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 .
Status of Claims
Claims 1-17 and 19-21 are rejected. Claim 18 is withdrawn.
Response to Arguments
Claim Objections
The previous claim objections have been withdrawn in view of the amendment.
Claim Interpretation
Regarding “sensor unit” in claims 1, 3, 5, 7, 9-11, 13-15, and 19-21, Applicant asserts that the words “receiving electric physiological signals” and the second connector complementary to the first connector in the claim provide the term “sensor unit” with sufficient structure for performing the sensing function. However, the Examiner disagrees. “Receiving electric physiological signals” is intended use and does not provide structure. Additionally, “the first and the second connector being complementary” in claim 1 says the system comprises these but does not relate to the sensor unit. Applicant is encouraged to amend what structure the sensor unit is as supported by the specification. For instance, is the sensor unit the plurality of electrodes in claim 1?
Regarding “communication unit” in claims 15, 19, and 20, Applicant argument that there are other options to serve as examples of wireless signal communication beyond Bluetooth Low Energy is found persuasive. As such, the communication unit has been interpreted as Bluetooth low energy; Radio Frequency Identification; Zigbee; or Wi-fi.
Claim Rejections - 35 USC § 112
Some of the previous 112(b) rejections have been withdrawn in view of the amendment.
Applicant asserts that a person of ordinary skill in the art would readily understand the scope of “wireless data communication via Bluetooth, Radio Frequency Identification, Zigbee, or Wi-fi.” However, these are all live registered Trademarks. MPEP 2173.05(u) states:
If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
The previous 112(d) rejections of claims 12-14 and 19-20 have been withdrawn in view of making claims 12 and 13 independent claims.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see Remarks, filed 12/19/25, with respect to claims 1-11, 15-17, and 19-21 have been fully considered and are persuasive. The 102 rejection of claims 1-11, 15-17, and 19-21 has been withdrawn. See the Examiner’s Note section below.
Claims 12-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Istvan (US 20040073127 filed on 5/16/03) in view of Fennell (US 20100014626 filed on 6/30/09).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/25 is being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities: “A receiver unit” in line 1 should recite –The system—to match the preamble of claim 1 which claim 15 depends from. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: “The receiver unit” in line 1 should recite –The wearable device—to match the preamble of claim 12 which claim 19 depends from. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “The receiver unit” in claim 1 should recite –The sensor unit” to match the preamble of claim 13 which claim 20 depends from. Appropriate correction is required.
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.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a sensor unit in claims 1, 3, 5, 7, 9-11, 13-15, and 19-21;
a receiver unit in claims 1-6, 8, 10-11, and 13-20; and
a communication unit in claims 15, 19, and 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For “a sensor unit” in claims 1, 3, 5, 7, 9-11, 13-15, and 19-21, the specification discloses “cooperating conductive elements in the second connector 13 of the sensor unit 4” (page 13). However, this does not recite what the structure of the sensor unit is.
For “a receiver unit” in claims 1-6, 8, 10-11, and 13-20, the specification discloses “the receiver unit comprises a processor” (page 5). Therefore, the Examiner is interpreting the receiver unit to be a processor.
For “a communication unit” in claims 15, 19, and 20, the specification discloses “the communication units 30 and 26, may be configured for enabling data communication via Bluetooth low energy. However, alternative data communication protocols may likewise be applied by the units 26 and 30” (page 12). The specification discloses Radio Frequency Identification; Zigbee; or Wi-fi as other wireless communication protocols (page 7). Therefore, the Examiner is interpreting the communication unit to be Bluetooth low energy; Radio Frequency Identification; Zigbee; or Wi-fi.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-17 and 19-21 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 recites the limitation "wherein first connector" in ¶3, lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the limitation to recite –wherein the first connector--. For the purposes of examination, the limitation is being interpreted as “wherein the first connector.”
Claim 9 contains the trademark/trade name Bluetooth, Radio Frequency Identification, Zigbee, and Wi-fi. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe wireless communication and, accordingly, the identification/description is indefinite.
Claim limitation “a sensor unit” in claims 1, 3, 5, 7, 9-11, 13-15, and 19-21 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not recite what the sensor unit is referring to. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Istvan (US 20040073127 filed on 5/16/03) in view of Fennell (US 20100014626 filed on 6/30/09).
