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 .
Response to Amendment
Claims filed on April 23rd, 2026 have been entered. Claims 1-12 and 16- 20 are pending in the application. The amendments to the specification and the claims overcome the previous objections and the previous 35 U.S.C. 112(b) rejections.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 does not add a further limitation as it recites the limitation :”wherein the compression structure comprises at least one of a wire, cable, and lace”, which has previously been set forth within independent claim 1 and therefore claim 11 is not in proper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-5 and 9- 11 under 35 U.S.C. 103 over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) has been withdrawn in light of applicant’s amendments; specifically Carabajal does not teach the compression structure comprising a spool operatively connected to the compression structure.
The rejection of claim 6 under 35 U.S.C. 103 over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Wang et al. (CN 113925560) has been withdrawn in light of applicant’s amendments; specifically Carabajal does not teach the compression structure comprising a spool operatively connected to the compression structure.
The rejection of claims 7, 8, 16, 19, and 20 under 35 U.S.C. 103 over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Zhang et al. (CN 116327297) has been withdrawn in light of applicant’s amendments; specifically Carabajal does not teach the compression structure comprising a spool operatively connected to the compression structure.
The rejection of claim 12 under 35 U.S.C. 103 over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of McEwen (US 5,181,522) has been withdrawn in light of applicant’s amendments; specifically Carabajal does not teach the compression structure comprising a spool operatively connected to the compression structure.
The rejection of claims 13, 14, and 15 under 35 U.S.C. 103 over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Olbu et al. (US 2017/01001310 has been withdrawn in light of the cancelation of claims 13- 15.
The rejection of claims 17 and 18 under 35 U.S.C. 103 over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and Zhang (CN 116327297) in further view of Gruentzig ‘112 (US 11,471, 112) has been withdrawn in light of applicant’s amendments; specifically Carabajal does not teach the compression structure comprising a spool operatively connected to the compression structure.
Claim(s) 1-5 and 9- 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164), and in view of Olbu et al. (US 2017/0100131).
Regarding claim 1, Carabajal teaches a wearable garment assembly (Fig. 21) configured to exert a pressure on the body of a user upon a successful detection of blood within the garment assembly (abstract, Paragraphs 0090- 0092), the wearable garment assembly comprising:
A multi-layer assembly having an inner layer and an outer layer, and a retention mechanism (sleeve) underneath the outer layer (In Paragraph 0038, Carabajal teaches that the tourniquet can be inserted into a sleeve which is then attached to a suit and inserted into a pocket. For purposes of examination, the inner layer is the layer of material of the pocket that is closest to the skin, and the outer layer is the layer of material above the sleeve.), the retention mechanism comprising a plurality of sleeves arranged at a first location (Paragraphs 0038 and 0046),
A compression assembly comprising a compression structure (tourniquets 2110 and 2112, adjustable component) disposed within the plurality of sleeves of the retention mechanism in a slidable relation thereto (Paragraphs 0038, 0084, and 0088)(Carabajal teaches in Paragraph 0081 that the adjustable component is adjustable separate from the tourniquet and the actuator, therefore, when adjusting the component, it would be in a slidable relation to the retention mechanism.), the compression structure comprising a cable (The adjustable component is taught to be a cable in Paragraph 0038);
A detection assembly comprising a plurality of sensors (physiological sensor 2160, 2162, blood detection sensor)(Paragraph 0091), and
At least one microcontroller (processing unit 2170)(Carabajal teaches in Paragraph 00108 that many of the elements can be done as a module, and the module can be a microcontroller, therefore, the processing unit can be a microcontroller.) operatively connected to the detection assembly and the compression assembly (Paragraph 0088), the at least one microcontroller configured to selectively dispose the compression assembly into and out of an operative orientation and an inoperative orientation (Paragraph 0083, processing unit is able to activate the tourniquet, thus putting the compression assembly into an operative orientation from an inoperative orientation. Furthermore, the activator is connected to as switch (2150, 2142) which is taught to turn on and off (Paragraph 0043).).
Carabajal does not teach a mid-layer, a retention mechanism disposed between either the inner layer and the mid-layer or between the mid-layer and the outer layer, the retention mechanism comprising a plurality of sleeves arranged at a first location, the compression structure being at least partially disposed within the plurality of sleeves, the compression assembly further comprising a spool operatively connected to the compression structure and a motor operatively configured to rotate the spool in a first direction to tighten the compression structure at the first location and in a second and opposite direction to loosen the compression structure, or the plurality of sensors each one disposed at an intended location of the inner layer.
