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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-14, 17-18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13 of U.S. Patent No. 12029844 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-11 and 13 of ‘844 are more specific than claims 2-14 and 17-18.
Claims 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12029844 B2 in view of Armstrong et al. (US 5,031,610)
While the claims are not identical, Armstrong teaches it is known to use a cover (80) which comprises at least one shutter (80) comprising a lever portion (78) and a cover portion (cover portion of 80 as shown in figure 1) configure to cover the second end of the interior flow pathway (Burnett’s cover is over the entire mouthpiece and thus as modified by Armstrong, the cover 80 also covers the entire mouthpiece and thus the second end of the interior flow pathway).
It would have been obvious to have modified Burnett to include at least one cover which comprises at least one shutter comprising a lever portion and a cover portion configured to cover the second end of the interior flow pathway so that the cover could be reusable.
Claims 19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12029844 B2 in view of Burnett (WO 2021/194880 A1).
While the claims are not identical Burnett teaches at least one processor [0105] configured to estimate one or more physiological parameters of a user based on measurements from the device [0109]-[0110] and a processor [0105] configured to begin taking measurements in response to the flow rate sensor detecting air flow [0234] (measurements of flow are taken once flow rate is sensed).
It would be obvious to include the processor as claimed in order to take measurements and obtain information related to the patient.
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 21 is 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.
Claim 21 recites “the flow rate sensor”. It is unclear which flow rate sensor applicant is referring to.
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.
Claim(s) 2-15 and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (WO 2021/194880 A1) in view of Abrams et al. (US 2003/0041859 A1).
Regarding claim 2, Burnett discloses: A spirometer-inhaler device (202) comprising:
a first portion (left side of figure 2);
a second portion (right side of figure 2; 206) extending from the first portion, the second portion comprising a mouthpiece [0104], wherein the mouthpiece comprises an opening (at right side of figure 2) and a plurality of flow rate sensors (222, 224) [0101];
a first flow path (212) configured to direct medication from the medicine canister to the opening of the mouthpiece (see figure 2), and
a second flow path (210) configured to direct exhaled air from the opening of the mouthpiece to one or more flow rate measurement devices (224), wherein the second flow path comprises a second flow rate sensor [0101], the second flow rate sensor configured to measure flow rate of exhaled air [0101].
Burnett does not explicitly disclose the first portion configured to removably receive a medicine canister, but does state that the device may be used with a medicine canister [0160]. Burnett does not explain how the inhaler would be connected however, one of ordinary skill in the art would understand the inhaler would have to be connected to the left end of figure 2. There are only two options for where the inhaler would connect. 1. The inhalation flow path 212 opening on the left end or 2. The entire opening at the left end. Therefore the examiner takes the position that it would be "Obvious to try" connecting the inhaler to the inhalation flow path on the left end of figure 2 as this is simply choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Further, Burnett does not explicitly disclose that wherein the first flow path comprises a first flow rate sensor configured to measure flow rate of inhaled air.
However, Burnett states that embodiments with an inhaler include a feature to track usage of the airway device and/or inhaler to monitor use compliance [0160].
Abrams teaches an adapter (4) for an inhaler (abstract) which monitors compliance by placing a first flow rate sensor configured to measure flow rate of inhaled air in the inhalation path (similar to first flow path of Burnett) (claim 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burnett to include a first flow rate sensor as claimed in order to track compliance and ensure the patient is using the inhaler properly [0034].
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Regarding claim 3, Burnett as modified does not explicitly disclose wherein the first flow rate sensor comprises a first propeller.
However, in another embodiment of Burnett (figure 32), Burnett teaches it is known to monitor flow rate via a first propellor (3210; [0240]).
It would have been obvious to one having ordinary skill in the art to have modified Burnett such that the first flow rate sensor comprises a first propeller as taught by Burnett as this is a known type of flow rate sensor.
Regarding claims 4-5, Burnett as modified further discloses the first propeller is configured to spin in response to a negative flow rate within the mouthpiece, wherein the negative flow rate is created within the mouthpiece by a user inhaling from the opening of the mouthpiece during use (the examiner notes that propellers spin in response to a flow rate in the flow path they are in and therefore the examiner takes the position that the first propeller is configured in response to a negative flow rate within the mouthpiece; see also [0240] of Burnett which explains pinwheel/propeller 3210 sensing air flow). The examiner also notes: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The examiner notes that the prior art teaches all the structural limitations of the claim.
Regarding claim 6, Burnett does not explicitly disclose wherein the second flow rate sensor (224) comprises a second propeller.
However, in another embodiment of Burnett (figure 32), Burnett teaches it is known to monitor flow rate via a second propellor (3210; [0240]).
It would have been obvious to one having ordinary skill in the art to have modified Burnett such that the second flow rate sensor comprises a second propeller as taught by Burnett as this is a known type of flow rate sensor.
