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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Foreign Priority (FR1900302) filed on January 14, 2019.
Response to Amendment
This office action is responsive to the amendment filed on February 17, 2026. As directed by the amendment: claims 1, 2, 5, 9, and 11-12 have been amended, claim 10 have been canceled, and no claims have been added. Thus, claims 1-9 and 11-12 are presently pending in the application.
Response to Arguments
Applicant argues on page 6-8 of the remarks that none of the cited references disclose or suggest “wherein the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice to allow maintaining a vertical orientation of the metered dose inhaler regardless of the inclination of the outlet orifice” in the new amended claims 1, 11, and 12. However, the applicant has amended the claims and new 103 rejections stated below addresses the new limitation of the claim.
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, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth et al. (US 20160030687 A1), hereafter known as Engelbreth, in view of Sladek (US 6014972 A).
Regarding Claim 1, Engelbreth discloses an inhalation chamber comprising
a body (housing 2; Figure 10-11; para 0062) having an inlet orifice (mouthpiece portion 20; Fig. 10-11; para. 0064) suitable for being connected to an outlet end piece of a metered dose inhaler (MDI actuator boot 96; Fig. 10; para. 0064),
an outlet orifice (inner ring-like housing component 460; Fig. 2; para. 0071) suitable for being connected to a mouthpiece or a mask (nasal mask 480; Fig. 2; para. 0071, 0075, 0084) configured to be applied-on a face of a patient(par. 0075, 0084; This limitation is functional), and
a sleeve (at 16; Fig. 10) extending between the inlet orifice and the outlet orifice (Fig. 10), wherein an axis of the inlet orifice is non-colinear with an axis of the outlet orifice (Fig 2, Fig 10-11: para. 0063; Examiner notes: inlet orifice is on a x axis and the outlet orifice is perpendicular on another axis; See Figure A below),
a handle comprising a support (MDI boot portal 18; Fig. 1-3; para. 0064) suitable for receiving the outlet end piece of the metered dose inhaler said support opening into the inlet orifice (Fig. 10).
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Figure A: Adapted Figure from Engelbreth
Engelbreth does not specifically disclose wherein the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice to allow maintaining a vertical orientation of the metered dose inhaler regardless of the inclination of the outlet orifice.
However, Sladek teaches a handle (Fig. 3C; 26) comprising a support suitable for receiving the outlet end piece of the metered dose inhaler (Fig. 3C; 12), said support opening into the inlet orifice (Fig. 3C; 30), wherein the handle is press fit into the sleeve (Col. 3 lns. 7-57) while being pivotally movable relative to the body around the axis of the inlet orifice to allow maintaining a vertical orientation of the metered dose inhaler regardless of the inclination of the outlet orifice (Examiner notes: this limitation is functional a person could hold the inhaler in position while the body could be moved making the handle being able to be “pivotally movable”, since the connection between the handle and inhaler is press fit (friction fit).).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Engelbreth to include the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice and is configured to hold and to manipulate the inhalation chamber with one hand and
Modified Engelbreth does not specifically disclose wherein the handle is press fit onto the sleeve.
However, Sladek discloses, a handle (Fig. 3C; 26) comprising a support suitable for receiving the outlet end piece of the metered dose inhaler (Fig. 3C; 12), said support opening into the inlet orifice (Fig. 3C; 30), wherein the handle is press fit into the sleeve (Col. 3 lns. 7-57) Examiner note that the connection using method of insertion requires one element to be male type and other element to be female type (Fig. 3C; Examiner interprets that in order to properly use the device of the connection pieces has to be inserted into the other) which appears that one of the ordinary skills in the art would have reasonable expectation when performing insertion method for connection between two parts.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Engelbreth to have that the handle is press fit onto the sleeve as the connection between the two parts in purpose of connecting accurately secure the mask conveniently and effectively (PG 4, lines 27-45).
Furthermore, the courts have held that rearrangement of parts requires only ordinary skill in the art and hence is considered a routine expedient. “In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950): Claims to the handle being press fit onto the sleeve which read on the prior art with regard that the position of the female connector being on the sleeve and the handle being the male connector is held unpatentable because changing how the connection is done would not have modified the operation of the device.” MPEP § 2144.04-VI-C.
