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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Claim 8 recites: “wherein said signal cable (12) and said charging cable are assembled within a single sheath and have a single connector for connecting to said multipole connector (7).” Such a structure is not depicted in Applicant’s Drawings.
Therefore, the claimed subject matter identified above must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
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:
“communication means” first recited in claim 1, whose corresponding structure is “…standards known as USB, and the radio-wave communication means may comprise a "wireless" communication line 10(Figure 3) realised according to standards known as Bluetooth, Wi-Fi or another commercial standard, for connecting the apparatus 1 to portable personal terminal 20, such as a smartphone or tablet PC (Page 6).
“status indicator means” first recited in claim 1, whose corresponding structure is “one or more LEDs.”
“control means, data processing means, result displaying means” first recited in claim 1. The closest corresponding structure which performs the functions of such means is understood to be “a computerised control unit” and/or the “programme” described in Page 2 of Applicant’s Specification.
“means for activating said bioimpedance meter device (4), for acquiring said data and for processing and storing the results” first recited in claim 2. The closest corresponding structure which performs the functions of such means is also understood to be “a computerised control unit” (Page 2).
“sensor means” first recited in claim 5. There is no corresponding structure for the term “sensor means.”
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.
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, 2, 5, and dependent claims thereof 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.
Re. Claim 1: Claim 1 possesses multiple limitations which render the claim indefinite.
Claim 1 recites: “a pocket-sized casing.” The application does not define what type of pocket this term covers, whether on a piece of clothing or on a significantly larger or smaller structure. Applicant’s disclosure does not provide further delineating structure or context for the term “pocket.” Thus, the size of the device is rendered indefinite.
Claim 1 recites: “a plurality of electrodes… connected to a respective signal cable (12).” Examiner notes that the term “respective” implies an individual signal cable for each electrode. Claim 1 later requires a multi-pin connector to be electrically connected to control unit (3) and bioimpedance meter device (4) by means of “said signal cable (12)” Since each electrode has a respective signal cable, it is unclear which signal cable the claim is referring to.
Claim 1 recites: “the current status of said apparatus.” Firstly, “the current status” lacks antecedent basis. Secondly, the metes and bounds of what can be considered a status are not defined in the claims nor discussed in Applicant’s disclosure (e.g., charging, on/off status, measurement mode, etc.).
Re. Claim 2: Claim 2 recites “said control means, said processing means, and result displaying means include means for activating said bioimpedance meter device (4), for acquiring said data and for processing and storing the results.” It is unclear if each one of the means listed includes the “means for” which follow. For instance, the claim may be read as requiring the following:
control means including means for activating said bioimpedance meter device (4), for acquiring said data and for processing and storing the results;
processing means including means for activating said bioimpedance meter device (4), for acquiring said data and for processing and storing the results;
result displaying means including means for activating said bioimpedance meter device (4), for acquiring said data and for processing and storing the results.
Examiner recommends replacing the terms “control means,” “processing means,” and “result displaying means” with a singular term which encompasses the function of each mean. However, Applicant must clarify whether each of such “means” has the corresponding structure of a “computerized control unit” or “computer programme.” See section regarding interpretation under 35 U.S.C. 112(f) above.
Re. Claim 5: Claim limitation “sensor means” 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. Applicant’s Specification recites only: “suitable sensor means, of a known type.” No further details are provided. 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.
Claims 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over:
Faragli et al. (EP 3387987 A1) (disclosed by Applicant) (hereinafter – Faragli) in view of
Peterson, Z. (2020) What is a printed circuit board? make circuits by connecting components, Altium. Available at: https://resources.altium.com/p/what-is-a-pcb (Accessed: 01 November 2025) (hereinafter – Peterson) in further view of
Hopkins, J. (2020) What are the differences between an integrated circuit and a microprocessor, Total Phase Blog. Available at: https://www.totalphase.com/blog/2020/12/differences-between-integrated-circuit-microprocessor/?srsltid=AfmBOorYImPnUSQsVd-6c7rHTheGKoT4rbaWUVoEesdRucd9EId6y_ld (Accessed: 01 November 2025) (hereinafter – Hopkins) in further view of
Vlach et al. (US 20120110228 A1) (hereinafter – Vlach) in further view of
Laakkonen et al. (US 20150272466 A1) (hereinafter – Laakkonen).