Regarding claim 7, Burnett further discloses wherein the first portion (as set forth above in claim 2) a central cavity configured to removably receive the medicine canister (left opening in 212 as set forth in claim 2 above)(see figures 1-3 of Abrams).
Regarding claim 8, Burnett further discloses wherein the first portion (as set forth above in claim 2) comprises a one way valve (218) configured to removably connect (fluidly connect) to the medicine canister and to direct medication from the medicine canister to the opening of the mouthpiece [0100].
Regarding claim 9, Burnett further discloses wherein the first flow path (212) comprises the one way valve (218) and the opening of the mouthpiece (figure 2).
Regarding claim 10, Burnett further discloses wherein the one way valve (218) is configured to form a seal with the medicine canister (a fluid seal), the seal configured to prevent exhaled air from entering the first flow path [0100].
Regarding claim 11, Burnett further discloses wherein the one way valve (218) is configured to deliver the medication from the medicine canister to the opening of the mouthpiece via the first flow path (see figure 2; 218 is in the inhalation flow path 212 and thus is configured to deliver medication to the opening of the mouthpiece via 212).
Regarding claim 12, Burnett further discloses wherein the first portion comprises an internal gap (gap within flow path 212) configured to direct medication from the medicine canister to the opening of the mouthpiece (the internal gap within 212 is configured to direct medication to the opening of the mouthpiece; see figure 2).
Regarding claim 13, Burnett further discloses further comprising an interior flow pathway (through 210) with a first end and a second end (left and right ends of 210), wherein the second flow pathway (210) comprises the interior flow pathway and the opening of the mouthpiece (see figure 2).
Regarding claim 14, Burnett further discloses wherein the first end (right side of 210) of the interior flow pathway is located adjacent the opening of the mouthpiece (see figure 2), wherein the second end (left end) of the interior flow pathway is located on a side portion of the first portion (see figure 2 which shows 210 on the side of 212).
Regarding claim 15, Burnett further discloses wherein the second flow path further comprises at least one cover (a single use barrier as per [0104]).
Regarding claim 18, Burnett further discloses wherein the second end (left end of 210) of the interior flow pathway is configured to removably connect to the one or more flow rate measurement devices (mouthpiece is removable as per [0104] and thus the left end of 210 is configured to be removably connected to the one or more flow rate measurement devices 224 located on the mouthpiece; see figure 2).
Regarding claim 19, Burnett further discloses at least one processor [0105] configured to estimate one or more physiological parameters of a user based on measurements from the device [0109]-[0110].
Regarding claim 20, Burnett further discloses wherein the first flow rate sensor is positioned adjacent the opening of the mouthpiece. Abrams teaches an adapter (see figure 1; 4) adjacent the opening of the mouthpiece with a flow sensor as set forth above for claim 2. Thus, it follows that the flow sensor is also adjacent the mouthpiece.
Regarding claim 21, Burnett further discloses a processor [0105] configured to begin taking measurements in response to the flow rate sensor detecting air flow [0234] (measurements of flow are taken once flow rate is sensed).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (WO 2021/194880 A1) in view of Abrams et al. (US 2003/0041859 A1) in further view of Armstrong et al. (US 5,031,610)
Regarding claim 16, Burnett as modified discloses the claimed invention as set forth in claim 15. Burnett discloses a one time barrier cover [0104] and therefore does not disclose wherein the at least one cover comprises at least one shutter comprising a lever portion and a cover portion configured to cover the second end of the interior flow pathway.
However, Armstrong teaches it is known to use a cover (80) which comprises at least one shutter (80) comprising a lever portion (78) and a cover portion (cover portion of 80 as shown in figure 1) configure to cover the second end of the interior flow pathway (Burnett’s cover is over the entire mouthpiece and thus as modified by Armstrong, the cover 80 also covers the entire mouthpiece and thus the second end of the interior flow pathway).
It would have been obvious to have modified Burnett to include at least one cover which comprises at least one shutter comprising a lever portion and a cover portion configured to cover the second end of the interior flow pathway so that the cover could be reusable.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burnett (WO 2021/194880 A1) in view of Abrams et al. (US 2003/0041859 A1) in further view of コルトヴスキー，ルーカス (JP 2020/500049 A), hereinafter JP.
Regarding claim 17, Burnett as modified discloses the claimed device of claim 13 but does not explicitly disclose wherein the interior flow pathway comprises a plurality of interior ribs configured to guide the second flow path from the opening of the mouthpiece to the second end of the plurality of interior ribs.
However, JP discloses it is known to provide ribs (8.3) in a flow path (5) to prevent or limit noise. (page 12, paragraph 5)
Therefore, it would have been obvious to have modified Burnett to include wherein the interior flow pathway comprises a plurality of interior ribs configured to guide the second flow path from the opening of the mouthpiece to the second end of the plurality of interior ribs as taught by JP for the benefit of reducing noise. (page 12, paragraph 5)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm CT.
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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