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 Amendment
The amendment filed 30 December 2025 has been entered. Claims 1, 4, 7-9, 11-12, and 15-20 are currently amended. Claims 2-3 are canceled. Claims 1 and 4-20 are pending in the application. Applicant’s amendments to the claims have overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 02 October 2025, with the exception of the 112(b) rejections of claims 19-20, restated below.
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 19-20 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.
Claims 19-20 recite the limitation “the compressor,” which has insufficient antecedent basis in the claims. Examiner recommends changing this limitation in all instances to read --the air compressor--.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 6-9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wass (US Patent No. 6,126,680) in view of Heaton et al. (US Patent No. 6,942,687), hereinafter Heaton.
Regarding claim 1, Wass teaches a brain chilling helmet (Fig. 5A: hood-like coverlet 10) comprising:
an air compressor operable to compress inlet air and discharge the compressed air through an outlet and an air chiller operable to reduce the temperature of air (Fig. 5A: cooling device 20 and air hose 18; col 5, lines 5-6: “This air-cooling device 20 provides forced, cooled air to the coverlet 10”);
a helmet, the helmet having a body which defines a cold air manifold (Fig. 5A: coverlet 10 with inner space between layers 12, 14);
and a plurality of inlet vents, each inlet vent in communication with the cold air manifold and positioned at positions on the body corresponding to an area of a head of a patient, the cold air manifold being in communication with the outlet of the air chiller, such that a high-pressure chilled air enters the manifold, and is conveyed through the plurality of inlet vents (col 5, lines 5-9: “This air-cooling device 20 provides forced, cooled air to the coverlet 10. This air passes between the two layers 12, 14 and disperses throughout the coverlet 10. This dispersed cooled air then diffuses through the air diffusing layer 12 toward the patient's head and neck region, thereby convectively cooling the head and neck”).
Wass is silent with respect to the outflow of cooled air that diffuses into the helmet and does not explicitly teach further comprising a plurality of outlet vents positioned to direct an air flow out of the helmet, such that an air flow passes into a volume defined by the helmet body through the plurality of inlet vents, through the volume defined by the helmet body, and out at least one of the outlet vents. However, in an analogous art, Heaton teaches a patient cooling enclosure with a plurality of outlet vents positioned to direct an air flow out of the enclosure, such that an air flow passes into a volume defined by the enclosure, through the volume, and out at least one of the outlet vents (Fig. 5A: outlets 66; col 6, lines 3-8: “Air fed into the enclosure from the outlets in the conduits (8) and (12) may leak to atmosphere through stitching or inherent leaks in the enclosure. However, in order to provide a more predictable air flow of refrigerated air from the enclosure, the side or end walls may be provided with outlets 66”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the helmet of Wass with a plurality of outlet vents, as taught by Heaton, in order to provide a more predictable air flow, as taught by Heaton.
Wass teaches an air compressor that provides cooled air itself and further does not explicitly teach an air chiller separate from the air compressor, wherein the outlet of the air compressor is in communication with an inlet of the air chiller. However, Heaton further teaches separate refrigeration and blowing units for cooled air (col 4, lines 64-65: “Connector halves (64) are supplied with refrigerated air from a refrigerator and a blower unit (80)”). In light of Heaton’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to make the air chiller and air compressor of Wass separate components, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Regarding claims 4 and 9, the combination teaches the device of claim 1 as described previously. Wass further teaches further comprising a neck covering connected to a bottom of the helmet body (Fig. 5B: neck collar 30; col 6, lines 41-42: “the coverlet is provided with a neck collar that allows for the cooling of the neck specifically”) and an air-tight face shield, wherein the neck covering and air-tight face shield are operable to discourage airflow and encourage the air to flow through the plurality of outlet vents (col 4, lines 62-65: “the coverlet 10 provides convective cooling of the brain by passing cooled air about the head and neck region of the patient in a substantially enclosed environment to minimize cooled air losses”).
Regarding claim 6, the combination teaches the device of claim 1 as described previously. Wass further teaches wherein the helmet body is flexible (col 4, line 66 – col 5, line 1: “The coverlet is preferably constructed of soft, flexible materials to surround the area of the head and neck region in which cooling is desired”).
Regarding claims 7-8, the combination teaches the device of claim 1 as described previously. Wass further teaches wherein at least two of the plurality of inlet vents are directed at a location corresponding to each temple of the head of the patient, and at least one of the plurality of vents is directed at a location corresponding to a forehead of the head of the patient (Fig. 5A: coverlet 10 configured to be positioned over patient’s face; examiner notes that the disclosed configuration would cover a patient’s forehead and temples and thus reads on the recited limitations).
Regarding claim 16, the combination teaches the device of claim 1 as described previously. Wass further teaches wherein the chiller and compressor are separate from the body of the helmet (Fig. 5A: cooling device 20 separate from coverlet 10).
Claims 5 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wass in view of Heaton and further in view of Dilligan et al. (US PGPub No. 2020/0375793), hereinafter Dilligan.
Regarding claim 5, Wass in view of Heaton teaches the device of claim 1 as described previously. The combination does not teach wherein the body comprises a hard outer shell. However, in an analogous art, Dilligan teaches a cooling cap assembly with a rigid outer shell so that an inflatable member can increase a contact area between a heat exchanger and a patient’s scalp (par. 0049). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with a hard outer shell, as taught by Dilligan, in order to increase contact area between the cooling device and the patient’s scalp, as taught by Dilligan.
