DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Objections
3. Applicant is advised that should claim 8 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 3, 4, 6, 11, and 13-17 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.
6. Claim 3 recites the limitation "the flexible coating" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from Claim 1, which fails to recite any mention of a ‘flexible coating’. However, Claim 2 does positively recite the limitation “a flexible coating”. This renders the claim indefinite. For examination purposes, Claim 3 will be assumed to be dependent from Claim 2. Proper correction is required.
7. Claim 4 recites the limitation “flexible coating fastening element" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 4 previously recites a ‘fastening element’, but not a “flexible coating fastening element”. This renders the claim indefinite. Proper correction is required.
8. Claim 6 recites the limitation “the physiological data collection element" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this refers to the “first” or “second” physiological data collection element, both recited in claim 1. Proper correction is required.
9. Claim 11 recites the limitation “at least one of the flexible connection elements" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 depends from Claim 1, and there is only one recitation of a “first flexible connection element”. It is unclear whether the recitation in Claim 11 is meant to refer to this “first” flexible connection element, alone, or if it may also refer to the “second” flexible connection element, recited in Claim 10, indicating improper dependency. Proper correction is required.
10. Claim 13 recites the limitation “the rotation guiding device" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 13 depends from Claim 12 (which depends from Claim 1), which fails to recite any mention of a ‘rotation guiding device’. This renders the claim indefinite. Proper correction is required.
11. Claim 14 recites the limitation "the rotating element" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from Claim 12, which fails to recite any mention of a ‘rotating element’. However, Claim 13 does positively recite the limitation “a rotating element”. This renders the claim indefinite. For examination purposes, Claim 14 will be assumed to be dependent from Claim 13. Proper correction is required.
12. Claim 14 recites the limitation "the fixed element" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from Claim 12, which fails to recite any mention of a ‘fixed element’. However, Claim 13 does positively recite the limitation “a fixed element”. This renders the claim indefinite. For examination purposes, Claim 14 will be assumed to be dependent from Claim 13. Proper correction is required.
13. Claim 15 recites the limitation "the standard connector" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from Claim 12, which fails to recite any mention of a ‘rotating element’. However, Claim 13 does positively recite the limitation “a standard connector”. This renders the claim indefinite. For examination purposes, Claim 15 will be assumed to be dependent from Claim 13. Proper correction is required.
14. Claim 15 recites the limitation "the periphery of the protrusion" in lines 2-3 and 4. There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from Claim 12, which fails to recite any mention of a ‘periphery of the protrusion’. This renders the claim indefinite. Proper correction is required.
15. Claim 15 recites the limitation "the first set of electrical tracks" in line 3 and “the electrical tracks” in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from Claim 12, which fails to recite any mention of a ‘set of electrical tracks’. This renders the claim indefinite. Proper correction is required.
16. Claim 16 recites the limitation "the periphery of the recess" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from Claim 12, which fails to recite any mention of a ‘periphery of the recess. This renders the claim indefinite. Proper correction is required.
17. Claim 16 recites the limitation "the second set of electrical tracks" in line 3 and “the electrical tracks” in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from Claim 12, which fails to recite any mention of a ‘set of electrical tracks’. This renders the claim indefinite. Proper correction is required.
18. Claim 16 recites the limitation "the recess of the fixed element" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from Claim 12, which fails to recite any mention of a ‘recess of the fixed element’. This renders the claim indefinite. Proper correction is required.
19. Claim 16 recites the limitation "the electrical circuit" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 16 depends from Claim 12, which depends from Claim 1. It is unclear whether “the electrical circuit” referred to in Claim 16 is referring to the “first” or “second” electrical circuit recited in Claim 1. This renders the claim indefinite. Proper correction is required.
20. Claim 17 recites the limitation "the protrusion" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from Claim 12, which fails to recite any mention of a ‘protrusion’. This renders the claim indefinite. Proper correction is required.
21. Claim 17 recites the limitation "the recess of the fixed element" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from Claim 12, which fails to recite any mention of a ‘recess of the fixed element’. This renders the claim indefinite. Proper correction is required.
