DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 16th, 2026.
Applicant's election with traverse of Group I (Claims 1-9, 11, and 19-21) in the reply filed on June 16th, 2026 is acknowledged. The traversal is on the ground(s) that the Office has not shown that a serious burden exists to examine all of the groups. This is not found persuasive because although Groups I, II, and III have similar limitations, the inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related inventions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are mutually exclusive in that Invention I is not directed to a barcode scan engine configured to optically scan a machine-readable image and determine a first alphanumeric string that is encoded in the machine-readable image, a processor coupled to the CDC and the engine and configured to receive the measurement from the CDC and to receive the first alphanumeric string from the engine, and Invention II is not directed to a movable element coupled to the sensor, wherein the movable element is configured to move along a translation axis with respect to a fixed element, and to allow rotation about at least one of a first rotation axis that is perpendicular to the translation axis and a second rotation axis that is perpendicular to both the translation axis and the first rotation axis; a switch disposed between the movable element and the fixed element and configured to electrically close when a gap between the movable element and the fixed element is less than or equal to a pre-determined value; and a processor coupled to the switch and to the CDC and configured to receive the measurement from the CDC when the switch electrically closes. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions III and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another materially different process such as a method for detecting pressure ulcers.
Inventions III and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus as claimed can be used to practice another materially different process such as a method for detecting pressure ulcers.
The requirement is still deemed proper and is therefore made FINAL.
Abstract
The abstract of the disclosure is objected to because of a minor informality. Lines 1-2 of the Abstract currently recite “measurement of the biocapacitance”, but should read “measurement of biocapacitance”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-9, 11, 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 “at least one of” in line 6. Further in line 6, Claim 1 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if both limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 1 recites “a first rotation axis that is perpendicular to the translation axis and a second rotation axis that is perpendicular to both the translation axis and the first rotation axis” in lines 6-8. It is unclear as to how the “second rotation axis” can be perpendicular to both “the translation axis and the first rotation axis”, if the “first rotation axis” is perpendicular to the “translation axis”. Clarification is requested.
Claim 5 recites “that of a reference capacitor” in line 2. It is unclear as to what “that” is referring to in the current claim limitations. Clarification is requested.
Claim 6 recites “that of the reference capacitor” in line 2. Similar to claim 5, it is unclear as to what “that” is referring to in the current claim limitations. Clarification is requested.
Claim 9 recites “monotonically increasing force” in line 3. It is unclear as to what exactly this limitation entails in the context of the current claim limitations. Examiner notes that in the field of mathematics, a monotonically increasing function is “one whose output never decreases as the input increases, meaning it either rises or stays constant” and when referring to the dictionary, “monotonic” is defined as “varying in such a way that it either never decreases or never increases”. Clarification is requested.
Claim Rejections - 35 USC § 103
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 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 1-5, 7-9, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Burns (U.S. Publication No. 2018/0220924; cited by Applicant) in view of Furnish (U.S. Publication No. 2010/0312233; cited by Applicant).
Regarding Claim 1, Burns teaches an apparatus for measuring biocapacitance of tissue (“an apparatus for identifying damaged tissue”; [0006]; “apparatus 180 can measure an electrical property or parameter that comprises...capacitance”; [0058]), the apparatus comprising:
a sensor (sensor; Figure 3 Element 174) comprising two electrodes (Fig. 1A and Fig. 1B);
a movable element coupled to the sensor, wherein the movable element is configured to move along a translation axis with respect to a fixed element, and to allow rotation about at least one of a first rotation axis that is perpendicular to the translation axis and a second rotation axis that is perpendicular to both the translation axis and the first rotation axis (“apparatus body 182 is flexible such that sensors 184A and 184B may be oriented at an angle to each other. In one aspect, one or more of sensors 184A and 184B are movable such the angle between a movable sensor and the other sensor may be varied”; [0057]; “one or more of sensors 187A and 187B are movable such the angle between the movable sensor and the other sensor may vary, for example to match the orientation of the skin under each of sensors 187A and 187B as apparatus 185 is closed around an ankle to position sensors 187A and 187B over locations 26R and 30R shown in FIG. 2C”; [0076]; Examiner’s Note: Examiner is interpreting the limitations as best understood, in view of the rejections under 35 U.S.C. 112(b) above);
a capacitance-to-digital converter (CDC) (“circuit is configured to convert...electrical property measured with the...sensor into the first SEM value”; [0096]; “apparatus 180 can measure an electrical property or parameter that comprises... capacitance”; [0058]; [0059] teaches wherein the information received by the processor from circuit comprises a digital signal) coupled to the sensor and configured to make a measurement of capacitance between the two electrodes (“electrical property or parameter that comprises…a capacitance” and “circuit (not shown) is electronically coupled to electrodes 110 and 120...configured to measure an electrical property between electrodes 110 and 120”; [0058]); and
a processor coupled to the CDC and configured to receive the measurement from the CDC (“a processor electronically coupled to the circuit and configured to receive the information regarding the electrical properties from the circuit”; [0007]).
