DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Species B, claims 14-23, in the reply filed on 16 Dec 2025 is acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species A, there being no allowable generic or linking claim.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “618” has been used to designate outlet 642 (Fig. 19). (Reference character 618 does not appear in the specification.) Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 23 is/are objected to because of the following informalities:
Claim 23, Ln. 9 recites “and connected to the inspiratory leg” which should read “the second ventilator valve connected to the inspiratory leg” for clarity
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14 and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (U.S. Pub. 2001/0035187).
Regarding claim 14, Smith discloses a ventilator valve (Fig. 1; ¶0019), comprising: a housing (Fig. 1 #10, 12; ¶0019), the housing having an inlet (Fig. 1 #16; ¶0019) for receiving breathing gas, the housing having a cover (Fig. 1 #12; ¶0019) with an outlet (Fig. 1 #18 or #20; ¶0019) in fluid communication with the inlet; and a shutter (Fig. 1 #22; ¶0021) rotatably disposed in a path between the inlet and the outlet (see also Figs. 2C-2D; ¶¶0021-0023), the shutter having an orifice (Figs. 2C-2D #32; ¶0023) configured to be in intermittent alignment with the inlet and the outlet (¶¶0021-0023) such that, as the shutter is rotated, the inlet and outlet are occluded when the orifice is not aligned (Figs. 1 & 2C-2D flow directed to only one of #18, 20; ¶¶0020-0022) and patent (Figs. 1 & 2C-2D directed to only other of #18, 20; ¶¶0020-0022) when the orifice is at least partially aligned between the inlet and the outlet.
Regarding claim 16, Smith discloses a coupler (Fig. 1 #34; ¶0025) configured for connection to a crank (¶0025 – motorized rotation of wiper plate 22 will use a crank) for manually rotating the shutter.
Regarding claim 17, Smith discloses the shutter is a disk (Figs. 1 & 2C-2D #22).
Regarding claim 18, Smith discloses the housing is cylindrical (Fig. 1 #10, 12).
Regarding claim 19, Smith discloses the shutter is contained within the housing (Fig. 1).
Allowable Subject Matter
Claim(s) 15 and 20-23 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 15, Smith fails to teach or suggest an exhaust pressure regulator for controlling a positive-end-of-expiration pressure ("PEEP") and connected to the outlet of the housing. Smith includes two outlets 18, 20. First fluid outlet 18 delivers gas flow to a patient while second fluid outlet 20 either vents to atmosphere or recycles back to the valve inlet 16 (¶0020). At neither of outlets 18, 20 would an exhaust pressure (PEEP) regulator be expected.
The instant application includes the exhaust pressure regulator at the outlet of the housing based upon the expected use of the claimed ventilator valve along an expiratory leg of a ventilator circuit (e.g. Fig. 20). The configuration of Smith is fully different as it does not include a separate expiratory leg. One of ordinary skill in the art would thus not have considered it prima facie obvious to have modified Smith in order to have arrived at the instantly claimed invention without improper hindsight reasoning.
Other prior art of note in regard to claim 14 are Sears et al. (U.S. Pub. 2014/0069428; Figs. 6-10B), Foote et al. (U.S. Pub. 2014/0283831; Figs. 2A-3 & 9A-9C), and Ye et al. (U.S. Pub. 2018/0085541; Figs. 7-9, 41-46 & 72). Similar to the above discussion of Smith, none of Sears, Foote or Ye teach or suggest a separate expiratory leg and thus each of those references additionally would not have obviously been modified to include the exhaust pressure (PEEP) regulator at the outlet of the housing. It is additionally noted that claim 14 has recited the shutter as rotatably moveable into a position which occludes flow, which eliminates prior art such as Saied (U.S. Pub. 2023/0075412) where flow is always allowed in some measure (e.g. through central orifices 144, 150 in Fig. 15).
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 20, Smith fails to teach or suggest a ventilator, comprising: a Y-shaped conduit having an inspiratory leg configured to be connected to a source of breathing gas, a patient leg configured to be connected to an endotracheal tube, and an expiratory leg; a safety valve coupled to the inspiratory leg; and a first ventilator valve according to claim14 and connected to the expiratory leg. As noted in the discussion of claim 15 above, the configuration of Smith is fully different from the claimed invention as Smith does not include a separate expiratory leg. Thus, one of ordinary skill in the art would not have considered it prima facie obvious to have modified Smith in order to have arrived at the instantly claimed invention without improper hindsight reasoning.
Each of the above discussed Sears, Foote and Ye similarly fail to teach or suggest the overall combination of elements within a ventilator as defined by the instant claim.
Further, one of ordinary skill in the art would not have considered it prima facie obvious to have transferred the valve of any of Smith, Sears, Foote or Ye into a different ventilator which includes the basic structures recited by the instant claim because of how the particular operation of the shutter valves in each of Smith, Sears, Foote and Ye is specifically designed to serve a different purpose than the purpose performed by the first ventilator valve connected to the expiratory leg of the instant claim.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785