Prosecution Insights
Last updated: July 17, 2026
Application No. 18/999,279

Devices for Application of Localized Hypothermic Therapy to the Human Ear

Non-Final OA §102§103
Filed
Dec 23, 2024
Priority
Oct 18, 2017 — provisional 62/573,716 +2 more
Examiner
SMITH, KAITLYN ELIZABETH
Art Unit
Tech Center
Assignee
Restorear Devices LLC
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
1y 11m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
478 granted / 817 resolved
-1.5% vs TC avg
Moderate +15% lift
Without
With
+14.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
32 currently pending
Career history
853
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
70.6%
+30.6% vs TC avg
§102
4.2%
-35.8% vs TC avg
§112
9.0%
-31.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 817 resolved cases

Office Action

§102 §103
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 . 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. Claim Objections Claim 7 is objected to because of the following informalities: Line 2 recites “heat transfer element” and should recite --the heat transfer element--. Appropriate correction is required. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1, 2 4-6, 8, 10, 11, 14, 16, 17, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2005/0089185 A1 to Allen (Allen). Regarding claim 1, Allen teaches an apparatus (ear seals 12), comprising a cold pack assembly (polyurethane casing 16) configured as an add-on element to an earpiece of a fully-assembled pair of auditory headphones of the type comprising a resilient headband (spring and suspension assembly 6) coupled to the earpiece (ear cups 4) to bias a contact surface of the earpiece toward compressive engagement against a portion of a wearer of the headphones; and a registration structure (integral flap 17) associated with the cold pack assembly (Fig. 3) and configured to removably interface the cold pack assembly in installed registration with the earpiece ([0020] which states in part “The cover 16 also includes an integral flap 17 for engaging an annular flange on a headset dome.”), and to dispose a heat transfer element ([0018] which states in part “composite material 18 that includes a flexible foam matrix material 14 (which contains a thermal storage material capable of storing thermal energy as latent heat of phase energy)”) of the cold pack assembly between the contact surface and the wearer such that at least a portion of the contact surface is spaced apart from the wearer (see annotate Fig. 3 below). PNG media_image1.png 582 988 media_image1.png Greyscale Regarding claim 2, Allen teaches the apparatus of claim 1 as well as wherein the cold pack assembly is passive ([0018] which states in part “a thermal storage material capable of storing thermal energy as latent heat of phase change”). Regarding claim 4, Allen teaches the apparatus of claim 1 as well as wherein the cold pack assembly is configured to circumscribe an opening of the earpiece, through which opening an auricle may pass during installation of the earpiece in registration on a wear’s head (Fig. 2). Regarding claim 5, Allen teaches the apparatus of claim 1 as well as wherein the cold pack assembly comprises an untethered heat transfer element ([0018] which states in part “a thermal storage material capable of storing thermal energy as latent heat of phase change”) to permit user motion unimpeded by a physical connection to an external thermally active device for application of cooling. Regarding claim 6, Allen teaches the apparatus of claim 1 as well as wherein the registration structure is configured to couple the cold pack assembly with an earpiece of a pair of ear-muff type headphones (Fig. 1 and [0020] which states in part “The cover 16 also includes an integral flap 17 for engaging an annular flange on a headset dome.”). Regarding claim 8, Allen teaches the apparatus of claim 1 as well as wherein the heat transfer assembly Is carried by the cold pack to dispose a portion of the heat transfer element in closest achievable proximity to an ear canal of a wearer (Figs. 1 and 3). Regarding claim 10, Allen teaches the apparatus of claim 1 as well as wherein the cold pack assembly is structured and arranged in harmony with the registration structure to maintain the heat transfer element at a posterior position with respect to the ear canal of the ear (Figs. 1 and 3). Regarding claim 11, Allen teaches the apparatus of claim 1 as well as wherein the registration structure comprises a coupling element configured to resist undesired decoupling of the cooling pack from the earpiece ([0020] which states in part “The cover 16 also includes an integral flap 17 for engaging an annular flange on a headset dome.”). Regarding claim 14, Allen teaches the apparatus of claim 1 as well as wherein the cooling assembly comprises a bulk cavity (Fig. 3 where open cell foam 26 and a flowable material 30 such as a dilatant silicone compound and a silicon oil, both of which are enclosed within a sheath) carrying thermal media disposed in thermal communication with the heat transfer element (Fig. 3) and the bulk cavity extends in a circumscribing direction entirely around the ear (Figs. 2 and 3). Regarding claim 16, Allen teaches the apparatus of claim 1 as well as wherein the heat transfer element comprises a floor of a contact cavity (Fig. 3), a first thermal media ([0018] which states in part “the composite material 18 that includes a flexible foam matrix 14 (that contains a thermal storage material capable of storing thermal energy as latent heat of phase change”), and the floor is transversely flexible and conformable to accommodate and conform user compression against surface structure in the vicinity of an ear of a wearer of the apparatus ([0018] which states in part “the composite material 18 that includes a flexible foam matrix 14 (that contains a thermal storage material capable of storing thermal energy as latent heat of phase change” and claim 3 which states in part “a flexible sheath into which the thermal storage medium is attached.”). Regarding claim 17, Allen teaches the apparatus of claim 16 as well a bulk cavity (Fig. 3 where open cell foam 26 and a flowable material 30 such as a dilatant silicone compound and a silicon oil, both of which are enclosed within a sheath) disposed in thermal communication with the contact cavity (Fig. 3), and a thermal media is disposed inside the bulk cavity ([0020] which states in part “a flowable material 30 such as a dilatant silicone compound and a silicon oil…”). Regarding claim 19, Allen teaches the apparatus of claim 17 as well as wherein the bulk cavity is insulated to resist direct heat transfer into the bulk cavity from the local environment (open cell foam 26 and a flowable material 30 such as a dilatant