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 .
Claim Objections
Claim(s) 29 is/are objected to because of the following informalities:
Claim 29, Ln. 2 recites “providinig" which should read “providing”
Claim 36, Ln. 2-3 recites “the gas source" which should read “the at least one gas source” for consistency with Ln. 1 of the claim
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) 31 and 37 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 31 recites the limitation “rapid switchover” in Ln. 4 which deems the claim indefinite. The term “rapid” in claim 31 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would be left to question what timing defines a “rapid” change as opposed to one which is not rapid? The claim will be examined without particular attention to the term “rapid.”
Claim 37 twice recites the limitation “the valve” which deems the claim indefinite. The claim also recites the limitation “the gas” in Ln. 2 which deems the claim indefinite. Claim 36, upon which claim 37 depends, has recited “at least one valve” and “at least one gas.” Because the instant claim only recites “the valve” instead of “the at least one valve” it is unclear whether the claim is specifying the at least one valve as being only a single valve (where “the valve” would be proper) or whether the claim has inadvertently missed writing the limitation as “the at least one valve.” Similarly, cecause the instant claim only recites “the gas” instead of “the at least one gas” it is unclear whether the claim is specifying the at least one gas as being only a single gas (where “the gas” would be proper) or whether the claim has inadvertently missed writing the limitation as “the at least one gas.” Applicant is requested to clarify the intent.
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) 19, 28-31 and 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Be’eri (U.S. Pub. 2007/0199566).
Regarding claim 19, Be’eri discloses a ventilator (Fig. 1C; ¶¶0059-0068) for the ventilation of a living being, wherein the ventilator comprises at least a gas module (Fig. 1C #110, 118’, 120, 170) and a control module (Fig. 1C #140), the gas module comprising at least a first blower and a second blower (Fig. 1C #112, 172; ¶¶0061, 0065) for generating a positive pressure and/or a negative pressure (Fig. 1C flow arrows I, E) and at least one connector (Fig. 1C interface between #119 and #120) for connection to a hose (Fig. 1C #119a or #119b), and the control module comprising at least a control unit (Fig. 1C #140) for controlling the gas module, and wherein the first blower has an opposite delivery direction to the second blower (Fig. 1C #112 directs toward patient while #172 directs away from patient).
Regarding claim 28, Be’eri discloses at least one of the first and second blowers is adapted to be capable of generating a negative pressure (¶0060).
Regarding claim 29, Be’eri discloses the ventilator is adapted to be capable of providing ventilation with a negative expiratory pressure (¶¶0041, 0060).
Regarding claim 30, Be’eri discloses the ventilator is adapted to be capable of generating a constant expiratory flow, a negative expiratory pressure being provided by one of the first and second blowers in the course of expiration (¶¶0041, 0060). A blower performing exsufflation is capable of being use to generate a constant expiratory flow. The language “capable of” in the claim only requires the blower to be able to be operated under the claimed conditions.
Regarding claim 31, Be’eri discloses the ventilator is adapted to be capable of carrying out a cough therapy (¶¶0060-0061), a patient being provided with a breathing gas at positive pressure by the first blower during the inspiration (¶¶0040, 0044), and after an end of the inspiration a rapid switchover being made to a breathing gas at negative pressure, provided by the second blower (¶¶0041, 0060).
Regarding claim 38, Be’eri discloses a method of ventilating a living being, wherein the method comprises ventilating the living being with the ventilator of claim 19 (see claim 19 above; Fig. 1C; ¶¶0059-0068– respiratory therapy system inherently used to ventilate a living being).
Claim Rejections - 35 USC § 102/103
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 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.
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) 19, 28-35 and 38 is/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 Tiemann et al. (U.S. Pub. 2019/0269966).
