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 Application No. (EP19209857.2) filed on the November 18, 2019.
Response to Amendment
This office action is responsive to the amendment filed on February 13, 2026. As directed by the amendment: claim 16, 28-23, and 25-29 has been amended, claims 17, 24, and 30 have been canceled, and claims 31-22 have been added. Thus, claims 16, 28-23, 25-29, and 31-21 are presently pending in the application.
Response to Arguments
Applicant argues on page 5 of the remarks that the objection made on claims. Previously, examiner suggests a few claim objections. Applicant response is persuasive, previous claim objections has been withdrawn.
Applicant argues on page 5 of the of the remarks that the 112(b)-rejection made on Claims 20, 24-30 and their dependences should be withdrawn. Applicant has amended the claims and response is persuasive; the previous 112(b)-rejection has been hereby withdrawn.
Applicant argues on page 5-6 of the of the remarks that the 112(d)-rejection made on Claims 24 and 30 and their dependences should be withdrawn. Applicant has canceled the claims so argument is moot.
Applicant argues on page 6-7 of the remarks that the 103-rejection of Fato et al. in view of Kaplan and Fabricius made on claims is improper. Examiner respectfully disagrees. In the 103 rejection, Examiner acknowledges FATO does not specifically teach, “the blister pack has non-numerical indicia which encode an individual, unique number that is associated with each dose”; however, Examiner then looks at KAPLAN to teach that there can be a blister strip (Fig. 13) that has non-numerical indicia (Fig. 13; 27) which encode an individual, unique number that is associated with each dose (para. 0049-0053). Examiner is not modifying the blister pack of KAPLAN to fit into FATO’s dry powder inhaler, but is stating that it would be obvious in modifying that the blister pack of FATO could have non-numerical indicia, which BRI could be anything that is not a number (e.g. colors, bars, letters, shapes, lights, lines, symbols), for the purpose of identification of specific information for the specific dose. Then, Examiner agrees that the new Modified FATO does not specifically teach that teach sensors are configured to read the non-numerical indicia and the monitor can determine the unique number of each dose. However, Examiner then looks at FABRICIUS to read on the limitation “sensors are configured to read the non-numerical indicia, the monitor can determine the unique number of each dose (para. 0224),” as it is known in the art that sensors are able to read certain indications for the purpose of allowing for the monitor to read the medication/dosage allowing for the monitor to better determine compliance/adherence.
Applicant’s arguments with respect to claim(s) 20, 21, 22-23, 27, 28 have been considered but are not persuasive as addressed above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 29 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, claim 16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 16, 18-20, 25-26, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fato et al. (US 20200171251 A1), hereafter as Fato, Kaplan et al. (US 20100300924 A1), hereafter as Kaplan, and Fabricius et al. (US 20050087473 A1), hereafter as Fabricius.
Regarding Claim 16, Fato discloses a system comprising a dry powder inhaler (Fig. 1A-3B; 100) and a monitor (Fig. 2A-3B; 110, 111), wherein the dry powder (see claim objection above) inhaler having a mouthpiece (Fig. 1A-3B; 104) and a housing (Fig. 1A-3B; 101) which contains a blister pack (para.0047), comprising a plurality of blisters (Examiner notes: the paragraph reads that various separate doses of the drug), wherein a blister, or group of blisters, provides a dose of powdered medicament for inhalation (para. 0047), wherein the inhaler is adapted for removably mounting the monitor (para. 0054; Fig. 3A), wherein the monitor comprises one or more sensors (Fig. 3A-3B; 112, 113; para. 0051), and a controller and memory which are configured to process and/or store information read by the sensors (para. 0047, 0051, 0067; “electronic circuitry”)
Fato does not disclose wherein the blister pack has non-numerical indicia which encode an individual, unique number that is associated with each dose.
However, Kaplan teaches a blister strip (Fig. 13) has non-numerical indicia (Fig. 13; 27) which encode an individual, unique number that is associated with each dose (para. 0049-0053).
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 blister pack of Fato to include non-numerical indicia which encode an individual, unique number that is associated with each dose as taught by Kaplan for the purpose of identification of specific information for the specific dose.
Modified Fato does not specifically teach sensors are configured to read the non-numerical indicia; the monitor can determine the unique number of each dose.
However, Fabricius teaches sensors are configured to read the non-numerical indicia, the monitor can determine the unique number of each dose (para. 0224).
