DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of group I drawn to claims 1-19 in the reply filed on 09/15/2025 is acknowledged.
Claim 20 has been cancelled. Election was made without traverse in the reply filed on 09/15/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the indentation as set forth in claim 3 and the pull string described in claims 8, 14 and 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 20 is objected to because of the following informalities: the status identifier for claim 20 should have been (Cancelled) instead of (Withdrawn) as applicant cancelled all the limitations of claim 20 in the response to the restriction requirement on 09/15/2025. Appropriate correction is required.
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 4 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The use of the term “further comprising: a medical professional; a patient” renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4 and 17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitation, “further comprising: a medical professional; a patient” positively recites part of the human body.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lowman U.S. Patent No. (4,071,031).
With respect to claim 1, Lowman discloses an inflatable leg elevator (as shown in fig.1) and ([Col.1], lines 6-10) capable of being utilized as an inflatable emergency medical device, comprising:
a main body (19, 20 and 15, fig.1);
the main body extending a length from a first end to a second end (as shown in fig.1);
the main body having opposing sides (as shown in fig.1);
the main body having a membrane (inflatable compartments 1 and 3, fig.1) and ([Col.2], lines 14-16);
wherein the membrane is configured to trap gas or air ([Col.2], line 17);
wherein the membrane is inflated with gas or air ([Col.2], line 17);
wherein when the membrane is inflated a shape is formed (as shown in fig.1);
wherein the shape formed is configured to elevate extremities ([Col.1], lines 6-10 and 37-39).
With respect to claim 2, Lowman discloses further comprising:
a first groove or trough (5, fig.1);
wherein the first groove is configured to receive a first extremity or leg of a patient ([Col.1], lines 6-10 and 37-39);
a second groove or trough (5, fig.1) and ([Col.2], lines 63-68);
wherein the second groove is configured to receive the second extremity or leg of the patient ([Col.1], lines 6-10 and 37-39).
With respect to claim 4, Lowman discloses a medical professional; a patient ([Col.1], lines 49-51).
With respect to claim 7, Lowman discloses an inflation port or valves (7 and 9); wherein the inflation port provides access from the outside of the membrane to a hollow interior, so that gas can be moved from the outside of the membrane to the hollow interior of the membrane ([Col.2], lines 14-20).
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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lowman as applied to claim 1 above, and further in view of Gardner U.S. Patent No. (Des, 345,797).
With respect to claim 3, Lowman substantially discloses a first support; a second support; a first groove and wherein the first groove is configured to receive a first extremity of a patient (as shown in the reproduced image of fig.1)
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except the invention as claimed except a spacer; a first groove; a second groove; wherein the second groove is configured to receive the second extremity of the patient; wherein the first groove is formed by an indentation between the first support and the spacer; wherein the second groove is formed by an indentation between the spacer and the second support. Lowman however, suggest in ([Col.2], lines 63-68, if both legs are to be elevated simultaneously, two units can be placed side-by-side, or a single unit with two troughs 5 can be constructed. The center compartments of a single, two trough unit may be connected together, depending upon whether or not it is desired that both legs be at the same angle and height. The middle and lower sections may likewise be interconnected).
Gardner however, teaches an ergonomic leg support comprising a first support; a second support; a spacer; a first groove; wherein the first groove is configured to receive a first extremity of a patient; a second groove; wherein the second groove is configured to receive the second extremity of the patient; wherein the first groove is formed by an indentation between the first support and the spacer; wherein the second groove is formed by an indentation between the spacer and the second support (as shown in the reproduced image of fig.1) below.
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In view of the teachings of Gardner, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating a spacer; a first groove; a second groove; wherein the second groove is configured to receive the second extremity of the patient; wherein the first groove is formed by an indentation between the first support and the spacer; wherein the second groove is formed by an indentation between the spacer and the second support if both legs are to be elevated simultaneously.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lowman as applied to claim 1 above, and further in view of Dempsey U.S. Publication No. (2020/0289349 A1).
With respect to claim 5, Lowman substantially discloses the invention as claimed except a storage container; wherein the storage container is configured to store the device therein for transporting the device and easily stowing the device. Lowman however, device is capable of being deflated for storage purposes.
Dempsey however, teaches a collapsible litter [0035] and (fig.2e); [0042, the litter can be stored in its closed configuration and is typically stored in its storage container 255].
