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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/24/2026 is acknowledged.
Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/24/2026. It is noted that claim 29 contains limitations in the alternative which are drawn to the non-elected invention, claim 29 should be amended to remove language pertaining to the non-elected invention.
Information Disclosure Statement
Due to a long list of IDS submitted, Examiner refers Applicant to MPEP 2004 and in particular to point 13 which states: It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant's attention and/or are known to be of most significance. See Penn Yan Boats, Inc. V. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff'd, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC V. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because the same reference character is being used for multiple structures thereby adding unnecessary complexity and obfuscating understanding of the invention. For example, reference character “2” has been used to designate a transfer member, a moveable member, a drive member, and a rotating collar; reference character “4” has been used to designate a housing element and a drive spring holder; reference character “5” has been used to designate a release member, a protection member, and a needle shroud; and reference character “51” has been used to designate a first stop feature, a displaceable element, and a resilient arm.
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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: angular direction C as described on page 33, line 12 of the substitute specification. 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. 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
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 27 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 27 recites in the initial state, the second stop feature is located distally with respect to the first stop feature. According to the initial state as shown in Fig. 34, the first (51) and second (22) stop features appear to occupy the same position. The specification does not support the second stop feature being distal to the first stop feature in the initial state. For examination purposes, the limitation will be interpreted as the second stop feature being proximate to the first stop feature as best understood.
Claim 29 recites, in the alternative, the second stop feature being a displaceable stop feature which is displaceable in a radial direction. However, such a limitation is not supported in the specification as originally filed.
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 17-36 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.
The last section of claim 17 recites “the protection member is in the post-release position… to prevent further movement of the protection member in a proximal direction before the protection member reaches the proximal position.” [emphasis added] The language states that the protection is in the post-release (i.e., final position) and is prevented from moving proximally (in order to keep the needle covered), however, the italicized phrase appears to indicate that the protection member will later reach the proximal position again. It is unclear how or why the protection member would possibly move proximally in the future when it is already in the final position and is being prevented from moving proximally thereby conflicting with any possible future proximal movement of the protection member. Claims 35 and 36 are rejected for similar reasons as set forth above regarding claim 17. For examination purposes, the limitation will not be considered.
Claim 22 recites the movable member is configured to “hold a displaceable stop feature in a first radial position…” It is unclear if this displaceable stop feature is referring to a part of the first stop feature, a part of the second stop feature, or another stop feature altogether. Since only the first stop feature is radially displaceable, the displaceable stop feature will be interpreted as part of the first stop feature.
Claim 33 recites a relative position which is only true in the released state, as the first stop feature is distal to the second stop feature in the post-released state, which contradicts the position defined by claim 33. Examiner suggests specifying that the claimed position occurs during in the released state.
Claim 27 recites the second stop feature being located proximally with respect to the second stop feature in the post-released state. The second stop feature cannot be located proximally with respect to itself and therefore indefinite.
Claim 31 recites a housing with the housing element fixed to or integrated in the housing. It is unclear if the housing is a separate element from the housing element. For examination purposes, both will be considered the same element.
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 17-22, 26, 27, 35, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2017/0056600 to Schoonmaker.
Regarding claim 17, Schoonmaker teaches a drug delivery device (Fig. 14) comprising a housing element (50), a protection member (20) arranged axially movable with respect to the housing element and configured to cover a drug delivery element (51), a movable member (10) arranged movable with respect to the housing element, a first stop feature (22) axially fixed with respect to the protection member (20), and a second stop feature (19, Fig. 30) configured to interact with the first stop feature, wherein the drug delivery device is configured to perform a drug delivery operation, wherein the drug delivery device is configured to be switchable from an initial state (Fig. 7) into a released state in which (i) the protection member is in a proximal position ([0056] & Fig. 29) and (ii) the movable member is configured to move into a locking position ([0057], 10 is fixed rotationally), wherein the drug delivery device is configured to be switchable from the released state into a post-released state (Fig. 30) by moving the protection member from the proximal position in a distal direction into a post-release position (Fig. 30), wherein in the post-released state (i) the protection member is in the post-release position (Fig. 30) and (ii) the movable member (10) is in the locking position ([0058]) in which the first (22) and second (19) stop features are configured to interact with each other to prevent a further movement of the protection member in a proximal direction ([0059], Fig. 30)
Regarding claim 18, Schoonmaker teaches the drug delivery device according to claim 17 as shown above, Schoonmaker further teaching the movable member is arranged axially movable with respect to the housing element, and in the released state, the movable member is configured to move axially into the locking position ([0057], 14 moves axially from A to B, Fig. 24).