Re. Claim 1: Faragli teaches an apparatus, comprising:
a pocket-sized casing (1) for carrying out bioimpedance measurements (Paragraph 0024: “The apparatus 1 comprises a portable device 4 for measuring bioelectrical impedance…;” see rejection under 35 U.S.C. regarding the term “pocket-sized”);
While Faragli teaches an electronic board contained in a casing, Faragli does not teach that the circuit board is a printed circuit board (PCB).
However, PCBs are well-apprised in the electronics industry (Peterson, page 1). It would have been obvious to one having skill in the art before the effective filing date to have modified the circuit board of Faragli to be a PCB as taught by Peterson, the motivation being that they provide a rigid support to hold components and provide a compact package that can be integrated into an end product (Page 1).
Faragli does not teach either the controller or the central instrument unit to be a “microprocessor integrated control unit.”
Hopkins teaches that a microprocessor are fundamental integrated systems often used in embedded designs (Page 3).
It would have been obvious to one having skill in the art before the effective filing date to have modified Faragli as modified by Peterson to utilize a microprocessor as the controlling component of the device, the motivation being that the use of microprocessors allows for integration of multiple small-scale processing circuits into a single chip, allowing for a scaling down of the components needed to process information (Page 3).
Faragli as modified by Peterson and Hopkins further teaches the apparatus further comprising
communication means for data exchange (10) (Paragraph 0026: “wireless data receiving and transmitting unit 7;” alternatively or additionally, Paragraph 0027: “Bluetooth”)
with a personal terminal device (20) (Paragraph 0026: “… communication with a remote electronic device, for example, a smartphone 3 or a tablet, so as to transmit at least the measurement data;” Figs. 1, 2);
a bioimpedance integrated circuit meter device (4) (Fig. 7: stimulus generator and reading circuit; Paragraph 0054),
interfaced to said control unit (3) (Fig. 7: see communication to processor or control unit),
capable of autonomously performing impedance measurement test functions on a person and making available raw results thereof (Paragraph 0046: continuous measurements; Paragraph 0026: transmission of measurement results);
a plurality of electrodes (11), arranged outside said casing (1) (Fig. 7: hand or foot electrode units; Figs. 1, 2: arrangement outside of casing)
and connected to a respective signal cable (12) for carrying electrical signals from/to said bioimpedance meter device (4) (Figs. 1, 2: electrical cables 21, 24 connected to hand and foot electrode units: Fig. 7: in/out signal cable);
a rechargeable storage battery (5), provided with a recharging circuit (6) for supplying power to said printed circuit board (2) (Fig. 7: battery and battery and power supply management unit; Paragraph 0026: “rechargeable electrical energy accumulator that can be recharged by a solar battery (not shown)).
Faragli as modified by Peterson and Hopkins does not teach a multi-pin connector electrically connected to control unit and bioimpedance meter device by means of said signal cable (12), for establishing connections between said electrodes and said bioimpedance meter device (4). Instead, Faragli states that “electrical cable… at the opposite end can be connected permanently to the portable device 4 or once again by means of a removable jack plug/jack socket connection” (Paragraphs 0037, 0039).
The concept of connecting multiple electrodes to a signal processing device and microcontroller is known from Vlach (Figs. 1-3).
It would have been obvious to one having skill in the art before the effective filing date to have modified Faragli as modified by Peterson and Hopkins to include a single entry point for connecting multiple electrodes as taught by Vlach, the motivation being that doing so reduces the number of separate ports needed to connect electrode pairs.
Faragli as modified by Peterson, Hopkins, and Vlach does not disclose that the multi-pin connector described above is secured to said printed circuit board (2) and electrically connected to said control unit (3) and to said bioimpedance meter device (4) by means of a dedicated recharging cable for establishing connections for said recharging circuit (6). While Faragli discloses a USB port (Paragraph 0026) for connection to a recharging circuit, it is not explicit that such a port connects to a dedicated charging cable.