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 modified Fato to include the sensors and a processor that is able to read non-numerical indica as taught by Fabricius for the purpose of allowing for the monitor to read the medication/dosage allowing for the monitor to better determine compliance/adherence (para. 0224).
Regarding Claim 18, Modified Fato discloses the system according to claim 16, wherein each dose of medicament is provided by a single blister (para. 0047; Fato) and wherein a non-numerical indicium (Fig. 13; 27; Kaplan) is associated with each blister.
Regarding Claim 19, Modified Fato discloses the system according to claim 16, wherein each dose of medicament is provided by a pair of blisters (para. 0047; Fato) and wherein a non-numerical indicium (Fig. 13; 27; Kaplan) is associated with each pair (para. 0053; Kaplan teaches that the nest and blister section can be a couple different blister sections 22).
Regarding Claim 25, Modified Fato discloses the system according to claim 16, wherein the monitor (Fig. 2A-3B; 110, 111) is configured to read the non-numerical indicia (Kaplan; Fig. 13; 27) as the blister pack is indexed (Fabricius, para.0224).
Regarding Claim 26, Modified Fato discloses the system according to claim 16, wherein the monitor (Fig. 2A-3B; 110, 111) has optical sensors for reading the non-numerical indicia (Kaplan; Fig. 13; 27) when the monitor is mounted on the inhaler (Fig. 1A-3B; 100) and wherein the indicia comprise three rows of printed blocks (Fabricius, para.0224).
Modified Fato does not specifically disclose three optical sensors.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add more sensors to the monitor to read the indicia that is bar code since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding Claim 29, Modified Fato discloses the system according to claim 16, wherein the monitor is removably attached to the inhaler (para. 0047).
Claim(s) 20 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fato, Kaplan, and Fabricius, as applied to claim 16 and 26, in further view of Doyle et al. (US 20120145586 A1), hereafter as Doyle
Regarding Claim 20, Modified Fato discloses the system according to claim 16,
Modified Fato does not specifically disclose wherein the indicia comprise three rows of printed blocks (Fig. 13; 27; Kaplan; Kaplan states the code/indicia could be any form of indication).
However, Doyle teaches wherein the non-numerical indicia comprise three rows of printed blocks (para. 0090; Fig. 26).
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 strip of Modified Fato to include the indicia comprise three rows of printed blocks as taught by Doyle for the purpose of aiding in automated packaging and/or dispensing (para. 0090).
Regarding Claim 31, Modified Fato discloses the system according to claim 20, wherein the non-numerical indicia is a 2D matrix code (para. 0090; Dolye).
Regarding Claim 32, Modified Fato discloses the system according to claim 26,
Modified Fato does not specifically teach wherein the non-numerical indicia is a 2D matrix code.
However, However, Doyle teaches wherein the non-numerical indicia is a 2D matrix code (para. 0090).
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 strip of Modified Fato to include the non-numerical indicia is a 2D matrix code as taught by Doyle for the purpose of aiding in automated packaging and/or dispensing (para. 0090).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fato, Kaplan, and Fabricius, as applied to claim 16, in further view of Gupta et al. (US 20190307975 A1), hereafter as Gupta.
Regarding Claim 21, Modified Fato discloses the system according to claim 16, wherein the blister pack (para.0047).
Modified Fato does not specifically teach the blister strip.
However, Gupta teaches a blister strip.
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 blister pack of Modified Fato to include the blister strip as taught by Gupta for the purpose of containing a number of discrete doses of powdered medicament and subsequent consumption for oral administration (para. 0004).
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fato, Kaplan, Fabricius, and Gupta, as applied to claim 21, in further view of Dudley et al. (US 20130206142 A1), hereafter as Dudley.
Regarding Claim 22, Modified Fato discloses the system according to claim 21,
Modified Fato does not disclose specifically wherein the inhaler further comprises a mouthpiece cover, wherein: in a first stage, moving the mouthpiece cover from a closed position to an intermediate position causes the blister strip to be advanced; in a second stage, moving the mouthpiece cover from the intermediate position to an open position causes a piercer to pierce one or more blisters.
However, Dudley teaches in a first stage, moving the cover from the closed position to an intermediate position causes a blister strip to be advanced (par 0057); in a second stage, moving the cover from the intermediate position to the open position causes a piercer to pierce an aligned blister (par 0057, 0023 discloses piercing the blister when the blister is in the piercing position).
