DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. According to the Amendment, filed 05 March 2026, the status of the claims is as follows:
Claims 1, 3, and 11 are currently amended;
Claims 4-10, 12, and 13 are previously presented; and
Claim 2 is canceled.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 5-8, filed 05 March 2026, with respect to the rejection of claims 1-13 under 35 U.S.C. 103 as being unpatentable over Ahmad et al., U.S. Patent Application Publication No. 2017/0119280 A1, have been fully considered in view of the Amendment, filed 05 March 2026, but is moot in view of a new ground(s) of rejection, which was necessitated by amendment, as discussed below.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad et al., U.S. Patent Application Publication No. 2017/0119280 A1 (“Ahmad”), in view of Mullinger et al., E.S. Patent No. 2289724 T3 (“Mullinger”).
As to Claim 1, Ahmad teaches the following:
A device for collecting exhaled breath (see “A breath capture device for determining the concentration of acetone in a breath sample from a user.” in Abstract, and see figs. 23 and 24), comprising:
a collecting terminal (“sterile interface”, not labeled) (see “a sterile interface to breath collection whereby a user can physically interact with the instrument” in para. [0374]), comprising a mouthpiece grip (“mouthpiece”) 202 receiving the exhaled breath to be subjected to examination (see “Component (202) is a mouthpiece, representing a sterile interface to breath collection whereby a user can physically interact with the instrument.” in para. [0374]), at least one collecting hole (not labeled, see fig. 23, the port/opening between “breathing hose (222)” and “mixing chamber (204)”), for collection a portion of exhaled breath from the collecting terminal (the breath is sampled into the “mixing chamber (204)”, see “Component (204) is a mixing chamber, a vessel that allows a sufficient store of mixed exhalation gases to accumulate so as to allow accurate sampling of the gas measurement equipment, described next.” in para. [0374] and fig. 23), and at least one discharge vent (not labeled, the port/opening between “mixing chamber (204)” and “flow measurement element (206)” in fig. 23) connected to a respective discharge duct (“gas sampling line”, not labeled) (see “Components (206, 210, and 212) comprise a gas sampling line, whereby a pump (212) removes gas from the mixing chamber (204) and pushes it through a flow measurement element (206) and a sensor element (210).” in para. [0374] and fig. 23); and
a suction device (“pump”) 212, which is connected to said at least one discharge vent (not labeled, the port/opening between “mixing chamber (204)” and “flow measurement element (206)” in fig. 23) of the collecting terminal through said respective discharge duct (“gas sampling line”, not labeled) and … at least one nanometric filter (“anti-viral/bacterial filter”) 224 …
Ahmad does not teach the following:
a suction device … comprising at least one nanometric filter through which the exhaled breath sucked through said discharge duct is purified.
However, Mullinger teaches the following:
a suction device (“suction device”) 40 comprising at least one nanometric filter (“filter”) 17 through which the exhaled breath sucked through a discharge duct (“flexible tube”) 41 is purified (see “In the form shown in the Figures 6a and 6b the first air outlet opening 12 and the second air inlet opening 14 match. In this way, the component 10 is configured as a three-way valve that allows an inhalation through the first circulation channel 13 although an exhalation is only possible through the second channel 16 traffic. In the second circulation channel 16, or associated with this, a filter 17 is provided that purifies the exhaled air and what decontaminate According to the shape of figures 6a / 6b, to the second channel 16 circulation is connected through a flexible tube 41 a suction device 40 that aspirates exhaled air.” in col. 8, ll. 23-35).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Ahmad’s suction device (“pump”) 212 to be Mullinger’s suction device (“suction device”) 40 comprising a nanometric filter (“anti-viral/bacterial filter”) 224 through which the exhaled breath sucked through a discharge duct (“flexible tube”) 41 is purified, in order to purify the exhaled air from decontaminates, which is the same purpose of Ahmad’s “anti-viral/bacterial filter 224”. Thus, it is a simple matter of changing one filter location in the exhalation circuit to another location, to yield the same predictable result, i.e. purify the exhaled air from decontaminates.
