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 “a protrusion and a groove arranged in the protrusion, wherein one of the protrusion and the groove is on the plunger rod and the other of the protrusion and the groove are on any component of the sub-assembly other than the plunger rod”, subject matter of claim 26, must be shown or the feature(s) canceled from the claim(s). 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 Objections
Claims 20-24 are objected to because of the following informalities:
Regarding claims 20-21 and 23, “a plane” should be corrected to “the plane” for claim language consistency.
Regarding claims 22 and 24, “a plane” should be corrected to “the plane” and “a circumferential” should be corrected to “the circumferential” for claim language consistency.
Appropriate correction is required.
Applicant is advised that should claim 16 be found allowable, claim 30 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 26 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 26, the limitation of “wherein one of the protrusion and the groove is on the plunger rod and the other of the protrusion and the groove are on any component of the sub-assembly other than the plunger rod” renders the claim unclear. The claim includes contradictory language. As the claim is written, both the protrusion and the groove must be on the plunger rod: “wherein one of the protrusion and the groove is on the plunger rod”. However, the next limitation limits the other of the protrusion and groove to be on any component other than the plunger rod: “the other of the protrusion and the groove are on any component of the sub-assembly other than the plunger rod”. The protrusion and the groove cannot both be on the plunger rod and simultaneously not be on the plunger rod. For purposes of examination, the Examiner is interpreting the claim to read “wherein one of the protrusion or the groove is on the plunger rod and the other of the protrusion or the groove are on any component of the sub-assembly other than the plunger rod”.
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.
Claims 17 and 27 are 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.
Regarding claim 17, the limitation of “wherein the component is the housing” fails to include all the limitations of claim 16, which claim 17 depends on. Claim 16 positively recites two independent structures, “a housing” and “a component of the sub-assembly”. Claim 17 further limits the component to be the housing which deletes a limitation.
Regarding claim 27, the limitation of “wherein the any component of the sub- assembly other than the plunger rod is the housing” fails to include all the limitations of claims 16 and 26, which claim 27 depends on. Claim 16 positively recites “a housing” and claim 26 positively recites “on any component of the sub-assembly other than the plunger rod”. Claim 27 further limits any component of the sub-assembly other than the plunger rod to be the housing which deletes a limitation.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmqvist (US 20150273162 A1).
Regarding claim 16, Holmqvist discloses a sub-assembly for a medicament delivery device (housing 10, actuation member 48, and holding member 70 of medicament delivery device of Fig. 1-2, see [0037], [0040], and [0042]), the sub-assembly extending along a longitudinal axis in a longitudinal direction from a proximal end to a distal end (housing 10, member 48, and member 70 all extending along a longitudinal axis L in a longitudinal direction from a proximal end to a distal end, [0037] & Fig. 1-2), the sub-assembly comprising:
a housing (housing 10, [0037] & Fig. 1-2; alternatively, housing 10 and holding member 70 may be interpreted as a housing as housing 10 and member 70 house components of the medicament delivery device, see Fig. 4); and
a plunger rod arranged at least partly inside the housing (actuation member 48 arranged inside housing 10, [0040] & Fig. 2 and 4), the plunger rod being rotationally locked relative to the housing ([0040]), wherein the plunger rod comprises a flexible arm, the flexible arm comprising a first surface facing towards the proximal end (member 48 comprises latching projection 58, which includes flexible section 62, [0041] & Fig. 6; cut-out or notch 102, which is being interpreted as a first surface, faces toward the proximal end, [0055] & Fig. 7-9); wherein a component of the sub-assembly other than the plunger rod comprises a second surface facing towards the distal end (holding member 70 comprises latching surface 64, [0048] & Fig. 6; surface 64 includes distal contact surface 100 and slanted section 104, [0055] & Fig. 7-9), with the first surface and the second surface being arranged so that, when the plunger rod moves towards the proximal end relative to the component during medicament delivery device use, the first surface and the second surface engage to flex the flexible arm in a circumferential direction relative to the component and then disengage so that the flexible arm flexes back relative to the component ([0051]-[0052] and [0055] Fig. 6-9; when member 48 moves toward the proximal end relative to member 70, notch 102 and section 104 engage to flex projection 58 in a circumferential direction relative to member 70 and then disengage so that projection 58 flexes back relative to member 70).
Regarding claim 17, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein the component is the housing (member 70 is being interpreted as part of the housing as member 70 houses components of the medicament delivery device, see Fig. 4).
Regarding claim 18, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein the housing comprises an outer housing (housing 10, [0037] & Fig. 1-4) and a rear cap, and the rear cap comprises the second surface (holding member 70 is being interpreted as a rear cap, as member 70 is provided in the rear of the medicament device, see Fig. 4; member 70 comprises surface 64, which comprises surface 100 and 104, [0055] & Fig. 6-9).
