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 .
Election/Restrictions
Applicant's election with traverse of claims 1-14, 21, and 22 in the reply filed on November 24, 2025 is acknowledged. The traversal is on the grounds that (1) the same or corresponding special technical features of Groups I to III are not set forth in the prior art, i.e. “Examiner does not cite at all to any portion of Kline to support his position” (remarks, pg. 8); and (2) there would not be search burden to examine Groups I to III (remarks, pgs. 8-9). This is not found persuasive for the following reasons. First, Examiner maintains that Kline sets forth the corresponding special technical feature of Groups I to III, as further evidenced by the prior art rejection set forth in the current office action. Moreover, applicant appears to be relying on a rule that is not required by 35 USC 371, i.e., rules governing Requirement for Unity of Invention does not consider whether there is a search burden. For at least the above reasons and in accordance with the restriction requirement set forth in the previous office action, applicant’s rejections are not persuasive. Non-elected claims 15-19 are withdrawn from consideration.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 9, 2023 has been considered by the examiner.
Claim Rejections - 35 USC § 112B
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “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,” which is indefinite for reciting relative terminology. What is “substantially flat”? The specification does not appear to provide an adequate definition of this relative term.
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).
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 (valves 33/31 depicted in Figs. 5, 13, and 14) mounted to said housing and having a pivoting part (one-way valve 33 exhausts initial/non-alveolar breath as depicted in Figs. 5 and 13) and a diverting part (one-way valve 31 diverts alveolar breath to condensing chamber 98 as depicted in Fig. 14; par.0017 “causing the exhaled breath to be diverted into a condensing chamber”), wherein said pivoting part is adjacent one side of said stop when said valve is in an initial position (one-way valve 33 is 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 (one-way valve 31 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 (valve 31 inherently returns to initial position; Fig. 14).
Although Kline does not explicitly teach said valve (33/31 in Figs. 5, 13, and 14) 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 33/31 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 valves 33/31 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).
Conclusion
No claim is allowed.
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.
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, Alexander Valvis can be reached at 5712724233. 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.
/PUYA AGAHI/Primary Examiner, Art Unit 3791