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 directed to claims 1-8 in the reply filed on 07/08/2026 is acknowledged. In summary, claims 1-20 are still pending, with claims 9-20 being withdrawn from consideration. Claims 1-8 are being examined on the merits.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: element 190b in fig. 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
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.
Claims 1, 3, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over David Horvath (WO 2023283291) in view of Christopher Horvath (US 20150133946).
Regarding claim 1, David Horvath discloses an insertion device for injecting an implant into an eye (abstract), the insertion device comprising:
a body comprising:
a push button comprising a button (fig. 1, dispense button 116), a first spring (fig. 2, torsion spring 148), and an arm extending from the button (fig. 2, dispense button arm 142), wherein the first spring biases the arm and the button in an upward position (paragraph 0051, “Torsion spring 148 may be provided to bias dispense button 116 in a generally upward direction out of the enclosure),
a pusher wire (fig. 5, plunger 172), and
a pushing mechanism comprising a shuttle (fig. 5, pusher 156) and a second spring (fig. 5, compression spring 160), wherein the pusher wire comprises a first end and a second end (fig. 5, plunger 172 has two ends) and wherein the second end of the pusher wire is coupled to the shuttle (paragraph 0061 describes an end of plunger 172 to be affixed into recess 198 of the pusher 156); and
an inserter tip comprising a needle (fig. 5, needle 112),
wherein, upon depression of the push button, the pushing mechanism is configured to displace the pusher wire, such that a portion of the pusher wire translates through the needle (paragraph 0062 describes the dispense button 116 being pressed to drive pusher 156 to the dispensed position, in which the implant is delivered).
David Horvath is silent to wherein the inserter tip is removably coupled to the body.
However, Christopher Horvath teaches an ocular implanting device (abstract) wherein a needle assembly is separable and replaceable from the assembly (paragraph 0252).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed inf David Horvath such that the inserter tip is removably coupled to the body, as taught by Christopher Horvath, for the purpose of providing a suitable structure that facilitates reuse of the device (see Christopher Horvath, paragraph 0253), thus allowing the device to be multiple use as opposed to single use.
Regarding claim 3, David Horvath discloses wherein the body further comprises a backbone (fig. 4, backbone comprises structure that forms slots 178 and pivot recess 146), wherein the push button and the pushing mechanism are integrated with the backbone (fig. 4 demonstrates rib 176 of pusher 156 going into slot 178, and protruding pins 144 of arm 142 going into pivot recess 146).
Regarding claim 6, David Horvath discloses the device further comprising: a retaining member (paragraph 0015 describes a bend in the cannula , a nail head, a dimple, etc. for retaining an implant within the cannula); and
an implant disposed within the needle (paragraph 0015), wherein the retaining member exerts a force on the implant, holding the implant in place within the needle (paragraph 0015).
Regarding claim 7, David Horvath discloses wherein depression of the push button causes the portion of the pusher wire to translate through the needle and into the implant, wherein a force exerted on the implant from the pusher wire is greater than the force from the retaining member, causing the implant to eject from the needle (paragraph 0015 describes the retaining feature retaining the implant within the cannula until the implant is pushed out by the plunger).
Regarding claim 8, David Horvath discloses wherein the implant comprises a pharmaceutical for delivery to the eye (paragraph 0002).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over David Horvath in view of Christopher Horvath, and further in view of Haffner (US 20150238687).
Regarding claim 2, David Horvath is silent to wherein the pusher wire translates through the needle at a consistent velocity, wherein the consistent velocity is independent of a force applied to the push button via depression of the push button.
However, Haffner teaches wherein the pusher wire translates through the needle at a consistent velocity (paragraph 0151 describes the velocity/energy the implant is released is determined by the spring 134, wherein with no other factors the velocity appears consistent), wherein the consistent velocity is independent of a force applied to the push button via depression of the push button (paragraph 0024, “Depression of the ejector button unlocks the spring but does not contribute to the force of implant ejection”)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in David Horvath such that the pusher wire translates through the needle at a consistent velocity, wherein the consistent velocity is independent of a force applied to the push button via depression of the push button, as taught by Haffner, for the purpose of providing a suitable structure that reduces variability in the implant administration (see Haffner, paragraph 0024).
Allowable Subject Matter
Claims 4-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, David Horvath discloses wherein the shuttle comprises a locking surface (fig. that receives a portion of the arm of the push button (fig. 5, locking surface 194 to prevent the button 116 from being downwardly depressed, paragraph 0059),
but does not teach wherein the shuttle comprises a first groove and a second groove, wherein the first groove and the second groove are configured to receive a portion of the arm of the push button (fig. 22, two grooves defined by gaps between posts 122 and 122’ on both sides, see annotated fig. 22 below, also see paragraph 0161 to describe interaction between posts and the wings/arm of the ejector button).
While the locking surface of David Horvath serves a similar role to the grooves of the instant invention, there does not appear to be an obvious motivation to modify the shuttle of David Horvath to include first and second grooves that receive a portion of the arm of the push button.
Haffner teaches a structure wherein a button (64) has a pair of arms (124) that engage with two posts (122, 122’) on each side of a shuttle (120) (fig. 22 shows posts 122, 122’, fig. 18A-E shows button 64 with wings 124). However, even if the space between the posts was interpreted to be a groove on each side forming a first and second groove, it would be more of a stretch to describe both wings 124 as being a singular arm such that both the first groove and the second groove each receive a portion of the arm.
Kalina (US 11376040) teaches wherein an arm (374) of a button (216) engages with a groove of a collet holder (col. 25, lines 20-28). However, not only does this not cure the deficiency of a first and a second groove, it does not appear combinable with the structure of David Horvath without major revisions. Moreover, Kalina’s dispenser does not dispense the implant upon depressing the button, but rather upon releasing the button (col. 5, lines 21-37).
For these reasons, claim 4 contains allowable subject material.
Claim 5 contains allowable subject material by virtue of being dependent on claim 4
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781
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