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 .
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 are: “a first coupling member” and “a second coupling member” in Claims 1 and 10. As Para. 0068 states that the coupling member can be the same, the Examiner is interpreting that both either could be one or more of a ring (Para. 0060), a bulkhead unit (Para. 0084), a plate (Para. 0090).
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.
Claim 4 is 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 4 recites the limitation "the first sensing hole on the circuit board". There is insufficient antecedent basis for this limitation in the claim, as the initial recitation is “a bottom plate having a first sensing hole formed thereon”. The Examiner is interpreting that the limitation should read “the first sensing hole on the bottom plate”.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-18 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 4889131 awarded to Salem et al, in view of U.S. Patent Publication 20190110774 awarded to Flynn.
Regarding Claims 1, 4-6, 10, and 13-15, Salem teaches a wearable sensing apparatuses comprising (abstract): a main body housing (belt 22) provided with a first coupling member (buckle 34’) and a second coupling member (buckle 34) for coupling a strap on opposing sides, and having a pressing hole formed on a bottom surface (Fig. 11, Col. 4, Lines 62-65, “The end modules 24, 32 are terminated at belt buckles 34, 34' with rods 70' engaged in appropriate recesses 81. Buckle 34' has an end loop 82 through which a permanent loop connection is made to belt 22”); a strain sensor (Fig. 12, pressure sensor 118) attached to the first coupling member or an inside of a first side wall of the main body housing provided with the first coupling member (Fig. 12, Col. 5, Lines 19-28, “Breathing functions are detected with breathing sensors 48.1 and 48.2 that are respectively located in modules 24 and 32. Sensor 48.2 is shown somewhat enlarged in FIGS. 12-16. A sensor holder 110 is shown formed of a continuous looped flexible web 66. The web loop is joined at stitch lines 112 to form parallel panels 114, 116. Panels 114, 116 form a pocket 117 in which a piezoelectric pressure sensor 118 is mounted. Stitch lines 120 form the ends of web 66 into channels 112 to receive rods 70, 70' that mount in web rod retainers 72, 72'”), and measuring a change in a shape of the first coupling member or an attached point of the first coupling member generated by tension of the strap according to breathing of the subject (Col. 1, Lines 57-64, “A sensor holder is interposed in the belt in such a way so as to convert part of an elongate tension change into opposing forces operative along a sensing axis that is directed generally transverse to the belt. A pressure transducer is placed in the holder with an orientation so as to preferentially respond to these transverse opposing forces to produce an electrical breathing signal”), and a circuit board embedded in the main body housing (Figs. 2-6, Col. 4, Lines 39-45, “With reference to FIGS. 2 and 6, module 24 includes a connector port 36.1 for an EKG electrode and a respiration transducer 48.1. Module 26 includes a transmitter 50 and audible alarm 52, module 28 a microprocessor 54 and part of an EKG sensor, and module 30 a battery 56. Module 32 includes connector port 36.3 for an EKG sensor and a second respiration transducer 48.2”). a computing device disposed to be spaced apart from the sensing apparatus, and embedded with a second circuit board (Figs. 2-6, Col. 4, Lines 39-45, “With reference to FIGS. 2 and 6, module 24 includes a connector port 36.1 for an EKG electrode and a respiration transducer 48.1. Module 26 includes a transmitter 50 and audible alarm 52, module 28 a microprocessor 54 and part of an EKG sensor, and module 30 a battery 56. Module 32 includes connector port 36.3 for an EKG sensor and a second respiration transducer 48.2”), having a counting circuit installed therein to calculate a breathing rate using a measurement signal of the strain sensor (Col. 6, Line 59 to Col. 7, Line 7, “Since the sensors 48 are quite sensitive to axial belt tension changes, they also respond to such small motions as produced from higher frequency heart beats. These, however, are excluded from the breathing signal on line 208 by employing an appropriate capacitor filter in the detector 204. The breathing signal on line 208 is in the form of pulses 209 whose repetition