DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 23 July 2026 have been fully considered but they are not persuasive.
Applicant argues that Maher does not teach the top plate comprising an orifice comprising a proximal and a distal opening defining a fluid path through the top plate into an inflatable bladder as Maher instead depicts a fluid path into an inflatable bladder from a lateral inlet or outlet port. However, as shown in annotated Fig. 8 below, Maher depicts an orifice with a proximal and distal opening as claimed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2-7, 11-14, 21, 22, 24, 25 and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0039365 A1 to Maher et al. (Maher).
Regarding claims 6 and 7, Maher teaches a system for applying cooling and compression to a site on a body region of a patient (title “Cervical Collar”), comprising a compression member (bladder 506) configured to apply compression to a compression site located in a body region of a patient, the compression member comprising a top plate (outer shell 502) comprising a transparent or translucent window ([0056]) for visibility of the site through the compression member and an orifice comprising a proximal opening and a distal opening defining a fluid path through the top plate into an inflatable bladder (see annotated Fig. 8 below), an inflatable bladder (multiple cooling chambers 530) having a fluid-tight interior configured to hold a volume of a coolant solution ([0048]), wherein the top plate is configured to limit upward expansion of the inflatable bladder such that the inflatable bladder is configured to expand downward and away from the top plate ([0045] which states “The outer shell 502 is made from a flexible plastic material…”), a valve ([0052] which states “Further, the inlet and outlet ports 534, 536 may include a valve to regulate the flow of cooling fluid into and/or out of the bladder 506.”) in fluid communication with the interior, the valve being configured to facilitate injection of the coolant solution into the interior of the inflatable bladder and to facilitate withdrawal of the coolant solution from the inflatable bladder ([0052] which states “the inlet and outlet ports 534, 536 may include a valve to regulate the flow of cooling fluid into and/or out of the bladder 506”), a temperature indicator (538 and [0054]), a securement system (outer shell 502 in combination with fastening device 512) configured to secure the compression member to the body region of the patient ([0044]), an amount of solid endothermic material (chemical 906 and [0053] which states in part “a chemical 906, such as but not limited to, ammonium nitrate”), a coolant delivery device (cooling pack 900) comprising a chamber (see Figs 9-11) configured for combining the endothermic material with an aqueous liquid (fluid 904) to from the coolant solution ([0053] which states in part “The cooling pack 900 is a granule-activation packet that uses a fluid 904, such as but not limited to, water and a chemical 906, such as but not limited to, ammonium nitrate that when mixed together create a cooling fluid. When a user strikes the cooling pack 900 with the palm of their hand, a prescribed amount of water will mix with the ammonium nitrate thereby creating a cooling fluid.”) and further configured to fluidly connect with the inflatable bladder and deliver the coolant solution to the interior ([0053] which stats in part “The cooling fluid from the cooling pack 900 can then be pumped into the bladder 506 via the inlet port 534 and into each chamber 530 via passageways 532, as described below.”). However, Maher is silent with respect to wherein the coolant solution assumes a temperature upon formation of about 33oF to about 55oF. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Maher to have the coolant solution assume the temperature of about 33oF to about 55oF, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
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Regarding claim 2, Maher teaches the system of claim 6 as well as wherein the temperature indicator comprises a thermochromic element configured to display a color to indicate one of the one or more temperature states ([0054] which states in part “In one example, the indicator 538 can change color based on the temperature of the cooling fluid. For example, the indicator 538 may be a first color (e.g., blue, dark blue, etc.) when the temperature of the cooling fluid is at a temperature that provides adequate cooling to the patient. As the temperature of the cooling fluid begins to lose its cooling effect (e.g., the cooling fluid begins to warm), the indicator 538 may turn a second color (e.g., orange). As the temperature of the cooling fluid continues to warm (e.g., approaches ambient temperature), the indicator 538 may turn a third color (e.g., red) indicating that the cooling fluid is no longer providing adequate cooling to the patient. The indicator 538 can provide a quick visual means for the EMT personnel to determine if the cooling pack 200 should be replaced or if additional cooling fluid should be pumped into bladder 506 with another cooling pack 900.”).
Regarding claim 3, Maher teaches the system of claim 6 as well as wherein the one or more temperature states include a cooling state comprising coolant solution temperatures at or below a target temperature ([0054]).
Regarding claim 4, Maher teaches the system of claim 6 as well as wherein the securement system comprises a collar (multiple panels 514) coupled to the compression member and one or more straps (fastening device 512) couplable to the collar (Fig. 7).
Regarding claim 5, Maher teaches the system of claim 6 as well as wherein the temperature indicator is integrated within the top plate ([0054]).
