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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 October 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 23 October 2025 wherein Claim 18 is amended, Claim 28 is cancelled, Claims 1 – 17, 19 – 21, 24, 27, 30 – 31, 35 – 37, and 39 were previously cancelled, and no claims have been newly added. Therefore, Claims 18, 22, 23, 25, 26, 29, 32 – 34, 38, and 40 are currently pending within the application.
Response to Arguments
Applicant’s arguments, see pages 8 – 10, filed 23 October 2025, with respect to the rejection(s) of independent claim(s) 18 and its respective dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cirillo et al. (US 2012/0053527 A1”) modified in view of Perot et al. (US 2013/0256166 A1), Larsen (US 2009/0069742 A1), and Cirillo et al. (US 10,773,032 B2).
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 29 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 29 recites “The medicament delivery device according to claim 28.” However, Claim 28 has been cancelled. It is unclear what the dependency of Claim 29 should be. Therefore, Claim 29 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim 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(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 is 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 29 recites “The medicament delivery device according to claim 28.” However, Claim 28 has been cancelled. Therefore, Claim 29 is rejected under 35 U.S.C. 112(d) 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.
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
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 18, 22 – 23, 25 – 26, 29, and 32 – 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo et al. (US 2012/0053527 A1; hereinafter referred to as “Cirillo”) modified in view of Perot et al. (US 2013/0256166 A1; hereinafter referred to as “Perot”), Larsen (US 2009/0069742 A1), and Cirillo et al. (US 10,773,032 B2; hereinafter referred to as “Cirillo ‘032”).
Cirillo is cited within the IDS dated April 13, 2019.
Larsen is cited in the Notice of References Cited dated April 18, 2024.
Perot is cited in the Notice of References Cited dated April 23, 2024.
With regards to claim 18, Cirillo discloses (Figs. 1, 11, 16, and 22) a medicament delivery device (110, 2204; see [0048], [0049] “An injection pen 110 is prefabricated,” [0082] “A removable attachment may be used for multiple uses of a medication injection supervisor device with different prefabricated injection pens,” and [0092] “prefabricated injection pen 2204” wherein as disclosed by these paragraphs the prefabricated injection pen 110 of Fig. 1 is an example prefabricated injection pen shown in forthcoming embodiments such as the prefabricated injection pen 2204 of Fig. 22), comprising:
a housing element (see at 2204 in Fig. 22) including a first side (see Examiner annotated Fig. 22 below; hereinafter referred to as Fig. A) and a second side (see Fig. A below) opposite the first side, wherein the housing element further includes a first end (see the Examiner annotated Fig. 1 below; hereinafter referred to as Fig. B) and a second end (see Fig. B below) opposite the first end;
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a mount (see at 2208 in Fig. 22; see [0092] “cavity 2208 formed in prefabricated injection pen 2204”) integral with the housing element (see Fig. 22), wherein the mount is positioned at the first end of the housing element (see Figs. A and B above), wherein the housing element is integral with an outer shell of the medicament delivery device such that the mount is permanently coupled to the medicament delivery device (see [0092] and Fig. 22 which discloses that the cavity, identified as the mount, is formed in the prefabricated injection pen), wherein the mount comprises four recesses (2208; see [0092] “Universal header 2202 and prefabricated injection pen 2204 may have one or more such cavity-pin couplings. For example, two or more cavity-pin couples may be provided along the length of the prefabricated pen 2204” wherein two or more cavity-pin couples can equal four cavity-pin couples) in a convex surface the housing element (see Fig. A above which shows the four recesses 2208 in a convex surface of the housing element) such that the mount does not protrude away from the housing element (see Fig. 22 and [0092] which discloses that the mount does not protrude away from the housing), wherein each of the four recesses are positioned only on the first side of the housing element (see Fig. 22 and Fig. A above which shows the four recesses being positioned only on the first side of the housing element); and
an auxiliary unit (130/2202; see [0048] “A medication injection supervisor device may include a universal header having one or more attachment features…these attachment features are described below with reference to FIGS. 19 – 23B,” [0049] “a universal header 130,” [0082], and [0092] “universal header 2202” wherein as disclosed by these paragraphs the universal header 130 of Fig. 1 is an example universal header shown in the forthcoming embodiments such as the universal header 2202 in Fig. 22) including four protrusions (2206; see [0092] “universal header 2202 having pin 2206 protruding into cavity 2208…one or more such cavity-pin couplings”) that are configured to be inserted in the four recesses to thereby releasably attach the auxiliary unit externally to the mount (see [0082] “Some examples of removable attachments…pin-cavity attachment mechanisms…These examples will not be described in more details with reference to corresponding figures”), wherein a relative position of the mount and the auxiliary unit is uniquely determined by the complimentary shape of the four protrusions and the four recesses (see [0092] and Figs. A – B above) such that the auxiliary unit has a concave surface that corresponds to the convex surface of the housing element (see Fig. A above which shows the auxiliary unit having a concave surface that corresponds to the convex surface of the housing element), wherein the auxiliary unit is positioned solely on the first side of the housing element such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device (see Figs. A – B above wherein the auxiliary unit is shown to be positioned solely on the first side of the housing element such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device), wherein the auxiliary unit comprises an electronics unit (902, 904; see [0051] “the universal header 130 that houses the electronics to be used on a variety of pens” and [0069] “an electronic assembly 904, a sensor 902”), wherein the electronics unit is activated when a user operates the medicament delivery device to set a dose (see [0069] “In most injection pens, users extend the plunger to dial a dosage. When the plunger is extended, the sensor 902 (e.g., a micro switch) is toggled to the open state. When the sensor 902 is toggled to the open state, the timer is reset to zero to indicate that the injection has started”), and wherein the auxiliary unit detects a longitudinal movement of a plunger rod of the medicament delivery device through the housing element (see Fig. 11 and [0069] – [0070] wherein the longitudinal movement is the plunger extending and the plunger being depressed through the housing element), and wherein the auxiliary unit (130/2202; see [0048], [0049], [0082], and [0092] wherein as disclosed by these paragraphs the universal header 130 of Fig. 1 is an example of a universal header shown in forthcoming embodiments such as the universal header 2202 of Fig. 22) is adapted to determine and to provide information about an operational state and/or usage of the medicament delivery device (see [0056] and [0062] “the device can facilitate remote monitoring of the patient’s condition by sending information wirelessly…send general summary information on daily or weekly usage to nominated numbers…” wherein this general summary information on daily or weekly usage is providing information about an operational state and usage of the medicament delivery device).
However Cirillo is silent with regards to:
wherein each of the four recesses are non-circular in shape, are elongated longitudinally, and are positioned only on the first side of the housing element, wherein a first pair of the four recesses are collinear on a first line extending from the first end to the second end, wherein a second pair of the four recesses are collinear on a second line extending from the first end to the second end, wherein the first line is spaced apart and parallel to the second line such that the first pair of the four recesses are not collinear with the second pair of the four recesses, wherein each of the four recesses are separated from one another by an outer surface of the housing element such that each of the four recesses are distinct from one another and are not otherwise connected to one another, wherein a distance from a first recess in the first pair of the four recesses to the first end of the housing element is substantially equal to a distance from a first recess in the second pair of the four recesses to the first end of the housing element, and wherein a distance from a second recess in the first pair of the four recesses to the first end of the housing element is substantially equal to a distance from a second recess in the second pair of the four recesses to the first end of the housing element; and
wherein the mount is configured to releasably attach to the auxiliary unit by magnetism; and
wherein the auxiliary unit is positioned solely on the first side of the housing element such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device in order to detect relative axial movements of a dose setting of the delivery device with respect to the housing element.
Nonetheless Perot, which is within the analogous art of mounts (see Figs. 10 – 12), teaches wherein each of the four recesses (115; see [0096] “recesses 115”) are non-circular in shape (see at 115 in Fig. 12), are elongated longitudinally (see at 115 in Fig. 12), and are positioned only on the first side of the housing element (see the recesses 115 positioned only on the topside of the second shell 111), wherein a first pair of the four recesses are collinear on a first line (see a line drawn between the first pair of the four recesses in Fig. C below) extending from the first end to the second end (see Examiner annotated Fig. 12 below; hereinafter referred to as Fig. C),
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wherein a second pair of the four recesses are collinear on a second line (see a line drawn between the second pair of the four recesses in Fig. C above) extending from the first end to the second end (see Fig. C above), wherein the first line is spaced apart and parallel to the second line such that the first pair of the four recesses are not collinear with the second pair of the four recesses (see Fig. C above), wherein each of the four recesses are separated from one another by an outer surface of the housing element such that each of the four recesses are distinct from one another and are not otherwise connected to one another (see Fig. C above and the outer surface of the second shell 111), wherein a distance from a first recess in the first pair of the four recesses (right recess in the annotated first pair of the four recess in Fig. C above) to the first end of the housing element is substantially equal to a distance from a first recess in the second pair of the four recesses (right recess in the annotated second pair of the four recesses in Fig. C above) to the first end of the housing element (see Fig. C above), and wherein a distance from a second recess in the first pair of the four recesses (left recess in the annotated first pair of the four recesses in Fig. C above) to the first end of the housing element is substantially equal to a distance from a second recess in the second pair of the four recesses (left recess in the annotated second pair of the four recesses in Fig. C above) to the first end of the housing element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify shape and positioning of the four recesses of the mount and the four protrusions of the auxiliary unit of the medicament delivery device of Cirillo in view of a teaching of Perot such that wherein each of the four recesses are non-circular in shape, are elongated longitudinally, and are positioned only on the first side of the housing element, wherein a first pair of the four recesses are collinear on a first line extending from the first end to the second end, wherein a second pair of the four recesses are collinear on a second line extending from the first end to the second end, wherein the first line is spaced apart and parallel to the second line such that the first pair of the four recesses are not collinear with the second pair of the four recesses, wherein each of the four recesses are separated from one another by an outer surface of the housing element such that each of the four recesses are distinct from one another and are not otherwise connected to one another, wherein a distance from a first recess in the first pair of the four recesses to the first end of the housing element is substantially equal to a distance from a first recess in the second pair of the four recesses to the first end of the housing element, and wherein a distance from a second recess in the first pair of the four recesses to the first end of the housing element is substantially equal to a distance from a second recess in the second pair of the four recesses to the first end of the housing element.
One of ordinary skill in the art would have been motivated to make this modification because Perot teaches these protrusions and recesses create a releasable connection between two components (see [0019] of Perot). The releasable connection would allow for the auxiliary unit to be reused while the medicament delivery device could be disposed of if so desired.
Although the four recesses and protrusions of Perot are taught to be on a planar surface (see Figs. 10 – 12 and [0096] of Perot) while the four recesses and protrusions of Cirillo are along a convex surface (see Fig. 22 and [0092] of Cirillo), Cirillo also teaches multiple embodiments (Fig. 10 and 20 of Cirillo) that provide evidentiary support that that mounts can either be planar or convex in their structure. In view of the total disclosure of Cirillo, one of ordinary skill in the art would have expected the modification to the mount of Cirillo in view of the teaching of Perot to be fully successful and achieve the expected result of attaching the auxiliary unit to the mount of the housing element of the medicament delivery device in a releasable manner.
The medicament delivery device of Cirillo modified in view of a teaching of Perot will hereinafter be referred to as the medicament delivery device of Cirillo and Perot.
However, neither Cirillo nor Perot teaches that the mount is configured to releasably attach to the auxiliary unit by magnetism; and
wherein the auxiliary unit is positioned solely on the first side of the housing element such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device in order to detect relative axial movements of a dose setting of the delivery device with respect to the housing element.
Nonetheless, Larsen which is within the analogous art of pen-type injection devices (see Abstract), teaches an auxiliary unit (Fig. 1a, #1) mounted to an outer casing of a mechanical drug delivery device (Fig. 1a, #2 and see [0041]). Larsen further teaches that the auxiliary unit (Fig. 1a, #1) is attached to the upper portion of the drug delivery device with a magnet (see [0041] “The module is attached to the upper part of the medication delivery device…using magnetic means, such as permanent magnetic means”).
It would have been obvious to one of ordinary skill, in the art before the effective filing date of the present invention, to modify the mount of the housing element of the medicament delivery device of Cirillo and Perot with a teaching of Larsen such that the mount is configured to releasably attach to the auxiliary unit by magnetism. Larsen shows a differing means of attaching the auxiliary unit to the mount. Therefore, it would have been obvious to one of ordinary skill in the art to modify the positive locking attachment/friction fit of the mount of the medicament delivery device of Cirillo and Perot with the magnets of Larsen for the predictable result of releasably attaching the two components together. This attachment mechanism provides a redundant attachment mechanism in case the positive locking attachment/friction fit of the mount fails.
The medicament delivery device of Cirillo and Perot modified in view of a teaching of Larsen will hereinafter be referred to as the medicament delivery device of Cirillo, Perot, and Larsen.
However, none of Cirillo, Perot, or Larsen teaches wherein the auxiliary unit is positioned solely on the first side of the housing element such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device in order to detect relative axial movements of a dose setting of the delivery device with respect to the housing element.
Nonetheless Cirillo ‘032, which is within the analogous art of monitoring devices (see abstract and title), teaches the auxiliary unit (1) is positioned solely on the first side of the housing element (see at 2) (see Fig. 1) such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device (see at 6 in Fig. 1) in order to detect relative axial movements of a dose setting of the delivery device with respect to the housing element (see Col. 5, line 57 – Col. 6, line 2 “The monitoring device 1 is made up of a housing 1 a containing a motion detection system 8 for detecting rotational and translational or longitudinal movement of the shaft on which the dose selector 5 and the push button 6 are located.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the auxiliary unit and housing of the medicament delivery device of Cirillo, Perot, and Larsen in view of a teaching of Cirillo ‘032 such that the auxiliary unit is positioned solely on the first side of the housing element such that the auxiliary unit does not extend to an end surface of the first end of the medicament delivery device in order to detect relative axial movements of a dose setting of the delivery device with respect to the housing element. One of ordinary skill in the art would have been motivated to make this modification because Cirillo ‘032 teaches that this functionality allows for the medicament delivery device to track the selected dosage of the user (see Col. 9, line 66 – Col. 10, line 13 of Cirillo ‘032). Tracking medication dosage is crucial to ensure effectiveness, prevent dangerous side effects, avoid harmful interactions, and provide doctors with accurate data for personalized treatment, preventing under-dosing or overdosing and improving the overall health outcomes.
The medicament delivery device of Cirillo, Perot, and Larsen modified in view of Cirillo ‘032 will hereinafter be referred to as the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032.
With regards to claim 22,the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, and Cirillo further teaches (Fig. 22) the mount (see at 2208 in Fig. 22; see [0092] “cavity 2208 formed in prefabricated injection pen 2204”) is configured to releasably attach to the auxiliary unit (2202; see [0092] “universal header 2202”) by positive locking (see [0082] and [0092] wherein the cavity-pin coupling is an example of positive locking).
With regards to claim 23, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, and Cirillo further teaches (Fig. 22) the mount (see at 2208 in Fig. 22; see [0092] “cavity 2208 formed in prefabricated injection pen 2204”) is configured to releasably attach to the auxiliary unit (2202; see [0092] “universal header 2202”) by friction-fit (see [0082] and [0092] wherein the cavity-pin coupling is an example of a friction-fit).
With regards to claim 25, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, however, this embodiment of Cirillo (Fig. 22) is silent with regards to the mount is configured to releasably attach to the auxiliary unit by a non-permanent adhesive.
Nonetheless, a second embodiment of Cirillo teaches (Fig. 19) an auxiliary unit (1902) attached to the surface of a prefabricated injection pen (1904). Cirillo further teaches that the auxiliary unit (1902) is attached to the surface of the prefabricated injection pen by a non-permanent adhesive (See [0081] “an adhesive may be used to form a removable attachment”).
It would have been obvious to one of ordinary skill, in the art before the effective filing date of the present invention, to modify the mount of the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 with a further teaching of Cirillo such that the mount is configured to releasably attach to the auxiliary unit by a non-permanent adhesive. One of ordinary skill in the art would have been motivated to make this modification, because Cirillo teaches that embodiments may be combined (see [0043] of Cirillo). Therefore, a person of ordinary skill would be motivated to create a removable attachment using both positive locking/friction fit and a non-permanent adhesive to achieve a removable attachment that allows for a medication injection supervisor device to be used with different prefabricated injection pens (see [0082] of Cirillo). This attachment mechanism provides a redundant attachment mechanism in case the positive locking attachment/friction fit or magnetism of the mount fails.
With regards to claim 26, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, and Cirillo further teaches (Fig. 22 and [0092]) that the mount (see at 2208 in Fig. 22; see [0092] “cavity 2208 formed in prefabricated injection pen 2204”) is shaped to only allow attachment to the correspondingly shaped auxiliary unit (2202; see [0092] “universal header 2202”; see Fig. 22 wherein the shape of the cavity/recesses matches the correspondingly shaped pin/protrusion).
With regards to claim 29, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 28 (see the 35 U.S.C. §§ 112(b) and 112(d) rejections above regarding the dependency of Claim 29), and Cirillo further teaches the auxiliary unit (130/2202; see [0048] “A medication injection supervisor device may include a universal header having one or more attachment features…these attachment features are described below with reference to FIGS. 19 – 23B”, [0049] “a universal header 130”, [0082], and [0092] “universal header 2202” wherein as disclosed by these paragraphs the universal header 130 of Fig. 1 is an example of a universal header shown in forthcoming embodiments such as the universal header 2202 of Fig. 22) is adapted to communicate measurements and information to another unit (see [0056] and [0062] “the device can facilitate remote monitoring of the patient’s condition by sending information wirelessly…send general summary information on daily or weekly usage to nominated numbers”).
With regards to claim 32, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, and Cirillo further teaches (Fig. 22) the medicament delivery device (2204; see [0092] “prefabricated injection pen 2204”) is a disposable medicament delivery device (see [0048] and [0082]).
With regards to claim 33, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, Cirillo further teaches (Fig. 22) the medicament delivery device comprises a pen injector (2204; see [0092] “prefabricated injection pen 2204”).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo, Perot, Larsen, and Cirillo ‘032 as applied to claim 18 above and in further view of Lindstedt et al. (WO 2016/128207 A1; hereinafter referred to as “Lindstedt”).
A copy of Lindstedt was provided in the Non-Final Rejection mailed February 19, 2021 and is listed as a Foreign Reference with the same date.
With regards to claim 34, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, however, Cirillo is silent with regards to the medicament delivery device comprises an inhalation device.
Nonetheless, Lindstedt which is within the analogous art of medicament delivery devices, teaches a medicament delivery device (Fig. 2) comprises an inhalation device (See page 6, lines 3-5 “medicament delivery devices may include a number of devices capable of delivery certain doses of medicament to a user, such as e.g. injection devices with or without injection needles, inhalers of all kinds,”). The invention of Lindstedt also teaches a releasably attachable auxiliary unit (See Abstract “usage management module is designed as an attachable unit (112)”).
It would have been obvious to one of ordinary skill, in the art before the effective filing date of the present invention, to modify the medicament delivery device of the housing element of the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 such that it comprises an inhalation device. Lindstedt shows a different medicament delivery device capable of delivering certain doses of medicament to a user. The alternate medicament delivery device (inhaler) and the auxiliary unit (usage management module) of Lindstedt are analogous to the medicament delivery device and auxiliary unit of the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the injection pen of the housing element of Cirillo, Perot, Larsen, and Cirillo ‘032 for the inhalation device of Lindstedt for the predictable result of delivering doses of medicament to a user.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo, Perot, Larsen, and Cirillo ‘032 as applied to claim 18 above and in further view of Bauss et al. (US 2018/0326164; hereinafter referred to as “Bauss”).
Bauss is cited within the Notice of References Cited dated September 1, 2022.
With regards to claim 38, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, however, Cirillo is silent with regards to wherein the auxiliary unit is configured to optically detect the longitudinal movement of the plunger rod of the medicament delivery device through the housing element through a window in the housing element.
Nonetheless Bauss, which is within the analogous art of pen-type injection devices, further teaches (Figs. 1-3) that the auxiliary unit (30) is configured to optically detect the longitudinal movement of the plunger rod (52) of the medicament delivery (see [0025] “A device capable of sensing force on components inside a medicament delivery device shown in the figures”) device through the housing element (10) through a window (50) in the housing element (see [0036] “an optical sensor 54 that is capable of providing a light beam 56 that is reflected back, detecting movement of components, such as the plunger rod 52 of the medicament delivery device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the auxiliary unit of the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 with a teaching of Bauss such that the auxiliary unit is configured to optically detect the longitudinal movement of the plunger rod of the medicament delivery device through the housing element through a window in the housing element. One of ordinary skill in the art would have been motivated to make this modification, as the optical sensor facilitates the detection of movement such as the start of the movement as well as the stop of the movement. Further, the speed of the movement during the dose delivery sequence may be monitored and compared to movement patterns of pretested and normally functioning medicament container for detecting possible injection problems of the medicament delivery device (see [0036] of Bauss).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cirillo, Perot, Larsen, and Cirillo ‘032 as applied to claim 18 above and in further view of Carlsson et al. (US 10,799,635; hereinafter referred to as “Carlsson”).
Carlsson is cited in the Notice of References Cited dated September 9, 2024
With regards to claim 40, the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 teaches the claimed invention of claim 18, however, Cirillo is silent with regards to wherein the electronics unit is deactivated after the dose has been fully delivered to the user.
Nonetheless, Carlsson which is within the analogous art of monitoring units (see Abstract), teaches the electronics unit is deactivated after the dose has been fully delivered to the user (see Col. 11, lines 21 – 37 “Regarding the activation of the monitoring unit, the electronic circuit could preferably be arranged with a suitable switch-off functionality, such as a timer function that will switch off the power to the circuitry after a certain period of time, for instance after completed medicament delivery operation. This will prolong the life of the power source in that it is not active when no action is taking place.” The Foreign Application Priority Data Ep 16161584 of Carlsson has a filing date of 3/22/2016 and the same disclosure on page 16, line 28 – page 17, line 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the electronics unit of the medicament delivery device of Cirillo, Perot, Larsen, and Cirillo ‘032 with a teaching of Carlsson such that the electronics unit is deactivated after the dose has been fully delivered to the user. One of ordinary skill in the art would have been motivated to make this modification, as Carlsson teaches that the life of the power source is prolonged by switching off the power to the circuitry after completing the medicament delivery operation (see Col. 11, lines 21 – 37 of Carlsson). Therefore, the battery of the medicament delivery device of Cirillo (see [0082] of Cirillo) could have a prolonged battery life by being modified in view of Carlsson to turn off after completing the medicament delivery device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Andersen et al. (US 2017/182256 A1) see [0018] and [0035] which discloses the detection of axial movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
01/27/2026