Gruentzig teaches a wearable garment assembly (Paragraph 0272)(Figs. 1A- 1E, 2, and 7) configured to exert a pressure on the body of a user (abstract and Paragraph 0268), the wearable garment assembly comprising: a multi-layer assembly (inner 60, outer layer 68, impact detection layer 62, wound sealing 64, pressure generating layer 66) comprising: a mid-layer (wound sealing layer 64) disposed between an inner layer (60) and an outer layer (68)(Paragraph 0270), and a compression assembly comprising a compression structure (pressure generating layer 66) and disposed in between the mid-layer and the outer layer (Fig. 7); a detection assembly comprising a plurality of sensors (impact detection layer 62)(Paragraph 0301) on the inner layer (see Fig. 7), and at least one controller (central unit 74) operatively connected to the detection assembly and the compression assembly (Paragraph 0061, 0276, and 0402).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the multi-layer assembly as taught by Carabajal to be the multi-layer assembly composed of the inner layer, mid layer, and outer layer with the plurality of sensors disposed on the inner layer as taught by Gruentzig for the purpose of detecting a signal and applying pressure to a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one multi-layer assembly for another because both assemblies are disclosed as equivalent structures for providing a wearable garment that detects a signal and applies pressure to a user (Carabajal, Paragraphs 0038 and 0090- 0092; Gruentzig, abstract and Paragraphs 0272 and 0402) and substitution of one for the other would have resulted in the predictable result of providing a multi-layer assembly able to be worn by a user and detect a signal. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding each one of the plurality of sensors disposed at an intended location of the inner layer, as Carabajal teaches that each sensor is disposed at a specific location (Paragraph 0046), in the combination, the plurality of sensors would be disposed at an intended location of the inner layer.
Regarding the retention mechanism disposed between either the inner layer and the mid-layer or between the mid-layer and the outer layer, within the combination, as Gruentzig teaches that there is an inner layer (60), a mid-layer (64), and an outer layer (68), with the compression structure (pressure generating layer 66) being disposed between the mid-layer and outer layer (Fig. 7), then as the retention mechanism is taught by Carabajal to comprise sleeves that hold the compression assembly and to be below the outer layer (Paragraph 0028), the retention mechanism and the compression assembly would be disposed between the mid-layer and the outer layer within the combination.
The combination of Carabajal and Gruentzig does not teach the compression assembly further comprising a spool operatively connected to the compression structure and a motor operatively configured to rotate the spool in a first direction to tighten the compression structure at the first location and in a second and opposite direction to loosen the compression structure.
Olbu (Olbu et al.) teaches a similar wearable garment assembly (Fig. 1) configured to exert a pressure on the body of a user (abstract and Paragraph 0004), the wearable garment assembly comprising: a compression assembly comprising a compression structure (strap and strap wires 5), wherein the compression assembly further comprises at least one spool (spool assembly and locking plate 2) collectively configured with a corresponding segment of the compression structure (strap wires 5) to wind it on the spool and exert a compression force on a corresponding limb of the user upon a rotation of the spool in a first direction (Paragraph 0013) and wherein the at least one spool is collectively configured with the corresponding segment of the compression structure to unwind it from the spool and at least partially reduce the compression force exerted on the corresponding limb of the user upon a rotation of the spool in a second and opposite direction (Paragraph 0015).
It would have been obvious to one of ordinary skill in the art to modify the compression assembly of the combination to have a spool and have the compression structure be wound on the spool as taught by Olbu for the purpose of providing pressure on a limb of a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one compression assembly for another because both assemblies are disclosed as equivalent structures for providing pressure on a limb of a user (Carabajal, abstract and Paragraph 0090; Olbu, Paragraphs 0004 and 0015). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 2, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Regarding wherein the multi-layer assembly is structured and dimensioned to define a top section corresponding to a shape of a torso and arms of the user, as Carabajal teaches in Paragraph 0038 that the wearable garment can resemble a suit, which is known to have a top and a bottom portion, then the multi-layer assembly of combination would be structured and dimensioned to define a top section.
Regarding claim 3, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Regarding wherein the multi-layer assembly is structured and dimension to define a bottom section corresponding to a shape of a lower torso and legs of the user, as Carabajal teaches in Paragraph 0038 that the wearable garment can resemble a suit, which is known to have a top and a bottom portion, then the multi-layer assembly of combination would be structured and dimensioned to define a bottom section.
Regarding claim 4, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Carabajal further teaches wherein the at least one microcontroller and the compression structure are collectively configured such that the compression structure exerts a compression force sufficient to at least partially reduce hemorrhaging around at least one limb of the user when the compression assembly is disposed in the operative orientation (Paragraph 0090).