In view of the teaching of Dempsey, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating a storage container; wherein the storage container is configured to store the device therein for transporting the device and easily stowing the device for storing the device when not in use.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lowman as applied to claim 1 above, and further in view of Ravikumar U.S. Publication No. (2007/0095353 A1).
With respect to claim 10, Lowman substantially discloses the invention as claimed except a securement strap; wherein the securement strap is configured to strap extremities of a patient to the device.
Ravikumar however, teaches a method and apparatus for eliminating or otherwise reducing or mitigating pressure on an individual's heel while the leg is in an extended position, while allowing for ambulation without completely removing the device (abstract) and (figs.2-3) comprising a securement strap is configured to strap extremities of a patient to the device [0051]-[0053].
In view of the teachings of Ravikumar, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating a securement strap is configured to strap extremities of a patient to the device in order to stabilize the anatomy of the user during use.
Claim(s) 6, 12-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lowman as applied to claim 1 above, and further in view of Gayes et al. U.S. Publication No. (2023/0128482 A1).
With respect to claim 6, Lowman substantially discloses the invention as claimed except comprising: a vitals detection system; wherein the vitals detection system activates when the system is activated; wherein the vitals detection system detects vitals of a patient engaged with the system; a vitals display; wherein the vitals display displays the vitals of the patient on the device.
Gayes et al. however, teaches an inflatable device for patient positioning (abstract) comprising one or more temperature sensors to monitor a patient's body temperature. Such temperature sensor(s) may communicate with internal computer 250 via external sensor interface 280. In turn, internal computer 250 may manage the heating elements to facilitate achievement and maintenance of a desirable body temperature [0270].
In view of the teachings of Gayes et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating a vitals detection system; wherein the vitals detection system activates when the system is activated; wherein the vitals detection system detects vitals of a patient engaged with the system; a vitals display; wherein the vitals display displays the vitals of the patient on the device to monitor the health condition of the user.
With respect to claim 12, the combination of Lowman/Gayes et al. substantially discloses the invention as claimed. Gayes et al. further teaches a vitals detection system; wherein the vitals detection system activates when the system is activated; wherein the vitals detection system detects vitals of a patient engaged with the system [0270].
With respect to claim 13, the combination of Lowman/Gayes et al. substantially discloses the invention as claimed. Gayes et al. further teaches a sensor system; the sensor system configured to detect various environmental metrics; the sensor system having a plurality of sensors [0270].
With respect to claim 15, the combination of Lowman/Gayes et al. substantially discloses the invention as claimed. Gayes et al. further teaches a global positioning system [0010].
Claim(s) 8-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lowman as applied to claim 1 above, and further in view of Garner et al. U.S. Publication No. (2020/0247513 A1).
With respect to claim 8, Lowman substantially discloses the invention as claimed except an activation trigger; wherein the activation trigger is a pull string, the pull string releasing pressurized gas into a hollow interior of the membrane; wherein releasing pressurized gas into the hollow interior causes the membrane to fill with gas and expand to an inflated position.
Garner et al. however, teaches an inflatable device comprising an inflation mechanism 16 can be actuated. The power source 30 (e.g. PCB battery that may provide power for operation of control device 190 and inflation mechanism 16 and submergence detector, etc.) can be turned on and the signal from the sensor elements can be evaluated by the control device. In response to detecting a submerged condition that is present continuously for at least as long as a pre-selected threshold as discussed herein, the control device can send an actuation signal to a trigger 34 for actuation of the biasing mechanism 140 for opening of at least one gas source 26 for inflation of one or more inflatable chambers 14. This can be achieved by melting a cord 71, cutting a cord 71, moving a sear, or otherwise actuating an actuator (e.g. motor, gas spring, etc.) to release a spring 74 of the biasing mechanism 140 or otherwise drive opening of a gas source 26. In some embodiments, the biasing mechanism 140 can also be released via a pull string connected to the gas source such that pulling of the pull spring by a user opens the gas source for inflation of the inflation chamber(s) [0144].
In view of the teachings of Garner et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating an activation trigger; wherein the activation trigger is a pull string, the pull string releasing pressurized gas into a hollow interior of the membrane; wherein releasing pressurized gas into the hollow interior causes the membrane to fill with gas and expand to an inflated position for regulating the firmness of the device.
With respect to claim 9, the combination of Lowman/Garner et al. substantially discloses the invention as claimed. Garner et al. further teaches a pressurized gas [0068]-[0069].
