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 .
Status of Claims
This Action is in response to the amendment filed on July 9, 2026.
As directed by the amendment: Claims 1, 4-7, and 10 were amended. Claims 8-9, 11, and 13-22 were cancelled. Claims 1-7, 10, and 12 are pending and currently under consideration for patentability under 37 CFR 1.104.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 1, line 15 recites “the output channel” which lacks antecedent basis in the specification. The word “output” does not appear in the specification, and the only “channels” mentioned are the overflow channel (408, Fig. 3A), and the air channel (314, Fig. 3A), which are different structures than the recited “output channel.”
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1, lines 5-6 recite “the at least one compression components” (plural) and the Examiner suggests –the at least one compression component— to use consistent language with claim 1, line 4.
Claim 1, line 10 recites “an treatment duration” and the Examiner suggests –a treatment duration--.
Claim 7, line 2 recites “at least on pressure switch” which appears to be a typographical error. The Examiner suggests –at least one pressure switch--.
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.
Claim Rejections - 35 USC § 112(b)
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 1-7, 10, and 12 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 1, line 12 recites “the tank” which lacks antecedent basis.
Claim 1, line 14 recites “the liquid circuit” which lacks antecedent basis.
Claim 1, line 15 recites “the output channel” which lacks antecedent basis.
Claim 1, the last line recites “the liquid pump” which lacks antecedent basis.
Claim 1, the last line recites “the liquid cavity” which lacks antecedent basis.
Claims 2-7, 10, and 12 are rejected based on their dependence on claim 1.
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) 1-5, 7, 10, and 12, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Schubert (10,813,825) in view of Lowe et al. (2020/0000628).
Regarding claim 1, Schubert discloses a compression apparatus (Fig. 1A) for applying pressure to a subject (the subject dons the compression apparatus), the compression apparatus comprising:
a compression system (fluid source 60, connecting element 70, tubing 50, Fig. 1A);
at least one compression component (first segment 20, second segment 30, Fig. 1A, the first segment includes an inflatable bladder; see col. 13, lines 29-38) connected to the compression system (connected by tubing 50 and connecting element 40, see Fig. 1A) and configured to be secured around the subject (one or more extensions 22 allow “for placement on a front of a knee” see col. 9, lines 35-39 and Figs. 5A-19), the at least one compression components (20, 30) comprising an air cavity (the first segment 20 includes an air bladder; “bladder is fitted in the interior of the first segment” see col. 13, lines 29-38, and see bladder chamber(s) 36, 37, 38, 39, Figs. 1C-1D);
the compression system comprising an air circuit (fluid source 60, connecting element 70, tubing 50, Fig. 1A, form an air circuit delivering air from fluid source 60 to the bladder of first segment 20 via connecting element 40; see col. 7, lines 5-18) configured to sequentially introduce air into the air cavity (“compression, is introduced cyclically … the treatment duration may include a plurality of cyclical inflation and deflation cycles over the treatment duration” see col. 15, lines 43-58 and see “Mode C” at col. 16, line 6, providing 30 seconds of inflation and 30 seconds of deflation. The cyclical inflation and deflation cycles sequentially introduce air into the air cavity, i.e., bladder) for a predetermined compression time (30 seconds ON, see “Mode C” of Table 1 at col. 16, line 6) and a predetermined decompression time (30 seconds OFF, see “Mode C” of Table 1 at col. 16, line 6) until a treatment duration is reached (“the treatment duration may be for only a few minutes or for many minutes”, see col. 15, lines 54-57; and see the 15 minute duration in “Mode C” of Table 1 at col. 16, line 6).
Schubert additionally discloses a liquid cavity (second segment 30 includes compartments 90, 94, Fig. 1B, these compartments of the second segment are for “encasing a temperature sensitive component or material … typically a fluid in liquid … form” see col. 17, lines 11-15; see col. 18, lines 40-43) that provides thermal therapy (see col. 17, lines 25-30).
However, Schubert is silent regarding a refrigeration circuit connected to [a] tank and configured to cool coolant disposed within the tank; wherein [a] liquid circuit further comprises an overflow channel disposed between and in fluidic communication with [an] output channel and the tank, the overflow channel configured to allow some of the coolant leaving [a] liquid pump to return to the tank without entering the liquid cavity.