Regarding claim 19, Schoonmaker teaches the drug delivery device according to claim 17 as shown above, Schoonmaker further teaching the movable member (10) is arranged rotatably with respect to the housing element, and in the released state, the movable member is configured to rotate (rotation arm 14 of lock collar 10 rotates).
Regarding claim 20, Schoonmaker teaches the drug delivery device according to claim 17 as shown above, Schoonmaker further teaching in the initial state (Fig. 7), the protection member is in a pre-release position which is distally offset with respect to the proximal position (Fig. 29), and the movable member is in a non-locking position in which an interaction of the first and second stop features is disabled such that the protection member is allowed to be moved from the pre-release position in the proximal direction into the proximal position (22 and 19 do not interact in the from the pre-release position to the proximal position).
Regarding claim 21, Schoonmaker teaches the drug delivery device according to claim 20 as shown above, Schoonmaker further teaching the drug delivery device is configured to be switchable from the initial state (Fig. 7) into the released state by moving the protection member from the pre-release position into the proximal position (the protection member is moved proximally in order to uncover the needle).
Regarding claim 22, Schoonmaker teaches the drug delivery device according to claim 20 as shown above, Schoonmaker further teaching the movable member in the non-locking position is configured to hold a displaceable stop feature in a first radial position when the protection member is moved in proximal direction ([0056], as 22 rides proximally up the ramp) and before the first stop feature reaches the second stop feature (the proximal movement occurs before 22 is locked in 19).
Regarding claim 26, Schoonmaker teaches the drug delivery device according to claim 17 as shown above, Schoonmaker further teaching the second stop feature (19) is axially and rotationally fixed with respect to the movable member (10, Fig. 30).
Regarding claim 27, Schoonmaker teaches the drug delivery device according to claim 26 as shown above, Schoonmaker further teaching in the initial state, the second stop feature is located proximate to the first stop feature, and in the post-released state, the second stop feature is located proximally with respect to the second stop feature (a portion of 19 is proximal to more distal portion of 19).
Regarding claim 35, Schoonmaker teaches a drug delivery device comprising a housing element (50), a protection member (20) arranged axially movable with respect to the housing element and configured to cover a drug delivery element (51), a movable member (10) arranged movable with respect to the housing element, a first stop feature (22) axially fixed with respect to the protection member (20), and a second stop feature (19, Fig. 30) configured to interact with the first stop feature, wherein the drug delivery device is configured to perform a drug delivery operation, wherein the drug delivery device is configured to be switchable from an initial state (Fig. 7) into a released state in which (i) the protection member is in a proximal position (Fig. 29) and the movable member is configured to move into a locking position (position of 10 in Fig. 30) and (ii) the movable member is configured to move axially in proximal direction and is configured to rotate ([0057], 14 moves axially and rotates from A to B), wherein the drug delivery device is configured to be switchable from the released state into a post-released state (Fig. 30) by moving the protection member from the proximal position (Fig. 29) in a distal direction into a post-release position (Fig. 30), and wherein in the post-released state (i) the protection member is in the post-release position (Fig. 30) and (ii) the movable member is in the locking position in which the first (22) and second (19) stop features are configured to interact with each other to prevent a further movement of the protection member in the proximal direction (Fig. 30)
Regarding claim 36, Schoonmaker teaches a drug delivery device comprising a housing element (50), a protection member (20) arranged axially movable with respect to the housing element and configured to cover a drug delivery element, a movable member (10) arranged movable with respect to the housing element, a first stop feature (22) axially fixed with respect to the protection member, and a second stop feature (19, Fig. 30) configured to interact with the first stop feature, wherein the drug delivery device is configured to perform a drug delivery operation, wherein the drug delivery device is configured to be switchable from an initial state (Fig. 7) into a released state in which (i) the protection member is in a proximal position (Fig. 29), (ii) the movable member moves into a locking position (position of 10 in Fig. 30) and (iii) the movable member moves axially in proximal direction and/or rotates ([0057], 14 moves axially and rotates from A to B), wherein the drug delivery device is configured to be switchable from the released state into a post-released state (Fig. 30) by moving the protection member from the proximal position (Fig. 29) in a distal direction into a post-release position (Fig. 30), wherein in the post-released state (i) the protection member is in the post-release position (Fig. 30) and (ii) the movable member is in the locking position (the position of 10 in the post-release position is interpreted as the locking position) in which the first (22) and second (19) stop features interact with each other to prevent a further movement of the protection member in a proximal direction (Fig. 30) .
