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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of claims 1-16 in the reply filed on 06/17/2026 is acknowledged. The traversal is on the ground(s) that Group I and Group II lack unity of invention because the groups do not share the same or corresponding technical feature. Since claim 16 now depends on claim 1, Groups I and II now share the same technical feature, thus claims 1-16 are now pending in the application.
The requirement is withdrawn.
Response to Amendment
This office action is responsive to the amendment filed on 06/17/2026. As directed by the amendment: claim 16 has been amended.
Thus, claims 1-16 are still pending in this application.
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 abstract of the disclosure is objected to because the paragraph exceeds 150 words in length.
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).
Claim Objections
Claims 1 and 8 are objected to because of the following informalities:
Claim 1, line 10, “a plunger ejection end” should read “the plunger ejection end”.
Claim 1, line 15, “the implanta-tion” should read “the implantation”.
Claim 8, line 3, “the pro-tective cap” should read “the protective cap”.
Claim 8, line 7, “posi-tion” should read “position”.
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 1-16 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.
Claim 1 recites the limitation "the region" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim.
For the purposes of examination, since the region of a free cannula tip is not previously cited in claim 1, examiner is interpreting the region of a free cannula tip as “a region of a free cannula tip”.
By virtue of dependency, claims 2-16 are also rejected.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 6, 9, 12, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Painchaud et al (US 20090182267 A1).
Regarding claim 1, Painchaud et al disclose an application apparatus (fig 3a,
60) for at least one implant (100) comprising a cannula (62), via which the implant (100) is supplied to a target implantation location (para 0080), comprising an applicator housing body (66) with a depot volume (102) for storing the implant (para 0080), comprising a plunger device (76) with a plunger (82), which can be displaced between an initial position, in which a plunger ejection end of the plunger (82) lies on a side of the depot volume (102) facing away from a free cannula tip (figs 3a-c), and an implantation position, in which a plunger ejection end lies in the region of a free cannula tip (figs 3d-f, para 0083), wherein the plunger device (76) comprises a plunger actuation body (80) to which the plunger (82) is connected, preferably in a rigid manner, wherein the applicator housing body (32) is configured for guiding a displacement movement of the plunger device (76) between the initial position (see figs 3a-c) and the implantation position (see figs 3d-c) but fail to expressly teach this embodiment of the invention comprising an initial-position locking device to releasably lock the applicator housing body with the plunger device in the initial position thereof, wherein the initial-position locking device can be switched between a locking position, in which the plunger device is fixed on the applicator housing body in the initial position, and a functional position, in which the plunger device can be displaced in order to displace the plunger relative to the applicator housing body.
However, Painchaud et al disclose in another embodiment an apparatus (10) for at least one implant (22) comprising an initial-position locking device (44 to 46) to releasably lock the applicator housing body (12) with the plunger device (18) in the initial position (fig 1a) thereof, wherein the initial-position locking device (44 to 46) can be switched between a locking position (fig 1a), in which the plunger device (18) is fixed on the applicator housing body (12) in the initial position (fig 1a, para 0059-61), and a functional position (fig1b-c), in which the plunger device (18) can be displaced in order to displace the plunger (18) relative to the applicator housing body (para 0065-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device 60 of Painchaud et al to have an initial-position locking device to releasably lock the applicator housing body with the plunger device in the initial position thereof, wherein the initial-position locking device can be switched between a locking position, in which the plunger device is fixed on the applicator housing body in the initial position, and a functional position, in which the plunger device can be displaced in order to displace the plunger relative to the applicator housing body as taught by Painchaud et al in embodiment of figure 1a-c. This would the benefit of having retaining means that enable the implant to be held in the receiver housing when the needle has not been introduced into the subject's body and while no pressure has been exerted on the plunger rod. Therefore, the device guarantees the user that there is no risk of the implant accidentally falling out of the device before the needle has been inserted into the subject's body (para 0014).
Regarding claim 5, Painchaud et al disclose the application apparatus according to Claim 1, characterized in that the applicator housing body (66) is configured having two parts, with an implant depot body (see annotated figure below) on the cannula side (fig 3b), in which preferably the depot volume (102) is situated for storing the implant (100), and with a guide body (see annotated figure below) for guiding the displacement movement of the plunger device (76) between the initial position and the implantation position (figs 3a-f).
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Regarding claim 6, Painchaud et al disclose the application apparatus according to Claim 1, characterized by a protective cap (64) for covering the cannula tip (tip of 62) in the initial position of the plunger device (figs 3a-c).
