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
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, “the patient” in line 1 should read –a patient—
In line 8 it appears that “to” following “the second air source” should be deleted
Appropriate correction is required.
Applicant is advised that should claim 7 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 10, 12, 13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 10 and 11, the limitation “flow through either or a viral filter governed by a tap that is configured to direct air from the free-breathing valve to at least one selected branch and viral filter” renders the claim indefinite because it is unclear what Applicant is attempting to claim. For examination purposes, the examiner will assume that the flow to the respective branches is controlled by a tap.
Claim 12 is rejected based on its dependency to claim 10. Further claim 12reads “to the or other alternate branches or viral filters” rendering it unclear. The claim should read –to the other alternate branch and filter”
Claim 13 is rejected because it depends upon itself. For examination purposes
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 1-3, 5, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Navalesi et al (EP 3 320 941), hereinafter Navalesi in view of Anderson et al (US 20019/0240435), hereinafter Anderson.
Regarding claim 1, Navalesi teaches a patient interface (Fig. 1) comprising:
a hood (Fig. 1: 10) comprising an interior (Fig. 1: interior of 11), the hood configured to fit over the patient's head so that the patient's head is located in the interior of the hood (Paragraph 131, an interior fluid volume enclosed by the container body 11 and by collar 12 where the patient’s head can be accommodated) and wherein the hood is configured to provide an enclosed breathing environment; (paragraph 3, paragraph 12, provides a closed environment)
an air inlet configured to communicate air from an air source (Fig. 1: 170, paragraph 156) to the hood interior; (Fig. 1: 17, paragraph 171, inlet duct 17)
an exhaust port configured to communicate air from the hood interior to an environment or enclosure external to the hood; (Fig. 1: outlet duct 18, paragraph 171)
a second inlet port (Fig. 1, 190, paragraph 105, paragraph 97) configured to communicate air from a second air source to (paragraph 91, second air source 30), the second inlet port being fluidly connected to a nasal delivery means located in the hood interior, (paragraph 97, See Fig. 1) the nasal delivery means configured to interface with a patient's nostrils and deliver the second air source to the patient's nose; (Fig. 1, connected to patient’s nose via conduit 21 to nasal prongs 22).
Navalesi does not explicitly state wherein the patient interface is configured so that the second inlet port receives a lower volume rate of air than the first inlet port and hood interior receives hence conserving the air supply required by the patient interface to meet a patient's oxygen requirements.
However, Navalesi teaches that the second inlet port receives between 1- 8 l/m at low flow.
Anderson teaches a breathing assistance system (abstract) and teaches that standard CPAP devices typically provide flow at 70 liters/minute for breathing at rest. (Paragraph 222)
Therefore, the combination of Navalesi and Anderson teaches wherein the patient interface is configured so that the second inlet port receives a lower volume rate of air than the first inlet port and hood interior receives hence conserving the air supply required by the patient interface to meet a patient's oxygen requirements.
It would have been obvious to a person of ordinary skill in the art to have provided the device with a second inlet port receiving second inlet volume rate lower than the first inlet port so that the patient receives the correct volume of air to provide CPAP.
Regarding claim 2, Navalesi in view of Anderson teaches the patient interface as claimed in claim 1 and Navalesi further teaches wherein the nasal delivery means is a nasal cannula. (Fig. 1: 22)
Regarding claim 3, Navalesi in view of Anderson teaches the patient interface as claimed in claim 1 and Navalesi further teaches wherein the second inlet port receives oxygenated air(Paragraph 92, the second breathable gas is a mixture of air) and the first inlet port receives ambient non-oxygenated air. (Paragraph 60, air)
Regarding claim 5, Navalesi in view of Anderson and Navalesi teaches the patient interface as claimed in claim 1 and Navalesi further teaches wherein the free-breathing valve is separate to the exhaust port. (Fig. 1, paragraph 65, anti-suffocation valve is separate from outlet duct 18)
Regarding claim 17, Navalesi in view of Anderson and Navalesi teaches a method of treatment of a patient requiring breathing assistance comprising: providing a patient interface as claimed in claim 1; (paragraphs 3-4)
fitting the patient interface to the patient;(paragraph 32, 156) providing an inlet air flow to the hood via the air inlet. (paragraph 27, paragraph 84, paragraph 172)
Regarding claim 18, Navalesi in view of Anderson teaches the patient interface of claim 1 and Navalesi teaches Use of a patient interface as claimed in claim 1 in providing breathing assistance to a patient in need thereof. (paragraphs 84, 172)
Claims 4, 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Navalesi in view of Anderson and further in view of Flynn, Sr. (US 2009/0260628), hereinafter Flynn.
Regarding claim 4, Navalesi in view of Anderson teaches the patient interface as claimed in claim 1 Navalesi further teaches wherein the patient interface further comprises at least one free-breathing valve (paragraph 65, Fig. 1: anti-suffocation valve 181) that is configured to automatically open to the environment or enclosure external to the hood in the event that the hood pressure falls below a pre-determined level; (paragraph 65) but does not teaches at least one viral filter located in series with the at least one free-breathing valve and before the environment or enclosure external to the hood.
However, Flynn teaches a face mask wherein at least one viral filter is located in series with the at least one free-breathing valve and before the environment or enclosure external to the mask. (Figs. 2-3, paragraph 67, anti-asphyxia valve is associated with exhalation port 265 , paragraph 66, filter 270 to filter air passing to ambient, paragraph 3, it may be necessary to filter air being exhaled by the patient if the patient has a medical condition which may result in a virus being exhaled)
It would have been obvious to a person of ordinary skill to include a viral filter in the patient interface of Navalesi in view of Anderson to prevent a virus being exhaled and infecting a nearby person. (paragraph 3)
Regarding claim 6, Navalesi in view of Anderson the patient interface as claimed in claim 1 but does not teach wherein the free-breathing valve is integral to the exhaust port.