With respect to claim 14, the combination of Lowman/Garner et al. substantially discloses the invention as claimed. Garner et al. further teaches an activation feature; the activation feature being a pull string [0144]; a deactivation feature; the deactivation feature being a release port which allows air to escape the membrane [0145].
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lowman as applied to claim 1 above, and further in view of Davis U.S. Patent No. (11,382,806 B2).
With respect to claim 11, Lowman substantially discloses the invention as claimed except a plurality of handholds; wherein the handholds are configured so that medical professionals can transport a user engaged with the system; a transport sheet; wherein the transport sheet is included with the system so as to be available for transporting a patient or covering a patient.
Davis however, teaches an inflatable mattress for transporting a patient comprising a plurality of handles (150, fig.1) and ([Col.5], lines 6-19) and a transport sheet for covering a patient (as shown in fig.7).
In view of the teachings of Davis, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating a plurality of handholds; wherein the handholds are configured so that medical professionals can transport a user engaged with the system; a transport sheet; wherein the transport sheet is included with the system so as to be available for transporting a patient or covering a patient that allows for easy positioning of a patient while maintaining constant leg elevation.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lowman U.S. Patent No. (4,071,031) in view of Gardner U.S. Patent No. (Des, 345,797) in Ravikumar U.S. Publication No. (2007/0095353 A1) and further in view of Garner et al. U.S. Publication No. (2020/0247513 A1).
With respect to claim 16, Lowman substantially discloses (as shown in fig.1) and ([Col.1], lines 6-10) capable of being utilized as an elevation system, comprising:
a main body (19, 20 and 15, fig.1);
the main body extending a length from a first end to a second end (as shown in fig.1);
the main body having opposing sides (as shown in fig.1);
the main body having a membrane (inflatable compartments 1 and 3, fig.1) and ([Col.2], lines 14-16);
a first groove; a second groove; a first support (as shown in the reproduced image of fig.1 below); a second support (as shown in the reproduced image of fig.1 below) and in ([Col.2], lines 63-68, if both legs are to be elevated simultaneously, two units can be placed side-by-side, or a single unit with two troughs 5 can be constructed. The center compartments of a single, two trough unit may be connected together, depending upon whether or not it is desired that both legs be at the same angle and height. The middle and lower sections may likewise be interconnected);
an inflation port or valves (7 and 9, fig.1); wherein the inflation port serves as a backup feature in the event that the activation feature fails to activate the pressurized gas and cause inflation to the device, the inflation port provides for inflation from the exterior of the device by forcing gas or air into a hollow interior of the device ([Col.2], lines 14-16).
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Lowman substantially discloses the invention as claimed except (1) a spacer; (2) a securement strap; wherein the securement strap is configured to strap extremities of a patient to the device, (3) a pressurized gas; an activation feature; wherein the activation feature is a pull string, the pull string releasing pressurized gas into a hollow interior of the membrane; wherein releasing pressurized gas into the hollow interior causes the membrane to fill with gas and expand to an inflated position; a deactivation feature; the deactivation feature being a release port which allows gas to escape the membrane.
Gardner however, teaches an ergonomic leg support comprising a first support; a second support; a spacer; a first groove; wherein the first groove is configured to receive a first extremity of a patient; a second groove; wherein the second groove is configured to receive the second extremity of the patient; wherein the first groove is formed by an indentation between the first support and the spacer; wherein the second groove is formed by an indentation between the spacer and the second support (as shown in the reproduced image of fig.1) below.
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In view of the teachings of Gardner, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman by incorporating a spacer; a first groove; a second groove; wherein the second groove is configured to receive the second extremity of the patient; wherein the first groove is formed by an indentation between the first support and the spacer; wherein the second groove is formed by an indentation between the spacer and the second support if both legs are to be elevated simultaneously.
The combination of Lowman/Gardner substantially discloses the invention as claimed except (2) a securement strap; wherein the securement strap is configured to strap extremities of a patient to the device, (3) a pressurized gas; an activation feature; wherein the activation feature is a pull string, the pull string releasing pressurized gas into a hollow interior of the membrane; wherein releasing pressurized gas into the hollow interior causes the membrane to fill with gas and expand to an inflated position; a deactivation feature; the deactivation feature being a release port which allows gas to escape the membrane.
Ravikumar however, teaches a method and apparatus for eliminating or otherwise reducing or mitigating pressure on an individual's heel while the leg is in an extended position, while allowing for ambulation without completely removing the device (abstract) and (figs.2-3) comprising a securement strap is configured to strap extremities of a patient to the device [0051]-[0053].
