Prosecution Insights
Last updated: April 19, 2026
Application No. 18/251,398

Ear-fitting device and warming device

Final Rejection §102§103
Filed
May 02, 2023
Examiner
DEMIE, TIGIST S
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Kobayashi Pharmaceutical Co. Ltd.
OA Round
2 (Final)
75%
Grant Probability
Favorable
3-4
OA Rounds
3y 3m
To Grant
97%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
322 granted / 428 resolved
+5.2% vs TC avg
Strong +22% interview lift
Without
With
+21.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
34 currently pending
Career history
462
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
46.7%
+6.7% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
18.6%
-21.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 428 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 . 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. Claims 1-5, 7-8, 10, 12, 14 and 18 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by IKEDA (JP 2006320363). Regarding claim 1, IKEDA discloses an ear-fitting device (an ear heating device 48) configured to be worn on an ear, comprising: a contact portion (part of outer portion of ear heating device 48) for contacting a predetermined site of an auricle; and a retainer portion (see annotated figure below) configured to retain a warming body (heating composition 28) for warming the predetermined site of an auricle through the contact portion; wherein the retainer portion is configured to retain the warming body in a state where it is spaced from the contact portion with by an air gap (the ventilation hole 34 is an air gap between the heating composition 28 and the outer portion of ear heating device 48, see fig.3). While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. A contact portion is any portion that is configured to be contacted by portion of ear. The retainer portion maybe any portion that is configured to retain (hold) the warming body where it is spaced from the contact portion by air gap. The ventilation holes (air gap) are between the warming body and the contact portion. PNG media_image1.png 484 886 media_image1.png Greyscale Regarding claim 2, IKEDA discloses the ear-fitting device according to claim 1, wherein the retainer portion is configured to retain the warming body in a state where the warming body is covered with the contact portion (fig.1). Regarding claim 3, IKEDA discloses the ear-fitting device according to claim 1, wherein the contact portion comprises: an annular side wall configured to be fitted to an ear concha (see annotated figure above); and a top plate portion that continues to one end of the annular side wall and having a contact surface configured to contact the bottom surface of the ear concha (see annotated figure above); and wherein the retainer portion is configured to retain the warming body in a state where the warming body is accommodated inside the annular side wall from the back side of the contact surface (see annotated figure above). Regarding claim 4, IKEDA discloses the ear-fitting device according to the ear-fitting device according to claim 3, wherein the retainer portion is configured to retain a hold portion (storage space 26) that projects from a body portion (wrapping bag 27) of the warming body (see annotated figure above), in a state where the body portion of the warming body is accommodated inside the annular side wall from the back side of the contact surface (see annotated figure above); and wherein the body portion of the warming body is spaced from the top plate portion with an air gap (the sound passage hole 44), in a state where the retainer portion retains the hold portion of the warming body and the hold portion of the warming body is in contact with the other end of the annular side wall (see annotated figure above). Regarding claim 5, IKEDA discloses the ear-fitting device according to claim 4, wherein the body portion of the warming body is spaced from the annular sidewall by an air gap (the sound passage hole 44), in a state where the retainer portion retains the hold portion of the warming body and the hold portion of the warming body is in contact with the other end of the annular side wall (abstract). Regarding claim 7, IKEDA discloses a warming device comprising the ear-fitting device and the warming body according to claim l (fig.1). Regarding claim 8, IKEDA discloses the ear-fitting device according to claim 2, wherein the contact portion comprises: an annular side wall configured to be fitted to an ear concha (see annotated figure above); and a top plate portion that continues to one end of the annular side wall and having a contact surface configured to contact the bottom surface of the ear concha (see annotated figure above); and wherein the retainer portion is configured to retain the warming body in a state where the warming body is accommodated inside the annular side wall from the back side of the contact surface (see annotated figure above). Regarding claim 10, IKEDA discloses a warming device comprising the ear-fitting device and the warming body according to claim 2 (abstract, fig.1). Regarding claim 12, IKEDA discloses