DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “particle detector” and “particle collector”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
A review of the specification shows that the following appears to be the corresponding structure: According to page 12 of Applicant’s specification the particle detector may be any particle counter (see the following description " The particle detection unit may be, for example, a particle counter such as a Grimm 1.108 optical particle counter (Grimm Aerosol Technik, Ainring, Germany), capable of counting, and sizing particles in 15 size intervals from 0.3 to 20 micrometre. But other optical particle counters such as a Grimm 1.107 and 1.109 may be used. Other manufacturers such as TSI have particle sizers but also time of flight equipment that may be used as particle detection units 10. Other options may be, Non-optical, electrostatically, conductance, condensation particle counters, Quartz Crystal Microbalance (QCM), Surface Plasmon Resonance (SPR) or surface acoustic-wave (SAW) etc. "); according to page 4 of Applicant’s specification, the particle collector corresponds to an impactor.
Claim Rejections - 35 USC § 112
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.
Claims 1, 2, 4-9, 11, and 13-21 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 9, and 13, the originally filed disclosure fails to provide support for “wherein real time is once every 1 to 4 seconds”. While paragraph [0059] of the published specification mentions a sample time “such as 1 second” or “2 seconds, such as 4 seconds, such as 10 seconds”, these time references are related to a sample time to detect a sufficient number of particles before updating an interface of a particle detection unit; sampling data every 1-4 seconds is not the same as performing an analysis every 1-4 seconds, nor is it the same as providing a display or warning once every 1-4 seconds. Paragraph [0090] states that a size distribution is produced “every six seconds”; which provides support for performing an analysis once every 6 seconds. If a size distribution which is analyzed to determine a lung condition is produced every six seconds, it is unclear how a real time analysis would occur every 1 to 4 seconds.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Response to Arguments
Applicant’s arguments, filed 28 April 2026, have been fully considered.
Regarding the rejections of the claims under 35 U.S.C. 112, first paragraph, Applicant’s arguments are not persuasive. “Continuously quantifying” does not provide support for a real time analysis being once every 1 to 4 seconds, nor does reciting a “sample time” of “1 second”, “2 seconds”, or “4 seconds”. As noted in paragraph 5 above, and in paragraph 7 of the Non-Final Rejection mailed out 28 January 2026, a sampling time is not the same as an analysis time. A sampling time refers to how often data is sampled/acquired. It does not refer to how often data is analyzed. While the specification provides support for sampling data once every 1 to 4 seconds, it fails to provide support for analyzing data once every 1 to 4 seconds or providing a warning once every 1 to 4 seconds.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mitton et al.’521 (US Pub No. 2008/0202521 – previously cited) in view of Olin et al.’635 (US Pub No. 2010/0297635 – previously cited) further in view of Liao et al.’007 (US Pub No. 2008/0243007 – previously cited), as discussed in paragraph 7 of the Final Rejection mailed out 11 July 2025, is the closest prior art. The combination of references teaches all of the elements of claims 1 and 13, with the exception of “wherein real time is once every 1 to 4 seconds”.
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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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