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 with traverse of Group I and Species I in the reply filed on 03/10/2026 is acknowledged. The traversal is on the ground(s) that Species III is part of Species I. Applicant amended instant application Paragraph 0039, removing contradictory language, resulting in Figures 5-6 being part of Species I. Due to the specification amendment, Examiner agrees there is now no Species III.
Since the traversal is on the grounds of a typo in the instant application, the restriction between Groups I-II and Species I-II is still deemed proper.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to under 37 CFR 1.83(a) and/or PCT Article 7, Paragraph (1). The drawings must show every feature of the invention specified in the claims, when they are necessary for the understanding of the invention. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
the push element
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 § 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 10-12 & 25-30 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.
As to Claim 10, the term “push element” is indefinite. The term is not discussed in the specification, except for a portion of the specification reciting the claim language. However, a push member, which also engages the syringe is discussed in the specification. As such, it is not clear if the claimed push element is the push member, or if the push element is an unknown structure, rendering the claim indefinite. For the purpose of examination, the push element will be interpreted as the push member.
As to Claim 25, the limitation “the shuttle system further a cam follower coupled to the one-way clutch, and a guide positioned radially relative to the cam follower” is indefinite. The limitation is incomplete. The limitation appears to be attempting to define a relationship between the shuttle system and the cam follower. However, it appears some words establishing the relationship were left out of the limitation. As such, the relationship between the shuttle system and the cam follower is not clear, rendering the claim indefinite. For the purpose of examination, the limitation will be interpreted as the shuttle system is further comprised of a cam follower coupled to the one-way clutch, and a guide positioned radially relative to the cam follower.
As to Claim 27, the phrase “a syringe of a syringe assembly”, in Line 6, is indefinite. A syringe assembly with a syringe was defined in Line 3. As such, it is not clear if the syringe and syringe assembly of Line 6 is the same syringe and syringe assembly of Line 3, or if a second syringe assembly with a second syringe is being defined in Line 6, rendering the claim indefinite. For the purpose of examination, the syringe assembly and syringe of Line 6 will be interpreted as the syringe assembly and syringe of Line 3.
The phrase “a plunger within the syringe”, in Line 8, is indefinite. A plunger was defined in Line 3. As such, it is not clear if the plunger of Line 8 is the plunger of Line 3, or if a second plunger is being defined in Line 8, rendering the claim indefinite. For the purpose of examination, the plunger of Line 8 will be interpreted as the plunger of Line 3.
Allowable Subject Matter
Claims 1-9 & 23-24 are allowed.
As to Claims 1 & 24, the prior art of record teaches a therapeutic agent delivery device with a syringe assembly comprising a plunger, a shuttle system, a drive mechanism with a lead screw engaging the plunger; a controller which activates the drive mechanism to rotate the lead screw in a first direction to distally move the shuttle system and move the syringe assembly from a first position to a second position to extend a needle from a distal end of the device; rotate the lead screw in a second direction, the lead screw driving the plunger to deliver the therapeutic agent…and ending activation of the drive mechanism but does not teach rotating the lead screw in the first direction after rotation of the lead screw in the second direction to retract the lead screw from the plunger and to facilitate movement of the shuttle system proximally. Therefore, the prior art of record fails to disclose each of the limitations of Claims 1 or 24. The closest art of record is McLoughlin (U.S. PGPub 2014/0358085). However, McLoughlin describes retracting the lead screw from the plunger by moving the lead screw in the second direction –see Figure 39G and Paragraph 0377. It would not be obvious to one of ordinary skill in the art to modify McLoughlin without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claims 1 and 24, is neither anticipated nor made obvious by the prior art of record.
Claims 2-9 & 23 depend on Claim 1, so are also allowed.
Claims 10-12 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims, since Claims 10-12 also depend on Claim 1.
Claims 25-26 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims, since Claims 25-26 depend on Claim 24.
Claims 27-30 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims, since Claims 10-12 also depend on Claim 1.
As to Claim 27, the prior art of record teaches a therapeutic agent delivery device with a syringe assembly comprising a plunger, a plunger drive and syringe movement system with a cam follower, a cam ramp, a one-way clutch coupled to the follower, a carriage coupled to a syringe of the syringe assembly; a lead screw coupled to the cam follower the lead screw engaged with the plunger; a motor coupled to the lead screw to drive the lead screw in a first direction and second direction; where driving the lead screw in the second direction facilitates expulsion of the therapeutic agent, but does not teach a one-way clutch or rotation of the lead screw in the first direction facilitates rotation of the cam follower to a position relative to the cam ramp to permit a displacement change to the carriage relative to the cam ramp. Therefore, the prior art of record fails to disclose each of the limitations of Claim 27. The closest art of record is McLoughlin (U.S. PGPub 2014/0358085). However, McLoughlin does not describe any relationship between the cam follower 194 and the rotation of lead screw 81. It would not be obvious to one of ordinary skill in the art to modify McLoughlin without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 27, is neither anticipated nor made obvious by the prior art of record.
Claims 28-30 depend on Claim 27, so would also be allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dahmani (2021/0023307) and Klitmose (2019/0336698) describe similar devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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