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 .
Response to Amendment
This office action is responsive to the amendment filed as July 27, 2026. As directed by the amendment: claims 1, 7, 13, and 14 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-18 are presently pending in the application.
Response to Arguments
Applicant argues on page 5 of the remarks that the objection made on claims should be withdrawn. Applicant’s response is persuasive, previous claim objections are hereby withdrawn
Applicant argues on page 5-8 of the remarks that the 103 rejections should be withdrawn. However, Applicant amended the claim to add new limitation from claim 1 “wherein the distal end is convex and wherein the convex distal end compensates for variation in the position of the blister strip which can occur as the unused portion of the blister strip decreases in size as the dry powder inhaler is used,” that was not previously considered. Applicant has amended the claims and a new 103 rejection stated below addresses the new limitation of the claim.
Applicant’s arguments with respect to claim(s) dependent from the independent claim have been considered but are not persuasive.
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) 1-14 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pocreva III et al. (US 20190175847 A1), hereafter as Pocreva III, in view of Fato et al. (US 20200171251 A1), hereafter as Fato and Sutherland et al. (US 20170173279 A1), hereafter as Sutherland.
Regarding Claim 1, Pocreva III discloses a monitor (Fig. 3-5; 24; para. 0061, 0064) which is attachable (para. 0061; 25, 25’) to a dry powder inhaler (Fig.1-2; 14; para. 0059-0060) that contains cartridge (para. 0005, 0013, 0015) and a plurality of non-numerical indicia (para. 0013, 0028; Examiner notes: Pocreva III teaches type identifiers, such as color, laser etchings, printed numbers; printed words to be recognizable by a sensory beam including a laser beam, RFID, optical recognition, image sensors and the like, the sensory beam can detect identifier codes integrally configured with the cartridge for detecting colors on the cartridges), the monitor comprising at least one optical sensor (para. 0070, 0077; Fig. 16) which is configured to read the non-numerical indicia (this limitation is functional; however, the prior art teaches these sensors are able to read the different indicia; 0028, 0070, 0077).
Pocreva III does not specifically teach a blister strip having a plurality of blisters.
However, Fato teaches that dry powder inhalers can have blister strip having a plurality of blisters (para. 0047; paragraph reads that various separate doses of the drug).
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 inhaler of Pocreva III to include the specifically a blister strip having a plurality of blisters as taught by Fato for the purpose of the predisposition of a dose of drug for subsequent administration through the inhalation (para. 0047).
Modified Pocreva III does not specifically teach that the optical sensor has a light guide having a proximal end adjacent to the sensor and a distal end remote from the sensor, wherein the distal end is convex and wherein the convex distal end compensates for variation in the position of the blister strip which can occur as the unused portion of the blister strip decreases in size as the dry powder inhaler is used but teaches that sensors can be provided, for example, in an air conduit on or within the inhaler or provided as a separate, detachable part as an accessory to the inhaler with a shape or configuration that can be adapted to the inhaler to which is to be adapted (para. 0085).
Sutherland does teach that the optical sensor (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122 ) has a light guide having a proximal end adjacent to the sensor (at the end of the sensors) and a distal end remote from the sensor (where 23 and 25; 1243 and 125 come out of), wherein the distal end is convex (Fig. 4 or Fig. 7B) .
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 optical sensor of Modified Pocreva III to be the optical sensor that has a light guide having a proximal end adjacent to the sensor and a distal end remote from the sensor, wherein the distal end is convex as taught by Sutherland because this shape is particularly useful for guiding radiation and for receiving and/or detecting the reflected beam (para. 0197, 0053).
Modified Pocreva does not disclose wherein the convex distal end compensates for variation in the position of the blister strip which can occur as the unused portion of the blister strip decreases in size as the dry powder inhaler is used (examiner notes: this limitation is saying “can” occur meaning it encompasses both options of both it occurring and also when it do not or “can not” occur ) .
However, Modified Pocreva teaches a optical sensor with a distal convex end on a monitor that fits into inhaler.
