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 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.
Regarding claim 36, claim 36 relies upon claim 35 which states that the one or more flow directors comprises two flow directors. However, claim 36 states “the one or more flow directors” so it is unclear if the two flow directors both are spaced apart from the nasal opening or if only one is spaced apart. The examiner will assume the two nasal directors are both spaced apart for examination purposes.
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 (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 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.
Claims 26-32, 34, 37-38, and 40-41 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Blaxland (US 2020/0206446), hereinafter Blaxland.
Regarding claim 26, Blaxland teaches a method (paragraph 18) comprising:
applying a patient interface apparatus to a patient (Paragraph 5, each chamber is fully enclosed and sealed against the patient’s face during use), the patient interface apparatus comprising:
a sealing mask forming a seal with a mouth and a nose of the patient (Paragraph 5, seals around the mouth and nose during use):
a first chamber in fluid communication with the mouth of the patient (Fig. 1: oral chamber 104);
a second chamber is fluid communication with the nose of the patient (Fig. 1: nasal chamber 102);
a dividing wall separating the first chamber from the second chamber (Fig. 5: 104a, paragraph 40, the top portion of oral chamber 104 provides a dividing wall from the nasal cavity);
one or more flow directors provided in or on the dividing wall that enable gas to flow into the second chamber from the first chamber (Fig. 5: element 106, paragraph 32, element 160 positioned between oral and nasal chambers);
a gas inlet fluidly connected to the first chamber (fig. 5: inflow tube 110); and
a gas outlet fluidly connected to the second chamber (Paragraph 34,Fig. 2: vent 122 is open to ambient and allows air to escape); and
providing a flow of gas to the patient through the patient interface apparatus (Paragraph 33, providing air through inflow tube 110) such that, during a portion of a breathing cycle of the patient in which the mouth of the patient is open (paragraph 36):
a first flow path is provided from the gas inlet of the patient interface apparatus, into the first chamber, into the mouth of the patient (Paragraph 36, allows air to flow freely into the patient’s mouth), out the nose of the patient into the second chamber (paragraph 36, out of the nose), and out the gas outlet of the patient interface apparatus; (paragraph 36 and out the vent)
a second flow path is provided from the gas inlet of the patient interface apparatus into the first chamber, through the one or more flow directors of the dividing wall, through the second chamber, and out the gas outlet of the patient interface apparatus; (paragraph 38, Fig. 3: air fluid path 140 from tubing 110 to oral chamber 104, through element 106 into chamber 102 and out vent 122)and
wherein the one or more flow directors are configured to resist flow along the second flow path such that the first flow path provides flushing of anatomical dead space of the patient. (Paragraph 34, the element 106 is a restrictive element and would therefore act to provide flushing of the anatomical dead space in the same way as applicant’s interface. Paragraph 13, the bias flow reduces the amount of dead space)
Regarding 27, Blaxland teaches the method of claim 26, and further teaches wherein the first flow path and the second flow path are provided during or after exhalation of the patient while the mouth of the patient is open. (The flow path would be provided during or after exhalation while the mouth of the patient is open since the mask is applied to the patient during the breathing cycle)
Regarding claim 28, Blaxland teaches the method of claim 26, wherein the second flow path does not pass through the nose or the mouth of the patient. (Paragraph 38, the examiner notes if the patient’s mouth is closed the flow path would not go through the patient’s mouth)
Regarding claim 29, Blaxland teaches the method of claim 26, and further teaches wherein the one or more flow directors cause a pressure of the second chamber to be less than a pressure of the first chamber. (Paragraph 34, the restrictive element and vent operate in conjunction to maintain an air pressure within the nasal chamber lower than an air pressure in the oral chamber)
Regarding claim 30, Blaxland teaches the method of claim 29, and further teaches wherein the gas outlet further causes the pressure of the second chamber to be less than the pressure of the first chamber. (Paragraph 34, the restrictive element and vent operate in conjunction to maintain an air pressure within the nasal chamber lower than an air pressure in the oral chamber)
Regarding claim 31, Blaxland teaches the method of claim 26, and further teaches wherein the one or more flow directors extend from the dividing wall. (Fig. 2, Fig. 5, 106 extends from wall at top of oral chamber)
Regarding claim 32, Blaxland teaches the method of claim 26, and further teaches wherein each of the one or more flow directors comprises an opening with a cross-sectional area from 20 mm2 to 160mm2. (Paragraph 35, cross section area ranging between about 20 mm2 to 500 mm2)
Regarding claim 34, the method of claim 26, wherein the one or more flow directors provide a flow restriction along the second flow path (paragraph 34, provides a flow restriction between the oral and nasal cavities) sufficient to cause a portion of the flow of gas to flow along the first flow path to provide the anatomical dead space flushing. (paragraph 36, the pressure differential allows air to flow freely into the patient’s mouth)
Regarding claim 37, Blaxland teaches the method of claim 26, and further teaches wherein the one or more flow directors are configured to direct the flow of gas into nares of the patient. (paragraph 38 air flows into the oral chamber and then into the nasal chamber. The examiner notes that air may then flow into the nares of the patient)