However, Flynn teaches a face mask wherein at least one viral filter is located in series with the at least one free-breathing valve is integral to the exhaust port. (Figs. 2-3, paragraph 67, anti-asphyxia valve is associated with exhalation port 265
It would have been obvious to a person of ordinary skill in the art to have modified Navalesi in view of Anderson so that the free-breathing valve was integral to the exhaust port to allow for a single exhaust outlet port.
Regarding claim 8, Navalesi in view of Anderson the patient interface as claimed in claim 1 and Navalesi further teaches comprising:
at least one free-breathing valve separate to the exhaust port that is configured to automatically open to the environment or enclosure external to the hood in the event that the hood pressure falls below a pre-determined level; (paragraph 65, Fig. 1: anti-suffocation valve 181)
Navalesi does not teach integral to the at least one free breathing valve is at least one viral filter located in series with the at least one free-breathing valve and before the environment or enclosure external to the hood.
However, Flynn teaches a face mask (Fig. 3) wherein at least one viral filter is located in series with at least one free breathing valve and before the environment or enclosure external to the mask. (Fig. 3, paragraph 67)
It would have been obvious to add a viral filter to the free-breathing valve of Navalesi as taught by Flynn in order to filter incoming air into the hood.
Regarding claim 9, Navalesi in view of Anderson the patient interface as claimed in claim 1 further comprising:
Navalesi teaches at least one free-breathing valve integral to the exhaust port that is configured to automatically open to the environment or enclosure external to the hood in the event that the hood pressure falls below a pre-determined level; (paragraph 65) and
However, Flynn teaches a face mask wherein a free breathing valve is integral to the exhaust port, at least one viral filter is located in series with the at least one free-breathing valve and before the environment or enclosure external to the mask. (Figs. 2-3, paragraph 67, anti-asphyxia valve is associated with exhalation port 265 , paragraph 66, filter 270 to filter air passing to ambient, paragraph 3, it may be necessary to filter air being exhaled by the patient if the patient has a medical condition which may result in a virus being exhaled)
It would have been obvious to a person of ordinary skill to include a viral filter in the patient interface of Navalesi in view of Anderson to prevent a virus being exhaled and infecting a nearby person. (paragraph 3)
Claims 7, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Navalesi in view of Anderson and further in view of Patil et al (US 2018/0311517), hereinafter Patil.
Regarding claim 7, Navalesi in view of Anderson the patient interface as claimed in claim 1, but do not teach a pressure sensor.
However, Patil teaches a smart respiratory face mask module wherein the patient interface further comprises a pressure sensor (Paragraphs 7, 28, electronics module including a pressure sensor mounted on the interior of the face mask) wherein the pressure sensor is fully contained within the hood interior and wherein the pressure sensor measures absolute pressure inside the hood. (paragraph 28, paragraph 33, paragraph 42)
It would have been obvious to a person of ordinary skill in the art to include a pressure sensor in the interior of the hood as taught by Patil in order to determine the pressure of the interior of the mask and to indicate if the hood properly fits. (paragraph 5)
Regarding claim 14, Navalesi in view of Anderson the patient interface as claimed in claim 1 further comprising:
a pressure sensor (Paragraphs 7, 28, electronics module including a pressure sensor mounted on the interior of the face mask) wherein the pressure sensor is fully contained within the hood interior and wherein the pressure sensor measures absolute pressure inside the hood. (paragraph 28, paragraph 33, paragraph 42)
It would have been obvious to a person of ordinary skill in the art to include a pressure sensor in the interior of the hood as taught by Patil in order to determine the pressure of the interior of the mask and to indicate if the hood properly fits. (paragraph 5)
Regarding claim 15, Navalesi in view of Anderson and Patil teaches the patient interface as claimed in claim 14 and Patil further teaches wherein the pressure sensor is not in fluid communication with the environment or enclosure external to the hood. (paragraph 28, located on the interior of the mask)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Navalesi in view of Anderson and further in view of Patil et al (US 2018/0311517), hereinafter Patil, and further in view of Flynn, Sr. (US 2009/0260628), hereinafter Flynn.
Regarding claim 16, Navalesi in view of Anderson the patient interface as claimed in claim 14 Navalesi teaches wherein the patient interface further comprises at least one free-breathing valve that is configured to automatically open to the environment or enclosure external to the hood in the event that the hood pressure falls below a pre-determined level; (Fig. 1, paragraph 65, anti-suffocation valve 181) and
However, Flynn teaches a face mask wherein at least one viral filter is located in series with the at least one free-breathing valve and before the environment or enclosure external to the mask. (Figs. 2-3, paragraph 67, anti-asphyxia valve is associated with exhalation port 265 , paragraph 66, filter 270 to filter air passing to ambient, paragraph 3, it may be necessary to filter air being exhaled by the patient if the patient has a medical condition which may result in a virus being exhaled)
It would have been obvious to a person of ordinary skill to include a viral filter in the patient interface of Navalesi in view of Anderson to prevent a virus being exhaled and infecting a nearby person. (paragraph 3)
Allowable Subject Matter
Claims 10-13 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Regarding claims 10-13, the prior art does not teach wherein the free-breathing valve is integral to two or more viral filters, each viral filter located on a separate branch and each branch extending from a point after the free-breathing valve, flow through either or a viral filter governed by a tap that is configured to direct air from the free-breathing valve to at least one selected branch and viral filter.
Regarding claim 13, the examiner has assumed that claim 13 depends upon claim 10 and includes all the limitations of claim 10.
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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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785