Lowe teaches a related thermal compression garment (therapy wrap 20, Fig. 4A, which includes a “fluid bladder 25 for circulating heat transfer fluid and a gas pressure bladder 28 which overlays the fluid bladder” see Fig. 4B, see para. [0138]), with a compression system (Fig. 8A) comprising a refrigeration circuit (the circuit connecting chiller 8005 and tank 7004, Fig. 8A) connected to a tank (cold tank 7004, Fig. 8A) and configured to cool (via chiller 8005, Fig. 8A) coolant disposed within the tank (bladder 25 receives “a fluid, such as a coolant” see the penultimate sentence of [0139]. The fluid is seen in the tank 7004, and the chilled coolant is fed to the tank at least partially through chiller 8005 as seen in Fig. 8A. Thus, the coolant disposed within the tank has been cooled by the chiller 8005); wherein a liquid circuit (liquid line(s) from tank 7004, to pumps 8001, 8002, to connector(s), to patient wrap(s) 1, 2, and returning to the cold tank 7004 in Fig. 8A) further comprises an overflow channel (see “1. Overflow Channel” in annotated Figure A below, corresponding to the recirculation manifold and its fluid outputs. This channel is used if the tank is at risk of being overfilled, “if the water levels get too low or too full (overflow), preventative steps may be taken” see line 3-4 of [0174], para. [0175], and see para. [0181]-[0186] describing scenarios in which the coolant from cold tank 7004 is routed to the hot tank if the cold tank is too full: “the tank to tank valves may perform in the following manner: Cold tank to hot tank valve: … When Thermal Therapy is not active or has been not active for 10 seconds, The valve between the cold tank to hot tank shall be open for 5 seconds and then closed for 5 seconds if the cold tank water level is an absolute delta of ¼” (+/- 1/8”) greater than the hot tank water level in order to maintain equal tank levels in between therapies … [or when thermal therapy is active] if the hot tank level is less than 3.6” H2O AND cold tank level exceeds 3.6” H2O” see para. [0181]-[0186], emphasis added) disposed between and in fluidic communication with an output channel (see “2. Output Channel” in annotated Figure A below) and the tank (7004, Fig. 8A. The fluid downstream of the overflow channel 1 ultimately returns to tank 7004 either through the chiller 8005 or indirectly by moving “to hot tank” and “from hot tank” in Fig. 8A. Thus, the overflow channel is between the output channel and the tank), the overflow channel (1) configured to allow some of the coolant leaving a liquid pump (i.e., Recirculation Pump 8001, Fig. 8A) to return to the tank (7004) without entering a liquid cavity (the liquid cavity is considered the one or more liquid bladder(s) in Patient Wrap(s) 1, 2, Fig. 8A-8B. The Overflow channel 1 allows at least some of the coolant leaving the liquid pump 8001 to return to the tank 7004 by: 1) being routed through chiller 8005 and returning to tank 7004, or 2) being sent “to hot tank” in Fig. 8A, which enters the hot tank 8007 “from cold tank” in Fig. 8B and can then return “to cold tank”, without entering the patient wrap(s). It is noted that the process described in para. [0181]-[0185] opens the “cold tank to hot tank” valve for 5 seconds and then closes for 5 seconds if the cold tank is overfilled. Thus, the overflow channel “allows” at least some of the coolant to (ultimately) return to the tank 7004 without entering the liquid cavity in the patient wrap(s)). Thus, the overflow channel (1) helps prevent either tank level from becoming too low or too full. The liquid circuit and refrigeration circuit provide advantages such as allowing the temperature of the liquid bladder (25, Fig. 4B) to be closely controlled (via control interface in Fig. 11A) for prolonged periods of time (cold therapy may be applied for up to 60 minutes, see Fig. 10B).
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Annotated Figure A (from Fig. 8A of Lowe): Lowe has an output channel (2) leading to an overflow channel (1, corresponding to the recirculation manifold and its fluid outputs) used to route liquid to the hot tank if the cold tank is at risk of being overfilled (see para. [0185]-[0186]). This routing is performed with the Cold Tank to Hot Tank Valve (labeled above).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Schubert include a refrigeration circuit connected to a tank and configured to cool coolant disposed within the tank, with a liquid circuit comprising an overflow channel disposed between and in fluidic communication with an output channel and the tank, the overflow channel configured to allow some of the coolant leaving a liquid pump to return to the tank without entering a liquid cavity as taught by Lowe to allow the operator to closely control, and adjust the therapeutic temperature for prolonged periods of time.