Regarding claim 19, Tiemann, in a first reading, discloses a ventilator (Fig. 1 #12; ¶0077) for the ventilation of a living being, wherein the ventilator comprises at least a gas module (Fig. 1 #7, 57; ¶0078) and a control module (Fig. 1 #2; ¶0084), the gas module comprising at least a first blower and a second blower (Fig. 1 #67; ¶0079 – #17 can include two blower units 67) for generating a positive pressure and/or a negative pressure (¶0079 – insufflation and/or exsufflation, with exsufflation including partial vacuum) and at least one connector (Fig. 1 #57; ¶0080) for connection to a hose, and the control module comprising at least a control unit (¶0084) for controlling the gas module, and wherein the first blower has an opposite delivery direction to the second blower (¶¶0079, 0081 – insufflation delivers gas toward from #67 to #57 while exsufflation under partial vacuum will pull gas from #57 to #67).
Tiemann, in a second reading, discloses a ventilator (Fig. 1 #100; ¶0077) for the ventilation of a living being, wherein the ventilator comprises at least a gas module (Fig. 1 #12, 22; ¶0077) and a control module (Fig. 1 two #2; ¶0084), the gas module comprising at least a first blower and a second blower (Fig. 1 individual #67; ¶¶0078-0079, 0081) for generating a positive pressure and/or a negative pressure (¶¶0079, 0081 – insufflation and/or exsufflation, with exsufflation including partial vacuum) and at least one connector (Fig. 1 two #57; ¶0080) for connection to a hose, and the control module comprising at least a control unit (¶0084) for controlling the gas module, and wherein the first blower has an opposite delivery direction to the second blower (¶¶0079, 0081 – insufflation delivers gas toward from #67 to #57 while exsufflation under partial vacuum will pull gas from #57 to #67).
In each of the two readings above it is considered inherent from the discussion in ¶¶0079, 0081 of Tiemann that insufflation flow being provided by a blower unit 67 to a patient and exsufflation flow being performed under partial vacuum by another blower unit 67 will necessarily require the two blower units 67 to be operating in opposite delivery directions.
However, assuming arguendo applicant disputes this inherency it alternately would have been prima facie obvious to one having ordinary skill in the art that when using two blowers with a same general positioning in a housing and/or system that when a first blower performs insufflation and a second blower performs exsufflation they would obviously operate in opposite delivery directions based upon the common knowledge in the art that insufflation involves forcing gas toward a patient while exsufflation involves pulling gas away from the patient.
Regarding claim 28, Tiemann discloses at least one of the first and second blowers is adapted to be capable of generating a negative pressure (¶¶0079, 0081 –partial vacuum).
Regarding claim 29, Tiemann discloses the ventilator is adapted to be capable of providing ventilation with a negative expiratory pressure (¶¶0029, 0079, 0081 – partial vacuum during exsufflation and expiration).
Regarding claim 30, Tiemann discloses the ventilator is adapted to be capable of generating a constant expiratory flow, a negative expiratory pressure being provided by one of the first and second blowers in the course of expiration (¶¶0029, 0079, 0081 – partial vacuum during exsufflation and expiration). A blower performing exsufflation is capable of being use to generate a constant expiratory flow. The language “capable of” in the claim only requires the blower to be able to be operated under the claimed conditions.
Regarding claim 31, Tiemann discloses the ventilator is adapted to be capable of carrying out a cough therapy (¶¶0079, 0081- alternating insufflation and exsufflation are useable to perform cough therapy), a patient being provided with a breathing gas at positive pressure by the first blower during the inspiration (¶0079 – insufflation), and after an end of the inspiration a rapid switchover being made to a breathing gas at negative pressure, provided by the second blower (¶0029 – exsufflation specifically during expiration).
Regarding claim 32, Tiemann discloses the ventilator is adapted to be capable of providing superimposed and/or oscillating ventilation (¶¶0079, 0081).
Regarding claim 33, Tiemann discloses the first blower determines a ventilation frequency and the second blower generates a superimposed frequency (¶¶0079, 0081).
Regarding claim 34, Tiemann discloses the first blower determines a ventilation frequency and the second blower generates a superimposed frequency (¶¶0079, 0081).
Regarding claim 35, Tiemann discloses the ventilator is adapted to be capable of providing superimposed ventilation and ventilation with a negative expiratory pressure simultaneously (¶¶0029, 0079, 0081).