Regarding claim 38, Blaxland teaches the method of claim 26, and further teaches wherein the one or more flow directors are configured to accelerate the flow of gas into nares of the patient. (Blaxland teaches flow directors of a similar design and cross sectional area as the instant application. Blaxland also teaches the flow directors restrict flow from a higher pressure cavity to a lower pressure cavity and so would accelerate flow. )
Regarding claim 40, Blaxland teaches the method of claim 26, and further teaches comprising providing the flow of gas to the patient through the patient interface apparatus such that, during a portion of the patient’s breathing cycle in which the mouth of the patient is closed:
the first flow path is blocked by the closed mouth of the patient, (if the patient’s mouth is closed flow would be blocked from flowing into the mouth which is the first flow path) and
the second flow path comprises passage through the inlet into the first chamber (paragraph 38, Fig. 3, from tube 110 into oral chamber), through the one or more flow directors (paragraph 38, Fig. 3, through flow director 106), whereby the one or more flow directors direct and/or accelerate the flow of gas into nares of the patient (paragraph 38, directs flow into nasal chamber 102 and could be breathed in through nasal opening in nasal chamber 102), out through nares of the patient into the second chamber, and out through the gas outlet. (air exhaled by the nares of the patient back into the chamber 102 would then leave through the gas outlet 122)
Regarding claim 41, Blaxland teaches the method of claim 26, wherein the gas outlet comprises a bias vent. (Fig. 5: 122, paragraphs 13 and 14 bias flow, paragraph 6, a constant flow of air is provided to the nasal chamber by providing a vent)
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 33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over
Regarding claim 33, Blaxland teaches the method of claim 26, and further teaches the flow directors have an opening (Fig. 5) but does not teach wherein each of the one or more flow directors comprises a velocity of the flow of gas through the opening is from 1m/s to 40 m/s.
However, it would have been obvious to one having ordinary skill in the art prior to the filing date of the invention to modify the device of Blaxland so that the flow directors have a velocity through the opening of 1m/s to 40m/s as claimed since it has been held that “where the only difference between the prior art and the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Further the examiner notes the instant applications states the velocity may vary with the gas pressure of the device (paragraph 811) and since the prior art device has a similar cross-sectional area and would be expected to perform similarly under the same gas pressures.
Further Applicant places no criticality on the claimed range merely stating it is between 1 and 40 m/s.
Regarding claim 35, Blaxland teaches the method of claim 26, but does not teach wherein the one or more flow directors comprise two flow directors.
However, the courts have held the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In the instant application, it appears that the second flow director would merely provide the expected result of a second opening into the nasal chamber.
Regarding claim 36, Blaxland teaches the method of claim 35, but it is unclear from the drawing whether a distal end of the one or more flow directors is spaced apart from a nasal opening of the patient.
Blaxland teaches the claimed method but is silent as to one or more flow directors spaced apart from a nasal opening. However, there are only two possible positions for the flow directors. The flow directors may be spaced apart from the nasal opening or directly connected to the nasal opening. Therefore, it would have been obvious to try, by a person of ordinary skill int the art, to place the flow directors spaced apart from the nasal opening of the patient since there are a finite number of identified, predictable potential solutions that one of ordinary skill in the art could have pursued with a reasonable expectation of success. Further, the examiner notes that, per paragraph 38, when air passes through 106 into the nasal chamber a portion is able to pass directly out of the vent so it would have been obvious to space apart the flow directors so a portion of the flow could always pass through the vents.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Blaxland in view of Duquette et al (US 2009/0165799), hereinafter Duquette.
Regarding claim 39, Blaxland teaches the method of claim 38, but does not teach wherein the flow directors each comprise a body that has a cross-sectional area that reduces from an inlet of the flow director to an outlet of the flow director.
However, Blaxland teaches that the flow director pressure drop depends on the length, the cross-sectional area, and the surface area roughness and that these aspects may vary as desired. (paragraph 34). Blaxland teaches the element 106 may have any size or shape as desired.
Duquette teaches a CPAP device (Abstract, Fig. 4) which has flow directors with a body that has a cross-sectional area that reduces from an inlet of the flow director to an outlet of the flow director. (Fig. 4:38, paragraph 27)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Blaxland so that the cross-sectional area reduces from an inlet of the flow director to an outlet of the flow director in order to direct air to the nasal area.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Blaxland in view of Stenzler et al (US 2007/0267017), hereinafter Stenzler.
Regarding claim 42, Blaxland teaches the method of claim 26, but does not teach wherein the gas outlet is configured to connect to an expiratory limb.
However, Stenzler teaches a breathing assistance apparatus wherein the gas outlet is configured to connect to an expiratory limb. (Paragraph 7, a conduit carries the expiratory gases, paragraph 55, the expiratory gases can be expelled through a valve in the mask or a further expiratory conduit).
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have substituted the outlet of Blaxland with the expiratory conduit of Stenzler since either option would provide the predictable result of allowing expiratory gases to be expelled.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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