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 .
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 plunger rod is rotationally coupled to the drive member, and wherein the plunger rod comprises a thread on an outer circumference which meshes with the housing or an insert of the housing of the drug delivery device” in claim 15 and “a reset mechanism, the reset mechanism comprising a coupling member adapted to selectively couple the plunger rod to a drive member such that a dispensing movement of the drive member is transferred to the plunger rod, and to decouple the plunger rod from the drive member such that a movement of the drive member is not transferred to the plunger rod and vice versa.” in claim 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because there are two instances of reference number 5 in Figure 2. It appears that the left-most instance should be corrected to reference number 4 to refer to the pinon.
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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains phrases which can be implied (“the present application also relates to” in last sentence). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: there appears to be a typo regarding “a removable cap 39” as opposed to “a removable cap 35” in paragraph [0085]. Appropriate correction is required.
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 1-17 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.
Regarding claim 1, the limitation “the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear and to mesh with the pinion on the drive shaft and with an internal gear of the cycloidal disc” in lines 5-7 (emphasis added) renders the claim indefinite. It is unclear if the cycloidal disc is adapted to by driving by a planet gear and also is adapted to mesh with the pinon of the drive shaft and an internal gear of itself, or the cycloidal disc is adapted to be driven by a planet gear and the planet gear is adapted to mesh with the pinon of the drive shaft and an internal gear of the cycloidal disc. For examination purposes, and consistent with the specification, the limitation “the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear and to mesh with the pinion on the drive shaft and with an internal gear of the cycloidal disc” has been interpreted as the cycloidal disc is adapted to be driven by a planet gear and also the planet gear is adapted to mesh with the pinon of the drive shaft and an internal gear of the cycloidal disc. It is suggested to amend claim 1, lines 5-7 to “the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear, wherein the planet gear is adapted
Regarding claim 12, the limitation “the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear and to mesh with the pinion on the drive shaft and with an internal gear of the cycloidal disc” in lines 8-10 (emphasis added) renders the claim indefinite. It is unclear if the cycloidal disc is adapted to by driving by a planet gear and also is adapted to mesh with the pinon of the drive shaft and an internal gear of itself, or the cycloidal disc is adapted to be driven by a planet gear and the planet gear is adapted to mesh with the pinon of the drive shaft and an internal gear of the cycloidal disc. For examination purposes, and consistent with the specification, the limitation “the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear and to mesh with the pinion on the drive shaft and with an internal gear of the cycloidal disc” has been interpreted as the cycloidal disc is adapted to be driven by a planet gear and also the planet gear is adapted to mesh with the pinon of the drive shaft and an internal gear of the cycloidal disc. It is suggested to amend claim 12, lines 8-10 to “the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear, wherein the planet gear is adapted
Claims 2-11 and 14-17 are rejected for being dependent upon one of rejected independent claims 1 and 12.
Allowable Subject Matter
Claims 1-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to anticipate or render obvious the cycloidal disc is adapted to be driven in an eccentric motion by means of a planet gear, wherein the planet gear is adapted to mesh with the pinion on the drive shaft and with an internal gear of the cycloidal disc” (see rejection under 35 USC 112 above) as required by independent claims 1 and 12.
The closest prior art of record is Nakamura (US 20210361150), Dahmani et al. (US 20210023307), and Hommann (US 20070225657).
Nakamura discloses a drive for a medical device comprising a drive mechanism comprising a pinon (13g) arranged on a drive shaft (13) and a cycloidal drive comprising a cycloidal disc (15) and a ring gear (18); and wherein the cycloidal disc is adapted to be driven in eccentric motion by a planet gear (14) that meshes with the pinon (Figure 5). However, Nakamura does not disclose that the planet gear meshes with an internal gear of the cycloidal disc. The planet gear (wave generator 14) causes motion of the cycloidal disc via rollers 14r and the cycloidal disc (external gear member 15) does not include an internal gear.
Dahmani discloses a drive for a drug delivery device (1000) comprising a drive mechanism (Figure 6) comprising a drive shaft and a pinon (710) arranged on the drive shaft, and a planet gear (720), but fails to explicitly disclose a cycloidal drive.
Hommann discloses a drug delivery device (Figures 1-2) comprising a cycloidal drive (40) comprising a cycloidal disc (42) and ring gear (44), but fails to explicitly disclose a planet gear that meshes with pinon on a drive shaft an internal gear of the cycloidal disc. Additionally, Hommann disclose that the cycloidal drive is part of a dose setting means, not a drive as claimed.
A modification to the drives disclosed by Nakamura, Dahmani, and/or Hommann to include all of these limitations would require altering the way the discloses drives were designed to function, and there is not motivation to suggest such modifications. Thus, for at least the foregoing reasons, the prior art of record fails to anticipate or render obvious the present invention as set forth in the independent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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