Regarding claim 5, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Regarding wherein the at least one microcontroller and the compression structure are collectively configured such that the compression structure does not exert a compression force on the individual when the compression assembly is disposed in the inoperative orientation, as Carabajal teaches that the activator is connected to as switch (2150, 2142) which is taught to turn on and off (Paragraph 0043), then the microcontroller and the compression structure would be able to dispose the compression assembly in an inoperative orientation, where the compression structure would not exert a compression force on the individual.
Regarding claim 9, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Carabajal further teaches wherein the intended location of the plurality of sensors comprises at least one of the approximate location of the brachial artery, the radial artery, the femoral artery, and the popliteal artery of the user (Paragraph 0039).
Regarding claim 10, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Carabajal further teaches wherein the retention mechanism comprises a plurality of sleeves (In Paragraph 0038, Carabajal teaches that the tourniquet can be inserted into a sleeve which is then attached to a suit and inserted into a pocket. Therefore the retention mechanism has a plurality of sleeves to surround the plurality of tourniquets.), the compression structure being at least partially disposed within the plurality of sleeves in non-movable relation thereto (Carabajal teaches in Paragraph 0051 that the tourniquet can be secured in the sleeve through a zipper, therefore it is partially disposed in a non-movable relation.).
Regarding claim 11, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
Carabajal further teaches wherein the compression structure comprises a cable (The adjustable component is taught to be a cable in Paragraph 0038).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Olbu et al. (US 2017/0100131), as applied to claim 1 above, in further view of Wang et al. (CN 113925560 English Machine Translation).
Regarding claim 6, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
The combination does not teach wherein the at least one microcontroller is configured to automatically dispose the compression assembly in the inoperative orientation after about fifteen minutes after it is disposed in the operative orientation.
Wang (Wang et al.) teaches a similar wearable garment assembly (Figs. 1- 4) for exerting pressure on the body of a user (Paragraph 0001 and 0006), wearable garment assembly comprising: a compression assembly (flexible body 10, tightening mechanism 20, rack portion 30), a motor (40) and a controller (controller 90), wherein the microcontroller is configured to signal that the compression assembly should be disposed in the inoperative orientation after a set amount of time (Paragraph 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the microcontroller as taught by the combination to automatically dispose the compression assembly in the inoperative orientation after a set amount of time as taught by Wang, since Wang teaches doing so will “prevent damage to human limbs caused by long- term bandaging” (Paragraph 0048).
Regarding wherein the microcontroller is configured to automatically dispose the compression assembly into the inoperative orientation after a set amount of time, it would have been obvious to one of ordinary skill to have the microcontroller accomplish this function as it has been held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (MPEP 2144).
The combination does not teach wherein the set amount of time is fifteen minutes.
However, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date to modify the set amount of time to be fifteen minutes as Wang teaches that the set amount of time can be anything, such as up to two hours (Paragraph 0048), and fifteen minutes is within that range. Furthermore, applicant has not shown unexpected results gleamed from having fifteen minutes be the set amount of time.
Claim(s) 7, 8, 16, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Olbu et al. (US 2017/0100131), as applied to claim 1 above, in further view of Zhang et al. (CN 116327297 English Machine Translation).
Regarding claim 7, Carabajal, Gruentzig, and Olbu make obvious the assembly as discussed above.
The combination does not teach wherein the at least one microcontroller and the compression structure are collectively configured to exert a compression force around at least one limb of the user upon at least one of the plurality of sensors detecting a predetermined change in voltage associated with the presence of blood around at least one limb of the user.
Zhang (Zhang et al.) teaches a similar wearable garment assembly (target area 100, auxiliary area 200, control area 300)(Fig. 1) configured to exert a pressure on the body of a user (Paragraph 0001 and 0010), the wearable garment assembly comprising: a compression assembly (target area 100, auxiliary 200) comprising a compression structure (target airbag 101, auxiliary airbag 201)(Paragraph 0043), a detection assembly comprising a voltage sensor, wherein the voltage sensor detects a predetermined change in voltage associated with the presence of blood around at least one limb of the user (Paragraph 0035 and 0047), and at least one microcontroller (the controller disposed on the control area 300) operatively connected to the detection assembly and the compression assembly, the at least one microcontroller configured to activate the compression structure to exert a compression force around at least one limb of the user upon the sensor detecting the change in voltage (Paragraphs 0035 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of sensors as taught by the combination to detect a change in voltage as taught by Zhang, since Zhang teaches that it is a known sensor in the art for tourniquets (Paragraph 0024), and that a voltage sensor aids in determining the completion of hemostasis (Paragraph 0035).
Regarding claim 8, Carabajal, Gruentzig, Olbu, and Zhang make obvious the assembly as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of sensors as taught by the combination to detect a change in voltage as taught by Zhang, since Zhang teaches that it is a known sensor in the art for tourniquets (Paragraph 0024), and that a voltage sensor aids in determining the completion of hemostasis (Paragraph 0035).
