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 .
Appropriate correction is required.
Claim Objections
Claim(s) 1-6 is/are objected to because of the following informalities:
Claim 1, Ln. 2 recites “inline” which should read “in line”
Claim 3, Ln. 2 recites “a exhalation valve” which should read “an exhalation valve”
Claim 4, Ln. 10 recites “to ventilator inline” which should read “to a ventilator in line”
Claim 6, Ln. 2 recites “a patient” which should read “the patient” following after claim 5
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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(s) 1-2 and 6 is/are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “[a]n inline resistance valve … which increases Positive End-Expiratory Pressure (PEEP) level provided to a patient” which deems the claim indefinite. The recites a function, i.e. increasing PEEP level, without reciting particular structure which performs the function. A common valve will not inherently increase PEEP. The claim thus improperly attempts to define the valve by what it does and not what it is (see MPEP 2173.05(g)). The disclosed structure which performs the increasing of PEEP is an orifice (e.g. orifice 24 in ¶0034) and that structure should be amended into the claim, though this structure will not be read into the claim at present.
Claim 6 recites the limitation “the orifice has a diameter and wherein decreasing the diameter increases PEEP level provided to a patient by the ventilator” which deems the claim indefinite. The claim is indefinite for several reasons as it is unclear what is being positively recited by the claim. As an initial matter, the active word “decreasing” leaves it unclear whether an active step and/or function is being claimed. There does not appear to be sufficient subject matter in the claim to substantiate an understanding of a claiming of an active step and/or function. Secondly, it is unclear whether the claim is merely stipulating that different sized orifices will cause different levels of PEEP or is attempting to somehow indicate the orifice size can be changed. Only the former interpretation appears supported by the present claim language. The claim at present will only be read as specifying the orifice as circular, based upon a plain language meaning of the term “diameter.”
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weert et al. (EP 2153859 A1).
Regarding claim 1, van Weert discloses an inline resistance valve (Figs. 5-6 #616, 622; ¶¶0023-0024) configured for placement before an exhalation valve (Figs. 5-6 #638; ¶0023) in a ventilator (Figs. 5-6; ¶¶0023-0024) and in line with exhalation flow (Figs. 5-6; ¶¶0023-0024) and which is capable of increasing Positive End-Expiratory Pressure (PEEP) level provided to a patient by the ventilator. It is noted that the claimed inline resistance valve is not recited as having any valve structure. The claiming of the inline resistance valve as increasing PEEP level represents an intended use and is given limited patentable weight in the absence of further defining limitations in the claim (see MPEP 2114). The obstruction 632 in the flow sensor 616 of van Weert will obviously increase a PEEP level compared to a system which includes no flow restrictor. It is noted that the disclosure of the instant application indicates the resistance valve need not have any traditional valve structure (e.g. ¶0034).
Regarding claim 2, van Weert discloses a ventilation apparatus (Figs. 1, 3 & 5-6; ¶¶0023-0024) comprising (a) a ventilator having an exhalation valve (Figs. 5-6 #638; ¶0023) and (b) the inline resistance valve of claim 1 (see above) positioned before the exhalation valve and in line with exhalation flow (Figs. 5-6; ¶¶0023-0024).
Regarding claim 3, van Weert discloses a method of increasing Positive End-Expiratory Pressure (PEEP) levels in a ventilator (Figs. 5-6; ¶¶0023-0024) having an exhalation valve (Figs. 5-6 #638; ¶0023) comprising placing a resistance valve (Figs. 5-6 #616, 622; ¶¶0023-0024) before the exhalation valve and in line with exhalation flow (Figs. 5-6; ¶¶0023-0024). The claim has no concern for what structure is performing the increasing of PEEP. It is noted that the disclosure of the instant application indicates the resistance valve need not have any traditional valve structure (e.g. ¶0034).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over van Weert et al. (EP 2153859 A1) in view of Tolmie et al. (U.S. Pub. 2010/0076332).
Regarding claim 4, van Weert discloses a Positive End-Expiratory Pressure (PEEP) valve apparatus (Figs. 5-6 #616, 622; ¶¶0023-0024), comprising: (a) a valve body (Figs. 5-6 #616, 622; ¶0024), said valve body having an inlet port (Fig. 6 bottom end of #622) and an outlet port (Fig. 6 left end of #616), the valve body comprising an inlet housing (Figs. 5-6 exterior of #622; ¶0023) and an outlet housing (Figs. 5-6 exterior of #616; ¶0024); and (b) an obstruction (Fig. 6 #632; ¶0024) in the valve body that is in fluidic communication with the inlet port and the outlet port; (c) wherein the orifice restricts fluid flow between the inlet port and the outlet port (¶0024 – function of an “obstruction”); and (d) wherein the inlet port and the outlet port are configured for connection to a ventilator in line with an exhaust path (Figs. 5-6; ¶¶0023-0024) and upstream of an exhaust valve in the ventilator (Figs. 5-6 #638; ¶0023). The recitation of the valve apparatus being specifically a PEEP valve represents an intended use is given limited patentable weight (MPEP 2111.02).
van Weert fails to explicitly disclose the obstruction comprises an orifice.
Tolmie teaches an expiratory flow sensor (Figs. 1-2 #18; ¶0016) comprising an orifice (Fig. 2 internal to #48; ¶0019). Tolmie teaches an orifice as an effective form of flow sensor in the art which allows detection of a pressure differential across a flow restriction (¶0019).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in van Weert the obstruction comprises an orifice based upon an obvious design choice to select a particular form of flow sensor in the art which allows detection of a pressure differential across a flow restriction in view of Tolmie.
Regarding claim 5, van Weert teaches the invention as modified above and together with Tolmie further suggests as obvious the orifice is sized to be capable of increasing PEEP level provided to a patient by the ventilator (van Weert – Fig. 6; Tolmie – Fig. 2). The flow restrictor 48 in the flow sensor 18 of Tolmie will obviously increase a PEEP level compared to a system which includes no flow restrictor.
Regarding claim 6, van Weert teaches the invention as modified above and Tolmie further suggests as obvious the orifice has a diameter (Tolmie – ¶0019 – effective inner diameter reduced obviously suggests a diameter through the flow restrictor 48) and wherein decreasing the diameter increases PEEP level provided to the patient by the ventilator.
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. Regarding claims 1 and 3 further attention is specifically drawn to: Sjostrand (U.S. Patent 3993059; Fig. 2), Cooke et al. (U.S. Pub. 2010/0306992; Fig. 3), Von Hollen et al. (U.S. Pub. 2013/0184619; Figs. 1 & 3), and Ji (U.S. Pub. 2017/0246421; Fig. 2).
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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785