Laakkonen teaches a USB male connector capable of receiving power from a dedicated recharging cable (Paragraph 0043: “Battery 14 can be charged with standard power grid USB hub recharger”).
Examiner notes that the USB male connector of Laakkonen and Vlach are analogous structures made under a common standard. Thus, it would have been obvious to one having skill in the art before the effective filing date to have modified the male connector of Faragli as modified by Peterson, Hopkins, and Vlach to also have charging capabilities as taught by Laakkonen, the motivation being that the combined device provides two differing methods of charging (i.e., via the USB port of Faragli or the USB male connector in communication with a USB hub recharger connected to a standard power grid), which diversifies how the device may be charged.
Faragli as modified by Peterson, Hopkins, Vlach and Laakkonen does not teach the device further comprising status indicator means (8), driven by said control unit (3) and visible from outside of said casing (1), for indicating the current status of said apparatus (100).
Laakkonen teaches the invention comprising status indicator means (8), driven by said control unit (3) and visible from outside of said casing (1), for indicating the current status of said apparatus (100) (Paragraph 0046-0048: LEDs indicate functionality and charge status).
It would have been obvious to one having skill in the art before the effective filing date to have modified Faragli as modified by Peterson, Hopkins, Vlach and Laakkonen to further include the status indicator means as taught by Laakkonen, the motivation being that doing so enables a user of the device to easily and intuitively comprehend possible alarm limits (Paragraph 0046), memory or operational parameter limits (Paragraph 0047), and charging status (Paragraph 0048).
Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen further teaches the invention:
wherein said personal terminal device (20) includes
control means, data processing means, and result displaying means (Figs. 1, 2: smartphone 3; Fig. 7: electronic device with controller with app installed),
comprising at least one dedicated application for connecting with said control unit (2) via said data exchange (10) (Paragraph 0027: “software application installed on the remote electronic device;” Fig. 7: “app installed;” Figs. 1, 2: Bluetooth connection),
for acquiring data produced by said bioimpedance meter device (4) (Paragraph 0026: “The portable device 4 comprises… a wireless data receiving and transmitting unit 7 suitable for communication with a remote electronic device, for example a smartphone 3 or a tablet, so as to transmit at least the measurement data”), and
for displaying on a display (21) of said personal terminal device (20) (Paragraph 0061: “The apparatus in accordance with the invention provides for a continuous physician-patient interface. The application allows for a dual interface: patient and physician. The physician can see both interfaces and especially the graphics needed to interpret the measurements obtained from the patient over a period of time. As regards the patient interface, the software developed makes it possible to take measurements correctly with both visual and voice instructions. The principal aim of the application is to enable the physician to monitor the patient's status remotely. Vice versa, the patient can be in contact with the physician at all times or send data by means of a fast connection with the hospital or with the outpatient facility in charge of his/her care”).
Re. Claim 2: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1. Faragli further teaches the invention wherein said control means, said processing means, and result displaying means include means
for activating said bioimpedance meter device (4), for acquiring said data and for processing and storing the results (see citations of rejection of claim 1 discussing an app; Paragraph 0057:” The system is interfaced by means of the app, which can be installed on any electronic device and it can enable setting of the parameters, sending commands to the control unit, receiving or sending data and information, for example about the system”),
either in a single cycle or according to multiple cycles periodically repeated for predetermined times or number of cycles for performing a bioimpedance Holter measurement (Paragraph 0046: continuous measurements throughout the day; Paragraph 0052: “punctual or continuous measurements;” Examiner notes that the claim does not specifically require performing a bioimpedance Holter measurement due to the structure of the “or” clauses; however, Applicant appears to merely define a “Holter” bioimpedance measurement as periodically running over long times (Pages 10-11)).
Re. Claim 3: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1. Faragli further teaches the invention wherein said communication means include communication via radio waves, operating using a standard protocol (Figs. 1, 2: see Bluetooth symbol 1; Paragraph 0027: ”The wireless data receiving and transmitting unit 7 communicates with a software application installed on the remote electronic device preferably via Bluetooth technology”).