Claims 17-25 and 29-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2013/0131602 to Kemp et al. (“Kemp”).
Regarding claim 17, Kemp teaches a drug delivery device comprising a housing element (2), a protection member (3) arranged axially movable with respect to the housing element and configured to cover a drug delivery element (6), a movable member (13/14) arranged movable with respect to the housing element, a first stop feature (3.9) axially fixed with respect to the protection member (3), and a second stop feature (2.3) configured to interact with the first stop feature, wherein the drug delivery device is configured to perform a drug delivery operation, wherein the drug delivery device is configured to be switchable from an initial state (Fig. 5A) into a released state (Fig. 6A) in which (i) the protection member (3) is in a proximal position (Fig. 6A) and (ii) the movable member is configured to move into a locking position (Fig. 7A), wherein the drug delivery device is configured to be switchable from the released state (Fig. 6A) into a post-released state (Fig. 7A) by moving the protection member from the proximal position (Fig. 6A) in a distal direction into a post-release position (Fig. 7A), wherein in the post-released state (i) the protection member is in the post-release position (Fig. 7A) and (ii) the movable member is in the locking position (the position of 13/14 in the post-release position is interpreted as the locking position) in which the first (3.9) and second (2.3) stop features are configured to interact with each other to prevent a further movement of the protection member in a proximal direction (Fig. 7A)
Regarding claim 18, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching the movable member is arranged axially movable with respect to the housing element ([0130], 13 moves longitudinally), and in the released state, the movable member is configured to move axially into the locking position ([0103], 13 is pushed in direction P).
Regarding claim 19, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching the movable member is arranged rotatably with respect to the housing element ([0130], 14 is rotationally free), and in the released state, the movable member is configured to rotate ([0130], 14 rotates to move the plunger).
Regarding claim 20, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching in the initial state (Fig. 5A) the protection member (3) is in a pre-release position which is distally offset with respect to the proximal position (3 in Fig. 5A is offset with respect to the proximal position of Fig. 6A), and the movable member is in a non-locking position in which an interaction of the first and second stop features is disabled such that the protection member is allowed to be moved from the pre-release position in the proximal direction into the proximal position (the first and second stop features do not interact tin the pre-release position).
Regarding claim 21, Kemp teaches the drug delivery device according to claim 20 as shown above, Kemp further teaching the drug delivery device is configured to be switchable from the initial state into the released state by moving the protection member from the pre-release (Fig. 5A) position into the proximal position (Fig. 6A).
Regarding claim 22, Kemp teaches the drug delivery device according to claim 20 as shown above, Kemp further teaching the movable member (13/14) in the non-locking position is configured to hold a displaceable stop feature in a first radial position when the protection member is moved in proximal direction and before the first stop feature reaches the second stop feature (first radial position of 3.9 in Fig. 6A).
Regarding claim 23, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching a plunger rod (8) arranged axially movable with respect to the housing element, and an energy member (11) configured to provide energy to induce an axial movement of the plunger rod in the distal direction, wherein in the released state (i) the plunger rod moves in the distal direction due to the energy provided by the energy member and (ii) the movable member is moved due to the energy provided by the energy member (Fig. 7A, the plunger and 14 move).
Regarding claim 24, Kemp teaches the drug delivery device according to claim 23 as shown above, Kemp further teaching the movable member and the plunger rod are operatively coupled such that a movement of the movable member in a first direction is converted into a movement of the plunger rod in the distal direction (14 rotates and plunger 8 moves distally), and in the released state, the energy member provides a force onto the movable member in which the movable member moves in the first direction and forces the plunger rod to move axially in the distal direction ([0130]).
