DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on April 16, 2026 were received and fully considered. Claims 1, 5, and 15 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 103
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.
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 1-14, 21, and 22 are rejected under 35 U.S.C. 102(A)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kline (US PG Pub. No. 2004/0162500 A1).
Kline was applied in the previous office action.
With respect to claim 1, Kline teaches a breath microbe assembly to receive both an upper respiratory breath and a lower respiratory breath of a user (Abstract “separation of the expired airway phase in an exhaled breath from the alveolar phase”; Note: alveolar phase breath originates deeper from the lungs and equates to lower respiratory breath, whereas exhaled breath from initial portion of the nasal/oral cavity equates to upper respiratory breath), said assembly comprising: a housing (cartridge assembly 20 in Fig. 5) having a first chamber (disposable cartridge 22 in Fig. 5) and a second chamber (condensing chamber 82 in Fig. 5), wherein a portion of said first chamber is configured to receive said upper respiratory breath and said lower respiratory breath (disposable cartridge 22 receives upper respiratory breath that is initially discarded via exhaust vent 32 when flap 36 is in the positional arrangement as depicted in Fig. 13; and lower respiratory breath passes through cartridge assembly 20 when flap 36 is in the positional arrangement as depicted in Fig. 14), and said second chamber is configured to receive said lower respiratory breath (condensing chamber 82 receives lower respiratory breath when flap 36 is in the positional arrangement as depicted in Fig. 14); a stop mounted within said first chamber (par.0070 “pin or boss 52 protruding from an exterior surface of the cartridge 22”; see also Figs. 8-11, 13, 14, and 16); and a valve (par.0027 “the valve is a directional flap”; see flap 36 in Figs. 11-15) mounted to said housing and having a pivoting part and a diverting part with said pivoting and diverting parts connected together to form said valve (Figs. 11-15 show valve 36, which comprises components 37-43 that form the valve 36 so as to pivot/divert breath to be exhausted either through the collection port 30 or the exhaust vent 32; Note: any 2 of the components 37-43 equate to pivoting and diverting parts when taking into consideration broadest reasonable interpretation), wherein said pivoting part is adjacent one side of said stop when said valve is in an initial position (one of the components 37-43 are adjacent to stop 52 when in an initial position as depicted in Fig. 13), said diverting part is adjacent another side opposite said one side of said stop when said valve is in an activated position (another of the components 37-43 is adjacent another side opposite one side of stop 52 when in an activated position, i.e., when exhaled breath is diverted into second chamber 22 as depicted in Fig. 14), and said valve returns to said initial position when a volume of breath of said user is dissipated (flap 36 returns to initial position; par.0073 “directional flap 36 in a normally-closed position”; see Figs. 11-15).
Although Kline does not explicitly teach said valve 36 automatically returns to said initial position when a volume of breath of said user is dissipated, such a modification would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons.
First, Kline expressly teaches:
[0023] In other features of this aspect, determining when the exhaled breath has transitioned from the expired airway phase to the alveolar phase includes determining when a predetermined level of a particular predetermined gas is reached; the particular predetermined gas is selected from the group consisting of CO.sub.2, O.sub.2, N.sub.2, CO and NO; the monitoring, diverting and condensing steps are repeated in order to increase the amount of condensate produced in the condensing chamber; the monitoring, diverting and condensing steps are repeated for a predetermined period of time; the monitoring, diverting and condensing steps are repeated until a predetermined volume of gas has passed into the condensing chamber; the monitoring and diverting steps are carried out automatically; and monitoring includes determining when the exhaled breath has transitioned from the expired airway phase to the alveolar phase, and diverting the flow of the exhaled breath based on the state of the monitored characteristic includes diverting the exhaled breath to the condensing chamber until it is determined that the alveolar phase of the exhaled breath has begun.
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Kline to automatically return said valve 36 to said initial positioned for the purpose of automatically transitioning the expired airway phase to the alveolar phase, as suggested by Kline (par.0023). Moreover, PHOSITA would have had predictable success modifying Kline so as to allow for automatic manipulation of valve 36 since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
With respect to claim 2, Kline teaches wherein said stop is mounted at an angle within said first chamber (stop 52 is at ninety-degree angle within said first chamber 22 depending upon the user’s viewing angle; see Figs. 13 and 14).
With respect to claim 3, Kline teaches further comprising a block disposed within the first chamber or the second chamber (Figs. 10-12).
With respect to claim 4, Kline teaches wherein said block is configured to prevent back flow of said upper respiratory breath into said second chamber (Figs. 10-12).
With respect to claim 5, Kline teaches wherein said block extends across a portion of said housing at an angle so that said pivoting part lays substantially flat on said block in said activated position (Figs. 10-12).
With respect to claim 6, Kline teaches wherein when a volume of breath reaches said valve, said volume of breath pushes said pivoting part to move said valve from said initial position to said activated position (abstract “sufficient volume of gas has been produced”; see also par.0087, 0097).
With respect to claim 7, Kline teaches wherein said pivoting part pivots about a pivot point when pushed by said volume of breath (Figs. 13-14).
With respect to claim 8, Kline teaches further comprising a mouthpiece mounted to said housing (par.0066 “disposable mouthpiece 14”; Fig. 5).
With respect to claim 9, Kline teaches wherein said mouthpiece is mounted to said first chamber (mouthpiece 14 is mounted on first chamber 22, as depicted in Fig. 5).
With respect to claim 10, Klein teaches wherein said housing is a T-shaped housing (inhalation port 26 in relation to first chamber 22 forms a T-shape, as depicted in Fig. 5).
With respect to claim 11, Kline teaches wherein said stop is further defined as a slanted tab that extends into said first chamber along a portion of a shape of said first chamber (Figs. 13-14).
With respect to claim 12, Kline teaches wherein said diverting part is weighted compared to said pivoting part to facilitate said automatic return of said valve (Figs. 13-14).
With respect to claim 13, Kline teaches wherein said pivoting part abuts said one side of said stop in said initial position and said diverting part abuts said another side opposite said one side of said stop in said activated position (Figs. 13-14).
With respect to claim 14, Kline teaches wherein said first chamber includes an inclined portion in said portion of said first chamber to channel a volume of breath into a smaller portion of said first chamber (Figs. 5, 13, and 14).
With respect to claim 21, Kline teaches wherein a first collection device is mounted to said first chamber (Figs. 5, 13, and 14).
With respect to claim 22, Kline teaches wherein a second collection device is mounted to said second chamber (Figs. 5, 13, and 14).
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were persuasive in view of amendment. Therefore, these rejections are withdrawn.
Applicant’s arguments filed with respect to the obviousness rejections raised in the previous office action have been considered, but are moot in view of Examiner’s updated interpretation of the claimed “valve”, which was necessitated by amendment. While the current obviousness rejection maintains the previous Kline reference, Examiner now interprets that Kline’s directional flap 36 (as depicted in Figs. 11-15) equates to the claimed valve. See also Kline’s par.0027, which expressly discloses “the valve is a directional flap”. Moreover, and given the lack of structural specificity with regards to the claimed “pivoting and diverting parts”, Examiner interprets that any 2 of Kline’s elements 37-43 correspond to the claimed pivoting and diverting parts. Please see prior art section above for more detail, including updated citations that were necessitated by amendment.
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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