Regarding wherein the compression structure is configured to exert a compression force sufficient to at least partially reduce hemorrhaging around at least one limb of the user upon at least one of the plurality of sensors detecting the predetermined change in voltage associated with the presence of blood around the at least one limb of the user adjacent to the brachial artery, the radial artery, and the femoral artery, as Carabajal teaches that the plurality of tourniquets are disposed at the specific arteries (Carabajal, Paragraph 0039) and the sensors are disposed in specific spots of the body (Carabajal, Paragraph 0046) and Zhang teaches that the sensor is disposed near the tourniquet (Zhang, Paragraphs 0035 and 0046), then the sensors of the combination are disposed adjacent to the brachial artery, the radial artery, and the femoral artery and detect the predetermined change in voltage associated with the presence of blood at those areas.
Regarding claim 16, Carabajal teaches a wearable garment assembly (Fig. 21) configured to automatically transmit a signal upon a successful detection of blood within the wearable garment assembly (abstract, Paragraphs 0090- 0092), the wearable garment assembly comprising:
A multi-layer assembly comprising: an inner layer and an outer layer (In Paragraph 0038, Carabajal teaches that the tourniquet can be inserted into a sleeve which is then attached to a suit and inserted into a pocket. For purposes of examination, the inner layer is the layer of material of the pocket that is closest to the skin, and the outer layer is the layer of material above the sleeve.), and a detection assembly comprising a plurality of sensors (physiological sensor 2160, 2162, blood detection sensor)(Paragraph 0091),
A retention mechanism (sleeve) underneath the outer layer (In Paragraph 0038, Carabajal teaches that the tourniquet can be inserted into a sleeve which is then attached to a suit and inserted into a pocket. For purposes of examination, the inner layer is the layer of material of the pocket that is closest to the skin, and the outer layer is the layer of material above the sleeve.) comprising a plurality of sleeves arranged at a first location (Paragraphs 0038 and 0046),
A compression assembly comprising a compression structure (tourniquets 2110 and 2112, adjustable component) disposed within the plurality of sleeves of the retention mechanism in a slidable relation thereto (Paragraphs 0038, 0084, and 0088)(Carabajal teaches in Paragraph 0081 that the adjustable component is adjustable separate from the tourniquet and the actuator, therefore, when adjusting the component, it would be in a slidable relation to the retention mechanism.), the compression structure comprising a cable (The adjustable component is taught to be a cable in Paragraph 0038);
A communication assembly (receiving unit 2190, 2175),
At least one microprocessor (processing unit 2170)(Carabajal teaches in Paragraph 00108 that many of the elements can be done as a module, and the module can be a microprocessor, therefore, the processing unit can comprise a microprocessor.) operatively connected to the detection assembly and the communication assembly (Paragraph 0088), the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit the signal upon the detection of physiological signal (Paragraph 0088 and 0090).
Carabajal does not teach a mid-layer, the plurality of sensors each one disposed at an intended location of the inner layer, a retention mechanism disposed between either the inner layer and the mid-layer or between the mid-layer and the outer layer, the compression assembly further comprising a spool operatively connected to the compression structure and a motor operatively configured to rotate the spool in a first direction to tighten the compression structure at the first location and in a second and opposite direction to loosen the compression structure, or wherein the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit the signal upon at least one of the plurality of sensors detecting a predetermined change in voltage associated with the presence of blood around at least one limb of the user.
Gruentzig teaches a wearable garment assembly (Paragraph 0272)(Figs. 1A- 1E, 2, and 7) configured to exert a pressure on the body of a user (abstract and Paragraph 0268), the wearable garment assembly comprising: a multi-layer assembly (inner 60, outer layer 68, impact detection layer 62, wound sealing 64, pressure generating layer 66) comprising: a mid-layer (wound sealing layer 64) disposed between an inner layer (60) and an outer layer (68)(Paragraph 0270), and a compression assembly comprising a compression structure (pressure generating layer 66) and disposed in between the mid-layer and the outer layer (Fig. 7); a detection assembly comprising a plurality of sensors (impact detection layer 62)(Paragraph 0301) on the inner layer (see Fig. 7), and at least one controller (central unit 74) operatively connected to the detection assembly and the compression assembly (Paragraph 0061, 0276, and 0402).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the multi-layer assembly as taught by Carabajal to be the multi-layer assembly composed of the inner layer, mid layer, and outer layer with the plurality of sensors disposed on the inner layer as taught by Gruentzig for the purpose of detecting a signal and applying pressure to a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one multi-layer assembly for another because both assemblies are disclosed as equivalent structures for providing a wearable garment that detects a signal and applies pressure to a user (Carabajal, Paragraphs 0038 and 0090- 0092; Gruentzig, abstract and Paragraphs 0272 and 0402) and substitution of one for the other would have resulted in the predictable result of providing a multi-layer assembly able to be worn by a user and detect a signal. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding each one of the plurality of sensors disposed at an intended location of the inner layer, as Carabajal teaches that each sensor is disposed at a specific location (Paragraph 0046), in the combination, the plurality of sensors would be disposed at an intended location of the inner layer.
