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 .
Drawings
The drawings are objected to because Figs. 2E & 2F appear to have been switched in their labeling (e.g. what is labeled as Fig. 2E appears to instead be Fig. 2F as Fig. 2E shows an expiration flow and what is labeled as Fig. 2F appears to instead be Fig. 2E as Fig. 2F shows a spontaneous inspiration flow). 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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) 2-21 is/are objected to because of the following informalities:
Claim 2, Ln. 10-11 recites “to permit expiratory gas to flow from the patient port to flow to the expiration port” where one of the two “to flow” portions of the limitation should be deleted (either of the two can be deleted to allow a suitable reading of the limitation)
Claim 9, Ln. 11-12 recites “to permit expiratory gas to flow from the patient port to flow to the expiration port” where one of the two “to flow” portions of the limitation should be deleted (either of the two can be deleted to allow a suitable reading of the limitation)
Claim 16, Ln. 10-11 recites “to permit expiratory gas to flow from the patient port to flow to the expiration port” where one of the two “to flow” portions of the limitation should be deleted (either of the two can be deleted to allow a suitable reading of the limitation)
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 7, 11 and 13 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 recites the limitation “the first valve comprises a rebreather valve.” The originally filed application only discusses non-rebreather valves and never a rebreather valve (e.g. ¶0048). There is thus lack of sufficient written description support in the originally filed application for the claiming of the first valve as a rebreather valve (instead of as a non-rebreather valve).
Claim 11 recites the limitation “each of the first valve, the second valve, and the third valve comprise at least one of ….” The language “at least one of” implies that the claim covers all embodiments defined by the claim’s various possible combinations, including where each of the three valves would include multiple of the recited valve options. There is not found to be sufficient written description support in the application as originally filed for the breadth of possible combinations defined by the claim, such as by example where each of the three valves would be defined simultaneously by all 11 valve options recited by the claim. Further, the originally filed application fails to specify that all three of the valves of claim 9 can be made from a diaphragm. The originally filed application only discusses certain structures as having the form of a diaphragm. Further, the originally filed application uses the term “diaphragm” in a manner which is fully distinct from its discussion of valves. Thus, in light of the specification of the originally filed application indicates the terms diaphragm and valve are not interchangeable and must be understood as distinct from each other. There is thus further not found to be sufficient written description support in the application as originally filed for the recitation of the three valves of claim as being a diaphragm based upon how the originally filed application uses the term diaphragm in a manner which is fully distinct from its discussion of valves. Applicant is encouraged to amend the claim to more specifically identify each have as having only one possible valve form (which is not a diaphragm).
Claim 13 recites the limitation “during spontaneous inspiration, the respiratory gas is introduced via the patient port.” The originally filed application never discusses spontaneous inspiration as introducing gas via the patient port. Instead, spontaneous inspiration is discussed as introducing gas only from other locations, such as via the ventilation port. (e.g. Fig. 1C). There is thus lack of sufficient written description support in the originally filed application for the claiming of respiratory gas being introduced via the patient port during spontaneous inspiration.
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) 7 and 9-15 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 7 recites the limitation “substantially resistance-free positive pressure ventilation” in Ln. 2-3 which deems the claim indefinite. Initially, it is noted that the language “substantially resistance-free” is relative language which must be interpreted in light of the specification. The language “resistance-free” is not specifically defined in the specification. There is discussion in ¶0009 of opening pressures as low as 0 cm H2O. However, ¶0085 discusses the term “substantially” as including variations of ±20%. It is thus unclear if the claim is attempting to claim an opening pressure of 0 cm H2O or is instead defining some other positive pressure opening amount which is “substantially resistance-free” but without clear bounds. For the purposes of examination the limitation will be interpreted as requiring the first valve to open at atmospheric pressure and this should be made clear in the claim language.
Claim 9 recites the limitation “the first valve having a cracking pressure that is substantially equal to atmospheric pressure” in Ln. 7-8 which deems the claim indefinite. The term “substantially” is discussed in ¶0085 of the specification as including variations of ±20%. It is thus unclear if the claim is specifically claiming a cracking pressure equal to atmospheric pressure or instead to some pressure which varies away from atmospheric pressure. For the purposes of examination the limitation will be interpreted without the term “substantially.”
Claim 11 recites the limitation “each of the first valve, the second valve, and the third valve comprise at least one of a diaphragm” in Ln. 2-3 which deems the claim indefinite. The term “diaphragm” is used throughout the specification to refer to particular structures which are never otherwise termed as valves (i.e. diaphragms 110, 210, 310). The term valve is introduced in ¶0005 of the specification as potentially referring to 10 types of valve, while never mentioning a diaphragm. Thus, in light of the specification of the term “diaphragm” must be understood as distinct from a valve, but the instant claim instead attempts to now merge the terms. There is thus confusion in the claim as to whether the term “diaphragm” has any particular meaning or not.