Regarding claim 25, Kemp teaches the drug delivery device according to claim 24 as shown above, Kemp further teaching the second stop feature circumferentially extends around a complete revolution of a rotational axis of the movable member (the second stop feature is interpreted as the circumferential portion of 2 that includes recesses 2.3).
Regarding claim 29, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching the first stop feature is a displaceable stop feature which is displaceable in radial direction (3.9 bends radially), and the first and second stop features are configured to (i) pass each other without interacting when the displaceable stop feature is in a first radial position (Fig. 9) and (ii) interact with each other when the displaceable stop feature is in a second radial position (Fig. 10).
Regarding claim 30, Kemp teaches the drug delivery device according to claim 29 as shown above, Kemp further teaching a lock interface is formed between the first stop feature and the second stop feature when interacting with each other (interface between 3.9 and 2.3 in Fig. 7A), the lock interface configured to prevent the displaceable stop feature from being displaced into the first radial position ([0151]).
Regarding claim 31, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching a housing with the housing element (2) fixed to or integrated in the housing (2), and a medicament container (4) with a needle (6), wherein the protection member is telescopically coupled to the housing (Fig. 6 to Fig. 7), wherein in the post-released position, the needle is covered by the protection member (Fig. 7A), and in the proximal position (Fig. 6A), the needle is exposed.
Regarding claim 32, Kemp teaches the drug delivery device according to claim 31 as shown above, Kemp further teaching the medicament container comprises a medicament or a drug (M).
Regarding claim 33, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching the second stop feature is located distally with respect to the first stop feature (Fig. 6A).
Regarding claim 34, Kemp teaches the drug delivery device according to claim 17 as shown above, Kemp further teaching the second stop feature comprises a recess or notch (3.9) into which the first stop feature projects or engages (Fig. 7A) when the first stop feature and the second stop feature interact with each other (Fig. 7A).
Regarding claim 35, Kemp teaches a drug delivery device comprising a housing element (2), a protection member (3) arranged axially movable with respect to the housing element and configured to cover a drug delivery element (6), a movable member (13/14) arranged movable with respect to the housing element, a first stop feature (3.9) axially fixed with respect to the protection member (3), and a second stop feature (2.3) configured to interact with the first stop feature, wherein the drug delivery device is configured to perform a drug delivery operation, wherein the drug delivery device is configured to be switchable from an initial state (Fig. 5A) into a released state (Fig. 6A) in which (i) the protection member (3) is in a proximal position (Fig. 6A) and the movable member is configured to move into a locking position (the position of 13/14 in the post-release position is interpreted as the locking position) and (ii) the movable member is configured to move axially in proximal direction and is configured to rotate ([0130], 13 is capable of moving axially and 14 is capable of rotation), wherein the drug delivery device is configured to be switchable from the released state (Fig. 6A) into a post-released state (Fig. 7A) by moving the protection member from the proximal position in a distal direction into a post-release position (Fig 7A), and wherein in the post-released state (i) the protection member is in the post-release position (Fig. 7A) and (ii) the movable member is in the locking position in which the first (3.9) and second (2.3) stop features are configured to interact with each other to prevent a further movement of the protection member in the proximal direction (Fig. 7A)
Regarding claim 36, Kemp teaches a drug delivery device comprising a housing element (2), a protection member (3) arranged axially movable with respect to the housing element and configured to cover a drug delivery element, a movable member (13/14) arranged movable with respect to the housing element, a first stop feature (3.9) axially fixed with respect to the protection member, and a second stop feature (2.3) configured to interact with the first stop feature, wherein the drug delivery device is configured to perform a drug delivery operation, wherein the drug delivery device is configured to be switchable from an initial state (Fig. 5A) into a released state (Fig. 6A) in which (i) the protection member is in a proximal position (Fig. 6A), (ii) the movable member moves into a locking position (Fig. 7A) and (iii) the movable member moves axially in proximal direction and/or rotates, wherein the drug delivery device is configured to be switchable from the released state into a post-released state by moving the protection member from the proximal position in a distal direction into a post-release position ([0130]), wherein in the post-released state (i) the protection member is in the post-release position (Fig. 7A) and (ii) the movable member is in the locking position (the position of 13/14 in the post-release position is interpreted as the locking position) in which the first (3.9) and second (2.3) stop features interact with each other to prevent a further movement of the protection member in a proximal direction (Fig. 7A)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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