Regarding the retention mechanism disposed between either the inner layer and the mid-layer or between the mid-layer and the outer layer, within the combination, as Gruentzig teaches that there is an inner layer (60), a mid-layer (64), and an outer layer (68), with the compression structure (pressure generating layer 66) being disposed between the mid-layer and outer layer (Fig. 7), then as the retention mechanism is taught by Carabajal to comprise sleeves that hold the compression assembly and to be below the outer layer (Paragraph 0028), the retention mechanism and the compression assembly would be disposed between the mid-layer and the outer layer within the combination.
The combination Carabajal and Gruentzig does not teach the compression assembly further comprising a spool operatively connected to the compression structure and a motor operatively configured to rotate the spool in a first direction to tighten the compression structure at the first location and in a second and opposite direction to loosen the compression structure, or wherein the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit the signal upon at least one of the plurality of sensors detecting a predetermined change in voltage associated with the presence of blood around at least one limb of the user.
Olbu (Olbu et al.) teaches a similar wearable garment assembly (Fig. 1) configured to exert a pressure on the body of a user (abstract and Paragraph 0004), the wearable garment assembly comprising: a compression assembly comprising a compression structure (strap and strap wires 5), wherein the compression assembly further comprises at least one spool (spool assembly and locking plate 2) collectively configured with a corresponding segment of the compression structure (strap wires 5) to wind it on the spool and exert a compression force on a corresponding limb of the user upon a rotation of the spool in a first direction (Paragraph 0013) and wherein the at least one spool is collectively configured with the corresponding segment of the compression structure to unwind it from the spool and at least partially reduce the compression force exerted on the corresponding limb of the user upon a rotation of the spool in a second and opposite direction (Paragraph 0015).
It would have been obvious to one of ordinary skill in the art to modify the compression assembly of the combination to have a spool and have the compression structure be wound on the spool as taught by Olbu for the purpose of providing pressure on a limb of a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one compression assembly for another because both assemblies are disclosed as equivalent structures for providing pressure on a limb of a user (Carabajal, abstract and Paragraph 0090; Olbu, Paragraphs 0004 and 0015). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach wherein the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit the signal upon at least one of the plurality of sensors detecting a predetermined change in voltage associated with the presence of blood around at least one limb of the user.
Zhang (Zhang et al.) teaches a similar wearable garment assembly (target area 100, auxiliary area 200, control area 300)(Fig. 1) configured to exert a pressure on the body of a user (Paragraph 0001 and 0010), the wearable garment assembly comprising: a compression assembly (target area 100, auxiliary 200) comprising a compression structure (target airbag 101, auxiliary airbag 201)(Paragraph 0043), a detection assembly comprising a voltage sensor, wherein the voltage sensor detects a predetermined change in voltage associated with the presence of blood around at least one limb of the user (Paragraph 0035 and 0047), and at least one microcontroller (the controller disposed on the control area 300) operatively connected to the detection assembly and the compression assembly, the at least one microcontroller configured to activate the compression structure to exert a compression force around at least one limb of the user upon the sensor detecting the change in voltage (Paragraphs 0035 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of sensors as taught by the combination to detect a change in voltage as taught by Zhang, since Zhang teaches that it is a known sensor in the art for tourniquets (Paragraph 0024), and that a voltage sensor aids in determining the completion of hemostasis (Paragraph 0035).
Regarding claim 19, Carabajal, Gruentzig, Olbu, and Zhang make obvious the assembly as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of sensors as taught by the combination to detect a change in voltage as taught by Zhang, since Zhang teaches that it is a known sensor in the art for tourniquets (Paragraph 0024), and that a voltage sensor aids in determining the completion of hemostasis (Paragraph 0035).
Regarding wherein the at least one microprocessor and the detection assembly are collectively configured to enable the communication assembly to automatically transmit the signal upon at least one of the plurality of sensors detecting the predetermined change in voltage associated with the presence of blood, as Carabajal teaches that the microprocessor and detection assembly are capable of enabling the communication assembly to automatically transmit the signal upon detection of a physiological signal (Carabajal, Paragraph 0088 and 0090), and the plurality of sensors of the combination are voltage sensors (Zhang Paragraph 0035), then they would enable the communication assembly to transmit the signal upon the sensors detecting the predetermined change in voltage associated with the presence of blood.