Claim 15 recites the limitation “the housing defines a spontaneous inspiration port that is fluidly coupled with an outside environment” in Ln. 2-3 which deems the claim indefinite. While the specification does disclose housing ports which operate as a spontaneous inspiration port those ports are only found to be drawn to ports already defined in claim 9 (e.g. Fig. 1C – the ventilation port operates as a spontaneous inspiration port, Fig. 2F – the expiration port operates as a spontaneous inspiration port). The claim is thus indefinite as it defines a new port structure which appears best understood as only drawn to an earlier defined port in the claim. The limitation should be amended to specify the spontaneous inspiration port as further defining at least one of the previously recited ports from claim 9.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 2-4, 11 and 15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,103,672. Although the claims at issue are not identical, they are not patentably distinct from each other because all requirements of instant claim 2 are found within the overall scope of patent claim 11 (e.g. first valve = the first atmospheric pressure valve, second valve = the first pressure-sensitive valve, third valve = the second pressure-sensitive valve), the instant claim merely being broader in scope. Similarly, all requirements of instant claim 9 are found within the overall scope of patent claim 11 (e.g. first valve = the first atmospheric pressure valve, second valve = the first pressure-sensitive valve, third valve = the second pressure-sensitive valve, “atmospheric” pressure valve expected to open at atmospheric pressure), the instant claim merely being broader in scope. A further mapping of dependent claims is as follows:
Instant claim 3 vs. patent claim 11
Instant claim 4 vs. patent claim 11
Instant claim 11 as obvious in view of patent claim 11 – the claim generally recites all common forms of valve in the respiratory art
Instant claim 15 as obvious in view of limitations in patent claim 7 – the patient inspiration flow path draws air in the event of spontaneous inspiration which implies a port must be provided to draw the spontaneously inspired air
Claim(s) 2-11 and 14-18 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 13 and 15-18 of U.S. Patent No. 12,011,546. Although the claims at issue are not identical, they are not patentably distinct from each other because all requirements of instant claim 2 are found within the overall scope of patent claim 1 (e.g. first valve = the first atmospheric pressure valve, second valve = the safety check valve, third valve = the second atmospheric pressure valve), the instant claim merely being broader in scope. Similarly, all requirements of instant claim 9 are found within the overall scope of either patent claim 1 or 13 (e.g. first valve = the first atmospheric pressure valve, second valve = the safety check valve, third valve = the second atmospheric pressure valve, “atmospheric” pressure valve expected to open at atmospheric pressure), the instant claim merely being broader in scope. Additionally, all requirements of instant claim 16 are found within the overall scope of either patent claim 1 or 13 (e.g. first valve = the first atmospheric pressure valve, second valve = the safety check valve, third valve = the second atmospheric pressure valve, “atmospheric” pressure valve expected to have a cracking pressure of between 0 and 10 cm of water), the instant claim merely being broader in scope. A further mapping of dependent claims is as follows:
Instant claim 3 vs. patent claim 1
Instant claim 4 vs. patent claim 4
Instant claim 5 vs. patent claim 5
Instant claim 6 vs. patent claim 5
Instant claim 7 vs. patent claim 7 (if the instant claim were instead to read “non-rebreather valve”)
Instant claim 8 vs. patent claim 1
Instant claim 10 vs. patent claim 2
Instant claim 11 vs. patent claim 6
Instant claim 14 vs. patent claim 16
Instant claim 15 vs. patent claim 15
Instant claim 17 vs. patent claim 17
Instant claim 18 vs. patent claim 18
Claim(s) 19-21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12,011,546 in view of Kuypers et al. (U.S. Pub. 2014/0144447). Patent claim 18 is silent on the particular type of physiological sensor(s) and whether there is a communications interface to transmit data from the physiological sensor(s).
Kuypers teaches a valve manifold (Figs. 1 & 5 #30; ¶0110) including a pressure sensor and a flow sensor at a patient port (¶¶0137-0140). Kuypers teaches data from the pressure sensor and the flow sensor as transmitted to allow control over inspiratory gas supply as well as to check for leakage (¶¶0137-0140).
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 patent claim 18 the one or more physiological sensors comprise one or both of a pressure sensor and a flow sensor (instant claim 19) and a communications interface that is configured to transmit data from the one or more physiological sensors to an external device (instant claims 20 and 21) in order to provide the benefit of allowing control over inspiratory gas supply as well as to check for leakage in view of Kuypers.