Regarding Claim 2, Modified Engelbreth discloses the inhalation chamber of claim 1, wherein a pivot axis (plane 10; Fig. 13; para. 0063; Examiner notes: Fig 13 is shown to show the axis/plan; Engelbreth) of the handle (Fig. 3C; 26; Sladek) and the axis of the outlet orifice (axis 6; Fig. 13; para. 0063) are orthogonal (Fig 2, 10-11; Figure A above; para. 0063; Engelbreth).
Regarding Claim 5, Modified Engelbreth discloses the inhalation chamber of claim 1, wherein the support (Fig. 3C; 26; Sladek) comprises an elastomeric portion (Col. 3 lns. 25-37; Saldek) configured to ensure a leak tight connection between the end piece of the metered dose inhaler and the handle Fig. 3C; 26: Examiner notes: this limitation is functional, Sladek teaches that the elastomeric boot adapter is used for holding the MDI inhaler in good alignment and it fits snugly).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth and Sladek, as applied to claim 1, in view of Chiesi (US-5165391-A).
Regrading Claim 3, Modified Engelbreth discloses the inhalation chamber of claim 1,
Engelbreth does not disclose wherein the body comprises two dismantlable shells.
Chiesi teaches wherein the body (Fig. 1) comprises two dismantlable shells (shells 1,2; Fig. 1; Co. 3 lines 56 -Co1. 4 lines 45).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Modified Engelbreth to include the body (Fig. 1) comprises two dismantlable shells (shells 1,2; Fig. 1; Col. 3 lines 56 -Co1. 4 lines 45) as taught by Chiesi for the purpose of being able to take apart the two shells and join them together (Fig. 1; Col. 3 lines 56 -Co1. 4 lines 45).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth and Sladek, and Chiesi, as applied to claim 3, in view of Sladek II (US 6039042 A).
Regarding Claim 4, Modified Engelbreth discloses the inhalation chamber of claim 3,
Modified Engelbreth does not disclose wherein at least one of said shells is transparent.
However, Sladek II further teaches that one the pieces (mouthpiece 11, membrane housing 14; Fig. is transparent.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shells of Modified Engelbreth to include that one of them is transparent as taught by Sladek II for the purpose of the patient being able to easily see exactly what is happening inside (Col. 6 lines 4-10).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth and Sladek, as applied to claim 1, in view of Kobayashi (US 20090165789 A1).
Regarding Claim 6, Modified Engelbreth discloses the inhalation chamber of claim 1, Engelbreth does not disclose further comprising a sensor configured to detect the inclination of the metered dose inhaler.
Kobayashi teaches comprising a sensor (inclination sensor 44; Fig. 7; para. 0069). configured to detect the inclination of the metered dose inhaler (inhaler; Fig. 6-7; par. 0068-0069).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Engelbreth to include a sensor (inclination sensor 44; Fig. 7; para. 0069) configured to detect the inclination of the metered dose inhaler as taught by Kobayashi for the purpose of detecting an abnormal orientation of the inhaler (para. 0069).
Regarding Claim 7, Modified Engelbreth discloses the inhalation chamber of claim 6, Kobayashi further teaches the sensor (inclination sensor 44; Fig. 7; para. 0069)
configured to be coupled to a control unit (control substrate 40; Fig. 7; para. 0069) configured to compare the measured inclination with an acceptable inclination range and to emit a signal (display unit 34; Fig. 6; para. 0069) depending on the result of said comparison destined for a luminous indicator, an audible warning device and/or a vibrator (para. 0069; Examiner notes: Kobayashi teaches that the signal could be a sound, a vibration generated by a vibration motor, or illumination through an LED or the like).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Engelbreth to include the sensor (inclination sensor 44; Fig. 7; para. 0069) configured to be coupled to a control unit (control substrate 40; Fig. 7; para. 0069) configured to compare the measured inclination with an acceptable inclination range and to emit a signal (display unit 34; Fig. 6; para. 0069) depending on the result of said comparison destined for a luminous indicator, an audible warning device and/or a vibrator as taught by Kobayashi for the purpose of detecting an abnormal orientation of the inhaler and alerting the user (para. 0069).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth, Sladek, and Kobayashi, as applied to claim 7, in view of Kim et al. (WO 2008097645 A1), hereafter as Kim.
Regrading Claim 8, Modified Engelbreth discloses the inhalation chamber of claim 7, wherein the body (housing 2; Figure 10-11; para 0062; Engelbreth) comprises at least one luminous indicator (display unit 34; Fig. 6; para. 0069; Kobayashi)
Modified Kobayasi does not specifically disclose that the indicator configured to light up differently depending on said comparison.