rate represents the breathing rate of the person wearing the belt. The leading edge 212 represents an inspiration or an expansion of the chest or abdomen while the trailing edge 214 represents a contraction or expiration. Breathing rate is measured from expansion to expansion or between successive leading edges 212, though trailing edges 212 could be used. The breath pulses are applied to an input bus of microprocessor 180, which in turn causes an LED 210 in module 26 (see also FIG. 6) to flash with each breath”), and a battery and a power communication line connecting the sensing apparatus and the computing device (Col. 8, Lines 13-20, “The start of operation of microprocessor 180 is initiated with a closure of buckle 34. This causes a closure of normally open switch 98 (see also FIG. 11) whereby the DC battery 56 is connected to power the circuit shown in FIG. 17. A signal indicative of start-up power is obtained through a second pole 280 of switch 92 and applied on line 282 to reset and initiate operation of the microprocessor 180”). Salem does not teach a diaphragm coupled to the pressing hole and provided with a flexible plate and provided with a stethoscope sensor that measures a heartbeat sound of the subject amplified by the diaphragm, wherein a bottom plate having a first sensing hole formed thereon is further disposed at a bottom of the main body housing, the stethoscope sensor is installed at a position corresponding to the first sensing hole on the circuit board, the heartbeat sound transferred by deformation of the diaphragm is amplified as it passes through a transient space between the diaphragm and the bottom plate, and the amplified heartbeat sound is input into the stethoscope sensor through the first sensing hole, further comprising a sealing pad, disposed between the circuit board and the bottom plate and having a second sensing hole, formed at a position corresponding to the first sensing hole to have a diameter smaller than that of the first sensing hole, wherein the diaphragm is formed in a shape and a material that further amplify a wavelength region representing the heartbeat of the subject, but does teach detecting a heart rate (Col. 1, Lines 10-15, “This invention relates to a device for monitoring physiological functions such as breathing and heart rate. More specifically, this invention relates to a belt that can be worn to sense breathing and/or heart rate and produces an alarm signal when dysfunctions are detected”).
However, in the art of wearable monitors (abstract), Flynn teaches a diaphragm coupled to the pressing hole and provided with a flexible plate (Para. 0054, “In one embodiment, as shown in FIG. 2, body coupler 24 is formed of an outer ring 114, which has a flexible non-conductive diaphragm 116 attached thereto and which spans the diameter of ring 114. Outer ring 114 may be formed either of thermoplastic polyurethane elastomers (TPU) or of closed cell polyurethane foam material, which can be made of different densities, and has an internal thread form 118 for attachment of outer ring 114 to distal end 47 of body 30”) and provided with a stethoscope sensor that measures a heartbeat sound of the subject amplified by the diaphragm (Para. 0054, “The TPU material is used when full spectrum of acoustic signals are to be recorded from a heart and closed cell polyurethane foam material is used only when infrasonic signals is to be recorded as this material acts as a passive filter and audible sound is shunted off”), wherein a bottom plate (back plate 38, Fig. 3) having a first sensing hole formed thereon is further disposed at a bottom of the main body housing (aperture 92), the stethoscope sensor is installed at a position corresponding to the first sensing hole on the circuit board, the heartbeat sound transferred by deformation of the diaphragm is amplified as it passes through a transient space between the diaphragm and the bottom plate (Para. 0054, the Examiner notes that diaphragms of stethoscopes work by transforming vibrational deformations to a detectable frequency), and the amplified heartbeat sound is input into the stethoscope sensor through the first sensing hole (Para. 0050, “Connection port 48 may be connected to a distal end of a flexible tube (i.e., such as flexible tube 26 shown in U.S. Patent Application Publication Number 2016/0095571, now U.S. Pat. No. 9,445,779), which may be formed of latex or rubber, and which has an earpiece (i.e., such as earpiece 28 shown in