As to Claim 3, Ahmad teaches the following:
wherein the collecting terminal (“sterile interface”, not labeled) comprises a stiff casing (not labeled, housing of “mouthpiece 202”) having said mouthpiece grip 202, wherein a blowing direction is defined (not labeled, see figs. 23 and 24, breath flow direction into the “breathing hose 222”), whereas a suction and washing direction of the exhaled breath is defined through said at least one discharge vent (the inlet of the “mouthpiece 202” through which the user discharges breath into the “mouthpiece 202”) from the collecting terminal, said blowing direction (inherent features of exhaled breath and the inlet of the “mouthpiece 202”) and said suction and washing direction being transversal to each other.
As to Claim 4, Ahmad teaches the following:
wherein the blowing direction and the suction and washing direction of the exhaled breath are perpendicular to one another (see direction of breath flow that is in “gas sampling line 206” relative to the breath flow in “mixing chamber 204” in figs. 23 and 24).
As to Claim 5, Ahmad teaches the following:
wherein the collecting terminal further comprises a handhold (“nosepiece”) 200, usable to approach the stiff casing to a user’s own mouth consisting of a pair of symmetrical bars projecting from said at least one discharge vent, whereby to thereby allowing a left-handed person is allowed to correctly grasp the collecting terminal (see “Component (200) is a nosepiece, used to constrain user breathing into the device through the mouth and to also eliminate leakage of breath gases through the nose.” in para. [0376]).
As to Claim 6, Ahmad teaches the following:
wherein said duct 222 is a flexible hose (see “Component (222) is a breathing hose, presenting a gas line between the user and the instrument without imposing a significant breathing resistance onto the user.” in para. [0374]).
As to Claim 7, Ahmad teaches the following:
a removable service module (“Components (206, 210, and 212)”), comprising one or more suction orifices thereto respective discharge ducts are connected by means of a corresponding quick coupling, inside thereof the aspirator and the nanometric filter are received (see “Components (206, 210, and 212) comprise a gas sampling line, whereby a pump (212) removes gas from the mixing chamber (204) and pushes it through a flow measurement element (206) and a sensor element (210).” in para. [0374]).
As to Claim 8, Ahmad teaches the following:
wherein said suction orifices are provided with respective valves which can be actuated to open or to close the suction orifice, particularly when it is not connected to a discharge duct (see “Components (206, 210, and 212) comprise a gas sampling line, whereby a pump (212) removes gas from the mixing chamber (204) and pushes it through a flow measurement element (206) and a sensor element (210).” in para. [0374]).
As to Claim 9, Ahmad teaches the following:
wherein the aspirator implements, in each single discharge duct, a suction flow with a flow rate not lower than 30 m3/h (see “In certain sensor configurations, particularly packed bed columns, a significant restriction to breathing is imposed by the sensor element. It is desirable to maintain breathing resistance as low as possible for user comfort, and thus a separate sample line allows the breath collection to be designed for optimal user interface, completely independent of sensor requirements which include, in general, known and steady flow rates and constant gas line pressures.” in para. [0374]).
As to Claim 10, Ahmad teaches the following:
wherein the nanometric filter is a ULPA U15 type or higher (see “anti-viral/bacterial filter” in para. [0374]).
As to Claim 11, Ahmad teaches the following:
wherein the collecting terminal (“sterile interface”, not labeled) comprises a rigid portion (“mixing chamber (204)”) 204, and said discharge vent (not labeled, the port/opening between “mixing chamber (204)” and “flow measurement element (206)” in fig. 23) being implemented in said rigid portion of the collecting terminal (see “Component (202) is a mouthpiece, representing a sterile interface to breath collection whereby a user can physically interact with the instrument. Component (224) is an anti-viral/bacterial filter, which provides protection from cross-contamination between the user and the instrument.” in para. [0374]).
As to Claim 12, Ahmad teaches the following:
wherein said rigid portion comprises an expansion vent (not labeled, inlet to “mixing chamber 204”) connected to an expansion bag (“mixing chamber”) 204 (see “Component (204) is a mixing chamber, a vessel that allows a sufficient store of mixed exhalation gases to accumulate so as to allow accurate sampling of the gas measurement equipment, described next.” in para. [0374]).
As to Claim 13, Ahmad teaches the following:
wherein at least one collecting hole (not labeled, inlet to “mixing chamber 204”) is connected to a respective collecting device (“mixing chamber”) 204.
Conclusion
7. 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 05/14/2026
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