a warming device comprising the ear-fitting device and the warming body according to claim 3 (abstract, fig.1). Regarding claim 14, IKEDA discloses the ear-fitting device according to the ear-fitting device according to claim 3, wherein the retainer portion is configured to retain a hold portion (storage space 26) that projects from a body portion (wrapping bag 27) of the warming body (see annotated figure above), in a state where the body portion of the warming body is accommodated inside the annular side wall from the back side of the contact surface (see annotated figure above); and wherein the body portion of the warming body is spaced from the top plate portion by the air gap (see annotated figure above), in a state where the retainer portion retains the hold portion of the warming body and the hold portion of the warming body is in contact with the other end of the annular side wall (see annotated figure above). Regarding claim 18, IKEDA discloses a warming device comprising the ear-fitting device and the warming body according to claim 4 (abstract, fig.1). 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. Claims 6, 9, 11,13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2006320363. Regarding claim 6, 9, 11 and 17, IKEDA discloses the ear-fitting device according to claim 1, wherein the retainer portion (see annotated figure above) is configured to retain the warming body (abstract). However, IKEDA does not disclose a distance from the contact portion to the warming body across the air gap is greater than 0 mm and equal to or less than 1 mm. It would have been an obvious matter of design choice to create the desired gap between the contact portion to the warming body including the gap being greater than 0 mm and equal to or less than 1 mm, since such a modification would have involved a mere change in the size of a component. A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Regarding claim 13, IKEDA discloses a warming device comprising the ear-fitting device and the warming body according to claim 6 (abstract, fig.1). Response to Arguments Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection applied a different interpretation of the prior art as discussed above. The examiner would like to note that claim 1 only requires a structure of contact portion and retainer portion. A contact portion is any portion that is configured to be contacted by portion of ear. The retainer portion maybe any portion that is configured to retain (hold) the warming body where it is spaced from the contact portion by air gap. The ventilation holes (air gap) are between the warming body and the contact portion. The claim languages do not require the air gap to serve as a specific thermally insulating function to suppress an abrupt temperature rise. Allowable Subject Matter Claim 21-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record which that, either alone or in combination discloses, suggests or renders obvious of wherein the contact portion comprises an annular side wall having a first end and a second end, and a top plate portion that continues to the first end of the annular side wall, the retainer portion is configured to retain a hold portion of the warming body, the warming body further having a body portion from which the hold portion projects, the body portion of the warming body is accommodated inside the annular side wall, and the retainer portion is configured to retain the warming body such that the body portion is spaced from the top plate portion by the air gap when the hold portion of the warming body is in contact with the second end of the annular side wall while also teaching each and every limitation set forth in independent claim. Claims 22-24 depend on claim 21 and therefore are objected. 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 TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-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, Joseph Stoklosa can be reached at 571-2721213. 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. /TIGIST S DEMIE/Primary Examiner, Art Unit 3794
Read full office action

Prosecution Timeline

May 02, 2023
Application Filed
Aug 22, 2025
Non-Final Rejection — §102, §103
Nov 20, 2025
Response Filed
Feb 25, 2026
Final Rejection — §102, §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12594089
MEDICAL TOOLS FOR AND METHODS OF GAINING ACCESS TO EXTRAVASCULAR SPACES
2y 5m to grant Granted Apr 07, 2026
Patent 12594185
TREATMENT SYSTEM HAVING GENERATOR AND FLUID TRANSFER CARTRIDGE
2y 5m to grant Granted Apr 07, 2026
Patent 12582465
TISSUE RESURFACING DEVICES AND METHODS THEREOF
2y 5m to grant Granted Mar 24, 2026
Patent 12582466
Ablation Assembly to Treat Target Regions of Tissue in Organs
2y 5m to grant Granted Mar 24, 2026
Patent 12575851
VIBRATION TRANSMISSION MEMBER, ULTRASONIC TREATMENT INSTRUMENT, AND METHOD OF MANUFACTURING VIBRATION TRANSMISSION MEMBER
2y 5m to grant Granted Mar 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
75%
Grant Probability
97%
With Interview (+21.6%)
3y 3m
Median Time to Grant
Moderate
PTA Risk
Based on 428 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month