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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph 0027, Line 4 states “the or spool”, it is suggested to change this to “the spool”.
Paragraph 0027, Line 5 states “of Example”, it is suggested to change this to “of example”.
Paragraph 0027, Line 21 states “Accordingly, When”, it is suggested to change this to “Accordingly, when”.
Appropriate correction is required.
Claim Objections
Claims 2- 20 are objected to because of the following informalities:
Claim 2, Line 1 states “claim 1 wherein multi-layer assembly”, it is suggested to change this to “claim 1, wherein the multi-layer assembly”. Claim 2, Line 1 states “a shape of the torso and arms of the user”, it is suggested to change this to “a shape of a torso and arms of the user”.
Claims 3-7 and 9-13, Line 1 states “claim 1 wherein”, it is suggested to change this to “claim 1, wherein”.
Claim 3, Line 1 states “multilayer”, it is suggested to change this to “multi-layer”.
Claim 3, Line 4 states “of the lower torso and the legs of the user”, it is suggested to change this to “of a lower torso and legs of the user”.
Claim 8, Line 1 states “claim 7 wherein”, it is suggested to change this to “claim 7, wherein”.
Claim 14, Line 1 states “claim 13 wherein”, it is suggested to change this to “claim 13, wherein”.
Claim 15, Line 1 states “claim 14 wherein”, it is suggested to change this to “claim 14, wherein”.
Claim 16, Line 5 states “the inner layer and the outer layer”, it is suggested to change this to “an inner layer and an outer layer”.
Claims 17- 19, Line 1 states “claim 16 wherein”, it is suggested to change this to “claim 16, wherein”.
Claim 19, Line 2 states “enable communication assembly”, it is suggested to change this to “enable the communication assembly”.
Claim 20, Line 5 states “the inner layer and the outer layer”, it is suggested to change this to “an inner layer and an outer layer”.
Claim 20, Line 6 states “and outer layer”, it is suggested to change this to “and the outer layer”.
Claim 20, Line 8 states “the torso”, it is suggested to change this to “a torso”.
Claim 20, Line 21 states “a signal upon the at least”, it is suggested to change this to “a signal from at least”.
Claim 20, Line 22 states “in voltage a change in voltage”, it is suggested to change this to “in voltage”.
Claim 20, Line 26 states “around a limb of the user”, it is suggested to change this to “around the at least one limb of the user”.
Appropriate correction is required.
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(s) is/are: “retention mechanism” in claims 1 and 20.
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.
The limitation “retention mechanism” in Claim 1, Line 6 and Claim 20, Line 6 is herein interpreted as a plurality of sleeves (Paragraph 0026), or any equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 16- 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6, Lines 2-4 recites the limitation “automatically dispose the compression assembly in the inoperative orientation after about fifteen minutes after it is disposed in the inoperative orientation.”, it is unclear if the microcontroller automatically disposes the assembly in the inoperative orientation after it is already in the inoperative orientation as set forth in the claim, or if the microcontroller automatically disposed the assembly in the inoperative orientation after it is in the operative orientation. For purposes of examination, this limitation is herein interpreted as “automatically dispose the compression assembly in the inoperative orientation after about fifteen minutes after it is disposed in the operative orientation.
Claim 16, Lines 11- 13 recites the limitation “the communication assembly to automatically transmit a 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 user”, it is unclear if the signal states is the signal mentioned in line 1 or a separate signal. For purposes of examination, this limitation is herein interpreted as the same signal within the preamble and therefore the recommendation for the claim is to have it state “transmit the signal”.
Claims 17- 19 are rejected for being dependent on or from rejected claim 16.
Claim 19, Lines 2- 4 recites the limitation “configured to enable the communication assembly to automatically transmit a signal upon at least one of the plurality of sensors detecting the predetermined change in voltage”, it is unclear if the signal states is the signal mentioned in claim 16 or a separate signal. For purposes of examination, this limitation is herein interpreted as the same signal within claim 16 and therefore the recommendation for the claim is to have it state “transmit the signal”.
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.
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).
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 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.),
A compression assembly comprising a compression structure (tourniquets 2110 and 2112, adjustable component) disposed within 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), 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, 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 claim 2, Carabajal and Gruentzig 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 and Gruentzig 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 and Gruentzig 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 and Gruentzig 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 and Gruentzig 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 and Gruentzig 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 and Gruentzig 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), as applied to claim 1 above, in further view of Wang et al. (CN 113925560 English Machine Translation).
Regarding claim 6, Carabajal and Gruentzig 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), as applied to claim 1 above, in further view of Zhang et al. (CN 116327297 English Machine Translation).
Regarding claim 7, Carabajal and Gruentzig 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, 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 sports 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 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 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.
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, 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 sports 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.),
A compression assembly comprising a compression structure (tourniquets 2110 and 2112, adjustable component) disposed within 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 (), 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.
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), as applied to claim 1 above, in further view of McEwen (US 5,181,522).
Regarding claim 12, Carabajal and Gruentzig 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) 13, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carabajal (WO 2017/023619) in view of Gruentzig (US 2017/0049164), as applied to claim 1 above, in further view of Olbu et al. (US 2017/0100131).
Regarding claims 13 and 14, Carabajal and Gruentzig make obvious the assembly as discussed above.
The combination does not teach wherein the compression assembly further comprises at least one stool collectively configured with a corresponding segment of the compression structure to wind it on the stool and exert a compression force on a corresponding limb of the user upon a rotation of the stool in a first direction in claim 13 and wherein the at least one stool is collectively configured with the corresponding segment of the compression structure to unwind it from the stool and at least partially reduce the compression force exerted on the corresponding limb of the user upon a rotation of the stool in a second and opposite direction in claim 14.
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 stool (spool assembly and locking plate 2) collectively configured with a corresponding segment of the compression structure (strap wires 5) to wind it on the stool and exert a compression force on a corresponding limb of the user upon a rotation of the stool in a first direction (Paragraph 0013) and wherein the at least one stool is collectively configured with the corresponding segment of the compression structure to unwind it from the stool and at least partially reduce the compression force exerted on the corresponding limb of the user upon a rotation of the stool 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 stool and have the compression structure be wound on the stool 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 15, Carabajal and Gruentzig make obvious the assembly as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the compression assembly of the combination to have a stool and have the compression structure be wound on the stool 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 wherein the compression assembly further comprises a portable motor operatively configured with the stool to selectively induce a rotation of the stool in the first direction and in the second and opposite direction, as Carabajal teaches the compression assembly further comprising a portable motor operatively connected with the compression structure (Paragraph 0075), within the combination, the portable motor would be connected with the stool to selectively induce a rotation of the stool in the first direction and in the second and opposite direction.
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 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, 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 transmit 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771