Regarding claim 2, the modified Schubert/Lowe device discloses wherein the predetermined compression time is between 30 and 50 seconds (30 seconds ON, see “Mode C” of Table 1 at col. 16, line 6 of Schubert).
Regarding claim 3, the modified Schubert/Lowe device discloses wherein the predetermined decompression time is between 10 and 30 seconds (30 seconds OFF, see “Mode C” of Table 1 at col. 16, line 6 of Schubert).
Regarding claim 4, the modified Schubert/Lowe device discloses wherein the treatment duration is between 2 and 5 hours (Schubert discloses the ability to provide treatment durations of “120 minutes or several hours”, see col. 22, lines 12-17).
Regarding claim 5, the modified Schubert/Lowe device discloses wherein the air circuit (fluid source 60, connecting element 70, tubing 50, Fig. 1A of Schubert, form an air circuit delivering air from fluid source 60 to the bladder of first segment 20 via connecting element 40; see col. 7, lines 5-18) comprises at least one air pump (fluid source 60, Fig. 1A of Schubert; “fluid is generally pressurized (e.g., by way of a pump that fluidly communicates with the device” see col. 7, lines 49-50 of Schubert; see also col. 8, lines 5-10 of Schubert), at least one solenoid valve (“source includes a controller operable with a pump, a valve mechanism (e.g., solenoid valve)” see col. 8, lines 5-6 of Schubert) and at least one pressure switch (pressure release mechanism, “pressure gauge, muffler and exhaust or release mechanism (e.g., mechanical blow valve or other active or passive mechanism), each of which are operable with the inlet tubing communicating with the pump and bladder. In this embodiment, the pressure gauge is in operable communication with the solenoid valve (regarding opening and pressure release) and with the pump (regarding starting and stopping the pump) and the release mechanism is in operable communication with the bladder as a passive safety mechanism to release pressure should it become greater than a maximum pressure set for the device” see col. 8, lines 7-17 of Schubert).
Regarding claim 7, the modified Schubert/Lowe device discloses wherein the at least one pressure switch is configured to release air from the air cavity when the pressure within the air cavity exceeds a set pressure (“release mechanism is in operable communication with the bladder as a passive safety mechanism to release pressure should it become greater than a maximum pressure set for the device” see col. 8, lines 7-17 of Schubert).
Regarding claim 10, the modified Schubert/Lowe device discloses wherein the refrigeration circuit (the circuit connecting chiller 8005 and tank 7004, Fig. 8A of Lowe) is configured to cool the coolant (via chiller 8005, Fig. 8A of Lowe) to a predetermined temperature (the cold tank temperature can be predetermined by the user interface 2000, Fig. 2 of Lowe; “user interface 2000 can be a touch screen with graphical icons that represent different treatment modalities and can include adjustable parameter settings, such as hot and cold temperature settings for example” see para. [0123], see also the last sentence of [0142] of Lowe).
Regarding claim 12, the modified Schubert/Lowe device discloses wherein the coolant has a temperature of between 6 and 24 °C (minimum cold reservoir temperature of 3°C, maximum cold reservoir setting of 13°C, see Fig. 10B of Lowe, this overlaps with the claimed range).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert (10,818,825) in view of Lowe et al. (2020/0000628) as applied to claim 5 above, and further in view of Perry et al. (2005/0187500)
Regarding claim 6, the modified Schubert/Lowe device discloses wherein the at least one air pump is configured to introduce air into the air cavity (“a pump, … introducing fluid into the bladder” see col. 13, lines 21-26 of Schubert). The modified device does not specifically state the at least one solenoid valve is configured to release air from the air cavity.
Perry teaches a related inflatable compression garment (Fig. 6) with at least one air pump (air pump 50, Fig. 5) configured to introduce air into at least one air cavity (bladder(s) 46a-c, 48a-c, Fig. 5), and at least one solenoid valve (solenoid valves 58a-c, 60a-c, Fig. 5) is configured to release air from the air cavity (“after the predetermined period of hold time (e.g., 15 seconds) has ended, the solenoid valve 58 will be commanded to open and permit the air chamber 12, 22 to deflate” see para. [0055] The venting operation releases air from the air cavity, through vent ports 66a-c, 68a-c, Fig. 5).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the solenoid valve(s) of Schubert/Lowe to have at least one solenoid valve configured to release air from the air cavity as taught by Perry because this is a combination of prior art elements to provide an expected result that the solenoid valves allow precise control over inflation/deflation timing, under command of the controller.
Response to Arguments
Applicant's arguments filed July 9, 2026, have been fully considered but they are not persuasive.