Regarding claim 12, Istvan teaches a wearable device, wherein the wearable device comprises a carrier suitable for being worn around an abdominal part of a body (reference 12 in Figs. 1 and 3 which touches the abdominal part of the body), and an electrode arrangement comprising a plurality of conductive electrodes, wherein the electrodes are arranged on the carrier enabling the plurality of electrodes to be brought in contact with a skin of the body in use (¶60-the chest assembly 12 is a one-piece flexible circuit that connects a plurality of electrode connectors 18. The electrode connectors 18 are configured to connect to electrodes 20 or electrically conductive adhesives. Preferably, the electrode connectors 18 have snap terminals that connect to electrodes 20 having snap terminals; references 18 and 20 in Figs. 1 and 3), and wherein the electrodes are arranged for receiving electric physiological signals from the body for enabling monitoring of the one or more vital signs (¶67-the electrical signals corresponding to physiological data of the patient pass from the electrode or sensor 20 to the electrically conductive element or trace 39, which, in turn, conveys the data to the remote body electronics unit 14; ¶85-the body electronics unit 14 controls the acquisition of the ECG signals from the chest assembly 12; references 18 and 20 in Figs. 1 and 3); wherein the wearable device further comprises a first connector (¶60-the electrode connectors 18 are configured to connect to electrodes 20 or electrically conductive adhesives. Preferably, the electrode connectors 18 have snap terminals that connect to electrodes 20 having snap terminals. Each electrode connector 18 connects to an electrically conductive element or trace for transmitting electrical signals; ¶80; Fig. 1), the first connector being configured for cooperating with a second connector of a sensor unit or a further second connector of a receiver unit for forming a connector assembly for establishing a detachable connection through which electrical signals can be exchanged between the wearable device and the sensor unit or the receiver unit (¶98-the base station 16 is removably mounted to a mounting plate secured near the ECG monitor 138 via suitable mounting means. Alternatively, the base station 16 can be incorporated into the monitor 138; ¶115-an adapter assembly 178 may be used to connect the chest assembly 12 or the precordial assembly 60 to the ECG monitor 138); wherein the wearable device comprises one or more conductive paths between the electrode arrangement and the first connector for bearing the electric physiological signals (¶60-the electrode connectors 18 are configured to connect to electrodes 20 or electrically conductive adhesives. Preferably, the electrode connectors 18 have snap terminals that connect to electrodes 20 having snap terminals. Each electrode connector 18 connects to an electrically conductive element or trace for transmitting electrical signals; ¶80; Fig. 1). However, Istvan does not teach and
wherein the sensor unit is configured for providing a sensor signal including an identification key data, and wherein the receiver unit is configured for providing the identification key data to the sensor unit via the wearable device, for enabling secure communication between the sensor unit and the receiver unit.
Fennell relates to maintaining secure communication between the transmitter unit and the data receiver unit (¶88). Fennell further teaches the invention using the following steps:
and wherein the sensor unit is configured for providing a sensor signal including an identification key data (¶101-the transmitter unit identification information may be retrieved (for example, from a nonvolatile memory) and transmitted (1020) to the receiver unit 104; ¶46-a memory (not shown) for storing data such as the identification information for the transmitter unit 102), and wherein the receiver unit is configured for providing the identification key data to the sensor unit via the device (¶102-a communication key (1030) optionally encrypted is received in one embodiment, and thereafter, sensor related data is transmitted with the communication key on a periodic basis such as, every 60 seconds, five minutes, or any suitable predetermined time intervals; ¶94-the generated key may be based on the transmitter ID or other suitable unique information so that the receiver unit 104 may use such information for purposes of generating the unique key for the bidirectional communication between the devices), for enabling secure communication between the sensor unit and the receiver unit (¶88-maintain secure communication between the transmitter unit and the data receiver unit).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Istvan to include wherein the sensor unit is configured for providing a sensor signal including an identification key data, and wherein the receiver unit is configured for providing the identification key data to the sensor unit via the wearable device, for enabling secure communication between the sensor unit and the receiver unit of Fennell in order to maintain secure communication (Fennell, ¶88).