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) 2-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flynn (U.S. Pub. 2007/0012360).
Regarding claim 2, Flynn ‘360 discloses an inspiratory resistor valve system (IRV) (Figs. 1-2; ¶0011-0021), comprising: a housing (Fig. 2 #16, 18; ¶0011); a ventilation port (Fig. 2 bottom of #18) that is configured to interface with a ventilation device (Figs. 1-2 #60; ¶0017); a patient port (Fig. 2 top of #16) that is configured to interface with a patient interface device (Fig. 1 #12; ¶0011); an expiration port (Figs. 1-2 #44; ¶0014); a first valve (Fig. 1 #30; ¶¶0013, 0018) that is configured to open during positive pressure ventilation to permit respiratory gas flow from the ventilation port to flow to the patient port; a second valve (Fig. 1 #50; ¶¶0015, 0020) that is configured to open during spontaneous inspiration to permit respiratory gas to flow to the patient port; and a third valve (Fig. 1 #40; ¶¶0014, 0019) that is configured to open during expiration to permit expiratory gas to flow from the patient port to flow to the expiration port.
Regarding claim 3, Flynn ‘360 discloses the third valve is configured to occlude the expiration port during positive pressure ventilation and during spontaneous inspiration (Fig. 1; ¶¶0018-0019).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn (U.S. Pub. 2007/0012360) in view of Flynn (U.S. Pub. 2009/0260628).
Regarding claim 5, Flynn ‘360 fails to disclose a filter interfaced with the expiration port.
Flynn ‘628 teaches a similar valve assembly to Flynn ‘360 (Figs. 9-10 #915; ¶0080). Flynn ‘628 teaches that instead of the illustrated positioning of annular filter 948 in Fig. 10 an annular filter can instead be located to surround the inhalation valve 930 at the base of the enlarged upper end portion 926 to cover the exhalation apertures 944, so that exhaled air passing through the exhalation apertures 944 must also pass through the annular filter while incoming oxygen (or an oxygen/air mixture, or a medication-laden oxygen/air mixture) passes through the central aperture of the annular filter and therefore is not filtered (¶0087). Flynn ‘628 thus teaches an obvious design choice alternative to interface the filter with the expiration port when only intending to filter exhaled air and not incoming oxygen (¶0087).
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 substituted in Flynn ‘360 a filter interfaced with the expiration port based upon an obvious design choice alternative to interface the filter with the expiration port when only intending to filter exhaled air and not incoming oxygen in view of Flynn ‘628.
Claim(s) 6, 16 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn (U.S. Pub. 2007/0012360) in view of Kuypers et al. (U.S. Pub. 2014/0144447).
Regarding claim 6, Flynn ‘360 is silent as to whether the IRV provides between 2 and 10 cm of water of expiratory resistance.
Kuypers teaches a valve manifold (Figs. 1 & 5 #30; ¶0110) and teaches providing PEEP of 10 cm H2O as a particularly desirable level when patient ventilation is being controlled (¶¶0143-0144).
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 Flynn ‘360 the IRV provides 10 cm of water of expiratory resistance in order to provide the benefit of specifying a particular expiratory resistance which will provide PEEP when patient ventilation is being controlled in view of Kuypers.
Regarding claim 16, Flynn ‘360 discloses an inspiratory resistor valve system (IRV) (Figs. 1-2; ¶0011-0021), comprising: a housing (Fig. 2 #16, 18; ¶0011); a ventilation port (Fig. 2 bottom of #18) that is configured to interface with a ventilation device (Figs. 1-2 #60; ¶0017); a patient port (Fig. 2 top of #16) that is configured to interface with a patient interface device (Fig. 1 #12; ¶0011); an expiration port (Figs. 1-2 #44; ¶0014); a first valve (Fig. 1 #30; ¶¶0013, 0018) that is configured to open during positive pressure ventilation to permit respiratory gas flow from the ventilation port to flow to the patient port; a second valve (Fig. 1 #50; ¶¶0015, 0020) that is configured to open during spontaneous inspiration to permit respiratory gas to flow to the patient port; and a third valve (Fig. 1 #40; ¶¶0014, 0019) that is configured to open during expiration to permit expiratory gas to flow from the patient port to flow to the expiration port.
Flynn ‘360 is silent as to whether the third valve having a cracking pressure of between 0 and 10 cm of water.
Kuypers teaches a valve manifold (Figs. 1 & 5 #30; ¶0110) and teaches providing PEEP of 10 cm H2O as a particularly desirable level when patient ventilation is being controlled (¶¶0143-0144).