However, Kim teaches a indicator (indicator light 962, 964; Fig. 23; para. 00112-00113) that is configured to light up differently depending on said comparison of acceptable range (para. 00113).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device with inclination luminous indicators of Modified Engelbreth to include as (indicator light 962, 964; Fig. 23; para. 00112-00113) that is configured to light up differently depending on said comparison of acceptable range (para. 00113) taught by Kim for the purpose of provide a visual indication of this condition (para. 000120).
Regrading Claim 9, Modified Engelbreth discloses the inhalation chamber according to of claim 8, wherein the body (housing 2; Figure 10-11; para 0062; Engelbreth) the control unit (control substrate 40; Fig. 7; para. 0069; Kobayashi) being configured to command the lighting up of one of said indicators (display unit 34; Fig. 6; para. 0069; Kobayashi; indicator light 962, 964; Fig. 23; para. 00112-00113; Kim) along the direction of rotation to apply to the support to incline the metered dose inhaler according to the acceptable inclination range (Examiner notes: Kobayashi teaches that the inclination sensor detects any abnormality in the inhaler posture) .
Modified Engelbreth does not discloses the body further comprises two arrow shaped luminous indicators arranged on either side of the support to indicate two opposite directions of rotation of said support.
However, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative shape of the claimed indicators being two arrow shaped luminous indicators, and a device having the claimed relative shape would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. [MPEP 2144.04, I. Aesthetic Design Changes].
It would have been obvious as to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the enclosure of Modified Engelbreth to have the enclosure arrow indicators arranged on either side of the support. Applicant places no criticality on one particular shape of the arrows of the enclosure (pages 7-9 of applicant' s specification indicate the claimed shape has no significance over another is present). Modifying the Modified Engelbreth to have the claimed shape would not have adverse effects on the performance of the device and thus the changing dimensions would not destroy the device. The courts have held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of 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”. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Modified Engelbreth does not specifically disclose that arrow indicators are arranged on either side of the support.
However, Modified Engelbreth does disclose indicators (display unit 34; Fig. 6; para. 0069; Kobayashi; indicator light 962, 964; Fig. 23; para. 00112-00113; Kim) located on the device (See Kim).
Due to an absence of the limitations of the indicators locations are arranged on either side of the support, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, one could place the indicators anywhere on the device as the indicators are used to light up or illuminates or flashes if the rate is outside an acceptable range. One would be motivated to place these indicators on either side of support to alert the user and provide a visual indication (para. 00113, 001120).
Claim(s) 11 are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth in view of Sladek and Sladek II.
Regarding Claim 11, Engelbreth discloses an inhalation chamber comprising:
a body (housing 2; Figure 10-11; para 0062) having an inlet orifice (mouthpiece portion 20; Fig. 10-11; para. 0064) suitable for being connected to an outlet end piece of a metered dose inhaler (MDI actuator boot 96; Fig. 10; para. 0064),
an outlet orifice (inner ring-like housing component 460; Fig. 2; para. 0071) suitable for being connected to a mouthpiece or a mask (nasal mask 480; Fig. 2; para. 0071, 0075, 0084) configured to be applied-on a face of a patient (para. 0075, 0084; This limitation is functional),
and a sleeve (at 16; Fig. 10) extending between the inlet orifice and the outlet orifice (Fig. 10), wherein an axis of the inlet orifice is non-colinear with an axis of the outlet orifice (Fig 2, Fig 10-11: para. 0063; Examiner notes: inlet orifice is on a x axis and the outlet orifice is perpendicular on another axis; See Figure A above), and
a handle comprising a support (MDI boot portal 18; Fig. 1-3; para. 0064) suitable for receiving the outlet end piece of the metered dose inhaler (Fig. 10), support opening into the inlet orifice (Fig. 10),
Engelbreth does not specifically disclose wherein the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice and is configured to hold and to manipulate the inhalation chamber with one hand and
However, Sladek teaches a handle (Fig. 3C; 26) comprising a support suitable for receiving the outlet end piece of the metered dose inhaler (Fig. 3C; 12), said support opening into the inlet orifice (Fig. 3C; 30), wherein the handle is press fit onto the sleeve (Col. 3 lns. 7-57) while being pivotally movable relative to the body around the axis of the inlet orifice to allow maintaining a vertical orientation of the metered dose inhaler regardless of the inclination of the outlet orifice (Examiner notes: this limitation is functional a person could hold inhaler in position while the body could be moved since the handle has elastomeric material making the handle being able to be “pivotally movable”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Engelbreth to include the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice and is configured to hold and to manipulate the inhalation chamber with one hand and
Modified Engelbreth does not teach and wherein the handle comprises a rigid material ensuring the connection with the body and an elastomeric material configured to ensure a connection between the support and the outlet end piece of the metered dose inhaler.