Regarding the argument that to better characterize the relationship between the output (overflow?) channel and surrounding features, Applicants have introduced the feature “output channel” which supplies coolant from the liquid pump to the liquid cavity, seen at least in Fig. 3A which has been highlighted in yellow (see the last paragraph of page 5 of the Remarks, through the associated figure on page 6), this argument is not persuasive.
First, it is noted that the recited “output channel” should have antecedent basis in the specification. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Second, the claims do not require that the output channel “supplies coolant from the liquid pump to the liquid cavity.” Third, the figure provided is in black and white, and it is unclear which channel Applicant has highlighted.
Regarding the argument that the overflow channel as recited in claim 1 further requires the overflow channel 408 to be configured to “allow some of the coolant leaving the liquid pump to return to the tank without entering the liquid cavity” (see the first paragraph of page 6 of the Remarks), this argument has been considered, and the Examiner notes that the Lowe reference discloses an overflow channel that reads on the amended limitation (see the 35 USC 103 rejection(s) above).
Regarding the argument that the 35 USC 112 rejection(s) should be withdrawn based upon the amendments to claim 4, and the cancellation of claim 22 (see page 7 of the Remarks), this argument is persuasive.
The previous rejection(s) of claims 4 and 22 under 35 USC 112 have been withdrawn. However, it is noted that the amendments to claim 1 have resulted in various rejections under 35 USC 112(b) (see above).
Regarding the argument that the 35 USC 101 rejection(s) should be withdrawn based upon the amendment to claim 1 and the cancellation of claim 21 (see the first two paragraphs of page 8 of the Remarks), this argument is persuasive and the 35 USC 101 rejection(s) have been withdrawn.
Regarding the argument that the 35 USC 103 rejection(s) is overcome because claim 1 has been amended to require “an overflow channel disposed between and in fluidic communication with the output channel and the tank, the overflow channel configured to allow some of the coolant leaving the liquid pump to return to the tank without entering the liquid cavity” and Schubert fails to disclose details on fluid paths and an overflow channel configured to allow some of the coolant leaving a liquid pump to return to the tank without first entering the liquid cavity (see the last paragraph of page 8 of the Remarks, through the first paragraph of page 9), this argument is not persuasive.
While the Examiner agrees that Schubert fails to disclose the amended limitation(s), the claims are still rejected under 35 USC 103 rejection(s) based upon the teachings of Lowe et al. (2020/0000628). See the 35 USC 103 rejection(s) above.
Regarding the argument that Roth fails to disclose an outflow path that returns some fluid to the tank after leaving a liquid pump and does not cure the deficiencies of Schubert, and that the overflow channel is advantageous in that excess coolant can be passively returned to the tank without first entering the liquid cavity … and Roth’s manifold valve 333 is used to control the maximum massaging pressure level reached in the bladders (see the second paragraph of page 9 of the Remarks), this argument has been considered, but it is moot because Roth is no longer relied upon in the current rejection(s). This is due to the claim amendments.
Regarding the argument that accordingly, amended independent claim 1 is allowable, and claims 2-7, 10, and 12 are likewise allowable due to their dependency from claim 1 (see the last paragraph of page 9 of the Remarks), this argument is not persuasive because claim 1 is not allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ballman (2,260,134) discloses a related thermal therapy pad that has an overflow conduit so that when a constant temperature is maintained in the system, the device will permit the overflow of fluid to pass backward into the system. Nethery (3,918,458) discloses a related thermal therapy pad that has a recycling coolant path that allows some of the coolant leaving the pump to be returned to the liquid tank without entering the liquid cavity of the thermal pad. Sauder (4,026,299) discloses a related thermal therapy pad with a reversing valve to chang ethe direction in which the refrigerant liquid is passing through the conduits and thus at least a portion of the liquid leaving a pump is returned without entering the thermal pad. Sauder (4,184,537) discloses a related thermal therapy pad with a pump configured to return at least some liquid to a cooling tank without entering the thermal pad. Bledsoe (8,613,762) discloses a related thermal therapy pad with a refrigeration circuit and fluid flow path. Wei et al. (CN 107596472 A) discloses a related thermal therapy pad with an overflow path connecting to a circulating pipeline, so the icewater tank does not exceed a particular height.
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 CHRISTOPHER E MILLER whose telephone number is (571)270-1473. The examiner can normally be reached Mon-Fri 9:00-5:30 (Eastern).
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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