch assembly 1200c and, thus, medical device 100 and adapter element 1225 are considered “removable from the casing”).
Regarding claim 6, Trapero Martin discloses that the adapter element is releasably mountable on said at least one electrode (“connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100” and “the connecting members 1225 are male snap connectors, other embodiments where the connecting members 1225 are female snap connectors”, paragraph [0093], where male and female snap connectors are known to be releasable and, thus, the adapter element is releasably mountable on said at least one electrode).
Regarding claim 7, Trapero Martin discloses that the adapter element comprises a body forming a reception opening for receiving said at least one electrode (“connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100”, paragraph [0093]).
Regarding claim 8, Trapero Martin discloses that the medical device comprises a housing forming a main housing portion and a header portion extending from the main housing portion (designation of “main housing portion” and “header portion” are arbitrary designations that fail to limit the structure of the medical device), and an electronics module 206/208 being arranged in or on the main housing portion (see annotated Figure 8 below).
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Regarding claim 9, Trapero Martin discloses that the header portion linearly extends from the main housing portion (see annotated Figure 8 above).
Regarding claim 10, Trapero Martin discloses that a first electrode is placed on the header portion and a second electrode is placed on the main housing portion (see annotated Figure 8 above where electrodes 225 are shown in both the main housing portion and the header portion).
Regarding claim 11, Trapero Martin discloses that an adapter element is mountable on each of the first electrode and the second electrode (the disclosure of Trapero Martin of “connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100”, paragraph [0093], is considered to show that there is an adapter element that corresponds to each of the connecting members 224/225 and, thus, the adapter element is mountable on each of the first electrode and the second electrode).
Regarding claim 12, Trapero Martin discloses that the adapter element and the fastening element are formed in one piece (see Figures 12, 14, 16, and 17 that shows the adapter element and fastening element in one piece).
Regarding claim 13, Trapero Martin discloses that the adapter element, the fastening element and the contact element are formed in one piece (see Figures 12, 14, 16, and 17 that shows the adapter element, fastening element, and contact element in one piece).
Regarding claim 14, Trapero Martin discloses a method for providing a sensing system for sensing biological signals externally on a patient, comprising: providing a medical device 100/100a/100b/100c/100d comprising at least one electrode 224/304 for sensing biological signals on a patient (see Figures 1, 3-6, and 12, “the connecting member 224 can be a metal electrode”, paragraph [0061], and “one or more lateral electrodes 304”, paragraph [0067]); mounting an adapter element 1225 mountable on said at least one electrode to electrically contact with the at least one electrode (“connecting members 1225 that can snap into a corresponding connecting member (e.g., the connecting member 224 of FIG. 3) on the electronic device 100.”, paragraph [0093]); providing a fastening component (first surface 1210 and second surface (not shown)) mountable on said adapter element and configured to attach the medical device externally to the patient (“the patch assembly 1200 includes a substrate with a first surface 1210 and a second surface (not shown) below the first surface 1210”, paragraph [0093] and “Referring to the second surface of the patch assembly 1200c, adhesive coverage is provided everywhere on the surface except where the lateral portion electrode contacts 1204 and electrode contacts 1202 (which could be, for example, dry electrodes, wet electrodes, semi-dry electrodes, etc.) are present.”, paragraph [0100]); providing a contact element 1202 mountable to the fastening component and configured to attach externally to the patient's skin for receiving biological signals and conducting said biological signals to the adapter element (“The electrodes 1202 can make physical contact to the skin of the user through the second surface (not shown) of the substrate, and the connecting members 1225 are provided on the first Surface 1210 of the substrate.”, paragraph [0093]); and encasing, using a casing 1500, the medical device and the adapter element in a mounted state in which the adapter element is mounted on said at least one electrode (see Figures 15 and 16). Further, it is respectfully submitted that the broadest reasonable interpretation for the term “implantable” is something that is capable of being implanted or inserted into a body, i.e. something that is of an appropriate size and shape to be placed inside the body. As such, it is respectfully submitted that the medical device Trapero Martin is of an appropriate size and shape such that it is capable of being implanted into a patient, and, thus, Trapero Martin is considered to disclose that the medical device is implantable into a patient, said at least one electrode being configured to electrically contact internal biological tissue to sense biological signals in an implanted state of the medical device.
Regarding claim 16, Trapero Martin discloses that the medical device comprises an elongate housing, and wherein the at least one electrode 224/304 comprises at least two electrodes provided on the housing and spaced from one another (see Figures 2-6), where the broadest reasonable interpretation for an elongate housing is one having a length greater than its width, whereby the annotated length and width shown in Figure 1 below satisfies this limitation.
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Regarding claim 17, Trapero Martin discloses that the at least two electrodes comprises two electrodes provided on each on either end of the elongate housing (see Figures 3-6).
Response to Arguments
Applicant's arguments filed August 18, 2026 have been fully considered and are considered moot in-part and non-persuasive in part. Those arguments which are considered moot will not be answered herein as the rejections to which they apply are no longer pending. Regarding the rejection of the claims as being anticipated by Trapero Martin, the Applicant argues that the amendments to the claims make it clear that “the claims require structural features facilitating the implantable nature of Applicant’s device” which are absent from the Martin reference. However, the amendments to the claims do not introduce any structural features, but just merely recite that the medical device comprises “at least one implantable electrode”. Apart from adding the intended use of “implantable” at various points in the claim, the amendments do not introduce any further structure that facilitates the implantable nature of Applicant’s device. Applicant argues that “the differences between implantable and skin surface contact electrodes is well known”, but fails to elaborate on what these differences are and fails to claim these differences. If there is a structural difference between an electrode that is placed subcutaneously and an electrode that is placed on the skin, what is such a structural difference and why is it not claimed? Applicant further argues that skin surface electrodes and implantable electrodes “operate based on difference sensing mechanisms, as is well known in the art” and argues that implantable electrodes use electrochemical sensing whereas skin surface electrodes measure electrical signals propagating through skin. However, this difference is not currently claimed. Applicant alleges that these structural features are “explicitly recited in the claims” however, the amendments to the claims merely recite “implantable”. Applicant is advised to amend the claims to include explicit recitations of the “structural differences” Applicant alleges. For at least the reasons given above, the rejections are considered to stand.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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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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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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