Regarding claim 9, Painchaud et al disclose the application apparatus according to Claim 1, characterized by a needle guard body (68) which, in the initial position of the plunger device (76), is arranged in a neutral position in which the cannula (62) projects out from the needle guard body (figs 3a-c), and which, on the displacement of the plunger device (76) from the initial position is transferred beyond the implantation position into a protective position, in which the needle guard body (68) receives the free cannula tip (figs 3d-f, para 0074).
Regarding claim 12, Painchaud et al disclose the application apparatus according to Claim 9, characterized by a protective position locking device for locking the plunger device (76) on the applicator body (66) after reaching the protective position (figs 3d-f, pusher 78 is locked into proximal end 78 of the housing after reaching the protective position and para 0031).
Regarding claim 15, Painchaud et al disclose the application apparatus according to Claim 1 for human-medical, veterinary-medical or cosmetic use (para 0002).
Regarding claim 16, Painchaud et al disclose the application apparatus according to Claim 1, further for use in the administering medicaments (para 0002)
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Painchaud et al (US 20090182267 A1) in view of Federick (US 4915686 A).
Regarding claim 2, Painchaud et al disclose the limitations of claim 1 as discussed above but fail to teach the initial-position locking device is configured such that the switching thereof between the locking position and the functional position takes place by twisting of the plunger device relative to the applicator housing body about a plunger longitudinal axis.
However, Federick teaches an implant injection device (1) comprising a plunger device (8+7) and an applicator housing body (2) wherein the initial-position locking device (fig 1, locking between surface 9 and projection 12) is configured such that the switching thereof between the locking position and the functional position takes place by twisting of the plunger device relative to the applicator housing body about a plunger longitudinal axis (figs 3-4 and col 3, lines 39-68 and col 4, lines 1-28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the initial-position locking device to switch between the locking position and the functional position takes place by twisting of the plunger device relative to the applicator housing body about a plunger longitudinal axis as taught by Federick. This modification would provide the benefit of having an alternative for unlocking the initial locking position by twisting the plunger device to break the linking between said housing and plunger (col 4, lines 21-28).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Painchaud et al (US 20090182267 A1) in view of Hostettler et al (US 20220047817 A1).
Regarding claim 3, Painchaud et al disclose the limitations of claim 1 as discussed above but fail to teach that the initial-position locking device comprises a reverse rotation protection which prevents a reverse displacement of the initial-position locking device from the functional position into the locking position.
However, Hostettler et al disclose an injection device comprising locking position (fig 2, para 0065) wherein the initial-position locking device comprises a reverse rotation protection which prevents a reverse displacement of the initial-position locking device from the functional position into the locking position (para 0020 and 0067).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the initial locking device of Painchaud et al to have the initial-position locking device comprises a reverse rotation protection which prevents a reverse displacement of the initial-position locking device from the functional position into the locking position as taught by Hostettler et al. This would provide the benefit of ensuring that said plunger device can rotate only in the direction that results in a movement of the plunger towards the implantation position direction (para 0067).
Regarding claim 4, Painchaud et al disclose the limitations of claim 1 as discussed above but fail to teach that the initial-position locking device is configured such that an acoustic signal is emitted on a switching of the initial-position locking device from the locking position into the functional position.
However, Hostettler et al disclose an injection device comprising locking position (fig 2, para 0065) wherein the initial-position locking device (53 to 22) is configured such that an acoustic signal is emitted on a switching of the initial-position locking device from the locking position into the functional position (para 0081).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the initial locking device of Painchaud et al to have the initial-position locking device is configured such that an acoustic signal is emitted on a switching of the initial-position locking device from the locking position into the functional position as taught by Hostettler et al. This would provide the benefit of having a sound signal to ensure the locking device is unlocked indicating that the device is ready for implantation (para 0081).
Claims 7, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Painchaud et al (US 20090182267 A1) in view of Novakovic et al (US 20150238687 A1).
Regarding claim 7, Painchaud et al disclose the limitations of claim 1 as discussed above and further teach the protective cap (64) is detachably connected to the applicator housing body (66) but fail to teach that preferably a detaching of the protective cap from the applicator housing body takes place by twisting the protective cap relative to the applicator housing body about a plunger longitudinal axis.
However, Novakovic et al disclose an implant delivery apparatus (40) comprising a protective cap (44) and applicator housing body (42) wherein a detaching of the protective cap from the applicator housing body takes place by twisting the protective cap relative to the applicator housing body about a plunger longitudinal axis (para 0131 and 0133).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the detaching of the protective cap from the applicator housing body of Painchaud et al to take place by twisting the protective cap relative to the applicator housing body about a plunger longitudinal axis as taught by Novakovic et al. This prevents accidental removal by requiring users to first twist the protective cap clockwise or counterclockwise before it can be pulled off the apparatus (para 0132-33).