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 Fato to include the a mouthpiece cover, in a first stage, moving the mouthpiece cover from a closed position to an intermediate position causes the blister strip to be advanced; in a second stage, moving the mouthpiece cover from the intermediate position to an open position causes a piercer to pierce one or more blisters as taught by Dudley so can help to ensure proper engagement as the cover may not be able to open if the monitor/accessory is not properly connected to the inhaler.
Regarding Claim 23, Modified Fato discloses the system according to claim 22,
Modified Fato does not disclose specifically wherein an inside of the mouthpiece cover has one or more cams for actuating one or more switches on the monitor as the cover is moved for determining the position and/or direction of motion of the cover.
However, Gupta further teaches wherein an inside of the mouthpiece cover has one or more cams (Fig. 15; 17/18; par 0323) for actuating one or more switches (Fig. 4; 2) on the housing for determining the position and/or direction of motion of the cover (Fig. 9a-93; para. 0323 discloses the cams activating the switch thus disclosing the cams operate the switch an providing information on the position/direction of motion of the cover, showing the cams operating the switch).
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 Modified Fato to include the cams and a switch as taught by Gupta for the purpose of the monitor can acquire information on the position/motion of the cover. It would have further been obvious to one of ordinary skill in the art to utilize/incorporate multiple switches so that further information regarding position/motion can be acquired.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fato, Kaplan, Fabricius, as applied to claim 16, in further view of Dudley and Gupta.
Regarding Claim 27, Modified Fato discloses the system according to claim 16, the inhaler is adapted for removably mounting the monitor (para. 0054; Fato)
Modified Fato does not disclose wherein the blister pack is a blister strip and, the inhaler further comprising a mouthpiece cover, wherein: - in a first stage, moving the mouthpiece cover from a closed position to an intermediate position causes the blister strip to be advanced; - in a second stage, moving the mouthpiece cover from the intermediate position to an open position causes a piercer to pierce one or more blisters.
However, Dudley teaches in a first stage, moving the cover from the closed position to an intermediate position causes a blister strip to be advanced (par 0057); in a second stage, moving the cover from the intermediate position to the open position causes a piercer to pierce an aligned blister (par 0057, 0023 discloses piercing the blister when the blister is in the piercing position).
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 Fato to include the a mouthpiece cover, in a first stage, moving the mouthpiece cover from a closed position to an intermediate position causes the blister strip to be advanced; in a second stage, moving the mouthpiece cover from the intermediate position to an open position causes a piercer to pierce one or more blisters as taught by Dudley so can help to ensure proper engagement as the cover may not be able to open if the monitor/accessory is not properly connected to the inhaler.
Modified Fato does not disclose wherein an inside of the mouthpiece cover has one or more cams for actuating one or more switches on an outer side of the monitor as the cover is moved for determining the position and/or direction of motion of the cover.
However, Gupta further teaches wherein an inside of the mouthpiece cover has one or more cams (Fig. 15; 17/18; par 0323) for actuating one or more switches (Fig. 4; 2) on the housing for determining the position and/or direction of motion of the cover (Fig. 9a-93; para. 0323 discloses the cams activating the switch thus disclosing the cams operate the switch an providing information on the position/direction of motion of the cover, showing the cams operating the switch).
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 Modified Fato to include the cams and a switch as taught by Gupta for the purpose of the monitor can acquire information on the position/motion of the cover. It would have further been obvious to one of ordinary skill in the art to utilize/incorporate multiple switches so that further information regarding position/motion can be acquired.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fato, Kaplan, Fabricius, as applied to Claim 16, in view of Morrison et al. (US 20170290527 A1) hereafter as Morrison.
Regarding Claim 28, Modified Fato discloses the system according to claim 16,
Modified Fato does not specifically disclose wherein the monitor has a pressure sensor for detecting inhalation on the mouthpiece when the monitor is mounted on the inhaler.
However, Morrison teaches a pressure sensor (9B-9C, 13; 912; para. 0170, 0179) on a monitor (Fig. 9A, 13; 910; para. 0179).
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 monitor of Modified Fato to include the pressure sensor as taught by Morrison for the purpose of compiling a compliance report (para. 0170, 0179).
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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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785