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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the dosage selection and expelling mechanism must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (part above 49 in Fig. 3) provided on one side of the grip base, and a clutch (52) being provided on the other side of the grip base (part below 49 in Fig. 3) for engagement with a dose selecting part ([0047], outer threading of 34) of a dosage selection and expelling mechanism (34) of the injection device to couple the grip base to the dosage selection and expelling mechanism 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]), 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.
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 (30/50), the dial grip comprising a grip base (30), a handling part (portions above 49 in Fig. 3) provided on one side of the grip base, and a clutch (50) being provided on the other side of the grip base for engagement with a dose selecting part of a dosage selection and expelling mechanism of an injection device to couple the grip base to the dosage selection and expelling mechanism for selecting a dosage with the dial grip ([0045]), the dial grip comprising at least one locking lever (56) being movable between a lock position and an unlock position ([0072]), 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, 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 (Fig. 2), and a dial grip (30/50, Fig. 4), 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]), the dial grip comprising at least one locking lever (56) being movable between a lock position and an unlock position ([0072]), 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, wherein a grip top (82) 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 is second grip top is not positively recited, and 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 (34) 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 (30) and a handling part (part above 49 in Fig. 3) provided on one side of the grip base, and wherein the clutch 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 (Fig. 4).
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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 with respect to drawing objections have been fully considered and are persuasive in-part. The drawing objections pertaining to dial sleeve and the dial grip have been withdrawn, but the drawing objection pertaining to the dosage selection and expelling mechanism remains. Applicant argues that a drawing for the claimed feature is not necessary for understanding the invention and that it is adequately disclosed. Examiner respectfully disagrees. First, given that the dosage selection and expelling mechanism is a significant element in the independent claim, a drawing is necessary for understanding. Second, the dosage selection and expelling mechanism is mentioned throughout the specification. However on page 7, line 1, it appears that only part 56, that is a portion of the overall dosage selection and expelling mechanism, is shown. Therefore, it is unclear if 56 alone represents the entire dosage selection and expelling mechanism or if there are additional components, which the specification appears to imply. The dosage selection and expelling mechanism appears to be a significant structure within the invention but it is unclear what components may be included with it. Examiner notes, if reference numeral 56 represents the only component of the dosage selection and expelling mechanism, it is unclear why the dosage selection and expelling mechanism is separately claimed when both represent the same structural element as it pertains to the claimed invention. Clarification is required.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections of 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 a discrete locking lever that engages a corresponding locking lever reception with the device body and that Byerly discloses an axial button movement that disengages internal splines and does not perform the function of preventing turning of the dial grip. Examiner submits that the function of preventing turning of the dial grip is not claimed and that claim 17 simple requires a movable “lever” that can “engage” with a “lever reception.” Given the broadest reasonable interpretation, the button of Byerly has been shown to have two positions and is capable of engaging with a spring, which is interpreted as the “lever reception.” Without additional language to exclude a button or the spring of Byerly, the button and spring read on the lever and lever reception of claim 17, the rejection stands.
Regarding claims 28 and 32, Applicant argues that the removable sensor module of Byerly is not a grip top of a dial grip and does not disclose a device in which a dial grip or grip top is exchanged as part of the dose setting structure. Examiner submits that the limitation of the dial grip or grip top being “exchanged as part of the dose setting structure” is not found in claim 28. Furthermore, claim 32 merely recites that the grip top is releasable and replaceable. As shown above regarding claim 32, the grip top is removable and is capable of being replaced since the second grip top is not positively recited. Applicant also argues that Byerly’s removable module does not attach to a “handling part.” Examiner submits that no handling part is recited in claim 32. Furthermore, claim 28 merely recites that the handling part is “provided on a one side of the grip base” and includes “at least one groove” that engages with the guide pin of the grip top. As shown above, the mapped handling part of Byerly, which includes portions of the outer surface of 42 above 49 are thereby provided on “one side” of the overall grip base 30, and the groove 208 of the outer surface of 42 engages a guide pin 216 of the grip top 82 as shown in Fig. 15, thereby meeting the limitations of the claim given the broadest reasonable interpretation. The rejection stands.
Conclusion
THIS ACTION IS MADE FINAL. 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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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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