Regarding claim 13, Painchaud et al disclose the limitations of claim 1 as discussed above and further disclose the application apparatus according to Claim 1, characterized by two applicator assemblies (see annotated figure below), - wherein preferably one of the two applicator assemblies is configured as depot assembly and comprises the cannula (62) and the implant depot body (102), - wherein preferably the other of the two applicator assemblies is configured as plunger assembly and comprises the plunger device (76) and the guide body (see annotated figure below) but fail to teach said applicator assemblies are initially separate and are able to be connected to one another via a detent connection.
However, Novakovic et al disclose an implant delivery apparatus (40) comprising two applicator assemblies (46/48 and 50) that are initially separate and are able to be connected to one another via a detent connection (figs 2 and 7, para 0115).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the applicator of Painchaud et al and incorporate the teachings of Novakovic et al to have applicator assemblies initially separate and are able to be connected to one another via a detent connection. This would provide a manufacture method to manufacture the applicator assemblies as separate pieces and then secured or snapped together for usage (para 0115).
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Regarding claim 14, Painchaud et al in view of Novakovic et al disclose the application apparatus according to Claim 13, characterized in that the depot assembly comprises the protective cap (64) and/or the needle guard body (68, figs 3a-f).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Painchaud et al (US 20090182267 A1) in view of Novakovic et al (US 20150238687 A1) and further in view of Federick (US 4915686 A).
Regarding claim 8, Painchaud et al in view of Novakovic et al disclose the limitations of claim 7,
Novakovic et al disclose that a first rotation direction, in which the protective cap (44) is to be twisted relative to the applicator housing body (42) about the plunger longitudinal axis , in order to detach the protective cap (44) from the applicator housing body (para 0081) but fail to teach it is aligned to a second rotation direction, in which the applicator housing body is to be twisted relative to the plunger device about the plunger longitudinal axis, in order to switch the initial-position locking device from the locking position into the functional position.
However, Federick teaches an implant injection device (1) comprising a plunger device (8+7) and an applicator housing body (2) wherein the initial-position locking device (fig 1, locking between surface 9 and projection 12) is configured such that the switching thereof between the locking position and the functional position takes place by twisting of the plunger device relative to the applicator housing body about a plunger longitudinal axis (figs 3-4 and col 3, lines 39-68 and col 4, lines 1-28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the twisting the protective cap relative to the applicator housing body to be aligned the initial-position locking device to switch between the locking position and the functional position takes place by twisting of the plunger device relative to the applicator housing body about a plunger longitudinal axis as taught by Federick. This modification would provide the benefit of having an alternative for unlocking the initial locking position by twisting the plunger device to break the linking between housing and plunger (col 4, lines 21-28).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Painchaud et al (US 20090182267 A1) in view of Schmalz (US 20120123324 A1).
Regarding claim 10, Painchaud et al disclose the limitations of claims 1 and 9 as discussed above but fail to teach the application apparatus is configured such that the plunger ejection end in the protective position of the needle guard body lies at a defined deposition distance in front of an anterior face side of the needle guard body.
However, Schmalz discloses a device (1) for injecting a solid (600) comprising a plunger injection end (end of rod 400) and an needle guard (200) wherein the application apparatus (1) is configured such that the plunger ejection end in the protective position of the needle guard body (fig 3) lies at a defined deposition distance in front of an anterior face side of the needle guard body (fig 3, needle 122 is in protective position by guard 200 after implant 600 is implanted).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the plunger ejection end in the protective position of the needle guard body lies at a defined deposition distance in front of an anterior face side of the needle guard body as taught by Schmalz. This would benefit the of allowing an user to insert the needle to the desired depth in the body, such that the implant comes to lie at the desired location and after the needle is driven back in protective position, the plunger ejection end, however, remains in place outside said guard, such that the implant can be maintained in the desired location (para 0018).
Regarding claim 11, Painchaud et al in view of Schmalz disclose the application apparatus according to Claim 10 but fail to teach that the deposition distance is at least 4.0 mm, preferably at least 4.5 mm.
Schmalz discloses a deposition distance (fig 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the deposition distance of Schmalz to have the deposition distance is at least 4.0 mm, preferably at least 4.5 mm 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 deposition distance of Schmalz would not operate differently with the claimed dimension and since the plunger ejection end in the protective position of the needle guard body lies at a defined deposition distance in front of an anterior face side of the needle guard body, the device would function appropriately having the claimed dimension. Further, applicant places no criticality on the dimension claimed, indicating simply that the deposition distance is preferably at least 4.0 mm, particularly preferably at least 4.5 mm. (specification (page 6, lines 22-25).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 09/03/2026
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