Sladek II teaches handle (main chamber 12 and elastomeric boot adapter 13; Fig. 1; Col. 3 line 21-Col. 4 line 29) comprise a rigid material (12) ensuring the connection with the body (11; Fig; Fig. 6; Col. 3 lines32-50, Col. 4 lines 31-54) an elastomeric portion (13) configured to ensure a connection between the end piece of the metered dose inhaler (mouthpiece 40A, inhaler 40; Fig. 1, 3; Col. 4 lines 1-29).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the support of Modified Engelbreth to include a rigid material ensuring the connection with the body and an elastomeric material configured to ensure a connection between the support and the outlet end piece of the metered dose inhaler as taught by Sladek II for the purpose of holding the MDI inhaler in good alignment and it fits snugly and also have a strong connection to the body (Col. 4 lines 1-29).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelbreth in view of Sladek and Chiesi.
Regarding Claim 12, Engelbreth discloses the inhalation chamber comprising:
a body (housing 2; Figure 10-11; para 0062) having an inlet orifice (mouthpiece portion 20; Fig. 10-11; para. 0064) suitable for being connected to an outlet end piece of a metered dose inhaler (MDI actuator boot 96; Fig. 10; para. 0064),
an outlet orifice (inner ring-like housing component 460; Fig. 2; para. 0071) suitable for being connected to a mouthpiece or a mask (nasal mask 480; Fig. 2; para. 0071, 0075, 0084) configured to be applied-on a face of a patient(par. 0075, 0084; This limitation is functional),
a sleeve (at 16; Fig. 10) extending between the inlet orifice and the outlet orifice (Fig. 10), wherein an axis of the inlet orifice is non-colinear with an axis of the outlet orifice (Fig 2, Fig 10-11: para. 0063; Examiner notes: inlet orifice is on a x axis and the outlet orifice is perpendicular on another axis; See Figure A above),
a handle comprising a support (MDI boot portal 18; Fig. 1-3; para. 0064) suitable for receiving the outlet end piece of the metered dose inhaler said support opening into the inlet orifice (Fig. 10).
Engelbreth does not specifically disclose wherein the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice and is configured to hold and to manipulate the inhalation chamber with one hand and allow maintaining a vertical orientation of the metered dose inhaler regardless of the inclination of the outlet orifice.
However, Sladek teaches a handle (Fig. 3C; 26) comprising a support suitable for receiving the outlet end piece of the metered dose inhaler (Fig. 3C; 12), said support opening into the inlet orifice (Fig. 3C; 30), wherein the handle is press fit onto the sleeve (Col. 3 lns. 7-57) while being pivotally movable relative to the body around the axis of the inlet orifice to allow maintaining a vertical orientation of the metered dose inhaler regardless of the inclination of the outlet orifice (Examiner notes: this limitation is functional a person could the inhaler in postion while the body could be moved making the handle being able to be “pivotally movable”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Engelbreth to include the handle is press fit onto the sleeve while being pivotally movable relative to the body around the axis of the inlet orifice and is configured to hold and to manipulate the inhalation chamber with one hand andinto the lower inlet of the connector thereby opening its valve automatically and allowing the aerosol drug to be introduced into the ventilator circui (Col. 3 lns. 25-37).
Modified Engelbreth does not teach wherein the body comprises two dismantlable shells assembled along a joint plane containing the axis of the inlet orifice around which the handle is configured to pivot.
Chiesi teaches wherein the body (Fig. 1) comprises two dismantlable shells (shells 1,2; Fig. 1; Co. 3 lines 56 -Co1. 4 lines 45) along a joint plane containing the axis of the inlet orifice (center plane 30; Fig. 2) around which the handle is configured to pivot (this limitation is functional).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Engelbreth to include the body (Fig. 1) comprises two dismantlable shells (shells 1,2; Fig. 1; Col. 3 lines 56 -Co1. 4 lines 45).
as taught by Chiesi for the purpose of being able to take apart the two shells and join them together (Fig. 1; Col. 3 lines 56 -Co1. 4 lines 45).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAAP AHMED ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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