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 .
DETAILED ACTION
1. This office action is in response to the amendment filed on 2/14/2025. As directed by the amendment, claims 1-2, 4-5, 7-15, and 17-20 have been amended, claims 3, 6, and 16 have been canceled, and no claims have been added. Thus, claims 1-2, 4-5, 7-15, and 17-20 are pending in the application.
Claim Rejections - 35 USC § 112
2. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
3. Claims 1-2, 4-5, and 7-15, and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claims 1 and 17, the mask “includes a leak detection material configured to detect a leakage location” (claim 1, ln. 2-3) and “An apparatus for identifying a location of a leak of a worn face mask” (claim 17, ln. 1-2) have not been described in the specification in such a way as to enable one skill in the art to make the invention. While the applicant discloses the concept adequately (i.e. movement of a filling material between a first portion and a second portion that indicates leakage), the applicant does not disclose how a filling material would accomplish movement from a first portion to a second portion. The applicant never discloses an actual material, but only discloses characteristics of a material (See Pp. 3-4, “the various filling materials are pressure sensitive material, pressure indicating sensor film, pressure sensitive color gel envelope, pressure sensitive gel envelope, pressure sensitive color ball envelope, pressure sensitive ball envelope, temperature sensitive material, thermo-chromatic material, temperature sensitive dye, temperature sensitive ink, temperature
sensitive paint, heat-shrink tubing, pressure shrinkable tubing, relative
humidity sensitive material, relative humidity indicator paper, scent
sensitive material, tape, glue, adhesives, or any combination thereof”). One is left only to guess what type of material or substance would be “pressure sensitive” or “temperature sensitive” that would move across a permeable material in response to a stimulus.
Applying the Wands factors:
(1) Breadth of claims – while claims 1 and 17 are not overly broad, the key limitation that performs the “leak detection” is quite broad. The applicant simply recites a “filling material” without disclosing any specific type of filling material that can perform the desired function. One of ordinary skill in the art attempting to make the apparatus would have no idea what material or substance to use from the almost infinite amount of materials and chemicals in the world;
(2) Nature of the Invention – The claim is directed to a leak detection apparatus, but the core of the apparatus lies in the “filling material” that moves in response to a stimulus (e.g. pressure or temperature). Thus, it is critical that one of ordinary skill in the art understands what type of material(s) can perform this desired function;
(3) The state of the prior art – As evidenced by no art being applied to the claims, the prior art does not appear to discuss “filing materials” that can perform the function of “leak detection” in a mask by moving in response to stimulus;
(4) The level of ordinary skill in the art – The level of ordinary skill in the art in this case would be an individual with knowledge on leak detection within face masks. This person would not be expected to have deep knowledge of filling material that is “pressure sensitive” or “temperature sensitive.” Therefore, instruction on what types of materials that could perform the “leak detection” function are critical to knowing how to make the invention;
(5) The level of predictability in the art – The current art does not appear to teach much (if anything) about filling material that is reactive to a stimulus for the purposes of detecting a leak in a face mask. Therefore, the amount of guidance by the applicant (e.g. what type of material(s) to use) is critical.
(6) The amount of guidance provided by the inventor – The inventor provides no specific materials that could be used within the apparatus. Instead, the inventor lists general characteristics of some non-specific material (e.g. pressure sensitive, temperature sensitive, humidity sensitive, scent sensitive, etc).
(7) The existence of a working example- The examiner is unaware of a working example.
(8) The quantity of experimentation needed to make or use the invention based on the current disclosure – As applicant has not provided any specific materials, one of ordinary skill in the art would have to experiment with all known materials to potentially arrive at a “filling material” that performs as required by the applicant’s invention.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Response to Arguments
4. Applicant’s arguments filed 2/14/2025 with respect to the 112(a) rejection and regarding pressure sensitive materials and temperature sensitive materials being found within publications in the public domain. The applicant cites to a number of publications that disclose pressure sensitive materials (e.g. pressure sensors, color-changing materials based on pressure) and temperature sensitive materials (color-changing materials based on temperature. However, the presence of pressure sensitive material and temperature sensitive material in scientific literature is alone not persuasive. The real question is whether the applicant has provided enough disclose for using pressure sensitive material and temperature sensitive material for use in a leak detection apparatus, wherein these materials accomplish leak detection via the disclosed leak detection mechanism (i.e. movement of the leak detection material from a first inner space to a second inner space across a permeable membrane as recited in claims 1 and 17). These material(s) that perform this type of leak detection function are the key to the applicant’s invention. Providing specifics as to the material the applicant is using in the invention is likewise crucial to enabling the invention. By withholding the material(s) the applicant is using in their invention, the applicant is not instructing the general public on how to make the device.
Allowable Subject Matter
5. Claims 1-2, 4-5, and 7-15, and 17-20 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(a) and 112(b) set forth in this Office action.
Conclusion
6. THIS ACTION IS MADE FINAL. 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 TIMOTHY A STANIS whose telephone number is (571)272-5139. The examiner can normally be reached on Mon - Fri 8:30-5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY A STANIS/Primary Examiner, Art Unit 3785