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 Flynn ‘360 the third valve having a cracking pressure of 10 cm of water in order to provide the benefit of specifying a particular expiratory resistance which will provide PEEP when patient ventilation is being controlled in view of Kuypers.
Regarding claim 18, Flynn ‘360 teaches the invention as modified above and Kuypers as incorporated therein further teaches one or more physiological sensors (¶¶0137-0140 – pressure sensor and flow sensor) disposed in
Regarding claim 19, Flynn ‘360 teaches the invention as modified above and Kuypers as incorporated therein further teaches the one or more physiological sensors comprise one or both of a pressure sensor and a flow sensor (¶¶0137-0140).
Regarding claim 20, Flynn ‘360 teaches the invention as modified above and Kuypers as incorporated therein further teaches a communications interface that is configured to transmit data from the one or more physiological sensors to an external device (¶¶0137-0138).
Regarding claim 21, Flynn ‘360 teaches the invention as modified above and Kuypers as incorporated therein further teaches the external device comprises .
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flynn (U.S. Pub. 2007/0012360) in view of Lurie et al. (U.S. Pub. 2005/0056277).
Regarding claim 8, Flynn ‘360 is silent as to whether the second valve has a cracking pressure of between -5 and -20 cm of water.
Lurie teaches a respiratory valve and teaches that for CPR applications the valve may be set to open when a negative intrathoracic pressure exceeds about -4 cm H2O to about -15 cm H2O while for non-CPR applications the valve may be set to open at about -3 cm H2O to about -12 cm H2O (¶0036). Lurie thus teaches inspiratory valve opening pressure ranges falling within the claimed range as desirable both for CPR applications and non-CPR applications.
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 Flynn ‘360 the second valve has a cracking pressure of between -5 and either -12 or -15 cm of water in order to provide the benefit of specifying a particular inspiratory valve opening pressure which is desirable both for CPR applications and non-CPR applications in view of Lurie.
Allowable Subject Matter
Claim(s) 4 and 17 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. These claims are solely rejected based upon the above nonstatutory double patenting rejections.
Claim(s) 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 9-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, Flynn ’360 fails to teach or suggest the first valve and the second valve are configured to occlude the ventilation port during expiration. The claim is understood to imply that both the first valve and the second valve must be in direct line along a flow path from the ventilation patient to the patient port. In Flynn ‘360 the second valve must be read as third one-way valve 50. However, third one-way valve 50 is not in a direct flow path between the top and bottom of valve assembly 14 (Fig. 1). Thus, third one-way valve 50 cannot be accurately read as “configured to occlude the ventilation port during expiration.”
Regarding claim 2 it is noted that the claim defines a particular set of three valves which each have a particular function. Other prior art readable on claim 2 are Stenzler et al. (U.S. Pub. 2004/0060560; Fig. 1) and Zhang et al. (CN 202777378 U; Figs. 3-7; see attached machine translation). Neither Stenzler nor Zhang teach or suggest both a first valve and a second valve configured to occlude a ventilation port during expiration as each reference only places a single inhalation directed valve along a path which would be directly engaged by expiration flow moving toward a ventilation port.
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 7, Flynn ’360 fails to teach or suggest the first valve comprises a rebreather valve that enables substantially resistance-free positive pressure ventilation. Flynn ‘360 fails to teach or suggest first one-way valve 30 is a rebreather valve and opens at atmospheric pressure.
Neither Stenzler nor Zhang, as mentioned in the discussion of claim 4 above, alternately teach or suggest the requirements 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.
Regarding claim 9, the prior art fails to teach or suggest an inspiratory resistor valve system (IRV) including all elements and functionality recited by the instant claim. Note is made that the claim defines a particular set of three valves which each have a particular function. Additionally, the first valve is recited as opening during positive pressure ventilation with a cracking pressure that is equal to atmospheric pressure.
None of the above cited Flynn ‘360, Stenzler or Zhang teach or suggest a first valve which opens at atmospheric pressure. Instead, one of ordinary skill in the art would have expected the first valves of Flynn ‘360, Stenzler or Zhang to all open with a cracking pressure somewhat above atmospheric pressure, as is common for inhalation valves in the respiratory art.
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 17, Flynn ’360 fails to teach or suggest the second valve is biased in a closed position by a spring. Flynn ’360 has no consideration of a spring being involved in the operation of third one-way valve 50.
Neither Stenzler nor Zhang, as mentioned in the discussion of claim 4 above, alternately teach or suggest the requirements 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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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