Re. Claim 4: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1. Faragli further teaches the invention wherein said plurality of electrodes (11) are four in number (Abstract: “a first pair of electrodes (10) and a second pair of electrodes (15)”), and
two of said plurality of electrodes are injector electrodes and two are receiver electrodes (Paragraph 0002: it is understood that the device of the Faragli operates via tetrapolar BIA analysis, which requires that two of the four electrodes utilized are current injection electrodes).
Re. Claim 5: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1. Regarding the limitation “sensor means connected to said control unit (2) and to said multi-pin connector (7) for alternatively recognizing and signaling presence of said signal cable (12) or of said charging cable,” Examiner notes that the control unit described in Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen would recognize and signal the presence of 1) the signal cable via the capability of detecting bioimpedance signals and 2) the charging cable via powering/charging of the device.
Re. Claims 6 and 7: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1, but does not teach the invention wherein said casing (1) has a shell shape, and is made of two half-shells (1a, 1b) capable of closing on each other.
Laakkonen further teaches the invention wherein said casing (1) has a shell shape, and is made of two half-shells (1a, 1b) capable of closing on each other (Fig. 3).
Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the housing shape and construction of Laakkonen for the housing shape and construction of Faragli. Thus, the simple substitution of one known element for another producing a predictable result (forming a housing for an electrode signal processing device) renders the claim obvious.
With respect to claim 7, the simple substitution of housing shape described in the rejection of claim 6 also teaches the limitations of claim 7, since the housing of Laakkonen is discoidal (Figs. 1-3).
Re. Claim 9: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1. Regarding the limitation “wherein said multi-pin connector (7) is made according to a Universal Serial Bus (USB) standard,” see rejection of claim 1.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over:
Faragli et al. (EP 3387987 A1) (disclosed by Applicant) (hereinafter – Faragli) in view of
Peterson, Z. (2020) What is a printed circuit board? make circuits by connecting components, Altium. Available at: https://resources.altium.com/p/what-is-a-pcb (Accessed: 01 November 2025) (hereinafter – Peterson) in further view of
Hopkins, J. (2020) What are the differences between an integrated circuit and a microprocessor, Total Phase Blog. Available at: https://www.totalphase.com/blog/2020/12/differences-between-integrated-circuit-microprocessor/?srsltid=AfmBOorYImPnUSQsVd-6c7rHTheGKoT4rbaWUVoEesdRucd9EId6y_ld (Accessed: 01 November 2025) (hereinafter – Hopkins) in further view of
Vlach et al. (US 20120110228 A1) (hereinafter – Vlach) in further view of
Laakkonen et al. (US 20150272466 A1) (hereinafter – Laakkonen) in further view of
Schwandt et al. (US 20120183259 A1) (disclosed by Applicant) (hereinafter – Schwandt).
Re. Claim 8: Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen teaches the invention according to claim 1, but does not teach the invention wherein said signal cable (12) and said charging cable are assembled within a single sheath and have a single connector for connecting to said multipole connector (7).
Schwandt teaches analogous art in the technology of device connectors (Abstract). Schwandt further teaches the invention wherein said signal cable (12) and said charging cable are assembled within a single sheath and have a single connector for connecting to said multipole connector (7) (Paragraph 0035: “In one example, the cable bundle 108 encloses the four optical pathways, the five electrical conductors of the USB interface, and the two electrical power conductors in a single wrapping. The single wrapping of the cable bundle 108 extends for an arbitrary length to a remote end of the cable bundle that is opposite the plug connector 106. The remote end of the cable bundle is able to have its own remote connector (not shown). The remote connector is able to be similar to the plug connector 106 or consist of one or more other types of connectors suitable to convey optical signals and electrical power signals, as is described in detail below…”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Faragli as modified by Peterson, Hopkins, Vlach, and Laakkonen to have sheathed multiple types of connectors in a single grouping as taught by Schwandt, the motivation being that doing so allows for a single cable to perform both communication of data as well as charging, and further reduces costs and product reliability concerns (Paragraph 0003).
Conclusion
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/JUSTIN XU/ Examiner, Art Unit 3791