22. Claim 17 recites the limitation "the rings of the first set of electrical tracks" in lines 3-4 and “the rings of the second set of electrical tracks” in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from Claim 12, which fails to recite any mention of ‘rings’ or ‘set of electrical tracks’. This renders the claim indefinite. Proper correction is required.
23. Claim 17 recites the limitation "the rotating element" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from Claim 12, which fails to recite any mention of a ‘rotating element’. This renders the claim indefinite. Proper correction is required.
24. Claim 17 recites the limitation "the fixed element" in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from Claim 12, which fails to recite any mention of a ‘fixed element’. This renders the claim indefinite. Proper correction is required.
Claim Rejections - 35 USC § 103
25. 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.
26. Claims 1, 2, 4-7, 9-11, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon U.S. 2020/0352510 (herein referred to as “Dhillon”) and in view of Hayes-Gill U.S. 10,898,097 (herein referred to as “Hayes-Gill”).
27. Regarding Claim 1, Dhillon teaches an adjustable patch device for physiological data collection and monitoring (Fig. 11A; para 0104), characterized in that it comprises:
a. a first control unit (Fig. 11A, ref num 230) comprising a first physiological data collection element (Fig. 11A, ref num 241, 242; para 0104, “Electrode leads 241, 242 measure bio-electrical signals for the ECG and IPG waveforms and secure the central sensing/electronics module 230”) and a first electrical circuit (para 0105, “by electronics in the central sensing/electronics module 230”);
b. a second control unit (Fig. 11A, ref num 260) comprising a second physiological data collection element (Fig 11A, ref num 247, 248; para 0104, “the optical sensor 236 includes two electrode leads 247, 248”) and a second electrical circuit (see Fig. 4, ref num 80 of optical sensor, ref num 36);
c. a first flexible connection element (Fig. 11A, ref num 234) electrically connecting the first control unit to the second control unit (see Fig. 11A, para 0104, “ flexible, wire-containing cable 234 connects the central sensing/electronics module 230 and the optical sensor 236”);
d. wherein the said first and second physiological data collection elements are electrically connected to said first and second electrical circuits (para 0105, “The electrode leads 241, 242, 247, 248 form two ‘pairs’ of leads, wherein one of the leads 241, 247 injects electrical current to measure IPG waveforms, and the other leads 242, 248 sense bio-electrical signals that are then processed by electronics in the central sensing/electronics module 230 to determine the ECG and IPG waveforms”);
e. wherein the first control unit and its respective physiological data collection element and electrical circuit are enclosed in a first casing (see Fig. 11A);
f. wherein the second control unit and its respective physiological data collection element and electrical circuit are enclosed in a second casing (see Fig. 11A);
g. wherein at least one electrical circuit is configured to condition, process, store, and/or transmit the physiological signals collected by said first physiological data collection element and second physiological data collection element (para 0105, “the other leads 242, 248 sense bio-electrical signals that are then processed by electronics in the central sensing/electronics module 230 to determine the ECG and IPG waveforms”)
h. wherein each of said first physiological data collection element and second physiological data collection element is selected from the group consisting of at least one electrode or a sensor based on the interaction of electromagnetic or mechanical waves with the user's body (para 0104, “electrode leads 241, 242 measure bio-electrical signals”; para 0105, “leads 241, 247 injects electrical current to measure IPG waveforms”); and
i. wherein the first flexible connection element is selected from the group consisting of a flexible electrical cable and a flexible flat cable (para 0106, “the flexible cable 234”).
Dhillon fails to teach the first flexible connection element is configured to adjust the positioning and distance between the first physiological data collection element and the second physiological data collection element.
Hayes-Gill teaches an adjustable patch device of analogous art (Fig. 1), wherein the patch device comprises a first flexible connection element to connect a first physiological data collection element and a second physiological data collection element (Fig. 1, ref num 13a connects ref nums 1 and 17). The first flexible connection element is configured to adjust the positioning and distance between the first physiological data collection element and the second physiological data collection element (Col. 11, lines 63-67 – Col. 12, line 1, “the flexible substructures 13a and 13b allow adjustment of the distance between the first sensing electrode 1 and the reference feature 17… adjustment of the positions of these electrodes”). This makes the adjustable patch more comfortable and conformable to the user wearing said patch (Col. 11, line 67 – Col. 12, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to have the flexible connection element configured to adjust the positioning and distance between physiological data collection elements in order to better conform the patch to the user.