Regarding claim 13, Istvan teaches a sensor unit, the sensor unit being configured for receiving electric physiological signals from one or more electrodes of a wearable device (¶80-the chest assembly 12 connects to the body electronics unit 14; ¶85; ¶89; Fig. 1), and for providing a sensor signal based on the received electric physiological signals (¶80-the chest assembly 12 connects to the body electronics unit 14; ¶85; ¶89; Fig. 1); wherein the sensor unit further comprises a second connector being complementary to a first connector of the wearable device to enable the second connector to cooperate therewith for forming a connector assembly (¶60-each electrode connector 18 connects to an electrically conductive element or trace for transmitting electrical signals. The electrically conductive elements or traces run along the chest assembly 12 and connect to a chest assembly connector 21; ¶80; Fig. 1), for enabling to establish a detachable connection between the sensor unit and the wearable device for receiving the electric physiological signals (¶12-the electrical signals are transmitted through the chest assembly and/or the precordial assembly to the body electronics unit, which removably secures to the patient via an armband; ¶80-81; Figs. 1, 5, and 6). However, Istvan does not teach wherein the sensor unit is configured for obtaining an identification key data stored in a memory of the wearable device by a receiver unit, and for providing the sensor signal including the identification key data, for enabling identification of the sensor unit after receipt of the sensor signal by the receiver unit.
Fennell teaches wherein the sensor unit is configured for obtaining an identification key data stored in a memory of the device by a receiver unit (¶101-the transmitter unit identification information may be retrieved (for example, from a nonvolatile memory) and transmitted (1020) to the receiver unit 104; ¶46-a memory (not shown) for storing data such as the identification information for the transmitter unit 102), and for providing the sensor signal including the identification key data, for enabling identification of the sensor unit after receipt of the sensor signal by the receiver unit (¶102-a communication key (1030) optionally encrypted is received in one embodiment, and thereafter, sensor related data is transmitted with the communication key on a periodic basis such as, every 60 seconds, five minutes, or any suitable predetermined time intervals; ¶94-the generated key may be based on the transmitter ID or other suitable unique information so that the receiver unit 104 may use such information for purposes of generating the unique key for the bidirectional communication between the devices).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Istvan to include wherein the sensor unit is configured for obtaining an identification key data stored in a memory of the wearable device by a receiver unit, and for providing the sensor signal including the identification key data, for enabling identification of the sensor unit after receipt of the sensor signal by the receiver unit of Fennell in order to maintain secure communication (Fennell, ¶88).
Regarding claim 14, the combination of Istvan and Fennell teaches the sensor unit according to claim 13, the sensor unit being configured for establishing a wireless connection with the receiver unit for providing the sensor signal to the receiver unit as a wireless signal (Istvan, ¶117-various air-interfaces (e.g., Bluetooth or IEEE 802.11b) can be used for transmitting the physiological and non-physiological data from the body electronics unit 14 to the base station 16; ¶94).
Examiner’s Note
Claims 1-11, 15-17, and 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 1, the scope of a wearable device comprising a carrier suitable for being worn around an abdominal part of the body, a plurality of conductive electrodes arranged on the carrier, a connector assembly comprising a first connector and a second connector, the first and the second connector being complementary, wherein the second connector is comprised by the sensor unit for enabling to establish a detachable connection between the sensor unit and the wearable device for receiving the electric physiological signals, the receiver unit comprises a further second connector complementary to the first connector for enabling to establish a detachable connection between the receiver unit and the wearable device, and wherein the sensor unit is configured for providing the sensor signal including an identification key data, and wherein the receiver unit is configured for providing the identification key data to the sensor unit via the wearable device, for enabling secure communication between the sensor unit and the receiver unit were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 20040073127; however it fails to recite the receiver unit comprises a further second connector complementary to the first connector for enabling to establish a detachable connection between the receiver unit and the wearable device, and wherein the sensor unit is configured for providing the sensor signal including an identification key data, and wherein the receiver unit is configured for providing the identification key data to the sensor unit via the wearable device, for enabling secure communication between the sensor unit and the receiver unit.
Claims 19 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792