Regarding claim 11, Maher teaches a method of applying compression with cooling to a compression site on a body region of a patient (see entire document), comprising providing an endothermic compression device comprising a compression member (bladder 506) configured to apply compression to a compression site located in a body region of a patient, the compression member comprising a top plate (outer shell 502) comprising a transparent or translucent window ([0056]) for visibility of the site through the compression member and an orifice comprising a proximal opening and a distal opening defining a fluid path through the top plate into an inflatable bladder (see annotated Fig. 8 above), an inflatable bladder (multiple cooling chambers 530) having a fluid-tight interior configured to hold a volume of a coolant solution ([0048]), wherein the top plate is configured to limit upward expansion of the inflatable bladder such that the inflatable bladder is configured to expand downward and away from the top plate ([0045] which states “The outer shell 502 is made from a flexible plastic material…”), a valve ([0052] which states “Further, the inlet and outlet ports 534, 536 may include a valve to regulate the flow of cooling fluid into and/or out of the bladder 506.”) in fluid communication with the interior, the valve being configured to facilitate injection of the coolant solution into the interior of the inflatable bladder and to facilitate withdrawal of the coolant solution from the inflatable bladder ([0052] which states “the inlet and outlet ports 534, 536 may include a valve to regulate the flow of cooling fluid into and/or out of the bladder 506”), a temperature indicator (538 and [0054]) and a securement system (outer shell 502 in combination with fastening device 512) configured to secure the compression member to the body region of the patient ([0044]), placing the compression member on the body region so that the inflatable bladder is situated directly over the compression site (Fig. 4), securing the endothermic compression device to the body region (Fig. 4), and injecting a volume of coolant solution through the valve into the interior of the inflatable bladder to provide cooling to the compression site at a temperature for a period of time ([0053]). However, Maher is silent with respect to wherein the coolant solution assumes a temperature upon formation of about 33oF to about 55oF. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Maher to have the coolant solution assume the temperature of about 33oF to about 55oF, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
Regarding claim 12, Maher teaches the method of claim 11 as well as wherein injecting the volume of the coolant solution further comprises providing a coolant delivery device (cooling pack 900) having a chamber (Figs. 9-11) containing an endothermic material (chemical 906 and [0053] which states in part “a chemical 609, such as but not limited to, ammonium nitrate”), wherein the coolant delivery device is configured to fluidly connect with the inflatable bladder through the valve ([0052-0053]), forming the coolant solution by adding an aqueous liquid to the chamber to combine with the endothermic material ([0053] which states in part “The cooling pack 900 is a granule-activation packet that uses a fluid 904, such as but not limited to, water and a chemical 906, such as but not limited to, ammonium nitrate that when mixed together create a cooling fluid. When a user strikes the cooling pack 900 with the palm of their hand, a prescribed amount of water will mix with the ammonium nitrate thereby creating a cooling fluid.”), fluidly connecting the coolant delivery device to the valve ([0052-0053]) and injecting the coolant solution through the valve into the interior of the inflatable bladder ([0053]).
Regarding claim 13, Maher teaches the method of claim 11 as well as maintaining cooling within a temperature range for the period of time by replacing the volume of coolant with a second volume of coolant having a temperature within the temperature range ([0053] which states in part “In addition, once the cooling fluid inside the blader 506 begins to warm, the empty cooling pack 900 can be attached to the outlet port 536 and a new cooling pack 900 can be attached to the inlet port 534. The cooling fluid from the new cooling pack 900 can then be pumped into the bladder 506 thereby forcing the warm fluid out of the bladder through the outlet port 536 and back into the original cooling pack 900. Thus, cooling fluid can essentially be continuously pumped through the collar 506 by EMT personnel who do not have access to a continuous external cooling system (described below) in the field.”).
Regarding claim 14, Maher teaches the method of claim 11, but not wherein the period of time is about 15 minutes to about 120 minutes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a time period of about 15 minutes to about 120 minutes 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.
Regarding claim 21, Maher teaches the method of claim 11 as well as wherein the temperature indicator is integrated within the top plate ([0054]).
Regarding claim 22, Maher teaches the system of claim 6 as well as wherein the valve is coupled to a tube (passageways 532) coupled to the top plate (see for example Fig. 8), wherein the tube is coupled to the top plate at a location adjacent to an outer edge of the compression member (see for example Fig. 8).
Regarding claim 24, Maher teaches the system of claim 6 as well as wherein the inflatable bladder is coupled to an underside of the top plate (see for example Fig. 2).
Regarding claim 25, Maher teaches the method of claim 11 as well as wherein the valve is coupled to a tube (passageways 532) coupled to the top plate (see for example Fig. 8), wherein the tube is coupled to the top plate at a location adjacent to an outer edge of the compression member (see for example Fig. 8).
Regarding claim 28, Maher teaches the method of claim 12 as well as wherein the endothermic material comprises one or more of ammonium nitrate ([0053] which states in part “a chemical 906, such as but not limited to, ammonium nitrate”), urea, biuret, ammonium chloride, potassium nitrate, ammonium perchlorate, potassium chlorate, potassium perchlorate, potassium chloride, silica gel, calcium ammonium nitrate, and calcium nitrate tetrahydrate.