U.S. Patent Application Publication Number 2016/0095571, now U.S. Pat. No. 9,445,779) at the proximal end of the tube. Such a flexible tube and earpiece, like a typical stethoscope, are known in art for transmitting sound. The flexible tube, when present, is attached to connection port 48, such that there is no air exchange between the flexible tube and body 30, and such that the passageway through the tube is in communication with distal chamber 100 via passageway 58 and aperture 56. When the earpiece is inserted into the ears of the medical personnel, this allows substantially no air exchange between cavity 50 of microphone 22 and the outside of microphone 22. The length of the flexible tube is adjusted so that maximum audible sound is received at the earpiece, which are used by medical personnel to hear the desired sounds in real time”), further comprising a sealing pad (insulating member 34, Paras. 0043-0044) disposed between the circuit board and the bottom plate and having a second sensing hole (aperture 89) formed at a position corresponding to the first sensing hole to have a diameter smaller than that of the first sensing hole (Fig. 3), wherein the diaphragm is formed in a shape and a material that further amplify a wavelength region representing the heartbeat of the subject (Para. 0054, “In one embodiment, as shown in FIG. 2, body coupler 24 is formed of an outer ring 114, which has a flexible non-conductive diaphragm 116 attached thereto and which spans the diameter of ring 114. Outer ring 114 may be formed either of thermoplastic polyurethane elastomers (TPU) or of closed cell polyurethane foam material, which can be made of different densities, and has an internal thread form 118 for attachment of outer ring 114 to distal end 47 of body 30. The TPU material is used when full spectrum of acoustic signals are to be recorded from a heart”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Salem by Flynn, i.e. by using the wearable stethoscope system of Flynn in the wearable system of Salem, for the predictable purpose of swapping one known heart rate monitor for another.
Regarding Claims 2 and 11, Salem modified by Flynn makes obvious the sensing apparatus according to Claims 1 and 10. Salem further teaches wherein the first coupling member includes: an elastic body to which the strain sensor is attached on one side (Col. 5, Lines 43-62, “The size of pocket 117 formed by web 66 is so selected that the sandwich structure formed by the elements, substrates, spacer and supports is snugly enclosed by panels 114, 116 when web 66 is placed in its operative position in belt 20 as shown in FIGS. 6, 12 and 13. Hence, when belt 20 is used and stretched to encircle a body, a belt tensioning occurs with forces in the directions as suggested by arrows 150, 152 in FIG. 14. These forces tend to reduce the width of pocket 117 by pulling on its sides so that the encircling panels 114, 116 introduce opposing forces as suggested by arrows 156, 158. Forces 156, 158 are substantially transverse to the tensioning forces in belt 20 at module 32 and parallel to the sensing axis of sensors 48.1 and 48.2. These forces cause peripheral supports 140, 142 that are in contact with panels 114, 116 to bend piezo elements 128, 130. When the tension decreases, the force arrows 150, 152 are either reversed or the forces reduced so that the panels allow the elements 128, 130 to return to a lower tension position”); and a coupling ring to which the strap is coupled, of which one side is connected to the other side of the elastic body, and the other side is separated from the elastic body (Fig. 11, showing the belt 22 coupling the ring structure attached to buckle end 90).
Regarding Claims 3 and 12, Salem modified by Flynn makes obvious the sensing apparatus according to Claims 2 and 11. Salem further teaches wherein a mounting groove is formed on a first side wall of the main body housing, and the first coupling member is mounted on the main body housing through the mounting groove, wherein one side of the coupling ring coupled to the elastic body is inserted into the mounting groove (Col. 4, Line 66 to Col. 5, Line 4, “As shown in FIG. 11, buckle 34 is formed of two separable clips, a female end 84 that is connected to a web 66 and a male end 86 that is connected to belt 22. Releasable latching elements 90 in male end 86 engage complementary edges 92 in female end 84 while depressable levers 94 are used to disengage the elements 90 from ends 92”).