28. Regarding Claim 2, Dhillon teaches the first flexible connection element comprises at least one layer of flexible coating, which extends to the respective terminal positions of attachment of the first flexible connection element to the first casing and the second casing and is configured to adjust the position of the physiological data collection elements.
Hayes-Gill teaches the first flexible connection element comprises at least one layer of flexible coating, which extends to the respective terminal positions of attachment of the first flexible connection element to the first casing and the second casing and is configured to adjust the position of the physiological data collection elements (see Fig. 1; Col. 11, lines 45-62, “Each of the first and third sensing electrodes 1, 3 and the common electrode 5 are attached to the region of the substrate 100 that carries the reference feature 17 by a respective flexible substructure 13a, 13b, 13c. Each flexible substructure 13a-13c is attached at a first end to a part of the substrate 100 that carries the reference feature 17, and at a second end to the circular region 21, 23, 25. Each flexible substructure is arranged to deform so as to allow the relative positions of the first and second end of each flexible substructure to be adjusted when the substrate is conformed to a surface (such as an abdomen), thereby altering the positions of the electrodes 1, 3, 5, relative at least one of: each other, the other electrodes 2, 4, and the reference feature 17. In other embodiments a similar flexible substructure can be used to connect electrodes 2 and 4 to the part of the substrate 100 that carries the reference feature 17. Such an arrangement may accommodate transverse (horizontal) stretching of the skin”). This makes the adjustable patch more comfortable and conformable to the user wearing said patch (Col. 11, line 67 – Col. 12, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon so that the flexible connection element contains a flexible coating layer to adjust the positioning and distance between physiological data collection elements in order to better conform the patch to the user.
29. Regarding Claim 4, Dhillon teaches at least one of the first casing and the second casing has a fastening element configured to secure a portion of the first flexible connection element when disposed in a contracted position, wherein this flexible coating fastening is located on any face of the casing (Fig. 4, ref num 34; para 0090, “The top portion 53 also includes a mechanical strain relief 68 that supports the cable 34”).
30. Regarding Claim 5, Dhillon teaches the electrical circuits are connected to a power source and comprise: a physiological signal conditioning circuits; a processing unit; and a wireless communication module with an external computing device and/or a memory module (para 0012, “The patch sensor features a sensing portion having a flexible housing that is worn entirely on the patient's chest and encloses a battery, wireless transmitter, and all the sensor's sensing and electronic components”; para 0080, “the patch sensor 10 wirelessly transmits it to an external gateway, which then forwards it to a cloud-based system”; Fig. 7; para 0105, “and the other leads 242, 248 sense bio-electrical signals that are then processed by electronics in the central sensing/electronics module 230 to determine the ECG and IPG waveforms”).
31. Regarding Claim 6, Dhillon teaches the physiological data collection element is selected from the group consisting of a gel electrode or a dry electrode (Fig. 11A, ref num 241, 242; para 0104, “Electrode leads 241, 242 measure bio-electrical signals for the ECG and IPG waveforms and secure the central sensing/electronics module 230”), wherein said electrode is configured to collect electrical signals obtained through techniques selected from the group consisting of electrocardiography, electromyography, electrogastrography, electrodermal activity, electroencephalography, body temperature, and electrooculography (para 0108, “IPG and PCG sensors can be used in a patch to detect respiratory conditions… electrocardiogram (ECG)…”; also see Abstract).
32. Regarding Claim 7, Dhillon teaches the sensors are selected from the group consisting of an oximetry sensor or a spectroscopy sensor (para 0115, “Both the IPG and PPG waveforms clearly show heartbeat-induced pulses. Processing the pulses in the IPG waveform yields heart rate, stroke volume and cardiac output, while processing them in the PPG waveform yields heart rate and pulse oximetry”).
