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
Claims 6 -8 are objected to because of the following informalities:
Regarding claim 6:
In line 4 add –outer-- before “housing”
In line 4, change “one of the parts” to –one of the two parts—
In line 5, Add –outer—before housing
In line 7, Add – outer—before housing
In line 9, change “the exterior” to – an exterior—
In line 9, change “the interior” to – an interior—
Regarding claim 7:
Change “on one part and slots on the other part” to –on one of the two parts and slots on a second of the two parts--
Regarding claim 8:
“the outside of the HME” should be –the exterior of the HME—to maintain consistency with claim 6
“the inside of the outer housing” should be –the interior of the outer housing—to maintain consistency with claim 6
Appropriate correction is required.
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 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ritter, III et al (US 2015/0343164), hereinafter Ritter in view of Korneff et al (US 2009/0301476), hereinafter Korneff.
Regarding claim 6, Ritter teaches an HME device (figs. 1-3), characterized in that the device can be selectively set in an HME mode or a bypass mode (paragraph 17, upon insertion of a nebulizer the heat and moisture exchange element is isolated from the breathing circuit and upon removal of the nebulizer, the heat and moisture exchange element is placed back into the circuit),
that the device includes an outer housing having at least two parts (Fig. 1: first part including 12,16, 18 and second part 20, paragraph 18, a heat and moisture exchanger sits in an enclosure 12 with ventilator port 16 and nebulizer port 18, cap 20 maintains the heat and moisture exchange element within the holder),
that one of the parts has an external port by which gas can flow through the housing (Figs. 2-3: 16, vent circuit communication port) and an internal port in selective flow communication with the external port (figs. 2-3: 44), paragraph 19, upper port 44 aligns with moisture exchange and is occluded when a nebulizer is attached)
that the device includes an HME unit arranged to be manually connected and disconnected with the internal port, (Paragraph 18, a heat and moisture exchange element 31 is inserted into the interior of housing 12, HME 31 can be connected and disconnected with port 44, see Figs. 4A, 4B, paragraph 19, HME 31 can be moved out of engagement with port 34 to occlude the HME and is thus manually connected and disconnected from the internal port)
that the exterior of the HME unit and the interior of the outer housing are configured to provide a bypass channel between them to enable gas flow through the device along the bypass channel when in the bypass mode, (Fig. 3: See arrows showing bypass flow along the exterior of HME unit housing 31 and the interior of housing 12 at port 18)
that the device includes a selector that in a bypass position selectively blocks gas flow through the internal port so that gas flow through the device bypasses the HME unit and flows instead along the bypass channel, (Fig. 3: when nebulizer is inserted the HME is raised and flow bypasses the HME unit and flows through bypass channel, paragraph 22) and
that the selector in an HME position enables flow through the device via the HME unit and blocks flow along the bypass channel. (See Fig. 2, paragraph 21, when no nebulizer is inserted the main spring urges HME to rest on the bottom and allows flow through the HME material 34)
Ritter does not teach that the two housing parts can be manually connected or disconnected from one another to enable access to the interior of the housing and that the two parts of the housing can be separated from one another to enable removal and replacement of the HME unit on the internal port.
However, Korneff teaches a heat and moisture exchange unit (16, Abstract, Fig. 1, Figs. 4A, 4B) with two housing parts that can be manually connected or disconnected from one another to enable access to the interior of the housing and that the two parts of the housing can be separated to enable removal and replacement of the HME. (Figs. 4A, 4B, paragraph 41, housing segments 76, 78 the housing segments can be separately formed and selectively assembled to one another. The examiner notes that replacement of HME in the housing would result in replacement of the HME on the internal port as claimed)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Ritter with the separable housing of Korneff so that the HME media can be readily accessed and replaced by removing the first housing segment from the second housing segment. (paragraph 41)
Regarding claim 10, Ritter in view of Korneff teaches an HME device according to claim 6, and Ritter further teaches characterized in that the selector includes a shutter plate (Figs. 2-3: side wall of HME housing 31) moveable in a plane at right angles to the axis of the device (See figs. 2-3: axis would run through the center of 14 so bottom of 31 moves at right angles to this axis) between a position where it covers an opening to the HME unit (Fig. 3: covers opening 44) and reveals a bypass opening (Fig. 3: reveals opening 46) to a position where it reveals the opening to the HME unit (Fig. 2: opening 44 open) and covers the bypass opening. (fig. 2: opening 46 covered)
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ritter, III et al (US 2015/0343164), hereinafter Ritter in view of Korneff et al (US 2009/0301476), hereinafter Korneff, further in view of Doherty et al (US 2008/00264413), hereinafter Doherty.
Regarding claim 7, Ritter in view of Korneff teaches an HME device according to claim 6, but does not teach characterized in that the two parts of the outer housing are connected with each other by bayonet lugs on one part and slots on the other part that are arranged to receive the lugs when the two parts are twisted relative to each other.
However, Doherty teaches connectors for connecting components in a breathing apparatus (Abstract) which teaches a bayonet fitting (paragraph 78) with two parts (Fig. 9a: parts 40 and 42) connected with each other by bayonet lugs on one part (Fig. 9a projections 47a, 47b, fig. 9b) and slots on the other part that are arranged to receive the lugs when the two parts are twisted relative to each other. (Fig. 9a, slots in component 42)
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 connection of Ritter in view of Korneff with the bayonet connection as taught by Doherty since the bayonet connection would have the predictable result of providing a secure connection between two components and further may be used in a situation where the connection of the components requires a particular alignment (paragraph 78)
Regarding claim 9, Ritter in view of Korneff teaches an HME device according to claim 6, but does not teach characterized in that the HME unit has a tapered coupling at one end removably fitted on a tapered fitting in one part of the outer housing.
However, Doherty teaches connectors for connecting components in a breathing apparatus (Abstract) which teaches a tapered coupling at one end removably fitted on a tapered fitting in one part of the outer housing. (paragraph 78, either or both components may be tapered or sloped to facilitate the insertion)
Therefore, it would have been obvious to a person or ordinary skill in the art prior to the filing date of the invention to have provided Ritter in view of Korneff with a tapered coupling at one end removably fitted on a tapered fitting in one part of the outer housing to facilitate the insertion. (paragraph 78)
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, the prior art does not teach a HME characterized in that the bypass channel is provided by an annular passage between the outside of the HME unit and the inside of the outer housing in combination with the features of claim 1. Additionally, a significant modification to the design of the Ritter device would be required to have the bypass channel provided by an annual passage outside of the HME unit as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Marler et al (US 2004/0123974) teaches an HME device with a bypass with an annular channel. However, Marler teaches the annular channel is the channel which goes through the HME media and not the bypass channel. (Fig. 3, Fig. 8)
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