Therefore, due to an absence of any teaching or disclosure in the prior art that the distal convex end compensates for variation in the position of the blister strip which can occur as the unused portion of the blister strip decreases in size as the dry powder inhaler is used, 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 would understand that as the dry powder is being used that necessarily the diameter of the blister in size and the optical sensor would compensates as the blister strip is being register.
Regarding Claim 2, Modified Pocreva III discloses the monitor according to claim 1, wherein the light guide (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland) has a generally trapezoidal cross-section (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland; the shape “generally” is trapezoidal; para. 0053), apart from the convex distal end.
Regarding Claim 3, Modified Pocreva III discloses the monitor according to claim 2, the proximal end (at the end of the sensors; Sutherland; Fig. 4 or Fig. 7) and the width of the distal end (the lines 23, 25 and 123, 125 at the end of the sensor; Fig. 4 and Fig. 7; Sutherland).
Modified Pocreva III does not specifically teach the dimension of wherein the ratio of the width of the proximal end to the width of the distal end is from 4:3 to 3:1.
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 dimensions of the claimed device, wherein the ratio of the width of the proximal end to the width of the distal end is from 4:3 to 3:1, 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. [MPEP 2144.04, I. Aesthetic Design Changes].
Therefore, it would have been prima facie obvious to modify the device taught by Modified Pocreva III to incorporate the ratio dimension of the light guide to obtain the invention as specified in claim 3, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size for the purpose of the light guide being able to adapted to the inhaler to which is to be adapted and could fit for its purpose and thus fails to patentably distinguish over the prior art of the Modified Pocreva III.
Regarding Claim 4, Modified Pocreva III discloses the monitor according to claim 3z wherein the width of the proximal end (at the end of the sensors; Sutherland; Fig. 4 or Fig. 7) and the width of the distal end (the lines 23, 25 and 123, 125 at the end of the sensor; Fig. 4 and Fig. 7; Sutherland).
Modified Pocreva III does not specifically teach the dimension of wherein the width of the proximal end is from 2 to 3 mm and the width of the distal end is from 1 to 1.5 mm.
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 dimensions of the claimed device, wherein the width of the proximal end is from 2 to 3 mm and the width of the distal end is from 1 to 1.5 mm, 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. [MPEP 2144.04, I. Aesthetic Design Changes].
Therefore, it would have been prima facie obvious to modify the device taught by Modified Pocreva III to incorporate the width dimensions of the light guide to obtain the invention as specified in claim 4, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size for the purpose of the light guide being able to adapted to the inhaler to which is to be adapted and could fit for its purpose and thus fails to patentably distinguish over the prior art of the Modified Pocreva III.
Regarding Claim 5, Modified Pocreva III discloses the monitor according to claim 1, convex distal end (the lines 23, 25 and 123, 125 at the end of the sensor; Fig. 4 and Fig. 7; Sutherland).
Modified Pocreva III does not specifically teach wherein the convex distal end has a radius of curvature of from 2 to 5 mm.
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 dimensions of the claimed device, convex distal end has a radius of curvature of from 2 to 5 mm, 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. [MPEP 2144.04, I. Aesthetic Design Changes].
Therefore, it would have been prima facie obvious to modify the device taught by Modified Pocreva III to incorporate the dimension of the convex distal end to obtain the invention as specified in claim 5, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size for the purpose of the light guide being able to adapted to the inhaler to which is to be adapted and could fit for its purpose and thus fails to patentably distinguish over the prior art of the Modified Pocreva III.
Regarding Claim 6, Modified Pocreva III discloses the monitor according to claim 1, light guide (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland).
Modified Pocreva III does not specifically teach wherein the light guide has a height of from 2 to 3 mm.
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 dimensions of the claimed device, light guide has a height of from 2 to 3 mm, 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. [MPEP 2144.04, I. Aesthetic Design Changes].
Therefore, it would have been prima facie obvious to modify the device taught by Modified Pocreva III to incorporate the height of the light guide to obtain the invention as specified in claim 6, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size for the purpose of the light guide being able to adapted to the inhaler to which is to be adapted and could fit for its purpose and thus fails to patentably distinguish over the prior art of the Modified Pocreva III.
Regarding Claim 7, Modified Pocreva III discloses the monitor (Fig. 3-5; 24; para. 0061; Pocreva III) according to claim 1, which is removably attachable to the inhaler (Fig. 1-2; 14; para. 0013, 0061; Pocreva III).
Regarding Claim 8, Modified Pocreva III discloses the monitor according to claim 1, the optical sensor (para. 0070, 0077; Fig. 16; Pocreva III; Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland).
Modified Pocreva III does not specifically disclose wherein the optical sensor comprises one or more photomicrosensors which emit and detect light.
However, Sutherland further teaches optical sensor (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122) comprises one or more photomicrosensors which emit and detect light (abstract; para.0199).
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 optical sensors of Modified Pocreva III to include one or more photomicrosensors which emit and detect light as taught by Sutherland for the purpose of detecting a dosage selected with and/or expelled by the drug delivery device and adapted to receive and/or detect any reflected infrared light emitted (para.0199).
Regarding Claim 9, Modified Pocreva III discloses the monitor according to claim 1, the optical sensor (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122).
Modified Pocreva III does not specifically disclose the optical sensor comprises a single light source and two or more photodetectors.
However, Sutherland teaches the optical sensor comprises a single light source (Fig. 7; 130) and two or more photodetectors (Fig. 4 or Fig. 7).
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 optical sensor of Modified Pocreva III to include a single light source and two or more photodetectors as taught by Sutherland for the purpose of only the returned or reflected radiation associated with one specific light pipe and a target beneath the light pipe and associated optical sensor being interrogated may contribute to the signal generated by this sensor and receive and process data from the sensor in order to identify the properties of the medicament delivery device, compare the identified properties of the medicament delivery device with the properties of the prescribed medicament delivery device stored in the compliance monitor memory, and determine if the prescribed medicament delivery device is attached to the compliance monitor (claim 2).
Regarding Claim 10, Modified Pocreva III discloses the monitor according to claim 1, wherein the optical sensor (para. 0070, 0077; Fig. 16; Pocreva III; Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122) operates in the infrared regions of the electromagnetic spectrum (para. 0028; Pocreva III).
Regarding Claim 11, Modified Pocreva III discloses the monitor according to claim 1, the light guide (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland).
Modified Pocreva III does not specifically disclose that the light guide is made from a transparent plastic material.
However, Sutherland teaches light guide is made from a transparent plastic material (para. 0208).
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 light guide of Modified Pocreva III to be a transparent plastic material as taught by Sutherland for the purpose of improving the light guiding by the at least one light pipe, and may also reduce influences of interfering light for example from outside of the light pipe. Thus, the signal-to-noise-ratio may be improved and manufacturing alter the reflectivity and/or absorption properties of the inhaler surfaces. (para. 0208).
Regarding Claim 12, Modified Pocreva III discloses the monitor according to claim 1, comprising two photomicrosensors and two light guides (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland).
Modified Pocreva III does not teach three photomicrosensors and light guides.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have three photo microsensors 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 17, Modified Pocreva III discloses the monitor according to claim 5, convex distal end (end of sensors where 23,25 ,123, 125 come out of Sutherland).
Modified Pocreva III does not specifically teach wherein the convex distal end has a radius of curvature of about 3mm.
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 dimensions of the claimed device, convex distal end has a radius of curvature of about 3mm, 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. [MPEP 2144.04, I. Aesthetic Design Changes].
Therefore, it would have been prima facie obvious to modify the device taught by Modified Pocreva III to incorporate the dimension of the convex distal end to obtain the invention as specified in claim 17, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired device size for the purpose of the light guide being able to adapted to the inhaler to which is to be adapted and could fit for its purpose and thus fails to patentably distinguish over the prior art of the Modified Pocreva III.
Regarding Claim 18, Modified Pocreva III discloses the monitor according claim 12, wherein the light guides (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland) are moulded as a single component (Fig. 4 and Fig. 7; Sutherland).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pocreva III, Fato, and Sutherland, as applied to claim 1, in view of Overfield et al. (US 9364619 B2), hereafter as Overfield.
Regarding Claim 13, Modified Pocreva III discloses a kit comprising the monitor (Fig. 3-5; 24; para. 0061, 0064) according to claim 1, and a dry powder inhaler (Fig.1-2; 14; para. 0059-0060) which contains a blister strip comprising a plurality of blisters (para. 0047; Fato), wherein the blister strip has non-numerical indicia (para. 0013, 0028; Pocreva III), and
Modified Pocreva III does not teach specifically wherein the inhaler has an aperture into which the light guide(s) are inserted when the monitor is mounted onto the inhaler.
However, Overfield teaches wherein the inhaler has an aperture (where 1202 fits into; Fig. 14; jacket) into which the light guide(s) (1202; Col. 10 line 21-45; Examiner notes: the sensor could be optical or any sensor that can detect signals generated within an inhaler) are inserted when the monitor is mounted onto the inhaler (Fig. 14-15; Col. 11 lines 19- Col. 12 line 4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify inhaler of Modified Pocreva III to include the an aperture inside where the sensor and light guide attached to the monitor could fit into as taught by Overfield for the purpose of the sensor being adapted to communicate or transmit signals and the data obtained from the detection sensors can be analyzed (Fig. 14-15; Col. 10 line 21-45).
Regarding Claim 14, Modified Pocreva III discloses a combination comprising the monitor (Fig. 3-5; 24; para. 0061, 0064) according to claim 1, mounted on a dry powder inhaler (Fig.1-2; 14; para. 0059-0060) which contains a blister strip comprising a plurality of blisters (para. 0047; Fato), wherein the blister strip has non-numerical indicia (para. 0013, 0028; Pocreva III), and wherein the light guide(s) (Fig. 4; 22, 24, 25 OR Fig. 7B; 124,122; Sutherland) on the monitor, so that the optical sensors (para. 0070, 0077; Fig. 16) can read the non-numerical indicia (this limitation is functional; however, the prior art teaches these sensors are able to read the different indicia; 0070, 0077).
Modified Pocreva III does not disclose specifically that the light guides are inserted into an aperture on the inhaler.
However, Overfield teaches wherein the inhaler has an aperture (where 1202 fits into; Fig. 14; jacket) into which the light guide(s) (1202; Col. 10 line 21-45; Examiner notes: the sensor could be optical or any sensor that can detect signals generated within an inhaler) are inserted when the monitor is mounted onto the inhaler (Fig. 14-15; Col. 11 lines 19- Col. 12 line 4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify inhaler of Modified Pocreva III to include the an aperture inside where the sensor and light guide attached to the monitor could fit into as taught by Overfield for the purpose of the sensor being adapted to communicate or transmit signals and the data obtained from the detection sensors can be analyzed (Fig. 14-15; Col. 10 line 21-45).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pocreva III, Fato, Sutherland and Overfield, as applied to claim 13, in view of Kaplan et al. (US 20100300924 A1), hereafter as Kaplan.
Regarding Claim 15, Modified Pocreva III discloses the kit according to claim 13, non-numerical indica that is encoded (para. 0013, 0028, 0070, 0077) and a dose of powdered medicament (para. 0005, 0013, 0015; Pocreva III; para. 0047; Fato).
Modified Pocreva III does not specifically disclose wherein the non-numerical indicia each 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 Modified Pocreva III 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 (para. 0049-0053).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pocreva III, Fato, Sutherland and Overfield, as applied to claim 14, in view of Kaplan.
Regarding Claim 16, Modified Pocreva III discloses the combination according to claim 14, non-numerical indica that is encoded (para. 0013, 0028, 0070, 0077) and a dose of powdered medicament (para. 0005, 0013, 0015; Pocreva III; para. 0047; Fato).
Modified Pocreva III does not specifically disclose wherein the non-numerical indicia each encode an individual, unique number that is associated with a 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 Modified Pocreva III 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 (para. 0049-0053).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of particular note include:
Hamilton (US 10441511 B2) teaches an inhaler with blisters an optical sensor attached.
Tunnell et al. (US 20150174349 A1) teaches a monitor that can attach to many places on the inhaler
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.
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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