33. Regarding Claim 9, Dhillon fails to teach a third control unit comprising a third physiological data collection element and a second flexible connection element, which electrically connects the third control unit to a control unit selected from the group consisting of the first control unit and the second control unit; and wherein the third physiological data collection element is selected from the group consisting of at least one electrode or a sensor based on the interaction of electromagnetic or mechanical waves with the user's body; and wherein the second flexible connection element is selected from the group consisting of a flexible electrical cable and a flexible flat cable and is configured to adjust a distance between the third physiological data collection element and the first or second physiological data collection element.
Hayes-Gill teaches a third control unit (Fig. 1, ref num 3) comprising a third physiological data collection element (Fig. 1, ref num 3 contains an electrode; Col. 11, lines 20-21) and a second flexible connection element (Fig. 1, ref num 13b), which electrically connects the third control unit to a control unit selected from the group consisting of the first control unit and the second control unit (Fig. 1, ref num 13b connects ref num 3 to ref num 17); and wherein the third physiological data collection elemen is selected from the group consisting of at least one electrode or a sensor based on the interaction of electromagnetic or mechanical waves with the user's body (Col. 11, lines 20-21); and wherein the second flexible connection element is selected from the group consisting of a flexible electrical cable and a flexible flat cable and is configured to adjust a distance between the third physiological data collection element and the first or second physiological data collection element (Col. 11, lines 63-67 – Col. 12, line 1, “the flexible substructures 13a and 13b allow adjustment of the distance between the first sensing electrode 1 and the reference feature 17 and the distance between the third sensing electrode 3 and the reference feature 17… adjustment of the positions of these electrodes”). This produces the same expected result of collecting physiological data (Col. 12, lines 45-48). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to include a third physiological data collection element as this produces the same expected result of collecting physiological data.
34. Regarding Claim 10, Dhillon fails to teach a fourth control unit comprising a fourth physiological data collection element and a third flexible connection element which connects the fourth control unit to the first control unit; wherein the fourth physiological data collection element includes at least one physiological data collection element selected from the group consisting of at least one electrode or a sensor based on the interaction of electromagnetic or mechanical waves with the user's body; and wherein the third flexible connection element is selected from the group consisting of a flexible electrical cable and a flexible flat cable and is configured to adjust a distance between adjacent physiological data collection elements when they are in contact with the user's body for physiological data collection.
Hayes-Gill teaches a fourth control unit (Fig. 1, ref num 5) comprising a fourth physiological data collection element (Fig. 1, ref num 5 contains an electrode; Col. 11, lines 20-21) and a third flexible connection element (Fig. 1, ref num 13c), which electrically connects the fourth control unit to the first control unit (Fig. 1, ref num 13c connects ref num 5 to ref num 17; Col.11, lines48-50); and wherein the fourth physiological data collection element is selected from the group consisting of at least one electrode or a sensor based on the interaction of electromagnetic or mechanical waves with the user's body (Col. 11, lines 20-21); and wherein the third flexible connection element is selected from the group consisting of a flexible electrical cable and a flexible flat cable and is configured to adjust a distance between adjacent physiological data collection elements when they are in contact with the user’s body for physiological data collection (Col. 11, lines 63-67 – Col. 12, line 1, “the flexible substructures 13a and 13b allow adjustment of the distance between the first sensing electrode 1 and the reference feature 17 and the distance between the third sensing electrode 3 and the reference feature 17… adjustment of the positions of these electrodes”; Col. 11, lines 51-57, “Each flexible substructure is arranged to deform so as to allow the relative positions of the first and second end of each flexible substructure to be adjusted when the substrate is conformed to a surface (such as an abdomen), thereby altering the positions of the electrodes 1, 3, 5, relative at least one of: each other, the other electrodes 2, 4, and the reference feature 17”). This produces the same expected result of collecting physiological data (Col. 12, lines 45-48). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to include a fourth physiological data collection element as this produces the same expected result of collecting physiological data.
35. Regarding Claim 11, Dhillon fails to teach that at least one of the flexible connection elements is a flexible flat cable, and the plane containing the at least one flexible connection element is parallel or orthogonal to the longitudinal plane containing the respective control units to which the flexible connection element is connected.