Regarding claims 19, 21, and 23, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein at least part of at least one of the first surface and the second surface is angled relative to a plane perpendicular to the longitudinal axis (both surface 102 and slanted section 104 are angled relative to a plane perpendicular to axis L, [0055] & Fig. 7-9).
Regarding claim 20, Holmqvist discloses all the limitations of claim 19. Holmqvist further discloses the sub-assembly wherein the at least part of at least one of the first surface and the second surface is angled relative to a plane perpendicular to the longitudinal axis at an angle (both surface 102 and slanted section 104 are angled relative to a plane perpendicular to axis L, [0055] & Fig. 7-9). Both surfaces 102 and section 104 appear to be angled at an angle of 45 degrees, as best seen in Fig. 8.
However, Holmqvist fails to explicitly disclose an angle of between 10 and 85 degrees. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause at least part of at least one of the first surface and the second surface to be angled relative to a plane perpendicular to the longitudinal axis at an angle of between 10 and 85 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the surfaces of Holmqvist appear to already be angled at an angle of between 10 and 85 degrees, as best seen in Fig. 8. The surfaces would not operate differently at the claimed angle since the surfaces would continue to interact with each other to provide an audible/tactile feedback. Further, applicant places no criticality on the claimed angle, indicating simply that “Typically, at least one of the protrusion on the rear cap and the protrusion on the plunger rod comprises a surface (such as the surface 78) that is angled relative to a plane perpendicular to the longitudinal axis… for example between 10 and 85 degrees”. (page 12 third paragraph).
With regard to claim 22, the first surface is being interpreted as the angled surface of projection 58 positioned proximally to notch 102, annotated below in Fig. 8 as “First Surface for Claim 22”. In this configuration, Holmqvist discloses all the limitations of claim 21.
Holmqvist further discloses the sub-assembly wherein the sub-assembly comprises a feedback surface angled relative to a plane perpendicular to the longitudinal axis (cut-out or notch 102 is angled relative to a plane perpendicular to axis L, [0055] & Fig. 1 and 8-9; notch 102 configured to provide both audible and tactile information to the user, [0055]), wherein the feedback surface is spaced apart in a circumferential direction relative to the longitudinal axis from a distal end of the first surface (as seen in Fig. 8, notch 102 is at least partially spaced apart in a circumferential direction relative to axis L from a distal end of the first surface, see annotated Fig. 8 below).
Regarding claim 24, Holmqvist discloses all the limitations of claim 23. Holmqvist further discloses the sub-assembly wherein the sub-assembly comprises a feedback surface angled relative to a plane perpendicular to the longitudinal axis (the feedback surface is being interpreted as the angled surface of projection 58 positioned proximally to notch 102, annotated below in Fig. 8 as “Feedback Surface for Claim 24”; this structure partially defines notch 102, Fig. 8; contact between the feedback surface and section 104 would provide tactile and audible information to a user, [0055]), wherein the feedback surface is spaced apart in a circumferential direction relative to the longitudinal axis from a proximal end of the first surface (as seen in Fig. 8, the feedback surface is at least partially spaced apart in a circumferential direction relative to axis L from a proximal end of the first surface, see annotated Fig. 8 below).
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Regarding claim 25, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein the component is rotationally locked relative to the housing (member 70 is not configured to rotate, [0042] and [0048] & Fig. 4).
Regarding claims 26-27, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein the plunger rod is rotationally locked relative to the housing by a protrusion and a groove arranged in the protrusion, wherein one of the protrusion and the groove is on the plunger rod and the other of the protrusion and the groove are on any component of the sub-assembly other than the plunger rod (member 48 is rotationally locked relative to member 70 by arm(s) 60, which are arranged on member 48, and groove(s) 66, which are arranged on member 70, [0040] and [0042] & Fig. 2 and 6-9).
Regarding claim 28, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein a distal end of the flexible arm is attached to a main body of the plunger rod (a distal end of projection 58, distal end surfaces 63, is attached to the main body of member 48 through flexible section 62 and arm 60, [0041] & Fig. 6 and 8-9), and wherein a proximal end of the flexible arm is free to flex relative to the main body of the plunger rod (the proximal end of projection 58 is being interpreted as at least one flexible section 62, [0041] & Fig. 6 and 8-9; flexible section 62 is configured to freely flex relative to arm 60 and button 54 of member 48, [0051] & Fig. 6-9).
Regarding claim 29, Holmqvist discloses all the limitations of claim 16. Holmqvist further discloses the sub-assembly wherein the flexible arm is in a recess or slot in a main body of the plunger rod (the space between arm 60 and push button 54, in which projection 58 is disposed and allowed to flex, is being interpreted as a slot or recess in the main body of member 48, see Fig. 6 and 8).
Regarding claim 30, Holmqvist discloses a medicament delivery device (abstract and [0037] & Fig. 1) comprising the sub-assembly of claim 16 (see the rejection of claim 16 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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