In view of the teachings of Ravikumar, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman/Gardner by incorporating a securement strap is configured to strap extremities of a patient to the device in order to stabilize the anatomy of the user during use.
The combination of Lowman/Gardner/Ravikumar substantially discloses the invention as claimed except (3) a pressurized gas; an activation feature; wherein the activation feature is a pull string, the pull string releasing pressurized gas into a hollow interior of the membrane; wherein releasing pressurized gas into the hollow interior causes the membrane to fill with gas and expand to an inflated position; a deactivation feature; the deactivation feature being a release port which allows gas to escape the membrane.
Garner et al. however, teaches an inflatable device comprising an inflation mechanism 16 can be actuated. The power source 30 (e.g. PCB battery that may provide power for operation of control device 190 and inflation mechanism 16 and submergence detector, etc.) can be turned on and the signal from the sensor elements can be evaluated by the control device. In response to detecting a submerged condition that is present continuously for at least as long as a pre-selected threshold as discussed herein, the control device can send an actuation signal to a trigger 34 for actuation of the biasing mechanism 140 for opening of at least one gas source 26 for inflation of one or more inflatable chambers 14. This can be achieved by melting a cord 71, cutting a cord 71, moving a sear, or otherwise actuating an actuator (e.g. motor, gas spring, etc.) to release a spring 74 of the biasing mechanism 140 or otherwise drive opening of a gas source 26. In some embodiments, the biasing mechanism 140 can also be released via a pull string connected to the gas source such that pulling of the pull spring by a user opens the gas source for inflation of the inflation chamber(s) [0144]; wherein the gas is a pressurized gas [0068]-[0069]; Garner et al. further teaches a deactivation feature; the deactivation feature being a release port which allows gas to escape the membrane [0145].
In view of the teachings of Garner et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman/Gardner/Ravikumar by incorporating a pressurized gas; an activation feature; wherein the activation feature is a pull string, the pull string releasing pressurized gas into a hollow interior of the membrane; wherein releasing pressurized gas into the hollow interior causes the membrane to fill with gas and expand to an inflated position; a deactivation feature; the deactivation feature being a release port which allows gas to escape the membrane to fill with gas and expand to an inflated position for regulating the firmness of the device.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lowman/Gardner/Ravikumar/ Garner et al. as applied to claim 16 above, and further in view of Davis U.S. Patent No. (11,382,806 B2).
With respect to claim 17, the combination of Lowman/Gardner/Ravikumar/ Garner et al. substantially discloses the invention as claimed. Lowman further discloses instructions of use (inherent use of the device by one of ordinary skill in the art); a medical professional; a patient ([Col.1], lines 49-51) except a transport sheet.
Davis however, teaches an inflatable mattress for transporting a patient comprising a plurality of handles (150, fig.1) and ([Col.5], lines 6-19) and a transport sheet for covering a patient (as shown in fig.7).
In view of the teachings of Davis, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman/Gardner/Ravikumar/ Garner et al. by incorporating a transport sheet for covering a patient that allows for easy positioning of a patient while maintaining constant leg elevation.
Claim(s) 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lowman/Gardner/Ravikumar/ Garner et al. as applied to claim 16 above, and further in view of Gayes et al. U.S. Publication No. (2023/0128482 A1).
With respect to claim 18, the combination of Lowman/Gardner/Ravikumar/ Garner et al. substantially discloses the invention as claimed except a vitals detection system; wherein the vitals detection system activates when the system is activated; wherein the vitals detection system detects vitals of a patient engaged with the system.
Gayes et al. however, teaches an inflatable device for patient positioning (abstract) comprising one or more temperature sensors to monitor a patient's body temperature. Such temperature sensor(s) may communicate with internal computer 250 via external sensor interface 280. In turn, internal computer 250 may manage the heating elements to facilitate achievement and maintenance of a desirable body temperature [0270].
In view of the teachings of Gayes et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Lowman/Gardner/Ravikumar/ Garner et al. by incorporating a vitals detection system; wherein the vitals detection system activates when the system is activated; wherein the vitals detection system detects vitals of a patient engaged with the system to monitor the health condition of the user.
With respect to claim 19, the combination of Lowman/Gardner/Ravikumar/ Garner et al./Gayes et al. substantially discloses the invention as claimed. Gayes et al. further teaches a global positioning system [0010].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786