Regarding at least one of the plurality of sensors detecting the predetermined change in voltage associated with the presence of blood around the at least one limb of the user adjacent to the brachial artery, the radial artery, the femoral artery, or the popliteal artery, as Carabajal teaches that the plurality of tourniquets are disposed at the specific arteries (Carabajal, Paragraph 0039) and the sensors are disposed in specific spots of the body (Carabajal, Paragraph 0046) and Zhang teaches that the sensor is disposed near the tourniquet (Zhang, Paragraphs 0035 and 0046), then the sensors of the combination are disposed adjacent to the brachial artery, the radial artery, and the femoral artery and detect the predetermined change in voltage associated with the presence of blood at those areas.
Regarding claim 20, Carabajal teaches a wearable garment assembly (Fig. 21) configured to exert a pressure on the body of a user upon a successful detection of blood within the garment assembly (abstract, Paragraphs 0090- 0092), the wearable garment assembly comprising:
A multi-layer assembly comprising: an inner layer and an outer layer, and a retention mechanism (sleeve) underneath the outer layer (In Paragraph 0038, Carabajal teaches that the tourniquet can be inserted into a sleeve which is then attached to a suit and inserted into a pocket. For purposes of examination, the inner layer is the layer of material of the pocket that is closest to the skin, and the outer layer is the layer of material above the sleeve.) comprising a plurality of sleeves arranged at a first location (Paragraphs 0038 and 0046),
A compression assembly comprising a compression structure (tourniquets 2110 and 2112, adjustable component) disposed within the plurality of sleeves of the retention mechanism in a slidable relation thereto (Paragraphs 0038, 0084, and 0088)(Carabajal teaches in Paragraph 0081 that the adjustable component is adjustable separate from the tourniquet and the actuator, therefore, when adjusting the component, it would be in a slidable relation to the retention mechanism.);
A detection assembly comprising a plurality of sensors (physiological sensor 2160, 2162, blood detection sensor)(Paragraph 0091),
A communication assembly (receiving unit 2190, 2175), and
At least one microprocessor (processing unit 2170)(Carabajal teaches in Paragraph 00108 that many of the elements can be done as a module, and the module can be a microcontroller, therefore, the processing unit can be a microprocessor.) collectively configured with the detection assembly and the communication assembly (Paragraph 0088), the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit a signal upon the detection of a physiological signal (Paragraph 0088 and 0090).
Regarding the at least one microcontroller, as Carabajal teaches that the system is capable of having multiple modules (Paragraph 0108), it would have been obvious to one of ordinary skill in the art before the effective filing date to have the processing unit comprise a microprocessor and a microcontroller, wherein the microcontroller and the compression structure are collectively configured to exert a compression force sufficient to at least partially reduce hemorrhaging around a limb of the user when the compression assembly is disposed in the operative orientation (Paragraph 0090).
Carabajal does not teach a mid-layer, a retention mechanism disposed between either the inner layer and the mid-layer or between the mid-layer and the outer layer, the plurality of sensors each one disposed at an intended location of the inner layer, a plurality of voltage sensors, or the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit a signal upon at least one of the plurality of voltage sensors determining a predetermined change in voltage between about 1.22 volts and 1.46 volts and associated with the presence of blood around at least one limb of the user.
Gruentzig teaches a wearable garment assembly (Paragraph 0272)(Figs. 1A- 1E, 2, and 7) configured to exert a pressure on the body of a user (abstract and Paragraph 0268), the wearable garment assembly comprising: a multi-layer assembly (inner 60, outer layer 68, impact detection layer 62, wound sealing 64, pressure generating layer 66) comprising: a mid-layer (wound sealing layer 64) disposed between an inner layer (60) and an outer layer (68)(Paragraph 0270), and a compression assembly comprising a compression structure (pressure generating layer 66) and disposed in between the mid-layer and the outer layer (Fig. 7); a detection assembly comprising a plurality of sensors (impact detection layer 62)(Paragraph 0301) on the inner layer (see Fig. 7), and at least one controller (central unit 74) operatively connected to the detection assembly and the compression assembly (Paragraph 0061, 0276, and 0402).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the multi-layer assembly as taught by Carabajal to be the multi-layer assembly composed of the inner layer, mid layer, and outer layer with the plurality of sensors disposed on the inner layer as taught by Gruentzig for the purpose of detecting a signal and applying pressure to a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one multi-layer assembly for another because both assemblies are disclosed as equivalent structures for providing a wearable garment that detects a signal and applies pressure to a user (Carabajal, Paragraphs 0038 and 0090- 0092; Gruentzig, abstract and Paragraphs 0272 and 0402) and substitution of one for the other would have resulted in the predictable result of providing a multi-layer assembly able to be worn by a user and detect a signal. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding each one of the plurality of sensors disposed at an intended location of the inner layer, as Carabajal teaches that each sensor is disposed at a specific location (Paragraph 0046), in the combination, the plurality of sensors would be disposed at an intended location of the inner layer.