Regarding claim 29, Maher teaches the system of claim 6 as well as herein the valve comprises a proximal and a distal opening defining a first lumen through the valve (inherent in the use of a valve), but not wherein the distal opening of the first lumen terminates at a proximal opening of the orifice of the top plate. It would have been an obvious matter of engineering design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to locate the first lumen as claimed, since it has been held that rearranging parts of an invention involves only routine skill in the art.
Regarding claim 30, Maher teaches the securement system of claim 4 as well as wherein the collar is less rigid than the top plate ([0045] which states in part “The outer shell 502 is made from a flexible plastic material, such as but not limited to polyethylene, polystyrene, etc. Further, both the front and back portions 508, 510 include multiple panels 514 each connected by hinged portions 516 that further facilitate in the flexibility of the outer shell 502. This configuration allows EMT personnel to control the flexibility of the collar 500 and easily adjust the collar 500 to fit the patient.”).
Regarding claim 31, Maher teaches a system for applying cooling and compression to a site on a body region of a patient (title “Cervical Collar”), comprising a compression member (bladder 506) configured to apply compression to a compression site located in a body region of a patient, the compression member comprising a top plate (front portion 508) comprising a transparent or translucent window ([0056]) for visibility of the site through the compression member and an orifice comprising a proximal opening and a distal opening defining a fluid path through the top plate into an inflatable bladder (see annotated Fig. 8 below), an inflatable bladder (multiple cooling chambers 530) having a fluid-tight interior configured to hold a volume of a coolant solution ([0048]), wherein the top plate is configured to limit upward expansion of the inflatable bladder such that the inflatable bladder is configured to expand downward and away from the top plate ([0045] which states “The outer shell 502 is made from a flexible plastic material…”), a valve ([0052] which states “Further, the inlet and outlet ports 534, 536 may include a valve to regulate the flow of cooling fluid into and/or out of the bladder 506.”) in fluid communication with the interior, the valve being configured to facilitate injection of the coolant solution into the interior of the inflatable bladder and to facilitate withdrawal of the coolant solution from the inflatable bladder ([0052] which states “the inlet and outlet ports 534, 536 may include a valve to regulate the flow of cooling fluid into and/or out of the bladder 506”), a temperature indicator (538 and [0054]), a securement system (outer shell 502 in combination with fastening device 512) configured to secure the compression member to the body region of the patient ([0044]), the securement system comprising a collar (multiple panels 514) coupled to the compression member (Fig. 7), the collar defining a plane defined by the area between its proximal and distal surface, wherein at least one of the compression member and top plate traverses the plane (Fig. 6), an amount of solid endothermic material (chemical 906 and [0053] which states in part “a chemical 906, such as but not limited to, ammonium nitrate”), a coolant delivery device (cooling pack 900) comprising a chamber (see Figs 9-11) configured for combining the endothermic material with an aqueous liquid (fluid 904) to from the coolant solution ([0053] which states in part “The cooling pack 900 is a granule-activation packet that uses a fluid 904, such as but not limited to, water and a chemical 906, such as but not limited to, ammonium nitrate that when mixed together create a cooling fluid. When a user strikes the cooling pack 900 with the palm of their hand, a prescribed amount of water will mix with the ammonium nitrate thereby creating a cooling fluid.”) and further configured to fluidly connect with the inflatable bladder and deliver the coolant solution to the interior ([0053] which stats in part “The cooling fluid from the cooling pack 900 can then be pumped into the bladder 506 via the inlet port 534 and into each chamber 530 via passageways 532, as described below.”). However, Maher is silent with respect to wherein the coolant solution assumes a temperature upon formation of about 33oF to about 55oF. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Maher to have the coolant solution assume the temperature of about 33oF to about 55oF, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maher in view of US 2014/0039584 A1 to Potter et al. (Potter).
Regarding claim 8, Maher teaches the system of claim 7, but not wherein the endothermic material further comprises at least one of a dissolution accelerant or an anticaking agent. Potter teaches an analogous device (title) to that of Maher where the material having an endothermic heat of solution in water includes urea, potassium chloride and ammonium chloride (claims 4 and 16). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Maher to substitute the endothermic material of Maher with that of Potter, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 9, the combination teaches the system of claim 8, but not wherein the endothermic material comprises about 70 wt% to about 90 wt% urea and about 10 wt% to about 30 wt% potassium chloride. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used the claimed wt% of urea and potassium chloride, since it has been held that here 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rozenthal (US 2013/0211484 A1) teaches a system for applying cooling and compression to a side on a body region of a patient (title “Therapeutic Brain Cooling System and Spinal cord Cooling System”) including a helmet body (210) with 6-10 cushion pads (106) between the head and the helmet body. The pads are inflated with gas released from a canister (103) inserted into valve (101) positioned at the top and lateral sides of the helmet body, which are connected to the pad system([0077-0078]).
Applicant's amendment necessitated any 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 KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at (303) 297-4726. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