Hayes-Gills teaches at least one of the flexible connection elements is a flexible flat cable (Fig. 1, ref nums 13a-13c), and the plane containing the at least one flexible connection element is parallel or orthogonal to the longitudinal plane containing the respective control units to which the flexible connection element is connected (Col. 11, lines 51-57, “Each flexible substructure is arranged to deform so as to allow the relative positions of the first and second end of each flexible substructure to be adjusted when the substrate is conformed to a surface (such as an abdomen), thereby altering the positions of the electrodes 1, 3, 5, relative at least one of: each other, the other electrodes 2, 4, and the reference feature 17”). Since the flexible connection element is configured to be arranged in multiple positions, this indicates that it may be arranged so that it is orthogonal to the longitudinal plane or parallel to said plane containing the control units. This makes the adjustable patch more comfortable and conformable to the user wearing said patch (Col. 11, line 67 – Col. 12, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon so that the flexible connection element is parallel/orthogonal to the control units since multiple placements of the control units improves the conformity of the patch to the user.
36. Regarding Claim 18, Dhillon teaches that the patch device is attached to the user’s body by means of a mechanism selected from the group consisting of adhesives, gel electrodes, or suction mechanisms (para 0104, “The optical sensor 236 includes two electrode leads 247, 248 that connect to adhesive electrodes and help secure the patch sensor 210 (and particularly the optical sensor 236) to the patient 12”).
37. Regarding Claim 19, Dhillon teaches at least one of the physiological data collection elements comprises a plurality of electrodes or sensors arrayed in proximity to each other ((Fig. 11A, ref num 241, 242; para 0104, “Electrode leads 241, 242 measure bio-electrical signals for the ECG and IPG waveforms and secure the central sensing/electronics module 230”).
38. Regarding Claim 20, Dhillon teaches that the electrodes are gel electrodes or dry electrodes (Fig. 11A, ref num 241, 242; para 0104, “Electrode leads 241, 242 measure bio-electrical signals for the ECG and IPG waveforms and secure the central sensing/electronics module 230”), wherein said electrode is configured to collect electrical signals obtained through techniques selected from the group consisting of electrocardiography, electromyography, electrogastrography, electrodermal activity, electroencephalography, body temperature, and electrooculography (para 0108, “IPG and PCG sensors can be used in a patch to detect respiratory conditions… electrocardiogram (ECG)…”; also see Abstract).
39. Regarding Claim 21, Dhillon teaches the sensors are selected from the group consisting of an oximetry sensor or a spectroscopy sensor (para 0115, “Both the IPG and PPG waveforms clearly show heartbeat-induced pulses. Processing the pulses in the IPG waveform yields heart rate, stroke volume and cardiac output, while processing them in the PPG waveform yields heart rate and pulse oximetry”).
40. Claims 3, 8, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon and Hayes-Gill, and further in view of Acquista U.S. 2017/0258402 (herein referred to as “Acquista”).
41. Regarding Claim 3, Dhillon teaches the upper portion and the lower portion of the respective casing are welded or joined by means of fitting elements (para 0090, “The bottom portion 70 also supports the Kapton® film 65… and includes a pair of snaps 84, 85 that connect to mated components on the top portion 53”).
Dhillon as modified fails to teach the assembly formed by the casing and the flexible coating is sealed.
Acquista teaches a patch device of analogous art (Fig. 4), wherein an assembly formed by a casing and a flexible connection element is sealed (Fig. 4, ref nums 501-503 = casing; ref num 510 = connection element; para 0065, “each shell 501-503 is preferably over-molded with the substrate 510 so that any seams between the bottom surface of the shell 501-503 and its top cover are covered by and sealed with the substrate 510”). This ensures that the patch remains water-resistance (para 0065-0066). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to have the casing and flexible coating of the flexible connection element sealed in order to provide the advantage of the patch being water-resistant.
42. Regarding Claims 8 and 22, Dhillon fails to teach additional sensors based on electromagnetic or mechanical waves which are not in contact with the user’s body.