Regarding Claims 7 and 16, Salem modified by Flynn makes obvious the sensing apparatus wherein the stethoscope sensor calculates a heartbeat rate using the measurement signal of the sensor (Para. 0054, “In one embodiment, as shown in FIG. 2, body coupler 24 is formed of an outer ring 114, which has a flexible non-conductive diaphragm 116 attached thereto and which spans the diameter of ring 114. Outer ring 114 may be formed either of thermoplastic polyurethane elastomers (TPU) or of closed cell polyurethane foam material, which can be made of different densities, and has an internal thread form 118 for attachment of outer ring 114 to distal end 47 of body 30. The TPU material is used when full spectrum of acoustic signals are to be recorded from a heart”), according to Claims 1 and 10 above. Salem further teaches wherein the second circuit board further includes: a counting circuit for calculating a breathing rate using a measurement signal of the strain sensor (Col. 6, Line 59 to Col. 7, Line 7, “Since the sensors 48 are quite sensitive to axial belt tension changes, they also respond to such small motions as produced from higher frequency heart beats. These, however, are excluded from the breathing signal on line 208 by employing an appropriate capacitor filter in the detector 204. The breathing signal on line 208 is in the form of pulses 209 whose repetition rate represents the breathing rate of the person wearing the belt. The leading edge 212 represents an inspiration or an expansion of the chest or abdomen while the trailing edge 214 represents a contraction or expiration. Breathing rate is measured from expansion to expansion or between successive leading edges 212, though trailing edges 212 could be used. The breath pulses are applied to an input bus of microprocessor 180, which in turn causes an LED 210 in module 26 (see also FIG. 6) to flash with each breath”) and a communication circuit for transmitting at least one among the calculated breathing rate and heartbeat rate to an outside (Col. 4, Lines 23-30, “Pulse, respiration, and other alarm conditions are transmitted by an rf transmitter in module 26 to a remote receiver/monitor 45. This includes a receiver that is matched to the transmitter and further provides appropriate decoding networks to determine what type of alarm condition is being sent from the portable belt 20. The receiver/monitor 45 provides both visual and audible alarm indications”).
Regarding Claims 8 and 17, Salem modified by Flynn makes obvious the sensing apparatus according to Claims 7 and 16. Salem further teaches wherein the second circuit board further includes a diagnosis circuit for determining an abnormal state or a disease name of the subject by using at least one among the calculated breathing rate and heart rate (Col. 6, Lines 22-34, “FIG. 17 illustrates an electrical schematic for detecting breathing and heart rate functions. A microprocessor 180 is employed in module 28 and is programmed to monitor sensor signals to identify alarm conditions. Alarm outputs are generated and applied to a local audible alarm 182 as well as a remote rf alarm transmitter 184. Four alarm conditions are identified, a respiration rate problem, associated with a signal on line 186; a heart rate problem, identified by a signal on line 188 and a low battery signal on line 190. A poor contact, pc, condition of the cardiac electrodes is identified by producing signals on both lines 186 and 190 at the same time”) and electrocardiogram measured by an electrocardiogram sensor (Col. 7, Lines 8-15, “A heart signal is produces as shown in FIG. 17 with replaceable EKG electrodes 220.1, 220.2 and 220.3 that are inserted in connector ports 36.1 through 36.3. Electrodes 220 are provided with conventional conductive jelly to assure good electrical skin contact, as belt 20 snugly encircles a body. One electrode, 220.3, serves as a reference electrode that is connected to circuit ground”).
Regarding Claims 9 and 18, Salem modified by Flynn makes obvious the sensing apparatus according to Claim 1 and 10. Salem further teaches an external ECG module including a plurality of electrocardiogram sensors, wherein the circuit board further includes an interface circuit for being connected with the external ECG module (Col. 7, Lines 8-15, “A heart signal is produces as shown in FIG. 17 with replaceable EKG electrodes 220.1, 220.2 and 220.3 that are inserted in connector ports 36.1 through 36.3. Electrodes 220 are provided with conventional conductive jelly to assure good electrical skin contact, as belt 20 snugly encircles a body. One electrode, 220.3, serves as a reference electrode that is connected to circuit ground”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung, can be reached at (571)-272-8506. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights