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 .
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.
Claims 17 and 19-36 are 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.
Claims 17 and 28 recite “a handling part provided on one side of the grip base… a clutch being provided on the other side of the grip base for engagement with a dose selecting part of a dosage selection and expelling mechanism… to couple the grip base to the dosage selection and expelling mechanism for selecting a dosage with the dial grip…” First, it is unclear if the handling part and the clutch are parts of the grip base or intended as separate elements which lie on opposing sides of the grip base. Second, it is unclear if the clutch or the dose selecting part is being used to couple the grip base to the dosage selection and expelling mechanism. Third, it is unclear what is being used to select a dosage and given the lack of disclosure of the dosage selection and expelling mechanism, it is unclear how this mechanism contributes to either dosage selection or expelling, especially since it is not clear if the dosage selection and expelling mechanism is being positively recited. Claims will be interpreted as best understood by the Examiner.
Claim 32 recites “wherein the dial grip is coupled to the dosage selection and expelling mechanism forming a mechanical interface to allow for dosage selection with the dial grip…” Similar to claims 17 and 28, it is unclear what is being actually being used for dosage selection and given the lack of disclosure of the dosage selection and expelling mechanism, it is unclear how this mechanism contributes to dosage selection, if at all. Claims will be interpreted as best understood by the Examiner.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 19-21, 24-26, 28-30, and 32-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2020/0023137 to Byerly et al. (“Byerly”).
Regarding claim 17, Byerly teaches a dial grip for an injection device (Figs. 3-4), the dial grip comprising a grip base (42/50), a handling part (42/60) provided on one side of the grip base, wherein the handling part is configured for a releasable attachment of a grip top (82 is releasable attached to 60, Fig. 6 and [0065]) and a clutch (52) being provided on the other side of the grip base for engagement with a dose selecting part (32) of a dosage selection and expelling mechanism (32) of the injection device to couple the grip base to the dosage selection and expelling mechanism ([0051]) for selecting a dosage with the dial grip ([0037]), the dial grip comprising at least one locking lever (56) being movable between a lock position and an unlock position ([0072], rotationally fixed position and position when rotational locking is disengaged), wherein the at least one locking lever can engage with a locking lever reception (68) provided within a body of the injection device when moved in the lock position for locking a turning of the dial grip (the bias of 68 keeps 56 rotationally locked to 42, [0043]), and wherein the locking lever and the locking lever reception prevent rotation of the dial grip relative to the injection device when no grip top is attached to the dial grip (relative rotation is prevented during the dose setting mode, [0042], and given that the grip top 82 is removable and is not required during the dose setting mode, the locking lever and locking lever reception of Byerly are capable of preventing relative rotation with the grip top 82 removed).
Regarding claim 19, Byerly teaches the dial grip of claim 17 as shown above, Byerly further teaching the handling part is configured for a releasable attachment of a grip top ([0065]).
Regarding claim 20, Byerly teaches the dial grip of claim 19 as shown above, Byerly further teaching the handling part comprises at least one fixture (208, Fig. 15) for the releasable attachment of the grip top.
Regarding claim 21, Byerly teaches the dial grip of claim 20 as shown above, Byerly further teaching the at least one fixture comprises at least one guide groove (208) and the grip top comprises one or more guide pins (216) provided on its inside surface for engaging with the at least one guide groove (Fig. 15).
Regarding claim 24, Byerly teaches the dial grip of claim 17 as shown above, Byerly further teaching the grip base further comprises a collar (32) coaxially arranged around the clutch (52, Fig. 2) and being provided for insertion between a dial sleeve (34) of the dosage selection and expelling mechanism and a body of the injection device (11), the collar being configured as a guide for at least one locking lever (56) of the dial grip.
Regarding claim 25, Byerly teaches the dial grip of claim 17 as shown above, Byerly further teaching electronics (120) configured for at least one of recording, storing, processing, or transmitting one or more drug dosages selected and expelled with an injection device ([0074]).
Regarding claim 26, Byerly teaches the dial grip of claim 25 as shown above, Byerly further teaching the electronics are configured to wirelessly exchange data with external devices ([0075], Bluetooth).
Regarding claim 28, Byerly teaches an exchangeable grip top (82, Fig. 4) for a dial grip, the dial grip comprising a grip base (42/50), a handling part (42/60) provided on one side of the grip base, wherein the handling part is configured for a releasable attachment of a grip top (82 is releasable attached to 60, Fig. 6 and [0065]), and a clutch (52) being provided on the other side of the grip base for engagement with a dose selecting part (32) of a dosage selection and expelling mechanism (32) of an injection device to couple the grip base to the dosage selection and expelling mechanism ([0051]) for selecting a dosage with the dial grip ([0037]), the dial grip comprising at least one locking lever (56) being movable between a lock position and an unlock position ([0072], rotationally fixed position and position when rotational locking is disengaged), wherein the at least one locking lever can engage with a locking lever reception (68) provided within a body of the injection device when moved in the lock position for locking a turning of the dial grip (the bias of 68 keeps 56 rotationally locked to 42, [0043]), wherein the grip top comprises at least one guide pin (216, Fig. 15) provided on an inside surface of the grip top for engaging with at least one guide groove (208) included in the handling part of the dial grip.
Regarding claim 29, Byerly teaches the grip top of claim 28 as shown above, Byerly further teaching electronics (120) configured for at least one of recording, storing, processing, or transmitting one or more drug dosages selected and expelled with an injection device ([0074]).
Regarding claim 30, Byerly teaches the grip top of claim 29 as shown above, Byerly further teaching the electronics are configured to wirelessly exchange data with external devices ([0075], Bluetooth).
Regarding claim 32, Byerly teaches an injection device comprising a body (16, Fig. 1) provided for housing a dosage selection and expelling mechanism (outer threading of 34), and a dial grip (42/50), wherein the dial grip is coupled to the dosage selection and expelling mechanism forming a mechanical interface to allow for dosage selection with the dial grip (via clutch 52, [0045] & [0047]), the dial grip comprising at least one locking lever (56) being movable between a lock position and an unlock position for locking a turning of the dial grip ([0072], rotationally fixed position and position when rotational locking is disengaged), wherein the locking lever and the locking lever reception prevent rotation of the dial grip relative to the injection device when no grip top is attached to the dial grip (relative rotation is prevented during the dose setting mode, [0042], and given that the grip top 82 is removable and is not required during the dose setting mode, the locking lever and locking lever reception of Byerly are capable of preventing relative rotation with the grip top 82 removed), wherein the dial grip comprises a grip base (42/50/52) and a handling part (42/60) provided on one side of the grip base, wherein the handling part is configured for a releasable attaching of a grip top (82 is releasable attached to 60, Fig. 6 and [0065]), wherein the at least one locking lever (56) can engage with a locking lever reception (68) provided within a body of the injection device when moved in the lock position, wherein the grip top of the dial grip is releasable from the dial grip such that it can be replaced by a second grip top ([0065], it is noted that since the grip top of Byerly is removable, the device of Byerly is capable of receiving a second structurally identical grip top).
Regarding claim 33, Byerly teaches the injection device of claim 32 as shown above, the second grip top would comprise electronics (12) configured for at least one of measuring, recording, storing, processing, or transmitting data related to one or more drug dosages selected or expelled with the injection device ([0074], again since the second grip top was not positively recited and the injection device of Byerly is capable is receiving a second grip top, the second grip top would have the same structure as the original grip top).
Regarding claim 34, Byerly teaches the injection device of claim 32 as shown above, Byerly teaching the dosage selection and expelling mechanism (50) having a mechanical interface on one open end of the body, and wherein a clutch (52) of the dial grip is coupled to a dose selecting part (32) of the dosage selection and expelling mechanism (Fig. 2) forming the mechanical interface to allow for dosage selection and expelling with the dial grip.
Regarding claim 35, Byerly teaches the injection device of claim 34 as shown above, Byerly teaching the dial grip comprises a grip base (42/50/52) and a handling part (42/60) provided on one side of the grip base, and wherein the clutch (52) is provided on the other side of the grip base to couple the grip base to the dosage selection and expelling mechanism for selecting a dosage with the dial grip ([0051]).
Regarding claim 36, Byerly teaches the injection device of claim 35 as shown above, Byerly teaching the grip top comprises at least one guide pin (26) provided on an inside surface of the grip top for engaging with at least one guide groove (208) included in the handling part of the dial grip (Fig. 15).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Byerly in view of U.S. Patent Publication No. 2018/0008779 to Hautaviita et al. (“Hautaviita”).
Regarding claim 22, Byerly teaches the dial grip of claim 21 as shown above but does not teach a holder.
Hautaviita teaches at least one guide groove (98, Figs. 4a-4b) comprises an end section (bottom of 98) and the at least one fixture further comprises a holder (96, Fig. 5) being arranged in the end section (Fig. 4b), wherein the one or more guide pins (124) can be seated in the end section and releasably fixed with the holder in the end section. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pin/groove configuration of Byerly with the pin/groove configuration of Hautaviita to obtain the predictable result of providing a releasable connection between a grip top and a grip base.
Regarding claim 23, Byerly and Hautaviita teach the dial grip of claim 22 as shown above, Hautaviita further teaching the at least one fixture further comprises a retention spring (94) being arranged in the handling part to exert a force on the holder (96), the retention spring being arranged to force at least one locking lever (50) of a dial grip into a lock position when no guide pin is seated in the end section ([0047]).
Claims 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Byerly in view of U.S. Patent Publication No. 2018/0064881 to Whalley et al. (“Whalley”).
Regarding claims 27 and 31, Byerly teaches the grip top of claims 25 and 29, respectively, as shown above, Byerly further teaching a battery as power supply for the electronics ([0074]) but does not teach contacts for recharging the battery.
Whalley teaches a battery including a rechargeable battery ([0057]) and contacts ([0057], communication interface, USB) wherein the electronics are particularly configured for data communication over the contacts ([0057]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Byerly with contacts as taught by Whalley to yield the predictable result of recharging the battery or providing wired data communication. Byerly already shows the use of a battery and a means of data communication, Whalley merely shows examples of a supplemental accessory (battery charger) or alternative data communication (wired) for the device of Byerly as would be understood by a skilled artisan. Once combined, the contact would be provided on an outside surface of the grip top of Byerly since the grip top houses the battery.
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant's arguments with respect to the art rejections have been fully considered but they are not persuasive. Regarding claim 17, Applicant argues that Byerly does not disclose the locking lever and the locking lever reception preventing rotation “when no grip top is attached to the dial grip.” Examiner respectfully disagrees. As acknowledged by Applicant on page 8 of the response, the dose setting member 30 including the dose button 56 is capable of operating with the module or grip top attached. The button and dose setting member are in the locked position during the dose setting operation, and therefore the dose setting operation, where the locking lever and the locking lever reception are engaged, can be performed without the grip top.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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