Regarding claim 38, Tiemann discloses a method of ventilating a living being, wherein the method comprises ventilating the living being with the ventilator of claim 19 (see claim 19 above; ¶0077 – respiratory therapy system inherently used to ventilate a living being).
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Be’eri (U.S. Pub. 2007/0199566) in view of Huddart et al. (U.S. Pub. 2006/0113690).
Regarding claim 36, Be’eri discloses at least one gas source (¶0098 – oxygen).
Be’eri fails to disclose the gas source is arranged between the connector and the first and second blowers, at least one gas from the gas source being introduced via at least one valve into a breathing gas delivered by one of the first and second blowers.
Huddart teaches a ventilator (Fig. 1) including a gas source arranged between a patient connector and a blower (Figs. 1 & 3 – oxygen source injects downstream of blower), at least one gas from the gas source being introduced via at least one valve (Fig. 3 #44; ¶0094) into a breathing gas delivered by the blower (Figs. 1 & 3). Huddart teaches injected of oxygen after a blower as providing the benefit of controlling a volume of oxygen, and thus a concentration of oxygen, inspired by the patient (¶0094).
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 incorporated in Be’eri the gas source is arranged between the connector and the first and second blowers, at least one gas from the gas source being introduced via at least one valve into a breathing gas delivered by one of the first and second blowers in order to provide the benefit of injecting oxygen after a positive pressure blower which allows controlling of a volume of oxygen, and thus a concentration of oxygen, inspired by the patient in view of Huddart. It is noted that injecting oxygen downstream of airflow generator 112 in Be’eri will locate the oxygen source as between the patient interface 120 and the airflow generators 112, 172 (Fig. 1C).
Regarding claim 37, Be’eri teaches the invention as modified above and together with Huddart further teaches a mixing region (Be’eri – Fig. 1C within #119a downstream of #112; Huddart – Fig. 3 space between #41, 42, 43) for better mixing of the breathing gas that is delivered and the gas that is introduced through the valve is arranged in a region of the valve (Huddart – Fig. 3 space between #41, 42, 43 is in a region of #44).
Allowable Subject Matter
Claim(s) 20-27 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 20, the prior art fails to teach or suggest the first blower and the second blower are connected to one another via their outlet ports while also meeting the requirement of claim 19 that the first blower and the second blower are part of a gas module for ventilation of a living being, and where the first blower has an opposite delivery direction to the second blower.
The prior art includes various teachings of two blowers operating in opposite delivery directions, to include: Sugiura et al. – U.S. Patent 6209540, Fig 1; Hansen – U.S. Pub. 2003/0015200, Fig. 2; Be’eri – U.S. Pub. 2007/0199566, Fig. 1C; Connor – U.S. Pub. 2012/0234232, Figs. 8-9; McDaniel – U.S. Pub. 2014/0116441, Fig. 2; Tiemann et al. – U.S. Pub. 2019/0269966, Fig. 1; Trivikram – U.S. Pub. 2019/0298947, Figs. 12-13; Fischer – DE 10 2018 100 473 B4, Figs. 1-2; Trivikram – U.S. Pub. 2021/0290876, Figs. 1-2; Sipes et al. – U.S. Pub. 2021/0308400, Fig. 1; Ruppell et al. – U.S. Pub. 2024/0058563, Fig. 7; and Rapoport et al. – U.S. Pub. 2024/0277966, Figs. 19-20.
However, the instant claim specifically requires a particular connection between the two blowers at their outlet ports. The term “connected” in the claim requires a direct physical interaction between the outlets of the first blower and the second blower. While the prior art includes teaching of a pair of blowers connected in series (e.g. Liu et al. – U.S. Pub. 2018/0200463, Figs. 2-4 & 7-10), such prior art only operates the pair of blowers in a same direction and not in the opposed directions required by claim 19.
The instant claim is thus found to define a particular connection between specifically oriented blowers (i.e. having opposite delivery directions) which is not found to have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing of the invention.
Regarding claim 21, the claim is found allowable over the prior art for the same general reasons discussed above in regard to claim 20.
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