Burns fails to teach a switch disposed between the movable element and the fixed element and configured to electrically close when a gap between the movable element and the fixed element is less than or equal to a pre-determined value; and wherein the system is configured to receive the measurement from the CDC when the switch electrically closes.
The invention described in Furnish is drawn to a system comprising a housing (stated as a “handpiece”) and an electrode disposed in the housing (“electrode is applied with a handpiece”; Abstract). Furnish teaches wherein the electrode is configured to contact the skin of a patient and the system is configured to apply an energy signal to the skin while the electrode is in contact with the skin (“active electrode surface is not energized until it is in actual contact with the patient's skin, and remains energized only while the active electrode surface remains in contact with the patient's skin”; Abstract). Furnish teaches wherein the electrode is disposed on a movable surface (Furnish [0036] teaches a “compression spring” coupled to a surface of the electrode) and a switch is disposed between the movable electrode and the fixed element (the housing of the “handpiece”) (“switch means are incorporated in the handpiece”; Abstract; [0009] teaches contact between the electrode and the switch). Furnish teaches wherein the switch is configured to electrically close when a gap between the movable element and the fixed element is less than or equal to a pre-determined value, and wherein the system is configured to receive the measurement from the CDC when the switch electrically closes (“axial movement of the electrode 18 indicated at 36 is equal to the contact gap 28. When the active electrode surface 20 of the handpiece 10 held by the physician is pressed against the patient's skin, the electrode 18 is displaced from its first to a second position, compressing the spring 24, and with sufficient pressure the contact gap 28 is closed and the electrode shank 16 becomes electrically-connected to the fixed contact 30, and thus voltage available at the output connector 33 of the RF generator 34 becomes active on the active electrode surface 20 thus applying RF energy to the skin tissue”; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the electrode-housing assembly described in Burns to include the switch assembly as described in Furnish because both inventions are drawn to an electrode assembly configured to apply energy to the skin of a patient triggered by a switching mechanism, while Furnish further teaches a switch assembly to prevent activation of the device until the device makes contact with the skin of the user (Furnish [0041]). The combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
Regarding Claim 2, Burns teaches wherein the electrodes are configured such that an electric field between the electrodes penetrates into the tissue when the sensor is positioned proximate to the tissue (“when an electric voltage is applied across electrodes 110 and 120, an electric field 140 is generated between electrodes 110 and 120 that extends outward from the plane of electrodes 110 and 120 toa distance 150, also referred to the depth of field”; Claim 1 the “sensor is configured to be placed against a first location on a patient's skin”; [0051]).
Regarding Claim 3, Burns teaches wherein the CDC is configured to repeatedly measure the capacitance between the electrodes at a pre-determined interval “apparatus 180 takes the measurements in sequence with a time interval between the measurements that ranges from zero to one second or more”; [0058]).
Regarding Claim 4, Burns teaches wherein the sensor further comprises an insulating cover layer coupled to the electrodes, and wherein the insulating cover layer is configured to prevent conductive contact between the electrodes and the tissue when the sensor is positioned proximate to the tissue (“sensor is configured to be placed against a first location on a patient's skin”; Claim 1; “electrodes 110 and 120 are covered with a cover layer 130 that is non-conductive so as to isolate electrodes 110 and 120 from each other and/or from external contact”; [0051]).
Regarding Claim 5, Burns teaches wherein the measurement comprises a comparison of the capacitance between the electrodes (“electrical property or parameter that comprises...a capacitance” and “circuit (not shown) is electronically coupled to electrodes 110 and 120...configured to measure an electrical property between electrodes 110 and 120”; [0058]), and that of a reference capacitor ([0061]; [0074); Examiner’s Note: Examiner is interpreting the limitations as best understood, in view of the rejections under 35 U.S.C. 112(b) above).
Regarding Claim 7, Burns teaches a visual indicator coupled to the processor (“apparatus 170 comprises a display configured to show one or more parameters;” [0056]; Fig. 3). Burns fails to teach wherein the processor is further configured to activate the visual indicator upon closure of the switch.
Furnish teaches wherein the processor is further configured to activate the visual indicator upon closure of the switch (a further object of the invention is an indicator to indicate to the physician when skin contact is made”; [0007]; “a light 80 (FIG. 8), sound or tactile (vibration, click, etc.) signal to let the user know that the electrode 60 is active”; [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the display system described in Burns to include a visual indicator activated upon closure of the switch as describe in Furnish in order to indicate to the physician when skin contact is successfully made (Furnish [0007]).
Regarding Claim 8, Burns fails to teach wherein the gap is disposed on the translation axis. Furnish teaches wherein the gap is disposed on the translation axis (Furnish Figure 2 (28) contact gap, (36) axial movement of the electrode; [0036]). Furnish teaches wherein such a configuration results in the creation of the switch in the assembly as described in the rejection of claim 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the electrode-housing assembly described in Burns to include the switch assembly as described in Furnish because both inventions are drawn to an electrode assembly configured to apply energy to the skin of a patient, while Furnish further teaches a switch assembly to prevent activation of the device until the device makes contact with the skin of the user (Furnish [0041]).