Regarding claims 19-20, Wass in view of Heaton teaches the device of claim 1 as described previously. The combination is silent with respect to the power source and does not explicitly teach further comprising a battery power source or power plug power source in electrical communication with the chiller and compressor. However, Dilligan teaches wherein the cooling cap assembly further comprises a battery power source or power plug power source such that the cooling unit can be operated portably and with different functionality based on an available power source (par. 0114: “the cooling unit (150) may comprise a portable power source (e.g., a battery), which may allow a patient to use the cooling system without access to an electrical outlet” and par. 0161: “a cooling unit may be operated in one of a plurality of operation states (e.g., full power, reduced power, battery power) with different functionality based on an available power source. For example, a pump and compressor may be turned on when at full power when the cooling unit is plugged into an AC power source while only a pump may be active when the cooling unit is in a battery power mode”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with either a battery power source or a power plug power source, as taught by Dilligan, in order to operate the device portably and with different functionality based on an available power source, as taught by Dilligan.
Claims 10-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wass in view of Heaton and further in view of Latham (US PGPub No. 2002/0103520).
Regarding claims 10-12, Wass in view of Heaton teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein the helmet is adjustable in size, wherein an air pressure from the compressor in the cold air manifold is operable to inflate a portion of the body to adjust the size of the helmet, wherein the portion of the body to be inflated is a flexible bladder and the flexible bladder is in communication with the cold air manifold via an inflation channel. However, in an analogous art, Latham teaches a head and neck cooling device that may be inflated with the coolant medium via an inflation channel in order to provide a more secure fit (par. 0110: “The panels and braces of the invention may incorporate inflatable members that may be inflated to provide a snug and secure fit of the various elements around the wearer. The inflatable members may be inflated with a suitable fluid including air, water or even the coolant medium itself. […] the inflatable members may be inflated in a regulated manner by, for example, a fluid pressure regulator having a regulatable valve;” examiner interprets adjusting fit as adjusting the size, and notes that inflating an inflatable member with the coolant medium necessarily involves inflating via an inflation channel). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with adjustable inflatable members as taught by Latham, in order to provide a snug and secure fit around the wearer, as taught by Latham.
Regarding claim 15, Wass in view of Heaton teaches the device of claim 1 as described previously. The combination does not teach wherein the air chiller and the air compressor are mounted to the body of the helmet. However, Latham further teaches wherein the cooling medium system is integral with the wearable portion of the cooling device (par. 0083: “[the] cooling medium system 108 functions as integral parts of the neck brace 32”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to mount the air chiller and the air compressor to the body of the helmet, as taught by Latham, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wass in view of Heaton and further in view of Durocher et al. (US PGPub No. 2019/0350297), hereinafter Durocher.
Wass in view of Heaton teaches the device of claim 1 as described previously, but the combination does not teach wherein the helmet is adjustable in size, or wherein the body comprises a plurality of adjustable sections that are movable relative to each other and lockable in a plurality of different positions, or wherein the body is adjustable by a ratchet and pawl assembly. However, in an analogous art, Durocher teaches a size adjustment mechanism for a sports helmet comprising a plurality of adjustable sections that are movable relative to each other and lockable in a plurality of different positions, that is, a ratchet and pawl assembly (Figs. 30 and 35-36: teeth 42, 43 that engage in apertures 44, 45; par. 0099: “The actuator 41 can be moved (in this case pivoted) by the wearer between a locked position, in which the first and second pairs of teeth 42, 43 engage in first and second plurality of pairs of apertures 44, 45 provided on the front outer shell member 22 (as best shown in FIG. 30) and thereby locks the outer shell members 22, 24 relative to one another, and a released position, in which the first and second pairs of teeth 42, 43 of the actuator 41 are disengaged from the first and second pairs of apertures 44, of the front outer shell member 22 and thereby permits the outer shell members 22, 24 to move relative to one another so as to adjust the size of the sports helmet 10”). Durocher is considered analogous to the claimed invention because it is reasonably pertinent to the problem faced by the inventor, namely, the problem of fitting the helmet to patients with different anatomical sizes. To provide the device of the combined reference with a ratchet and pawl size adjustment mechanism, as taught by Durocher, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, because one of ordinary skill in the art would have recognized that applying the known technique taught by Durocher (ratchet and pawl size adjustment) to the device of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system that is mechanically adjustable in size such that it can snugly and securely fit each patient.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wass in view of Heaton and further in view of Kreck et al. (US PGPub No. 2013/0030411), hereinafter Kreck.
Wass in view of Heaton teaches the device of claim 1 as described previously. The combination does not teach wherein the air chiller is operable to reduce a temperature of air at the air chiller outlet to below 0 °C or below 0 °F. However, in an analogous art, Kreck teaches that a chilling medium having a temperature in a range between -30 to -20 °C is effective for hypothermic brain treatment with an acceptable risk of injury (par. 0170: “Beneficial results of brain cooling can be seen, for example, with cerebral cooling to approximately 33 °C. However, the brain can tolerate much lower temperatures. […] Brief skin and upper airway exposures to liquid with temperature between -30 to -20 °C. may also carry an acceptable risk of soft tissue injury;” examiner notes that temperatures between -30 to -20 °C are below 0 °F). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by modifying the chiller to reduce a temperature of the outlet air below 0 °F, as taught by Kreck, 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. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments, filed 30 December 2025, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Heaton. As described previously, Heaton teaches a plurality of outlet vents positioned to direct air flow of cooling air out of an enclosure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Augustine et al. (US Patent No. 4,572,188) teaches a cap for applying heated or cooled air to the scalp and head of a patient wherein an inflated tube provides a contact barrier that forces air from inlet vents to circulate through an enclosed volume and exit through an outlet vent (see Fig. 3 and col 4, lines 56-61).
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./ Examiner, Art Unit 3794
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