silicone compound and a silicon oil located in the bulk cavity as seen in Fig. 3 acts as insulation), and the bulk cavity is insulated to resist direct heat transfer into the bulk cavity from the head and/or structure to avoid contact with the head (open cell foam 26 and a flowable material 30 such as a dilatant silicone compound and a silicon oil located in the bulk cavity as seen in Fig. 3 acts as insulation). Regarding claim 20, Allen teaches the apparatus of claim 17 as well as wherein the bulk cavity is insulated to resist direct heat transfer into the bulk cavity from the ear (open cell foam 26 and a flowable material 30 such as a dilatant silicone compound and a silicon oil located in the bulk cavity as seen in Fig. 3 acts as insulation). Claim(s) 1, 3, 4 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by JP 2006-230761 A to Fumino (Fumino, see machine translation). Regarding claim 1, Fumino teaches an apparatus (Figs. 9 and 10), comprising a cold pack assembly (Fig. 10) configured as an add-on element to an earpiece of a fully-assembled pair of auditory headphones of the type comprising a resilient headband (bow-shaped member 42) coupled to the earpiece (Fig. 9) to bias a contact surface of the earpiece toward compressive engagement against a portion of a wearer of the headphones ([0044] which states in part “an elastic bow-shaped member 42 formed in a U shape.”), and registration structure associated with the cold pack assembly and configured to removably interface the cold pack assembly in installed registration with the earpiece ([0044] which states in part “The headphone type 7C shown in FIGS. 9 and 10 is provided with a substrate 40 forming a probe main body at one end or both ends of an elastic bow-shaped member 42 formed in a U shape. Is configured to be freely inserted and removed from the headphone body 43.”), and to dispose a heat transfer element (Peltier element 9) o he cold pack assembly between the contact surface and the wearer (Fig. 9) such that at least a portion of the contact surface is spaced apart from the wearer (Figs. 9 and 10). Regarding claim 3, Fumino teaches the apparatus of claim 1 as well as wherein the cold pack assembly comprises a thermally active thermal element (Peltier element 9). Regarding claim 4, Fumino teaches the apparatus of claim 1 as well as wherein the cold pack assembly is configured to circumscribe an opening of the earpiece, through which opening auricle may pass during installation of eh earpiece in registration on a wearer’s head 9Figs. 9 and 10 and [0045] which states in part “According to the headphone-type probe 7C shown in FIGS. 9 and 10, the cooling portion of the probe can be easily applied to the back of the ear…”). Regarding claim 6, Fumino teaches the apparatus of claim 1 as well as wherein the registration structure is configured to couple the cold pack assembly with an earpiece of a pair of ear-muff type headphones (Figs. 9 and 10). Regarding claim 7, Fumino teaches the apparatus of claim 1 as well as wherein the heat transfer element is configured for thermal configuration with a localized area extending only partially around a circumference of an ear of the wearer (Figs. 9 and 10 and [0044]). Regarding claim 8, Fumino teaches the apparatus of claim 1 as well as wherein the heat transfer assembly to dispose a portion of the heat transfer element in closest achievable proximity to an ear canal of a wearer ([0044]). Regarding claim 9, Fumino teaches the apparatus of claim 1 as well as wherein a portion of the heat transfer element, when installed on a wearer, is disposed between an ear helix and skin covering the wearer’s skull ([0044]). 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. 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. Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of US 2003/0177195 A1 to Sze et al. (Sze). Regarding claims 12 and 13, Allen teaches the apparatus of claim 11, but not wherein the coupling element is configured to form a structural interference fit against a cooperating portion of the headphones or wherein the coupling element is configured to form a friction fit against a cooperating portion of the headphones. Sze teaches an analogous apparatus (title) to that of Allen where the housing structure (122) and the front housing (140) may be attached to one another by, for example, screws, bolts, rivets, an adhesive, an interference fit, or other attachments known in the art ([0025]) such that elements located within the housing can be accessed through the housing (i.e. 122 and 140 are removably interfaced). It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coupling element of Allen for the interference/friction fit or other attachments known in the art as taught by Sze, since applicant has not disclosed that an interference/friction fit solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the coupling of Allen or Sze. It is noted that interference fits are also known as press fits or friction fits. Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of US 2014/0039584 A1 to Potter et al. (Potter). Regarding claim 15, Allen teaches the apparatus of claim 1, but not wherein thermochromic ink is disposed in association with the apparatus to inform of the operational status of the apparatus. Potter teaches thermal pockets (40) equipped with a temperature sensor and that a particularly convenient temperature sensor is thermochromic ink printed on the exterior of the pocket ([0029]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included thermochromic ink to allow for a visually readable and convenient sensor which changes color as the temperature changes. Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen. Regarding claim 18, Allen teaches the apparatus of claim 17 as well as the bulk cavity is sized to hold more volume of heat transfer media than the contact cavity (Fig. 3), but not that the bulk cavity is sized to hold between two times and about twenty five times the volume of a heat transfer media that is held in the contact cavity. 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 the bulk cavity to be sized to hold between two times and about twenty five times the volume of a heat transfer media that is held in the contact cavity, 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. Conclusion 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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Prosecution Timeline

Dec 23, 2024
Application Filed
Jun 17, 2026
Non-Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
73%
With Interview (+14.6%)
3y 6m (~1y 11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 817 resolved cases by this examiner. Grant probability derived from career allowance rate.

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