Regarding the retention mechanism disposed between either the inner layer and the mid-layer or between the mid-layer and the outer layer, within the combination, as Gruentzig teaches that there is an inner layer (60), a mid-layer (64), and an outer layer (68), with the compression structure (pressure generating layer 66) being disposed between the mid-layer and outer layer (Fig. 7), then as the retention mechanism is taught by Carabajal to comprise sleeves that hold the compression assembly and to be below the outer layer (Paragraph 0028), the retention mechanism and the compression assembly would be disposed between the mid-layer and the outer layer within the combination.
The combination of Carabajal and Gruentzig does not teach the compression assembly further comprising a spool operatively connected to the compression structure and a motor operatively configured to rotate the spool in a first direction to tighten the compression structure at the first location and in a second and opposite direction to loosen the compression structure or a plurality of voltage sensors or the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit a signal upon at least one of the plurality of voltage sensors determining a predetermined change in voltage between about 1.22 volts and 1.46 volts and associated with the presence of blood around at least one limb of the user.
Olbu (Olbu et al.) teaches a similar wearable garment assembly (Fig. 1) configured to exert a pressure on the body of a user (abstract and Paragraph 0004), the wearable garment assembly comprising: a compression assembly comprising a compression structure (strap and strap wires 5), wherein the compression assembly further comprises at least one spool (spool assembly and locking plate 2) collectively configured with a corresponding segment of the compression structure (strap wires 5) to wind it on the spool and exert a compression force on a corresponding limb of the user upon a rotation of the spool in a first direction (Paragraph 0013) and wherein the at least one spool is collectively configured with the corresponding segment of the compression structure to unwind it from the spool and at least partially reduce the compression force exerted on the corresponding limb of the user upon a rotation of the spool in a second and opposite direction (Paragraph 0015).
It would have been obvious to one of ordinary skill in the art to modify the compression assembly of the combination to have a spool and have the compression structure be wound on the spool as taught by Olbu for the purpose of providing pressure on a limb of a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one compression assembly for another because both assemblies are disclosed as equivalent structures for providing pressure on a limb of a user (Carabajal, abstract and Paragraph 0090; Olbu, Paragraphs 0004 and 0015). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach a plurality of voltage sensors or the at least one microprocessor and the detection assembly collectively configured to enable the communication assembly to automatically transmit a signal upon at least one of the plurality of voltage sensors determining a predetermined change in voltage between about 1.22 volts and 1.46 volts and associated with the presence of blood around at least one limb of the user.
Zhang (Zhang et al.) teaches a similar wearable garment assembly (target area 100, auxiliary area 200, control area 300)(Fig. 1) configured to exert a pressure on the body of a user (Paragraph 0001 and 0010), the wearable garment assembly comprising: a compression assembly (target area 100, auxiliary 200) comprising a compression structure (target airbag 101, auxiliary airbag 201)(Paragraph 0043), a detection assembly comprising a voltage sensor, wherein the voltage sensor detects a predetermined change in voltage associated with the presence of blood around at least one limb of the user (Paragraph 0035 and 0047), and at least one microcontroller (the controller disposed on the control area 300) operatively connected to the detection assembly and the compression assembly, the at least one microcontroller configured to activate the compression structure to exert a compression force around at least one limb of the user upon the sensor detecting the change in voltage (Paragraphs 0035 and 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of sensors as taught by the combination to detect a change in voltage as taught by Zhang, since Zhang teaches that it is a known sensor in the art for tourniquets (Paragraph 0024), and that a voltage sensor aids in determining the completion of hemostasis (Paragraph 0035).
Regarding determining a predetermined change in voltage between about 1.22 volts and 1.46 volts and associated with the presence of blood around at least one limb of the user, as the combination discloses the claimed invention except for the predetermined change in voltage being between about 1.22 volts and 1.46 volts. Zhang sets forth that the predetermined value detected is a result effective variable, wherein the change in voltage detected is dependent on the amount of blood (Paragraph 0035). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify the predetermined change in voltage to be between 1.22 volts and 1.46 volts, for the purpose of detecting blood in the wearable garment, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (MPEP 2144.05)(In re Aller, 105 USPQ 233). Furthermore, applicant places no criticality on these values.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Olbu et al. (US 2017/0100131), as applied to claim 1 above, in further view of McEwen (US 5,181,522).