Regarding Claim 9, Burns fails to teach a spring positioned between the movable element and the fixed element configured to provide a monotonically increasing force along the translation axis to separate the moving element and the fixed element.
Furnish teaches wherein a compression spring is positioned between the movable element (Furnish [0036] teaches a “compression spring” coupled to a surface of the electrode) and the fixed element (the housing of the “handpiece”) and configured to provide a monotonically increasing force along the translation axis to separate the moving element and the fixed element (“the electrode is biased outwardly in a first position as shown in the figure by an internal compression spring 24”; [0036]). Furnish teaches wherein such a configuration results in the creation of the switch in the assembly as described in the rejection of claim 1 above.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the electrode-housing assembly described in Burns to include the switch assembly as described in Furnish because both inventions are drawn to an electrode assembly configured to apply energy to the skin of a patient, while Furnish further teaches a switch assembly to prevent activation of the device until the device makes contact with the skin of the user (Furnish [0041]).
Regarding Claim 19, Burns teaches wherein the electrodes comprise a center electrode and a ring electrode (“FIG. 8A depicts an array 400 of electrodes 410 that are configured, e.g. connected to a measurement circuit, to form an exemplary sensor 430, according to the present disclosure. In one aspect, a single hexagonal electrode 410 that is labeled with a “1” forms a center electrode and a ring of electrodes 410 that are marked with a “2” are interconnected to form a ring electrode. In an aspect, electrodes 410 between the center and ring electrode are electrically “floating.” In one aspect, electrodes 410 between the center and ring electrode are grounded or connected to a floating ground. In an aspect, electrodes 410 that are outside the ring electrode are electrically “floating.” In one aspect, electrodes 410 that are outside the virtual ring electrode are grounded or connected to a floating ground”; [0083]).
Regarding Claim 20, Burns teaches wherein the sensor further comprises a substrate (electrodes 110 and 120 are disposed on a common surface of a substrate 100; [0051]).
Regarding Claim 21, Burns teaches wherein the electrodes are disposed on a common surface of the substrate and therefore coplanar with each other (electrodes 110 and 120 are disposed on a common surface of a substrate 100; [0051]; Figure 1B).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Burns and Furnish, as applied in Claim 5 above, further in view of Hargreaves (U.S. Publication No. 2008/0048680; cited by Applicant).
Regarding Claim 6, the elements of claim 5 are rejected as described above. As described in the rejection of claim 5, Burns-Furnish teaches wherein the measurement comprises a comparison of the capacitance between the electrodes (“electrical property or parameter that comprises...a capacitance” and “circuit (not shown) is electronically coupled to electrodes 110 and 120...configured to measure an electrical property between electrodes 110 and 120”; Burns [0058]), and that of a reference capacitor (Burns [0061]; [0074]; Examiner’s Note: Examiner is interpreting the limitations as best understood, in view of the rejections under 35 U.S.C. 112(b) above). Burns-Furnish does not teach wherein the comparison comprises use of a sigma-delta method.
The invention described in Hargreaves is drawn to “methods, systems and devices...for detecting a measurable capacitance using sigma-delta measurement techniques that are implementable on many standard microcontrollers without requiring external active analog components” (Hargreaves [0007]). Hargreaves teaches wherein “a capacitance detection and/or measurement circuit can be readily formulated using sigma-delta modulation techniques” (Hargreaves [0020]). It is noted by Examiner that Applicant recognizes “the sigma delta method is well known to a person of ordinary skill in the art, and can be found in standard electrical engineering references” in [0089] of the Applicant’s Specification.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the comparison step described in Burns-Furnish-Schulman to utilize the known method of sigma- delta capacitance derivation as described in Hargreaves because, as recognized by Applicant, “the sigma delta method is well known to a person of ordinary skill in the art, and can be found in standard electrical engineering references” (Applicant’s Specification [0089]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burns and Furnish, as applied in Claim 1 above, further in view of Liebmann (U.S. Patent No. 5,815,416; cited by Applicant).
Regarding Claim 11, the elements of claim 1 are rejected as described above. Burns-Furnish teaches a switch system as described in the rejections as set forth above. Burns-Furnish does not teach wherein the processor is further configured such that after a first measurement is received upon a first closure of the switch, the processor is configured to electrically open the switch before a second measurement may be received.
The invention in Liebmann describes the functioning of switches in electrical measurement systems (Liebmann Abstract). Liebmann teaches wherein the processor is further configured such that after a first measurement is received upon a first closure of the switch, the processor is configured to electrically open the switch before a second measurement may be received (Liebmann Column 7 Lines 25-46).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the switch system described in Burns-Furnish to include the step of opening the switch before a second measurement may be received in order to reset the circuit between measurements (Liebmann Column 7 Lines 29-34).
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791
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