Acquista teaches a patch device of analogous art (Fig. 21), wherein there are additional sensors based on electromagnetic or mechanical waves which are not in contact with the user’s body (Fig. 21, ref num 750 is in contact with the garment, ref num 710; para 0129). This is just another configuration that achieves the same expected result of measuring the physiological data of the target (para 0132). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to include additional sensors that are not in contact with the user’s body as this produces the same expected result of measuring the physiological data of the target.
43. Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon and Hayes-Gill, and further in view of Gobron U.S. 2007/0184682 (herein referred to as “Gobron”).
44. Regarding Claim 12, Dhillon fails to teach in that the first casing optionally comprises a position orienting device configured to allow rotation of the assembly comprising a control unit / flexible connection element around an axis contained within the center of an adjacent control unit when the said flexible connection element is parallel or orthogonal to the longitudinal plane containing the respective control unit.
Gobron teaches a patch device of analogous art (Fig. 1), wherein the patch device comprising a first casing that comprises a position orienting device (para 0066, “the connector may allow for circuit ends 3 to have free, 360 degree rotation with respect to each other about the separate conducting member located at the centering axis 5 of the connector assembly. Alternatively, the circuit ends may be restricted by several mechanisms to only allow a certain degree of rotation or no rotation at all”) configured to allow rotation of the assembly comprising a control unit and flexible connection element around an axis contained within the center of an adjacent control unit (para 0066; Figs. 8A, 8B, 11A-11C) when the said flexible connection element is parallel or orthogonal to the longitudinal plane containing the respective control unit (Fig. 15D). This improves the flexibility and conformity of the casings and their placement on the patient’s body, so that they may have a greater degree of freedom when moving (para 0007-0009). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to allow rotation of the assembly in order to improve the wearability of the patch device.
45. Regarding Claim 13, Dhillon fails to teach the rotation guiding device consists of a rotating element with a protrusion and a fixed element with a recess, wherein the fixed element is connected to the electrical circuit contained in the control unit and the rotating element is connected to the flexible connection element through a standard connector.
Gobron teaches the rotation guiding device consists of a rotating element with a protrusion and a fixed element with a recess (Fig. 11A-11C, ref nums 15 and 16), wherein the fixed element is connected to the electrical circuit contained in the control unit (Claim 23, “said circuit ends such that a pin may be inserted into the aperture to restrict the degree of rotation of said circuit ends when the connector body is connected”) and the rotating element is connected to the flexible connection element through a standard connector (para 0066, “hole 15 may vary in size depending on the range of the angle of rotation that is desired”). This improves the flexibility and conformity of the casings and their placement on the patient’s body, so that they may have a greater degree of freedom when moving (para 0007-0009). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to include a rotating element with a protrusion and fixed element, as this contributes to the rotating guiding device in order to provide better movement to the patient when the patch is attached thereto.
46. Regarding Claim 14, Dhillon fails to teach the rotating element (11) fits into and rotates on the fixed element (12), wherein the fitting is attained through a protrusion on the bottom of the rotating element (11) and a recess on the top of the fixed element (12), wherein the said protrusion and recess have homologous cylindrical shapes.
Gobron teaches the rotating element fits into and rotates on the fixed element (Fig. 11A-11C, ref nums 15 and 16; Claim 23, “said circuit ends such that a pin may be inserted into the aperture to restrict the degree of rotation of said circuit ends when the connector body is connected”). While Gobron fails to explicitly teach the fitting is attained through protrusion on the bottom of the rotating element, it is commonly known that the pin (i.e., ref num 16) is a protrusion that would be inserted into a recess (see Fig. 11A-11C). It is also well known that It would have been an obvious matter of design choice to make the different portions of the protrusion and recess whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. This improves the flexibility and conformity of the casings and their placement on the patient’s body, so that they may have a greater degree of freedom when moving (para 0007-0009). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dhillon to include a rotating element with a protrusion and fixed element, as this contributes to the rotating guiding device in order to provide better movement to the patient when the patch is attached thereto.
Allowable Subject Matter
47. Claims 15-17 contain allowable subject matter. The prior art of record fails to specifically teach a standard connector that is electrically connected to a periphery of a protrusion of a rotating element through a set of electrical tracks, wherein the electrical tracks take a form of rings. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
48. Claims 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
49. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights