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 Arguments
Applicant's arguments filed 9/29/2025 have been fully considered but they are not persuasive. Applicant asserts that Goolsby in view of Lampropoulos fails to disclose the activating component remaining removably attached to the housing after operation of the tensioning device to apply constrictive pressure around the limb of the patient sufficient to restrict at least arterial blood flow through the limb. Claims 1 and 15 are drawn to the apparatus, not is method of use. As noted in the rejection, Goolsby teaches a pull tab but it is unclear if the pull tab can remain removably attached to the housing after operation of the tensioning device since the pull tab is associated with packaging, and it is unclear if the packaging must be removed prior to operation of the tensioning device. Lampropoulos teaches a pull tab that is not associated with any packaging of the device and can be removed at any time by the user to start the timer. It would have been obvious to one of ordinary skill in the art to have modified Goolsby to include a removable pull tab that is not associated with packaging or strap closure, the removal of which starts the timer, and can be removed after the tensioning device is operated to apply tension to the flexible band and constrictive pressure around the patient’s limb sufficient to restrict at least arterial blood flow through the limb as this is merely a substitution of one configuration for starting a timer for another (removal of pull tab associated with removal of packaging, and subsequent strap closure initiates timer versus removal of pull tab alone that initiates timer and removal can occur after band is tensioned by windlass), wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success. In so far as applicant is asserting that Goolsby in view of Lampropoulos does not expressly disclose removing the pull tab after the tensioning device is operated to apply constrictive pressure around the limb of the patient sufficient to restrict at least arterial blood flow through the limb, it is noted that this is a recitation of intended use in claims 1 and 15. Since the pull tab taught by Lampropoulos can be removed at any time by the user, it is clearly capable of remaining removably attached to the house after operation of the tensioning device to apply constrictive pressure sufficient to restrict at least arterial blood flow through the limb.
With respect to the method of claim 17, the examiner maintains that it would have been obvious to one of ordinary skill in the art to have removed the activating component of the prior art of Goolsby as modified by Lampropoulos from the timer apparatus to activate the timer after the step of adjusting the tensioning device to apply constrictive pressure around the body part sufficient to restrict at least arterial blood flow through the limb since Lampropoulos teaches an activating component (pull tab) that is free to be removed by the user at any time and one skilled in the art would recognize that removal of the tab after the claimed adjusting step merely leads to the predictable result of accurately measuring the amount of time that arterial blood flow has been restricted through the body part. Lampropoulos discloses that the timer may be configured to measure time from when the device is positioned on the art and the tensioning device is initially inflated ([0037]). Applicant asserts that the “initially inflated” configuration of the tensioning device of Lampropoulos does not correspond to application of constrictive pressure sufficient to restrict at least arterial blood flow through the limb, and asserts that “initially inflated” corresponds to when inflation initially starts, but applicant does not provide any evidence that this is the case. Additionally, Goolsby expressly discloses starting a timer after operating the tensioning device to apply constrictive pressure around the limb of the patient sufficient to restrict at least arterial blood flow through the limb (see fig. 24, noting step 2 reads “Twisting the rod until all bright red bleeding stops”, and the timer is not started until after step 3). Thus, the examiner maintains that one skilled in the art would have found it obvious to remove the pull tab of the prior art of Goolsby in view of Lampropoulos after the step of adjusting the tensioning device to apply constrictive pressure around the body part sufficient to restrict at least arterial blood flow through the limb because it is the restriction in arterial blood flow that may eventually cause tissue damage if it occurs for too long, and thus the duration of this restriction will be more accurately measured/monitored via the timer.
Claim Rejections - 35 USC § 103
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) 1, 4-6, 9, 11-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsby et al. (US 2018/0353189) in view of Lampropoulos et al. (US 2018/0014832) and Flodin et al. (US 2016/0379469).
Regarding claims 1, 15, and 17, Goolsby discloses a tourniquet comprising a flexible band (14,18) for encircling and applying pressure to a limb of a patient, a fastening element (38; corresponding structure includes a buckle in instant application, see fig. 1 and par. [0039] of instant spec.) for securing a first portion of the flexible band to a second portion of the flexible band, a tensioning device (74; corresponding structure includes a windlass structure 106 in instant application) operative to apply tension to the flexible band and constrictive pressure around the limb of the patient ([0064]) sufficient to restrict at least arterial blood flow through the limb (in the same manner as the windlass of the instant invention), and a timer apparatus (43) coupled to the tourniquet, the timer apparatus comprising a housing (strap 86), a display (49) coupled to the housing, a switch (portion of circuitry held open by plastic device inserted during manufacturing as discussed in [0077]) operatively controlled externally to the housing (by removal of plastic device, which closes switch as understood in view of [0077]), and a microcontroller (circuitry operating timer: [0075]) responsive to closure of the switch via removal of plastic device). The timer apparatus is affixed to the flexible band (see fig. 3). The switch of the timer apparatus comprises an activating component (plastic device inserted during manufacturing as per [0077]) that is removably attachable to the housing and when attached to the housing, the switch is open and the microcontroller is in an inactive condition (i.e., circuit is interrupted by plastic device). Removal of the activating component closes the switch which activates the microcontroller to measure elapsed time starting from activation, and the activation of the microcontroller to measure elapsed time is not reversible so that the measuring of elapsed time is not vulnerable to being erroneously stopped. In particular, Goolsby discloses an embodiment wherein there is no timer restart button, and activation starts via removal of plastic device inserted during manufacturing (see [0076] and [0077]). The timer measures elapsed time starting from activation of the timer ([0077], [0085]) and is considered a single-use switch. Regarding claim 17, Goolsby discloses a method of applying a tourniquet comprising providing a constriction device comprising a band (14,18), fastening element (38), tensioning device (74), and timer apparatus 43) as discussed above, manipulating the flexible band around a body part of a patient (as understood in view of fig. 1), coupling the first and second ends of the flexible band to encircle the body part (fig. 1), and adjusting the tensioning device to apply constrictive pressure around the body part sufficient to restrict at least arterial blood flow through the body part (via 74; [0057], [0064]).
Goolsby discloses that the timer is meant to measure elapsed time starting after operation of the tensioning device as understood in view of at least paragraph [0085] and fig. 24. Goolsby discloses removing the activating component, thereafter operating the tensioning device to apply constrictive pressure around the limb of the patient, and thereafter closing the strap to hold the tensioning device in place which automatically starts the timer (see description in fig. 27, which reads “Thin plastic divider (prevents circuit connection prior to use and preserves battery life and is automatically removed when strap is opened to clip windlass rod.).” and “In this design the timer automatically starts once the windlass rod is secured with the strap”; see also [0077], [0083]-[0085]). Thus, Goolsby fails to expressly disclose that the activating component remains removably attached to the housing after operation of the tensioning device to apply constrictive pressure around the limb of the patient sufficient to restrict at least arterial blood flow through the limb. Regarding apparatus claims 1 and 15, the limitation “wherein the activating component remains removably attached to the housing after operation of the tensioning device to apply constrictive pressure around the limb of the patient sufficient to restrict at least arterial blood flow through the limb” and the limitation “wherein the activating component is removable from the timer apparatus after operation of the tensioning device” are recitations of intended use and the prior art must only be capable of carrying out the function in order to meet the limitation. However, it is unclear if the activating component of Goolsby is capable of remaining removably attached to the housing after operation of the tensioning device, or if it is capable of being removed from the timer apparatus after operation of the tensioning device because it is unclear whether the packaging, which is never clearly illustrated and which the activating component is removed with, has to be removed prior to operation of the tensioning device. Regarding method claim 17, Goolsby fails to disclose removing activating component after the step of adjusting the tensioning device.
Lampropoulos discloses another device used to apply constrictive pressure to a limb of a patient, the device comprising a timer (fig. 5; [0035]). According to Lampropoulos the timer starts measuring elapsed time from a reference period, and the reference period may be when a pull tab is actuated and this can occur after the device is positioned to apply a constrictive force on the limb of the patient and a tensioning device (bladder 120) has been operated (i.e., inflated) to apply tension to the band and constrictive pressure around the limb of the patient ([0037]). One skilled in the art would understand the term “pull tab” to refer to a tab that is pulled from the device in order to start the timer. It would have been obvious to one of ordinary skill in the art to have modified Goolsby to include a removable pull tab that is not associated with packaging or strap closure, the removal of which starts the timer, and can be removed after the tensioning device is operated to apply tension to the flexible band and constrictive pressure around the patient’s limb sufficient to restrict at least arterial blood flow through the limb as this is merely a substitution of one configuration for starting a timer for another (removal of pull tab associated with removal of packaging, and subsequent strap closure initiates timer versus removal of pull tab alone that initiates timer and removal can occur after band is tensioned by windlass), wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Goolsby also does not expressly disclose a power source for the timer apparatus and does not expressly disclose that when the microcontroller is in the inactive condition (i.e., the circuit is not complete due to presence of plastic device as per [0077]), the microcontroller does not receive power from the power supply. Goolsby also does not expressly disclose that the microcontroller is in electrical communication with the display.
Flodin discloses another timer capable of tracking elapsed time and integrated with a medical device (abstract). In order to activate the timer, a plastic tab (158) positioned between a microcontroller (132) and a battery (118) is removed, thus allowing the circuitry (120) to connect to the battery and thus providing power to the microcontroller (see figs. 11a,b and fig. 2; [0064]). The microcontroller is also in electrical communication with the display in order to allow the elapsed time, measured by the microcontroller, to be communicated to the display (see fig. 5B of Flodin; [0048]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Goolsby to include a power supply, and to position the plastic device disclosed in par. [0077] of Goolsby between the microcontroller and the power supply, in order to power the circuitry of the timer of Goolsby, and allow the plastic device, when present, to prevent the microcontroller from receiving power from the power supply. It would also have been obvious to place the display and microcontroller of Goolsby in electrical communication as taught by Flodin in order for the elapsed time measured by the microcontroller to be communicated to the display.
Regarding claim 4, the activating component is configured for single use (i.e., it can be used once).
Regarding claim 5, as discussed above, Flodin teaches that the activating component (plastic device of par. [0077] of Goolsby) is positioned between the microcontroller and the battery (see fig. 2, 11a and 11b of Flodin).
Regarding claim 6, the power supply comprises one or more batteries as taught by Flodin (see 118 in fig. 2).
Regarding claim 9, at least a portion of the timer apparatus is integral with the flexible band (see fig. 2 of Goolsby; noting that integral is given its broadest reasonable interpretation of “formed as a unit with another part”).
Regarding claims 11 and 12, the tensioning device comprises a windlass (74 of Goolsby) and does not comprise electrical circuitry.
Regarding claim 13, once activated, the timer apparatus cannot return to the inactive condition without opening the housing or exhausting the power supply since the plastic device discussed in par. [0077] of Goolsby is removed to initiate activation, and Goolsby discloses that the device may not include a timer reset ([0076]).
Regarding claim 14, the tourniquet is configured for single-handed self-application. That is to say, it is possible for a user to apply the tourniquet to his or herself, or to another person, using only one hand, in the same manner as the instant invention.
Regarding claim 18, as further taught by Lampropoulos, the timer displays an elapsed tourniquet time on the display (i.e., the elapsed time since device has been placed around limb and tensioned [0037]-[0038]).
Regarding claim 19, it would have been considered obvious to remove the activating component of Goolsby as modified by Lampropoulos from the timer immediately following adjusting the tensioning device to apply constrictive pressure around the body part since the timer is meant to display the amount of time constrictive pressure has been applied to the body by the tourniquet.
Regarding claim 20, although Goolsby does not expressly disclose manipulating the flexible band and adjusting the tensioning device single-handed, such a step would have been considered obvious anytime a user is applying the device to him/herself (e.g., in an emergency situation where the user is alone) at a location on one arm that does not allow for two-handed application.
Claim(s) 10 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsby in view of Flodin and Lampropoulos, as applied to claim 1 above and further in view of Wang et al. (US 2022/0175393). Goolsby in view of Flodin and Lampropoulos discloses the invention substantially as stated above except for the timer apparatus being removably affixed to the flexible strap.
Wang discloses another tourniquet having a timer apparatus. The timer apparatus (10) is removably affixed to the flexible band (20) of the tourniquet via a waterproof housing (11) that comprises an attachment means (12/121) for coupling the timer apparatus to the flexible band at a targeted point of attachment. Such a releasable connection between the timer and flexible band allows the two parts to be easily separated for cleaning or disinfection by the user if desired ([0038]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Goolsby to removably affix the timer apparatus to the flexible band via a housing having an attachment means for coupling the timer apparatus to the flexible band as taught by Wang in order to allow separation of the parts for cleaning, disinfection, or replacement of a faulty or broken timer or strap.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsby in view of Flodin and Lampropoulos, as applied to claim 1 above and further in view of Pienkowski et al. (US 2010/0234877). Goolsby in view of Lampropoulos and Flodin discloses the invention substantially as stated above including that the microcontroller is mounted on a printed circuit board as taught by Flodin (see fig. 2), but does not expressly disclose that the microcontroller is in electrical communication with a voltage regulator.
Pienkowski discloses another tourniquet with a timer apparatus (see claim 8 of Pienkowski), the timer apparatus comprising a microcontroller (38; fig. 3). Pienkowski discloses that the timer may include a voltage regulator (46) in communication with the microcontroller in order to ensure that proper voltage is applied to each of the electrical components during operation ([0034]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Goolsby to include a voltage regulator in the timer apparatus as taught by Pienkowski in order to ensure that proper voltage is applied to each electrical component of the timer (e.g., the microcontroller and display).
Regarding claim 8, Goolsby discloses the invention substantially as stated above except for the housing of the timer apparatus being one or more of shock resistant, waterproof, or water resistant. Pienkowski teaches constructing the housing (enclosure 28) of a timer apparatus of a tourniquet such that it is waterproof ([0034]). It would have been obvious to one of ordinary skill in the art to further modify the prior art of Goolsby to construct the housing to be waterproof or water resistant in view of the teachings of Pienkowski for the predictable result of protecting circuitry within the timer apparatus from water or other liquids.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsby in view of Flodin and Lampropoulos as applied to claim 15 above and further in view of Engwall (US 2018/0317935) and Pienkowski et al. (US 2010/0234877). Goolsby in view of Flodin and Lampropoulos discloses the invention substantially as stated above including that the power supply comprising one or more batteries (as taught by Flodin) and that the microcontroller of the timer is mounted on a printed circuit board (fig. 2 of Flodin), the activating component of the switch comprising a tab positioned between the microcontroller and the power supply ([0077] of Goolsby and figs. 11a,b of Flodin), wherein the microcontroller is in an inactive state when the tab is attached to the housing (due to presence of tab, which interrupts circuit). Goolsby discloses that the timer indicates how long the tourniquet has been applied to the injured person via a display (49; [0075]), but fails to expressly disclose that the display on the timer is a digital display, and further fails to disclose a voltage regulator as claimed.
Engwall discloses another tourniquet having a timer attached thereto, wherein the timer is used to keep track of the amount of time the tourniquet has been applied to the user (see abstract). Engwall discloses that the timer may have a digital display ([0016]). It would have been obvious to one of ordinary skill in the art to have provided a digital display on the timer of Goolsby of the time elapsed since the tourniquet has been applied to the injured person in view of Engwall’s disclosure that a digital display on a timer used in combination with a tourniquet is known in the art and one skilled in the art would understand that a digital display provides an easily understandable and precise indication of the elapsed time to the user.
Pienkowski discloses another tourniquet with a timer apparatus (see claim 8 of Pienkowski), the timer apparatus comprising a microcontroller (38; fig. 3). Pienkowski discloses that the timer may include a voltage regulator (46) in communication with the microcontroller in order to ensure that proper voltage is applied to each of the electrical components during operation ([0034]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Goolsby to include a voltage regulator in the timer apparatus as taught by Pienkowski in order to ensure that proper voltage is applied to each electrical component of the timer (e.g., the microcontroller and display).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goolsby in view of Flodin and Lampropoulos, as applied to claim 5 above and further in view of Ortega et al. (US 2008/0278336). Goolsby in view of Flodin and Lampropoulos discloses the invention substantially as stated above including an activating component comprising a release tab having a portion within the housing and a portion external to the housing ([0077] of Goolsby; figs. 11a,b of Flodin), but fails to disclose that the portion within the housing is narrower.
Ortega discloses another medical device having an activating component in the form of a release tab (26) that leaves the device in a powered off condition until energized by the battery upon pulling the release tab out ([0043]). As illustrated in figs.1-3, the release tab has a portion within the housing which is narrower than a portion of the tab external to the housing. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Goolsby as modified by Flodin to provide the portion of the release tab external to the housing with a wider dimension than the portion within the housing as taught by Ortega for the obvious advantage of providing an enlarged grasping portion.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 12/1/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771