Regarding claim 12, Carabajal, Gruentzig and Olbu make obvious the assembly as discussed above.
The combination does not teach wherein the compression structure is configured to define a plurality of braids or loops and to provide for an increased coverage around at least one limb of the user.
McEwen teaches a similar wearable garment assembly (Fig. 6) configured to exert pressure on the body of a user (abstract), the wearable garment assembly comprising a compression assembly comprising a compression structure (occlusive band 76), wherein the compression structure is configured to define a plurality of loops (segments 116, 188, 120, 122, and 124) and to provide for an increased coverage around at least one limb of the user (Compared to a singular segments, the plurality of loops would provide an increased coverage around the limb of a user.).
It would have been obvious to one of ordinary skill in the art to modify the compression structure as taught by the combination to comprise a plurality of loops as taught by McEwen for the purpose of covering a limb of a user to exert pressure on the body of the user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one compression structure for another because both compression structures are disclosed as equivalent structures for exerting pressure on the body of the user (Carabajal; abstract and Paragraph 0090, McEwen, abstract) and substitution of one for the other would have resulted in the predictable result of providing a structure that provides increased coverage around a limb of a user. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164) and in view of Olbu et al. (US 2017/0100131) and in view of Zhang et al. (CN 116327297 English Machine Translation), as applied to claim 16 above, in further view of Gruentzig ‘112 (US 11,471,112).
Regarding claims 17 and 18, Carabajal, Gruentzig, Olbu and Zhang make obvious the assembly as discussed above.
The combination does not teach wherein the communication assembly comprises a transmitter configured to transmit the signal to emergency medical services (EMS) in claim 17 or wherein the signal comprises a short message service (SMS) to authorities or first responders in claim 18.
Gruentzig ‘112 teaches a similar wearable garment assembly (Column 7, Lines 35- 40)(Fig. 1) configured to exert a pressure on the body of a user upon a successful detection of a physiological sign (abstract, Column 8, Lines 17- 21), the garment assembly comprising: a compression assembly comprising a compression structure (Column 17, Lines 37- 40), a detection assembly comprising a plurality of sensors (Column 8, Line 17- 19), at least one controller (Column 17, Lines 47- 54), and a communication assembly (information processing unit) wherein the communication assembly comprises a transmitter configured to transmit the signal to emergency medical services and wherein the signal comprises a short message service (SMS) (Column 11, Line 38- 47; Column 20, Lines 8- 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the garment as taught by the combination to comprise a transmitter that transmits a signal to EMS and comprises an SMS, since Gruentzig ‘112 teaches that this allows for a first responder to be better prepared to treat an injured user when notified (Column 11, Lines 34- 47).
Response to Arguments
Applicant's arguments filed April 23rd, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 14- 19, regarding the combination of Carabajal, Gruentzig, and Olbu not teaching the newly added claim language has been fully considered but are not persuasive. As discussed above, the combination teaches the newly added claim language, that of the retention mechanism comprising a plurality of sleeves (Paragraph 0028 of Carabajal), and wherein the compression assembly further comprises at least one spool (spool assembly and locking plate 2 of Olbu) collectively configured with a corresponding segment of the compression structure (strap wires 5 of Olbu) to wind it on the spool and exert a compression force on a corresponding limb of the user upon a rotation of the spool in a first direction (Paragraph 0013 of Olbu) and wherein the at least one spool is collectively configured with the corresponding segment of the compression structure to unwind it from the spool and at least partially reduce the compression force exerted on the corresponding limb of the user upon a rotation of the spool in a second and opposite direction (Paragraph 0015 of Olbu).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above, it would have been obvious to one of ordinary skill in the art to modify the multi-layer assembly as taught by Carabajal to be the multi-layer assembly composed of the inner layer, mid layer, and outer layer with the plurality of sensors disposed on the inner layer as taught by Gruentzig for the purpose of detecting a signal and applying pressure to a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one multi-layer assembly for another because both assemblies are disclosed as equivalent structures for providing a wearable garment that detects a signal and applies pressure to a user (Carabajal, Paragraphs 0038 and 0090- 0092; Gruentzig, abstract and Paragraphs 0272 and 0402) and substitution of one for the other would have resulted in the predictable result of providing a multi-layer assembly able to be worn by a user and detect a signal. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). Also, it would have been obvious to one of ordinary skill in the art to modify the compression assembly of the combination to have a spool and have the compression structure be wound on the spool as taught by Olbu for the purpose of providing pressure on a limb of a user. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one compression assembly for another because both assemblies are disclosed as equivalent structures for providing pressure on a limb of a user (Carabajal, abstract and Paragraph 0090; Olbu, Paragraphs 0004 and 0015). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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